[Federal Register Volume 78, Number 191 (Wednesday, October 2, 2013)]
[Rules and Regulations]
[Pages 60709-60715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24127]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0912; FRL-9399-6]


Methoxyfenozide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
methoxyfenozide in or on multiple commodities which are identified and 
discussed later in this document. Additionally, this regulation removes 
several established time-limited and permanent tolerances, as they will 
be superseded by tolerances established by this document. Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 2, 2013. Objections and 
requests for hearings must be received on or before December 2, 2013, 
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-2012-0912, 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

[[Page 60710]]

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. To access the OCSPP test guidelines 
referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2012-0912 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 
December 2, 2013. 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-2012-0912, 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.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 January 16, 2013 (78 FR 3377) (FRL-9375-
4), 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 
2E8118) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.544 be amended by 
establishing tolerances for residues of the insecticide methoxyfenozide 
(3-methoxy-2-methylbenzoic acid 2-(3,5-dimethylbenzoyl)-2-(1,1-
dimethylethyl) hydrazide) in or on atemoya at 0.6 parts per million 
(ppm); berry, low growing, except cranberry, subgroup 13-07G at 1.5 
ppm; biriba at 0.6 ppm; caneberry subgroup 13-07A at 6 ppm; cherimoya 
at 0.6 ppm; custard apple at 0.6 ppm; date at 7 ppm; fruit, pome, group 
11-10 at 1.5 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, 
subgroup 13-07F at 1 ppm; grain, aspirated grain fractions at 80 ppm; 
herb subgroup 19A, except chive at 400 ppm; ilama at 0.6 ppm; pea and 
bean, dried shelled, except soybean, subgroup 6C, except pea, 
blackeyed, seed and pea, southern, seed at 0.5 ppm; sorghum, grain, 
forage at 9 ppm; sorghum, grain, grain at 4 ppm; sorghum, grain, stover 
at 15 ppm; sorghum, sweet, forage at 9 ppm; sorghum, sweet, grain at 4 
ppm; sorghum, sweet, stalk at 9 ppm; sorghum, sweet, stover at 15 ppm; 
soursop at 0.6 ppm; sugar apple at 0.6 ppm; and vegetable, fruiting, 
group 8-10 at 2 ppm.
    Additionally, the petition requested that EPA establish tolerances 
under paragraph (d)(2) for indirect or inadvertent residues of 
methoxyfenozide in or on rapeseed subgroup 20A at 1.0 ppm and sunflower 
subgroup 20B at 1.0 ppm, and to amend the tolerance for herb and spice, 
group 19, except coriander, leaves at 4.5 ppm to spice subgroup 19B at 
4.5 ppm. Upon approval of the proposed tolerances listed under ``New 
Tolerances,'' the petition finally requested that EPA remove the 
following commodities from paragraph (a)(1): Bean, dry seed at 0.24 
ppm; coriander, leaves at 30 ppm; grape at 1.0 ppm; fruit, pome, group 
11 at 1.5 ppm; okra at 2.0 ppm; pea, dry seed at 2.5 ppm; strawberry at 
1.5 ppm; and vegetable, fruiting, group 8 at 2.0 ppm. That document 
referenced a summary of the petition prepared on behalf of IR-4 by Dow 
AgroSciences, LLC, 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 
revised the proposed tolerance levels for several commodities. The 
Agency has also removed the time-limited tolerances for several 
commodities and the established tolerance in or on grain, aspirated 
grain fractions. 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 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 methoxyfenozide including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with methoxyfenozide 
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.
    The main target organs identified from the toxicity studies on 
methoxyfenozide were the liver, thyroid, and red blood cells, though 
many of the available short-term or subchronic toxicity studies showed

[[Page 60711]]

little or no toxicity. Effects of methoxyfenozide on the blood in 
mammals (methemoglobinemia, decreased red blood cell parameters, Heinz 
body formation) are consistent with those of other hydrazine compounds. 
Hematologic parameters in the rat and dog were affected by exposure to 
methoxyfenozide. Mild anemia (decreases in red blood cell count, 
hematocrit and hemoglobin) was observed in both species following 
chronic dietary exposure, along with methemoglobinemia and red blood 
cell structural abnormalities. Increased platelets were also observed. 
An increase in the cellularity of rib and sternum bone marrow, along 
with macrophage pigmentation in the liver and spleen, were reported in 
the dog. No significant hematological changes were seen in the dog or 
rat subchronic studies, or the rat 2 week range-finding studies; 
however, hematological effects were observed in the dog 2 week range-
finding study, along with increased spleen weight. No hematological 
effects were reported in the mouse.
    Increased liver weight and periportal hypertrophy were observed in 
the rat and dog. These findings were observed in the rat following 2-
week, subchronic or chronic dietary exposure and in the dietary 
reproductive toxicity study, and in the dog following chronic exposure. 
In the rat 2-week toxicity study, increased adrenal gland weight and 
minimal hypertrophy of the zone fasciculata, and increased thyroid 
follicular cell hypertrophy/hyperplasia were also observed. Thyroid 
hypertrophy and altered colloid and increased adrenal weights were 
observed in the rat chronic oral study, and the incidence and severity 
of chronic progressive glomerulonephropathy was increased. Thyroid 
weights were increased in the dog following chronic exposure.
    Acute and subchronic oral neurotoxicity studies in the rat did not 
show evidence of potential neurotoxicity. In the acute study, decreased 
hindlimb grip strength on day 0 was reported in males. This finding was 
only observed at the limit dose in males and was not observed in the 
subchronic neurotoxicity study and was therefore not considered 
evidence of neurotoxicity. No clinical signs of toxicity or 
neurohistopathology were observed in other guideline studies.
    No maternal or developmental effects were observed in either the 
rat or rabbit developmental toxicity studies. In the rat 2-generation 
reproductive toxicity study, no offspring or reproductive toxicity was 
observed, and parental effects were limited to increased liver weight 
and microscopic periportal hypertrophy. In an immunotoxicity study in 
the rat, no immunotoxicity was observed.
    There was no evidence of carcinogenicity in the rat combined 
chronic toxicity and carcinogenicity study or the mouse carcinogenicity 
study. No mutagenic or clastogenic potential was observed in the 
battery of genotoxicity studies on methoxyfenozide. Based on these 
findings, methoxyfenozide has been classified as ``not likely to be 
carcinogenic to humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by methoxyfenozide 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: ``Methoxyfenozide. Human Health Risk 
Assessment to Support Proposed New Uses on Herbs, Caneberries, Dates 
and Sorghum; to Establish Rotational Crop Tolerances in the Rapeseed 
and Sunflower Oilseed Subgroups; as well as to Extend and Update Crop 
Group Tolerances on Multiple Commodities'' at pp. 35-41 in docket ID 
number EPA-HQ-OPP-2012-0192.

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 methoxyfenozide used 
for human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of July 11, 2012 (77 FR 40806) (FRL-
9354-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to methoxyfenozide, EPA considered exposure under the 
petitioned-for tolerances as well as all existing methoxyfenozide 
tolerances in 40 CFR 180.544. EPA assessed dietary exposures from 
methoxyfenozide 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. No such effects were 
identified in the toxicological studies for methoxyfenozide; therefore, 
a quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used Dietary Exposure Evaluation Model software with the 
Food Commodity Intake Database (DEEM-FCID) Version 3.16, which uses 
food consumption data from the U.S. Department of Agriculture's 
(USDA's) National Health and Nutrition Examination Survey, ``What We 
Eat in America'' (NHANES/WWEIA) from 2003 through 2008. As to residue 
levels in food, EPA utilized tolerance-level residues, DEEM (Version 
7.81) default processing factors as necessary, an empirical processing 
factor for orange juice, and 100 percent crop treated (PCT) for all 
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that methoxyfenozide 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 PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for methoxyfenozide. 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 methoxyfenozide in drinking water. These simulation 
models take into account data on the physical, chemical,

[[Page 60712]]

and fate/transport characteristics of methoxyfenozide. 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 Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of 
methoxyfenozide for chronic exposures for non-cancer assessments are 
estimated to be 51.6 parts per billion (ppb) for surface water and 251 
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 251 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). Methoxyfenozide is 
currently registered for the following uses that could result in 
residential exposures: Ornamental uses, including on residential 
property. EPA assessed residential exposure using the following 
assumptions: Adult handlers were assessed for short-term inhalation 
exposures from mixing, loading, and applying methoxyfenozide using a 
manually pressurized hand wand, backpack sprayer, or hose-end sprayer. 
Since the short- and intermediate-term toxicological endpoints are the 
same, only short-term exposures have been assessed and are assumed to 
be protective of intermediate-term exposures. A postapplication 
exposure assessment was not conducted for adults because the handler 
assessment is expected to be protective of postapplication exposure via 
the inhalation route. Although there is also potential for dermal 
exposure, there is no expectation of dermal risk to any population, 
including infants and children, based on the lack of dermal toxicity 
for methoxyfenozide. Furthermore, the potential for postapplication 
oral exposures to children is not expected since the extent to which 
young children engage in activities associated with areas where 
residential ornamentals are grown or use these areas for prolonged 
periods of play is low. 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 methoxyfenozide to share a common mechanism of 
toxicity with any other substances, and methoxyfenozide does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
methoxyfenozide 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 Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. Based on the results in the 
developmental toxicity studies in rats and rabbits and in the 2-
generation reproduction study in rats, no increased sensitivity of 
fetuses or pups, as compared to adults, was demonstrated for 
methoxyfenozide. There are no concerns or residual uncertainties for 
pre- or postnatal toxicity following exposure to methoxyfenozide.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for methoxyfenozide is complete.
    ii. There is no indication that methoxyfenozide is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that methoxyfenozide 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 chronic dietary food exposure assessment was performed 
based on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to methoxyfenozide in drinking water. Based on the 
discussion in Unit III.C.3., residential exposures to children or 
toddlers are not expected. These assessments will not underestimate the 
exposure and risks posed by methoxyfenozide.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
methoxyfenozide is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
methoxyfenozide from food and water will utilize 84% 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 
methoxyfenozide is not expected.

[[Page 60713]]

    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). 
Methoxyfenozide 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 methoxyfenozide.
    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 MOE of 530 for adult 
handlers. Because EPA's level of concern for methoxyfenozide is a MOE 
of 100 or below, this MOE is 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). Methoxyfenozide is currently registered for uses that could 
result in intermediate-term residential exposure. However, based on the 
information in Unit III.C.3., an intermediate-term aggregate exposure 
assessment was not performed and is not necessary.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, methoxyfenozide 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 methoxyfenozide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, using high performance liquid 
chromatography (HPLC), with either mass spectrometric detection (LC/MS) 
or ultraviolet detection (HPLC/UV), 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 MRLs for methoxyfenozide in or on 
commodities associated with this action. Codex has established MRLs in 
or on grapes at 1 milligram/kilogram (mg/kg); pepper and tomato at 2 
mg/kg; pome fruits at 2 mg/kg; and strawberries at 2 mg/kg. The U.S. 
tolerances for small vine climbing fruit, except fuzzy kiwifruit 
subgroup 13-07F at 1.0 ppm (represented by grape); and vegetable, 
fruiting, group 8-10 (represented by commodities including pepper and 
tomato) at 2.0 ppm are harmonized with the Codex MRLs for grape and for 
pepper and tomato, respectively.
    Additionally, the EPA is establishing a tolerance in or on fruit, 
pome, group 11-10 at 2.0 ppm, which is increased from the current 
tolerance of 1.5 ppm for fruit, pome, group 11, in order to harmonize 
with the Codex MRL in or on fruit, pome at 2 mg/kg. The Agency is also 
establishing a tolerance in or on berry, low growing, subgroup 13-07G, 
except cranberry (represented by strawberry) at 2.0 ppm, in order to 
harmonize with the Codex MRL in or on strawberry at 2 mg/kg. The 13-07G 
tolerance is being increased from the current tolerance of 1.5 ppm in 
or on strawberry.
    The recommended tolerance of 0.50 ppm in or on pea and bean, dried 
shelled, except soybeans subgroup 6C, was proposed at the Agency's 
request to better harmonize with the existing Codex MRL of 0.5 mg/kg in 
or on dried beans. This tolerance will supersede the current tolerances 
in or on dried beans at 0.24 ppm, and in or on dried peas at 2.5 ppm. 
The Codex has not established MRLs for other commodities associated 
with this action.

C. Revisions to Petitioned-For Tolerances

    Based on the data supporting the petition, EPA has revised the 
proposed tolerances for several commodities, as follows: Date from 7.0 
ppm to 8.0 ppm; grain, aspirated grain fractions from 80 ppm to 120 
ppm; sorghum, grain, forage from 9.0 ppm to 15 ppm; sorghum, grain, 
grain from 4.0 ppm to 6.0 ppm; sorghum, grain, stover from 15 ppm to 20 
ppm; sorghum, sweet, forage from 9.0 ppm to 15 ppm; sorghum, sweet, 
grain from 4.0 ppm to 6.0 ppm; sorghum sweet, stalk from 9.0 ppm to 15 
ppm; and sorghum, sweet, stover from 15 ppm to 20 ppm. The Agency 
revised these tolerance levels based on analysis of the residue field 
trial data using the Organization for Economic Cooperation and 
Development (OECD) tolerance calculation procedures. As previously 
discussed, EPA has also revised the following proposed tolerances in 
order to harmonize with established Codex MRLs: Berry, low growing, 
subgroup 13-07G, except cranberry from 1.5 ppm to 2.0 ppm, and fruit, 
pome, group 11-10 from 1.5 ppm to 2.0 ppm.
    EPA is establishing a tolerance in or on herb subgroup 19A, except 
chive at 400 ppm. The petition to the Agency requested concurrently to 
amend the established tolerance for indirect or inadvertent residues in 
or on herb and spice, group 19, except coriander, leaves at 4.5 ppm to 
spice subgroup 19B at 4.5 ppm, because a permanent tolerance in or on 
subgroup 19A was proposed to be established and an inadvertent 
tolerance is no longer needed when a commodity has a tolerance allowing 
for direct treatment. However, because the permanent tolerance being 
established in or on herb subgroup 19A does not include a tolerance for 
chive and chive is not included in subgroup 19B, the Agency determined 
that it is also necessary to maintain a tolerance for the indirect or 
inadvertent residues of methoxyfenozide in or on chive, as the 
commodity was previously covered by the group 19 indirect or 
inadvertent residue tolerance. Therefore, EPA is also establishing an 
individual tolerance for the indirect or inadvertent residues of 
methoxyfenozide in or on chive at 4.5 ppm.
    Additionally, EPA determined that the time-limited tolerances in or 
on sorghum, forage at 30.0 ppm; sorghum, grain at 0.05 ppm; and 
sorghum, stover at 60.0 ppm should be removed because the tolerances 
expired on December 31, 2012, and because they will be superseded by 
permanent tolerances for these commodities. Finally, the Agency has 
determined that the established

[[Page 60714]]

tolerance in or on grain, aspirated fractions at 2.0 ppm should be 
removed, as it will be superseded by the grain, aspirated grain 
fractions tolerance at 120 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of 
methoxyfenozide (3-methoxy-2-methylbenzoic acid 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide) in or on atemoya at 
0.60 ppm; berry, low growing, subgroup 13-07G, except cranberry at 2.0 
ppm; biriba at 0.60 ppm; caneberry subgroup 13-07A at 6.0 ppm; 
cherimoya at 0.60 ppm; custard apple at 0.60 ppm; date at 8.0 ppm; 
fruit, pome, group 11-10 at 2.0 ppm; fruit, small, vine climbing, 
except fuzzy kiwifruit, subgroup 13-07F at 1.0 ppm; grain, aspirated 
grain fractions at 120 ppm; herb subgroup 19A, except chive at 400 ppm; 
ilama at 0.60 ppm; pea and bean, dried shelled, except soybean, 
subgroup 6C, except pea, blackeyed, seed and pea, southern, seed at 
0.50 ppm; sorghum, grain, forage at 15 ppm; sorghum, grain, grain at 
6.0 ppm; sorghum, grain, stover at 20 ppm; sorghum, sweet, forage at 15 
ppm; sorghum, sweet, grain at 6.0 ppm; sorghum, sweet, stalk at 15 ppm; 
sorghum, sweet, stover at 20 ppm; soursop at 0.60 ppm; sugar apple at 
0.60 ppm; and vegetable, fruiting, group 8-10 at 2.0 ppm. This 
regulation additionally establishes tolerances for indirect or 
inadvertent residues in or on rapeseed subgroup 20A at 1.0 ppm and 
sunflower subgroup 20B at 1.0 ppm. The regulation also amends the 
tolerance for indirect or inadvertent residues in or on herb and spice, 
group 19, except coriander, leaves at 4.5 ppm to spice subgroup 19B at 
4.5 ppm and chive at 4.5 ppm.
    This regulation additionally removes the established tolerances in 
or on bean, dry, seed at 0.24 ppm; coriander, leaves at 30 ppm; fruit, 
pome, group 11 at 1.5 ppm; grain, aspirated fractions at 2.0 ppm; grape 
at 1.0 ppm; okra at 2.0 ppm; pea, dry, seed at 2.5 ppm; strawberry at 
1.5 ppm; and vegetable, fruiting, group 8 at 2.0 ppm. Finally, this 
regulation removes the time-limited tolerances in or on sorghum, forage 
at 30.0 ppm; sorghum, grain at 0.05 ppm; and sorghum, stover at 60.0 
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 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 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: September 26, 2013.
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.  180.544:
0
a. Remove bean, dry, seed; coriander, leaves; fruit, pome, group 11; 
grain, aspirated fractions; grape; okra; pea, dry seed; strawberry; and 
vegetable, fruiting, group 8 from the table in paragraph (a)(1).
0
b. Remove and reserve paragraph (b).
0
c. Remove herb and spice, group 19, except coriander, leaves from the 
table in paragraph (d)(2).
0
d. Add the following commodities in alphabetical order to the tables in 
paragraphs (a)(1) and (d)(2) as shown.


Sec.  180.544  Methoxyfenozide; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Atemoya......................................................       0.60
 
 
                                * * * * *
Berry, low growing, subgroup 13-07G, except cranberry........       2.0
Biriba.......................................................       0.60
 
                                * * * * *
Caneberry subgroup 13-07A....................................       6.0
 
                                * * * * *
Cherimoya....................................................       0.60

[[Page 60715]]

 
 
                                * * * * *
Custard apple................................................       0.60
Date.........................................................       8.0
 
                                * * * * *
Fruit, pome, group 11-10.....................................       2.0
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup       1.0
 13-07F......................................................
 
                                * * * * *
Grain, aspirated grain fractions.............................     120
 
                                * * * * *
Herb subgroup 19A, except chive..............................     400
 
                                * * * * *
Ilama........................................................       0.60
 
                                * * * * *
Pea and bean, dried shelled, except soybean, subgroup 6C,           0.50
 except pea, blackeyed, seed and pea, southern, seed.........
 
                                * * * * *
Sorghum, grain, forage.......................................      15
Sorghum, grain, grain........................................       6.0
Sorghum, grain, stover.......................................      20
Sorghum, sweet, forage.......................................      15
Sorghum, sweet, grain........................................       6.0
Sorghum, sweet, stalk........................................      15
Sorghum, sweet, stover.......................................      20
Soursop......................................................       0.60
 
                                * * * * *
Sugar apple..................................................       0.60
 
                                * * * * *
Vegetable, fruiting, group 8-10..............................       2.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
    (d) * * *
    (2) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Chive........................................................       4.5
 
                                * * * * *
Rapeseed subgroup 20A........................................       1.0
Spice subgroup 19B...........................................       4.5
Sunflower subgroup 20B.......................................       1.0
------------------------------------------------------------------------

[FR Doc. 2013-24127 Filed 10-1-13; 8:45 am]
BILLING CODE 6560-50-P