[Federal Register Volume 84, Number 183 (Friday, September 20, 2019)]
[Rules and Regulations]
[Pages 49475-49479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18015]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0424; FRL-9994-82]
Dinotefuran; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
dinotefuran in or on persimmon. Mitsui Chemicals Agro, Inc., c/o Landis
International, Inc. requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 20, 2019. Objections and
requests for hearings must be received on or before November 19, 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-2018-0424, 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 (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: 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 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-2018-0424 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
November 19, 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-2018-0424, 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 August 14, 2018 (83 FR 40272) (FRL-9981-
10), 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
8E8687) by Mitsui Chemicals Agro, Inc., c/o Landis International, Inc.,
P.O. Box 5126, Valdosta, GA 31603-5126. The petition requested that 40
CFR part 180.603 be amended by establishing tolerances for residues of
the insecticide dinotefuran (N-methyl-N'-nitro-N'';-[(tetrahydro-3-
furanyl)methyl)] guanidine) and metabolites DN (1-methyl-3-(tetrahydro-
3-furylmethyl)guanidine) and UF (1-methyl-3-(tetrahydro-3-furylmethyl)-
urea), in or on persimmon at 2 parts per million (ppm). That document
referenced a summary of the petition prepared by Mitsui Chemicals Agro,
Inc., c/o Landis International, Inc., the registrant, which is
available in the docket, http://www.regulations.gov. Two comments were
received on the notice of filing; however, neither comment is relevant
to this action.
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
[[Page 49476]]
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 dinotefuran including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with dinotefuran 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.
Dinotefuran is a neonicotinoid pesticide and acts as an agonist on
insect nicotinic acetylcholine receptors. Typically, low to moderate
levels of neonicotinoids, such as dinotefuran, activate the nicotinic
acetylcholine receptors causing stimulation of the peripheral nervous
system (PNS). High levels of neonicotinoids (agonists) can
overstimulate the PNS, maintaining cation channels in the open state
which blocks the action potential and leads to paralysis.
The main target organ of toxicity for dinotefuran is the nervous
system, but effects on the nervous system were only observed at high
doses. Nervous system toxicity was manifested as clinical signs and
decreased motor activity seen after acute dosing (in both rats and
rabbits); changes in motor activity are consistent with effects on the
nicotinic cholinergic nervous system seen after repeated dosing. The
other significant effects were decreases in body weight and/or body
weight gain, but even these effects occurred at or near the limit dose.
Changes in spleen and thymus weights were seen in mice, rats, and dogs
following subchronic and chronic dietary exposures. However, these
weight changes were not corroborated with alterations in hematology
parameters, histopathological lesions in these organs, or toxicity to
the hematopoietic system. Furthermore, in the immunotoxicity studies in
rats and mice, no effects on T-cell dependent antibody response (TDAR)
were seen when tested up to the limit dose. There were also no changes
in spleen and thymus weight, and there were no histopathological
lesions in these organs. In addition, the developmental immunotoxicity
study showed no effects on functionality of the immune system in rats
following exposure to dinotefuran at the limit dose during the
prenatal, postnatal, and post-weaning periods. Because of the lack of
immunotoxicity seen in the immunotoxicity studies in mice, rats, and
developing rats, the thymus weight changes seen in dogs and the spleen
weight changes seen in mice and rats in the subchronic and chronic oral
studies were not considered to be toxicologically relevant.
No systemic or neurotoxic effects were seen following repeated
dermal applications at the limit dose to rats in the 28-day dermal
toxicity study. Also, no systemic or portal of entry effects were seen
following repeated inhalation exposure at the maximum obtainable
concentrations to rats in the 28-day inhalation study. In the
developmental toxicity study in rats, no maternal or developmental
toxicity was seen at the limit dose. In rabbits, maternal toxicity
manifested as clinical signs of neurotoxicity, but no developmental
toxicity was seen. In the reproduction study in rats, parental,
offspring, and reproductive toxicity was seen at the limit dose.
Parental toxicity included decreased body weight weights/gains,
transient decrease in food consumption, and decreased thyroid weights.
Offspring toxicity was characterized as decreased forelimb grip
strength or hindlimb grip strength in the F1 pups. There was no adverse
effect on reproductive performance at any dose. In the developmental
neurotoxicity study, no maternal or offspring toxicity was seen at any
dose including the limit dose.
Dinotefuran is classified as ``Not Likely to be Carcinogenic to
Humans'' based on lack of evidence of carcinogenicity in rats and mice
in two adequate rodent carcinogenicity studies. There was no evidence
of mutagenicity in both the in vivo and in vitro assays.
Dinotefuran has low acute toxicity by oral, dermal, and inhalation
exposure routes. It does not irritate the eye but causes a low level of
skin irritation; it is not a dermal sensitizer.
Specific information on the studies received and the nature of the
adverse effects caused by dinotefuran as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Human Health Risk Assessment to Support
New Use on Imported Persimmon on page 18 in docket ID number EPA-HQ-
OPP-2018-0424.
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 dinotefuran used for
human risk assessment is discussed in Unit III.B of the final rule
published in the Federal Register of April 10, 2013 (78 FR 21267) (FRL-
9381-5).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to dinotefuran, EPA considered exposure under the petitioned-
for tolerances as well as all existing dinotefuran tolerances in 40 CFR
180.603. EPA assessed dietary exposures from dinotefuran 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 dinotefuran. In estimating acute
dietary exposure, EPA used food consumption information from the United
States
[[Page 49477]]
Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
As to residue levels in food, EPA assumed 100 percent crop treated
(PCT) and tolerance-level residues for all current crops.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and
tolerance-level residues for all current crops.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that dinotefuran 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 percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for dinotefuran. Tolerance level residues and/or 100
PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for dinotefuran in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of dinotefuran. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Variable Volume Water Model
(PRZM/VVWM), Pesticide Flooded Application Model (PFAM), and Pesticide
Root Zone Model Ground Water (PRZM GW), the estimated drinking water
concentrations (EDWCs) of dinotefuran for acute exposures are estimated
to be 84 parts per billion (ppb) for surface water and 154 ppb for
ground water, and for chronic exposures for non-cancer assessments are
estimated to be 19.5 ppb for surface water and 132 ppb for ground
water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 154 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 132 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). Dinotefuran is
currently registered for the following uses that could result in
residential exposures: Turf, ornamentals, vegetable gardens, roach and
ant bait, pet spot-ons, indoor aerosol sprays, crack and crevice
sprays, etc. EPA assessed residential exposure using the following
assumptions: Because no dermal or inhalation endpoints were chosen for
dinotefuran, residential handler and post-application residential
dermal and inhalation exposure scenarios were not assessed. As a
result, risk assessments were only completed for post-application
scenarios in which incidental oral exposures are expected. Children
(ages 1 to < 2 years old) may receive short-term hand-to-mouth
exposures from post-application exposure to fogger application in
indoor rooms or areas. Children (ages 1 to < 2 years old) may receive
intermediate- and chronic/long-term hand-to-mouth exposures from post-
application exposure to spot-on application to dogs (small). The post-
application exposure and risk estimates for all existing residential
uses resulted in risk estimates that are not of concern (MOEs ranged
from 1,200 to 4,600). Further information regarding EPA standard
assumptions and generic inputs for residential exposures may be found
at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found dinotefuran to share a common mechanism of
toxicity with any other substances, and dinotefuran does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
dinotefuran 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 http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. In the prenatal studies, no
maternal or developmental toxicity was seen at the limit dose in rats.
In rabbits, maternal toxicity manifested as clinical signs of
neurotoxicity, but no developmental toxicity was seen. In the rat
reproduction study, parental, offspring, and reproductive toxicity was
seen at the limit dose. Parental toxicity included decreased body
weight gain, transient decrease in food consumption, and decreased
thyroid weights. Offspring toxicity was characterized as a decreased
forelimb grip strength or hindlimb grip strength in the F1
pups. There was no adverse effect on reproductive performance at any
dose. In the developmental neurotoxicity study, no maternal or
offspring toxicity was seen at any dose including the limit dose.
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 dinotefuran is complete.
ii. The neurotoxic potential of dinotefuran has been adequately
considered. Dinotefuran is a neonicotinoid and has a neurotoxic mode of
pesticidal action. Consistent with the mode of action, changes in motor
activity were seen in repeat-dose studies, including the subchronic
neurotoxicity study. Additionally, decreased grip strength and brain
weight were observed in the offspring of a multi-generation
reproduction study albeit at doses close to the limit dose. For these
reasons, a developmental neurotoxicity (DNT) study was required. The
DNT study did not show evidence of a unique sensitivity of the
developing nervous system; no effects on
[[Page 49478]]
neurobehavioral parameters were seen in the offspring at any dose,
including the limit dose.
iii. As discussed in Unit III.D.2., there is no evidence that
dinotefuran results in increased susceptibility in in utero rats or
rabbits in the prenatal developmental studies or in young rats in the
2-generation reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues, corrected for additional
residues which are of concern for the risk assessment only. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to dinotefuran in drinking water. EPA
used similarly conservative assumptions to assess post-application
exposure of children. These assessments will not underestimate the
exposure and risks posed by dinotefuran.
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 dinotefuran will occupy 10% of the aPAD for children 1-2 years 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
dinotefuran from food and water will utilize 4.8% of the cPAD for
children 1-2 years 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
dinotefuran is 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).
Dinotefuran 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 dinotefuran.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined food, water, and short-
term residential exposures result in aggregate MOEs of 740. Because
EPA's level of concern for dinotefuran is a MOE of 100 or below, these
MOEs are not of concern.
4. Intermediate- and long-term risk. Intermediate- and long-term
aggregate exposure takes into account intermediate- and long-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Dinotefuran is currently registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate- and long-term residential exposures to
dinotefuran.
Using the exposure assumptions described in this unit for
intermediate- and long-term exposures, EPA has concluded that the
combined food, water, and intermediate- and long-term residential
exposures result in an aggregate MOE of 1,400 for children 1 to < 2
years old from background dietary exposures and post-application hand-
to-mouth exposures from pet spot-on applications to small dogs.
Although adults are expected to also have long-term post-application
exposures to dinotefuran due to the pet spot-on treatments,
quantitative dermal and inhalation assessments are not required since
there was no dermal and inhalation hazard identified in the toxicity
database and oral exposure is not anticipated for adults. Therefore,
the intermediate- and chronic/long-term aggregate assessment for adults
is equivalent to the chronic dietary exposure and risk assessment for
the most highly exposed adult population subgroup, adults 20-49 years
old, and is not of concern. Because EPA's level of concern for
dinotefuran is a MOE of 100 or below, these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, dinotefuran 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 dinotefuran residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, a high-performance liquid
chromatography/tandem mass spectrometry (HPLC/MS/MS) method for the
determination of residues of dinotefuran, and the metabolites DN and
UF; an HPLC/ultraviolet (UV) detection method for the determination of
residues of dinotefuran; and HPLC/MS and HPLC/MS/MS methods for the
determination of DN and UF) 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 an MRL for residues of dinotefuran on
persimmons.
V. Conclusion
Therefore, tolerances are established for residues of dinotefuran,
N-methyl-N '-nitro-N ''-[(tetrahydro-3-furanyl)methyl)] guanidine and
metabolites DN (1-methyl-3-(tetrahydro-3-furmethyl)guanidine) and UF
(1-methyl-3-(tetrahydro-3-furmethyl)-urea), in or on persimmon at 2
ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
[[Page 49479]]
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); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or 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 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: August 8, 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. In Sec. 180.603, add alphabetically the entry ``Persimmon'' to the
table in paragraph (a)(1) to read as follows:
Sec. 180.603 Dinotefuran; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
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* * * * *
Persimmon \1\........................................... 2
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\1\ There are no U.S. registrations for use of dinotefuran on this
commodity.
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[FR Doc. 2019-18015 Filed 9-19-19; 8:45 am]
BILLING CODE 6560-50-P