[Federal Register Volume 77, Number 87 (Friday, May 4, 2012)]
[Rules and Regulations]
[Pages 26450-26456]
From the Federal Register Online via the Government Publishing 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: [email protected].

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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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: [email protected].

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