Emamectin Benzoate; Pesticide Tolerances, 44718-44725 [2019-18386]
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Federal Register / Vol. 84, No. 166 / Tuesday, August 27, 2019 / Rules and Regulations
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(oxyethylene) polymers where the alkyl
chain contains a minimum of six
carbons and a minimum number
average molecular weight (in amu)
1,100’’ in the table to read as follows:
5. In § 180.960, revise the inert
ingredients ‘‘a-Alkyl-w-hydroxypoly
(oxypropylene) and/or poly
■
Polymer
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
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CAS No.
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a-Alkyl-w-hydroxypoly
9002–92–0; 9004–95–9; 9004–98–2; 9005–00–9; 9035–85–2; 9038–29–3; 9038–43–1; 9040–05–5; 9043–30–5;
(oxypropylene) and/or poly
9087–53–0; 25190–05–0; 24938–91–8; 25231–21–4; 251553–55–6; 26183–52–8; 26468–86–0; 26636–39–5;
(oxyethylene) polymers
27252–75–1; 27306–79–2; 31726–34–8; 34398–01–1; 34398–05–5; 37251–67–5; 37311–00–5; 37311–01–6;
where the alkyl chain con37311–02–7; 37311–04–9; 39587–22–9; 50861–66–0; 52232–09–4; 52292–17–8; 52609–19–5; 57679–21–7;
tains a minimum of six
59112–62–8; 60828–78–6; 61702–78–1; 61723–78–2; 61725–89–1; 61791–13–7; 61791–20–6; 61791–28–4;
carbons and a minimum
61804–34–0; 61827–42–7; 61827–84–7; 62648–50–4; 63303–01–5; 63658–45–7; 63793–60–2; 64366–70–7;
number average molecular
64415–24–3; 64415–25–4; 64425–86–1; 65104–72–5; 65150–81–4; 66455–14–9: 66455–15–0; 67254–71–1;
weight (in amu) 1,100.
67763–08–0; 68002–96–0; 68002–97–1; 68131–39–5; 68131–40–8; 68154–96–1; 68154–97–2; 68154–98–3;
68155–01–1; 68213–23–0; 68213–24–1; 68238–81–3; 68238–82–4; 68409–58–5; 68409–59–6; 68439–30–5;
68439–45–2; 68439–46–3; 68439–48–5; 68439–49–6; 68439–50–9; 68439–51–0; 68439–53–2; 68439–54–3;
68458–88–8; 68526–94–3; 68526–95–4; 68551–12–2; 68551–13–3; 68551–14–4; 68603–20–3; 68603–25–8;
68920–66–1; 68920–69–4; 68937–66–6; 68951–67–7; 68954–94–9; 68987–81–5; 68991–48–0; 69011–36–5;
69013–18–9; 69013–19–0; 69227–20–9; 69227–21–0; 69227–22–1; 69364–63–2; 70750–27–5; 70879–83–3;
70955–07–6; 71011–10–4; 71060–57–6; 71243–46–4; 72066–65–0; 72108–90–8; 72484–69–6; 72854–13–8;
72905–87–4; 73018–31–2; 73049–34–0; 74432–13–6; 74499–34–6; 78330–19–5; 78330–20–8; 78330–21–9;
78330–23–1; 79771–03–2; 84133–50–6; 85422–93–1; 97043–91–9; 97953–22–5; 102782–43–4; 103331–86–
8; 103657–84–7; 103657–85–8; 103818–93–5; 103819–03–0; 106232–83–1; 111905–54–5; 116810–31–2;
116810–32–3; 116810–33–4; 120313–48–6; 120944–68–5; 121617–09–2; 126646–02–4; 126950–62–7;
127036–24–2; 139626–71–4; 152231–44–2; 154518–36–2; 157627–86–6; 157627–88–8; 157707–41–0;
157707–43–2; 159653–49–3; 160875–66–1; 160901–20–2; 160901–09–7; 160901–19–9; 161025–21–4;
161025–22–5; 166736–08–9; 169107–21–5; 172588–43–1; 176022–76–7; 196823–11–7; 287935–46–0;
288260–45–7; 303176–75–2; 954108–36–2; 2222805–23–2
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[FR Doc. 2019–18362 Filed 8–26–19; 8:45 am]
178 (see also Unit I.C. of the
BILLING CODE 6560–50–P
SUPPLEMENTARY INFORMATION).
40 CFR Part 180
[EPA–HQ–OPP–2018–0088; FRL–9997–10]
Emamectin Benzoate; Pesticide
Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of emamectin
benzoate (referred to as emamectin in
this document) in or on multiple
commodities which are identified and
discussed later in this document.
Interregional Research Project No. 4 (IR–
4) and Syngenta Crop Protection, LLC
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
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SUMMARY:
This regulation is effective
August 27, 2019. Objections and
requests for hearings must be received
on or before October 28, 2019, and must
be filed in accordance with the
instructions provided in 40 CFR part
DATES:
A. Does this action apply to me?
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2018–0088, 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.
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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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I. General Information
ADDRESSES:
ENVIRONMENTAL PROTECTION
AGENCY
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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 Publishing Office’s eCFR site at https://www.ecfr.gov/cgi-bin/
text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
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Federal Register / Vol. 84, No. 166 / Tuesday, August 27, 2019 / Rules and Regulations
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–2018–0088 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 28, 2019. 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–
2018–0088, 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.
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II. Summary of Petitioned-for Tolerance
In the Federal Register of July 24,
2018 (83 FR 34968) (FRL–9980–31),
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 7E8644) by IR–4,
IR–4 Project Headquarters, Rutgers, The
State University of New Jersey, 500
College Road East, Suite 201W,
Princeton, NJ 08540. The petition
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requested that 40 CFR part 180 be
amended by establishing tolerances for
residues of emamectin, including its
metabolites and degradates in or on the
raw agricultural commodities:
Artichoke, globe at 0.06 parts per
million (ppm), Brassica, leafy greens,
subgroup 4–16B at 0.050 ppm, Celtuce
at 0.100 ppm, Cherry subgroup 12–12A
at 0.10 ppm, Fennel, Florence at 0.100
ppm, Fruit, pome, group 11–10 at 0.025
ppm, Herb subgroup 19A at 0.50 ppm,
Kohlrabi at 0.050 ppm, Leafy greens
subgroup 4–16A at 0.100 ppm, Leaf
petiole vegetable subgroup 22B at 0.100
ppm, Nut, tree, group 14–12 at 0.02
ppm, Vegetable, brassica, head and
stem, group 5–16 at 0.050 ppm, and
Vegetable, fruiting, group 8–10 at 0.020
ppm. The petition also proposed to
amend 40 CFR 180.505 by removing the
tolerances for residues of emamectin,
including its metabolites and
degradates, in or on the raw agricultural
commodities: Fruit, pome, group 11 at
0.025 ppm, Nut, tree, group 14 at 0.02
ppm, Pistachio at 0.02 ppm, Turnip,
greens at 0.050 ppm, Vegetable, leafy,
except brassica, group 4 at 0.100 ppm,
Vegetable, brassica, leafy, group 5 at
0.050 ppm, and Vegetable fruiting,
group 8 at 0.020 ppm.
That document referenced a summary
of the petition prepared by Syngenta,
the registrant, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
In the Federal Register of August 24,
2018 (83 FR 42818) (FRL–9982–37),
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 7F8640) by
Syngenta Crop Protection, LLC, P.O.
Box 18300, Greensboro, NC 27419–
8300. The petition requested that 40
CFR part 180 be amended by
establishing a tolerance for residues of
emamectin, including its metabolites
and degradates in or on vegetable,
cucurbit, group 9 at 0.03 ppm. That
document referenced a summary of the
petition prepared by Syngenta, the
registrant, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon review of the data
supporting the petition, EPA is
establishing tolerances that vary from
what the petitioner requested, as
authorized under FFDCA section
408(d)(4)(A)(i). EPA’s explanation for
those variations are contained in Unit
IV.C.
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44719
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 emamectin
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with emamectin 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.
The main target organ for emamectin
is the nervous system; treatment-related
clinical signs (tremors, ptosis, ataxia,
mydriasis, and hunched posture) and
neuropathology (neuronal degeneration
in the brain and in peripheral nerves
and muscle fiber degeneration) were
found in most of the emamectin studies
in rats, dogs, rabbits, and mice.
Decreased body weight was also a
frequent finding.
Integral to the dose-response
assessment in mammals for this class of
compounds is the role of P-glycoprotein
(P-gp) in target tissues. P-gp is a member
of the adenosine triphosphate (ATP)
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binding cassette transporter protein
class/group, which reside in the plasma
membrane and function as a
transmembrane efflux pump, moving
xenobiotics from the intracellular to the
extracellular domain. P-gp is found in
the canalicular surface of hepatocytes,
the apical surface of proximal tubular
cells in the kidneys, brush border
surface of enterocytes, luminal surface
of blood capillaries of the brain (blood
brain barrier), placenta, ovaries, and the
testes. As an efflux transporter, P-gp acts
as a protective barrier to keep
xenobiotics out of the body by excreting
them into bile, urine, and intestinal
lumen, and prevents accumulation of
these compounds in the brain and
gonads, as well as in the fetus.
Therefore, test animals with genetic
polymorphisms that compromise P-gp
expression are particularly susceptible
to emamectin and abamectin induced
neurotoxicity.
In this connection, some CF–1 mice
have a polymorphism for the gene
encoding P-gp and are either devoid
(homozygous) or have diminished
(heterozygous) levels of P-gp. These
mice are found to be uniquely sensitive
to the neurotoxic effects of emamectin
and abamectin. In addition, the neonatal
rat is also particularly sensitive to
emamectin and abamectin as P-gp is
undetectable in the neonatal rat brain.
The first detection of P-gp is on postnatal day (PND) 7 and does not reach
adult levels until approximately PND
28. As shown in the reproductive and
DNT studies, neonatal rats are sensitive
to the effects of abamectin-induced pup
body weight reductions and death. In
contrast, in the developing human fetus,
the presence of P-gp was found as early
as 22 weeks of gestation. Based on the
difference in the ontogeny of P-gp in
neonatal rats and human newborns, the
Agency does not believe that the early
post-natal findings in the rat are
relevant to human newborns or young
children, at this time.
The human multidrug resistance
(MDR–1) gene encoding P-gp and
polymorphism of MDR–1 gene are well
studied. The literature data are
inconclusive with respect to the
functional significance of the genetic
variance in P-gp in humans. Currently,
the reported cases of polymorphism of
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the MDR–1 gene in human populations
have not been shown to result in a loss
of P-gp function similar to that found in
CF–1 mice. Given the ontogeny of P-gp
and the lack of convincing evidence
from the literature on human
polymorphism of MDR–1 gene resulting
in diminished P-gp function, the
Agency considers the results of the
studies with CF–1 mice not relevant for
human health risk assessment.
Therefore, the Agency is using results
from toxicological studies conducted in
the species that do not have diminished
P-gp function for selecting toxicity
endpoints and PODs for risk assessment.
Among the test animals with fully
functional P-gp, the beagle dog is the
most sensitive species.
Emamectin did not elicit increased
fetal sensitivity in developmental
toxicity studies in rats and rabbits. In
the reproductive toxicity study,
emamectin produced neuronal
degeneration in the brain and spinal in
parental and offspring animals at similar
dose level (1.8 mg/kg/day), and no
increase in quantitative sensitivity was
found in the pup with respect to the
neurotoxicity. However, in the
developmental neurotoxicity study in
rats, there was an increase in both
quantitative and qualitative sensitivity
in the pups as no adverse effect was
seen at the highest dose tested (3.6/2.5
mg/kg/day) in parental animals, while at
0.6 mg/kg/day, the pups showed a doserelated decrease in open field motor
activity at post-natal day 17. Body
tremors, hind-limb extension, and
auditory startle were also observed in
the high dose pups (3.6/2.5 mg/kg/day).
The carcinogenicity and mutagenicity
studies provide no indication that
emamectin is carcinogenic or
mutagenic. Emamectin is classified as
‘‘not likely to be carcinogenic to
humans.’’
Specific information on the studies
received and the nature of the adverse
effects caused by emamectin 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 ‘‘Emamectin (Emamectin
Benzoate). Human Health Risk
Assessment in Support of Establishing
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Permanent Tolerances on Globe
Artichoke, Cherry Subgroup 12–12A,
Herb Subgroup 19A, and Crop Group
Conversions and Expansions to include
Pome Fruit Group 11–10, Tree Nut
Group 14–12, Brassica Vegetable Head
and Stem Group 5–16, Brassica Leafy
Greens Subgroup 4–16B, Leafy Greens
Subgroup 4–16A, Leaf Petiole Vegetable
Subgroup 22B, Fruiting Vegetable Group
8–10, and individual tolerances for
Florence Fennel, Kohlrabi, Celtuce, and
Cucurbit Vegetables Group 9’’ on pages
42–48 in docket ID number EPA–HQ–
OPP–2018–0088.
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://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for emamectin used for
human risk assessment is shown in
Table 1 of this unit.
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44721
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR EMAMECTIN FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Dietary, all durations ..........................
(General population including infants
and children).
Point of departure and
uncertainty/safety
factors
NOAEL = 0.25 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
.......................................
Cancer (Oral, dermal, inhalation) ......
RfD, PAD, LOC for risk
assessment
Study and toxicological effects
Acute RfD = 0.0025 mg/
kg/day.
aPAD = 0.0025 mg/kg/
day
Chronic RfD = 0.0025
mg/kg/day.
cPAD = 0.0025 mg/kg/
day.
.......................................
Subchronic and chronic oral toxicity studies in dogs.
Subchronic LOAEL = 0.5 mg/kg/day based skeletal muscle atrophy and
white matter multifocal degeneration in the brains of both sexes and
white matter multifocal degeneration in the spinal cords of males.
Chronic LOAEL=0.5 mg/kg/day based on axonal degeneration in the
pons, medulla, and peripheral nerves (sciatic, sural, and tibial); whole
body tremors; stiffness of the hind legs, spinal cord axonal degeneration, and muscle fiber degeneration.
Classification: Not Likely to be carcinogenic to humans based on the absence of significant increase in tumor incidence 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).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to emamectin, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
emamectin tolerances in 40 CFR
180.505. EPA assessed dietary
exposures from emamectin 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.
Such effects were identified for
emamectin. In estimating acute dietary
exposure, EPA used 2003–2008 food
consumption information from the U.S.
Department of Agriculture’s National
Health and Nutrition Examination
Survey, What We Eat in America,
(NHANES/WWEIA). As to residue levels
in food, a refined acute assessment was
conducted. The assessment relied upon
percent crop treated (PCT) data, and a
combination of monitoring data from
the Pesticide Data Program (PDP) and
field trial data. For hog meat, a tolerance
level residue was assumed. For all other
livestock commodities, anticipated
residue values were used.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used 2003–2008 food consumption
data from the USDA’s NHANES/
WWEIA. As to residue levels in food, a
refined chronic assessment was
conducted. The assessment relied upon
the same data as above, except for using
mean field trial data for cottonseed, tree
nuts, globe artichoke, cherry subgroup
12–12A, and herb subgroup 19A.
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iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that emamectin 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. 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.
Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only if:
• Condition a: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
• Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition c: Data are available on
pesticide use and food consumption in
a particular area, and the exposure
estimate does not understate exposure
for the population in such area. In
addition, the Agency must provide for
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periodic evaluation of any estimates
used. To provide for the periodic
evaluation of the estimate of PCT as
required by FFDCA section 408(b)(2)(F),
EPA may require registrants to submit
data on PCT.
The Agency estimated the PCT for
existing uses as follows:
Specific values used in the acute
assessment for percent crop treated are:
10% almonds, 20% apples, 20%
broccoli, 40% brussels sprouts, 25%
cabbage, 20% cauliflower, 40% celery,
10% chicory, 2.5% cotton, 20% lettuce,
20% pears, 15% peppers, 2.5%
pistachios, 10% spinach, 20% tomatoes,
and 2.5% walnuts.
Specific values used in the chronic
assessment for percent crop treated are:
2.5% almonds, 10% apples, 5%
broccoli, 20% brussels sprouts, 10%
cabbage, 5% cauliflower, 20% celery,
5% chicory, 10% lettuce, 5% pears, 5%
peppers, 2.5% pistachios, 5% spinach,
15% tomatoes, and 2.5% walnuts.
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and
California Department of Pesticide
Regulation (CalDPR) Pesticide Use
Reporting (PUR) for the chemical/crop
combination for the most recent 10
years. EPA uses an average PCT for
chronic dietary risk analysis and a
maximum PCT for acute dietary risk
analysis. The average PCT figures for
each existing use is derived by
combining available public and private
market survey data for that use,
averaging across all observations, and
rounding up to the nearest 5%, except
for those situations in which the average
PCT is less than 1% or less than 2.5%.
In those cases, the Agency would use
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less than 1% or less than 2.5% as the
average PCT value, respectively. The
maximum PCT figure is the highest
observed maximum value reported
within the most recent 10 years of
available public and private market
survey data for the existing use and
rounded up to the nearest multiple of
5%, except where the maximum PCT is
less than 2.5%, in which case, the
Agency uses less than 2.5% as the
maximum PCT.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for emamectin in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of emamectin.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
Based on the Pesticide in Water
Calculator (PWC), the estimated
drinking water concentrations (EDWCs)
of emamectin for acute exposures are
estimated to be 1.5 parts per billion
(ppb) for surface water and EDWCs for
chronic exposures are estimated to be
1.15 ppb for surface water. No
groundwater concentrations are
predicted for emamectin, as the model
(PRZM–GW; pesticide root zone
model—groundwater) indicates
emamectin will not break through into
groundwater over the 100-year course of
the modeled scenario.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For the
acute dietary risk assessment, the water
concentration value of 1.5 ppb was used
to assess the contribution to drinking
water and for the chronic dietary risk
assessment, the water concentration of
value 1.15 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).
Residential exposures are not
anticipated from the proposed uses of
emamectin, nor are they anticipated
from existing uses of emamectin since
they are agricultural uses, restricted use
products (i.e., restricted to use by
certified applicators only), or are limited
to non-residential areas (i.e.,
commercial and industrial areas) with
the exception of a gel bait product. The
ready-to-use (RTU) gel bait product is
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registered for use in multiple locations,
including in residential areas. As the
RTU product requires no mixing/
loading, the only potential for
residential handler exposure is via
application. When applying this
product according to use directions, bait
points and bait beads are intended to be
placed in cracks and crevices where
direct contact by adults is anticipated to
be negligible. Post-application
exposures for adults and children are
also unlikely due to the nature of the
application method, and the location of
the bait placement. Therefore, a
residential exposure assessment has not
been conducted and there are no
residential risk estimates recommended
for use in the aggregate risk assessment
for emamectin.
4. Cumulative effects from substances
with a common mechanism of toxicity.
The Agency is required to consider the
cumulative risks of chemicals sharing a
common mechanism of toxicity. In
2016, EPA’s Office of Pesticide
Programs released a guidance document
entitled Pesticide Cumulative Risk
Assessment: Framework for Screening
Analysis (https://www.epa.gov/
pesticide-science-and-assessingpesticide-risks/pesticide-cumulativerisk-assessment-framework). This
document provides guidance on how to
screen groups of pesticides for
cumulative evaluation using a two-step
approach beginning with the evaluation
of available toxicological information
and if necessary, followed by a riskbased screening approach. This
framework supplements the existing
guidance documents for establishing
common mechanism groups (CMGs) and
conducting cumulative risk assessments
(CRA).
The Agency has utilized this
framework for abamectin and
determined that abamectin along with
emamectin form a candidate CMG of the
avermectin macrocyclic lactones. This
group of pesticides is considered a
candidate CMG because they share
characteristics to support a testable
hypothesis for a common mechanism of
action and while there are sufficient
toxicological data to suggest a common
pathway, there are not adequate data to
establish those key events in a pathway
as described in the mode of action/
adverse outcome pathway (MOA/AOP)
framework (e.g., lack of dose or
temporal concordance of proposed key
events).
In 2017, the Agency conducted a
screening-level cumulative exposure
analysis consistent with the guidance
described in the cumulative screening
framework. The screening-level
cumulative assessment for the
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avermectin macrocyclic lactones,
abamectin and emamectin, indicated
that cumulative aggregate dietary and
residential exposures for abamectin and
emamectin were below the Agency’s
levels of concern.
Based upon updated use information
(i.e., new uses), the Agency has updated
its screening-level cumulative exposure
analysis for the avermectin macrocyclic
lactones, including abamectin and
emamectin. This updated screeninglevel cumulative exposure assessment
for the avermectin macrocyclic lactones,
abamectin and emamectin, indicated
that that cumulative aggregate dietary
and residential exposures for abamectin
and emamectin were below the
Agency’s levels of concern. The
screening memo, titled ‘‘Avermectin
Macrocyclic Lactones, Abamectin and
Emamectin. Cumulative Screening Risk
Assessment’’ can be found in docket ID
number EPA–HQ–OPP–2018–0088 at
https://www.regulations.gov.
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.
Emamectin did not elicit increased fetal
sensitivity in developmental toxicity
studies in rats and rabbits. In the
reproductive toxicity study, emamectin
produced neuronal degeneration in the
brain and spinal cord in parental and
offspring animals at a similar dose level
(1.8 mg/kg/day), and no increase in
quantitative sensitivity was found in the
pup with respect to the neurotoxicity.
However, in the developmental
neurotoxicity study in rats, there was an
increase in both quantitative and
qualitative sensitivity in the pups as no
adverse effect was seen at the highest
dose tested (3.6/2.5 mg/kg/day) in
parental animals, while at 0.6 mg/kg/
day, the pups showed a dose-related
decrease in open field motor activity at
post-natal day 17. Body tremors, hindlimb extension, and auditory startle
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were also observed in the high dose
pups (3.6/2.5 mg/kg/day).
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 emamectin
is complete.
ii. The proposed MOA is interaction
with GABA receptors leading to
neurotoxicity. The clinical signs
observed in the emamectin database are
consistent with the proposed MOA.
Following emamectin exposure,
neurotoxicity has been seen across
multiple studies and species of test
animals. Neurotoxic effects seen in
various studies are consistent with the
MOA of emamectin, and the selected
toxicity endpoints and POD is
protective of the neurotoxic effects in
the data.
iii. As discussed above, the
developmental neurotoxicity study
showed an increase in both quantitative
and qualitative sensitivity in the pups as
indicated by a dose-related decrease in
open field motor activity at post-natal
day 17 at 0.6 mg/kg/day. Body tremors,
hind-limb extension, and auditory
startle were also observed in the high
dose pups (2.5 mg/kg/day), while no
adverse effects were seen in the parental
animals at the highest tested dose (3.6
mg/kg/day). However, the toxicity
endpoint and POD (0.25 mg/kg/day)
selected for risk assessment are
protective of the effects seen in the
pups.
iv. There are no residual uncertainties
for emamectin with respect to the
exposure databases. Although the
dietary exposure estimates are partially
refined, anticipated residue estimates
for most commodities were derived
from field trials which are still
considered conservative since field
trials are conducted under maximum
use conditions (maximum allowed
application rate and number of
applications, minimum pre-harvest
interval, etc.). Monitoring data were
used for apples in the acute assessment
since apple juice had a significant
impact on exposure. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to emamectin in
drinking water. There are no anticipated
exposures to residential handlers, or for
post-application exposure of adults and
children. These assessments will not
underestimate the exposure and risks
posed by emamectin.
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E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
emamectin will occupy 26% of the
aPAD for children 1 to 2 years old, the
population group receiving the greatest
exposure.
2. Chronic risk: Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to emamectin
from food and water will utilize 3.4% 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
emamectin is not expected.
3. Short-term risk. A short-term
adverse effect was identified; however,
emamectin is not registered for any use
patterns that would result in short-term
residential exposure. Short-term risk is
assessed based on short-term residential
exposure plus chronic dietary exposure.
Because there is no short-term
residential exposure and chronic dietary
exposure has already been assessed
under the appropriately protective
cPAD (which is at least as protective as
the POD used to assess short-term risk),
no further assessment of short-term risk
is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating short-term risk for
emamectin.
4. Intermediate-term risk. An
intermediate-term adverse effect was
identified; however, emamectin is not
registered for any use patterns that
would result in intermediate-term
residential exposure. Intermediate-term
risk is assessed based on intermediateterm residential exposure plus chronic
dietary exposure. Because there is no
intermediate-term residential exposure
and chronic dietary exposure has
already been assessed under the
appropriately protective cPAD (which is
at least as protective as the POD used to
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44723
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
emamectin.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
emamectin 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 emamectin
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate methods (Method 244–92–3
and Method 244–92–3, Revision 1) are
available for the enforcement of
tolerances on plants. The methods
determine residues of emamectin and its
regulated isomers and degradates/
metabolites using high performance
liquid chromatography with
fluorescence detection (HPLC/FLD).
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has established MRLs for
emamectin on various commodities that
are different than the tolerances
established for emamectin in the United
States.
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The U.S. and Codex residue
definitions are not harmonized. The
U.S. residue definition for emamectin
includes the sum of emamectin and its
metabolites (8,9-isomer) for plants and
livestock. The Codex residue definition
includes only emamectin for plants and
livestock commodities.
Codex has MRLs for residues of
emamectin on tomato, tomatillo, bell
pepper, and non-bell pepper, the
representative commodities of the
fruiting vegetable group 8–10 at 0.02
ppm each. The U.S. tolerance at 0.02
ppm for residues on crop group 8–10 is
being harmonized with these Codex
MRLs.
Codex has an MRL for residues of
emamectin on mustard greens, the
representative commodity for Brassica
leafy greens subgroup 4–16B at 0.2 ppm.
The U.S. tolerance on subgroup 4–16B
is being harmonized with Codex
mustard greens, the representative
commodity, at 0.20 ppm.
Codex has MRLs for residues of
emamectin on head lettuce at 1 ppm
and leaf lettuce at 0.7 ppm. The current
U.S. tolerance is 0.1 ppm for subgroup
4–16A, which has head lettuce, leaf
lettuce, and spinach as the
representative commodities. EPA is
therefore harmonizing the tolerance for
subgroup 4–16A with Codex head
lettuce at 1 ppm.
Codex has MRLs for apple and pear at
0.02 ppm each. EPA harmonizing the
tolerance on pome fruit, group 11–10
with these MRLs at 0.02 ppm.
For tree nut crop group 14–12, the
Codex MRLs for residues on the
representative commodities of this
group is 20x lower than the U.S.
tolerances being established in this
rulemaking. Lowering the tolerance
could cause U.S. growers to have
violative residues when following label
instructions; therefore, EPA is not
harmonizing the tolerance with the
Codex MRLs.
For all other commodities, Codex
does not have established MRLs.
The tolerance on Brassica leafy greens
subgroup 4–16B is being set at 0.2 ppm
instead of the proposed level at 0.050
ppm and the tolerance on leafy greens
subgroup 4–16A is being set at 1 ppm
instead of 0.1 ppm to harmonize with
Codex.
For the proposed tolerance on fennel,
Florence, the commodity definition was
corrected to be Fennel, florence, fresh
leaves and stalk.
For the other commodities and crop
groups, the tolerances differ from the
petitioned-for tolerances due to the use
of HED rounding class practice.
The proposed tolerance for
emamectin on vegetable, cucurbit, group
9 at 0.03 ppm is not necessary because
the available data support the existing
tolerance of 0.02 ppm for that crop
group.
C. Revisions to Petitioned-For
Tolerances
For new uses on globe artichoke, herb
subgroup 19A, and cherry subgroup 12–
12A, the tolerances differ slightly from
those proposed by IR–4 due to
differences in calculating parent
equivalents of emamectin metabolites
from the residue data.
The currently established tolerance on
crop group 11 and the proposed
tolerance on crop group 11–10 are both
at 0.025 ppm. The tolerance for pome
fruit crop group 11–10 is being
established at 0.02 ppm to harmonize
with Codex MRLs on apple and pear.
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
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V. Conclusion
Therefore, tolerances are established
for residues of emamectin, including its
metabolites and degradates in or on the
raw agricultural commodities Artichoke,
globe at 0.05 ppm; Brassica, leafy
greens, subgroup 4–16B at 0.2 ppm;
Celtuce at 0.1 ppm; Cherry subgroup
12–12A at 0.09 ppm; Fennel, florence,
fresh leaves and stalk at 0.1 ppm; Fruit,
pome, group 11–10 at 0.02 ppm; Herb
subgroup 19A at 0.4 ppm; Kohlrabi at
0.05 ppm; Leaf petiole vegetable
subgroup 22B at 0.1 ppm; Leafy greens
subgroup 4–16A at 1 ppm; Nut, tree,
group 14–12 at 0.02 ppm; Vegetable,
brassica, head and stem, group 5–16 at
0.05 ppm; and Vegetable, fruiting, group
8–10 at 0.02 ppm.
Additionally, the following existing
tolerances are removed as unnecessary
due to the establishment of the above
tolerances: Fruit, pome, group 11 at
0.025; Nut, tree, group 14 at 0.02 ppm;
Pistachio at 0.02 ppm; Turnip, greens at
0.050 ppm; Vegetable, brassica, leafy,
group 5 at 0.050 ppm; Vegetable
fruiting, group 8 at 0.020 ppm; and
Vegetable, leafy, except brassica, group
4 at 0.100 ppm.
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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 tolerances in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
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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.
jspears on DSK3GMQ082PROD with RULES
Dated: August 8, 2019.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
*
*
*
Fennel, florence, fresh
leaves and stalk ................
Fruit, pome, group 11–10 .....
*
*
*
*
Herb subgroup 19A ..............
Kohlrabi .................................
Leaf petiole vegetable subgroup 22B .........................
Leafy greens subgroup 4–
16A ....................................
Nut, tree, group 14–12 .........
*
*
Communications Commission, 445 12th
Street SW, Room CY–A257,
Washington, DC 20554. This document
will also be available via ECFS at
*
https://docs.fcc.gov/public/
attachments/FCC-19-80A1.docx.
0.1 Documents will be available
0.02 electronically in ASCII, Microsoft Word,
and/or Adobe Acrobat. The complete
text may be purchased from the
*
Commission’s copy contractor, 445 12th
0.4 Street SW, Room CY–B402, Washington,
0.05 DC 20554. Alternative formats are
available for people with disabilities
0.1
(Braille, large print, electronic files,
1 audio format), by sending an email to
0.02 fcc504@fcc.gov or calling the
Commission’s Consumer and
Governmental Affairs Bureau at (202)
*
418–0530 (voice), (202) 418–0432
(TTY).
Parts per
million
Commodity
*
44725
*
*
Vegetable, brassica, head
and stem, group 5–16 .......
0.05
Synopsis
1. In this Third Report and Order
Therefore, 40 CFR chapter I is
(Third Order), we interpret sections of
amended as follows:
Vegetable, fruiting, group 8–
10 ......................................
0.02 the Communications Act of 1934, as
amended (the Act) that govern how
PART 180—[AMENDED]
local franchising authorities (LFAs) may
*
*
*
*
*
■ 1. The authority citation for part 180
regulate cable operators and cable
[FR Doc. 2019–18386 Filed 8–26–19; 8:45 am]
television services, with specific focus
continues to read as follows:
BILLING CODE 6560–50–P
on issues remanded from the United
Authority: 21 U.S.C. 321(q), 346a and 371.
States Court of Appeals for the Sixth
■ 2. In § 180.505, amend the table in
Circuit (Sixth Circuit) in Montgomery
paragraph (a)(1) as follows:
FEDERAL COMMUNICATIONS
County, Md. et al. v. FCC.
■ i. Add alphabetically the entries
COMMISSION
2. Every LFA as well as every ‘‘cable
‘‘Artichoke, globe’’; ‘‘Brassica, leafy
operator’’ that offers ‘‘cable service’’
greens, subgroup 4–16B’’; ‘‘Celtuce’’;
47 CFR Part 76
must comply with the cable franchising
‘‘Cherry subgroup 12–12A’’; ‘‘Fennel,
provisions of Title VI of the Act. Section
[MB Docket No. 05–311; FCC 19–80]
florence, fresh leaves and stalk’’; ‘‘Fruit,
621(b)(1) prohibits a cable operator from
pome, group 11–10’’; ‘‘Herb subgroup
Local Franchising Authorities’
providing cable service without first
19A’’; ‘‘Kohlrabi’’; ‘‘Leaf petiole
Regulation of Cable Operators and
obtaining a cable franchise, while
vegetable subgroup 22B’’; ‘‘Leafy greens Cable Television Services
section 621(a)(1) circumscribes the
subgroup 4–16A’’; ‘‘Nut, tree, group 14–
power of LFAs to award or deny such
AGENCY: Federal Communications
12’’; ‘‘Vegetable, brassica, head and
franchises. In addition, section 622
Commission.
stem, group 5–16’’; and ‘‘Vegetable,
allows LFAs to charge franchise fees
fruiting, group 8–10’’;
ACTION: Final rule.
and sets the upper boundaries of those
■ ii. Remove the entries for ‘‘Fruit,
fees. Notably, section 622 caps the fee
SUMMARY
:
In
this
document,
the
Federal
pome, group 11’’; ‘‘Nut, tree, group 14’’;
at five percent of a ‘‘cable operator’s
Communications
Commission
‘‘Pistachio’’; ‘‘Turnip, greens’’;
gross revenues derived . . . from the
(Commission)
adopts
rules
governing
‘‘Vegetable, brassica, leafy, group 5’’;
operation of the cable system to provide
how
local
franchising
authorities
may
‘‘Vegetable fruiting, group 8’’; and
cable service.’’ 1 When Congress initially
regulate
cable
operators
and
cable
‘‘Vegetable, leafy, except brassica, group
adopted
these sections in 1984, it
television services.
4’’.
explained
that it was setting forth a
DATES: These rule revisions are effective
The additions read as follows:
federal policy to ‘‘define and limit the
on September 26, 2019.
authority that a franchising authority
§ 180.505 Emamectin; tolerances for
FOR FURTHER INFORMATION CONTACT: For
residues.
may exercise through the franchise
additional information on this
process.’’ Congress also expressly
(a) * * *
proceeding, contact Maria Mullarkey or
preempted any state or local laws or
(1) * * *
Raelynn Remy of the Media Bureau,
actions that conflict with those
Policy Division, at Maria.Mullarkey@
Parts per
definitions and limits.2
Commodity
fcc.gov, Raelynn.Remy@fcc.gov or (202)
million
3. As summarized in detail in the
418–2120.
Second Further Notice of Proposed
SUPPLEMENTARY INFORMATION: This is a
Rulemaking (FNPRM) (83 FR 51911,
*
*
*
*
*
summary of the Commission’s Third
Oct. 15, 2018), the Commission has an
Report and Order, FCC 19–80, adopted
extensive history of rulemakings and
Artichoke, globe ....................
0.05
on August 1, 2019. The full text is
litigation interpreting sections 621 and
Brassica, leafy greens, subgroup 4–16B .....................
0.2 available for public inspection and
1 47 U.S.C. 542.
Celtuce ..................................
0.1 copying during regular business hours
2 Id. 556(c).
Cherry subgroup 12–12A .....
0.09 in the FCC Reference Center, Federal
VerDate Sep<11>2014
17:38 Aug 26, 2019
Jkt 247001
*
PO 00000
*
Frm 00045
*
Fmt 4700
*
Sfmt 4700
*
E:\FR\FM\27AUR1.SGM
27AUR1
]]>Agencies
[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Rules and Regulations]
[Pages 44718-44725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18386]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0088; FRL-9997-10]
Emamectin Benzoate; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
emamectin benzoate (referred to as emamectin in this document) in or on
multiple commodities which are identified and discussed later in this
document. Interregional Research Project No. 4 (IR-4) and Syngenta Crop
Protection, LLC requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 27, 2019. Objections and
requests for hearings must be received on or before October 28, 2019,
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-2018-0088, 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
Publishing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
[[Page 44719]]
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-2018-0088 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 28, 2019. 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-2018-0088, 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 July 24, 2018 (83 FR 34968) (FRL-9980-
31), 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
7E8644) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201W, Princeton,
NJ 08540. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of emamectin, including its
metabolites and degradates in or on the raw agricultural commodities:
Artichoke, globe at 0.06 parts per million (ppm), Brassica, leafy
greens, subgroup 4-16B at 0.050 ppm, Celtuce at 0.100 ppm, Cherry
subgroup 12-12A at 0.10 ppm, Fennel, Florence at 0.100 ppm, Fruit,
pome, group 11-10 at 0.025 ppm, Herb subgroup 19A at 0.50 ppm, Kohlrabi
at 0.050 ppm, Leafy greens subgroup 4-16A at 0.100 ppm, Leaf petiole
vegetable subgroup 22B at 0.100 ppm, Nut, tree, group 14-12 at 0.02
ppm, Vegetable, brassica, head and stem, group 5-16 at 0.050 ppm, and
Vegetable, fruiting, group 8-10 at 0.020 ppm. The petition also
proposed to amend 40 CFR 180.505 by removing the tolerances for
residues of emamectin, including its metabolites and degradates, in or
on the raw agricultural commodities: Fruit, pome, group 11 at 0.025
ppm, Nut, tree, group 14 at 0.02 ppm, Pistachio at 0.02 ppm, Turnip,
greens at 0.050 ppm, Vegetable, leafy, except brassica, group 4 at
0.100 ppm, Vegetable, brassica, leafy, group 5 at 0.050 ppm, and
Vegetable fruiting, group 8 at 0.020 ppm.
That document referenced a summary of the petition prepared by
Syngenta, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.
In the Federal Register of August 24, 2018 (83 FR 42818) (FRL-9982-
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
7F8640) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR part 180 be amended
by establishing a tolerance for residues of emamectin, including its
metabolites and degradates in or on vegetable, cucurbit, group 9 at
0.03 ppm. That document referenced a summary of the petition prepared
by Syngenta, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA is
establishing tolerances that vary from what the petitioner requested,
as authorized under FFDCA section 408(d)(4)(A)(i). EPA's explanation
for those variations are contained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has 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 emamectin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with emamectin 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.
The main target organ for emamectin is the nervous system;
treatment-related clinical signs (tremors, ptosis, ataxia, mydriasis,
and hunched posture) and neuropathology (neuronal degeneration in the
brain and in peripheral nerves and muscle fiber degeneration) were
found in most of the emamectin studies in rats, dogs, rabbits, and
mice. Decreased body weight was also a frequent finding.
Integral to the dose-response assessment in mammals for this class
of compounds is the role of P-glycoprotein (P-gp) in target tissues. P-
gp is a member of the adenosine triphosphate (ATP)
[[Page 44720]]
binding cassette transporter protein class/group, which reside in the
plasma membrane and function as a transmembrane efflux pump, moving
xenobiotics from the intracellular to the extracellular domain. P-gp is
found in the canalicular surface of hepatocytes, the apical surface of
proximal tubular cells in the kidneys, brush border surface of
enterocytes, luminal surface of blood capillaries of the brain (blood
brain barrier), placenta, ovaries, and the testes. As an efflux
transporter, P-gp acts as a protective barrier to keep xenobiotics out
of the body by excreting them into bile, urine, and intestinal lumen,
and prevents accumulation of these compounds in the brain and gonads,
as well as in the fetus. Therefore, test animals with genetic
polymorphisms that compromise P-gp expression are particularly
susceptible to emamectin and abamectin induced neurotoxicity.
In this connection, some CF-1 mice have a polymorphism for the gene
encoding P-gp and are either devoid (homozygous) or have diminished
(heterozygous) levels of P-gp. These mice are found to be uniquely
sensitive to the neurotoxic effects of emamectin and abamectin. In
addition, the neonatal rat is also particularly sensitive to emamectin
and abamectin as P-gp is undetectable in the neonatal rat brain. The
first detection of P-gp is on post-natal day (PND) 7 and does not reach
adult levels until approximately PND 28. As shown in the reproductive
and DNT studies, neonatal rats are sensitive to the effects of
abamectin-induced pup body weight reductions and death. In contrast, in
the developing human fetus, the presence of P-gp was found as early as
22 weeks of gestation. Based on the difference in the ontogeny of P-gp
in neonatal rats and human newborns, the Agency does not believe that
the early post-natal findings in the rat are relevant to human newborns
or young children, at this time.
The human multidrug resistance (MDR-1) gene encoding P-gp and
polymorphism of MDR-1 gene are well studied. The literature data are
inconclusive with respect to the functional significance of the genetic
variance in P-gp in humans. Currently, the reported cases of
polymorphism of the MDR-1 gene in human populations have not been shown
to result in a loss of P-gp function similar to that found in CF-1
mice. Given the ontogeny of P-gp and the lack of convincing evidence
from the literature on human polymorphism of MDR-1 gene resulting in
diminished P-gp function, the Agency considers the results of the
studies with CF-1 mice not relevant for human health risk assessment.
Therefore, the Agency is using results from toxicological studies
conducted in the species that do not have diminished P-gp function for
selecting toxicity endpoints and PODs for risk assessment. Among the
test animals with fully functional P-gp, the beagle dog is the most
sensitive species.
Emamectin did not elicit increased fetal sensitivity in
developmental toxicity studies in rats and rabbits. In the reproductive
toxicity study, emamectin produced neuronal degeneration in the brain
and spinal in parental and offspring animals at similar dose level (1.8
mg/kg/day), and no increase in quantitative sensitivity was found in
the pup with respect to the neurotoxicity. However, in the
developmental neurotoxicity study in rats, there was an increase in
both quantitative and qualitative sensitivity in the pups as no adverse
effect was seen at the highest dose tested (3.6/2.5 mg/kg/day) in
parental animals, while at 0.6 mg/kg/day, the pups showed a dose-
related decrease in open field motor activity at post-natal day 17.
Body tremors, hind-limb extension, and auditory startle were also
observed in the high dose pups (3.6/2.5 mg/kg/day).
The carcinogenicity and mutagenicity studies provide no indication
that emamectin is carcinogenic or mutagenic. Emamectin is classified as
``not likely to be carcinogenic to humans.''
Specific information on the studies received and the nature of the
adverse effects caused by emamectin 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 ``Emamectin (Emamectin
Benzoate). Human Health Risk Assessment in Support of Establishing
Permanent Tolerances on Globe Artichoke, Cherry Subgroup 12-12A, Herb
Subgroup 19A, and Crop Group Conversions and Expansions to include Pome
Fruit Group 11-10, Tree Nut Group 14-12, Brassica Vegetable Head and
Stem Group 5-16, Brassica Leafy Greens Subgroup 4-16B, Leafy Greens
Subgroup 4-16A, Leaf Petiole Vegetable Subgroup 22B, Fruiting Vegetable
Group 8-10, and individual tolerances for Florence Fennel, Kohlrabi,
Celtuce, and Cucurbit Vegetables Group 9'' on pages 42-48 in docket ID
number EPA-HQ-OPP-2018-0088.
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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for emamectin used for
human risk assessment is shown in Table 1 of this unit.
[[Page 44721]]
Table 1--Summary of Toxicological Doses and Endpoints for Emamectin 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
----------------------------------------------------------------------------------------------------------------
Dietary, all durations........... NOAEL = 0.25 mg/kg/ Acute RfD = 0.0025 Subchronic and chronic oral
(General population including day. mg/kg/day. toxicity studies in dogs.
infants and children). UFA = 10x........... aPAD = 0.0025 mg/kg/ Subchronic LOAEL = 0.5 mg/kg/day
UFH = 10x........... day. based skeletal muscle atrophy and
FQPA SF = 1x........ Chronic RfD = white matter multifocal
0.0025 mg/kg/day. degeneration in the brains of
cPAD = 0.0025 mg/kg/ both sexes and white matter
day. multifocal degeneration in the
spinal cords of males.
.................... ................... Chronic LOAEL=0.5 mg/kg/day based
on axonal degeneration in the
pons, medulla, and peripheral
nerves (sciatic, sural, and
tibial); whole body tremors;
stiffness of the hind legs,
spinal cord axonal degeneration,
and muscle fiber degeneration.
------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: Not Likely to be carcinogenic to humans based on the absence
of significant increase in tumor incidence 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).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to emamectin, EPA considered exposure under the petitioned-for
tolerances as well as all existing emamectin tolerances in 40 CFR
180.505. EPA assessed dietary exposures from emamectin 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.
Such effects were identified for emamectin. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption information from
the U.S. Department of Agriculture's National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, a refined acute assessment was conducted. The
assessment relied upon percent crop treated (PCT) data, and a
combination of monitoring data from the Pesticide Data Program (PDP)
and field trial data. For hog meat, a tolerance level residue was
assumed. For all other livestock commodities, anticipated residue
values were used.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used 2003-2008 food consumption data from the USDA's
NHANES/WWEIA. As to residue levels in food, a refined chronic
assessment was conducted. The assessment relied upon the same data as
above, except for using mean field trial data for cottonseed, tree
nuts, globe artichoke, cherry subgroup 12-12A, and herb subgroup 19A.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that emamectin 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.
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.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit
data on PCT.
The Agency estimated the PCT for existing uses as follows:
Specific values used in the acute assessment for percent crop
treated are: 10% almonds, 20% apples, 20% broccoli, 40% brussels
sprouts, 25% cabbage, 20% cauliflower, 40% celery, 10% chicory, 2.5%
cotton, 20% lettuce, 20% pears, 15% peppers, 2.5% pistachios, 10%
spinach, 20% tomatoes, and 2.5% walnuts.
Specific values used in the chronic assessment for percent crop
treated are: 2.5% almonds, 10% apples, 5% broccoli, 20% brussels
sprouts, 10% cabbage, 5% cauliflower, 20% celery, 5% chicory, 10%
lettuce, 5% pears, 5% peppers, 2.5% pistachios, 5% spinach, 15%
tomatoes, and 2.5% walnuts.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figures for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
to the nearest 5%, except for those situations in which the average PCT
is less than 1% or less than 2.5%. In those cases, the Agency would use
[[Page 44722]]
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for emamectin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of emamectin. 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 Pesticide in Water Calculator (PWC), the estimated
drinking water concentrations (EDWCs) of emamectin for acute exposures
are estimated to be 1.5 parts per billion (ppb) for surface water and
EDWCs for chronic exposures are estimated to be 1.15 ppb for surface
water. No groundwater concentrations are predicted for emamectin, as
the model (PRZM-GW; pesticide root zone model--groundwater) indicates
emamectin will not break through into groundwater over the 100-year
course of the modeled scenario.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 1.5 ppb was used to assess
the contribution to drinking water and for the chronic dietary risk
assessment, the water concentration of value 1.15 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).
Residential exposures are not anticipated from the proposed uses of
emamectin, nor are they anticipated from existing uses of emamectin
since they are agricultural uses, restricted use products (i.e.,
restricted to use by certified applicators only), or are limited to
non-residential areas (i.e., commercial and industrial areas) with the
exception of a gel bait product. The ready-to-use (RTU) gel bait
product is registered for use in multiple locations, including in
residential areas. As the RTU product requires no mixing/loading, the
only potential for residential handler exposure is via application.
When applying this product according to use directions, bait points and
bait beads are intended to be placed in cracks and crevices where
direct contact by adults is anticipated to be negligible. Post-
application exposures for adults and children are also unlikely due to
the nature of the application method, and the location of the bait
placement. Therefore, a residential exposure assessment has not been
conducted and there are no residential risk estimates recommended for
use in the aggregate risk assessment for emamectin.
4. Cumulative effects from substances with a common mechanism of
toxicity. The Agency is required to consider the cumulative risks of
chemicals sharing a common mechanism of toxicity. In 2016, EPA's Office
of Pesticide Programs released a guidance document entitled Pesticide
Cumulative Risk Assessment: Framework for Screening Analysis (https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework). This document provides guidance
on how to screen groups of pesticides for cumulative evaluation using a
two-step approach beginning with the evaluation of available
toxicological information and if necessary, followed by a risk-based
screening approach. This framework supplements the existing guidance
documents for establishing common mechanism groups (CMGs) and
conducting cumulative risk assessments (CRA).
The Agency has utilized this framework for abamectin and determined
that abamectin along with emamectin form a candidate CMG of the
avermectin macrocyclic lactones. This group of pesticides is considered
a candidate CMG because they share characteristics to support a
testable hypothesis for a common mechanism of action and while there
are sufficient toxicological data to suggest a common pathway, there
are not adequate data to establish those key events in a pathway as
described in the mode of action/adverse outcome pathway (MOA/AOP)
framework (e.g., lack of dose or temporal concordance of proposed key
events).
In 2017, the Agency conducted a screening-level cumulative exposure
analysis consistent with the guidance described in the cumulative
screening framework. The screening-level cumulative assessment for the
avermectin macrocyclic lactones, abamectin and emamectin, indicated
that cumulative aggregate dietary and residential exposures for
abamectin and emamectin were below the Agency's levels of concern.
Based upon updated use information (i.e., new uses), the Agency has
updated its screening-level cumulative exposure analysis for the
avermectin macrocyclic lactones, including abamectin and emamectin.
This updated screening-level cumulative exposure assessment for the
avermectin macrocyclic lactones, abamectin and emamectin, indicated
that that cumulative aggregate dietary and residential exposures for
abamectin and emamectin were below the Agency's levels of concern. The
screening memo, titled ``Avermectin Macrocyclic Lactones, Abamectin and
Emamectin. Cumulative Screening Risk Assessment'' can be found in
docket ID number EPA-HQ-OPP-2018-0088 at https://www.regulations.gov.
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. Emamectin did not elicit
increased fetal sensitivity in developmental toxicity studies in rats
and rabbits. In the reproductive toxicity study, emamectin produced
neuronal degeneration in the brain and spinal cord in parental and
offspring animals at a similar dose level (1.8 mg/kg/day), and no
increase in quantitative sensitivity was found in the pup with respect
to the neurotoxicity. However, in the developmental neurotoxicity study
in rats, there was an increase in both quantitative and qualitative
sensitivity in the pups as no adverse effect was seen at the highest
dose tested (3.6/2.5 mg/kg/day) in parental animals, while at 0.6 mg/
kg/day, the pups showed a dose-related decrease in open field motor
activity at post-natal day 17. Body tremors, hind-limb extension, and
auditory startle
[[Page 44723]]
were also observed in the high dose pups (3.6/2.5 mg/kg/day).
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 emamectin is complete.
ii. The proposed MOA is interaction with GABA receptors leading to
neurotoxicity. The clinical signs observed in the emamectin database
are consistent with the proposed MOA. Following emamectin exposure,
neurotoxicity has been seen across multiple studies and species of test
animals. Neurotoxic effects seen in various studies are consistent with
the MOA of emamectin, and the selected toxicity endpoints and POD is
protective of the neurotoxic effects in the data.
iii. As discussed above, the developmental neurotoxicity study
showed an increase in both quantitative and qualitative sensitivity in
the pups as indicated by a dose-related decrease in open field motor
activity at post-natal day 17 at 0.6 mg/kg/day. Body tremors, hind-limb
extension, and auditory startle were also observed in the high dose
pups (2.5 mg/kg/day), while no adverse effects were seen in the
parental animals at the highest tested dose (3.6 mg/kg/day). However,
the toxicity endpoint and POD (0.25 mg/kg/day) selected for risk
assessment are protective of the effects seen in the pups.
iv. There are no residual uncertainties for emamectin with respect
to the exposure databases. Although the dietary exposure estimates are
partially refined, anticipated residue estimates for most commodities
were derived from field trials which are still considered conservative
since field trials are conducted under maximum use conditions (maximum
allowed application rate and number of applications, minimum pre-
harvest interval, etc.). Monitoring data were used for apples in the
acute assessment since apple juice had a significant impact on
exposure. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to emamectin in
drinking water. There are no anticipated exposures to residential
handlers, or for post-application exposure of adults and children.
These assessments will not underestimate the exposure and risks posed
by emamectin.
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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to emamectin will occupy 26% of the aPAD for children 1 to 2 years old,
the population group receiving the greatest exposure.
2. Chronic risk: Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
emamectin from food and water will utilize 3.4% 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
emamectin is not expected.
3. Short-term risk. A short-term adverse effect was identified;
however, emamectin is not registered for any use patterns that would
result in short-term residential exposure. Short-term risk is assessed
based on short-term residential exposure plus chronic dietary exposure.
Because there is no short-term residential exposure and chronic dietary
exposure has already been assessed under the appropriately protective
cPAD (which is at least as protective as the POD used to assess short-
term risk), no further assessment of short-term risk is necessary, and
EPA relies on the chronic dietary risk assessment for evaluating short-
term risk for emamectin.
4. Intermediate-term risk. An intermediate-term adverse effect was
identified; however, emamectin is not registered for any use patterns
that would result in intermediate-term residential exposure.
Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for emamectin.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, emamectin 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 emamectin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate methods (Method 244-92-3 and Method 244-92-3, Revision 1)
are available for the enforcement of tolerances on plants. The methods
determine residues of emamectin and its regulated isomers and
degradates/metabolites using high performance liquid chromatography
with fluorescence detection (HPLC/FLD).
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.
The Codex has established MRLs for emamectin on various commodities
that are different than the tolerances established for emamectin in the
United States.
[[Page 44724]]
The U.S. and Codex residue definitions are not harmonized. The U.S.
residue definition for emamectin includes the sum of emamectin and its
metabolites (8,9-isomer) for plants and livestock. The Codex residue
definition includes only emamectin for plants and livestock
commodities.
Codex has MRLs for residues of emamectin on tomato, tomatillo, bell
pepper, and non-bell pepper, the representative commodities of the
fruiting vegetable group 8-10 at 0.02 ppm each. The U.S. tolerance at
0.02 ppm for residues on crop group 8-10 is being harmonized with these
Codex MRLs.
Codex has an MRL for residues of emamectin on mustard greens, the
representative commodity for Brassica leafy greens subgroup 4-16B at
0.2 ppm. The U.S. tolerance on subgroup 4-16B is being harmonized with
Codex mustard greens, the representative commodity, at 0.20 ppm.
Codex has MRLs for residues of emamectin on head lettuce at 1 ppm
and leaf lettuce at 0.7 ppm. The current U.S. tolerance is 0.1 ppm for
subgroup 4-16A, which has head lettuce, leaf lettuce, and spinach as
the representative commodities. EPA is therefore harmonizing the
tolerance for subgroup 4-16A with Codex head lettuce at 1 ppm.
Codex has MRLs for apple and pear at 0.02 ppm each. EPA harmonizing
the tolerance on pome fruit, group 11-10 with these MRLs at 0.02 ppm.
For tree nut crop group 14-12, the Codex MRLs for residues on the
representative commodities of this group is 20x lower than the U.S.
tolerances being established in this rulemaking. Lowering the tolerance
could cause U.S. growers to have violative residues when following
label instructions; therefore, EPA is not harmonizing the tolerance
with the Codex MRLs.
For all other commodities, Codex does not have established MRLs.
C. Revisions to Petitioned-For Tolerances
For new uses on globe artichoke, herb subgroup 19A, and cherry
subgroup 12-12A, the tolerances differ slightly from those proposed by
IR-4 due to differences in calculating parent equivalents of emamectin
metabolites from the residue data.
The currently established tolerance on crop group 11 and the
proposed tolerance on crop group 11-10 are both at 0.025 ppm. The
tolerance for pome fruit crop group 11-10 is being established at 0.02
ppm to harmonize with Codex MRLs on apple and pear.
The tolerance on Brassica leafy greens subgroup 4-16B is being set
at 0.2 ppm instead of the proposed level at 0.050 ppm and the tolerance
on leafy greens subgroup 4-16A is being set at 1 ppm instead of 0.1 ppm
to harmonize with Codex.
For the proposed tolerance on fennel, Florence, the commodity
definition was corrected to be Fennel, florence, fresh leaves and
stalk.
For the other commodities and crop groups, the tolerances differ
from the petitioned-for tolerances due to the use of HED rounding class
practice.
The proposed tolerance for emamectin on vegetable, cucurbit, group
9 at 0.03 ppm is not necessary because the available data support the
existing tolerance of 0.02 ppm for that crop group.
V. Conclusion
Therefore, tolerances are established for residues of emamectin,
including its metabolites and degradates in or on the raw agricultural
commodities Artichoke, globe at 0.05 ppm; Brassica, leafy greens,
subgroup 4-16B at 0.2 ppm; Celtuce at 0.1 ppm; Cherry subgroup 12-12A
at 0.09 ppm; Fennel, florence, fresh leaves and stalk at 0.1 ppm;
Fruit, pome, group 11-10 at 0.02 ppm; Herb subgroup 19A at 0.4 ppm;
Kohlrabi at 0.05 ppm; Leaf petiole vegetable subgroup 22B at 0.1 ppm;
Leafy greens subgroup 4-16A at 1 ppm; Nut, tree, group 14-12 at 0.02
ppm; Vegetable, brassica, head and stem, group 5-16 at 0.05 ppm; and
Vegetable, fruiting, group 8-10 at 0.02 ppm.
Additionally, the following existing tolerances are removed as
unnecessary due to the establishment of the above tolerances: Fruit,
pome, group 11 at 0.025; Nut, tree, group 14 at 0.02 ppm; Pistachio at
0.02 ppm; Turnip, greens at 0.050 ppm; Vegetable, brassica, leafy,
group 5 at 0.050 ppm; Vegetable fruiting, group 8 at 0.020 ppm; and
Vegetable, leafy, except brassica, group 4 at 0.100 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 tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
[[Page 44725]]
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 8, 2019.
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. 180.505, amend the table in paragraph (a)(1) as follows:
0
i. Add alphabetically the entries ``Artichoke, globe''; ``Brassica,
leafy greens, subgroup 4-16B''; ``Celtuce''; ``Cherry subgroup 12-
12A''; ``Fennel, florence, fresh leaves and stalk''; ``Fruit, pome,
group 11-10''; ``Herb subgroup 19A''; ``Kohlrabi''; ``Leaf petiole
vegetable subgroup 22B''; ``Leafy greens subgroup 4-16A''; ``Nut, tree,
group 14-12''; ``Vegetable, brassica, head and stem, group 5-16''; and
``Vegetable, fruiting, group 8-10'';
0
ii. Remove the entries for ``Fruit, pome, group 11''; ``Nut, tree,
group 14''; ``Pistachio''; ``Turnip, greens''; ``Vegetable, brassica,
leafy, group 5''; ``Vegetable fruiting, group 8''; and ``Vegetable,
leafy, except brassica, group 4''.
The additions read as follows:
Sec. 180.505 Emamectin; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Artichoke, globe........................................ 0.05
Brassica, leafy greens, subgroup 4-16B.................. 0.2
Celtuce................................................. 0.1
Cherry subgroup 12-12A.................................. 0.09
* * * * *
------------------------------------------------------------------------
Fennel, florence, fresh leaves and stalk................ 0.1
Fruit, pome, group 11-10................................ 0.02
* * * * *
------------------------------------------------------------------------
Herb subgroup 19A....................................... 0.4
Kohlrabi................................................ 0.05
Leaf petiole vegetable subgroup 22B..................... 0.1
Leafy greens subgroup 4-16A............................. 1
Nut, tree, group 14-12.................................. 0.02
* * * * *
------------------------------------------------------------------------
Vegetable, brassica, head and stem, group 5-16.......... 0.05
* * * * *
------------------------------------------------------------------------
Vegetable, fruiting, group 8-10......................... 0.02
------------------------------------------------------------------------
* * * * *
[FR Doc. 2019-18386 Filed 8-26-19; 8:45 am]
BILLING CODE 6560-50-P
