Document ID: EPA-HQ-OPP-2013-0428-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Abamectin
Posted Date: 2016-05-02T04:00Z

[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]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at 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

[[Page 26148]]

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

[[Page 26149]]

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

[[Page 26150]]

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
----------------------------------------------------------------------------------------------------------------
                                      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.
----------------------------------------------------------------------------------------------------------------
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

[[Page 26152]]

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