Spinetoram; Pesticide Tolerances, 38976-38981 [2018-16989]
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38976
Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Rules and Regulations
SUBSTITUTES THAT ARE ACCEPTABLE SUBJECT TO USE CONDITIONS
End-use
Substitute
Household refrigerators,
freezers,
and combination refrigerators
and freezers
(New equipment only).
Isobutane (R600a).
Propane (R290).
R-441A .........
Decision
Acceptable
subject to
use conditions.
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Use conditions
Further information
As of September 7, 2018: ................................................
These refrigerants may be used only in new equipment
designed specifically and clearly identified for the refrigerant (i.e., none of these substitutes may be used
as a conversion or ‘‘retrofit’’ refrigerant for existing
equipment designed for a different refrigerant).
These refrigerants may be used only in a refrigerator or
freezer, or combination refrigerator and freezer, that
meets all requirements listed in the 2nd edition of the
Underwriters Laboratories (UL) Standard for Safety:
Household and Similar Electrical Appliances—Safety—Part 2–24: Particular Requirements for Refrigerating Appliances, Ice-Cream Appliances and IceMakers, UL 60335–2–24, dated April 28, 2017.
Applicable OSHA requirements at 29 CFR part 1910
must be followed, including those at 29 CFR 1910.106
(flammable and combustible liquids), 1910.110 (storage and handling of liquefied petroleum gases),
1910.157 (portable fire extinguishers), and 1910.1000
(toxic and hazardous substances).
Proper ventilation should be maintained at all times during the manufacture and storage of equipment containing hydrocarbon refrigerants through adherence to
good manufacturing practices as per 29 CFR
1910.106. If refrigerant levels in the air surrounding
the equipment rise above one-fourth of the lower flammability limit, the space should be evacuated and reentry should occur only after the space has been
properly ventilated.
Technicians and equipment manufacturers should wear
appropriate personal protective equipment, including
chemical goggles and protective gloves, when handling these refrigerants. Special care should be taken
to avoid contact with the skin since these refrigerants,
like many refrigerants, can cause freeze burns on the
skin.
A Class B dry powder type fire extinguisher should be
kept nearby.
Technicians should only use spark-proof tools when
working on refrigerators and freezers with these refrigerants.
Any recovery equipment used should be designed for
flammable refrigerants.
Any refrigerant releases should be in a well-ventilated
area, such as outside of a building.
Only technicians specifically trained in handling flammable refrigerants should service refrigerators and
freezers containing these refrigerants. Technicians
should gain an understanding of minimizing the risk of
fire and the steps to use flammable refrigerants safely.
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Note: The use conditions in this appendix contain references to certain standards from Underwriters Laboratories Inc. (UL). The standards are incorporated by reference, and the referenced sections are made part of the regulations in part 82:
1. UL 471. Commercial Refrigerators and Freezers. 10th edition. Supplement SB: Requirements for Refrigerators and Freezers Employing a Flammable Refrigerant
in the Refrigerating System. Underwriters Laboratories, Inc. November 24, 2010.
2. UL 484. Room Air Conditioners. 8th edition. Supplement SA: Requirements for Room Air Conditioners Employing a Flammable Refrigerant in the Refrigerating
System and Appendices B through F. December 21, 2007, with changes through August 3, 2012.
3. UL 541. Refrigerated Vending Machines. 7th edition. Supplement SA: Requirements for Refrigerated Venders Employing a Flammable Refrigerant in the Refrigerating System. December 30, 2011.
4. UL Standard 60335–2–24. Standard for Safety: Requirements for Household and Similar Electrical Appliances,—Safety—Part 2–24: Particular Requirements for
Refrigerating Appliances, Ice-Cream Appliances and Ice-Makers, Second edition, dated April 28, 2017.
The Director of the Federal Register
approves the incorporation by reference of
the material under ‘‘Use Conditions’’ in the
table ‘‘SUBSTITUTES THAT ARE
ACCEPTABLE SUBJECT TO USE
CONDITIONS’’ (5 U.S.C. 552(a) and 1 CFR
part 51). Copies of UL Standards 471, 484,
541, and 60335–2–24, may be purchased by
mail at: COMM 2000, 151 Eastern Avenue,
Bensenville, IL 60106; Email: orders@
shopulstandards.com; Telephone: 1–888–
853–3503 in the U.S. or Canada (other
countries dial 1–415–352–2178); internet
address: https://www.shopulstandards.com/
Catalog.aspx.
You may inspect a copy at U.S. EPA’s Air
Docket; EPA West Building, Room 3334;
1301 Constitution Ave. NW, Washington, DC
or at the National Archives and Records
Administration (NARA). For questions
regarding access to these standards, the
telephone number of EPA’S Air Docket is
202–566–1742. For information on the
availability of this material at NARA, call
202–741–6030, or go to: https://
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www.archives.gov/federal-register/cfr/ibrlocations.html.
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[FR Doc. 2018–16773 Filed 8–7–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0352; FRL–9978–83]
Spinetoram; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of spinetoram in
or on tea, dried and tea, instant. Dow
AgroSciences, LLC., requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
SUMMARY:
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This regulation is effective
August 8, 2018. Objections and requests
for hearings must be received on or
before October 9, 2018, and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2017–0352, 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
DATES:
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Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW, Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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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–2017–0352 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before October 9, 2018. 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
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as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2017–0352, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of October 23,
2017 (82 FR 49020) (FRL–9967–37),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 7E8554) by Dow
AgroSciences LLC, 9330 Zionsville
Road, Indianapolis, Indiana 46268–
1054. The petition requested that 40
CFR 180.635 be amended by
establishing tolerances for residues of
the insecticide spinetoram, in or on tea,
dried at 70 parts per million (ppm) and
tea, instant at 70 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.
There were no comments received in
response to the notice of filing.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
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all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for 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 its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. 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, therefore,
the Agency has assessed and
summarized the toxicological profile for
both together. The primary toxic effect
observed from exposure to spinetoram
and spinosad 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
the toxicological database 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 spinetoram or
spinosad exposure. In developmental
studies, no maternal or developmental
effects were seen in rats or rabbits. In
the rat reproduction toxicity studies,
offspring toxicity (decreased litter size,
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survival, and body weights with
spinosad; increased incidence of late
resorptions and post-implantation loss
with spinetoram) was seen in the
presence of parental toxicity (increased
organ weights, mortality, and
histopathological findings) at
approximately the same dose for both
chemicals. Dystocia and/or other
parturition abnormalities were observed
with both spinetoram and spinosad in
the reproduction toxicity studies. There
was no evidence of neurotoxicity,
immunotoxicity, or carcinogenicity from
spinetoram exposure.
Specific information on the studies
received and the nature of the adverse
effects caused by spinetoram as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
‘‘Spinosad/Spinetoram. Human Health
Risk Assessment in Support of Proposed
Spinetoram Tolerance for Residues in/
on Imported Tea’’ at page 8 in docket
ID number EPA–HQ–OPP–2017–0352
and in document ‘‘Spinosad/
Spinetoram. Draft Human Health Risk
Assessment for Registration Review,’’ at
pages 12–17 in docket ID number EPA–
HQ–OPP–2011–0666.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
Spinetoram and spinosad should be
considered toxicologically identical in
the same manner that metabolites are
generally considered toxicologically
identical to the parent. As a result,
studies from both toxicological
databases were considered for endpoint
selection.
A summary of the toxicological
endpoints for spinetoram used for
human risk assessment is shown in
Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPINETORAM/SPINOSAD FOR USE IN HUMAN
HEALTH RISK ASSESSMENT
Exposure/scenario
Point of departure
and uncertainty/
safety factors
Acute dietary (All populations) ..
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
A dose and endpoint of concern attributable to a single dose was not observed.
Chronic dietary (All populations)
NOAEL = 2.49 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD =
0.0249 mg/kg/day.
cPAD = 0.0249 mg/
kg/day.
Chronic Toxicity—Dog (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.
Incidental oral short-term (1 to
30 days) and intermediateterm (1 to 6 months).
NOAEL = 4.9 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
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.
Dermal (All durations) ...............
Inhalation short-term (1 to 30
days) and Intermediate-Term
(1–6 months).
No hazard was identified for dermal exposure; therefore, a quantitative dermal assessment is not needed.
Inhalation (or oral)
study NOAEL =
4.9 mg/kg/day (inhalation assumed
equivalent to oral).
UFA = 10x
UFH = 10x
FQPA SF = 1x
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Cancer (Oral, dermal, inhalation).
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.
Classified as ‘‘not likely to be carcinogenic to humans.’’
FQPA SF = Food Quality Protection Act Safety Factor. 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). UFDB = to account for the absence of data or other data deficiency. 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
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exposure to spinetoram and spinosad,
EPA considered exposure under the
petitioned-for tolerances as well as all
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existing spinetoram tolerances in 40
CFR 180.635 as well as existing
spinosad tolerances. With the exception
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Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Rules and Regulations
of tea, 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 active
ingredients 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. The risk assessment
included commodities that have
tolerances for both spinosad and
spinetoram as well as commodities
where only spinosad tolerances are
established. EPA aggregated exposure by
assuming that all commodities, with the
exception of tea, contain spinosad
(because side-by-side spinetoram and
spinosad residue data indicated that
spinetoram residues were less than or
equal to spinosad residues); for tea, EPA
assumed spinetoram residues were
present. EPA assessed dietary exposures
from spinetoram 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. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA NHANES/WWEIA
(2003–2008). As to residue levels in
food, EPA assumed 100 percent crop
treated (PCT), average field-trial
residues or tolerance-level residues for
crop commodities, average residues
from the livestock feeding studies,
spinosad residue estimates for fish/
shellfish (residues of spinetoram in fish/
shellfish are expected to be
insignificant), and experimental or
default processing factors.
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 percent
crop treated (PCT) information. EPA did
not use PCT information in the dietary
assessment for spinetoram. 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
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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
Pesticide Root Zone Model Ground
Water (PRZM GW), the estimated
drinking water concentrations (EDWCs)
of spinetoram for acute exposures are
estimated to be 25.9 parts per billion
(ppb) for surface water and below the
levels of detection for ground water. For
chronic exposures for non-cancer
assessments, the spinetoram EDWCs are
estimated to be 19.3 ppb for surface
water and well below the levels of
detection for ground water. EDWCs of
spinosad for acute exposures are
estimated to be 30.6 ppb for surface
water and below the levels of detection
for ground water. For chronic exposures
for noncancer assessments, the
spinetoram EDWCs are estimated to be
22.8 ppb for surface water and below
the levels of detection for ground water.
Modeled estimates of drinking water
concentration were directly entered into
the dietary exposure model. For chronic
dietary risk assessment, the water
concentration of value 22.8 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).
EPA assessed residential exposure
using the following assumptions: The
use on tea will not result in residential
exposure; however, spinetoram and
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38979
spinosad are currently registered for
uses that could result in residential
exposures including home lawns and
pet (cats/kittens) spot-on applications;
therefore, there is potential for
residential handler and post-application
exposures to both spinetoram and
spinosad. 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 the following ‘‘worstcase’’ residential exposure scenarios as:
(1) Adult residential handler (inhalation
exposure from applications to lawns
and turf) and (2) child (1–<2 years)
(hand-to-mouth exposures from postapplication exposure to turf). Because
EPA’s level of concern for spinetoram is
a MOE below 100, the MOEs for both of
these residential exposure scenarios are
not of concern. In addition, the shortterm assessment is protective of
intermediate-term exposure as the shortand intermediate-term PODs are
identical. 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 spinetoram to
share a common mechanism of toxicity
with any other substances, and
spinetoram does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that spinetoram does not have
a common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s website at https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
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D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There is no evidence of increased
prenatal or postnatal susceptibility.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for spinetoram
is adequate for FQPA SF consideration.
ii. There is no evidence of
neurotoxicity from spinetoram
exposure.
iii. There is no evidence that
spinetoram results in increased pre- or
post-natal susceptibility in rats or
rabbits.
iv. There are no residual uncertainties
identified in the exposure databases.
EPA made conservative (protective)
assumptions in assessing exposures and
these assessments will not
underestimate the exposure and risks
posed by spinetoram.
amozie on DSK3GDR082PROD with RULES
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
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18:24 Aug 07, 2018
Jkt 244001
and no acute dietary endpoint was
selected. Therefore, spinetoram is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to spinetoram
from food and water will utilize 72% 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 is not expected;
therefore, the chronic dietary estimate
represents the chronic aggregate
estimate.
3. Short- and Intermediate-term risk.
Short- and Intermediate-term aggregate
exposures takes into account short-term
and intermediated-term residential
exposures plus chronic exposure to food
and water (considered to be a
background exposure level). Spinetoram
is currently registered for uses that
could result in short- and intermediateterm residential exposure, and the
Agency has determined that it is
appropriate to aggregate chronic
exposure through food and water with
short- and intermediate-term residential
exposures to spinetoram.
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 780 for adults (handler) and
200 for children (post-application).
Because EPA’s level of concern for
spinetoram is a MOE below 100, these
MOEs are not of concern. In addition,
the short-term assessment is protective
of intermediate-term exposure as the
short- and intermediate-term PODs are
identical.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
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
Adequate enforcement methodology
is available for both plant and livestock
commodities. Method GRM 05.03
(HPLC/MS/MS) is an acceptable method
for the determination of spinetoram
residues in a variety of crops. Methods
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
GRM 05.15 and GRM 06.08 (HPLC/MS)
are acceptable methods for
determination of spinetoram residues in
bovine and poultry tissues, milk, cream,
and eggs. Both methods are available to
enforce the tolerance expression.
The methods may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for spinetoram.
V. Conclusion
Therefore, tolerances are established
for residues of spinetoram, expressed as
the combined residues of XDE–175–J: 1H-as-indaceno[3,2-d]oxacyclododecin7,15-dione, 2-[(6-deoxy-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-[(6-deoxy-3-O-ethyl-2,4-di-Omethyl-a-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-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[3,2-
E:\FR\FM\08AUR1.SGM
08AUR1
38981
Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Rules and Regulations
d]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-2,4-di-O-methyla-L-mannopyranosyl) oxy]-9-ethyl-14methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,
9,10,11,12,13,14,15,16a,16b-octade
cahydro-1H-as-indaceno[3,2-d]
oxacyclododecin-13-yl]oxy)-2methyltetrahydro-2H-pyran-3yl(methyl)formamide, in or on tea, dried
at 70 parts per million (ppm) and tea,
instant at 70 ppm.
amozie on DSK3GDR082PROD with RULES
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997); or Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). 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,
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18:24 Aug 07, 2018
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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).
and pests, Reporting and recordkeeping
requirements.
Dated: July 24, 2018.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.635 add alphabetically the
entries for ‘‘Tea, dried’’; and ‘‘Tea,
instant’’; and footnote 1 to the table in
paragraph (a) to read as follows:
■
§ 180.635 Spinetoram; tolerances for
residues.
(a) * * *
*
*
*
Tea, dried 1 ...........................
Tea, instant 1 .........................
*
*
*
Fmt 4700
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*
70
70
*
*
*
*
*
[FR Doc. 2018–16989 Filed 8–7–18; 8:45 am]
BILLING CODE 6560–50–P
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
Frm 00031
*
*
*
1 There are no U.S. registrations as of August 8, 2018 for use on tea.
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).
PO 00000
Parts per
million
Commodity
E:\FR\FM\08AUR1.SGM
08AUR1
Agencies
[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Rules and Regulations]
[Pages 38976-38981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16989]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0352; FRL-9978-83]
Spinetoram; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
spinetoram in or on tea, dried and tea, instant. Dow AgroSciences,
LLC., requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective August 8, 2018. Objections and
requests for hearings must be received on or before October 9, 2018,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0352, 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
[[Page 38977]]
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration 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: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0352 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 9, 2018. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0352, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of October 23, 2017 (82 FR 49020) (FRL-
9967-37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E8554) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis,
Indiana 46268-1054. The petition requested that 40 CFR 180.635 be
amended by establishing tolerances for residues of the insecticide
spinetoram, in or on tea, dried at 70 parts per million (ppm) and tea,
instant at 70 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. There were no comments received in
response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for 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 its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. 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, therefore, the
Agency has assessed and summarized the toxicological profile for both
together. The primary toxic effect observed from exposure to spinetoram
and spinosad 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
the toxicological database 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 spinetoram or spinosad exposure. In developmental studies, no
maternal or developmental effects were seen in rats or rabbits. In the
rat reproduction toxicity studies, offspring toxicity (decreased litter
size,
[[Page 38978]]
survival, and body weights with spinosad; increased incidence of late
resorptions and post-implantation loss with spinetoram) was seen in the
presence of parental toxicity (increased organ weights, mortality, and
histopathological findings) at approximately the same dose for both
chemicals. Dystocia and/or other parturition abnormalities were
observed with both spinetoram and spinosad in the reproduction toxicity
studies. There was no evidence of neurotoxicity, immunotoxicity, or
carcinogenicity from spinetoram exposure.
Specific information on the studies received and the nature of the
adverse effects caused by spinetoram as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Spinosad/Spinetoram. Human Health
Risk Assessment in Support of Proposed Spinetoram Tolerance for
Residues in/on Imported Tea'' at page 8 in docket ID number EPA-HQ-OPP-
2017-0352 and in document ``Spinosad/Spinetoram. Draft Human Health
Risk Assessment for Registration Review,'' at pages 12-17 in docket ID
number EPA-HQ-OPP-2011-0666.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
Spinetoram and spinosad should be considered toxicologically
identical in the same manner that metabolites are generally considered
toxicologically identical to the parent. As a result, studies from both
toxicological databases were considered for endpoint selection.
A summary of the toxicological endpoints for spinetoram used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Spinetoram/Spinosad 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.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 2.49 mg/kg/ Chronic RfD = Chronic Toxicity--Dog
day. 0.0249 mg/kg/day. (Spinetoram).
UFA = 10x........... cPAD = 0.0249 mg/kg/ LOAEL = 5.36/5.83 mg/kg/day (males/
UFH = 10x........... day. females) based on arteritis and
FQPA SF = 1x........ necrosis of the 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/ Residential LOC for Subchronic Oral Toxicity--Dog
30 days) and intermediate-term day. MOE <100. Study (with spinosad).
(1 to 6 months). UFA = 10x........... LOAEL = 9.73 mg/kg/day based on
UFH = 10x........... microscopic changes in multiple
FQPA SF = 1x........ organs, clinical signs of
toxicity, decreases in body
weights and food consumption, and
biochemical evidence of anemia
and liver damage.
----------------------------------------------------------------------------------------------------------------
Dermal (All durations)........... No hazard was identified for dermal exposure; therefore, a quantitative
dermal assessment is not needed.
----------------------------------------------------------------------------------------------------------------
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 MOE <100. Study (with spinosad).
months). mg/kg/day LOAEL = 9.73 mg/kg/day based on
(inhalation assumed microscopic changes in multiple
equivalent 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.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. 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). UFDB = to account for the absence of data or other
data deficiency. 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. With the
exception
[[Page 38979]]
of tea, 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
active ingredients 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. The risk
assessment included commodities that have tolerances for both spinosad
and spinetoram as well as commodities where only spinosad tolerances
are established. EPA aggregated exposure by assuming that all
commodities, with the exception of tea, contain spinosad (because side-
by-side spinetoram and spinosad residue data indicated that spinetoram
residues were less than or equal to spinosad residues); for tea, EPA
assumed spinetoram residues were present. EPA assessed dietary
exposures from spinetoram 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. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA (2003-2008). As to residue levels in food, EPA assumed 100
percent crop treated (PCT), average field-trial residues or tolerance-
level residues for crop commodities, average residues from the
livestock feeding studies, spinosad residue estimates for fish/
shellfish (residues of spinetoram in fish/shellfish are expected to be
insignificant), and experimental or default processing factors.
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 percent crop treated (PCT) information.
EPA did not use PCT information in the dietary assessment for
spinetoram. 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
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of spinetoram for acute exposures
are estimated to be 25.9 parts per billion (ppb) for surface water and
below the levels of detection for ground water. For chronic exposures
for non-cancer assessments, the spinetoram EDWCs are estimated to be
19.3 ppb for surface water and well below the levels of detection for
ground water. EDWCs of spinosad for acute exposures are estimated to be
30.6 ppb for surface water and below the levels of detection for ground
water. For chronic exposures for noncancer assessments, the spinetoram
EDWCs are estimated to be 22.8 ppb for surface water and below the
levels of detection for ground water.
Modeled estimates of drinking water concentration were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 22.8 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).
EPA assessed residential exposure using the following assumptions:
The use on tea will not result in residential exposure; however,
spinetoram and spinosad are currently registered for uses that could
result in residential exposures including home lawns and pet (cats/
kittens) spot-on applications; therefore, there is potential for
residential handler and post-application exposures to both spinetoram
and spinosad. 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 the following ``worst-case'' residential exposure
scenarios as: (1) Adult residential handler (inhalation exposure from
applications to lawns and turf) and (2) child (1-<2 years) (hand-to-
mouth exposures from post-application exposure to turf). Because EPA's
level of concern for spinetoram is a MOE below 100, the MOEs for both
of these residential exposure scenarios are not of concern. In
addition, the short-term assessment is protective of intermediate-term
exposure as the short- and intermediate-term PODs are identical.
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 spinetoram to share a common mechanism of
toxicity with any other substances, and spinetoram does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
spinetoram does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
[[Page 38980]]
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There is no evidence of
increased prenatal or postnatal susceptibility.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for spinetoram is adequate for FQPA SF
consideration.
ii. There is no evidence of neurotoxicity from spinetoram exposure.
iii. There is no evidence that spinetoram results in increased pre-
or post-natal susceptibility in rats or rabbits.
iv. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in assessing
exposures and these assessments will not underestimate the exposure and
risks posed by spinetoram.
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 is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
spinetoram from food and water will utilize 72% 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 is not expected; therefore, the chronic dietary estimate
represents the chronic aggregate estimate.
3. Short- and Intermediate-term risk. Short- and Intermediate-term
aggregate exposures takes into account short-term and intermediated-
term residential exposures plus chronic exposure to food and water
(considered to be a background exposure level). Spinetoram is currently
registered for uses that could result in short- and intermediate-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short- and intermediate-term residential exposures to spinetoram.
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 780 for adults
(handler) and 200 for children (post-application). Because EPA's level
of concern for spinetoram is a MOE below 100, these MOEs are not of
concern. In addition, the short-term assessment is protective of
intermediate-term exposure as the short- and intermediate-term PODs are
identical.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, 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
Adequate enforcement methodology is available for both plant and
livestock commodities. Method GRM 05.03 (HPLC/MS/MS) is an acceptable
method for the determination of spinetoram residues in a variety of
crops. Methods GRM 05.15 and GRM 06.08 (HPLC/MS) are acceptable methods
for determination of spinetoram residues in bovine and poultry tissues,
milk, cream, and eggs. Both methods are available to enforce the
tolerance expression.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for spinetoram.
V. Conclusion
Therefore, tolerances are established for residues of spinetoram,
expressed as the combined residues of XDE-175-J: 1-H-as-indaceno[3,2-
d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-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-[(6-deoxy-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-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-
[[Page 38981]]
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]-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[3,2-d]oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-
3-yl(methyl)formamide, in or on tea, dried at 70 parts per million
(ppm) and tea, instant at 70 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 Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 24, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.635 add alphabetically the entries for ``Tea, dried'';
and ``Tea, instant''; and footnote 1 to the table in paragraph (a) to
read as follows:
Sec. 180.635 Spinetoram; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Tea, dried \1\.......................................... 70
Tea, instant \1\........................................ 70
* * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of August 8, 2018 for use on tea.
* * * * *
[FR Doc. 2018-16989 Filed 8-7-18; 8:45 am]
BILLING CODE 6560-50-P