43524 Federal Register / Vol. 77, No. 143 / Wednesday, July 25, 2012 / Rules and Regulations 

[FR Doc. C2–2012–9978 Filed 7–24–12; 8:45 am] 

BILLING CODE 1505–01–D 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0792; FRL–9352–8] 

Acetamiprid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of acetamiprid in 

or on multiple commodities which are 

identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

25, 2012. Objections and requests for 

hearings must be received on or before 

September 24, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0792, is 

available at http://www.regulations.gov 

or at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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–2011–0792 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 September 24, 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–2011–0792, 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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.htm. 

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 

Tolerance 

In the Federal Register of November 

9, 2011 (76 FR 69690) (FRL–9325–1), 

EPA issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1E7919) by Interregional 

Research Project Number 4 (IR–4), 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.578 be 

amended by establishing tolerances for 

residues of the insecticide acetamiprid, 

N 1-[(6-chloro-3-pyridyl)methyl]- N 2- 

cyano- N 1-methylacetamidine, in or on 

asparagus at 0.8 ppm; Brassica, leafy 

greens, subgroup 5B at 15 parts per 

million (ppm); turnip greens at 15 ppm; 

corn, sweet, kernel plus cob with husks 

removed at 0.01 ppm; corn, sweet, 

forage at 10 ppm; corn, sweet, stover at 

30 ppm; vegetable, fruiting, group 8–10 

at 0.20 ppm; fruit, citrus, group 10–10 

at 0.50 ppm; fruit, pome, group 11–10 

at 1.0 ppm; and Brassica, head and 

stem, subgroup 5A at 1.20 ppm. It also 

requested that upon approval of the 

aforementioned tolerances, to remove 

the established tolerances in 40 CFR 

180.578 for fruit, citrus, group 10 at 0.50 

ppm; fruit, pome, group 11 at 1.0 ppm; 

vegetable, fruiting, group 8 at 0.20 ppm; 

and vegetable, Brassica, leafy, group 5 at 

1.20 ppm. The fruit, citrus, group 10; 

fruit, pome, group 11; and vegetable, 

fruiting, group 8 tolerances will be 

superseded by the updated crop group 

tolerances. The vegetable, Brassica, 

leafy group 5 tolerance will be 

superseded by the Brassica, leafy 

greens, subgroup 5B and Brassica, head 

and stem, subgroup 5A tolerances. That 


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notice referenced a summary of the 

petition prepared by Nisso America, 

Inc., the registrant, which is available in 

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

One comment was received on the 

notice of filing. EPA’s response to this 

comment is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA is not 

establishing tolerances for sweet corn 

and its related commodities. The reason 

for these changes is explained in Unit 

IV.D. 

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 acetamiprid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with acetamiprid 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. 

Acetamiprid is moderately toxic in 

acute lethality studies via the oral route 

of exposure and is minimally toxic via 

the dermal and inhalation routes of 

exposure. It is not an eye or skin irritant, 

nor is it a dermal sensitizer. 

Acetamiprid does not appear to have 

specific target organ toxicity. 

Generalized toxicity was observed as 

decreases in body weight, body weight 

gain, food consumption and food 

efficiency in all species tested. 

Generalized liver effects were also 

observed in mice and rats 

(hepatocellular vacuolation in rats and 

hepatocellular hypertrophy in mice and 

rats); the effects were considered to be 

adaptive. Other effects observed in the 

oral studies include amyloidosis of 

multiple organs in the mouse 

oncogenicity study, tremors in high 

dose females in the mouse subchronic 

study, and microconcretions in the 

kidney papilla and mammary 

hyperplasia in the rat chronic/ 

oncogenicity study. No effects were 

observed in a dermal toxicity study in 

rabbits. 

In the rat developmental study, fetal 

shortening of the 13th rib was observed 

in fetuses at the same dose level that 

produced maternal effects (reduced 

body weight and body weight gain and 

increased liver weights). In the 

developmental rabbit study, no 

developmental effects were observed in 

fetuses at doses that reduced maternal 

body weight and food consumption. In 

the reproduction study, decreased body 

weight, body weight gain, and food 

consumption were observed in parental 

animals while significant reductions in 

pup weights were seen in the offspring 

in both generations. Also observed were 

reduction in litter size, and viability and 

weaning indices among F2 offspring as 

well as significant delays in the age to 

attain vaginal opening and preputial 

separation. In the developmental 

neurotoxicity study, parental effects 

were limited to decreased body weight 

and body weight gains, while the 

offspring effects noted were decreased 

body weights and body weight gains, 

decreased pre-weaning survival (postnatal days (PNDs) 0–1), and decreased 

maximum auditory startle response in 

males on PNDs 20 and 60. 

In the acute neurotoxicity study, male 

and female rats displayed decreased 

motor activity, tremors, walking and 

posture abnormalities, dilated pupils, 

coldness to the touch and decreased 

grip strength and foot splay at the 

highest dose tested (HDT). There was a 

decrease in the auditory startle response 

in male rats at the HDT in the 

developmental neurotoxicity study; 

additionally, tremors were noted in 

female mice at the HDT in the 

subchronic feeding study. 

In four week immunotoxicity studies 

performed in both sexes of rats and 

mice, no effects on the immune system 

were observed up to the highest dose, 

although significant reductions in body 

weight and body weight gain were noted 

at that dose. 

Based on acceptable carcinogenicity 

studies in rats and mice, EPA has 

determined that acetamiprid is ‘‘not 

likely to be carcinogenic to humans.’’ 

The classification is based on the 

absence of an increase in the incidence 

of tumors in a mouse carcinogenicity 

study; and in a rat chronic/ 

carcinogenicity study, the absence of a 

dose-response and the lack of a 

statistically significant increase in the 

mammary adenocarcinoma incidence by 

pair-wise comparison of the mid- and 

high-dose groups with the controls 

(although the incidence exceeded the 

historical control data from the same 

laboratory, it was within the range of 

values from the supplier). There was no 

clear evidence of a mutagenic effect. 

Acetamiprid tested positive as a 

clastogen in an in vitro study but not in 

an in vivo study. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by acetamiprid 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 ‘‘Acetamiprid: Human Health Risk 

Assessment for New Uses on Asparagus; 

Brassica, Leafy Greens, Subgroup 5B, 

and Turnip Greens; and Sweet Corn; 

and Updated Crop Group Definitions for 

Fruiting Vegetables, Citrus, and Pome 

Fruit’’, pp. 35–40 in docket ID number 

EPA–HQ–OPP–2011–0792. 

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 


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reference dose (RfD)—and a safe margin 

of exposure (MOE) or aggregate risk 

index (ARI). 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 acetamiprid used for 

human risk assessment is shown in the 

Table of this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ACETAMIPRID 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 (All populations) NOAEL = 10 mg/kg/day UFA

= 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.10 mg/kg/day 

aPAD = 0.10 mg/kg/day 

Co-critical studies. 

Developmental Neurotoxicity in rat. 

LOAEL = 45 mg/kg/day based on decreased 

early pup survival on PND 0–1, and decreased 

startle response on PND 20/60 in males. 

Acute Neurotoxicity Study in rat. 

LOAEL = 30 mg/kg/day based on decreased locomotor activity. 

Chronic dietary (All populations).NOAEL= 7.1 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.071 mg/kg/ 

day 

cPAD = 0.071 mg/kg/day 

Chronic Toxicity/Oncogenicity Study in rats. 

LOAEL = 17.5 mg/kg/day based on decreased 

body weight and body weight gains in females 

and hepatocellular vacuolation in males. 

Short- and Intermediate-Term 

Incidental Oral. (1–30 days 

and 1–6 months).

NOAEL= 10 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Developmental Neurotoxicity in rat. 

LOAEL = 45 mg/kg/day based on decreased 

body weight and body weight gains in offspring, decreased early pup survival on PND 

0–1, and decreased startle response on PND 

20/60 in males. 

Short- and Intermediate-term 

Dermal. (1–30 days, 1–6 

months).

NOAEL= 10 mg/kg/day 

Dermal Absorption Rate = 

10% 

UFA= 10x 

UFH= 10x 

FQPA SF = 1x 

LOC for MOE = 100 Developmental Neurotoxicity in rat. LI≤LOAEL = 

45 mg/kg/day based on decreased body 

weight and body weight gains in offspring, decreased early pup survival on PND 0–1, and 

decreased startle response on PND 20/60 in 

males. 

Short- and Intermediate-term 

Inhalation (1–30 days, 1–6 

months).

Oral study NOAEL= 10 mg/ 

kg/day. UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

UFDB = 10x 

LOC for MOE = 1,000 Developmental Neurotoxicity in rat. 

LOAEL = 45 mg/kg/day based on decreased 

body weight and body weight gains in offspring, decreased early pup survival on PND 

0–1, and decreased startle response on PND 

20/60 in males. 

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). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). PND = 

post-natal day. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to acetamiprid, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing acetamiprid tolerances in 40 

CFR 180.578. EPA assessed dietary 

exposures from acetamiprid 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 acetamiprid. 

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 performed the acute 

analysis based on tolerance level 

residues and assumed 100 percent crop 

treated (PCT). Empirical processing 

factors were used for processed 

commodities unless such data were not 

available, in which case dietary 

exposure evaluation model (DEEM) 

default processing factors from Version 

7.81 were used. 

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 

performed the chronic analysis based on 

tolerance level residues and assumed 

100 PCT. Empirical processing factors 

were used for processed commodities 

unless such data were not available, in 

which case DEEM default processing 

factors from Version 7.81 were used. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that acetamiprid 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. EPA did not use 


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anticipated residue and/or PCT 

information in the dietary assessment 

for acetamiprid. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for acetamiprid in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of acetamiprid. 

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 First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCI– 

GROW) models the estimated drinking 

water concentrations (EDWCs) of 

acetamiprid for surface water are 

estimated to be 95.2 parts per billion 

(ppb) for acute exposures and 26.6 ppb 

for chronic exposure. For ground water, 

the EDWC is 0.035 ppb. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 95.2 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 26.6 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). 

Acetamiprid is currently registered for 

the following uses that could result in 

residential exposures: Indoor and 

outdoor residential settings, including 

crack and crevice and spray 

applications. Mattress treatments were 

also assessed as there is a pending 

application for this use. EPA assessed 

residential exposure using the following 

assumptions: Exposure for adults (from 

short-term dermal and inhalation 

exposure) applying crack and crevice 

and mattress treatments; and 

postapplication exposure for adults 

(from short- and intermediate-term 

dermal and inhalation exposure) and for 

children 3–6 years old (from short- and 

intermediate-term dermal, inhalation 

and hand-to-mouth exposure) following 

crack and crevice and mattress 

treatments. 

Dermal, oral, and inhalation risks for 

short- and intermediate-term exposures 

were combined since the toxicological 

endpoints and points of departure were 

the same. However, due to the lack of 

the required inhalation toxicity study, 

the Agency has determined that a 10X 

FQPA factor must be retained as a 

database uncertainty factor for 

inhalation exposure only, raising the 

LOC to 1,000 for inhalation scenarios. 

As such, the level of concern (LOC) 

values were different (i.e. dermal and 

oral LOC = 100, while inhalation LOC 

= 1,000) and therefore, the respective 

risk estimates are combined using the 

aggregate risk index (ARI) approach. 

This approach reflects risk estimates 

resulting from exposure via the dermal, 

inhalation, and oral routes. An ARI of 

greater than 1 indicates risks that are not 

of concern. 

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 acetamiprid to 

share a common mechanism of toxicity 

with any other substances, and 

acetamiprid does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that acetamiprid 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 pre- and postnatal toxicology 

database for acetamiprid includes rat 

and rabbit developmental toxicity 

studies, a 2-generation reproduction 

toxicity study in rats and a 

developmental-neurotoxicity study 

(DNT) study in rats. There was no 

evidence of quantitative or qualitative 

susceptibility of rat or rabbit fetuses 

following in utero exposure to 

acetamiprid in the developmental 

toxicity studies. However, both the 

developmental neurotoxicity and 2- 

generation reproduction studies showed 

an increase in qualitative susceptibility 

of pups to acetamiprid. Effects in pups 

in the reproduction study included 

delays in preputial separation and 

vaginal opening, as well as reduced 

litter size, decreased pup viability and 

weaning indices; offspring effects 

observed in the developmental 

neurotoxicity study included decreased 

body weight and body weight gains, 

decreased pup viability and decreased 

maximum auditory startle response in 

males. These effects were seen in the 

presence of less severe maternal toxicity 

(decreased body weight and body 

weight gain. No evidence of increased 

quantitative susceptibility was observed 

in the studies. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X for dermal and oral 

exposure pathways. However, a 10X SF 

is being retained as a database 

uncertainty factor for assessing 

inhalation exposure and risk only. This 

decision is based on the following 

findings: 

i. The toxicology data base is 

complete (with the exception of an 

inhalation study) and acceptable 

guideline studies for developmental, 

reproductive toxicity, neurotoxicity 

(including DNT) and immunotoxicity 

are available. 

ii. Acetamiprid produced signs of 

neurotoxicity in the high dose groups in 

the acute and developmental 

neurotoxicity studies in rats and the 

subchronic toxicity study in mice. 

However, no neurotoxic findings were 

reported in the subchronic neurotoxicity 

study in rats. Additionally, there are 

clear NOAELs identified for the effects 

observed in the toxicity studies. The 

doses and endpoints selected for risk 

assessment are protective and account 

for all toxicological effects observed in 

the database. 


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iii. No quantitative or qualitative 

evidence of increased susceptibility of 

fetuses to in utero exposure to 

acetamiprid was observed in either the 

developmental toxicity study in rats or 

rabbits. Although increased qualitative 

susceptibility was seen in the 

reproduction toxicity and the DNT 

study, the degree of concern for the 

effects is low. There are clear NOAELs 

for the offspring effects and regulatory 

doses were selected to be protective of 

these effects. No other residual 

uncertainties were identified with 

respect to susceptibility. The endpoints 

and doses selected for acetamiprid are 

protective of adverse effects in both 

offspring and adults. 

iv. Currently, inhalation exposure is 

being assessed using hazard information 

from the developmental neurotoxicity 

study, which is an oral study. In the 

absence of an inhalation study, there is 

uncertainty about potential portal of 

entry effects occurring via the inhalation 

route of exposure. Therefore, EPA is 

recommending a 28-day inhalation 

study and retaining a 10X FQPA factor 

as a database uncertainty factor for the 

inhalation route of exposure only, 

pending submission of the required 

study. 

v. The exposure databases (dietary 

food, drinking water, and residential) 

are complete and the risk assessment for 

each potential exposure scenario 

includes all metabolites and/or 

degradates of concern and does not 

underestimate the potential risk to 

infants or children. The dietary 

exposure assessments were based on 

tolerance level residues and assumed 

100 PCT. Empirical processing factors 

were used for processed commodities 

unless such data were not available, in 

which case DEEM default processing 

factors from Version 7.81 were used. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to acetamiprid 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 acetamiprid. 

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 ARI 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

acetamiprid will occupy 52% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to acetamiprid 

from food and water will utilize 33% 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 acetamiprid 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 

(considered to be a background 

exposure level). Acetamiprid is 

currently registered for uses that could 

result in short- and intermediate-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short- and intermediateterm residential exposures to 

acetamiprid. 

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 

ARIs of 3.41 for adults and 1.45 for 

children. Because EPA’s level of 

concern for acetamiprid is an ARI of 1 

or below, these ARIs 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, 

acetamiprid 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 acetamiprid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

liquid chromatography/mass 

spectrometry mass spectrometry (LC/ 

MS/MS), (Method #KP–216R0 and its 

variant #KP–216R1) is available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@epa.

gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

For the specific new use commodities 

associated with this tolerance petition, 

the Codex has not established a MRL for 

acetamiprid. 

C. Response to Comments 

An anonymous citizen objected to the 

presence of any pesticide residues on 

food. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned 

completely. However, the existing legal 

framework provided by section 408 of 

the FFDCA contemplates that tolerances 

greater than zero may be set when 

persons seeking such or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. This citizen’s comment 

appears to be directed at the underlying 

statute and not EPA’s implementation of 

it; the citizen has made no contention 

that the EPA has acted in violation of 

the statutory framework. 

D. Revisions to Petitioned-For 

Tolerances 

EPA has determined that the available 

data are insufficient for establishing the 

proposed tolerances on sweet corn. Five 

additional field trials are required to 

support this use. 


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Federal Register / Vol. 77, No. 143 / Wednesday, July 25, 2012 / Rules and Regulations 43529 

V. Conclusion 

Therefore, tolerances are established 

for residues of acetamiprid, N 1-[(6- 

chloro-3-pyridyl)methyl]- N 2-cyano- N 

1-methylacetamidine, in or on asparagus 

at 0.80 ppm; Brassica, leafy greens, 

subgroup 5B at 15 ppm; turnip greens at 

15 ppm; vegetable, fruiting, group 8–10 

at 0.20 ppm; fruit, citrus, group 10–10 

at 0.50 ppm; fruit, pome, group 11–10 

at 1.0 ppm; and Brassica, head and 

stem, subgroup 5A at 1.20 ppm. 

Also, due to the tolerances established 

in this unit by this document, the 

following existing tolerances are 

removed as unnecessary: Fruit, citrus, 

group 10; fruit, pome, group 11; 

vegetable, fruiting, group 8; and 

vegetable, Brassica, leafy, group 5. 

VI. Statutory and Executive Order 

Reviews 

This final rule 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 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 FFDCA section 408(d), 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 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 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 

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: July 17, 2012. 

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 180.578 is amended by 

removing the entries for ‘‘fruit, citrus, 

group 10’’; ‘‘fruit, pome, group 11’’; 

‘‘vegetable, fruiting, group 8’’; and 

‘‘vegetable, Brassica, leafy, group 5’’ and 

by alphabetically adding the following 

entries to the table in paragraph (a)(1) to 

read as follows: 

§ 180.578 Acetamiprid; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Asparagus ..................................... 0.80 

* * * * * 

Brassica, head and stem, subgroup 5A ................................... 1.20 

Brassica, leafy greens, subgroup 

5B .............................................. 15 

* * * * * 

Fruit, citrus, group 10–10 ............. 0.50 

Fruit, pome, group 11–10 ............. 1.0 

* * * * * 

Turnip greens ............................... 15 

* * * * * 

Vegetable, fruiting, group 8–10 .... 0.20 

* * * * * 

* * * * * 

[FR Doc. 2012–18059 Filed 7–24–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–1987–0002; FRL–9703–4] 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List: Deletion 

of the Fort Dix Landfill Superfund Site 

AGENCY: Environmental Protection 

Agency. 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) Region 2 is publishing a 

direct final Notice of Deletion of the 

Fort Dix Landfill Superfund Site (Site), 

located in Pemberton Township, New 

Jersey, from the National Priorities List 

(NPL). The NPL, promulgated pursuant 

to section 105 of the Comprehensive 

Environmental Response, 

Compensation, and Liability Act 

(CERCLA) of 1980, as amended, is an 

appendix of the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). This direct 


TKELLEY on DSK3SPTVN1PROD with RULES