[Federal Register Volume 67, Number 183 (Friday, September 20, 2002)]
[Rules and Regulations]
[Pages 59169-59177]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 02-23808]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0238; FRL-7198-9]
Azoxystrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of azoxystrobin and its z-isomer in or on caneberry subgroup at 5.0
part per million (ppm); cranberry at 0.50 ppm; hop, dried cones at 20.0
ppm; pistachio at 0.50 ppm; vegetable, legume, edible podded, subgroup,
except soybean at 3.0 ppm; pea and bean, succulent shelled, subgroup,
except cowpea at 0.50 ppm; and pea and bean, dried shelled, except
soybean subgroup, except cowpea and field pea at 0.50. The
Interregional Research Project 4 (IR-4) and Syngenta Crop
Protection, Inc. requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act (FQPA) of 1996.
DATES: This regulation is effective September 20, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0238,
must be received on or before November 19, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0238 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460;
telephone number: (703) 308-9368; e-mail address:
jamerson.hoyt@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0238. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of May 1, 2002 (67 FR 21676) (FRL-6834-7)
and August 22, 2001 (66 FR 44136) (FRL- 6794-6) , EPA issued notices
pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the
FQPA (Public Law 104-170), announcing the filing of pesticide petitions
(PP 2E6356, 2E6372, 2E6375, and 2E6376) by IR-4, 681 U.S. Highway
1 South, North Brunswick, NJ 08902-3390 and 0F6218 by Syngenta
Crop Protection, Inc., 410 Swing Road, P.O. Box 18300, Greensboro, NC
27409-8300. These notices included summaries of the petitions prepared
by Syngenta Crop Protection, the registrant. There were no comments
received in response to the notices of filing.
The petitions requested that 40 CFR 180.507 be amended by
establishing tolerances for combined residues of the fungicide
azoxystrobin, methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate and the Z-isomer of azoxystrobin,
methyl(Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxyphenyl)-3-
methoxyacrylate, in or on food commodities as follows:
1. PP 2E6356 proposed a tolerance for the caneberry subgroup at 5.0
ppm.
2. PP 2E6372 proposed to increase the established tolerance for
pistachio from 0.02 ppm to 1.0 ppm. The petition was subsequently
revised to propose a tolerance for pistachio at 0.50 ppm.
3. PP 2E6376 proposed a tolerance for cranberry at 0.50 ppm.
4. PP 0F6218 proposed tolerances for the vegetable, legume, group
at 3.0 ppm; hop, dried cones at 50 ppm. The petition was subsequently
revised to propose tolerances for the vegetable, legume, edible podded
subgroup, except soybean at 3.0 ppm; pea and bean, succulent shelled,
subgroup, except cowpea at 0.50 ppm; pea and bean, dried shelled,
except soybean subgroup, except cowpea and field pea at 0.50; and hop,
dried cones at 20.0 ppm.
[[Page 59170]]
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for combined residues of azoxystrobin and its
Zisomer on caneberry subgroup at 5.0 ppm; cranberry at 0.50 ppm; hop,
dried cones, at 20.0 ppm; pistachio at 0.50 ppm; vegetable, legume,
edible podded, subgroup, except soybean at 3.0 ppm; pea and bean,
succulent shelled, subgroup, except cowpea at 0.50 ppm; pea and bean,
dried shelled, except soybean subgroup, except cowpea and field pea at
0.50. EPA's assessment of exposures and risks associated with
establishing the tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by azoxystrobin is
discussed in Unit III.A. of the Federal Register of September 29, 2000
(65 FR 58404) (FRL-6749-1).
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology Q* is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-\6\ or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for azoxystrobin used for human risk assessment is shown in
the following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for Azoxystrobin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (general population NOAEL = <200 mg/kg/day FQPA SF = 1X Acute Neurotoxicity -
including infants and children) UF = 300............... aPAD = acute RfD/FQPA Rat
Acute RfD = 0.7 mg/kg/ SF. LOAEL = 200 mg/kg based
day. = 0.67 mg/kg/day....... on diarrhea at 2 hours
post dose at all dose
levels up to and
including the LOAEL
----------------------------------------------------------------------------------------------------------------
[[Page 59171]]
Chronic dietary (all populations) NOAEL= 18 mg//kg/day FQPA SF = 1X Combined Chronic
UF = 100............... cPAD = chronic RfD/FQPA Toxicity/
Chronic RfD = 0.18 mg/ SF. Carcinogenicity
kg/day. = 0.18 mg/kg/day....... Feeding study - Rat
LOAEL in males/females
= 34/117 mg/kg/day
based on reduced body
weights in both sexes
and bile duct lesions
in males
----------------------------------------------------------------------------------------------------------------
Short-term (1-7 days) Incidental Oral NOAEL= 25 mg//kg/day FQPA SF = 1X Prenatal Developmental
(Residential) UF = 100............... Oral Toxicity - Rat
LOAEL = 100 mg/kg/day
based on increased
maternal diarrhea,
urinary incontinence,
and salivation
----------------------------------------------------------------------------------------------------------------
Intermediate-term (1 week to several NOAEL= 21 mg//kg/day FQPA SF = 1X 90-Day Feeding - Rat
months) incidental oral UF = 100............... LOAEL = 211/223 mg/kg/
(Residential)........................ day in males/females
based on decreased
body weight gain in
both sexes and
clinical signs
indicative of reduced
nutrition
----------------------------------------------------------------------------------------------------------------
Short-term, intermediate-term, and None No dermal or systemic 21-Day Repeated Dose
long-term dermal (Residential) toxicity was seen at Dermal - Rat
the limit dose (1,000
mg/kg/day). This risk
assessment was not
performed.
----------------------------------------------------------------------------------------------------------------
Short-term (1-7 days) inhalation Oral NOAEL= 25 mg/kg/ LOC for MOE = 100 Prenatal Developmental
(Residential) day (Residential).......... Oral Toxicity - Rat
Use route-to-route LOAEL = 100 mg/kg/day
extrapolation based on increased
(inhalation absorption maternal diarrhea,
rate = 100%).. urinary incontinence,
and salivation
----------------------------------------------------------------------------------------------------------------
Intermediate-term (1 week to several Oral NOAEL= 21 mg/kg/ LOC for MOE = 100 90-Day Feeding - Rat
months) inhalation day (Residential).......... LOAEL = 211/223 mg/kg/
(Residential)........................ Use route-to-route day in males/females
extrapolation based on decreased
(inhalation absorption body weight gain in
rate = 100%).. both sexes and
clinical signs
indicative of reduced
nutrition
----------------------------------------------------------------------------------------------------------------
Long-term (greater than 180 days) NOAEL = N/A This risk assessment is
inhalation not applicable to the
use scenario for
azoxystrobin
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.507) for the combined residues of azoxystrobin
and its Zisomer, in or on a variety of raw agricultural commodities at
levels ranging from 0.01 ppm (pecans) to 55 ppm (soybean hay), and on
meat, fat, and meat byproducts of cattle, goats, hogs, horses, and
sheep at levels ranging from 0.01 to 0.07 ppm, and on milk at 0.006
ppm. Time-limited tolerances (set to expire on December 31, 2003) are
established at 30 ppm for the Brassica, head and stem subgroup; at 0.5
ppm for chick pea, seed; at 3.0 ppm for lychee; and at 2.0 ppm for
pepper. Risk assessments were conducted by EPA to assess dietary
exposures from azoxystrobin in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1 day or
single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the acute
exposure assessments: 100% of the crops with azoxystrobin tolerances
(established and recommended) are treated and that all commodities
contain tolerance level residues when consumed (with the exception of
those with processing factors). DEEM\TM\ default processing/
concentration factors were used for all processed commodities.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment, the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1989-1992 nationwide CSFII and accumulated exposure to the
chemical for each commodity. The following assumptions were made for
the chronic exposure assessments: 100% of the crops with azoxystrobin
tolerances (established and recommended) are treated and that all
commodities contain
[[Page 59172]]
tolerance level residues when consumed (with the exception of those
with processing factors). DEEM\TM\ default processing/concentration
factors were used for all processed commodities.
iii. Cancer. Azoxystrobin was classified by the Agency as not
likely to be a human carcinogen. Therefore, a cancer dietary exposure
analysis was not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for azoxystrobin in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of azoxystrobin.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The SCI-GROW model is used to predict pesticide
concentrations in shallow ground water. For a screening-level
assessment for surface water, EPA will use FIRST (a tier 1 model)
before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset
of the PRZM/EXAMS model that uses a specific high-end runoff scenario
for pesticides. While both FIRST and PRZM/EXAMS incorporate an index
reservoir environment, the PRZM/EXAMS model includes a percent crop
area factor as an adjustment to account for the maximum percent crop
coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
highly unlikely that drinking water concentrations would exceed human
health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to azoxystrobin, they are
further discussed in the aggregate risk sections.
Although moderately persistent in soils and stable to hydrolysis,
the likelihood of azoxystrobin moving into ground water and surface
water is low due to high soil/water partitioning coefficients and low
single application rates. Three major degradates were detected and
found to have greater potential to move through soil than the parent
compound.
Based on the FIRST model, the estimated environmental
concentrations (EECs) of azoxystrobin for acute and chronic exposures
are estimated to be 170 parts per billion (ppb), and 33 ppb for surface
water, respectively. Based on the SCI-GROW model the EECs of
azoxystrobin for both acute and chronic exposures are estimated to be
3.1 ppb for ground water. These values were based on the highest use
rate (turf use). These values represent upper-bound estimates of the
concentrations that might be found in surface water and ground water
which result from the use of azoxystrobin on turf.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Azoxystrobin is currently registered for use on the following
residential non-dietary sites: turf and ornamentals. The risk
assessment was conducted using the following residential exposure
assumptions: Products containing azoxystrobin are registered for
application to turf and ornamentals. They may be applied to turf at
rates up to 0.95 lb active ingredient (ai) per acre (not to exceed 5 lb
ai/acre/yr) and to ornamentals at rates up to 0.75 lb/ai/per acre every
7 to 14 days, but not to exceed 5 lb ai/acre/yr. The currently
registered labels do not prohibit homeowners from mixing/loading/
applying either the flowable concentrate or the water-dispersible
granule formulations. This residential exposure and risk assessment was
conducted using the application rate for turf because it is the highest
single use rate.
Residential handlers may receive short-term dermal and inhalation
exposure to azoxystrobin when mixing, loading, and applying the
formulations. Adults and children may be exposed to azoxystrobin
residues from dermal contact with foliage during post-application
activities. Toddlers may receive short- and intermediate-term oral
exposure from incidental ingestion during post-application activities.
As no dermal endpoint was selected by the Agency, a dermal exposure
and risk assessment was not conducted for residential handlers or post-
application activities.
Therefore, only the following exposure scenarios resulting from
lawn treatment were assessed: (1) Toddlers' incidental ingestion of
pesticide residues on lawns from hand-to-mouth transfer, (2) object-to-
mouth transfer from mouthing of pesticide-treated turfgrass, and (3)
incidental ingestion of soil from pesticide-treated residential areas,
(4) short-term inhalation for residential handlers. Post-application
exposures from various activities following lawn treatment are
considered to be the most common and significant in residential
settings. The exposure via incidental ingestion of other plant material
may occur but is considered negligible.
The exposure and risk estimates for the post-application
residential exposure scenarios are assessed for the day of application
(day 0) because it is assumed that toddlers could contact the lawn
immediately after application. Both short-term and intermediate-term
exposure are expected. Risk from short-term and intermediate-term
incidental ingestion by toddlers is assessed by comparing these
exposures to the NOAELs of 25 milligrams/kilogram/day (mg/kg/day) and
21 mg/kg/day, respectively. Short-term adult handler risk is assessed
by comparing exposure to the short-term inhalation NOAEL of 25 mg/kg/
day.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether azoxystrobin has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
azoxystrobin does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that azoxystrobin has a
[[Page 59173]]
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62
FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. The developmental and
reproductive toxicity data, from a prenatal development study in rats,
a prenatal development study in rabbits, and a two-generation
reproductive toxicity study in rats, did not indicate increased
susceptibility of young rats or rabbits to in utero and/or postnatal
exposure.
3. Conclusion. There is a complete toxicity data base for
azoxystrobin and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X safety factor to protect infants and children should be
removed. The FQPA factor is removed because: (1) The toxicology data
base is complete; (2) the developmental and reproductive toxicity data
did not indicate increased susceptibility of rats or rabbits to in
utero and/or postnatal exposure; (3) unrefined chronic dietary exposure
estimates (assuming all commodities contain tolerance level residues)
will overestimate dietary exposure; (4) modeling data are used for
ground and surface source drinking water exposure assessments resulting
in estimates considered to be upper-bound concentrations.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
azoxystrobin will occupy 12% of the aPAD for the U.S. population, 12%
of the aPAD for females (13-50 years old), 21% of the aPAD for children
(1-6 years old), and 12% of the aPAD for seniors (55+ years). In
addition, there is potential for acute dietary exposure to azoxystrobin
in drinking water. After calculating DWLOCs and comparing them to the
EECs for surface water and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 2:
Table 2.--Aggregate Risk Assessment for Acute Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.7 12 170 3.1 21,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.7 21 170 3.1 5,300
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 0.7 12 170 3.1 18,000
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years) 0.7 12 170 3.1 21,000
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
azoxystrobin from food will utilize 13% of the cPAD for the U.S.
population, 21% of the cPAD for children (1-6 years old), 12% of the
cPAD for females (13-50 years old), and 14% of the cPAD for seniors
(55+ years old). Based on the use pattern, chronic residential exposure
to residues of azoxystrobin is not expected. In addition, there is
potential for chronic dietary exposure to azoxystrobin in drinking
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the cPAD, as shown in the following Table 3:
[[Page 59174]]
Table 3.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.18 13 33 3.1 5,500
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.18 21 33 3.1 1,400
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 0.18 12 33 3.1 4,800
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years) 0.18 14 33 3.1 5,400
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). The short-term
aggregate risk assessment estimates risks likely to result from 1- to
30-day exposure to azoxystrobin residues from food, drinking water, and
residential pesticide uses. High-end estimates of residential exposure
are used in the short-term assessment, while average values are used
for food and drinking water exposure.
A short-term risk assessment is required for adults because there
is a residential handler inhalation exposure scenario. In addition, a
short-term risk assessment is required for infants and children because
there is a residential post-application oral exposure scenario. As no
short-term dermal endpoint was established, there is no dermal
component to this aggregate risk assessment.
Azoxystrobin is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for azoxystrobin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 1,100 for adults and 450 for
children (1-6 years old). These aggregate MOEs do not exceed the
Agency's level of concern for aggregate exposure to food and
residential uses. In addition, short-term DWLOCs were calculated and
compared to the EECs for chronic exposure of azoxystrobin in ground
water and surface water. After calculating DWLOCs and comparing them to
the EECs for surface water and ground water, EPA does not expect short-
term aggregate exposure to exceed the Agency's level of concern, as
shown in the following Table 4:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 1,100 100 33 3.1 6,800
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 450 100 33 3.1 1,900
----------------------------------------------------------------------------------------------------------------
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). The
intermediate-term aggregate risk assessment estimates risks likely to
result from 1-6 months of exposure to azoxystrobin residues from food,
drinking water, and residential pesticide uses. High-end estimates of
residential exposure are used in the intermediate-term assessment,
while average values are used for food and drinking water exposure.
An intermediate-term risk assessment is not required for adults
because residential handler scenarios are not expected to occur for
longer than a short-term timeframe. However, an intermediate-term risk
assessment is required for infants and children because there is a
residential post-application oral exposure scenario. As no dermal
endpoint was established, there is no dermal component to this
aggregate risk assessment.
Azoxystrobin is currently registered for use(s) that could result
in intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for azoxystrobin.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 440 for
children 1-6 years old. These aggregate MOEs do not exceed the Agency's
level of concern for aggregate exposure to food and residential uses.
In addition, intermediate-term DWLOCs were calculated and compared to
the EECs for chronic exposure of azoxystrobin in ground water and
surface water. After calculating DWLOCs and comparing them to the EECs
for surface water and ground water, EPA does not expect intermediate-
term aggregate exposure to exceed the Agency's level of concern, as
shown in the following Table 5:
[[Page 59175]]
Table 5.-- Aggregate Risk Assessment for Intermediate-Term Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Intermediate-
Population Subgroup MOE (Food + Concern Water EEC Water EEC Term DWLOC
Residential) (LOC) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 440 100 33 3.1 1,600
----------------------------------------------------------------------------------------------------------------
5. Aggregate cancer risk for U.S. population. Azoxystrobin was
classified by EPA as not likely to be a human carcinogen. The Agency
concludes that pesticides uses of azoxystrobin are not likely to pose a
carcinogenic hazard to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to azoxystrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate methodology is available for enforcement of the proposed
tolerances for azoxystrobin and its z-isomer on plants. An enforcement
method for azoxystrobin in livestock commodities has been validated by
the EPA analytical laboratory for the analysis of milk and livestock
tissues.
The method may be requested from: Paul Golden, US EPA/OPP/BEAD/ACB,
Environmental Science Center, 701 Mapes Road, Fort Meade, MD 20755-
5350; telephone number: (410) 305-2960; Fax: (410) 305-3091; e-mail
address: RAM Mailbox.
B. International Residue Limits
No Codex, Canadian, or Mexican maximum residue limits (MRLs) have
been established for residues of azoxystrobin on caneberries,
cranberries, pistachios, hops, or legumes.
V. Conclusion
Therefore, the tolerances are established for combined residues of
azoxystrobin, methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate and the z-isomer of azoxystrobin,
methyl(Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxyphenyl)-3-
methoxyacrylate, in or on caneberry subgroup at 5.0 ppm; cranberry at
0.50 ppm; hop, dried cones at 20.0 ppm; pistachio at 0.5 ppm;
vegetable, legume, edible podded, subgroup, except soybean at 3.0 ppm;
pea and bean, succulent shelled, subgroup, except cowpea at 0.50 ppm;
and pea and bean, dried shelled, except soybean subgroup, except cowpea
and field pea at 0.50.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2002-0238 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
19, 2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at 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 Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy
[[Page 59176]]
of your request to the PIRIB for its inclusion in the official record
that is described in Unit I.B.2. Mail your copies, identified by docket
ID number OPP-2002-0238, to: Public Information and Records Integrity
Branch, Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460. In person or by courier, bring a copy
to the location of the PIRIB described in Unit I.B.2. You may also send
an electronic copy of your request via e-mail to: 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).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 13, 2002.
Richard P. Keigwin, Jr.,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 374.
2. Section 180.507 is amended by revising the entry for pistachio
and alphabetically adding the following
[[Page 59177]]
commodities to the table in paragraph (a) to read as follows:
Sec. 180.507 Azoxystrobin; tolerances for residues.
(a) General. * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Caneberry subgroup............................. 5.0
Cranberry...................................... 0.50
* * * * *
Hops, dried cones.............................. 20.0
* * * * *
Pea and bean, dried shelled, except soybean, 0.50
subgroup, except cowpea, and field pea........
Pea and bean, succulent shelled, subgroup, 0.50
except cowpea.................................
Pistachio...................................... 0.50
* * * * *
Vegetable, legume, edible podded, subgroup, 3.0
except soybean................................
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 02-23808 Filed 9-19-02; 8:45 am]
BILLING CODE 6560-50-S