Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations 56133 

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

■ 2. Section 180.1285 is revised to read 

as follows: 

§ 180.1285 Polyoxin D zinc salt; exemption 

from the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for the 

residues of polyoxin D zinc salt in or on 

all food commodities when applied as a 

fungicide and used in accordance with 

good agricultural practices. 

[FR Doc. 2012–22315 Filed 9–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0433; FRL–9359–6] 

Dinotefuran; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of dinotefuran in 

or on multiple commodities which are 

identified and discussed later in this 

document. Also, due to the tolerances 

established by this document, the 

Agency is removing the existing 

tolerances for grape and potato as 

unnecessary. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 12, 2012. Objections and 

requests for hearings must be received 

on or before November 13, 2012, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0433, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Andrew Ertman, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2011–0433 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 November 13, 2012. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (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– 

2011–0433, 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 September 

7, 2011 (76 FR 55329) (FRL–8886–7), 

EPA issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1E7863) by IR–4, 500 

College Rd. East, Suite 201 W, 

Princeton, NJ 08540. 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, including its 

metabolites and degradates, in or on 

berry, low growing, except strawberry, 

subgroup 13–07H at 0.2 parts per 

million (ppm); watercress at 5.0 ppm; 

onion, green, subgroup 3–07B at 6.0 

ppm; onion, bulb, subgroup 3–07A at 

0.07 ppm; peach at 0.9 ppm; vegetable, 

tuberous and corm, subgroup 1C at 0.05 

ppm; fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13–07F at 0.9 

ppm; and tea, plucked leaves at 25.0 

ppm. That notice 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. 

Also, due to the tolerances established 

by this document, the following existing 

tolerances are being removed as 

unnecessary: Grape and potato. 

Based upon review of the data 

supporting the petition, EPA has 


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56134 Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations 

modified the levels for which tolerances 

are being established for the bulb onion 

subgroup 3–07A, the green onion 

subgroup 3–07B, peach, tea, and 

watercress. 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 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 effect on T-cell 

dependent antibody response (TDAR) 

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 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 

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 no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov on pages 39–44 of 

the document titled ‘‘Revised: 

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. 

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 


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Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations 56135 

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. EPA notes that in the 

last final rule for dinotefuran, published 

in the Federal Register of December 18, 

2009 (74 FR 67098) (FRL–8803–1), the 

points of departure for many exposure 

scenarios differ than what is reported in 

this document. Since the last risk 

assessment, the Agency has re-evaluated 

the dinotefuran toxicological database 

and updated the hazard characterization 

and dose response assessment. This 

toxicology database reevaluation has 

resulted in changes to the toxicity 

endpoints, points of departure, and 

safety factors for several routes of 

exposure from those presented in 

previous EPA risk assessments for 

dinotefuran. For a more detailed 

discussion of the endpoint selection and 

reasons for the changes, 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—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– 

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). 

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) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). 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 

CSFII. As to residue levels in food, EPA 

assumed 100 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 PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

dinotefuran. Tolerance level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for 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 First Index Reservoir 

Screening Tool (FIRST), and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

dinotefuran for acute exposures are 

estimated to be 91.31 parts per billion 

(ppb) for surface water and 3.5 ppb for 

ground water and for chronic exposures 

for non-cancer assessments are 

estimated to be 25.16 ppb for surface 

water and 3.5 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 91.31 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 


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assessment, the water concentration of 

value 25.16 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, pets, 

indoor aerosol sprays, and crack and 

crevice sprays. EPA assessed residential 

exposure using the following 

assumptions: Residential handler 

exposures were not assessed because no 

dermal or inhalation hazards were 

identified. For this same reason, postapplication residential dermal and 

inhalation exposure scenarios were not 

assessed. The Agency only considered 

post-application scenarios in which 

incidental oral exposures to children are 

expected. The oral exposures assessed 

included incidental oral exposures from 

turf, ant bait, ready to use garden trigger 

sprayers, dog and cat spot on treatment, 

indoor broadcast, and indoor crack and 

crevice uses. Of all these scenarios, 

treated turf was determined to result in 

the highest levels of exposure. 

In assessing risks from residential 

exposures, EPA combines different 

residential sources of exposure that 

could reasonably be expected to occur 

on the same day. While it is possible for 

children to be exposed to indoor 

broadcast sprays on hard surfaces/ 

carpets and to spot-on treatment to cats 

or dogs on the same day, these 

exposures have not been combined in 

this assessment because incidental oral 

hand-to-mouth exposure from treated 

turf is higher and still results in an MOE 

that does not exceed the Agency’s LOC. 

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 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 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 study was required. Upon 

review of the developmental 

neurotoxicity study, it was concluded 

that there is no evidence of a unique 

sensitivity to the developing nervous 

system since no effects on 

neurobehavioral parameters were seen 

in the offspring at doses that 

approached or exceeded 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 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 5.8% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to dinotefuran 

from food and water will utilize 2.6% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 


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Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations 56137 

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 an 

aggregate MOE of 3,000 for children 1– 

2 years old from hand to mouth 

exposure from treated turf, the scenario 

with the highest exposure. Because 

EPA’s level of concern for dinotefuran is 

a MOE of 100 or below, this MOE is 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 

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 for any of the 

commodities in this Notice. 

C. Revisions to Petitioned-For 

Tolerances 

Use of the Organization of Economic 

and Cooperation and Development 

tolerance calculation procedures 

indicates that the tolerances for residues 

in/on the onion subgroup 3–07A, onion 

subgroup 3–07B, peach, tea, and 

watercress should be established at 0.15 

ppm, 5.0 ppm, 1.0 ppm, 50 ppm, and 

8.0 ppm, respectively, instead of those 

values proposed. 

V. Conclusion 

Therefore, tolerances are established 

for residues of dinotefuran, (RS)-1- 

methyl-2-nitro-3-((tetrahydro-3- 

furyl)methyl)guanidine, including its 

metabolites and degradates, in or on 

berry, low growing, except strawberry, 

subgroup 13–07H at 0.2 ppm; watercress 

at 8.0 ppm; onion, green, subgroup 3– 

07B at 5.0 ppm; onion, bulb, subgroup 

3–07A at 0.15 ppm; peach at 1.0 ppm; 

vegetable, tuberous and corm, subgroup 

1C at 0.05 ppm; fruit, small, vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F at 0.9 ppm; and tea, 

dried at 50 ppm. 

Also, the following existing tolerances 

are removed as unnecessary: Grape and 

potato. These commodities are covered 

by the new crop group tolerances for 

fruit, small, vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F, and 

vegetable, tuberous and corm, subgroup 

1C. 

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 


srobinson on DSK4SPTVN1PROD with RULES
56138 Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations 

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: August 28, 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 by 

removing the entries for ‘‘Grape’’ and 

‘‘Potato’’ and alphabetically adding the 

following entries and a footnote to the 

table in paragraph (a)(1) to read as 

follows: 

§ 180.603 Dinotefuran; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

Berry, low growing, except 

strawberry, subgroup 13– 

07H ...................................... 0 .2 

***

* *

* * 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F ...................... 0 .9 

***

* *

* * 

Onion, bulb, subgroup 3–07A 0 .15 

Onion, green, subgroup 3– 

07B ...................................... 5 .0 

Peach ...................................... 1 .0 

***

* *

* * 

Tea, dried1 .............................. 50 

***

* *

* * 

Vegetable, tuberous and 

corm, subgroup 1C ............. 0 .05 

Watercress .............................. 8 .0 

1There are no U.S. registrations for tea. 

* * * * * 

[FR Doc. 2012–22205 Filed 9–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Docket No. CDC–2012–0007; NIOSH–257] 

42 CFR Part 88 

RIN 0920–AA49 

World Trade Center Health Program; 

Addition of Certain Types of Cancer to 

the List of WTC-Related Health 

Conditions 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Final rule. 

SUMMARY: Title I of the James Zadroga 9/ 

11 Health and Compensation Act of 

2010 amended the Public Health Service 

Act (PHS Act) to establish the World 

Trade Center (WTC) Health Program. 

The WTC Health Program, which is 

administered by the Director of the 

National Institute for Occupational 

Safety and Health (NIOSH), within the 

Centers for Disease Control and 

Prevention (CDC), provides medical 

monitoring and treatment to eligible 

firefighters and related personnel, law 

enforcement officers, and rescue, 

recovery, and cleanup workers who 

responded to the September 11, 2001, 

terrorist attacks in New York City, at the 

Pentagon, and in Shanksville, 

Pennsylvania, and to eligible survivors 

of the New York City attacks. In 

accordance with WTC Health Program 

regulations, which establish procedures 

for adding a new condition to the list of 

covered health conditions, this final 

rule adds to the List of WTC-Related 

Health Conditions the types of cancer 

proposed for inclusion by the notice of 

proposed rulemaking. 

DATES: This final rule is effective 

October 12, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Frank J. Hearl, PE, Chief of Staff, 

National Institute for Occupational 

Safety and Health, Centers for Disease 

Control and Prevention, Patriots Plaza, 

Suite 9200, 395 E St. SW., Washington, 

DC 20201. Telephone: (202) 245–0625 

(this is not a toll-free number). Email: 

WTCpublicinput@cdc.gov. 

SUPPLEMENTARY INFORMATION: This 

notice of final rulemaking is organized 

as follows: 

I. Executive Summary 

II. Public Participation 

III. Background 

A. WTC Health Program Statutory 

Authority 

B. Need for Rulemaking 

C. Review of Scientific Evidence 

D. Physician Determination and Program 

Certification of WTC-Related Health 

Conditions Including Types of Cancer 

E. Effects of Rulemaking on Federal 

Agencies 

IV. Methods Used by the Administrator To 

Determine Whether To Add Cancer or 

Types of Cancer to the List of WTCRelated Health Conditions 

V. Administrator’s Determination Concerning 

Petition 001: Addition of Cancers to the 

List of WTC-Related Health Conditions, 

42 CFR 88.1 

VI. Summary of Final Rule and Response to 

Public Comments 

VII. Regulatory Assessment Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

B. Regulatory Flexibility Act 

C. Paperwork Reduction Act 

D. Small Business Regulatory Enforcement 

Fairness Act 

E. Unfunded Mandates Reform Act of 1995 

F. Executive Order 12988 (Civil Justice) 

G. Executive Order 13132 (Federalism) 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

J. Plain Writing Act of 2010 

VIII. Final Rule 


srobinson on DSK4SPTVN1PROD with RULES