Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations 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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–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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26148 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations 

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-Odemethyl avermectin A1) and less than 

or equal to 20% avermectin B1b (5-Odemethyl-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 doseresponse 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). Pgp 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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Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations 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 Pgp 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-observedadverse-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-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for abamectin used for human 

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26150 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations 

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

Exposure/scenario 

Point of departure and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary and Chronic dietary (All populations).NOAEL = 0.25 mg/kg/

day. 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.0025 mg/

kg/day. 

aPAD = 0.0025 mg/kg/

day 

Chronic RfD = 0.0025 

mg/kg/day 

cPAD = 0.0025 mg/kg/

day 

Subchronic & chronic oral toxicity studies in dogs. 

Chronic LOAEL = 0.50 mg/kg/day based on body 

tremors, one death, liver pathology, decreased body 

weight. 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. 

Dermal short-term (1 to 30 

days).

Oral study NOAEL = 

0.25 mg/kg/day (dermal absorption rate = 

1%. 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ....... Subchronic & chronic oral toxicity studies in dogs. 

Chronic LOAEL = 0.50 mg/kg/day based on body 

tremors, one death, liver pathology, decreased body 

weight. 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 

days).

Oral study NOAEL = 

0.25 mg/kg/day (Toxicity via the inhalation 

route assumed to be 

equivalent) to oral 

route. 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ....... Subchronic & chronic oral toxicity studies in dogs. 

Chronic LOAEL = 0.50 mg/kg/day based on body 

tremors, one death, liver pathology, decreased body 

weight. 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. 

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. 

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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 wellestablished 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-scienceand-assessing-pesticide-risks/aboutwater-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 nonoccupational, 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/pesticidescience-and-assessing-pesticide-risks/

standard-operating-proceduresresidential-pesticide. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA’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 

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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, Pgp 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 foreand 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 

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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 intermediateterm 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, 

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Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations 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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.449, the table in paragraph 

(a) is revised to read as follows: 

§ 180.449 Avermectin B1 and its delta-8,9- 

isomer; tolerances for residues. 

(a) * * * 

Commodity Parts per 

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 

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26156 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations 

Commodity Parts per 

million 

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 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) ................................. 0.01 

Fruit, citrus, group 10–10 .................................................................................................................................................................... 0.02 

Fruit, pome, group 11–10 .................................................................................................................................................................... 0.02 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F ................................................................................................... 0.02 

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 

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