[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Rules and Regulations]
[Pages 26147-26156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10230]
[[Page 26147]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0428; FRL-9945-29]
Abamectin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
abamectin in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4), Syngenta Crop Protection, and Y-TEX Corporation requested
these tolerances in four separate petitions under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 2, 2016. Objections and
requests for hearings must be received on or before July 1, 2016, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0428, is available at http://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 http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0428 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
July 1, 2016. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0428, by one of
the following methods:
Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerances
In the Federal Register of September 12, 2013 (78 FR 56185) (FRL-
9399-7), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3) announcing the filing of pesticide petitions by
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W., Princeton, NJ 08540 (PP 3E8175) and Syngenta Crop
Protection, LLC, P.O. Box 18300, Greensboro, NC 27419 (PP 3F8184). The
petitions requested that 40 CFR 180.449 be amended by establishing
tolerances for residues of the insecticide avermectin (abamectin)
determined by measuring only avermectin B1, a mixture of
avermectins containing greater than or equal to 80% avermectin
B1a (5-O-demethyl avermectin A1) and less than or
equal to 20% avermectin B1b (5-O-demethyl-25-de(1-
methylpropyl)-25-(1-methylethyl) avermectin A1), and its
delta-8,9-isomer in or on caneberry subgroup 13-07A at 0.20 parts per
million (ppm) (PP 3E8175), and corn, field, sweet, and pop at 0.01 ppm;
corn, field and pop, forage at 0.2 ppm; corn, field and pop, grain at
0.01 ppm; corn, field and pop, stover at 0.6 ppm; corn, sweet, forage
at 0.2 ppm; corn, sweet, kernel plus cob with husk removed at 0.01 ppm;
corn, sweet, stover at 0.5 ppm; soybean at 0.01 ppm; soybean, forage at
0.3 ppm; soybean, hay at 1 ppm; and soybean, seed at 0.01 ppm (PP
3F8184). That document referenced summaries of the petitions prepared
by Syngenta Crop Protection, the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notices of filing.
In the Federal Register of February 25, 2014 (79 FR 10458) (FRL-
9906-77), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3) announcing the filing of pesticide petition by Y-TEX
Corporation, 1825 Big Horn Avenue, P.O. Box 1450, Cody, WY 82414 (PP
3F8200). The petition requested that 40 CFR 180.449 be amended by
increasing an established tolerance for the combined residues of the
insecticide
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avermectin B1 (a mixture of avermectins containing greater
than or equal to 80% avermectin B1a (5-O-demethyl avermectin
A1) and less than or equal to 20% avermectin B1b
(5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl) avermectin
A1)) and its delta-8,9-isomer, in or on milk from 0.005 ppm
to 0.01 ppm. That document referenced a summary of the petition
prepared by Y-TEX Corporation, the registrant, which is available in
the docket for docket ID number EPA-HQ-OPP-2013-0264, http://www.regulations.gov. There were no FFDCA-related comments received in
response to the notice of filing.
In the Federal Register of February 11, 2015 (80 FR 7559) (FRL-
9921-94), 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 by IR-
4, 500 College Road East, Suite 201 W., Princeton, NJ 08540 (PP
4E8309). The petition requested that 40 CFR 180.449 be amended by
establishing tolerances for residues of the insecticide avermectin
(abamectin) determined by measuring only avermectin B1, a
mixture of avermectins containing greater than or equal to 80%
avermectin B1a (5-O-demethyl avermectin A1) and
less than or equal to 20% avermectin B1b (5-O-demethyl-25-
de(1-methylpropyl)-25-(1-methylethyl) avermectin A1), and
its delta-8,9-isomer in or on fruit, stone, group 12-12 at 0.09 ppm,
fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at
0.02 ppm, nut, tree, group 14-12 at 0.01 ppm, vegetable, fruiting,
group 8-10 at 0.07 ppm, fruit, citrus, group 10-10 at 0.02 ppm, berry,
low growing, subgroup 13-07G at 0.05 ppm, fruit, pome, group 11-10 at
0.02 ppm, papaya at 0.40 ppm, star apple at 0.40 ppm, black sapote at
0.40 ppm, sapodilla at 0.40 ppm, canistel at 0.40 ppm, mamey sapote at
0.40 ppm, guava at 0.015 ppm, feijoa at 0.015 ppm, jaboticaba at 0.015
ppm, wax jambu at 0.015 ppm, starfruit at 0.015 ppm, passionfruit at
0.015 ppm, acerola at 0.015 ppm, lychee 0.01 ppm, longan at 0.01 ppm,
Spanish lime at 0.01 ppm, rambutan at 0.01 ppm, pulasan at 0.01 ppm,
pineapple at 0.015 ppm, bean at 0.015 ppm, and onion, green, subgroup
3-07B at 0.08 ppm. Upon the approval of the aforementioned tolerances,
IR-4 requested removal of established tolerances of abamectin,
including its metabolites and degradates, in or on the following
commodities: Bean, dry, seed at 0.01 ppm, citrus at 0.02 ppm, apple at
0.02 ppm, pear at 0.02 ppm, fruit, stone, group 12 at 0.09 ppm, nut,
tree, group 14 at 0.01 ppm, pistachio at 0.01 ppm, grape at 0.02 ppm,
strawberry at 0.05 ppm and vegetable, fruiting, group 8 at 0.02 ppm.
That document referenced summaries of the petitions prepared by
Syngenta Crop Protection, the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
Based upon review of the data supporting the petitions, EPA has
modified the level at which tolerances are being established for some
commodities. The reasons for these changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has 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 abamectin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with abamectin 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.
Abamectin is a mixture of avermectin B1 [a mixture of
avermectins containing greater than or equal to 80% avermectin
B1a (5-O-demethyl avermectin A1) and less than or
equal to 20% avermectin B1b (5-O-demethyl-25-de(1-
methylpropyl)-25-(1-methylethyl) avermectin A1)] and its
delta-8,9-isomer. Avermectins are macrocyclic lactones produced as
natural fermentation products of the soil bacterium Streptomyces
avermitilis. Currently, abamectin and emamectin are the only members of
this group with active pesticide registrations. The two components of
abamectin, B1a and B1b, have very similar
biological and toxicological properties. Emamectin, which is a
derivative of abamectin, is a structurally and toxicologically related
chemical. The only difference between abamectin and emamectin is that
abamectin has a hydroxyl moiety at the 4'' position of the
tetrahydropyrane ring, whereas in emamectin the hydroxyl group is
replaced by a methylamine.
Since the last time the EPA assessed abamectin (Federal Register of
March 27, 2013 (78 FR 18519) (FRL-9379-1)), the Agency has re-evaluated
the entire abamectin and emamectin toxicological database along with
currently available literature information on the toxicity of the
abamectin and emamectin to ensure consistent hazard evaluation for
these structurally related pesticides. This hazard characterization and
dose-response assessment represents a more refined analysis than
previous assessments, using the literature data to enhance the
characterization of the studies submitted to the Agency.
Available toxicity data show that, with single dose or repeated
dose administration, the primary target organ of abamectin is the
nervous system, and that decreased body weight is also one of the most
frequent findings. Neurotoxicity (including tremors, mydriasis, ataxia,
and death) was seen in mice, dogs, and rats. Developmental effects such
as cleft palate were reported in rabbits. Abamectin was shown to bind
to the gamma aminobutyric acid (GABA) receptors, and this interaction
was believed to result in neurotoxicity. The GABA receptor interaction
also plays a role in development; cleft palate findings may reflect the
interaction of abamectin on the GABA receptor. Generally the finding of
cleft palate was seen at higher dose levels than those for
neurotoxicity.
Integral to the dose response assessment in mammals for this class
of compounds is P-glycoprotein (P-gp). P-gp is a member of adenosine
triphosphate (ATP) binding cassette transporter proteins, which reside
in the plasma membrane and function as a transmembrane efflux pump,
moving
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xenobiotics from the intracellular to the extracellular domain. P-gp is
found in the canallicular surface of hepatocytes, the apical surface of
proximal tubular cells in the kidneys, the brush border surface of
enterocytes, and the 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 abamectin-induced neurotoxicity (Lankas et al., 1997).
An example is the rat. 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 (Matsuoka, 1999). As
shown in the reproductive and developmental neurotoxicity (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, P-gp was found as early as 22 weeks of
gestation (Daood, MJ, 2008; van Kalken, et al., 1991). Based on the
difference in the ontogeny of P-gp in neonatal rat and human newborn,
the Agency, at this time, does not believe that the early post-natal
findings in the rat to be relevant to human newborns or young children.
Similarly, the CF-1 mouse is also uniquely sensitive to the
neurotoxic effects of abamectin and its derivative, emamectin. Some CF-
1 mice have a polymorphism for the gene encoding P-gp and are either
devoid (homozygous) or have diminished (heterozygous) level of P-gp.
The Agency does not consider the results of studies with CF-1 mice to
be relevant for human health risk assessment because there is a lack of
convincing evidence from the literature on human polymorphism of human
multidrug resistance (MDR-1) gene resulting in diminished P-gp
function. Although many studies on human multidrug resistance (MDR-1)
gene encoding P-gp and polymorphism of MDR-1 gene are available, the
data are inconclusive with respect to the functional significance of
the genetic variance in P-gp in human. At the present, 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 (Macdonald & Gledhill, 2007). As a result, the Agency does
not consider the toxic effects observed in CF-1 mouse studies to be
representative of abamectin (and emamectin) effects in humans.
Therefore, the Agency is using results from toxicological studies
conducted in the species (rats, CD-1 mice, rabbits, and dogs) that do
not have diminished P-gp function for selecting toxicity endpoints and
points of departure for risk assessment. Among the test animals with
fully functional P-gp, the beagle dog is the most sensitive species.
For various durations of treatment (subchronic (12- and 18-weeks)
and chronic oral toxicity studies in dogs), clinical signs [tremors and
mydriasis (decreased pupillary light response)] of neurotoxicity were
observed in the at the lowest observed adverse effect level (LOAEL) of
0.5 milligram/kilogram (mg/kg); the no observed adverse effect level
(NOAEL) was 0.25 mg/kg. Tremors and mydriasis were observed as early as
the first week of exposure. The Agency assumes that these clinical
signs could result from a single dose for the following reasons:
1. Kinetic data demonstrates rapid absorption/excretion. With oral
dosing in rats and mice, abamectin was absorbed rapidly, and maximum
concentration in blood was achieved within 4-8 hours after
administration. It was rapidly eliminated from the body, almost
exclusively in the feces, and did not accumulate in the body after
repeated exposure.
2. In an acute neurotoxicity study (ACN) in rat (range finding and
main studies), clinical signs of neurotoxicity such as reduced foot
splay reflex, ataxia, tremors, and mydriasis (decreased pupillary light
response) were observed from a single dose. Most of the effects
observed in the rat ACN were consistent with those seen in the
subchronic and chronic dog studies.
3. The neurotoxic effects produced by abamectin in beagle dogs did
not progress with time. The effects seen in the subchronic (gavage) and
chronic dog studies were similar despite the varied durations of
treatment, suggesting the response could be due to each individual
exposure rather than to accumulation of abamectin in tissues. Clinical
signs such as ataxia and or whole body tremors were reported within 3
hours of the first dose at higher dose levels.
Based on these considerations, 0.25 mg/kg/day was selected as a
point of departure for risk assessment for all the exposure scenarios,
and the toxicity endpoints were clinical signs of neurotoxicity.
Carcinogenicity studies in rats and mice (CD-1) and mutagenicity
studies provide no indication that abamectin is carcinogenic or
mutagenic.
Specific information on the studies received and the nature of the
adverse effects caused by abamectin 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 http://www.regulations.gov in the document titled ``Abamectin. Human Health
Risk Assessment for Uses on Caneberry Subgroup 13-07A; Soybean; Sweet
Corn; Ear Tags for Lactating Dairy Cattle; Golf Course Turf; Bean;
Onion, Green, Subgroup 3-07B; Fruit, Pome, Group 11-10; Fruit, Small
Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F; Berry, Low
Growing, Subgroup 13-07G; Vegetable, Fruiting, Group 8-10; Greenhouse
Tomato; Fruit, Citrus, Group 10-10; Fruit, Stone, Group 12-12; and Nut,
Tree, Group 14-12; and Various Tropical Fruits'' on page 53 in docket
ID number EPA-HQ-OPP-2013-0428.
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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for abamectin used for
human
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risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Abamectin for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary and Chronic dietary NOAEL = 0.25 mg/kg/ Acute RfD = 0.0025 Subchronic & chronic oral
(All populations). day. mg/kg/day. toxicity studies in dogs.
UFA = 10x............ aPAD = 0.0025 mg/kg/ Chronic LOAEL = 0.50 mg/kg/day
UFH = 10x............ day. based on body tremors, one
FQPA SF = 1x......... Chronic RfD = 0.0025 death, liver pathology,
mg/kg/day. decreased body weight.
cPAD = 0.0025 mg/kg/ Mydriasis was seen during week
day. one in one dog.
Subchronic LOAEL = 0.5 mg/kg/
day based on mydriasis during
week one, death at 1.0 mg/kg/
day.
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Dermal short-term (1 to 30 days).. Oral study NOAEL = LOC for MOE = 100... Subchronic & chronic oral
0.25 mg/kg/day toxicity studies in dogs.
(dermal absorption Chronic LOAEL = 0.50 mg/kg/day
rate = 1%. based on body tremors, one
UFA = 10x............ death, liver pathology,
UFH = 10x............ decreased body weight.
FQPA SF = 1x......... Mydriasis was seen during week
one in one dog.
Subchronic LOAEL = 0.5 mg/kg/
day based on mydriasis during
week one, death at 1.0 mg/kg/
day.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30 Oral study NOAEL = LOC for MOE = 100... Subchronic & chronic oral
days). 0.25 mg/kg/day toxicity studies in dogs.
(Toxicity via the Chronic LOAEL = 0.50 mg/kg/day
inhalation route based on body tremors, one
assumed to be death, liver pathology,
equivalent) to oral decreased body weight.
route. Mydriasis was seen during week
UFA = 10x............ one in one dog.
UFH = 10x............ Subchronic LOAEL = 0.5 mg/kg/
FQPA SF = 1x......... day based on mydriasis during
week one, death at 1.0 mg/kg/
day.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation). Classification: ``Not likely to be Carcinogenic to Humans'' based on the
absence of significant tumor increases 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 abamectin, EPA considered exposure under the petitioned-for
tolerances as well as all existing abamectin tolerances in 40 CFR
180.449. EPA assessed dietary exposures from abamectin 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 abamectin. In estimating acute
dietary exposure, EPA used food consumption information from the 2003-
2008 United States Department of Agriculture (USDA) National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As
to residue levels in food, a refined acute dietary exposure assessment
was conducted for all proposed and established food uses of abamectin.
Anticipated residues derived from field trial data for most plant
commodities were used in the acute dietary exposure assessment.
Tolerance-level residues were used for poultry and swine livestock
commodities. Because cattle may be exposed to residues of abamectin
through diet and ear tag, upper-bound anticipated residues were
estimated from the maximum values found in cattle feeding studies and
dermal magnitude of residue studies. For all other livestock
commodities, upper-bound anticipated residues were estimated from
secondary residues from consuming treated feed. Empirical and default
processing factors and maximum percent crop treated (PCT) estimates
were used, as available.
ii. Chronic exposure. The Agency selected a point of departure for
chronic effects that is the same as the point of departure for acute
effects and so is relying on the acute assessment to be protective of
chronic effects. So, the Agency assessed chronic exposure for purposes
of providing background dietary exposure for use in the residential
short-term assessments. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the 2003-2008 USDA
NHANES/WWEIA. As to residue levels in food, a refined chronic dietary
exposure assessment was conducted for all proposed and established food
uses of abamectin. Average residues for plant commodities from field
trials were used. Residue levels based on maximum reasonable dietary
burden for secondary residues in livestock (beef and dairy cattle) and
the highest residues found in the magnitude of residue studies for
cattle ear tags were used in the chronic assessment for livestock
commodities. Tolerance values were used for poultry and swine to
account for poultry and swine consuming treated feed. Residues from use
in food handling establishments were included. Empirical and default
processing factors and average PCT estimates were used, as available.
[[Page 26151]]
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that abamectin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and PCT information. 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, 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 following maximum PCT estimates were used in the acute dietary
risk assessment for the following crops that are currently registered
for abamectin: Almond: 80%; apple: 30%; apricot: 30%; avocado: 60%;
bean, dry: 2.5%; cantaloupe: 45%; celery: 70%; cherry: 20%; cotton:
30%; cucumber: 10%; grape: 35%; grapefruit: 90%; hazelnut: 2.5%;
honeydew: 35%; lemon: 55%; lettuce: 45%; nectarine: 20%; onion, bulb:
10%; orange: 70%; peach: 25%; pear: 85%; pecan: 2.5%; pepper: 30%;
pistachio: 2.5%; plum/prune: 35%; potato: 20%; pumpkin: 10%; spinach:
45%; squash: 15%; strawberry: 45%; tangerine: 55%; tomato: 25%; walnut:
55%; and watermelon: 15%.
The PCT values that were used to refine the livestock commodities
for the acute assessment were based on: Sweet corn (44%) for beef,
goat, horse, and sheep commodities; and the food handling establishment
uses (5%) for hog and poultry meat and meat byproducts.
The following average PCT estimates were used in the chronic
dietary risk assessment for the following crops that are currently
registered for abamectin: Almond: 70%; apple: 10%; apricot: 15%;
avocado: 35%; bean, dry: 2.5%; cantaloupe: 25%; celery: 45%; cherry:
5%; cotton: 20%; cucumber: 5%; grape: 15%; grapefruit: 70%; hazelnut:
2.5%; honeydew: 20%; lemon: 40%; lettuce: 20%; nectarine: 20%; onion,
bulb: 2.5%; orange: 40%; peach: 10%; pear: 70%; pecan: 1%; pepper: 15%;
pistachio: 2.5%; plum/prune: 10%; potato: 5%; pumpkin: 5%; spinach:
25%; squash: 5%; strawberry: 30%; tangerine: 35%; tomato: 10%; walnuts:
25%; and watermelons: 5%.
The PCT values that were used to refine the livestock commodities
(cattle, goats, horses, and sheep) for the chronic assessment were
based on: Cotton (30%), soybean (8%), and sweet corn (38%). The PCT for
poultry and hog commodities is based on the food handling establishment
PCT since the tolerances for food handling establishment uses result in
residues considerably higher than secondary residues from hogs and
poultry consuming treated feed. All commodities included for food
handling residues were assigned the value of 5%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
The following maximum PCT estimates were used in the acute dietary
risk assessment for the following new uses of abamectin:
Blackberries: 68%; boysenberry: 68%; corn, sweet 57%; loganberry:
68%; raspberries: 68%; soybeans: 11%.
The following average PCT estimates were used in the chronic
dietary risk assessment for the following new uses of abamectin:
Blackberries: 56%; boysenberry: 56%; corn, sweet 45%; loganberry:
68%; raspberries: 56%; soybeans: 8%.
EPA estimates of the PCTn of abamectin represents the upper bound
of use expected during the pesticide's initial five years of
registration; that is, PCTn for abamectin is a threshold of use that
EPA is reasonably certain will not be exceeded for each registered use
site. The PCTn recommended for use in the chronic dietary assessment is
calculated as the average PCT of the market leader or leaders, (i.e.,
the one(s) with the greatest PCT) on that site over the three most
recent years of available data. The PCTn recommended for use in the
acute dietary assessment is the maximum observed PCT over the same
period. Comparisons are only made among pesticides of the same
pesticide types (e.g., the market leader for insecticides on the use
site is selected for comparison with a new insecticide). The market
leader included in the estimation may not be the same for each year
since different pesticides may dominate at different times.
Typically, EPA uses USDA/NASS as the source data because it is
publicly available and directly reports values for PCT. When a specific
use site is not reported by USDA/NASS, EPA uses proprietary data and
calculates the PCT given reported data on acres treated and acres
grown. If no data are available, EPA may extrapolate PCTn from other
crops, if the production area and pest spectrum are substantially
similar.
A retrospective analysis to validate this approach shows few cases
where the PCT for the market leaders were exceeded. Further review of
these cases identified factors contributing to the exceptionally high
use of a new pesticide. To evaluate whether the PCTn for abamectin
could be exceeded, EPA considered whether there may be unusually high
pest pressure, as indicated in emergency exemption requests for
abamectin; the pest spectrum of the new pesticide in comparison with
the market leaders and whether the market leaders are well-established
for that use; and whether pest resistance issues with past market
leaders provide abamectin with significant market potential. Given
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currently available information, EPA concludes that it is unlikely that
actual PCT for abamectin will exceed the estimated PCT for new uses
during the next five years.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which abamectin may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for abamectin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of abamectin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Tier II surface water concentration calculator (SWCC)
computer model and Tier I Screening Concentration in Ground Water (SCI-
GROW) model and Tier I Pesticide Root Zone Model Ground Water (PRZM
GW), the estimated drinking water concentrations (EDWCs) of abamectin
for acute exposures are estimated to be 0.76 parts per billion (ppb)
for surface water and 0.074 ppb for ground water and for chronic
exposures are estimated to be 0.30 ppb for surface water and <=0.0031
ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model either via point estimates or
using residue distribution files.
For acute dietary risk assessment, a drinking water residue
distribution file was used to assess the contribution to drinking
water.
For chronic dietary risk assessment, the water concentration of
value 0.30 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).
Abamectin is currently registered for the following uses that could
result in residential exposures: Homeowner bait and bait station
products that include an outdoor granular bait formulation for use on
fire ant mounds, and several indoor ready-to-use baits of both dust and
gel formulations. In addition, as part of the current request, the
registrant has proposed a use on golf course turf.
EPA assessed residential exposure using the following assumptions:
For residential handlers, both dermal and inhalation short-term
exposure is expected from the currently registered bait and bait
station uses. Quantitative exposure/risk assessment considered the
following scenarios: Loading/applying granular bait outdoor via (1)
push-type spreaders, (2) belly grinders, (3) spoons, (4) hand, and (5)
cup or shaker; and (6) applying granular bait indoor by hand (as a
surrogate for a ready-to-use dust bait).
Post-application residential exposure for adults and children (1 to
<2) is unlikely for the currently registered uses of abamectin. For
currently registered outdoor treatments, adults and children are not
expected to directly contact fire ant mounds. For currently registered
indoor pest control, bait placements are intended to be placed in
cracks and crevices where direct contact by adults and children (1 to
<2) is unlikely.
However, residential post-application exposure for adults and
children (6 to <11 and 11 to <16) is possible for the newly proposed
use of abamectin on golf courses. Adults and children (6 to <11 and 11
to <16) performing physical post-application activities on golf course
turf may receive dermal exposure to abamectin residues. The scenarios,
lifestages, and routes of exposure include: Golfing for adults
(dermal), children 11 to <16 years old (dermal), and children 6 to <11
years old (dermal).
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA's Office of Pesticide Programs (OPP) has previously developed
guidance documents for establishing common mechanism groups (CMGs)
(Guidance for Identifying Pesticide Chemicals and Other Substances that
have a Common Mechanism of Toxicity (1999)) and conducting cumulative
risk assessments (CRAs) (Guidance on Cumulative Risk Assessment of
Pesticide Chemicals that have a Common Mechanism of Toxicity (2002)).
In 2016, EPA's Office of Pesticide Programs released another guidance
document entitled Pesticide Cumulative Risk Assessment: Framework for
Screening Analysis. All three of these documents can be found at http://www.regulations.gov in docket ID EPA-HQ-OPP-2015-0422.
The Agency has utilized this 2016 screening framework for abamectin
and determined that abamectin along with emamectin form a candidate
CMG. This group of pesticides is considered a candidate CMG because
they share characteristics to support a testable hypothesis for a
common mechanism of action. Following this determination, the Agency
conducted a screening-level cumulative risk assessment consistent with
the 2016 guidance document. This screening assessment indicates that
that cumulative dietary and residential aggregate exposures for
abamectin and emamectin are below the Agency's levels of concern. No
further cumulative evaluation is necessary for abamectin and emamectin.
The Agency's screening-level cumulative analysis can be found at
http://www.regulations.gov in the document titled ``Abamectin. Human
Health Risk Assessment for Uses on Caneberry Subgroup 13-07A; Soybean;
Sweet Corn; Ear Tags for Lactating Dairy Cattle; Golf Course Turf;
Bean; Onion, Green, Subgroup 3-07B; Fruit, Pome, Group 11-10; Fruit,
Small Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F; Berry,
Low Growing, Subgroup 13-07G; Vegetable, Fruiting, Group 8-10;
Greenhouse Tomato; Fruit, Citrus, Group 10-10; Fruit, Stone, Group
[[Page 26153]]
12-12; and Nut, Tree, Group 14-12; and Various Tropical Fruits'' on
page 74 (Appendix H) in docket ID number EPA-HQ-OPP-2013-0428.
Additionally, when the Agency issued the notice in the Federal
Register announcing the availability of the draft framework guidance,
the EPA also received comments on the draft human health risk
assessment for abamectin, which was included in that docket as an
example of how EPA would implement the draft framework guidance. The
response to those comments can be found in docket ID number EPA-HQ-OPP-
2013-0428.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10x) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (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. An increase in qualitative
susceptibility was seen in the rabbit developmental toxicity study,
where decreases in body weight and food consumption were seen in
maternal animals at 2.0 mg/kg/day. In contrast, the fetal effects were
much more severe, consisting of cleft palate, clubbed foot, and death
at 2.0 mg/kg/day. The point of departure (0.25 mg/kg/day) selected from
the dog studies is more than 8x lower than the dose where rabbit fetal
effects were seen. Therefore, it is protective of fetal effects seen in
the rabbit developmental toxicity study.
The rat reproduction toxicity and developmental neurotoxicity
studies demonstrated both qualitative and quantitative susceptibility
in the pups to the effects of abamectin (decrease pup weights and
increased postnatal pup mortality). This observation is consistent with
the finding that P-gp is not fully developed in rat pups until
postnatal day 28. Therefore, during the period from birth to postnatal
day 28, the rat pups are substantially more susceptible to the effects
of abamectin than adult rats. However, in humans, P-gp has been
detected in the fetus at 22 weeks of pregnancy, and the human newborns
have functioning P-gp. Therefore, human infants and children are not
expected to have enhanced sensitivity as seen in rat pups.
3. Conclusion. Currently, the toxicity endpoints and points of
departure for all exposure scenarios are selected from the subchronic
and chronic oral toxicity studies in the dogs. The points of departure
selected from the dog studies are based on clear NOAELs and protective
of all the adverse effects seen in the studies conducted in human
relevant studies with rats, CD-1 mice, and rabbits. Therefore, EPA has
determined that the safety of infants and children would be adequately
protected if the FQPA SF were reduced to 1x. That decision is based on
the following findings:
i. The toxicity database for abamectin is complete.
ii. The proposed mode of action (MOA) is interaction with GABA
receptors leading to neurotoxicity. The findings of neurotoxic signs
observed in the abamectin database are consistent with the proposed
MOA. Signs of neurotoxicity ranging from decreases in foot splay
reflex, mydriasis (i.e., excessive dilation of the pupil), curvature of
the spine, decreased fore- and hind-limb grip strength, tip-toe gate,
tremors, ataxia, or spastic movements of the limbs are reported in
various studies with different durations of abamectin exposure. In
dogs, mydriasis was the most common finding at doses as low as 0.5 mg/
kg/day at one week of treatment. No neuropathology was observed.
Because the PODs used for assessing aggregate exposure to abamectin and
the PODs for assessing cumulative exposure for abamectin and emamectin
are protective of these neurotoxic effects in the U.S. population, as
well as infants and children, no additional data concerning
neurotoxicity is needed at this time to be protective of potential
neurotoxic effects.
iii. As explained in Unit III.D.2 ``Prenatal and postnatal
sensitivity'', the enhanced susceptibility seen in the rabbit
developmental toxicity, the rat reproduction, and the rat developmental
neurotoxicity studies do not present a risk concern.
iv. There are no residual uncertainties identified in the exposure
databases. The chronic and acute dietary food exposure assessment are
refined including use of anticipated residues, default processing
factors, and percent crop treated; however, these refinements are
considered protective because field trials are conducted to represent
use conditions leading to the maximum residues in food when the product
is used in accordance with the label and do not underestimate
exposures. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to abamectin in
drinking water. EPA used similarly conservative assumptions to assess
post-application exposure of children. These assessments will not
underestimate the exposure and risks posed by abamectin.
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 abamectin will occupy 88% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions discussed in this
unit for chronic exposure, the chronic dietary exposure from food and
water to abamectin will occupy 11% of the cPAD for children 1-2 years
old, the population group receiving the greatest exposure. Based on the
explanation in Unit III.C.3., regarding residential use patterns,
chronic residential exposure to residues of abamectin is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Abamectin is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to abamectin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 4,400 for adults,
3,600 for children 11 to <16 years old, and 2,100 for children 6 to <11
years old. Because EPA's level of concern for abamectin is
[[Page 26154]]
a MOE of 100 or below, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
An intermediate-term adverse effect was identified; however,
abamectin 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 the acute dietary risk assessment is protective of all
exposure durations (since the point of departure is the same for all
exposure durations), no further assessment of intermediate-term risk is
necessary.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, abamectin 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 abamectin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methods for abamectin in plant and livestock
commodities are available in the Pesticide Analytical Manual, Volume II
(PAM II).
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established MRLs for abamectin on sweet corn,
soybean, papaya, star apple, black sapote, sapodilla, canistel, mamey
sapote, guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit,
acerola, lychee, longan, Spanish lime, rambutan, pulasan, pineapple,
bean or green onion commodities. Additionally, there are no Codex MRLs
for abamectin on the commodities in the caneberry subgroup 13-07A;
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F; or
fruit, stone, group 12-12.
The following U.S. tolerances are harmonized with established,
related Codex MRLs: Fruit, pome, group 11-10; and nut, tree, group 14-
12.
The Codex MRL on citrus is not harmonized with the U.S. tolerance
on fruit, citrus, group 10-10, and the Codex MRL on strawberry is not
harmonized with the recommended U.S. tolerance on berry, low-growing,
subgroup 13-07G. Residue data underlying these U.S. tolerances supports
tolerances that are higher than the established Codex MRLs on these
related commodities.
Codex MRLs for abamectin on fruiting vegetable commodities are not
harmonized with the U.S. tolerance on vegetable, fruiting, group 8-10.
The residue data underlying the U.S. fruiting vegetable tolerance
resulted in a tolerance that is higher than the established Codex MRL
on sweet peppers. Codex has also established a separate tolerance on
dried chili pepper that is higher than the U.S. fruiting vegetable
tolerance.
There are some Codex MRLs on livestock commodities, but none of the
Codex MRLs are set at the same level as the tolerance levels EPA is
establishing today; however, the U.S. cannot harmonize with the Codex
MRLs on livestock commodities since the Codex MRLs reflect different
uses (i.e., different dietary burdens) as compared to the uses in the
United States, which also reflect the direct treatment of cattle via
ear tags. Setting U.S. tolerances at Codex MRL levels would result in
tolerance violations for some livestock commodities.
C. Revisions to Petitioned-For Tolerances
Although not requested, EPA is establishing a tolerance of 0.40 ppm
for ``grain, aspirated grain fractions'' since aspirated grain
fractions are associated with soybeans. The recommended tolerance of
0.40 ppm for ``grain, aspirated grain fractions'' is based on residues
of <0.006 ppm in soybean seed and a concentration factor of 59X in
aspirated grain fractions.
EPA is also increasing some of the established livestock tolerances
based on a new dietary burden calculation that includes the proposed
uses on soybeans and sweet corn as well as a proposed use for ear tags
for lactating dairy cattle. Because of these calculations, EPA is
increasing the established tolerances on cattle fat from 0.03 to 0.05
ppm; cattle meat byproducts from 0.06 to 0.09 ppm; fat of goat, horse
and sheep from 0.01 to 0.03 ppm; meat byproducts of goat, horse, and
sheep from 0.02 to 0.04 ppm; and milk from 0.005 to 0.015 ppm.
Finally, EPA is not establishing tolerances for ``corn, field,
sweet, and pop; corn, field and pop, forage; corn, field and pop,
grain; corn, field and pop, stover'' because the petitioner withdrew
those tolerance requests.
D. Literature References
Daood., MJ, Tsai, C., Ahdab-Barmada, M., and Watchko, JF (2008). ABC
transporter (P-gp/ABCB1, MRP1/ABCC1, BCRP/ABCG2) expression in the
developing Human CNS. Neuropediatrics. 2008 August; 39(4): 211.
Lankas, GR, Cartwright, ME, and Umbenhauer, D. (1997) P-Glycoprotein
deficiency in a subpopulation of CF-1 mice enhances avermectin-
induced neurotoxicity. Toxicol. and Appl. Pharmacol. 143: 357-365.
Macdonald, N. and Gledhill, A. (2007). Potential impact of ABCB1 (p-
glycoprotein) polymorphisms on avermectin toxicity in human. Arch
Toxicol (2007) 81:553-563.
Matsukoa, Y., Okazaki, M., Kitamura, Y., and Taniguchi, T. (1999).
Developmental expression of P-glycoprotein (multidrug resistance
gene product) in the rat brain. Journal of Neurobiology, 39(3), 383-
392.
van Kalken, CK, Giaccone, G., van der Valk, P., Kuiper, CM,
Hadisaputro, MMN, Bosma, SAA, Scheper, RJ, Meijer, CJLM, and Pinedo,
HM (1992). Multidrug resistance gene (P-glycoprotein) expression in
the human fetus. American Journal of Pathology, vol 141 No.5,
November 1992.
V. Conclusion
Therefore, tolerances are established for residues of abamectin in
or on acerola at 0.015 ppm; bean at 0.015 ppm; berry, low growing,
subgroup 13-07G at 0.05 ppm; black sapote at 0.40 ppm; caneberry
subgroup 13-07A at 0.20 ppm; canistel at 0.40 ppm; corn, sweet, forage
at 0.20 ppm; corn, sweet, kernel plus cob with husk removed at 0.01
ppm; corn, sweet, stover at 0.50 ppm; feijoa at 0.015 ppm; fruit,
citrus, group 10-10 at 0.02 ppm; fruit, pome, group 11-10 at 0.02 ppm;
fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F
0.02 ppm; fruit, stone, group 12-12 at 0.09 ppm; grain, aspirated grain
fractions at 0.40 ppm; guava at 0.015 ppm; jaboticaba at 0.015 ppm;
longan at 0.01 ppm; lychee at 0.01 ppm; mamey sapote at 0.40 ppm; nut,
[[Page 26155]]
tree, group 14-12 at 0.01 ppm; onion, green, subgroup 3-07B at 0.08
ppm; papaya at 0.40 ppm; passionfruit at 0.015 ppm; pineapple at 0.015
ppm; pulasan at 0.01 ppm; rambutan at 0.01 ppm; sapodilla at 0.40 ppm;
soybean, forage at 0.30 ppm; soybean, hay at 1.0 ppm; soybean, seed at
0.01 ppm; Spanish lime at 0.01 ppm; star apple at 0.40 ppm; starfruit
at 0.015 ppm; vegetable, fruiting, group 8-10 at 0.07 ppm; and wax
jambu at 0.015 ppm.
In addition, EPA is increasing the established tolerances on
cattle, fat from 0.03 to 0.05 ppm; cattle, meat byproducts from 0.06 to
0.09 ppm; fat of goat, horse, and sheep from 0.01 to 0.03 ppm; meat
byproducts of goat, horse, and sheep from 0.02 to 0.04 ppm; and milk
from 0.005 to 0.015 ppm.
And lastly EPA is removing the following tolerances as unnecessary
due to the establishment of the aforementioned tolerances: Apple at
0.02 ppm; bean, dry, seed at 0.01 ppm; citrus at 0.02 ppm; fruit,
stone, group 12 at 0.09 ppm; grape at 0.02 ppm; nut, tree, group 14 at
0.01 ppm; pear at 0.02 ppm; pistachio at 0.01 ppm; strawberry at 0.05
ppm; and vegetable, fruiting, group 8 at 0.020 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). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 22, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.449, the table in paragraph (a) is revised to read as
follows:
Sec. 180.449 Avermectin B1 and its delta-8,9-isomer;
tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Acerola................................................. 0.015
Almond, hulls........................................... 0.10
Apple, wet pomace....................................... 0.10
Avocado................................................. 0.020
Bean.................................................... 0.015
Berry, low growing, subgroup 13-07G..................... 0.05
Black sapote............................................ 0.40
Caneberry subgroup 13-07A............................... 0.20
Canistel................................................ 0.40
Cattle, fat............................................. 0.05
Cattle, meat............................................ 0.02
Cattle, meat byproducts................................. 0.09
Celeriac, roots......................................... 0.05
Celeriac, tops.......................................... 0.05
Chive, dried leaves..................................... 0.02
Chive, fresh leaves..................................... 0.01
Citrus, dried pulp...................................... 0.10
[[Page 26156]]
Citrus, oil............................................. 0.10
Corn, sweet, forage..................................... 0.20
Corn, sweet, kernel plus cob with husk removed.......... 0.01
Corn, sweet, stover..................................... 0.50
Cotton, gin byproducts.................................. 1.0
Cotton, undelinted seed................................. 0.02
Feijoa.................................................. 0.015
Food products in food handling establishments (other 0.01
than those already covered by higher tolerances as a
result of use on growing crops, and other than those
already covered by tolerances on milk, meat, and meat
byproducts)............................................
Fruit, citrus, group 10-10.............................. 0.02
Fruit, pome, group 11-10................................ 0.02
Fruit, small vine climbing, except fuzzy kiwifruit, 0.02
subgroup 13-07F........................................
Fruit, stone, group 12-12............................... 0.09
Goat, fat............................................... 0.03
Goat, meat.............................................. 0.02
Goat, meat byproducts................................... 0.04
Grain, aspirated grain fractions........................ 0.40
Guava................................................... 0.015
Herb subgroup 19A, except chive......................... 0.030
Hog, fat................................................ 0.01
Hog, meat............................................... 0.02
Hog, meat byproducts.................................... 0.02
Hop, dried cones........................................ 0.20
Horse, fat.............................................. 0.03
Horse, meat............................................. 0.02
Horse, meat byproducts.................................. 0.04
Jaboticaba.............................................. 0.015
Longan.................................................. 0.01
Lychee.................................................. 0.01
Mamey sapote............................................ 0.40
Milk.................................................... 0.015
Nut, tree, group 14-12.................................. 0.01
Onion, bulb, subgroup 3-07A............................. 0.01
Onion, green, subgroup 3-07B............................ 0.08
Papaya.................................................. 0.40
Passionfruit............................................ 0.015
Peppermint, tops........................................ 0.010
Pineapple............................................... 0.015
Plum, prune, dried...................................... 0.025
Poultry, meat........................................... 0.02
Poultry, meat byproducts................................ 0.02
Pulasan................................................. 0.01
Rambutan................................................ 0.01
Sapodilla............................................... 0.40
Sheep, fat.............................................. 0.03
Sheep, meat............................................. 0.02
Sheep, meat byproducts.................................. 0.04
Soybean, forage......................................... 0.30
Soybean, hay............................................ 1.0
Soybean, seed........................................... 0.01
Spanish lime............................................ 0.01
Spearmint, tops......................................... 0.010
Star apple.............................................. 0.40
Starfruit............................................... 0.015
Vegetable, cucurbit, group 9............................ 0.005
Vegetable, fruiting, group 8-10......................... 0.07
Vegetable, leafy, except brassica, group 4.............. 0.10
Vegetable, tuberous and corm, subgroup 01C.............. 0.01
Wax jambu............................................... 0.015
------------------------------------------------------------------------
* * * * *
[FR Doc. 2016-10230 Filed 4-29-16; 8:45 am]
BILLING CODE 6560-50-P