Indaziflam; Pesticide Tolerances, 4624-4630 [2014-01363]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 79, Number 19 (Wednesday, January 29, 2014)]
[Rules and Regulations]
[Pages 4624-4630]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01363]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0014; FRL-9903-88]


Indaziflam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
indaziflam in or on coffee, banana, and palm oil. Bayer Crop Science 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective January 29, 2014. Objections and 
requests for hearings must be received on or before March 31, 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-2013-0014, is available at https://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 https://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:

[[Page 4625]]

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 https://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-2013-0014 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 
March 31, 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-2013-0014, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 15, 2013 (78 FR 32) (FRL-9378-
4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2E8125) by Bayer Crop Science, 2 T.W. Alexander Drive; P.O. Box 12014; 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.653 be amended by establishing tolerances for residues of the 
herbicide indaziflam, N-[(1R, 2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-
yl-1,3,5-triazine-2,4-diamine]-6-(1-fluoroethyl) and its fluoroethyl-
indaziflam metabolite, each expressed as the parent compound, in or on 
coffee at 0.01 part per million (ppm), banana at 0.01 ppm, and palm oil 
at 0.03 ppm. That document referenced a summary of the petition 
prepared by Bayer CropScience, the registrant, which is available in 
the docket, https://www.regulations.gov. A comment was received on the 
notice of filing. EPA's response to this comment is discussed 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 indaziflam including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with indaziflam 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 is the major target for indaziflam toxicity in 
rats and dogs, with the dog being the more sensitive species based on 
neuropathology (degenerative nerve fibers in the brain, spinal cord and 
sciatic nerve). Clinical signs of neurotoxicity were observed in the 
acute, subchronic, and developmental neurotoxicity studies and 
consisted primarily of tremors, changes in activity and reactivity, 
repetitive chewing, dilated pupils, and oral, perianal, and nasal 
staining. Similar clinical signs of neurotoxicity were observed in the 
2-generation reproduction study, the rat chronic toxicity study, and 
the combined rat carcinogenicity/chronic toxicity study. Neuropathology 
findings were also observed in the rat manifested as focal/multifocal 
vacuolation of the median eminence of the brain and the pituitary pars 
nervosa and degenerative nerve fibers in the gasserian ganglion, 
sciatic nerve, and tibial nerve. Evidence of neurotoxicity was not seen 
in the mouse.
    Other organs affected by indaziflam in mice and rats include the 
kidney, liver, thyroid, stomach, seminal vesicles, and ovaries. Effects 
on the kidney were observed following chronic exposure in rats and mice 
while effects on the liver were observed following chronic exposure in 
the rat. Effects on the thyroid were only observed in multiple

[[Page 4626]]

dose rat studies. Chronic exposures also lead to atrophied or small 
seminal vesicles in male and female mice. However, these effects 
occurred at higher doses than those at which neurotoxicity was observed 
in the dog.
    Decreased body weight gain was observed in most studies following 
exposure to indaziflam. There was no evidence of immunotoxicity in the 
available studies, which included a guideline immunotoxocity study in 
the rat. No systemic effects were observed in the rat following a 28-
day dermal exposure period.
    No evidence of increased quantitative or qualitative susceptibility 
was seen in developmental toxicity studies in rats and rabbits or in a 
reproduction study in rats. In the rat developmental toxicity study, 
decreased fetal weight was observed in the presence of maternal effects 
that included decreased body weight gain and food consumption. No 
developmental effects were observed in rabbits up to maternally toxic 
dose levels. Decreased pup weight and delays in sexual maturation 
(preputial separation in males and vaginal patency in females) were 
observed in the rat 2-generation reproductive toxicity study, along 
with clinical signs of toxicity, at a dose causing parental toxicity 
that included coarse tremors, renal toxicity and decreased weight gain. 
In the developmental neurotoxicity study, transiently decreased motor 
activity (PND 21 only) in male offspring was observed and was 
considered a potential neurotoxic effect. It was observed at a dose 
that also caused clinical signs of neurotoxicity along with decreased 
body weight in maternal animals.
    Indaziflam showed no evidence of carcinogenicity in the 2-year 
dietary rat and mouse bioassays. All genotoxicity studies that were 
conducted on indaziflam were negative.
    Testing in acute lethality studies with indaziflam resulted in low 
toxicity via the oral, dermal, and inhalation routes of exposure. 
Indaziflam was not an irritant to eyes Category IV) or skin and was not 
a skin sensitizer.
    Specific information on the studies received and the nature of the 
adverse effects caused by indaziflam 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 https://www.regulations.gov in document Indaziflam. Human Health Risk 
Assessment to Support Proposed New Import Tolerances (Without a U.S. 
Registration) on Banana, Coffee, and Palm Oil at page 33 in docket ID 
number EPA-HQ-OPP-2013-0014.

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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for indaziflam used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Indaziflam 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 (General population      NOAEL = 7.5 mg/kg/day..  Acute RfD = 0.075 mg/kg/ Subchronic Gavage
 including infants and children).      UFA = 10x..............   day.                     Toxicity Study in
                                       UFH =10x...............  aPAD = 0.075 mg/kg/day.   Dogs.
                                       FQPA SF = 1x...........                           LOAEL = 15 mg/kg/day
                                                                                          based on axonal
                                                                                          degenerative
                                                                                          microscopic findings
                                                                                          in the brain, spinal
                                                                                          cord and sciatic
                                                                                          nerve.
Chronic dietary (All populations)....  NOAEL= 2 mg/kg/day.....  Chronic RfD = 0.02 mg/   Chronic Dietary
                                       UFA = 10x..............   kg/day.                  Toxicity Study in
                                       UFH = 10x..............  cPAD = 0.02 mg/kg/day..   Dogs.
                                       FQPA SF = 1x...........                           LOAEL = 6/7 mg/kg/day M/
                                                                                          F based on nerve fiber
                                                                                          degenerative lesions
                                                                                          in the brain, spinal
                                                                                          cord and sciatic
                                                                                          nerve.
Incidental oral short-term (1 to 30    NOAEL= 7.5 mg/kg/day...  LOC for MOE = 100......  Subchronic Gavage
 days).                                UFA = 10x..............                            Toxicity Study in
                                       UFH = 10x..............                            Dogs.
                                       FQPA SF = 1x...........                           LOAEL = 15 mg/kg/day
                                                                                          based on axonal
                                                                                          degenerative
                                                                                          microscopic findings
                                                                                          in the brain, spinal
                                                                                          cord and sciatic
                                                                                          nerve.
Incidental oral intermediate-term (1   NOAEL= 7.5 mg/kg/day...  LOC for MOE = 100......  Subchronic Gavage
 to 6 months).                         UFA = 10x..............                            Toxicity Study in
                                       UFH = 10x..............                            Dogs.
                                       FQPA SF = 1x...........                           LOAEL = 15 mg/kg/day
                                                                                          based on axonal
                                                                                          degenerative
                                                                                          microscopic findings
                                                                                          in the brain, spinal
                                                                                          cord and sciatic
                                                                                          nerve.

[[Page 4627]]

 
Dermal short-term (1 to 30 days).....  Dermal (or oral) study   LOC for MOE = 100......  Subchronic Gavage
                                        NOAEL = 7.5 mg/kg/day                             Toxicity Study in
                                        (dermal absorption                                Dogs.
                                        factor) = 7.3%.                                  LOAEL = 15 mg/kg/day
                                       UFA = 10x..............                            based on axonal
                                       UFH = 10x..............                            degenerative
                                       FQPA SF = 1x...........                            microscopic findings
                                                                                          in the brain, spinal
                                                                                          cord and sciatic
                                                                                          nerve.
Dermal intermediate-term (1 to 6       Dermal (or oral) study   LOC for MOE = 100......  Subchronic Gavage
 months).                               NOAEL = 7.5 mg/kg/day                             Toxicity Study in
                                        (dermal absorption                                Dogs.
                                        factor) = 7.3%.                                  LOAEL = 15 mg/kg/day
                                       UFA = 10x..............                            based on axonal
                                       UFH = 10x..............                            degenerative
                                       FQPA SF = 1x...........                            microscopic findings
                                                                                          in the brain, spinal
                                                                                          cord and sciatic
                                                                                          nerve.
Inhalation short-term (1 to 30 days).  Inhalation (or oral)     LOC for MOE = 100......  Subchronic Gavage
                                        study NOAEL = 7.5 mg/                             Toxicity Study in
                                        kg/day (Inhalation                                Dogs.
                                        toxicity considered                              LOAEL = 15 mg/kg/day
                                        equivalent to oral                                based on axonal
                                        toxicity).                                        degenerative
                                       UFA = 10x..............                            microscopic findings
                                       UFH = 10x..............                            in the brain, spinal
                                       FQPA SF = 1x...........                            cord and sciatic
                                                                                          nerve.
Inhalation (1 to 6 months)...........  Inhalation (or oral)     LOC for MOE = 100......  Subchronic Gavage
                                        study NOAEL = 7.5 mg/                             Toxicity Study in
                                        kg/day (Inhalation                                Dogs.
                                        toxicity considered                              LOAEL = 15 mg/kg/day
                                        equivalent to oral                                based on axonal
                                        toxicity).                                        degenerative
                                       UFA = 10x..............                            microscopic findings
                                       UFH = 10x..............                            in the brain, spinal
                                       FQPA SF = 1x...........                            cord and sciatic
                                                                                          nerve.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....  No evidence of carcinogenicity. Classified as ``Not Likely to be
                                        Carcinogenic to Humans.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligrams/kilogram/day. MOE = margin of exposure. 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). UFL = use of a LOAEL to extrapolate a NOAEL.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to indaziflam, EPA considered exposure under the petitioned-
for tolerances as well as all existing indaziflam tolerances in 40 CFR 
180.653. EPA assessed dietary exposures from indaziflam 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 indaziflam. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA)'s 2003-2008 National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, the acute dietary assessment assumes 100% crop 
treated (PCT) along with tolerance or maximum residue level estimates 
for indaziflam. It used DEEM-WWEIA analyses to estimate the dietary 
exposure of the U.S. population and various population subgroups.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's 2003-2008 
NHANES/WWEIA. As to residue levels in food, the chronic dietary 
assessment used the same residue levels, analysis and PCT assumptions 
used in the acute dietary assessment.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that indaziflam does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for indaziflam. 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 indaziflam in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of indaziflam. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
indaziflam equivalents for acute exposures are estimated to be 84 parts 
per billion (ppb) for surface water and 3.7 ppb for ground water. For 
chronic exposures for non-cancer assessments

[[Page 4628]]

the estimates are 26 ppb for surface water and 3.7 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 84 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 26 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). Indaziflam is 
currently registered for the following uses that could result in 
residential exposures: Home lawn/turf and gardens/tree uses. There are 
no new indaziflam residential uses associated with this regulatory 
action. A re-evaluation of existing indaziflam residential uses was 
conducted to incorporate updated policies and guidance in place since 
previous risk assessments. Short-term dermal and inhalation handler 
exposures for residential are expected for those making applications at 
their homes and short-term dermal and incidental oral exposures are 
expected via contact with residues following applications in outdoor 
home environments. For adults, the highest exposure was from dermal 
post-application high-contact (playing) activities on treated turf 
during spray applications. The highest exposure scenarios for children 
1<2 years old were from dermal post-application high-contact (playing) 
and incidental oral exposure from treated turf. These exposure 
scenarios were then combined to determine a total residential exposure 
and risk estimate for children to be used for the aggregate assessment. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found indaziflam to share a common mechanism of 
toxicity with any other substances, and indaziflam does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
indaziflam 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 https://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 toxicology database for 
indaziflam consists of developmental toxicity studies in rats and 
rabbits and a reproduction study in rats. No developmental effects were 
observed in rabbits up to maternally toxic dose levels. Offspring 
effects in the developmental toxicity study in rats, developmental 
neurotoxicity study in rats, and the multigeneration toxicity study in 
rats only occurred in the presence of maternal toxicity and were not 
considered more severe than the parental effects. EPA concluded that 
there is no evidence of increased quantitative or qualitative 
susceptibility to rat or rabbit fetuses exposed in utero and/or post-
natally to indaziflam.
    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 indaziflam is complete.
    ii. The endpoints selected for risk assessment are based on and are 
protective of the neurotoxic effects seen in the guideline studies.
    iii. There is no evidence that indaziflam results in increased 
susceptibility in utero in rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on tolerance or maximum residue levels for residues of concern and 
assumed 100 PCT. EPA made conservative (protective) assumptions in the 
ground water and surface water modeling used to assess exposure to 
indaziflam in drinking water. EPA used similarly conservative 
assumptions to assess dermal post-application exposure as well as 
incidental oral exposure of children. These assessments will not 
underestimate the exposure and risks posed by indaziflam.

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 indaziflam will occupy 19% of the aPAD for infants <1 year 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 
indaziflam from food and water will utilize 8% of the cPAD for infants 
<1 year old, the population group receiving the greatest exposure. 
Based on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of indaziflam is not 
expected.
    3. Short-and intermediate-term risk. Short-term aggregate exposure 
takes into account short-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Indaziflam is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to indaziflam.

[[Page 4629]]

    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 1,400 for adults 
(post-application) and 560 for children (post-application). Because 
EPA's level of concern for indaziflam is a MOE of 100 or below, these 
MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, indaziflam 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 indaziflam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem 
mass spectrometry detection [LC/MS/MS] method (DH-003-P07-02) for fruit 
and nut tree matrices for indaziflam and FDAT) is available to enforce 
the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint 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 a MRL for indaziflam.

C. Response to Comments

    EPA received a comment to the notice of filing which said that 
pesticide residues should not be increased. The Agency understands the 
commenter's concerns and recognizes that some individuals believe that 
pesticides should be banned on agricultural crops. However, the 
existing legal framework provided by section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA) states that tolerances may be set when 
persons seeking such tolerances or exemptions have demonstrated that 
the pesticide meets the safety standard imposed by that statute. This 
citizen's comment appears to be directed at the underlying statute and 
not EPA's implementation of it; the citizen has made no contention that 
EPA has acted in violation of the statutory framework.

V. Conclusion

    Therefore, tolerances are established for residues of indaziflam, 
N-[(1R, 2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl-1,3,5-triazine-2,4-
diamine]-6-(1-fluoroethyl) and its fluoroethyl-indaziflam metabolite, 
each expressed as the parent compound, in or on coffee, green bean at 
0.01 ppm, banana at 0.01 ppm, and palm oil at 0.03 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: January 10, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

[[Page 4630]]

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.  180.653, alphabetically add the following commodities, 
redesignate footnote 1 as footnote 2, and add a new footnote 1 to the 
table in paragraph (a) to read as follows:


Sec.  180.653  Indaziflam; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Banana \1\.................................................         0.01
Coffee, green bean \1\.....................................         0.01
 
                                * * * * *
Palm, oil \1\..............................................         0.03
 
                                * * * * *
------------------------------------------------------------------------
\1\ No U.S. Registrations as of 12/02/2013.

* * * * *
[FR Doc. 2014-01363 Filed 1-28-14; 8:45 am]
BILLING CODE 6560-50-P