Document ID: EPA-HQ-OPP-2005-0540-0009
Agency: epa
Document Type: Rule
Title: Azoxystrobin; Pesticide Tolerance
Posted Date: 2006-08-23T12:51:02Z

[Federal Register: August 23, 2006 (Volume 71, Number 163)]
[Rules and Regulations]               
[Page 49358-49363]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23au06-16]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0540; FRL-8086-9]

 
Azoxystrobin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of azoxystrobin in or on vegetables, foliage of legume, group 7; 
vegetables, fruiting, group 8 (except tomato); pea and bean, succulent 
shelled, subgroup 6B; pea and bean, dried shelled, except soybean 
subgroup, 6C; citrus, dried pulp; citrus, oil; and fruit, citrus, Group 
10. Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA). EPA is also 
deleting several existing tolerances that are no longer needed as a 
result of this action.

DATES: This regulation is effective August 23, 2006. Objections and 
requests for hearings must be received on or before October 23, 2006, 
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-2005-0540. All documents in the 
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: madden.barbara@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:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    In addition to accessing 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 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/
[fxsp0]ecfr. To access the OPPTS Harmonized 

Guidelines referenced in this document, go directly

[[Page 49359]]

to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2005-0540 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 on or 
before October 23, 2006.
    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2005-0540 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 
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of March 8, 2006 (71 FR 11624) (FRL-7765-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
5E6916) by Interregional Research Project 4 (IR-4), 681 US 
Highway 1 South, North Brunswick, NJ 08902-3390. The petition requested 
that 40 CFR 180.507 be amended by establishing a tolerance for combined 
residues of the fungicide 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 citrus, dried pulp at 20.0 
parts per million (ppm); citrus, oil at 40.0 ppm; fruit, citrus, group 
10 at 10.0 ppm; vegetable, foliage of legume, group 7 at 30.0 ppm; 
vegetable, fruiting, group 8, except tomato at 2.0 ppm; pea and bean, 
succulent shelled, subgroup 6B at 0.5 ppm; pea and bean, dried shelled, 
except soybean, subgroup 6C at 0.5 ppm; animal feed, nongrass, group 
18, forage at 30.0 ppm; animal feed, nongrass, group 18 hay at 55.0 
ppm. That notice included a summary of the petition prepared by 
Syngenta, the registrant on behalf of the Interregional Research 
Project Number 4 (IR-4). One comment was received on the notice of 
filing. EPA's response to this comment is discussed in Unit IV.C.
    EPA is also deleting several established tolerances in Sec.  
180.507(a)(1) and (a)(3) that are no longer needed. The revisions to 
Sec.  180.507(a)(1) are as follows:
    i. Delete eggplant and pepper tolerances at 2.0 ppm. Replaced with 
vegetable, fruiting group 8 (except tomato) at 2.0 ppm.
    ii. Delete soybean, forage at 25.0. Replaced with vegetable, 
foliage of legume, group 7 at 30.0 ppm.
    The revision to paragraph (a)(3) is to delete the time-limited 
tolerance for potato at 0.03 ppm because it has expired and remove it 
from Sec.  180.507.
    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....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2) of FFDCA, for a tolerance 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] on citrus, dried pulp at 20.0 ppm; citrus, oil at 40.0 
ppm; fruit, citrus, group 10 at 10.0 ppm; vegetable, foliage of legume, 
group 7 at 30.0 ppm; vegetable, fruiting, group 8, except tomato at 2.0 
ppm; pea and bean, succulent shelled, subgroup 6B at 0.5 ppm; and pea 
and bean, dried shelled, except soybean, subgroup 6C at 0.5 ppm. EPA's 
assessment of exposures and risks associated with establishing the 
tolerance 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. Specific information on the studies received and the nature 
of the toxic 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 can be found at http://www.epa.gov/fedrgstr/EPA-PEST/2000/September/Day-29/p25051.htm
.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level

[[Page 49360]]

of concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.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 (65 FR 58404) 
(FRL-6749-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.507) for the 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 
a variety of raw agricultural commodities. In addition, tolerances for 
livestock commodities have been established for the residues of 
azoxystrobin [methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate] in or on milk; meat, fat, and meat 
byproducts (mbyp) of cattle, goat, hog, horse, and sheep. Risk 
assessments were conducted by EPA to assess 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 one-day or single exposure.
     In conducting the acute dietary exposure assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\TM\), which incorporates food consumption 
data as reported by respondents in the USDA 1994-1996 and 1998 
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), 
and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the acute exposure assessments: One 
hundred percent of proposed and registered crops are assumed treated 
with azoxystrobin and tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: Some percent crop treated information for selected crops 
and tolerance-level residues.
    iii. Cancer. Azoxystrobin is classified as ``not likely to be a 
human carcinogen.'' Therefore, a cancer dietary exposure assessment was 
not performed.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on 
the actual percent of food treated for assessing chronic dietary risk 
only if the Agency can make the following findings: Condition 1, that 
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 such 
pesticide residue; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if 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 section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit 
data on PCT.
    The Agency used PCT information as follows: almond, 20%; apricot, 
15%; asparagus, 1%; dry beans and peas, 1%; green beans, 25%; garden 
beets, 15%; sugar beets, 1%; blueberry, 15%; cabbage, 5%; cantaloupes, 
10%; carrot, 10%; celery, 10%; cherry, 5%; sweet corn, 10%; cucumber, 
15%; filbert, 5%; garlic, 50%; grape, 10%; grapefruit, 20%; guar, 1%; 
honeydew melon, 5%; lettuce, 1%; mustard greens, 15%; onion, 10%; 
orange, 17%; parsley, 30%; peach, 5%; peanut, 10%; pecan, 1%; pepper, 
10%; pistachio, 30%; prunes and plum, 1%; potato, 25%; pumpkin, 20%; 
rapeseed (canola), 5%; rice, 25%; safflower, 5%; soybean, 1%; spinach, 
10%; summer and winter squash, 15%; strawberry, 20%; sunflower, 5%; 
tangerine, 20%; tomato, 20%; turnip greens, 15%; walnut, 1%; 
watermelon, 25%; and wheat, 1%.
     EPA estimates projected percent crop treated (PPCT) for a new 
pesticide use by assuming that the percent crop treated (PCT) during 
the pesticide's initial five years of use on a specific use site will 
not exceed the average PCT of the dominant pesticide (i.e., the one 
with the greatest PCT) on that site over the three most recent surveys. 
Comparisons are only made among pesticides of the same pesticide types 
(i.e., the dominant fungicide on the use site is selected for 
comparison with a new fungicide). The PCTs included in the average may 
be each for the same pesticide or for different pesticides since the 
same or different pesticides may dominate for each year selected. 
Typically, EPA uses USDA/NASS as the source for raw PCT data because it 
is publicly available and does not have to be calculated from available 
data sources. When a specific use site is not surveyed by USDA/NASS, 
EPA uses proprietary data and calculates the estimated PCT.
     The estimated PPCT for azoxystrobin on PH oranges is based on the 
recent PCT of market leader imazilil. The estimated PPCT for this new 
use of azoxystrobin is a high-end estimate that is highly unlikely to 
be exceeded during the initial five years of actual use. This is based 
on the fact that azoxystrobin complements imazilil in fungicide 
resistance programs to control imazilil-resistant populations of 
Penicillium spp. (green mold disease) and to reduce the potential for 
crop losses from fungicide-resistant populations of the pathogen. 
Azoxystrobin is highly unlikely to exceed imazilil use because it is 
used in imazilil resistance management. Thus the given PPCT for 
azoxystrobin is appropriate for use in chronic dietary risk assessment.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for azoxystrobin in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on

[[Page 49361]]

the physical 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 and SCI-GROW models, the estimated environmental 
concentrations (EECs) of azoxystrobin for chronic exposures are 
estimated to be 33 parts per billion (ppb) for surface water and 3.1 
ppb for ground water.The estimated drinking water concentrations 
(EDWCs) for azoxystrobin were calculated based on a maximum application 
rate for turf of 0.55 lb ai/A/application with 9 applications per year. 
Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model (DEEM-FCID). For chronic 
dietary risk assessment, the annual average concentration of 33 ppb was 
used to access 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 use on the following 
residential non-dietary sites: Residential turfgrass and ornamentals, 
as well as indoor surfaces. The risk assessment was conducted using the 
following residential exposure 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.
    Inhalation daily doses for residential handlers were calculated for 
the WDG formulation using data for mixing, loading and applying a 
liquid. Based on PHED unit exposure values from other handler scenarios 
with these formulation types, the exposure from a WDG is expected to be 
less than that of handling a liquid. The open mixing, loading, and 
applying liquid using a low pressure handwand (PHED) handler scenario 
was evaluated. The residential exposure and risk assessment for turf 
and ornamentals was conducted using the application rate for turf 
because it is the highest use rate.
    Exposures were estimated for residential handler activities 
including: Mix, load and spot application of liquid formulation (low-
pressure hand sprayer), and mix, load and broadcast application of 
liquid formulation (garden hose-end sprayer). In addition, short-term 
exposures were estimated for infants and children for postapplication 
exposure scenarios resulting from indoor surface treatment including: 
Toddlers' incidental ingestion of pesticide residues on hard indoor 
surfaces from hand-to-mouth transfer, and toddlers' incidental 
ingestion of pesticide residues on carpet/textile indoor surfaces from 
hand-to-mouth transfer. Intermediate-term exposures were also estimated 
for infants and children for residential post-application oral 
exposures.
    The exposure estimates are based on some upper-percentile (i.e., 
maximum application rate, initial amount of transferrable residue and 
duration of exposure) and some central tendency (i.e., surface area, 
hand-to-mouth activity, and body weight) assumptions and are considered 
to be representative of high-end exposures. The uncertainties 
associated with this assessment stem from the use of an assumed amount 
of pesticide available from turf, and assumptions regarding transfer of 
chemical residues and hand-to mouth activity. The estimated exposures 
are believed to be reasonable high-end estimates.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to azoxystrobin and 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 not assumed that azoxystrobin has 
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 the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold 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 data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The developmental and 
reproductive toxicity data, from a Prenatal Development Study in Rats, 
a Prenatal Development Study in Rabbits, and a Two-Generation 
Reproductive Toxicity Study in Rats, did not indicate increased 
susceptibility of young rats or rabbits to in utero and/or postnatal 
exposure.
    3. Conclusion. There is a complete toxicity data base for 
azoxystrobin and exposure data are complete or are estimated based on 
data that reasonably account for potential exposures. The Agency has 
determined that the 10X FQPA safety factor to protect infants and 
children should be removed (that is, set to 1) because, in addition to 
the completeness of the toxicological database and the lack of 
increased susceptibility of young rats and rabbits to pre- and 
postnatal exposure to azoxystrobin, the unrefined acute and chronic 
dietary exposure estimates will overestimate dietary exposure from 
food, and ground and surface water modeling data produce upper-bound 
concentration estimates. The residential postapplication assessment is 
based upon the residential SOPs. 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.

[[Page 49362]]

E. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs) which are used 
as a point of comparison against estimated drinking water 
concentrations (EDWCs). The DWLOC values are not regulatory standards 
for drinking water, but are theoretical upper limits on a pesticide's 
concentration in drinking water in light of total aggregate exposure to 
a pesticide in food and residential uses. More information on the use 
of DWLOCs in dietary aggregate risk assessments can be found at http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf
.

    More recently the Agency has used another approach to estimate 
aggregate exposure through food, residential and drinking water 
pathways. In this approach, modeled surface and ground water EDWCs are 
directly incorporated into the dietary exposure analysis, along with 
food. This provides a more realistic estimate of exposure because 
actual body weights and water consumption from the CSFII are used. The 
combined food and water exposures are then added to estimated exposure 
from residential sources to calculate aggregate risks. The resulting 
exposure and risk estimates are still considered to be high end, due to 
the assumptions used in developing drinking water modeling inputs.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to azoxystrobin will occupy 27 % of the aPAD for the U.S. population, 
24 % of the aPAD for females 13 years and older, 24 % of the aPAD for 
infants (<  1year old), and 74 % of the aPAD for children 1-2 years old, 
the subpopulation at greatest exposure. Therefore, EPA does not expect 
the aggregate exposure to exceed 100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
azoxystrobin from food and water will utilize 8 % of the cPAD for the 
U.S. population, 6 % of the cPAD for all infants (< 1 year old), and 19% 
of the cPAD for children 1-2 years old, the subpopulation at greatest 
exposure. Based on the use pattern, chronic residential exposure to 
residues of azoxystrobin is not expected. Therefore, EPA does not 
expect the aggregate exposure to exceed 100% of the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Azoxystrobin is 
currently registered for use that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic food, water and short-term exposures 
for azoxystrobin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water and residential 
exposures aggregated result in aggregate MOEs of 1,800 for the U.S. 
population, 2,150 for youth 13-19 years old, 250 for all infants less 
than one year old, 200 for children one to two years old and 2,150 for 
females 13-49 years old. These aggregate MOEs do not exceed the 
Agency's level of concern, a MOE of 100, for aggregate exposure to 
food, water and residential uses.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).of the risk 
from food and water, which do not exceed the Agency's level of concern. 
Azoxystrobin is currently registered for use(s) that could result in 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food, water and 
intermediate-term exposures for azoxystrobin.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food, water and 
residential exposures aggregated result in aggregate MOEs of 260 for 
children one to two years old. These aggregate MOEs do not exceed the 
Agency's level of concern, a MOE of 100, for aggregate exposure to 
food, water and residential uses.
    5. Aggregate cancer risk for U.S. population. Azoxystrobin has been 
classified as not likely to be carcinogenic to humans. Therefore, 
azoxystrobin is expected to pose at most a negligible 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, and to infants and children from aggregate 
exposure to azoxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methodology is available for enforcement of these 
tolerances. The gas chromatography/nitrogen phosphorous detector (GC/ 
NPD) method (RAM 243/04) has undergone a method validation by the EPA 
analytical laboratory. EPA comments have been incorporated and the 
revised method (designated RAM 243) will be submitted to FDA for 
inclusion in PAM, Volume II as an enforcement method. 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

    There are no Codex MRLs for azoxystrobin. Canada and Mexico have a 
MRL for tomato at 0.2. Mexico also has a MRL for chili pepper at 2.0 
ppm. These existing MRLs match those being established. There are no 
other Canadian or Mexican MRLs for commodities of concern in this 
action. Therefore, there are no international harmonization issues 
associated with this action.

C. Response to Comments

    One comment was received from a private citizen who opposed the 
manufacturing and selling of this product due to potential effects on 
the environment. This comment is considered irrelevant because the 
safety standard for approving tolerances under section 408 of FFDCA 
focuses on potential harms to human health and does not permit 
consideration of effects on the environment.

V. Conclusion

    Therefore, the tolerance is established for combined residues 
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] on citrus, dried pulp at 20.0 ppm; citrus, oil at 40.0 
ppm; fruit, citrus, group 10 at 10.0 ppm; vegetable, foliage of legume, 
group 7 at 30.0 ppm; vegetable, fruiting, group 8, except tomato at 2.0 
ppm; pea and bean, succulent shelled, subgroup 6B at 0.5 ppm; and pea 
and bean, dried shelled, except soybean, subgroup 6C at 0.5 ppm.

[[Page 49363]]

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this 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). 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., or 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). 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); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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: August 11, 2006.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.507 is amended in paragraph (a)(1), in the table, by 
removing the commodities eggplant; pepper; and soybean, forage; by 
alphabetically adding the commodities vegetable, foliage of legume; and 
vegetable, fruiting; and by revising the commodities citrus, dried 
pulp; citrus, oil; fruit, citrus; pea and bean, dried shelled, except 
soybean; and pea and bean, succulent shelled; and by removing paragraph 
(a)(3) to read as follows:

Sec.  180.507  Azoxystrobin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Citrus, dried pulp                          20.0
Citrus, oil                                 40.0
                                * * * * *
Fruit, citrus, group 10                     10.0
                                * * * * *
Pea and bean, dried shelled, except         0.5
 soybean, subgroup 6C
Pea and bean, succulent shelled, subgroup   0.5
 6B
                                * * * * *
Vegetable, foliage of legume, group 7       30.0
Vegetable, fruiting, group 8, except        2.0
 tomato
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-13656 Filed 8-22-06; 8:45 am]

BILLING CODE 6560-50-S