Document ID: EPA-HQ-OPP-2009-0162-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Difenoconazole
Posted Date: 2010-04-28T04:00Z

[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Rules and Regulations]
[Pages 22256-22263]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9759]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0162; FRL-8817-3]

 Difenoconazole Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
fungicide difenoconazole in or on: Almond, hulls; brassica, head and 
stem, subgroup 5A; brassica, leafy green, subgroup 5B; citrus, dried 
pulp; citrus, oil; fruit, citrus, group 10; grape; grape, raisin; nut, 
tree, group 14; onion, bulb, subgroup 3-07A; onion, green, subgroup 3-
07B; pistachio; and vegetable, cucurbit, group 9. EPA is also revising 
the difenoconazole crop and animal tolerance expressions; deleting all 
section 18 difenoconazole tolerances that are no longer needed as a 
result of this action; reinstating tolerances for wheat forage, wheat 
grain, and wheat straw, which were inadvertently removed when previous 
tolerances were established; correcting the existing tolerance for 
beet, sugar; and deleting the grape import superscript. Syngenta Crop 
Protection, Inc. requested the new tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 28, 2010. Objections and 
requests for hearings must be received on or before June 28, 2010, 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-2009-0162. All documents in the 
docket are listed in the docket index available at http://www.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: Rosemary Kearns, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5611; e-mail address: kearns.rosemary@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

[[Page 22257]]

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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To 
access the OPPTS Harmonized Test Guidelines referenced in this document 
electronically, please go to http://www.epa.gov/oppts and select ``Test 
Methods & Guidelines'' on the left-side navigation menu.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0162 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 June 28, 2010.
    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-2009-0162, 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 Facility'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 April 8, 2009 (74 FR 15971) (FRL-8407-
4), 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 
8F7482) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, 
NC 27419. The petition requested that 40 CFR 180.475 be amended by 
establishing tolerances for residues of the fungicide difenoconazole, 
1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-
ylmethyl]-1H-1,2,4-triazole, in or on: Almond, hulls at 7 ppm; 
brassica, head and stem, subgroup 5A at 1.9 ppm; brassica, leafy green, 
subgroup 5B at 30 ppm; citrus, dried pulp at 2.5 ppm; citrus, oil at 28 
ppm; fruit, citrus, group 10 at 0.6 ppm; grape at 4 ppm; grape, raisin 
at 14 ppm; nut, tree, group 14 at 0.03 ppm; onion, bulb, subgroup 3-07A 
at 6 ppm; onion, green, bulb, subgroup 3-07B at 0.15 ppm; pistachios at 
0.03 ppm; vegetable, cucurbit, group 9 at 0.7 ppm. Although a tree nut 
group tolerance is being established, a separate pistachio tolerance is 
needed because pistachios are not currently part of the tree nut, group 
14. 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 has 
increased the proposed tolerance for both brassica, leafy green, 
subgroup 5B; and onion, green, subgroup 3-07B. EPA has decreased the 
proposed tolerance for citrus, dried pulp; citrus, oil; grape, raisin; 
and onion, bulb, subgroup 3-07A. EPA is also revising the 
difenoconazole crop and animal tolerance expressions; deleting all 
difenoconazole section 18 tolerances that are no longer needed as a 
result of this action; reinstating tolerances for wheat forage, wheat 
grain, and wheat straw, which were inadvertently removed when previous 
tolerances were established; deleting the grape import superscript 
designation; and correcting the existing tolerance for beet, sugar. The 
reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with 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 residues of difenoconazole in or on almond, hulls at 7.0 
ppm; brassica, head and stem, subgroup 5A at 1.9 ppm; brassica, leafy 
greens, subgroup 5B at 35 ppm; citrus, dried pulp at 2.0 ppm; citrus, 
oil at 25 ppm; fruit, citrus, group 10 at 0.60 ppm; grape at 4.0 ppm; 
grape, raisin at 6.0 ppm; nut, tree, group 14 at 0.03 ppm; onion, bulb, 
subgroup 3-07A at 0.20 ppm; onion, green, subgroup 3-07B at 6.0 ppm; 
pistachio at 0.03 ppm; and vegetable, cucurbit, group 9 at 0.70 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.
    Difenoconazole possesses low acute toxicity by the oral, dermal and

[[Page 22258]]

inhalation routes of exposure. It is not considered to be an eye or 
skin irritant and is not a sensitizer. Difenoconazole exhibits some 
evidence of neurotoxicity in the database, but the effects are 
transient or occur at doses exceeding the limit dose. It is not 
mutagenic and it is not a developmental or reproductive toxicant. 
Chronic effects in rats and mice are seen as cumulative decreases in 
body weight gains.
    No evidence of carcinogenicity was seen in rats. Evidence for 
carcinogenicity was seen in mice where liver tumors were induced at 
doses which were considered to be excessively high for carcinogenicity 
testing. Treatment-related non-neoplastic lesions were confined to the 
liver. Difenoconazole is classified as a possible human carcinogen. 
Based on excessive toxicity observed at the doses at which tumors were 
seen, the absence of tumors at the lower doses, and the absence of 
genotoxic effects, EPA considers the cancer effects to be a threshold 
effect.
    Specific information on the studies received and the nature of the 
adverse effects caused by difenoconazole 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.regulations.gov in document ``Difenoconazole FQPA Human Health Risk 
Assessment for the Section 3 Registration of Difenoconazole New Uses on 
Bulb Vegetables, Brassica Leafy Vegetables, Cucurbit Vegetables, Citrus 
Fruits, Grapes, Pistachios, and Tree Nuts'' at pages 51-63 in docket ID 
number EPA-HQ-OPP-2009-0162.

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 difenoconazole used 
for human risk assessment can be found at http://www.regulations.gov in 
document ``Difenoconazole FQPA Human Health Risk Assessment for the 
Section 3 Registration of Difenoconazole New Uses on Bulb Vegetables, 
Brassica Leafy Vegetables, Cucurbit Vegetables, Citrus Fruits, Grapes, 
Pistachios, and Tree Nuts'' at pages 16-18 in docket ID number EPA-HQ-
OPP-2009-0162.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to difenoconazole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing difenoconazole 
tolerances in 40 CFR 180.475. EPA assessed dietary exposures from 
difenoconazole 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 assumed 
tolerance-level residues, 100% crop treated for all the registered and 
proposed crops, and default processing factors.
    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 assumed tolerance-
level residues for some commodities, field trial residues for the 
majority of commodities, and 100% crop treated. EPA used experimental 
processing factors for some crops and default processing factors for 
the remainder.
    iii. Cancer. A quantitative exposure assessment to evaluate cancer 
risk is unnecessary. The cancer NOAEL for difenoconazole is higher than 
the NOAEL used as a Point of Departure in calculating the chronic RfD. 
Therefore, chronic exposure would be equal to or greater than the 
exposure value used in assessing cancer risk, and the chronic dietary 
risk estimate is protective of any cancer effects.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use PCT information in the dietary assessment for 
difenoconazole. EPA did use anticipated residues in the chronic dietary 
assessment for difenoconazole; field trial residues and experimental 
processing factors were used for some commodities.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such Data Call-Ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for difenoconazole in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of difenoconazole. 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 using PRZM/EXAMS and Screening Concentration in Ground 
Water (SCI-GROW) models, the estimated drinking water concentrations

[[Page 22259]]

(EDWCs) of difenoconazole for acute exposures are estimated to be 15.8 
parts per billion (ppb) for surface water and 0.0123 ppb for ground 
water. EDWCs for chronic exposures for non-cancer assessments are 
estimated to be 10.4 ppb for surface water and 0.0123 ppb for ground 
water.
    EDWCs for chronic exposures for cancer assessments are estimated to 
be 7.62 ppb for surface water and 0.0123 ppb for ground water. These 
EDWCs are the same or lower than the EDWC for chronic non-cancer 
exposure.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of 
15.8 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 10.4 ppb 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).
    Difenoconazole is currently registered for the following uses that 
could result in residential exposures: ornamentals. EPA assessed 
residential exposure using the following assumptions: No new 
residential uses are being requested at this time. However, adults and 
adolescents may be exposed to difenoconazole from its currently 
registered use on ornamentals.
    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.'' Difenoconazole is a member 
of the triazole-containing class of pesticides, often referred to as 
the conazoles. EPA is not currently following a cumulative risk 
approach based on a common mechanism of toxicity for the conazoles. The 
conazole pesticides, as a whole, tend to exhibit carcinogenic, 
developmental, reproductive, and/or neurological effects in mammals. 
Additionally, all the members of this class of compounds are capable of 
forming, via environmental and metabolic activities, 1,2,4-triazole, 
triazolylalanine and/or triazolylacetic acid. These metabolites have 
also been shown to cause developmental, reproductive, and/or 
neurological effects. Structural similarities and sharing a common 
effect does not constitute a common mechanism of toxicity. Evidence is 
needed to establish that the chemicals operate by the same, or 
essentially the same sequence of major biochemical events. Hence, the 
underlying basis of toxicity is the same, or essentially the same for 
each chemical. A number of potential events could contribute to the 
toxicity of conazoles (e.g., altered cholesterol levels, stress 
responses, altered DNA methylation). At this time, there is not 
sufficient evidence to determine whether conazoles share common 
mechanisms of toxicity. Without such understanding, there is no basis 
to make a common mechanism of toxicity finding for the diverse range of 
effects found. Investigations into the conazoles are currently being 
undertaken by EPA's Office of Research and Development. When the 
results of this research are available, the Agency will make a 
determination of whether there is a common mechanism of toxicity and, 
therefore, a basis for assessing cumulative risk. 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.
    Triazole-derived pesticides can form the common metabolite 1,2,4-
triazole and three triazole conjugates (triazole alanine, triazole 
acetic acid, and triazolylpyruvic acid). To support existing tolerances 
and to establish new tolerances for triazole-derivative pesticides, 
including prothioconazole, EPA conducted a human health risk assessment 
for exposure to 1,2,4-triazole, triazole alanine, and triazole acetic 
acid resulting from the use of all current and pending uses of any 
triazole-derived fungicide as of September 1, 2005. The risk assessment 
is a highly conservative, screening-level evaluation in terms of 
hazards associated with common metabolites (e.g., use of a maximum 
combination of uncertainty factors) and potential dietary and non-
dietary exposures (i.e., high end estimates of both dietary and non-
dietary exposures). In addition, the Agency retained the additional 10X 
FQPA safety factor for the protection of infants and children. The 
assessment included evaluations of risks for various subgroups, 
including those comprised of infants and children. The Agency's 
September 1, 2005 risk assessment can be found in the propiconazole 
reregistration docket at http://www.regulations.gov (docket ID EPA-HQ-
OPP-2005-0497).
    In October and December of 2008, EPA updated the dietary and 
aggregate risk assessments for exposure to 1,2,4-triazole, triazole 
alanine, triazole acetic acid, and triazolylpyruvic acid resulting from 
the use of all current and pending uses of any triazole-derived 
fungicide to support existing tolerances and to establish new 
tolerances for new uses of metconazole (canola, corn, cotton, and 
sugarcane; PP 7F7221, 7F7292, 08FL03), propiconazole (beets, parsley, 
and pineapple; PP 7F7300), prothioconazole (wheat and barley; PP 
7F7279), and tetraconazole (grapes; PP 7E7273). These updated dietary 
and aggregate assessments are below the Agency's level of concern. 
These updated triazole risk assessments can be found in the rule's 
docket (EPA-HQ-OPP-2008-0327) and the following associated dockets at 
http://www.regulations.gov.

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 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 Agency determined that 
the available studies indicate no increased susceptibility of rats or 
rabbits to in utero and/or postnatal exposure to difenoconazole. In the 
prenatal developmental toxicity studies in rats and rabbits and the 
two-generation reproduction study in rats, toxicity to the fetuses/
offspring, when observed, occurred at equivalent or higher dosed than 
in the maternal/parental animals. The developmental toxicity was 
manifested as alterations in fetal ossifications at 171 mg/kg/day; the 
developmental NOAEL was 85 mg/kg/day. In a developmental toxicity study 
in rabbits, maternal and developmental toxicity were seen at the same 
dose level (75 mg/kg/day). Maternal toxicity in rabbits were manifested 
as decreased in body weight gain and decreased in food consumption, 
while developmental toxicity was manifested as decreased

[[Page 22260]]

fetal weight. In a 2-generation reproduction study in rats, there were 
decreases in maternal body weight gain and decreases in body weights of 
F1 males at the LOAEL of 12.5 mg/kg/day; the parental systemic and off 
spring toxicity NOAEL was 1.25 mg/kg/day.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for difenoconazole is adequate for 
conducting this risk assessment. In accordance with 40 CFR part 158 
toxicology data requirements, an immunotoxicity study (OPPTS Harmonized 
Guideline 870.7800) is required for difenoconazole. In the absence of 
specific immunotoxicity studies, EPA has evaluated the available 
difenoconazole toxicity data to determine whether an additional 
database uncertainty factor is needed to account for potential 
immunotoxicity. There are no indications in the available studies that 
organs associated with immune function, such as the thymus and spleen, 
are affected by difenoconazole, and difenoconazole does not belong to a 
class of chemicals (e.g., the organotins, heavy metals, or halogenated 
aromatic hydrocarbons) that would be expected to be immunotoxic. 
Therefore, EPA does not believe that conducting immunotoxicity testing 
will result in a point of departure lower than those already selected 
for difenoconazole risk assessment, and an additional database 
uncertainty factor is not needed to account for the lack of this study.
    ii. Difenoconazole exhibits some evidence of neurotoxicity in the 
database, but the effects are transient or occur at doses exceeding the 
limit dose. There is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no indication of increased susceptibility of rats or 
rabbits fetuses to in utero and/or postnatal exposure in the 
developmental and reproductive toxicity data.
    iv. Although some storage stability data are still required, 
tolerances and field trial data used in the risk assessment are 
sufficiently high, that even if residues degrade in frozen storage 
prior to analysis, the risk assessment will be protective. Although a 
confined rotational crop study is still required, the plant back 
interval is sufficiently long that no detectable residues are expected 
in rotated commodities. Furthermore, conservative (protective) acute 
dietary food exposure assessments were performed based on 100% crop 
trested and tolerance-level residues. Chronic dietary exposure 
assessments were based on tolerance-level residues for some 
commodities, field trial residues for the majority of commodities, and 
experimental processing factor for some crops, and 100% crop treated. 
The field trial data and experimental processing factors from 
processing studies are based on reliable data from the maximum use 
rate, and are unlikely to understate the residues. EPA also made 
conservative (protective) assumptions in the ground water and surface 
water modeling used to assess exposure to difenoconazole in drinking 
water. EPA used similarly conservative assumptions to assess post-
application exposure of children as well as incidental oral exposure of 
toddlers. These assessments will not underestimate the exposure and 
risks posed by difenoconazole.

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. Using the exposure assumptions described in this 
unit for acute exposure, EPA has concluded that acute exposure to 
difenoconazole from food and water will utilize 16% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
difenoconazole from food and water will utilize 44% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
difenoconazole are not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Difenoconazole is currently registered for ornamentals that could 
result in short-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with short-term residential exposures to difenoconazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures aggregated result in aggregate MOEs of at 
least 180. Values higher than 100 are not of concern. The proposed 
residential scenarios result in exposure only to adults. Therefore, 
short-term aggregate assessments were not conducted for infants and 
children.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Difenoconazole is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to difenoconazole through food and water, which has already been 
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. As discussed above 
the chronic dietary risk assessment is protective of any cancer 
effects.
    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 difenoconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methodology is available to enforce the 
tolerances listed under 40 CFR 180.475. Method AG-575B (gas 
chromatography/nitrogen-phosphorus detection) is available for 
enforcement in crops, and Method AG-676 (gas chromatography/mass 
selective detection) is available for confirmation. Method AG-676A is 
available for enforcement and confirmation in canola and barley. Method 
REM 147.07b (liquid chromatography/mass spectrometry/mass spectrometry) 
is available for enforcement in livestock and methods AG-544A (gas 
chromatography/nitrogen-phosphorus

[[Page 22261]]

detection) and REM 147.06 (high performance liquid chromatography/UV 
detection), which determine difenoconazole and CGA 205375, 
respectively, are available for confirmation. These methods may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (401) 305-2905; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    Codex Maximum Residue Limits (MRLs) for residues of difenoconazole 
per se have been established at 0.3 ppm for leek, 0.5 ppm for broccoli, 
0.2 ppm for Brussels sprouts, 0.2 ppm for cabbage, 0.2 ppm for 
cauliflower, and 0.1 ppm for grape. Canadian and Mexican MRLs have been 
established for difenoconazole; however, no MRLs have been established 
for the requested crops. Based on the submitted field trial data for 
brassica vegetables, green onions, and grapes, harmonization with 
established Codex MRLs is not possible because the MRLs for brassica 
vegetables, leek, and grape are lower than residue values seen in U.S. 
field trials. This is a result of differences in agricultural 
practices.

C. Response to Comments

    There were no public comments received.

D. Revisions to Petitioned-For Tolerances

    1. The existing time-limited section 18 tolerances in/on almond and 
almond, hulls are 0.05 ppm, and 5.0 ppm, respectively. This rule 
establishes new tolerances in/on the nut, tree, group 14 (which 
includes almonds); and on almond, hulls, at 0.03 ppm and 7.0 ppm, 
respectively. As explained below, keeping the currently established 
higher section 18 tolerance in/on almond (0.05 ppm) is not needed and 
is being revoked, and because a new higher tolerance for almond, hulls 
is being established at 7.0 ppm, the currently established lower 
section 18 tolerances in/on almond, hulls (5.0 ppm) is also being 
revoked.
    The section 18 tolerances were based on the same almond field trial 
study used to establish the new section 3 nut, tree, group 14 
tolerance, and to revise the almond, hulls tolerance. The original data 
were submitted by Interregional Research Project Number 4 (IR-4) in 
support of the section 18 and then samples were transferred to Syngenta 
where they were re-analyzed and the new re-analysis data were submitted 
in support of this section 3 petition. The differences in the analyses/
re-analyses data of the same almond and almond hulls samples is the 
reason for the differences in section 18 and section 3 tolerance 
determinations. It should be noted that in the original data submitted 
by IR-4, residues in/on all nutmeat samples were determined to be <0.05 
ppm and so the section 18 tolerance in/on almonds was set at 0.05 ppm.
    2. The existing time-limited section 18 tolerances for cantaloupe, 
cucumber, and watermelon are all 1.0 ppm. This rule establishes a new 
tolerance for vegetable, cucurbit group 9 (which includes all three 
crops) at a lower tolerance of 0.70 ppm. The section 18 tolerances are 
based on translation from available fruiting vegetable data using a 1-
day PHI. For this petition, Syngenta has provided actual cucurbit 
vegetable data reflecting the section 18 use rate and a more 
conservative 0-day PHI, which resulted in a lower tolerance. Therefore, 
separate higher tolerances at 1.0 ppm are not needed for cantaloupe, 
cucumber, and watermelon, and the section 18 tolerances in/on these 
crops are being revoked.
    3. Based upon review of the residue data supporting the petition, 
EPA has increased the proposed tolerance for brassica, leafy green, 
subgroup 5B from 30 ppm to 35 ppm.
    4. The registrant requested a tolerance for bulb onions, subgroup 
3-07A at 6.0 ppm, and for green onions, subgroup 3-07B at 0.15 ppm. 
These proposed tolerances appear to have been transposed by the 
petitioner. Based on the submitted residue data, EPA is establishing 
tolerances at 0.20 ppm for onions, bulb, subgroup 3-07A and at 6.0 ppm 
for onions, green, subgroup 3-07B.
    5. EPA has decreased the proposed tolerances for citrus, dried pulp 
(2.5 ppm); citrus, oil (28 ppm); and grape, raisin (14 ppm). The 
processing data indicate the proposed tolerances for processed 
commodities are too high and that tolerances of 2.0 ppm for citrus, 
dried pulp; 25 ppm for citrus, oil; and 6.0 ppm for grape, raisin are 
appropriate.
    6. EPA is revising the existing difenoconazole tolerance 
expressions in paragraphs (a)(1) and (a)(2) to clarify what needs to be 
analyzed for tolerance compliance.
    7. Tolerances are being reinstated at 0.1 ppm for wheat forage; 
wheat grain; and wheat straw. These tolerances were inadvertently 
removed from 40 CFR 180.475(a) as a result of a rulemaking that added 
new difenoconazole tolerances but used inaccurate terminology as to how 
the CFR was to be amended. (73 FR 1503, January 9, 2008) (FRL-8343-5).
    8. The petitioner previously requested beet, sugar at 0.3 ppm via 
petition 6F7115 which published August 22, 2007. (72 FR 47010) (FRL-
8142-5). The associated rule for that petition published January 9, 
2008, and erroneously established this tolerance at 0.01 ppm even 
though the preamble to that rule noted that the petition sought a 
tolerance level 0.3 ppm. (73 FR 1503, January 9, 2008). Therefore, the 
existing beet sugar tolerance is being revised from 0.01 to 0.3 ppm to 
correct this inadvertent error.
    9. Revising the existing grape tolerance and deleting the import 
superscript designation which is no longer needed.

V. Conclusion

    Therefore, tolerances are established for residues of the 
fungicide, difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-
4methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on almond, 
hulls at 7.0 ppm; brassica, head and stem, subgroup 5A at 1.9 ppm; 
brassica, leafy greens, subgroup 5B at 35 ppm; citrus, dried pulp at 
2.0 ppm; citrus, oil at 25 ppm; fruit, citrus, group 10 at 0.60 ppm; 
grape at 4.0 ppm; grape, raisin at 6.0 ppm; nut, tree, group 14 at 0.03 
ppm; onion, bulb, subgroup 3-07A at 0.20 ppm; onion, green, subgroup 3-
07B at 6.0 ppm; pistachio at 0.03 ppm; and vegetable, cucurbit, group 9 
at 0.70 ppm. This rule also revises the crop and animal difenoconazole 
tolerance expressions; deletes all section 18 difenoconazole tolerances 
that are no longer needed as a result of this action; reinstates 0.1 
ppm tolerances for wheat forage, wheat grain, and wheat straw; corrects 
the existing tolerance for beet, sugar to 0.3 ppm; and deletes the 
grape import superscript designation.

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, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from

[[Page 22262]]

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: April 19, 2010.
G. Jeffrey Herndon,
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 180.475 is amended by revising paragraph (a)(1); revising 
(a)(2) introductory text; and removing and reserving paragraph (b).

Sec.  180.475  Difenoconazole; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
difenoconazole, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance 
levels specified below is to be determined by measuring only 
difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-
dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on the following raw 
agricultural commodities:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Almond, hulls.........................................                                                       7.0
Apple, wet pomace.....................................                                                       4.5
Banana\1\.............................................                                                       0.2
Barley, grain.........................................                                                       0.1
Barley, hay...........................................                                                      0.05
Barley, straw.........................................                                                      0.05
Beet, sugar...........................................                                                       0.3
Beet, sugar, dried pulp...............................                                                       1.9
Brassica, head and stem, subgroup 5A..................                                                       1.9
Brassica, leafy green, subgroup 5B....................                                                        35
Canola, seed..........................................                                                      0.01
Citrus, dried pulp....................................                                                       2.0
Citrus, oil...........................................                                                        25
Corn, sweet, forage...................................                                                      0.01
Corn, sweet, kernel plus cob with husks removed.......                                                      0.01
Corn, sweet, stover...................................                                                      0.01
Cotton, gin byproducts................................                                                      0.05
Cotton, undelinted seed...............................                                                      0.05
Fruit, citrus, group 10...............................                                                      0.60
Fruit, pome group 11..................................                                                       1.0
Grape.................................................                                                       4.0
Grape, raisin.........................................                                                       6.0
Nut, tree, group 14...................................                                                      0.03
Onion, bulb, subgroup 3-07A...........................                                                      0.20
Onion, green, subgroup 3-07B..........................                                                       6.0
Papaya\1\.............................................                                                      0.30
Pistachio.............................................                                                      0.03
Potato, processed waste...............................                                                      0.04
Rye, grain\1\.........................................                                                       0.1
Vegetable, cucurbit, group 9..........................                                                      0.70

[[Page 22263]]

 
Vegetable, fruiting, group 8..........................                                                      0.60
Vegetable, tuberous and corm, subgroup 1C.............                                                      0.01
Wheat, forage.........................................                                                       0.1
Wheat, grain..........................................                                                       0.1
Wheat, straw..........................................                                                       0.1
----------------------------------------------------------------------------------------------------------------
\1\There are no U.S. registrations.

    (2) Tolerances are established for residues of difenoconazole, 
including its metabolites and degradates, in the commodities in the 
table below. Compliance with the tolerance levels specified below is to 
be determined by measuring difenoconazole, 1-[2-[2-chloro-4-(4-
chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-
triazole, and its metabolite, CGA-205375, 1-[2-chloro-4-(4-chloro-
phenoxy)phenyl]-2-[1,2,4]triazol-1-yl-ethanol, in the following 
commodities:
* * * * *
    (b) Section 18 emergency exemptions. [Reserved]
* * * * *

[FR Doc. 2010-9759 Filed 4-27-10; 8:45 am]
BILLING CODE 6560-50-S