Epoxiconazole; Pesticide Tolerance, 53984-53989 [E6-14994]
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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 ...................
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*
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
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*
0.01
0.01
0.01
0.05
0.05
*
*
*
*
*
*
0.10
0.10
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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]
*
*
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*
[FR Doc. E6–15090 Filed 9–12–06; 8:45 am]
BILLING CODE 6560–50–S
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[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:
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• 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.
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In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2005–0071, 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
telephone number for the Docket
Facility is (703) 305–5805.
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II. Background and Statutory Findings
In the Federal Register of September
22, 2000, (65 FR 57338) (FRL–6737–8),
and February 15, 2006, (71 FR 7952)
(FRL–7759–5), EPA issued notices
pursuant to section 408(d)(3) of FFDCA,
21 U.S.C. 346a(d)(3), announcing the
filing of pesticide petitions (PP 7E4885
and 0E6128) by BASF Corporation,
Agricultural Products, P.O. Box 13528;
Research Triangle Park, NC 27709–3528.
These petitions requested that 40 CFR
180 be amended by establishing
tolerances for residues of the fungicide
epoxiconazole, (2RS, 3SR)-3-(2chlorophenyl)-2-(4-fluorophenyl)-2(1H1,2,4-triazol-1-yl)methyl oxirane, in or
on bananas at 0.5 parts per million
(ppm) (PP 7E4885) and coffee, bean at
0.05 ppm (PP 0E6128). These notices
included a summary of the petition
prepared by BASF, the registrant.
Comments were received on the notices
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of filing. EPA’s response to these
comments is discussed in Unit IV., C
below.
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
epoxiconazole in or on bananas at 0.5
parts per million (ppm) and coffee, bean
at 0.05 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,
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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
epoxiconazole as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://
www.regulations.gov under the docket
ID number EPA–HQ–OPP–2005–0071–
0005.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which 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 LOAEL
identified 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 and 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/
oppfead1/trac/science/, and https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
Summaries of the toxicological
endpoints for epoxiconazole used for
the human risk assessment are shown in
the following Table 1.
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TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR EPOXICONAZOLE FOR USE IN HUMAN RISK
ASSESSMENT.
Exposure/Scenario
Dose used in risk assessment, interspecies and intraspecies and any traditional UF
Special FQPA SF and level of
concern for risk assessment
Study and toxicological effects
NOAEL = 5 mg/kg/day
UF = 100
Acute RfD = 0.05 mg/kg/day
Special FQPA SF = 1X
aPAD = acute RfD/
Special FQPA SF = 0.05 mg/kg/
day
Developmental toxicity - rat
LOAEL = 15 mg/kg/day based on
increased incidence of skeletal
variations
Chronic dietary (all populations)
NOAEL = 2 mg/kg/day
UF = 100
Chronic RfD = 0.02 mg/kg/day
Special FQPA SF = 1X
cPAD = chronic RfD/
Special FQPA SF = 0.02 mg/kg/
day
2–Year rat carcinogenicity
LOAEL = 7 mg/kg/day based on
increased incidences of ovarian
cysts
and
adrenal
histopathological findings in females
Cancer (oral, dermal, inhalation)
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Acute dietary (females 13-49
years of age).
Classification: Likely human carcinogen with a Q1*(mg/kg/day)-1 of 3.04 x 10-2 by oral route based on the occurrence of liver tumors in male and female mice
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. This final rule establishes the
first tolerances for residues of
epoxiconazole in or on imported
bananas and coffee. There are no
registered uses in the United States,
therefore the only expected exposure to
epoxiconazole is from imported bananas
and coffee. Risk assessments were
conducted by EPA to assess dietary
exposures from epoxiconazole in food
as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a one-day or
single exposure.
In conducting the acute dietary
exposure assessment EPA used the
Dietary Exposure Evaluation Model
software with the Food Commodity
Intake Database (DEEM-FCIDTM), which
incorporates food consumption data as
reported by respondents in the United
States Department of Agriculture
(USDA) 1994–1996 and 1998
Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII), and
accumulated exposure to the chemical
for each commodity. The following
assumptions were made for the acute
exposure assessments: The acute
analysis was based on the highly
conservative assumption of tolerancelevel residues and 100% crop treated
(CT).
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the DEEM-FCIDTM, 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
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following assumptions were made for
the chronic exposure assessments: The
chronic analysis was based on the
highly conservative assumption of
tolerance-level residues and 100% CT.
iii. Cancer. The Agency classified
epoxiconazole as ‘‘likely to be
carcinogenic to humans’’ by the oral
route based on the occurrence of liver
tumors in male and female mice. The
cancer dietary exposure estimate for the
general U.S. population is 3 x10-5 mg/
kg/day. The cancer dietary exposure
assessment was performed for the
general U.S. population using
anticipated residues, and 100% CT.
Anticipated residues were calculated for
coffee and banana using the average
field trial values from the crop field trial
data.
iv. Anticipated residue and percent
crop treated (PCT) information. Section
408(b)(2)(E) of FFDCA authorizes EPA
to use available data and information on
the anticipated residue levels of
pesticide residues in food and the actual
levels of pesticide chemicals that have
been measured in food. If EPA relies on
such information, EPA must 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. As required by
section 408(b)(2)(E) of FFDCA, EPA will
issue a Data Call-In for information
relating to anticipated residues to be
submitted no later than 5 years from the
date of issuance of this tolerance.
2. Dietary exposure from drinking
water. There is no expectation that
epoxiconazole residues would occur in
surface water or ground water sources of
drinking water. Epoxiconazole is
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proposed for use only on imported
coffee and banana commodities, the sole
anticipated exposure route for the U.S.
population is via dietary (food)
exposure. There are no registered uses
of epoxiconazole in the United States.
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).
Epoxiconazole is not registered for
use on any sites that would result in
residential exposure and a non-dietary
risk assessment is not required.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
mulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Epoxiconazole 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
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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
prothioconazole reregistration docket at
https://www.regulations.gov, docket ID
number EPA–HQ–OPP–2005–0497.
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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.–
a. There is no evidence of susceptibility
following in utero exposure in the rabbit
developmental toxicity and both in
utero and postnatal exposure in the 2generation rat reproduction study.
b. There is low concern for the
susceptibility seen in the rat
developmental toxicity study because
the effects observed were relatively mild
for both the pregnant dams (decrease in
body weight gain/food consumption)
and the rat pups (increased incidence of
minor skeletal variations - rudimentary
cervical ribs and accessory 14th rib).
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c. There does not appear to be any
enhanced susceptibility in the young to
endocrine effects based on the results of
the two-generation study (parental male
reduced adrenal weights were not
observed in offspring).
d. Although there is some uncertainty
associated with the acute and
subchronic neurotoxicity data, it is
unlikely that the information requested
to upgrade these studies will alter the
NOAELs used for the dietary endpoints.
This is because the positive findings in
the acute neurotoxicity study were mild
and at high doses (1,000 mg/kg in males
and 2,000 mg/kg in females). Also, the
piloerection observed in the females in
the acute neurotoxicity study would
likely have been noted or recorded
during the subchronic and chronic
rodent studies as part of the daily
cageside observations for clinical signs.
Clinical observations were made, but no
signs were noted in any of the studies.
This suggests that chronic exposure up
to 80 mg/kg/day in rats (rat
carcinogenicity study) does not lead to
readily observable clinical signs such as
piloerection.
e. The non-cancer dietary food
exposure assessment utilizes proposed
tolerance level residues and 100% CT
information for all commodities. By
using these screening-level assessments,
acute and chronic exposures/risks will
not be underestimated.
f. Drinking water and residential
exposure are not expected.
3. Conclusion. There is a complete
toxicity data base for epoxiconazole and
exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures. There
is no evidence of susceptibility
following in utero and/or postnatal
exposure in the rabbit developmental
toxicity and in the 2-generation rat
reproduction study. There is low
concern for the susceptibility seen in
the rat developmental toxicity study and
no residual uncertainty for prenatal
and/or postnatal toxicity. There is no
evidence of significant neurotoxicity, as
indicated by both the acute and
subchronic neurotoxicity studies. Acute
and chronic dietary food exposure
estimates are based on conservative
(Tier 1) assumptions, and will not
underestimate exposure/risk. There is
no potential for drinking water or
residential exposure. Based on these
data and conclusions, there are no
FQPA UFs and the FQPA Safety Factor
can be reduced to 1x.
E. Aggregate Risks and Determination of
Safety
1. Acute risk. Using the exposure
assumptions discussed in this unit for
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acute exposure, the acute dietary
exposure from food to epoxiconazole
will occupy 2% of the aPAD for females
13-49 years, the only population
subgroup of concern. There are no
proposed or existing residential uses for
epoxiconazole. The proposed uses are
limited to imported bananas and coffee.
Since there are no registered uses
associated with epoxiconazole in the
U.S., the only route of exposure is
dietary (food only). Aggregate risk is
limited to dietary exposure (food only)
and does not exceed the Agency’s level
of concern.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to epoxiconazole from
food will utilize 1.0% of the cPAD for
the U.S. population, 3.7% of the cPAD
for all infants <1 year, and 4.6% of the
cPAD for children 1-2 years, the most
highly exposed population subgroup.
There are no residential uses for
epoxiconazole that result in chronic
residential exposure to epoxiconazole,
and no exposure is expected from
drinking water. Therefore, aggregate risk
does not exceed the Agency’s level of
concern.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Epoxiconazole is not registered for
use on any sites that would result in
residential exposure and there is no
expectation that epoxiconazole residues
would occur via drinking water
consumption. Therefore, the aggregate
risk is the sum of the risk from food,
which does not exceed the Agency’s
level of concern.
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).
Epoxiconazole is not registered for
use on any sites that would result in
residential exposure and there is no
expectation that epoxiconazole residues
would occur via drinking water
consumption. Therefore, the aggregate
risk is the sum of the risk from food,
which does not exceed the Agency’s
level of concern.
5. Aggregate cancer risk for U.S.
population. The Agency classified
epoxiconazole as ‘‘likely to be
carcinogenic to humans’’by the oral
route based on the occurrence of liver
tumors in male and female mice. The
estimated unit risk, Q1* is 3.04 x 10-2.
The cancer dietary exposure estimate for
the general U.S. population is 9.03 x
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10-7 which is below the Agency’s level
of concern (generally in the range of 1x
10-6).
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
epoxiconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(gas chromatography/electron capture
detector (GC/ECD) method - BASF
method 309/1) is available to enforce
the tolerance expression. The method
may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 0755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
B. International Residue Limits
Codex Alimentarius and Canada have
not established or proposed any MRLs
for epoxiconazole. As there are no
established or proposed MRLs for either
banana or coffee, harmonization with
international tolerances is not an issue
for the current petitions.
C. Response to Comments
A private citizen responded to PP
0E6128. Comments were received on
February 15, 2006 objecting to the use,
manufacturing and sale of this product.
The comments further stated that not
enough tests have been completed (long
term or combined tests), that there is
little indication of safety and questioned
the validity of animal testing.
The Agency response is as follows:
The Agency has a complete toxicity
database on epoxiconazole, including
several long-term or chronic studies.
The commenter submitted no scientific
information or data to support their
claims. For additional in-depth
response, refer to docket EPA–HQ–
OPP–2004–0325, 69 FR 63083 at https://
www.regulations.gov.
rmajette on PROD1PC67 with RULES1
V. Conclusion
Therefore, tolerances are established
for residues of epoxiconazole, [rel-1[[(2R,3S)-3-(2-chlorophenyl)-2-(4fluorophenyl)oxiranyl]methyl]-1H-1,2,4triazole], in or on bananas at 0.5 ppm
and coffee at 0.05 ppm.
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
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15:10 Sep 12, 2006
Jkt 208001
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
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive Order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
E:\FR\FM\13SER1.SGM
13SER1
Federal Register / Vol. 71, No. 177 / Wednesday, September 13, 2006 / Rules and Regulations
and pests, Reporting and recordkeeping
requirements.
Dated: August 28, 2006.
James Jones,
Director, Office of Pesticide 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 180.619 is added to read as
follows:
I
§ 180.619 Epoxiconazole; tolerances for
residues.
comments that oppose it. We have
explained the reasons for this
authorization in the preamble of the
immediate final rule. Unless we get
written comments which oppose this
authorization during the comment
period, the immediate final rule will
become effective on the date it
establishes, and we will not take further
action on this proposal. If we receive
comments that oppose this action, we
will withdraw the immediate final rule
and it will not take effect. We will
respond to public comments in a later
final rule based on this proposal. You
may not have another opportunity for
comment.
Final authorization will become
effective on November 13, 2006 unless
EPA receives adverse written comment
on or before October 13, 2006. If EPA
receives such comment, it will publish
a timely withdrawal of this immediate
final rule in the Federal Register and
inform the public that this authorization
will not take effect.
Parts per
ADDRESSES: Submit your comments,
Commodity
million
identified by Docket ID No. EPA–R04–
RCRA–2006–0575 by one of the
Banana* ....................................
0.5
Coffee*
0.05 following methods:
• https://www.regulations.gov: Follow
*No U.S. Registration as of August 4, 2006
the on-line instructions for submitting
(b) Section 18 emergency exemptions. comments.
• E-mail: middlebrooks.gail@epa.gov.
[Reserved]
• Fax: (404) 562–8439 (prior to
(c) Tolerances with regional
faxing, please notify the EPA contact
Registrations. [Reserved]
listed below).
(d) Indirect or inadvertent residues.
• Mail: Send written comments to
[Reserved]
Gail Middlebrooks, RCRA Services
[FR Doc. E6–14994 Filed 9–12–06; 8:45 am]
Section, RCRA Programs Branch, Waste
BILLING CODE 6560–50–S
Management Division, U.S.
Environmental Protection Agency, The
Sam Nunn Federal Center, 61 Forsyth
ENVIRONMENTAL PROTECTION
Street, SW., Atlanta, Georgia 30303–
AGENCY
8960.
• Hand Delivery: Gail Middlebrooks,
40 CFR Part 271
RCRA Services Section, RCRA Programs
[EPA–R04–RCRA–2006–0575; FRL–8219–5]
Branch, Waste Management Division,
U.S. Environmental Protection Agency,
Alabama: Final Authorization of State
The Sam Nunn Federal Center, 61
Hazardous Waste Management
Forsyth Street, SW., Atlanta, Georgia
Program Revision
30303–8960. Such deliveries are only
accepted during the Docket’s normal
AGENCY: Environmental Protection
hours of operation, and special
Agency (EPA).
arrangements should be made for
ACTION: Immediate final rule.
deliveries of boxed information.
SUMMARY: Alabama has applied to EPA
Instructions: Direct your comments to
for Final authorization of the changes to Docket ID No. EPA–R04–RCRA–2006–
its hazardous waste program under the
0575. EPA’s policy is that all comments
Resource Conservation and Recovery
received will be included in the public
Act (RCRA). EPA proposes to grant final docket without change and may be
authorization to Alabama. In the ‘‘Rules made available online at https://
and Regulations’’ section of this Federal www.regulations.gov including any
Register, EPA is authorizing the changes personal information provided, unless
by an immediate final rule. EPA did not the comment includes information
make a proposal prior to the immediate
claimed to be Confidential Business
final rule because we believe this action Information (CBI), or other information
is not controversial and do not expect
whose disclosure is restricted by statute.
DATES:
rmajette on PROD1PC67 with RULES1
(a) General. Tolerances are
established for the residues of the
fungicide epoxiconazole [(rel-1[[(2R,3S)-3-(2-chlorophenyl)-2-(4fluorophenyl)oxiranyl]methyl]-1H-1,2,4triazole]) in or on the following
commodities:
VerDate Aug<31>2005
15:10 Sep 12, 2006
Jkt 208001
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
53989
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or e-mail. The
https://www.regulations.gov website is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through https://
www.regulations.gov, your e-mail
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses. (For additional information
about EPA’s public docket, visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm).
Docket: All documents in the docket
are listed in the https://
www.regulations.gov index. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available either
electronically in https://
www.regulations.gov, or in hard copy.
You may view and copy Alabama’s
application at the EPA Region 4 Library,
The Sam Nunn Atlanta Federal Center,
61 Forsyth Street, SW., Atlanta, Georgia
30303–8960. The Library is open from 8
a.m. to 4:30 p.m. Monday through
Friday, excluding legal holidays. The
Library telephone number is (404) 562–
8190.
You may also view and copy
Alabama’s application from 8 a.m. to
4:30 p.m. at The Alabama Department of
Environmental Management, 1400
Coliseum Blvd., Montgomery, Alabama
36110–2059.
FOR FURTHER INFORMATION CONTACT: Gail
Middlebrooks, RCRA Services Section,
RCRA Programs Branch, Waste
Management Division, U.S.
Environmental Protection Agency, The
Sam Nunn Federal Center, 61 Forsyth
Street, SW., Atlanta, Georgia 30303–
8960; (404) 562–8494; fax number: (404)
E:\FR\FM\13SER1.SGM
13SER1
]]>Agencies
[Federal Register Volume 71, Number 177 (Wednesday, September 13, 2006)]
[Rules and Regulations]
[Pages 53984-53989]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14994]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0071; FRL-8080-9]
Epoxiconazole; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
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:
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.
[[Page 53985]]
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0071, 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
telephone number for the Docket Facility is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of September 22, 2000, (65 FR 57338) (FRL-
6737-8), and February 15, 2006, (71 FR 7952) (FRL-7759-5), EPA issued
notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3),
announcing the filing of pesticide petitions (PP 7E4885 and 0E6128) by
BASF Corporation, Agricultural Products, P.O. Box 13528; Research
Triangle Park, NC 27709-3528. These petitions requested that 40 CFR 180
be amended by establishing tolerances for residues of the fungicide
epoxiconazole, (2RS, 3SR)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-2(1H-
1,2,4-triazol-1-yl)methyl oxirane, in or on bananas at 0.5 parts per
million (ppm) (PP 7E4885) and coffee, bean at 0.05 ppm (PP 0E6128).
These notices included a summary of the petition prepared by BASF, the
registrant. Comments were received on the notices of filing. EPA's
response to these comments is discussed in Unit IV., C below.
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 epoxiconazole in or
on bananas at 0.5 parts per million (ppm) and coffee, bean at 0.05 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 epoxiconazole 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 https://
www.regulations.gov under the docket ID number EPA-HQ-OPP-2005-0071-
0005.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which 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 LOAEL
identified 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 and 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/oppfead1/trac/science/, and
https://www.epa.gov/pesticides/factsheets/riskassess.htm.
Summaries of the toxicological endpoints for epoxiconazole used for
the human risk assessment are shown in the following Table 1.
[[Page 53986]]
Table 1.--Summary of Toxicological Dose and Endpoints for Epoxiconazole for Use in Human Risk Assessment.
----------------------------------------------------------------------------------------------------------------
Dose used in risk
assessment, Special FQPA SF and
Exposure/Scenario interspecies and level of concern for Study and toxicological
intraspecies and any risk assessment effects
traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-49 years of NOAEL = 5 mg/kg/day Special FQPA SF = 1X Developmental toxicity
age). UF = 100............... aPAD = acute RfD/...... rat
Acute RfD = 0.05 mg/kg/ Special FQPA SF = 0.05 LOAEL = 15 mg/kg/day
day. mg/kg/day. based on increased
incidence of skeletal
variations
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL = 2 mg/kg/day Special FQPA SF = 1X 2-Year rat
UF = 100............... cPAD = chronic RfD/.... carcinogenicity
Chronic RfD = 0.02 mg/ Special FQPA SF = 0.02 LOAEL = 7 mg/kg/day
kg/day. mg/kg/day. based on increased
incidences of ovarian
cysts and adrenal
histopathological
findings in females
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: Likely human carcinogen with a Q1*(mg/kg/day)-1 of 3.04 x
10-2 by oral route based on the occurrence of liver tumors in male and
female mice
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. This final rule
establishes the first tolerances for residues of epoxiconazole in or on
imported bananas and coffee. There are no registered uses in the United
States, therefore the only expected exposure to epoxiconazole is from
imported bananas and coffee. Risk assessments were conducted by EPA to
assess dietary exposures from epoxiconazole in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one-day or single exposure.
In conducting the acute dietary exposure assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM), which incorporates food
consumption data as reported by respondents in the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII), and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the acute exposure assessments: The acute
analysis was based on the highly conservative assumption of tolerance-
level residues and 100% crop treated (CT).
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCIDTM, 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: The chronic analysis was based on the highly
conservative assumption of tolerance-level residues and 100% CT.
iii. Cancer. The Agency classified epoxiconazole as ``likely to be
carcinogenic to humans'' by the oral route based on the occurrence of
liver tumors in male and female mice. The cancer dietary exposure
estimate for the general U.S. population is 3 x10-5 mg/kg/
day. The cancer dietary exposure assessment was performed for the
general U.S. population using anticipated residues, and 100% CT.
Anticipated residues were calculated for coffee and banana using the
average field trial values from the crop field trial data.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must 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. As required by section 408(b)(2)(E) of FFDCA, EPA
will issue a Data Call-In for information relating to anticipated
residues to be submitted no later than 5 years from the date of
issuance of this tolerance.
2. Dietary exposure from drinking water. There is no expectation
that epoxiconazole residues would occur in surface water or ground
water sources of drinking water. Epoxiconazole is proposed for use only
on imported coffee and banana commodities, the sole anticipated
exposure route for the U.S. population is via dietary (food) exposure.
There are no registered uses of epoxiconazole in the United States.
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).
Epoxiconazole is not registered for use on any sites that would
result in residential exposure and a non-dietary risk assessment is not
required.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the mulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Epoxiconazole 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
[[Page 53987]]
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 prothioconazole reregistration docket at https://
www.regulations.gov, 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.-a. There is no evidence of
susceptibility following in utero exposure in the rabbit developmental
toxicity and both in utero and postnatal exposure in the 2-generation
rat reproduction study.
b. There is low concern for the susceptibility seen in the rat
developmental toxicity study because the effects observed were
relatively mild for both the pregnant dams (decrease in body weight
gain/food consumption) and the rat pups (increased incidence of minor
skeletal variations - rudimentary cervical ribs and accessory
14th rib).
c. There does not appear to be any enhanced susceptibility in the
young to endocrine effects based on the results of the two-generation
study (parental male reduced adrenal weights were not observed in
offspring).
d. Although there is some uncertainty associated with the acute and
subchronic neurotoxicity data, it is unlikely that the information
requested to upgrade these studies will alter the NOAELs used for the
dietary endpoints. This is because the positive findings in the acute
neurotoxicity study were mild and at high doses (1,000 mg/kg in males
and 2,000 mg/kg in females). Also, the piloerection observed in the
females in the acute neurotoxicity study would likely have been noted
or recorded during the subchronic and chronic rodent studies as part of
the daily cageside observations for clinical signs. Clinical
observations were made, but no signs were noted in any of the studies.
This suggests that chronic exposure up to 80 mg/kg/day in rats (rat
carcinogenicity study) does not lead to readily observable clinical
signs such as piloerection.
e. The non-cancer dietary food exposure assessment utilizes
proposed tolerance level residues and 100% CT information for all
commodities. By using these screening-level assessments, acute and
chronic exposures/risks will not be underestimated.
f. Drinking water and residential exposure are not expected.
3. Conclusion. There is a complete toxicity data base for
epoxiconazole and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. There is no
evidence of susceptibility following in utero and/or postnatal exposure
in the rabbit developmental toxicity and in the 2-generation rat
reproduction study. There is low concern for the susceptibility seen in
the rat developmental toxicity study and no residual uncertainty for
prenatal and/or postnatal toxicity. There is no evidence of significant
neurotoxicity, as indicated by both the acute and subchronic
neurotoxicity studies. Acute and chronic dietary food exposure
estimates are based on conservative (Tier 1) assumptions, and will not
underestimate exposure/risk. There is no potential for drinking water
or residential exposure. Based on these data and conclusions, there are
no FQPA UFs and the FQPA Safety Factor can be reduced to 1x.
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 to
epoxiconazole will occupy 2% of the aPAD for females 13-49 years, the
only population subgroup of concern. There are no proposed or existing
residential uses for epoxiconazole. The proposed uses are limited to
imported bananas and coffee. Since there are no registered uses
associated with epoxiconazole in the U.S., the only route of exposure
is dietary (food only). Aggregate risk is limited to dietary exposure
(food only) and does not exceed the Agency's level of concern.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
epoxiconazole from food will utilize 1.0% of the cPAD for the U.S.
population, 3.7% of the cPAD for all infants <1 year, and 4.6% of the
cPAD for children 1-2 years, the most highly exposed population
subgroup. There are no residential uses for epoxiconazole that result
in chronic residential exposure to epoxiconazole, and no exposure is
expected from drinking water. Therefore, aggregate risk does not exceed
the Agency's level of concern.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Epoxiconazole is not registered for use on any sites that would
result in residential exposure and there is no expectation that
epoxiconazole residues would occur via drinking water consumption.
Therefore, the aggregate risk is the sum of the risk from food, which
does not exceed the Agency's level of concern.
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).
Epoxiconazole is not registered for use on any sites that would
result in residential exposure and there is no expectation that
epoxiconazole residues would occur via drinking water consumption.
Therefore, the aggregate risk is the sum of the risk from food, which
does not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. The Agency classified
epoxiconazole as ``likely to be carcinogenic to humans''by the oral
route based on the occurrence of liver tumors in male and female mice.
The estimated unit risk, Q1* is 3.04 x 10-2. The
cancer dietary exposure estimate for the general U.S. population is
9.03 x
[[Page 53988]]
10-7 which is below the Agency's level of concern (generally
in the range of 1x 10-6).
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 epoxiconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/electron
capture detector (GC/ECD) method - BASF method 309/1) is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 0755-5350; telephone number: (410) 305-2905;
e-mail address: residuemethods@epa.gov.
B. International Residue Limits
Codex Alimentarius and Canada have not established or proposed any
MRLs for epoxiconazole. As there are no established or proposed MRLs
for either banana or coffee, harmonization with international
tolerances is not an issue for the current petitions.
C. Response to Comments
A private citizen responded to PP 0E6128. Comments were received on
February 15, 2006 objecting to the use, manufacturing and sale of this
product. The comments further stated that not enough tests have been
completed (long term or combined tests), that there is little
indication of safety and questioned the validity of animal testing.
The Agency response is as follows: The Agency has a complete
toxicity database on epoxiconazole, including several long-term or
chronic studies. The commenter submitted no scientific information or
data to support their claims. For additional in-depth response, refer
to docket EPA-HQ-OPP-2004-0325, 69 FR 63083 at https://
www.regulations.gov.
V. Conclusion
Therefore, tolerances are established for residues of
epoxiconazole, [rel-1-[[(2R,3S)-3-(2-chlorophenyl)-2-(4-
fluorophenyl)oxiranyl]methyl]-1H-1,2,4-triazole], in or on bananas at
0.5 ppm and coffee at 0.05 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides
[[Page 53989]]
and pests, Reporting and recordkeeping requirements.
Dated: August 28, 2006.
James Jones,
Director, 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 180.619 is added to read as follows:
Sec. 180.619 Epoxiconazole; tolerances for residues.
(a) General. Tolerances are established for the residues of the
fungicide epoxiconazole [(rel-1-[[(2R,3S)-3-(2-chlorophenyl)-2-(4-
fluorophenyl)oxiranyl]methyl]-1H-1,2,4-triazole]) in or on the
following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Banana*.................................................... 0.5
Coffee* 0.05
------------------------------------------------------------------------
*No U.S. Registration as of August 4, 2006
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional Registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E6-14994 Filed 9-12-06; 8:45 am]
BILLING CODE 6560-50-S
