Document ID: EPA-HQ-OPP-2007-0416-0003
Agency: epa
Document Type: Rule
Title: Azoxystrobin; Pesticide Tolerances
Posted Date: 2008-07-09T04:00Z

[Federal Register: July 9, 2008 (Volume 73, Number 132)]
[Rules and Regulations]               
[Page 39240-39247]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy08-14]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0416; FRL-8371-9]

 
Azoxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of azoxystrobin (methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate) and its Z isomer (methyl (Z)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) in or on 
animal feed, nongrass, forage, group 18 at 45 parts per million (ppm); 
animal feed, nongrass, hay, group 18 at 120 ppm; barley, forage at 25 
ppm; cotton, gin byproducts at 45 ppm; cotton, undelinted seed at 0.6 
ppm; grain, aspirated fractions at 420 ppm; rice, wild, grain at 5.0 
ppm; sorghum, forage at 25 ppm; sorghum, grain at 11 ppm; sorghum, 
stover at 40 ppm; and wheat, forage at 25 ppm. Syngenta Crop 
Protection, Inc. requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA). EPA is also deleting certain 
azoxystrobin tolerances that are no longer needed as a result of this 
action.

DATES: This regulation is effective July 9, 2008. Objections and 
requests for hearings must be received on or before September 8, 2008, 
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-2007-0416. To access the 
electronic docket, go to http://www.regulations.gov, and search for the 
docket number. All documents in the docket are listed in the docket 
index available in 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) 305-5805.

FOR FURTHER INFORMATION CONTACT: John Bazuin, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7381; e-mail address: bazuin.john@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American

[[Page 39241]]

Industrial Classification System (NAICS) codes have been provided to 
assist you and others in determining whether this action might apply to 
certain entities. If you have any questions regarding the applicability 
of this action to a particular entity, consult the person listed under 
FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket 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 pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0416 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 September 8, 2008.
    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-2007-0416, 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'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 September 28, 2007 (72 FR 55204) (FRL-
8147-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
6F7106 and 7F7198) by Syngenta Crop Protection, Inc., P.O. Box 18300, 
Greensboro, NC 27409. Petition PP 6F7106 requested that 40 CFR 
180.507(a)(1) be amended by establishing tolerances for combined 
residues of the fungicide azoxystrobin (methyl (E)-2-(2-(6-(2-
cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) and the Z 
isomer of azoxystrobin (methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate in or on barley, forage at 30 ppm; non-
grass animal feeds, forage at 35 ppm; non-grass animal feeds, hay at 
100 ppm; sorghum, forage at 25 ppm; sorghum, grain at 9 ppm; sorghum, 
stover at 40 ppm; and wheat, forage at 30 ppm. Petition PP 6F7106 also 
requested that 40 CFR 180.507(a)(2) be amended by establishing 
tolerances for residues of the fungicide azoxystrobin in or on cattle, 
kidney at 1.00 ppm; cattle, liver at 5.10 ppm; cattle, meat byproducts 
(except liver and kidney) at 0.07 ppm; goat, kidney at 1.00 ppm; goat, 
liver at 5.10 ppm; goat, meat byproducts (except liver and kidney) at 
0.07 ppm; egg, white at 0.01 ppm; egg, yolk at 0.15 ppm; hog, kidney at 
0.03 ppm; hog, liver at 0.23 ppm; hog, meat byproducts (except liver 
and kidney) at 0.01 ppm; horse, kidney at 1.00 ppm; horse, liver at 
5.10 ppm; poultry, fat at 0.01 ppm; poultry, liver at 0.12 ppm; 
poultry, meat at 0.02 ppm; sheep, kidney at 1.00 ppm; sheep, liver at 
5.10 ppm; sheep, meat byproducts (except liver and kidney) at 0.07 ppm. 
Petition PP 6F7106 additionally requested that 40 CFR 180.507(a)(1) be 
amended by increasing the tolerance for the combined residues of the 
fungicide azoxystrobin and the Z isomer of azoxystrobin in or on 
aspirated grain fractions to 112 ppm; increasing the tolerances for the 
residues of the fungicide azoxystrobin in or on cattle, fat to 0.13 
ppm; cattle, meat to 0.07 ppm; goat, fat to 0.13 ppm; goat, meat to 
0.07 ppm; hog, fat to 1.10 ppm; horse, meat to 0.07 ppm; milk to 0.05 
ppm; sheep, fat to 0.13 ppm; and sheep, meat to 0.07 ppm; and leaving 
the tolerance for the residues of the fungicide azoxystrobin and the Z 
isomer of azoxystrobin in or on hog, meat unchanged at 0.01 ppm. 
Petition PP 7F7198 requested that 40 CFR 180.507(a)(1) be amended by 
establishing a permanent tolerance for combined residues of the 
fungicide azoxystrobin and the Z isomer of azoxystrobin in or on rice, 
wild at 5.0 ppm and by changing the tolerances for combined residues of 
the fungicide azoxystrobin and the Z isomer of azoxystrobin in or on 
cotton, gin byproducts to 35 ppm and cotton, undelinted seed to 0.7 
ppm. That notice referenced a summary of the petition prepared 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 the petition, EPA is not 
modifying the tolerances for ruminant and swine raw agricultural 
commodities (RACs) or establishing tolerances for poultry RACs. EPA is, 
however, increasing the proposed tolerance for sorghum grain from 9 ppm 
to 11 ppm, increasing the proposed tolerance for aspirated grain 
fractions from 112 ppm to 420 ppm, reducing the proposed tolerances of 
30 ppm for both wheat forage and barley forage to 25 ppm, reducing the 
proposed tolerance for undelinted cotton seed from 0.7 to 0.6 ppm, 
increasing the proposed tolerance for cotton gin byproducts from 35 to 
45 ppm, increasing the proposed tolerance for non-grass animal feeds, 
forage from 35 to 45 ppm, and increasing the proposed tolerance for 
non-grass animal feeds, hay from 100 to 120 ppm. EPA is also revoking 
the two expired time-limited tolerances for safflower, seed at 1.0 ppm; 
and for Brassica, head and stem, subgroup 5A of 30 ppm in 40 CFR 
180.507(b). The rice, wild tolerance in 40 CFR 180.507(b) is also being 
revoked. 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

[[Page 39242]]

other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) of 
FFDCA requires EPA to give special consideration to exposure of infants 
and children to the pesticide chemical residue in establishing a 
tolerance and to ``ensure that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to the 
pesticide chemical residue. . . .''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for combined residues of azoxystrobin (methyl (E)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) and the Z 
isomer of azoxystrobin (methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate) in or on animal feed, nongrass, 
forage, group 18 at 45 ppm; animal feed, nongrass, hay, group 18 at 120 
ppm; barley, forage at 25 ppm; cotton, gin byproducts at 45 ppm; 
cotton, undelinted seed at 0.6 ppm; grain, aspirated fractions at 420 
ppm; rice, wild, grain at 5.0 ppm; sorghum, forage at 25 ppm; sorghum, 
grain at 11 ppm; sorghum, stover at 40 ppm; and wheat, forage at 25 
ppm. EPA's assessment of exposures and risks associated with 
establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children
    Azoxystrobin has low acute toxicity via the oral, dermal and 
inhalation routes of exposure. Azoxystrobin is not an eye or skin 
irritant and is not a skin sensitizer. The most common toxicity 
findings from administration of azoxystrobin to rats, via the oral 
route, were decreased body weight, decreased food intake/utilization, 
increased diarrhea, and other clinical toxicity observations such as, 
increased urinary incontinence, hunched postures and distended 
abdomens. There were no developmental effects in the rat and rabbit 
developmental studies. In the reproduction study, decreased body 
weights and increased adjusted liver weights were observed at the same 
dose in both offspring and parental animals. In both the acute and 
subchronic neurotoxicity studies, there were no consistent indications 
of treatment-related neurotoxicity. There was no evidence of 
carcinogenicity in rats and mice at acceptable dose levels. 
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 lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule 
published in the Federal Register of September 29, 2000 (65 FR 58404) 
(FRL-6749-1).

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-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see 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 September 29, 2000.

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.
    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, a 100% crop treated assumption, and default processing 
factors for all existing and proposed uses.
    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 and default processing factors for all existing and proposed 
uses. As to percent crop treated, EPA used data on the actual 
percentage of crop treated for some existing uses and assumed 100% crop 
treated for all proposed uses, and all other existing uses.
    iii. Cancer. The Agency has determined that azoxystrobin is not 
likely to be a human carcinogen, so an exposure assessment to estimate 
cancer risk is unnecessary.
    iv. Percent crop treated (PCT) information. EPA did not use 
anticipated residue information in the dietary assessment for 
azoxystrobin.

[[Page 39243]]

Tolerance level residues were assumed for all food commodities.
    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: Acerola - 100%; almond 
- 20%; amaranth, leafy - 100%; apricot - 15%; arrowroot - 100%; 
artichoke, globe - 100%; artichoke, Jerusalem - 100%; arugula - 100%; 
asparagus - 1%; avocado - 100%; balsam pear - 100%; banana - 100%; 
barley - 100%; basil - 100%; bean, black - 1%; bean, broad - 1%; bean, 
cowpea - 1%; bean, great northern - 1%; bean, kidney - 1%; bean, lima - 
1%; bean, mung - 1%; bean, navy - 1%; bean, pink - 1%; bean, pinto - 
1%; bean, snap - 25%; beet, garden - 15%; beet, sugar - 1%; blackberry 
- 100%; blueberry - 15%; boysenberry - 100%; Brazil nut - 100%; 
broccoli - 100%; Brussels sprouts - 100%; burdock - 100%; butternut - 
100%; cabbage - 5%; canistel - 100%; cantaloupe - 10%; cardoon - 100%; 
carrot - 10%; casaba - 100%; cashew - 100%; cassava - 100%; cattle fat, 
kidney, liver, meat, and meat byproducts - 100%; cauliflower - 100%; 
celeriac - 100%; celery - 10%; celtuce - 100%; chayote - 100%; 
cherimoya - 100%; cherry - 5%; chestnut - 100%; chickpea - 1%; chicory 
- 100%; Chinese waxgourd - 100%; chive - 100%; chrysanthemum, garland - 
100%; cinnamon - 100%; citrus citron - 100%; citrus hybrids - 100%; 
citrus, oil - 100%; collards - 100%; coriander - 100%; corn, field - 
100%; corn, pop - 100%; corn, sweet - 10%; cottonseed, oil - 1%; 
cranberry - 100%; cress, garden - 100%; cress, upland - 100%; cucumber 
- 15%; currant - 100%; dandelion, leaves - 100%; dasheen, corm - 100%; 
dasheen, leaves - 100%; dewberry - 100%; dill, seed - 100%; dillweed - 
100%; eggplant - 100%; elderberry - 100%; endive - 100%; feijoa - 100%; 
fennel, Florence - 100%; filbert - 5%; flaxseed, oil - 5%; garlic - 
50%; ginger - 100%; ginseng - 100%; goat fat, kidney, liver, meat, and 
meat byproducts - 100%; gooseberry - 100%; grape - 10%; grapefruit - 
20%; guar, seed - 1%; guava - 100%; herbs, other - 100%; hickory nut - 
100%; honeydew melon - 5%; hop - 100%; horse, meat - 100%; horseradish 
- 100%; huckleberry - 100%; jaboticaba - 100%; jackfruit - 100%; kale - 
100%; kohlrabi - 100%; kumquat - 100%; leek - 100%; lemon - 100%; 
lemongrass - 100%; lentil, seed - 1%; lettuce, head - 1%; lettuce, leaf 
- 1%; lime - 100%; loganberry - 100%; longan - 100%; loquat - 100%; 
lychee - 100%; macadamia nut - 100%; mango - 100%; marjoram - 100%; 
milk - 100%; mustard greens - 15%; nectarine - 100%; okra - 100%; 
onion, dry bulb - 10%; onion, green - 10%; orange - 17%; papaya - 100%; 
parsley - 30%; parsley, turnip-rooted - 100%; passionfruit - 100%; 
pawpaw - 100%; pea, succulent - 1%; pea, dry - 1%; pea, edible podded - 
25%; pea, pigeon - 1%; peach - 5%; peanut - 10%; pecan - 1%; pepper, 
bell - 10%; pepper, non-bell - 10%; peppermint - 100%; persimmon - 
100%; pistachio - 30%; plantain - 100%; plum - 1%; pork fat, kidney, 
liver, meat, meat byproducts, and skin - 100%; potato - 25%; pummelo - 
100%; pumpkin - 20%; radicchio - 100%; radish - 100%; radish, Oriental 
- 100%; rape greens - 100%; rapeseed, oil - 5%; raspberry - 100%; 
rhubarb - 100%; rice - 25%; rutabaga - 100%; safflower - 5%; salsify, 
roots - 100%; salsify, tops - 100%; sapote, Mamey - 100%; savory - 
100%; shallot - 100%; sheep fat, kidney, liver, meat, and meat 
byproducts - 100%; sorghum - 100%; soursop - 100%; soybean - 1%; 
Spanish lime - 100%; spearmint - 100%; spices, other - 100%; spinach - 
10%; squash, summer - 15%; squash, winter - 15%; starfruit - 100%; 
strawberry - 20%; sugar apple - 100%; sunflower - 5%; sweet potato - 
100%; Swiss chard - 100%; tamarind - 100%; tangerine - 20%; tanier - 
100%; tomatillo - 100%; tomato - 20%; turmeric - 100%; turnip, roots - 
100%; turnip, greens - 15%; walnut - 1%; watercress - 100%; watermelon 
- 25%; wheat - 1%; wild rice - 100%; yam, true - 100%; and yam bean - 
100%.
    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 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) model for 
surface water and the Screening Concentration in Ground Water (SCI-
GROW) model for ground water, the

[[Page 39244]]

estimated drinking water concentrations (EDWCs) of azoxystrobin for 
acute exposures are estimated to be 173 parts per billion (ppb) for 
surface water and 3.1 ppb for ground water and for chronic exposures 
for non-cancer assessments are estimated to be 33 ppb for surface water 
and 3.1 ppb for ground water. 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 for surface water was used to assess the contribution to drinking 
water. For chronic dietary risk assessment, the water concentration 
value of 33 ppb for surface water 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: residential turf grass and 
ornamentals, as well as indoor surfaces. EPA assessed residential 
exposure using the following assumptions. Residential handlers may 
receive short-term dermal and inhalation exposure to azoxystrobin when 
mixing, loading and applying the formulations. Adults and children may 
be exposed to azoxystrobin residues from dermal contact with foliage/
surfaces during postapplication activities. Toddlers may receive short- 
and intermediate-term oral exposure from incidental ingestion during 
postapplication activities.
    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 (Food 
Quality Protection Act) 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 available studies do not 
indicate any evidence of increased susceptibility and there are no 
residual uncertainties with regard to prenatal toxicity in rats or 
rabbits following in utero and/or postnatal exposure to azoxystrobin. 
In the prenatal developmental toxicity studies in rats and rabbits and 
the 2-generation reproduction study in rats, any observed toxicity to 
the offspring occurred at equivalent or higher doses than it did to 
parental animals.
    3. Conclusion. The Agency has retained the FQPA SF at 3X, for the 
following reasons:
    i. The toxicology data base is complete.
    ii. The developmental and reproductive toxicity data do not 
indicate increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure.
    iii. Although a NOAEL was not identified in the study used to 
derive the aPAD, a 3X (as opposed to a 10X) is adequate to extrapolate 
a NOAEL due to the low concern for the effect seen taking into account 
the nature of the effect seen (transient diarrhea) and the overall 
toxicity of this chemical;
    iv. The acute dietary food exposure assessment utilizes existing 
and proposed tolerance level residues and 100 PCT information for all 
commodities;
    v. The chronic dietary exposure analysis for azoxystrobin is a 
somewhat refined assessment using less than 100% of the crop treated 
data for selected existing crops (but a 100 PCT value for all new 
crops);
    vi. The exposure assessments will not underestimate the potential 
dietary (food and drinking water) or non-dietary exposures for infants 
and children from the use of azoxystrobin;
    vii. The dietary drinking water assessment utilizes water 
concentration values generated by model and associated modeling 
parameters which are designed to provide conservative, health 
protective, high-end estimates of water concentrations which are not 
likely to be exceeded; and
    viii. The residential postapplication assessment is based upon the 
residential standard operating procedures. The assessment is based upon 
surrogate study data. These data are reliable and are not expected to 
underestimate risk 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 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-, intermediate-, 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, and does not include dermal, inhalation, or incidental 
oral exposure. Using these exposure assumptions, EPA has concluded that 
acute exposure to azoxystrobin will occupy 70% of the aPAD for children 
1-2 years old, the population group receiving the greatest exposure, 
and 25% of the aPAD for the U.S. population as a whole.
    2. Chronic risk. The chronic aggregate risk assessment takes into 
account average estimates of exposure to azoxystrobin from consumption 
in food and drinking water. Using these exposure assumptions, EPA has 
concluded that chronic exposure to azoxystrobin will utilize 15% of the 
cPAD for children 1-2 years old, the population group receiving the 
greatest exposure, and 6% of the cPAD for the U.S. population as a 
whole.
    3. Short-term risk. Short-term aggregate exposure takes into 
account

[[Page 39245]]

short-term (1-30 day) residential exposure plus chronic exposure to 
food and drinking water (considered to be a background exposure level).
    Azoxystrobin is currently registered for uses that could result in 
short-term residential exposure both for adults (because there is a 
residential handler inhalation exposure scenario) and for toddlers and 
children (because there is a residual post-application oral exposure 
scenario). Dermal studies with azoxystrobin identified no toxic 
endpoints so dermal exposure to azoxystrobin is not expected to pose a 
short-term risk. The Agency has determined that it is appropriate to 
aggregate chronic exposure through food and drinking water with short-
term residential exposures to azoxystrobin in performing this 
assessment. High-end estimates of residential exposure are used in the 
short-term assessment but average (i.e., chronic) exposure values are 
used for food and drinking water exposure. Toddlers' incidental oral 
exposure is assumed to include hand-to-mouth exposure, object-to-mouth 
exposure, and exposure via incidental ingestion of soil.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has calculated the following aggregated short-term 
food, water, and residential exposures and resulting MOEs. For the U.S. 
population and all assessed subgroups the NOAEL used was 25 milligrams/
kilograms/day (mg/kg/day). For the U.S. population the estimated food 
and drinking water exposure was 0.009878 mg/kg/day, the residential 
exposure estimate was 0.00011 mg/kg/day, and the aggregate MOE was 
2503. For the subgroup children (1-2 years) the estimated food and 
drinking water exposure was 0.026629 mg/kg/day, the residential 
exposure estimate was 0.089 mg/kg/day, and the aggregate MOE was 216. 
For the subgroup youth (13-19 years) the estimated food and drinking 
water exposure was 0.009499 mg/kg/day, the residential exposure 
estimate was 0.00011 mg/kg/day, and the aggregate MOE was 2602. For the 
subgroup females (13-49 years old) the estimated food and drinking 
water exposure was 0.008081 mg/kg/day, the residential exposure 
estimate was 0.00011 mg/kg/day, and the aggregate MOE was 3052. None of 
these MOEs exceeds the Agency's level of concern for azoxystrobin. The 
level of concern for azoxystrobin is for MOEs below 100.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term (1 to 6 months) 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 
intermediate-term residential oral exposure for toddlers and children, 
so an exposure assessment was conducted for that scenario. No endpoint 
has been selected for intermediate-term dermal exposure to azoxystrobin 
so no dermal assessment was performed. Intermediate-term residential 
handler scenarios are not expected to occur, so this risk assessment 
was not conducted for adults. The Agency has determined that it is 
appropriate to aggregate chronic exposure to azoxystrobin through food 
and drinking water with intermediate-term residential exposures to 
azoxystrobin in doing this assessment. High-end estimates of 
residential exposure are used in the intermediate-term assessment but 
average (i.e., chronic) exposure values are used for food and drinking 
water exposure.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures aggregated 
result in an aggregate MOE for the population subgroup children 1-2 
years old of 291, which does not exceed the Agency's level of concern. 
This value and MOE are derived from a NOAEL for this subgroup of 20 mg/
kg/day, an LOC MOE of 100, an estimated average food and drinking water 
exposure of 0.026629 mg/kg/day, and an estimated oral residential 
exposure of 0.042 mg/kg/day.
    5. Aggregate cancer risk for U.S. population.The Agency has 
determined that azoxystrobin is not likely to be a human carcinogen, 
and thus azoxystrobin is not expected to pose a cancer risk.
    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

    For analysis of plant commodities for residues of azoxystrobin and 
the Z isomer of azoxystrobin a gas chromatography with nitrogen 
phosphorus detector (GC/NPD) method (RAM 243/04) has been validated by 
the Agency, revised, and sent to the Food and Drug Administration (FDA) 
for inclusion in the Pesticide Analytical Manual (PAM), Volume II. This 
method is adequate for enforcement of the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    No CODEX maximum residue levels (MRLs) have been established for 
azoxystrobin. No Canadian or Mexican MRLs have been established for 
azoxystrobin in or on the crops for which tolerances are being 
established in this document.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA is not 
modifying the existing tolerances for ruminant and swine raw 
agricultural commodities (RACs) because a recalculation of the dietary 
burdens of ruminants and swine indicates that no such changes are 
necessary, while the proposed kidney and liver tolerances are covered 
by existing meat byproducts tolerances. EPA is not establishing 
tolerances for poultry RACs because a recalculation of dietary burdens 
for poultry continues to indicate that there is no reasonable 
expectation of finite residues in poultry commodities. EPA is raising 
the proposed tolerance for sorghum grain from 9 ppm to 11 ppm based on 
a review of the residue field trial data and EPA's statistical 
examination of the residue data. The proposed tolerance of 112 ppm in 
or on aspirated grain fractions is being raised to 420 ppm based on a 
residue for sorghum grain of 8.46 ppm and a processing factor of 49.4x. 
EPA is reducing the proposed tolerance of 30 ppm in or on wheat forage 
to 25 ppm based on a review of the wheat forage field trial data and 
EPA's statistical examination of the residue data; these data have also 
been translated to barley, forage with the result that this proposed 
tolerance is also being reduced from 30 to 25 ppm. A review of the 
residue data from use on cotton leads EPA to reduce the proposed 
tolerance for undelinted cotton seed from 0.7 to 0.6 ppm and to 
increase the proposed tolerance for cotton gin byproducts from 35 to 45 
ppm. EPA is also raising the proposed tolerance for non-grass animal 
feeds, forage from 35 to 45 ppm and the proposed tolerance for non-
grass animal feeds, hay from 100 to 120 ppm based on a review of the 
field trial data for use on alfalfa and clover forage and hay and EPA's 
statistical examination of the residue data. EPA is also revoking the

[[Page 39246]]

time-limited tolerance for Brassica, head and stem, subgroup 5A of 30 
ppm, and for safflower, seed at 1.0 ppm, both in 40 CFR 180.507(b), 
because they expired on December 31, 2006, and June 30, 2008, 
respectively. Furthermore, Brassica, head and stem, subgroup 5A and 
safflower, seed have existing tolerances under 40 CFR 180.507(a)(1). 
The rice, wild time-limited tolerance in 40 CFR 180.507(b) is also 
being revoked because it is being superceded by a permanent tolerance 
for rice, wild, grain.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
azoxystrobin (methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate) and the Z isomer of azoxystrobin 
(methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-
methoxyacrylate) in or on animal feed, nongrass, forage, group 18 at 45 
ppm; animal feed, nongrass, hay, group 18 at 120 ppm; barley, forage at 
25 ppm; cotton, gin byproducts at 45 ppm; cotton, undelinted seed at 
0.6 ppm; grain, aspirated fractions at 420 ppm; rice, wild, grain at 
5.0 ppm; sorghum, forage at 25 ppm; sorghum, grain at 11 ppm; sorghum, 
stover at 40 ppm; and wheat, forage at 25 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, 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 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 30, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.507 is amended by:
0
i. Removing the first entry for ``grain, aspirated fractions'' at 10 
ppm in paragraph (a)(1).
0
ii. Revising the entries ``cotton, gin byproducts''; ``cotton, 
undelinted seed''; and ``grain, aspirated fractions.''
0
iii. Alphabetically adding entries to the table in paragraph (a)(1).
0
iv. Removing the text of paragraph (b) and reserving the paragraph 
designation and heading.

Sec.  180.507  Azoxystrobin; tolerances for residues.

    (a) General. (1) * * *

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Animal feed, nongrass, forage, group 18...............                                                        45
Animal feed, nongrass, hay, group 18..................                                                       120
                                                    * * * * *
Barley, forage........................................                                                        25
                                                    * * * * *
Cotton, gin byproducts................................                                                        45
Cotton, undelinted seed...............................                                                       0.6
                                                    * * * * *
Grain, aspirated fractions............................                                                       420

[[Page 39247]]

                                                    * * * * *
Rice, wild, grain.....................................                                                       5.0
                                                    * * * * *
Sorghum, forage.......................................                                                        25
Sorghum, grain........................................                                                        11
Sorghum, stover.......................................                                                        40
                                                    * * * * *
Wheat, forage.........................................                                                        25
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemption. [Reserved]
* * * * *
[FR Doc. E8-15517 Filed 7-8-08; 8:45 am]

BILLING CODE 6560-50-S