Document ID: EPA-HQ-OPP-2011-0541-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fenpyroximate
Posted Date: 2012-12-12T05:00Z

[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Rules and Regulations]
[Pages 73945-73951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29900]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0541; FRL-9360-3]

Fenpyroximate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of the 
insecticide fenpyroximate in or on multiple commodities identified and 
discussed later in this document. In addition, this regulation removes 
established tolerances for certain commodities/groups superseded by 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 December 12, 2012. Objections and 
requests for hearings must be received on or before February 11, 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-2011-0541, is available either 
electronically through http://www.regulations.gov or in hard copy at 
the OPP Docket in the Environmental Protection Agency Docket Center 
(EPA/DC), located in EPA West, 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. 
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).

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/

[[Page 73946]]

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-2011-0541 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 
February 11, 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 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-2011-0541, 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 Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection 
Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania 
Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for 
hand delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.

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

II. Summary of Petitioned-For Tolerance

    In the Federal Register of Wednesday, September 7, 2011 (76 FR 
55329) (FRL-8886-7), EPA issued a notice pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 1E7881) by IR-4, Project Headquarters, 500 College Road 
East, Suite 201 W, Princeton, NJ 08540; and on Wednesday, May 2, 2012 
(77 FR 25954) (FRL-9346-1) for PP 1F7902 by Nichino America, Inc., 4550 
New Linden Hill Road, Suite 501, Wilmington, DE 19808. The petitions 
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) 
methyene]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 avocado at 0.2 parts 
per million (ppm); bean, snap at 0.4 ppm; canistel at 0.2 ppm; cucumber 
at 0.25 ppm; fruit, citrus, group 10-10 at 0.6 ppm; fruit, pome, group 
11-10 at 0.4 ppm; mango at 0.2 ppm; papaya 0.2 ppm; sapodilla at 0.2 
ppm; sapote, black at 0.2 ppm; sapote, mamey at 0.2 ppm; star apple at 
0.2 ppm; tea, plucked leaves at 15 ppm; and vegetable, fruiting, group 
8-10 at 0.2 ppm; corn, field, grain at 0.02 ppm; corn, field, forage/
silage at 2.0 ppm; corn, field, stover at 7.0 ppm; corn, field, 
aspirated fractions at 2.0 ppm; corn, pop, grain at 0.02 ppm; corn, 
pop, forage/silage at 2.0 ppm; corn, pop, stover at 7.0 ppm; and corn, 
pop, aspirated fractions at 2.0 ppm. In addition, petition 1E7881 
proposed to remove established tolerances in or on the raw agricultural 
commodities/groups: Fruit, citrus, group 10 at 0.60 ppm; fruit, pome, 
group 11 at 0.40 ppm; and vegetable, fruiting, group 8 at 0.20 ppm. The 
notices referenced a summary of the respective petition prepared by 
Nichino America, Inc., the registrant, available in the docket, http://www.regulations.gov. There were no comments received in response to 
these notices of filing. Based upon review of the data supporting the 
petitions, EPA is establishing tolerance levels for certain commodities 
other than the proposed level. 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 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 induced 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 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 (50 milligrams/kilogram/
day (mg/kg bw/day)) 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.

[[Page 73947]]

    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 no developmental effects reported 
at the levels tested. In the rat two-generation reproductive toxicity 
study, there was no indication of increased pre- or post-natal 
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 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 (1) Proposed Section 3 Uses on Cucumber, Snap Bean, 
Avocado, Black Sapote, Canistel, Mamey Sapote, Mango, Papaya, 
Sapodilla, Star Apple, Corn (Field, Pop, Silage, and Grown for Seed); 
(2) Updated Tolerances for Citrus Fruit- Group 10-10, Pome Fruit Group 
11-10, and Fruiting Vegetable Group 8-10; (4) the Establishment of a 
Tolerance on Imported Tea; (3) Increase in Maximum Seasonal Application 
Rate on Mint; and (4) Proposed Label Amendment to Include Aerial 
Applications to Existing Uses on Citrus in Texas, Melons, Fruiting 
Vegetables, and Snap Beans,'' dated April 16, 2012 at p. 32 in docket 
ID number EPA-HQ-OPP-2011-0541-0005.

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 shown in 
the following Table.

  Table--Summary of Toxicological Doses and Endpoints for Fenpyroximate for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50       NOAEL = 5.0 mg/kg bw  aRfD =.............  Prenatal Developmental Toxicity
 years of age).                    UFA = 10x...........  aPAD = 0.05 mg/kg     Study--Rat. LOAEL = 25 mg/kg/day
                                   UFH = 10x...........   bw.                  based on increase in the fetal
                                   FQPA SF = 1x........                        incidence of additional thoracic
                                                                               ribs.
Acute dietary (General population  NOAEL = 37.5 mg/kg    aRfD =.............  Acute Neurotoxicity Study--Rat.
 including infants and children).   bw.                  aPAD = 0.375 mg/kg   LOAEL = 150 mg/kg bw based on
                                   UFA = 10x...........   bw.                  decreased motor activity (total
                                   UFH = 10x...........                        activity counts and total time
                                   FQPA SF = 1x........                        spent in movement) in both sexes,
                                                                               and a reduction in auditory
                                                                               startle response in females at 24
                                                                               hours post dose, and mild
                                                                               dehydration in males.
Chronic dietary (All populations)  NOAEL = 5.0 mg/kg/    cRfD =.............  Chronic toxicity--Dogs.
                                    day.                 cPAD = 0.05 mg/kg/   LOAEL = 15 mg/kg/day based on an
                                   UFA = 10x...........   day.                 increased incidence of
                                   UFH = 10x...........                        bradycardia, diarrhea, and
                                   FQPA SF = 1x........                        decreases in cholesterol, body-
                                                                               weight gain, and food consumption
                                                                               (M); vomiting, diarrhea, excess
                                                                               salivation and decrease
                                                                               cholesterol in females.

[[Page 73948]]

 
Cancer (Oral, dermal, inhalation)                 Classification: ``Not likely to be carcinogen.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. mg/kg bw = milligram/kilogram of body weight. NOAEL = no-
  observed-adverse-effect-level. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose.
  UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
  sensitivity among members of the human population (intraspecies).

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 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 100 percent crop treated (PCT), tolerance-level residues for 
all commodities, DEEM\TM\ (ver. 7.81) default processing factors for 
all commodities except for apple, pear, and grape juice; 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 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed 100 PCT, 
tolerance-level residues for all commodities, and DEEM\TM\ (ver. 7.81) 
default processing factors for most commodities except for apple, pear, 
and grape juice; 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 percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for fenpyroximate. Tolerance-level residues and 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), a 
Provisional Cranberry Model and Screening Concentration in Ground Water 
(SCI-GROW) 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, 
termiticides, 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 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 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

[[Page 73949]]

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 pre-
natal and post-natal toxicity to fenpyroximate is low because (1) there 
was a clear NOAEL in the rat prenatal developmental toxicity study; (2) 
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; (3) in the rabbit, there were no developmental effects 
reported at the levels tested, and (4) in the rat two-generation 
reproductive toxicity study, there was no indication of increased pre- 
or post-natal 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 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. 
However, for the reasons noted in Unit III.D.2., the concern is low.
    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 uses that will result in residential exposure. 
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 3.6% of the aPAD for children 1 to 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 9.0% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. There are no residential uses for fenpyroximate.
    3. Short- and intermediate-term risks. Short-term and intermediate-
term aggregate exposure takes into account short-term 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 exposure. 
Short- and intermediate-term risks are assessed based on short- and 
intermediate term residential exposures plus chronic dietary exposure. 
Because there are no short- and intermediate-term residential exposure 
and chronic dietary exposure has already been assessed under the 
appropriately protective cPAD (which is at least as protective as the 
POD used to assess short- and intermediate-term risks), no further 
assessments of short- and intermediate-term risks are 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 with nitrogen/
phosphorus detection (GC/NPD), Method S19, has passed an Agency 
validation) and is available to enforce the tolerance expression.
    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 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/
on several crop commodities. Harmonization with the Codex MRLs is not 
possible because the U.S. tolerance expressions include both the parent 
fenpyroximate and additional metabolites/isomers. However, the Agency 
is lowering the pome fruit tolerance from 0.40 ppm to 0.30 ppm in order 
to harmonize with the Codex MRL level. Similarly, based on recently

[[Page 73950]]

submitted residue data on citrus, EPA is lowering the existing citrus 
fruit tolerance from 0.60 ppm to 0.50 ppm in order to harmonize with 
the Codex MRL level.

C. Revisions to Petitioned-For Tolerances

    EPA modified/revised certain IR-4 proposed tolerances based on 
results from the Organization for Economic Co-operation and Development 
(OECD) tolerance calculation procedures in order to determine 
appropriate tolerance levels from available U.S. residue data. The 
proposed tolerance at 0.20 ppm for avocado, black sapote, mamey sapote, 
canistel, mango, papaya, sapodilla, and star apple was lowered to 0.15 
ppm. Similarly, proposed tolerances for cucumber and tea, dried were 
increased from 0.25 ppm to 0.40 ppm, and from 15 ppm to 20 ppm, 
respectively. The submitted residue data for corn grain were not 
entered into the tolerance spreadsheet for OECD calculations because 
all treated samples showed combined fenpyroximate residues below the 
level of quantitation (LOQ) of 0.02 ppm. However, based on available 
residue data, EPA established a tolerance for grain, aspirated 
fractions at 0.40 ppm to replace proposed tolerances for corn, field 
aspirated fractions at 2.0 ppm and corn, pop aspirated fractions at 2.0 
ppm. In addition, EPA established a tolerance for corn, refined oil at 
0.05 ppm. Also, tolerances for fruit, citrus crop group 10-10 and 
fruit, pome, group 11-10 were reduced to 0.50 ppm and 0.30 ppm, 
respectively, in order to harmonize with Codex MRL.
    The Agency is deleting the existing tolerance for okra at 0.20 ppm 
since it is included in vegetable, fruiting group 8-10 established by 
this action. In addition, EPA corrected commodity definitions to comply 
with current EPA policy as follows: ``corn, field, forage/silage'' and 
``corn, pop, forage/silage'' were corrected to ``corn, field, forage'' 
and ``corn, pop, forage,'' respectively, and ``tea, plucked leaves'' 
was corrected to ``tea, dried.''
    Finally, EPA has revised the tolerance expression to clarify (1) 
that, as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of fenpyroximate not specifically mentioned; 
and (2) that compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of the 
insecticide fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-
phenoxy-1H-pyrazol-4-yl)methyene]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, including its metabolites and 
degradates in or on avocado at 0.15 ppm, bean, snap, succulent at 0.40 
ppm, canistel at 0.15 ppm, corn, field, grain at 0.02 ppm, corn, field, 
forage at 2.0 ppm, corn, field, stover at 7.0 ppm, corn, pop, grain at 
0.02 ppm, corn, pop, forage at 2.0 ppm, corn, pop, stover at 7.0 ppm, 
corn, field, refined oil at 0.05 ppm, grain, aspirated fractions at 
0.40 ppm, cucumber at 0.4 ppm, fruit, citrus, group 10-10 at 0.50 ppm, 
fruit, pome, group 11-10 at 0.30 ppm, mango at 0.15 ppm, papaya 0.15 
ppm, sapodilla at 0.15 ppm, sapote, black at 0.15 ppm, sapote, mamey at 
0.15 ppm, star apple at 0.15 ppm, tea, dried at 20 ppm, and vegetable, 
fruiting, group 8-10 at 0.20 ppm.
    Lastly, EPA is removing the entries for ``fruit, citrus, group 
10,'' ``fruit, pome, group 11,'' ``okra'' and ``vegetable, fruiting, 
group 8'' from the table at 40 CFR 180.566(a)(1) since ``new 
tolerances'' established by this action will supersede the existing 
tolerances.

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) (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.

[[Page 73951]]

    Dated: December 4, 2012.
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.  180.566 revise paragraph (a)(1), and the introductory texts 
of paragraphs (a)(2), (a)(3) and (b) to read as follows:

Sec.  180.566  Fenpyroximate; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide fenpyroximate, including its metabolites and degradates, in 
or on the commodities in the table below. Compliance with the tolerance 
levels specified in the table is to be determined by measuring only the 
sum of 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, calculated as the 
stoichiometric equivalent of fenpyroximate.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................         3.0
Avocado....................................................         0.15
Bean, snap, succulent......................................         0.40
Berry, low growing, subgroup 13-07G........................         1.0
Canistel...................................................         0.15
Citrus, dried pulp.........................................         2.5
Citrus, oil................................................        10
Corn, field, forage........................................         2.0
Corn, field, grain.........................................         0.02
Corn, field, refined oil...................................         0.05
Corn, field, stover........................................         7.0
Corn, pop, forage..........................................         2.0
Corn, pop, grain...........................................         0.02
Corn, pop, stover..........................................         7.0
Cotton, gin byproducts.....................................        10
Cotton, undelinted seed....................................         0.10
Cucumber...................................................         0.40
Fruit, citrus, group 10-10.................................         0.50
Fruit, pome, group 11-10...................................         0.30
Grain, aspirated fractions.................................         0.40
Grape......................................................         1.0
Hop, dried cones...........................................        10
Mango......................................................         0.15
Melon subgroup 9A..........................................         0.10
Nut, tree, group 14........................................         0.10
Papaya.....................................................         0.15
Peppermint, tops...........................................         7.0
Pistachio..................................................         0.10
Sapodilla..................................................         0.15
Sapote, black..............................................         0.15
Sapote, mamey..............................................         0.15
Spearmint, tops............................................         7.0
Star, apple................................................         0.15
Tea, dried \1\.............................................        20
Vegetable, fruiting, group 8-10............................         0.20
------------------------------------------------------------------------
\1\ There are no U.S. Registrations.

    (2) Tolerances are established for residues of the insecticide 
fenpyroximate, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified in the table is to be determined by measuring only the sum of 
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl)methylene]amino]oxy]methyl]benzoate and its metabolites 
(E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-
methyleneaminooxymethyl]benzoic acid and (E)-1,1-dimethylethyl-2-
hydroxyethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate, calculated as the 
stoichiometric equivalent of fenpyroximate.
* * * * *
    (3) Tolerances are established for residues of the insecticide 
fenpyroximate, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified in the table is to be determined by measuring only the sum of 
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl)methylene]amino]oxy]methyl]benzoate and its metabolite 
(E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-
methyleneaminooxymethyl]benzoic acid, calculated as the stoichiometric 
equivalent of fenpyroximate.
* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the insecticide fenpyroximate, including 
its metabolites and degradates in or on the commodities in the table 
below. Compliance with the tolerance levels specified in the table is 
to be determined by measuring only the sum of 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, calculated as the 
stoichiometric equivalent of fenpyroximate.
* * * * *

[FR Doc. 2012-29900 Filed 12-11-12; 8:45 am]
BILLING CODE 6560-50-P