Metconazole; Pesticide Tolerance, 56383-56388 [06-8256]
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Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and 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.
V. 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: September 20, 2006.
James Jones,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is
amended as follows:
I
Parts per
million
Commodity
Barley, grain .............................
Barley, straw .............................
Bean, dry, seed ........................
Bean, succulent ........................
Canola, seed ............................
Cattle, fat ..................................
Cattle, meat byproducts ...........
Cattle, meat ..............................
Corn, field, forage .....................
Corn, field, grain .......................
Corn, field, stover .....................
Corn, pop, grain ........................
Corn, pop, stover ......................
Corn, sweet, forage ..................
Corn, sweet, kernel plus cob
with husks removed ..............
Corn, sweet, stover ..................
Cotton, undelinted seed ...........
Egg ...........................................
Goat, fat ....................................
Goat, meat byproducts .............
Goat, meat ................................
Hog, fat .....................................
Hog, meat byproducts ..............
Hog, meat .................................
Horse, fat ..................................
Horse, meat byproducts ...........
Horse, meat ..............................
Milk ...........................................
Oat, forage ................................
Oat, grain ..................................
Oat, straw .................................
Onion, bulb ...............................
Peanut ......................................
Peanut, hay ..............................
Poultry, fat ................................
Poultry, meat byproducts ..........
Poultry, meat ............................
Rice, grain ................................
Rice, straw ................................
Safflower, seed .........................
Sheep, fat .................................
Sheep, meat byproducts ..........
Sheep, meat .............................
Soybean, seed ..........................
Wheat, forage ...........................
Wheat, grain .............................
Wheat, straw .............................
0.2
0.2
0.2
0.2
0.03
0.05
0.1
0.05
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.05
0.05
0.1
0.05
0.05
0.1
0.05
0.05
0.1
0.05
0.05
0.5
0.2
0.2
0.2
0.2
0.2
0.1
0.1
0.1
0.2
0.2
0.2
0.05
0.1
0.05
0.2
0.5
0.2
0.2
*
*
*
*
*
4. Section 180.355 is amended by
revising the table in paragraph (a)(1) to
read as follows:
PART 180—[AMENDED]
I
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
§ 180.143
aniline and expressed as parent
compound, in or on food commodities
as follows:
[Removed]
§ 180.355 Bentazon; tolerances for
residues.
(a) General. (1) *
2. Section 180.143 is removed.
I 3. Section 180.301 is amended by
revising paragraph (a) to read as follows:
*
*
I
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§ 180.301 Carboxin; tolerances for
residues.
(a) General. Tolerances are
established for the combined residues of
the fungicide carboxin (5,6-dihydro-2methyl-1,4-oxathiin-3-carboxanilide)
and its metabolites determined as
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Parts per
million
Commodity
Bean, dry, seed ........................
Bean, succulent ........................
Corn, field, forage .....................
Corn, field, grain .......................
Corn, field, stover .....................
Corn, pop, grain ........................
Corn, sweet, kernel plus cob
with husks removed ..............
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0.05
0.5
3.0
0.05
3.0
0.05
0.05
56383
Parts per
million
Commodity
Cowpea, forage ........................
Cowpea, hay .............................
Flax, seed .................................
Pea, dry, seed ..........................
Pea, field, hay ...........................
Pea, field, vines ........................
Pea, succulent ..........................
Peanut ......................................
Peanut, hay ..............................
Pepper, nonbell ........................
Peppermint, tops ......................
Rice, grain ................................
Rice, hulls .................................
Rice, straw ................................
Sorghum, forage .......................
Sorghum, grain .........................
Sorghum, grain, stover .............
Soybean, forage .......................
Soybean, hay ............................
Soybean, seed ..........................
Spearmint, tops ........................
*
*
*
*
10.0
3.0
1.0
1.0
8.0
3.0
3.0
0.05
3.0
0.05
1.0
0.05
0.25
3.0
0.20
0.05
0.05
8.0
8.0
0.05
1.0
*
§§ 180.1238 and 180.1239
[Removed]
5. Section 180.1238 and 180.1239 are
removed.
I
[FR Doc. 06–8255 Filed 9–26–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0016; FRL–8085–2]
Metconazole; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of metconazole in
or on bananas. BASF Agricultural
Products requested this tolerance 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 27, 2006. Objections and
requests for hearings must be received
on or before November 27, 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–2005–0016. 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.
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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
athttps://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:
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
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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. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gpo/
opptsfrs/home/guidelin.htm
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–2005–0016 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 27, 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–2005–0016, 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
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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) 3055805.
II. Background and Statutory Findings
In the Federal Register of April 8,
2005, (67 FR 18008) (FRL–7703–7), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 9E5052) by BASF
Agricultural Products, 26 Davis Drive,
P.O. Box 13528, Research Triangle Park,
NC 27709–3528 agent for Kureha
Corporation, 3–3–2 NihonbashiHamacho, Chuo-ku, Tokyo 103–8552,
Japan. The petition requested that 40
CFR be amended by establishing a
tolerance for residues of the fungicide
metconazole, 5-[(4chlorophenyl)methyl]-2,2-dimethyl-1(1H-1,2,4-triazol-1ylmethyl)cyclopentanol, in or on
bananas at 0.05 parts per million (ppm).
That notice included a summary of the
petition prepared by BASF Agricultural
Products, the agent for the petitioner.
Comments were received on the notice
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.
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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 a tolerance for residues of
metconazole on banana at 0.1 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
metconazole as well as the no-observedadverse-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–2005–0016.
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
of concern are 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
56385
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/
oppfead1/trac/science/, and https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for metconazole used for
human risk assessment is shown in
Table 1 of this unit:
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR METCONAZOLE 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
Acute Dietary (Females 13-49
years of age)
NOAEL = 12 mg/kg/day
UF = 100
Acute RfD = 0.12 mg/kg/day
Special FQPA SF = 1X
aPAD = acute RfD/FQPA
SF = 0.12 mg/kg/day
Developmental toxicity - rats
LOAEL = 30 mg/kg/day based on increases in
skeletal variations
Chronic Dietary (All populations)
NOAEL = 4.3 mg/kg/day
UF = 100
Chronic RfD = 0.04 mg/kg/
day
Special FQPA SF = 1X
cPAD = chronic RfD/Special FQPA
SF = 0.04 mg/kg/day
Chronic oral toxicity - rats
LOAEL = 13.1 mg/kg/day based on increased
liver
(M)
weights
and
associated
hepatocellular lipid vacuolation (M) and
centrilobular hypertrophy (M). Same effects
seen (F) at 54 mg/kg/day, plus increased
speen weight
Cancer (oral, dermal, inhalation)
Classification: ‘‘Not Likely to be Carcinogenic to Humans’’
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. There are currently no
tolerances established (40 CFR 180) for
the residues of metconazole. Use of
metconazole on soybeans has been
authorized under Section 18 of FIFRA.
Risk assessments were conducted by
EPA to assess dietary exposures from
metconazole in/on imported bananas
and soybeans as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1–day or single
exposure.
In conducting the acute dietary
exposure assessment EPA used the
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Dietary Exposure Evaluation Model
software with the Food Commodity
Intake Database (DEEM-FCIDTM, version
2.03), which incorporates food
consumption data as reported by
respondents in the United States
Department of Agriculture (USDA)
1994–1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated
exposure to the chemical for each
commodity. The following assumptions
were made for the acute exposure
assessment: Tolerance level residues
and 100% crop treated were assumed
for bananas and soybeans.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the software with the (DEEMFCIDTM, version 2.03), which
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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 and 100% crop
treated were assumed for bananas and
soybeans.
iii. Cancer. Metconazole is classified
as ‘‘Not Likely to be Carcinogenic to
Humans’’ based on convincing evidence
that carcinogenic effects are not likely
below a defined dose range. A nongenotoxic mode of action for mouse
liver tumors was established. An
exposure assessment is not necessary.
2. Dietary exposure from drinking
water. There is no expectation that
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residues from metconazole use on
imported banana would occur in surface
or ground water sources of 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
metconazole. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/models4.htm.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening
Concentration in Groundwater (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
metconazole, resulting from use on
soybeans for acute exposures are
estimated to be 1.57 parts per billion
(ppb) for surface water and 0.04 ppb for
ground water. The EDWCs for chronic
exposures are estimated to be 0.48 ppb
for surface water and 0.04 ppb for
ground water. Use on imported bananas
will not contribute to residues in water
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).
Metconazole 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
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.’’
Metconazole 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. 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,
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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.
Metconazole is a triazole-derived
pesticide. This class of compounds can
form the common metabolite 1,2,4triazole and two triazole conjugates
(triazole alanine and triazole acetic
acid). To support existing tolerances
and to establish new tolerances for
triazole-derivative pesticides, including
metconazole, U.S. EPA conducted a
human health risk assessment for
exposure to 1,2,4-triazole, triazole
alanine, and triazole acetic acid
resulting from the use of all current and
pending uses of any triazole-derived
fungicide. The risk assessment is a
highly conservative, screening-level
evaluation in terms of hazards
associated with common metabolites
(e.g., use of a maximum combination of
uncertainty factors) and potential
dietary and non-dietary exposures (i.e.,
high end estimates of both dietary and
non-dietary exposures). In addition, the
Agency retained the additional 10X
FQPA safety factor for the protection of
infants and children. The assessment
includes evaluations of risks for various
subgroups, including those comprised
of infants and children. The Agency’s
complete risk assessment is found in the
propiconazole reregistration docket at
https://www.regulations.gov, Docket
Identification (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
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assessments either directly through use
of a Margin of Exposure (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 FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
The database for metconazole is
adequate for FQPA consideration. The
two-generation reproduction study was
performed with cis-only metconazole
(not cis/trans metconazole). However,
the database contains a sufficient
number of subchronic and
developmental toxicity studies with cis/
trans metconazole to adequately assess
cis/trans metconazole toxicity and to
bridge the data gap. In addition,
acceptable development toxicity studies
are available in both rats and rabbits.
The effect seen in these studies do not
indicate that pups are more susceptible:
pup effects were only seen in the
presence of maternal toxicity and, in
general, were of comparable or less
severity to the effects observed in
adults. Metconazole did not exhibit
neurotoxicity in any of the submitted
data.
3. Conclusion. There is a complete
toxicity data base for metconazole 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 developmental toxicity
studies in rats or rabbits, and in the 2generation rat reproduction study. There
are no residual uncertainties concerning
prenatal and postnatal toxicity and no
neurotoxicity concerns. The acute and
chronic dietary (food + drinking water)
exposure assessments are conservative
assessments that are based on reliable
data and will not underestimate
exposure/risk. There is no potential for
drinking water exposure from the
proposed use on imported bananas.
Additionally, there is no potential for
residential exposure. Based on these
data and conclusions, the FQPA Safety
Factor is reduced to 1X.
E. Aggregate Risks and Determination of
Safety
To assess aggregate risk, drinking
water estimates were incorporated
directly into the dietary analysis, rather
than using back-calculated drinking
water levels of comparison (DWLOCs).
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Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations
To better evaluate aggregate risk
associated with exposure through food
and drinking water, EPA is no longer
comparing Estimated Drinking Water
Concentrations (EDWCs) generated by
water quality models with DWLOC.
Instead, EPA is now directly
incorporating the actual water quality
model output concentrations into the
risk assessment. This method of
incorporating water concentration into
our aggregate assessments relies on
actual CSFII reported drinking water
consumptions and more appropriately
reflects the full distribution of drinking
water concentrations.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
metconazole will occupy < 1% of the
aPAD for females 13 years and older, the
only population subgroup of concern.
EPA does not expect the aggregate
exposure to exceed 100% of the aPAD,
and therefore is below 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 metconazole from food
and water will utilize 2% of the cPAD
for the U.S. population, 5% of the cPAD
for children 1-2 years old, the most
highly exposed population subgroup.
There are no residential uses for
metconazole that result in chronic
residential exposure to metconazole.
EPA does not expect the aggregate
exposure to exceed 100% of the cPAD,
and therefore is below 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).
Metconazole is not registered for use
on any sites that would result in
residential exposure. Therefore, the
aggregate risk is the sum of the risk from
food and water, which do 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).
Metconazole is not registered for use
on any sites that would result in
residential exposure. Therefore, the
aggregate risk is the sum of the risk from
food and water, which do not exceed
the Agency’s level of concern.
5. Aggregate cancer risk for U.S.
population. The Agency has classified
metconazole as ‘‘Not Likely to be
Carcinogenic to Humans’’ based on
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16:20 Sep 26, 2006
Jkt 208001
convincing evidence that carcinogenic
effects are not likely below a defined
dose range and that carcinogenic effects
were seen in animals only at higher
doses. A non-genotoxic mode of action
for mouse liver tumors was established.
Given that metconazole’s cancer effects
are a threshold effect and that the
threshold is well above other chronic
effects, the chronic RfD is protective
against any cancer risk.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population and to infants and children
from aggregate exposure to metconazole
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(gas chromatography/nitrogen
phosphorus detection (GC/NPD) method
(American Cyanamid Method M 2722))
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 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are currently no Canadian,
Mexican or Codex MRL or tolerances for
metconazole.
C. Response to Comments
A private citizen responded to PP
9E5052. Comments were received on
April 17, 2005 objecting to the use and
sale of this product, animal testing,
profiteering and lack of satisfactory
combined and long-term testing. The
Agency response is as follows: The
Agency has a toxicity data base and it
is considered sufficient to adequately
assess metconazole, which includes
several long-term or chronic studies.
The commenter submitted no scientific
information or data to support their
claims. EPA has responded to such
generalized comments on numerous
previous occasions, for example, on
January 7, 2005 (70 FR 1354) (FRL–
7681–9) and on October 29, 2004 (69 FR
63083) (FRL–7691–4).
V. Conclusion
Therefore, a tolerance is established
for residues of metconazole, 5-[(4chlorophenyl)methyl]-2,2-dimethyl-1(1H-1,2,4-triazol-1ylmethyl)cyclopentanol, in or on banana
at 0.1 ppm.
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Fmt 4700
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56387
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–). 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 104–13, 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
E:\FR\FM\27SER1.SGM
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56388
Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 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.
sroberts on PROD1PC70 with RULES
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.
requests for hearings must be received
on or before November 27, 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
Dated: September 18, 2006.
docket for this action under docket
James Jones,
identification (ID) number EPA–HQ–
Director, Office of Pesticide Programs.
OPP–2005–0058. All documents in the
docket are listed in the index for the
I Therefore, 40 CFR chapter I is
docket. Although listed in the index,
amended as follows:
some information is not publicly
PART 180—[AMENDED]
available, e.g., Confidential Business
Information (CBI) or other information
I 1. The authority citation for part 180
whose disclosure is restricted by statute.
continues to read as follows:
Certain other material, such as
Authority: 21 U.S.C. 321(q), 346a and 371.
copyrighted material, is not placed on
I 2. Section 180.617 is added to read as
the Internet and will be publicly
follows:
available only in hard copy form.
Publicly available docket materials are
§ 180.617 Metconazole; tolerances for
available in the electronic docket at
residues.
https://www.regulations.gov, or, if only
(a) General. Tolerances are
available in hard copy, at the OPP
established for the residue of the
Regulatory Public Docket in Rm.
fungicide metconazole (5-[(4S–4400, One Potomac Yard (South
chlorophenyl)methyl]-2,2-dimethyl-1Building), 2777 S. Crystal Drive,
(1H-1,2,4-triazol-1Arlington, VA. The Docket Facility is
ylmethyl)cyclopentanol) in or on the
open from 8:30 a.m. to 4 p.m., Monday
following commodity:
through Friday, excluding legal
holidays. The Docket telephone number
Commodity
Parts per million
is (703) 305–5805.
Banana1 ................
0.1 FOR FURTHER INFORMATION CONTACT:
Bryant Crowe, Registration Division
1 No U.S. registration as of August 30, 2006.
(7505P), Office of Pesticide Programs,
(b) Section 18 emergency exemptions. Environmental Protection Agency, 1200
[Reserved]
Pennsylvania Ave., NW., Washington,
(c) Tolerances with regional
DC 20460–0001; telephone number:
registrations. [Reserved]
(703) 305–0025; e-mail address:
(d) Indirect or inadvertent residues.
crowe.bryant@epa.gov.
[Reserved]
SUPPLEMENTARY INFORMATION:
[FR Doc. 06–8256 Filed 9–26–06; 8:45 am]
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).
[EPA–HQ–OPP–2005–0058; FRL–8091–5]
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17:39 Sep 26, 2006
Jkt 208001
I. General Information
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
Ethaboxam; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of ethaboxam in
or on grape at 6.0 parts per million
(ppm), with no U.S. registration. Landis
International, Inc., agent for LG Life
Sciences, Ltd. requested this tolerance
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 27, 2006. Objections and
PO 00000
Frm 00054
Fmt 4700
Sfmt 4700
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
E:\FR\FM\27SER1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 187 (Wednesday, September 27, 2006)]
[Rules and Regulations]
[Pages 56383-56388]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8256]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0016; FRL-8085-2]
Metconazole; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
metconazole in or on bananas. BASF Agricultural Products requested this
tolerance 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 27, 2006. Objections and
requests for hearings must be received on or before November 27, 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-2005-0016. 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.
[[Page 56384]]
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 athttps://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: 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 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.
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. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at https://
www.epa.gpo/opptsfrs/home/guidelin.htm
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-2005-0016 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 27, 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-2005-0016, 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 8, 2005, (67 FR 18008) (FRL-7703-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9E5052) by BASF Agricultural Products, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, NC 27709-3528 agent for Kureha Corporation, 3-
3-2 Nihonbashi-Hamacho, Chuo-ku, Tokyo 103-8552, Japan. The petition
requested that 40 CFR be amended by establishing a tolerance for
residues of the fungicide metconazole, 5-[(4-chlorophenyl)methyl]-2,2-
dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, in or on bananas
at 0.05 parts per million (ppm). That notice included a summary of the
petition prepared by BASF Agricultural Products, the agent for the
petitioner. Comments were received on the notice 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.
[[Page 56385]]
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 a tolerance for residues of metconazole on
banana at 0.1 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 metconazole 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-2005-0016.
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
of concern are 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, 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.
A summary of the toxicological endpoints for metconazole used for
human risk assessment is shown in Table 1 of this unit:
Table 1.--Summary of Toxicological Dose and Endpoints for metconazole 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 = 12 mg/kg/day Special FQPA SF = 1X Developmental toxicity
age) UF = 100............... aPAD = acute RfD/FQPA.. rats
Acute RfD = 0.12 mg/kg/ SF = 0.12 mg/kg/day.... LOAEL = 30 mg/kg/day
day. based on increases in
skeletal variations
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL = 4.3 mg/kg/day Special FQPA SF = 1X Chronic oral toxicity -
UF = 100............... cPAD = chronic RfD/ rats
Chronic RfD = 0.04 mg/ Special FQPA. LOAEL = 13.1 mg/kg/day
kg/day. SF = 0.04 mg/kg/day.... based on increased
liver (M) weights and
associated
hepatocellular lipid
vacuolation (M) and
centrilobular
hypertrophy (M). Same
effects seen (F) at 54
mg/kg/day, plus
increased speen weight
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: ``Not Likely to be Carcinogenic to Humans''
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. There are currently no
tolerances established (40 CFR 180) for the residues of metconazole.
Use of metconazole on soybeans has been authorized under Section 18 of
FIFRA. Risk assessments were conducted by EPA to assess dietary
exposures from metconazole in/on imported bananas and soybeans as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
In conducting the acute dietary exposure assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM, version 2.03), which
incorporates food consumption data as reported by respondents in the
United States Department of Agriculture (USDA) 1994-1996 and 1998
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII),
and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the acute exposure assessment:
Tolerance level residues and 100% crop treated were assumed for bananas
and soybeans.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the software with 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 and 100% crop treated were assumed for bananas and
soybeans.
iii. Cancer. Metconazole is classified as ``Not Likely to be
Carcinogenic to Humans'' based on convincing evidence that carcinogenic
effects are not likely below a defined dose range. A non-genotoxic mode
of action for mouse liver tumors was established. An exposure
assessment is not necessary.
2. Dietary exposure from drinking water. There is no expectation
that
[[Page 56386]]
residues from metconazole use on imported banana would occur in surface
or ground water sources of 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 metconazole. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at https://www.epa.gov/oppefed1/
models/water/models4.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Groundwater (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
metconazole, resulting from use on soybeans for acute exposures are
estimated to be 1.57 parts per billion (ppb) for surface water and 0.04
ppb for ground water. The EDWCs for chronic exposures are estimated to
be 0.48 ppb for surface water and 0.04 ppb for ground water. Use on
imported bananas will not contribute to residues in water 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).
Metconazole 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 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.''
Metconazole 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. 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.
Metconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazole alanine and triazole acetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including metconazole, U.S. EPA
conducted a human health risk assessment for exposure to 1,2,4-
triazole, triazole alanine, and triazole acetic acid resulting from the
use of all current and pending uses of any triazole-derived fungicide.
The risk assessment is a highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of uncertainty factors) and
potential dietary and non-dietary exposures (i.e., high end estimates
of both dietary and non-dietary exposures). In addition, the Agency
retained the additional 10X FQPA safety factor for the protection of
infants and children. The assessment includes evaluations of risks for
various subgroups, including those comprised of infants and children.
The Agency's complete risk assessment is found in the propiconazole
reregistration docket at https://www.regulations.gov, Docket
Identification (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
Margin of Exposure (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 FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity. The database for metconazole
is adequate for FQPA consideration. The two-generation reproduction
study was performed with cis-only metconazole (not cis/trans
metconazole). However, the database contains a sufficient number of
subchronic and developmental toxicity studies with cis/trans
metconazole to adequately assess cis/trans metconazole toxicity and to
bridge the data gap. In addition, acceptable development toxicity
studies are available in both rats and rabbits. The effect seen in
these studies do not indicate that pups are more susceptible: pup
effects were only seen in the presence of maternal toxicity and, in
general, were of comparable or less severity to the effects observed in
adults. Metconazole did not exhibit neurotoxicity in any of the
submitted data.
3. Conclusion. There is a complete toxicity data base for
metconazole 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 developmental toxicity studies in rats or rabbits, and in the 2-
generation rat reproduction study. There are no residual uncertainties
concerning prenatal and postnatal toxicity and no neurotoxicity
concerns. The acute and chronic dietary (food + drinking water)
exposure assessments are conservative assessments that are based on
reliable data and will not underestimate exposure/risk. There is no
potential for drinking water exposure from the proposed use on imported
bananas. Additionally, there is no potential for residential exposure.
Based on these data and conclusions, the FQPA Safety Factor is reduced
to 1X.
E. Aggregate Risks and Determination of Safety
To assess aggregate risk, drinking water estimates were
incorporated directly into the dietary analysis, rather than using
back-calculated drinking water levels of comparison (DWLOCs).
[[Page 56387]]
To better evaluate aggregate risk associated with exposure through
food and drinking water, EPA is no longer comparing Estimated Drinking
Water Concentrations (EDWCs) generated by water quality models with
DWLOC. Instead, EPA is now directly incorporating the actual water
quality model output concentrations into the risk assessment. This
method of incorporating water concentration into our aggregate
assessments relies on actual CSFII reported drinking water consumptions
and more appropriately reflects the full distribution of drinking water
concentrations.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to metconazole will occupy < 1% of the aPAD for females 13 years and
older, the only population subgroup of concern. EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, and therefore is below
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
metconazole from food and water will utilize 2% of the cPAD for the
U.S. population, 5% of the cPAD for children 1-2 years old, the most
highly exposed population subgroup. There are no residential uses for
metconazole that result in chronic residential exposure to metconazole.
EPA does not expect the aggregate exposure to exceed 100% of the cPAD,
and therefore is below 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).
Metconazole is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do 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).
Metconazole is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
5. Aggregate cancer risk for U.S. population. The Agency has
classified metconazole as ``Not Likely to be Carcinogenic to Humans''
based on convincing evidence that carcinogenic effects are not likely
below a defined dose range and that carcinogenic effects were seen in
animals only at higher doses. A non-genotoxic mode of action for mouse
liver tumors was established. Given that metconazole's cancer effects
are a threshold effect and that the threshold is well above other
chronic effects, the chronic RfD is protective against any cancer risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population and to infants and children from aggregate
exposure to metconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/nitrogen
phosphorus detection (GC/NPD) method (American Cyanamid Method M 2722))
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 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are currently no Canadian, Mexican or Codex MRL or tolerances
for metconazole.
C. Response to Comments
A private citizen responded to PP 9E5052. Comments were received on
April 17, 2005 objecting to the use and sale of this product, animal
testing, profiteering and lack of satisfactory combined and long-term
testing. The Agency response is as follows: The Agency has a toxicity
data base and it is considered sufficient to adequately assess
metconazole, which includes several long-term or chronic studies. The
commenter submitted no scientific information or data to support their
claims. EPA has responded to such generalized comments on numerous
previous occasions, for example, on January 7, 2005 (70 FR 1354) (FRL-
7681-9) and on October 29, 2004 (69 FR 63083) (FRL-7691-4).
V. Conclusion
Therefore, a tolerance is established for residues of metconazole,
5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-
ylmethyl)cyclopentanol, in or on banana at 0.1 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-). 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 104-13, 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
[[Page 56388]]
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 and pests, Reporting and
recordkeeping requirements.
Dated: September 18, 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 180.617 is added to read as follows:
Sec. 180.617 Metconazole; tolerances for residues.
(a) General. Tolerances are established for the residue of the
fungicide metconazole (5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1H-
1,2,4-triazol-1-ylmethyl)cyclopentanol) in or on the following
commodity:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Banana1........................................ 0.1
------------------------------------------------------------------------
\1\ No U.S. registration as of August 30, 2006.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 06-8256 Filed 9-26-06; 8:45 am]
BILLING CODE 6560-50-S
