Flonicamid; Pesticide Tolerances, 21941-21946 [2017-09592]
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Federal Register / Vol. 82, No. 90 / Thursday, May 11, 2017 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0013; FRL–9959–91]
Flonicamid; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of flonicamid in
or on multiple commodities which are
identified and discussed later in this
document. In addition, this regulation
revokes the established tolerance for
vegetable, fruiting, group 8–10 that is
superseded by this action. Interregional
Research Project Number 4 (IR–4) and
ISK Biosciences Corporation requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May
11, 2017. Objections and requests for
hearings must be received on or before
July 10, 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).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0013, 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, Director,
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.
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ADDRESSES:
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
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producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2016–0013 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 July 10, 2017. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2016–0013, 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.
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• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of May 19,
2016 (81 FR 31581) (FRL–9946–02);
August 12, 2016 (81 FR 53379) (FRL–
9949–53) and December 9, 2016 (81 FR
89036) (FRL–9953–69), EPA issued
documents pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of pesticide
petitions (PPs) by IR–4 (PP 5E8428); and
ISK Biosciences (PP 5F8416 and
6F8443), respectively. These petitions
request that 40 CFR 180.613 be
amended by establishing tolerances for
residues of the insecticide flonicamid,
N-(cyanomethyl)-4-(trifluoromethyl)-3pyridinecarboxamide, and its
metabolites, TFNA (4trifluoromethylinicotinic acid), TFNA–
AM (4-trifluoromethylnicotinamide),
and TFNG, N-(4trifluoromethylnicotinoyl)glycine,
calculated as the stoichiometric
equivalent of flonicamid, in or on
several commodities as follows.
Pesticide petition 5E8428 submitted by
IR–4 Project Headquarters, Rutgers, The
State University of New Jersey, 500
College Road East, Suite 201 W.,
Princeton, NJ 08540 requests to increase
the existing tolerance on Vegetables,
fruiting, group 8–10 from 0.4 ppm to
1.50 ppm. Pesticide petitions 5F8416
and 6F8443 submitted by ISK
Biosciences Corporation, 7470 Auburn
Rd., Suite A, Concord, OH 44077
request tolerances on tea at 40 ppm and
fruit, citrus group 10–10 at 1.5 ppm,
respectively. All supporting documents
for this final rule, which bundles the
three above-referenced petitions for
purposes of this final rule, are found in
docket ID EPA–HQ–OPP–2016–0013.
Summaries of the petitions prepared
by IR4 and the registrant, ISK
Biosciences Corporation, are available
in the following dockets at https://
www.regulations.gov: PP 5E8428 in
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Docket: EPA–HQ–OPP–2016–0013; PP
5F8416 in Docket: EPA–HQ–OPP–2011–
0985; and PP 6F8443 in EPA–HQ–OPP–
2015–0561. Comments were received on
the notices of filings. EPA’s responses to
the comments are discussed in Unit
IV.C.
Based upon review of the data
supporting the petition, EPA has revised
the tolerance level for certain crops and
corrected commodity definitions to be
consistent with current EPA policies.
The reasons for these changes are
explained in Unit IV.D.
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III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for flonicamid,
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with flonicamid follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity database and considered its
validity, completeness, and reliability as
well as the relationship of the results of
the studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
Flonicamid and its metabolites of
concern, TFNA, TFNA–AM, TFNG,
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TFNG–AM, and TFNA–OH,
demonstrated low toxicity in acute oral
toxicity studies. Fonicamid showed no
systemic toxicity in a 28-day dermal
study at the limit dose.
Feeding studies in rats and dogs show
the kidney and liver are the target
organs for flonicamid toxicity. In repeatdose subchronic and chronic oral
toxicity studies, the consistently
observed adverse effect in rats and mice
were kidney toxicity (i.e., hyaline
deposition and nephritis); in dogs,
vomiting and increased percentage of
reticulocytes (an indicator for potential
anemia).
There is no evidence that flonicamid
results in increased susceptibility
(qualitative or quantitative) in utero in
rats or rabbits in the prenatal
developmental studies or in young rats
in the 2-generation reproduction study.
In the rat prenatal developmental
toxicity study, maternal toxicity
consisted of kidney toxicity (i.e.,
nephritis) in the absence of
developmental toxicity at the highestdose tested (HDT); in the rabbit,
maternal toxicity consisted of decreased
food consumption in the absence of
developmental toxicity at the HDT. In
the rat reproduction and fertility effects
study, parental toxicity (i.e., kidney
hyaline deposition and luteinizing
hormone level increases) occurred at
doses much lower than doses causing
offspring effects (i.e., decreased body
weight and delayed sexual maturation).
There are no concerns for flonicamid
neurotoxicity. In the acute neurotoxicity
study in rats, signs of toxicity such as
decreased motor activity, tremors,
impaired gait, and impaired respiration
were observed at lethal dose levels
(1000 mg/kg). In the subchronic
neurotoxicity study, decreased body
weight, food consumption, foot splay,
and motor activity were observed in
males at doses greater than 67 mg/kg/
day, and in females at 722 mg/kg/day.
In the immunotoxicity study in mice,
there were no indications of increased
immunotoxic potential in the T-cell
dependent antibody response (TDAR)
assay at the limit dose.
Mutagenicity studies were negative
for flonicamid and its metabolites of
concern. Treatment-related lung tumors
were observed in CD–1 mice. This
tumor type, however, is associated with
species and strain sensitivity and is not
directly correlated with cancer risks in
humans. Nasal cavity tumors in male
Wistar rats were linked to incisor
inflammation. Nasolacrimal duct tumor
findings for females were confounded
by the lack of a dose-response, and the
biological significance of these tumors is
questionable. The determination of
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carcinogenicity potential for flonicamid
was based on the weight of the evidence
approach and resulted in the
classification of ‘‘suggestive evidence of
carcinogenicity, but not sufficient to
assess human carcinogenic potential.’’
The Agency determined that
quantification of risk using a non-linear
approach (i.e., using a chronic reference
dose (cRfD)) adequately accounts for all
chronic toxicity, including
carcinogenicity that could result from
exposure to flonicamid.
Specific information on the studies
received and the nature of the adverse
effects caused by flonicamid as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
‘‘Subject: Flonicamid. Human Health
Risk Assessment for New Uses on
Legume Vegetables, Subgroups 6A, 6B,
and 6C; Add Directions for use on
Greenhouse Grown Peppers and
Increase the Tolerance for Residues on
Fruiting Vegetables, Group 8–10; New
Use on Citrus Fruits, Group 10–10; and
a Tolerance without U.S. Registration
for residues in/on Dried Tea’’ at page 28
in docket ID number EPA–HQ–OPP–
2016–0013.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
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www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for flonicamid used for
human risk assessment is discussed in
Unit III.B. of the final rule published in
the Federal Register of November 14,
2012 (77 FR 67771) (FRL–9368–7).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to flonicamid, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
flonicamid tolerances in 40 CFR
180.613. EPA assessed dietary
exposures from flonicamid in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1-day or single
exposure. No such effects were
identified in the toxicological studies
for flonicamid; therefore, a quantitative
acute dietary exposure assessment is
unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the Dietary Exposure
Evaluation Model—Food Commodity
Intake Database (DEEM–FCIDTM),
Version 3.16, which incorporates 2003–
2008 food consumption information
from the U.S. Department of
Agriculture’s (USDA’s) National Health
and Nutrition Examination Survey,
What We Eat in America, (NHANES/
WWEIA). As to residue levels in food,
EPA used an unrefined chronic dietary
assessment conducted assuming 100
percent crop treated (PCT) estimates,
tolerance-level residues for all
commodities, and empirical or Dietary
Exposure Evaluation Model—Food
Commodity Intake Database (DEEM–
FCIDTM) default processing factors. The
processing factor was set to 1.0 for
potato granules/flakes, tomato paste and
tomato puree; for all other processed
commodities DEEM default processing
factors were used.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that a nonlinear RfD
approach is appropriate for assessing
cancer risk to flonicamid. Cancer risk
was assessed using the same exposure
estimates as discussed in Unit III.C.1.ii.,
chronic exposure.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for flonicamid. Tolerance level residues
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and/or 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 flonicamid in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of flonicamid.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
The drinking water assessment was
conducted using both a parent only
exposure, and a total toxic residue
approach, which considers the parent
compound and its major degradates of
concern. Total toxic residues include 4trifluoromethylnicotinic acid (TFNA), 4trifluoromethylnictinamide (TFNAAM), 6-hydro-4-trifluoromethylnicotinic
acid (TFNA-OH), N-(4trifluoromethylnicotinoyl)glycine
(TFNG), and N-(4trifluoromethylnicotinoyl)glycinamide
(TFNG-AM).
Based on the Pesticide Root Zone
Model Ground Water (PRZM GW), the
estimated drinking water concentrations
(EDWCs) of flonicamid for chronic
exposures for non-cancer assessments
are estimated to be 0.94 parts per billion
(ppb) for surface water and 9.92 ppb for
ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration value of 9.92 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).
Flonicamid 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://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/
standard-operating-proceduresresidential-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
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‘‘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 flonicamid to
share a common mechanism of toxicity
with any other substances, and
flonicamid does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that flonicamid 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://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
The prenatal and postnatal toxicity
database for flonicamid includes
prenatal developmental toxicity studies
in rats and rabbits and a multigeneration
reproduction toxicity study in rats.
There is no evidence that flonicamid
results in increased susceptibility
(qualitative or quantitative) in utero in
rats or rabbits in the prenatal
developmental studies or in young rats
in the multi-generation reproduction
study. No developmental effects were
seen in rabbits. In the multi-generation
reproduction study, developmental
delays in the offspring (decreased body
weights, delayed sexual maturation)
were seen only in the presence of
parental toxicity (kidney and blood
effects). Also, there are clear NOAELs
and LOAELs for all effects. The degree
of concern for prenatal and/or post-natal
susceptibility is, therefore, low due to
the lack of evidence of qualitative and
quantitative susceptibility.
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3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X, except where
assessing risks from inhalation exposure
as discussed below. Those decisions are
based on the following findings:
i. The toxicity database for flonicamid
is essentially complete, except for an
outstanding subchronic 28-day
inhalation study. In the absence of a
subchronic inhalation study, EPA has
retained a 10X FQPA SF to assess risks
from inhalation exposure, although at
present, residential inhalation exposure
is not expected from existing or pending
uses of flonicamid.
ii. There is no evidence that
flonicamid is a neurotoxic chemical. As
discussed in Unit III.A., EPA has
concluded that the clinical signs
observed from available acute and
subchronic neurotoxicity studies were
not the result of a neurotoxic
mechanism. Therefore, there is no need
for a developmental neurotoxicity study
or additional UFs to account for
neurotoxicity.
iii. There is no evidence that
flonicamid results in increased
susceptibility in utero in 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 chronic dietary food exposure
assessment was based on 100 PCT,
tolerance-level residues and where
applicable, default processing factors.
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to flonicamid in drinking water. These
assessments will not underestimate the
exposure and risks posed by flonicamid.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
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a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, flonicamid is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to flonicamid
from food and water will utilize 59% of
the cPAD for children 1–2 years old the
population group receiving the greatest
exposure. There are no residential uses
for flonicamid.
3. Short- and intermediate-term risks.
Short- and intermediate-term aggregate
exposures take into account short- and
intermediate-term residential exposures
plus chronic exposure to food and water
(considered to be a background
exposure level). Flonicamid is not
registered for any use patterns that
would result in short- and intermediateterm residential exposures.
4. Aggregate cancer risk for U.S.
population. Based on the information
referenced in Unit III.A., EPA has
concluded that the cPAD is protective of
possible cancer effects from flonicamid,
and as evidenced in Unit III.E.2,
aggregate exposure to flonicamid is
below the cPAD.
5. 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 flonicamid
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(FMC Method No. P–3561M, a liquid
chromatography with tandem mass
spectrometry (LC/MS/MS) method) is
available to enforce the tolerance
expression for flonicamid and its
metabolites in or on plant commodities.
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
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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 flonicamid.
C. Response to Comments
1. Anonymous comments: One
comment each on petitions, 5E8428 and
5F8416, was received. Both comments
claim that flonicamid is a ‘‘toxic
pesticide’’ and residues at any level in
food commodities including tea (leaves)
should not be allowed and requested
that EPA deny setting tolerances for the
petition-for new uses of flonicamid. One
comment stated that the proposed
flonicamid use would add to about
25,000 toxic chemicals currently in the
environment and combine to create
even more toxic chemical residues in
food and drinking water further
increasing harmful effects to humans
and environment.
Agency response: The Agency
understands the commenters’ concerns
and recognizes that some individuals
believe that pesticides should be banned
completely. However, under the existing
legal framework provided by FFDCA
section 408, EPA is authorized to
establish pesticide tolerances or
exemptions where persons seeking such
tolerances or exemptions have
demonstrated that the pesticide meets
the safety standard imposed by that
statute.
When new or amended tolerances are
requested for the presence of the
residues of a pesticide and its
toxicologically significant metabolite(s)
in food or feed, the Agency, as is
required by FFDCA section 408,
estimates the risk of the potential
exposure to these residues by
performing an aggregate risk assessment.
Such a risk assessment integrates the
individual assessments that are
conducted for food, drinking water, and
residential exposures. Additionally, the
Agency, as is further required by FFDCA
Section 408, considers available
information concerning what are termed
the cumulative toxicological effects of
the residues of that pesticide and of
other substances having a common
mechanism of toxicity with it. The
Agency has concluded after this
assessment that there is a reasonable
certainty that no harm will result from
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exposure to the residues of interest.
Therefore, the proposed tolerance(s) are
found to be acceptable.
2. Comment: A comment on petition
6F8443 stressed the importance of the
Agency’s use of concise and reliable
analytical methods to identify and
quantify chemical residues of
flonicamid and various fungicides in
order to draw accurate and definitive
scientific conclusions regarding their
effects on the environment.
Agency response: An available,
accurate and concise EPA approved
analytical method is a prerequisite for
EPA pesticide registration and critical to
the Agency’s ability to identify, monitor
and enforce pesticides residues,
including metabolites and degradates of
concern, that may exist in trace amounts
in plants, animals and the environment.
Unit IV.A. of this document identifies
the specific analytical method used by
the Agency in enforcing appropriate
flonicamid use as well as how
additional information can be obtained
on the method.
pmangrum on DSK3GDR082PROD with RULES
D. Revisions to Petitioned-For
Tolerances
Although the petitioner requested that
the vegetable, fruiting group 8–10
tolerances be increased from 0.4 ppm to
1.5 ppm, data submitted did not support
an increase in tolerances for the entire
subgroup. The submitted data (which
examined residues on greenhouse
peppers only) only support an increase
for the commodities in subgroup 8–10B.
Therefore, EPA is maintaining the
existing tolerance level for crops in
subgroup 8–10A and revising the
tolerance level for crops in subgroup 8–
10B. Using the Organization for
Economic Cooperation and
Development (OECD) tolerance
calculation procedures and available
field trial data (average) residues, EPA is
establishing a tolerance for Pepper/
Eggplant subgroup 8–10B at 3.0 ppm,
instead of at 1.5 ppm as requested.
V. Conclusion
Therefore, tolerances are established
for residues of flonicamid, N(cyanomethyl)-4-(trifluoromethyl)-3pyridinecarboxamide, and its
metabolites, TFNA (4trifluoromethylinicotinic acid), TFNAAM (4-trifluoromethylnicotinamide),
and TFNG, N-(4trifluoromethylnicotinoyl)glycine,
calculated as the stoichiometric
equivalent of flonicamid, in or on Fruit,
citrus, group 10–10 at 1.5 ppm; Pepper/
Eggplant, subgroup 8–10B at 3.0 ppm;
Tea at 40 ppm; and Tomato subgroup 8–
10A at 0.4 ppm. In addition, EPA is
revoking the existing tolerance for
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Jkt 241001
Vegetable, fruiting, group 8–10 because
it is superseded by the new tolerances
for subgroups 8–10A and 8–10B.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
PO 00000
Frm 00033
Fmt 4700
Sfmt 4700
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: March 21, 2017.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.613:
i. Remove ‘‘Vegetable, fruiting, group
8–10’’ from the table in paragraph (a).
■ ii. Add alphabetically the following
commodities to the table in paragraph
(a): ‘‘Fruit, citrus, group 10–10’’;
‘‘Pepper/Eggplant, subgroup 8–10B’’;
and ‘‘Tomato subgroup 8–10A’’.
■ iii. Add ‘‘Tea’’ to the table in
paragraph (a) and add footnote 1.
The additions to the table in
paragraph (a) read as follows:
■
■
§ 180.613 Flonicamid; tolerances for
residues.
(a) * * *
Commodity
*
*
*
*
Fruit, citrus, group 10–10 ...........
E:\FR\FM\11MYR1.SGM
11MYR1
Parts per
million
*
1.5
21946
Federal Register / Vol. 82, No. 90 / Thursday, May 11, 2017 / Rules and Regulations
*
*
*
*
Pepper/Eggplant, subgroup 8–
10B ..........................................
*
*
*
*
Tea1 ............................................
*
*
*
*
Tomato subgroup 8–10A ............
*
*
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
*
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
3.0
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
*
Parts per
million
Commodity
*
*
40
*
0.4
*
1 There are no U.S. registrations for tea as
of May 11, 2017.
*
*
*
*
*
[FR Doc. 2017–09592 Filed 5–10–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0160; FRL–9960–50]
Fluazinam; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
pmangrum on DSK3GDR082PROD with RULES
VerDate Sep<11>2014
14:36 May 10, 2017
Jkt 241001
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?
This regulation establishes a
tolerance for residues of fluazinam in or
on tea, dried. ISK Biosciences
Corporation requested this tolerance
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective May
11, 2017. Objections and requests for
hearings must be received on or before
July 10, 2017, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0160, 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 Divison
SUMMARY:
I. General Information
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2016–0160 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 July 10, 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
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2016–0160, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of May 19,
2016 (81 FR 31583) (FRL–9946–02),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 6E8449) by ISK
Biosciences Corporation, 7470 Auburn
RD, Suite A, Concord, OH 44077. The
petition requested that 40 CFR 180.574
be amended by establishing tolerances
for residues of the fungicide fluazinam,
in or on dried tea at 5.0 parts per
million (ppm). That document
referenced a summary of the petition
prepared by ISK Biosciences
Corporation, the registrant, which is
available in the docket, https://
www.regulations.gov. One comment was
received on the notice of filing. EPA’s
response to these comments is
discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA has revised
the proposed tolerance from 5.0 ppm to
6.0 ppm. The reason for these changes
are explained in Unit IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
E:\FR\FM\11MYR1.SGM
11MYR1
Agencies
[Federal Register Volume 82, Number 90 (Thursday, May 11, 2017)]
[Rules and Regulations]
[Pages 21941-21946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09592]
[[Page 21941]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0013; FRL-9959-91]
Flonicamid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
flonicamid in or on multiple commodities which are identified and
discussed later in this document. In addition, this regulation revokes
the established tolerance for vegetable, fruiting, group 8-10 that is
superseded by this action. Interregional Research Project Number 4 (IR-
4) and ISK Biosciences Corporation requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 11, 2017. Objections and
requests for hearings must be received on or before July 10, 2017, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0013, 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, Director,
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 EPA's
tolerance regulations at 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.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0013 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
July 10, 2017. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0013, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of May 19, 2016 (81 FR 31581) (FRL-9946-
02); August 12, 2016 (81 FR 53379) (FRL-9949-53) and December 9, 2016
(81 FR 89036) (FRL-9953-69), EPA issued documents pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of
pesticide petitions (PPs) by IR-4 (PP 5E8428); and ISK Biosciences (PP
5F8416 and 6F8443), respectively. These petitions request that 40 CFR
180.613 be amended by establishing tolerances for residues of the
insecticide flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-
pyridinecarboxamide, and its metabolites, TFNA (4-
trifluoromethylinicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric
equivalent of flonicamid, in or on several commodities as follows.
Pesticide petition 5E8428 submitted by IR-4 Project Headquarters,
Rutgers, The State University of New Jersey, 500 College Road East,
Suite 201 W., Princeton, NJ 08540 requests to increase the existing
tolerance on Vegetables, fruiting, group 8-10 from 0.4 ppm to 1.50 ppm.
Pesticide petitions 5F8416 and 6F8443 submitted by ISK Biosciences
Corporation, 7470 Auburn Rd., Suite A, Concord, OH 44077 request
tolerances on tea at 40 ppm and fruit, citrus group 10-10 at 1.5 ppm,
respectively. All supporting documents for this final rule, which
bundles the three above-referenced petitions for purposes of this final
rule, are found in docket ID EPA-HQ-OPP-2016-0013.
Summaries of the petitions prepared by IR4 and the registrant, ISK
Biosciences Corporation, are available in the following dockets at
https://www.regulations.gov: PP 5E8428 in
[[Page 21942]]
Docket: EPA-HQ-OPP-2016-0013; PP 5F8416 in Docket: EPA-HQ-OPP-2011-
0985; and PP 6F8443 in EPA-HQ-OPP-2015-0561. Comments were received on
the notices of filings. EPA's responses to the comments are discussed
in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
revised the tolerance level for certain crops and corrected commodity
definitions to be consistent with current EPA policies. The reasons for
these changes are explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for flonicamid, including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with flonicamid follows.
A. Toxicological Profile
EPA has evaluated the available toxicity database and considered
its validity, completeness, and reliability as well as the relationship
of the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Flonicamid and its metabolites of concern, TFNA, TFNA-AM, TFNG,
TFNG-AM, and TFNA-OH, demonstrated low toxicity in acute oral toxicity
studies. Fonicamid showed no systemic toxicity in a 28-day dermal study
at the limit dose.
Feeding studies in rats and dogs show the kidney and liver are the
target organs for flonicamid toxicity. In repeat-dose subchronic and
chronic oral toxicity studies, the consistently observed adverse effect
in rats and mice were kidney toxicity (i.e., hyaline deposition and
nephritis); in dogs, vomiting and increased percentage of reticulocytes
(an indicator for potential anemia).
There is no evidence that flonicamid results in increased
susceptibility (qualitative or quantitative) in utero in rats or
rabbits in the prenatal developmental studies or in young rats in the
2-generation reproduction study. In the rat prenatal developmental
toxicity study, maternal toxicity consisted of kidney toxicity (i.e.,
nephritis) in the absence of developmental toxicity at the highest-dose
tested (HDT); in the rabbit, maternal toxicity consisted of decreased
food consumption in the absence of developmental toxicity at the HDT.
In the rat reproduction and fertility effects study, parental toxicity
(i.e., kidney hyaline deposition and luteinizing hormone level
increases) occurred at doses much lower than doses causing offspring
effects (i.e., decreased body weight and delayed sexual maturation).
There are no concerns for flonicamid neurotoxicity. In the acute
neurotoxicity study in rats, signs of toxicity such as decreased motor
activity, tremors, impaired gait, and impaired respiration were
observed at lethal dose levels (1000 mg/kg). In the subchronic
neurotoxicity study, decreased body weight, food consumption, foot
splay, and motor activity were observed in males at doses greater than
67 mg/kg/day, and in females at 722 mg/kg/day. In the immunotoxicity
study in mice, there were no indications of increased immunotoxic
potential in the T-cell dependent antibody response (TDAR) assay at the
limit dose.
Mutagenicity studies were negative for flonicamid and its
metabolites of concern. Treatment-related lung tumors were observed in
CD-1 mice. This tumor type, however, is associated with species and
strain sensitivity and is not directly correlated with cancer risks in
humans. Nasal cavity tumors in male Wistar rats were linked to incisor
inflammation. Nasolacrimal duct tumor findings for females were
confounded by the lack of a dose-response, and the biological
significance of these tumors is questionable. The determination of
carcinogenicity potential for flonicamid was based on the weight of the
evidence approach and resulted in the classification of ``suggestive
evidence of carcinogenicity, but not sufficient to assess human
carcinogenic potential.'' The Agency determined that quantification of
risk using a non-linear approach (i.e., using a chronic reference dose
(cRfD)) adequately accounts for all chronic toxicity, including
carcinogenicity that could result from exposure to flonicamid.
Specific information on the studies received and the nature of the
adverse effects caused by flonicamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Subject: Flonicamid. Human Health
Risk Assessment for New Uses on Legume Vegetables, Subgroups 6A, 6B,
and 6C; Add Directions for use on Greenhouse Grown Peppers and Increase
the Tolerance for Residues on Fruiting Vegetables, Group 8-10; New Use
on Citrus Fruits, Group 10-10; and a Tolerance without U.S.
Registration for residues in/on Dried Tea'' at page 28 in docket ID
number EPA-HQ-OPP-2016-0013.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://
[[Page 21943]]
www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-
human-health-risk-pesticides.
A summary of the toxicological endpoints for flonicamid used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of November 14, 2012 (77 FR 67771)
(FRL-9368-7).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flonicamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing flonicamid tolerances in 40 CFR
180.613. EPA assessed dietary exposures from flonicamid in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for flonicamid; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model--Food
Commodity Intake Database (DEEM-FCIDTM), Version 3.16, which
incorporates 2003-2008 food consumption information from the U.S.
Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, EPA used an unrefined chronic dietary
assessment conducted assuming 100 percent crop treated (PCT) estimates,
tolerance-level residues for all commodities, and empirical or Dietary
Exposure Evaluation Model--Food Commodity Intake Database (DEEM-
FCID\TM\) default processing factors. The processing factor was set to
1.0 for potato granules/flakes, tomato paste and tomato puree; for all
other processed commodities DEEM default processing factors were used.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to flonicamid. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for flonicamid. Tolerance level residues and/or 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 flonicamid in
drinking water. These simulation models take into account data on the
physical, chemical, and fate/transport characteristics of flonicamid.
Further information regarding EPA drinking water models used in
pesticide exposure assessment can be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
The drinking water assessment was conducted using both a parent
only exposure, and a total toxic residue approach, which considers the
parent compound and its major degradates of concern. Total toxic
residues include 4-trifluoromethylnicotinic acid (TFNA), 4-
trifluoromethylnictinamide (TFNA-AM), 6-hydro-4-
trifluoromethylnicotinic acid (TFNA-OH), N-(4-
trifluoromethylnicotinoyl)glycine (TFNG), and N-(4-
trifluoromethylnicotinoyl)glycinamide (TFNG-AM).
Based on the Pesticide Root Zone Model Ground Water (PRZM GW), the
estimated drinking water concentrations (EDWCs) of flonicamid for
chronic exposures for non-cancer assessments are estimated to be 0.94
parts per billion (ppb) for surface water and 9.92 ppb for ground
water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 9.92 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). Flonicamid 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found flonicamid to share a common mechanism of
toxicity with any other substances, and flonicamid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flonicamid 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for flonicamid includes prenatal developmental
toxicity studies in rats and rabbits and a multigeneration reproduction
toxicity study in rats. There is no evidence that flonicamid results in
increased susceptibility (qualitative or quantitative) in utero in rats
or rabbits in the prenatal developmental studies or in young rats in
the multi-generation reproduction study. No developmental effects were
seen in rabbits. In the multi-generation reproduction study,
developmental delays in the offspring (decreased body weights, delayed
sexual maturation) were seen only in the presence of parental toxicity
(kidney and blood effects). Also, there are clear NOAELs and LOAELs for
all effects. The degree of concern for prenatal and/or post-natal
susceptibility is, therefore, low due to the lack of evidence of
qualitative and quantitative susceptibility.
[[Page 21944]]
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X, except where assessing risks from
inhalation exposure as discussed below. Those decisions are based on
the following findings:
i. The toxicity database for flonicamid is essentially complete,
except for an outstanding subchronic 28-day inhalation study. In the
absence of a subchronic inhalation study, EPA has retained a 10X FQPA
SF to assess risks from inhalation exposure, although at present,
residential inhalation exposure is not expected from existing or
pending uses of flonicamid.
ii. There is no evidence that flonicamid is a neurotoxic chemical.
As discussed in Unit III.A., EPA has concluded that the clinical signs
observed from available acute and subchronic neurotoxicity studies were
not the result of a neurotoxic mechanism. Therefore, there is no need
for a developmental neurotoxicity study or additional UFs to account
for neurotoxicity.
iii. There is no evidence that flonicamid results in increased
susceptibility in utero in 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 chronic dietary food exposure assessment was based on
100 PCT, tolerance-level residues and where applicable, default
processing factors. EPA made conservative (protective) assumptions in
the ground and surface water modeling used to assess exposure to
flonicamid in drinking water. These assessments will not underestimate
the exposure and risks posed by flonicamid.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
flonicamid is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flonicamid from food and water will utilize 59% of the cPAD for
children 1-2 years old the population group receiving the greatest
exposure. There are no residential uses for flonicamid.
3. Short- and intermediate-term risks. Short- and intermediate-term
aggregate exposures take into account short- and intermediate-term
residential exposures plus chronic exposure to food and water
(considered to be a background exposure level). Flonicamid is not
registered for any use patterns that would result in short- and
intermediate-term residential exposures.
4. Aggregate cancer risk for U.S. population. Based on the
information referenced in Unit III.A., EPA has concluded that the cPAD
is protective of possible cancer effects from flonicamid, and as
evidenced in Unit III.E.2, aggregate exposure to flonicamid is below
the cPAD.
5. 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 flonicamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (FMC Method No. P-3561M, a liquid
chromatography with tandem mass spectrometry (LC/MS/MS) method) is
available to enforce the tolerance expression for flonicamid and its
metabolites in or on plant commodities.
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 flonicamid.
C. Response to Comments
1. Anonymous comments: One comment each on petitions, 5E8428 and
5F8416, was received. Both comments claim that flonicamid is a ``toxic
pesticide'' and residues at any level in food commodities including tea
(leaves) should not be allowed and requested that EPA deny setting
tolerances for the petition-for new uses of flonicamid. One comment
stated that the proposed flonicamid use would add to about 25,000 toxic
chemicals currently in the environment and combine to create even more
toxic chemical residues in food and drinking water further increasing
harmful effects to humans and environment.
Agency response: The Agency understands the commenters' concerns
and recognizes that some individuals believe that pesticides should be
banned completely. However, under the existing legal framework provided
by FFDCA section 408, EPA is authorized to establish pesticide
tolerances or exemptions where persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by that statute.
When new or amended tolerances are requested for the presence of
the residues of a pesticide and its toxicologically significant
metabolite(s) in food or feed, the Agency, as is required by FFDCA
section 408, estimates the risk of the potential exposure to these
residues by performing an aggregate risk assessment. Such a risk
assessment integrates the individual assessments that are conducted for
food, drinking water, and residential exposures. Additionally, the
Agency, as is further required by FFDCA Section 408, considers
available information concerning what are termed the cumulative
toxicological effects of the residues of that pesticide and of other
substances having a common mechanism of toxicity with it. The Agency
has concluded after this assessment that there is a reasonable
certainty that no harm will result from
[[Page 21945]]
exposure to the residues of interest. Therefore, the proposed
tolerance(s) are found to be acceptable.
2. Comment: A comment on petition 6F8443 stressed the importance of
the Agency's use of concise and reliable analytical methods to identify
and quantify chemical residues of flonicamid and various fungicides in
order to draw accurate and definitive scientific conclusions regarding
their effects on the environment.
Agency response: An available, accurate and concise EPA approved
analytical method is a prerequisite for EPA pesticide registration and
critical to the Agency's ability to identify, monitor and enforce
pesticides residues, including metabolites and degradates of concern,
that may exist in trace amounts in plants, animals and the environment.
Unit IV.A. of this document identifies the specific analytical method
used by the Agency in enforcing appropriate flonicamid use as well as
how additional information can be obtained on the method.
D. Revisions to Petitioned-For Tolerances
Although the petitioner requested that the vegetable, fruiting
group 8-10 tolerances be increased from 0.4 ppm to 1.5 ppm, data
submitted did not support an increase in tolerances for the entire
subgroup. The submitted data (which examined residues on greenhouse
peppers only) only support an increase for the commodities in subgroup
8-10B. Therefore, EPA is maintaining the existing tolerance level for
crops in subgroup 8-10A and revising the tolerance level for crops in
subgroup 8-10B. Using the Organization for Economic Cooperation and
Development (OECD) tolerance calculation procedures and available field
trial data (average) residues, EPA is establishing a tolerance for
Pepper/Eggplant subgroup 8-10B at 3.0 ppm, instead of at 1.5 ppm as
requested.
V. Conclusion
Therefore, tolerances are established for residues of flonicamid,
N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, and its
metabolites, TFNA (4-trifluoromethylinicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric
equivalent of flonicamid, in or on Fruit, citrus, group 10-10 at 1.5
ppm; Pepper/Eggplant, subgroup 8-10B at 3.0 ppm; Tea at 40 ppm; and
Tomato subgroup 8-10A at 0.4 ppm. In addition, EPA is revoking the
existing tolerance for Vegetable, fruiting, group 8-10 because it is
superseded by the new tolerances for subgroups 8-10A and 8-10B.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 21, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.613:
0
i. Remove ``Vegetable, fruiting, group 8-10'' from the table in
paragraph (a).
0
ii. Add alphabetically the following commodities to the table in
paragraph (a): ``Fruit, citrus, group 10-10''; ``Pepper/Eggplant,
subgroup 8-10B''; and ``Tomato subgroup 8-10A''.
0
iii. Add ``Tea'' to the table in paragraph (a) and add footnote 1.
The additions to the table in paragraph (a) read as follows:
Sec. 180.613 Flonicamid; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Fruit, citrus, group 10-10.................................. 1.5
[[Page 21946]]
* * * * *
Pepper/Eggplant, subgroup 8-10B............................. 3.0
* * * * *
Tea\1\..................................................... 40
* * * * *
Tomato subgroup 8-10A....................................... 0.4
* * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for tea as of May 11, 2017.
* * * * *
[FR Doc. 2017-09592 Filed 5-10-17; 8:45 am]
BILLING CODE 6560-50-P