[Federal Register Volume 77, Number 87 (Friday, May 4, 2012)]
[Rules and Regulations]
[Pages 26450-26456]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10689]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0179; FRL-9345-6]
Metconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
Metconazole, including its metabolites and degradates in or on
sugarcane, cane. BASF Corporation requested the tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 4, 2012. Objections and
requests for hearings must be received on or before July 3, 2012, 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-2011-0179. 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: Tamue L. Gibson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-9096; email address: gibson.tamue@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 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.
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-2011-0179 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
July 3, 2012. 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
[[Page 26451]]
request, identified by docket ID number EPA-HQ-OPP-2011-0179, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online 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 April 20, 2011 (76 FR 22067) (FRL-8869-
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
0F7807) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC 27709-3528. The petition requested that 40 CFR part
180 be amended by establishing tolerances for residues of the fungicide
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 sugarcane, cane at 0.06 parts per million
(ppm); and sugarcane, molasses at 0.08 ppm. That notice referenced a
summary of the petition prepared by BASF Corporation, 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, tolerances
for sugarcane, molasses are not being established. The reason for this
change is 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.
Metconazole was shown to affect the liver, kidney, spleen, and
certain blood parameters in all the species tested. Dose levels at
which these effects occur are similar across species with the rat and
dog being slightly more sensitive than the mouse. Like other triazoles,
a primary target organ in mammalian toxicity studies is the liver.
Liver toxicity was seen in the mouse, rat and dog following oral
exposure to metconazole via subchronic or chronic exposure durations.
While liver effects have been reported consistently across multiple
durations and species, these effects were considered slight and minimal
in some studies and appeared to be ``adaptive'' responses. However,
based on the weight of evidence from the consistency of these reported
effects and evidence that these effects increase in severity with
duration, and leading to liver tumors in the chronic mouse study, they
were considered ``adverse'' and formed the basis of the study lowest
observed adverse effect levels (LOAELs). Metconazole is considered
nongenotoxic and the liver tumors 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 is evidence of liver effects (microsomal induction,
liver weight increases, hypertrophy) at 47.6 milligrams/kilograms/day
(mg/kg/day), but no effects at 4.5 mg/kg/day in the mode of action
studies in the mouse. There is no concern for mutagenicity. The chronic
Reference Dose of 0.04 mg/kg/day based on the 2-year chronic rat study
with a no observed adverse effect level (NOAEL) of 4.3 mg/kg/day would
be protective of early liver disturbances seen in the mouse studies.
Therefore, the Agency has determined that the quantification of risk
using a non-linear approach (i.e., Reference dose (RfD)) will
adequately account for all chronic toxicity, including carcinogenicity,
that could result from exposure to metconazole.
Other major critical effects observed in oral studies were
decreased body weight, decreased body weight gains, and blood effects
(reductions in erythrocyte and/or platelet parameters) in the mouse,
rat, dog and/or rabbit. Splenic effects including increased spleen
weight and hyperplasia were observed in the mouse, rat and dog at dose
levels where liver effects were also observed. In dogs, lenticular
degeneration (cataracts) was observed at the highest dose tested (HDT)
(114 mg/kg/day). Furthermore, at high dietary levels, there is evidence
that metconazole is a gastrointestinal irritant in the dog.
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 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 standard
battery of tests submitted. Information available from the 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 do not indicate any neurotoxic
signs. 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.
[[Page 26452]]
Specific information on the studies received and the nature of the
adverse effects caused by metconazole as well as the NOAEL and the
LOAEL from the toxicity studies can be found at http://www.regulations.gov in document ``Metconazole: Human Health Risk
Assessment for Proposed Uses on Sugarcane,'' at page 36 in docket ID
number EPA-HQ-OPP-2011-0179.
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 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
the following Table.
Table--Summary of Toxicological Doses and Endpoints for Metconazole for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (Females 13-50 NOAEL = 12 mg/kg/day Acute RfD = 0.12 mg/ Developmental toxicity in rats.
years of age). UFA = 10x........... kg/day. LOAEL = 30 mg/kg/day based on
UFH = 10x........... aPAD = 0.12 mg/kg/ increases in skeletal variations.
FQPA SF = 1x........ day. At 75 mg/kg/day increased
incidence of post-implantation
loss, hydrocephaly and visceral
anomaliea (cranial hemorrhage,
dilated renal pelvis, dilated
ureters, and displaced testis)
were reported.
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Acute dietary (General population An appropriate dose/endpoint attributable to a single dose was not observed
including infants and children). in the available oral toxicity studies reviewed.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL= 4.3 mg/kg/day Chronic RfD = 0.04 Chronic oral toxicity study in
UFA = 10x........... mg/kg/day. rats.
UFH = 10x........... cPAD = 0.04 mg/kg/ LOAEL = 13.1 mg/kg/day based on
FQPA SF = 1x........ day. increased liver (M) weights and
associated hepatocellular lipid
vacuolation (M) and centrilobular
hypertrophy(M). Similar effects
were observed in females at 54 mg/
kg/day, plus increased spleen
weight.
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Incidental oral short-term (1 to NOAEL= 9.1 mg/kg/day LOC for MOE = 100.. 28-Day oral toxicity study in
30 days). UFA = 10x........... rats.
UFH = 10x........... LOAEL = 90.5 mg/kg/day based on
FQPA SF = 1x........ decreased body weight (M),
increased liver and kidney weight
and hepatocellular hypertrophy
and vacuolation (M/F).
----------------------------------------------------------------------------------------------------------------
Incidental oral intermediate-term NOAEL= 6.4 mg/kg/day LOC for MOE = 100.. 90-Day oral toxicity study in
(1 to 6 months). UFA= 10x............ rats.
UFH= 10x............ LOAEL = 19.2 mg/kg/day based on
FQPA SF = 1x........ increased spleen wt (F) and
hepatic vacuolation (M).
----------------------------------------------------------------------------------------------------------------
Dermal short-term and Quantification of dermal risk is not needed due to lack of systemic or dermal
intermediate-term. toxicity at the Limit Dose in a 21-day dermal toxicity study in the rat, the
lack of target organ toxicity or neurotoxicity, and the lack of
developmental or reproductive toxicity in the absence of parental effects
which were looked for in the dermal toxicity.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 100.. 28-Day oral toxicity study in
days). study NOAEL= 9.1 mg/ rats.
kg/day (inhalation LOAEL = 90.5 mg/kg/day based on
absorption rate = decreased body weight (M),
100%). increased liver and kidney weight
UFA = 10x........... and hepatocellular hypertrophy
UFH = 10x........... and vacuolation (M/F).
FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
[[Page 26453]]
Inhalation (1 to 6 months)....... Inhalation (or oral) LOC for MOE = 100.. 90-Day oral toxicity study in
study NOAEL = 6.4 rats.
mg/kg/day LOAEL = 19.2 mg/kg/day based on
(inhalation increased spleen wt (F) and
absorption rate = hepatic vacuolation (M).
100%).
UFA = 10x...........
UFH = 10x...........
FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: ``Not likely to be Carcinogenic to Humans'' based on evidence
that a non-genotoxic mode of action for mouse liver tumors was established
and that carcinogenic effects were not likely below a defined dose that does
not cause mitogenesis.
----------------------------------------------------------------------------------------------------------------
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 = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
concern. M = male animals. F= female animals. Mg/kg/day = milligrams per kilogram per day. LOAEL= lowest
observed adverse effect level. NOAEL = no observed adverse effect level.
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. Such effects were identified
for metconazole. In estimating acute dietary exposure, EPA used food
consumption information from the U. S. Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA made the
following assumptions for the acute exposure assessment: Tolerance-
level residues and 100 percent crop treated (PCT). EPA used Dietary
Exposure Evaluation Model (DEEM\TM\) version 7.81 default processing
factors.
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 made the following
assumptions for the chronic exposure assessment: Tolerance-level
residues and 100 PCT. EPA used DEEM\TM\ version 7.81 default processing
factors.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
determined that the quantification of risk using a non-linear approach
will adequately account for all chronic toxicity, including
carcinogenicity, that could result from exposure to metconazole.
Therefore, the chonic RfD is expected to be protective of chronic
toxicity including carcinogenicity. For the purpose of assessing cancer
risk under this approach EPA relied upon the exposure estimate
discussed in Unit III.C.1.ii.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for metconazole. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
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 0.38 ppb for ground water.
Chronic exposures for non-cancer assessments are estimated to be
38.16 ppb for surface water and 0.38 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 turf and ornamental uses. Adults and adolescents
may experience short- and intermediate-term dermal exposure from
golfing and other activities on treated turf, as well as from tending
treated ornamentals. Children may experience short- and intermediate-
term dermal and incidental oral exposure from activities on treated
turf. However, because dermal toxicity endpoints for the appropriate
durations of exposure were not identified, and because inhalation
exposure is considered to be insignificant for postapplication
exposures, only children's incidental oral postapplication exposures
have been assessed. Postapplication 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
[[Page 26454]]
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 (EPA, 2002). In conazoles, however, a variable
pattern of toxicological responses is found; 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 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.
Triazole-derived pesticides can form the metabolite 1,2,4-triazole
(T) and two triazole conjugates triazolylalanine (TA) and
triazolylacetic acid (TAA). To support existing tolerances and to
establish new tolerances for triazole-derivative pesticides, EPA
conducted an initial human-health risk assessment for exposure to T,
TA, and TAA resulting from the use of all current and pending uses of
any triazole-derived fungicide as of September 1, 2005. The risk
assessment was 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 Food Quality Protection Act (FQPA) safety factor (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 complete risk assessment can be found in the
propiconazole reregistration docket at http://www.regulations.gov,
Docket Identification (ID) Number EPA-HQ-OPP-2005-0497 and an update to
the aggregate human health risk assessment for free triazoles and its
conjugates may be found in Docket Identification (ID) Number EPA-HQ-
OPP-2011-0179 entitled ``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. Developmental studies in
rats and rabbits show some evidence of developmental effects, but only
at dose levels that are maternally toxic. There was no quantitative
susceptibility to the fetuses of rats or rabbits following in utero
exposure to metconazole. In the developmental toxicity study in rats,
skeletal variations (predominantly lumbar ribs) occurred in the
presence of maternal toxicity (decreased body weight gains). In the
prenatal developmental toxicity study in rabbits, developmental effects
(increased post-implantation loss and reduced fetal body weights) were
observed at the same dose that caused maternal toxicity (decreased body
weight gains, reduced food consumption and alterations in hematology
parameters). In the 2-generation reproduction study in rats, offspring
toxicity (reduced fetal body weights F2 offspring and decreased
viability in F1 and F2 offspring) was observed only at the HDT, a dose
which also resulted in parental toxicity as evidenced by reduced
parental body weight and body weight gains, increased incidence of
fatty hepatocyte changes in male parental animals and increased
incidence of spleen congestion in F1 parental females. In the rat
study, there is a concern for qualitative susceptibility (skeletal
variation in the presence of minimal maternal toxicity) due to the
presence of more severe effects at higher dose levels such as post-
implantation loss, hydrocephaly and visceral anomalies. However, there
is a clear NOAEL for these effects and the point of departure for this
endpoint is based on skeletal variations. Therefore, it is concluded
that there is no residual uncertainty for prenatal and/or postnatal
toxicity.
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:
The toxicity database is complete except for an acute
neurotoxicity study.
There is no concern for neurotoxicity with metconazole.
However, in accordance with the revised 40 CFR part 158 data
requirements, a neurotoxicity battery is required for risk assessment.
The existing metconazole database does not include an acute
neurotoxicity study, and thus remains a data deficiency. An acceptable
subchronic neurotoxicity study showed no neurotoxic effects at levels
that produced systemic toxicity in the study, as well as in other
subchronic and chronic studies. Therefore, concern for potential
neurotoxicity is low and the 10X FQPA factor is not retained.
There is no evidence of susceptibility following in utero
exposure in the rabbit developmental study. In the rat developmental
study there is qualitative evidence of susceptibility, however the
concern is low since the developmental effects 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. Dietary exposure
assessments were conducted using tolerance level residues and assumed
100 PCT. Therefore, the acute and chronic dietary (food only) exposure
is considered an upper bound conservative estimate. The contribution
from drinking water is minimal. The Agency concludes that the acute and
[[Page 26455]]
chronic exposure estimates in this analysis are unlikely to
underestimate actual exposure. The drinking water component of the
dietary assessment utilizes water concentration values generated by
model and associated modeling parameters which are designed to provide
conservative, health protective, high-end estimates of water
concentrations which will not likely be exceeded. While there is
potential for postapplication residential exposure, the Agency used the
current conservative approaches for residential assessment. Exposures
are unlikely to be under estimated because the assessment was a
screening level assessment.
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
acute PAD (aPAD) and chronic PAD (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 years
old, 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-term risk. Short-term risk takes into account short-term
residential exposure plus chronic exposure to food and drinking water
(considered to be a background exposure level). Metconazole is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to metconazole.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and non-occupational/residential post application exposures result in
aggregate MOEs of 420 for children 1-2 years old and 1,700 for adults.
Because EPA's level of concern for metconazole is a MOE of 100 or
below, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term risk takes into
account intermediate-term residential exposure plus chronic exposure to
food and drinking water (considered to be a background exposure level).
Metconazole is currently registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to metconazole.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and non-occupational residential
exposures result in aggregate MOEs of 460 for children 1-2 years old
and 1,700 for adults. Because EPA's level of concern for metconazole is
a MOE of 100 or below, these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. As explained in Unit
III.A., the Agency has determined that the quantification of risk using
a non-linear (i.e., RfD) approach will adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to metconazole. Therefore, based on the results of the chronic
risk assessment discussed in Unit III.E.2., metconazole is not expected
to pose a cancer risk to humans.
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, or to infants and children from aggregate
exposure to metconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography/tandem mass spectrometry (HPLC/MS/MS) method BASF D0604)
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; email 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 sugarcane.
C. Revisions to Petitioned-For Tolerances
Based on the results of the sugarcane crop field data and the
tolerance calculation procedures, EPA has determined that separate
tolerances for sugarcane, molasses are unnecessary. The highest
metconazole residue from the sugarcane field trials is 0.036 ppm. This
residue multiplied by the processing factor for molasses (0.036 x 1.2)
yields 0.043 ppm. As this is less than the tolerance for sugarcane,
cane at 0.06 ppm, the sugarcane, cane tolerance will cover molasses.
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, including its metabolites and degradates in or
on sugarcane, cane at 0.06 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,
[[Page 26456]]
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, 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: April 24, 2012.
Daniel J. Rosenblatt,
Acting 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 alphabetically adding the following
commodity to the table in paragraph (a) to read as follows:
Sec. 180.617 Metconazole; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Sugarcane, cane............................................. 0.06
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-10689 Filed 5-3-12; 8:45 am]
BILLING CODE 6560-50-P