Azoxystrobin; Pesticide Tolerances, 53174-53179 [E9-24813]
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53174
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Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Rules and Regulations
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SUPPLEMENTARY INFORMATION:
[FR Doc. E9–25055 Filed 10–15–09; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0076; FRL–8794–4]
Azoxystrobin; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends the
established tolerances for residues of
azoxystrobin in or on barley bran; barley
grain; and barley straw. Interregional
Research Project Number 4 (IR-4)
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective
October 16, 2009. Objections and
requests for hearings must be received
on or before December 15, 2009, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2009–0076. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7390; e-mail address:
nollen.laura@epa.gov.
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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 entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2009–0076 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
as required by 40 CFR part 178 on or
before December 15, 2009.
In addition to filing an objection or
hearing request with the Hearing Clerk
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as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2009–0076, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of April 8,
2009 (74 FR 15971) (FRL–8407–4), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 8E7474) by
Interregional Research Project Number 4
(IR-4), IR-4 Project Headquarters, 500
College Rd. East, Suite 201 W.,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.507 be
amended by increasing established
tolerances for residues of the fungicide
azoxystrobin, [methyl( E )-2-(2-(6-(2cyanophenoxy) pyrimidin-4yloxy)phenyl)-3-methoxyacrylate] and
the Z-isomer of azoxystrobin, [methyl( Z
)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4yloxy)phenyl)-3 methoxyacrylate], in or
on barley, grain from 0.1 parts per
million (ppm) to 3.0 ppm and barley,
straw from 4.0 ppm to 7.0 ppm. That
notice referenced a summary of the
petition prepared on behalf of IR-4 by
Syngenta Crop Protection, Inc., the
registrant, which is available to the
public in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Based upon review of the data
supporting these petitions, EPA has
determined that the currently
established tolerance in or on barley
bran should also be increased and has
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determined that the tolerance
expression should be revised. The
reasons for these changes are explained
in Unit IV.C.
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III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of 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) of FFDCA
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) of FFDCA 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....’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, 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 for the petitioned-for
tolerances for residues of azoxystrobin
on barley bran at 6.0 ppm; barley grain
at 3.0 ppm; and barley straw at 7.0 ppm.
EPA’s assessment of exposures and risks
associated with establishing 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.
Azoxystrobin has a low acute toxicity
via the oral, dermal and inhalation
routes of exposure. It is not an eye or
skin irritant and is not a skin sensitizer.
Dietary administration of azoxystrobin
to rats resulted in decreased body
weights, decreased food intake and
utilization, increased diarrhea and other
clinical toxicity observations (increased
urinary incontinence, hunched postures
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and distended abdomens). In dogs,
effects on liver/biliary function were
found after oral administration. In the
acute neurotoxicity study in rats,
increased incidence of diarrhea was
observed at all dose levels tested
including the lowest-observed-adverseeffect-level (LOAEL). Decreased body
weight/weight gain and food utilization
was noted in the rat subchronic
neurotoxicity study. There were no
consistent indications of treatmentrelated neurotoxicity in either the acute
or subchronic neurotoxicity studies.
In the rat developmental toxicity
study, diarrhea, urinary incontinence
and salivation were observed in
maternal animals; in the rabbit
developmental toxicity study, maternal
animals exhibited decreased body
weight gain. No adverse treatmentrelated developmental effects were seen
in either study. In the rat reproduction
study, offspring and parental effects
(decreased body weights and increased
adjusted liver weights) were observed at
the same dose.
There was no evidence of
carcinogenicity in rats and mice at
acceptable dose levels. As a result, EPA
has classified azoxystrobin as ‘‘not
likely to be carcinogenic to humans.’’
Azoxystrobin induced a weak
mutagenic response in the mouse
lymphoma assay, but the activity
expressed in vitro is not expected to be
expressed in whole animals.
Specific information on the studies
received and the nature of the adverse
effects caused by azoxystrobin as well as
the no-observed-adverse-effect-level
(NOAEL) and the LOAEL from the
toxicity studies can be found at https://
www.regulations.gov in document
‘‘Azoxystrobin. Human Health Risk
Assessment for a Section 3 Amendment
to Reduce the Preharvest Interval for
Barley Grain and Straw and to Add Seed
Treatment Uses on Head and Stem
Brassica Vegetables (Subgroup 5A) and
Sorghum, Grain.’’, pages 48–51 in
docket ID number EPA–HQ–OPP–2009–
0076.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
effects are observed (the NOAEL) in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a Benchmark Dose
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(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction
with the POD to take into account
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. Safety is assessed for acute
and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-term, intermediate-term,
and chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the Level of Concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for azoxystrobin used for
human risk assessment can be found at
https://www.regulations.gov in document
‘‘Azoxystrobin. Human Health Risk
Assessment for a Section 3 Amendment
to Reduce the Preharvest Interval for
Barley Grain and Straw and to Add Seed
Treatment Uses on Head and Stem
Brassica Vegetables (Subgroup 5A) and
Sorghum, Grain.’’, pages 19–20 in
docket ID number EPA–HQ–OPP–2009–
0076.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to azoxystrobin, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing azoxystrobin tolerances in 40
CFR 180.507. EPA assessed dietary
exposures from azoxystrobin in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and 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.
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In estimating acute dietary exposure,
EPA used food consumption
information from the United States
Department of Agriculture (USDA)
1994–1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels
in food, EPA used tolerance-level
residues and assumed 100 percent crop
treated (PCT).
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
CSFII. As to residue levels in food, EPA
used tolerance-level residues,
incorporated PCT data for some existing
uses and assumed 100 PCT for the
remaining crops including barley.
iii. Cancer. Based on the absence of
carcinogenicity in two adequate rodent
carcinogenicity studies, EPA has
classified azoxystrobin as ‘‘not likely to
be carcinogenic to humans;’’ therefore, a
quantitative exposure assessment to
evaluate cancer risk is unnecessary.
iv. Percent crop treated (PCT)
information. Section 408(b)(2)(F) of
FFDCA states that the Agency may use
data on the actual percent of food
treated for assessing chronic dietary risk
only if:
• Condition a: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
• Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition c: Data are available on
pesticide use and food consumption in
a particular area, the exposure estimate
does not understate exposure for the
population in such area.
In addition, the Agency must provide
for periodic evaluation of any estimates
used. To provide for the periodic
evaluation of the estimate of PCT as
required by FFDCA section 408(b)(2)(F),
EPA may require registrants to submit
data on PCT.
The Agency used PCT information as
follows:
Almonds, 25%; apricot, 15%;
artichoke, 25%; asparagus, 2.5%;
blackberries, 5%; blueberries, 10%;
broccoli, 5%; cabbage, 5%; cantaloupes,
10%; carrot, 10%; cauliflower, 2.5%;
celery, 10%; cherry, 5%; cottonseed,
5%; cucumber, 15%; dried beans/peas,
1%; field corn, 2.5%; filbert (hazelnut),
5%; garlic, 60%; grape, 5%; grapefruit,
25%; green beans, 5% lettuce, 2.5%;
mustard greens, 15%; onion, 10%;
orange, 5%; green peas, 2.5%; peach,
5%; peanut, 15%; pecan, 2.5%; pepper,
15%; pistachio, 20%; potato, 30%;
pumpkin, 20%; raspberry, 5%; rice,
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35%; soybean, 2.5%; spinach, 10%;
squash, 15%; strawberry, 30%; sugar
beets, 5%; sweet corn, 10%; tangerine,
20%; tomato, 15%; walnut, 1%;
watermelon, 20%; and wheat, 2.5%.
In most cases, EPA uses available data
from USDA/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and the
National Pesticide Use Database for the
chemical/crop combination for the most
recent 6 years. EPA uses an average PCT
for chronic dietary risk analysis. The
average PCT figure for each existing use
is derived by combining available
public and private market survey data
for that use, averaging across all
observations, and rounding to the
nearest 5%, except for those situations
in which the average PCT is less than
one. In those cases, 1% is used as the
average PCT and 2.5% is used as the
maximum PCT. EPA uses a maximum
PCT for acute dietary risk analysis. The
maximum PCT figure is the highest
observed maximum value reported
within the recent 6 years of available
public and private market survey data
for the existing use and rounded up to
the nearest multiple of 5%.
The Agency believes that the three
conditions discussed in Unit III.C.1.iv.
have been met. With respect to
Condition a, PCT estimates are derived
from Federal and private market survey
data, which are reliable and have a valid
basis. The Agency is reasonably certain
that the percentage of the food treated
is not likely to be an underestimation.
As to Conditions b and c, regional
consumption information and
consumption information for significant
subpopulations is taken into account
through EPA’s computer-based model
for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available reliable information on
the regional consumption of food to
which azoxystrobin may be applied in
a particular area.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for azoxystrobin in drinking water.
These simulation models take into
account data on the physical, chemical,
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and fate/transport characteristics of
azoxystrobin. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the First Index Reservoir
Screening Tool (FIRST) and Screening
Concentration in Ground Water (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
azoxystrobin for surface water are
estimated to be 173 parts per billion
(ppb) for acute exposures and 33 ppb for
chronic exposures. For ground water,
the estimated drinking water
concentration is 3.1 ppb.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 173 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 33 ppb was used to assess the
contribution to drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, 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 the following uses that could result
in residential exposures: Turf grass,
ornamentals, indoor surfaces, and
treated paints (preservative
incorporation). EPA assessed residential
exposure using the following
assumptions: Adults were assessed for
short-term inhalation exposures when
mixing, loading and applying
azoxystrobin. For short-term and
intermediate-term postapplication
exposures, toddlers and children were
assessed for incidental oral exposure
(hand-to-mouth exposure, object-tomouth exposure and exposure through
incidental ingestion of soil) from contact
with treated foliage and surfaces. Adults
were not assessed for intermediate-term
risk, as intermediate-term residential
handler scenarios are not expected to
occur. A dermal exposure assessment
was not conducted for residential
handlers or for postapplication activities
because no dermal endpoint was
identified.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
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
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substances that have a common
mechanism of toxicity.’’
EPA has not found azoxystrobin to
share a common mechanism of toxicity
with any other substances, and
azoxystrobin does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that azoxystrobin does not
have 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 EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) 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 database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA SF. In applying this provision,
EPA either retains the default value of
10X, or uses a different additional safety
factor when reliable data available to
EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity.
The prenatal and postnatal toxicity
database for azoxystrobin is complete
and includes prenatal developmental
toxicity studies in rats and rabbits and
a 2–generation reproduction study in
rats. In these studies, offspring toxicity
was observed at equivalent or higher
doses than those resulting in parental
toxicity; thus, there is no evidence of
increased susceptibility and there are no
residual uncertainties with regard to
prenatal and/or postnatal toxicity.
3. Conclusion. EPA has reduced the
FQPA SF to 3X in assessing acute
dietary risk. An additional safety factor
is needed for acute risk assessment to
account for the use of a LOAEL from the
acute neurotoxicity study in rats in
deriving the acute reference dose used
for assessing acute dietary exposure for
all populations including infants and
children. EPA has determined that
reliable data show that it would be safe
for infants and children to reduce the
FQPA safety factor to 1X. To account for
the use of a LOAEL from the acute
neurotoxicity study in rats the Agency
believes that a 3X FQPA SF (as opposed
to a 10X) will be adequate to extrapolate
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a NOAEL in assessing acute risk and
that no additional safety factor is
needed for short-term, intermediateterm, and chronic risk assessment based
on the following considerations:
i. The concern is low for the use of a
LOAEL to extrapolate a NOAEL, given
the relatively insignificant nature of the
effect (transient diarrhea seen in the rat);
the fact that diarrhea was only seen in
studies involving gavage dosing in the
rat but not in repeat dosing through
dietary administration in rats, mice,
rabbits, and dogs; the very high dose
level needed to reach the acute oral
lethal dose (LD)50 (>5000 milligrams/
kilogram (mg/kg)), and the overall low
toxicity of azoxystrobin. NOAELs were
used for short-term, intermediate-term,
and chronic risk assessments.
ii. The toxicity database for
azoxystrobin is complete except for
immunotoxicity testing. Recent changes
to 40 CFR part 158 make
immunotoxicity testing (OPPTS
Guideline 870.7800) required for
pesticide registration; however, the
existing data are sufficient for endpoint
selection for exposure/risk assessment
scenarios, and for evaluation of the
requirements under the FQPA. There
are no indications in the available
studies that organs associated with
immune function, such as the thymus
and spleen, are affected by azoxystrobin
and azoxystrobin does not belong to a
class of chemicals (e.g., the organotins,
heavy metals, or halogenated aromatic
hydrocarbons) that would be expected
to be immunotoxic. Based on the above
considerations in this unit, EPA does
not believe that conducting the
immunotoxicity study will result in a
dose less than the point of departure
already used in this risk assessment,
and an additional database uncertainty
factor for potential immunotoxicity does
not need to be applied.
iii. Clinical signs noted in the acute
and subchronic neurotoxicity studies
were not considered treatment related
because of a lack of dose-response,
inconsistency of observations at
different time points, variability of
pretreatment values and/or small
magnitude of response. There is no need
for a developmental neurotoxicity study
or additional UFs to account for
neurotoxicity.
iv. There is no evidence that
azoxystrobin results in increased
susceptibility to in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2–generation
reproduction study.
v. The acute and chronic dietary
exposure assessments were performed
based on tolerance-level residues. The
acute dietary assessment incorporated
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53177
100 PCT information, and the chronic
dietary exposure assessment was
somewhat refined using PCT
information for selected crops. EPA
made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to azoxystrobin in drinking water. EPA
used similarly conservative assumptions
to assess postapplication exposure of
children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by azoxystrobin.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases given the
estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing
the estimated aggregate food, water, and
residential exposure to the POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute dietary
consumption of food and drinking
water. Using the exposure assumptions
discussed in this unit for acute
exposure, the acute dietary exposure
from food and water to azoxystrobin
will occupy 70% of the aPAD for
children 1–2 years old, the population
group receiving the greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to azoxystrobin
from food and water will utilize 9.6% of
the cPAD for children 1–2 years old, the
population group receiving the greatest
exposure. Based on the explanation in
Unit III.C.3., regarding residential use
patterns, chronic residential exposure to
residues of azoxystrobin is not expected.
3. Short-term and intermediate-term
risk. Short-term and intermediate-term
aggregate exposure takes into account
short-term and intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Azoxystrobin is currently registered for
uses that could result in short-term and
intermediate-term residential exposure
and the Agency has determined that it
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is appropriate to aggregate chronic
exposure through food and water with
short-term and intermediate-term
residential exposures to azoxystrobin.
Using the exposure assumptions
described in this unit for short-term and
intermediate-term exposures, EPA has
concluded the combined short-term
food, water, and residential exposures
result in an aggregate MOE of 240 for
children 1–2 years old (the population
group receiving the greatest exposure),
and has concluded the combined
intermediate-term food, water, and
residential exposures result in an
aggregate MOE of 340 for children 1–2
years old (the population group
receiving the greatest intermediate-term
exposure). As the aggregate MOEs for
short-term and intermediate-term
exposure are greater than 100 (the LOC)
for all population subgroups assessed,
short-term and intermediate-term
aggregate exposures to azoxystrobin are
not of concern to EPA.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in mice and
rats in two adequate carcinogenicity
studies, azoxystrobin was classified as
‘‘not likely to be carcinogenic to
humans,’’ and is not expected to pose a
cancer risk to humans.
5. 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, or to infants and children
from aggregate exposure to azoxystrobin
residues.
IV. Other Considerations
CPrice-Sewell on DSKDVH8Z91PROD with RULES
A. Analytical Enforcement Methodology
Adequate enforcement methodologies
are available to enforce the tolerance
expression and have been submitted to
FDA for inclusion in the Pesticide
Analytical Manual (PAM) Volume II: A
gas chromatography method with
nitrogen-phosphorus detection (GC/
NPD), RAM 243/04, for the enforcement
of tolerances for residues of
azoxystrobin and its Z-isomer in crop
commodities; and a GC/NPD method,
RAM 255/01, for the enforcement of
tolerances of azoxystrobin in livestock
commodities. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
Codex Maximum Residue Limits
(MRLs) have been established for
azoxystrobin in or on barley grain at 0.5
VerDate Nov<24>2008
15:49 Oct 15, 2009
Jkt 220001
ppm; and straw and fodder of cereal
grains (except maize) at 15 ppm. The
Codex MRLs for barley grain and straw
are based on field trials conducted in
Europe and on residues present at a 35–
42 day pre-harvest interval (PHI). The
recommended U.S. tolerances on barley
grain (3.0 ppm) and straw (7.0 ppm) are
based on residues present at a 14–day
PHI. The U.S. tolerance for barley grain
is higher due to the shorter PHI; thus,
the barley grain tolerance and MRLs
cannot be harmonized between the U.S.
and Codex. Codex MRLs for forages,
straws and the like are set on a dryweight basis, whereas U.S. tolerances
are set on an as-fed basis; therefore, the
U.S. tolerance on barley straw cannot be
harmonized with the Codex MRL for
straw and fodder of cereal grains
(including barley, oats, rice and wheat
data) at this time.
C. Revisions to Petitioned-For
Tolerances
Based upon review of the data
supporting the petition, EPA has revised
the existing tolerance for barley bran
from 0.2 ppm to 6.0 ppm. Based on
previously-submitted wheat processing
data, a tolerance for barley bran was
established at 0.2 ppm; however, the
proposed PHI reduction for barley grain
results in higher residues in barley grain
and the potential for increased residues
in barley bran. Using the highest average
field trial data for barley grain harvested
at the 14–day PHI (1.85 ppm) and the
concentration factor for wheat bran (3x),
expected residues in barley bran would
be 5.55 ppm. The expected barley bran
residues exceed the proposed tolerance
increase for barley grain at 3.0 ppm and
the existing tolerance for barley bran at
0.2 ppm. Therefore, the Agency is
increasing the established tolerance for
azoxystrobin in or on barley bran from
0.2 ppm to 6.0 ppm.
Additionally, EPA has revised the
tolerance expression to clarify:
1. That, as provided in FFDCA section
408(a)(3), the tolerance covers
metabolites and degradates of
azoxystrobin not specifically
mentioned; and
2. That compliance with the specified
tolerance levels is to be determined by
measuring only the specific compounds
mentioned in the tolerance expression.
This change was made to both the
tolerance expressions for plant
commodities and animal commodities
because it makes no substantive change
to the meaning of the tolerance but
rather only clarifies the existing
language.
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V. Conclusion
Therefore, established tolerances are
amended for residues of azoxystrobin,
[methyl( E )-2-(2-(6-(2-cyanophenoxy)
pyrimidin-4-yloxy)phenyl)-3methoxyacrylate] and the Z-isomer of
azoxystrobin, [methyl( Z )-2-(2-(6-(2cyanophenoxy)pyrimidin-4yloxy)phenyl)-3 methoxyacrylate], in or
on barley, bran at 6.0 ppm; barley, grain
at 3.0 ppm; and barley, straw at 7.0
ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA 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 final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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., 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).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, 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.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
E:\FR\FM\16OCR1.SGM
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Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Rules and Regulations
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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: October 7, 2009.
Lois Rossi,
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:
CPrice-Sewell on DSKDVH8Z91PROD with RULES
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.507 is amended in
paragraph (a)(1) by revising the
introductory text and by revising the
entries for ‘‘Barley, bran’’; ‘‘Barley,
grain’’; and ‘‘Barley, straw’’ in the table;
and in paragraph (a)(2) by revising the
introductory text to read as follows:
■
VerDate Nov<24>2008
15:49 Oct 15, 2009
Jkt 220001
§ 180.507 Azoxystrobin; tolerances for
residues.
53179
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
(a) General. (1) Tolerances are
established for residues of the fungicide, management requirements of the
program. If the Federal Emergency
azoxystrobin, including its metabolites
Management Agency (FEMA) receives
and degradates, in or on the
documentation that the community has
commodities in the following table.
adopted the required floodplain
Compliance with the tolerance levels
management measures prior to the
specified in the table is to be
effective suspension date given in this
determined by measuring only the sum
rule, the suspension will not occur and
of azoxystrobin, [methyl( E )-2-(2-(6-(2a notice of this will be provided by
cyanophenoxy) pyrimidin-4publication in the Federal Register on a
yloxy)phenyl)-3-methoxyacrylate], and
the Z-isomer of azoxystrobin [methyl( Z subsequent date.
)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4DATES: Effective Dates: The effective
yloxy)phenyl)-3 methoxyacrylate] in or
date of each community’s scheduled
on the commodity.
suspension is the third date (‘‘Susp.’’)
listed in the third column of the
Commodity
Parts per million
following tables.
FOR FURTHER INFORMATION CONTACT: If
*
*
*
*
*
Barley, bran ....................
6.0 you want to determine whether a
particular community was suspended
*
*
*
*
*
Barley, grain ...................
3.0 on the suspension date or for further
information, contact David Stearrett,
*
*
*
*
*
Barley, straw ...................
7.0 Mitigation Directorate, Federal
*
*
*
*
*
Emergency Management Agency, 500 C
Street, SW., Washington, DC 20472,
(2) Tolerances are established for
(202) 646–2953.
residues of the fungicide, azoxystrobin,
SUPPLEMENTARY INFORMATION: The NFIP
including its metabolites and
enables property owners to purchase
degradates, in or on the commodities in flood insurance which is generally not
the following table. Compliance with
otherwise available. In return,
the tolerance levels specified in the
communities agree to adopt and
table is to be determined by measuring
administer local floodplain management
only the sum of azoxystrobin, [methyl(
aimed at protecting lives and new
E )-2-(2-(6-(2-cyanophenoxy) pyrimidin- construction from future flooding.
4-yloxy)phenyl)-3-methoxyacrylate],
Section 1315 of the National Flood
and the Z-isomer of azoxystrobin
Insurance Act of 1968, as amended, 42
[methyl( Z )-2-(2-(6-(2U.S.C. 4022, prohibits flood insurance
cyanophenoxy)pyrimidin-4coverage as authorized under the NFIP,
yloxy)phenyl)-3 methoxyacrylate] in or
42 U.S.C. 4001 et seq.; unless an
on the commodity.
appropriate public body adopts
*
*
*
*
*
adequate floodplain management
measures with effective enforcement
[FR Doc. E9–24813 Filed 10–15–09; 8:45 am]
measures. The communities listed in
BILLING CODE 6560–50–S
this document no longer meet that
statutory requirement for compliance
with program regulations, 44 CFR part
DEPARTMENT OF HOMELAND
59. Accordingly, the communities will
SECURITY
be suspended on the effective date in
the third column. As of that date, flood
Federal Emergency Management
insurance will no longer be available in
Agency
the community. However, some of these
communities may adopt and submit the
44 CFR Part 64
required documentation of legally
[Docket ID FEMA–2008–0020; Internal
enforceable floodplain management
Agency Docket No. FEMA–8099]
measures after this rule is published but
prior to the actual suspension date.
Suspension of Community Eligibility
These communities will not be
AGENCY: Federal Emergency
suspended and will continue their
Management Agency, DHS.
eligibility for the sale of insurance. A
notice withdrawing the suspension of
ACTION: Final rule.
the communities will be published in
SUMMARY: This rule identifies
the Federal Register.
communities, where the sale of flood
In addition, FEMA has identified the
insurance has been authorized under
Special Flood Hazard Areas (SFHAs) in
the National Flood Insurance Program
these communities by publishing a
(NFIP), that are scheduled for
Flood Insurance Rate Map (FIRM). The
PO 00000
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E:\FR\FM\16OCR1.SGM
16OCR1
Agencies
[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Rules and Regulations]
[Pages 53174-53179]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24813]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0076; FRL-8794-4]
Azoxystrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends the established tolerances for residues
of azoxystrobin in or on barley bran; barley grain; and barley straw.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 16, 2009. Objections and
requests for hearings must be received on or before December 15, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0076. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; e-mail address: nollen.laura@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 entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0076 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 as required by 40 CFR part 178
on or before December 15, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0076, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E7474) by Interregional Research Project Number 4 (IR-4), IR-4 Project
Headquarters, 500 College Rd. East, Suite 201 W., Princeton, NJ 08540.
The petition requested that 40 CFR 180.507 be amended by increasing
established tolerances for 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 or
on barley, grain from 0.1 parts per million (ppm) to 3.0 ppm and
barley, straw from 4.0 ppm to 7.0 ppm. That notice referenced a summary
of the petition prepared on behalf of IR-4 by Syngenta Crop Protection,
Inc., the registrant, which is available to the public in the docket,
https://www.regulations.gov. There were no comments received in response
to the notice of filing.
Based upon review of the data supporting these petitions, EPA has
determined that the currently established tolerance in or on barley
bran should also be increased and has
[[Page 53175]]
determined that the tolerance expression should be revised. The reasons
for these changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 for the petitioned-for
tolerances for residues of azoxystrobin on barley bran at 6.0 ppm;
barley grain at 3.0 ppm; and barley straw at 7.0 ppm. EPA's assessment
of exposures and risks associated with establishing 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.
Azoxystrobin has a low acute toxicity via the oral, dermal and
inhalation routes of exposure. It is not an eye or skin irritant and is
not a skin sensitizer. Dietary administration of azoxystrobin to rats
resulted in decreased body weights, decreased food intake and
utilization, increased diarrhea and other clinical toxicity
observations (increased urinary incontinence, hunched postures and
distended abdomens). In dogs, effects on liver/biliary function were
found after oral administration. In the acute neurotoxicity study in
rats, increased incidence of diarrhea was observed at all dose levels
tested including the lowest-observed-adverse-effect-level (LOAEL).
Decreased body weight/weight gain and food utilization was noted in the
rat subchronic neurotoxicity study. There were no consistent
indications of treatment-related neurotoxicity in either the acute or
subchronic neurotoxicity studies.
In the rat developmental toxicity study, diarrhea, urinary
incontinence and salivation were observed in maternal animals; in the
rabbit developmental toxicity study, maternal animals exhibited
decreased body weight gain. No adverse treatment-related developmental
effects were seen in either study. In the rat reproduction study,
offspring and parental effects (decreased body weights and increased
adjusted liver weights) were observed at the same dose.
There was no evidence of carcinogenicity in rats and mice at
acceptable dose levels. As a result, EPA has classified azoxystrobin as
``not likely to be carcinogenic to humans.'' Azoxystrobin induced a
weak mutagenic response in the mouse lymphoma assay, but the activity
expressed in vitro is not expected to be expressed in whole animals.
Specific information on the studies received and the nature of the
adverse effects caused by azoxystrobin as well as the no-observed-
adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies
can be found at https://www.regulations.gov in document ``Azoxystrobin.
Human Health Risk Assessment for a Section 3 Amendment to Reduce the
Preharvest Interval for Barley Grain and Straw and to Add Seed
Treatment Uses on Head and Stem Brassica Vegetables (Subgroup 5A) and
Sorghum, Grain.'', pages 48-51 in docket ID number EPA-HQ-OPP-2009-
0076.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-term,
intermediate-term, and chronic-term risks are evaluated by comparing
food, water, and residential exposure to the POD to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded. This latter value is referred to as the Level of
Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for azoxystrobin used for
human risk assessment can be found at https://www.regulations.gov in
document ``Azoxystrobin. Human Health Risk Assessment for a Section 3
Amendment to Reduce the Preharvest Interval for Barley Grain and Straw
and to Add Seed Treatment Uses on Head and Stem Brassica Vegetables
(Subgroup 5A) and Sorghum, Grain.'', pages 19-20 in docket ID number
EPA-HQ-OPP-2009-0076.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to azoxystrobin, EPA considered exposure under the petitioned-
for tolerances as well as all existing azoxystrobin tolerances in 40
CFR 180.507. EPA assessed dietary exposures from azoxystrobin in food
as follows:
i. Acute exposure. Quantitative acute dietary exposure and 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.
[[Page 53176]]
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA used tolerance-
level residues and assumed 100 percent crop treated (PCT).
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance-level
residues, incorporated PCT data for some existing uses and assumed 100
PCT for the remaining crops including barley.
iii. Cancer. Based on the absence of carcinogenicity in two
adequate rodent carcinogenicity studies, EPA has classified
azoxystrobin as ``not likely to be carcinogenic to humans;'' therefore,
a quantitative exposure assessment to evaluate cancer risk is
unnecessary.
iv. Percent crop treated (PCT) information. Section 408(b)(2)(F) of
FFDCA states that the Agency may use data on the actual percent of food
treated for assessing chronic dietary risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used PCT information as follows:
Almonds, 25%; apricot, 15%; artichoke, 25%; asparagus, 2.5%;
blackberries, 5%; blueberries, 10%; broccoli, 5%; cabbage, 5%;
cantaloupes, 10%; carrot, 10%; cauliflower, 2.5%; celery, 10%; cherry,
5%; cottonseed, 5%; cucumber, 15%; dried beans/peas, 1%; field corn,
2.5%; filbert (hazelnut), 5%; garlic, 60%; grape, 5%; grapefruit, 25%;
green beans, 5% lettuce, 2.5%; mustard greens, 15%; onion, 10%; orange,
5%; green peas, 2.5%; peach, 5%; peanut, 15%; pecan, 2.5%; pepper, 15%;
pistachio, 20%; potato, 30%; pumpkin, 20%; raspberry, 5%; rice, 35%;
soybean, 2.5%; spinach, 10%; squash, 15%; strawberry, 30%; sugar beets,
5%; sweet corn, 10%; tangerine, 20%; tomato, 15%; walnut, 1%;
watermelon, 20%; and wheat, 2.5%.
In most cases, EPA uses available data from USDA/National
Agricultural Statistics Service (USDA/NASS), proprietary market
surveys, and the National Pesticide Use Database for the chemical/crop
combination for the most recent 6 years. EPA uses an average PCT for
chronic dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than one. In those cases, 1% is used as the average PCT and 2.5%
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary
risk analysis. The maximum PCT figure is the highest observed maximum
value reported within the recent 6 years of available public and
private market survey data for the existing use and rounded up to the
nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which azoxystrobin may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for azoxystrobin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of azoxystrobin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of azoxystrobin for
surface water are estimated to be 173 parts per billion (ppb) for acute
exposures and 33 ppb for chronic exposures. For ground water, the
estimated drinking water concentration is 3.1 ppb.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 173 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 33 ppb was used to assess
the contribution to drinking 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 the following uses that
could result in residential exposures: Turf grass, ornamentals, indoor
surfaces, and treated paints (preservative incorporation). EPA assessed
residential exposure using the following assumptions: Adults were
assessed for short-term inhalation exposures when mixing, loading and
applying azoxystrobin. For short-term and intermediate-term
postapplication exposures, toddlers and children were assessed for
incidental oral exposure (hand-to-mouth exposure, object-to-mouth
exposure and exposure through incidental ingestion of soil) from
contact with treated foliage and surfaces. Adults were not assessed for
intermediate-term risk, as intermediate-term residential handler
scenarios are not expected to occur. A dermal exposure assessment was
not conducted for residential handlers or for postapplication
activities because no dermal endpoint was identified.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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
[[Page 53177]]
substances that have a common mechanism of toxicity.''
EPA has not found azoxystrobin to share a common mechanism of
toxicity with any other substances, and azoxystrobin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
azoxystrobin does not have 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 EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for azoxystrobin is complete and includes prenatal
developmental toxicity studies in rats and rabbits and a 2-generation
reproduction study in rats. In these studies, offspring toxicity was
observed at equivalent or higher doses than those resulting in parental
toxicity; thus, there is no evidence of increased susceptibility and
there are no residual uncertainties with regard to prenatal and/or
postnatal toxicity.
3. Conclusion. EPA has reduced the FQPA SF to 3X in assessing acute
dietary risk. An additional safety factor is needed for acute risk
assessment to account for the use of a LOAEL from the acute
neurotoxicity study in rats in deriving the acute reference dose used
for assessing acute dietary exposure for all populations including
infants and children. EPA has determined that reliable data show that
it would be safe for infants and children to reduce the FQPA safety
factor to 1X. To account for the use of a LOAEL from the acute
neurotoxicity study in rats the Agency believes that a 3X FQPA SF (as
opposed to a 10X) will be adequate to extrapolate a NOAEL in assessing
acute risk and that no additional safety factor is needed for short-
term, intermediate-term, and chronic risk assessment based on the
following considerations:
i. The concern is low for the use of a LOAEL to extrapolate a
NOAEL, given the relatively insignificant nature of the effect
(transient diarrhea seen in the rat); the fact that diarrhea was only
seen in studies involving gavage dosing in the rat but not in repeat
dosing through dietary administration in rats, mice, rabbits, and dogs;
the very high dose level needed to reach the acute oral lethal dose
(LD)50 (>5000 milligrams/kilogram (mg/kg)), and the overall
low toxicity of azoxystrobin. NOAELs were used for short-term,
intermediate-term, and chronic risk assessments.
ii. The toxicity database for azoxystrobin is complete except for
immunotoxicity testing. Recent changes to 40 CFR part 158 make
immunotoxicity testing (OPPTS Guideline 870.7800) required for
pesticide registration; however, the existing data are sufficient for
endpoint selection for exposure/risk assessment scenarios, and for
evaluation of the requirements under the FQPA. There are no indications
in the available studies that organs associated with immune function,
such as the thymus and spleen, are affected by azoxystrobin and
azoxystrobin does not belong to a class of chemicals (e.g., the
organotins, heavy metals, or halogenated aromatic hydrocarbons) that
would be expected to be immunotoxic. Based on the above considerations
in this unit, EPA does not believe that conducting the immunotoxicity
study will result in a dose less than the point of departure already
used in this risk assessment, and an additional database uncertainty
factor for potential immunotoxicity does not need to be applied.
iii. Clinical signs noted in the acute and subchronic neurotoxicity
studies were not considered treatment related because of a lack of
dose-response, inconsistency of observations at different time points,
variability of pretreatment values and/or small magnitude of response.
There is no need for a developmental neurotoxicity study or additional
UFs to account for neurotoxicity.
iv. There is no evidence that azoxystrobin results in increased
susceptibility to in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
v. The acute and chronic dietary exposure assessments were
performed based on tolerance-level residues. The acute dietary
assessment incorporated 100 PCT information, and the chronic dietary
exposure assessment was somewhat refined using PCT information for
selected crops. EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to
azoxystrobin in drinking water. EPA used similarly conservative
assumptions to assess postapplication exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by azoxystrobin.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
azoxystrobin will occupy 70% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
azoxystrobin from food and water will utilize 9.6% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
azoxystrobin is not expected.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Azoxystrobin
is currently registered for uses that could result in short-term and
intermediate-term residential exposure and the Agency has determined
that it
[[Page 53178]]
is appropriate to aggregate chronic exposure through food and water
with short-term and intermediate-term residential exposures to
azoxystrobin.
Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded the combined
short-term food, water, and residential exposures result in an
aggregate MOE of 240 for children 1-2 years old (the population group
receiving the greatest exposure), and has concluded the combined
intermediate-term food, water, and residential exposures result in an
aggregate MOE of 340 for children 1-2 years old (the population group
receiving the greatest intermediate-term exposure). As the aggregate
MOEs for short-term and intermediate-term exposure are greater than 100
(the LOC) for all population subgroups assessed, short-term and
intermediate-term aggregate exposures to azoxystrobin are not of
concern to EPA.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in mice and rats in two adequate
carcinogenicity studies, azoxystrobin was classified as ``not likely to
be carcinogenic to humans,'' and is not expected to pose a cancer risk
to humans.
5. 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, or to infants and children from aggregate
exposure to azoxystrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies are available to enforce the
tolerance expression and have been submitted to FDA for inclusion in
the Pesticide Analytical Manual (PAM) Volume II: A gas chromatography
method with nitrogen-phosphorus detection (GC/NPD), RAM 243/04, for the
enforcement of tolerances for residues of azoxystrobin and its Z-isomer
in crop commodities; and a GC/NPD method, RAM 255/01, for the
enforcement of tolerances of azoxystrobin in livestock commodities. The
method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
Codex Maximum Residue Limits (MRLs) have been established for
azoxystrobin in or on barley grain at 0.5 ppm; and straw and fodder of
cereal grains (except maize) at 15 ppm. The Codex MRLs for barley grain
and straw are based on field trials conducted in Europe and on residues
present at a 35-42 day pre-harvest interval (PHI). The recommended U.S.
tolerances on barley grain (3.0 ppm) and straw (7.0 ppm) are based on
residues present at a 14-day PHI. The U.S. tolerance for barley grain
is higher due to the shorter PHI; thus, the barley grain tolerance and
MRLs cannot be harmonized between the U.S. and Codex. Codex MRLs for
forages, straws and the like are set on a dry-weight basis, whereas
U.S. tolerances are set on an as-fed basis; therefore, the U.S.
tolerance on barley straw cannot be harmonized with the Codex MRL for
straw and fodder of cereal grains (including barley, oats, rice and
wheat data) at this time.
C. Revisions to Petitioned-For Tolerances
Based upon review of the data supporting the petition, EPA has
revised the existing tolerance for barley bran from 0.2 ppm to 6.0 ppm.
Based on previously-submitted wheat processing data, a tolerance for
barley bran was established at 0.2 ppm; however, the proposed PHI
reduction for barley grain results in higher residues in barley grain
and the potential for increased residues in barley bran. Using the
highest average field trial data for barley grain harvested at the 14-
day PHI (1.85 ppm) and the concentration factor for wheat bran (3x),
expected residues in barley bran would be 5.55 ppm. The expected barley
bran residues exceed the proposed tolerance increase for barley grain
at 3.0 ppm and the existing tolerance for barley bran at 0.2 ppm.
Therefore, the Agency is increasing the established tolerance for
azoxystrobin in or on barley bran from 0.2 ppm to 6.0 ppm.
Additionally, EPA has revised the tolerance expression to clarify:
1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of azoxystrobin not specifically
mentioned; and
2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression. This change was made to both the tolerance
expressions for plant commodities and animal commodities because it
makes no substantive change to the meaning of the tolerance but rather
only clarifies the existing language.
V. Conclusion
Therefore, established tolerances are amended for 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-yloxy)phenyl)-3
methoxyacrylate], in or on barley, bran at 6.0 ppm; barley, grain at
3.0 ppm; and barley, straw at 7.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). 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., 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).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, 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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the
[[Page 53179]]
various levels of government or between the Federal Government and
Indian tribes. Thus, the Agency has determined that Executive Order
13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 9, 2000) do not apply to this final
rule. In addition, this final rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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: October 7, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.507 is amended in paragraph (a)(1) by revising the
introductory text and by revising the entries for ``Barley, bran'';
``Barley, grain''; and ``Barley, straw'' in the table; and in paragraph
(a)(2) by revising the introductory text to read as follows:
Sec. 180.507 Azoxystrobin; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
fungicide, azoxystrobin, including its metabolites and degradates, in
or on the commodities in the following table. Compliance with the
tolerance levels specified in the table is to be determined by
measuring only the sum 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-yloxy)phenyl)-3 methoxyacrylate] in or on the commodity.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Barley, bran......................................... 6.0
* * * * *
Barley, grain........................................ 3.0
* * * * *
Barley, straw........................................ 7.0
* * * * *
------------------------------------------------------------------------
(2) Tolerances are established for residues of the fungicide,
azoxystrobin, including its metabolites and degradates, in or on the
commodities in the following table. Compliance with the tolerance
levels specified in the table is to be determined by measuring only the
sum 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-yloxy)phenyl)-3
methoxyacrylate] in or on the commodity.
* * * * *
[FR Doc. E9-24813 Filed 10-15-09; 8:45 am]
BILLING CODE 6560-50-S