12596 Federal Register / Vol. 74, No. 56 / Wednesday, March 25, 2009 / Rules and Regulations 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. 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, or otherwise have any unique 

impacts or local governments. 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) (Public 

Law 104–4). 

Although this action does not 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), EPA seeks to 

achieve environmental justice, the fair 

treatment and meaningful involvement 

of any group, including minority and/or 

low-income populations, in the 

development, implementation, and 

enforcement of environmental laws, 

regulations, and policies. As such, to the 

extent that information is publicly 

available or was submitted in comments 

to EPA, the Agency considered whether 

groups or segments of the population, as 

a result of their location, cultural 

practices, or other factors, may have 

atypical or disproportionately high and 

adverse human health impacts or 

environmental effects from exposure to 

the pesticide discussed in this 

document, compared to the general 

population. 

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this rule in the Federal 

Register. This rule 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: February 24, 2009. 

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 §180.960, the table is amended 

by adding alphabetically the following 

polymer to read: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

*****

Castor oil, 

ethoxylated, oleate, 

minimum number 

average molecular 

weight (in amu) 

2,000.

220037–02–5 

*****

[FR Doc. E9–6258 Filed 3–24–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0845; FRL–8401–5] 

Dinotefuran; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for combined 

residues of dinotefuran, [ N -methyl- N 

′-nitro- N′′ -((tetrahydro-3- 

furanyl)methyl)guanidine] and its 

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

methyl-3-(tetrahydro-3- 

furylmethyl)urea], expressed as 

dinotefuran in or on rice, grain. This 

action is 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 rice. 

This regulation establishes a maximum 

permissible level for residues of 

dinotefuran in this food commodity. 

The time-limited tolerance expires and 

is revoked on December 31, 2009. 

DATES: This regulation is effective 

March 25, 2009. Objections and requests 

for hearings must be received on or 

before May 26, 2009, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0845. All documents in the 

docket are listed in the docket index 

available in http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Libby Pemberton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9364; e-mail address: 

pemberton.libby@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. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 


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• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR cite at http:// 

www.gpoaccess.gov/ecfr. 

C. 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. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2008–0845 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before May 26, 2009. 

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 that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2008–0845, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

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

and 346a(1)(6), is establishing timelimited tolerances for combined 

residues of dinotefuran. This timelimited tolerance expires and is revoked 

on December 31, 2009. EPA will publish 

a document in the Federal Register to 

remove the revoked tolerances for the 

combined residues of the insecticide, 

dinotefuran, [N -methyl- N ′-nitro- N′′ 

-((tetrahydro-3- 

furanyl)methyl)guanidine] and its 

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

methyl-3-(tetrahydro-3- 

furylmethyl)urea], expressed as 

dinotefuran from the CFR. 

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 section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on section 18 related timelimited tolerances to set binding 

precedents for the application of section 

408 of FFDCA and the new safety 

standard to other tolerances and 

exemptions. Section 408(e) of FFDCA 

allows EPA to establish 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 Rice and FFDCA 

Tolerances 

Texas declared a crisis exemption 

under FIFRA section 18 for the use of 

dinotefuran on rice for control of rice 

stink bug (Oebalus pugnax (F.). 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

the combined residues of dinotefuran, [ 

N -methyl- N ′-nitro- N′′ -((tetrahydro-3- 

furanyl)methyl)guanidine] and its 

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

methyl-3-(tetrahydro-3- 

furylmethyl)urea], expressed as 

dinotefuran in or on rice, grain. In doing 

so, EPA considered the safety standard 

in section 408(b)(2) of FFDCA, and EPA 

decided that the necessary tolerance 

under section 408(l)(6) of FFDCA would 

be consistent with the safety standard 

and with FIFRA section 18. Consistent 

with the need to move quickly on the 

emergency exemption in order to 

address an urgent non-routine situation 

and to ensure that the resulting food is 

safe and lawful, EPA is issuing this 

tolerance without notice and 

opportunity for public comment as 

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

Although these time-limited tolerances 

expire and are revoked on December 31, 

2009, under section 408(l)(5) of FFDCA, 

residues of the pesticide not in excess 

of the amounts specified in the 

tolerance remaining in or on rice, grain 

after that date will not be unlawful, 

provided the pesticide was applied in a 


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manner that was lawful under FIFRA, 

and the residues do not exceed a level 

that was authorized by these timelimited 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 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether dinotefuran 

meets FIFRA’s registration requirements 

for use on rice or whether permanent 

tolerances for this use would be 

appropriate. Under these circumstances, 

EPA does not believe that this timelimited tolerance decision serves as a 

basis for registration of dinotefuran by a 

State for special local needs under 

FIFRA section 24(c). Nor does this 

tolerance serve as the basis for persons 

in any State other than Texas to use this 

pesticide on these 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 

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 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 request 

and the time-limited tolerances for 

combined residues of the insecticide, 

dinotefuran, [ N -methyl- N ′-nitro- N′′ 

-((tetrahydro-3- 

furanyl)methyl)guanidine] and its 

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

methyl-3-(tetrahydro-3- 

furylmethyl)urea], expressed as 

dinotefuran. EPA’s assessment of 

exposures and risks associated with 

establishing time-limited tolerances 

follows. 

A. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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 can be found at 

http://www.regulations.gov in document 

Section 18 Emergency Exemptions for 

the Use of Dinotefuran on Rice in Texas 

to Control Stink Bugs, on page number 

6 in docket ID number EPA–HQ–OPP– 

2008–0845. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to dinotefuran, EPA 

considered exposure under the timelimited tolerance established 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 exposure. 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% crop treated (PCT) and tolerance 

level residues. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA insert 1994–1996 and 

1998 CSFII. As to residue levels in food, 

EPA assumed 100 PCT and tolerance 

level residues. 

iii. Cancer. Dinotefuran is classified 

as not likely to be a carcinogen, so no 

dietary assessment was performed for 

cancer. 

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/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for dinotefuran in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of dinotefuran. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

dinotefuran for surface water, the acute 

and chronic total EDWCs (parent + 

metabolites) are 281 parts per billion 


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(ppb) for acute and 139 ppb for chronic, 

respectively. The acute and chronic 

ground water total EDWC (parent + 

metabolites) is 4.9 ppb. 

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 

uses that could result in residential 

exposures during the application of 

products containing dinotefuran and 

from entering areas previously treated 

with dinotefuran, such as lawns where 

children might play, or golf courses and 

home gardens that could lead to 

exposures for adults. The Agency 

combines risks resulting from exposures 

to individual chemicals when it is likely 

they can occur simultaneously based on 

the use pattern and the behavior 

associated with the exposed population. 

For this assessment, the Agency has 

added together risk values for adults 

applying dinotefuran to residential 

lawns and then being exposed to the 

treated lawn. For children, dermal and 

incidental oral exposures from activities 

on treated lawn were combined. These 

are considered to represent worst case 

scenarios for co-occurring residential 

exposures. The proposed section 18 

uses of dinotefuran do not add any 

additional residential exposures or 

risks. 

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 the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website 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. 

2. Prenatal and postnatal sensitivity. 

EPA evaluated the potential for 

increased susceptibility of infants and 

children from exposure to dinotefuran. 

EPA concluded that the toxicology 

database for dinotefuran is adequate for 

FQPA assessment. Available studies 

include developmental toxicity studies 

in rats and rabbits, a reproductive 

toxicity study in rats, and acute and 

subchronic neurotoxicity studies in rats. 

EPA concluded that there is low 

concern for prenatal and/or postnatal 

toxicity resulting from exposure to 

dinotefuran. However, there is a 

concern for neurotoxicity and 

developmental neurotoxicity resulting 

from exposure to dinotefuran, and also 

a concern for immunotoxicity following 

exposure to dinotefuran during the 

period of organogenesis. 

3. Conclusion. Considering the overall 

toxicity profile and the doses and 

endpoints selected for risk assessment 

for dinotefuran, the EPA characterized 

the degree of concern for the effects 

observed in the rat reproduction study 

as low, noting these effects occurred in 

the presence of parental toxicity and 

only at the highest dose tested. For all 

toxicity endpoints established for 

dinotefuran, a NOAEL lower than this 

offspring NOAEL is used. No residual 

uncertainties were identified. 

The absence of a NOAEL for the 

chronic dog study and the need for a 

developmental immunotoxicity (DIT) 

study generate some uncertainty 

regarding the protectiveness of the 

chronic regulatory endpoint and longterm LOC. Accordingly, EPA does not 

have reliable data supporting adoption 

of a safety factor other than the default 

additional 10x factor as specified in 

FFDCA section 408(b)(2)(C). The 

chronic endpoint and long-term LOC 

have therefore been generated using an 

overall safety/uncertainty factor of 1,000 

(representing 100x for inter-species 

extrapolation and intra-species 

variation, and an additional 10x 

pursuant to FFDCA section 408(b)(2)(C), 

i.e., use of a LOAEL). However, the 

Agency does not have similar concerns 

regarding acute, short-term, and 

intermediate-term risk assessments, 

since the absence of a NOAEL only 

occurred in a chronic study. 

EPA concluded that there is concern 

for developmental neurotoxicity 

following exposure to dinotefuran, and 

recommended that a developmental 

neurotoxicity (DNT) study in rats be 

conducted. However, EPA determined 

that a database uncertainty factor 

(UFDB) is not needed to account for the 

lack of the DNT study. The Agency 

believes there are reliable data showing 

that the regulatory endpoints are 

protective of children despite the need 

for a developmental neurotoxicity 

study. Developmental neurotoxicity 

data received and reviewed for other 

compounds in this chemical class (i.e., 

neonicotinoids) including thiacloprid, 

clothianidin, and imidacloprid, indicate 

that the results of the required DNT 

study will not likely impact the 

regulatory doses selected for 

dinotefuran. 

EPA also concluded that there is a 

concern for immunotoxicity following 

exposure to dinotefuran during the 

period of organogenesis. This concern 

was based on the decreases in absolute 

and adjusted thymus and spleen 

weights observed in several species in 

various studies. In addition, the 

available data indicate that the juvenile 

rats appeared to be more sensitive/ 

susceptible to these effects than adults 

in the 2–generation reproduction study. 

Therefore, EPA recommended that 

testing be conducted to assess immune 

system function in adults and young 

animals following exposure during the 

period of organogenesis. A protocol for 

this testing was developed by the 

registrant and these studies are now 

ongoing. 

D. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Shortterm, intermediate-term, and chronicVerDate Nov<24>2008 00:39 Mar 25, 2009 Jkt 217001 PO 00000 Frm 00065 Fmt 4700 Sfmt 4700 E:\FR\FM\25MRR1.SGM 25MRR1

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12600 Federal Register / Vol. 74, No. 56 / Wednesday, March 25, 2009 / Rules and Regulations 

term risks are evaluated by comparing 

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. The aggregate acute risk 

estimates include exposure to residues 

of dinotefuran in food and drinking 

water. Since the acute dietary exposure 

assessment already includes the highest 

acute exposure from the drinking water 

modeling data, no further calculations 

are necessary. The acute risk estimate 

for all populations, resulting from 

aggregate exposure to dinotefuran in 

food and drinking water is below EPA’s 

LOC. The food and drinking water 

exposure estimates for the most highly 

exposed subgroup, children 1–2 yrs old, 

is 4.4% of the aPAD. 

2. Chronic risk. The aggregate chronic 

risk estimates include exposure to 

residues of dinotefuran in food and 

drinking water. Since the chronic 

dietary exposure assessment already 

includes the highest chronic exposure 

from the drinking water modeling data, 

no further calculations are necessary. 

The EPA concluded that dinotefuran 

exposure from food consumption will 

utilize 42% of the cPAD for the general 

U. S. population and 86% for children 

1–2 years old, the most sensitive 

subgroup. Dinotefuran is not expected 

to pose a chronic dietary risk for the 

general population (including children 

and infants). The chronic risk estimate 

for all populations, resulting from 

aggregate exposure to dinotefuran in 

food and drinking water is below EPA’s 

LOC. 

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). Because there are 

existing residential uses of dinotefuran, 

short-term aggregate risk assessments 

based on exposure from oral, inhalation, 

and dermal routes were considered. 

However, the toxicological effects for 

oral and inhalation routes of exposure 

are different (i.e., neurotoxicity for oral 

and decrease in body weight for 

inhalation); and therefore, these 

exposure scenarios have not been 

combined. Also, because no systemic 

toxicity was seen at the limit dose in a 

28–day dermal toxicity study, no 

quantification of short-term dermal risk 

is required. Therefore, a short-term 

aggregate risk assessment was not 

performed. An intermediate-term 

aggregate risk assessment was 

performed as a screening level 

assessment, which will apply to shortterm aggregate risk. 

4. Intermediate-term risk. An 

intermediate-term aggregate risk 

assessment was performed as a 

screening level assessment. 

Intermediate-term aggregate risk 

assessments were performed for adults 

and children. For children, the 

subgroup with the highest estimated 

chronic dietary exposure (children 1–2 

years old) was aggregated with 

residential exposures to children 

playing on treated lawns (dermal and 

oral hand-to-mouth exposures) in order 

to calculate the worst case intermediateterm aggregate risk to children. The 

reciprocal MOE method was used to 

conduct the intermediate-term aggregate 

risk assessment for children, since the 

LOCs are identical for all MOEs in the 

calculation. For adults, the aggregate 

risk index (ARI) method was used, since 

LOC are not identical for all types of 

exposure in the calculation. For 

children, the aggregate MOE is 400 

which is greater than 100, and therefore 

does not exceed EPA’s LOC. For adults, 

the total aggregate ARI is 5.5 which is 

greater than 1, and therefore does not 

exceed EPA’s LOC. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children, 

from aggregate exposure to dinotefuran 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(for plant commodities (High 

Performance Liquid Chromatography 

(HPLC)/Mass Spectrometry (MS); HPLC/ 

Ultraviolet (UV); and HPLC/MS/MS)) 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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are currently no established 

Codex, Canadian, or Mexican maximum 

residue limits for residues of 

dinotefuran in/on plant or livestock 

commodities. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for combined residues of the 

insecticide, dinotefuran, [ N -methyl- N 

′-nitro- N′′ -((tetrahydro-3- 

furanyl)methyl)guanidine] and its 

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

methyl-3-(tetrahydro-3- 

furylmethyl)urea], expressed as 

dinotefuran, in or on rice, grain at 2.8 

parts per million (ppm). These 

tolerances expire and are revoked on 

December 31, 2011. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under sections 408(e) and 408(l)(6) of 

FFDCA 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 in accordance with 

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

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


sroberts on PROD1PC70 with RULES
Federal Register / Vol. 74, No. 56 / Wednesday, March 25, 2009 / Rules and Regulations 12601 

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) (Public Law 104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: February 24, 2009. 

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 

revising paragraph (b) to read as follows: 

§ 180.603 Dinotefuran; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

combined residues of Dinotefuran, [ N 

-methyl- N ′-nitro- N′′ -((tetrahydro-3- 

furanyl)methyl)guanidine] and its 

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

methyl-3-(tetrahydro-3- 

furylmethyl)urea], expressed as 

dinotefuran in or on the specified 

agricultural commodities, resulting from 

use of the pesticide pursuant to FFIFRA 

section 18 emergency exemptions. The 

tolerances expire and are revoked on the 

date specified in the table. 

Commodity Parts per million Expiration/ 

revocation date 

Rice, grain .................................................................................................................................................... 2.8 12/31/09 

* * * * * 

[FR Doc. E9–6253 Filed 3–24–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006-0875; FRL–8400–8] 

Fenpropathrin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fenpropathrin 

in or on almond, hulls at 4.5 parts per 

million (ppm); cherry, sweet, at 5.0 

ppm; cherry, tart at 5.0 ppm; fruit, 

stone, crop group 12 (except cherry) at 

1.4 ppm; nuts, tree, crop group 14 at 

0.10 ppm; pistachio at 0.10 ppm, PP 

4E6867; avocado at 1.0 ppm; black 

sapote at 1.0 ppm; canistel at 1.0 ppm; 

maney sapote at 1.0 ppm; mango at 1.0 

ppm; papaya at 1.0 ppm; sapodilla at 1.0 

ppm; star apple at 1.0 ppm, PP 6E7066; 

caneberry, subgroup 13-07A at 12 ppm; 

and olive at 5.0 ppm, PP 7E7298. In 

addition, the Agency is deleting a timelimited tolerance on currant at 15 ppm 

which had an expiration date of 12/31/ 

2008. The Interregional Research Project 

Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 25, 2009. Objections and requests 

for hearings must be received on or 

before May 26, 2009, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2006–0875. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; e-mail address: 

jackson.sidney@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 


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