Acetamiprid; Pesticide Tolerances for Emergency Exemption, 17146-17151 [2017-07131]
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Federal Register / Vol. 82, No. 67 / Monday, April 10, 2017 / Rules and Regulations
TABLE 1—EPA APPROVED NORTH CAROLINA REGULATIONS
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Subchapter 2D
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BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0005; FRL–9959–90]
Acetamiprid; Pesticide Tolerances for
Emergency Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
time-limited tolerances for residues of
acetamiprid in or on sugarcane, cane
and sugarcane, molasses. This action is
associated with the issuance of a crisis
exemption under the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizing use of the
pesticide on sugarcane. This regulation
establishes maximum permissible levels
for residues of acetamiprid in or on
sugarcane, cane and sugarcane,
molasses. The time-limited tolerances
expire on December 31, 2019.
DATES: This regulation is effective April
10, 2017. Objections and requests for
hearings must be received on or before
June 9, 2017, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2017–0005, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
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SUMMARY:
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I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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Paragraph (a)(3) of Section
.1002 is hereby rescinded as
this paragraph is inconsistent
with the limits on the waiver of
sovereign immunity established in section 118(a) of the
CAA.
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in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael L. Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under section 408(g) of the Federal
Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2017–0005 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 June 9, 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–
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2017–0005, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/where-sendcomments-epa-dockets.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Background and Statutory Findings
EPA, on its own initiative, in
accordance with FFDCA sections 408(e)
and 408(l)(6) of, 21 U.S.C. 346a(e) and
346a(l)(6), is establishing time-limited
tolerances for residues of acetamiprid,
(1E)-N-[(6-chloro-3-pyridinyl)methyl]N’-cyano-N-methylethanimidamide, in
or on sugarcane, cane at 45 parts per
million (ppm) and sugarcane, molasses
at 600 ppm. These time-limited
tolerances expire on December 31, 2019.
Section 408(l)(6) of FFDCA requires
EPA to establish a time-limited
tolerance or exemption from the
requirement for a tolerance for pesticide
chemical residues in food that will
result from the use of a pesticide under
an emergency exemption issued under
FIFRA section 18. Such tolerances can
be established without providing notice
or period for public comment. EPA does
not intend for its actions on FIFRA
section 18 related time-limited
tolerances to set binding precedents for
the application of FFDCA section 408
and the safety standard to other
tolerances and exemptions. Section
408(e) of FFDCA allows EPA to
establish a tolerance or an exemption
from the requirement of a tolerance on
its own initiative, i.e., without having
received any petition from an outside
party.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
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all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Section 18 of FIFRA authorizes EPA
to exempt any Federal or State agency
from any provision of FIFRA, if EPA
determines that ‘‘emergency conditions
exist which require such exemption.’’
EPA has established regulations
governing such emergency exemptions
in 40 CFR part 166.
III. Emergency Exemption for
Acetamiprid on Sugarcane and FFDCA
Tolerances
With EPA’s concurrence, the
Louisiana Department of Agriculture
and Forestry (LDAF) declared a crisis on
June 17, 2016 necessitating the use of
acetamiprid to control the West Indian
canefly on sugarcane. At that time,
LDAF stated that substantial yield losses
had likely already occurred in
sugarcane, and the West Indian canefly
populations were moving into other
crops nearby, posing significant risk to
these crops as well.
The state agency asserted that an
emergency condition exists in
accordance with the criteria for
approval of an emergency exemption,
and issued a crisis exemption under
FIFRA section 18 to allow the use of
acetamiprid on sugarcane for control of
West Indian canefly in Louisiana. After
having reviewed the submission, EPA
concurred that an emergency condition
exists.
As part of its evaluation of the
emergency exemption application, EPA
assessed the potential risks presented by
residues of acetamiprid in or on
sugarcane cane and sugarcane molasses.
In doing so, EPA considered the safety
standard in FFDCA section 408(b)(2),
and EPA decided that the necessary
tolerance under FFDCA section 408(l)(6)
would be consistent with the safety
standard and with FIFRA section 18.
Consistent with the need to move
quickly on the emergency exemption in
order to address an urgent non-routine
situation and to ensure that the resulting
food is safe and lawful, EPA is issuing
these tolerances without notice and
opportunity for public comment as
provided in FFDCA section 408(l)(6).
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Although these time-limited tolerances
expire on December 31, 2019, under
FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts
specified in the tolerances remaining in
or on sugarcane cane and sugarcane
molasses after that date will not be
unlawful, provided the pesticide was
applied in a manner that was lawful
under FIFRA, and the residues do not
exceed a level that was authorized by
these time-limited tolerances at the time
of that application. EPA will take action
to revoke these time-limited tolerances
earlier if any experience with, scientific
data on, or other relevant information
on this pesticide indicate that the
residues are not safe.
Because these time-limited tolerances
are being approved under emergency
conditions, EPA has not made any
decisions about whether acetamiprid
meets FIFRA’ s registration
requirements for use on sugarcane, or
whether permanent tolerances for this
use would be appropriate. Under these
circumstances, EPA does not believe
that this time-limited tolerance decision
serves as a basis for registration of
acetamiprid by a State for special local
needs under FIFRA section 24(c). Nor
do these tolerances by themselves serve
as the authority for persons in any State
other than Louisiana to use this
pesticide on the applicable crops under
FIFRA section 18 absent the issuance of
an emergency exemption applicable
within that State. For additional
information regarding the emergency
exemption for acetamiprid, contact the
Agency’s Registration Division at the
address provided under FOR FURTHER
INFORMATION CONTACT.
IV. Aggregate Risk Assessment and
Determination of Safety
Consistent with the factors specified
in FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure expected as a result
of this emergency exemption request
and the time-limited tolerances for
residues of acetamiprid on sugarcane,
cane at 45 ppm and sugarcane, molasses
at 600 ppm. EPA’s assessment of
exposures and risks associated with
establishing time-limited tolerances
follows.
A. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
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evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks.
The complete human health risk
assessment for this action may be found
at https://www.regulations.gov in the
document ‘‘Acetamiprid. Aggregate
Human Health Risk Assessment for the
Proposed FIFRA Section 18 Specific
Exemption Use of the Insecticide on
Sugarcane in Louisiana’’ in the docket
for ID number EPA–HQ–OPP–2017–
0005. Additionally, a summary of the
toxicological endpoints for acetamiprid
used for human risk assessment is
discussed in Unit III. of the final rule
published in the Federal Register of
November 6, 2015 (80 FR 68772) (FRL–
9936–12).
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to acetamiprid, EPA
considered exposure under the timelimited tolerances established by this
action as well as all existing acetamiprid
tolerances in 40 CFR 180.578. EPA
assessed dietary exposures from
acetamiprid in food as follows:
i. Acute exposure. Acute effects were
identified for acetamiprid. In estimating
acute dietary exposure, EPA used food
consumption information from the
United States Department of Agriculture
(USDA) 2003–2008 National Health and
Nutrition Examination Survey; What We
Eat in America (NHANES/WWEIA). As
to residue levels in food, EPA assumed
one hundred percent crop treated (PCT),
and established and proposed tolerance
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level residues except as follows for
sugarcane molasses. No residue data
were available for sugarcane molasses,
and residue data from sweet corn stover
were used as a surrogate. The Agency
determined it appropriate to translate
corn stover data to sugarcane, and the
use patterns and maximum application
rates for sweet corn and sugarcane are
similar. The residue level of 240 ppm
acetamiprid in sugarcane molasses and
sugarcane molasses baby food was used
for dietary risk assessment, which is less
than the recommended tolerance of 600
parts per million (ppm). The 240 ppm
level is based on the highest average
field trial acetamiprid residue level of
20 ppm in sweet corn stover, multiplied
by the average molasses processing
factor of 12X. The average processing
factor was derived from molasses
processing data for 9 other pesticides,
and results in a residue estimate that is
more representative of potential levels
which could occur in these
commodities.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA again used the food consumption
data from the USDA’s 2003–2008
NHANES/WWEIA. Residue levels in
food were included as explained in Unit
IV.B.1.i. of this document at tolerancelevel residues for established and
proposed tolerances and 240 ppm for
sugarcane molasses and sugarcane
molasses baby food. Additionally, 100
PCT was assumed.
iii. Cancer. Based on the data
referenced in Unit IV.A., EPA has
concluded that acetamiprid does not
pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for acetamiprid. As detailed in the
previous section, residues were
estimated for sugarcane molasses and
sugarcane molasses baby food based
upon data for sweet corn and
incorporating an appropriate processing
factor derived from processing data for
9 other pesticides in sugarcane.
Tolerance level residues were used for
the remainder of the commodities and
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 acetamiprid in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of acetamiprid.
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Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
EPA used the Food Quality Protection
Act Index Reservoir Screening Tool and
the Provisional Cranberry Model to
generate to generate surface water
Estimated Drinking Water
Concentrations (EDWCs) for use in the
human health dietary risk assessment,
while the Pesticide Root Zone Model for
Groundwater was used to generate
groundwater EDWCs. The EDWCs of
acetamiprid for acute exposures were
estimated at 88.3 parts per billion (ppb)
for surface water and 49.7 ppb for
ground water. For chronic exposures
(non-cancer assessment) the EDWCs
were estimated at 32.2 ppb for surface
water and 45.0 ppb for ground water. To
assess dietary exposure contribution
from drinking water, the higher acute
EDWC of 88.3 ppb was used for acute
assessment and for chronic exposures,
the higher EDWC of 45 ppb was used.
These modeled EDWCs were directly
entered into the dietary exposure model.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Residential exposures to acetamiprid
could result from the currently
registered uses of spot-on dog
treatments, application to mattresses,
and as crack and crevice treatments. For
the dog spot-on products, EPA
determined that short- and
intermediate-term residential exposures
may occur for residential (nonprofessional) applicators through
dermal and inhalation routes; and shortintermediate- and long-term exposures
may occur post-application for adults
and children through dermal exposures,
and also through incidental oral
ingestion for children 1–2 years old. For
the mattress, crack, and crevice
treatments, short- and intermediate-term
residential handler exposure may occur
through dermal and inhalation routes;
and short- and intermediate-term
exposures may occur post application
for adults and children through dermal
and inhalation routes, and also through
incidental oral ingestion for children 1–
2 years old. Further information
regarding EPA standard assumptions
and generic inputs for residential
exposures may be found at: https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/standard-
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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 acetamiprid to
share a common mechanism of toxicity
with any other substances, and
acetamiprid does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that acetamiprid does not have
a common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site at https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
C. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional SF when reliable data
available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity.
The pre- and post-natal toxicity
databases for acetamiprid include
developmental toxicity studies in the rat
and rabbit, developmental neurotoxicity
(DNT) study in rats and a 2-generation
reproduction toxicity study in rats.
There was no evidence of increased
quantitative or qualitative susceptibility
of rat or rabbit fetuses following in utero
exposure to acetamiprid in the
developmental toxicity studies. In the
DNT and 2-generation reproduction
studies there was no evidence of
quantitative increased susceptibility
observed However, there was evidence
of increased qualitative susceptibility of
rat pups seen in the studies. In the DNT
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study in rats, although both maternal
and offspring effects were seen at the
same dose level, offspring animals were
more severely affected. Decreased preweaning survival, and decreased
maximum auditory startle response
were observed in the presence of limited
maternal toxicity (body weight effects).
In the 2-generation reproduction study,
effects observed were a decrease in
mean body weight, body weight gain,
and food consumption in the parental
animals, and significant reductions in
body weights in pups (both
generations). Also, reduction in litter
size and viability and weaning indices
were seen among the second generation
of offspring, as well as significant delays
in the age to attain vaginal opening and
preputial separation. These offspring
adverse effects were more severe than
the parental effects.
3. Conclusion. EPA has determined
that reliable data show that the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for
acetamiprid is complete.
ii. Although there was evidence of
increased qualitative susceptibility of
the young in the DNT and 2-generation
reproduction studies in rats, there are
clear NOAELs identified for the effects
observed in the toxicity studies. Also,
there was no evidence of increased
quantitative or qualitative susceptibility
of rat or rabbit fetuses in the
developmental toxicity studies.
iii. Acetamiprid produced signs of
neurotoxicity in the high dose groups in
the acute and developmental
neurotoxicity studies in rats and the
subchronic toxicity study in mice.
However, no neurotoxic findings were
reported in the subchronic neurotoxicity
study in rats. Additionally, there are
clear NOAELs identified for the effects
observed in the toxicity studies. The
doses and endpoints selected for risk
assessment are protective and account
for all toxicological effects observed in
the database, including neurotoxicity.
iv. There are no residual uncertainties
identified in the exposure databases.
EPA made conservative (protective)
assumptions in exposure assessments
(food, drinking water and residential)
assessment, including the use of 100
PCT assumptions, tolerance-level
residue values, and upper-bound
estimates of potential exposure through
drinking water. In addition, the
residential exposure assessment was
conducted such that residential
exposure and risk will not be
underestimated. The aggregate exposure
and risk estimates considered are
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expected to over-estimate the actual
exposure and risk anticipated, based on
the current and proposed use patterns;
no risk estimates of concern were
identified. These assessments will not
underestimate the exposure and risks
posed by acetamiprid.
D. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
acetamiprid will occupy 69% of the
aPAD for children 1 to 2 years old, the
population group receiving the greatest
exposure. Typically, EPA does not
consider residential exposures when
assessing acute aggregate risk unless
such exposures can be characterized as
a series of single-day exposures. For
acetamiprid, residential exposures are
assessed as short- and intermediate-term
exposures. Therefore, acute aggregate
risk estimates for acetamiprid are
equivalent to the acute dietary risk
estimates which are not of concern.
2. Chronic risk. Using the exposure
assumptions described in unit IV. for
chronic exposure, EPA has concluded
that chronic exposure to acetamiprid
from food and water will utilize 62% of
the cPAD for children 1 to 2 years old,
the population group receiving the
greatest exposure. Dietary exposure
from food and water, considered to be
a background exposure level, is
included in aggregate exposures for all
population groups. Based on the
explanation in Unit IV.B.3., adult
aggregate chronic exposures also
include long-term post-application
dermal exposure from contact with dogs
following spot-on treatment. For
children 1 to 2 years old, aggregate
chronic exposures also include longterm post-application dermal and
incidental oral exposures from contact
with spot-on treated dogs. The chronic
dietary exposure and post-application
pet spot-on residential exposure were
aggregated and compared to the longterm POD. Adult and children long-term
aggregate MOEs were 390 and 100,
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respectively, and are above the level of
concern of an MOE <100, indicating that
risk estimates are not of concern. The
chronic dietary exposure estimates are
highly conservative, assuming
tolerance-level residues for registered
uses and 100 PCT for all commodities.
Therefore, EPA also considers the
aggregate MOEs to be conservative
estimates.
3. Short- and Intermediate-term risk.
Acetamiprid is currently registered for
uses that could result in short/
intermediate-term residential exposure.
Short- (1 to 30 days) and intermediateterm (1–6 months) 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). Toxicological endpoints
and points of departure for assessing
short- and intermediate-term risks
(including oral, dermal, and inhalation
routes of exposure) are identical for
acetamiprid. Therefore, separate
assessments were not conducted and
one risk assessment addresses both of
these durations. Using the exposure
assumptions described in unit IV.B.3.
for short/intermediate-term exposures,
EPA has concluded the combined short/
intermediate-term food, water, and
residential exposures result in aggregate
MOEs of 290 for adults and 110 for
children. Because EPA’s level of
concern for acetamiprid is an MOE of
<100, these MOEs do not indicate risks
of concern.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
acetamiprid is classified as ‘‘not likely
to be carcinogenic to humans’’ and is
therefore not expected to pose a cancer
risk to humans.
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 acetamiprid
residues.
pmangrum on DSK3GDR082PROD with RULES
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies
are available to enforce the tolerance
expression, including gas
chromatography with electron capture
detection (GC/ECD) for vegetables and
non-citrus fruits, high performance
liquid chromatography with ultraviolet
detection (HPLC/UV) for citrus fruits
only, and HPLC with tandem mass
spectrometric detection (LC/MS/MS) for
vegetables and non-citrus fruits.
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The methods may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex is a joint United Nations
Food and Agriculture Organization/
World Health Organization food
standards program, and it is recognized
as an international food safety
standards-setting organization in trade
agreements to which the United States
is a party. EPA may establish a tolerance
that is different from a Codex MRL;
however, FFDCA section 408(b)(4)
requires that EPA explain the reasons
for departing from the Codex level. The
Codex has not established an MRL for
acetamiprid on sugarcane.
VI. Conclusion
Therefore, time-limited tolerances are
established for residues of acetamiprid,
(1E)-N-[(6-chloro-3-pyridinyl)methyl]N′-cyano-N-methylethanimidamide, in
or on sugarcane, cane at 45 ppm and
sugarcane, molasses at 600 ppm. These
tolerances expire on December 31, 2019.
VII. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA sections 408(e) and
408(l)(6). The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require
any special considerations under
PO 00000
Frm 00054
Fmt 4700
Sfmt 4700
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established in accordance with
FFDCA sections 408(e) and 408(l)(6),
such as the tolerances in this final rule,
do not require the issuance of a
proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA
submitted 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
E:\FR\FM\10APR1.SGM
10APR1
Federal Register / Vol. 82, No. 67 / Monday, April 10, 2017 / Rules and Regulations
and pests, Reporting and recordkeeping
requirements.
Dated: March 16, 2017.
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 § 180.578, revise paragraph (b) to
read as follows:
■
§ 180.578
residues.
Acetamiprid; tolerances for
*
*
*
*
*
(b) Section 18 emergency exemptions.
Time-limited tolerances specified in the
following table are established for
residues of the acetamiprid, (1E)-N-[(6chloro-3-pyridinyl)methyl]-N’-cyano-Nmethylethanimidamide, in or on the
specified agricultural commodities,
resulting from use of the pesticide
pursuant to FIFRA section 18
emergency exemptions. Compliance
with the tolerance levels specified
below is to be determined by measuring
only acetamiprid. The tolerances expire
on the date specified in the table.
Parts per
million
Commodity
Sugarcane, cane
Sugarcane, molasses ............
*
*
*
Expiration
date
45
600
*
12/31/2019
12/31/2019
*
[FR Doc. 2017–07131 Filed 4–7–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 300
[EPA–HQ–SFUND–2003–0010; FRL–9960–
74–Region 7]
National Oil and Hazardous
Substances Pollution Contingency
Plan; National Priorities List: Partial
Deletion of the Omaha Lead Superfund
Site
Environmental Protection
Agency.
ACTION: Final rule.
pmangrum on DSK3GDR082PROD with RULES
AGENCY:
The U. S. Environmental
Protection Agency (EPA) Region 7
announces the deletion of 294
residential parcels of the Omaha Lead,
Superfund Site (Site) located in Omaha,
SUMMARY:
VerDate Sep<11>2014
14:16 Apr 07, 2017
Jkt 241001
Nebraska, from the National Priorities
List (NPL). The NPL, promulgated
pursuant to section 105 of the
Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA) of 1980, as amended, is
an appendix of the National Oil and
Hazardous Substances Pollution
Contingency Plan (NCP). This partial
deletion pertains to 294 residential
parcels. The remaining parcels of the
Site will remain on the NPL and are not
being considered for deletion as part of
this action. The EPA and the State of
Nebraska, through the Nebraska
Department of Environmental Quality,
determined that all appropriate
Response actions under CERCLA were
completed at the identified parcels.
However, this deletion does not
preclude future actions under
Superfund.
DATES:
This action is effective April 10,
2017.
EPA has established a
docket for this action under Docket
Identification No. EPA–HQ–SFUND–
2003–0010. All documents in the docket
are listed on the https://
www.regulations.gov Web site. Although
listed in the index, some information is
not publicly available, i.e., Confidential
Business Information or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically through https://
www.regulations.gov or in hard copy at
the site information repositories.
Locations, contacts, phone numbers and
viewing hours of the Site information
repositories are:
• EPA Region 7, 11201 Renner
Boulevard, Lenexa, Kansas 66219, open
from 8 a.m. to 4 p.m. Monday–Friday.
• W. Dale Clark Library, located at
215 S. 15th Street, Omaha, NE 68102,
open 10 a.m. to 8 p.m. Monday–
Thursday; 10 a.m. to 6 p.m. Friday and
Saturday; and 1 p.m. to 6 p.m. Sunday.
FOR FURTHER INFORMATION CONTACT: Don
Bahnke, Remedial Project Manager, U.S.
Environmental Protection Agency,
Region 7, SUPR/LMSE, 11201 Renner
Boulevard, Lenexa, KS 66219, telephone
(913) 551–7747, email: bahnke.donald@
epa.gov.
SUPPLEMENTARY INFORMATION: The
portion of the site to be deleted from the
NPL are 294 residential parcels of the
Omaha Lead Superfund site, Omaha,
Nebraska. A Notice of Intent of Partial
Deletion for this Site was published in
ADDRESSES:
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Frm 00055
Fmt 4700
Sfmt 9990
17151
the Federal Register (81 FR 65315) on
September 22, 2016.
The closing date for comments on the
Notice of Intent for Partial Deletion was
October 24, 2016. Two public comments
were received. One comment was
supportive of this action, and the other
appears to be a misunderstanding of the
current status of the Site. Neither
comment is a significant adverse
comment and the docket already
contains information concerning the
current status of the site. The EPA took
steps to minimize lead contaminated
particulates being released during the
remediation of the yards. The site has
already undergone remediation and the
source of the contamination has been
addressed. And with no adverse
comments, the EPA still believes that
the partial deletion action is
appropriate.
EPA maintains the NPL as the list of
sites that appear to present a significant
risk to public health, welfare, or the
environment. Deletion of a site from the
NPL does not preclude further remedial
action. Whenever there is a significant
release from a site deleted from the NPL,
the deleted site may be restored to the
NPL without application of the hazard
ranking system. Deletion of portions of
a site from the NPL does not affect
responsible party liability, in the
unlikely event that future conditions
warrant further actions.
List of Subjects in 40 CFR Part 300
Environmental protection, Air
pollution control, Chemicals, Hazardous
waste, Hazardous substances,
Intergovernmental relations, Penalties,
Reporting and recordkeeping
requirements, Superfund, Water
pollution control, Water supply.
Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C.
9601–9657; E.O. 12777, 56 FR 54757, 3 CFR
1991 Comp., p. 351; E.O. 12580, 52 FR 2923,
3 CFR 1987 Comp., p. 193.
Dated: March 20, 2017.
Edward H. Chu,
Acting Regional Administrator, Region 7.
[FR Doc. 2017–07123 Filed 4–7–17; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Rules and Regulations]
[Pages 17146-17151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07131]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0005; FRL-9959-90]
Acetamiprid; Pesticide Tolerances for Emergency Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
residues of acetamiprid in or on sugarcane, cane and sugarcane,
molasses. This action is associated with the issuance of a crisis
exemption under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) authorizing use of the pesticide on sugarcane. This regulation
establishes maximum permissible levels for residues of acetamiprid in
or on sugarcane, cane and sugarcane, molasses. The time-limited
tolerances expire on December 31, 2019.
DATES: This regulation is effective April 10, 2017. Objections and
requests for hearings must be received on or before June 9, 2017, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0005, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect
of this regulation and may also request a hearing on those objections.
You must file your objection or request a hearing on this regulation in
accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2017-0005 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 June 9, 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-
[[Page 17147]]
2017-0005, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(l)(6), is
establishing time-limited tolerances for residues of acetamiprid, (1E)-
N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-methylethanimidamide, in or
on sugarcane, cane at 45 parts per million (ppm) and sugarcane,
molasses at 600 ppm. These time-limited tolerances expire on December
31, 2019.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption issued under FIFRA section 18.
Such tolerances can be established without providing notice or period
for public comment. EPA does not intend for its actions on FIFRA
section 18 related time-limited tolerances to set binding precedents
for the application of FFDCA section 408 and the safety standard to
other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Acetamiprid on Sugarcane and FFDCA
Tolerances
With EPA's concurrence, the Louisiana Department of Agriculture and
Forestry (LDAF) declared a crisis on June 17, 2016 necessitating the
use of acetamiprid to control the West Indian canefly on sugarcane. At
that time, LDAF stated that substantial yield losses had likely already
occurred in sugarcane, and the West Indian canefly populations were
moving into other crops nearby, posing significant risk to these crops
as well.
The state agency asserted that an emergency condition exists in
accordance with the criteria for approval of an emergency exemption,
and issued a crisis exemption under FIFRA section 18 to allow the use
of acetamiprid on sugarcane for control of West Indian canefly in
Louisiana. After having reviewed the submission, EPA concurred that an
emergency condition exists.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of acetamiprid
in or on sugarcane cane and sugarcane molasses. In doing so, EPA
considered the safety standard in FFDCA section 408(b)(2), and EPA
decided that the necessary tolerance under FFDCA section 408(l)(6)
would be consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment as provided in FFDCA
section 408(l)(6). Although these time-limited tolerances expire on
December 31, 2019, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerances
remaining in or on sugarcane cane and sugarcane molasses after that
date will not be unlawful, provided the pesticide was applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by these time-limited tolerances at the time
of that application. EPA will take action to revoke these time-limited
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
acetamiprid meets FIFRA' s registration requirements for use on
sugarcane, or whether permanent tolerances for this use would be
appropriate. Under these circumstances, EPA does not believe that this
time-limited tolerance decision serves as a basis for registration of
acetamiprid by a State for special local needs under FIFRA section
24(c). Nor do these tolerances by themselves serve as the authority for
persons in any State other than Louisiana to use this pesticide on the
applicable crops under FIFRA section 18 absent the issuance of an
emergency exemption applicable within that State. For additional
information regarding the emergency exemption for acetamiprid, contact
the Agency's Registration Division at the address provided under FOR
FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with the factors specified in FFDCA section
408(b)(2)(D), EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure expected as a result of this emergency exemption request and
the time-limited tolerances for residues of acetamiprid on sugarcane,
cane at 45 ppm and sugarcane, molasses at 600 ppm. EPA's assessment of
exposures and risks associated with establishing time-limited
tolerances follows.
A. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in
[[Page 17148]]
evaluating the risk posed by human exposure to the pesticide. For
hazards that have a threshold below which there is no appreciable risk,
the toxicological POD is used as the basis for derivation of reference
values for risk assessment. PODs are developed based on a careful
analysis of the doses in each toxicological study to determine the dose
at which no adverse effects are observed (the NOAEL) and the lowest
dose at which adverse effects of concern are identified (the LOAEL).
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
The complete human health risk assessment for this action may be
found at https://www.regulations.gov in the document ``Acetamiprid.
Aggregate Human Health Risk Assessment for the Proposed FIFRA Section
18 Specific Exemption Use of the Insecticide on Sugarcane in
Louisiana'' in the docket for ID number EPA-HQ-OPP-2017-0005.
Additionally, a summary of the toxicological endpoints for acetamiprid
used for human risk assessment is discussed in Unit III. of the final
rule published in the Federal Register of November 6, 2015 (80 FR
68772) (FRL-9936-12).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to acetamiprid, EPA considered exposure under the time-limited
tolerances established by this action as well as all existing
acetamiprid tolerances in 40 CFR 180.578. EPA assessed dietary
exposures from acetamiprid in food as follows:
i. Acute exposure. Acute effects were identified for acetamiprid.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
2003-2008 National Health and Nutrition Examination Survey; What We Eat
in America (NHANES/WWEIA). As to residue levels in food, EPA assumed
one hundred percent crop treated (PCT), and established and proposed
tolerance level residues except as follows for sugarcane molasses. No
residue data were available for sugarcane molasses, and residue data
from sweet corn stover were used as a surrogate. The Agency determined
it appropriate to translate corn stover data to sugarcane, and the use
patterns and maximum application rates for sweet corn and sugarcane are
similar. The residue level of 240 ppm acetamiprid in sugarcane molasses
and sugarcane molasses baby food was used for dietary risk assessment,
which is less than the recommended tolerance of 600 parts per million
(ppm). The 240 ppm level is based on the highest average field trial
acetamiprid residue level of 20 ppm in sweet corn stover, multiplied by
the average molasses processing factor of 12X. The average processing
factor was derived from molasses processing data for 9 other
pesticides, and results in a residue estimate that is more
representative of potential levels which could occur in these
commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA again used the food consumption data from the USDA's
2003-2008 NHANES/WWEIA. Residue levels in food were included as
explained in Unit IV.B.1.i. of this document at tolerance-level
residues for established and proposed tolerances and 240 ppm for
sugarcane molasses and sugarcane molasses baby food. Additionally, 100
PCT was assumed.
iii. Cancer. Based on the data referenced in Unit IV.A., EPA has
concluded that acetamiprid does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for acetamiprid. As detailed in the previous
section, residues were estimated for sugarcane molasses and sugarcane
molasses baby food based upon data for sweet corn and incorporating an
appropriate processing factor derived from processing data for 9 other
pesticides in sugarcane. Tolerance level residues were used for the
remainder of the commodities and 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 acetamiprid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of acetamiprid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
EPA used the Food Quality Protection Act Index Reservoir Screening
Tool and the Provisional Cranberry Model to generate to generate
surface water Estimated Drinking Water Concentrations (EDWCs) for use
in the human health dietary risk assessment, while the Pesticide Root
Zone Model for Groundwater was used to generate groundwater EDWCs. The
EDWCs of acetamiprid for acute exposures were estimated at 88.3 parts
per billion (ppb) for surface water and 49.7 ppb for ground water. For
chronic exposures (non-cancer assessment) the EDWCs were estimated at
32.2 ppb for surface water and 45.0 ppb for ground water. To assess
dietary exposure contribution from drinking water, the higher acute
EDWC of 88.3 ppb was used for acute assessment and for chronic
exposures, the higher EDWC of 45 ppb was used. These modeled EDWCs were
directly entered into the dietary exposure model.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Residential exposures to acetamiprid could result from the
currently registered uses of spot-on dog treatments, application to
mattresses, and as crack and crevice treatments. For the dog spot-on
products, EPA determined that short- and intermediate-term residential
exposures may occur for residential (non-professional) applicators
through dermal and inhalation routes; and short- intermediate- and
long-term exposures may occur post-application for adults and children
through dermal exposures, and also through incidental oral ingestion
for children 1-2 years old. For the mattress, crack, and crevice
treatments, short- and intermediate-term residential handler exposure
may occur through dermal and inhalation routes; and short- and
intermediate-term exposures may occur post application for adults and
children through dermal and inhalation routes, and also through
incidental oral ingestion for children 1-2 years old. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at: https://www.epa.gov/pesticide-
science-and-assessing-pesticide-risks/standard-
[[Page 17149]]
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 acetamiprid to share a common mechanism of
toxicity with any other substances, and acetamiprid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
acetamiprid does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
C. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional SF when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. The pre- and post-natal
toxicity databases for acetamiprid include developmental toxicity
studies in the rat and rabbit, developmental neurotoxicity (DNT) study
in rats and a 2-generation reproduction toxicity study in rats. There
was no evidence of increased quantitative or qualitative susceptibility
of rat or rabbit fetuses following in utero exposure to acetamiprid in
the developmental toxicity studies. In the DNT and 2-generation
reproduction studies there was no evidence of quantitative increased
susceptibility observed However, there was evidence of increased
qualitative susceptibility of rat pups seen in the studies. In the DNT
study in rats, although both maternal and offspring effects were seen
at the same dose level, offspring animals were more severely affected.
Decreased pre-weaning survival, and decreased maximum auditory startle
response were observed in the presence of limited maternal toxicity
(body weight effects). In the 2-generation reproduction study, effects
observed were a decrease in mean body weight, body weight gain, and
food consumption in the parental animals, and significant reductions in
body weights in pups (both generations). Also, reduction in litter size
and viability and weaning indices were seen among the second generation
of offspring, as well as significant delays in the age to attain
vaginal opening and preputial separation. These offspring adverse
effects were more severe than the parental effects.
3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for acetamiprid is complete.
ii. Although there was evidence of increased qualitative
susceptibility of the young in the DNT and 2-generation reproduction
studies in rats, there are clear NOAELs identified for the effects
observed in the toxicity studies. Also, there was no evidence of
increased quantitative or qualitative susceptibility of rat or rabbit
fetuses in the developmental toxicity studies.
iii. Acetamiprid produced signs of neurotoxicity in the high dose
groups in the acute and developmental neurotoxicity studies in rats and
the subchronic toxicity study in mice. However, no neurotoxic findings
were reported in the subchronic neurotoxicity study in rats.
Additionally, there are clear NOAELs identified for the effects
observed in the toxicity studies. The doses and endpoints selected for
risk assessment are protective and account for all toxicological
effects observed in the database, including neurotoxicity.
iv. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in exposure
assessments (food, drinking water and residential) assessment,
including the use of 100 PCT assumptions, tolerance-level residue
values, and upper-bound estimates of potential exposure through
drinking water. In addition, the residential exposure assessment was
conducted such that residential exposure and risk will not be
underestimated. The aggregate exposure and risk estimates considered
are expected to over-estimate the actual exposure and risk anticipated,
based on the current and proposed use patterns; no risk estimates of
concern were identified. These assessments will not underestimate the
exposure and risks posed by acetamiprid.
D. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to acetamiprid will occupy 69% of the aPAD for children 1 to 2 years
old, the population group receiving the greatest exposure. Typically,
EPA does not consider residential exposures when assessing acute
aggregate risk unless such exposures can be characterized as a series
of single-day exposures. For acetamiprid, residential exposures are
assessed as short- and intermediate-term exposures. Therefore, acute
aggregate risk estimates for acetamiprid are equivalent to the acute
dietary risk estimates which are not of concern.
2. Chronic risk. Using the exposure assumptions described in unit
IV. for chronic exposure, EPA has concluded that chronic exposure to
acetamiprid from food and water will utilize 62% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Dietary exposure from food and water, considered to be a
background exposure level, is included in aggregate exposures for all
population groups. Based on the explanation in Unit IV.B.3., adult
aggregate chronic exposures also include long-term post-application
dermal exposure from contact with dogs following spot-on treatment. For
children 1 to 2 years old, aggregate chronic exposures also include
long-term post-application dermal and incidental oral exposures from
contact with spot-on treated dogs. The chronic dietary exposure and
post-application pet spot-on residential exposure were aggregated and
compared to the long-term POD. Adult and children long-term aggregate
MOEs were 390 and 100,
[[Page 17150]]
respectively, and are above the level of concern of an MOE <100,
indicating that risk estimates are not of concern. The chronic dietary
exposure estimates are highly conservative, assuming tolerance-level
residues for registered uses and 100 PCT for all commodities.
Therefore, EPA also considers the aggregate MOEs to be conservative
estimates.
3. Short- and Intermediate-term risk. Acetamiprid is currently
registered for uses that could result in short/intermediate-term
residential exposure. Short- (1 to 30 days) and intermediate-term (1-6
months) 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). Toxicological endpoints
and points of departure for assessing short- and intermediate-term
risks (including oral, dermal, and inhalation routes of exposure) are
identical for acetamiprid. Therefore, separate assessments were not
conducted and one risk assessment addresses both of these durations.
Using the exposure assumptions described in unit IV.B.3. for short/
intermediate-term exposures, EPA has concluded the combined short/
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 290 for adults and 110 for children. Because EPA's
level of concern for acetamiprid is an MOE of <100, these MOEs do not
indicate risks of concern.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, acetamiprid is classified as ``not likely to be carcinogenic
to humans'' and is therefore not expected to pose a cancer risk to
humans.
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 acetamiprid residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies are available to enforce the
tolerance expression, including gas chromatography with electron
capture detection (GC/ECD) for vegetables and non-citrus fruits, high
performance liquid chromatography with ultraviolet detection (HPLC/UV)
for citrus fruits only, and HPLC with tandem mass spectrometric
detection (LC/MS/MS) for vegetables and non-citrus fruits.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex is a joint United Nations Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established an MRL for acetamiprid on sugarcane.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
acetamiprid, (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-
methylethanimidamide, in or on sugarcane, cane at 45 ppm and sugarcane,
molasses at 600 ppm. These tolerances expire on December 31, 2019.
VII. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This
action does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
Since tolerances and exemptions that are established in accordance
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA submitted 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
[[Page 17151]]
and pests, Reporting and recordkeeping requirements.
Dated: March 16, 2017.
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. 180.578, revise paragraph (b) to read as follows:
Sec. [emsp14]180.578 Acetamiprid; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of the
acetamiprid, (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-
methylethanimidamide, in or on the specified agricultural commodities,
resulting from use of the pesticide pursuant to FIFRA section 18
emergency exemptions. Compliance with the tolerance levels specified
below is to be determined by measuring only acetamiprid. The tolerances
expire on the date specified in the table.
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Sugarcane, cane............................... 45 12/31/2019
Sugarcane, molasses........................... 600 12/31/2019
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-07131 Filed 4-7-17; 8:45 am]
BILLING CODE 6560-50-P