

[Federal Register: May 3, 2006 (Volume 71, Number 85)]
[Rules and Regulations]               
[Page 25961-25966]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my06-15]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0540; FRL-8063-2]

 
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, [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 Herb Subgroup 19A, fresh leaves; Herb 
Subgroup 19A, dried leaves; Spice Subgroup 19B, except black pepper; 
Rapeseed, seed; Rapeseed, Indian; Mustard, Indian, seed; Mustard, 
field, seed; Mustard, seed; Flax, seed; Sunflower, seed; Safflower, 
seed; Crambe, seed. 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).

DATES: This regulation is effective May 3, 2006. Objections and 
requests for hearings must be received on or before July 3, 2006.

ADDRESSES:  To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. 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 on the regulations.gov Web site. (EDOCKET, EPA's 
electronic public docket and comment system was replaced on November 
25, 2005, by an enhanced federal-wide electronic docket management and 
comment system located at http://www.regulations.gov. Follow the on-

line instructions.) Although listed in the index, some information is 
not publicly available, i.e., 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 either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This 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.
     Important Note: OPP will be moving to a new location the 
first week of May 2006. As a result, from Friday, April 28 to Friday, 
May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any 
deliveries at the Crystal Mall 2 address and this facility 
will be closed to the public. Beginning on May 8, 2006, the OPP 
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will 
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S. 
Crystal Drive, Arlington, VA 22202. The mail code for the mailing 
address will change to (7502P), but will otherwise remain the same. The 
OPP Regulatory Public Docket telephone number and hours of operation 
will remain the same after the move.

FOR FURTHER INFORMATION CONTACT:  Barbara Madden, Registration Division 
(7505C), 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.

[[Page 25962]]

     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 and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket), you may 

access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr.
 A frequently updated electronic version of 40 CFR part 180 is 

available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr. To 

access the OPPTS Harmonized Guidelines referenced in this document, go 
directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm
.


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 petitions (PP 
3E6637, 3E6749, and 4E6823) by Interregional Research Project 
4 (IR-4), 681 US Highway 1 South, North Brunswick, NJ 
08902-3390. The petitions requested that 40 CFR 180.507 be amended by 
establishing a tolerance 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 Herb Subgroup 19A, fresh leaves at 50 parts 
per million (ppm) (PP 4E6823); Herb Subgroup 19A, dried leaves at 260 
ppm (PP 4E6823); Spice Subgroup 19B, except black pepper at 38 ppm (PP 
3E6637); Rapeseed, seed at 0.5 ppm (PP 3E6749); Rapeseed, Indian at 0.5 
ppm (PP 3E6749); Mustard, Indian, seed at 0.5 ppm (PP 3E6749); Mustard, 
field, seed at 0.5 ppm (PP 3E6749); Mustard, seed at 0.5 ppm (PP 
3E6749); Flax, seed at 0.5 ppm (PP 3E6749); Sunflower, seed at 0.5 ppm 
(PP 3E6749); Safflower, seed at 0.5 ppm (PP 3E6749); and Crambe, seed 
at 0.5 ppm (PP 3E6749). 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 the tolerance established for coriander, 
leaves in Sec.  180.507(a), since it is being replaced by establishing 
the Herb Subgroup 19A and Spice Subgroup 19B.
    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 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] on Herb Subgroup 19A, fresh leaves at 50 ppm; Herb 
Subgroup 19A, dried leaves at 260 ppm; Spice Subgroup 19B, except black 
pepper at 38 ppm; rapeseed, seed at 0.5 ppm; Rapeseed, Indian at 0.5 
ppm; Mustard, Indian, seed at 0.5 ppm; Mustard, field, seed at 0.5 ppm; 
Mustard, seed at 0.5 ppm; Flax, seed at 0.5 ppm; Sunflower, seed at 0.5 
ppm; Safflower, seed at 0.5 ppm; and Crambe, seed 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 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.


[[Page 25963]]

    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 1-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\, Version 2.03), which incorporates food 
consumption data as reported by respondents in the United States 
Department of Agriculture (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 treated with azoxystrobin 
(100% CT) and tolerance-level residues for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the DEEM-FCID\TM\, Version 2.03, which 
incorporates food consumption data as reported by respondents in the 
USDA 1994-1996 and 1998 nationwide CSFII, and accumulated exposure to 
the chemical for each commodity. The following assumptions were made 
for the chronic exposure assessments: One hundred percent of proposed 
and registered crops are treated with azoxystrobin (100% CT) and 
tolerance-level residues for all commodities.
    iii. Cancer. Azoxystrobin is classified as ``not likely to be a 
human carcinogen.'' Therefore, a cancer dietary exposure assessment was 
not performed.
    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 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 FQPA Index Reservoir Screening Tool (FIRST) and 
screening concentration in ground water (SCI-GROW) models, the 
estimated environmental concentrations (EECs) of azoxystrobin for acute 
exposures are estimated to be 170 parts per billion (ppb) for surface 
water and 3.1 ppb for ground water. The EECs for chronic exposures are 
estimated to be 33 ppb for surface water and 3.1 ppb for ground water.
    The drinking water estimates are based upon the crop with the 
highest application rate (turf). The use of azoxystrobin on turf has 
the highest single and yearly application rate at 0.55 pound/active 
ingredient/Acre (lb ai/A) and 5 lb ai/A/year, respectively, this 
application rate was used in the FIRST and SCI-GROW models to estimate 
the concentrations of this chemical in surface water and ground water, 
respectively.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model (DEEM-FCID\TM\). For acute 
dietary risk assessment, the peak water concentration value of 107 ppb 
was used to access the contribution to drinking water. 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 post-
application activities. Toddlers may receive short- and intermediate-
term oral exposure from incidental ingestion during post-application 
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 post-application 
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

[[Page 25964]]

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 2-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 database 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 water and surface water modeling data produce upper-
bound concentration estimates. The residential post-application 
assessment is based upon the residential standard operational 
procedures (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.

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 water 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, 23% of the aPAD for 
infants (< 1 year 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 28% of the cPAD for the 
U.S. population, 19% of the cPAD for All infants (< 1 year old), and 70% 
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 500 for the U.S. 
population, 550 for youth 13-19 years old, 200 for all infants less 
than 1 year old, 120 for children 1 to 2 years old and 580 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

[[Page 25965]]

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 120 for 
children 1 to 2 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, Canadian, or Mexican MRLs for azoxystrobin in 
or on the proposed commodities. Therefore, harmonization of tolerances 
is not an issue.

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 the FFDCA 
focuses on potential harms to human health and does not permit 
consideration of effects on the environment.

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] on Herb Subgroup 19A, fresh leaves at 50 ppm; Herb 
Subgroup 19A, dried leaves at 260 ppm; Spice Subgroup 19B, except black 
pepper at 38 ppm; Rapeseed, seed at 0.5 ppm; Rapeseed, Indian at 0.5 
ppm; Mustard, Indian, seed at 0.5 ppm; Mustard, field, seed at 0.5 ppm; 
Mustard, seed at 0.5 ppm; Flax, seed at 0.5 ppm; Sunflower, seed at 0.5 
ppm; Safflower, seed at 0.5 ppm; and Crambe, seed at 0.5 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and 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 July 3, 
2006.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objetion or hearing request 
may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number EPA-HQ-OPP-2005-0540, to: Public 
Information and Records Integrity Branch, Information Technology and 
Resource Management Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. In person or by courier, bring a copy to the 
location of the PIRIB described in ADDRESSES.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(s) in the manner sought 
by the

[[Page 25966]]

requestor would be adequate to justify the action requested (40 CFR 
178.32).

VII. 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.

VIII. 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: April 25, 2006.
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 deleting the entries for ``Herb 
subgroup 19A, dried, except chive,'' and ``Herb subgroup 19A, fresh, 
except chive,'' and by alphabetically adding the following commodities 
to the table in paragraph (a) to read as follows:


Sec.  180.507   Azoxystrobin.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Crambe, seed.........................................                0.5
                                * * * * *
Flax, seed...........................................                0.5
                                * * * * *
Herb Subgroup 19A, dried leaves......................                260
Herb Subgroup 19A, fresh leaves......................                 50
                                * * * * *
Mustard, field, seed.................................                0.5
Mustard, Indian, seed................................                0.5
Mustard, seed........................................                0.5
                                * * * * *
Rapeseed, Indian.....................................                0.5
Rapeseed, seed.......................................                0.5
                                * * * * *
Safflower, seed......................................                0.5
                                * * * * *
Spice Subgroup 19B, except black pepper..............                 38
                                * * * * *
Sunflower, seed......................................                0.5
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 06-4157 Filed 5-2-06; 8:45 am]

BILLING CODE 6560-50-S
