Spinetoram; Pesticide Tolerances, 80275-80283 [2015-32329]
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Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Rules and Regulations
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
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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: December 16, 2015.
Susan Lewis,
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 § 180.434:
a. Redesignate paragraph (a) as
paragraph (a)(1).
■ b. Add a new paragraph (a)(2).
The amendments read as follows:
■
■
§ 180.434 Propiconazole; tolerances for
residues.
(a) General. (1) * * *
(2) Tolerances are established for
propiconazole, including its metabolites
and degradates, in or on the
commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only propiconazole, 1-[[2(2,4-dichlorophenyl)-4-propyl-1,3dioxolan-2-yl]methyl]-1H-1,2,4-triazole,
in or on the commodity.
Commodity
Parts per
million
Tea 1 .....................................
4.0
1 There
are no United States registrations
for use of propiconazole on tea as of December 24, 2015.
*
*
*
*
*
[FR Doc. 2015–32328 Filed 12–23–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2013–0730; FRL–9933–39]
Spinetoram; Pesticide Tolerances
Environmental Protection
Agency (EPA).
AGENCY:
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ACTION:
80275
Final rule.
This regulation establishes
tolerances for residues of spinetoram in
or on multiple commodities that are
identified and discussed later in this
document. In addition, this regulation
removes a number of existing tolerances
for residues of spinetoram that are
superseded by this action. Interregional
Research Project # 4 (IR-4) requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 24, 2015. Objections and
requests for hearings must be received
on or before February 22, 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–2013–0730, 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 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:
SUMMARY:
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).
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• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2013–0730 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 February 22, 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–
2013–0730, 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
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available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-for Tolerance
In the Federal Register of Monday,
December 30, 2013 (78 FR 79359) (FRL–
9903–69) and Wednesday, November 4,
2015 (80 FR 68289) (FRL–9936–13),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing and
subsequent filing of an amendment to
pesticide petition (PP 3E8203) by IR–4,
500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180 be amended
by establishing tolerances for the
combined residues of the insecticide
spinetoram, expressed as a combination
of XDE–175–J: 1-;H-as-indaceno[3,2d]
oxacyclododecin-7,15-dione, 2-[(6deoxy-3-O-ethyl-2,4-di-O-methyl-aLmannopyranosyl)oxy]-13-[[(2R,5S,6R)5-(dimethylamino)tetrahydro-6-methyl2Hpyran-2-yl]oxy]-9-ethyl-2,3,3a,4,5,
5a,5b,6,9,10,11,12,13,14,16a,16bhexadecahydro 14-methyl-(2R,3aR,5aR,
5bS,9S,13S,14R,16aS,16bR); XDE–175–
L: 1H-as-indaceno[3,2d]
oxacyclododecin-7,15-dione, 2-[(6deoxy-3-O-ethyl-2,4-di-O-methyl-a-L
mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5(dimethylamino)tetrahydro-6-methyl2Hpyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,
5b,6,9,10,11,12,13,14,16a,16btetradecahydro-4,14-dimethyl-(2S,
3aR,5aS,-5bS,9S,13S,14R,16aS,16bS);
ND–J: (2R,3aR,5aR,5bS,9S,13S,14R,
16aS,16bR)-9-ethyl-14-methyl-13[[(2S,5S,6R)-6-methyl-5-(methylamino)
tetrahydro-2H-pyran-2-yl]oxy]-7,15dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,
13,14,15,16a,16b-octadecahydro-1H-asindaceno[3,2-d]oxacyclododecin-2-yl 6deoxy-3-O-ethyl-2,4-di-O-methyl-alphaL-manno pyranoside; and NF–J: (2R,3S,
6S)-6-([(2R,3aR,5aR,5bS,9S,13S,
14R,16aS,16bR)-2-[(6-deoxy-3-Oethyl2,4-di-O-methyl-alpha-Lmannopyranosyl)oxy]-9-ethyl-14methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,
9,10,11,12,13,14,15,16a,16boctadecahydro-1H-as-indaceno[3,2d]
oxacyclododecin-13-yl]oxy)-2-methyl
tetrahydro-2H-pyran-3-yl(methyl)
formamide in or on the following raw
agricultural commodities: Berry, low
growing, subgroup 13–07G, except
blueberry, lowbush, and cranberry at 1.0
parts per million (ppm); bushberry
subgroup 13–07B, except lingonberry at
0.25 ppm; caneberry subgroup 13–07A
at 0.7 ppm; coffee, green bean at 0.2
ppm; coffee, instant at 0.4 ppm; coffee,
roasted bean at 0.4 ppm; cottonseed
subgroup 20C at 0.04 ppm; fruit, citrus,
group 10–10 at 0.3 ppm; fruit, pome
group 11–10 at 0.2 ppm; fruit, small,
vine climbing, except fuzzy kiwifruit,
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subgroup 13–07F at 0.5 ppm; fruit,
stone, group 12–12 at 0.2 ppm; nuts,
tree, group 14–12 at 0.1 ppm; onion,
bulb, subgroup 3–07A at 0.1 ppm;
onion, green, subgroup 3–07B at 2.0
ppm; quinoa, grain at 0.04 ppm; and
vegetable, fruiting, group 8–10 at 0.4
ppm. In addition, the petitioner
proposes based upon establishment of
the new tolerances above, to remove the
following established spinetoram
tolerances that are superseded by this
action: Bushberry subgroup 13B at 0.25
ppm; caneberry subgroup 13A at 0.70
ppm; cotton, undelinted seed at 0.04
ppm; fruit, citrus, group 10 at 0.30 ppm;
fruit, pome, group 11 at 0.20 ppm; fruit,
stone, group 12 at 0.20 ppm; grape at
0.50 ppm; juneberry at 0.25 ppm;
lingonberry at 0.25 ppm; nut tree, group
14 at 0.10 ppm; okra at 0.40 ppm; onion,
green at 2.0 ppm; pistachio at 0.10 ppm;
salal at 0.25 ppm; strawberry at 1.0
ppm; vegetable, bulb, group 3, except
green onion at 0.10 ppm; and vegetable,
fruiting group 8 at 0.4 ppm. That
document referenced a summary of the
petition prepared by Dow AgroSciences,
the registrant, which is available in the
docket, https://www.regulations.gov. A
single comment was received on the
notice of filing, EPA’s response to the
comment is discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA has made
certain modifications to petitioned-for
actions. The reasons for these changes
are explained in Unit IV.C.
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
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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 spinetoram
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with spinetoram follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
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.
Spinetoram and spinosad are
considered by EPA to be toxicologically
identical for human health risk
assessment based on their very similar
chemical structures and similarity of the
toxicological databases for currently
available studies. The primary toxic
effect observed from exposure to
spinosad or spinetoram was
histopathological changes in multiple
organs (specific target organs were not
identified). Vacuolization of cells and/or
macrophages was the most common
histopathological finding noted across
both toxicological databases with the
dog being the most sensitive species. In
addition to the numerous organs
observed with histopathological
changes, anemia was noted in several
studies.
There was no evidence of increased
quantitative or qualitative susceptibility
from spinosad or spinetoram exposure.
In developmental studies, no maternal
or developmental effects were seen in
rats or rabbits. In the rat reproduction
toxicity studies, offspring toxicity was
seen in the presence of parental toxicity
at approximately the same dose for both
chemicals (75–100 milligram/kilogram/
day (mg/kg/day)). Parental toxicity was
evidenced by increased organ weights,
mortality, and histopathological
findings in several organs. Offspring
effects included decreased litter size,
survival, and body weights with
spinosad while an increased incidence
of late resorptions and postimplantation loss was seen with
spinetoram. Dystocia and/or other
parturition abnormalities were observed
with both chemicals.
Spinosad and spinetoram are
classified as having low acute toxicity
via the oral, dermal, and inhalation
routes of exposure. Neither chemical is
an eye or dermal irritant. Spinetoram
was found to be a dermal sensitizer. No
hazard was identified for dermal
exposure; therefore a quantitative
dermal assessment is not needed. In
acute and subchronic neurotoxicity
studies, there was no evidence of
neurotoxicity from exposure to spinosad
or spinetoram. In an immunotoxicity
study with spinosad, systemic effects
(decreased body weights, increased liver
weights, and abnormal hematology
results) were seen at the highest dose
tested (141 mg/kg/day); however, there
was no evidence of immunotoxicity.
Spinosad and spinetoram are
classified as ‘‘not likely to be
carcinogenic to humans’’ based on lack
of evidence of carcinogenicity in mice
and rats and negative findings in
mutagenicity assays.
Specific information on the studies
received and the nature of the adverse
effects caused by spinetoram and
spinosad as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can
be found at https://www.regulations.gov
in documents including: 1) ‘‘Spinosad
and Spinetoram—Human Health Risk
Assessment to Support the Section 3
Registration Request for Application to
Coffee and for Updates to Several Crop
Group/Subgroup Commodity
Definitions,’’ dated March 10, 2015 at
pp. 31, and 2) ‘‘Spinosad/Spinetoram.
Addendum to Human Health aggregate
Risk assessment D415812 (T. Bloem et
al., 10–Mar–2015) to Support a New Use
on Quinoa’’, dated November 2015 in
docket ID number EPA–HQ–OPP–2013–
0730.
80277
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
LOEAL 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://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
Spinosad and spinetoram should be
considered toxicologically identical in
the same manner that metabolites are
generally considered toxicologically
identical to the parent. Although, as
stated above, the doses and endpoints
for spinosad and spinetoram are similar,
they are not identical due to variations
in dosing levels used in the spinetoram
and spinosad toxicological studies. EPA
compared the spinosad and spinetoram
doses and endpoints for each exposure
scenario and selected the lower of the
two doses for use in human risk
assessment.
A summary of the toxicological
endpoints for spinosad/spinetoram used
for human risk assessment is shown in
Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPINOSAD/SPINETORAM FOR USE IN HUMAN
HEALTH RISK ASSESSMENT
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Exposure/scenario
Point of departure
and uncertainty/safety factors
Acute dietary (All Populations)
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RfD, PAD, LOC for
risk assessment
Study and toxicological effects
A dose and endpoint of concern attributable to a single dose was not observed.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPINOSAD/SPINETORAM FOR USE IN HUMAN
HEALTH RISK ASSESSMENT—Continued
Exposure/scenario
Chronic dietary (All populations)
Incidental oral short-term (1 to
30 days) and intermediateterm (1 to 6 months).
Inhalation short-term (1 to 30
days) and Intermediate-Term
(1–6 months).
Point of departure
and uncertainty/safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
NOAEL= 2.49 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL= 4.9 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Inhalation (or oral)
study NOAEL= 4.9
mg/kg/day (inhalation assumed
equivalent to oral).
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD =
0.0249 mg/kg/day.
cPAD = 0.0249 mg/
kg/day
Chronic Toxicity—Dog Study (with spinetoram) LOAEL = 5.36/
5.83 mg/kg/day (males/females) based on arteritis and necrosis of the arterial walls of the epididymides in males and
of the thymus, thyroid, larynx, and urinary bladder in females.
Residential LOC for
MOE <100.
Subchronic Oral Toxicity—Dog Study (with spinosad) LOAEL =
9.73 mg/kg/day based on microscopic changes in multiple organs, clinical signs of toxicity, decreases in body weights and
food consumption, and biochemical evidence of anemia and
liver damage.
Subchronic Oral Toxicity—Dog Study (with spinosad) LOAEL =
9.73 mg/kg/day based on microscopic changes in multiple organs, clinical signs of toxicity, decreases in body weights and
food consumption, and biochemical evidence of anemia and
liver damage.
Cancer (Oral, dermal, inhalation).
Residential LOC for
MOE <100.
Classified as ‘‘not likely to be carcinogenic to humans.’’
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LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure.
NOAEL = no-observed-adverse-effect level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty
factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population
(intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to spinetoram and spinosad,
EPA considered exposure under the
petitioned-for tolerances as well as all
existing spinetoram tolerances in 40
CFR 180.635 as well as existing
spinosad tolerances. EPA assessed
dietary exposures from spinetoram and
spinosad 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 spinetoram or
spinosad; therefore, a quantitative acute
dietary exposure assessment is
unnecessary.
ii. Chronic exposure. Spinosad is
registered for application to all of the
same crops as spinetoram, with similar
pre-harvest and retreatment intervals,
and application rates greater than or
equal to spinetoram. Further, both
products control the same pest species.
For this reason, EPA has concluded it
would overstate exposure to assume that
residues of both spinosad and
spinetoram would appear on the same
food. Rather, EPA aggregated exposure
by assuming that all commodities
contain spinosad residues (because side-
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by-side spinetoram and spinosad
residue data indicated that spinetoram
residues were less than or equal to
spinosad residues).
In conducting the chronic dietary
exposure assessment for spinetoram,
EPA used the Dietary Exposure
Evaluation Model—Food Consumption
Intake Database (DEEMFCID, ver. 3.16)
which incorporates food consumption
data from the United States Department
of Agriculture (USDA) National Health
and Nutrition Examination Survey,
What We Eat in America (NHANES/
WWEIA; 2003–2008). The chronic
analysis assumed 100 percent crop
treated (PCT), average field-trial
residues or tolerance-level residues for
crop commodities, average residues
from the livestock feeding studies,
experimental processing factors when
available, and modeled drinking water
estimates.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that spinetoram 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 100
percent crop treated (PCT) information
were used. Section 408(b)(2)(E) of
FFDCA authorizes EPA to use available
data and information on the anticipated
residue levels of pesticide residues in
food and the actual levels of pesticide
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Sfmt 4700
residues that have been measured in
food. If EPA relies on such information,
EPA must require pursuant to FFDCA
section 408(f)(1) that data be provided 5
years after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
levels anticipated. For the present
action, EPA will issue such data call-ins
as are required by FFDCA section
408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be
required to be submitted no later than
5 years from the date of issuance of
these tolerances.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for spinetoram and spinosad in drinking
water. These simulation models take
into account data on the physical,
chemical, and fate/transport
characteristics of spinetoram and
spinosad. Further information regarding
EPA drinking water models used in
pesticide exposure assessment can be
found at https://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/
about-water-exposure-models-usedpesticide.
Based on the Surface Water
Concentration Calculator (SWCC) and
Screening Concentration in Ground
Water (SCIGROW) models, the
estimated drinking water concentrations
(EDWCs) of spinetoram for acute
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exposures are estimated to be 8.6 parts
per billion (ppb) for surface water and
0.072 ppb for ground water. For chronic
exposures for non-cancer assessments
are estimated to be 5.9 ppb for surface
water and 0.072 ppb for ground water.
EDWCs of spinosad for acute exposures
are estimated to be 25.0 ppb for surface
water and 1.1 ppb for ground water. For
chronic exposures for noncancer
assessments are estimated to be 21.7
ppb for surface water and 1.1 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 21.7 ppb
was used to assess the contribution to
drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Spinetoram and spinosad are
currently registered for uses that could
result in residential exposures including
lawns, gardens, turfgrass, ornamentals,
fire ant mounds, and spot-on pet
applications. There is potential for
residential handler and postapplication
exposures to both spinosad and
spinetoram. Since spinosad and
spinetoram control the same pests, EPA
concludes that these products will not
be used for the same uses in
combination with each other and thus
combining spinosad and spinetoram
residential exposures would overstate
exposure. EPA assessed residential
exposure for both spinosad and
spinetoram using the most conservative
residential exposure scenarios for either
chemical.
EPA assessed residential exposure
using the following assumptions:
Residential handler (short-term
inhalation exposures) and postapplication (short-term incidental oral)
exposures are expected as a result of the
following registered uses: (1)
Application of spinosad to gardens,
turfgrass, ornamentals and fire ant
mounds; (2) application of spinetoram
to lawns, gardens, and ornamentals; and
(3) spot-on application of spinetoram to
cats and kittens. The Agency
determined the ‘‘worst-case’’ scenarios
for handler and post-application
exposures as: (1) Adult residential
handler inhalation exposure from
mixing/loading/applying liquid
formulations to turf via backpack
sprayer, and (2) child (1–<2 years)
residential post-application incidental
oral (hand-to-mouth) exposure from
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liquid formulation on turf/home
gardens/ornamentals. These worst-case
exposure estimates were used in the
aggregate assessment of residential
exposure to spinosad and spinetoram.
Aggregating exposure resulting from
the turf and pet uses was not conducted
as the products control different pests
and, therefore, application on the same
day is unlikely. Use survey data indicate
that concurrent use of separate pesticide
products that contain the same active
ingredient to treat the same or different
pests does not typically occur.
Furthermore, a number of issues are
considered when combining residential
exposure scenarios, including whether
aggregating additional uses is
appropriate in light of the already
conservative assumptions inherent in
the assessment. When assessing
individual short-term residential
postapplication exposure scenarios,
EPA assumes exposure occurs to zeroday residues (i.e., day of application
residues) day after day. EPA also
assumes that an individual performs the
same postapplication activities,
intended to represent high end
exposures as described in the
Residential SOPS, day after day for the
same amount of time every day (i.e., no
day to day variation), although doing
intense contact activities on the day of
application subsequent to application
for multiple chemicals would not be
anticipated. Once calculated, these
exposure estimates are then compared
to points of departure that are typically
based on weeks of dosing in test
animals. For spinosad/spinetoram, the
short-term risk assessment has the
additional conservatism of basing the
level of concern for short-term exposure
(30-days) on a toxicity study involving
continuous exposure over 90 days.
Current EPA policy requires
assessment for residential postapplication exposures of short- (1 to 30
days), intermediate- (1 to 6 months), and
long-term (greater than 6 months)
exposures from spot-on products due to
the preventative nature of these
products and the potential for extended
usage in more temperate parts of the
country. However, for spinetoram, there
is no progression of toxicity with time;
therefore, the short-term assessment is
protective of intermediate- and longterm exposure.
Available turf transferable residue
(TTR) data on spinosad in support of
turf uses and spinetoram data on
dislodgeable residues from petting after
topical administration to cats were
incorporated into the exposure
assessment. Spinosad and spinetoram
dislodgeable-foliar residue (DFR)
studies are unnecessary at this time as
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80279
there is no hazard via the dermal route
of exposure.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/
standard-operating-proceduresresidential-pesticide.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘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 spinosad or
spinetoram to share a common
mechanism of toxicity with any other
substances, and neither spinosad nor
spinetoram appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that spinosad and spinetoram
do not have a common mechanism of
toxicity with other substances. For
information regarding EPA’s efforts to
determine which chemicals have a
common mechanism of toxicity and to
evaluate the cumulative effects of such
chemicals, see EPA’s Web site at
https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/
cumulative-assessment-risk-pesticides.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
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.
There was no evidence of increased
quantitative or qualitative susceptibility
of rat and rabbit fetuses to in-utero
exposure to spinetoram or spinosad. In
developmental studies, no maternal or
developmental effects were seen in rats
or rabbits. In the rat reproduction
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toxicity studies, offspring toxicity was
seen in association with parental
toxicity at approximately the same dose
for both spinetoram and spinosad.
Therefore, there is no evidence of
increased susceptibility and there are no
concerns or residual uncertainties for
pre-natal and/or post-natal toxicity.
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. That decision is
based on the following findings:
i. The toxicity database for spinetoram
and spinosad is complete. There is no
evidence of neurotoxicity,
developmental/reproductive toxicity,
immunotoxicity, mutagenicity, or
carcinogenicity from spinetoram or
spinosad exposure. Therefore, no
additional database uncertainty factor
(UF) is needed.
ii. There is no indication of
spinetoram or spinosad neurotoxicity
from available acute and subchronic
neurotoxicity studies in rats and there is
no need for a developmental
neurotoxicity study.
iii. There is no evidence that
spinetoram or spinosad results in
increased susceptibility in in utero rats
or rabbits in the prenatal developmental
studies or in young rats in the 2generation reproduction study.
iv. There are no residual uncertainties
identified in the spinetoram and
spinosad exposure databases. The
dietary exposure assessment is
conservative as it assumes 100 PCT and
residue estimates are based on field trial
data. Moreover, EPA made conservative
(protective) assumptions in the ground
and surface water modeling used to
assess exposure to spinetoram and
spinosad in drinking water. EPA used
similarly conservative assumptions to
assess post-application exposure of
children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by spinetoram and spinosad.
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.
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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, spinetoram and
spinosad are 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 spinetoram and
spinosad from food and water will
utilize 64% of the cPAD for children 1–
2 years old, the population group
receiving the greatest exposure. Based
on the explanation in Unit III.C.3.,
regarding residential use patterns,
chronic residential exposure to residues
of spinetoram and spinosad 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). Spinetoram and
spinosad is currently registered for uses
that could result in short-term
residential exposure, and the Agency
has determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to spinetoram and spinosad.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in aggregate
MOEs of 220 for children and 1,000 for
adults. Because EPA’s level of concern
for spinetoram and spinosad is a MOE
of < 100, these MOEs are not of concern.
EPA has concluded that the combined
intermediate-term and long-term food,
water, and residential exposures result
in aggregate MOEs that will not fall
below the short-term aggregate MOEs
since there is no progression of
spinetoram toxicity with time. Because
EPA’s level of concern for spinetoram
and spinosad is a MOE of < 100, these
MOEs are not of concern.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies
with spinosad, spinetoram is 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 spinetoram
residues.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Method GRM 05.04 is a highperformance liquid chromatography
(HPLC)/mass spectrometry (MS)/MS
method which has been determined to
be adequate for enforcement of existing
spinetoram plant tolerances. The
method has been validated on a widevariety of crops and EPA concluded that
it is sufficient to enforce the tolerances
established by this action.
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.
Codex MRLs for spinetoram are
currently established in or on several of
the relevant crops or crop groups or
subgroups affected by this action. EPA
harmonizes with existing Codex MRLs
whenever feasible. The recommended
fruit, stone, group 12–12 tolerance and
the Codex MRL are harmonized. But
harmonization with the currently
established Codex MRLs is
inappropriate for the following crop
groups and subgroups as harmonization
may result in exceedances of the
tolerances when the pesticide is applied
using the labeled instructions:
Bushberry, subgroup 13–07B; fruit,
citrus, group 10–10; fruit, pome, group
11–10; fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13–
07F; nut, tree, group 14–12; onion,
green, subgroup 3–07B; and vegetable,
fruiting, group 8–10. Also, EPA is not
harmonizing the U.S. tolerance for
onion, bulb, subgroup 3–07A (0.10 ppm)
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with the Codex MRL (0.01 ppm). The
current U.S. spinetoram tolerance of
0.10 is based on components XDE–175–
J, XDE–175–L, ND–J, and NF–J, with the
limit of quantitation (LOQ) for each of
0.01 ppm. EPA concludes that a
spinetoram tolerance <0.04 ppm is not
appropriate and harmonization with a
Codex MRL at 0.01 ppm is not practical.
tkelley on DSK3SPTVN1PROD with RULES
C. Response to Comments
One comments was received from the
Center for Biological Diversity and
concerned endangered species;
specifically stating that EPA cannot
approve these new uses prior to
completion of consultations with the
U.S. Fish and Wildlife Service and the
National Marine Fisheries Service (‘‘the
Services’’). This comment is not
relevant to the Agency’s evaluation of
safety of the spinetoram tolerances;
section 408 of the FFDCA focuses on the
potential harms to human health and
does not permit consideration of effects
on the environment.
D. Revisions to Petitioned-for
Tolerances
EPA made corrections to several
commodity definitions to conform to
current Agency practices and revised
certain proposed tolerance levels based
on the available field trial data, the
Organization for Economic Co-operation
and Development (OECD) tolerance
calculation procedures and/or for
purposes of harmonization, including
the following: (1) Proposed tolerance of
0.2 ppm in/on coffee, green bean was
established at 0.04 ppm; (2) proposed
tolerance in/on fruit, stone, group 12–12
at 0.20 ppm, established at 0.30 ppm; (3)
proposed tolerance in/on caneberry,
subgroup 13–07A at 0.7 ppm,
established at 0.80 ppm; (4) proposed
tolerance in/on bushberry, subgroup 13–
07B at 0.25 ppm, established at 0.50
ppm; (5) proposed tolerance in/on berry,
low growing, subgroup 13–07G, except
cranberry at 1.0 ppm, established at 0.90
ppm; and (6) a proposed tolerance of
0.04 ppm in/on both coffee, instant and
coffee, roasted bean was determined to
be unnecessary because the tolerance on
the raw agricultural commodity covers
residues on the processed commodities.
In addition, the Agency is updating
the tolerance expression for spinetoram
as follows to reflect current EPA
policies: ‘‘Tolerances are established for
residues of the insecticide spinetoram,
including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only the sum
of XDE–175–J: 1-H-as-indaceno[3,2d]
oxacyclododecin-7,15-dione, 2-[(6-
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Jkt 238001
deoxy-3-O-ethyl-2,4-di-O-methyl-aLmannopyranosyl)oxy]-13-[[(2R,5S,6R)5-(dimethylamino)tetrahydro-6-methyl2H-pyran2-yl]oxy]-9-ethyl-2,3,3a,4,5,
5a,5b,6,9,10,11,12,13,14,16a,16bhexadecahydro-14methyl-,(2R,3aR,5aR,
5bS,9S,13S,14R,16aS,16bR); XDE–175–
L: 1H-as-indaceno[3,2d]
oxacyclododecin-7,15-dione, 2-[(6deoxy-3-O-ethyl-2,4-di-O-methyl-a-L
mannopyranosyl)oxy]-13-[[(2R,5
S,6R)-5-(dimethylamino)tetrahydro-6methyl-2H-pyran2-yl]oxy]-9-ethyl-2,3,
3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-4,14-dimethyl, (2S,
3aR,5aS,5bS,9S,13S,14R,16aS,16bS);
ND–J: (2R,3aR,5aR,5bS,9S,
13S,14R,16aS,16bR)-9-ethyl-14-methyl13-[[(2S,5S,6R)-6-methyl-5(methylamino)tetrahydro-2H-pyran-2yl]oxy]-7,15-dioxo-2,3,3a,4,5,5a,5b,6,
7,9,10,11,12,13,14,15,16a,16boctadecahydro-1H-as-indaceno[3,2d]oxacyclododecin-2-yl-6-deoxy-3-Oethyl-2,4-di-O-methyl-a-Lmannopyranoside; and NF–J: (2R,3S,
6S)-6([(2R,3aR,5aR,5bS,9S,13S,14R,
16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4di-O-methyl-a-Lmannopyranosyl)oxy]9-ethyl-14-methyl-7,15-dioxo-2,3,3a,4,5,
5a,5b,6,7,9,10,11,12,13,14,15,16a,16boctadecahydro-1H-as-indaceno[3,2-d]
oxacyclododecin-13-yl]oxy)2methyltetrahydro-2H-pyran-3yl(methyl)formamide, calculated as the
stoichiometric equivalent of spinetoram.
V. Conclusion
Therefore, tolerances are established
for residues of the insecticide
spinetoram, including its metabolites
and degradates, in or on the
commodities listed below. Compliance
with the tolerance levels specified
below is to be determined by measuring
only the sum of XDE–175–J: 1-H-asindaceno[3,2-d]oxacyclododecin-7,15dione,2-[(6deoxy-3-O-ethyl-2,4-di-Omethyl-a-L-mannopyranosyl)oxy]-13[[(2R,5S,6R)5(dimethylamino)tetrahydro-6-methyl2H-pyran-2yl]oxy]-9-ethyl-2,3,3a,4,5,5a,
5b,6,9,10,11,12,13,14,16a,16bhexadecahydro-14-methyl-,(2R,3aR,5aR,
5bS,9S,13S,14R, 16aS,16bR); XDE–175–
L: 1H-as-indaceno[3,2-d]
oxacyclododecin-7,15-dione, 2[(6deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)5(dimethylamino)tetrahydro-6-methyl2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,
6,9,10,11,12,13,14,16a,16btetradecahydro-4,14-dimethyl-,(2S,
3aR,5aS,5bS,9S,13S,14R,16aS,16bS);
ND–J: (2R,3aR,5aR,5bS,9S,13S,14R,R,
16aS,16bR)-9-ethyl-14-methyl-13[[(2S,
5S,6R)-6-methyl-5-(methylamino)
tetrahydro-2H-pyran-2-yl]oxy]-7,15dioxo2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,
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14,15,16a,16b-octadecahydro-1H-asindaceno[3,2d]oxacyclododecin-2-yl-6deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranoside; and NF–J: (2R,3S,
6S)-6-([(2R,3aR,5aR,5bS,9S,13S,14R,
16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4di-O-methyl-a-L-mannopyranosyl)oxy]9-ethyl-14-methyl-7,15-dioxo-2,3,3a,4,5,
5a,5b,6,7,9,10,11,12,13,14,15,16a,16boctadecahydro-1H-as-indaceno[3,2d]
oxacyclododecin-13-yl]oxy)-2methyltetrahydro-2H-pyran-3-yl(methyl)
formamide, calculated as the
stoichiometric equivalent of spinetoram
in or on berry, low growing, subgroup
13–07G, except cranberry at 0.90 ppm;
bushberry, subgroup 13–07B at 0.50
ppm; caneberry subgroup 13–07A at
0.80 ppm; coffee, green bean at 0.04
ppm; cottonseed subgroup 20C at 0.04
ppm; fruit, citrus, group 10–10 at 0.30
ppm; fruit, pome, group 11–10 at 0.20
ppm; fruit, small, vine climbing,
subgroup 13–07F, except fuzzy kiwifruit
at 0.50 ppm; fruit, stone 12–12 at 0.30
ppm; nut, tree, group 14–12 at 0.10
ppm; onion, bulb, subgroup 3–07A at
0.10 ppm; onion, green, subgroup 3–07B
at 2.0 ppm; quinoa, grain at 0.04 ppm;
and vegetable, fruiting, group 8–10 at
0.40 ppm. In addition, EPA is removing
the following existing spinetoram
tolerances that are superseded by this
action including: Bushberry subgroup
13B at 0.25 ppm; caneberry subgroup
13A at 0.70 ppm; cotton, undelinted
seed at 0.02 ppm; fruit, citrus, group 10
at 0.30 ppm; fruit, pome, group 11 at
0.20 ppm; fruit, stone, group 12 at 0.20
ppm; grape at 0.50 ppm; juneberry at
0.25 ppm; lingonberry at 0.25 ppm; nut
tree, group 14 at 0.10 ppm; okra at 0.40
ppm; onion, green at 2.0 ppm; pistachio
at 0.10 ppm; salal at 0.25 ppm;
strawberry at 1.0 ppm; vegetable, bulb,
group 3, except green onion at 0.10
ppm; and vegetable, fruiting group 8 at
0.4 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
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
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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 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).
tkelley on DSK3SPTVN1PROD with RULES
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
VerDate Sep<11>2014
17:12 Dec 23, 2015
Jkt 238001
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: December 15, 2015.
Susan Lewis,
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 § 180.635, in paragraph (a):
a. Revise the introductory text.
b. Remove from the table in paragraph
(a) the entries for: Bushberry subgroup
13B at 0.25 ppm; caneberry subgroup
13A at 0.70 ppm; cotton, undelinted
seed at 0.02 ppm; fruit, citrus, group 10
at 0.30 ppm; fruit, pome, group 11 at
0.20 ppm; fruit, stone, group 12 at 0.20
ppm; grape at 0.50 ppm; juneberry at
0.25 ppm; lingonberry at 0.25 ppm; nut
tree, group 14 at 0.10 ppm; okra at 0.40
ppm; onion, green at 2.0 ppm; pistachio
at 0.10 ppm; salal at 0.25 ppm;
strawberry at 1.0 ppm; vegetable, bulb,
group 3, except green onion at 0.10
ppm; and vegetable, fruiting group 8 at
0.4 ppm.
■ c. Add alphabetically the following
commodities to the table in paragraph
(a).
The revision and additions read as
follows:
■
■
■
§ 180.635 Spinetoram; tolerance for
residues.
(a) General. Tolerances are
established for residues of the
insecticide spinetoram, including its
metabolites and degradates, in or on the
commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only the sum of XDE–175–J:
1-H-as-indaceno[3,2-d]oxacyclododecin7,15-dione,2-[(6deoxy-3-O-ethyl-2,4-diO-methyl-a-L-mannopyranosyl)oxy]-13[[(2R,5S,6R)-5(dimethylamino)
tetrahydro-6-methyl-2H-pyran-2-yl]
oxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,
12,13,14,16a,16b-hexadecahydro-14methyl-,(2R,3aR,5aR,5bS,9S,13S,14R,
16aS,16bR); XDE–175–L: 1H-asindaceno[3,2-d]oxacyclododecin-7,15dione,2-[(6deoxy-3-O-ethyl-2,4-di-Omethyl-a-L-mannopyranosyl)oxy]-13[[(2R,5S,6R)-5(dimethylamino)
PO 00000
Frm 00076
Fmt 4700
Sfmt 4700
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,
16a,16b-tetradecahydro-4,14-dimethyl-,
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS);
ND–J: (2R,3aR,5aR,5bS,9S,13S,14R,
16aS,16bR)-9-ethyl-14-methyl-13[[(2S,
5S,6R)-6-methyl-5-(methylamino)
tetrahydro-2H-pyran-2-yl]oxy]-7,15dioxo2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,
14,15,16a,16b-octadecahydro-1H-asindaceno[3,2d]oxacyclododecin-2-yl-6deoxy-3-O-ethyl-2,4-di-O-methyl-a-Lmannopyranoside; and NF–J: (2R,3S,
6S)-6-([(2R,3aR,5aR,5bS,9S,13S,14R,
16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4di-O-methyl-a-L-mannopyranosyl)oxy]9-ethyl-14-methyl-7,15-dioxo-2,3,3a,4,5,
5a,5b,6,7,9,10,11,12,13,14,15,16a,16boctadecahydro-1H-as-indaceno[3,2d]
oxacyclododecin-13-yl]oxy)-2methyltetrahydro-2H-pyran-3-yl(methyl)
formamide, calculated as the
stoichiometric equivalent of spinetoram.
Parts per
million
Commodity
*
*
*
Berry, low growing, subgroup 13–07G, except
cranberry .........................
*
*
*
*
Bushberry subgroup 13–
07B ..................................
Caneberry subgroup 13–
07A ..................................
*
*
*
*
Coffee, green bean .............
*
*
0.04
*
*
*
Cottonseed subgroup 20C
*
*
0.04
*
*
*
Fruit, citrus, group 10–10 ...
Fruit, pome, group 11–10 ...
Fruit, small, vine climbing,
subgroup 13–07F, except
fuzzy kiwifruit ...................
Fruit, stone 12–12 ..............
*
*
0.30
0.20
*
*
*
Nut, tree, group 14–12 .......
*
*
0.10
*
*
*
Onion, bulb, subgroup 3–
07A ..................................
Onion, green, subgroup 3–
07B ..................................
*
*
*
*
*
Quinoa, grain ......................
*
*
0.04
*
*
*
Vegetable, fruiting, group
8–10 ................................
*
*
*
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*
0.90
*
0.50
0.80
0.50
0.30
0.10
2.0
0.40
*
*
Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Rules and Regulations
*
*
*
*
Internet if you send them to PRA@
fcc.gov.
To request materials in accessible
formats for people with disabilities
(Braille, large print, electronic files,
audio format), send an email to fcc504@
fcc.gov or call the Consumer and
Governmental Affairs Bureau at (202)
418–0530 (voice), (202) 418–0432
(TTY).
*
[FR Doc. 2015–32329 Filed 12–23–15; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 54
Synopsis
[WC Docket Nos. 13–184 and 10–90; FCC
14–189]
Modernizing the E-rate Program for
Schools and Libraries
Federal Communications
Commission.
ACTION: Final rule; announcement of
effective date.
AGENCY:
In this document, the
Commission announces that the Office
of Management and Budget (OMB) has
approved, for a period of three years, the
information collection associated with
the Commission’s Second E-rate
Modernization Report and Order and
Order on Reconsideration (Second Erate Modernization Order). This
document is consistent with the
(Second E-rate Modernization Order,
which stated that the Commission
would publish a document in the
Federal Register announcing the
effective date of those rules.
DATES: 47 CFR 54.504(a)(1)(iii),
published at 80 FR 5961, February 4,
2015, is effective December 24, 2015.
FOR FURTHER INFORMATION CONTACT:
James Bachtell, Wireline Competition
Bureau at (202) 418–7400 or TTY (202)
418–0484.
SUPPLEMENTARY INFORMATION: This
document announces that, on December
2, 2015, OMB approved, for a period of
three years, the new information
collection requirements contained in the
Commission’s Second E-rate
Modernization Order, FCC 14–189,
published at 80 FR 5961, February 4,
2015. The OMB Control Number is
3060–0806. The Commission publishes
this document as an announcement of
the effective date of 47 CFR
54.504(a)(1)(iii).
If you have any comments on the
burden estimates listed below, or how
the Commission can improve the
collections and reduce any burdens
caused thereby, please contact Nicole
Ongele, Federal Communications
Commission, Room 1–A620, 445 12th
Street SW., Washington, DC 20554.
Please include the OMB Control
Number, 3060–0806, in your
correspondence. The Commission will
also accept your comments via the
tkelley on DSK3SPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
17:12 Dec 23, 2015
Jkt 238001
As required by the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507),
the FCC is notifying the public that it
received OMB approval on December 2,
2015, for the information collection
requirements contained in the
Commission’s rule at 47 CFR
54.504(a)(1)(iii).
Under 5 CFR part 1320, an agency
may not conduct or sponsor a collection
of information unless it displays a
current, valid OMB Control Number.
No person shall be subject to any
penalty for failing to comply with a
collection of information subject to the
Paperwork Reduction Act that does not
display a current, valid OMB Control
Number. The OMB Control Number is
3060–0806.
The foregoing document is required
by the Paperwork Reduction Act of
1995, Pub. L. 104–13, October 1, 1995,
and 44 U.S.C. 3507.
The total annual reporting burdens
and costs for the respondents are as
follows:
OMB Control Number: 3060–0806.
OMB Approval Date: December 2,
2015.
OMB Expiration Date: December 31,
2018.
Title: Universal Service—Schools and
Libraries Universal Service Program,
FCC Forms 470 and 471.
Form Numbers: FCC Forms 470 and
471.
Respondents: State, local or tribal
government public institutions, and
other not-for-profit institutions.
Number of Respondents and
Responses: 52,700 respondents, 82,090
responses.
Estimated Time per Response: 3.5
hours for FCC Form 470 (3 hours for
response; 0.5 hours for recordkeeping;
4.5 hours for FCC Form 471 (4 hours for
response; 0.5 hours for recordkeeping).
Frequency of Response: On occasion,
annual reporting, and recordkeeping
requirements.
Obligation to Respond: Required to
obtain or retain benefits. Statutory
authority for this information collection
is contained in 47 U.S.C. 151–154, 201–
205, 218–220, 254, 303(r), 403, and 405.
Total Annual Burden: 334,405 hours.
Total Annual Cost: No cost.
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Frm 00077
Fmt 4700
Sfmt 9990
80283
Privacy Act Impact Assessment: No
impact(s).
Nature and Extent of Confidentiality:
There is no assurance of confidentiality
provided to respondents concerning this
information collection. However,
respondents may request materials or
information submitted to the
Commission or to the Administrator be
withheld from public inspection under
47 CFR 0.459 of the Commission’s rules.
Needs and Uses: The Commission
seeks to revise OMB 3060–0806 to
conform this information collection to
the program changes set forth in the
Second Report and Order and Order on
Reconsideration (Second E-Rate
Modernization Order) (WC Docket No.
13–184, WC Docket No. 10–90, FCC 14–
189; 80 FR 5961, February 4, 2015).
Collection of the information on FCC
Forms 470 and 471 is necessary so that
the Commission and the Universal
Service Administrative Company
(USAC) have sufficient information to
determine if entities are eligible for
funding pursuant to the schools and
libraries support mechanism (the E-rate
program), to determine if entities are
complying with the Commission’s rules,
and to prevent waste, fraud, and abuse.
In addition, the information is necessary
for the Commission to evaluate the
extent to which the E-rate program is
meeting the statutory objectives
specified in section 254(h) of the 1996
Act, and the Commission’s own
performance goals established in the
Report and Order and Further Notice of
Proposed Rulemaking (E-rate
Modernization Order), 79 FR 49160,
August 19, 2014 and Second E-rate
Modernization Order, 80 FR 5961,
February 4, 2015. This information
collection is being revised to modify
FCC Form 471 pursuant to program and
rule changes in the Second E-rate
Modernization Order and to
accommodate USAC’s new online portal
as well as the requirement that all FCC
Forms 471 be electronically filed.
Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. 2015–32321 Filed 12–23–15; 8:45 am]
BILLING CODE 6712–01–P
E:\FR\FM\24DER1.SGM
24DER1
]]>Agencies
[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Rules and Regulations]
[Pages 80275-80283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32329]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0730; FRL-9933-39]
Spinetoram; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
spinetoram in or on multiple commodities that are identified and
discussed later in this document. In addition, this regulation removes
a number of existing tolerances for residues of spinetoram that are
superseded by this action. Interregional Research Project # 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective December 24, 2015. Objections and
requests for hearings must be received on or before February 22, 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-2013-0730, 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 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).
[[Page 80276]]
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0730 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
February 22, 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-2013-0730, 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 Monday, December 30, 2013 (78 FR 79359)
(FRL-9903-69) and Wednesday, November 4, 2015 (80 FR 68289) (FRL-9936-
13), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing and subsequent filing of an
amendment to pesticide petition (PP 3E8203) by IR-4, 500 College Road
East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40
CFR 180 be amended by establishing tolerances for the combined residues
of the insecticide spinetoram, expressed as a combination of XDE-175-J:
1-;H-as-indaceno[3,2d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-
ethyl-2,4-di-O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2Hpyran-2-yl]oxy]-9-ethyl-
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro 14-methyl-
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR); XDE-175-L: 1H-as-
indaceno[3,2d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-
O-methyl-a-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2Hpyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-
(2S,3aR,5aS,-5bS,9S,13S,14R,16aS,16bS); ND-J:
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13-
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-
ethyl-2,4-di-O-methyl-alpha-L-manno pyranoside; and NF-J: (2R,3S,6S)-6-
([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-Oethyl-2,4-di-O-
methyl-alpha-L-mannopyranosyl)oxy]-9-ethyl-14-methyl-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-
indaceno[3,2d]oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-3-
yl(methyl)formamide in or on the following raw agricultural
commodities: Berry, low growing, subgroup 13-07G, except blueberry,
lowbush, and cranberry at 1.0 parts per million (ppm); bushberry
subgroup 13-07B, except lingonberry at 0.25 ppm; caneberry subgroup 13-
07A at 0.7 ppm; coffee, green bean at 0.2 ppm; coffee, instant at 0.4
ppm; coffee, roasted bean at 0.4 ppm; cottonseed subgroup 20C at 0.04
ppm; fruit, citrus, group 10-10 at 0.3 ppm; fruit, pome group 11-10 at
0.2 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup
13-07F at 0.5 ppm; fruit, stone, group 12-12 at 0.2 ppm; nuts, tree,
group 14-12 at 0.1 ppm; onion, bulb, subgroup 3-07A at 0.1 ppm; onion,
green, subgroup 3-07B at 2.0 ppm; quinoa, grain at 0.04 ppm; and
vegetable, fruiting, group 8-10 at 0.4 ppm. In addition, the petitioner
proposes based upon establishment of the new tolerances above, to
remove the following established spinetoram tolerances that are
superseded by this action: Bushberry subgroup 13B at 0.25 ppm;
caneberry subgroup 13A at 0.70 ppm; cotton, undelinted seed at 0.04
ppm; fruit, citrus, group 10 at 0.30 ppm; fruit, pome, group 11 at 0.20
ppm; fruit, stone, group 12 at 0.20 ppm; grape at 0.50 ppm; juneberry
at 0.25 ppm; lingonberry at 0.25 ppm; nut tree, group 14 at 0.10 ppm;
okra at 0.40 ppm; onion, green at 2.0 ppm; pistachio at 0.10 ppm; salal
at 0.25 ppm; strawberry at 1.0 ppm; vegetable, bulb, group 3, except
green onion at 0.10 ppm; and vegetable, fruiting group 8 at 0.4 ppm.
That document referenced a summary of the petition prepared by Dow
AgroSciences, the registrant, which is available in the docket, https://www.regulations.gov. A single comment was received on the notice of
filing, EPA's response to the comment is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has made
certain modifications to petitioned-for actions. The reasons for these
changes are explained in Unit IV.C.
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
[[Page 80277]]
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
spinetoram including exposure resulting from the tolerances established
by this action. EPA's assessment of exposures and risks associated with
spinetoram follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
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.
Spinetoram and spinosad are considered by EPA to be toxicologically
identical for human health risk assessment based on their very similar
chemical structures and similarity of the toxicological databases for
currently available studies. The primary toxic effect observed from
exposure to spinosad or spinetoram was histopathological changes in
multiple organs (specific target organs were not identified).
Vacuolization of cells and/or macrophages was the most common
histopathological finding noted across both toxicological databases
with the dog being the most sensitive species. In addition to the
numerous organs observed with histopathological changes, anemia was
noted in several studies.
There was no evidence of increased quantitative or qualitative
susceptibility from spinosad or spinetoram exposure. In developmental
studies, no maternal or developmental effects were seen in rats or
rabbits. In the rat reproduction toxicity studies, offspring toxicity
was seen in the presence of parental toxicity at approximately the same
dose for both chemicals (75-100 milligram/kilogram/day (mg/kg/day)).
Parental toxicity was evidenced by increased organ weights, mortality,
and histopathological findings in several organs. Offspring effects
included decreased litter size, survival, and body weights with
spinosad while an increased incidence of late resorptions and post-
implantation loss was seen with spinetoram. Dystocia and/or other
parturition abnormalities were observed with both chemicals.
Spinosad and spinetoram are classified as having low acute toxicity
via the oral, dermal, and inhalation routes of exposure. Neither
chemical is an eye or dermal irritant. Spinetoram was found to be a
dermal sensitizer. No hazard was identified for dermal exposure;
therefore a quantitative dermal assessment is not needed. In acute and
subchronic neurotoxicity studies, there was no evidence of
neurotoxicity from exposure to spinosad or spinetoram. In an
immunotoxicity study with spinosad, systemic effects (decreased body
weights, increased liver weights, and abnormal hematology results) were
seen at the highest dose tested (141 mg/kg/day); however, there was no
evidence of immunotoxicity.
Spinosad and spinetoram are classified as ``not likely to be
carcinogenic to humans'' based on lack of evidence of carcinogenicity
in mice and rats and negative findings in mutagenicity assays.
Specific information on the studies received and the nature of the
adverse effects caused by spinetoram and spinosad as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in documents including: 1) ``Spinosad and
Spinetoram--Human Health Risk Assessment to Support the Section 3
Registration Request for Application to Coffee and for Updates to
Several Crop Group/Subgroup Commodity Definitions,'' dated March 10,
2015 at pp. 31, and 2) ``Spinosad/Spinetoram. Addendum to Human Health
aggregate Risk assessment D415812 (T. Bloem et al., 10-Mar-2015) to
Support a New Use on Quinoa'', dated November 2015 in docket ID number
EPA-HQ-OPP-2013-0730.
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 LOEAL 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
Spinosad and spinetoram should be considered toxicologically
identical in the same manner that metabolites are generally considered
toxicologically identical to the parent. Although, as stated above, the
doses and endpoints for spinosad and spinetoram are similar, they are
not identical due to variations in dosing levels used in the spinetoram
and spinosad toxicological studies. EPA compared the spinosad and
spinetoram doses and endpoints for each exposure scenario and selected
the lower of the two doses for use in human risk assessment.
A summary of the toxicological endpoints for spinosad/spinetoram
used for human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Spinosad/Spinetoram for Use in Human Health Risk
Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All Populations).. A dose and endpoint of concern attributable to a single dose was not
observed.
----------------------------------------------------------------------------------------------------------------
[[Page 80278]]
Chronic dietary (All populations) NOAEL= 2.49 mg/kg/ Chronic RfD = Chronic Toxicity--Dog Study (with
day. 0.0249 mg/kg/day. spinetoram) LOAEL = 5.36/5.83 mg/
UFA = 10x........... cPAD = 0.0249 mg/kg/ kg/day (males/females) based on
UFH = 10x........... day. arteritis and necrosis of the
FQPA SF = 1x........ arterial walls of the
epididymides in males and of the
thymus, thyroid, larynx, and
urinary bladder in females.
Incidental oral short-term (1 to NOAEL= 4.9 mg/kg/day Residential LOC for Subchronic Oral Toxicity--Dog
30 days) and intermediate-term UFA = 10x........... MOE <100. Study (with spinosad) LOAEL =
(1 to 6 months). UFH = 10x........... 9.73 mg/kg/day based on
FQPA SF = 1x........ microscopic changes in multiple
organs, clinical signs of
toxicity, decreases in body
weights and food consumption, and
biochemical evidence of anemia
and liver damage.
Inhalation short-term (1 to 30 Inhalation (or oral) Residential LOC for Subchronic Oral Toxicity--Dog
days) and Intermediate-Term (1-6 study NOAEL= 4.9 mg/ MOE <100. Study (with spinosad) LOAEL =
months). kg/day (inhalation 9.73 mg/kg/day based on
assumed equivalent microscopic changes in multiple
to oral). organs, clinical signs of
UFA = 10x........... toxicity, decreases in body
UFH = 10x........... weights and food consumption, and
FQPA SF = 1x........ biochemical evidence of anemia
and liver damage.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classified as ``not likely to be carcinogenic to humans.''
----------------------------------------------------------------------------------------------------------------
LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE =
margin of exposure. NOAEL = no-observed-adverse-effect level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
(interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spinetoram and spinosad, EPA considered exposure under the
petitioned-for tolerances as well as all existing spinetoram tolerances
in 40 CFR 180.635 as well as existing spinosad tolerances. EPA assessed
dietary exposures from spinetoram and spinosad 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
spinetoram or spinosad; therefore, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure. Spinosad is registered for application to all
of the same crops as spinetoram, with similar pre-harvest and
retreatment intervals, and application rates greater than or equal to
spinetoram. Further, both products control the same pest species. For
this reason, EPA has concluded it would overstate exposure to assume
that residues of both spinosad and spinetoram would appear on the same
food. Rather, EPA aggregated exposure by assuming that all commodities
contain spinosad residues (because side- by-side spinetoram and
spinosad residue data indicated that spinetoram residues were less than
or equal to spinosad residues).
In conducting the chronic dietary exposure assessment for
spinetoram, EPA used the Dietary Exposure Evaluation Model--Food
Consumption Intake Database (DEEMFCID, ver. 3.16) which incorporates
food consumption data from the United States Department of Agriculture
(USDA) National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA; 2003-2008). The chronic analysis assumed 100
percent crop treated (PCT), average field-trial residues or tolerance-
level residues for crop commodities, average residues from the
livestock feeding studies, experimental processing factors when
available, and modeled drinking water estimates.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that spinetoram 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 100 percent crop treated (PCT)
information were used. Section 408(b)(2)(E) of FFDCA authorizes EPA to
use available data and information on the anticipated residue levels of
pesticide residues in food and the actual levels of pesticide residues
that have been measured in food. If EPA relies on such information, EPA
must require pursuant to FFDCA section 408(f)(1) that data be provided
5 years after the tolerance is established, modified, or left in
effect, demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spinetoram and spinosad in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of spinetoram and spinosad. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Surface Water Concentration Calculator (SWCC) and
Screening Concentration in Ground Water (SCIGROW) models, the estimated
drinking water concentrations (EDWCs) of spinetoram for acute
[[Page 80279]]
exposures are estimated to be 8.6 parts per billion (ppb) for surface
water and 0.072 ppb for ground water. For chronic exposures for non-
cancer assessments are estimated to be 5.9 ppb for surface water and
0.072 ppb for ground water. EDWCs of spinosad for acute exposures are
estimated to be 25.0 ppb for surface water and 1.1 ppb for ground
water. For chronic exposures for noncancer assessments are estimated to
be 21.7 ppb for surface water and 1.1 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 21.7 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).
Spinetoram and spinosad are currently registered for uses that
could result in residential exposures including lawns, gardens,
turfgrass, ornamentals, fire ant mounds, and spot-on pet applications.
There is potential for residential handler and postapplication
exposures to both spinosad and spinetoram. Since spinosad and
spinetoram control the same pests, EPA concludes that these products
will not be used for the same uses in combination with each other and
thus combining spinosad and spinetoram residential exposures would
overstate exposure. EPA assessed residential exposure for both spinosad
and spinetoram using the most conservative residential exposure
scenarios for either chemical.
EPA assessed residential exposure using the following assumptions:
Residential handler (short-term inhalation exposures) and post-
application (short-term incidental oral) exposures are expected as a
result of the following registered uses: (1) Application of spinosad to
gardens, turfgrass, ornamentals and fire ant mounds; (2) application of
spinetoram to lawns, gardens, and ornamentals; and (3) spot-on
application of spinetoram to cats and kittens. The Agency determined
the ``worst-case'' scenarios for handler and post-application exposures
as: (1) Adult residential handler inhalation exposure from mixing/
loading/applying liquid formulations to turf via backpack sprayer, and
(2) child (1-<2 years) residential post-application incidental oral
(hand-to-mouth) exposure from liquid formulation on turf/home gardens/
ornamentals. These worst-case exposure estimates were used in the
aggregate assessment of residential exposure to spinosad and
spinetoram.
Aggregating exposure resulting from the turf and pet uses was not
conducted as the products control different pests and, therefore,
application on the same day is unlikely. Use survey data indicate that
concurrent use of separate pesticide products that contain the same
active ingredient to treat the same or different pests does not
typically occur. Furthermore, a number of issues are considered when
combining residential exposure scenarios, including whether aggregating
additional uses is appropriate in light of the already conservative
assumptions inherent in the assessment. When assessing individual
short-term residential postapplication exposure scenarios, EPA assumes
exposure occurs to zero-day residues (i.e., day of application
residues) day after day. EPA also assumes that an individual performs
the same postapplication activities, intended to represent high end
exposures as described in the Residential SOPS, day after day for the
same amount of time every day (i.e., no day to day variation), although
doing intense contact activities on the day of application subsequent
to application for multiple chemicals would not be anticipated. Once
calculated, these exposure estimates are then compared to points of
departure that are typically based on weeks of dosing in test animals.
For spinosad/spinetoram, the short-term risk assessment has the
additional conservatism of basing the level of concern for short-term
exposure (30-days) on a toxicity study involving continuous exposure
over 90 days.
Current EPA policy requires assessment for residential post-
application exposures of short- (1 to 30 days), intermediate- (1 to 6
months), and long-term (greater than 6 months) exposures from spot-on
products due to the preventative nature of these products and the
potential for extended usage in more temperate parts of the country.
However, for spinetoram, there is no progression of toxicity with time;
therefore, the short-term assessment is protective of intermediate- and
long-term exposure.
Available turf transferable residue (TTR) data on spinosad in
support of turf uses and spinetoram data on dislodgeable residues from
petting after topical administration to cats were incorporated into the
exposure assessment. Spinosad and spinetoram dislodgeable-foliar
residue (DFR) studies are unnecessary at this time as there is no
hazard via the dermal route of exposure.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found spinosad or spinetoram to share a common
mechanism of toxicity with any other substances, and neither spinosad
nor spinetoram appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that spinosad and spinetoram do not have a common mechanism
of toxicity with other substances. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's Web site at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the 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. There was no evidence of
increased quantitative or qualitative susceptibility of rat and rabbit
fetuses to in-utero exposure to spinetoram or spinosad. In
developmental studies, no maternal or developmental effects were seen
in rats or rabbits. In the rat reproduction
[[Page 80280]]
toxicity studies, offspring toxicity was seen in association with
parental toxicity at approximately the same dose for both spinetoram
and spinosad. Therefore, there is no evidence of increased
susceptibility and there are no concerns or residual uncertainties for
pre-natal and/or post-natal toxicity.
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. That decision is based on the following
findings:
i. The toxicity database for spinetoram and spinosad is complete.
There is no evidence of neurotoxicity, developmental/reproductive
toxicity, immunotoxicity, mutagenicity, or carcinogenicity from
spinetoram or spinosad exposure. Therefore, no additional database
uncertainty factor (UF) is needed.
ii. There is no indication of spinetoram or spinosad neurotoxicity
from available acute and subchronic neurotoxicity studies in rats and
there is no need for a developmental neurotoxicity study.
iii. There is no evidence that spinetoram or spinosad 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
spinetoram and spinosad exposure databases. The dietary exposure
assessment is conservative as it assumes 100 PCT and residue estimates
are based on field trial data. Moreover, EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to spinetoram and spinosad in drinking water. EPA
used similarly conservative assumptions to assess post-application
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by spinetoram and spinosad.
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,
spinetoram and spinosad are 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
spinetoram and spinosad from food and water will utilize 64% of the
cPAD for children 1-2 years old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
spinetoram and spinosad 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). Spinetoram
and spinosad is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to spinetoram and spinosad.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 220 for children
and 1,000 for adults. Because EPA's level of concern for spinetoram and
spinosad is a MOE of < 100, these MOEs are not of concern.
EPA has concluded that the combined intermediate-term and long-term
food, water, and residential exposures result in aggregate MOEs that
will not fall below the short-term aggregate MOEs since there is no
progression of spinetoram toxicity with time. Because EPA's level of
concern for spinetoram and spinosad is a MOE of < 100, these MOEs are
not of concern.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies with spinosad, spinetoram is 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 spinetoram residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Method GRM 05.04 is a high-performance liquid chromatography
(HPLC)/mass spectrometry (MS)/MS method which has been determined to be
adequate for enforcement of existing spinetoram plant tolerances. The
method has been validated on a wide-variety of crops and EPA concluded
that it is sufficient to enforce the tolerances established by this
action.
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.
Codex MRLs for spinetoram are currently established in or on
several of the relevant crops or crop groups or subgroups affected by
this action. EPA harmonizes with existing Codex MRLs whenever feasible.
The recommended fruit, stone, group 12-12 tolerance and the Codex MRL
are harmonized. But harmonization with the currently established Codex
MRLs is inappropriate for the following crop groups and subgroups as
harmonization may result in exceedances of the tolerances when the
pesticide is applied using the labeled instructions: Bushberry,
subgroup 13-07B; fruit, citrus, group 10-10; fruit, pome, group 11-10;
fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F;
nut, tree, group 14-12; onion, green, subgroup 3-07B; and vegetable,
fruiting, group 8-10. Also, EPA is not harmonizing the U.S. tolerance
for onion, bulb, subgroup 3-07A (0.10 ppm)
[[Page 80281]]
with the Codex MRL (0.01 ppm). The current U.S. spinetoram tolerance of
0.10 is based on components XDE-175-J, XDE-175-L, ND-J, and NF-J, with
the limit of quantitation (LOQ) for each of 0.01 ppm. EPA concludes
that a spinetoram tolerance <0.04 ppm is not appropriate and
harmonization with a Codex MRL at 0.01 ppm is not practical.
C. Response to Comments
One comments was received from the Center for Biological Diversity
and concerned endangered species; specifically stating that EPA cannot
approve these new uses prior to completion of consultations with the
U.S. Fish and Wildlife Service and the National Marine Fisheries
Service (``the Services''). This comment is not relevant to the
Agency's evaluation of safety of the spinetoram tolerances; section 408
of the FFDCA focuses on the potential harms to human health and does
not permit consideration of effects on the environment.
D. Revisions to Petitioned-for Tolerances
EPA made corrections to several commodity definitions to conform to
current Agency practices and revised certain proposed tolerance levels
based on the available field trial data, the Organization for Economic
Co-operation and Development (OECD) tolerance calculation procedures
and/or for purposes of harmonization, including the following: (1)
Proposed tolerance of 0.2 ppm in/on coffee, green bean was established
at 0.04 ppm; (2) proposed tolerance in/on fruit, stone, group 12-12 at
0.20 ppm, established at 0.30 ppm; (3) proposed tolerance in/on
caneberry, subgroup 13-07A at 0.7 ppm, established at 0.80 ppm; (4)
proposed tolerance in/on bushberry, subgroup 13-07B at 0.25 ppm,
established at 0.50 ppm; (5) proposed tolerance in/on berry, low
growing, subgroup 13-07G, except cranberry at 1.0 ppm, established at
0.90 ppm; and (6) a proposed tolerance of 0.04 ppm in/on both coffee,
instant and coffee, roasted bean was determined to be unnecessary
because the tolerance on the raw agricultural commodity covers residues
on the processed commodities.
In addition, the Agency is updating the tolerance expression for
spinetoram as follows to reflect current EPA policies: ``Tolerances are
established for residues of the insecticide spinetoram, including its
metabolites and degradates, in or on the commodities in the table
below. Compliance with the tolerance levels specified below is to be
determined by measuring only the sum of XDE-175-J: 1-H-as-
indaceno[3,2d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-
O-methyl-[alpha]-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2H-pyran2-yl]oxy]-9-ethyl-
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14methyl-
,(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR); XDE-175-L: 1H-as-
indaceno[3,2d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-
O-methyl-[alpha]-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2H-pyran2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl,
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); ND-J:
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13-
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl-6-deoxy-3-O-
ethyl-2,4-di-O-methyl-[alpha]-L-mannopyranoside; and NF-J: (2R,3S,6S)-
6([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-
O-methyl-[alpha]-Lmannopyranosyl)oxy]-9-ethyl-14-methyl-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-
indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2methyltetrahydro-2H-pyran-3-
yl(methyl)formamide, calculated as the stoichiometric equivalent of
spinetoram.
V. Conclusion
Therefore, tolerances are established for residues of the
insecticide spinetoram, including its metabolites and degradates, in or
on the commodities listed below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of XDE-
175-J: 1-H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione,2-[(6deoxy-3-O-
ethyl-2,4-di-O-methyl-[alpha]-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-
5(dimethylamino)tetrahydro-6-methyl-2H-pyran-2yl]oxy]-9-ethyl-
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-methyl-
,(2R,3aR,5aR,5bS,9S,13S,14R, 16aS,16bR); XDE-175-L: 1H-as-indaceno[3,2-
d]oxacyclododecin-7,15-dione, 2-[(6deoxy-3-O-ethyl-2,4-di-O-methyl-
[alpha]-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-
5(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-
,(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS);ND-J:
(2R,3aR,5aR,5bS,9S,13S,14R,R,16aS,16bR)-9-ethyl-14-methyl-
13[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2d]oxacyclododecin-2-yl-6-deoxy-3-O-
ethyl-2,4-di-O-methyl-[alpha]-L-mannopyranoside; and NF-J: (2R,3S,6S)-
6-([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-
O-methyl-[alpha]-L-mannopyranosyl)oxy]-9-ethyl-14-methyl-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-
indaceno[3,2d] oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-
3-yl(methyl)formamide, calculated as the stoichiometric equivalent of
spinetoram in or on berry, low growing, subgroup 13-07G, except
cranberry at 0.90 ppm; bushberry, subgroup 13-07B at 0.50 ppm;
caneberry subgroup 13-07A at 0.80 ppm; coffee, green bean at 0.04 ppm;
cottonseed subgroup 20C at 0.04 ppm; fruit, citrus, group 10-10 at 0.30
ppm; fruit, pome, group 11-10 at 0.20 ppm; fruit, small, vine climbing,
subgroup 13-07F, except fuzzy kiwifruit at 0.50 ppm; fruit, stone 12-12
at 0.30 ppm; nut, tree, group 14-12 at 0.10 ppm; onion, bulb, subgroup
3-07A at 0.10 ppm; onion, green, subgroup 3-07B at 2.0 ppm; quinoa,
grain at 0.04 ppm; and vegetable, fruiting, group 8-10 at 0.40 ppm. In
addition, EPA is removing the following existing spinetoram tolerances
that are superseded by this action including: Bushberry subgroup 13B at
0.25 ppm; caneberry subgroup 13A at 0.70 ppm; cotton, undelinted seed
at 0.02 ppm; fruit, citrus, group 10 at 0.30 ppm; fruit, pome, group 11
at 0.20 ppm; fruit, stone, group 12 at 0.20 ppm; grape at 0.50 ppm;
juneberry at 0.25 ppm; lingonberry at 0.25 ppm; nut tree, group 14 at
0.10 ppm; okra at 0.40 ppm; onion, green at 2.0 ppm; pistachio at 0.10
ppm; salal at 0.25 ppm; strawberry at 1.0 ppm; vegetable, bulb, group
3, except green onion at 0.10 ppm; and vegetable, fruiting group 8 at
0.4 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 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
[[Page 80282]]
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 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).
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: December 15, 2015.
Susan Lewis,
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. 180.635, in paragraph (a):
0
a. Revise the introductory text.
0
b. Remove from the table in paragraph (a) the entries for: Bushberry
subgroup 13B at 0.25 ppm; caneberry subgroup 13A at 0.70 ppm; cotton,
undelinted seed at 0.02 ppm; fruit, citrus, group 10 at 0.30 ppm;
fruit, pome, group 11 at 0.20 ppm; fruit, stone, group 12 at 0.20 ppm;
grape at 0.50 ppm; juneberry at 0.25 ppm; lingonberry at 0.25 ppm; nut
tree, group 14 at 0.10 ppm; okra at 0.40 ppm; onion, green at 2.0 ppm;
pistachio at 0.10 ppm; salal at 0.25 ppm; strawberry at 1.0 ppm;
vegetable, bulb, group 3, except green onion at 0.10 ppm; and
vegetable, fruiting group 8 at 0.4 ppm.
0
c. Add alphabetically the following commodities to the table in
paragraph (a).
The revision and additions read as follows:
Sec. 180.635 Spinetoram; tolerance for residues.
(a) General. Tolerances are established for residues of the
insecticide spinetoram, including its metabolites and degradates, in or
on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only the sum of
XDE-175-J: 1-H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione,2-[(6deoxy-
3-O-ethyl-2,4-di-O-methyl-[alpha]-L-mannopyranosyl)oxy]-13-
[[(2R,5S,6R)-5(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-
ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-
methyl-,(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR); XDE-175-L: 1H-as-
indaceno[3,2-d]oxacyclododecin-7,15-dione,2-[(6deoxy-3-O-ethyl-2,4-di-
O-methyl-[alpha]-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-
5(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-
,(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); ND-J:
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13[[(2S,5S,6R)-
6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-7,15-
dioxo2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-
as-indaceno[3,2d]oxacyclododecin-2-yl-6-deoxy-3-O-ethyl-2,4-di-O-
methyl-[alpha]-L-mannopyranoside; and NF-J: (2R,3S,6S)-6-
([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-O-
methyl-[alpha]-L-mannopyranosyl)oxy]-9-ethyl-14-methyl-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-
indaceno[3,2d]oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-3-
yl(methyl)formamide, calculated as the stoichiometric equivalent of
spinetoram.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Berry, low growing, subgroup 13-07G, except cranberry... 0.90
* * * * *
Bushberry subgroup 13-07B............................... 0.50
Caneberry subgroup 13-07A............................... 0.80
* * * * *
Coffee, green bean...................................... 0.04
* * * * *
Cottonseed subgroup 20C................................. 0.04
* * * * *
Fruit, citrus, group 10-10.............................. 0.30
Fruit, pome, group 11-10................................ 0.20
Fruit, small, vine climbing, subgroup 13-07F, except 0.50
fuzzy kiwifruit........................................
Fruit, stone 12-12...................................... 0.30
* * * * *
Nut, tree, group 14-12.................................. 0.10
* * * * *
Onion, bulb, subgroup 3-07A............................. 0.10
Onion, green, subgroup 3-07B............................ 2.0
* * * * *
Quinoa, grain........................................... 0.04
* * * * *
Vegetable, fruiting, group 8-10......................... 0.40
* * * * *
------------------------------------------------------------------------
[[Page 80283]]
* * * * *
[FR Doc. 2015-32329 Filed 12-23-15; 8:45 am]
BILLING CODE 6560-50-P
