18710 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0403; FRL–9340–7] 

Acetamiprid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of acetamiprid in 

or on food/feed handling establishments 

and soybeans. Nippon Soda Co., Ltd., 

c/o Nisso America, Inc., requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 28, 2012. Objections and requests 

for hearings must be received on or 

before May 29, 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–2011–0403. 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: 

Jennifer Urbanski, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–0156; email address: 

urbanski.jennifer@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–2011–0403 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 May 29, 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–2011–0403, 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 

EPA has received two petitions for 

tolerances for the insecticide 

acetamiprid. In the Federal Register of 

March 29, 2011 (76 FR 17374) (FRL– 

8867–4), 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 0F7812) by 

Nippon Soda Co., Ltd., c/o Nisso 

America, Inc., 45 Broadway, Suite 2120, 

New York, NY 10006. The petition 

requested that 40 CFR 180.578 be 

amended by establishing tolerances for 

residues of acetamiprid, N 1-[(6-chloro3-pyridyl)methyl]-N 2-cyano-N 1- 

methylacetamidine, including its 

metabolites and degradates, in or on 

food/feed handling establishments at 

0.05 parts per million (ppm). That 

notice referenced a summary of the 

petition prepared by Nippon Soda Co., 

Ltd., the registrant, which is available in 

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

There were no comments received in 

response to the notice of filing. 

In the Federal Register of July 6, 2011 

(76 FR 39358) (FRL–8875–6), 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 1F7844) by 

Nippon Soda Co., Ltd., c/o Nisso 

America, Inc., 45 Broadway, Suite 2120, 

New York, NY 10006. The petition 

requested that 40 CFR 180.578 be 

amended by establishing tolerances for 

residues of acetamiprid, N 1-[(6-chloro3-pyridyl)methyl]-N 2-cyano-N 1- 

methylacetamidine, in or on soybean, 

seed at 0.02 ppm and soybean, hulls at 

0.04 ppm. That notice referenced a 

summary of the petition prepared by 


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Nippon Soda Co., Ltd., 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 petitions, EPA has 

revised the tolerance associated with 

use in food handling establishments to 

0.01 ppm in all food/feed items other 

than those covered by a higher tolerance 

from use on growing crops. EPA has 

also revised the tolerance to 0.03 ppm 

in soybean, seed and has added a 

tolerance of 5.0 ppm for grain, aspirated 

fractions. The reason for this change 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 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 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 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). 

In the rat developmental study, fetal 

shortening of the 13th rib was observed 

at the same dose level that produced 

maternal effects (reduced body weight 

and body weight gain and increased 

liver weights). No developmental effects 

were observed in the rabbit at doses that 

reduced maternal body weight and food 

consumption. Effects in pups in the 2- 

generation rat 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 (DNT) 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 

effects (decreased body weight and body 

weight gain) in the maternal animals. 

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 DNT; 

additionally, tremors were noted in 

female mice at the HDT in the 

subchronic feeding study. 

In 4-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.’’ 

This determination is based on the 

absence of a dose-response or statistical 

significance for the increased incidence 

in mammary adenocarcinomas observed 

in the rat carcinogenicity study, as well 

as the lack of evidence of carcinogenic 

effects in the mouse cancer study. 

Acetamiprid tested positive as a 

clastogen in an in vitro mammalian 

chromosome aberration assay in 

Chinese hamster ovary cells. There was 

no sign of mutagenicity in other 

mutagenicity studies for acetamiprid. 

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 

‘‘Acetamiprid Human Health Risk 

Assessment for New Uses on Soybean 

and in Food/Feed Handling 

Establishments’’ at pages 29–34 in 

docket ID number EPA–HQ–OPP–2011– 

0403. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for acetamiprid human risk 

assessment is shown in Table 1 of this 

unit. 


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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 (General population including infants 

and children).

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 

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. 

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

days and 1 to 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. 

Dermal short- and intermediate-term (1 to 30 

days and 1 to 6 months).

Dermal (or 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. 

Inhalation short- and intermediate-term (1 to 30 

days and 1 to 6 months).

Inhalation (or 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. 

Cancer (Oral, dermal, inhalation).Not likely to be carcinogenic to humans (2005 revised Agency cancer guidelines). 

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 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 acute analyses 

based on tolerance level residues and 

assumed 100% crop treated. Empirical 

processing factors were used for 

processed commodities unless such data 

were not available, in which case 

DEEMTM 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 chronic 

analyses based on tolerance level 

residues and assumed 100% crop 

treated. Empirical processing factors 

were used for processed commodities 

unless such data were not available, in 

which case DEEMTM 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 percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for acetamiprid. Tolerance level 

residues and/or 100% CT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 


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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 

the following residential exposure 

scenarios: 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. 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.’’ 

Acetamiprid is a member of the 

neonicotinoid class of pesticides which 

also includes thiamethoxam, 

clothianidin, imidacloprid and several 

other active ingredients. Structural 

similarities or common effects do not 

constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same sequence of 

major biochemical events. Although the 

neonicotinoids bind selectively to insect 

nicotinic acetylcholine receptors 

(nAChR), the specific binding site(s)/ 

receptor(s) are unknown at this time. 

Additionally, the commonality of the 

binding activity itself is uncertain, as 

preliminary evidence suggests that 

clothianidin operates by direct 

competitive inhibition, while 

thiamethoxam is a non-competitive 

inhibitor. Furthermore, even if future 

research shows that neonicotinoids 

share a common binding activity to a 

specific site on insect nicotinic 

acetylcholine receptors, there is not 

necessarily a relationship between this 

pesticidal action and a mechanism of 

toxicity in mammals. Structural 

variations between the insect and 

mammalian nAChRs produce 

quantitative differences in the binding 

affinity of the neonicotinoids towards 

these receptors, which, in turn, confers 

the notably greater selective toxicity of 

this class towards insects, including 

aphids and leafhoppers, compared to 

mammals. Additionally, the most 

sensitive toxicological effect in 

mammals differs across the 

neonicotinoids (e.g., testicular tubular 

atrophy with thiamethoxam; 

mineralized particles in thyroid colloid 

with imidacloprid). Thus, there is 

currently no evidence to indicate that 

neonicotinoids share common 

mechanisms of toxicity, and EPA is not 

following a cumulative risk approach 

based on a common mechanism of 

toxicity for the neonicotinoids. In 

addition, acetamiprid does not appear to 

produce a toxic metabolite produced by 

other substances. Therefore, for the 

purposes of this tolerance action, EPA 

has not assumed that acetamiprid has 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 the policy statements 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism 

released by EPA’s Office of Pesticide 

Programs on 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 prenatal 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 DNT and 2- 

generation reproduction studies showed 

an increase in qualitative susceptibility 

of pups. 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 

DNT 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 decreased body weight and 

body weight gain in the maternal 

animals, indicating increased qualitative 

susceptibility of fetuses and offspring to 

acetamiprid. Quantitative evidence of 

increased susceptibility was not 

observed in any study. 

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. With the exception of a subchronic 

inhalation study, the toxicity database 

for acetamiprid is complete. Currently, 

inhalation exposure is being assessed by 


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using hazard information from the 

developmental neurotoxicity study, 

which is an oral study. The inhalation 

risks estimated by this approach are 

very low. Application of a 10-fold factor 

to account for the uncertainty associated 

with this approach would not result in 

risk estimates of concern. 

ii. Acetamiprid produced signs of 

neurotoxicity in the high dose groups in 

the acute and developmental 

neurotoxicity studies in rats. 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. However, no 

neurotoxic findings were reported in the 

subchronic neurotoxicity study. There 

was a decrease in the auditory startle 

response in the male rats in the DNT. 

Tremors in the high dose female mice in 

the subchronic feeding study were the 

only other potentially neurotoxic effects 

observed in the other studies. EPA has 

selected doses and endpoints for risk 

assessment that account for these 

neurological effects; therefore, the 

Agency has no residual concern 

regarding neurotoxicity with respect to 

being protective of human health. 

iii. EPA determined that neither 

quantitative nor qualitative evidence of 

increased susceptibility of fetuses to in 

utero exposure to acetamiprid was 

observed in either the developmental 

toxicity study in rat or rabbit. However, 

in the 2-generation reproduction study, 

qualitative evidence of increased 

susceptibility of rat pups was observed. 

While parental and offspring NOAELs 

and LOAELs are set at the same doses, 

the effects in the offspring (including 

decreased viability) are considered to be 

more severe than those observed in the 

parents (decreased body weight and 

decreased weight gain). In the DNT 

study, maternal and offspring effects 

were observed at the same dose. 

However, the offspring effects included 

decreased pup viability which is 

considered to be more severe than the 

maternal body weight effects. Therefore, 

EPA concluded that there was evidence 

of increased qualitative susceptibility to 

fetuses exposed in utero and/or during 

lactation in the DNT study. Quantitative 

evidence of increased susceptibility was 

not observed in any study. 

Since there is evidence of increased 

qualitative susceptibility of the young 

following in utero exposure to 

acetamiprid in the rat reproduction 

study, and increased qualitative 

susceptibility to pups in the DNT study, 

EPA performed a degree of concern 

analysis to determine the level of 

concern for the effects observed when 

considered in the context of all available 

toxicity data and to identify any 

residual uncertainties after establishing 

toxicity endpoints and traditional 

uncertainty factors to be used in the 

acetamiprid risk assessment. 

Considering the overall toxicity 

profile and the endpoints and doses 

selected for the acetamiprid risk 

assessment, EPA characterized the 

degree of concern for the effects 

observed in the acetamiprid DNT study 

as low, noting that there is a clear 

NOAEL for the offspring effects and 

regulatory doses were selected to be 

protective of these effects. No other 

residual uncertainties were identified. 

EPA believes that the endpoints and 

doses selected for acetamiprid are 

protective of adverse effects in both 

offspring and adults. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary exposure assessments were 

based on tolerance level residues and 

assumed 100% crop treated. Empirical 

processing factors were used for 

processed commodities unless such data 

were not available, in which case 

DEEMTM default processing factors from 

Version 7.81 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 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 

acetamiprid will occupy 50% 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 

MOEs of 350 for adults and 160 for 

children aged 3–5 years. Because EPA’s 

level of concern for acetamiprid is a 

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 

(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 


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Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Rules and Regulations 18715 

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. 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 EPA has acted in violation of the 

statutory framework. 

D. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petition, EPA has 

determined that the requested tolerance 

(0.02 ppm) for soybean seed is too low. 

Residues in field trials (maximum = 

0.025 ppm) exceed the requested 

tolerance level and therefore the Agency 

has established a tolerance of 0.03 ppm 

for soybean seed using the Organization 

for Economic Cooperation and 

Development tolerance calculation 

procedures. Although there was no 

petitioned-for tolerance for aspirated 

grain fractions and residue data was not 

provided for this commodity, EPA 

determined that such a tolerance is 

needed. In processing studies, residues 

concentrated in soybean hulls by 1.65X, 

indicating the potential for 

concentration into aspirated grain 

fractions. In lieu of empirical data, the 

Agency used a theoretical concentration 

factor of 200X to derive a tolerance level 

for aspirated grain fractions of 5.0 ppm. 

EPA is establishing a tolerance at that 

level. The petitioned-for tolerance for 

food-feed handling establishments (0.05 

ppm) has the potential to confound 

enforcement actions for field crops that 

have a tolerance for residues of 

acetamiprid of less than 0.05 ppm. 

Given the residue levels observed in the 

food-feed handling establishment study 

in conjunction with the exaggerated 

application rate in that study, residues 

of acetamiprid are not expected to 

exceed 0.01 ppm as a result of the 

requested use in such facilities. 

Therefore, the Agency has established a 

tolerance of 0.01 ppm in all food/feed 

items other than those covered by a 

higher tolerance from use on growing 

crops. EPA has also revised the 

tolerance expression in paragraphs 

(a)(1), (a)(2) and (c) to correct the name 

of the chemical to (1E)-N-[(6-chloro-3- 

pyridinyl)methyl]-N′-cyano-Nmethylethanimidamide. 

V. Conclusion 

Therefore, tolerances are established 

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

chloro-3-pyridinyl)methyl]-N′-cyano-Nmethylethanimidamide, in or on 

soybean, seed at 0.03 ppm; soybean, 

hulls at 0.04 ppm; grain, aspirated 

fractions at 5.0 ppm; and commodities 

treated in food/feed handling 

establishments at 0.01 ppm. 

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 

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. 


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18716 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Rules and Regulations 

Dated: March 16, 2012. 

Lois Rossi, 

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 as 

follows: 

■ i. Revising the introductory text of 

paragraphs (a)(1), (a)(2), and (c). 

■ ii. Adding alphabetically the 

commodities ‘‘Grain, aspirated 

fractions’’, ‘‘Soybean, hulls’’ and 

‘‘Soybean, seed’’ to the table in 

paragraph (a)(1). 

■ iii. Adding paragraph (a)(3). 

§ 180.578 Acetamiprid; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the 

insecticide acetamiprid (1E)-N-[(6- 

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

metabolites and degradates, in or on the 

commodities in the table below as a 

result of the application of acetamiprid. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only acetamiprid in or on the 

following commodities. 

Commodity Parts per 

million 

* * * * * 

Grain, aspirated fractions ........... 5 .0 

* * * * * 

Soybean, hulls ............................ 0 .04 

Soybean, seed ............................ 0 .03 

* * * * * 

* * * * * 

(2) Tolerances are established 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 the commodities in 

the table below as a result of the 

application of acetamiprid. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

acetamiprid and (1E)-N-[(6-chloro-3- 

pyridinyl)methyl]-N′-cyano-Nethanimidamide in or on the following 

commodities. 

* * * * * 

(3) A tolerances of 0.01 ppm is 

established for residues of the 

insecticide acetamiprid, including its 

metabolites and degradates, in or on all 

food/feed items (other than those 

covered by a higher tolerance in 

paragraph (a)(1) or (a)(2) of this section 

as a result of the use on growing crops) 

as a result of the application of 

acetamiprid in food/feed handling 

establishments. Compliance with the 

0.01 ppm tolerance level is to be 

determined by measuring only 

acetamiprid (1E)-N-[(6-chloro-3- 

pyridinyl)methyl]-N′-cyano-Nmethylethanimidamide in or on the 

commodities. 

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registrations are established 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 the commodities in 

the table below as a result of the 

application of acetamiprid. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only acetamiprid in or on the following 

commodities. 

* * * * * 

[FR Doc. 2012–7461 Filed 3–27–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Transportation Security Administration 

49 CFR Part 1572 

[Amendment No. 1572–9] 

Transportation Security Administration 

Postal Zip Code Change; Technical 

Amendment 

AGENCY: Transportation Security 

Administration, DHS. 

ACTION: Final rule. 

SUMMARY: This rule is a technical 

change to correct a regulatory reference 

to TSA’s postal zip code. This rule 

revises existing regulations to reflect 

organizational changes and it has no 

substantive effect on the public. 

DATES: Effective March 28, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Devara Achuko, Office of the Chief 

Counsel, TSA–2, Transportation 

Security Administration, 601 South 

12th Street, Arlington, VA 20598–6002; 

telephone (571) 227–2649; facsimile 

(571) 227–1378; email 

devara.achuko@dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Justification for Immediate Adoption 

This action is being taken without 

providing the opportunity for notice and 

comment, and it provides for an 

effective date less than 30 days after 

publication in the Federal Register. 

This rule relates only to agency 

organization, procedure, and practice. 

Therefore, under 5 U.S.C. 553(b)(3)(A), 

this rule is exempt from notice and 

comment rulemaking requirements. The 

changes made by the rule will have no 

substantive effect on the public; 

therefore, under 5 U.S.C. 553(d), this 

rule may become effective less than 30 

days after publication in the Federal 

Register. 

Background 

Beginning December 17, 2008, the 

postal zip codes for TSA headquarters 

facilities in Virginia and Maryland 

changed to new zip codes that are 

unique to TSA to enhance the safety and 

security of incoming mail to the 

Department of Homeland Security 

(DHS) and its components. The physical 

locations of TSA’s facilities, however, 

did not change. The new TSA zip code 

for Virginia addresses changed to 20598 

and for Maryland addresses changed to 

20588. TSA locations in Washington, 

DC continued to use their existing zip 

codes. In addition, the last four digits of 

the new zip code format (zip + 4) now 

represent an office’s routing symbol. 

Since 2008, through other rulemaking 

actions, TSA revised most sections of 

TSA regulations (chapter XII of title 49, 

Transportation, of the Code of Federal 

Regulations, parts 1500–1699) that 

contain TSA mailing addresses with 

outdated postal zip codes. The only 

remaining zip code that is out of date is 

§ 1572.5(e)(2). 

Technical Amendment 

This document amends section 

1572.5(e)(2) in order to make this 

editorial change to the zip code from 

‘‘22202–4220’’ to ‘‘20598–6019’’. TSA 

makes no other changes to the section. 

List of Subjects in 49 CFR Part 1572 

Appeals, Commercial driver’s license, 

Criminal history background checks, 

Explosives, Facilities, Hazardous 

materials, Incorporation by reference, 

Maritime security, Motor carriers, Motor 

vehicle carriers, Ports, Seamen, Security 

measures, Security threat assessment, 

Vessels, Waivers. 

The Amendment 

For the reasons set forth in the 

preamble, the Transportation Security 

Administration amends part 1572 of 


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