Document ID: EPA-HQ-OPP-2012-0454-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fenpropidin
Posted Date: 2014-02-11T05:00Z

[Federal Register Volume 79, Number 28 (Tuesday, February 11, 2014)]
[Rules and Regulations]
[Pages 8091-8096]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02936]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0454; FRL-9904-31]

Fenpropidin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fenpropidin in or on banana. Syngenta, Crop Protection, LLC requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective February 11, 2014. Objections and 
requests for hearings must be received on or before April 14, 2014, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0454, 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: RDFRNotices@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

[[Page 8092]]

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-2012-0454 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
April 14, 2014. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0454, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of December 19, 2012 (77 FR 75082) (FRL-
9372-6), 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 
2E7980) by Syngenta, LLC, P.O. Box 18300, Greensboro, NC 27419-8300. 
The petition requested that EPA establish import tolerances for 
residues of the fungicide fenpropidin, in or on banana, unbagged fruit 
at 9.0 parts per million (ppm) and banana, pulp from unbagged fruit at 
0.40 ppm. That document referenced a summary of the petition prepared 
by Syngenta Crop Protection, LLC, the registrant, which is available in 
the docket, http://www.regulations.gov. One comment was received in 
response to the notice of filing.
    Based upon review of the data supporting the petition, tolerances 
for banana, unbagged fruit have been revised from 9.0 to 10 ppm. The 
reason for this change is explained in Unit IV.D.

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 fenpropidin including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fenpropidin 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 nervous system, eye, stomach, esophagus, and skin are the major 
target organs for fenpropidin. The principal toxic effects in 
laboratory animals following oral exposure to fenpropidin are irritant 
effects on the esophagus, stomach, and skin, with peripheral parts of 
the body (tail and ears) affected as well. The skin lesions in the 
mouse following oral exposure include dry and/or flaky skin on tail, 
paws, and ears, loss of tail tip; hyperkeratosis of tail, ear, 
esophagus, subcutis, stomach, dermatitis of ear and tail, and 
hyperplasia of the nose. Skin lesions in the rat following chronic oral 
exposure include dry and flaky skin around mouth, tail tip missing, 
pustules on tail, and damaged or shortened tails. The skin lesions in 
the dog following oral exposure via capsules included indurated and 
inelastic pads; scale formation on external ear; reddening of skin of 
thoracic, inguinal, and axillary regions; hardened foot pads; 
microscopic findings of acanthosis of the epidermis and ear; 
hyperkeratosis of footpad and ear; and skin inflammation following 
chronic oral exposure. An acute lethality study shows that fenpropidin 
is not acutely toxic by the oral route of exposure.
    Clinical signs of neurotoxicity and neuropathology are the other 
major toxic effects observed following oral exposure in the rat and 
dog, and the dog is the most sensitive species for the neurotoxic 
effects. In the rat 90-day neurotoxicity study, hindpaw grip strength 
was decreased in both sexes and forepaw grip strength was decreased in 
males during the functional observational battery (FOB) evaluations. 
Bilateral hindlimb paralysis/paresis, which correlated with the 
histopathological finding of demyelination of the spinal cord, cranial 
and spinal nerve roots, and proximal peripheral nerve, was

[[Page 8093]]

observed in one female rat at the highest dose tested. In dogs, paresis 
was observed in one male dog that was sacrificed on week 38, and 
demyelination of the spinal cord was observed in three of four male 
dogs at the high dose.
    In the chronic toxicity/carcinogenicity study in rats, benign 
pancreatic cell adenomas were seen in high-dose male rats. Tumors were 
not increased in the mouse carcinogenicity study in either sex or in 
the female rat. Mutagenicity is not of concern. Although the rat study 
showed that fenpropidin was associated with benign pancreatic islet 
cell adenomas in the male, the Agency determined that quantification of 
risk using a non-linear approach; i.e., the chronic reference dose 
(RfD), for fenpropidin will adequately account for all chronic 
toxicity, including carcinogenicity, that could result from exposure to 
fenpropidin. The conclusion is based on the following considerations: 
(i) The tumors found were benign; (ii) the tumors are common age-
related tumors; (iii) the tumors occurred in only one sex in one 
species; (iv) fenpropidin is not mutagenic; and (v) no carcinogenic 
response was seen in either sex in the mouse.
    Specific information on the studies received and the nature of the 
adverse effects caused by fenpropidin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Fenpropidin: Human Health Risk 
Assessment to Support the Proposed Tolerance for Imported Bananas'' at 
page 10 in docket ID number EPA-HQ-OPP-2012-0454.

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 fenpropidin used for 
human risk assessment is shown in the following table.

      Summary of Toxicological Doses and Endpoints for Fenpropidin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                       Point of  departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years of  NOAEL = 10 mg/kg/day...  Acute RfD = 0.10 mg/kg/  Developmental toxicity
 age).                                 UFA = 10x..............   day.                     study (rabbit).
                                       UFH = 10x..............  aPAD = 0.10 mg/kg/day..  LOAEL = 20 mg/kg/day
                                       FQPA SF = 1x...........                            based on [on increased
                                                                                          fetal (litter)
                                                                                          incidence of
                                                                                          malformations
                                                                                          (persistent truncus
                                                                                          arteriosus, severely
                                                                                          malaligned sternebrae)
                                                                                          and decreased male
                                                                                          fetal body weight in
                                                                                          the absence of
                                                                                          maternal effects.
                                                                                          (does dosed on GD 7-
                                                                                          28).
Acute dietary (Infants and children).  NOAEL = 7 mg/kg/day....  Acute RfD = 0.07 mg/kg/  Developmental
                                       UFA = 10x..............   day.                     neurotoxicity study
                                       UFH = 10x..............  aPAD = 0.07 mg/kg/day..   (rat).
                                       FQPA SF = 1x...........                           LOAEL = 27 mg/kg/day
                                                                                          based on [decreased
                                                                                          brain weight,
                                                                                          decreased radial
                                                                                          thickness of the
                                                                                          cortex at level 3, and
                                                                                          decreased vertical
                                                                                          height of the dentate
                                                                                          hilus at level 3 in
                                                                                          females on PND 72.
Chronic dietary (All populations)....  NOAEL= 2.3 mg/kg/day...  Chronic RfD = 0.023 mg/  Rat chronic/
                                       UFA = 10x..............   kg/day.                  carcinogenicity.
                                       UFH = 10x..............  cPAD = 0.023 mg/kg/day.  LOAEL = 11.8 mg/kg/day
                                       FQPA SF = 1x...........                            based on [decreased
                                                                                          body weight and body
                                                                                          weight gains in
                                                                                          females, clinical
                                                                                          signs in males and
                                                                                          females (pustules on
                                                                                          tail, missing tail
                                                                                          tip, and dry, flaky
                                                                                          skin around mouth),
                                                                                          and microscopic liver
                                                                                          lesions (centrilobular
                                                                                          fat) in females.
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....      Quantification of risk using a non-linear approach; i.e., RfD, for
                                         fenpropidin will adequately account for all chronic toxicity, including
                                            carcinogenicity, that could result from exposure to fenpropidin.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point derived from observed dose-response data and used
  to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human
  exposures. NOAEL = no observed adverse effect level.
LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animals to
  humans (interspecies). UFH = potential variation in sensitivity among members of the human population
  (intraspecies). FQPA SF = FQPA Safety Factor. cPAD = chronic population adjusted dose. RfD = reference dose. N/
  A = not applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenpropidin, EPA assessed dietary exposures from 
fenpropidin 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

[[Page 8094]]

exposure. Such effects were identified for fenpropidin. In estimating 
acute dietary exposure, EPA used food consumption information from the 
United States Department of Agriculture's (USDA) National Health and 
Nutrition Examination Survey, What We Eat In America (NHANES/WWEIA) 
conducted from 2003-2008. As to residue levels in food, EPA made the 
following assumptions for the acute exposure assessment: Residues will 
be present in bananas at the highest field trial value from banana pulp 
(the edible portion of the fruit), 100 percent crop treated (PCT), and 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID) Version 3.16.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA conducted from 2003-2008 as well. As to residue levels in food, 
EPA made the following assumptions for the chronic exposure assessment: 
Residues will be present in bananas at the average field trial values 
from banana pulp, 100 PCT, and DEEM-FCID Version 3.16.
    iii. Cancer. Based on the data summarized in Unit III.A., the 
Agency has concluded that a nonlinear RfD approach is appropriate for 
assessing cancer risk to fenpropidin. Cancer risk was assessed using 
the same exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA used anticipated 
residues in the dietary assessment for fenpropidin. One hundred PCT and 
field trial residues were assumed for all food commodities. Section 
408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such Data Call-Ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The proposed tolerance in 
or on imported banana will not impact residues in the U.S. drinking 
water. Therefore, a drinking water assessment was not needed.
    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). Fenpropidin 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 fenpropidin to share a common mechanism of 
toxicity with any other substances, and fenpropidin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fenpropidin 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. The potential impact of in 
utero fenpropidin exposure was investigated in two developmental 
toxicity studies (one in the rat and one in the rabbit), a rat 
developmental neurotoxicity study (DNT) and a two multi-generation 
reproduction toxicity study in rats. In the rat developmental toxicity 
study, a quantitative susceptibility was observed; asymmetrically 
shaped sternebrae 5 occurred at the high dose in the absence 
of maternal toxicity. In the rabbit developmental study, a quantitative 
susceptibility was noted with an increase in fetal (litter) incidence 
of malformations (persistent truncus arteriosus and severely malaligned 
sternebrae) in the absence of maternal toxicity. A qualitative 
susceptibility was noted in the rat developmental neurotoxicity study 
(DNT). In that study, the pup effects were: Increased number of dead 
pups/cannibalized pups; decreased brain weight; decreased radial 
thickness of the cortex (level 3); decreased male pup body weight 
during the preweaning period; and decreased vertical height of the 
dentate hilus (level 3) in PND 72 females. At the same dose in the 
maternal animals, the only adverse effect observed was skin irritation 
(scabbing and hair loss around the mouth and forelimbs). Qualitative 
susceptibility in the 2-generation reproduction study was based on the 
decrease in pup body weights and delayed onset of sexual maturation 
observed at the same dose that resulted in decreased maternal body 
weight and increased incidence/severity of cortical fatty changes in 
adrenals. The apparent enhanced sensitivity may be due to the limited 
number of evaluations conducted in dams in these studies rather than a 
true sensitivity of the young. Clear NOAELs were established for the 
endpoints of concern, and these are the basis for the acute dietary 
endpoints for females 13+ and for infants and children.
    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 fenpropidin is complete.
    ii. The level of concern for neurotoxicity is low because there is 
a developmental neurotoxicity study in rats, the effects are well 
characterized, the dose-response curve for these effects are well 
characterized, and clear NOAELs have been identified.
    iii. Though there is evidence of quantitative susceptibility in the 
rat and rabbit developmental toxicity studies and qualitative 
susceptibility in the 2-generation reproduction study in rats and the 
DNT in rats, the endpoints and doses selected for risk assessment are 
protective for these effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on conservative

[[Page 8095]]

high-end assumptions in the dietary exposure assessment, including the 
use of 100 PCT assumptions and field trial residues. This is an import 
tolerance; therefore, there is no drinking water, no residential, and 
no occupational exposure.

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. Partially refined acute dietary exposure assessments 
were performed using individual points of departure (PODs) for the two 
population subgroups all infants and children, and females 13-49 years 
old. Using the exposure assumptions discussed in this unit for acute 
exposure, the acute dietary exposure to fenpropidin from food will 
occupy 3% of the aPAD for infants <1 year old and <1% of the aPAD for 
females 13-49 years old, for the populations at the 95th percentile of 
exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fenpropidin from food will utilize <1% of the cPAD for children 1-2 
years old, the population group receiving the greatest exposure. There 
are no residential uses for fenpropidin.
    3. Short- and Intermediate-term risk. 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). Since the petitioner is 
proposing a tolerance in/on imported banana and since fenpropidin is 
not registered for any use patterns that would result in short-term and 
intermediate-term residential exposure, selection of incidental oral, 
dermal, and inhalation point of departures for assessment of 
residential exposure is not required.
    4. Aggregate cancer risk for U.S. population. In the chronic 
toxicity/carcinogenicity study in rats, benign pancreatic cell adenomas 
were seen in high-dose male rats. Tumors were not increased in the 
mouse carcinogenicity study in either sex or in the female rat. 
Mutagenicity is not of concern. Although the rat study showed that 
fenpropidin was associated with benign pancreatic islet cell adenomas 
in the male, the Agency determined that quantification of risk using a 
non-linear approach; i.e., the chronic reference dose (RfD), for 
fenpropidin will adequately account for all chronic toxicity, including 
carcinogenicity, that could result from exposure to fenpropidin. The 
conclusion is based on the following considerations: (i) The tumors 
found were benign; (ii) the tumors are common age-related tumors; (iii) 
the tumors occurred in only one sex in one species; (iv) fenpropidin is 
not mutagenic; and (v) no carcinogenic response was seen in either sex 
in the mouse.
    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 fenpropidin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (independent laboratory validation 
trial (ILV) and liquid chromatography with mass spectrometric (LC-MS/
MS) detection method (Method No. REM 164.09)) are available to enforce 
the tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email 
address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint 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 not established MRLs for fenpropidin.

C. Response to Comments

    One comment was received from an anonymous commenter objecting to 
increasing the tolerances. The comment contained no scientific data or 
evidence to rebut the Agency's conclusions that no harm will result to 
infants and children from aggregate exposure to fenpropidin residues.

D. Revisions to Petitioned-for Tolerances

    Based on the analysis of the residue field trial data and 
Organization for Economic Cooperation and Development (OECD) tolerance 
calculator procedure, a banana tolerance of 10 ppm for residues of 
fenpropidin is appropriate. The Agency excluded residue values from one 
of the field trials. The study author reported that samples from that 
field trial may have been mislabeled as residues were higher in the 
control samples; therefore, results from this test were not used in the 
tolerance calculations. A tolerance for banana pulp is not required; 
tolerances are to be established on the whole banana fruit.

 V. Conclusion

    Therefore, tolerances are established for residues of fenpropidin, 
(1-[3-[4-(1,1-dimethylethyl)phenyl]-2-methylpropyl]piperidine), 
including its metabolites and degradates, in or on banana at 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

[[Page 8096]]

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: January 31, 2014.
Steven P. Bradbury,
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. Add Sec.  180.676 to subpart C, to read as follows:

Sec.  180.676  Fenpropidin; tolerances for residues.

    (a) General. Tolerances are established for the residues of 
fenpropidin, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only fenpropidin (1-
[3-[4-(1,1-dimethylethyl)phenyl]-2-methylpropyl]piperidine).

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
Banana \1\.............................................             10
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of December 13, 2013.

    (b) Section 18 tolerance. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2014-02936 Filed 2-10-14; 8:45 am]
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