Difenoconazole; Pesticide Tolerance, 53979-53984 [E6-15090]
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Federal Register / Vol. 71, No. 177 / Wednesday, September 13, 2006 / Rules and Regulations
‘‘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
XI. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 31, 2006.
James Jones,
Director, Office of Pesticides Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1271 is added to
subpart D to read as follows:
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I
§ 180.1271 Eucalyptus oil; exemption from
the requirement of a tolerance.
An exemption from the requirement
of tolerance is established for residues
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of eucalyptus oil in or on honey,
honeycomb, and honeycomb with
honey when used at 2g or less
eucalyptus oil per hive, where the
eucalyptus oil contains 80% or more
eucalyptol.
[FR Doc. E6–14995 Filed 9–12–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0024; FRL– 8085–1]
Difenoconazole; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of
difenoconazole, (1-[2-[2-chloro-4-(4chlorophenoxy)phenyl]-4-methyl-1,3dioxolan-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)-2chlorophenyl]-4-methyl-1,3-dioxolan-2yl-methyl)-1H-1,2,4-triazole, to the
following, (1-[2-[2-chloro-4-(4chlorophenoxy)phenyl]-4-methyl-1,3dioxolan-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
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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
https://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.
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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 https://
www.regulations.gov, you may access
this ‘‘Federal Register’’ document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
www.gpoaccess.gov/ecfr.
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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: https://
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
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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-(4chlorophenoxy)phenyl]-4-methyl-1,3dioxolan-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 (https://www.epa.gov/
pesticides/foodfeed/); for these reasons,
a tolerance is not required.
EPA is also deleting several
established tolerances in § 180.475(b)
that are no longer needed, as a result of
this action. The tolerance deletions
under § 180.475(b) are time-limited
tolerances established under section 18
emergency exemptions that are
superceded by the establishment of
permanent tolerances for
difenoconazole § 180.475(a). The
revisions to § 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 § 180.475(b), because a
permanent tolerance for corn, sweet,
kernel plus cob with husks removed at
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0.01 ppm is being established by this
action under § 180.475(a).
2. Delete the time-limited tolerance
(expires 12/31/08) for corn, sweet,
forage at 0.1 ppm under § 180.475(b),
because a permanent tolerance for corn,
sweet, forage at 0.01 ppm is being
established by this action under
§ 180.475(a).
3. Delete the time-limited tolerance
(expires 12/31/08) for corn, sweet,
stover at 0.1 ppm under § 180.475(b)
because a permanent tolerance for corn,
sweet, stover at 0.01 ppm is being
established by this action under
§ 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 https://
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-(4chlorophenoxy)phenyl]-4-methyl-1,3dioxolan-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
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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 noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at the following website:
https://www.epa.gov/fedrgstr/EPA-PEST/
2000/September/Day-15/p23773.htm.
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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 nonthreshold 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 https://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
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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 (DEEMFCIDTM, 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 DEEMTM,
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-FCIDTM, 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
DEEMTM, 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.
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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 https://www.epa.gov/
oppfead1/trac/science.
Based on the First Index Reservoir
Screening Tool (FIRST) and screening
concentration in groundwater (SCIGROW) 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 nonoccupational, 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
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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 https://www.epa.gov/
pesticides/cumulative. The Agency’s
risk assessment for the common
metabolites is available in the
propiconazole reregistration docket at
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
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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.
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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
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13SER1
Federal Register / Vol. 71, No. 177 / Wednesday, September 13, 2006 / Rules and Regulations
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.
rmajette on PROD1PC67 with RULES1
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-[2chloro-4-(4-chlorophenoxy)phenyl]-4methyl-1,3-dioxolan-2-ylmethyl]-1H1,2,4-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-(4chlorophenoxy)-2-chlorophenyl]-4methyl-1,3-dioxolan-2-yl-methyl)-1H1,2,4-triazole, to the following, (1-[2-[2chloro-4-(4-chlorophenoxy)phenyl]-4methyl-1,3-dioxolan-2-ylmethyl]-1H1,2,4-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.
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15:10 Sep 12, 2006
Jkt 208001
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
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
53983
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).
E:\FR\FM\13SER1.SGM
13SER1
53984
Federal Register / Vol. 71, No. 177 / Wednesday, September 13, 2006 / Rules and Regulations
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.
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.475 is amended as
follows:
I 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-(4chlorophenoxy)-2-chlorophenyl]-4methyl-1,3-dioxolan-2-yl-methyl)-1H1,2,4-triazole’’ to ‘‘(1-[2-[2-chloro-4-(4chlorophenoxy)phenyl]-4-methyl-1,3dioxolan-2-ylmethyl]-1H-1,2,4triazole)’’; by alphabetically adding
commodities to the table; and
I ii. Paragraph (b) is removed and
reserved.
I The amendments read as follows:
I
§ 180.475 Difenoconazole; tolerances for
residues.
*
Commodity
*
*
*
Barley, hay ......................
Barley, straw ...................
*
*
*
Corn, sweet, forage ........
Corn, sweet, kernel plus
cob with husks removed .........................
Corn, sweet, stover ........
Cotton, gin byproducts ...
Cotton, undelinted seed
*
*
*
Fruit, pome, group 113 ...
*
*
*
Grape3 ............................
*
*
*
Parts per million
*
*
0.05
0.05
*
*
0.01
0.01
0.01
0.05
0.05
*
*
*
*
*
*
0.10
0.10
rmajette on PROD1PC67 with RULES1
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]
BILLING CODE 6560–50–S
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15:10 Sep 12, 2006
Jkt 208001
[EPA–HQ–OPP–2005–0071; FRL–8080–9]
Epoxiconazole; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
Therefore, 40 CFR chapter I is
amended as follows:
*
40 CFR Part 180
AGENCY:
I
(a) *
ENVIRONMENTAL PROTECTION
AGENCY
SUMMARY: This regulation establishes
tolerances for residues of epoxiconazole
in or on bananas and coffee. BASF
Corporation, Agricultural Products
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
September 13, 2006. Objections and
requests for hearings must be received
on or before November 13, 2006.
ADDRESSES: EPA has established a
docket for this action under docket
Identification (ID) number EPA–HQ–
2005–0071. 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
https://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 telephone number for the
Docket Facility is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Mary L. Waller, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9354; e-mail
address:waller.mary@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
affectedP entities may include, but are
not limited to:
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
• Crop production (NAICS 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
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–2005–0071 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.
E:\FR\FM\13SER1.SGM
13SER1
Agencies
[Federal Register Volume 71, Number 177 (Wednesday, September 13, 2006)]
[Rules and Regulations]
[Pages 53979-53984]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15090]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://
www.regulations.gov, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://
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: https://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
(https://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 https://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: https://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 https://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 https://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 https://www.epa.gov/pesticides/
cumulative. The Agency's risk assessment for the common metabolites is
available in the propiconazole reregistration docket at
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]
BILLING CODE 6560-50-S