[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Rules and Regulations]
[Pages 50898-50904]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20841]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0621; FRL-8882-7]
Metconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
metconazole in or on the bushberry subgroup 13-07B and the tuberous and
corm vegetable subgroup 1C. The Interregional Research Project No. 4
(IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective August 17, 2011. Objections and
requests for hearings must be received on or before October 17, 2011,
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-2010-0621. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9367; e-mail address: ertman.andrew@epa.gov.
[[Page 50899]]
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I Get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the
harmonized test guidelines referenced in this document electronically,
please go http://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0621 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 17, 2011. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0621, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Summary of Petitioned-For Tolerance
In the Federal Register of September 8, 2010 (75 FR 54629) (FRL-
8843-3), 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
0E7743) by Interregional Research Project Number 4 (IR-4) Project
Headquarters, Rutgers, The State University of New Jersey, 500 College
Road East, Suite 201 W, Princeton, NJ 08450. The petition requested
that 40 CFR 180.617 be amended by establishing tolerances for residues
of the fungicide metconazole, 5-[(4-chlorophenyl)-methyl]-2,2-dimethyl-
1-(1 H -1,2,4-triazol-1-ylmethyl) cyclopentanol), measured as the sum
of cis- and trans isomers, in or on bushberry subgroup 13-07B at 0.35
parts per million (ppm); and tuberous and corm vegetable subgroup 1C at
0.02 ppm. That notice referenced a summary of the petition prepared by
Valent, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the levels at which tolerances are being established for the
tuberous and corm vegetables subgroup 1C and the bushberry subgroup 13-
07B. Additionally, the commodity definition for the tuberous and corm
vegetables subgroup 1C is being corrected. The reasons for these
changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for metconazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with metconazole
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.
Acute oral and dermal toxicities to metconazole are moderate, while
acute inhalation toxicity is low. Metconazole is a moderate eye
irritant and a mild skin irritant. It is not a skin sensitizer. The
liver is the primary target organ in the mouse, rat and dog following
oral exposure to metconazole via subchronic or chronic exposure
durations. Developmental studies in rats and
[[Page 50900]]
rabbits show some evidence of developmental effects, but only at dose
levels that are maternally toxic. Metconazole did not demonstrate the
potential for neurotoxicity in the four species (mouse, rat, dog and
rabbit) tested. Metconazole is considered non-genotoxic and liver
tumors seen in a chronic mouse study appear to have been formed via a
mitogenic mode of action and therefore, metconazole is classified as
``not likely to be carcinogenic to humans'' at levels that do not cause
mitogenesis. There was no evidence of immunotoxicity at dose levels
that produced systemic toxicity. No immunotoxic effects are evident for
metconazole at dose levels as high as 52 milligrams/kilogram/day (mg/
kg/day) in rats, which is 12 times higher than the chronic dietary
point of departure (4.3 mg/kg/day). Metconazole did not demonstrate
neurotoxicity in the subchronic neurotoxicity study or the other
submitted studies including acute, subchronic and chronic studies in
several species, developmental toxicity studies in the rat and rabbit
and a 2-generation reproduction study in the rat. No effects were noted
on brain weights and no clinical signs possibly related to
neurotoxicity were noted up to and including the high doses in all
studies.
Specific information on the studies received and the nature of the
adverse 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 http://www.regulations.gov in docket ID number EPA-HQ-OPP-2010-0621 on pages
44-50 of the document titled ``Metconazole: Human Health Risk
Assessment for Proposed Uses on Tuberous and Corm Vegetables Subgroup
1C and Bushberry Subgroup 13-07B.''
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern (LOC) to use in evaluating the risk posed by human exposure to
the pesticide. For hazards that have a threshold below which there is
no appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for metconazole used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Metconazole for Use in Human Health Risk Assessment
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Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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Acute Dietary (General Population, An appropriate dose/endpoint attributable to a single dose was not
including Infants and Children). observed in the available oral toxicity studies reviewed.
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Acute dietary (Females 13-49 years of NOAEL = 12 mg/kg/day... Acute RfD = 0.12 mg/kg/ Developmental toxicity
age). UFA = 10x.............. day. in rats: LOAEL = 30 mg/
UFH = 10x.............. aPAD = 0.12 mg/kg/day.. kg/day based on
FQPA SF = 1x........... increases in skeletal
variations.
Chronic dietary (All populations).... NOAEL = 4.3 mg/kg/day.. Chronic RfD = 0.04 mg/ Chronic oral toxicity
UFA = 10x.............. kg/day. study in rats: LOAEL =
UFH = 10x.............. cPAD = 0.04 mg/kg/day.. 13.1 mg/kg/day based
FQPA SF = 1x........... on increased liver
Males (M) weights and
associated
hepatocellular lipid
vacuolation (M) and
centrilobular
hypertrophy (M).
Similar effects were
observed in Females
(F) at 54 mg/kg/day,
plus increased spleen
weight.
Incidental oral short-term (1 to 30 NOAEL = 9.1 mg/kg/day.. LOC for MOE = 100...... 28-Day oral toxicity
days). UFA = 10x.............. study in rats: LOAEL =
UFH = 10x.............. 90.5 mg/kg/day based
FQPA SF = 1x........... on decreased body
weight (M), increased
liver and kidney
weight and
hepatocellular
hypertrophy and
vacuolation (M/F).
Incidental oral intermediate-term (1 NOAEL= 6.4 mg/kg/day... LOC for MOE = 100...... 90-Day oral toxicity
to 6 months). UFA = 10x.............. study in rats: LOAEL =
UFH = 10x.............. 19.2 mg/kg/day based
FQPA SF = 1x........... on increased spleen wt
(F) and hepatic
vacuolation (M).
Inhalation short-term (1 to 30 days). NOAEL= 9.1 mg/kg/day... LOC for MOE = 100...... 28-Day oral toxicity
UFA = 10x.............. study in rats: LOAEL =
UFH = 10x.............. 90.5 mg/kg/day based
FQPA SF = 1x........... on decreased body
weight (M), increased
liver and kidney
weight and
hepatocellular
hypertrophy and
vacuolation (M/F).
[[Page 50901]]
Inhalation (1 to 6 months)........... NOAEL= 6.4 mg/kg/day... LOC for MOE = 100...... 90-Day oral toxicity
UFA = 10x.............. study in rats: LOAEL =
UFH = 10x.............. 19.2 mg/kg/day based
FQPA SF = 1x........... on increased spleen wt
(F) and hepatic
vacuolation (M).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).... Classification: ``Not likely to be Carcinogenic to Humans.''
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
adjusted dose (a = actue, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
concern.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to metconazole, EPA considered exposure under the petitioned-
for tolerances as well as all existing metconazole tolerances in 40 CFR
180.617. EPA assessed dietary exposures from metconazole in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
No such effects were identified in the toxicological studies for
metconazole for the general U.S. population including infants and
children; therefore, a quantitative acute dietary exposure assessment
is unnecessary for these population subgroups. However, such effects
were identified for metconazole for females 13-49 years of age. In
estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA assumed that
metconazole residues are present in all registered and proposed food
commodities at tolerance levels and that 100% of the crops were
treated.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed that
metconazole residues are present in all registered and proposed food
commodities at tolerance levels and that 100% of the crops were
treated.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that metconazole does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for metconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of metconazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models the estimated drinking water concentrations (EDWCs) of
metconazole for acute exposures are estimated to be 45.48 parts per
billion (ppb) for surface water and 0.064 ppb for ground water. For
chronic exposures for non-cancer assessments they are estimated to be
38.16 ppb for surface water and 0.064 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 45.48 ppb was used to
assess the contribution to drinking water.
For chronic dietary risk assessment, the water concentration of
value 38.16 ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Metconazole is
currently registered for the following uses that could result in
residential exposures: Turf and ornamentals. EPA assessed residential
exposure using the following assumptions: Adults, adolescents, and
children may be exposed to metconazole from its currently registered
uses on turf and ornamentals. No dermal toxicity endpoints for short-
and intermediate-term durations were identified up to the limit dose.
Therefore, only residential handler and postapplication inhalation
exposures for adults, and residential post-application incidental oral
exposures for children have been assessed. For adults applying
metconazole to turf, short- and intermediate-term exposures were
assessed for mixer/loader/applicators with a low pressure handwand
sprayer. Post-application risks to children following the application
of metconazole to home lawns were calculated for short- and
intermediate-term incidental oral exposures. Further information
regarding EPA standard assumptions and generic inputs for residential
exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
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 their 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. In conazoles, however, a variable pattern of
toxicological responses is found. Some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in
[[Page 50902]]
rats. Some induce developmental, reproductive, and neurological effects
in rodents. Furthermore, the conazoles produce 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 their
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 Web site at http://www.epa.gov/pesticides/cumulative.
Metconazole is a triazole-derived pesticide. Triazole-derived
pesticides can form the common metabolite, 1,2,4-triazole and three
triazole conjugates (triazole alanine, triazole acetic acid, and
triazolylpyruvic acid). To support existing tolerances and to establish
new tolerances for triazole-derivative pesticides, including
metconazole, 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 SF for the protection of infants and
children. The assessment included evaluations of risks for various
subgroups, including those comprised of infants and children. The
Agency's risk assessment can be found in the propiconazole
reregistration docket at http://www.regulations.gov, Docket
Identification Number EPA-HQ-OPP- 2005-0497 and an update to assess the
addition of the commodities included in this action may be found in
docket ID number EPA-HQ-OPP-2010-0621 in the document titled ``Common
Triazole Metabolites: Updated Aggregate Human Health Risk Assessment To
Address Tolerance Petitions for Metconazole.''
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. Acceptable developmental
toxicity studies are available in the rat and rabbit as well as a 2-
generation reproductive toxicity study in the rat. There is no evidence
of susceptibility following in utero exposure in the rabbit. In the rat
there is qualitative evidence of susceptibility, however the concern is
low since the developmental effects are characterized as variations
(not malformations), occur in the presence of maternal toxicity, the
NOAELs are well defined, and the dose/endpoint is used for acute
dietary risk assessment for the sensitive population. There is no
evidence of increased susceptibility in the offspring based on the
result of the 2-generation reproduction study.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
i. The toxicity database for metconazole is complete except for a
neurotoxicity study. Changes to 40 CFR 180.158 make the acute
neurotoxicity testing (OPPTS Guideline 870.6200) required for pesticide
registration. Although this study is not yet available for metconazole,
the available data do not show any evidence of neurotoxicity.
Metconazole did not demonstrate neurotoxicity in the subchronic
neurotoxicity study or the other submitted studies including acute,
subchronic and chronic studies in several species, developmental
toxicity studies in the rat and rabbit and a 2-generation reproduction
study in the rat. No effects were noted on brain weights and no
clinical signs possibly related to neurotoxicity were noted up to and
including the high doses in all studies. Therefore, EPA does not
believe that conducting the acute neurotoxicity study will result in an
endpoint lower than the ones used in risk assessment for metconazole.
Consequently, an additional database uncertainty factor does not need
to be applied.
ii. There is no evidence of susceptibility following in utero
exposure in the rabbit. In the rat there is qualitative evidence of
susceptibility, however the concern is low since the developmental
effects are characterized as variations (not malformations), occur in
the presence of maternal toxicity, the NOAELs are well defined, and the
dose/endpoint is used for acute dietary risk assessment for the
sensitive population. There is no evidence of increased susceptibility
in the offspring based on the result of the 2-generation reproduction
study.
iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 percent crop treated and tolerance-level residues. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to metconazole in drinking water. EPA
used similarly conservative assumptions to assess postapplication
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by metconazole.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
aPAD and cPAD). For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
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 3.8% of the aPAD for females 13-49, the only
population subgroup of concern.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
metconazole from food and water will utilize 12.6% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
metconazole is not expected.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and
[[Page 50903]]
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Metconazole is currently registered for uses that could result in
short- and intermediate-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short- and intermediate-term residential exposures
to metconazole.
Using the exposure assumptions described in this unit for short-
and intermediate-term exposures, EPA has concluded, that the short-and
intermediate-term aggregate MOEs from dietary exposure (food + drinking
water) and non-occupational/residential handler exposure (inhalation)
for adults are 1,700 for both.
The short-and intermediate-term aggregate MOEs from dietary
exposure (food + drinking water) and non-occupational/residential post-
application exposure (incidental oral) for children 1-2 years old are
420 and 460, respectively. Because EPA's level of concern for
metconazole is a MOE of 100 or below, these MOEs are not of concern.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, metconazole is not expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to metconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate gas chromatography method with nitrogen-phosphorus-
detection (GC/NPD) is available for data collection and enforcement of
tolerances for residues of metconazole parent isomers (cis- and trans-
metconazole) in plant commodities based on Valent Method RM-41C-1,
``Determination of cis and trans-Metconazole in Crops.'' An adequate
high performance liquid chromatography (HPLC) method is available for
data collection and enforcement of tolerances for residues of 1,2,4-
triazole (T), triazole alanine (TA), and triazole acetic acid (TAA).
The methods 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
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for metconazole on potato or
blueberry or the respective crop subgroups.
C. Revisions to Petitioned-For Tolerances
IR-4 proposed establishing tolerances on the bushberry subgroup 13-
07B at 0.35 ppm and the tuberous and corm vegetable subgroup 1C at 0.02
ppm. Upon review, these levels are being revised to 0.40 ppm and 0.04
ppm, respectively. EPA used the tolerance spreadsheet in the Agency's
Guidance for Setting Pesticide Tolerances Based on Field Trial Data to
determine the appropriate tolerance level for bushberries. The
tolerance spreadsheet was not used to calculate the tolerance for
tuberous and corm vegetables because residues in potatoes were below
the LOQ (< 0.04 ppm). The proposed tolerance of 0.02 ppm for tuberous
and corm vegetables is too low. The tolerance should be established at
0.04 ppm, reflecting the combined LOQs of the metconazole enforcement
method of 0.02 ppm for each of the cis- and trans- isomers of
metconazole. Also, the correct commodity definition for tuberous and
corm vegetables subgroup 1C is ``Vegetable, tuberous and corm, subgroup
1C'' and is being changed accordingly. Finally, EPA has revised the
tolerance expression in paragraph (a)(1) to clarify:
1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of metconazole not specifically
mentioned; and
2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression. Because the tolerance expressions in paragraphs
(a)(1) and (a)(2) are now identical, EPA is combining (a)(1) and (a)(2)
into a newly designated paragraph (a) and placing all the commodities
from these two paragraphs into a single table.
V. Conclusion
Therefore, tolerances are established for residues of metconazole,
5-[(4-chlorophenyl)-methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-
ylmethyl)cyclopentanol, measured as the sum of cis- and trans- isomers,
in or on the bushberry subgroup 13-07B at 0.40 ppm, and vegetable,
tuberous and corm, subgroup 1C at 0.04 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments,
[[Page 50904]]
on the relationship between the national government and the States or
tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000) do not apply to this final rule. In addition, this final rule
does not impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 9, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
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 amended by revising paragraph (a) to read as
follows:
Sec. 180.617 Metconazole; tolerances for residues.
(a) General. Tolerances are established for residues of
metconazole, including its metabolites and degradates, in or on the
commodities in the following table. Compliance with the tolerance
levels specified below is to be determined by measuring only
metconazole [5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1H-1,2,4-
triazol-1-ylmethyl)cyclopentanol] as the sum of its cis- and trans-
isomers in or on the following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls.............................................. 4.0
Banana \1\................................................. 0.1
Barley, grain.............................................. 2.5
Barley, hay................................................ 7.0
Barley, straw.............................................. 7.0
Beet, sugar, dried pulp.................................... 0.70
Beet, sugar, molasses...................................... 0.08
Beet, sugar, roots......................................... 0.07
Bushberry subgroup 13-07B.................................. 0.40
Canola seed................................................ 0.04
Cattle, meat byproducts.................................... 0.04
Corn, field, forage........................................ 3.0
Corn, field, grain......................................... 0.02
Corn, field, stover........................................ 4.5
Corn, pop, grain........................................... 0.02
Corn, pop, stover.......................................... 4.5
Corn, sweet, forage........................................ 3.0
Corn, sweet, kernel plus cob with husks removed............ 0.01
Corn, sweet, stover........................................ 4.5
Cotton, gin byproducts..................................... 8.0
Cotton, undelinted seed.................................... 0.25
Egg........................................................ 0.04
Fruit, stone, group 12..................................... 0.20
Goat, meat byproducts...................................... 0.04
Grain, aspirated grain fractions........................... 7.0
Horse, meat byproducts..................................... 0.04
Nut, tree, group 14........................................ 0.04
Oat, grain................................................. 1.0
Oat, hay................................................... 17
Oat, straw................................................. 6.0
Peanut..................................................... 0.04
Peanut, refined oil........................................ 0.05
Pistachio.................................................. 0.04
Rye, grain................................................. 0.25
Rye, straw................................................. 14
Sheep, meat byproducts..................................... 0.04
Soybean, forage............................................ 3.0
Soybean, hay............................................... 6.0
Soybean, hulls............................................. 0.08
Soybean, seed.............................................. 0.05
Vegetable, tuberous and corn, subgroup 1C.................. 0.04
Wheat, grain............................................... 0.15
Wheat, hay................................................. 16
Wheat, milled byproducts................................... 0.20
Wheat, straw............................................... 18
------------------------------------------------------------------------
\1\ No U.S. registration as of August 30, 2006.
* * * * *
[FR Doc. 2011-20841 Filed 8-16-11; 8:45 am]
BILLING CODE 6560-50-P