Tolfenpyrad; Pesticide Tolerances for Emergency Exemptions, 46929-46934 [2017-21797]
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Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Rules and Regulations
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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 exemptions 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,
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Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: September 5, 2017.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
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46929
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[FR Doc. 2017–21787 Filed 10–6–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
Therefore, 40 CFR chapter I is
amended as follows:
40 CFR Part 180
PART 180—[AMENDED]
Tolfenpyrad; Pesticide Tolerances for
Emergency Exemptions
[EPA–HQ–OPP–2017–0309; FRL–9967–72]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, add alphabetically the
inert ingredient to the table to read as
follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
Inert ingredients
*
*
Tall oil fatty acids
(CAS Reg. No.
61790–12–3).
*
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Limits
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............
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Uses
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Solvent/carrier.
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3. In § 180.930, add alphabetically the
inert ingredient to the table to read as
follows:
■
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
*
*
*
*
Inert ingredients
*
*
Tall oil fatty acids
(CAS Reg. No.
61790–12–3).
*
*
Limits
*
............
*
*
Uses
*
*
Solvent/carrier.
*
*
4. In § 180.940(a), add alphabetically
the inert ingredient to the table to read
as follows:
■
§ 180.940(a) Tolerance exemptions for
active and inert ingredients for use in
antimicrobial formulations (Food contact
surface sanitizing solutions).
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(a) * * *
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Inert ingredients
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Tall oil fatty acid
(CAS Reg. No.
61790–12–3).
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Limits
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Uses
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Solvent/carrier.
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Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
time-limited tolerances for residues of
tolfenpyrad in or on dry bulb onion and
watermelon. This action is in response
to EPA’s granting of emergency
exemptions under the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizing use of the
pesticide on dry bulb onion and
watermelon. This regulation establishes
maximum permissible levels for
residues of tolfenpyrad in or on these
commodities. The time-limited
tolerances expire on December 31, 2020.
DATES: This regulation is effective
October 10, 2017. Objections and
requests for hearings must be received
on or before December 11, 2017, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2017–0309, 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 L. 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:
SUMMARY:
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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).
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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 Printing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&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 and select ‘‘Test
Guidelines for Pesticides and Toxic
Substances.’’
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
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2017–0309 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before December 11, 2017. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
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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–
2017–0309, 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 time-limited
tolerances for residues of tolfenpyrad (4chloro-3-ethyl-1-methyl-N-[4-(ptolyloxy)benzyl]pyrazole-5carboxamide), including its metabolites
and degradates, in or on dry bulb onion
at 0.09 parts per million (ppm), and
watermelon at 0.7 ppm. These timelimited tolerances expire on December
31, 2020.
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
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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 Exemptions for
Tolfenpyrad on Dry Bulb Onion and
Watermelon, and FFDCA Tolerances
The Texas Department of Agriculture
(TDA) stated that an emergency
situation required the use of tolfenpyrad
on dry bulb onions (Allium cepa) to
control onion thrips (Thrips tabaci
Lindeman) in the Texas counties of
Cameron, Dimmitt, Frio, Hidalgo,
Maverick, Starr, Uvalde, Willacy and
Zavala. According to TDA, this year’s
exceptionally mild winter and record
high heat caused the development of
large populations of onion thrips, a
principle pest of onions, early in the
onion crop cycle. The threshold level
for applying pesticides to control thrips
in onions is 5 to 25 thrips per plant, and
TDA stated that over 100 thrips per
plant were observed in Texas’ dry bulb
onion fields in early March, 2017. TDA
stated that multiple applications of
registered pesticides were not
controlling these extreme population
levels which can reduce yields and bulb
size by as much as 50%. In addition, the
transmission of iris yellow spot virus in
onions, exclusively vectored by onion
thrips, is a concern, and several onion
fields have been observed with positive
symptoms. TDA stated that this virus
severely affects the shipping quality of
onions, and can be more devastating
than damage from the thrips themselves.
Upon EPA concurrence, TDA allowed
the use of tolfenpyrad under the
provisions of a crisis exemption
beginning on March 17, 2017, and
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subsequently requested a specific
exemption to allow the use of
tolfenpyrad in dry bulb onions to
continue beyond the 15 days provided
by a crisis exemption alone.
Separately, the Hawaii Department of
Agriculture (HDA) stated that an
emergency developed due to outbreaks
of melon thrips in watermelon fields at
unusually high levels, (up to 200 thrips
per leaf), which registered pesticides
were not controlling. HDA stated that
above-average rainfall caused rapid
growth of host plants, leading to
development of very high levels of
melon thrips in areas near watermelon
fields. Subsequently, a 6-week drought
caused early dry-down of this rainyseason vegetation, prompting massive
migrations of melon thrips into
neighboring watermelon fields. HDA
stated that the melon thrips infestations
have caused stunted vines, foliage
discoloration, and in some instances
have caused such severe damage that
the plants no longer produce fruit. The
melon aphid also transmits the tomato
spotted wilt virus, which causes silver
mottle disease in watermelon, further
damaging the plants and causing
additional yield losses. HDA stated that
some watermelon acreage was
abandoned due to the high level of
damage from melon thrips infestations,
and that significant yield and economic
losses would occur in the remaining
watermelon acreage without the
requested use of tolfenpyrad. Upon EPA
concurrence, HDA allowed the use of
tolfenpyrad under the provisions of a
crisis exemption, beginning on May 31,
2017, subsequently requesting a specific
exemption to allow the use of
tolfenpyrad in watermelon to continue
beyond the 15 days provided under a
crisis exemption alone.
After having reviewed the
submissions, EPA determined that
emergency conditions exist for these
States, and that the criteria for approval
of the emergency exemptions had been
met. Therefore, EPA authorized specific
exemptions under FIFRA section 18 for
the use of tolfenpyrad on dry bulb onion
for control of onion thrips in Texas, and
on watermelon for control of melon
thrips in Hawaii.
As part of its evaluation of the
emergency exemption applications, EPA
assessed the potential risks presented by
residues of tolfenpyrad in or on dry bulb
onion and watermelon. In doing so, EPA
considered the safety standard in
FFDCA section 408(b)(2), and 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
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emergency exemptions in order to
address urgent, non-routine situations
and to ensure that the resulting food is
safe and lawful, EPA is issuing these
tolerances without notice and
opportunity for public comment as
provided in FFDCA section 408(l)(6).
Although these time-limited tolerances
expire on December 31, 2020, under
FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts
specified in the tolerances remaining in
or on dry bulb onion or watermelon
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 these timelimited tolerances at the time of that
application. EPA will take action to
revoke these time-limited tolerances
earlier if any experience with, scientific
data on, or other relevant information
on this pesticide indicate that the
residues are not safe.
Because these time-limited tolerances
are being approved under emergency
conditions, EPA has not made any
decisions about whether tolfenpyrad
meets FIFRA’s registration requirements
for use on dry bulb onion and
watermelon or whether permanent
tolerances for these uses would be
appropriate. Under these circumstances,
EPA does not believe that these timelimited tolerance decisions serve as
bases for registration of tolfenpyrad by
a State for special local needs under
FIFRA section 24(c), nor do these
tolerances by themselves serve as the
authority for persons in any States other
than Texas and Hawaii to use this
pesticide on the applicable crops under
FIFRA section 18, absent the issuance of
an emergency exemption applicable
within that State. For additional
information regarding the emergency
exemptions for tolfenpyrad, contact the
Agency’s Registration Division at the
address provided under FOR FURTHER
INFORMATION CONTACT.
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 these emergency exemptions and the
time-limited tolerances for residues of
tolfenpyrad on dry bulb onion at 0.09
ppm, and watermelon at 0.7 ppm. EPA’s
assessment of exposures and risks
associated with establishing the timelimited tolerances follows.
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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 to humans by
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
profile and endpoints for tolfenpyrad
used for human health risk assessment
is discussed in Table 1 of the final rule
published in the Federal Register of
January 9, 2014, (79 FR 1599) (FRL–
9904–70).
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to tolfenpyrad, EPA
considered exposures under the timelimited tolerances established by this
action as well as all existing tolfenpyrad
tolerances in 40 CFR 180.675. EPA
assessed dietary exposures from
tolfenpyrad in food as follows:
i. Acute exposure. Acute dietary
exposure is quantified and risk
assessments are performed for a fooduse 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 tolfenpyrad. 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
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Eat in America (NHANES/WWEIA). For
the purposes of this acute exposure
assessment, EPA assumed tolerancelevel residues and 100 percent crop
treated (PCT) for those crops on which
tolfenpyrad use is registered and
proposed.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 2003–2008 NHANES/
WWEIA. For the purposes of this
chronic exposure assessment, EPA
assumed 100 PCT and incorporated
average residue levels from crop field
trials for registered and proposed uses of
tolfenpyrad.
iii. Cancer. No evidence of
carcinogenicity was observed in cancer
studies with mice and rats. For further
detail on the results of these studies see
‘‘Tolfenpyrad. Human Health Risk
Assessment’’ at https://
www.regulations.gov in docket ID
number EPA–HQ–OPP–2012–0909.
Therefore, in accordance with EPA’s
Final Guidelines for Carcinogen Risk
Assessment (March 2005), tolfenpyrad
is classified as ‘‘not likely to be
carcinogenic to humans’’ and a cancer
risk assessment is unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. Section
408(b)(2)(E) of FFDCA authorizes EPA
to use available data and information on
the anticipated residue levels of
pesticide residues in food and the actual
levels of pesticide residues that have
been measured in food. If EPA relies on
such information, EPA must require
pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the
tolerance is established, modified, or
left in effect, demonstrating that the
levels in food are not above the levels
anticipated. For the present action, EPA
will issue such data call-ins as are
required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section
408(f)(1). Data will be required to be
submitted no later than 5 years from the
date of issuance of these tolerances.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for tolfenpyrad in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of tolfenpyrad.
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 Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening
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Concentration in Ground Water (SCI–
GROW) models, the estimated drinking
water concentrations (EDWCs) of
tolfenpyrad are 26.9 ppb for acute
exposure and 12.2 ppb for chronic
exposure. These modeled estimates of
drinking water concentrations were
directly entered into the dietary
exposure model.
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).
Tolfenpyrad is not registered for any
specific use patterns that would result
in residential exposure. Further
information regarding EPA standard
assumptions and generic inputs for
residential exposures may be found at:
https://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/standardoperating-procedures-residentialpesticide.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found tolfenpyrad to
share a common mechanism of toxicity
with any other substances, and
tolfenpyrad does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that tolfenpyrad does not have
a common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site at https://
www.epa.gov/pesticide-science-andassessing-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
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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.
No evidence of increased quantitative or
qualitative susceptibility was observed
in developmental toxicity studies in rats
or rabbits or a reproduction toxicity
study in rats. However, the
developmental immunotoxicity study
(DIT) in rats suggests increased
qualitative susceptibility in the young
since toxicity observed in offspring
animals was more pronounced than
toxicity seen in maternal animals at the
same dose. No evidence of quantitative
susceptibility was seen in the study.
There is low concern and there are no
residual uncertainties regarding the
increased qualitative prenatal and/or
postnatal susceptibility observed for
tolfenpyrad. When the DIT and the
reproduction study are considered
together, the offspring toxicity in the
DIT is comparable in severity to
maternal toxicity observed at the same
dose in the reproduction study. Since
the adverse effects in young occurred at
exposure levels that have shown
comparable effects in adults, EPA does
not consider the DIT persuasive
evidence of an increased susceptibility
of infants or children to tolfenpyrad.
Additionally, the effects observed in the
DIT study are well-characterized, a clear
NOAEL was identified, and the
endpoints chosen for risk assessment
are protective of potential offspring
effects since a dermal hazard was not
identified for tolfenpyrad, inhalation
risk assessments are based on a route
specific inhalation study, and the POD
used for chronic dietary risk assessment
is lower than where offspring effects
were seen in the DIT study.
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
tolfenpyrad is complete.
ii. There is no indication that
tolfenpyrad is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. Although there is possibly
increased qualitative susceptibility in
the young in the DIT study in rats, there
are no residual uncertainties regarding
increased susceptibility for tolfenpyrad
since, (1) comparable maternal toxicity
was observed at the same dose in the
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reproduction study, (2) the offspring
effects observed in the DIT study are
well characterized and there is a clear
NOAEL for the effects seen, (3) no
evidence of quantitative susceptibility
was seen in the DIT study and
susceptibility was not observed
(quantitative or qualitative) in rat or
rabbit developmental toxicity or
reproduction studies tested at similar
doses, (4) the endpoints and PODs
selected for risk assessment are
protective, and (5) direct non-dietary
exposure to children is not anticipated
since there are no residential uses for
tolfenpyrad. Thus, an additional FQPA
safety factor is not necessary to protect
infants and children.
iv. There are no residual uncertainties
identified in the exposure databases.
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to tolfenpyrad in drinking water.
Accordingly, these assessments will not
underestimate the exposure and risks
posed by tolfenpyrad.
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. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food, drinking water
and relevant residential exposure
scenarios. Since there are no residential
uses for tolfenpyrad, acute residential
exposure is not anticipated and acute
aggregate exposure results from dietary
exposure to residues in food and
drinking water alone. Therefore, acute
aggregate risk estimates are equivalent
to the acute dietary risk estimates. Using
the exposure assumptions discussed in
this unit for acute exposure, the acute
dietary exposure from food and water to
tolfenpyrad will occupy 56% of the
aPAD for the general U.S. population.
Children 3–5 years old are the highestexposed population subgroup with an
estimated acute dietary exposure of 80%
of the aPAD. Typically, EPA has
concerns when estimated exposures
exceed 100% of the acute or chronic
population-adjusted dose (aPAD or
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cPAD). Acute dietary risk estimates are
below EPA’s level of concern for all
populations.
2. Chronic risk. A chronic aggregate
risk assessment takes into account
chronic exposure estimates from dietary
consumption of food and drinking water
and relevant residential exposure
scenarios. Since there are no residential
uses for tolfenpyrad, chronic residential
exposure is not anticipated and chronic
aggregate exposure to tolfenpyrad
results from dietary exposure to
residues in food and drinking water
alone. Therefore, chronic aggregate risk
estimates for tolfenpyrad are equivalent
to the chronic dietary risk estimates.
Using the exposure assumptions
described in this unit for chronic
exposure, EPA has concluded that
chronic exposure to tolfenpyrad from
food and water will utilize 32% of the
cPAD for the general U.S. population,
and 81% of the cPAD for children 1–2
years old (the population group
receiving the greatest exposure).
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic dietary exposure from food and
water (considered to be a background
(average) exposure level). A short-term
adverse effect was identified; however,
tolfenpyrad is not registered for any use
patterns that would result in short-term
residential exposure. Because there is
no short-term residential exposure and
chronic dietary exposure has already
been assessed under the appropriately
protective cPAD (which is at least as
protective as the POD used to assess
short-term risk), no further assessment
of short-term risk is necessary, and EPA
relies on the chronic dietary risk
assessment for evaluating short-term
risk for tolfenpyrad.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
dietary exposure from food and water
(considered to be a background
exposure level). An intermediate-term
adverse effect was identified; however,
tolfenpyrad is not registered for any use
patterns that would result in
intermediate-term residential exposure.
Because there is no intermediate-term
residential exposure and chronic dietary
exposure has already been assessed
under the appropriately protective
cPAD (which is at least as protective as
the POD used to assess intermediateterm risk), no further assessment of
intermediate-term risk is necessary, and
EPA relies on the chronic dietary risk
assessment for evaluating intermediateterm risk for tolfenpyrad.
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5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
tolfenpyrad 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 tolfenpyrad
residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(liquid chromatography/tandem mass
spectrometry (LC/MS/MS)) is available
to enforce the tolerance expression.
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level. The Codex has not
established MRLs for tolfenpyrad
residues in dry bulb onion or
watermelon.
VI. Conclusion
Therefore, time-limited tolerances are
established for residues of tolfenpyrad
(4-chloro-3-ethyl-1-methyl-N-[4-(ptolyloxy)benzyl]pyrazole-5carboxamide), including its metabolites
and degradates, in or on onion, dry bulb
at 0.09 ppm, and watermelon at 0.7
ppm. These tolerances expire on
December 31, 2020.
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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). 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 tolerances in this final rule,
do not require the issuance of a
proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
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: September 25, 2017.
Michael L. Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.675, revise paragraph (b) to
read as follows:
■
§ 180.675 Tolfenpyrad; tolerances for
residues.
*
*
*
*
*
(b) Section 18 emergency exemptions.
Time-limited tolerances specified in the
following table are established for
residues of tolfenpyrad, (4-chloro-3ethyl-1-methyl-N-[4-(ptolyloxy)benzyl]pyrazole-5carboxamide, including its metabolites
and degradates, in or on the specified
agricultural commodities, resulting from
use of the pesticide pursuant to FIFRA
section 18 emergency exemptions.
Compliance with the tolerance levels
specified below is to be determined by
measuring only tolfenpyrad, 4-chloro-3ethyl-1-methyl-N-[4-(ptolyloxy)benzyl]pyrazole-5carboxamide. The tolerances expire on
the dates specified in the table.
Parts per
million
Commodity
Onion, dry bulb ........................................................................................................................................................
Vegetable, fruiting, group 8–10 ...............................................................................................................................
Watermelon ..............................................................................................................................................................
*
*
*
*
*
DEPARTMENT OF COMMERCE
[FR Doc. 2017–21797 Filed 10–6–17; 8:45 am]
National Oceanic and Atmospheric
Administration
BILLING CODE 6560–50–P
Pmangrum on DSK3GDR082PROD with RULES
50 CFR Part 635
RIN 0648–XF727
Atlantic Highly Migratory Species;
Atlantic Bluefin Tuna Fisheries
National Marine Fisheries
Service (NMFS), National Oceanic and
AGENCY:
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Atmospheric Administration (NOAA),
Commerce.
Temporary rule; closure of the
General category fishery.
ACTION:
NMFS closes the General
category fishery for large medium and
giant (i.e., measuring 73 inches curved
fork length or greater) Atlantic bluefin
tuna (BFT) until the General category
reopens on December 1, 2017. This
action is being taken to prevent
overharvest of the General category
October through November 2017 BFT
subquota and help ensure reasonable
SUMMARY:
[Docket No. 150121066–5717–02]
0.09
0.70
0.70
Expiration
date
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[Federal Register Volume 82, Number 194 (Tuesday, October 10, 2017)]
[Rules and Regulations]
[Pages 46929-46934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21797]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0309; FRL-9967-72]
Tolfenpyrad; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
residues of tolfenpyrad in or on dry bulb onion and watermelon. This
action is in response to EPA's granting of emergency exemptions under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on dry bulb onion and watermelon. This
regulation establishes maximum permissible levels for residues of
tolfenpyrad in or on these commodities. The time-limited tolerances
expire on December 31, 2020.
DATES: This regulation is effective October 10, 2017. Objections and
requests for hearings must be received on or before December 11, 2017,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0309, 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 L. 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:
[[Page 46930]]
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 Printing 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 and select
``Test Guidelines for Pesticides and Toxic Substances.''
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
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2017-0309 in the subject line on the first page of your submission. All
objections and requests for a hearing must be in writing, and must be
received by the Hearing Clerk on or before December 11, 2017. Addresses
for mail and hand delivery of objections and hearing requests are
provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0309, 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 time-limited tolerances for residues of tolfenpyrad (4-
chloro-3-ethyl-1-methyl-N-[4-(p-tolyloxy)benzyl]pyrazole-5-
carboxamide), including its metabolites and degradates, in or on dry
bulb onion at 0.09 parts per million (ppm), and watermelon at 0.7 ppm.
These time-limited tolerances expire on December 31, 2020.
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 Exemptions for Tolfenpyrad on Dry Bulb Onion and
Watermelon, and FFDCA Tolerances
The Texas Department of Agriculture (TDA) stated that an emergency
situation required the use of tolfenpyrad on dry bulb onions (Allium
cepa) to control onion thrips (Thrips tabaci Lindeman) in the Texas
counties of Cameron, Dimmitt, Frio, Hidalgo, Maverick, Starr, Uvalde,
Willacy and Zavala. According to TDA, this year's exceptionally mild
winter and record high heat caused the development of large populations
of onion thrips, a principle pest of onions, early in the onion crop
cycle. The threshold level for applying pesticides to control thrips in
onions is 5 to 25 thrips per plant, and TDA stated that over 100 thrips
per plant were observed in Texas' dry bulb onion fields in early March,
2017. TDA stated that multiple applications of registered pesticides
were not controlling these extreme population levels which can reduce
yields and bulb size by as much as 50%. In addition, the transmission
of iris yellow spot virus in onions, exclusively vectored by onion
thrips, is a concern, and several onion fields have been observed with
positive symptoms. TDA stated that this virus severely affects the
shipping quality of onions, and can be more devastating than damage
from the thrips themselves. Upon EPA concurrence, TDA allowed the use
of tolfenpyrad under the provisions of a crisis exemption beginning on
March 17, 2017, and
[[Page 46931]]
subsequently requested a specific exemption to allow the use of
tolfenpyrad in dry bulb onions to continue beyond the 15 days provided
by a crisis exemption alone.
Separately, the Hawaii Department of Agriculture (HDA) stated that
an emergency developed due to outbreaks of melon thrips in watermelon
fields at unusually high levels, (up to 200 thrips per leaf), which
registered pesticides were not controlling. HDA stated that above-
average rainfall caused rapid growth of host plants, leading to
development of very high levels of melon thrips in areas near
watermelon fields. Subsequently, a 6-week drought caused early dry-down
of this rainy-season vegetation, prompting massive migrations of melon
thrips into neighboring watermelon fields. HDA stated that the melon
thrips infestations have caused stunted vines, foliage discoloration,
and in some instances have caused such severe damage that the plants no
longer produce fruit. The melon aphid also transmits the tomato spotted
wilt virus, which causes silver mottle disease in watermelon, further
damaging the plants and causing additional yield losses. HDA stated
that some watermelon acreage was abandoned due to the high level of
damage from melon thrips infestations, and that significant yield and
economic losses would occur in the remaining watermelon acreage without
the requested use of tolfenpyrad. Upon EPA concurrence, HDA allowed the
use of tolfenpyrad under the provisions of a crisis exemption,
beginning on May 31, 2017, subsequently requesting a specific exemption
to allow the use of tolfenpyrad in watermelon to continue beyond the 15
days provided under a crisis exemption alone.
After having reviewed the submissions, EPA determined that
emergency conditions exist for these States, and that the criteria for
approval of the emergency exemptions had been met. Therefore, EPA
authorized specific exemptions under FIFRA section 18 for the use of
tolfenpyrad on dry bulb onion for control of onion thrips in Texas, and
on watermelon for control of melon thrips in Hawaii.
As part of its evaluation of the emergency exemption applications,
EPA assessed the potential risks presented by residues of tolfenpyrad
in or on dry bulb onion and watermelon. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2), and 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 exemptions in order to address
urgent, non-routine situations and to ensure that the resulting food is
safe and lawful, EPA is issuing these tolerances without notice and
opportunity for public comment as provided in FFDCA section 408(l)(6).
Although these time-limited tolerances expire on December 31, 2020,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerances remaining in or on dry bulb
onion or watermelon 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 these time-
limited tolerances at the time of that application. EPA will take
action to revoke these time-limited tolerances earlier if any
experience with, scientific data on, or other relevant information on
this pesticide indicate that the residues are not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
tolfenpyrad meets FIFRA's registration requirements for use on dry bulb
onion and watermelon or whether permanent tolerances for these uses
would be appropriate. Under these circumstances, EPA does not believe
that these time-limited tolerance decisions serve as bases for
registration of tolfenpyrad by a State for special local needs under
FIFRA section 24(c), nor do these tolerances by themselves serve as the
authority for persons in any States other than Texas and Hawaii to use
this pesticide on the applicable crops under FIFRA section 18, absent
the issuance of an emergency exemption applicable within that State.
For additional information regarding the emergency exemptions for
tolfenpyrad, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.
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 these emergency exemptions and the
time-limited tolerances for residues of tolfenpyrad on dry bulb onion
at 0.09 ppm, and watermelon at 0.7 ppm. EPA's assessment of exposures
and risks associated with establishing the time-limited tolerances
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 to humans by 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 profile and endpoints for
tolfenpyrad used for human health risk assessment is discussed in Table
1 of the final rule published in the Federal Register of January 9,
2014, (79 FR 1599) (FRL-9904-70).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tolfenpyrad, EPA considered exposures under the time-
limited tolerances established by this action as well as all existing
tolfenpyrad tolerances in 40 CFR 180.675. EPA assessed dietary
exposures from tolfenpyrad in food as follows:
i. Acute exposure. Acute dietary exposure is quantified 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 tolfenpyrad. 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
[[Page 46932]]
Eat in America (NHANES/WWEIA). For the purposes of this acute exposure
assessment, EPA assumed tolerance-level residues and 100 percent crop
treated (PCT) for those crops on which tolfenpyrad use is registered
and proposed.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. For the purposes of this chronic exposure assessment, EPA
assumed 100 PCT and incorporated average residue levels from crop field
trials for registered and proposed uses of tolfenpyrad.
iii. Cancer. No evidence of carcinogenicity was observed in cancer
studies with mice and rats. For further detail on the results of these
studies see ``Tolfenpyrad. Human Health Risk Assessment'' at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2012-0909.
Therefore, in accordance with EPA's Final Guidelines for Carcinogen
Risk Assessment (March 2005), tolfenpyrad is classified as ``not likely
to be carcinogenic to humans'' and a cancer risk assessment is
unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for tolfenpyrad in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of tolfenpyrad. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
tolfenpyrad are 26.9 ppb for acute exposure and 12.2 ppb for chronic
exposure. These modeled estimates of drinking water concentrations were
directly entered into the dietary exposure model.
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).
Tolfenpyrad is not registered for any specific use patterns that
would result in residential exposure. 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 found tolfenpyrad to share a common mechanism of
toxicity with any other substances, and tolfenpyrad does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
tolfenpyrad does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticide-science-and-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. No evidence of increased
quantitative or qualitative susceptibility was observed in
developmental toxicity studies in rats or rabbits or a reproduction
toxicity study in rats. However, the developmental immunotoxicity study
(DIT) in rats suggests increased qualitative susceptibility in the
young since toxicity observed in offspring animals was more pronounced
than toxicity seen in maternal animals at the same dose. No evidence of
quantitative susceptibility was seen in the study. There is low concern
and there are no residual uncertainties regarding the increased
qualitative prenatal and/or postnatal susceptibility observed for
tolfenpyrad. When the DIT and the reproduction study are considered
together, the offspring toxicity in the DIT is comparable in severity
to maternal toxicity observed at the same dose in the reproduction
study. Since the adverse effects in young occurred at exposure levels
that have shown comparable effects in adults, EPA does not consider the
DIT persuasive evidence of an increased susceptibility of infants or
children to tolfenpyrad. Additionally, the effects observed in the DIT
study are well-characterized, a clear NOAEL was identified, and the
endpoints chosen for risk assessment are protective of potential
offspring effects since a dermal hazard was not identified for
tolfenpyrad, inhalation risk assessments are based on a route specific
inhalation study, and the POD used for chronic dietary risk assessment
is lower than where offspring effects were seen in the DIT study.
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 tolfenpyrad is complete.
ii. There is no indication that tolfenpyrad is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. Although there is possibly increased qualitative
susceptibility in the young in the DIT study in rats, there are no
residual uncertainties regarding increased susceptibility for
tolfenpyrad since, (1) comparable maternal toxicity was observed at the
same dose in the
[[Page 46933]]
reproduction study, (2) the offspring effects observed in the DIT study
are well characterized and there is a clear NOAEL for the effects seen,
(3) no evidence of quantitative susceptibility was seen in the DIT
study and susceptibility was not observed (quantitative or qualitative)
in rat or rabbit developmental toxicity or reproduction studies tested
at similar doses, (4) the endpoints and PODs selected for risk
assessment are protective, and (5) direct non-dietary exposure to
children is not anticipated since there are no residential uses for
tolfenpyrad. Thus, an additional FQPA safety factor is not necessary to
protect infants and children.
iv. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to tolfenpyrad in
drinking water. Accordingly, these assessments will not underestimate
the exposure and risks posed by tolfenpyrad.
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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food,
drinking water and relevant residential exposure scenarios. Since there
are no residential uses for tolfenpyrad, acute residential exposure is
not anticipated and acute aggregate exposure results from dietary
exposure to residues in food and drinking water alone. Therefore, acute
aggregate risk estimates are equivalent to the acute dietary risk
estimates. Using the exposure assumptions discussed in this unit for
acute exposure, the acute dietary exposure from food and water to
tolfenpyrad will occupy 56% of the aPAD for the general U.S.
population. Children 3-5 years old are the highest-exposed population
subgroup with an estimated acute dietary exposure of 80% of the aPAD.
Typically, EPA has concerns when estimated exposures exceed 100% of the
acute or chronic population-adjusted dose (aPAD or cPAD). Acute dietary
risk estimates are below EPA's level of concern for all populations.
2. Chronic risk. A chronic aggregate risk assessment takes into
account chronic exposure estimates from dietary consumption of food and
drinking water and relevant residential exposure scenarios. Since there
are no residential uses for tolfenpyrad, chronic residential exposure
is not anticipated and chronic aggregate exposure to tolfenpyrad
results from dietary exposure to residues in food and drinking water
alone. Therefore, chronic aggregate risk estimates for tolfenpyrad are
equivalent to the chronic dietary risk estimates. Using the exposure
assumptions described in this unit for chronic exposure, EPA has
concluded that chronic exposure to tolfenpyrad from food and water will
utilize 32% of the cPAD for the general U.S. population, and 81% of the
cPAD for children 1-2 years old (the population group receiving the
greatest exposure).
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic dietary exposure
from food and water (considered to be a background (average) exposure
level). A short-term adverse effect was identified; however,
tolfenpyrad is not registered for any use patterns that would result in
short-term residential exposure. Because there is no short-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess short-term risk), no further
assessment of short-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short-term risk for
tolfenpyrad.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
dietary exposure from food and water (considered to be a background
exposure level). An intermediate-term adverse effect was identified;
however, tolfenpyrad is not registered for any use patterns that would
result in intermediate-term residential exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for tolfenpyrad.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, tolfenpyrad 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 tolfenpyrad residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography/tandem mass
spectrometry (LC/MS/MS)) is available to enforce the tolerance
expression.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established MRLs for tolfenpyrad residues in dry bulb onion or
watermelon.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
tolfenpyrad (4-chloro-3-ethyl-1-methyl-N-[4-(p-
tolyloxy)benzyl]pyrazole-5-carboxamide), including its metabolites and
degradates, in or on onion, dry bulb at 0.09 ppm, and watermelon at 0.7
ppm. These tolerances expire on December 31, 2020.
[[Page 46934]]
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). 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 tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
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: September 25, 2017.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.675, revise paragraph (b) to read as follows:
Sec. 180.675 Tolfenpyrad; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of
tolfenpyrad, (4-chloro-3-ethyl-1-methyl-N-[4-(p-
tolyloxy)benzyl]pyrazole-5-carboxamide, including its metabolites and
degradates, in or on the specified agricultural commodities, resulting
from use of the pesticide pursuant to FIFRA section 18 emergency
exemptions. Compliance with the tolerance levels specified below is to
be determined by measuring only tolfenpyrad, 4-chloro-3-ethyl-1-methyl-
N-[4-(p-tolyloxy)benzyl]pyrazole-5-carboxamide. The tolerances expire
on the dates specified in the table.
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Onion, dry bulb......................... 0.09 12/31/2020
Vegetable, fruiting, group 8-10......... 0.70 12/31/19
Watermelon.............................. 0.70 12/31/2020
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-21797 Filed 10-6-17; 8:45 am]
BILLING CODE 6560-50-P