3508 Federal Register / Vol. 79, No. 14 / Wednesday, January 22, 2014 / Rules and Regulations 

Therefore, this instruction heading is 

corrected in this notice. 

Correction 

In the final rule published in the 

Federal Register on November 29, 2013 

(78 FR 71904), on page 71977, third 

column, instruction 102 is corrected to 

read: ‘‘102. Table NN–2 to subpart NN 

is revised to read as follows:’’. 

List of Subjects 40 CFR Part 98 

Environmental protection, 

Administrative practice and procedure, 

Greenhouse gases, Reporting and 

recordkeeping requirements. 

Dated: January 14, 2014. 

Janet G. McCabe, 

Acting Assistant Administrator, Office of Air 

and Radiation. 

[FR Doc. 2014–01214 Filed 1–21–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0755; FRL–9402–8] 

Dinotefuran; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation modifies 

existing time-limited tolerances 

established at 40 CFR 180.603 under 

section 408 of the Federal Food, Drug, 

and Cosmetic Act (FFDCA), for residues 

of dinotefuran in or on pome fruit and 

stone fruit by raising them from 1.0 ppm 

to 2.0 ppm. A document published in 

the Federal Register of November 9, 

2012, which first established the 

tolerances in response to EPA’s granting 

of an emergency exemption under 

Section 18 of the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

authorizing use of the pesticide on 

pome fruit and stone fruit. The previous 

tolerances were supported by surrogate 

residue data in pears. Additional 

residue data has been produced on 

peach indicating that residues may be 

higher than suggested by the residue 

data in pears. Review of the new data 

has concluded that the tolerance levels 

for pome and stone fruits should be 

increased to 2.0 ppm. Therefore, this 

regulation modifies the maximum 

permissible level for residues of 

dinotefuran in or on these commodities 

by raising them from 1.0 ppm to 2.0 

ppm. The time-limited tolerances expire 

on December 31, 2015. 

DATES: This regulation is effective 

January 22, 2014. Objections and 

requests for hearings must be received 

on or before March 24, 2014, 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–2012–0755, 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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703)305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

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–2012–0755 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 March 24, 2014. 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– 

2012–0755, 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. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with FFDCA sections 408(e) 

and 408(l)(6) of, 21 U.S.C. 346a(e) and 

346a(1)(6), is modifying the time-limited 

tolerances for residues of dinotefuran, 

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

furanyl)methyl)guanidine including its 

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


pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 79, No. 14 / Wednesday, January 22, 2014 / Rules and Regulations 3509 

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

in or on Fruit, stone, Group 11, and 

Fruit, pome, Group 12 by revising to 2.0 

parts per million (ppm). The current 

time-limited tolerances were first 

established for these crop groups at 1.0 

ppm in a rule published in the Federal 

Register document on November 9, 

2012. These modified time-limited 

tolerances expire on December 31, 2015. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under FIFRA section 18. Such 

tolerances can be established or 

modified without providing notice or 

period for public comment. EPA does 

not intend for its actions on FIFRA 

section 18 related time-limited 

tolerances to set binding precedents for 

the application of FFDCA section 408 

and the safety standard to other 

tolerances and exemptions. Section 

408(e) of FFDCA allows EPA to 

establish or modify a tolerance or an 

exemption from the requirement of a 

tolerance on its own initiative, i.e., 

without having received any petition 

from an outside party. 

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.’’ 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Dinotefuran on Pome and Stone Fruit 

and FFDCA Tolerances 

Eight state lead agricultural agencies 

have requested and received emergency 

exemptions for the use of dinotefuran 

on pome and stone fruits to control the 

brown marmorated stink bug (BMSB) for 

the past two years. The states are: 

Delaware, Maryland, Michigan, New 

Jersey, North Carolina, Pennsylvania, 

Virginia, and West Virginia. The States 

claimed that the abrupt increase and 

spread of damaging populations of 

BMSB, a recently introduced invasive 

species, resulted in an urgent and nonroutine situation with significant 

economic losses of over 20% expected 

without the use of dinotefuran as an 

additional pest management tool. 

After having reviewed the 

submissions, EPA determined that 

emergency conditions exist for these 

States, and that the criteria for approval 

of emergency exemptions are met. EPA 

has authorized specific exemptions 

under FIFRA section 18 for the use of 

dinotefuran on pome fruit and stone 

fruit for control of the BMSB in the eight 

states listed previously. Time-limited 

tolerances were established at 1.0 ppm 

in or on stone and pome fruits, 

previously, in connection with these 

actions. The tolerances were supported 

by surrogate residue data in pears. Since 

then, additional residue data has been 

produced in peach indicating that 

residues may be higher than suggested 

by the pear data. EPA has reviewed the 

new data and concluded that a tolerance 

level of 2.0 ppm is appropriate. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

raising the tolerances for residues of 

dinotefuran in or on pome fruit and 

stone fruit. In doing so, EPA considered 

the safety standard in FFDCA section 

408(b)(2), and EPA decided that the 

necessary tolerance under FFDCA 

section 408(l)(6) would be consistent 

with the safety standard and with 

FIFRA section 18. 

Consistent with the need to move 

quickly on the emergency exemptions in 

order to address an urgent non-routine 

situation and to ensure that the resulting 

food is safe and lawful, EPA is issuing 

this modification of the initial 

tolerances without notice and 

opportunity for public comment as 

provided in FFDCA section 408(l)(6). 

Although these time-limited tolerances 

expire on December 31, 2015, under 

FFDCA section 408(l)(5), residues of the 

pesticide not in excess of the amounts 

specified in the tolerance remaining in 

or on pome fruit and stone fruit after 

that date will not be unlawful, provided 

the pesticide was applied in a manner 

that was lawful under FIFRA, and the 

residues do not exceed a level that was 

authorized by these time-limited 

tolerances at the time of that 

application. EPA will take action to 

revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

were approved under emergency 

conditions, EPA has not made any 

decisions about whether dinotefuran 

meets FIFRA’s registration requirements 

for use on pome fruit and stone fruit or 

whether permanent tolerances for this 

use would be appropriate. Under these 

circumstances, EPA does not believe 

that these time-limited tolerance 

decisions serve as a basis for registration 

of dinotefuran by a State for special 

local needs under FIFRA section 24(c). 

Nor do these tolerances by themselves 

serve as the authority for persons in any 

State other than those named previously 

in this notice to use this pesticide on the 

applicable crops under FIFRA section 

18 absent the issuance of an emergency 

exemption applicable within that State. 

For additional information regarding the 

emergency exemption for dinotefuran, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with 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 expected as a result 

of this emergency exemption use and 

the time-limited tolerances for residues 

of dinotefuran on pome fruit and stone 

fruit at 2.0 ppm. EPA’s assessment of 

exposures and risks associated with 

these time-limited tolerances follows. 

A. 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 


pmangrum on DSK3VPTVN1PROD with RULES
3510 Federal Register / Vol. 79, No. 14 / Wednesday, January 22, 2014 / Rules and Regulations 

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 

discussed in Unit III of the final rule 

published in the Federal Register of 

September 12, 2012 (77 FR 56133) 

(FRL–9359–6). These endpoints remain 

unchanged since that date. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to dinotefuran, EPA 

considered exposure under the timelimited tolerances as modified by this 

action as well as all existing dinotefuran 

tolerances in 40 CFR 180.603. EPA 

assessed dietary exposures from 

dinotefuran in food as follows: 

i. Acute and Chronic exposures. 

Acute and chronic effects were 

identified for dinotefuran. In estimating 

acute and chronic dietary exposures, 

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 commodities. 

ii. Cancer. Based on the data 

referenced in Unit IV.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. 

iii. 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 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), Pesticide Root 

Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS) and 

the 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 for surface water and 4.9 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure models. For 

acute dietary risk assessment, the water 

concentration value of 269 ppb was 

used to assess the dietary exposure 

contribution from drinking water. For 

chronic dietary risk assessment, the 

water concentration value of 257 ppb 

was used to assess the dietary exposure 

contribution from 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 Level 

of Concern (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. 

C. 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 SF when reliable data 

available to EPA support the choice of 

a different factor. 


pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 79, No. 14 / Wednesday, January 22, 2014 / Rules and Regulations 3511 

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 and offspring 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 that 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 

from potential residues in drinking 

water. EPA used similarly conservative 

assumptions to assess postapplication 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by dinotefuran. 

D. 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 12% 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 5.7% of 

the cPAD for Children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

the unit 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 

MOE of 690 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 when 

MOEs are less than 100, this MOE is not 

of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

non-dietary, non-occupational 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 pathways. 

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 intermediate-term 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 risks from 

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. A more detailed discussion of 

the aggregate risk assessments and 

determination of safety may be found at 

http://www.regulations.gov in Docket ID 

number EPA–HQ–OPP–2012–0755, in 

the aggregate human risk assessment 

document for this action, entitled 

‘‘Dinotefuran ID#: 13MI04 Section 18 

Emergency Exemption for Use on Pome 

Fruits and Stone Fruits in Michigan to 

Control Brown Marmorated Stink 

Bugs.’’ 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

(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) are 

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; 


pmangrum on DSK3VPTVN1PROD with RULES
3512 Federal Register / Vol. 79, No. 14 / Wednesday, January 22, 2014 / Rules and Regulations 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established MRLs for dinotefuran in or 

on pome fruit and stone fruit. 

VI. Conclusion 

Therefore, the established timelimited tolerances for residues of 

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

((tetrahydro-3-furanyl)methyl)guanidine 

including its metabolites and 

degradates, in or on pome fruit and 

stone fruit are modified by raising them 

to 2.0 ppm. These tolerances expire on 

December 31, 2015. 

VII. Statutory and Executive Order 

Reviews 

This final rule modifies tolerances 

under FFDCA sections 408(e) and 

408(l)(6). 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 in accordance with 

FFDCA sections 408(e) and 408(l)(6), 

such as the tolerances 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, but 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). 

VIII. 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: January 10, 2014. 

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 § 180.603, revise the table in 

paragraph (b) to read as follows: 

§ 180.603 Dinotefuran; tolerances for 

residues. 

* * * * * 

(b) * * * 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Fruit, pome, Group 

11 ...................... 2.0 12/31/2015 

Fruit, stone, Group 

12 ...................... 2.0 12/31/2015 

* * * * * 

[FR Doc. 2014–01079 Filed 1–21–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0829; FRL–9904–19] 

Acetochlor; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of acetochlor in 

or on sugar beets and peanuts. 

Monsanto Company requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 22, 2014. Objections and 

requests for hearings must be received 

on or before March 24, 2014, 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–2012–0829, 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 


pmangrum on DSK3VPTVN1PROD with RULES