Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Rules and Regulations 69653 

* * * * * 

[FR Doc. 2011–28945 Filed 11–8–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0619; FRL–8890–2] 

Abamectin (avermectin); Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of abamectin 

(avermectin) in or on onion, bulb, 

subgroup 3–07A; chive, fresh leaves; 

chive, dried leaves; and bean, dry, seed. 

This regulation additionally removes 

time-limited tolerances on bean, lima, 

seed; and onion, bulb, as the tolerances 

will be superseded by permanent 

tolerance. Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 9, 2011. Objections and 

requests for hearings must be received 

on or before January 9, 2012, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0619. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

nollen.laura@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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://ecfr.gpoaccess.gov/cgi/t/ 

text/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–2010–0619 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 January 9, 2012. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0619, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of August 11, 

2010 (75 FR 48667) (FRL–8840–6), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 0E7738) by IR–4, 

500 College Rd. East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.449 be 

amended by establishing tolerances for 

residues of the insecticide abamectin 

(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 bean, dry, 

seed at 0.01 parts per million (ppm); 

chive, dried leaves at 0.07 ppm; chive, 

fresh leaves at 0.01 ppm; and onion, 

bulb, subgroup 3–07A at 0.01 ppm. That 

notice referenced a summary of the 

petition prepared on behalf of IR–4 by 

Syngenta Crop Protection, Inc., the 

registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 


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69654 Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Rules and Regulations 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance for chive, dried 

leaves. Additionally, the Agency has 

revised the tolerance expression for all 

established commodities to be 

consistent with current Agency policy. 

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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 

(avermectin) including exposure 

resulting from the tolerances established 

by this action. EPA’s assessment of 

exposures and risks associated with 

abamectin (avermectin) 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 (avermectin) has moderate 

to high acute toxicity by the oral route, 

high acute toxicity by the inhalation 

route, and low acute toxicity by the 

dermal route. It is slightly irritating to 

the skin, but is not an ocular irritant or 

a dermal sensitizer. The main target 

organ for abamectin (avermectin) is the 

nervous system. Neurotoxicity and 

developmental effects were detected in 

multiple studies and species of test 

animals. Signs of neurotoxicity were 

reported in studies of rats, mice, and 

dog and included decreases in foot 

splay reflex, mydriasis, curvature of the 

spine, decreased fore- and hind-limb 

grip strength, tip-toe gate, tremors, 

ataxia, or spastic movements of the 

limbs. Decreased body weight was also 

one of the most frequent findings. 

Severe effects, including death and 

morbid sacrifice, were noted in studies 

with rats and mice following repeated 

exposures. 

Increased qualitative and/or 

quantitative susceptibility was seen in 

prenatal developmental toxicity studies 

in mice and rabbits, and the 

reproductive toxicity and 

developmental neurotoxicity studies in 

rats. Developmental data indicate that 

the most sensitive effect of abamectin 

(avermectin) on fetuses is the increase 

in the incidence of cleft palates in mice 

and rabbits in the presence of no or 

minimal maternal toxicity. No maternal 

or developmental toxicity was seen in 

the prenatal developmental toxicity 

study in rats. 

The rat reproductive toxicity studies 

(two 1-generation reproduction studies 

and a 2-generation reproduction study) 

noted decreased pup body weights and/ 

or survival at lower dose levels than 

those that caused parental toxicity. The 

developmental neurotoxicity studies in 

rats noted pup mortality and/or 

decreased body weights in the absence 

of maternal toxicity; there were no signs 

of neurotoxicity noted. In both the rat 

reproduction and a developmental 

neurotoxicity study, the data clearly 

indicated that the decrease in pup body 

weight seen at one dose level rapidly 

progressed to death at the next higher 

tested dose level. Oncogenicity and 

mutagenicity studies provide no 

indication that abamectin (avermectin) 

is carcinogenic or mutagenic; 

abamection (avermectin) has been 

classified as ‘‘not likely to be 

carcinogenic to humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by abamectin 

(avermectin) as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies can 

be found at http://www.regulations.gov 

in document: ‘‘Abamectin. Human 

Health Risk Assessment for Proposed 

Uses on the Bulb Onion Subgroup 3– 

07A, Chives, and Dry Beans,’’ pp. 54–58 

in docket ID number EPA–HQ–OPP– 

2010–0619. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and the 

LOAEL. Uncertainty/safety factors are 

used in conjunction with the POD to 

calculate a safe exposure level— 

generally referred to as a populationadjusted 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://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for abamectin (avermectin) 

used for human risk assessment is 

shown in Table 1 of this unit. 


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Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Rules and Regulations 69655 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ABAMECTIN (AVERMECTIN) 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 (General population including infants 

and children).

NOAEL = 0.5 mg/kg/day ...

UFA = 10x 

UFH = 10x FQPA SF = 1x 

Acute RfD = 0.005 mg/kg/ 

day.

aPAD = 0.005 mg/kg/day ..

12-Week dose-range finding study in dogs 

LOAEL = 1.0 mg/kg/day based on mydriasis seen 1–5 

times during the first week of treatment; Acute 

neurotoxicity study in rats 

LOAEL = 1.5 mg/kg/day based on increased incidence 

of foot splay. 

Chronic dietary (All populations).NOAEL= 0.12 mg/kg/day ..

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

Chronic RfD = 0.0012 mg/ 

kg/day.

cPAD = 0.0004 mg/kg/day 

Combined data: Three rat reproduction studies and 

two rat developmental neurotoxicity studies 

LOAEL = 0.2 mg/kg/day based on decreased pup 

body weight in pups at 0.2 mg/kg/day. 

Incidental oral short- and intermediate-term (1 to 30 

days and 1 to 6 months).

NOAEL= 0.12 mg/kg/day ..

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

LOC for MOE = 300 .......... Combined data: Three rat reproduction studies and 

two rat developmental neurotoxicity studies 

LOAEL = 0.2 mg/kg/day based on decreased pup 

body weight. 

Dermal (all durations) .......... Dermal (or oral) study .......

NOAEL = 0.12 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

LOC for MOE = 300 .......... Combined data: Three rat reproduction studies and 

two rat developmental neurotoxicity studies 

LOAEL = 0.2 mg/kg/day based on decreased pup 

body weight. 

Inhalation (all durations) ...... Dermal (or oral) study .......

NOAEL = 0.12 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

LOC for MOE = 300 .......... Combined data: Three rat reproduction studies and 

two rat developmental neurotoxicity studies 

LOAEL = 0.2 mg/kg/day based on decreased pup 

body weight. 

Cancer (Oral, dermal, inhalation).‘‘Not likely to be carcinogenic to humans’’ based on the absence of significant increase in tumor incidence in two 

adequate rodent carcinogenicity studies. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to abamectin (avermectin), 

EPA considered exposure under the 

petitioned-for tolerances as well as all 

existing abamectin (avermectin) 

tolerances in 40 CFR 180.449. EPA 

assessed dietary exposures from 

abamectin (avermectin) 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 (avermectin). In estimating 

acute dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA utilized 

tolerance level residues for the proposed 

crops and okra and anticipated residues 

for the remaining commodities. 

Empirical processing factors and 

percent crop treated (PCT) data were 

also used, when available. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

utilized tolerance level residues for the 

proposed crops and okra, and average 

residues from field trials for the 

remaining crops. Empirical processing 

factors and PCT were also used, when 

available. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that abamectin (avermectin) 

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. 

For the acute dietary assessment, the 

maximum PCT for existing uses were 

estimated as follows: 


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69656 Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Rules and Regulations 

Almonds, 75%; apples, 10%; apricots, 

5%; avocados, 60%; cantaloupes, 30%; 

celery, 65%; cherries, 2.5%; cotton, 

20%; cucumbers, 10%; grapefruit, 80%; 

grapes, 25%; honeydew, 35%; lemons, 

55%; lettuce, 20%; oranges, 45%; 

peaches, 2.5%; pears, 80%; pecans, 

2.5%; peppers, 25%; potatoes, 2.5%; 

prunes, 10%; pumpkins, 10%; spinach, 

45%; squash, 10%; strawberries, 45%; 

tangerines, 65%; tomatoes, 20%; 

walnuts, 20%; and watermelons, 10%. 

For the chronic dietary assessment, 

the average PCT for existing uses were 

estimated as follows: 

Almonds, 50%; apples, 5%; apricots, 

5%; avocados, 40%; cantaloupes, 15%; 

celery, 40%; cherries, 1%; cotton, 5%; 

cucumbers, 5%; grapefruit, 60%; grapes, 

10%; honeydew, 20%; lemons, 35%; 

lettuce, 10%; oranges, 25%; peaches, 

1%; pears, 70%; pecans, 1%; peppers, 

10%; potatoes, 1%; prunes, 2.5%; 

pumpkins, 2.5%; spinach, 20%; squash, 

5%; strawberries, 30%; tangerines, 60%; 

tomatoes, 10%; walnuts, 10%; and 

watermelons, 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 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 (avermectin) 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 (avermectin) in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of abamectin 

(avermectin). Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

abamectin (avermectin) for acute 

exposures are estimated to be 2.3 parts 

per billion (ppb) for surface water and 

1.6 × 10¥3 ppb for ground water, and for 

chronic exposures for non-cancer 

assessments are estimated to be 1.3 ppb 

for surface water and 1.6 × 10¥3 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 2.3 ppb was used 

to assess the contribution to drinking 

water. For chronic dietary risk 

assessment, the water concentration of 

value 1.3 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 (avermectin) is currently 

registered for the following uses that 

could result in residential handler and 

postapplication exposures: Granular 

baits used to treat lawns and indoor 

crack and crevice dust products. EPA 

assessed residential exposure using the 

following assumptions: Adults were 

assessed for short- and intermediateterm residential handler and 

postapplication exposures (dermal and 

inhalation). Children were assessed for 

short- and intermediate-term 

postapplication dermal, inhalation, and 

incidental ingestion exposures (hand-tomouth and object-to-mouth). 

Recreational exposures to turf are 

expected to be similar to, or less than, 

those described above, and were 

therefore not assessed. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www.epa.gov/pesticides/trac/ 

science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found abamectin (avermectin) to share a 

common mechanism of toxicity with 

any other substances, and abamectin 

(avermectin) does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that abamectin (avermectin) 

does not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The abamectin (avermectin) toxicity 

database is adequate to evaluate 


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Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Rules and Regulations 69657 

potential increased susceptibility of 

infants and children, and includes 

developmental toxicity studies in rat, 

mice, and rabbits; two 1-generation rat 

reproductive toxicity studies in rat; a 2- 

generation reproductive toxicity study 

in rat; and two developmental 

neurotoxicity studies in rat. No 

developmental effects were seen in the 

rat developmental toxicity study. 

However, increased quantitative 

susceptibility was noted in the prenatal 

developmental toxicity studies in mice 

and rabbits, the rat reproductive toxicity 

studies, and the developmental 

neurotoxicity studies in rat. 

3. Conclusion. In previous abamectin 

(avermectin) risk assessments, the 10x 

FQPA safety factor was retained as a 

database uncertainty factor for the lack 

of a developmental neurotoxicity study. 

Two developmental neurotoxicity 

studies have now been submitted and 

reviewed and the findings in these 

studies were considered in the 

identification of toxicological points of 

departure and uncertainty/safety factors. 

EPA has determined that reliable data 

show the safety of infants and children 

would be adequately protected if the 

FQPA SF were reduced to 1X for the 

acute dietary assessment and 3X for all 

assessments other than acute dietary. 

That decision is based on the following 

findings: 

i. For all risk assessments involving 

repeated exposures to abamectin 

(avermectin), EPA determined that a 3x 

safety factor would be appropriate, 

based on the severity of effects (decrease 

in pup body weight and mortality) and 

the steepness of the dose-response curve 

seen in the developmental neurotoxicity 

study and three reproductive toxicity 

studies in the rat. These studies have 

documented a very narrow dose range 

from NOAEL (0.12 mg/kg/day) to 

adverse effect (0.2 mg/kg/day) to severe 

adverse effect (0.4 mg/kg/day). Dose 

spacing is commonly greater than 2x 

between NOAEL and LOAEL, and the 

3x difference between the NOAEL and 

the dose that induced mortality in the 

pups in the developmental 

neurotoxicity study provides little 

margin of safety for the severity of the 

effects seen. 

Retaining an additional 3x FQPA 

safety factor effectively provides a 10x 

margin between the dose which causes 

death (0.4 mg/kg/day) and the NOAEL 

adjusted by the additional safety factor 

(0.12 mg/kg/day/3x = 0.04 mg/kg/day). 

A dose spacing of 10x between a 

NOAEL and LOAEL is as broad, if not 

broader, than the dose spacing generally 

used in animal testing and thus removes 

the residual concern of the steepness of 

the dose-response curve and the severe 

effects noted. 

Additionally, this adjusted point of 

departure (0.04 mg/kg/day) would 

address the concerns for the increased 

susceptibility seen at higher doses in the 

2-generation reproduction study in rats 

(LOAEL = 0.4 mg/kg/day), prenatal 

developmental study in mice (LOAEL = 

0.75 mg/kg/day), the prenatal 

developmental toxicity study in rabbits 

(LOAEL = 2 mg/kg/day), and the 1- 

generation rat reproduction study 

(LOAEL = 0.2 mg/kg/day). 

With respect to acute dietary 

exposure, the endpoint selected for risk 

assessment is based on mydriasis 

observed in dogs. The EPA determined 

that the additional 3x factor applied to 

chronic and other exposure scenarios is 

not applicable to acute exposure for the 

following reasons: 

a. The concerns noted for steepness of 

the dose-response curve and the severity 

of effects were not seen in the studies 

where mydriasis occurred. 

b. The reduced body weights noted in 

studies following repeated exposure to 

abamectin (avermectin) are not a single 

dose effect. 

c. The increased susceptibility seen in 

the prenatal developmental toxicity 

studies, reproductive toxicity studies, 

and the developmental neurotoxicity 

studies were seen at a dose lower 

(LOAEL 0.2 mg/kg/day) than the dose 

(LOAEL 1.0 mg/kg/day) that caused 

mydriasis. 

Therefore, EPA has determined that it 

would be appropriate if the FQPA SF 

were reduced to 1X for the acute dietary 

assessment. 

ii. The toxicity database for abamectin 

(avermectin) is complete, except for 

immunotoxicity testing. Recent changes 

to 40 CFR part 158 imposed new data 

requirements for immunotoxicity testing 

(OPPTS Guideline 870.7800) for 

pesticide registration. However, the 

toxicity database for abamectin 

(avermectin) provides no indication of 

immunotoxicity and abamectin 

(avermectin) does not belong to a class 

of chemicals that would be expected to 

be immunotoxic. EPA does not believe 

that conducting an immunotoxicity 

study will result in a NOAEL less than 

the NOAELs of 0.5 mg/kg/day and 0.12 

mg/kg/day already set for abamectin 

(avermectin) acute and repeated 

exposures, respectively, and an 

additional uncertainty factor is not 

needed to account for potential 

immunotoxicity. 

iii. Signs of neurotoxicity ranging 

from decrease 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 were reported 

in various studies with different 

durations of abamectin (avermectin) 

exposure in rats, mice, and dogs. 

However, the results of two submitted 

rat developmental neurotoxicity studies 

did not show any evidence of 

neurotoxicity. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute and chronic dietary exposure 

assessments were refined and utilized 

tolerance level or anticipated residues, 

default or empirical processing factors, 

and PCT estimates. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to abamectin 

(avermectin) in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by abamectin (avermectin). 

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 (avermectin) will occupy 

30% of the aPAD for infants less than 

1 year old, the population group 

receiving the greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to abamectin 

(avermectin) from food and water will 

utilize 50% 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 (avermectin) is not 

expected. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 


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69658 Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Rules and Regulations 

(considered to be a background 

exposure level). Abamectin (avermectin) 

is currently registered for uses that 

could result in short- and intermediateterm residential exposures, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short- and intermediate-term residential 

exposures to abamectin (avermectin). 

Using the exposure assumptions 

described in this unit for short- and 

intermediate-term exposures, EPA has 

concluded the combined short- and 

intermediate-term food, water, and 

residential exposures result in aggregate 

MOEs of 1200 for the general population 

and 500 for children 1–2 years old. 

Because EPA’s level of concern for 

abamectin (avermectin) is a MOE of 300 

or below, these MOEs are not of 

concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

abamectin (avermectin) is not expected 

to pose a cancer risk to humans. 

5. 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 

(avermectin) residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

are available in Pesticide Analytical 

Manual II (PAM II) for citrus and 

processed fractions (Method I), ginned 

cottonseed (Method IA), and bovine 

tissues and milk (Method II). 

Additionally, Method M–073 and M– 

936–95–2 have been validated by the 

Agency and submitted for inclusion in 

PAM II as enforcement methods. These 

five methods are adequate for 

enforcement of the tolerances on plants 

and livestock. 

Method M–073 and M–936–95–2 may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

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. 

There are currently no Codex MRLs 

for abamectin (avermectin) on 

commodities associated with this 

petition. 

C. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petition, EPA revised the 

proposed tolerance for chive, dried 

leaves from 0.07 ppm to 0.02 ppm. EPA 

revised the tolerance level based on 

analysis of the residue field trial data 

using the Agency’s Tolerance 

Spreadsheet in accordance with the 

Agency’s Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data. 

Additionally, the Agency has revised 

the tolerance expression to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of abamectin 

(avermectin) not specifically mentioned; 

and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of abamectin (avermectin), 

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 onion, bulb, subgroup 3–07A at 

0.01 ppm; chive, fresh leaves at 0.01 

ppm; chive, dried leaves at 0.02 ppm; 

and bean, dry, seed at 0.01 ppm. This 

regulation additionally removes the 

time-limited tolerances on bean, lima, 

seed at 0.005 ppm; and onion, bulb at 

0.005 ppm, as they will be superseded 

by permanent tolerances. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule 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 final rule 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 section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule 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 section 408(n)(4) of FFDCA. 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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

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 


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Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Rules and Regulations 69659 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: September 30, 2011. 

Daniel J. Rosenblatt, 

Acting 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. Section 180.449 is amended in 

paragraph (a) by revising the 

introductory text and alphabetically 

adding the following commodities to the 

table and by revising paragraph (b) to 

read as follows: 

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

isomer; tolerances for residues. 

(a) General. Tolerances are 

established for residues of abamectin 

(avermectin), including its metabolites 

and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

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 the following commodities: 

Commodity Parts per 

million 

*****

Bean, dry, seed ...................... 0.01 

*****

Chive, dried leaves ................. 0.02 

Chive, fresh leaves ................. 0.01 

*****

Onion, bulb, subgroup 3–07A 0.01 

*****

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. 2011–28666 Filed 11–8–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0583; FRL–8891–4] 

Methacrylic Acid-Methyl MethacrylatePolyethylene Glycol Monomethyl Ether 

Methacrylate Graft Copolymer; 

Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of methacrylic 

acid-methyl methacrylate-polyethylene 

glycol monomethyl ether methacrylate 

graft copolymer when used as an inert 

ingredient in a pesticide chemical 

formulation. Akzo Noel Surface 

Chemistry LLC submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

methacrylic acid-methyl methacrylatepolyethylene glycol monomethyl ether 

methacrylate graft copolymer on food or 

feed commodities. 

DATES: This regulation is effective 

November 9, 2011. Objections and 

requests for hearings must be received 

on or before January 9, 2012, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2011–0583. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Alganesh Debesai, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8353; email address: 

debesai.alganesh@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. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 


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