Indaziflam; Pesticide Tolerances, 30982-30987 [2017-14107]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Rules and Regulations]
[Pages 30982-30987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14107]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0166; FRL-9962-61]


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 multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective July 5, 2017. Objections and 
requests for hearings must be received on or before September 5, 2017, 
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-2016-0166, 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), West William Jefferson Clinton 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:  Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main 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 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-2016-0166 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 
September 5, 2017. 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-2016-0166, 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.html.
    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 May 19, 2016 (81 FR 31581) (FRL-9946-
02), 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 
6E8452) by IR-4, Rutgers University, 500 College Rd. East, Suite 201 W, 
Princeton, NJ 08540. 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]-6-(1-
fluoroethyl)-1,3,5-triazine-2,4-diamine) in or on bushberry, subgroup 
13-07B at 0.01 parts per million (ppm); caneberry, subgroup 13-07A at 
0.01 ppm; coffee, green bean at 0.01 ppm; fruit, small, vine climbing, 
except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm; hop, dried cones 
at 0.03 ppm; fruit, stone, group 12-12 at 0.01 ppm; and nut, tree, 
group 14-12 at 0.01 ppm. Additionally, the petition requested that 
tolerances be established for the crops in the proposed crop subgroup 
23A (small fruit, edible peel subgroup) at 0.01 ppm, including acerola; 
African plum; agritos, almondette; appleberry; arbutus berry; bayberry, 
red; bignay; breadnut; cabeluda; carandas-plum; Ceylon iron wood; 
Ceylon olive; cherry-of-the-Rio-Grande; Chinese olive, black; Chinese 
olive, white; chirauli-nut; cocoplum; desert-date; false sandalwood; 
fragrant manjack; gooseberry, Abyssinian; gooseberry, Ceylon; 
gooseberry,

[[Page 30983]]

otaheite; governor's plum; grumichama; guabiroba; guava berry; guava, 
Brazilian; guava, Costa Rican; guayabillo; illawarra plum; Indian-plum; 
Jamaica-cherry; jambolan; kaffir-plum; kakadu plum; kapundung; karnada; 
lemon aspen; mombin, yellow; monos plum; mountain cherry; olive; 
persimmon, black; pitomba; plum-of-Martinique; rukam; rumberry; sea 
grape; sete-capotes; silver aspen; water apple; water pear; water 
berry; and wax jambu.
    Upon establishment of the tolerances referenced above, IR-4 
requested to remove existing tolerances in 40 CFR 180.653 for residues 
of the herbicide indaziflam (N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-
inden-1-yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine) in or on 
fruit, stone, group 12 at 0.01 ppm; nut, tree, group 14 at 0.01 ppm; 
grape at 0.01 ppm; and pistachio at 0.01 ppm. That May 19, 2016 
document referenced a summary of the petition prepared by Bayer 
CropScience, the registrant, which is available in the docket, https://www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the level at which the tolerance is being established for 
hops. Other tolerances being established vary from the petition 
requests in minor ways. These differences and the reasons for these 
changes are 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 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 toxicity in rats and 
dogs. Evidence of neurotoxicity (e.g., decreased motor activity, 
clinical signs, and/or neuropathology) was observed in both species 
throughout the database, which included the dog subchronic and chronic 
toxicity studies; the rat acute, subchronic, and developmental 
neurotoxicity studies; the rat two-generation reproduction study; the 
rat chronic toxicity study; and the rat combined carcinogenicity/
chronic toxicity study. In repeated-dose studies, the dog was the more 
sensitive species, showing the lowest no-observed-adverse-effect-levels 
(NOAELs) and lowest-observed-adverse-effect-levels (LOAELs) among all 
available studies, based on neuropathology (degenerative nerve fibers 
in the brain, spinal cord, and sciatic nerve). At higher doses, three 
dogs in the subchronic study were prematurely terminated due to 
excessive clinical signs including ataxia, tremors, decreased pupil 
response, seizures, and other findings.
    In the rat, a marginal decrease in motor/locomotor activity was 
observed in females in the acute neurotoxicity study. Decreases in 
motor/locomotor activity were also seen in the subchronic neurotoxicity 
study in females and in the developmental neurotoxicity study in male 
offspring at post-natal day (PND) 21. 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 included 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 dose rat 
studies and usually in the male only. Increased thyroid stimulating 
hormone (TSH) measured at 3 and 14 weeks in the 90-day and 1-year 
studies showed an increase in males at week 3. Histopathological 
alterations (thyroid follicular cell hypertrophy at 90 days and 1 year, 
as well as colloid alterations at chronic exposure times) were 
observed, but no increases in thyroid weight were noted. Thyroid 
histopathology was observed at a lower dose in the two-year study, 
compared to the 90-day and 1-year studies. Chronic exposures also led 
to atrophied or small seminal vesicles in male rats and glandular 
erosion/necrosis in the stomach and blood-filled ovarian cysts/
follicles in female mice. However, these effects occurred at higher 
doses than those at which neurotoxicity was observed in the dog. In 
rats, effects observed on the liver, thyroid, kidney, and seminal 
vesicles occurred at doses that were similar to or higher than those 
that produced neurotoxicity. Decreased body weight gain was also 
observed in most studies following exposure to indaziflam. There was no 
evidence of immunotoxicity in the available studies, which included a 
guideline immunotoxicity 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, a 
developmental neurotoxicity study in rats, 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

[[Page 30984]]

separation in males and vaginal patency in females) were observed in 
offspring in the rat two-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 rat 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 two-year 
dietary rat and mouse bioassays. All genotoxicity studies that were 
conducted on indaziflam were negative.
    Specific information on the studies received and the nature of the 
adverse effects caused by indaziflam as well as the NOAEL and the LOAEL 
from the toxicity studies can be found at https://www.regulations.gov in 
the document titled ``Indaziflam--Aggregate Human Health Risk 
Assessment of Proposed New Uses, Crop Group Conversions, and Expansions 
from Representative Commodities to Crop Groups'' on page 28 in docket 
ID number EPA-HQ-OPP-2016-0466.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for indaziflam used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of January 29, 2014 (79 FR 4624) 
(FRL-9903-88).

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 U.S. 
Department of Agriculture'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 risk assessment was based on 
tolerance-level residues and 100 percent crop treated (PCT).
    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 risk 
assessment was based on tolerance-level residues and 100 PCT.
    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 or PCT information in the dietary assessment for 
indaziflam. 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 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide in Water Calculator (PWC) and the Tier 1 
Rice model, the estimated drinking water concentrations (EDWCs) of 
indaziflam for acute exposures are estimated to be 84 parts per billion 
(ppb) for surface water and 3.7 ppb for ground water, and for chronic 
exposures are estimated to be 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 the acute dietary risk 
assessment, the water concentration value of 84 ppb was used to assess 
the contribution to drinking water. For the 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: Turf, gardens, and trees. EPA 
assessed residential exposure using the following assumptions: Short-
term dermal and inhalation handler exposure is expected for adults as a 
result of applying products containing indaziflam to lawns/turf and 
gardens/trees using a variety of application equipment. Short-term 
post-application dermal exposure is expected for adults, children 
11<16, and children 6<11 years old as a result of playing, mowing and/
or golfing on treated turf. Short-term dermal and incidental oral 
exposure (hand to mouth, object to mouth, incidental soil ingestion) is 
expected for children 1<2 years old as a result from playing on treated 
turf/lawns. Lastly, short-term post-application dermal exposure is 
expected for adults and children 6<11 years old as result of 
application to gardens and trees. The Agency selected only the most 
conservative, or worst case, residential adult and child scenarios to 
be included in the aggregate estimates, based on the lowest overall MOE 
(i.e., highest risk estimates). The worst case residential exposure 
scenario for both adults and children resulted from short-term dermal 
and incidental oral (for children only) post-application exposure to 
treated turf. Further information regarding EPA standard

[[Page 30985]]

assumptions and generic inputs for residential exposures may be found 
at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. No evidence of increased 
quantitative or qualitative susceptibility was seen in developmental 
toxicity studies in rats and rabbits, a developmental neurotoxicity 
study in rats, 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 offspring in the rat two-
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.
    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. Evidence of neurotoxicity was observed in dogs and rats 
throughout the database, which included the dog subchronic toxicity 
study, the rat subchronic toxicity, the rat acute, subchronic, and 
developmental neurotoxicity screening batteries, the rat two-generation 
reproduction study, the rat chronic toxicity study, and the rat 
combined carcinogenicity/chronic toxicity study. Evidence of 
neurotoxicity was manifested as neuropathology in dogs and as decreased 
motor activity and clinical signs (e.g., tremors) in rats. Evidence of 
neurotoxicity was the most consistent effect (seen in dogs and rats), 
the most sensitive toxicological finding (based on neuropathology in 
dogs), and the basis for the risk assessment. The endpoints selected 
for risk assessment are based on and protective of the neurotoxic 
effects seen in the guideline studies.
    iii. No developmental effects were observed in rabbits up to 
maternally toxic dose levels. Offspring effects in the developmental 
neurotoxicity study in rats and multi-generation toxicity studies only 
occurred in the presence of maternal toxicity and were not considered 
more severe than the parental effects. In addition, clear NOAELs/LOAELs 
were identified for these studies. Therefore, EPA concluded that there 
is no evidence of increased quantitative or qualitative susceptibility 
to rat or rabbit fetuses exposed in utero and/or postnatally to 
indaziflam.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to indaziflam in drinking water. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children as well as incidental oral exposure of toddlers. 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 all 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 all 
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-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.
    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 1400 for adults 
and 580 for children. Because EPA's level of concern for indaziflam is 
a MOE of 100

[[Page 30986]]

or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
indaziflam is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no 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 intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
indaziflam.
    5. 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.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to 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 any MRLs for indaziflam.

C. Response to Comments

    Two comments were received in response to the Notice of Filing. The 
first comment was in support of the petition. The second comment was 
against the petition and stated in part that ``this product should not 
get approval'' and that ``no residue should be permitted on any food or 
other plant.'' The Agency 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. EPA 
has assessed the effects of this chemical on human health and 
determined that aggregate exposure to it will be safe. The comment 
provides no information to support a different conclusion.

D. Revisions to Petitioned-For Tolerances

    For hops, the proposed tolerance level of 0.03 ppm was based on 
residues from 4 field trials at levels below the level of quantitation 
(LOQ) (<0.01), and a residue of 0.02 ppm from one trial (13-QC06), 
being entered into the Organization for Economic Cooperation and 
Development (OECD) tolerance calculation procedure. However, the FDAT 
(metabolite) portion of the residue from Trial 13-QC06 was not 
converted to parent equivalents by the petitioner. When this is 
converted, the combined residue is 0.033 ppm, and the result of the 
OECD tolerance calculation procedure is 0.06 ppm. Therefore, the 
tolerance level being established in/on hops, dried cones is 0.06 ppm.
    The petition requested that a tolerance be established for 
``coffee, green bean''. Since a tolerance already exists for that 
commodity at the level requested but with a notation that there are no 
U.S. registrations for use of indaziflam on coffee, the Agency is 
simply removing the footnote in 40 CFR 180.653 that states there are no 
U.S. registrations for coffee.
    Lastly, the petition sought the establishment of tolerances 
covering all the crops listed in the proposed crop group 23A. Since the 
crop group has been established for tropical and subtropical, small 
fruit, edible peel subgroup 23A, EPA is establishing the crop subgroup 
tolerance rather than individual tolerances for each of the named 
commodities.
    Although not requested, EPA is also removing the existing tolerance 
for ``olive'' because it is superseded by the new crop subgroup 23A 
tolerance.

V. Conclusion

    Therefore, tolerances are established for residues of indaziflam, 
N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-(1-fluoroethyl)-
1,3,5-triazine-2,4-diamine, including its metabolites and degradates, 
in or on the following: Bushberry subgroup 13-07B at 0.01 ppm; 
caneberry subgroup 13-07A at 0.01 ppm; fruit, small, vine climbing, 
except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm; fruit, stone, 
group 12-12 at 0.01 ppm; fruit, tropical and subtropical, small fruit, 
edible peel, subgroup 23A at 0.01 ppm; hop, dried cones at 0.06 ppm; 
and nut, tree, group 14-12 at 0.01 ppm.
    Additionally, the footnote is removed from the existing tolerance 
for ``coffee, green bean'' and the following existing tolerances are 
removed as unnecessary since they are superseded by the newly 
established tolerances: Fruit, stone, group 12; grape; nut, tree, group 
14; olive; and pistachio.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action 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 action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44

[[Page 30987]]

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 action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 12, 2017.
Michael L. Goodis,
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 the table in paragraph (a) of Sec.  180.653;
0
a. Add alphabetically the entries ``Bushberry subgroup 13-07B''; 
``Caneberry subgroup 13-07A''; ``Fruit, small, vine climbing, except 
fuzzy kiwifruit, subgroup 13-07F''; ``Fruit, stone, group 12-12''; 
``Fruit, tropical and subtropical, small fruit, edible peel, subgroup 
23A''; ``Hop, dried cones''; and ``Nut, tree, group 14-12'';
0
b. Remove the footnote 1 from the entry for ``Coffee, green bean''; and
0
c. Remove the entries for ``Fruit, stone, group 12''; ``Grape''; ``Nut, 
tree, group 14''; ``Olive''; and ``Pistachio''.
    The additions read as follows:


Sec.  180.653   Indaziflam; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Bushberry subgroup 13-07B...............................            0.01
Caneberry subgroup 13-07A...............................            0.01
Coffee, green bean......................................            0.01
 
                              * * * * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit,                0.01
 subgroup 13-07F........................................
Fruit, stone, group 12-12...............................            0.01
Fruit, tropical and subtropical, small fruit, edible                0.01
 peel, subgroup 23A.....................................
Hop, dried cones........................................            0.06
Nut, tree, group 14-12..................................            0.01
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-14107 Filed 7-3-17; 8:45 am]
BILLING CODE 6560-50-P