[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Rules and Regulations]
[Pages 18805-18810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07559]



[[Page 18805]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0258; FRL-9907-67]


Metaflumizone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
metaflumizone in or on eggplant, pepper, tomato, and tomato, paste. 
BASF Corporation requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 4, 2014. Objections and 
requests for hearings must be received on or before June 3, 2014, 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-2013-0258, 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), EPA West 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; 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. 
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 
Printing 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-2013-0258 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 
June 3, 2014. 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-2013-0258, 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 
20460-0001.
     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.htm.
    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 June 5, 2013 (78 FR 33785) (FRL-9386-2), 
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 3E8146) 
by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27790. 
The petition requested that 40 CFR 180.657 be amended by establishing 
tolerances for residues of the insecticide metaflumizone, (E and Z 
isomers; 2-[2-(4-cyanophenyl)-1-[3-(trifluoromethyl) 
phenyl]ethylidene]-N-[4-(trifluoromethoxy)phenyl] 
hydrazinecarboxamide), and its metabolite (4-{2-oxo-2-[3-
(trifluoromethyl) phenyl]ethyl{time} -benzonitrile), in or on eggplant 
at 0.6 parts per million (ppm); pepper at 0.6 ppm; and tomato at 0.6 
ppm. That document 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, EPA has 
determined that the tolerances for eggplant and pepper should each be 
established at 1.5 ppm, the tolerance for tomato should be established 
at 0.60 ppm, and that an additional tolerance for tomato, paste should 
be established at 1.2 ppm. The reasons for these changes are explained 
in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include

[[Page 18806]]

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 metaflumizone including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with metaflumizone 
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.
    Hematotoxicity (toxicity of the blood) was the primary toxic effect 
of concern following subchronic or chronic oral exposures to 
metaflumizone. Splenic extramedullary hematopoiesis, increased 
hemosiderin, and anemia were the most common hematotoxic effects 
reported after repeated oral dosing with metaflumizone. Chronic oral 
(gavage) exposures to dogs resulted in slight decreases in mean 
corpuscular hemoglobin concentration and total hemoglobin, leading to 
increased plasma bilirubin, increased urinary urobilinogen, and 
increased hemosiderin in the liver. In a chronic toxicity/
carcinogenicity study in mice, anemia was observed in the form of 
increased hemosiderin in the spleen, increased mean absolute 
reticulocyte count, decreased mean corpuscular volume, and mean 
corpuscular hemoglobin.
    The postulated pesticidal mode of action of metaflumizone involves 
inhibition of sodium channels in target insect species; however, in 
mammals (rats), there were only clinical signs of neurotoxicity (i.e., 
piloerection and body temperature variations) with no neuropathology in 
the presence of systemic toxicity (e.g., recumbency and poor general 
state) following acute or repeated exposures. Similarly, several immune 
system organs seem to be affected following metaflumizone 
administration via the oral, dermal, and inhalation routes (e.g., the 
presence of macrophages in the thymus, lymphocyte necrosis in the 
mesenteric lymph nodes, and diffuse atrophy of the mandibular); 
however, there was no evidence of any functional deficits at the 
highest dose tested in a recently submitted and reviewed guideline 
immunotoxicity study. Therefore, the clinical neurotoxicity signs and 
the effects on the immune system organs following metaflumizone 
administration are likely to be secondary to the hematotoxic effects.
    Metaflumizone induced an increased incidence of a missing 
subclavian artery at a relatively high dose that also caused severe 
maternal toxicity (e.g., late term abortions) in the developmental 
toxicity study in rabbits. There was no evidence (quantitative or 
qualitative) of increased susceptibility following in utero exposures 
to rats or rabbit and following pre- and post natal exposures. There 
was no evidence that metaflumizone is genotoxic and carcinogenicity 
studies with mice and rabbits were negative.
    Specific information on the studies received and the nature of the 
adverse effects caused by metaflumizone as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Metaflumizone: Human-Health Risk 
Assessment for Tolerances in/on Imported Tomato, Pepper, and Eggplant'' 
in docket ID number EPA-HQ-OPP-2013-0258.

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 (LOCs) 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 metaflumizone used for 
human risk assessment is provided below:
    i. Acute dietary endpoint (general population including infants and 
children). An acute dietary endpoint was not established for this 
population group since an endpoint of concern (effect) attributable to 
a single dose was not identified in the database. Studies considered 
for this endpoint included the acute neurotoxicity study for which no 
toxicity was observed at any dose including the highest dose tested: 
The limit dose (1,000 mg/kg/day).
    ii. Acute dietary endpoint (females 13-49 years old). This endpoint 
was established based on a developmental effect observed in the rabbit 
developmental toxicity study that can be potentially due to a single 
dose of metaflumizone. This effect consisted of an increased incidence 
of an absent subclavian artery in the offspring at the LOAEL of 300 mg/
kg bw/day metaflumizone (NOAEL = 100 mg/kg bw/day). The rat 
developmental toxicity study was also considered for this endpoint; 
however, no developmental effects were observed in this study at the 
highest dose tested of 120 mg/kg bw/day metaflumizone. A combined 
uncertainty factor (UF) of 300 was applied to account for interspecies 
(10x) and intraspecies (10x) extrapolation. A Food Quality Protection 
Act (FQPA) safety factor (SF) of 3x was retained because the rabbit 
developmental toxicity study was performed via oral gavage dosing. In 
an absorption study submitted by the petitioner, dietary exposures 
(which are more relevant for human exposures) exhibited an 
approximately 2-fold greater absorption into the systemic circulation 
than oral gavage dosing and, thus, can potentially lead to toxicity at 
2-fold lower levels of exposure. Thus, the acute population adjusted 
dose (aPAD) for females 13-49 years old is estimated to be 0.33 mg/kg 
bw/day.
    iii. Chronic dietary endpoint. This endpoint was established based 
on the systemic toxicity observed in the chronic toxicity study with 
dogs. At the LOAEL of 30 mg/kg bw/day (NOAEL =

[[Page 18807]]

12 mg/kg bw/day), the effects consisted of reduced general health 
condition, slight to severe ataxia, recumbency, and severe salivation, 
slight decreases in mean corpuscular hemoglobin concentration and total 
hemoglobin, increased plasma bilirubin, increased urinary urobilinogen, 
and increased hemosiderin in the liver. A combined UF of 300 was 
applied to account for interspecies (10x) and intraspecies (10x) 
extrapolation and an FQPA safety factor of 3x. The FQPA safety factor 
of 3x was retained because the chronic toxicity study was performed via 
capsule dosing, which is a bolus dose very similar to gavage dosing 
(this accounts for the 2-fold greater absorption observed in dietary 
versus oral gavage exposures, as described in Unit III.B.ii.). Thus, 
the chronic population adjusted dose (cPAD) is estimated to be 0.040 
mg/kg bw/day.
    iv. Incidental oral (short- and intermediate-term). This endpoint 
was selected on the basis of the maternal effects observed in the rat 
2-generation reproductive toxicity study at the LOAEL of 50 mg/kg bw/
day metaflumizone (NOAEL = 20 mg/kg bw/day). Maternal toxicity 
consisted of poor general health and body weight deficits which were 
also associated with improper nursing behavior. Similar effects were 
also noted in a developmental neurotoxicity study (gavage, range 
finding) also considered for this endpoint. In this study, poor 
maternal health was also observed at the LOAEL of 120 mg/kg bw/day 
metaflumizone (NOAEL = 80 mg/kg bw/day). Both studies considered for 
this endpoint achieved a clear maternal NOAEL for the offspring 
effects, but the NOAEL of 20 mg/kg bw/day for the 2-generation 
reproductive toxicity study is considered more protective. The Agency's 
LOC for this scenario is 300 based on a 10x intraspecies factor, a 10x 
interspecies factor, and an FQPA safety factor of 3x (to account for 
the 2-fold greater absorption observed in dietary versus oral gavage 
exposures, as described in Unit III.B.ii.).
    v. Dermal (short- and intermediate-term). This endpoint was based 
on a rat 90-day dermal toxicity study in which deficits in body weight, 
body-weight gain and food consumption (in males and females); 
anogenital smearing; increased macrophages in the thymus; lymphocyte 
necrosis in the mesenteric lymph nodes; diffuse atrophy of the 
mandibular lymph node; and increased hemosiderin in the liver (females 
only) were observed at the LOAEL of 300 mg/kg bw/day (NOAEL = 100 mg/kg 
bw/day). The Agency's LOC for this scenario is 100 based on a 10x 
interspecies factor and a 10x intraspecies factor.
    vi. Inhalation (short- and intermediate-term). There is a 28-day 
inhalation study that is adequate for both exposure durations. There 
was no NOAEL identified for female rats. At the LOAEL of 0.10 mg/L 
metaflumizone (NOAEL = 0.03 mg/L), histopathology of the nasal tissues, 
lungs, thymus, prostate, and adrenal cortex was observed in males. The 
LOAEL identified in females resulted in lymphocyte necrosis in the 
mesenteric lymph node.
    The methods and dosimetry equations described in EPA's reference 
concentration (RfC) guidance (1994) are suited for calculating human-
equivalent concentrations (HECs) based on the inhalation toxicity point 
of departure (NOAEL, LOAEL) for use in MOE calculations. The regional-
deposited-dose ratio (RDDR), which accounts for the particulate 
diameter (mass median aerodynamic diameter (MMAD) and geometric 
standard deviation [[sigma]g] of aerosols), can be used to 
estimate the different dose fractions deposited along the respiratory 
tract. The RDDR accounts for interspecies differences in ventilation 
and respiratory-tract surface areas. Thus, the RDDR can be used to 
adjust an observed inhalation particulate exposure of an animal to the 
predicted inhalation exposure for a human. For the subchronic 
inhalation toxicity study with metaflumizone, an RDDR was estimated at 
2.81 based on systemic effects (lymphocyte necrosis in the mesenteric 
lymph node) in females at the LOAEL of 0.03 mg/L (no NOAEL established) 
and a MMAD of 1.7[mu]m and [sigma]g of 2.7.
    For this action with metaflumizone, only residential handler 
scenarios are being assessed for which 2-hr/day inhalation exposures 
are assumed. Adjustment to shorter exposure scenarios relative to the 
animal toxicity study duration (e.g., 2 hr residential exposures) 
should only be made if there is time-course information that would 
support a shorter time-frame. Since there is no such information 
available for metaflumizone, the unadjusted animal POD was used for HEC 
estimation. The HEC equals the product of the LOAEL from the study and 
the RDDR or 0.084 mg/L. The FQPA SF of 10x is being retained for lack 
of a NOAEL for females in the study. The standard interspecies 
extrapolation UF can be reduced from 10x to 3x due to the HEC 
calculation accounting for interspecies differences in pharmacokinetics 
(not pharmacodynamic). The intraspecies UF remains at 10x. Therefore, 
the LOC for this scenario is 300, which includes the FQPA SF of 10x, 
interspecies (3x), and intraspecies (10x) extrapolation.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to metaflumizone, EPA considered exposure under the 
petitioned-for tolerances as well as all existing metaflumizone 
tolerances in 40 CFR 180.657. EPA assessed dietary exposures from 
metaflumizone 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 metaflumizone. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) National Health and Nutrition Examination Survey, 
What We Eat in America (NHANES/WWEIA). This dietary survey was 
conducted from 2003 to 2008. As to residue levels in food, EPA assumed 
tolerance-level residues. It was further assumed that 100% of crops 
with the requested uses of metaflumizone were treated.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA. As to residue levels in food, EPA assumed tolerance-level 
residues. It was further assumed that 100% of crops with the requested 
uses of metaflumizone were treated.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that metaflumizone does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for metaflumizone. Tolerance level residues and/or 100% crop 
treated (CT) 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 metaflumizone in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of metaflumizone. Further information regarding EPA 
drinking water models used in pesticide exposure assessment

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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 
metaflumizone for acute exposures are estimated to be 1.14 parts per 
billion (ppb) for surface water and 0.00214 ppb for ground water. The 
EDWCs of metaflumizone for chronic exposures for non-cancer chronic 
assessments are estimated to be 0.597 ppb for surface water and 0.00214 
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 1.14 ppb was used to 
assess the contribution of drinking water. For chronic dietary risk 
assessment, the water concentration value of 0.597 ppb was used to 
assess the contribution of 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). Metaflumizone is 
currently registered for the following uses that could result in 
residential exposures: As a fire ant bait for application to lawns, 
landscapes, golf courses, and other non-cropland area; and as a fly 
bait for use around industrial buildings, commercial facilities, 
agricultural structures/premises, and recreational facilities/areas.
    EPA assessed residential exposure using the following assumptions: 
Fire ant bait applications to home lawns are expected to result in 
short-term, residential handler exposure to adults. Fire ant bait 
applications to lawns and golf-courses are expected to result in short-
term, post-application dermal exposure to adults, children 11 to <16 
years old, and children 1 to <2 years old, and incident oral exposure 
for children 1 to <2 years old. For the fly bait product, residential 
handler exposure is not expected, because the product is applied by 
commercial handlers. The fly bait product is expected to result in 
short-term, post-application dermal exposure to adults, children 11 to 
<16 years old, and children 1 to <2 years old, and incident oral 
exposure for children 1 to <2 years old.
    For residential handlers, dermal and inhalation exposures are 
combined since the endpoints are similar for these routes. For children 
(1- to <2-year-olds), post-application hand-to-mouth and dermal 
exposures are combined. Since the LOCs for the dermal, inhalation and 
incidental oral routes are not the same (dermal LOC = 100, inhalation 
LOC = 300, and incidental oral LOC = 300), these routes were combined 
using the aggregate risk index approach. Further information regarding 
EPA standard assumptions and generic inputs for residential exposures 
may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found metaflumizone to share a common mechanism of 
toxicity with any other substances, and metaflumizone does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
metaflumizone does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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 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. There is no evidence for 
increased qualitative or quantitative sensitivity/susceptibility 
resulting from pre- and/or postnatal exposures. In the rat prenatal 
development toxicity study, there was no offspring toxicity reported at 
any dose tested whereas in the rabbit study a maltransformation based 
on an absent subclavian artery was noted to occur only in the presence 
of severe maternal toxicity. Similarly, offspring mortality in the 2-
generation reproductive toxicity occurred only in the presence of a 
poor maternal health state. Thus, there is no evidence for increased 
susceptibility.
    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 from 10x to 3x for all oral exposure scenarios; 
retained at 10x for inhalation exposure scenarios; and reduced to 1x 
for dermal exposures. That decision is based on the following findings:
    i. The toxicity database for metaflumizone is complete.
    ii. There is no indication that metaflumizone directly affects the 
nervous system. Clinical signs consisting of piloerection and body 
temperature variations were observed only in the absence of 
neuropathology and in the presence of a poor general state. There is no 
need for a developmental neurotoxicity study or additional uncertainty 
factors to account for neurotoxicity.
    iii. There is no evidence that metaflumizone results in increased 
susceptibility in the prenatal developmental studies in rats and 
rabbits or in developing rats in the 2-generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases.
    The dietary analyses assumed tolerance-level residues, 100% CT, and 
modeled drinking water estimates. Therefore, EPA concludes that while 
the submission of data/information by the petitioner addressing the 
residue chemistry deficiencies identified in a previous petition may 
conceivably result in adjustment of the maximum theoretical residue 
estimate, actual metaflumizone dietary exposure estimates will not be 
greater than those generated in the current risk assessment. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to metaflumizone in drinking water. 
EPA used similarly conservative assumptions to assess postapplication 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by metaflumizone.
    v. Dietary exposures (which are more relevant for human exposures) 
exhibited an approximately 2-fold greater absorption into the systemic 
circulation as compared to oral gavage and, thus,

[[Page 18809]]

can potentially lead to toxicity at 2-fold lower levels of exposure. 
Applying a FQPA SF of 3x for all oral exposure scenarios is adequate to 
protect against any greater toxicity that might occur in dietary 
exposures (absorption was noted to be 2-fold greater in dietary versus 
oral gavage studies).
    vi. The FQPA SF of 10x is being retained for inhalation exposure 
scenarios for the use of a LOAEL instead of a NOAEL (no NOAEL achieved) 
for histopathological lesions consisting of lymphocyte necrosis in the 
mesenteric lymph node. The FQPA SF of 10x is adequate because the 
effect (lymphocyte necrosis) is considered minimal to slight and does 
not exhibit a strong dose dependence.
    vii. The FQPA SF for dermal exposure scenarios is being reduced 
from 10x to 1x since there is a route-specific study with a clear 
NOAEL.

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 metaflumizone will occupy 1.6% of the aPAD for females 13-49 years 
old.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
metaflumizone from food and water will utilize 5.8% 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 
metaflumizone 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). Metaflumizone 
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 metaflumizone. Since the LOC and 
toxicological points of departure for the short-term dermal and oral 
routes of exposure differ, the aggregate risk index method was used to 
determine aggregate risk (aggregate risk indices >1 are not a risk of 
concern).
    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 aggregate risk indices of 43 for 
the general population, and 27 for children 1-2 years old. Because 
EPA's LOC for metaflumizone is an aggregate risk index less than 1, the 
aggregate risks are 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). Metaflumizone is currently registered for uses that could 
result in intermediate-term residential exposure; however, since the 
PODs for the short- and intermediate-term durations are the same for 
metaflumizone, the short-term aggregate assessment is protective of 
intermediate-term exposures.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, metaflumizone 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 metaflumizone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatograph/mass 
spectrometer/mass spectrometer (LC/MS/MS) Method 531/0) 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 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 established an MRL for metaflumizone in or on tomato 
at 0.6 ppm. This MRL is the same as the tolerance established for 
metaflumizone in or on tomato in the United States. The Codex has 
established MRLs for metaflumizone in or on eggplant at 0.6 ppm and 
pepper at 0.6 ppm. These MRLs are different than the tolerances 
established for metaflumizone in the United States.
    The currently established Codex MRLs are based on the 2009 Joint 
Food and Agricultural Organization/World Health Organization (FAO/WHO) 
Meeting on Pesticide Residues (JMPR) metaflumizone report, and this 
report was utilized in the Agency's residue chemistry review. The 
difference in the United States tolerances and the Codex MRLs is thus 
due to the following issues:
    i. The United States metaflumizone tolerance expression for crops 
includes metaflumizone (E and Z isomers) and the metabolite M320I04. 
The Codex MRL expression differs in that it does not include M320I04. 
The Agency determined that M320I04 should be included as a residue of 
concern for risk assessment and tolerance enforcement purposes as it is 
identified at significant concentrations in the submitted metabolism 
study and is the primary residue in some processed commodities.
    ii. Harmonization with the Codex MRLs for pepper and eggplant is 
not appropriate because the U.S. residue data for pepper (and eggplant 
by translation) indicate maximum residues of in excess of 0.6 ppm. The 
1.5 ppm tolerances for both pepper and eggplant are based on the 
Organisation for Economic Co-operation and Development (OECD) 
tolerance-calculation procedure. The current Codex MRLs were 
established using the North American Free Trade Agreement (NAFTA) 
tolerance-calculation procedure which allowed the establishment of 
tolerances less than the

[[Page 18810]]

highest residues; the OECD tolerance-calculation procedure does not 
permit this.

C. Revisions to Petitioned-for Tolerances

    For pepper and eggplant, the available data indicate that residues 
may be greater than the proposed 0.6 ppm tolerance. Using the OECD 
tolerance-calculation procedure, EPA determined that a tolerance of 1.5 
ppm is appropriate for both pepper and eggplant. Based on the highest-
average field-trial residue and an average tomato paste processing 
factor of 2.94x, the Agency concluded that a tomato, paste tolerance of 
1.2 ppm should be established.

V. Conclusion

    Therefore, tolerances are established for residues of 
metaflumizone, (E and Z isomers; 2-[2-(4-cyanophenyl)-1-[3-
(trifluoromethyl)phenyl]ethylidene]-N-[4-(trifluoromethoxy)phenyl] 
hydrazinecarboxamide) and its metabolite 4-{2-oxo-2-[3-
(trifluoromethyl)phenyl]ethyl{time} -benzonitrile, in or on eggplant at 
1.5 ppm; pepper at 1.5 ppm; tomato at 0.60 ppm; and tomato, paste at 
1.2 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under 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 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 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 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) (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 of 1995 (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).

List of Subjects in 40 CFR Part 180

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

    Dated: March 28, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. In Sec.  180.657:
0
a. Add alphabetically the commodities to the table in paragraph (a).
0
b. Add footnote 1 to the table in paragraph (a).
    The additions read as follows:


Sec.  180.657  Metaflumizone; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Eggplant \1\...............................................          1.5
 
                                * * * * *
Pepper \1\.................................................          1.5
Tomato \1\.................................................         0.60
Tomato, paste \1\..........................................          1.2
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of April 4, 2014.

* * * * *
[FR Doc. 2014-07559 Filed 4-3-14; 8:45 am]
BILLING CODE 6560-50-P