Federal Register / Vol. 78, No. 118 / Wednesday, June 19, 2013 / Rules and Regulations 36671 

Dated: June 14, 2013. 

Michael K. Yudin, 

Delegated the authority to perform the 

functions and the duties of the Assistant 

Secretary for Special Education and 

Rehabilitative Services. 

[FR Doc. 2013–14652 Filed 6–18–13; 8:45 am] 

BILLING CODE 4000–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0626; FRL–9391–2] 

Acetamiprid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances and modifies existing 

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 June 

19, 2013. Objections and requests for 

hearings must be received on or before 

August 19, 2013, 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–2012–0626, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0626 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 August 19, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0626, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.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 February 

27, 2013 (78 FR 13295) (FRL–9380–2), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 3E8147) by IR–4, 

500 College Road East, Suite 201W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.578 be 

amended by establishing tolerances for 

residues of the insecticide, acetamiprid, 

(1E)-N-[(6-chloro-3-pyridinyl)methyl]- 

N′-cyano-N-methylethanimidamide, 

including its metabolites and 

degradates, in or on corn, sweet, kernel 

plus cob with husks removed at 0.01 

ppm; corn, sweet, forage at 15 ppm; and 

corn, sweet, stover at 30 ppm. The 

petition also proposed increasing the 

existing tolerances in fat, meat, and 

meat byproducts of cattle, goat, horse, 

and sheep, and milk. Tolerances in 

cattle, goat, horse, and sheep meat are 

proposed at 0.30 ppm; cattle, goat, 

horse, and sheep fat at 0.20 ppm; cattle, 

goat, horse, and sheep meat byproducts 

at 0.70 ppm; and milk at 0.30 ppm. That 

document referenced a summary of the 

petition prepared by Nisso America 

Incorporated, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. 

In the Federal Register of September 

28, 2012 (77 FR 59578) (FRL–9364–6), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 2F8060) by 

Nippon Soda Co., Ltd. c/o Nisso 

America Inc., 88 Pine St., 14th Fl., New 

York, NY 10005. The petition requested 

that 40 CFR 180.578 be amended by 

increasing the existing tolerances for 

residues of the insecticide, acetamiprid, 

(1E)-N-[(6-chloro-3-pyridinyl)methyl]- 

N′-cyano-N-methylethanimidamide, 

including its metabolites and 


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degradates, in or on the citrus fruit crop 

group 10–10 at 1.0 ppm; and citrus, 

dried pulp at 2.4 ppm. That document 

referenced a summary of the petition 

prepared by Nisso America 

Incorporated, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. 

There were no comments received in 

response to either notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

determined that the existing tolerance 

for dried citrus pulp does not need to be 

increased. The reason for these changes 

is explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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 (1) the 

absence of an increase in the incidence 

of tumors in a mouse carcinogenicity 

study; and (2) 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 the New Use 

on Sweet Corn and Increased Tolerance 

on Citrus’’ on pages 27–32 in docket ID 

number EPA–HQ–OPP–2012–0626. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 


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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 acetamiprid used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—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 mo.).

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 mo.).

Oral study NOAEL = 

10 mg/kg/day dermal absorption rate 

= 10%.

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 Inhalation (1–30 

days, 1–6 mo.).

Oral study NOAEL = 

10 mg/kg/day (inhalation absorption 

rate = 100%).

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. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 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 

2003–2008 U.S. Department of 

Agriculture’s (USDA’s) National Health 

and Nutrition Examination Survey, 

What We Eat in America, (NHANES/ 

WWEIA). As to residue levels in food, 

EPA assumed 100 percent crop treated 

(PCT) and tolerance level residues in the 

assessment. 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. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the 2003–2008 USDA NHANES/ 

WWEIA. As to residue levels in food, 

EPA assumed 100 PCT and tolerance 

level residues in the assessment. 

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 

anticipated residue and/or PCT 

information in the dietary assessment 

for acetamiprid. Tolerance level 


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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 acute exposures are 

estimated to be 95.2 parts per billion 

(ppb) for surface water and 0.035 ppb 

for ground water and for chronic 

exposures are estimated to be 26.6 ppb 

for surface water and 0.035 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 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 mattress 

treatments. 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. 

In the previous risk assessment for 

acetamiprid, EPA had concluded that a 

subchronic inhalation study was 

required, and an additional 10X FQPA 

factor was retained as a database 

uncertainty factor, which raised the 

LOC to 1,000 for inhalation scenarios. 

Because the LOC values were different 

(i.e. dermal and oral LOC = 100, while 

inhalation LOC = 1,000) the respective 

risk estimates were combined using the 

aggregate risk index (ARI) approach. 

Since then, however, this conclusion 

was reevaluated based on a request from 

the registrant, and EPA has now 

concluded that this study is not 

required. Please refer to section D.3.i for 

further details on this inhalation study 

requirement conclusion. Therefore, the 

risk estimates utilize the combined MOE 

approach, as opposed to the ARI 

approach. 

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 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. That decision is 

based on the following findings: 

i. The toxicology data base is 

complete and acceptable guideline 

studies for developmental, reproductive 

toxicity, neurotoxicity (including DNT) 

and immunotoxicity are available. 

In determining the need for a 

subchronic inhalation study, EPA’s 

weight of evidence decision process 

included both hazard and exposure 

considerations as well as incorporation 

of a presumed 10X Database Uncertainty 

Factor (UFdb) for the lack of this study. 

Thus, the Agency’s Level of Concern in 

the weight of the evidence evaluation 

for inhalation exposure risk assessment 

is a Margin of Exposure (MOE) of 1,000, 

which includes the 10X inter-species 

extrapolation factor, 10X intra-species 

variation factor, and the 10X UFdb. The 

Agency had previously determined that 

the required 21/28-day inhalation study 

in rats was needed to address data 

uncertainties related to potential 

inhalation risk primarily associated 

with occupational exposure, which 

presented the scenarios with the highest 

potential inhalation exposure. After 

reconsideration, EPA has determined 

that the inhalation study is no longer 

required, primarily because exposure 

levels are expected to be lower than 


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previously anticipated, and residential 

exposures are expected to be very low. 

In fact, for residential, non-dietary 

exposures, the use of an oral Point of 

Departure (POD) resulted in MOEs 

higher than the LOC of 1,000. This 

indicates that the lack of an inhalation 

study does not reduce the overall 

confidence in the risk assessment or 

result in an uncertainty (i.e., the study 

will not provide a POD sufficiently low 

to result in a risk of concern). 

Additionally, in the case of acetamiprid, 

the oral POD is based on a very sensitive 

endpoint (effects in rat pups) seen in a 

developmental neurotoxicity study. 

Therefore, there is high confidence that 

the Agency is not underestimating risks 

in the absence of this study. Because 

EPA’s decision to waive the study 

essentially incorporates an additional 

10X UFdb (i.e. the study was only 

waived because risks were at least 10X 

lower than required by use of the interand intraspecies safety factors), a second 

additional 10X FQPA SF is not being 

retained for the protection of infants and 

children. 

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. 

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. 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 the Dietary Exposure 

Evaluation Model (DEEM) default 

processing factors were used. EPA made 

conservative (protective) assumptions in 

the ground water 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 aPAD and 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 

acetamiprid will occupy 68% 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 60% 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 

MOEs of 330 for adults and 120 for 

children. Because EPA’s level of 

concern for acetamiprid is an MOE of 

100 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, 

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 chromotagraphy with tandem 

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. 

There are currently no established 

Codex MRLs for acetamiprid on sweet 

corn. There are Codex MRLs on 

livestock commodities, with the revised 

livestock tolerances for the U.S. being 

higher than the Codex values. Given the 


tkelley on DSK3SPTVN1PROD with RULES
36676 Federal Register / Vol. 78, No. 118 / Wednesday, June 19, 2013 / Rules and Regulations 

revised use pattern including sweet 

corn, these higher U.S. livestock 

commodity tolerances are warranted. 

However, this is not considered to be a 

significant trade irritant, as livestock 

commodities are rarely shipped 

internationally. With the citrus (crop 

group 10–10) tolerance increase to 1.0 

ppm, the U.S. will be harmonized with 

Codex MRLs. 

C. Revisions to Petitioned-For 

Tolerances 

For citrus, dried pulp, based on a 

review of the residue data, the Agency 

has determined that a revised citrus 

pulp tolerance is not needed and that 

the existing tolerance of 1.2 ppm is 

adequate. 

V. Conclusion 

Therefore, tolerances are established 

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

chloro-3-pyridinyl)methyl]-N′-cyano-Nmethylethanimidamide, including its 

metabolites and degradates, in or on 

corn, sweet, forage at 15 ppm; corn, 

sweet, kernel plus cob with husks 

removed at 0.01 ppm; and corn, sweet, 

stover at 30 ppm. In addition, existing 

tolerances are increased as follows: 

Cattle, fat at 0.20 ppm; cattle, meat at 

0.30 ppm; cattle, meat byproducts at 

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

1.0 ppm; goat, fat at 0.20 ppm; goat, 

meat at 0.30 ppm; goat, meat byproducts 

at 0.70 ppm; horse, fat at 0.20 ppm; 

horse, meat at 0.30 ppm; horse, meat 

byproducts at 0.70 ppm; milk at 0.30 

ppm; and sheep, fat at 0.20 ppm; sheep, 

meat at 0.30 ppm; sheep, meat 

byproducts at 0.70 ppm. 

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) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 13, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR part 180 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 as 

follows: 

■ i. In paragraph (a)(1), add 

alphabetically the commodities ‘‘corn, 

sweet, kernel plus cob with husks 

removed,’’ ‘‘corn, sweet, forage,’’ ‘‘corn, 

sweet, stover’’ to the table; and revise 

the entry for ‘‘fruit, citrus, group 10– 

10’’. 

■ ii. In paragraph (a)(2), revise the 

entries for and ‘‘cattle, fat’’, ‘‘cattle, 

meat’’, ‘‘cattle, meat byproducts’’; goat, 

fat’’, ‘‘goat, meat’’, ‘‘goat, meat 

byproducts’’; ‘‘horse, fat’’, ‘‘horse, 

meat’’, ‘‘horse, meat byproducts’’; 

‘‘milk’’; and ‘‘sheep, fat’’, ‘‘sheep, meat’’, 

and ‘‘sheep, meat byproducts’’. 

The additions and revisions read as 

follows: 

§ 180.578 Acetamiprid; tolerances for 

residues. 

(a)(1) * * * 

Commodity Parts per 

million 

* * * * * 

Corn, sweet, kernel plus cob 

with husks removed .......... 0.01 

Corn, sweet, forage .............. 15 

Corn, sweet, stover ............... 30 

* * * * * 

Fruit, citrus, group 10–10 ..... 1.0 

* * * * * 

(a)(2) * * * 

Commodity Parts per 

million 

Cattle, fat .............................. 0.20 

Cattle, meat .......................... 0.30 

Cattle, meat byproducts ....... 0.70 

* * * * * 

Goat, fat ................................ 0.20 

Goat, meat ............................ 0.30 

Goat, meat byproducts ......... 0.70 

* * * * * 

Horse, fat .............................. 0.20 

Horse, meat .......................... 0.30 

Horse, meat byproducts ....... 0.70 

Milk ....................................... 0.30 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 118 / Wednesday, June 19, 2013 / Rules and Regulations 36677 

Commodity Parts per 

million 

* * * * * 

Sheep, fat ............................. 0.20 

Sheep, meat ......................... 0.30 

Sheep, meat byproducts ...... 0.70 

* * * * * 

[FR Doc. 2013–14653 Filed 6–18–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0780; FRL–9389–9] 

Triforine, Pesticide Tolerances; 

Technical Correction 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Correcting amendments. 

SUMMARY: EPA issued a final rule in the 

Federal Register of May 29, 2013, 

concerning tolerances for triforine on 

blueberry and tomato. This document 

corrects a typographical error to the 

section number. 

DATES: This final rule correction is 

effective June 19, 2013. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0780, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Heather Garvie, Registration Division, 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington DC 

20460–0001; telephone number: (703) 

308–0034; email address: 

garvie.heather@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

The Agency included in the final rule 

a list of those who may be potentially 

affected by this action. 

II. What does this technical correction 

do? 

EPA is correcting the CFR section 

number assigned to the pesticide 

tolerance for triforine, which was 

published in the Federal Register of 

May 29, 2013 (78 FR 32146). 

Specifically, EPA is changing the 

section number from § 180.1321 to 

§ 180.673 so that the pesticide tolerance 

can be correctly placed in 40 CFR part 

180, subpart C. 

III. Why is this correction issued as a 

final rule? 

Section 553 of the Administrative 

Procedure Act (APA) (5 U.S.C. 

553(b)(3)(B)) provides that, when an 

agency for good cause finds that notice 

and public procedure are impracticable, 

unnecessary, or contrary to the public 

interest, the agency may issue a final 

rule without providing notice and an 

opportunity for public comment. EPA 

has determined that there is good cause 

for making this technical correction 

final without prior proposal and 

opportunity for comment, because this 

is merely a change in section number 

and is not a substantive change. EPA 

finds that this constitutes good cause 

under 5 U.S.C. 553(b)(3)(B). 

IV. Do any of the statutory and 

Executive Order reviews apply to this 

action? 

A discussion of statutory and 

Executive Order Review was included 

in the original document published on 

May 29, 2013. 

V. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 7, 2013. 

Daniel J Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR part 180 is 

corrected 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. 

§ 180.1321 [Redesignated] 

■ 2. Section 180.1321 is redesignated as 

§ 180.673, and transferred from subpart 

D to subpart C. 

[FR Doc. 2013–14495 Filed 6–18–13; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 5 

[ET Docket No. 10–236 and 06–155; FCC 

13–76] 

Radio Experimentation and Market 

Trials—Streamlining Rules 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document the 

Commission modifies on its own motion 

the rules adopted in this proceeding 

regarding transfer and assignment of 

experimental licenses of its rules. Upon 

reflection, the Commission found it in 

the public interest to specifically 

prohibit the transfer of program, 

medical testing, and compliance testing 

experimental radio licenses, while 

continuing to permit conventional 

experimental authorizations to be 

transferred with the written approval of 

the Commission. There is an 

inconsistency between the adopted rule 

and this prohibition, which is resolved 

by clearly prohibiting such transfers. In 

making this rule modification, it is 

noted that the rules provide options for 

entities to obtain an experimental 

license to ensure continuation of all 

experiments without lapse including 

those being conducted under a program, 

medical testing, and compliance testing 

license. Thus, this action will result in 

no harm to any qualified license 

applicant or licensee. 

DATES: This rule requires approval by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act (PRA), and will become effective 

after the Commission publishes a notice 

in the Federal Register announcing 

such approval and the relevant effective 

date. 

FOR FURTHER INFORMATION CONTACT: 

Rodney Small, Office of Engineering 

and Technology, 202–418–2452, 

Rodney.Small@fcc.gov. 


tkelley on DSK3SPTVN1PROD with RULES