[Federal Register Volume 78, Number 79 (Wednesday, April 24, 2013)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09701]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Azoxystrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
azoxystrobin in or on multiple commodities discussed later in this
document. Syngenta Crop Protection, LLC requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April 24, 2013. Objections and
requests for hearings must be received on or before June 24, 2013, 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: The docket for these actions, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0282, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Erin Malone, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 347-0253; email address: [email protected].
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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's eCFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 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-2012-0282 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 24, 2013. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
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 (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0282, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of April 4, 2012 (77 FR 20336) (FRL-9340-
4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1E7945) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR 180.507 be amended by
establishing an import tolerance 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,
cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate] in or on
ginseng extract (red ginseng extract and ginseng extract) at 0.5 parts
per million (ppm). That document referenced a summary of the petition
prepared by Syngenta Crop Protection, LLC, the registrant, which is
available in the docket EPA-HQ-OPP-2012-0041, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
Additionally, in the Federal Register of May 23, 2012 (77 FR 30484)
(FRL-9347-8), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide
petitions (PP 2F7976 and PP 2F7984) by Syngenta Crop Protection, LLC,
P.O. Box 18300, Greensboro, NC 27419-8300. The petitions requested that
40 CFR 180.507 be amended by:
Establishing 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,
methoxyacrylate], in or on oats, forage at 4 parts per million (ppm);
oats, hay at 7 ppm; oats, straw at 3 ppm; oats, grain at 1 ppm; rye,
forage at 4 ppm; rye, straw at 0.8 ppm; rye, grain at 0.07 ppm;
poultry, meat at 0.01 ppm; poultry, liver at 0.2 ppm; poultry, fat at
0.01 ppm; egg at 0.1 ppm; cattle, liver at 0.5 ppm; cattle, kidney at
0.1 ppm; hog, liver at 0.2 ppm; hog, kidney at 0.03 ppm (PP 2F7976);
Amending established tolerances for barley, hay from 15
ppm to 7 ppm; barley, straw from 7 ppm to 8 ppm; barley, grain from 3
ppm to 2 ppm; wheat, forage from 25 ppm to 10 ppm; wheat, straw from 4
ppm to 6 ppm; wheat, hay from 15 ppm to 20 ppm; grain aspirated
fractions from 420 ppm to 460 ppm; cattle, fat from 0.03 ppm to 0.3
ppm; hog, fat from 0.01 ppm to 0.1 ppm; hog, meat from 0.01 ppm to 0.02
ppm; (PP 2F7984).
The notices referenced summaries of the petitions prepared by
Syngenta Crop Protection, LLC, the registrant, which is available in
the dockets EPA-HQ-OPP-2012-0282 and EPA-HQ-OPP-2012-0283, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA is
establishing tolerances that vary from what the petitioner requested.
The reason for these changes is 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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for azoxystrobin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with azoxystrobin 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
The toxicological profile for azoxystrobin has not changed since
the final rule published in the Federal Register of July 13, 2012 (77
FR 41285) (FRL-9352-2). See that rule for a summary of the
toxicological profile and references to supporting Agency documents
that discuss specific information on the toxicity studies received and
the nature of the adverse effects caused by azoxystrobin as well as the
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). 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 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 is discussed in Unit III.B. of the final rule
published in the Federal Register of July 13, 2012 (77 FR 41286) (FRL-
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.
Such effects were identified for azoxystrobin. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture's (USDA) National Health and Nutrition
Examination Survey, What We Eat in
America (NHANES/WWEIA) conducted from 2003 to 2008. As to residue
levels in food, the acute dietary exposure assessment of azoxystrobin
is partially refined by using highest residue values for citrus fruits
and assuming tolerance-level residues for all other existing and
proposed commodities. One hundred percent of the crops were assumed
treated with azoxystrobin and DEEM (Dietary Exposure Evaluation Model)
version 7.81 default processing factors were used except where
tolerances were established for processed commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA's (NHANES/
WWEIA) conducted from 2003 to 2008, as well. As to residue levels in
food, a slightly refined chronic dietary analysis for azoxystrobin was
conducted using tolerance-level residues and average percent crop
treated estimates when available. DEEM version 7.81 default processing
factors were assumed except for where tolerances were established for
processed commodities or when processing studies show no concentration.
An updated screening level usage analysis (SLUA) of azoxystrobin from
2011 was used for percent crop treated.
iii. Cancer. The rat and the mouse carcinogenicity studies on
azoxystrobin do not show an increase in tumor incidence. Azoxystrobin
is classified as ``not likely to be carcinogenic to humans.''
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated or actual residues and percent crop treated (PCT)
information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use
available data and information on the anticipated residue levels of
pesticide residues in food and the actual levels of pesticide residues
that have been measured in food. If EPA relies on such information, EPA
must require pursuant to FFDCA section 408(f)(1) that data be provided
5 years after the tolerance is established, modified, or left in
effect, demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such Data Call-Ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
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 estimated the PCT for existing uses as follows: Almonds,
25%; apricots, 10%; artichokes, 25%; asparagus, 2.5%; green beans, 10%;
blackberries, 5%; blueberries, 10%; broccoli, 5%; cabbage, 10%;
cantaloupes, 10%; carrots, 10%; cauliflower, 2.5%; celery, 10%;
cherries, 5%; corn, 2.5%; cotton, 5%; cucumbers, 20%; dry beans/peas,
1%; garlic, 60%; grapefruit, 20%; grapes, 5%; hazelnuts (filberts), 5%;
lettuce, 2.5%; onions, 10%; oranges, 5%; peaches, 5%; peanuts, 15%;
green peas, 2.5%; pecans, 2.5%; peppers, 15%; pistachios, 15%;
potatoes, 35%; prunes, 2.5%; pumpkins, 20%; raspberries, 5%; rice, 35%;
soybeans, 2.5%; spinach, 10%; squash, 15%; strawberries, 30%; sugar
beets, 5%; sweet corn, 10%; tangerines, 15%; tomatoes, 15%; walnuts,
1%; watermelon, 20%; and wheat, 2.5%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
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 1%. 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), the
highest estimated drinking water concentrations (EDWCs) of azoxystrobin
for acute exposures are estimated to be 173 parts per billion (ppb) for
surface water and 33 ppb for chronic exposures for non-cancer
assessments. Based on the Screening Concentration in Groundwater,
version 2.3, August 8, 2003 (SCI-GROW), the EDWC for ground water is
3.1 ppb for all exposures.
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 value of 33 ppb was used to assess
the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
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: Outdoor residential (lawns, ornamentals, flower gardens,
vegetables, fruit and nut trees, berries and vines) and recreational
(golf courses, parks and athletic fields) sites. Additionally,
azoxystrobin is registered for uses on indoor carpets/other surfaces,
and in treated paints (preservative incorporation). EPA assessed
residential exposure using the following assumptions:
Residential uses will result in short-term (1 to 30 days)
handler exposure; residential handlers are assumed to be wearing short-
sleeved shirts, short pants, shoes, and socks during the application;
and because there was no dermal endpoint chosen for azoxystrobin,
residential handler risk from exposure was assessed for the inhalation
The Agency assumed that post-application exposure in
residential settings is expected to be short-term in duration only.
Residential post-application inhalation exposure in outdoor settings is
considered negligible; however, residential post-application inhalation
exposure in indoor settings has been assessed for adults and children.
Further information regarding EPA's standard assumptions and
generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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 Web site 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 Safety
Factor (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
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
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 regards to prenatal and/or postnatal
3. Conclusion. EPA has retained the FQPA SF, reduced 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. 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 based on the following considerations:
The effect seen (transient diarrhea seen in the rat) is of
a nature that is relatively insignificant;
The diarrhea was only seen in studies involving gavage
dosing in the rat but not in repeat dosing through dietary
administration in rats and mice, and not through gavage dosing in
The very high dose level needed to reach the acute oral
lethal dose (LD)50 (>5,000 milligrams/kilogram (mg/kg)), and
the overall low toxicity of azoxystrobin.
However, EPA has determined that reliable data show that it would
be safe for infants and children to reduce the FQPA safety factor to 1X
for short-term, intermediate-term, and chronic risk assessment. This
determination is based on the following considerations.
i. The toxicity database for azoxystrobin is complete except for
immunotoxicity. 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 that would be expected to be
immunotoxic. Based on the above considerations, 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.
ii. Clinical signs, including transient diarrhea and decreased body
weight, body weight gain, and food utilization, were noted in the acute
and subchronic neurotoxicity studies, but were not considered
indicative of neurotoxicity. There is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. 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
iv. There are no residual uncertainties in the azoxystrobin
exposure database. While some refinements were incorporated into the
dietary exposure calculations, EPA is confident that the aggregate risk
from exposure to azoxystrobin in food, drinking water, and residential
pathways will not be underestimated. The acute dietary (food) exposure
assessment utilized conservative upper-bound inputs including 100% of
the proposed and registered crops treated, and tolerance-level residues
for all existing and proposed commodities, except citrus fruits where
the highest field trial residue was used as a refinement. The chronic
dietary exposure assessment was partially refined, and used tolerance-
level residues for all commodities and PCT estimates when available
(SLUA, 07/13/11). Although the acute and chronic assessments included
minor refinements, the use of
field trial and PCT estimates ensures that actual exposures/risks from
residues in food will not be underestimated. The drinking water
assessment utilized water concentration values generated by models and
associated modeling parameters which are designed to produce
conservative, health protective, high-end estimates of water
concentrations which are not likely to be exceeded. The dietary (food
and drinking water) exposure assessment does not underestimate the
potential exposure for infants, children, or women of child-bearing
In addition, the residential exposure assessment is based on the
updated 2012 Residential SOPs employing surrogate study data, including
conservative exposure assumptions based on Day 0 dermal/oral contact to
turf and surfaces treated at the maximum application rate. These data
are reliable and are not expected to underestimate risks to adults or
children. The Residential SOPs are based upon reasonable ``worst-case''
assumptions and are not expected to underestimate risk.
E. Aggregate Risks and Determination of Safety.
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute aggregate risk would be equivalent
to the acute dietary exposure from food and water to azoxystrobin will
occupy 41% of the aPAD for children 1-2 years old, the population group
receiving the greatest exposure.
2. Chronic risk. Based on the explanation in Unit III.C.3.,
regarding residential use patterns, chronic residential exposure to
residues of azoxystrobin is not expected. Therefore, the chronic
aggregate risk would be equivalent to the chronic dietary exposure
estimate and was 17% of the cPAD for the most highly exposed subgroup,
children 1-2 years old.
3. Short-term risk. Short-term aggregate exposure takes into
account short-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
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to azoxystrobin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 920 for general
U.S. population and 190 for children 1 to 2 years old. Because EPA's
level of concern for azoxystrobin is a MOE of 100 or below, these MOEs
are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Azoxystrobin is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, EPA relies
on chronic dietary exposure to evaluate intermediate-term aggregate
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, azoxystrobin is not expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, 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 methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established MRLs for azoxystrobin on oat, forage;
oat, hay; rye, forage; barley, hay; wheat, forage; wheat, hay; and
grain aspirated fractions.
The Codex has established MRLs for azoxystrobin in or on ginseng,
dried including red ginseng at 0.5 ppm; rye, grain at 0.2 ppm and
wheat, grain at 0.2 ppm. These MRLs are the same as the tolerances
established for azoxystrobin in the United States.
The Codex has established MRLs for azoxystrobin in or on oats,
grain at 0.5 ppm and barley, grain at 0.5 ppm. These MRLs are different
than the tolerances established for azoxystrobin in the United States.
The U.S. tolerance on oat grain (1.5 ppm) and barley grain (3 ppm)
could not be harmonized since the Codex MRLs are lower. Setting the
U.S. tolerance to be consistent with the Codex MRLs might lead to
residues in excess of the tolerance, despite legal use of the pesticide
in accordance with the registered label.
C. Revisions to Petitioned-For Tolerances
The tolerance levels requested by the petitioners are based on
residue data submitted using lower application rates than are found on
the registered label; therefore, EPA used the proportionality principle
(JMPR Report 2011) to estimate residue values that reflect the higher
application rates on the registered label. In doing this exercise, EPA
determined that an adjustment to the wheat, grain tolerance was
required to reflect the application rates for the pesticide.
The proposed tolerance on ginseng extract (red ginseng extract and
extract) is not needed because the tolerance on ginseng will cover the
expected residues in these processed commodities.
The proposed amended tolerance for grain aspirated fractions is not
needed due to the current tolerance being sufficient. EPA is not
establishing the tolerances as proposed for livestock commodities as
there was no increased dietary burden on livestock with the new uses,
the existing tolerances were sufficient.
The tolerance expression in 40 CFR 180.507(a)(2) is incorrect and
Therefore, tolerances are established for residues of azoxystrobin,
methoxyacrylate and the Z-isomer of azoxystrobin, [methyl(Z)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate], in or on
oat, forage at 5.0 ppm; oat, hay at 10.0 ppm; oat, straw at 3.0 ppm;
oat, grain at 1.5 ppm; rye, forage at 7.0 ppm; rye, straw at 1.5 ppm;
rye, grain at 0.2 ppm; barley, hay at 10.0 ppm; barley, straw 15.0 ppm;
wheat, forage from at 15.0 ppm; wheat, straw at 10.0 ppm; wheat, hay at
30.0 ppm; and wheat, grain at 0.2 ppm. In conjunction with
establishment of the wheat grain tolerance at 0.2 ppm, the existing
tolerance on wheat bran needs to be deleted from 40 CFR 180.507(a)(1).
Also, EPA is establishing a tolerance for residues of azoxystrobin
methoxyacrylate] and the Z-isomer of azoxystrobin, [methyl(Z)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate], in or on
ginseng at 0.5 ppm. Although, as of the date of publication of this
rule, there are no U.S. registrations for use of azoxystrobin on
ginseng, this tolerance will allow for imports of treated ginseng
meeting this tolerance level.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this 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 FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
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) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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
Dated: April 12, 2013.
Daniel J. Rosenblatt,
Acting 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. In Sec. 180.507:
a. Revise the entries for ``Barley, hay'', ``Barley, straw'', ``Wheat,
grain'', ``Wheat, hay'', ands ``Wheat, straw'' in the table in
b. Add alphabetically the entries for ``Ginseng'', ``Oats, forage'',
``Oats, grain'', ``Oats, hay'', ``Oats, straw'', ``Rye, forage'',
``Rye, grain'', ``Rye, straw'' to the table in paragraph (a)(1);
c. Remove the entry in the table in paragraph (a)(1) for ``Wheat,
d. Add footnote 1 to the table in paragraph (a)(1); and
e. Revise the introductory text of paragraph (a)(2)
The revisions and additions read as follows:
Sec. 180.507 Azoxystrobin; tolerances for residues.
(a) * * *
(1) * * *
* * * * *
Barley, hay................................................ 10.0
Barley, straw.............................................. 15.0
* * * * *
Ginseng \1\................................................ 0.5
* * * * *
Oats, forage............................................... 5.0
Oats, grain................................................ 1.5
Oats, hay.................................................. 10.0
Oats, straw................................................ 3.0
* * * * *
Rye, forage................................................ 7.0
Rye, grain................................................. 0.2
Rye, straw................................................. 1.5
* * * * *
Wheat, grain............................................... 0.2
Wheat, hay................................................. 30.0
Wheat, straw............................................... 10.0
\1\ There are no United States registrations for use of azoxystrobin on
(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
azoxystrobin, [methyl(E)-2-(2-(6-(2-cyanophenoxy) pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate] in or on the commodity.
* * * * *
[FR Doc. 2013-09701 Filed 4-23-13; 8:45 am]
BILLING CODE 6560-50-P