
[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Rules and Regulations]
[Pages 10381-10387]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3795]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2008-0168; FRL-9333-4]


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 citrus fruit, tree nuts, almond hulls; and 
grape. BASF Corporation requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 22, 2012. Objections and 
requests for hearings must be received on or before April 23, 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-2008-0168. 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: Julie Chao, Registration Division 
(7505P), Office of Pesticide Programs,

[[Page 10382]]

Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8735; email 
address: chao.julie@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2008-0168 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 
April 23, 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 request, identified by docket ID 
number EPA-HQ-OPP-2008-0168, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of August 10, 2011 (76 FR 49396) (FRL-8882-
8), 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 
7F7260) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 
27709. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the insecticide metaflumizone, 
in or on: Fruit, citrus, group 10 at 0.04 ppm; nut, tree, group 14 at 
0.04 ppm; almond, hulls at 0.04 ppm; and grape at 0.04 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.

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 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. 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,

[[Page 10383]]

and diffuse atrophy of the mandibular); however, there was no evidence 
of any functional deficits at the highest dose tested (HDT) 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 the document entitled ``Metaflumizone. Revised 
Human-Health Risk Assessment Associated with a Section 3 Registration 
for a Fire Ant Bait for Application to Citrus, Tree Nuts, and Grape, 
and a new Section 3 Registration for a Fly Bait for Application around 
Industrial, Commercial, Agricultural, and Recreational Facilities/
Structures and Premises'' in docket ID number EPA-HQ-OPP-2008-0168.

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 metaflumizone used for 
human risk assessment is provided in this unit:
    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 in which no 
toxicity was observed at any dose including the HDT, which is the limit 
dose (1,000 milligrams/kilograms/day (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 body/weight/day (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 HDT of 120 mg/kg bw/day metaflumizone. A combined uncertainty 
factor of 300 was applied to account for interspecies (10X) and 
intraspecies (10X) extrapolation and a Food Quality Protection Act 
(FQPA) safety factor of 3X. 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 = 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, leading to 
increased plasma bilirubin, increased urinary urobilinogen, and 
increased hemosiderin in the liver. A combined uncertainty factor of 
300 was applied to account for interspecies (10X) and intraspecies 
(10X) extrapolation and an FQPA safety factor of 3X. 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 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 level of concern for 
this scenario is 300 based on a 10X intraspecies factor, a 10X 
interspecies factor, and an FQPA safety factor of 3X.
    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 level of concern 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 for this exposure scenario. There was no NOAEL 
identified for female rats. At the LOAEL of 0.10 mg/Liter (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 Agency's level of concern for this scenario 
is 1,000 based on a 10X interspecies factor, a 10X intraspecies factor, 
and an FQPA safety factor of 10X. Route-specific toxicity studies were 
selected for assessment of

[[Page 10384]]

short-intermediate-term dermal, inhalation, and oral exposures. Short-
intermediate-term dermal and inhalation exposures can be aggregated 
based on the immunotoxic effects seen at the LOAEL in the selected 
studies. Short/intermediate-term oral, dermal, and inhalation exposures 
can be aggregated based on the decreased body weight or decreased body-
weight gain effects seen at the LOAEL in the selected oral and dermal 
studies and at doses above the LOAEL in the selected inhalation study.

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. 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) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). 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 1994-1996 
and 1998 CSFII. 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 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 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 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 to drinking water. For chronic dietary risk 
assessment, the water concentration of value 0.597 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). Metaflumizone is 
currently registered for the following uses that could result in 
residential exposures: Pet spot-on products to control fleas on dogs 
and cats; fire ant bait products for application to lawns, landscapes, 
golf courses, and other non-cropland area. In addition, a pending fly 
bait product is proposed for use in areas where people may be present; 
therefore, a residential exposure assessment was performed for this 
use.
    EPA assessed residential exposure using the following assumptions: 
For the pet spot-on products, residential handler exposure is not 
expected, because the product is applied directly from a tube to the 
pet. Pet spot-on applications are expected to result in short- and 
intermediate-term post-application dermal exposure to all populations, 
and incident oral exposure (i.e., hand-to-mouth) for children 3 to <6 
years of age. For the 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, landscapes, golf-courses, 
and other non-cropland areas are expected to result in short-term, 
post-application dermal exposure to adults, adolescents, and children 3 
to <6 years old, and incident oral exposure for children 3 to <6 years 
old. For the pending fly bait product, residential handler exposure is 
not expected, because the product is applied by commercial handlers. 
The pending fly bait product is expected to result in short-term, post-
application dermal exposure to adults and children 3 to <6 years old, 
and incident oral exposure to children 3 to <6 years old.
    For residential handlers, dermal and inhalation exposures are 
combined since the endpoints are similar for these routes. For children 
(3 to <6 year olds), post-application hand-to-mouth and dermal 
exposures are combined. Since the levels of concern (LOCs) for the 
dermal, inhalation and incidental oral routes are not the same (dermal 
LOC = 100, inhalation LOC = 1,000, 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

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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. 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 prenatal 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 safety factor 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 in utero rats or rabbits in the prenatal 
developmental studies or in young 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 
PCT, and modeled drinking water estimates. Therefore, HED concludes 
that while the submission of data/information by the petitioner 
addressing the residue chemistry deficiencies 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 and, thus, can potentially lead to toxicity at 2-fold lower 
levels of exposure. Applying a FQPA safety factor 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 safety factor 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 safety factor of 10X is 
adequate due to the severity of lymphocyte necrosis being minimal to 
slight and not exhibiting a strong dose dependence.
    vii. The FQPA safety factor 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% of the aPAD for females 13-49 years 
old. An acute dietary exposure estimate was generated for females 13-49 
years old, but not for the remaining population subgroups since an 
endpoint attributed to a single dose was not identified for those 
populations.
    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 <1% 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 level of 
concern (LOC) is different for dermal and oral exposures (100 and 300, 
respectively), 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 3 for the 
general population, and 2 for children 1-2 years old. Since the LOCs 
for the dermal, inhalation and incidental oral routes are not the same 
(dermal LOC = 100, inhalation LOC = 1,000, and incidental oral LOC = 
300), these routes were combined using the aggregate risk index 
approach. Because EPA's LOC for metaflumizone is an aggregate risk 
index less than 1, the aggregate risks are not of concern. These 
aggregate risk indices utilize residential exposure estimates from the 
pet spot-on products, which represent the worst-case exposure scenario. 
However, it should be noted that all registered pet spot-on products 
containing metaflumizone are pending voluntary cancellation; therefore, 
these aggregate risk indices can be considered conservative.
    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;

[[Page 10386]]

however, since the PODs for the short- and intermediate-term durations 
are the same for metaflumizone, the short-term aggregate assessment is 
protective of longer-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: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for metaflumizone.

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: Fruit, 
citrus, group 10 at 0.04 ppm; nut, tree, group 14 at 0.04 ppm; almond, 
hulls at 0.04 ppm; and grape at 0.04 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, 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: February 3, 2012.
Steven Bradbury,
Director, 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 180.657 is added to subpart C to read as follows:


Sec.  180.657  Metaflumizone; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide metaflumizone, including its metabolites and degradates, in 
or on the commodities listed in the following table. Compliance with 
the tolerance levels specified in the following table is to be 
determined by measuring only the sum of metaflumizone (E and Z isomers; 
2-[2-(4-cyanophenyl)-1-[3-(trifluoromethyl) phenyl]ethylidene]-N-[4-
(trifluoromethoxy)phenyl]

[[Page 10387]]

hydrazinecarboxamide) and its metabolite 4-{2-oxo-2-[3-
(trifluoromethyl) phenyl]ethyl{time} -benzonitrile, calculated as the 
stoichiometric equivalent of metaflumizone, in or on the following 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls................................................       0.04
Fruit, citrus, group 10......................................       0.04
Grape........................................................       0.04
Nut, tree, group 14..........................................       0.04
------------------------------------------------------------------------

     (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2012-3795 Filed 2-21-12; 8:45 am]
BILLING CODE 6560-50-P


