[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Rules and Regulations]
[Pages 30982-30987]
[FR Doc No: 2017-14107]

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

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.

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

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 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), 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://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:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-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: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of 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,

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, http://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

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 http://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 http://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 http://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

assumptions and generic inputs for residential exposures may be found
at http://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 http://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

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:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
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

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


[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Notices]
[Page 73182]
[FR Doc No: 2016-25574]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79110; File No. SR-CBOE-2016-064]

 Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Withdrawal of Proposed Rule Change Relating to
SPX Combo Orders

October 18, 2016.
    On September 8, 2016, Chicago Board Options Exchange, Incorporated
(``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to modify the minimum trading increment applicable
to SPX Combo Orders. The proposed rule change was published for comment
in the Federal Register on September 26, 2016.\3\ The Commission
received no comments regarding the proposal. On October 13, 2016, the
Exchange withdrew the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 78885 (September 20,
2016), 81 FR 66105.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\4\
---------------------------------------------------------------------------

    \4\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-25574 Filed 10-21-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: May 15, 2006 (Volume 71, Number 93)]
[Notices]
[Page 28023-28024]
[DOCID:fr15my06-41]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-8170-1; Docket No. EPA-HQ-ORD-2006-0260]

Science Assessment for Sulfur Oxides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; Call for Information.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) is undertaking
to update and revise, where appropriate, the air quality criteria for
sulfur oxides (SO\x\), last addressed in EPA/600/FP-93/002,
``Supplement to the Second Addendum (1986) to Air Quality Criteria for
Particulate Matter and Sulfur Oxides (1982): Assessment of New Findings
on Sulfur Dioxide Acute Exposure Health Effects in Asthmatic
Individuals,'' published in August 1994 by the Office of Research and
Development, National Center for Environmental Assessment. Interested
parties are invited to assist the EPA in developing and refining the
scientific information base for updating this assessment of scientific
information for sulfur oxides by submitting research studies that have
been published, accepted for publication, or presented at a public
scientific meeting. Areas where additional new information will be
particularly useful to EPA for this project are described in the
SUPPLEMENTARY INFORMATION section of this notice.

DATES: All materials submitted under this call for information should
be received on or before June 15, 2006.

ADDRESSES: Submit materials, identified by Docket ID No. EPA-HQ-ORD-
2006-0260, by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>; Office of Environmental Information
(OEI) Docket in the Headquarters EPA Docket Center.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460.
     Hand Delivery: The Office of Environmental Information
(OEI) Docket is located in the EPA Headquarters Docket Center, Room
B102 EPA West Building, 1301 Constitution Ave., NW., Washington, DC.
The EPA Docket Center 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<PHONE_NUMBER>, and the
telephone number for the OEI Docket is<PHONE_NUMBER>. Such deliveries
are only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    If you provide information in writing, please submit one unbound
original, with pages numbered consecutively, and three copies. For
attachments, provide an index, number pages consecutively with the main
text, and submit an unbound original and three copies.
    Instructions: Direct your materials to Docket ID No. EPA-HQ-ORD-
2006-0260. It is EPA's policy to include all submitted materials in the
public docket without change and to make the materials available online
at http://www.regulations.gov, including any personal information

provided, unless the included information is claimed as Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to

www.regulations.gov or e-mail. The http://www.regulations.gov Web site

is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it within the
submitted material. If you submit information directly to EPA by e-mail
without going through http://www.regulations.gov, your e-mail address

will be automatically captured and included as part of the information
that is placed in the public docket and made available on the Internet.
If you submit materials electronically, EPA recommends that you include
your name and other contact information with any disk or CD-ROM you
submit. If EPA cannot read your submitted material due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your submission. Electronic files should avoid the use
of special characters, any form of encryption, and be free of any
defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

    Docket: Documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the

EPA HQ Docket Center.

FOR FURTHER INFORMATION CONTACT: For technical information, contact
Mary Ross, facsimile:<PHONE_NUMBER> or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. Does This Action Apply to Me?

    Section 108(a) of the Clean Air Act directs the Administrator to
identify certain pollutants that ``may reasonably be anticipated to
endanger public health and welfare'' and to issue air quality criteria
for them. These air quality criteria are to ``accurately reflect the
latest scientific knowledge useful in indicating the kind and extent of
all identifiable effects on public health or welfare which may be
expected from the presence of [a] pollutant in the ambient air * * *.''
Under section 109 of the Act, EPA is then to establish National Ambient
Air Quality Standards (NAAQS) for each pollutant for which EPA has
issued criteria. Section 109(d) of the Act subsequently requires
periodic review and, if appropriate, revision of existing air quality
criteria to reflect advances in scientific knowledge on the effects of
the pollutant on public health and welfare. EPA is also to revise the
NAAQS, if appropriate, based on the revised criteria.
    SOX are one of six principal (or ``criteria'')
pollutants for which EPA has established national ambient air quality
standards (NAAQS). Periodically, EPA reviews the scientific basis for
these standards and prepares a science assessment document
(historically referred to as a ``criteria document''). The science
assessment provides the scientific basis for additional technical and
policy assessments that form the basis for EPA decisions on the
adequacy of a current NAAQS and the appropriateness of new or revised
standards. One of the first steps in this process is to announce the
beginning of this periodic NAAQS review and the start of the
development of the science assessment by requesting the public to
submit scientific literature that they want to bring to the attention
of the Agency. The Clean Air Scientific Advisory Committee (CASAC), a
review committee of the EPA's Science Advisory Board (SAB), is mandated
by the Clean Air Act with performing an independent expert scientific
review of the air quality criteria. This involves review of draft(s) of
EPA's science assessment document. As this process proceeds, the public
will have opportunities to review and comment on draft(s) of the
science assessment document for SOX. These opportunities
will also be announced in the Federal Register.

B. What Should I Consider as I Prepare Materials for Submission to EPA?

    Since completion of the 1994 ``Supplement to the Second Addendum
(1986) to Air Quality Criteria for Particulate Matter and Sulfur Oxides
(1982): Assessment of New Findings on Sulfur Dioxide Acute Exposure
Health Effects in Asthmatic Individuals,'' EPA has continued to follow
the scientific research on SOX exposure and its effects on
public health and the environment and has gathered appropriate studies.
The Agency is particularly interested in additional new information
concerning: (1) Atmospheric science aspects (e.g., sources , emissions,
atmospheric transformation and transport, air quality concentrations,
patterns and trends); (2) exposure and dosimetry aspects; (3) health
effects aspects, including information derived from human and animal
toxicological studies of SO2 and transformation products
(e.g. sulfates, sulfuric acid); and (4) ecological effects of
SO2 and transformation products, such as those arising from
wet and dry deposition of sulfates and/or sulfuric acid. These and
other selected literature relevant to a review of the NAAQS for sulfur
oxides will be assessed in the forthcoming revised science assessment
for SOX. One or more drafts of the science assessment
document for SOX are expected to be made available by EPA
for public comment and CASAC review. After this call for information,
other opportunities for submission of new peer-reviewed papers
(published or in-press) will be possible as part of public comment on
the draft documents that will be reviewed by CASAC.

    Dated: May 3, 2006.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. E6-7340 Filed 5-12-06; 8:45 am]

BILLING CODE 6560-50-P