
[Federal Register Volume 78, Number 79 (Wednesday, April 24, 2013)]
[Rules and Regulations]
[Pages 24094-24100]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09701]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0282; FRL-9384-2]


Azoxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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: Malone.Erin@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. 
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 
20460-0001.
     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, 
[methyl(Z)-2-(2-(6-(2-

[[Page 24095]]

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, 
[methyl(Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-
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 
children.
    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-
adverse-effect-level (LOAEL).

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-
9352-2).

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.
    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

[[Page 24096]]

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 
used in

[[Page 24097]]

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 
route only.
     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 
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 
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 
toxicity.
    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 
rabbits; and
     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 
study.
    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

[[Page 24098]]

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 
age.
    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 
risk.
    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: 
residuemethods@epa.gov.

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 
ginseng

[[Page 24099]]

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 
was revised.

 V. Conclusion

    Therefore, tolerances are established 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 
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 
[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 
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 
recordkeeping requirements.

    Dated: April 12, 2013.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.507:
0
a. Revise the entries for ``Barley, hay'', ``Barley, straw'', ``Wheat, 
grain'', ``Wheat, hay'', ands ``Wheat, straw'' in the table in 
paragraph (a)(1);
0
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);
0
c. Remove the entry in the table in paragraph (a)(1) for ``Wheat, 
bran'';
0
d. Add footnote 1 to the table in paragraph (a)(1); and
0
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) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
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

[[Page 24100]]

 
 
                                * * * * *
Wheat, grain...............................................          0.2
Wheat, hay.................................................         30.0
Wheat, straw...............................................         10.0
------------------------------------------------------------------------
\1\ There are no United States registrations for use of azoxystrobin on
  ginseng.

    (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


