Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51597 

PART 51—REQUIREMENTS FOR 

PREPARATION, ADOPTION AND 

SUBMITTAL OF IMPLEMENTATION 

PLANS 

■ 1. The authority citation for Part 51 

continues to read as follows: 

Authority: 23 U.S.C. 101; 42 U.S.C. 7401–

7671q. 

Subpart G—Control Strategy 

■ 2. Section 51.121 is amended by 

adding paragraph (s) to read as follows: 

§ 51.121 Findings and requirements for 

submission of State implementation plan 

revisions relating to emissions of oxides of 

nitrogen. 

* * * * * 

(s) Stay of Finding of Significant 

Contribution with respect to the 1-hour 

standard. Notwithstanding any other 

provisions of this subpart, the 

effectiveness of paragraph (a)(1) of this 

section is stayed as it relates to the State 

of Georgia, only as of September 30, 

2005. 

[FR Doc. 05–17031 Filed 8–30–05; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0224; FRL–7732–3] 

Methoxyfenozide; Pesticide Tolerances 

for Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

methoxyfenozide in or on sorghum 

grain, sorghum grain forage, and 

sorghum grain stover. 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 

sorghum grain. This regulation 

establishes a maximum permissible 

level for residues of methoxyfenozide in 

these food commodities. These 

tolerances will expire and are revoked 

on December 31, 2007. 

DATES: This regulation is effective 

August 31, 2005. Objections and 

requests for hearings must be received 

on or before October 31, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2005–

0224. All documents in the docket are 

listed in the EDOCKET index at http:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall#2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Stacey Milan Groce, Registration 

Division (7505C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–2505; e-mail address: 

milan.stacey@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) 

• 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 and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available on E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 408 

(l)(6) of the Federal Food, Drug, and 

Cosmetic Act (FFDCA), 21 U.S.C. 346a, 

is establishing tolerances for residues of 

the insecticide methoxyfenozide, 

benzoic acid, 3-methoxy-2-methyl-2- 

(3,5-dimethylbenzoyl)-2-(1,1- 

dimethylethyl)hydrazide, in or on 

sorghum grain at 0.05 parts per million 

(ppm), sorghum grain forage at 15 ppm, 

and sorghum grain stover at 125 ppm. 

These tolerances will expire and are 

revoked on December 31, 2007. EPA 

will publish a document in the Federal 

Register to remove the revoked 

tolerances from the Code of Federal 

Regulations. 

Section 408(l)(6) of the FFDCA 

requires EPA to establish time-limited 

tolerances or exemptions from the 

requirement of 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 tolerances 

to set binding precedents for the 

application of section 408 of the FFDCA 

and the new safety standard to other 

tolerances and exemptions. Section 

408(e) of the 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 the 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 the 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 

51598 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of the 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 the 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.’’ This provision was not 

amended by the Food Quality Protection 

Act of 1996 (FQPA). EPA has 

established regulations governing such 

emergency exemptions in 40 CFR part 

166. 

III. Emergency Exemption for 

Methoxyfenozide on Sorghum Grain, 

Sorghum Grain Forage, Sorghum Grain 

Stover and FFDCA Tolerances 

The southwestern corn borer is a 

major pest on corn, but has become 

problematic for Louisiana sorghum 

producers in recent years. The 

southwestern corn borer is known to 

infest grain sorghum and had not been 

documented as an important pest of this 

crop until 2002, when heavy moth 

infestations developed in corn and 

migrated to late planted sorghum fields. 

Grain sorghum is usually planted in the 

spring, but adverse weather conditions 

and planting conflicts ensure that a 

significant amount of acreage will be 

planted late. These conditions can 

provide a susceptible host for heavy 

southwestern corn borer moth flight 

during late summer. This unexpected 

heavy migration into grain sorghum has 

left many growers without adequate 

technology to control this pest. 

The sugarcane borer is a major pest of 

corn grown in the vicinity of sugarcane. 

The sugarcane borer recently became an 

important pest of corn in parts of 

Louisiana where no sugarcane is 

produced. This northern shift in the 

infestation range of the sugarcane borer 

is likely the result of mild winters and 

an increase in reduced tillage crop 

production, which has allowed this pest 

to become established outside of its 

normal range. Heavy populations of 

sugarcane borer moth infestations have 

migrated to late planted sorghum fields 

and growers have been ill-prepared in 

handling this disease. 

The Louisiana State AgCenter 

recommends the following two 

insecticides: Cypermethrin and lambdacyhalothrin for control of the 

southwestern corn borer when they are 

applied before the larvae bore into the 

stalk. However, the short-lived residual 

effectiveness of both pyrethroids 

requires an effective scouting program 

to carefully time applications. This 

practice is not available in Louisiana 

and there are currently no insecticides 

registered for control of the sugarcane 

borer on grain sorghum. 

Methoxyfenozide is a suitable 

alternative because of its moderate 

residual life and low risk to humans and 

most non-target organisms. 

Planting grain sorghum early is an 

important management practice against 

both the southwestern corn borer and 

the sugarcane borer. Early planted 

sorghum usually matures before 

southwestern corn borer and sugarcane 

borer populations reach their peak 

migration from their host plants. 

However, this practice is limited by 

weather conditions, which often delay 

planting sorghum acreage until late 

spring and early summer. Shredding the 

crop stubble followed by tillage is no 

longer feasible since most sorghum is 

now grown under reduced tillage 

conditions. Natural enemies destroy 

large numbers of the southwestern corn 

borer, but not at levels necessary to 

prevent significant loss. EPA has 

authorized under FIFRA section 18 the 

use of methoxyfenozide on grain 

sorghum to control southwestern corn 

borer and sugarcane borer for use on 

grain sorghum in Louisiana. After 

having reviewed the submission, EPA 

concurs that emergency conditions exist 

for this State. 

As part of its assessment of this 

emergency exemption, EPA assessed the 

potential risks presented by residues of 

methoxyfenozide in or on sorghum 

grain, sorghum grain forage, and 

sorghum grain stover. In doing so, EPA 

considered the safety standard in 

section 408(b)(2) of the FFDCA, and 

EPA decided that the necessary 

tolerances under section 408(l)(6) of the 

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 

these tolerances without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of the 

FFDCA. Although these tolerances will 

expire and are revoked on December 31, 

2007, under section 408(l)(5) of the 

FFDCA, residues of the pesticide not in 

excess of the amounts specified in the 

tolerance remaining in or on sorghum 

grain, sorghum grain forage, sorghum 

grain stover after that date will not be 

unlawful, provided the pesticide is 

applied in a manner that was lawful 

under FIFRA, and the residues do not 

exceed a level that was authorized by 

these tolerances at the time of that 

application. EPA will take action to 

revoke these 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 tolerances are being 

approved under emergency conditions, 

EPA has not made any decisions about 

whether methoxyfenozide meets EPA’s 

registration requirements for use on 

sorghum grain, sorghum grain forage, 

sorghum grain stover or whether 

permanent tolerances for this use would 

be appropriate. Under these 

circumstances, EPA does not believe 

that these tolerances serves as a basis for 

registration of methoxyfenozide by a 

State for special local needs under 

FIFRA section 24(c). Nor do these 

tolerances serve as the basis for any 

State other than Louisiana to use this 

pesticide on this crop under section 18 

of FIFRA without following all 

provisions of EPA’s regulations 

implementing FIFRA section 18 as 

identified in 40 CFR part 166. For 

additional information regarding the 

emergency exemption for 

methoxyfenozide, contact the Agency’s 

Registration Division at the address 

provided under FOR FURTHER

INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see the final 

rule on Bifenthrin Pesticide Tolerances 

of November 26, 1997 (62 FR 62961) 

(FRL–5754–7). 

Consistent with section 408(b)(2)(D) 

of the FFDCA, 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 methoxyfenozide and to 

make a determination on aggregate 

exposure, consistent with section 

408(b)(2) of the FFDCA, for time-limited 

tolerances for residues of 

methoxyfenozide in or on sorghum 

grain at 0.05 ppm, sorghum grain forage 

at 15 ppm, and sorghum grain stover at 

125 ppm. EPA’s assessment of the 

dietary exposures and risks associated 

with establishing these tolerances 

follows. 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51599 

A. Toxicological Endpoints 

The dose at which no adverse effects 

are observed (the NOAEL) from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological 

endpoint. However, the lowest dose at 

which adverse effects of concern are 

identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect 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. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intra species differences. 

For dietary risk assessments (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (aRfD or cRfD) where + the RfD is 

equal to the NOAEL divided by the 

appropriate UF (RfD = NOAEL/UF). 

Where an additional safety factor is 

retained due to concerns unique to the 

FQPA, this additional factor is applied 

to the RfD by dividing the RfD by such 

additional factor. The acute or chronic 

Population Adjusted Dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of FQPA SF. 

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the level of concern (LOC). 

For example, when 100 is the 

appropriate UF (10X to account for 

interspecies differences and 10X for 

intraspecies differences) the LOC is 100. 

To estimate risk, a ratio of the NOAEL 

to exposures (margin of exposure (MOE) 

= NOAEL/exposure) is calculated and 

compared to the LOC. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk is expressed as 1 x 10-6 or one 

in a million). Under certain specific 

circumstances, MOE calculations will 

be used for the carcinogenic risk 

assessment. In this non-linear approach, 

a ‘‘point of departure’’ is identified 

below which carcinogenic effects are 

not expected. The point of departure is 

typically a NOAEL based on an 

endpoint related to cancer effects 

though it may be a different value 

derived from the dose response curve. 

To estimate risk, a ratio of the point of 

departure to exposure (MOEcancer = point 

of departure/exposures) is calculated. A 

summary of the toxicological endpoints 

for methoxyfenozide used for human 

risk assessment is shown in the 

following Table 1: 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR METHOXYFENOZIDE FOR USE IN HUMAN RISK

ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF 

FQPA SF* and Level of 

Concern for Risk Assessment Study and Toxicological Effects 

Acute dietary (females 13-50 

years of age and the general 

population including infants 

and children) 

None None No appropriate endpoint was identified in the 

oral toxicity studies, including the acute 

neurotoxicity study in rats and the developmental toxicity studies in rats and rabbits 

Chronic dietary all populations NOAEL = 10.2 mg/kg/day 

UF = 100 

Chronic RfD = 0.10 mg/kg/ 

day 

FQPA SF = 1 

cPAD = chronic RfD 

FQPA SF = 0.10 mg/kg/day 

2–Year combined chronic feeding/carcinogenicity, rats 

LOAEL = 411 mg/kg/day based on 

hematological changes (decreased RBC, hemoglobin and hematocrit), liver toxicity (increased weights, hypertrophy), 

histopathological changes in thyroid (increased follicular cell hyppertrophy, altered 

colloid), possible adrenal toxicity (increased 

weights) 

Short-term, intermediate-term, 

long-term dermal and Inhalation 

None None No systemic toxicity was observed at the limit 

dose following repeated dermal application to 

rats 

Based on low vapor pressure, the low acute 

toxicity of both the technical and formulated 

products as well as the application rate and 

application method, there is minimal concern 

for inhalation exposure. 

Cancer (oral, dermal, inhalation) Methoxyfenozide has been 

classified as a ‘‘not likely’’ human carcinogen 

The classification is based on the lack of evidence of carcinogenicity in male and female 

rats as well as in male and female mice and 

on the lack of genotoxocity in an acceptable 

battery of mutagenicity studies 

*The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.544) for the 

residues of methoxyfenozide, in or on a 

variety of raw agricultural commodities 

including the pome fruits crop group, 

apple pomace, cotton seed, cotton gin 

byproducts, sweet corn, field corn, milk, 

meat, fat, liver, and meat byproducts of 

cattle, goats, hogs, horses, and sheep. 

Risk assessments were conducted by 

EPA to assess dietary exposures from 

methoxyfenozide in food as follows: 

i. Acute exposure. Acute dietary risk 

assessments are performed for a foodVerDate Aug<18>2005 16:14 Aug 30, 2005 Jkt 205001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\FR\FM\31AUR1.SGM 31AUR1
51600 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

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. No appropriate 

endpoint was identified in the oral 

toxicity studies including the acute 

neurotoxicity study in rats and the 

developmental toxicity studies in rats 

and rabbits. Therefore, acute dietary risk 

assessments were not conducted. 

ii. Chronic exposure. In conducting 

this chronic dietary risk assessment the 

Dietary Exposure Evaluation Model 

(DEEMTM) analysis evaluated the 

individual food consumption as 

reported by respondents in the United 

States Department of agriculture (USDA) 

1989–1992 nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII) and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: 

100% of all crops were treated and all 

resulting residues were at tolerance 

level. 

iii. Cancer. Methoxyfenozide has been 

classified as a ‘‘not likely human 

carcinogen.’’ The classification is based 

on the lack of evidence of 

carcinogenicity in male and female rats 

as well as in male and female mice and 

on the lack of genotoxicity in an 

acceptable battery of mutagenicity 

studies. Therefore, risk assessments to 

estimate cancer were not conducted. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

methoxyfenozide in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

methoxyfenozide. 

The Agency uses the Generic 

Estimated Environmental Concentration 

(GENEEC) or the Pesticide Root Zone/ 

Exposure Analysis Modeling System 

(PRZM/EXAMS) to estimate pesticide 

concentrations in surface water and SCIGROW, which predicts pesticide 

concentrations in ground water. In 

general, EPA will use GENEEC (a Tier 

1 model) before using PRZM/EXAMS (a 

Tier 2 model) for a screening-level 

assessment for surface water. The 

GENEEC model is a subset of the PRZM/ 

EXAMS model that uses a specific highend runoff scenario for pesticides. 

GENEEC incorporates a farm pond 

scenario, while PRZM/EXAMS 

incorporate an index reservoir 

environment in place of the previous 

pond scenario. The PRZM/EXAMS 

model includes a percent crop (PC) area 

factor as an adjustment to account for 

the maximum percent crop coverage 

within a watershed or drainage basin. 

The Agency uses the First Index 

Reservoir Screening Tool (FIRST) or the 

PRZM/EXAMS to produce estimates of 

pesticide concentrations in an index 

reservoir. The SCI-GROW model is used 

to predict pesticide concentrations in 

shallow ground water. For a screeninglevel assessment for surface water EPA 

will generally use FIRST (a Tier 1 

model) before using PRZM/EXAMS (a 

Tier 2 model). The FIRST model is a 

subset of the PRZM/EXAMS model that 

uses a specific high-end runoff scenario 

for pesticides. While both FIRST and 

PRZM/EXAMS incorporate an index 

reservoir environment, the PRZM/ 

EXAMS model includes a PC area factor 

as an adjustment to account for the 

maximum percent crop coverage within 

a watershed or drainage basin. 

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. The 

primary use of these models by the 

Agency at this stage is to provide a 

coarse screen for sorting out pesticides 

for which it is highly unlikely that 

drinking water concentrations would 

ever exceed human health levels of 

concern. 

Since the models used are considered 

to be screening tools in the risk 

assessment process, the Agency does 

not use estimated environmental 

concentrations (EECs) from these 

models to quantify drinking water 

exposure and risk as a %RfD or %PAD. 

Instead drinking water levels of 

comparison (DWLOCs) are calculated 

and used as a point of comparison 

against the model estimates of a 

pesticide’s concentration in water. 

DWLOCs are theoretical upper limits on 

a pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food, and from 

residential uses. Since DWLOCs address 

total aggregate exposure to 

methoxyfenozide, they are further 

discussed in the aggregate risk sections 

below. 

Based on the PRZM/EXAMS and SCIGROW models the estimated 

environmental concentrations (EECs) of 

methoxyfenozide for chronic exposures 

are estimated to be 30 parts per billion 

(ppb) for surface water and 3.5 ppb for 

ground 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). 

Methoxyfenozide is not registered for 

use on any sites that would result in 

residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the 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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

methoxyfenozide and any other 

substances and methoxyfenozide does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 

methoxyfenozide has 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 of the 

FFDCA provides that EPA shall apply 

an additional tenfold margin of safety 

(MOS) for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the data base on 

toxicity and exposure unless EPA 

determines that a different MOS will be 

safe for infants and children. MOS are 

incorporated into EPA risk assessments 

either directly through use of a MOE 

analysis or through using uncertainty 

(safety) factors in calculating a dose 

level that poses no appreciable risk to 

humans. 

2. Developmental toxicity studies. In a 

developmental toxicity study in rats 

regarding maternal findings, there were 

no deaths orclinical signs, nor were 

there any effects on body weights or 

food consumption. No changes were 

noted in any of the reproductive 

parameters. Fetal examinations did not 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51601 

reveal any effects on body weight or 

gross/visceral/skeletal aspects. The 

maternal NOAEL is 1,000 milligram/ 

kilogram/day (mg/kg/day) Highest dose 

tested (HDT) and the maternal LOAEL is 

greater than 1,000 mg/kg/day. The 

developmental NOAEL is 1,000 mg/kg/ 

day and the developmental LOAEL is 

greater than 1,000 mg/kg/day. 

In a developmental toxicity study in 

rabbits regarding maternal findings, 

there were no deaths or clinical signs, 

nor were there any effects on body 

weights, weight gains, or food 

consumption. No changes were noted in 

any of the reproductive parameters. 

Fetal examinations did not reveal any 

effects on body weight or gross/visceral/ 

skeletal aspects. The maternal NOAEL is 

1,000 mg/kg/day HDT, and the maternal 

LOAEL is greater than 1,000 mg/kg/day. 

The developmental NOAEL is 1,000 mg/ 

kg day and the developmental LOAEL is 

greater than 1,000 mg/kg day. 

3. Reproductive toxicity study. In a 2- 

generation reproduction study, the 

LOAEL for systemic toxicity is 20,000 

ppm (1,551.9 mg/kg day), based on 

increased absolute and relative liver 

weights in males and females and on the 

hepatocellular hypertrophy in males 

and females. The NOAEL for systemic 

toxicity is 2,000 ppm (153.4 mg/kg/day). 

There were no treatment related 

reproductive effects on the P1 and P2

males and females or their F1 and F2

offspring. Therefore, the NOAEL for 

reproductive toxicity is greater than 

20,000 ppm (1,551.9–2,036.5 mg/kg day) 

HDT. The LOAEL for reproductive 

toxicity was not identified. 

4. Neurotoxicity. In an acute oral 

neurotoxicity study in rats, there were 

no observable signs of a neurotoxic 

effect at the highest concentration in 

females. Functional observational 

battery (FOB) assessment on day 0 

revealed a decrease in hindlimb grip 

strength for males in the 2,000 mg/kg 

group. Motor activity assessment 

remained comparable to controls 

throughout the study for males and 

females in all exposure groups. No 

neuropathological endpoints were 

observed during the histological 

examinations of the peripheral or 

central nervous systems of these 

animals at any exposure concentration. 

Based on the absence of any substance 

related effects on body weight or body 

weight gain and any clinical signs of 

toxicity, the NOAEL for systemic 

toxicity is a concentration of 2,000 mg/ 

kg for males and females. The NOAEL 

for neurotoxic effects is 200 mg/kg for 

females. Based on a decrease in 

hindlimb grip strength on day 0 in the 

2,000 mg/kg male group, the NOAEL for 

males is 1,000 mg/kg and the LOAEL for 

males is 2,000 mg/kg. No LOAEL was 

established for systemic effects in males 

or females or for neurotoxic effects in 

females. 

In a subchronic oral neurotoxicity 

study in rats, there were no observable 

signs of a neurotoxic effect at the 

highest concentration in males or 

females. FOB and MA remained 

comparable to controls throughout the 

study and no neuropathological 

endpoints were observed during the 

histological exams of these animals at 

any exposure concentration. Based on 

the absence of any substance related 

effects on body weight or body weight 

gain and any clinical signs of toxicity, 

the NOAEL for systemic toxicity is also 

2,000 ppm for males (1,318 mg/kg/day), 

and females (1,577 mg/kg/day). No 

LOAEL was established for systemic or 

neurotoxic effects. 

In none of the other oral toxicity 

studies on methoxyfenozide were there 

any signs of neurotoxicity. The studies 

considered included all the available 

toxicology studies on methoxyfenozide. 

5. Conclusion. There is a complete 

toxicity data base for methoxyfenozide 

and no additional studies are required at 

this time. The scientific and regulatory 

quality of the toxicology data base for 

methoxyfenozide is high and is 

considered sufficient to clearly define 

the toxicity of this chemical. There is, 

therefore, high confidence in the hazard 

and dose-response assessments 

conducted for this chemical. Exposure 

data are complete or are estimated based 

on data that reasonably accounts for 

potential exposures. 

The toxicology data provided no 

indication of increased susceptibility in 

rats or rabbits from in utero and/or post 

natal exposure to methoxyfenozide. In 

the prenatal developmental toxicity 

studies in rats and rabbits, no 

developmental toxicity was observed at 

the limit dose, which is the HDT. In the 

2-generation reproduction study in rats, 

no effects in the offspring were observed 

at the HDT. In none of the oral toxicity 

studies on methoxyfenozide were there 

any signs of neurotoxicity. The studies 

considered included all the available 

toxicology studies on methoxyfenozide. 

Therefore, the Agency has determined 

that the FQPA Safety Factor (as required 

by the FQPA of August 3, 1996) can be 

reduced to 1X in assessing the risk 

posed by this chemical. 

D. Aggregate Risks and Determination of 

Safety 

To estimate total aggregate exposure 

to a pesticide from food, drinking water, 

and residential uses, the Agency 

calculates DWLOCs which are used as a 

point of comparison against the model 

estimates of a pesticide’s concentration 

in water (EECs). DWLOC values are not 

regulatory standards for drinking water. 

DWLOCs are theoretical upper limits on 

a pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food and residential 

uses. In calculating a DWLOC, the 

Agency determines how much of the 

acceptable exposure ( i.e., the PAD) is 

available for exposure through drinking 

water e.g., allowable chronic water 

exposure mg/kg day = cPAD - (average 

food + chronic non-dietary, nonoccupational exposure). This allowable 

exposure through drinking water is used 

to calculate a DWLOC. 

A DWLOC will vary depending on the 

toxic endpoint, drinking water 

consumption, and body weights. Default 

body weights and consumption values 

as used by EPA Office of Water are used 

to calculate DWLOCs: 2 liter (L)/70 kg 

(adult male), 2L/60 kg (adult female), 

and 1L/10 kg (child). Default body 

weights and drinking water 

consumption values vary on an 

individual basis. This variation will be 

taken into account in more refined 

screening-level and quantitative 

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer. 

When EECs for surface water and 

ground water are less than the 

calculated DWLOCs, EPA concludes 

with reasonable certainty that exposures 

to methoxyfenozide in drinking water 

(when considered along with other 

sources of exposure for which EPA has 

reliable data) would not result in 

unacceptable levels of aggregate human 

health risk at this time. Because EPA 

considers the aggregate risk resulting 

from multiple exposure pathways 

associated with a pesticide’s uses, levels 

of comparison in drinking water may 

vary as those uses change. If new uses 

are added in the future, EPA will 

reassess the potential impacts of 

methoxyfenozide on drinking water as a 

part of the aggregate risk assessment 

process. 

1. Acute risk. No appropriate 

endpoint was identified in the oral 

toxicity studies including the acute 

neurotoxicity study in rats and the 

developmental toxicity studies in rats 

and rabbits. Therefore, acute dietary risk 

assessments were not conducted. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to methoxyfenozide from 

food will utilize 23% of the cPAD for 

the U.S. population, 37% of the cPAD 

51602 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

for all infants < 1–year old, the infant 

subpopulation at greatest exposure and 

71% of the cPAD for children 1-2 years 

old, the children subpopulation at 

greatest exposure. There are no 

residential uses for methoxyfenozide 

that result in chronic residential 

exposure to methoxyfenozide. In 

addition, despite the potential for 

chronic dietary exposure to 

methoxyfenozide in drinking water, 

after calculating DWLOCs and 

comparing them to conservative model 

estimated environmental concentrations 

of methoxyfenozide in surface water 

and ground water, EPA does not expect 

the aggregate exposure to exceed 100% 

of the cPAD, as shown in the following 

Table 2: 

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO METHOXYFENOZIDE

Population Subgroup cPAD mg/ 

kg/day 

%cPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. population 0.10 23 30 3.5 2,700 

Infants (< 1–year old) 0.10 37 30 3.5 630 

Children (1-2 years old) 0.10 71 30 3.5 290 

3. Short-term risk. Short-term and 

intermediate-term aggregate exposures 

take into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Methoxyfenozide is not registered for 

use on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which were previously 

addressed. 

4. Aggregate cancer risk for U.S. 

population. Methoxyfenozide has been 

classified as a ‘‘not likely’’ human 

carcinogen. The classification is based 

on the lack of evidence of 

carcinogenicity in male and female rats 

as well as in male and female mice and 

on the lack of genotoxicity in an 

acceptable battery of mutagenicity 

studies. Therefore, risk assessments to 

estimate cancer risk were not 

conducted. 

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, and to infants and children 

from aggregate exposure to 

methoxyfenozide residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. The method for use on corn 

matrices (grain, forage, stover) is TR 34–

00–38. Information on the analytical 

methodology may be requested from: 

Calvin Furlow, Public Information 

Resources and Services Branch (7502C), 

Office of Pesticide Programs, 

Environmental Protection Agency, Ariel 

Rios Building, 1200 Pennsylvania 

Avenue, N.W., Washington, D.C, 20460, 

telephone number: (703) 305–5229; email address: furlow.calvin@epa.gov. 

B. International Residue Limits 

There are no established or proposed 

Codex, Canadian, or Mexican limits for 

residues of methoxyfenozide in or on 

plant or animal commodities. Therefore, 

no compatibility issues exist regarding 

the proposed U.S. tolerances. 

C. Conditions 

Plantback (recropping) restrictions 

should appear on the registered labels. 

These restrictions should specify that 

the crops for which methoxyfenozide 

use is registered may be replanted at any 

time, and all other crops grown for food 

or feed may be replanted after 7 days. 

The existing livestock tolerances are 

adequate for the uses proposed under 

these emergency exemptions. 

VI. Conclusion 

Therefore, tolerances are established 

for residues of methoxyfenozide, 

benzoic acid, 3-methoxy-2-methyl-2- 

(3,5-dimethylbenzoyl)-2-(1,1- 

dimethylethyl)hydrazide, in or on grain 

sorghum at 0.05 ppm, grain sorghum 

forage at 15 ppm, and grain sorghum 

stover at 125 ppm. 

VII. Objections and Hearing Requests 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, 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. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the FFDCA 

provides essentially the same process 

for persons to ‘‘object’’ to a regulation 

for an exemption from the requirement 

of a tolerance issued by EPA under new 

section 408(d) of the FFDCA, as was 

provided in the old sections 408 and 

409 of the FFDCA. However, the period 

for filing objections is now 60 days, 

rather than 30 days. 

A. What Do I Need to Do to File an 

Objection or Request a Hearing? 

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2005–0224 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 October 31, 2005. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issue(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51603 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 2005. The Office of the 

Hearing Clerk is open from 8 a.m. to 4 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number 

for the Office of the Hearing Clerk is 

(202) 564–6255. 

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VII.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by the docket ID 

number OPP–2005–0224, to: Public 

Information and Records Integrity 

Branch, Information Resources and 

Services Division (7502C), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001. In person or by courier, bring a 

copy to the location of the PIRIB 

described in ADDRESSES. You may also 

send an electronic copy of your request 

via e-mail to: opp-docket@epa.gov. 

Please use an ASCII file format and 

avoid the use of special characters and 

any form of encryption. Copies of 

electronic objections and hearing 

requests will also be accepted on disks 

in WordPerfect 6.1/8.0 or ASCII file 

format. Do not include any CBI in your 

electronic copy. You may also submit an 

electronic copy of your request at many 

Federal Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issue(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

VIII. Statutory and Executive Order 

Reviews 

This final rule establishes timelimited tolerances] under section 408 of 

the FFDCA. 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 

rule has been exempted from review 

under Executive Order 12866 due to its 

lack of significance, this rule is not 

subject to Executive Order 13211, 

Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

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). Since 

tolerances and exemptions that are 

established on the basis of a FIFRA 

section 18 exemption under section 408 

of the 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive Order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

IX. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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. 

51604 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

Dated: August 19, 2005. 

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 § 180.554, the table in paragraph 

(b) is amended by alphabetically adding 

commodities to read as follows: 

§ 180.544 Methoxyfenozide; tolerance for 

residues. 

* * * * * 

(b) *** 

Commodity Parts per million Expiration/revocation date 

sorghum, grain 0.05 12/31/2007 

sorghum, grain, forage 15 12/31/2007 

sorghum, grain, stover 125 12/31/2007 

* * * * * 

[FR Doc. 05–17131 Filed 8–30–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0217; FRL–7731–6] 

Flonicamid; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for combined residues of 

flonicamid and its metabolites in or on 

certain plant and livestock 

commodities. ISK Biosciences requested 

this tolerance under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA). 

DATES: This regulation is effective 

August 31, 2005. Objections and 

requests for hearings must be received 

on or before October 31, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0217. All documents in the docket are 

listed in the EDOCKET index athttp:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: Ann 

Sibold, Registration Division (7505C), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6502; e-mail 

address:sibold.ann@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 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

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 underFOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines athttp://www.epa.gpo/ 

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings 

In the Federal Register of May 23, 

2003 (68 FR 28218) (FRL–7307–5), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 3F6552) by ISK 

Biosciences, 7470 Auburn Road, suite 

A, Concord, Ohio 44077. The petition 

requested that 40 CFR part 180 be 

amended by establishing a tolerance for 

the combined residues of the insecticide 

flonicamid, [N-(cyanomethyl)-4- 

trifluoromethylnicotinamide] and its 

metabolites, TFNA, (4- 

trifluoromethylnicotinic acid), TFNAAM, (4-trifluoromethylnicotinamide) 

and TFNG, [N-(4- 

trifluoromethylnicotinoyl)glycine] in or 

on the raw agricultural commodities: 

Celery, at 1.2 parts per million (ppm); 

cotton, at 0.5 ppm; cotton, gin trash, at 

6.0 ppm; cotton, hulls, at 1.0 ppm; 

cotton, meal, at 1.0 ppm; fruit, pome, 

group 11, at 0.2 ppm; fruit, stone, group 

12, except plum and fresh prune plum, 

at 0.7 ppm; lettuce, head, at 1.0 ppm; 

lettuce, leaf, at 4.0 ppm; plum, at 0.1 

ppm; potato, at 0.2 ppm; potato, flakes, 

at 0.4 ppm; prune, fresh, at 0.1; spinach, 

at 9.0 ppm; tomato, paste, at 2.0 ppm; 

tomato, puree, at 0.5 ppm; vegetable,