[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Rules and Regulations]
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
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 http://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 http://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)
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: firstname.lastname@example.org.
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
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://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
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: http://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,
http://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
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
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
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 http://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-
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
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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for azoxystrobin used for
human risk assessment can be found at http://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
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
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.
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
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 http://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
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 http://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
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
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
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
is appropriate to aggregate chronic exposure through food and water
with short-term and intermediate-term residential exposures to
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
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:
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
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.
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
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: October 7, 2009.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
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:
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