Dinotefuran; Pesticide Tolerance for Emergency Exemption, 59932-59936 [2019-24268]
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Federal Register / Vol. 84, No. 216 / Thursday, November 7, 2019 / Rules and Regulations
B. Notice and Public Procedure
1. Executive Orders
The Commission is an independent
regulatory agency under section 3(b) of
Executive Order (‘‘E.O.’’) 12866 (Sept.
30, 1993), 58 FR 51735 (Oct. 4, 1993);
E.O. 13563 (Jan. 18, 2011), 76 FR 3821
(Jan. 21, 2011); E.O. 13771 (Jan. 30,
2017), 82 FR 9339 (Feb. 3, 2017); E.O.
13777 (Feb. 24, 2017), 82 FR 12285
(Mar. 1, 2017); and E.O. 13132 (Aug. 4,
1999), 64 FR 43255 (Aug. 10, 1999).
The Commission has determined that
this rulemaking does not have ‘‘takings
implications’’ under E.O. 12630 (Mar.
15, 1988), 53 FR 8859 (Mar. 18, 1988).
The Commission has determined that
these regulations meet all applicable
standards set forth in E.O. 12988 (Feb.
5, 1996), 61 FR 4729 (Feb. 7, 1996).
2. Statutory Requirements
Although notice-and-comment
rulemaking requirements under the
Administrative Procedure Act (‘‘APA’’)
do not apply to rules of agency
procedure (5 U.S.C. 553(b)(3)(A)), the
Commission invites members of the
interested public to submit comments
on this final rule. The Commission will
accept public comment until December
9, 2019.
The Commission has determined that
this rulemaking is exempt from the
requirements of the Regulatory
Flexibility Act (‘‘RFA’’) (5 U.S.C. 601 et
seq.), because the proposed rule would
not have a significant economic impact
on a substantial number of small
entities.
The Commission has determined that
this rule is not a ‘‘major rule’’ under the
Small Business Regulatory Enforcement
Fairness Act (‘‘SBREFA’’) (5 U.S.C.
804(2)).
The Commission has determined that
the Paperwork Reduction Act (‘‘PRA’’)
(44 U.S.C. 3501 et seq.) does not apply
because these rules do not contain any
information collection requirements that
require the approval of the OMB.
The Commission has determined that
the Congressional Review Act (‘‘CRA’’)
(5 U.S.C. 801 et seq.) does not apply
because, pursuant to 5 U.S.C. 804(3)(C),
these rules are rules of agency
procedure or practice that do not
substantially affect the rights or
obligations of non-agency parties.
The Commission has determined that
this rulemaking is not a major Federal
action significantly affecting the quality
of the human environment requiring an
environmental assessment under the
National Environmental Policy Act
(‘‘NEPA’’) (42 U.S.C. 4321 et seq.).
The Commission is an independent
regulatory agency, and as such, is not
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subject to the requirements of the
Unfunded Mandates Reform Act
(‘‘UMRA’’) (2 U.S.C. 1532 et seq.).
List of Subjects in 29 CFR Part 2700
Administrative practice and
procedure, Mine safety and health,
Penalties, Whistleblowing.
PART 2700—PROCEDURAL RULES
Accordingly, the interim rule
amending 29 CFR part 2700, which was
published at 78 FR 77354 on December
23, 2013, and corrected at 79 FR 3104
on January 17, 2014, is adopted as final
without change.
■
Dated: November 1, 2019.
Marco M. Rajkovich, Jr.,
Chairman, Federal Mine Safety and Health
Review Commission.
[FR Doc. 2019–24251 Filed 11–6–19; 8:45 am]
BILLING CODE 6735–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0357; FRL–10000–96]
Dinotefuran; Pesticide Tolerance for
Emergency Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
time-limited tolerance for residues of
dinotefuran in or on fuzzy kiwifruit.
This action is in response to EPA’s
granting of an emergency exemption
under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on fuzzy
kiwifruit. This regulation establishes a
maximum permissible level for residues
of dinotefuran in or on this commodity.
The time-limited tolerance expires on
December 31, 2022.
DATES: This regulation is effective
November 7, 2019. Objections and
requests for hearings must be received
on or before January 6, 2020 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–2019–0357, 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
SUMMARY:
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Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through 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. To access the OCSPP test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/aboutepa/about-officechemical-safety-and-pollutionprevention-ocspp.
C. How can I file an objection or hearing
request?
Under section 408(g) of the Federal
Food, Drug, and Cosmetic Act (FFDCA),
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
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proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2019–0357 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
January 6, 2020. 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–
2019–0357, 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/where-sendcomments-epa-dockets.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Background and Statutory Findings
EPA, on its own initiative, in
accordance with FFDCA sections 408(e)
and 408(l)(6) of, 21 U.S.C. 346a(e) and
346a(1)(6), is establishing a time-limited
tolerance for residues of dinotefuran,
and its metabolites DN,1-methyl-3(tetrahydro-3-furylmethyl)guanidine,
and UF, 1-methyl-3-(tetrahydro-3furylmethyl)urea, calculated as the
stoichiometric equivalent of
dinotefuran, in or on kiwifruit, fuzzy at
0.9 part per million (ppm). This timelimited tolerance expires on December
31, 2022.
Section 408(l)(6) of FFDCA requires
EPA to establish a time-limited
tolerance or exemption from the
requirement for a tolerance for pesticide
chemical residues in food that will
result from the use of a pesticide under
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an emergency exemption granted by
EPA under FIFRA section 18. Such
tolerances can be established without
providing notice or period for public
comment. EPA does not intend for its
actions on FIFRA section 18 related
time-limited tolerances to set binding
precedents for the application of FFDCA
section 408 and the safety standard to
other tolerances and exemptions.
Section 408(e) of FFDCA allows EPA to
establish a tolerance or an exemption
from the requirement of a tolerance on
its own initiative, i.e., without having
received any petition from an outside
party.
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. . . .’’
Section 18 of FIFRA authorizes EPA
to exempt any Federal or State agency
from any provision of FIFRA, if EPA
determines that ‘‘emergency conditions
exist which require such exemption.’’
EPA has established regulations
governing such emergency exemptions
in 40 CFR part 166.
III. Emergency Exemption for
Dinotefuran on Fuzzy Kiwifruit and
FFDCA Tolerance
According to the Alabama Department
of Agriculture and Industries (ADAI), in
2017 brown marmorated stink bug
(BMSB) damage was observed in a small
block of nursery stock plants. This
observation alerted the staff at the kiwi
nursery to the potential of BMSB for the
2018 crop season. ADAI claimed that in
2018, BMSB severely damaged the
kiwifruit crop, making it unmarketable.
ADAI estimated losses as high as 50%
for 2018 and projected 2019 losses to be
over $1.6 million without the use of this
section 18 emergency exemption.
After having reviewed the
submission, EPA determined that an
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emergency condition exists for this
State, and that the criteria for approval
of an emergency exemption are met.
EPA has authorized a specific
exemption under FIFRA section 18 for
the use of dinotefuran on fuzzy kiwifruit
for control of brown marmorated stink
bug in Alabama.
As part of its evaluation of the
emergency exemption application, EPA
assessed the potential risks presented by
residues of dinotefuran in or on fuzzy
kiwifruit. In doing so, EPA considered
the safety standard in FFDCA section
408(b)(2), and EPA decided that the
necessary tolerances under FFDCA
section 408(l)(6) would be consistent
with the safety standard and with
FIFRA section 18. Consistent with the
need to move quickly on the emergency
exemption in order to address an urgent,
non-routine situation and to ensure that
the resulting food is safe and lawful,
EPA is issuing this tolerance without
notice and opportunity for public
comment as provided in FFDCA section
408(l)(6). Although this time-limited
tolerance expires on December 31, 2022,
under FFDCA section 408(l)(5), residues
of the pesticide not in excess of the
amount specified in the tolerance
remaining in or on fuzzy kiwifruit after
that date will not be unlawful, provided
the pesticide was applied in a manner
that was lawful under FIFRA, and the
residues do not exceed a level that was
authorized by this time-limited
tolerance at the time of that application.
EPA will take action to revoke this timelimited tolerance earlier if any
experience with, scientific data on, or
other relevant information on this
pesticide indicate that the residues are
not safe.
Because this time-limited tolerance is
being approved under emergency
conditions, EPA has not made any
decisions about whether dinotefuran
meets FIFRA’s registration requirements
for use on fuzzy kiwifruit or whether a
permanent tolerance for this use would
be appropriate. Under these
circumstances, EPA does not believe
that this time-limited tolerance decision
serves as a basis for registration of
dinotefuran by a State for special local
needs under FIFRA section 24(c), nor
does this tolerance by itself serve as the
authority for persons in any State other
than Alabama to use this pesticide on
the applicable crop under FIFRA section
18, absent the issuance of an emergency
exemption applicable within that State.
For additional information regarding the
emergency exemption for dinotefuran,
contact the Agency’s Registration
Division at the address provided under
FOR FURTHER INFORMATION CONTACT.
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IV. Aggregate Risk Assessment and
Determination of Safety
Consistent with 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 expected as a result
of this emergency exemption request
and the time-limited tolerance for
residues of dinotefuran on kiwifruit,
fuzzy at 0.9 ppm. EPA’s assessment of
exposures and risks associated with
establishing the time-limited tolerance
follows.
A. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks.
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 21269) (FRL–9381–5).
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to dinotefuran, EPA
considered exposure under the timelimited tolerance established by this
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action 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. Acute effects were
identified for dinotefuran. In estimating
acute dietary exposure, EPA used food
consumption information from the
United States 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
tolerance-level residues, corrected for
additional residues which are of
concern for risk assessment, default
processing factors when appropriate,
and 100% crop treated assumptions.
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 tolerance-level residues,
corrected for additional residues which
are of concern for the risk assessment,
default processing factors when
appropriate, and 100% crop treated
assumptions.
iii. Cancer. Based on the data
referenced in Unit IV.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 100% CT 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
https://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
Based on the Tier 1 Rice Model, the
estimated drinking water concentrations
(EDWCs) for surface water are 269 parts
per billion (ppb) for acute exposure and
257 ppb for chronic exposure. Based on
the use on turf, ornamentals, and
Christmas trees, the EDWCs for ground
water are 154 ppb for acute exposure
and 132 ppb for chronic exposure.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
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acute dietary risk assessment, the water
concentration value of 269 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration
value of 257 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).
Dinotefuran is currently registered for
uses that could result in short-term
residential exposures: (Turf,
ornamentals, indoor foggers, indoor
broadcast, spot-ons, crack and crevice).
Dinotefuran is also used on dogs, cats,
and horses (spot-on and/or spray). The
only potential post-application exposure
pathway that was quantitatively
assessed is the incidental oral exposure
pathway for children 1 to less than 2
years old due to currently registered
uses. The resulting margins of exposure
(MOEs) range from 1,200 to 5,500,000
and are significantly greater than EPA’s
level of concern (LOC = 100).
Residential exposure is not anticipated
from the proposed use on kiwifruit;
therefore, an updated residential
exposure assessment was not
conducted.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at: https://www.epa.gov/
pesticide-science-and-assessingpesticide-risks/standard-operatingprocedures-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
made a common mechanism of toxicity
finding as to dinotefuran and 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 https://
www.epa.gov/pesticide-science-and-
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assessing-pesticide-risks/cumulativeassessment-risk-pesticides.
C. 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 SF when reliable data
available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity.
There was no evidence (qualitative or
quantitative) of increased susceptibility
of the young following in utero
exposures to rats and rabbits and
following pre- and post-natal exposure
to rats for 2-generations.
3. Conclusion. EPA has determined
that reliable data show that 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
neurobehavioral parameters were seen
in the offspring at any dose, including
the limit dose.
iii. 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% CT and
tolerance-level residues corrected for
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additional residues of concern for risk
assessment. 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 as well
as incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by dinotefuran.
D. 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 11% of the
aPAD for children 1 to 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 5.2% of
the cPAD for (children 1 to 2 years old)
the population group receiving the
greatest exposure. Based on the
explanation in the unit regarding
residential use patterns, chronic
residential exposure to residues of
dinotefuran 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). 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 short-term food, water, and
residential exposures result in aggregate
MOEs of 720 for children 1 to less than
2 years old from post-application hand-
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to-mouth exposures from fogger
applications in indoor rooms or areas to
control fleas. Although adults are
expected to have short-term handler and
post-application exposures to
dinotefuran due to registered residential
use patterns, quantitative dermal and
inhalation assessments are not required
since there was no dermal and
inhalation hazard identified in the
toxicity database. Therefore, the shortterm aggregate assessment for adults is
equivalent to the chronic dietary
exposure and risk estimate for the most
highly exposed adult population
subgroup, adults 20 to 49 years old, and
is not of concern (1.4% cPAD). Because
EPA’s level of concern for dinotefuran 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
non-dietary, non-occupational 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 intermediateterm residential exposure, and the
Agency has determined that it is
appropriate to aggregate chronic
exposure through food and water with
intermediate-term residential exposures
to dinotefuran.
Using the exposure assumptions
described in this unit for intermediateterm exposures, EPA has concluded that
the combined intermediate-term food,
water, and residential exposures result
in aggregate MOEs of 1,400 for children
1 to less than 2 years old. The
recommended residential exposure
estimates for use in the children 1 to
less than 2 years old intermediate- and
chronic/long-term aggregate assessment
reflects post-application hand-to-mouth
exposures from pet spot-on applications
to small dogs. Although adults are
expected to also have long-term postapplication 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 estimate for
the most highly exposed adult
population subgroup, adults 20 to 49
years old, and is not of concern (1.4%
cPAD). Because EPA’s level of concern
for dinotefuran is an MOE of 100 or
below, these MOEs are not of concern.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
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Federal Register / Vol. 84, No. 216 / Thursday, November 7, 2019 / Rules and Regulations
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.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies
(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) are
available to enforce the tolerance
expression.
The methods may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established an
MRL for residues of dinotefuran on
kiwifruit, fuzzy.
VI. Conclusion
Therefore, a time-limited tolerance is
established for residues of dinotefuran
and its metabolites DN,1-methyl-3(tetrahydro-3-furylmethyl)guanidine,
VerDate Sep<11>2014
15:54 Nov 06, 2019
Jkt 250001
and UF, 1-methyl-3-(tetrahydro-3furylmethyl)urea, calculated as the
stoichiometric equivalent of
dinotefuran, in or on kiwifruit, fuzzy at
0.9 ppm. This tolerance expires on
December 31, 2022.
VII. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA sections 408(e) and
408(l)(6). 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 in accordance with
FFDCA sections 408(e) and 408(l)(6),
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
PO 00000
Frm 00018
Fmt 4700
Sfmt 9990
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).
VIII. 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: October 25, 2019.
Daniel Rosenblatt,
Acting 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. In § 180.603, add alphabetically an
entry for ‘‘Kiwifruit, fuzzy’’ to the table
in paragraph (b) to read as follows:
■
§ 180.603 Dinotefuran; tolerances for
residues.
*
*
*
(b) * * *
*
*
Parts per
million
Commodity
*
*
Kiwifruit, fuzzy ...
*
*
*
*
*
0.9
*
Expiration
date
*
12/31/2022
*
[FR Doc. 2019–24268 Filed 11–6–19; 8:45 am]
BILLING CODE 6560–50–P
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]]>Agencies
[Federal Register Volume 84, Number 216 (Thursday, November 7, 2019)]
[Rules and Regulations]
[Pages 59932-59936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24268]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0357; FRL-10000-96]
Dinotefuran; Pesticide Tolerance for Emergency Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
residues of dinotefuran in or on fuzzy kiwifruit. This action is in
response to EPA's granting of an emergency exemption under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of
the pesticide on fuzzy kiwifruit. This regulation establishes a maximum
permissible level for residues of dinotefuran in or on this commodity.
The time-limited tolerance expires on December 31, 2022.
DATES: This regulation is effective November 7, 2019. Objections and
requests for hearings must be received on or before January 6, 2020 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-2019-0357, 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 40 CFR
part 180 through 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. To access the OCSPP test guidelines referenced in this
document electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp.
C. How can I file an objection or hearing request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 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
[[Page 59933]]
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2019-0357 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 January 6, 2020. 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-2019-0357, 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/where-send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is
establishing a time-limited tolerance for residues of dinotefuran, and
its metabolites DN,1-methyl-3-(tetrahydro-3-furylmethyl)guanidine, and
UF, 1-methyl-3-(tetrahydro-3-furylmethyl)urea, calculated as the
stoichiometric equivalent of dinotefuran, in or on kiwifruit, fuzzy at
0.9 part per million (ppm). This time-limited tolerance expires on
December 31, 2022.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
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. . .
.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Dinotefuran on Fuzzy Kiwifruit and FFDCA
Tolerance
According to the Alabama Department of Agriculture and Industries
(ADAI), in 2017 brown marmorated stink bug (BMSB) damage was observed
in a small block of nursery stock plants. This observation alerted the
staff at the kiwi nursery to the potential of BMSB for the 2018 crop
season. ADAI claimed that in 2018, BMSB severely damaged the kiwifruit
crop, making it unmarketable. ADAI estimated losses as high as 50% for
2018 and projected 2019 losses to be over $1.6 million without the use
of this section 18 emergency exemption.
After having reviewed the submission, EPA determined that an
emergency condition exists for this State, and that the criteria for
approval of an emergency exemption are met. EPA has authorized a
specific exemption under FIFRA section 18 for the use of dinotefuran on
fuzzy kiwifruit for control of brown marmorated stink bug in Alabama.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of dinotefuran
in or on fuzzy kiwifruit. In doing so, EPA considered the safety
standard in FFDCA section 408(b)(2), and EPA decided that the necessary
tolerances under FFDCA section 408(l)(6) would be consistent with the
safety standard and with FIFRA section 18. Consistent with the need to
move quickly on the emergency exemption in order to address an urgent,
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and opportunity
for public comment as provided in FFDCA section 408(l)(6). Although
this time-limited tolerance expires on December 31, 2022, under FFDCA
section 408(l)(5), residues of the pesticide not in excess of the
amount specified in the tolerance remaining in or on fuzzy kiwifruit
after that date will not be unlawful, provided the pesticide was
applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by this time-limited tolerance
at the time of that application. EPA will take action to revoke this
time-limited tolerance earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions about whether
dinotefuran meets FIFRA's registration requirements for use on fuzzy
kiwifruit or whether a permanent tolerance for this use would be
appropriate. Under these circumstances, EPA does not believe that this
time-limited tolerance decision serves as a basis for registration of
dinotefuran by a State for special local needs under FIFRA section
24(c), nor does this tolerance by itself serve as the authority for
persons in any State other than Alabama to use this pesticide on the
applicable crop under FIFRA section 18, absent the issuance of an
emergency exemption applicable within that State. For additional
information regarding the emergency exemption for dinotefuran, contact
the Agency's Registration Division at the address provided under FOR
FURTHER INFORMATION CONTACT.
[[Page 59934]]
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with 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 expected as a result of this emergency exemption request and
the time-limited tolerance for residues of dinotefuran on kiwifruit,
fuzzy at 0.9 ppm. EPA's assessment of exposures and risks associated
with establishing the time-limited tolerance follows.
A. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
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 21269) (FRL-
9381-5).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to dinotefuran, EPA considered exposure under the time-limited
tolerance established by this action 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. Acute effects were identified for dinotefuran.
In estimating acute dietary exposure, EPA used food consumption
information from the United States 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
tolerance-level residues, corrected for additional residues which are
of concern for risk assessment, default processing factors when
appropriate, and 100% crop treated assumptions.
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 tolerance-level
residues, corrected for additional residues which are of concern for
the risk assessment, default processing factors when appropriate, and
100% crop treated assumptions.
iii. Cancer. Based on the data referenced in Unit IV.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 100%
CT 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Tier 1 Rice Model, the estimated drinking water
concentrations (EDWCs) for surface water are 269 parts per billion
(ppb) for acute exposure and 257 ppb for chronic exposure. Based on the
use on turf, ornamentals, and Christmas trees, the EDWCs for ground
water are 154 ppb for acute exposure and 132 ppb for chronic exposure.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 269 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 257 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 uses that could result in
short-term residential exposures: (Turf, ornamentals, indoor foggers,
indoor broadcast, spot-ons, crack and crevice). Dinotefuran is also
used on dogs, cats, and horses (spot-on and/or spray). The only
potential post-application exposure pathway that was quantitatively
assessed is the incidental oral exposure pathway for children 1 to less
than 2 years old due to currently registered uses. The resulting
margins of exposure (MOEs) range from 1,200 to 5,500,000 and are
significantly greater than EPA's level of concern (LOC = 100).
Residential exposure is not anticipated from the proposed use on
kiwifruit; therefore, an updated residential exposure assessment was
not conducted.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at: https://www.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 made a common
mechanism of toxicity finding as to dinotefuran and 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 https://www.epa.gov/pesticide-
science-and-
[[Page 59935]]
assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
C. 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 SF when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. There was no evidence
(qualitative or quantitative) of increased susceptibility of the young
following in utero exposures to rats and rabbits and following pre- and
post-natal exposure to rats for 2-generations.
3. Conclusion. EPA has determined that reliable data show that 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 neurobehavioral parameters
were seen in the offspring at any dose, including the limit dose.
iii. 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% CT and tolerance-level residues corrected for additional
residues of concern for risk assessment. 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 as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
dinotefuran.
D. 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 11% of the aPAD for children 1 to 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 5.2% of the cPAD for
(children 1 to 2 years old) the population group receiving the greatest
exposure. Based on the explanation in the unit regarding residential
use patterns, chronic residential exposure to residues of dinotefuran
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). 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 short-term food, water,
and residential exposures result in aggregate MOEs of 720 for children
1 to less than 2 years old from post-application hand-to-mouth
exposures from fogger applications in indoor rooms or areas to control
fleas. Although adults are expected to have short-term handler and
post-application exposures to dinotefuran due to registered residential
use patterns, quantitative dermal and inhalation assessments are not
required since there was no dermal and inhalation hazard identified in
the toxicity database. Therefore, the short-term aggregate assessment
for adults is equivalent to the chronic dietary exposure and risk
estimate for the most highly exposed adult population subgroup, adults
20 to 49 years old, and is not of concern (1.4% cPAD). Because EPA's
level of concern for dinotefuran 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 non-dietary, non-occupational
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-term residential exposures to dinotefuran.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 1,400 for children 1 to less than 2 years old. The
recommended residential exposure estimates for use in the children 1 to
less than 2 years old intermediate- and chronic/long-term aggregate
assessment reflects 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 estimate for the most highly exposed adult
population subgroup, adults 20 to 49 years old, and is not of concern
(1.4% cPAD). Because EPA's level of concern for dinotefuran is an MOE
of 100 or below, these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
[[Page 59936]]
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.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies (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) are available to enforce the tolerance
expression.
The methods 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
kiwifruit, fuzzy.
VI. Conclusion
Therefore, a time-limited tolerance is established for residues of
dinotefuran and its metabolites DN,1-methyl-3-(tetrahydro-3-
furylmethyl)guanidine, and UF, 1-methyl-3-(tetrahydro-3-
furylmethyl)urea, calculated as the stoichiometric equivalent of
dinotefuran, in or on kiwifruit, fuzzy at 0.9 ppm. This tolerance
expires on December 31, 2022.
VII. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). 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 in accordance
with FFDCA sections 408(e) and 408(l)(6), 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).
VIII. 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: October 25, 2019.
Daniel Rosenblatt,
Acting 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 an entry for ``Kiwifruit,
fuzzy'' to the table in paragraph (b) to read as follows:
Sec. 180.603 Dinotefuran; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
* * * * *
Kiwifruit, fuzzy.............................. 0.9 12/31/2022
------------------------------------------------------------------------
* * * * *
[FR Doc. 2019-24268 Filed 11-6-19; 8:45 am]
BILLING CODE 6560-50-P
