[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Rules and Regulations]
[Pages 30619-30625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12936]



40 CFR Part 180

[EPA-HQ-OPP-2014-0230; FRL-9927-11]

Metconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
metconazole in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA). In addition, this regulation removes established 
tolerances for certain commodities/groups superseded by this action, 
and deletes expired tolerances.

DATES: This regulation is effective May 29, 2015. Objections and 
requests for hearings must be received on or before July 28, 2015, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0230, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.


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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/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-2014-0230 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 28, 2015. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0230, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at  http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 23, 2014 (79 FR 29729) (FRL-9910-
29), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
4E8244) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201 W, Princeton, NJ 08540. 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-(1H-1,2,4-triazol-1-ylmethyl)-cyclopentanol, in or on fruit, stone, 
group 12-12 at 0.2 parts per million (ppm); nut, tree, group 14-12 at 
0.04 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 
0.15 ppm; rapeseed subgroup 20A at 0.08 ppm; and sunflower subgroup 20B 
at 0.9 ppm. The petition also requested that current established 
tolerances for residues of the fungicide metconazole in or on canola 
seed at 0.04 ppm; fruit, stone, group 12 at 0.20 ppm; pistachio at 0.04 
ppm; and nut, tree, group 14 at 0.04 ppm be removed once the proposed 
tolerances were approved. That document referenced a summary of the 
petition prepared by Valent U.S.A Corporation, the registrant, which is 
available in the docket, http://www.regulations.gov. Comments were 
received on the notice of filing. EPA's

[[Page 30620]]

response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
determined the tolerance for the sunflower subgroup 20B should be 0.7 
ppm. The reason for this change is explained in Unit IV.D.

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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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. Metconazole affects the liver, kidney, spleen, and various 
blood parameters at various dose levels across species. Specifically, 
in the mouse, rat, and dog, liver toxicity was seen after oral exposure 
in both subchronic and chronic exposures. Metconazole produces liver 
tumors in mice through a mitogenic mode of action (i.e., non-
genotoxic), and in the absence of a genotoxic mode of action, 
metconazole is classified as ``not likely to be carcinogenic to 
humans'' at levels that do not cause mitogenesis.
    Oral studies revealed critical effects of metconazole on body 
weight and blood erythrocyte and/or platelet parameters in the mouse, 
rat, dog and/or rabbit. Hyperplasia and increased weight were observed 
in the spleen in the mouse, rat, and dog at dose levels where liver 
affects were also observed. Lenticular degeneration (cataracts) were 
observed at the highest dose tested 114 milligrams/kilogram/day (mg/kg/
day) in dogs. In addition, there was evidence that at high dietary 
levels metconazole is a gastrointestinal irritant in the dog.
    In rats and rabbits developmental studies displayed some evidence 
of developmental effects but largely at dose levels that are maternally 
toxic. There was no quantitative or qualitative susceptibility in 
rabbit fetuses after in utero exposure to metconazole. In prenatal 
developmental toxicity studies in rabbits there was an increase in 
post-implantation loss and reduced fetal body weights at the same dose 
level that caused maternal toxicity. In rats, the developmental study 
showed skeletal variations at the lowest-observed-adverse-effect-level 
(LOAEL) in the absence of maternal toxicity. The 2-generation 
reproduction studies revealed offspring and parental toxicity only at 
the highest tested dose. There is low concern for quantitative 
susceptibility (skeletal variations in the absence of maternal toxicity 
in the developmental study) because the endpoint and point of departure 
are based on the effects in the fetus, for which there is a clear 
NOAEL. Therefore, it is concluded that there are no residual 
uncertainties for pre- and/or post-natal toxicity.
    Metconazole did not demonstrate neurotoxicity in the subchronic 
neurotoxicity study, or any of the other studies in the toxicity data 
base. The requirement for an acute neurotoxicity study has been waived 
because of the absence of neurotoxic signs throughout the database, 
even at the highest dose levels tested.
    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/
    EPA has classified metconazole as: ``Not Likely to be Carcinogenic 
to Humans'' based on convincing evidence demonstrating the following: 
(1) That a non-genotoxic mode of action for liver tumors was 
established in the mouse; (2) that the carcinogenic effects were not 
likely to occur below a defined dose that does not cause mitogenesis 
based on bioassays in the rat and the mouse; and (3) a lack of in vitro 
or in vivo mutagenicity. The established chronic RfD, which is below 
the level at which mitogenesis occurred in the rat and mouse, is deemed 
to be protective of mitogenesis/carcinogenesis, and no quantification 
is required.
    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 LOAEL from the toxicity studies 
can be found at http://www.regulations.gov in document at 
``Metconazole. Human Health Risk Assessment for a Section 3 
Registration of New Uses on Dry Shelled Pea and Beans (Except Soybean) 
Crop Subgroup 6C and Sunflower Crop Subgroup 20B; Crop Group Expansion 
to Rapeseed Subgroup 20A; and Crop Group Conversion to Fruit, Stone, 
Group 12-12; and Nut, Tree, Group 14-12'' in docket ID number EPA-HQ-

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.

[[Page 30621]]

  Table 1--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 (the next higher
                                                                               dose level) 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
Incidental oral short-term (1 to   NOAEL= 9.1 mg/kg/day  Residential LOC for  28-Day oral toxicity study in
 30 days).                         UFA = 10x...........   MOE = 100.           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).
Dermal short-term (1 to 30 days).  Quantification of dermal risk is not required due to lack of systemic or
                                    dermal toxicity at the Limit Dose in a 21-day dermal toxicity study in the
                                    rat, the lack of neurotoxicity, and the lack of developmental and/or
                                    reproductive toxicity in the absence of parental effects, which were not
                                    looked for in the dermal toxicity.
Inhalation short-term (1 to 30     Inhalation (or oral)  Residential LOC for  28-Day oral toxicity study in
 days).                             study NOAEL= 9.1 mg/  MOE = 1000.          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 = 10x (UFDB)
Cancer (Oral, dermal, inhalation)           Classification: ``Not likely to be Carcinogenic to Humans''.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day= milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population

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 
    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 population including infants and children; 
therefore, a quantitative acute dietary exposure assessment is 
unnecessary for the general population.
    Such effects were identified for metconazole for females 13-49 
years old. In estimating acute dietary exposure, EPA used food 
consumption information from the Dietary Exposure Evaluation Model with 
the Food Commodity Intake Database (DEEM-FCID). This software 
incorporates 2003-2008 food consumption data from the U.S. Department 
of Agriculture's National Health and Nutrition Examination Survey, What 
We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA 
assumed 100 percent crop treated (PCT) and tolerance-level residues for 
most crops. For cereal grains and livestock commodities, maximum 
residue levels of metabolites from field trials were added to the 
metconazole tolerance levels.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used food consumption information from the DEEM-FCID. 
This software incorporates 2003-2008 food consumption data from the 
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and 
tolerance-level residues for most crops. For cereal grains and 
livestock commodities, maximum residue levels of metabolites from field 
trials were added to the metconazole tolerance levels.
    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

[[Page 30622]]

purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for metconazole. Tolerance-level and metabolite 
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 Tier I Pesticide Root Zone Model-Ground Water (PRZM-
GW), the estimated drinking water concentrations (EDWC) of metconazole 
are estimated to be 51.8 parts per billion (ppb) for acute exposures 
and not applicable for chronic (non-cancer) exposures. Based on the 
Tier II Surface Water Concentration Calculator (SWCC) model, the EDWCs 
are estimated to be 49.6 ppb for acute exposures and 43.9 ppb for 
chronic (non-cancer) exposures.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment for females, the water concentration value of 51.8 ppb-was 
used to assess the contribution to drinking water. For chronic dietary 
risk assessment, the water concentration of value 43.9 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: For 
residential handler exposure, the Agency assumed that residential use 
will result in short-term (1-30 days) dermal and inhalation exposures. 
Because there was no dermal endpoint chosen for metconazole, 
residential handler risk from exposure to metconazole was assessed for 
the inhalation route only.
    The Agency assumed that post-application exposure in residential 
settings is short-term in duration only. No dermal endpoint was chosen 
for metconazole; therefore a dermal post-application risk assessment 
was not conducted for adults or children. Residential post-application 
inhalation exposure in outdoor settings is considered negligible. The 
scenarios evaluated were short-term post-application incidental oral 
exposure to children 1 to <2 years old from granular and water 
dispersible granular metconazole formulations.
    In the previous tolerance action for metconazole which published in 
the Federal Register of August 17, 2011 (76 FR 50898) (FRL-8882-7), the 
Agency also assessed intermediate-term exposures. However, in 2012 the 
EPA revised the residential standard operating procedures (SOPs) and 
based on these revisions has determined that intermediate-exposures are 
not expected. Further information regarding EPA standard assumptions 
and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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, the conazoles. Although conazoles act similarly in plants 
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 conclusive data 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. This class of 
compounds can form the common metabolite 1,2,4-triazole and two 
triazole conjugates (triazolylalanine and triazolylacetic 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, 
triazolylalanine, and triazolylacetic acid resulting from the use of 
all current and pending uses of any triazole-derived fungicide. The 
risk assessment is a highly conservative, screening-level evaluation in 
terms of hazards associated with common metabolites (e.g., use of a 
maximum combination of uncertainty factors) and potential dietary and 
non-dietary exposures (i.e., high end estimates of both dietary and 
non-dietary exposures). In addition, the Agency retained the additional 
10X FQPA safety factor for the protection of infants and children. The 
assessment includes evaluations of risks for various subgroups, 
including those comprised of infants and children. The Agency's 
complete risk assessment is found in the propiconazole reregistration 
docket at http://www.regulations.gov, Docket Identification (ID) Number 
    An updated dietary exposure and risk analysis for the common 
triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA), 
triazolylacetic acid (TAA), and triazolylpyruvic acid (TP) was 
conducted in October 2013, in association with a registration request 
for several other triazole fungicides. That analysis concluded that 
risk estimates were below the Agency's level of concern for all 
population groups. The proposed new uses of metconazole did not result 
in an increase in the dietary exposure estimates for free triazole or 
conjugated triazoles. Therefore, this last dietary exposure analysis 
for free triazole or conjugated triazoles did not need to be updated. A 
copy of this assessment may be found in the docket for this action at 

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

[[Page 30623]]

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 Safety Factor (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. For analyzing the 
developmental and reproductive impact and toxicity of metconazole, two 
developmental studies in the rat, two developmental studies in the 
rabbit, and one multi-generation reproduction study were used. There 
was evidence of quantitative susceptibility in one developmental rat 
study, but not in the four other studies. Concern is for susceptibility 
low since susceptibility was not corroborated by the other studies; 
concern is low also because the NOAELs are well defined, and the dose/
endpoint is used for acute dietary risk assessment for the sensitive 
    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, except for inhalation exposure scenarios 
for which the Agency is retaining the 10X. That decision is based on 
the following findings:
    i. The toxicity database for metconazole is complete, except for 
the subchronic inhalation study. A 10x uncertainty factor has been 
retained for purposes of determining the inhalation endpoint to account 
for the absence of this data. However, only adult handlers are expected 
to be exposed via the inhalation route.
    ii. There is no indication that metconazole is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. Although one developmental rat study showed indications of 
quantitative susceptibility, EPA has determined that additional safety 
factors are not necessary to account for any potential risk because 
that susceptibility was not corroborated by the other developmental and 
reproduction studies and the developmental NOAEL for the study that 
showed quantitative susceptibility is well defined. Moreover, the dose/
endpoint identified in the rat developmental study is being used for 
acute dietary risk assessment for the sensitive population.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues for most crops. For cereal 
grains and livestock commodities, maximum residue levels of metabolites 
from field trials were added to the metconazole tolerance levels. 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 post 
application exposure of children as well as incidental oral exposure of 
children 1 to <2 years old. 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 
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 4.6% of the aPAD for females 13 to 49 years 
old, the only population subgroup of potential 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 14% 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 aggregate exposure takes into 
account short-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-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 residential exposures result in an aggregate MOEs of 630 for 
children 1 to <2 years old, which is not of concern. For adults, oral 
dietary and inhalation risk estimates were combined using the total 
aggregated risk index (ARI) methodology since the levels of concern 
(LOC) for oral dietary exposure (LOC = 100) and inhalation exposure 
(LOC = 1,000) are different. The short-term aggregate ARI for adults is 
5.3, which is greater than 1 and is therefore not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
metconazole is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., 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 (Nitrogen-Phosphorus-Detection 
(GC/NPD) method, Valent Method RM-41C-1-1) is available to enforce the 
tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905;

[[Page 30624]]

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 United Nations 
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.

C. Response to Comments

    EPA received two comments to the Notice of Filling. One comment 
concerned a chemical other than metconazole and therefore is not 
relevant to this action. The other was a request to reconsider 
``loosening tolerances'' for several pesticide petitions, including for 
metconazole. The commenter points to an American Academy of Pediatrics 
Policy statement regarding pesticide exposure in children, a Centers 
for Disease Control and Prevention report on human exposure to 
environmental chemicals, and a President's Cancer Panel regarding 
reducing environmental cancer risks in supporting the request to 
reconsider the tolerance amendments proposed for metconazole.
    The Agency understands the commenter's concerns and recognizes that 
some individuals believe that certain pesticide chemicals should not be 
permitted in our food, or that pesticide tolerances should be 
``significantly tightened'' as the commenter notes. However, the 
existing legal framework provided by section 408 of the Federal Food, 
Drug and Cosmetic Act (FFDCA) states that tolerances may be set when 
EPA determines that aggregate exposure to that pesticide is safe, i.e., 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the pesticide chemical residue. When making this 
determination, EPA considers the toxicity, including any potential 
carcinogenicity, of the pesticide and all anticipated dietary exposures 
and all other exposures for which there is reliable information. EPA 
also gives special consideration to the potential susceptibility and 
exposures of infants and children to the pesticide chemical residue 
when making this determination. For metconazole, the Agency has 
considered all the available data, including all available data 
concerning the potential for carcinogenicity of metconazole and its 
metabolites, and concluded after conducting a risk assessment, that 
there is a reasonable certainty that no harm will result from aggregate 
human exposure to metconazole and that, accordingly, the metconazole 
tolerances are safe.

D. Revisions to Petitioned-For Tolerances

    The petitioner requested a tolerance on the sunflower subgroup 20B 
at 0.9 ppm. EPA is establishing a tolerance for that subgroup at 0.7 
ppm based on the Organisation for Economic Co-operation and Development 
(OECD) tolerance calculation procedures.

V. Conclusion

    Therefore, tolerances are established for residues of metconazole, 
ylmethyl)-cyclopentanol, in or on fruit, stone, group 12-12 at 0.2 ppm; 
nut, tree, group 14-12 at 0.04 ppm; pea and bean, dried shelled, except 
soybean, subgroup 6C at 0.15 ppm; rapeseed subgroup 20A at 0.08 ppm; 
and sunflower subgroup 20B at 0.7 ppm. Additionally, the existing 
tolerances for canola seed; fruit, stone, group 12; nut, tree, group 
14; and pistachio are being removed since they are superseded by this 

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) 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 action has been 
exempted from review under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), such as the tolerances 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

[[Page 30625]]

List of Subjects in 40 CFR part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 19, 2015.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

2. In Sec.  180.617:
a. Remove the entries in the table in paragraph (a) for ``Canola 
seed,'' ``Fruit, stone, group 12,'' ``Nut, tree, group 14,'' and 
b. Add alphabetically the entries for ``Fruit, stone, group 12-12'', 
``Nut, tree, group 14-12'', ``Pea and bean, dried shelled, except 
soybean, subgroup 6C'', ``Rapeseed subgroup 20A'', and ``Sunflower 
subgroup 20B'' to the table in paragraph (a).
c. Revise paragraph (b).
    The additions and revision read as follows:

Sec.  180.617  Metconazole; tolerance for residues.

    (a) * * *

                                                              Parts per
                         Commodity                             million
                                * * * * *
Fruit, stone, group 12-12.................................          0.2
                                * * * * *
Nut, tree, group 14-12....................................          0.04
                                * * * * *
Pea and bean, dried shelled, except soybean, subgroup 6C..          0.15
                                * * * * *
Rapeseed subgroup 20A.....................................          0.08
                                * * * * *
Sunflower subgroup 20B....................................          0.7
                                * * * * *

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2015-12936 Filed 5-28-15; 8:45 am]