70908 Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 / Rules and Regulations 

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: November 15, 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. In § 180.466, paragraph (a), revise 

the introductory text, alphabetically add 

the following commodities and footnote 

1 to the table to read as follows: 

§ 180.466 Fenpropathrin; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of 

fenpropathrin, including its metabolites 

and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only fenpropathrin (alphacyano-3-phenoxy-benzyl 2,2,3,3 

tetramethylcyclopropanecarboxylate). 

Commodity Parts per 

million 

Acerola .................................. 3.0 

* * * * * 

Atemoya ................................ 1.5 

* * * * * 

Biriba ..................................... 1.5 

* * * * * 

Cherimoya ............................ 1.5 

* * * * * 

Custard apple ....................... 1.5 

* * * * * 

Feijoa .................................... 3.0 

* * * * * 

Guava ................................... 3.0 

* * * * * 

Ilama ..................................... 1.5 

Jaboticaba ............................ 3.0 

* * * * * 

Longan .................................. 7.0 

Lychee .................................. 7.0 

Commodity Parts per 

million 

* * * * * 

Passionfruit ........................... 3.0 

* * * * * 

Pulasan ................................. 7.0 

Rambutan ............................. 7.0 

* * * * * 

Soursop ................................ 1.5 

Spanish lime ......................... 7.0 

* * * * * 

Starfruit ................................. 3.0 

* * * * * 

Sugar apple .......................... 1.5 

Tea, dried 1 ........................... 2.0 

* * * * * 

Wax jambu ............................ 3.0 

1There are no U.S. registrations as of November 28, 2012, for the use of fenpropathrin 

on tea, dried. 

* * * * * 

[FR Doc. 2012–28721 Filed 11–27–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0060; FRL–9365–1] 

Dinotefuran; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of dinotefuran in 

or on rice grain, egg, and poultry meat 

byproducts. Mitsui Chemicals Agro Inc., 

c/o Landis International, Inc., requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 28, 2012. Objections and 

requests for hearings must be received 

on or before January 28, 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–2012–0060, 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 


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Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 / Rules and Regulations 70909 

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 (7505P), 

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 

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://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–2012–0060 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 28, 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– 

2012–0060, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (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 1F7953) by Mitsui 

Chemicals Agro, Inc., c/o Landis 

International Ltd., P. O. Box 5126, 

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- 

furyl)methyl)guanidine and its major 

metabolites DN, 1-methyl-3-(tetrahydro3-furylmethyl)guanidine and UF, 1- 

methyl-3-(tetrahydro-3-furylmethyl)- 

urea, in or on rice, grain at 10 parts per 

million (ppm). That document 

referenced a summary of the petition 

prepared by Mitsui Chemicals Agro, 

Inc., the registrant, which is available in 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the level for which the 

tolerance is being established for rice, 

grain. EPA has also established 

tolerances for residues of dinotefuran in 

eggs and poultry, meat byproducts. The 

reason for these changes is explained in 

Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for denotefuran 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with denotefuran 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 


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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 90 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 effect 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 and thymus weight 

and there were no histopathological 

lesions in these organs in those studies. 

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,’’ at 

pages 40–45 in docket ID number EPA– 

HQ–OPP–2012–0060. 

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 dinotefuran used for 

human risk assessment is shown in 

Table 1 of this unit. The dinotefuran 

hazard profile was updated in the most 

recent risk assessment completed on 

July 20, 2012, and nothing has changed 

since that update. For a more detailed 

discussion of the endpoint selection, 

refer to Appendix A.3 on pages 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 1—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 ..................

aRfD = 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 ..................

cRfD = 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. 


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Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 / Rules and Regulations 70911 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DINOTEFURAN FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Incidental Oral Short-Term 

(1–30 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. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members 

of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 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 U.S. Department of 

Agriculture (USDA) National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA). 

This dietary survey was conducted from 

2003 to 2008. As to residue levels in 

food, EPA assumed 100 percent crop 

treated (PCT) and tolerance-level 

residues for all current and proposed 

crops. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

Continuing Survey of Food Intake 

(CSFII). As to residue levels in food, 

EPA assumed 100 percent crop treated 

(PCT) and tolerance-level residues for 

all current and proposed 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% CT 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 to 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 and 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, pet 

spot-ons, indoor aerosol sprays, crack 

and crevice sprays. EPA assessed 

residential exposure using the following 

assumptions: Each of these existing 

residential use patterns were reassessed 

in the latest human health risk 

assessment using the updated 2012 

Residential Standard Operating 

Procedures and body weights. Refer to 

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. 

There are no non-dietary exposure 

scenarios associated with use on rice. 

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 


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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. 

In the pre-natal 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 

neurotoxicity study. Additionally, 

decreased grip strength and brain 

weight was 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. 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 percent 

crop treated (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 for 

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 percent 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 

percent of the cPAD for children 1 to 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 for children for cooccurring post-application exposure 

resulting in the greatest exposure (i.e., 

from the potentially co-occurring use of 

the total release fogger product and the 

existing cat and dog spot-on uses. 

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 U.S. 

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 


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Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 / Rules and Regulations 70913 

available to enforce the tolerance 

expression. 

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 a MRL 

for dinotefuran for any of the 

commodities in this rule. 

C. Revisions to Petitioned-For 

Tolerances 

Use of the Organization of Economic 

Cooperation and Development tolerance 

calculation procedures indicates that 

the tolerances for residues in or on rice 

grain should be established at 9.0 ppm, 

instead of 10.0 ppm proposed by the 

registrant. The appropriate residue 

definition is rice, grain. 

EPA has also concluded that poultry 

tolerances in egg and poultry meat 

byproducts at 0.01 ppm are now needed 

as a result of the increased dietary 

burden resulting from addition of rice 

grain and bran to the diet. 

V. Conclusion 

Therefore, tolerances are established 

for residues of dinotefuran, (R,S)-1-

methyl-2-nitro-3-((tetrahydro-3-furanyl)

methyl)guanidine, including its 

metabolites and degradates, in or on 

rice, grain at 9.0 ppm, and in or on egg 

and poultry, meat byproducts at 0.01 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: October 26, 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 180.603 is amended as 

follows: 

■ i. Add an entry for ‘‘rice, grain’’ in 

alphabetical order to the table in 

paragraph (a)(1). 

■ ii. Add entries for ‘‘egg’’ and ‘‘poultry, 

meat byproducts’’ in alphabetical order 

to the table in paragraph (a)(2). 

■ iii. Revise paragraph (b) to read as set 

forth below. 

The added and revised text read as 

follows: 

§ 180.603 Dinotefuran, tolerances for 

residues. 

(a) * * * (1) * * * 

Commodity Parts per 

million 

*****

Rice, grain ................................ 9.0 

*****

(2) * * * 


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70914 Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 / Rules and Regulations 

1See also 73 FR 32473 (June 9, 2008), and 75 FR 

12123 (March 15, 2010). 2Note that a sentence in the preamble of the 

August 2011 final rule (76 FR at 52882, col. 2) 

stated: ‘‘Yet, as noted above for S12.3.2(a)(10), the 

instruction that was in S12.3.3(a)(9) and S12.3.4(h) 

(to ‘minimize the angle’) [emphasis added] has not 

been deleted but is now integrated into the 

procedures of S12.3.3(a)(9) and S12.3.4(h).’’ This 

sentence referred to incorrect section numbers and 

should have stated ‘‘Yet, as noted above for 

S12.3.2(a)(10), the instruction that was in 

S12.3.3(a)(10) and S12.3.4(i) [emphasis added] (to 

‘minimize the angle’) has not been deleted but is 

now integrated * * *.’’ 

3See 77 FR 49964, August 17, 2012. Final rule 

updating Office of the Secretary of Transportation 

regulations delegating authority from the Secretary 

to Departmental officers. 

Commodity Parts per 

million 

*****

Egg ........................................... 0.01 

*****

Poultry, meat byproducts .......... 0.01 

*****

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. 2012–28472 Filed 11–27–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 571 

[Docket No. NHTSA–2010–0032] 

RIN 2127–AK82 

Federal Motor Vehicle Safety 

Standards; Side Impact Protection 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation. 

ACTION: Final rule; correcting 

amendments. 

SUMMARY: On August 24, 2011 we 

published a final rule responding to a 

petition for reconsideration of a final 

rule on the Federal motor vehicle safety 

standard for side impact protection. In 

today’s document, we correct a minor 

error in that rule. The agency is also 

correcting several typographical errors 

in the standard. 

DATES: This rule is effective November 

28, 2012. 

FOR FURTHER INFORMATION CONTACT: For 

non-legal issues, you may call Louis N. 

Molino, NHTSA Office of 

Crashworthiness Standards, telephone 

202–366–1740. For legal issues, you 

may call Deirdre Fujita, NHTSA Office 

of Chief Counsel, telephone 202–366– 

2992. You may send mail to these 

officials at the National Highway Traffic 

Safety Administration, 1200 New Jersey 

Avenue SE., West Building, 

Washington, DC 20590. 

SUPPLEMENTARY INFORMATION: This 

document makes two corrections to 

Federal Motor Vehicle Safety Standard 

(FMVSS) No. 214, ‘‘Side impact 

protection,’’ 49 CFR 571.214. 

On September 11, 2007, NHTSA 

published a final rule adopting a pole 

test into FMVSS No. 214. Later, NHTSA 

published responses to petitions for 

reconsideration of parts of that rule, 

including a final rule published August 

24, 2011 (76 FR 52880).1 The August 24, 

2011, document had a minor error, 

which we are correcting today. We are 

also making corrections to typographical 

errors in FMVSS No. 214 which 

occurred previously in the FMVSS No. 

214 rulemaking. 

Correcting Amendments 

This notice makes minor corrections 

to FMVSS No. 214 in two areas. First, 

it removes S12.3.4(i) from the regulatory 

text of FMVSS No. 214. S12.3.4(i) 

contains obsolete instructions for 

leveling the head of a test dummy. In 

the preamble of the August 2011 final 

rule, NHTSA explained that it was 

moving head-leveling instructions 

contained in S12.3.4(i) to paragraph 

(h).2 As a result of that move, S12.3.4(i) 

was no longer needed, but NHTSA 

inadvertently did not remove S12.3.4(i) 

from the regulatory text. To correct that 

error, we are removing and reserving 

S12.3.4(i), and making a conforming 

change to S12.3.4(j). 

Second, the agency has identified 

minor typographical errors in several 

sections of FMVSS No. 214 that 

occurred in the past. These errors are 

related to the positioning of the 5th 

percentile adult female dummy. In three 

of the five sections, S12.3.2(c), 

S12.3.3(c) and S12.3.4(l), the ‘‘±’’ 

symbols for the discrete arm position 

settings were not set forth correctly, and 

in some instances extraneous text was 

inadvertently added when the 

amendments were printed in the Code 

of Federal Regulations. In S12.3.3(a)(4), 

the ± symbol was incorrectly 

represented by just a plus sign for the 

longitudinal centerline tolerance, and in 

S12.3.4(c), the metric unit of millimeters 

(mm) was used in both the metric 

tolerance of the seating reference point 

(SgRP) and its English conversion. This 

document corrects these errors. 

This document also amends the 

authority citation for 49 CFR Part 571, 

by changing the citation to the DOT 

regulation setting forth delegations 

made by the Secretary to Departmental 

officials.3

List of Subjects in 49 CFR Part 571 

Imports, Motor vehicle safety, Motor 

vehicles, Rubber and rubber products, 

and Tires. 

Accordingly, 49 CFR part 571 is 

corrected by making the following 

correcting amendments: 

PART 571—FEDERAL MOTOR 

VEHICLE SAFETY STANDARDS 

■ 1. The authority citation for part 571 

of title 49 is revised to read as follows: 

Authority: 49 U.S.C. 322, 30111, 30115, 

30117, and 30166; delegation of authority at 

49 CFR 1.95. 

■ 2. Section 571.214 is amended by: 

■ a. Revising S12.3.2(c), S12.3.3(a)(4), 

S12.3.3(c), S12.3.4(c); 

■ b. Removing and reserving S12.3.4(i) 

and 

■ c. Revising S12.3.4(j) and S12.3.4(l). 

The revisions read as follows: 

§ 571.214 Standard No. 214; Side impact 

protection. 

* * * * * 

S12.3.2 * * * 

(c) Driver arm/hand positioning. Place 

the dummy’s upper arm such that the 

angle between the projection of the arm 

centerline on the midsagittal plane of 

the dummy and the torso reference line 

is 45° ± 5°. The torso reference line is 

defined as the thoracic spine centerline. 

The shoulder-arm joint allows for 

discrete arm positions at 0, ± 45, ± 90, 

± 135, and 180 degree settings where 

positive is forward of the spine. 

* * * * * 

S12.3.3 * * * 

(a) * * * 

(4) Bench seats. Position the 

midsagittal plane of the dummy vertical 

and parallel to the vehicle’s longitudinal 

centerline and the same distance from 

the vehicle’s longitudinal centerline, 

within ± 10 mm (± 0.4 in), as the 

midsagittal plane of the driver dummy. 

* * * * * 

(c) Passenger arm/hand positioning. 

Place the dummy’s upper arm such that 

the angle between the projection of the 

arm centerline on the midsagittal plane 

of the dummy and the torso reference 

line is 45° ± 5°. The torso reference line 

is defined as the thoracic spine 

centerline. The shoulder-arm joint 

allows for discrete arm positions at 0, ± 


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