Document ID: EPA-HQ-OPP-2012-0716-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fenpyroximate
Posted Date: 2013-06-17T04:00Z

[Federal Register Volume 78, Number 116 (Monday, June 17, 2013)]
[Rules and Regulations]
[Pages 36093-36097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14213]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0716; FRL-9388-2]

Fenpyroximate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
fenpyroximate in or on multiple commodities identified and discussed 
later in this document. In addition, this regulation removes an 
established tolerance for a certain commodity superseded by this 
action. The Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective June 17, 2013. Objections and 
requests for hearings must be received on or before August 16, 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-2012-0716, 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: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; email address: jackson.sidney@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. 
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-2012-0716 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

[[Page 36094]]

before August 16, 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-2012-0716, 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 Wednesday, November 7, 2012 (77 FR 
66781) (FRL-9367-5), 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 2E8072) by Interregional Research Project Number 4 (IR-4), 
500 College Road East, Suite 201W, Princeton, NJ 08540. The petition 
requested that 40 CFR 180.566 be amended by establishing tolerances for 
residues of the insecticide fenpyroximate, (E)-1,1-dimethylethyl 4-
[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate and its Z-isomer, (Z)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate in or on fruit, stone, group 12-
12 at 2.0 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, 
subgroup 13-07F at 1.0 ppm; and vegetable, tuberous and corm, subgroup 
1C at 0.1 ppm. That document referenced a summary of the petition 
prepared by Nichino America, Inc., 4550 New Linden Hill Rd., 
Wilmington, DE 19808, 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 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 fenpyroximate including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with fenpyroximate 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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.
    Fenpyroximate was classified as having moderate acute oral and 
inhalation toxicity in rats. It exhibited low dermal acute toxicity and 
was neither a skin nor eye irritant. Fenpyroximate was a slight to 
moderate sensitizer by the maximization test method. Subchronic and 
chronic oral exposures to fenpyroximate resulted in overall systemic 
toxicity (no specific target organ/tissue was identified). The most 
sensitive species tested was the dog. The effects reported in the dog 
included slight bradycardia, deficits in food consumption, body weight, 
body-weight gain, and an increased incidence of emesis and diarrhea. 
Emaciation and torpor (sluggish inactivity) were reported in female 
dogs at lower dose levels than males. The highest dose tested in the 
dog resulted in first- and second-degree heart block, increased urea 
concentration, decreased glucose, and altered plasma electrolyte levels 
among other signs of toxicity. In subchronic and chronic studies with 
rats, the primary effect was decreased body-weight gain in both sexes 
with hematological changes (e.g., higher counts of red blood cells) at 
higher doses.
    In a rat prenatal developmental toxicity study, a fenpyroximate 
dose level that marginally affected maternal body weight and food 
consumption also resulted in an increased litter incidence of increased 
thoracic ribs, indicating increased prenatal (qualitative) 
susceptibility. In the rabbits, there were no developmental effects 
reported at any of the dose levels tested. In the rat 2-generation 
reproductive toxicity study, there was no indication of increased 
prenatal or postnatal susceptibility; maternal toxicity (decreased body 
weight) and offspring toxicity (decreased lactational weight gain in 
both generations) occurred at the same dose. Reproductive parameters 
were not affected. Acute and subchronic neurotoxicity studies in the 
rat show no evidence that fenpyroximate specifically targets the 
nervous system. In the acute neurotoxicity study, neurotoxicity signs 
such as decreases in motor activity occurred in the presence of other 
effects including decreases in body weight and food consumption, and in 
the absence of neuropathology. Similar results were noted in a delayed 
acute neurotoxicity study in the hen where no effects (neurotoxic or 
otherwise) were reported. The results of the rat subchronic 
neurotoxicity study did not indicate any neurotoxicity-specific 
effects; deficits in body weight and food consumption were the main 
effects reported. Effects reported in a rat immunotoxicity study were 
limited to decreased body-weight gain, indicating the fenpyroximate 
does not directly target the immune system. There is no evidence of 
carcinogenic potential for fenpyroximate based on the results of 
carcinogenicity studies via the oral route in either the rats or mice 
resulting in the carcinogenicity classification of ``not likely'' to be 
carcinogenic to humans. Genotoxicity studies including mutagenicity did 
not

[[Page 36095]]

demonstrate any genotoxic potential resulting from fenpyroximate 
exposure.
    Specific information on the studies received and the nature of the 
adverse effects caused by fenpyroximate 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: ``Fenpyroximate. Human-Health Risk 
Assessment for Proposed Section 3 Uses on Stone Fruits (Group 12-12), 
Tuberous and Corm Vegetables (Subgroup 1C), and Small Vine Climbing 
Fruits Except Kiwifruit (Subgroup 13-07F), dated May 8, 2013 at 
Appendix A'', p. 30 in docket ID number EPA-HQ-OPP-2012-0716-0003.

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 fenpyroximate used for 
human risk assessment is discussed in Unit III. of the final rule 
published in the Federal Register of Wednesday, December 12, 2012 (77 
FR 73945) (FRL-9360-3).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenpyroximate, EPA considered exposure under the 
petitioned-for tolerances as well as all existing fenpyroximate 
tolerances in 40 CFR 180.566. EPA assessed dietary exposures from 
fenpyroximate 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 fenpyroximate. In estimating acute dietary exposure, EPA used the 
Dietary Exposure Evaluation Model--Food Consumption Intake Database 
(DEEM-FCID, ver. 3.16), which incorporates consumption information from 
the U.S. Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA); 2003-2008. 
As to residue levels in food, EPA assumed 100 percent crop treated 
(PCT), tolerance-level residues for all commodities, DEEM (ver. 7.81) 
default processing factors for all commodities except for apple, pear, 
and grape juice; grape, raisin; orange, grapefruit, tangerine, lemon 
and lime juice; tomato paste and puree; and peppermint and spearmint 
oil. Chemical-specific data were used to calculate empirical processing 
factors for these commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT, 
tolerance-level residues for all commodities, DEEM (ver. 7.81) default 
processing factors for all commodities except for apple, pear, and 
grape juice; grape, raisin; orange, grapefruit, tangerine, lemon and 
lime juice; tomato paste and puree; and peppermint and spearmint oil. 
Chemical-specific data were used to calculate empirical processing 
factors for these commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fenpyroximate 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 or PCT information in the dietary assessment for 
fenpyroximate. 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 fenpyroximate in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fenpyroximate. 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 First Index Reservoir Screening Tool (FIRST) model, 
the Screening Concentration in Ground Water (SCI-GROW) model, and a 
Provisional Cranberry Model, the Agency calculated conservative 
estimated drinking water concentrations (EDWCs) of fenpyroximate. Tier 
1, EDWCs reflect exposure in drinking water to the residues of 
fenpyroximate and its isomer/degradate, its cis isomer M-1, and its 
carboxylic acid M-3, all of which are assumed to have similar toxicity.
    For acute exposures, EDWCs are estimated to be 43 parts per billion 
(ppb) for surface water and 0.27 ppb for ground water.
    For chronic exposures, EDWCs are estimated to be 8.6 ppb for 
surface water and 0.27 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 43 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 8.6 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, 
termiticide, and flea and tick control on pets). Fenpyroximate is not 
registered for any specific use patterns that would result in 
residential exposure.
    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 fenpyroximate to share a common mechanism of 
toxicity with any other substances, and fenpyroximate does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of

[[Page 36096]]

this tolerance action, therefore, EPA has assumed that fenpyroximate 
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 evidence of 
increased prenatal (qualitative) susceptibility in a rat prenatal 
developmental toxicity study. A dose level that marginally affected 
maternal body weight and food consumption also resulted in an increased 
litter incidence of increased thoracic ribs. However, concern for 
prenatal and postnatal toxicity to fenpyroximate is low because:
    i. There was a clear NOAEL in the rat prenatal developmental 
toxicity study;
    ii. The NOAEL for this developmental study is being used as POD for 
the acute dietary risk assessment for the population of concern-females 
13-49 years old;
    iii. In the rabbit, there were no developmental effects reported at 
the levels tested; and
    iv. In the rat 2-generation reproductive toxicity study, there was 
no indication of increased prenatal or postnatal 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 to 1X for all exposure scenarios. That decision is 
based on the following findings:
    i. The toxicity database for fenpyroximate is complete.
    ii. There is no indication that fenpyroximate is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is evidence that fenpyroximate results in increased 
susceptibility in utero rats or rabbits in the prenatal developmental 
studies or in young rats in the 2-generation reproduction study. 
Increased (qualitative) prenatal susceptibility was seen following oral 
exposures in the rat developmental toxicity study, but the concern for 
these effects is low, for the reasons noted in Unit III.D.2. Therefore, 
a 10X FQPA safety factor is not necessary to account for this increased 
susceptibility of infants and children.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessment utilizes tolerance-
level residues (established or recommended) and 100 PCT for all 
proposed/established commodities. By using these assumptions, the acute 
and chronic exposures/risks will not be underestimated. The dietary 
drinking water assessment utilizes water concentration values generated 
by models and associated modeling parameters, which are designed to 
provide conservative, health-protective, high-end estimates of water 
concentrations that will not likely be exceeded. There are no 
registered or proposed residential uses. These assessments will not 
underestimate the exposure and risks posed by fenpyroximate.

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 fenpyroximate will occupy 13% of the aPAD for females 13-49 years 
old and 6.2% of the aPAD for children 1-2 years old, the population 
group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fenpyroximate from food and water will utilize 15% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for fenpyroximate.
    3. Short- and intermediate-term risks. Short-, and intermediate-
term aggregate exposure takes into account short-, and intermediate-
term residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short-, and 
intermediate-term adverse effects were identified; however, 
fenpyroximate is not registered for any use patterns that would result 
in short-, and intermediate-term residential exposures. Therefore, no 
further assessment of short-, and intermediate-term risks is necessary. 
EPA relies on the chronic dietary risk assessment for evaluating short-
, and intermediate-term risks for fenpyroximate.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fenpyroximate is not expected to pose a cancer risk to humans.
    5. 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 fenpyroximate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography method with 
nitrogen/phosphorus detection (GC/NPD), Method S19) is available to 
enforce the tolerance expression. Method S19 has passed an Agency 
validation and has a limit of quantitation (LOQ) of 0.05 ppm for the 
combined residues of fenpyroximate and M-1 in snap beans and avocados. 
A data-gathering liquid chromatography/mass spectroscopy/mass 
spectroscopy (LC/MS/MS) method is also available.
    These methods 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

[[Page 36097]]

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.
    Codex MRLs are established for residues of fenpyroximate per se in 
grapes (fresh and dried). Harmonization with the Codex MRLs is not 
possible because the U.S. tolerance expression includes an additional 
isomer and the U.S. use pattern requires a higher numerical value.

C. Revisions to Petitioned-For Tolerances

    As EPA explained in its latest crop group rulemaking (77 FR 50617, 
August 22, 2012), EPA will attempt to conform petitions seeking 
tolerances for crop groups to the newer established crop groups, rather 
than establish new tolerances under the pre-existing crop groups, as 
part of its effort to eventually convert tolerances for any pre-
existing crop group to tolerances with coverage under the revised crop 
group. Therefore, although the petitioner requested tolerances for 
``Fruit, stone, group 12'', EPA evaluated and is establishing 
tolerances for the crop group ``Fruit, stone, group 12-12.''
    Lastly, the Agency is removing the entry for ``grape'' from the 
table at 40 CFR 180.566 (a)(1) since the tolerance for ``Fruit, small, 
vine climbing, except fuzzy kiwifruit, subgroup 13-07F'' at 1.0 ppm 
established by this action will subsume the existing tolerance.

V. Conclusion

    Therefore, tolerances are established for residues the insecticide 
fenpyroximate, including its metabolites and degradates, in or on the 
commodities Fruit, small, vine climbing, except fuzzy kiwifruit, 
subgroup 13-07F at 1.0 ppm; Fruit, stone, group 12-12 at 2.0; and 
Vegetable, tuberous and corm, subgroup 1C at 0.10 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: June 3, 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. Section 180.566 is amended by removing the entry for ``grape, 1.0'' 
and by alphabetically adding the following entries to the table in 
paragraph (a)(1) to read as follows:

Sec.  180.566  Fenpyroximate; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit,                 1.0
 subgroup 13-07F...........................................
Fruit, stone, group 12-12..................................          2.0
 
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C..................         0.10
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-14213 Filed 6-14-13; 8:45 am]
BILLING CODE 6560-50-P