Indaziflam; Pesticide Tolerances, 54510-54516 [2019-21715]
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Federal Register / Vol. 84, No. 197 / Thursday, October 10, 2019 / Rules and Regulations
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this action and other
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the U.S. House of Representatives, and
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This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).
C. Petitions for Judicial Review
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by December 9, 2019. Filing a
petition for reconsideration by the
Administrator of this final rule does not
affect the finality of this action for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action, which
approves the District’s 2008 8-hour
ozone RACT SIP revision, may not be
challenged later in proceedings to
enforce its requirements (See section
307(b)(2)).
Dated: September 23, 2019.
Cosmo Servidio,
Regional Administrator, Region III.
List of Subjects in 40 CFR Part 52
Subpart J—District of Columbia
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VOC RACT and Negative Declarations—VOC Source
Categories under the 2008 8-Hour ozone NAAQS.
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District of Columbia .......
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[FR Doc. 2019–21861 Filed 10–9–19; 8:45 am]
BILLING CODE 6560–50–P
40 CFR Part 180
[EPA–HQ–OPP–2018–0561; FRL–9999–70]
Indaziflam; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of indaziflam in
or on the tropical and subtropical fruit
(edible peel) group 23 and tropical and
subtropical fruit (inedible peel) group
24. Interregional Research Project
Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
October 10, 2019. Objections and
requests for hearings must be received
on or before December 9, 2019, and
must be filed in accordance with the
SUMMARY:
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Authority: 42 U.S.C. 7401 et seq.
§ 52.470
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Identification of plan.
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(e)* * *
State
submittal
date
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EPA approval
date
Additional
explanation
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08/29/2018
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10/10/2019, .......................
[Insert Federal Register
citation].
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instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2018–0561, 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.
I. General Information
ADDRESSES:
ENVIRONMENTAL PROTECTION
AGENCY
1. The authority citation for part 52
continues to read as follows:
■
2. Amend § 52.470, in the table in
paragraph (e) by adding an entry for
‘‘VOC RACT and Negative
Declarations—VOC Source Categories
under the 2008 8-Hour ozone NAAQS’’
at the end of the table to read as follows:
Authority: 42 U.S.C. 7401 et seq.
Applicable
geographic area
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PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
■
Environmental protection, Air
pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone,
Reporting and recordkeeping
requirements, Volatile organic
compounds.
Name of non-regulatory SIP revision
*
40 CFR part 52 is amended as follows:
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:
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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
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the Government Publishing Office’s eCFR 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–2018–0561 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
December 9, 2019. 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–
2018–0561, 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 December
21, 2018 (83 FR 65660) (FRL–9985–67),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
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346a(d)(3), announcing the filing of a
pesticide petition (PP 8E8686) by IR–4,
IR–4 Project Headquarters, Rutgers, The
State University of New Jersey, 500
College Road East, Suite 201 W,
Princeton, NJ 08540. The petition
requested that 40 CFR part 180 be
amended by establishing tolerances for
residues of indaziflam, N-[(1R,2S)-2,3dihydro-2,6-dimethyl-1H-inden-1-yl]-6(1-fluoroethyl)-1,3,5-triazine-2,4diamine, including its metabolites and
degradates, in or on the raw agricultural
commodities Fruit, tropical and
subtropical, edible peel, group 23 at
0.01 ppm and Fruit, tropical and
subtropical, inedible peel, group 24 at
0.01 ppm. The petition also requested to
amend 40 CFR 180.653 by removing the
established tolerance for residues of
indaziflam in or on the raw agricultural
commodity Fruit, tropical and
subtropical, small fruit, edible peel,
subgroup 23A at 0.01 ppm. That
document referenced a summary of the
petition prepared by Bayer CropScience,
the registrant, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Although not requested, EPA is
removing the tolerance for ‘‘banana’’
since it is covered by the new group 24
tolerance. Also, the tolerance expression
is being modified as well. The reasons
for these changes are explained in Unit
IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
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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.
Metabolism studies with rats indicate
that indaziflam is rapidly and
completely (>90%) absorbed by the oral
route, although absorption may become
saturated at higher doses. Following
absorption, indaziflam is distributed to
multiple tissues, with the highest levels
found in the liver, skin, and thyroid.
Metabolism of indaziflam was extensive
and occurred primarily via oxidation to
form carboxylic acid and hydroxylated
metabolites. Based on in vivo dermal
absorption data from rats and
comparative in vitro absorption data
from rat and human skin, dermal
absorption for humans is estimated to be
7.3%.
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 (DNT) studies; the rat twogeneration 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
effects levels (NOAELs) and lowest
observed adverse effects 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
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activity were also seen in the
subchronic neurotoxicity study in
females and in the DNT 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
following subchronic or chronic
exposure.
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. 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. However,
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these effects in the rat occurred at
higher doses than those at which
neurotoxicity was observed in the dog.
Decreased body weight was also
observed in most subchronic and
chronic studies following oral 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.
Since the previous assessment, the
maternal findings in the rat
developmental toxicity study have been
revised because the decreases in
maternal weight gain and food
consumption did not result in reduced
mean maternal body weight at any dose
tested and no other maternal findings
were reported. Decreased mean fetal
weight was observed at the highest dose
tested, indicating increased quantitative
susceptibility. However, no evidence of
increased quantitative or qualitative
susceptibility was seen in
developmental toxicity studies in
rabbits, a developmental neurotoxicity
study in rats, or in a 2-generation
reproduction study in rats. No
developmental effects were observed in
rabbits up to maternally toxic dose
levels. Decreased pup weight and delays
in sexual maturation (preputial
separation in males and vaginal patency
in females) were observed in the rat
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.
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
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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 the Proposed
New Use on Lowbush Blueberry, and
Crop Group Expansions to Tropical and
Subtropical Fruit, Edible Peel, Group 23
and Tropical and Subtropical Fruit,
Inedible Peel, Group 24’’ on pages 29–
39 in docket ID number EPA–HQ–OPP–
2018–0561.
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-andassessing-pesticide-risks/assessinghuman-health-risk-pesticide.
A summary of the toxicological
endpoints for indaziflam used for
human risk assessment is shown in
Table 1 of this unit.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR INDAZIFLAM FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Acute dietary (General population including infants and
children and females 13 to 49
years old).
Chronic dietary (All populations)
Incidental oral short-term (1 to
30 days).
Dermal short-term (1 to 30
days).
Inhalation short-term (1 to 30
days).
Cancer (Oral, dermal, inhalation).
Point of departure
and
uncertainty/safety
factors
RfD, PAD, LOC
for risk
assessment
Study and toxicological
effects
NOAEL = 7.5 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL= 2 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL= 7.5 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Oral study NOAEL =
7.5 mg/kg/day
(dermal absorption
rate = 7.3%).
UFA = 10x
UFH = 10x
FQPA SF = 1x
Oral study NOAEL=
7.5 mg/kg/day (inhalation absorption
rate = 100%).
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 0.075
mg/kg/day aPAD =
0.075 mg/kg/day.
Subchronic Gavage Toxicity Study in Dogs.
LOAEL = 15 mg/kg/day, based on axonal degenerative microscopic findings in the brain, spinal cord, and sciatic nerve.
Chronic RfD = 0.02
mg/kg/day cPAD =
0.02 mg/kg/day.
Chronic Dietary Toxicity Study in Dogs.
LOAEL = 6⁄7 mg/kg/day M/F, based on nerve fiber degenerative
lesions in the brain, spinal cord, and sciatic nerve.
LOC for MOE = 100
Subchronic Gavage Toxicity Study in Dogs.
LOAEL = 15 mg/kg/day, based on axonal degenerative microscopic findings in the brain, spinal cord, and sciatic nerve.
LOC for MOE = 100
Subchronic Gavage Toxicity Study in Dogs.
LOAEL = 15 mg/kg/day, based on axonal degenerative microscopic findings in the brain, spinal cord, and sciatic nerve.
LOC for MOE = 100
Subchronic Gavage Toxicity Study in Dogs.
LOAEL = 15 mg/kg/day, based on axonal degenerative microscopic findings in the brain, spinal cord, and sciatic nerve.
No Evidence of Carcinogenicity. Classified as ‘‘Not Likely to be Carcinogenic to Humans.’’
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies).
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 2003–2008 food
consumption information from the U.S.
Department of Agriculture’s (USDA’s)
National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA). As to
residue levels in food, the acute
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assessment was based on tolerance-level
residues and 100 percent crop treated
(PCT).
ii. Chronic exposure. In estimating
chronic dietary exposure, EPA used
2003–2008 food consumption
information from the USDA’s NHANES/
WWEIA. As to residue levels in food,
the chronic 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 estimates 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
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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 assessments can be found at
https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
Residues of concern in drinking water
are indaziflam, triazine indanone,
indaziflam-carboxylic acid, indaziflamolefin, indaziflam-hydroxyethyl, and
fluoroethyl diaminotriazine (FDAT).
With the exception of FDAT, all of the
metabolites are assumed to have
comparable toxicity to the parent due to
structural similarity (i.e., both rings
intact). However, FDAT, a single-ring
metabolite, is not expected to be more
toxic than the parent indaziflam based
on FDAT’s non-neurotoxic mode of
action. The Agency calculated total
indaziflam estimated drinking water
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concentrations (EDWCs) for residues of
concern that are structurally similar to
indaziflam (i.e., indaziflam, triazineindanone, indaziflam-carboxylic acid,
indaziflam-hydroxyethyl, and
indaziflam-olefin), and separate EDWCs
for total FDAT, including its
fluoroethyl-triazinanedione (ROI1)
degradate. The Agency combined the
total indaziflam and total FDAT EDWCs
for use in the dietary assessments.
Based on the Pesticide in Water
Calculator (PWC), the EDWCs of
combined residues 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
value of 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 nonoccupational, 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. Shortterm post-application dermal exposure
is expected for adults, children 11 to
less than 16 years old, and children 6
to less than 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 to
less than 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 to less than 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
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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 https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/standardoperating-procedures-residentialpesticide.
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 website at https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-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.
Since the previous assessment, the
maternal findings in the rat
developmental toxicity study have been
revised because the decreases in
maternal weight gain and food
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consumption did not result in reduced
mean maternal body weight at any dose
tested and no other maternal findings
were reported. Decreased mean fetal
weight was observed at the highest dose
tested, indicating increased quantitative
susceptibility. However, no evidence of
increased quantitative or qualitative
susceptibility was seen in
developmental toxicity studies in
rabbits, a developmental neurotoxicity
study in rats, or in a 2-generation
reproduction study in rats. No
developmental effects were observed in
rabbits up to maternally toxic dose
levels. Decreased pup weight and delays
in sexual maturation (preputial
separation in males and vaginal patency
in females) were observed in the rat
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 is being
used as the basis for the risk assessment.
iii. No developmental effects were
observed in rabbits up to maternally
toxic dose levels. Offspring effects in the
DNT 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. However, decreased
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Federal Register / Vol. 84, No. 197 / Thursday, October 10, 2019 / Rules and Regulations
fetal weight was observed in the rat
developmental toxicity study in the
absence of adverse maternal effects.
Therefore, the Agency concluded that
there is evidence of increased
quantitative susceptibility to rat fetuses
exposed in utero to indaziflam. In all
studies, clear NOAELs/LOAELs were
identified for maternal/parental and
fetal/offspring effects.
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 postapplication 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 less than 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 7.8% of
the cPAD for all infants less than 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
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16:03 Oct 09, 2019
Jkt 250001
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 1,400 for
adults and 580 for children 1 to less
than 2 years old. Because EPA’s level of
concern for indaziflam is an 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 intermediateterm 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
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Frm 00051
Fmt 4700
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54515
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. Revisions to Petitioned-For
Tolerances
Although not requested, EPA is also
removing the existing tolerance for
‘‘banana’’ because it is superseded by
the new crop group 24 tolerance. Also,
EPA is amending the tolerance
expression for indaziflam to correct the
residues that should be measured in
determining compliance with the
established tolerance levels. The Agency
has determined that residues of the
FDAT metabolite should be aggregated
with residues of indaziflam when
evaluating compliance with established
tolerance levels. This revision does not
require any changes in tolerance levels
because those tolerance levels were
established based on aggregated
residues of FDAT and indaziflam. In
accordance with its policy to improve
the consistency and clarity of its
tolerance expressions, EPA is revising
the tolerance expression in this
rulemaking.
V. Conclusion
Therefore, tolerances are established
for residues of indaziflam in or on Fruit,
tropical and subtropical, edible peel,
group 23 at 0.01 ppm and Fruit, tropical
and subtropical, inedible peel, group 24
at 0.01 ppm.
Additionally, the existing tolerances
for both the tropical and subtropical,
small fruit, edible peel, subgroup 23A
and banana are removed as unnecessary
due to the establishment of the above
tolerances.
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Federal Register / Vol. 84, No. 197 / Thursday, October 10, 2019 / Rules and Regulations
Lastly, the tolerance expression in
paragraph (a) is modified to read as
follows: ‘‘General. Tolerances are
established for residues of the herbicide
indaziflam, N-[(1R,2S)-2,3-dihydro-2,6dimethyl-1H-inden-1-yl]-6-(1fluoroethyl)-1,3,5-triazine-2,4-diamine,
including its metabolites and
degradates, in or on the commodities in
the following table. Compliance with
the tolerance levels specified in the
table below is to be determined by
measuring only indaziflam and FDAT,
6-[(1R)-1-fluoroethyl]-1,3,5-triazine-2,4diamine, calculated as the
stoichiometric equivalent of indaziflam,
in or on the commodity.’’
VI. Statutory and Executive Order
Reviews
This action establishes and modifies
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),
nor is it considered a regulatory action
under Executive Order 13771, entitled
‘‘Reducing Regulations and Controlling
Regulatory Costs’’ (82 FR 9339, February
3, 2017). 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 tolerances 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
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16:03 Oct 09, 2019
Jkt 250001
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: September 18, 2019.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.653(a) is amended as
follows:
■ a. Revise the introductory text; and
■ b. In the table:
■ i. Add a heading for the table;
■ ii. Remove the entry for ‘‘Banana’’;
■
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Frm 00052
Fmt 4700
Sfmt 4700
iii. Add alphabetically the entries
‘‘Fruit, tropical and subtropical, edible
peel, group 23’’ and ‘‘Fruit, tropical and
subtropical, inedible peel, group 24’’;
■ iv. Remove the entry for ‘‘Fruit,
tropical and subtropical, small fruit,
edible peel, subgroup 23A’’; and
■ v. Remove footnote 2 to the table.
The revision and additions read as
follows:
■
§ 180.653 Indaziflam; tolerances for
residues.
(a) General. Tolerances are
established for residues of the herbicide
indaziflam, N-[(1R,2S)-2,3-dihydro-2,6dimethyl-1H-inden-1-yl]-6-(1fluoroethyl)-1,3,5-triazine-2,4-diamine,
including its metabolites and
degradates, in or on the commodities in
the following table. Compliance with
the tolerance levels specified in the
following table is to be determined by
measuring only indaziflam and FDAT,
6-[(1R)-1-fluoroethyl]-1,3,5-triazine-2,4diamine, calculated as the
stoichiometric equivalent of indaziflam,
in or on the commodity.
TABLE 1 TO PARAGRAPH (a)
Parts per
million
Commodity
*
*
*
*
*
Fruit, tropical and subtropical,
edible peel, group 23 ..............
Fruit, tropical and subtropical, inedible peel, group 24 ..............
*
*
*
*
*
*
*
*
0.01
0.01
*
*
[FR Doc. 2019–21715 Filed 10–9–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 271
[EPA–R04–RCRA–2019–0425; FRL–10001–
05–Region 4]
North Carolina: Final Authorization of
State Hazardous Waste Management
Program Revisions
Environmental Protection
Agency (EPA).
ACTION: Final authorization.
AGENCY:
The Environmental Protection
Agency (EPA) is granting North Carolina
final authorization for changes to its
hazardous waste program under the
Resource Conservation and Recovery
Act (RCRA). The Agency published a
SUMMARY:
E:\FR\FM\10OCR1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Rules and Regulations]
[Pages 54510-54516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21715]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0561; FRL-9999-70]
Indaziflam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
indaziflam in or on the tropical and subtropical fruit (edible peel)
group 23 and tropical and subtropical fruit (inedible peel) group 24.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 10, 2019. Objections and
requests for hearings must be received on or before December 9, 2019,
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-2018-0561, 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: [email protected].
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
[[Page 54511]]
the Government Publishing 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-2018-0561 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
December 9, 2019. 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-2018-0561, 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 December 21, 2018 (83 FR 65660) (FRL-
9985-67), 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
8E8686) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR part 180 be
amended by establishing tolerances 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 raw agricultural commodities Fruit, tropical and
subtropical, edible peel, group 23 at 0.01 ppm and Fruit, tropical and
subtropical, inedible peel, group 24 at 0.01 ppm. The petition also
requested to amend 40 CFR 180.653 by removing the established tolerance
for residues of indaziflam in or on the raw agricultural commodity
Fruit, tropical and subtropical, small fruit, edible peel, subgroup 23A
at 0.01 ppm. That document referenced a summary of the petition
prepared by Bayer CropScience, the registrant, which is available in
the docket, https://www.regulations.gov. There were no comments received
in response to the notice of filing.
Although not requested, EPA is removing the tolerance for
``banana'' since it is covered by the new group 24 tolerance. Also, the
tolerance expression is being modified as well. The reasons for these
changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for 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.
Metabolism studies with rats indicate that indaziflam is rapidly
and completely (>90%) absorbed by the oral route, although absorption
may become saturated at higher doses. Following absorption, indaziflam
is distributed to multiple tissues, with the highest levels found in
the liver, skin, and thyroid. Metabolism of indaziflam was extensive
and occurred primarily via oxidation to form carboxylic acid and
hydroxylated metabolites. Based on in vivo dermal absorption data from
rats and comparative in vitro absorption data from rat and human skin,
dermal absorption for humans is estimated to be 7.3%.
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 (DNT) 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 effects
levels (NOAELs) and lowest observed adverse effects 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
[[Page 54512]]
activity were also seen in the subchronic neurotoxicity study in
females and in the DNT 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 following subchronic or chronic exposure.
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. 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. However,
these effects in the rat occurred at higher doses than those at which
neurotoxicity was observed in the dog. Decreased body weight was also
observed in most subchronic and chronic studies following oral 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.
Since the previous assessment, the maternal findings in the rat
developmental toxicity study have been revised because the decreases in
maternal weight gain and food consumption did not result in reduced
mean maternal body weight at any dose tested and no other maternal
findings were reported. Decreased mean fetal weight was observed at the
highest dose tested, indicating increased quantitative susceptibility.
However, no evidence of increased quantitative or qualitative
susceptibility was seen in developmental toxicity studies in rabbits, a
developmental neurotoxicity study in rats, or in a 2-generation
reproduction study in rats. No developmental effects were observed in
rabbits up to maternally toxic dose levels. Decreased pup weight and
delays in sexual maturation (preputial separation in males and vaginal
patency in females) were observed in the rat 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.
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 the Proposed New Use on Lowbush Blueberry, and Crop Group
Expansions to Tropical and Subtropical Fruit, Edible Peel, Group 23 and
Tropical and Subtropical Fruit, Inedible Peel, Group 24'' on pages 29-
39 in docket ID number EPA-HQ-OPP-2018-0561.
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-pesticide.
A summary of the toxicological endpoints for indaziflam used for
human risk assessment is shown in Table 1 of this unit.
[[Page 54513]]
Table 1--Summary of Toxicological Doses and Endpoints for Indaziflam for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population NOAEL = 7.5 mg/kg/ Acute RfD = 0.075 Subchronic Gavage Toxicity Study
including infants and children day. mg/kg/day aPAD = in Dogs.
and females 13 to 49 years old). UFA = 10x........... 0.075 mg/kg/day. LOAEL = 15 mg/kg/day, based on
UFH = 10x........... axonal degenerative microscopic
FQPA SF = 1x........ findings in the brain, spinal
cord, and sciatic nerve.
Chronic dietary (All populations) NOAEL= 2 mg/kg/day.. Chronic RfD = 0.02 Chronic Dietary Toxicity Study in
UFA = 10x........... mg/kg/day cPAD = Dogs.
UFH = 10x........... 0.02 mg/kg/day. LOAEL = \6/7\ mg/kg/day M/F, based
FQPA SF = 1x........ on nerve fiber degenerative
lesions in the brain, spinal
cord, and sciatic nerve.
Incidental oral short-term (1 to NOAEL= 7.5 mg/kg/day LOC for MOE = 100.. Subchronic Gavage Toxicity Study
30 days). UFA = 10x........... in Dogs.
UFH = 10x........... LOAEL = 15 mg/kg/day, based on
FQPA SF = 1x........ axonal degenerative microscopic
findings in the brain, spinal
cord, and sciatic nerve.
Dermal short-term (1 to 30 days). Oral study NOAEL = LOC for MOE = 100.. Subchronic Gavage Toxicity Study
7.5 mg/kg/day in Dogs.
(dermal absorption LOAEL = 15 mg/kg/day, based on
rate = 7.3%). axonal degenerative microscopic
UFA = 10x........... findings in the brain, spinal
UFH = 10x........... cord, and sciatic nerve.
FQPA SF = 1x........
Inhalation short-term (1 to 30 Oral study NOAEL= LOC for MOE = 100.. Subchronic Gavage Toxicity Study
days). 7.5 mg/kg/day in Dogs.
(inhalation LOAEL = 15 mg/kg/day, based on
absorption rate = axonal degenerative microscopic
100%). findings in the brain, spinal
UFA = 10x........... cord, and sciatic nerve.
UFH = 10x...........
FQPA SF = 1x........
------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) No Evidence of Carcinogenicity. Classified as ``Not Likely to be Carcinogenic
to Humans.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
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 2003-2008 food consumption information from
the U.S. Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
As to residue levels in food, the acute assessment was based on
tolerance-level residues and 100 percent crop treated (PCT).
ii. Chronic exposure. In estimating chronic dietary exposure, EPA
used 2003-2008 food consumption information from the USDA's NHANES/
WWEIA. As to residue levels in food, the chronic 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 estimates 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 assessments can be
found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Residues of concern in drinking water are indaziflam, triazine
indanone, indaziflam-carboxylic acid, indaziflam-olefin, indaziflam-
hydroxyethyl, and fluoroethyl diaminotriazine (FDAT). With the
exception of FDAT, all of the metabolites are assumed to have
comparable toxicity to the parent due to structural similarity (i.e.,
both rings intact). However, FDAT, a single-ring metabolite, is not
expected to be more toxic than the parent indaziflam based on FDAT's
non-neurotoxic mode of action. The Agency calculated total indaziflam
estimated drinking water
[[Page 54514]]
concentrations (EDWCs) for residues of concern that are structurally
similar to indaziflam (i.e., indaziflam, triazine-indanone, indaziflam-
carboxylic acid, indaziflam-hydroxyethyl, and indaziflam-olefin), and
separate EDWCs for total FDAT, including its fluoroethyl-
triazinanedione (ROI1) degradate. The Agency combined the total
indaziflam and total FDAT EDWCs for use in the dietary assessments.
Based on the Pesticide in Water Calculator (PWC), the EDWCs of
combined residues 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 value of 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 to
less than 16 years old, and children 6 to less than 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 to less than 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 to less than 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 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 website 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. Since the previous
assessment, the maternal findings in the rat developmental toxicity
study have been revised because the decreases in maternal weight gain
and food consumption did not result in reduced mean maternal body
weight at any dose tested and no other maternal findings were reported.
Decreased mean fetal weight was observed at the highest dose tested,
indicating increased quantitative susceptibility. However, no evidence
of increased quantitative or qualitative susceptibility was seen in
developmental toxicity studies in rabbits, a developmental
neurotoxicity study in rats, or in a 2-generation reproduction study in
rats. No developmental effects were observed in rabbits up to
maternally toxic dose levels. Decreased pup weight and delays in sexual
maturation (preputial separation in males and vaginal patency in
females) were observed in the rat 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 is being used as the basis for the risk assessment.
iii. No developmental effects were observed in rabbits up to
maternally toxic dose levels. Offspring effects in the DNT 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. However, decreased
[[Page 54515]]
fetal weight was observed in the rat developmental toxicity study in
the absence of adverse maternal effects. Therefore, the Agency
concluded that there is evidence of increased quantitative
susceptibility to rat fetuses exposed in utero to indaziflam. In all
studies, clear NOAELs/LOAELs were identified for maternal/parental and
fetal/offspring effects.
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 less than 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 7.8% of the cPAD for all
infants less than 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 1,400 for adults and 580 for
children 1 to less than 2 years old. Because EPA's level of concern for
indaziflam is an 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: (410) 305-2905; email
address: [email protected].
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. Revisions to Petitioned-For Tolerances
Although not requested, EPA is also removing the existing tolerance
for ``banana'' because it is superseded by the new crop group 24
tolerance. Also, EPA is amending the tolerance expression for
indaziflam to correct the residues that should be measured in
determining compliance with the established tolerance levels. The
Agency has determined that residues of the FDAT metabolite should be
aggregated with residues of indaziflam when evaluating compliance with
established tolerance levels. This revision does not require any
changes in tolerance levels because those tolerance levels were
established based on aggregated residues of FDAT and indaziflam. In
accordance with its policy to improve the consistency and clarity of
its tolerance expressions, EPA is revising the tolerance expression in
this rulemaking.
V. Conclusion
Therefore, tolerances are established for residues of indaziflam in
or on Fruit, tropical and subtropical, edible peel, group 23 at 0.01
ppm and Fruit, tropical and subtropical, inedible peel, group 24 at
0.01 ppm.
Additionally, the existing tolerances for both the tropical and
subtropical, small fruit, edible peel, subgroup 23A and banana are
removed as unnecessary due to the establishment of the above
tolerances.
[[Page 54516]]
Lastly, the tolerance expression in paragraph (a) is modified to
read as follows: ``General. Tolerances are established 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, including its
metabolites and degradates, in or on the commodities in the following
table. Compliance with the tolerance levels specified in the table
below is to be determined by measuring only indaziflam and FDAT, 6-
[(1R)-1-fluoroethyl]-1,3,5-triazine-2,4-diamine, calculated as the
stoichiometric equivalent of indaziflam, in or on the commodity.''
VI. Statutory and Executive Order Reviews
This action establishes and modifies 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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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 tolerances 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: September 18, 2019.
Michael 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. Section 180.653(a) is amended as follows:
0
a. Revise the introductory text; and
0
b. In the table:
0
i. Add a heading for the table;
0
ii. Remove the entry for ``Banana'';
0
iii. Add alphabetically the entries ``Fruit, tropical and subtropical,
edible peel, group 23'' and ``Fruit, tropical and subtropical, inedible
peel, group 24'';
0
iv. Remove the entry for ``Fruit, tropical and subtropical, small
fruit, edible peel, subgroup 23A''; and
0
v. Remove footnote 2 to the table.
The revision and additions read as follows:
Sec. 180.653 Indaziflam; tolerances for residues.
(a) General. Tolerances are established 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, including its
metabolites and degradates, in or on the commodities in the following
table. Compliance with the tolerance levels specified in the following
table is to be determined by measuring only indaziflam and FDAT, 6-
[(1R)-1-fluoroethyl]-1,3,5-triazine-2,4-diamine, calculated as the
stoichiometric equivalent of indaziflam, in or on the commodity.
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Fruit, tropical and subtropical, edible peel, group 23...... 0.01
Fruit, tropical and subtropical, inedible peel, group 24.... 0.01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2019-21715 Filed 10-9-19; 8:45 am]
BILLING CODE 6560-50-P
