68772 Federal Register / Vol. 80, No. 215 / Friday, November 6, 2015 / Rules and Regulations 

Rule No. Rule title 

State 

effective 

date 

EPA 

Effective 

date 

Final rule citation/date Comments 

(11) XI ......... Reports and Revisions ....... 1/22/1972 6/30/1972 37 FR 10842, 5/31/72.

(12) XII ........ Visibility Protection Class I 9/6/1988 3/17/1989 54 FR 6912, 2/15/89.

(13) XIII ....... Sweetwater PM10 Attainment Plan.1/25/1979 8/1/1979 44 FR 38473, 7/02/79.

(14) XIV ....... Stack Height Good Engineering Practice.12/9/1988 4/16/1989 54 FR 11186, 3/17/89.

(15) XV ........ Small Business Assistance 

Program.

11/30/1993 8/19/1994 59 FR 31548, 6/20/94.

(16) XVI ....... City of Sheridan—PM10 Air 

Quality Control and Maintenance Plan.

10/30/1990 7/25/1994 59 FR 32360, 6/23/94.

(17) XVII ...... PSD Implementation for 

NOx.

11/20/1990 6/23/1991 56 FR 23811, 5/24/91.

(18) XVIII ..... Interstate Transport, Wyoming Interstate Transport 

SIP satisfying the requirement of Section 

110(a)(2)(D)(i) of the CAA 

for the 1997 8-hour 

ozone and PM2.5 standards.

4/15/2008 7/7/2008 73 FR 26019, 5/08/08.

(19) XIX ....... Powder River Basin PM10

Memorandum of Agreement.

12/22/1993 10/11/1995 60 FR 47290, 9/12/95.

(20) XX ........ Addressing Regional Haze 

Visibility Protection For 

The Mandatory Federal 

Class I Areas Required 

Under 40 CFR 51.309.

1/7/2011 1/11/2013 77 FR 73926, 12/12/12.

(21) XXI ....... Infrastructure SIP for Section 110(a)(2)—1997 

PM2.5 NAAQS.

3/26/2008 12/6/2013 78 FR 73445, 12/06/13.

(22) XXII ...... Infrastructure SIP for Section 110(a)(2)—2006 

PM2.5 NAAQS.

8/19/2011 9/9/2015 80 FR 47857, 8/10/2015.

(23) XXIII ..... Infrastructure SIP for Section 110(a)(2)—1997 

Ozone NAAQ.

12/10/2009 8/24/2011 76 FR 44265, 7/25/11.

(24) XXIV ..... Air Quality Control Regions 

and Emissions Inventory.

1/22/1972 6/30/1972 37 FR 10842, 5/31/72.

(25) XXV ...... Wyoming State Implementation Plan for Regional 

Haze for 309(g).

1/12/2011 3/3/2014 79 FR 5032, 1/30/14 ................... Excluding portions of the 

following: Chapters 6.4, 

6.5.7, 6.5.8, and 7.5. EPA 

disapproved (1) the NOX

BART determinations for 

(a) Laramie River Units 

1–3, (b) Dave Johnston 

Unit 3, and (c) Wyodak 

Unit 1; (2) the State’s 

monitoring, recordkeeping, and reporting requirements for BART 

units; and (3) the State’s 

reasonable progress 

goals. 

[FR Doc. 2015–27902 Filed 11–5–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0740; FRL–9936–12] 

Acetamiprid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation revises 

existing tolerances with regional 

restrictions for residues of acetamiprid 

in or on clover, forage and clover, hay. 

Interregional Research Project Number 4 

(IR–4) requested this tolerance action 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 6, 2015. Objections and 

requests for hearings must be received 

on or before January 5, 2016, and must 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 80, No. 215 / Friday, November 6, 2015 / Rules and Regulations 68773 

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–2014–0740, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0740 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before January 5, 2016. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2014–0740, 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, EPA/DC, 

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

Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of February 

11, 2015 (80 FR 7559) (FRL–9921–94), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 4E8307) by IR–4, 

IR–4 Project Headquarters, 500 College 

Road East, Suite 201 W., Princeton, NJ 

08540. The petition requested that 40 

CFR 180.578 be amended by revising 

(increasing) tolerances for residues of 

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

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

metabolites and degradates, in or on 

clover, forage from 0.10 to 0.3 parts per 

million (ppm) and clover, hay from 0.01 

to 1.5 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. A 

comment was received on the notice of 

filing. EPA’s response to this comment 

is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

modified the tolerance for clover, hay 

from what was requested. 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 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 

mstockstill on DSK4VPTVN1PROD with RULES

68774 Federal Register / Vol. 80, No. 215 / Friday, November 6, 2015 / Rules and Regulations 

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 

reductions 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, and 

decreased maximum auditory startle 

response. 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 were clinical signs (decreases 

auditory startle, tremors) noted in rats 

and mice in the developmental 

neurotoxicity (DNT) and subchronic 

mouse studies. However, no neurotoxic 

effects were seen in the subchronic 

neurotoxicity study in rats. No 

neuropathology was observed in the 

toxicology studies. 

In 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. 

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 document, 

‘‘Subject: Acetamiprid. Human Health 

Risk Assessment.... .for Use of the 

Insecticide on Clover.... .Interval 

(Regional Registration)’’ dated 

September 2, 2015 at pp. 42 in docket 

ID number EPA–HQ–OPP–2014–0740. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and the 

LOAEL are identified. 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 used for 

human risk assessment is discussed in 

Unit III of the final rule published in the 

Federal Register of June 19, 2013 (78 FR 

36671) (FRL–9391–2). However, in this 

tolerance rule, an additional new use is 

considered spot-on treatments for dogs. 

This newly proposed spot-on dog 

treatment to control fleas, ticks, and 

mosquitoes has potential for long-term 

exposure in residential indoor settings; 

therefore, the Agency selected 

additional endpoints and POD for the 

following exposure/scenarios: (1) Longterm (>6 months) incidental oral (handto-mouth in children) and (2) Long-term 

(>6 months) dermal. The endpoints/

PODs selected were the same for both 

scenarios, based on effects observed in 

a rat chronic toxicity/oncogenicity 

study. In the study, at the LOAEL of 

17.5 milligram/kilogram/day (mg/kg/

day), decreased body weight and body 

weight gains were noted in females and 

hepatocellular vacuolation were noted 

in males. The NOAEL in the study is 7.1 

mg/kg/day. The level of concern (LOC) 

is 100, based on an interspecies 

uncertainty factor of 10X, an intraspecies uncertainty factor of 10X, and 

an Food Quality Protection Act (FQPA) 

safety factor of 1X. 

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 the Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 80, No. 215 / Friday, November 6, 2015 / Rules and Regulations 68775 

Database (DEEM–FCID), Version 3.16. 

This software uses 2003–2008 food 

consumption data from the US 

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. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used DEEM–FCID, 

Version 3.16 and food consumption data 

from the 2003–2008 USDA NHANES/

WWEIA. As to residue levels in food, 

EPA assumed 100 PCT and tolerancelevel residues in the assessment. 

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 

residues and 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. 

EPA used the Food Quality Protection 

Act Index Reservoir Screening Tool 

(FIRST) and the Provisional Cranberry 

Model to generate surface water 

Estimated Drinking Water 

Concentrations (EDWCs) for use in the 

human health dietary risk assessment, 

while the Pesticide Root Zone Model for 

Groundwater (PRZM–GW) was used to 

generate groundwater EDWCs. The 

EDWCs of acetamiprid for acute 

exposures are 88.3 parts per billion 

(ppb) for surface water and 49.7 ppb for 

ground water. For chronic exposures for 

non-cancer assessments are estimated to 

be 32.2 ppb for surface water and 45.0 

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 88.3 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 45 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: Controlling a 

wide variety of indoor and outdoor 

insect pests using insecticide traps, 

crack and crevice treatments, soil 

treatments, and sprays. There is also a 

proposal to register acetamiprid for use 

by homeowners and commercial 

applicators as a monthly topical spot-on 

product for dogs only (not cats) to 

provide continuous protection against 

fleas, ticks, and mosquitoes. Residential 

exposure from proposed dog spot-on 

product is anticipated to result in 

dermal exposures for adult handlers. In 

addition, residential post-application 

dermal exposures are expected for 

adults and children 1 to 2 years old, and 

incidental oral exposures for children 1 

to 2 years old. Inhalation exposure from 

the use of the spot-on product is 

considered negligible. Therefore, only 

dermal and incidental oral exposure 

were assessed for the proposed product. 

Residential post-application 

exposures are expected to be short- (1 to 

30 days), intermediate- (1 to 6 months) 

for the indoor treatments, and long-term 

(greater than 6 months) in duration from 

pet spot-on products. Residential 

handler exposure is assumed to be 

short-term due to the intermittent nature 

of homeowner spot-on applications 

(once-monthly treatment). 

EPA assessed all these uses and 

conducted an aggregate residential 

exposure using the following 

assumptions: 

Residential handler exposures: The 

Agency used short-term and 

intermediate-term dermal and 

inhalation exposure estimates to adult 

applicators from applications to 

mattresses, cracks and crevices in the 

aggregate risk assessment. 

Post-application exposures: The 

Agency used short-term and 

intermediate-term dermal and 

inhalation exposure estimates to adults 

and children 1 to 2 years old from 

indoor applications (mattress treatment 

and crack and crevice treatments) and 

long-term dermal exposure estimates to 

adults and children 1 to 2 years old 

from contact with spot-on treated pets. 

In addition, the Agency used short-term 

and intermediate-term hand-to-mouth 

exposure estimates to children 1–2 years 

old from indoor applications and longterm hand-to-mouth exposure estimates 

from contact with spot-on treated pets. 

EPA combines risk values resulting 

from separate routes of exposure when 

it is likely they can occur 

simultaneously based on the use pattern 

and the behavior associated with the 

exposed population, and if the hazard 

associated with the PODs is similar 

across routes. Residential postapplication inhalation exposure is 

expected to be negligible from the 

proposed spot-on product; therefore, a 

quantitative assessment was not 

performed. 

For children 1 to 2 years old, postapplication dermal and incidental oral 

(hand-to-mouth) exposures were 

combined for short-, intermediate-, and 

long-term durations. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

pesticides/science/residential-exposuresop.html. 

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 

mstockstill on DSK4VPTVN1PROD with RULES

68776 Federal Register / Vol. 80, No. 215 / Friday, November 6, 2015 / Rules and Regulations 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act Safety 

Factor (FQPA 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 post-natal toxicity 

databases for acetamiprid include 

developmental toxicity studies in the rat 

and rabbit, developmental neurotoxicity 

(DNT) study in rats and a 2-generation 

reproduction toxicity study in rats. 

There was no evidence of increased 

quantitative or qualitative susceptibility 

of rat or rabbit fetuses following in utero 

exposure to acetamiprid in the 

developmental toxicity studies. In the 

DNT and 2-generation reproduction 

studies there was no evidence of 

quantitative increased susceptibility 

observed. However, there was evidence 

of increased qualitative susceptibility of 

rat pups seen in the studies. In the DNT 

study in rats, although both maternal 

and offspring effects were seen at the 

same dose level, offspring animals were 

more severely affected. Decreased preweaning survival, and decreased 

maximum auditory startle response 

were observed in the presence of limited 

maternal toxicity (body weight effects). 

In the 2-generation reproduction study, 

effects observed were a decrease in 

mean body weight, body weight gain, 

and food consumption in the parental 

animals, and significant reductions in 

body weights in pups (both 

generations). Also, reduction in litter 

size and viability and weaning indices 

were seen among F2 offspring, as well as 

significant delays in the age to attain 

vaginal opening and preputial 

separation. These offspring adverse 

effects were more severe than the 

parental effects. 

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 database for 

acetamiprid is complete. 

ii. Although there was evidence of 

increased qualitative susceptibility of 

the young in the DNT and 2-generation 

reproduction studies, there are clear 

NOAELs identified for the effects 

observed in the toxicity studies. Also, 

there was no evidence of increased 

quantitative or qualitative susceptibility 

of rat or rabbit fetuses in the 

developmental toxicity studies. 

iii. 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, including neurotoxicity. 

iv. EPA has used conservative 

assumptions in the exposure (food, 

drinking water, and residential) 

assessment, including the use of 100 

PCT assumptions, tolerance-level 

residue values, and upper-bound 

estimates of potential exposure through 

drinking water. In addition, the 

residential exposure assessment was 

conducted such that residential 

exposure and risk will not be 

underestimated. The aggregate exposure 

and risk estimates considered are 

expected to over-estimate the actual 

exposure and risk anticipated, based on 

the current and proposed use patterns; 

no risk estimates of concern were 

identified. 

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 67% of the 

aPAD for children 1–2 years old, the 

population subgroup receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions discussed in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to acetamiprid 

from food and water will utilize 61% of 

the cPAD for children 1–2 years old, the 

population subgroup receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., adult 

aggregate exposures reflect background 

exposure from food and water, plus 

long-term post-application dermal 

exposure from contact with dogs 

following spot-on treatment. For 

children 1–2 years old, long-term 

aggregate assessment reflects postapplication dermal and hand-to-mouth 

(incidental) exposures from contact with 

spot-on treated dogs. The chronic 

dietary exposure and post-application 

pet spot-on residential exposure were 

aggregated and compared to the longterm POD. Adult and children long-term 

aggregate MOEs were 570 and 100, 

respectively, are ≥100, and indicate that 

risk estimates are not of concern. The 

chronic dietary exposure estimates are 

highly conservative, assuming 

tolerance-level residues and 100 PCT for 

all commodities. Therefore, EPA also 

considers the aggregate MOEs to be 

conservative estimates. 

3. Short- and Intermediate-term risk. 

Short-term and intermediate aggregate 

exposure take 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. Toxicological endpoints 

and POD for assessing short- and 

intermediate-term risks associated with 

exposure to acetamiprid are identical. 

Therefore, separate assessments are not 

being conducted for these durations. 

Using the exposure assumptions 

described in this unit for short- and 

intermediate-term exposures which 

represent the combined short- and 

intermediate-term food, water, and 

residential exposures aggregate. 

Additionally, for adults, reflect dermal 

and inhalation exposures from 

applications to mattresses, cracks and 

crevices, and for children 1–2 years old 

short- and intermediate- term aggregate 

assessment reflects dermal, inhalation, 

and hand-to-mouth exposures from 

post-application exposures following 

indoor applications. 

EPA concluded the combined shortand intermediate-term food, water, and 

residential exposures result in aggregate 

MOEs of 300 for adults and 110 for 

children. Both short- and intermediateterm aggregate MOEs are ≥100, and 

indicate that risks are not of concern. 

The chronic dietary exposure estimates 

are highly conservative, assuming 

tolerance-level residues and 100 PCT for 

all commodities. Therefore, EPA also 

considers the aggregate MOEs to be 

conservative estimates. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 80, No. 215 / Friday, November 6, 2015 / Rules and Regulations 68777 

adequate rodent carcinogenicity studies, 

acetamiprid is classified as ‘‘not likely 

to be carcinogenic to human’’ and 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 methodologies 

are available to enforce the tolerance 

expression including; (1) gas 

chromatography with electron capture 

detection (GC/ECD) and (2) highperformance liquid chromotography 

(HPLC) with tandem mass spectrometric 

detection liquid chromotography/mass 

spectrometry/mass spectrometry (LC/

MS/MS). 

The methods 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. 

The Codex has not established MRLs 

for acetamiprid in or on clover, forage 

or clover, hay. 

C. Response to Comments 

One comment expressed concern 

generally for pesticide residues 

remaining on harvested food crops and 

potential human health concerns. The 

commenter further states that ‘‘it is the 

responsibility of our government to 

protect American consumers for being 

harmed by the food they eat and that 

this action is a step in the right direction 

for establishing a safer, healthier food 

system . . . .’’ The Agency agrees with 

these comments. 

D. Revisions to Petitioned-For 

Tolerances 

Available and relevant field trial data 

support a clover tolerance of 2.0 ppm, 

instead of the proposed tolerance of 1.5 

ppm, in clover hay. The petitioner used 

residues in clover hay from all field 

trials which included pre-harvest 

intervals (PHIs) ranging from 27 to 63 

days to calculate the proposed 1.5 ppm 

tolerance level. Since the proposed 

labeling stipulates a PHI of 30 days, EPA 

utilized only those residue data for 

clover hay collected at PHIs of 27–32 

days as the input dataset for the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculation procedure, which yielded a 

clover hay tolerance level at 2.0 ppm. 

In clover forage, the recommended 

tolerance level includes an additional 

significant figure (0.30 ppm rather than 

0.3 ppm). This is in order to avoid the 

situation where rounding of a residue 

result to the level of precision of the 

tolerance expression would be 

considered non-violative (such as 0.34 

ppm being rounded to 0.3 ppm). 

V. Conclusion 

Therefore, revised tolerances with 

regional restrictions 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 

clover, forage at 0.30 ppm and clover, 

hay at 2.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the 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 action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

mstockstill on DSK4VPTVN1PROD with RULES

68778 Federal Register / Vol. 80, No. 215 / Friday, November 6, 2015 / Rules and Regulations 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: October 29, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.578, revise the tolerance for 

commodities in the table in paragraph 

(c) to read as follows: 

§ 180.578 Acetamiprid; tolerances for 

residues. 

* * * * * 

(c) * * * 

Commodity Parts per 

million 

Clover, forage ....................... 0.30 

Clover, hay ........................... 2.0 

* * * * * 

[FR Doc. 2015–28356 Filed 11–5–15; 8:45 am] 

BILLING CODE 6560–50–P 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

48 CFR Parts 1817 and 1852 

NASA Federal Acquisition Regulation 

Supplement 

AGENCY: National Aeronautics and 

Space Administration. 

ACTION: Technical amendments. 

SUMMARY: NASA is making technical 

amendments to the NASA FAR 

Supplement (NFS) to provide needed 

editorial changes. 

DATES: Effective: November 6, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Manuel Quinones, NASA, Office of 

Procurement, Contract and Grant Policy 

Division, via email at 

manuel.quinones@nasa.gov, or 

telephone (202) 358–2143. 

SUPPLEMENTARY INFORMATION: 

I. Background 

As part of NASA’s retrospective 

review of existing regulations pursuant 

to section 6 of Executive Order 13563, 

Improving Regulation and Regulatory 

Review, NASA conducted a 

comprehensive review of its regulations 

and published two final rules in the 

Federal Register. The final rule 

published on March 12, 2015, (80 FR 

12935) requires the following editorial 

changes: 

• Renumber section 1817.7300 as 

1817.7000 and section 1817.7302 as 

1817.7002. The final rule published on 

March 12, 2015, redesignated subpart 

1817.73 as 1817.70, but failed to address 

its subsections. 

• Correct the clause date at section 

1852.215–81. 

List of Subject in 48 CFR Parts 1817 and 

1852 

Government procurement. 

Manuel Quinones, 

NASA FAR Supplement Manager. 

Accordingly, 48 CFR parts 1817 and 

1852 are amended as follows: 

PART 1817—SPECIAL CONTRACTING 

METHODS 

■ 1. The authority citation for part 1817 

is revised to read as follows: 

Authority: 51 U.S.C. 20113(a) and 48 CFR 

chapter 1. 

Subpart 1817–70 [Amended] 

1817.7300 and 1817.7302 [Redesignated 

as 1817.7000 and 1817.7002] 

■ 2. Amend subpart 1817.70 by 

redesignating section 1817.7300 as 

1817.7000 and section 1817.7302 as 

1817.7002. 

PART 1852—SOLICITATION 

PROVISIONS AND CONTRACT 

CLAUSES 

■ 3. The authority citation for part 1852 

continues to read as follows: 

Authority: 51 U.S.C. 20113(a) and 48 CFR 

chapter 1. 

1852.215–81 [Amended] 

■ 4. Amend section 1852.215–81 by 

removing ‘‘FEB 1998’’ and adding ‘‘APR 

2015’’ in its place. 

[FR Doc. 2015–28309 Filed 11–5–15; 8:45 am] 

BILLING CODE 7510–13–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 665 

[Docket No. 150615523–5973–03] 

RIN 0648–XD998 

Pacific Island Pelagic Fisheries; 2015 

U.S. Territorial Longline Bigeye Tuna 

Catch Limits for Guam 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final specifications. 

SUMMARY: In this final rule, NMFS 

specifies a 2015 limit of 2,000 metric 

tons (mt) of longline-caught bigeye tuna 

for Guam. NMFS will allow the territory 

to allocate up to 1,000 mt each year to 

U.S. longline fishing vessels in a 

specified fishing agreement that meets 

established criteria. As an 

accountability measure, NMFS will 

monitor, attribute, and restrict (if 

necessary) catches of longline-caught 

bigeye tuna, including catches made 

under a specified fishing agreement. 

These catch limits and accountability 

measures support the long-term 

sustainability of fishery resources of the 

U.S. Pacific Islands. 

DATES: The final specifications are 

effective November 6, 2015, through 

December 31, 2015. The deadline to 

submit a specified fishing agreement 

pursuant to 50 CFR 665.819(b)(3) for 

review is December 7, 2015. 

ADDRESSES: Copies of the fishery 

ecosystem plans are available from the 

Western Pacific Fishery Management 

Council (Council), 1164 Bishop St., 

Suite 1400, Honolulu, HI 96813, tel 

808–522–8220, fax 808–522–8226, or 

www.wpcouncil.org. 

Copies of the environmental 

assessment (EA) and finding of no 

significant impact for this action, 

identified by NOAA–NMFS–2015–0077, 

are available from www.regulations.gov, 

or from Michael D. Tosatto, Regional 

Administrator, NMFS Pacific Islands 

Region (PIR), 1845 Wasp Blvd., Bldg. 

176, Honolulu, HI 96818. 

FOR FURTHER INFORMATION CONTACT: 

Jarad Makaiau, NMFS PIRO Sustainable 

Fisheries, 808–725–5176. 

SUPPLEMENTARY INFORMATION: NMFS is 

specifying a catch limit of 2,000 mt of 

longline-caught bigeye tuna for Guam in 

2015. NMFS is also authorizing the 

territory to allocate up to 1,000 mt of its 

2,000 mt bigeye tuna limit to U.S. 

mstockstill on DSK4VPTVN1PROD with RULES