Federal Register / Vol. 78, No. 69 / Wednesday, April 10, 2013 / Rules and Regulations 21267 

(2) Priority group 2. An application 

not meeting the criteria of paragraph 

(a)(1) of this section but meeting the 

criteria of paragraph (a)(1)(i) of this 

section. Projects within this priority 

group will be further prioritized the 

same as in paragraphs (a)(1)(i)(A) 

through (a)(1)(i)(H) of this section. 

(3) Priority group 3. An application 

not meeting the criteria of paragraph 

(a)(1) of this section but meeting the 

criteria of paragraph (a)(1)(ii) of this 

section. 

(4) Priority group 4. An application 

not meeting the criteria of paragraph 

(a)(1) of this section but meeting the 

criteria of paragraph (a)(1)(iii) of this 

section. 

(5) Priority group 5. An application 

not meeting the criteria of paragraph 

(a)(1) of this section but meeting the 

criteria of paragraph (a)(1)(iv) of this 

section. Projects within this priority 

group will be further prioritized the 

same as in paragraphs (a)(1)(iv)(A) 

through (a)(1)(iv)(F) of this section. 

(6) Priority group 6. An application 

not meeting the criteria of paragraph 

(a)(1) of this section but meeting the 

criteria of paragraph (a)(1)(v) of this 

section. 

(7) Priority group 7. An application 

not meeting the criteria of paragraph 

(a)(1) of this section but meeting the 

criteria of paragraph (a)(1)(vi) of this 

section. 

(8) Priority group 8. An application 

not meeting the criteria of paragraph 

(a)(1) of this section but meeting the 

criteria of paragraph (a)(1)(vii) of this 

section. 

* * * * * 

(d) Applications in each priority or 

subpriority group will be further 

prioritized based on the date the 

application was received in VA (the 

earlier the application was received, the 

higher the priority given). Projects will 

be prioritized under this paragraph after 

all prioritization is completed under the 

projects’ priority or subpriority group, 

as specified in paragraph (a) of this 

section, and only if necessary to give 

separate priorities to applications that 

have the same priority ranking after the 

prioritization specified in paragraph (a) 

of this section is accomplished. 

(e) If any State home in a State has 

been cited by a VA safety office, VA 

engineering office, or other VA office 

with responsibility for life and safety 

inspections; a State or local government 

agency (including a Fire Marshal); or an 

accrediting institution (including the 

Joint Commission on Accreditation of 

Healthcare Organizations) for conditions 

that threaten the lives or safety of one 

or more of the residents or program 

participants in the facility, the State 

must include in any application 

submitted under § 59.20 or its updates 

to such application its plan to address 

all such citations. If VA determines that 

the State’s plan fails to set forth how it 

will address such citations in a 

reasonable period of time, then VA will 

prioritize all applications of such State 

as follows: 

(1) Applications that meet the criteria 

of paragraph (a)(1) of this section, but do 

not meet the criteria of paragraphs 

(a)(1)(i) or (vii) of this section, will be 

prioritized in subpriority group 6 of 

priority group 1 (paragraph (a)(1)(vi) of 

this section). 

(2) Applications not meeting the 

criteria for placement in priority group 

1 (paragraph (a)(1) of this section) and 

not meeting the criteria of subpriority 

group 1 of priority group 1 (paragraph 

(a)(1)(i) of this section) will be 

prioritized in priority group 7 

(paragraph (a)(7) of this section). 

* * * * * 

(h) Except for applications that must 

be included in subpriority group 1 of 

priority group 1, applications for 

projects with components that could be 

prioritized in more than one priority 

group will be placed in the priority 

group toward which the largest share of 

the cost of the project is allocated. Once 

the correct priority group is determined, 

applications for projects with 

components that could be prioritized in 

more than one subpriority group in that 

priority group will be placed in the 

subpriority group toward which the 

largest share of the cost of the project is 

allocated. For example, if a project for 

which 25 percent of the funds needed 

would address seismic issues and 75 

percent of the funds needed would be 

for building construction in a State with 

a great need for new beds, the project 

would be placed in subpriority group 3. 

If the highest-cost component of an 

application for multiple projects does 

not meet the criteria for placement in 

priority group 1, subpriority group 1, 

because it is estimated to cost 

$400,000.00 or more, it will be 

prioritized based on the component 

with the next largest share of the cost. 

* * * * * 

[FR Doc. 2013–08366 Filed 4–9–13; 8:45 am] 

BILLING CODE P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0092; FRL–9381–5] 

Dinotefuran; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of dinotefuran in 

or on all food/feed items (other than 

those covered by a higher tolerance as 

a result of use on growing crops) in 

food/feed handling establishments. 

BASF Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

10, 2013. Objections and requests for 

hearings must be received on or before 

June 10, 2013, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0092, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Rita 

Kumar, Registration Division, Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 308–8291; 

email address: kumar.rita@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 

mstockstill on DSK4VPTVN1PROD with RULES

21268 Federal Register / Vol. 78, No. 69 / Wednesday, April 10, 2013 / Rules and Regulations 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0092 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 June 10, 2013. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0092, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

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

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of May 23, 

2012 (77 FR 30481) (FRL–9347–8), 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 1F7967) by BASF 

Corporation, c/o Landis International 

Inc., P.O. Box 5126, 3185 Madison 

Highway, Valdosta, GA 31603. The 

petition requested that 40 CFR 180.603 

be amended by establishing tolerances 

for residues of the insecticide 

dinotefuran, (RS)-1-methyl-2-nitro-3- 

((tetrahydro-3-furanyl)methyl)guanidine 

in or on food/feed commodities not 

covered by a higher tolerance at 0.01 

parts per million (ppm). That document 

referenced a summary of the petition 

prepared by BASF Corporation, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

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 dinotefuran 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with dinotefuran 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. 

Dinotefuran has low acute toxicity by 

oral, dermal, and inhalation exposure 

routes. It is not a dermal sensitizer, but 

causes a low level of skin irritation. The 

main target of toxicity is the nervous 

system, but effects on the nervous 

system were only observed at high 

doses. Nervous system toxicity was 

manifested as clinical signs and 

decreased motor activity seen after acute 

dosing (in both rats and rabbits) and 

changes in motor activity which are 

consistent with effects on the nicotinic 

cholinergic nervous system seen after 

repeated dosing. Typically, low to 

moderate levels of neonicotinoids, such 

as dinotefuran, activate the nicotinic 

acetylcholine receptors causing 

stimulation of the peripheral nervous 

system (PNS). High levels of 

neonicotinoids can over stimulate the 

PNS, maintaining cation channels in the 

open state which blocks the action 

potential and leads to paralysis. 

Dinotefuran was well tolerated at high 

doses following dietary administration 

for ninety days to mice, rats, and dogs. 

The most sensitive effects were 

decreases in body weight and/or body 

weight gain, but even these effects 

occurred at or near the limit dose. 

Changes in spleen and thymus weights 

were seen in mice, rats and dogs 

following subchronic and chronic 

dietary exposures. However, these 

weight changes were not corroborated 

with alterations in hematology 

parameters, histopathological lesions in 

these organs, or toxicity to the 

hematopoietic system. Furthermore, the 

toxicology data base contains 

immunotoxicity studies in mice and rats 

and a developmental immunotoxicity 

study in rats. In the immunotoxicity 

studies there were no effects on T-cell 

dependent antibody response when 

tested up to the limit dose in male and 

female mice and in male and female 

rats. There were no changes in spleen 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 78, No. 69 / Wednesday, April 10, 2013 / Rules and Regulations 21269 

and thymus weight and there were no 

histopathological lesions in these 

organs. In the developmental 

immunotoxicity study, there was no 

evidence of an effect on the 

functionality of the immune system in 

rats that were exposed to dinotefuran at 

the limit dose during the prenatal, 

postnatal, and post-weaning periods. 

Consequently, the thymus weight 

changes seen in dogs and the spleen 

weight changes seen in mice and rats 

were not considered to be 

toxicologically relevant. 

No systemic or neurotoxicity was seen 

following repeated dermal applications 

at the limit dose to rats for 28 days. No 

systemic or portal of entry effects were 

seen following repeated inhalation 

exposure at the maximum obtainable 

concentrations to rats for 28 days. 

In the prenatal studies, no maternal or 

developmental toxicity was seen at the 

limit dose in rats. In rabbits, maternal 

toxicity manifested as clinical signs of 

neurotoxicity, but no developmental 

toxicity was seen. In the reproduction 

study, parental, offspring, and 

reproductive toxicity was seen at the 

limit dose. Parental toxicity included 

decreased body weight gain, transient 

decrease in food consumption, and 

decreased thyroid weights. Offspring 

toxicity was characterized as decreased 

forelimb grip strength or hindlimb grip 

strength in the F1 pups. There was no 

adverse effect on reproductive 

performance at any dose. In the 

developmental neurotoxicity study, no 

maternal or offspring toxicity was seen 

at any dose including the limit dose. 

There was no evidence of 

carcinogenicity in male and female mice 

and in male and female rats fed diets 

containing dinotefuran at the limit dose 

for 78 weeks to mice and 104 weeks to 

rats. Dinotefuran was non-mutagenic in 

both in vivo and in vitro assays. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by dinotefuran as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov in document 

‘‘Dinotefuran: Human Health Risk 

Assessment for Proposed Section 3 Uses 

on Rice and Food/Feed Handling 

Establishments, and New Horse Spot-On 

and Total Release Fogger Products’’ 

pages 40–45 in docket ID number EPA– 

HQ–OPP–2012–0092. 

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 (U/SF) 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 nonthreshold 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 dinotefuran used for 

human risk assessment is shown in the 

Table of this unit. The dinotefuran 

hazard profile was updated in the risk 

assessment completed on July 20, 2012, 

and nothing has changed since this 

update. For a more detailed discussion 

of the endpoint selection, refer to 

Appendix A.3 on pp 44–47 in the 

document titled ‘‘Dinotefuran: Human 

Health Risk Assessment for Proposed 

Section 3 Uses on Tuberous and Corm 

Vegetables Subgroup 1C, Onion 

Subgroup 3–07A, Onion Subgroup 

3–07B, Small Fruit Subgroup 13–07F, 

Berry Subgroup 13–07H, Peach, and 

Watercress, And a Tolerance on 

Imported Tea’’ in docket ID number 

EPA–HQ–OPP–2011–0433. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DINOTEFURAN 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 = 125 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1.25 

mg/kg/day.

aPAD = 1.25 mg/kg/ 

day 

Developmental Toxicity Study in Rabbits. LOAEL = 300 mg/kg/ 

day based on clinical signs in does (prone position, panting, 

tremor and erythema) seen following the first dose on Gestation Day 6. 

Chronic dietary (All populations) NOAEL= 99.7 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 1.0 

mg/kg/day.

cPAD = 1.0 mg/kg/ 

day 

Chronic Toxicity/Carcinogenicity Study in Rats. LOAEL = 991 

mg/kg/day based on decreased body weight gain and 

nephrotoxicity. 

Incidental oral short-term (1 to 

30 days).

NOAEL= 99.7 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Chronic Toxicity/Carcinogenicity Study in Rats. LOAEL = 991 

mg/kg/day based on decreased body weight gain and 

nephrotoxicity. 

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

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

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

sensitivity among members of the human population (intraspecies). 

mstockstill on DSK4VPTVN1PROD with RULES

21270 Federal Register / Vol. 78, No. 69 / Wednesday, April 10, 2013 / Rules and Regulations 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to dinotefuran, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing dinotefuran tolerances in 40 

CFR 180.603. EPA assessed dietary 

exposures from dinotefuran 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 

dinotefuran. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

under the 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 for all current 

crops. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA under NHANES/ 

WWEIA. As to residue levels in food, 

EPA assumed 100 PCT and tolerancelevel residues for all current crops. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that dinotefuran 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 dinotefuran. Tolerance level residues 

and/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for dinotefuran in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of dinotefuran. 

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 Tier 1 Rice Model and 

Screening Concentration in Ground 

Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of dinotefuran for acute 

exposures are estimated to be 269 parts 

per billion (ppb) for surface water and 

4.9 ppb for ground water, and for 

chronic exposures for non-cancer 

assessments are estimated to be 253–257 

ppb, depending upon retention time 

from 10–30 days, for surface water and 

4.9 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 269 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 257 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. 

Dinotefuran is currently registered for 

the following uses that could result in 

residential exposures: Turf, 

ornamentals, vegetable gardens, roach 

and ant bait, pet spot-ons, indoor 

aerosol sprays, crack and crevice sprays, 

etc. EPA assessed residential exposure 

using the following assumptions: 

Because no dermal or inhalation 

endpoints were chosen for dinotefuran, 

post-application residential dermal and 

inhalation exposure scenarios were not 

assessed. As a result, risk assessments 

were only completed for postapplication scenarios in which 

incidental oral exposures are expected. 

The post-application exposure and risk 

estimates for all existing residential uses 

resulted in risk estimates that are not of 

concern (MOEs ranged from 1,100 to 

5,900,000). Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http:// 

www.epa.gov/pesticides/trac/science/ 

trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found dinotefuran to 

share a common mechanism of toxicity 

with any other substances, and 

dinotefuran does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that dinotefuran does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

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

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA 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. 

In the prenatal studies, no maternal or 

developmental toxicity was seen at the 

limit dose in rats. In rabbits, maternal 

toxicity manifested as clinical signs of 

neurotoxicity but no developmental 

toxicity was seen. In the rat 

reproduction study, parental, offspring, 

and reproductive toxicity was seen at 

the limit dose. Parental toxicity 

included decreased body weight gain, 

transient decrease in food consumption, 

and decreased thyroid weights. 

Offspring toxicity was characterized as 

decreased forelimb grip strength or 

hindlimb grip strength in the F1 pups. 

There was no adverse effect on 

reproductive performance at any dose. 

In the developmental neurotoxicity 

study, no maternal or offspring toxicity 

was seen at any dose including the limit 

dose. 

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 toxicity database for 

dinotefuran is complete. 

ii. The neurotoxic potential of 

dinotefuran has been adequately 

considered. Dinotefuran is a 

neonicotinoid and has a neurotoxic 

mode of pesticidal action. Consistent 

with the mode of action, changes in 

motor activity were seen in repeat-dose 

studies, including the subchronic 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 78, No. 69 / Wednesday, April 10, 2013 / Rules and Regulations 21271 

neurotoxicity study. Additionally, 

decreased grip strength and brain 

weight were observed in the offspring of 

a multi-generation reproduction study 

albeit at doses close to the limit dose. 

For these reasons, a developmental 

neurotoxicity (DNT) study was required. 

The DNT study did not show evidence 

of a unique sensitivity of the developing 

nervous system; no effects on 

neurobehavioral parameters were seen 

in the offspring at any dose, including 

the limit dose. 

iii. As discussed in Unit III.D.2., there 

is no evidence that dinotefuran results 

in increased susceptibility in in utero 

rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 2-generation reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to dinotefuran 

in drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children from 

incidental oral exposures. These 

assessments will not underestimate the 

exposure and risks posed by 

dinotefuran. 

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 

dinotefuran will occupy 7.6% of the 

aPAD for all infants < 1 year old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to dinotefuran 

from food and water will utilize 3.9 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 dinotefuran is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Dinotefuran is currently 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

dinotefuran. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 790. Because EPA’s level of 

concern for dinotefuran is a MOE of 100 

or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Intermediate-term exposure is not 

expected for the adult residential 

exposure pathway. Therefore, the 

intermediate-term aggregate risk would 

be equivalent to the chronic dietary 

exposure estimate. For children, 

intermediate-term incidental oral 

exposures could potentially occur from 

indoor uses. However, while it is 

possible for children to be exposed for 

longer durations, the magnitude of 

residues is expected to be lower due to 

dissipation or other activities. Since 

incidental oral short- and intermediateterm toxicity endpoints and points of 

departure are the same, the short-term 

aggregate risk estimate, which includes 

the highest residential exposure 

estimate (from turf), is protective of any 

intermediate-term exposures. 

5. Aggregate cancer risk for 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

dinotefuran is not expected to pose a 

cancer risk to humans. 

6. 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 dinotefuran 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

a high performance liquid 

chromatography/tandem mass 

spectrometry (HPLC/MS/MS method for 

the determination of residues of 

dinotefuran, and the metabolites DN, 

and UF; an HPLC/ultraviolet (UV) 

detection method for the determination 

of residues of dinotefuran; and HPLC/ 

MS and HPLC/MS/MS methods for the 

determination of DN and UF) is 

available to enforce the tolerance 

expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for dinotefuran. 

V. Conclusion 

Therefore, a tolerance of 0.01 ppm is 

established for residues of dinotefuran, 

(RS)-1-methyl-2-nitro3-((tetrahydro-3- 

furanyl)methyl)guanidine, including its 

metabolites and degradates, in or on all 

food and/or feed commodities (other 

than those already covered by a higher 

tolerance as a result of use on growing 

crops or inadvertent residues) in food 

and/or feed handling establishments 

where food and/or feed products are 

held, stored, processed, prepared, or 

served. Compliance with the tolerance 

level is to be determined by measuring 

only dinotefuran. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

mstockstill on DSK4VPTVN1PROD with RULES

21272 Federal Register / Vol. 78, No. 69 / Wednesday, April 10, 2013 / Rules and Regulations 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 2, 2013. 

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 180.603 is amended by 

adding paragraph (a)(3) to read as 

follows: 

§ 180.603 Dinotefuran; tolerances for 

residues. 

(a) * * * 

(3) A tolerance of 0.01 parts per 

million is established for residues of the 

insecticide dinotefuran, (RS)-1-methyl2-nitro-3-((tetrahydro-3- 

furanyl)methyl)guanidine, including its 

metabolites and degradates, in or on all 

food and/or feed commodities (other 

than those covered by a higher tolerance 

as a result of use on growing crops or 

inadvertent residues) when residues 

result from application of dinotefuran in 

food and/or feed handling 

establishments where food and/or feed 

products are held, stored, processed, 

prepared, or served. Compliance with 

the tolerance level is to be determined 

by measuring only dinotefuran. 

* * * * * 

[FR Doc. 2013–08400 Filed 4–9–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2013–0002] 

Final Flood Elevation Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Base (1% annual-chance) 

Flood Elevations (BFEs) and modified 

BFEs are made final for the 

communities listed below. The BFEs 

and modified BFEs are the basis for the 

floodplain management measures that 

each community is required either to 

adopt or to show evidence of being 

already in effect in order to qualify or 

remain qualified for participation in the 

National Flood Insurance Program 

(NFIP). 

DATES: The date of issuance of the Flood 

Insurance Rate Map (FIRM) showing 

BFEs and modified BFEs for each 

community. This date may be obtained 

by contacting the office where the maps 

are available for inspection as indicated 

in the table below. 

ADDRESSES: The final BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street SW., Washington, DC 20472, 

(202) 646–4064, or (email) 

Luis.Rodriguez3@fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 

listed below for the modified BFEs for 

each community listed. These modified 

elevations have been published in 

newspapers of local circulation and 

ninety (90) days have elapsed since that 

publication. The Deputy Associate 

Administrator for Mitigation has 

resolved any appeals resulting from this 

notification. 

This final rule is issued in accordance 

with section 110 of the Flood Disaster 

Protection Act of 1973, 42 U.S.C. 4104, 

and 44 CFR part 67. FEMA has 

developed criteria for floodplain 

management in floodprone areas in 

accordance with 44 CFR part 60. 

mstockstill on DSK4VPTVN1PROD with RULES