Document ID: EPA-HQ-OPP-2006-0024-0003
Agency: epa
Document Type: Rule
Title: Difenoconazole; Pesticide Tolerance
Posted Date: 2006-09-13T13:16:35Z

[Federal Register: September 13, 2006 (Volume 71, Number 177)]
[Rules and Regulations]               
[Page 53979-53984]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13se06-10]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0024; FRL- 8085-1]

 
Difenoconazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
difenoconazole, (1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-
1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole), when used as a seed 
treatment in or on barley, hay; barley, straw; corn, sweet, forage; 
corn, sweet, kernel plus cob with husks removed; corn, sweet, stover; 
cotton, gin byproducts; cotton, undelinted seed; and as a foliar 
treatment on fruit, pome, group 11 (import); and on grape (import). 
Syngenta Crop Protection, Inc. requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA). This rule also revises the 
chemical name of the active ingredient, difenoconazole, from [(2S,4R)/
(2R/4S)]/[(2R/4R)]/(2S,4S) 1-(2-[4-(4-chlorophenoxy)-2-chlorophenyl]-4-
methyl-1,3-dioxolan-2-yl-methyl)-1H-1,2,4-triazole, to the following, 
(1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-
ylmethyl]-1H-1,2,4-triazole). EPA is also deleting certain 
difenoconazole tolerances that are no longer needed as result of this 
action.

DATES: This regulation is effective September 13, 2006. Objections and 
requests for hearings must be received on or before November 13, 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-2006-0024. 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: Tony Kish, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9443; e-mail address: kish.tony@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.

[[Page 53980]]

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/ecfr
.

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-2006-0024 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 November 13, 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-2006-0024, 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 April 12, 2006 (71 FR 18748) (FRL-7765-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
0F6155, 6F4748, 8F4953, and 9E5076) by Syngenta Crop Protection, Inc., 
P.O. Box 18300, Greensboro, NC 27419-8300. 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), when used as a seed treatment, in or on barley, hay at 0.05 
parts per million (ppm) (PP 6F4748); barley, straw at 0.05 ppm (PP 
6F4748); corn, sweet, forage at 0.01 ppm (PP 0F6155); corn, sweet, 
kernel plus cob with husks removed at 0.01 ppm (PP 0F6155); corn, 
sweet, stover at 0.01 ppm (PP 0F6155); cotton, gin byproducts at 0.05 
ppm (PP 8F4953); cotton, undelinted seed at 0.05 ppm (PP 8F4953); and 
as a foliar treatment on fruit, pome, group 11 at 0.10 ppm (PP 9E5076); 
and on grape at 0.1 ppm (9E5076). That notice included a summary of the 
petition prepared by Syngenta Crop Protection, Inc., the registrant. 
There were no comments received in response to the notice of filing.
    Syngenta requested a tolerance of 0.05 ppm on barley, forage. 
However, a tolerance is not being established for barley forage 
because: It is an insignificant animal feed item; it is not included in 
Table 1 of the Residue Chemistry Test Guidelines, OPPTS 860.1000; and 
it is not an accepted name in the Food and Feed Commodity Vocabulary 
(http://www.epa.gov/pesticides/foodfeed/); for these reasons, a 

tolerance is not required.
    EPA is also deleting several established tolerances in Sec.  
180.475(b) that are no longer needed, as a result of this action. The 
tolerance deletions under Sec.  180.475(b) are time-limited tolerances 
established under section 18 emergency exemptions that are superceded 
by the establishment of permanent tolerances for difenoconazole Sec.  
180.475(a). The revisions to Sec.  180.475 are as follows:
    1. Delete the time-limited tolerance (expires 12/31/08) for corn, 
sweet, kernel plus cob with husks removed at 0.1 ppm under Sec.  
180.475(b), because a permanent tolerance for corn, sweet, kernel plus 
cob with husks removed at 0.01 ppm is being established by this action 
under Sec.  180.475(a).
    2. Delete the time-limited tolerance (expires 12/31/08) for corn, 
sweet, forage at 0.1 ppm under Sec.  180.475(b), because a permanent 
tolerance for corn, sweet, forage at 0.01 ppm is being established by 
this action under Sec.  180.475(a).
    3. Delete the time-limited tolerance (expires 12/31/08) for corn, 
sweet, stover at 0.1 ppm under Sec.  180.475(b) because a permanent 
tolerance for corn, sweet, stover at 0.01 ppm is being established by 
this action under Sec.  180.475(a).
    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 residues of difenoconazole, (1-
[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-
ylmethyl]-1H-1,2,4-triazole), when used as a seed treatment in or on 
barley, hay at 0.05 ppm; barley, straw at 0.05 ppm; corn, sweet, forage 
at 0.01 ppm; corn, sweet, kernel plus cob with

[[Page 53981]]

husks removed at 0.01 ppm; corn, sweet, stover at 0.01 ppm; cotton, gin 
byproducts at 0.05 ppm; cotton, undelinted seed at 0.05 ppm; and as a 
foliar treatment on fruit, pome, group 11 at 0.10 ppm; and on grape at 
0.10 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 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 the 
following website: http://www.epa.gov/fedrgstr/EPA-PEST/2000/September/Day-15/p23773.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/factsheets/riskassess.htm
.

    A summary of the toxicological endpoints for difenoconazole used 
for human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of September 15, 2000 (65 FR 55911) 
(FRL-6589-3).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.475) for the residues of difenoconazole, in or 
on a variety of raw agricultural commodities. Risk assessments were 
conducted by EPA to assess 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. The only population subgroup 
for which an acute dietary exposure analysis was performed was females 
13-49 years old. No endpoint of concern for the general population that 
was attributable to a single exposure (dose) from the oral toxicity 
studies was identified. The Dietary Exposure Evaluation Model with Food 
Commodity Intake Database (DEEM-FCID\TM\, version 2.03) analysis 
evaluated the individual food consumption 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: Tolerance-level residues; 100% percent of each 
crop treated; and DEEM\TM\, version 7.76, processing factors for all 
proposed and registered 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: Tolerance-level residues for barley, rye, and all 
proposed commodities; anticipated residues for all previously 
registered commodities, except barley and rye; 100% of each crop 
treated; and DEEM\TM\, version 7.76, default processing factors for all 
commodities.
    iii. Cancer. The Agency determined that a reference dose (RfD) 
approach is appropriate to evaluate potential cancer risk to 
difenoconazole because the chronic RfD is lower than the cancer RfD. No 
separate exposure assessment was conducted for evaluating cancer risk.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the 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 chemicals that have been 
measured in food. If EPA relies on such information, EPA must pursuant 
to section 408(f)(1) require 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. Following 
the initial data submission, EPA is authorized to require similar data 
on a time frame it deems appropriate. For the present action, EPA will 
issue such data call-ins for information relating to anticipated 
residues as are required by FFDCA section 408(b)(2)(E) and authorized 
under FFDCA section 408(f)(1). Such data call-ins will be required to 
be submitted no later than 5 years from the date of issuance of this 
tolerance.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for difenoconazole 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 difenoconazole. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppfead1/trac/science.

    Based on the First Index Reservoir Screening Tool (FIRST) and 
screening concentration in groundwater (SCI-GROW) models, the estimated 
environmental concentrations (EECs) of difenoconazole for acute 
exposures are estimated to be 0.60 parts per billion (ppb) for surface 
water and 0.00084 ppb for ground water. The EECs for chronic exposures 
are estimated to be 0.14 ppb for surface water and 0.00084 ppb for 
ground 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 not registered for use on any sites that would 
result in residential exposure.
    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

[[Page 53982]]

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. Although conazoles act similarly in plants (fungi) by 
inhibiting ergosterol biosynthesis, there is not necessarily a 
relationship between this pesticidal activity and their mechanism of 
toxicity in mammals. Structural similarities do 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 (EPA, 2002). A variable pattern of 
toxicological responses are found for conazoles. Some are hepatotoxic 
and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. 
Some induce developmental, reproductive, and neurological effects in 
rodents. Furthermore, the conazoles have a diverse range of biochemical 
events including altered cholesterol levels, stress responses, and 
altered DNA methylation. It is not clearly understood whether these 
biochemical events are directly connected to the toxicological 
outcomes. Thus, there is currently no evidence to indicate that 
conazoles share common mechanisms of toxicity and EPA is not following 
a cumulative risk approach based on a common mechanism of toxicity for 
the conazoles. For information regarding EPA's procedures for 
cumulating effects from substances found to have a common mechanism of 
toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative.
 The Agency's risk assessment for the common metabolites is 

available in the propiconazole reregistration docket at 
http://www.regulations.gov in docket ID number EPA-HQ-OPP-2005-0497.

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 evidence shows that 
difenoconazole is neither a developmental nor a reproductive toxicant, 
and that there are no residual uncertainties in the toxicology database 
for difenoconazole. Therefore, infants and children are not expected to 
exhibit increased sensitivity and the Agency's LOC for prenatal and 
postnatal toxicity is not exceeded.
    3. Conclusion. The Agency has concluded that the default 10x FQPA 
Safety Factor should be reduced to 1x in assessments of both acute and 
chronic dietary exposures, for the following reasons: There is a 
complete toxicological database for difenoconazole; there was no 
evidence of increased pre-natal or post-natal susceptibility to 
difenoconazole; difenoconazole is neither a developmental nor a 
reproductive toxicant; exposure data are complete, or are estimated, 
based on data that reasonably account for potential exposures; and 
there is high overall confidence in the risk assessment.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to difenoconazole will occupy < 1.0% of the acute population adjusted 
dose (aPAD) for females 13-49 years old. An endpoint of concern 
attributable to a single exposure (dose) was not identified from the 
oral toxicity studies (including the rat and rabbit developmental 
toxicity studies) for the general U.S. population, or for the infants 
and children subgroups, therefore acute risk analyses were not 
performed for these groups.
    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 2.4% of the chronic 
population adjusted dose (cPAD) for the U.S. population; 10% of the 
cPAD for all infants (< 1 year old); and 16% of the cPAD for children 1-
2 years old. There are no residential uses for difenoconazole that 
result in chronic residential exposure to difenoconazole.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure in addition to chronic exposure to food 
and water (which are considered to be the background exposure level).
    Difenoconazole is not registered for use on any site(s) that would 
result in residential exposure, so the aggregate short-term risk is 
solely the sum of the risk from food and water. These risks do not 
exceed the Agency's LOC.
    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).
    Difenoconazole is not registered for use on any site(s) that would 
result in residential exposure, so the aggregate short-term risk is 
solely the sum of the risk from food and water. These risks do not 
exceed the Agency's LOC.
    5. Aggregate cancer risk for U.S. population. The Agency determined 
that an RfD approach is appropriate to evaluate potential cancer risks 
to difenoconazole. The chronic risk assessment adequately protects 
against cancer risk because the chronic RfD is lower than the cancer 
RfD.
    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 difenoconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available for tolerance 
enforcement. Method AG-575B, the current enforcement method for plant 
commodities, quantitates levels of difenoconazole by gas chromatography 
(GC) with nitrogen/phosphorous (N/P) detection. Its limit of 
quantitation (LOQ) is 0.01 ppm for difenoconazole residues. Method AG-
544, the current enforcement method for livestock commodities, also 
quantitates levels of difenoconazole by GC with N/P detection. The LOQs 
for difenoconazole residues using this method are 0.01 ppm in meat and 
eggs and 0.01 ppm in milk. Additionally a GC/mass-spectrometry 
detection (MSD) method for the confirmation of difenoconazole residues 
in/on canola seed has recently undergone petition method validation 
(PMV) at EPA's Analytical Chemistry Lab (ACL). The confirmatory method 
has been determined to be suitable for tolerance enforcement once the

[[Page 53983]]

revisions recommended by ACL are incorporated into it.

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits (MRLs) for difenoconazole. Therefore, no 
conflict exists between any of the existing and proposed U.S. 
difenoconazole tolerances and any difenoconazole MRL.

C. Response to Comments

    A notice of filing was published in the Federal Register, of April 
12, 2006 (71 FR 18748, FRL-7765-7, EPA-HQ-OPP-2006-0024). No public 
comments were received regarding the notice.

V. Conclusion

    Tolerances are established for residues of difenoconazole, (1-[2-
[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-
1H-1,2,4-triazole), when used as a seed treatment, in or on barley, hay 
at 0.05 ppm; barley, straw at 0.05 ppm; corn, sweet, forage at 0.01 
ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, 
sweet, stover at 0.01 ppm; cotton, gin byproducts at 0.05 ppm; cotton, 
undelinted seed at 0.05 ppm; and as a foliar treatment on fruit, pome, 
group 11 at 0.10 ppm; and on grape at 0.10 ppm.
    This rule also changes the chemical name of the active ingredient, 
difenoconazole, from (2S,4R)/(2R/4S)]/[(2R/4R)]/(2S,4S) 1-(2-[4-(4-
chlorophenoxy)-2-chlorophenyl]-4-methyl-1,3-dioxolan-2-yl-methyl)-1H-
1,2,4-triazole, to the following, (1-[2-[2-chloro-4-(4-
chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-
triazole). The change in the chemical name of the active ingredient is 
necessary to conform to the nomenclature of the Chemical Abstracts 
Service, the body which the Office of Pesticide Programs regards as 
authoritative for issues of chemical nomenclature. This name change 
makes no substantive change to either the chemical identity of 
difenoconazole or to the effect of the tolerances.
    EPA is not establishing the requested tolerance of 0.05 ppm on 
barley, forage, because as stated previously, a tolerance is no longer 
required for this commodity. EPA is also deleting several established 
tolerances in Sec.180.475 (b) that are no longer needed, as a result of 
this action: 0.1 ppm on corn, sweet, kernel plus cob with husks removed 
with a 12/31/08 expiration date; 0.1 ppm on corn, sweet, forage with a 
12/31/08 expiration data; and 0.1 ppm on corn, sweet, stover with a 12/
31/08 expiration date.

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. 801et 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).

[[Page 53984]]

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 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 180.475 is amended as follows:
0
i. In paragraph (a) by revising the chemical name of the active 
ingredient, difenoconazole, from ``(2S,4R)/(2R/4S)]/[(2R/4R)]/(2S,4S) 
1-(2-[4-(4-chlorophenoxy)-2-chlorophenyl]-4-methyl-1,3-dioxolan-2-yl-
methyl)-1H-1,2,4-triazole'' to ``(1-[2-[2-chloro-4-(4-
chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-
triazole)''; by alphabetically adding commodities to the table; and
0
ii. Paragraph (b) is removed and reserved.
0
The amendments read as follows:

Sec.  180.475  Difenoconazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Barley, hay..........................................               0.05
Barley, straw........................................               0.05
                                * * * * *
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, pome, group 11\3\.............................               0.10
                                * * * * *
Grape\3\.............................................               0.10
                                * * * * *
------------------------------------------------------------------------
\3\ There are no U.S. Registrations on fruit, pome, group 11 or on
  grapes, as of September 13, 2006.

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. E6-15090 Filed 9-12-06; 8:45 am]

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