Spiromesifen; Pesticide Tolerances, 45844-45849 [2018-19760]
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Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Rules and Regulations
mexyl, (acetic acid [(5-chloro-8quinolinyl)oxy]-, 1-methylhexyl ester;
CAS Reg. No. 99607–70–2) and its acid
metabolite (5-chloro-8quinolinoxyacetic acid), expressed as
cloquintocet-mexyl, in or on the
following commodities:
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*
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*
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[FR Doc. 2018–19757 Filed 9–10–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0505; FRL–9982–21]
Spiromesifen; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of spiromesifen in
or on coffee. Bayer CropScience
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective
September 11, 2018. Objections and
requests for hearings must be received
on or before November 13, 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–2017–0505, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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DATES:
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I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them.
Potentially affected entities may
include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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–2017–0505 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 November 13, 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–
2017–0505, by one of the following
methods:
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• 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 February
27, 2018 (83 FR 8408) (FRL–9972–17),
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 7E8584) by Bayer
CropScience, 2 T.W. Alexander Drive,
Research Triangle Park, NC 27709. The
petition requested that 40 CFR part 180
be amended by establishing tolerances
for residues of spiromesifen; 2-oxo-3(2,4,6-trimethylphenyl)-1oxaspiro[4.4]non-3-en-4-yl 3,3dimethylbutanoate, and its enol
metabolite (4-hydroxy-3-(2,4,6trimethylphenyl)-1-oxaspiro[4.4]non-3en-2-one calculated as the
stoichiometric equivalent of
spiromesifen in or on the raw
agricultural commodities: Coffee bean,
green at 0.20 parts per million (ppm);
coffee, instant at 0.20 ppm; and coffee
bean, roasted at 0.20 ppm. That
document referenced a summary of the
petition prepared by Bayer CropScience,
the registrant, which is available in the
docket, https://www.regulations.gov.
Comments were received on the notice
of filing. EPA’s response to these
comments is discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA has
modified the commodities for which
tolerances are being established. The
reason for these changes is explained in
Unit IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
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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 spiromesifen
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with spiromesifen 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.
Following oral administration of
spiromesifen, the target organs included
the thyroid gland for rats and dogs
(increased thyroid-stimulating hormone
(TSH), increased thyroxine binding
capacity, decreased triiodothyronine
(T3) and thyroxine (T4) levels, colloidal
alteration, and thyroid follicular cell
hypertrophy), the liver for rats and dogs
(increased alkaline phosphatase, alanine
transaminase (ALT), and decreased
cholesterol and triglycerides), the spleen
for rats (atrophy, decreased spleen cell
count, and increased macrophages), and
the adrenal gland for mice
(discoloration, decrease in fine
vesiculation, and the presence of
cytoplasmic eosinophilia in zona
fasciculata cells). For rats, additional
effects included reduced body weights
and clinical signs (piloerection, reduced
motility, spastic gait, and increased
reactivity when touched).
There were no adverse effects in rats
following dermal exposure up to the
limit dose (1,000 milligrams/kilograms/
day (mg/kg/day)). Decreased spleen
weights were also observed for rats in a
5-day inhalation toxicity study, along
with gross pathological findings in the
lung (dark red areas or foci) and clinical
signs (e.g., tremors, clonic-tonic
convulsions, reduced activity,
bradypnea, etc.).
While the clinical signs observed in
rats following oral and inhalation
exposures could indicate neurotoxicity,
there was no evidence of neurotoxicity
in the rest of the toxicological database,
including the acute neurotoxicity study
up to the limit dose (2,000 milligrams/
kilograms (mg/kg)) and the subchronic
neurotoxicity study; however, the doses
tested in the subchronic neurotoxicity
study were lower than the doses causing
clinical signs in the 90-day dietary
study in rats. There was no evidence of
immunotoxicity in an antibody plaquecell forming assay.
There was no evidence of increased
pre- or post-natal susceptibility. In the
developmental toxicity studies in rats
and rabbits, maternal effects were
observed in the absence of fetal effects.
In the rat two-generation reproductive
toxicity study, the reported parental
effects, consisting of decreased spleen
weights (relative and absolute) and a
decreasing number of ovarian follicles,
occurred at a dose level that also caused
pup body weight decrements during
lactation.
Spiromesifen is classified as ‘‘Not
likely to be Carcinogenic to Humans’’
based on the absence of treatmentrelated tumors in two adequate rodent
carcinogenicity studies. There was no
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concern for mutagenicity or
genotoxicity.
Specific information on the studies
received and the nature of the adverse
effects caused by spiromesifen 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 the document
titled, ‘‘Spiromesifen. Human Health
Risk Assessment in Support of Proposed
Tolerance for Residues of in/on
Imported Coffee’’ in docket ID number
EPA–HQ–OPP–2017–0505.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which the NOAEL and the
LOAEL are identified. Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for spiromesifen used for
human risk assessment is shown in
Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPIROMESIFEN FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Point of departure and
uncertainty/safety factors
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Exposure/scenario
Acute dietary (All populations) .............
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RfD, PAD, LOC for risk
assessment
Study and toxicological effects
No appropriate toxicological effect attributable to a single dose was observed. Therefore, a dose and
endpoint were not identified for this risk assessment.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SPIROMESIFEN FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Point of departure and
uncertainty/safety factors
RfD, PAD, LOC for risk
assessment
Chronic dietary (All populations) .........
NOAEL = 2.2 mg/kg/day
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.022
mg/kg/day.
cPAD = 0.022 mg/kg/
day
Two-Generation Reproduction Study—Rats
Parental LOAEL = 8.8 mg/kg bw/day based on
significantly decreased spleen weight (absolute
and relative in parental females and F1 males)
and significantly decreased growing ovarian
follicles in females.
Oral short-term (1 to 30 days) and intermediate-term (1–6 months).
NOAEL = 2.2 mg/kg/day
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100 ......
Two-Generation Reproduction Study—Rats
Parental LOAEL = 8.8 mg/kg bw/day based on
significantly decreased spleen weight (absolute
and relative in parental females and F1 males)
and significantly decreased growing ovarian
follicles in females.
Inhalation short-term (1 to 30 days)
and intermediate-term (1–6 months).
Inhalation study NOAEC
= 0.0794 mg/L/day.
UFA = 3x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 30
5-Day Inhalation Toxicity Study—Rats LOAEC =
0.5143 mg/L/day based on clinical signs (tremors, clonic-tonic convulsions, reduced activity,
bradypnea, labored breathing, vocalization,
avoidance reaction, giddiness, piloerection,
limp, emaciation, cyanosis, squatted posture,
apathy and salivation), gross pathology (dark
red areas or foci in the lungs and bloated
stomachs and pale livers), and decreased
spleen weights.
Cancer (Oral, dermal, inhalation) ........
Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on the absence of treatment-related tumors in two adequate rodent carcinogenicity studies.
Study and toxicological effects
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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). UFH = potential variation in
sensitivity among members of the human population (intraspecies). NOAEC = non-observed adverse-effect concentration. LOAEC = lowest-observed adverse-effect concentration.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to spiromesifen, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing spiromesifen tolerances in 40
CFR 180.607. EPA assessed dietary
exposures from spiromesifen 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 spiromesifen; 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 United States Department of
Agriculture (USDA) National Health and
Nutrition Examination Survey, What We
Eat in America (NHANES/WWEIA;
2003–2008). As to residue levels in
food, the chronic (food and water)
analysis assumed 100 percent crop
treated (PCT) and tolerance-level
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residues or tolerance-level residues
adjusted to account for the residue of
concern.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that spiromesifen does not
pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue or PCT information
in the dietary assessment for
spiromesifen. Tolerance level residues
or tolerance-level residues adjusted to
account for the residue of concern and
100 PCT were assumed for all food
commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for spiromesifen in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
spiromesifen. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www2.epa.gov/
pesticide-science-and-assessing-
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pesticide-risks/about-water-exposuremodels-used-pesticide.
Based on the Provisional Cranberry
model and Pesticide Water Calculator—
Groundwater (PWC–GW) model, the
estimated drinking water concentrations
(EDWCs) of spiromesifen for chronic
exposures are estimated to be 188 parts
per billion (ppb) for surface water and
116 ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For the
chronic dietary risk assessment, the
water concentration of value 188 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).
Spiromesifen is currently registered
for the following uses that could result
in residential exposures: Ornamentals.
EPA assessed residential exposure using
the following assumptions: Short-term
inhalation exposure to residential
handlers is expected. A dermal
assessment (handler and post-
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application) was not conducted since no
hazard was identified via the dermal
route. Post-application inhalation
exposures were not assessed due to the
low vapor pressure and the expected
dilution in outdoor sites. Postapplication incidental oral exposure is
considered unlikely since the use is
restricted to ornamental plants (turf
treatment is not permitted). Therefore,
only short-term inhalation exposure to
handlers was assessed. Further
information regarding EPA standard
assumptions and generic inputs for
residential exposures may be found at
https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/standardoperating-procedures-residentialpesticide.
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 spiromesifen to
share a common mechanism of toxicity
with any other substances, and
spiromesifen does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that spiromesifen 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
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
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data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There was no evidence of increased preor post-natal susceptibility. In the
developmental toxicity studies in rats
and rabbits, maternal effects were
observed in the absence of fetal effects.
In the rat two-generation reproductive
toxicity study, the reported parental
effects, consisting of decreased spleen
weights (relative and absolute) and a
decreasing number of ovarian follicles,
occurred at a dose level that also caused
pup body weight decrements during
lactation.
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
spiromesifen is complete.
ii. There is no indication that
spiromesifen is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional uncertainty factors (UFs) to
account for neurotoxicity.
iii. There is no evidence that
spiromesifen results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2-generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to spiromesifen
in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children as well
as incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by spiromesifen.
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, spiromesifen 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 spiromesifen
from food and water will utilize 68% of
the cPAD for children 1 to 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
spiromesifen 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). Spiromesifen 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 spiromesifen.
Because the level of concern (LOC) for
inhalation (LOC for MOEs <30) and oral
(LOC for MOEs <100) exposure differ,
the aggregate assessment was calculated
using the aggregate risk index (ARI)
approach. The ARI was devised as a
way to aggregate MOEs that have
dissimilar uncertainty factors. The ARI
is an extension of the MOE concept and
as with the MOE, risk increases as the
ARI decreases. An ARI that is greater
than or equal to 1 is not of concern.
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 an
aggregate ARI of 1.87. Because EPA’s
level of concern for spiromesifen is an
ARI of 1 or below, this ARI is not of
concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
An intermediate-term adverse effect
was identified; however, spiromesifen is
not registered for any use patterns that
would result in intermediate-term
residential exposure. Intermediate-term
risk is assessed based on intermediateterm residential exposure plus chronic
dietary exposure. Because there is no
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intermediate-term residential exposure
and chronic dietary exposure has
already been assessed under the
appropriately protective cPAD (which is
at least as protective as the POD used to
assess intermediate-term risk), no
further assessment of intermediate-term
risk is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating intermediate-term risk for
spiromesifen.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
spiromesifen is not expected to pose a
cancer risk to humans.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to spiromesifen
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(liquid chromatography/mass
spectrometry/mass spectrometry (LC/
MS/MS)) is available to enforce the
tolerance expression.
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.
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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 has a MRL for residues of only
spiromesifen in/on coffee beans of 0.05
ppm. Since the residue expression for
the U.S. and Codex tolerances differ and
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since the maximum combined residues
of spiromesifen and BSN 2060-enol in/
on coffee green bean from the field trials
was greater than 0.1 ppm,
harmonization with the Codex
expression/value is not possible. Note
that BSN 2060-enol is included in the
tolerance expression due to the
demonstrated degradation of parent to
BSN 2060-enol during storage.
C. Response to Comments
Three comments were submitted to
the docket for this action. Two
comments, one about ‘‘China’s ongoing
economic war against the United States’’
and another about air and water
pollution in China relative to that of the
United States, are not relevant to this
action. The third comment stated in part
that ‘‘the people drinking coffee should
not have this toxic chemical as part of
its drink.’’
The Agency recognizes that some
individuals believe that pesticides
should be banned on agricultural crops;
however, the existing legal framework
provided by section 408 of the FFDCA
states that tolerances may be set when
persons seeking such tolerances or
exemptions have demonstrated that the
pesticide meets the safety standard
imposed by that statute. This citizen’s
comment appears to be directed at the
underlying statute and not EPA’s
implementation of it; the citizen has
made no contention that EPA has acted
in violation of the statutory framework
nor have they provided any specific
information or allegation that would
support a finding that these tolerances
are unsafe.
D. Revisions to Petitioned-For
Tolerances
The green coffee bean tolerance being
established is identical to that proposed
by the petitioner. EPA has determined
that separate tolerances for the
processed commodities of roasted coffee
bean and instant coffee are unnecessary
because the processing data indicates
that combined residues of spiromesifen
and BSN 2060-enol do not concentrate
in roasted or instant coffee.
V. Conclusion
Therefore, a tolerance is established
for residues of spiromesifen, including
its metabolites and degradates, in or on
coffee, green bean at 0.20 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
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Fmt 4700
Sfmt 4700
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), nor is it considered a
regulatory action under 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.).
E:\FR\FM\11SER1.SGM
11SER1
Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Rules and Regulations
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).
DEPARTMENT OF COMMERCE
VII. Congressional Review Act
RIN 0648–XG458
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).
International Fisheries; Western and
Central Pacific Fisheries for Highly
Migratory Species; Closure of Purse
Seine Fishery on the High Seas in 2018
50 CFR Part 300
[Docket No. 180209155–8589–02]
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; fishery closure.
AGENCY:
NMFS announces that the
U.S. purse seine fishery on the high seas
in the area of application of the
Environmental protection,
Convention on the Conservation and
Administrative practice and procedure,
Management of Highly Migratory Fish
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping Stocks in the Western and Central
Pacific Ocean (Convention) between the
requirements.
latitudes of 20° N and 20° S will close
as a result of reaching the 2018 limit on
Dated: August 28, 2018.
purse seine fishing effort in that area.
Michael Goodis,
This action is necessary for the United
Director, Registration Division, Office of
States to implement provisions of a
Pesticide Programs.
conservation and management measure
adopted by the Commission for the
Therefore, 40 CFR chapter I is
Conservation and Management of
amended as follows:
Highly Migratory Fish Stocks in the
Western and Central Pacific Ocean
PART 180—[AMENDED]
(WCPFC or Commission) and to satisfy
the obligations of the United States
■ 1. The authority citation for part 180
under the Convention, to which it is a
continues to read as follows:
Contracting Party.
Authority: 21 U.S.C. 321(q), 346a and 371.
DATES: Effective 00:00 on September 18,
2018 coordinated universal time (UTC),
■ 2. In § 180.607, add alphabetically the
until 24:00 on December 31, 2018 UTC.
commodity ‘‘coffee, green bean’’ and
FOR FURTHER INFORMATION CONTACT: Rini
footnote 1 to the table in paragraph
Ghosh, NMFS Pacific Islands Regional
(a)(1) to read as follows:
Office, 808–725–5033.
SUPPLEMENTARY INFORMATION:
§ 180.607 Spiromesifen; tolerances for
U.S. purse seine fishing in the area of
residues.
application of the Convention, or
(a) * * *
Convention Area, is managed, in part,
under the Western and Central Pacific
(1) * * *
Fisheries Convention Implementation
Act (16 U.S.C. 6901 et seq.). Regulations
Parts per
Commodity
million
implementing the Act are at 50 CFR part
300, subpart O. On behalf of the
Secretary of Commerce, NMFS
*
*
*
*
*
promulgates regulations under the Act
1
Coffee, green bean .................
0.20 as may be necessary to carry out the
obligations of the United States under
*
*
*
*
*
the Convention, including
1 This use has not been registered in the
implementation of the decisions of the
United States as of August 28, 2018.
Commission.
Pursuant to WCPFC Conservation and
*
*
*
*
*
Management Measure 2017–01, NMFS
[FR Doc. 2018–19760 Filed 9–10–18; 8:45 am]
issued regulations that established a
BILLING CODE 6560–50–P
limit of 1,370 fishing days that may be
used by U.S. purse seine fishing vessels
List of Subjects in 40 CFR Part 180
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National Oceanic and Atmospheric
Administration
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16:11 Sep 10, 2018
Jkt 244001
SUMMARY:
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45849
on the high seas between the latitudes
of 20° N and 20° S in the Convention
Area in calendar year 2018 (see final
rule at 83 FR 33851, published July 18,
2018, codified at 50 CFR 300.223). A
fishing day means any day in which a
fishing vessel of the United States
equipped with purse seine gear searches
for fish, deploys a fish aggregating
device (FAD), services a FAD, or sets a
purse seine, with the exception of
setting a purse seine solely for the
purpose of testing or cleaning the gear
and resulting in no catch (see definition
at 50 CFR 300.211).
Based on data submitted in logbooks
and other available information, NMFS
expects that the 2018 limit of 1,370
fishing days will be reached, and in
accordance with the procedures
established at 50 CFR 300.223(a),
announces that the purse seine fishery
on the high seas between the latitudes
of 20° N and 20° S in the Convention
Area will be closed starting at 00:00 on
September 18, 2018 UTC, and will
remain closed until 24:00 on December
31, 2018 UTC. Accordingly, it shall be
prohibited for any fishing vessel of the
United States equipped with purse seine
gear to be used for fishing on the high
seas between the latitudes of 20° N and
20° S in the Convention Area from 00:00
on September 18, 2018 UTC until 24:00
December 31, 2018 UTC, except that
such vessels will not be prohibited from
bunkering in that area during that
period (50 CFR 300.223(a)). Fishing
means using any vessel, vehicle, aircraft
or hovercraft for any of the following
activities, or attempting to do so: (1)
Searching for, catching, taking, or
harvesting fish; (2) engaging in any
other activity which can reasonably be
expected to result in the locating,
catching, taking, or harvesting of fish for
any purpose; (3) placing, searching for,
or recovering fish aggregating devices or
associated electronic equipment such as
radio beacons; (4) engaging in any
operations at sea directly in support of,
or in preparation for, any of the
activities previously described in
elements (1) through (3) of this
definition, including, but not limited to,
bunkering; or (5) engaging in
transshipment at sea, either unloading
or loading fish (see definition at 50 CFR
300.211). As noted above, bunkering
will not be prohibited in the closure
area during the closure period. This rule
does not prohibit lawful fishing with
purse seine gear within the U.S.
Exclusive Economic Zone within the
Convention Area.
Classification
There is good cause under 5 U.S.C.
553(b)(B) to waive prior notice and
E:\FR\FM\11SER1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Rules and Regulations]
[Pages 45844-45849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19760]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0505; FRL-9982-21]
Spiromesifen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
spiromesifen in or on coffee. Bayer CropScience requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 11, 2018. Objections and
requests for hearings must be received on or before November 13, 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-2017-0505, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration 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-2017-0505 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
November 13, 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-2017-0505, 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 February 27, 2018 (83 FR 8408) (FRL-
9972-17), 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
7E8584) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle
Park, NC 27709. The petition requested that 40 CFR part 180 be amended
by establishing tolerances for residues of spiromesifen; 2-oxo-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate, and its enol metabolite (4-hydroxy-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one calculated as the
stoichiometric equivalent of spiromesifen in or on the raw agricultural
commodities: Coffee bean, green at 0.20 parts per million (ppm);
coffee, instant at 0.20 ppm; and coffee bean, roasted at 0.20 ppm. That
document referenced a summary of the petition prepared by Bayer
CropScience, the registrant, which is available in the docket, https://www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
modified the commodities for which tolerances are being established.
The reason for these changes is explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA
[[Page 45845]]
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 spiromesifen including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with spiromesifen 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.
Following oral administration of spiromesifen, the target organs
included the thyroid gland for rats and dogs (increased thyroid-
stimulating hormone (TSH), increased thyroxine binding capacity,
decreased triiodothyronine (T3) and thyroxine
(T4) levels, colloidal alteration, and thyroid follicular
cell hypertrophy), the liver for rats and dogs (increased alkaline
phosphatase, alanine transaminase (ALT), and decreased cholesterol and
triglycerides), the spleen for rats (atrophy, decreased spleen cell
count, and increased macrophages), and the adrenal gland for mice
(discoloration, decrease in fine vesiculation, and the presence of
cytoplasmic eosinophilia in zona fasciculata cells). For rats,
additional effects included reduced body weights and clinical signs
(piloerection, reduced motility, spastic gait, and increased reactivity
when touched).
There were no adverse effects in rats following dermal exposure up
to the limit dose (1,000 milligrams/kilograms/day (mg/kg/day)).
Decreased spleen weights were also observed for rats in a 5-day
inhalation toxicity study, along with gross pathological findings in
the lung (dark red areas or foci) and clinical signs (e.g., tremors,
clonic-tonic convulsions, reduced activity, bradypnea, etc.).
While the clinical signs observed in rats following oral and
inhalation exposures could indicate neurotoxicity, there was no
evidence of neurotoxicity in the rest of the toxicological database,
including the acute neurotoxicity study up to the limit dose (2,000
milligrams/kilograms (mg/kg)) and the subchronic neurotoxicity study;
however, the doses tested in the subchronic neurotoxicity study were
lower than the doses causing clinical signs in the 90-day dietary study
in rats. There was no evidence of immunotoxicity in an antibody plaque-
cell forming assay.
There was no evidence of increased pre- or post-natal
susceptibility. In the developmental toxicity studies in rats and
rabbits, maternal effects were observed in the absence of fetal
effects. In the rat two-generation reproductive toxicity study, the
reported parental effects, consisting of decreased spleen weights
(relative and absolute) and a decreasing number of ovarian follicles,
occurred at a dose level that also caused pup body weight decrements
during lactation.
Spiromesifen is classified as ``Not likely to be Carcinogenic to
Humans'' based on the absence of treatment-related tumors in two
adequate rodent carcinogenicity studies. There was no concern for
mutagenicity or genotoxicity.
Specific information on the studies received and the nature of the
adverse effects caused by spiromesifen 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 the document titled, ``Spiromesifen. Human
Health Risk Assessment in Support of Proposed Tolerance for Residues of
in/on Imported Coffee'' in docket ID number EPA-HQ-OPP-2017-0505.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for spiromesifen used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Spiromesifen for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations).... No appropriate toxicological effect attributable to a single dose was
observed. Therefore, a dose and endpoint were not identified for this risk
assessment.
----------------------------------------------------------------------------------------------------------------
[[Page 45846]]
Chronic dietary (All populations).. NOAEL = 2.2 mg/kg/day. Chronic RfD = 0.022 mg/ Two-Generation Reproduction
UFA = 10x............. kg/day. Study--Rats
UFH = 10x............. cPAD = 0.022 mg/kg/day Parental LOAEL = 8.8 mg/kg
FQPA SF = 1x.......... bw/day based on
significantly decreased
spleen weight (absolute
and relative in parental
females and F1 males) and
significantly decreased
growing ovarian follicles
in females.
----------------------------------------------------------------------------------------------------------------
Oral short-term (1 to 30 days) and NOAEL = 2.2 mg/kg/day. LOC for MOE = 100..... Two-Generation Reproduction
intermediate-term (1-6 months). UFA = 10x............. Study--Rats
UFH = 10x............. Parental LOAEL = 8.8 mg/kg
FQPA SF = 1x.......... bw/day based on
significantly decreased
spleen weight (absolute
and relative in parental
females and F1 males) and
significantly decreased
growing ovarian follicles
in females.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30 Inhalation study NOAEC LOC for MOE = 30 5-Day Inhalation Toxicity
days) and intermediate-term (1-6 = 0.0794 mg/L/day. Study--Rats LOAEC = 0.5143
months). UFA = 3x.............. mg/L/day based on clinical
UFH = 10x............. signs (tremors, clonic-
FQPA SF = 1x.......... tonic convulsions, reduced
activity, bradypnea,
labored breathing,
vocalization, avoidance
reaction, giddiness,
piloerection, limp,
emaciation, cyanosis,
squatted posture, apathy
and salivation), gross
pathology (dark red areas
or foci in the lungs and
bloated stomachs and pale
livers), and decreased
spleen weights.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).. Classification: ``Not likely to be Carcinogenic to Humans'' based on the
absence of treatment-related tumors in two adequate rodent carcinogenicity
studies.
----------------------------------------------------------------------------------------------------------------
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). UFH = potential variation in sensitivity among
members of the human population (intraspecies). NOAEC = non-observed adverse-effect concentration. LOAEC =
lowest-observed adverse-effect concentration.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spiromesifen, EPA considered exposure under the petitioned-
for tolerances as well as all existing spiromesifen tolerances in 40
CFR 180.607. EPA assessed dietary exposures from spiromesifen 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 spiromesifen; 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 United States
Department of Agriculture (USDA) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA; 2003-2008).
As to residue levels in food, the chronic (food and water) analysis
assumed 100 percent crop treated (PCT) and tolerance-level residues or
tolerance-level residues adjusted to account for the residue of
concern.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that spiromesifen does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
spiromesifen. Tolerance level residues or tolerance-level residues
adjusted to account for the residue of concern and 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spiromesifen in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of spiromesifen. 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 Provisional Cranberry model and Pesticide Water
Calculator--Groundwater (PWC-GW) model, the estimated drinking water
concentrations (EDWCs) of spiromesifen for chronic exposures are
estimated to be 188 parts per billion (ppb) for surface water and 116
ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the chronic dietary risk
assessment, the water concentration of value 188 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).
Spiromesifen is currently registered for the following uses that
could result in residential exposures: Ornamentals. EPA assessed
residential exposure using the following assumptions: Short-term
inhalation exposure to residential handlers is expected. A dermal
assessment (handler and post-
[[Page 45847]]
application) was not conducted since no hazard was identified via the
dermal route. Post-application inhalation exposures were not assessed
due to the low vapor pressure and the expected dilution in outdoor
sites. Post-application incidental oral exposure is considered unlikely
since the use is restricted to ornamental plants (turf treatment is not
permitted). Therefore, only short-term inhalation exposure to handlers
was assessed. 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 spiromesifen to share a common mechanism of
toxicity with any other substances, and spiromesifen does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
spiromesifen 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.
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 pre- or post-natal susceptibility. In the developmental
toxicity studies in rats and rabbits, maternal effects were observed in
the absence of fetal effects. In the rat two-generation reproductive
toxicity study, the reported parental effects, consisting of decreased
spleen weights (relative and absolute) and a decreasing number of
ovarian follicles, occurred at a dose level that also caused pup body
weight decrements during lactation.
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 spiromesifen is complete.
ii. There is no indication that spiromesifen is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors (UFs) to account for neurotoxicity.
iii. There is no evidence that spiromesifen results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to spiromesifen 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
spiromesifen.
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,
spiromesifen 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
spiromesifen from food and water will utilize 68% of the cPAD for
children 1 to 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
spiromesifen 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). Spiromesifen
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 spiromesifen.
Because the level of concern (LOC) for inhalation (LOC for MOEs
<30) and oral (LOC for MOEs <100) exposure differ, the aggregate
assessment was calculated using the aggregate risk index (ARI)
approach. The ARI was devised as a way to aggregate MOEs that have
dissimilar uncertainty factors. The ARI is an extension of the MOE
concept and as with the MOE, risk increases as the ARI decreases. An
ARI that is greater than or equal to 1 is not of concern.
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 an aggregate ARI of 1.87. Because
EPA's level of concern for spiromesifen is an ARI of 1 or below, this
ARI is not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
An intermediate-term adverse effect was identified; however,
spiromesifen is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no
[[Page 45848]]
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for spiromesifen.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, spiromesifen is not expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to spiromesifen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry (LC/MS/MS)) is available to enforce the
tolerance expression.
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:
[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.
Codex has a MRL for residues of only spiromesifen in/on coffee
beans of 0.05 ppm. Since the residue expression for the U.S. and Codex
tolerances differ and since the maximum combined residues of
spiromesifen and BSN 2060-enol in/on coffee green bean from the field
trials was greater than 0.1 ppm, harmonization with the Codex
expression/value is not possible. Note that BSN 2060-enol is included
in the tolerance expression due to the demonstrated degradation of
parent to BSN 2060-enol during storage.
C. Response to Comments
Three comments were submitted to the docket for this action. Two
comments, one about ``China's ongoing economic war against the United
States'' and another about air and water pollution in China relative to
that of the United States, are not relevant to this action. The third
comment stated in part that ``the people drinking coffee should not
have this toxic chemical as part of its drink.''
The Agency recognizes that some individuals believe that pesticides
should be banned on agricultural crops; however, the existing legal
framework provided by section 408 of the FFDCA states that tolerances
may be set when persons seeking such tolerances or exemptions have
demonstrated that the pesticide meets the safety standard imposed by
that statute. This citizen's comment appears to be directed at the
underlying statute and not EPA's implementation of it; the citizen has
made no contention that EPA has acted in violation of the statutory
framework nor have they provided any specific information or allegation
that would support a finding that these tolerances are unsafe.
D. Revisions to Petitioned-For Tolerances
The green coffee bean tolerance being established is identical to
that proposed by the petitioner. EPA has determined that separate
tolerances for the processed commodities of roasted coffee bean and
instant coffee are unnecessary because the processing data indicates
that combined residues of spiromesifen and BSN 2060-enol do not
concentrate in roasted or instant coffee.
V. Conclusion
Therefore, a tolerance is established for residues of spiromesifen,
including its metabolites and degradates, in or on coffee, green bean
at 0.20 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), nor is it considered a
regulatory action under 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.).
[[Page 45849]]
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: August 28, 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. 180.607, add alphabetically the commodity ``coffee, green
bean'' and footnote 1 to the table in paragraph (a)(1) to read as
follows:
Sec. 180.607 Spiromesifen; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Coffee, green bean \1\..................................... 0.20
* * * * *
------------------------------------------------------------------------
\1\ This use has not been registered in the United States as of August
28, 2018.
* * * * *
[FR Doc. 2018-19760 Filed 9-10-18; 8:45 am]
BILLING CODE 6560-50-P
