Flonicamid; Pesticide Tolerances, 52348-52352 [2016-18666]
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Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 63
[EPA–HQ–OAR–2013–0696; FRL–9950–26–
OAR]
RIN 2060–AS86
Technical Amendments to
Performance Specification 18 and
Procedure 6
Environmental Protection
Agency (EPA).
ACTION: Partial withdrawal of direct
final rule.
AGENCY:
Because the Environmental
Protection Agency (EPA) received
adverse comment, we are withdrawing a
portion of the May 19, 2016, direct final
rule that made several minor technical
amendments to the performance
specifications and test procedures for
hydrogen chloride (HCl) continuous
emission monitoring systems (CEMS).
The adverse comments related to
revisions to Procedure 6 and thus the
EPA is withdrawing the portion of the
direct final rule that revised Procedure
6.
DATES: Effective August 8, 2016, the
EPA withdraws the revisions to
Procedure 6, sections 4.1.5, 4.1.5.1,
4.1.5.3, and 5.2.4.2, published at 81 FR
31515, on May 19, 2016.
FOR FURTHER INFORMATION CONTACT: Ms.
Candace Sorrell, U.S. EPA, Office of Air
Quality Planning and Standards, Air
Quality Assessment Division,
Measurement Technology Group (Mail
Code: E143–02), Research Triangle Park,
NC 27711; telephone number: (919)
541–1064; fax number: (919) 541–0516;
email address: sorrell.candace@epa.gov.
SUPPLEMENTARY INFORMATION: On May
19, 2016, the EPA published a direct
final rule that makes minor technical
amendments to the performance
specifications and test procedures for
hydrogen chloride (HCl) continuous
emission monitoring systems (CEMS).
81 FR 31515. In the direct final rule, the
EPA stated that if we received adverse
comment by July 5, 2016, the EPA
would publish a timely withdrawal and
address the comments in a subsequent
final rule based on the proposed rule
also published on May 19, 2016 (81 FR
31577). The May 19, 2016, direct final
rule noted that if the EPA received
adverse comment on an amendment,
paragraph, or section of this rule and, if
that provision may be severed from the
remainder of the rule, the EPA may
adopt as final those provisions of the
rule that are not the subject of an
adverse comment.
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SUMMARY:
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In this instance, the EPA received an
adverse comment on an amendment to
the quality assurance provision in
Procedure 6, related to above span
requirements. 81 FR 31517. The
portions of the direct final rule revising
Performance Standard 18 are severable
from the revisions to Procedure 6. Thus,
the EPA is only withdrawing the
revisions to Procedure 6. The EPA will
address the comment in a subsequent
final action, which will be based on the
parallel proposed rule also published on
May 19, 2016 (81 FR 31515). As stated
in the parallel proposal, we will not
institute a second comment period on
this proposed action. The revisions to
Performance Standard 18 in the May 19,
2016, direct final rule are not affected
and will become effective on August 17,
2016, as provided in the direct final
rule.
List of Subjects in 40 CFR Part 60
Environmental protection,
Administrative practice and procedure,
Air pollution control, Continuous
emission monitoring systems, Hydrogen
chloride, Performance specifications,
Test methods and procedures.
Dated: July 28, 2016.
Janet G. McCabe,
Acting Assistant Administrator.
[FR Doc. 2016–18682 Filed 8–5–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0561; FRL–9949–19]
Flonicamid; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of flonicamid in
or on hops, tree nuts (crop group 14–12
except pistachio), and pistachio. ISK
Biosciences Corporation requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
August 8, 2016. Objections and requests
for hearings must be received on or
before October 7, 2016, and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
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The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0561, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan T. Lewis, 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:
ADDRESSES:
I. General Information
Accordingly, amendatory instruction
3 in the direct final rule published in
the Federal Register on May 19, 2016,
at 81 FR 31520, is withdrawn as of
August 8, 2016.
SUMMARY:
Unit I.C. of the SUPPLEMENTARY
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/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
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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–2015–0561 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before October 7, 2016. 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–
2015–0561, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of October 21,
2015 (80 FR 63731) (FRL–9935–29),
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 5F8369) by ISK
Biosciences Corporation, 7470 Auburn
Road, Suite A, Concord, Ohio 44077.
The petition requested that 40 CFR
180.613 be amended by establishing
tolerances for residues of the insecticide
flonicamid, [(N-(cyanomethyl)-4trifluoromethyl)-3pyridinecarboxamide) or (Ncyanomethyl-4-
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trifluoromethylnicotinamide (IUPAC))],
in or on hops at 20 parts per million
(ppm), tree nuts (crop group 14–12)
except pistachio at 0.15 parts per
million (ppm), pistachio at 0.60 parts
per million (ppm). That document
referenced a summary of the petition
prepared by ISK Bioscience
Corporation, the registrant, which is
available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
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 data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by flonicamid as well as the no-
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observed-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
are discussed in the final rule published
in the Federal Register of November 14,
2012 (77 FR 67771) (FRL–9368–7).
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 the NOAEL and the
LOAEL are identified. 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/pesticides/factsheets/
riskassess.htm.
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.
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
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acute dietary exposure assessment is
unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA’s National Health and
Nutrition Examination Survey, What We
Eat in America, (NHANES/WWEIA). As
to residue levels in food, the chronic
dietary exposure assessment was a
conservative assessment conducted
using tolerance-level residues,
conservative ground water/drinking
water estimates, and 100 percent crop
treated (PCT).
iii. Cancer. Based on the data
referenced in Unit III.A., EPA has
concluded that flonicamid does not
pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue and/or PCT
information in the dietary assessment
for flonicamid. Tolerance level residues
and/or 100 PCT were assumed for all
food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for 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://www.epa.gov/oppefed1/models/
water/index.htm.
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 (TFNA–
AM), 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 of value 9.92 ppb
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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.
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://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act Safety
Factor (FQPA 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 of
increased susceptibility (qualitative or
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quantitative) in rats or rabbits exposed
to flonicamid in utero 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 postnatal
susceptibility is, therefore, low due to
the lack of evidence of qualitative and
quantitative susceptibility.
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 as noted
below. That decision is based on the
following findings:
i. The toxicity database for flonicamid
is nearly complete. The database is
missing a subchronic inhalation study.
A subchronic inhalation study is
required because the use of an oral POD
results in MOEs which do not meet the
target MOE for a waiver (MOE=1,000).
The Agency notified the registrant of the
Data Call-In (DCI) for the 28-day
inhalation study on January 5, 2016 and
is awaiting submission of the study. In
the absence of a subchronic inhalation
study, EPA has retained a 10X FQPA SF
to assess risks for inhalation exposure
scenarios. However, residential
inhalation exposures are not expected.
ii. The available data base for
flonicamid includes acute and
subchronic neurotoxicity studies. As
discussed in Unit III.A., EPA has
concluded that the clinical signs
observed in those studies were not the
result of a neurotoxic mechanism and
therefore a developmental neurotoxicity
study is not required.
iii. There is no evidence that
flonicamid results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2-generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The chronic dietary food exposure
assessment was based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to flonicamid in
drinking water. These assessments will
not underestimate the exposure and
risks posed by flonicamid.
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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 30% of
the cPAD for children 1–2 years old, the
population group receiving the greatest
exposure. There are no residential uses
for flonicamid. Based on the
explanation in Unit III.C.3., regarding
residential use patterns, chronic
residential exposure to residues of
flonicamid is not expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). A short-term adverse
effect was identified; however,
flonicamid is not registered for any use
patterns that would result in short-term
residential exposure. Short-term risk is
assessed based on short-term residential
exposure plus chronic dietary 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
flonicamid.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level). An
intermediate-term adverse effect was
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identified; however, flonicamid is not
registered for any use patterns that
would result in intermediate-term
residential exposure. Intermediate-term
risk is assessed based on intermediateterm residential exposure plus chronic
dietary exposure. Because there is no
intermediate-term residential exposure
and chronic dietary exposure has
already been assessed under the
appropriately protective cPAD (which is
at least as protective as the POD used to
assess intermediate-term risk), no
further assessment of intermediate-term
risk is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating intermediate-term risk for
flonicamid.
5. 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.
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 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
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52351
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 proposed an MRL
for flonicamid in or on pistachio. The
Codex has established an MRL for
flonicamid in or on hops at 20.0 ppm.
These MRLs are the same as the
tolerances established for flonicamid in
the United States. The Codex has also
established MRLs for flonicamid in or
on almond and pecan at 0.01 ppm.
These MRLs are different than the
tolerances established for flonicamid in
the United States. The U.S. cannot
harmonize the Nut, tree, group 14–12,
except pistachio tolerance with the
Codex MRLs on pecan and almond
because residue field trial data show
residues well above 0.01 ppm.
C. Revisions to Petitioned-For
Tolerances
The Agency is removing certain
commodities from the table at § 180.613
(a) to eliminate redundancies upon the
establishment of new crop group
tolerances that were not identified in
the petition: Cucumber at 1.5 ppm and
okra at 0.40 ppm.
V. Conclusion
Therefore, tolerances are established
for residues of flonicamid, [(N(cyanomethyl)-4-trifluoromethyl)-3pyridinecarboxamide) or (Ncyanomethyl-4trifluoromethylnicotinamide (IUPAC))],
in or on hops at 20.0 ppm, tree nuts
(crop group 14–12) except pistachio at
0.15 ppm, and pistachio at 0.60 ppm.
Also, as a housekeeping measure, the
Agency is removing three individual
tolerances that are subsumed within
other crop group tolerances contained in
§ 180.613: Cucumber at 1.5 ppm is
superseded by inclusion in the
established vegetable, cucurbit, group 9
tolerance at 1.5 ppm; and okra at 0.40
ppm is superseded by inclusion in the
established vegetable, fruiting, group 8–
10 tolerance at 0.40 ppm.
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
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52352
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations
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).
VerDate Sep<11>2014
13:12 Aug 05, 2016
Jkt 238001
VII. Congressional Review Act
DEPARTMENT OF THE INTERIOR
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).
Office of the Secretary of the Interior
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: July 26, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.613, amend the table in
paragraph (a)(1) as follows:
■ a. Remove the commodities
‘‘Cucumber’’ and ‘‘Okra’’.
■ b. Revise the commodities ‘‘Hop,
dried cones’’ and ‘‘Nut, Tree, group 14–
12’’.
■ c. Add alphabetically the commodity
‘‘Pistachio’’.
The revisions and addition read as
follows:
■
43 CFR Part 10
[NPS–WASO–NAGPRA–21514;
PX.XVPAD0522.0.1]
RIN 1024–AE34
Civil Penalties Inflation Adjustments;
Correction
AGENCY:
ACTION:
Office of the Secretary, Interior.
Interim final rule; correction.
The Office of the Secretary of
the Interior is correcting an interim final
rule that appeared in the Federal
Register on Tuesday June 28, 2016 (81
FR 41858). This rule adjusts the level of
civil monetary penalties contained in
U.S. Department of the Interior
regulations implementing the Native
American Graves Protection and
Repatriation Act with an initial ‘‘catchup’’ adjustment under the Federal Civil
Penalties Inflation Adjustment Act
Improvements Act of 2015 and Office of
Management and Budget guidance. The
corrections are administrative and
procedural related to submitting
comments.
SUMMARY:
This correction is effective
August 8, 2016.
DATES:
A.J.
North, National Park Service, 1849 C
Street NW., Washington, DC 20240,
telephone: 202–513–7742.
FOR FURTHER INFORMATION CONTACT:
In volume
81, number 124 of the Federal Register
of Tuesday June 28, 2016 on page
41858, the following corrections are
§ 180.613 Flonicamid; tolerances for
residues.
made:
1. On page 41858 the RIN in the
(a) * * *
heading is corrected to read as follows:
(1) * * *
1024–AE34
2. On page 41858, in the second
Parts per
Commodity
million
column, the text following
• Federal eRulemaking Portal: https://
www.regulations.gov. is corrected to
*
*
*
*
*
read: Search for the Docket Number
Hop, dried cones ..................
20.0
DOI–2016–0004 or RIN 1024–AE34 and
Nut, Tree, group 14–12 except pistachio ....................
0.15 follow the instructions for submitting
comments.
*
*
*
*
*
*
*
*
*
*
Pistachio ...............................
*
*
*
*
*
*
*
0.60
*
*
*
SUPPLEMENTARY INFORMATION:
Dated: July 25, 2016.
Michael J. Bean,
Principal Deputy Assistant Secretary for Fish
and Wildlife and Parks.
[FR Doc. 2016–18666 Filed 8–5–16; 8:45 am]
[FR Doc. 2016–18643 Filed 8–5–16; 8:45 am]
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Agencies
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Rules and Regulations]
[Pages 52348-52352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18666]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0561; FRL-9949-19]
Flonicamid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
flonicamid in or on hops, tree nuts (crop group 14-12 except
pistachio), and pistachio. ISK Biosciences Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 8, 2016. Objections and
requests for hearings must be received on or before October 7, 2016,
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-2015-0561, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan T. Lewis, 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
[[Page 52349]]
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-2015-0561 in the
subject line on the first page of your submission. All objections and
requests for a hearing must be in writing, and must be received by the
Hearing Clerk on or before October 7, 2016. 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-2015-0561, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of October 21, 2015 (80 FR 63731) (FRL-
9935-29), 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
5F8369) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A,
Concord, Ohio 44077. The petition requested that 40 CFR 180.613 be
amended by establishing tolerances for residues of the insecticide
flonicamid, [(N-(cyanomethyl)-4-trifluoromethyl)-3-pyridinecarboxamide)
or (N-cyanomethyl-4-trifluoromethylnicotinamide (IUPAC))], in or on
hops at 20 parts per million (ppm), tree nuts (crop group 14-12) except
pistachio at 0.15 parts per million (ppm), pistachio at 0.60 parts per
million (ppm). That document referenced a summary of the petition
prepared by ISK Bioscience Corporation, the registrant, which is
available in the docket, https://www.regulations.gov. There were no
comments received in response to the notice of filing.
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 data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. 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 are discussed in the final rule
published in the Federal Register of November 14, 2012 (77 FR 67771)
(FRL-9368-7).
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 the NOAEL and the LOAEL are identified.
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/pesticides/factsheets/riskassess.htm.
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.
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
[[Page 52350]]
acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's National
Health and Nutrition Examination Survey, What We Eat in America,
(NHANES/WWEIA). As to residue levels in food, the chronic dietary
exposure assessment was a conservative assessment conducted using
tolerance-level residues, conservative ground water/drinking water
estimates, and 100 percent crop treated (PCT).
iii. Cancer. Based on the data referenced in Unit III.A., EPA has
concluded that flonicamid does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for flonicamid. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for 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://www.epa.gov/oppefed1/models/water/index.htm.
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 of value 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.
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://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA 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 multi-generation
reproduction toxicity study in rats. There is no evidence of increased
susceptibility (qualitative or quantitative) in rats or rabbits exposed
to flonicamid in utero 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
postnatal susceptibility is, therefore, low due to the lack of evidence
of qualitative and quantitative susceptibility.
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 as noted below. That decision is
based on the following findings:
i. The toxicity database for flonicamid is nearly complete. The
database is missing a subchronic inhalation study. A subchronic
inhalation study is required because the use of an oral POD results in
MOEs which do not meet the target MOE for a waiver (MOE=1,000). The
Agency notified the registrant of the Data Call-In (DCI) for the 28-day
inhalation study on January 5, 2016 and is awaiting submission of the
study. In the absence of a subchronic inhalation study, EPA has
retained a 10X FQPA SF to assess risks for inhalation exposure
scenarios. However, residential inhalation exposures are not expected.
ii. The available data base for flonicamid includes acute and
subchronic neurotoxicity studies. As discussed in Unit III.A., EPA has
concluded that the clinical signs observed in those studies were not
the result of a neurotoxic mechanism and therefore a developmental
neurotoxicity study is not required.
iii. There is no evidence that flonicamid results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary food exposure assessment was based on
100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to flonicamid in drinking water. These assessments
will not underestimate the exposure and risks posed by flonicamid.
[[Page 52351]]
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 30% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for flonicamid. Based on the
explanation in Unit III.C.3., regarding residential use patterns,
chronic residential exposure to residues of flonicamid is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). A short-term
adverse effect was identified; however, flonicamid is not registered
for any use patterns that would result in short-term residential
exposure. Short-term risk is assessed based on short-term residential
exposure plus chronic dietary 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
flonicamid.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
flonicamid is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
flonicamid.
5. 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.
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 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 proposed an MRL for flonicamid in or on
pistachio. The Codex has established an MRL for flonicamid in or on
hops at 20.0 ppm. These MRLs are the same as the tolerances established
for flonicamid in the United States. The Codex has also established
MRLs for flonicamid in or on almond and pecan at 0.01 ppm. These MRLs
are different than the tolerances established for flonicamid in the
United States. The U.S. cannot harmonize the Nut, tree, group 14-12,
except pistachio tolerance with the Codex MRLs on pecan and almond
because residue field trial data show residues well above 0.01 ppm.
C. Revisions to Petitioned-For Tolerances
The Agency is removing certain commodities from the table at Sec.
180.613 (a) to eliminate redundancies upon the establishment of new
crop group tolerances that were not identified in the petition:
Cucumber at 1.5 ppm and okra at 0.40 ppm.
V. Conclusion
Therefore, tolerances are established for residues of flonicamid,
[(N-(cyanomethyl)-4-trifluoromethyl)-3-pyridinecarboxamide) or (N-
cyanomethyl-4-trifluoromethylnicotinamide (IUPAC))], in or on hops at
20.0 ppm, tree nuts (crop group 14-12) except pistachio at 0.15 ppm,
and pistachio at 0.60 ppm.
Also, as a housekeeping measure, the Agency is removing three
individual tolerances that are subsumed within other crop group
tolerances contained in Sec. 180.613: Cucumber at 1.5 ppm is
superseded by inclusion in the established vegetable, cucurbit, group 9
tolerance at 1.5 ppm; and okra at 0.40 ppm is superseded by inclusion
in the established vegetable, fruiting, group 8-10 tolerance at 0.40
ppm.
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
[[Page 52352]]
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: July 26, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.613, amend the table in paragraph (a)(1) as follows:
0
a. Remove the commodities ``Cucumber'' and ``Okra''.
0
b. Revise the commodities ``Hop, dried cones'' and ``Nut, Tree, group
14-12''.
0
c. Add alphabetically the commodity ``Pistachio''.
The revisions and addition read as follows:
Sec. 180.613 Flonicamid; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Hop, dried cones........................................ 20.0
Nut, Tree, group 14-12 except pistachio................. 0.15
* * * * *
Pistachio............................................... 0.60
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2016-18666 Filed 8-5-16; 8:45 am]
BILLING CODE 6560-50-P