57216 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

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.

VIII. 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.

Dated: September 16, 2004.

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 180.432 is revised to read as 

follows:

§ 180.432 Lactofen; tolerances for 

residues.

(a) Tolerances are established for 

residues of the herbicide lactofen, 1-

(carboethoxy)ethyl 5-[2-chloro-4-

(trifluoromethyl)phenoxy]-2- 

nitrobenzoate, in or on the following 

raw agricultural commodities:

Commodity Parts per 

million 

Beans, snap, succulent (excluding limas) ........................ 0.01

Cotton, gin byproducts ............. 0.02

Cotton, undelinted seed ........... 0.01

Peanut ...................................... 0.01

Soybean, seed .......................... 0.01

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved]

[FR Doc. 04–21500 Filed 9–23–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0209; FRL–7680–9]

Tebufenozide; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes 

tolerances for residues of tebufenozide 

in or on tuberous and corm vegetables 

(except potato) subgroup 1D, grape, 

citrus (crop group 10), and citrus oil and 

indirect or inadvertent combined 

residues of tebufenozide, benzoic acid, 

3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide and its 

metabolite benzoic acid, 3,5-dimethyl-1-

(1,1dimethylethyl)-2-[4-(1-

hydroxyethyl)benzoyl]hydrazide in or 

on forage, fodder, hay and straw of 

cereal grain; forage, fodder, straw and 

hay of non-grass animal feed; forage, 

fodder and hay of grass and foliage of 

legume vegetables. Dow AgroSciences 

and Interregional Research Project 

Number 4 (IR-4) requested these 

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 

September 24, 2004. Objections and 

requests for hearings must be received 

on or before November 23, 2004.

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–2004–

0209. 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:

Joseph M. Tavano, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6411; e-mail address: 

tavano.joseph@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 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57217

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

In the Federal Register of March 19, 

2001 (66 FR 15443–15459) (FRL–6766–

7), 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 0F6176) by Rohm 

and Haas, 100 Independence Mall West, 

Philadelphia, PA 19106, which has been 

subsequently purchased by Dow 

AgroSciences LLC, 9330 Zionsville Rd., 

Indianapolis, IN 46268. The petition 

requested that 40 CFR 180.482 be 

amended by establishing a tolerance for 

residues of the insecticide tebufenozide, 

benzoic acid, 3,5-dimethyl-1-(1,1-

dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide, in or on citrus 

(crop group 10) and citrus oil at 0.80 

and 10 parts per million (ppm), 

respectively. That notice included a 

summary of the petition prepared by 

Rohm and Haas, the registrant at the 

time. There were no comments received 

in response to the notice of filing. 

In the Federal Register of March 12, 

2003 (68 FR 11846–11850) (FRL–7295–

4), EPA issued a notice pursuant to 

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

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

pesticide petitions (PP 2E6397 and PP 

2E 6413), by Interregional Research 

Project Number 4 (IR-4), 681 U.S. 

Highway #1, South Brunswick, NJ 

08902. The petitions requested that 40 

CFR 180.482 be amended by 

establishing tolerances for residues of 

the insecticide, tebufenozide, benzoic 

acid, 3,5-dimethyl-1-(1,1-

dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide, in or on grape 

at 3.0 ppm (PP 2E6413) and vegetable, 

tuberous and corm (except potato) 

subgroup 1D at 0.01 ppm (PP 2E6397). 

That notice included a summary of the 

petition prepared by IR-4. There were 

no comments received in response to 

the notice of filing. 

In the Federal Register of January 28, 

2004 (69 FR 4147–4151) (FRL–7335–9), 

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 7F4824), by Dow 

AgroSciences LLC, 9330 Zionsville Rd., 

Indianapolis, IN 46268. The petition 

requested that 40 CFR 180.482 be 

amended by establishing tolerances for 

indirect or inadvertent combined 

residues of tebufenozide, benzoic acid, 

3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide and its 

metabolite benzoic acid, 3,5-dimethyl-1-

(1,1dimethylethyl)-2-[4-(1-

hydroxyethyl)benzoyl]hydrazide in or 

on forage, fodder, hay and straw of 

cereal grain; forage, fodder, straw and 

hay of non-grass animal feed; forage, 

fodder and hay of grass and foliage of 

legume vegetables at 0.5, 0.5, 0.5, and 

0.1 ppm, respectively. That notice 

included a summary of the petition 

prepared by Dow AgroSciences, the 

registrant. One comment was received 

in response to this notice. The 

commentator stated that there should be 

a zero tolerance since the data 

supporting the tolerance was too old. 

EPA, however, believes that the data 

submitted in 1999 are still relevant and 

reliable. The submitted studies were 

conducted pursuant to EPA regulations 

and guidelines and the commentor has 

offered no reason as to why the data 

from these studies is unreliable.

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....’’

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 FFDCA 

and a complete description of the risk 

assessment process, see the final rule on 

Bifenthrin Pesticide Tolerances (62 FR 

62961, November 26, 1997) (FRL–5754–

7).

III. Aggregate Risk Assessment and 

Determination of Safety

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

of 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 and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for residues of 

tebufenozide on tuberous and corm 

vegetables (except potato) subgroup 1D, 

grape, citrus (crop group 10), and citrus 

oil at 0.015, 3.0, 0.80, and 15.0 ppm and 

indirect or inadvertent combined 

residues of tebufenozide, benzoic acid, 

3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide and its 

metabolite benzoic acid, 3,5-dimethyl-1-

(1,1dimethylethyl)-2-[4-(1-

hydroxyethyl)benzoyl]hydrazide in or 

on forage, fodder, hay and straw of ceral 

grain; forage, fodder, straw and hay of 

non-grass animal feed; forage, fodder 

and hay of grass and foliage of legume 

vegetables at 1.0, 1.0, 1.0, and 0.20 ppm. 

EPA’assessment of exposures and risks 

associated with establishing the 

tolerance follows.

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. The nature of the 

toxic effects caused by tebufenozide as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies reviewed are discussed 

in the Federal Register of October 21, 

1999 (64 FR 56690–56697) (FRL–6382–

6).

B. 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 level 

of concern (LOC). However, the lowest 

57218 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

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 

intraspecies differences.

Three other types of safety or 

uncertainty factors may be used: 

‘‘Traditional uncertainty factors;’’ the 

‘‘special FQPA safety factor;’’ and the 

‘‘default FQPA safety factor.’’ By the 

term ‘‘traditional uncertainty factor,’’

EPA is referring to those additional 

uncertainty factors used prior to FQPA 

passage to account for database 

deficiencies. These traditional 

uncertainty factors have been 

incorporated by the FQPA into the 

additional safety factor for the 

protection of infants and children. The 

term ‘‘special FQPA safety factor’’ refers 

to those safety factors that are deemed 

necessary for the protection of infants 

and children primarily as a result of the 

FQPA. The ‘‘default FQPA safety factor’’

is the additional 10X safety factor that 

is mandated by the statute unless it is 

decided that there are reliable data to 

choose a different additional factor 

(potentially a traditional uncertainty 

factor or a special FQPA safety factor).

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

by an UF of 100 to account for 

interspecies and intraspecies differences 

and any traditional uncertainty factors 

deemed appropriate (RfD = NOAEL/UF). 

Where a special FQPA safety factor or 

the default FQPA safety factor is used, 

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 safety factor.

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the 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). An example of how such a 

probability risk is expressed would be to 

describe the risk as one in one hundred 

thousand (1 X 10-5), one in a million (1 

X 10-6), or one in ten million (1 X 10-7). 

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 tebufenozide used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of October 21, 1999 

(64 FR 56690–56697) (FRL–6382–6).

C. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.482) for the 

residues of tebufenozide, in or on a 

variety of raw agricultural commodities. 

Risk assessments were conducted by 

EPA to assess dietary exposures from 

tebufenozide in food as follows:

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse 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. An appropriate 

endpoint attributable to a single dose 

was not identified. This risk is 

considered to be negligible. 

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEMFCIDTM), which incorporates food 

consumption data as reported by 

respondents in the U.S. Department of 

Agriculture 1994–1996 and 1998 

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: For the 

tolerances established in this action it 

was assumed that 100% of the crops 

would be treated with tebufenozide. 

Percent crop treated (PCT) estimates 

were used for some already existing 

tolerances. No anticipated residues were 

used.

iii. Cancer. Tebufenozide has been 

classified as a Group E ‘‘No evidence of 

carcinogenicity for humans.’’ Thus, 

tebufenozide is considered to pose at 

most a negligible risk of cancer and a 

quantitative exposure assessment for 

assessing cancer risk is unnecessary.

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(F) of FFDCA states that the 

Agency may use data on the actual 

percent of food treated for assessing 

chronic dietary risk only if the Agency 

can make the following findings:

Condition 1, that the data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain such pesticide residue.

Condition 2, that the exposure 

estimate does not underestimate 

exposure for any significant 

subpopulation group.

Condition 3, if data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area.

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by section 408(b)(2)(F) of 

FFDCA, EPA may require registrants to 

submit data on PCT.

The Agency used PCT information in 

Table 1 of this unit as follows:

Estimates of PTC were used for the 

following crops. In all cases the 

maximum estimate was used.

TABLE 1.—PERCENT CROP TREATED

Commodity Average Maximum 

Almonds <1% <1%

Apples 1% 2%

Beans/Peas, dry 0% 1%

Cotton 1% 4%

Walnuts 10% 16%

Cabbage, fresh 2% 3%

Cole crops 1% 2%

Spinach, fresh 2% 3%

Spinach, processed 20% 29%

The Agency believes that the three 

conditions listed in this unit have been 

met. With respect to Condition 1, PCT 

estimates are derived from Federal and 

private market survey data, which are 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57219

reliable and have a valid basis. EPA uses 

a weighted average PCT for chronic 

dietary exposure estimates. This 

weighted average PCT figure is derived 

by averaging State-level data for a 

period of up to 10 years, and weighting 

for the more robust and recent data. A 

weighted average of the PCT reasonably 

represents a person’s dietary exposure 

over a lifetime, and is unlikely to 

underestimate exposure to an individual 

because of the fact that pesticide use 

patterns (both regionally and nationally) 

tend to change continuously over time, 

such that an individual is unlikely to be 

exposed to more than the average PCT 

over a lifetime. For acute dietary 

exposure estimates, EPA uses an 

estimated maximum PCT. The exposure 

estimates resulting from this approach 

reasonably represent the highest levels 

to which an individual could be 

exposed, and are unlikely to 

underestimate an individual’s acute 

dietary exposure. The Agency is 

reasonably certain that the percentage of 

the food treated is not likely to be an 

underestimation. As to Conditions 2 and 

3, regional consumption information 

and consumption information for 

significant subpopulations is taken into 

account through EPA’s computer-based 

model for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available information on the 

regional consumption of food to which 

tebufenozide may be applied in a 

particular area.

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

tebufenozide 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 

tebufenozide.

The Agency uses the Generic 

Estimated Environmental Concentration 

(GENEEC) or the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) to estimate 

pesticide concentrations in surface 

water and Screening Concentration in 

Ground Water (SCI-GROW), 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 high-end 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 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 

screen for sorting out pesticides for 

which it is unlikely that drinking water 

concentrations would 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), which are the 

model estimates of a pesticide’s 

concentration in water. EECs derived 

from these models are used 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 tebufenozide 

they are further discussed in the 

aggregate risk sections in Unit III.E.

Based on the PRZM/EXAMS and SCIGROW models, the EECs of 

tebufenozide for acute exposures are 

estimated to be 15 parts per billion 

(ppb) for surface water and 1.19 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).

Tebufenozide 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 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 

tebufenozide and any other substances 

and tebufenozide 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 tebufenozide 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 OPP concerning 

common mechanism determinations 

and procedures for cumulating effects 

from substances found to have a 

common mechanism on EPA’s web site 

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

cumulative/.

D. Safety Factor for Infants and 

Children

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold 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. Margins of safety 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. In applying this provision, 

EPA either retains the default value of 

10X when reliable data do not support 

the choice of a different factor, or, if 

reliable data are available, EPA uses a 

different additional safety factor value 

based on the use of traditional 

uncertainty factors and/or special FQPA 

safety factors, as appropriate.

2. Prenatal and postnatal sensitivity. 

EPA evaluated the potential for 

increased susceptibility of infants and 

children from exposure to tebufenozide. 

EPA concluded that there are no

57220 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

concerns or residual uncertainties for 

prenatal and postnatal toxicity.

3. Conclusion. There is a complete 

toxicity database for tebufenozide and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. Based 

on these data, EPA determined that the 

10X SF to protect infants and children 

should be removed. The FQPA factor is 

removed because:

i. The toxicology database is 

complete.

ii. There is no indication of increased 

susceptibility of rats or rabbit fetuses to 

in utero and/or postnatal exposure in 

the developmental and reproductive 

toxicity data.

iii. Dietary exposure estimates are 

only partially refined by use of PCT 

information and therefore provide a 

very conservative (health-protective) 

estimate of dietary exposure through 

food.

iv. Modeling is used for the ground 

and surface source drinking water 

exposure assessments, resulting in 

estimates that are conservative upperbound concentrations.

v. There are currently no registered 

residential uses for tebufenozide and 

therefore, non-dietary exposure to 

infants and children is not expected.

vi. No evidence of neurotoxicity was 

reported.

E. 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 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 + residential 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 the EPA’s 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, OPP concludes 

with reasonable certainty that exposures 

to the pesticide in drinking water (when 

considered along with other sources of 

exposure for which OPP has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

this time. Because OPP 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, OPP will reassess the potential 

impacts of residues of the pesticide in 

drinking water as a part of the aggregate 

risk assessment process.

1. Acute risk. An acute exposure risk 

assessment was not performed since no 

toxicity endpoint for tebufenozide 

attributable to a single dose was 

identified. Acute risk from exposure to 

tebufenozide is expected to be 

negligible.

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to tebufenozide from food 

will utilize 25% of the cPAD for the 

U.S. population, 27% of the cPAD for 

all infants (1 year), and 92% of the 

cPAD for children 1–2 years. There are 

no residential uses for tebufenozide that 

result in chronic residential exposure to 

tebufenozide. In addition, there is 

potential for chronic dietary exposure to 

tebufenozide in drinking water. After 

calculating DWLOCs and comparing 

them to the EECs for surface and ground 

water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD, as shown in Table 2 of this 

unit:

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

Population Subgroup cPAD mg/kg/day %cPAD (Food) Surface Water 

EEC (ppb) 

Ground Water 

EEC (ppb) 

Chronic DWLOC 

(ppb) 

U.S. Population 0.02 milligram/

kilogram/day 

(mg/kg/day)

25 15 1.19 530

All Infants (<1year) 0.02 mg/kg/day 27 15 1.19 150

Children 1–2 years 0.02 mg/kg/day 92 15 1.19 16

Children 3–5 years 0.02 mg/kg/day 64 15 1.19 75

Children 6–12 years 0.02 mg/kg/day 32 15 1.19 140

Youth 13–19 years 0.02 mg/kg/day 17 15 1.19 170

Adults 20–29 years 0.02 mg/kg/day 18 15 1.19 580

Adults 50+ years 0.02 mg/kg/day 21 15 1.19 560

Females 13–49 years 0.02 mg/kg/day 18 15 1.19 490

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level).

Tebufenozide is not registered for use 

on any sites that would result in 

residential exposure. Therefore, the 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57221

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern.

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level).

Tebufenozide 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 do not exceed 

the Agency’s level of concern.

5. Aggregate cancer risk for U.S. 

population. Tebufenozide is classified 

as ‘‘no evidence of carcinogenic for 

humans;’’ therefore, tebufenozide is 

expected to pose no greater than a 

negligible cancer risk.

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to tebufenozide 

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Citrus (Crop Group 10)

The analytical method used for 

analysis of tebufenozide residues in/on 

oranges, lemons, and grapefruit was 

Preliminary Residue Method for RH–

5992 in Citrus (Orange, Grapefruit, 

Lemon and Mandarin Orange), Y.Meng 

and D.W.Chu, Rohm and Haas 

Analytical Method TR 34–96–184, 12/4/

96. This (high performance liquid 

chromatography using ultraviolet 

(HPLC-UV) detection) method is very 

similar to the proposed food tolerance 

enforcement method for plant 

commodities (TR 34–94–38) and thus is 

adequate for collection of residue data, 

ergo, the method is suitable for the 

quantitation of tebufenozide in/on citrus 

commodities. The Agency has 

previously requested that the petitioner 

revise the analytical method submitted 

for enforcement purposes on directly 

treated crops (TR 34–94–38) to correct 

deficiencies noted during Agency 

method validation. Adequate recovery 

data for citrus samples (fortified with 

tebufenozide) were provided. The limit 

of detection (LOD) for tebufenozide in/

on citrus was 0.006 ppm. The limit of 

quantitation (LOQ) for tebufenozide in/

on citrus was 0.020 ppm.

Grape

Grape samples were analyzed for 

tebufenozide, via HPLC/UV, using the 

Del Monte Research Center 

Tebufenozide Working Method. This 

working method was based on 

Tolerance Enforcement Method for RH–

5992 in Vegetables (Cabbage, Lettuce, 

Mustard Greens, Spinach, Broccoli and 

Celery), Rohm and Haas Analytical 

Method TR 34–94–41, 11/3/94. Minor 

modifications were made that would not 

negatively affect the performance of the 

method. Adequate recovery data for 

grape samples (fortified with 

tebufenozide) were provided. Method 

TR 34–94–41 has been conditionally 

approved by the Agency as an analytical 

enforcement method, pending 

incorporation of the corrections noted 

during the Analytical Chemistry 

Branch/BEAD’s petition method 

validation (PMV) trial. This method is 

considered adequate for the 

enforcement of tebufenozide residues 

in/on grapes. The LOD for tebufenozide 

in/on grape was 0.004 ppm. The LOQ 

for tebufenozide in/on grape was 0.013 

ppm.

Sweet Potato and Yam

Sweet potato root samples were 

analyzed for tebufenozide, via HPLC/

UV, using the Del Monte Research 

Center Tebufenozide Working Method. 

This working method was based on 

Tolerance Enforcement Method for RH–

5992 in Vegetables (Cabbage, Lettuce, 

Mustard Greens, Spinach, Broccoli and 

Celery), Rohm and Haas Analytical 

Method TR 34–94–41, 11/3/94. Minor 

modifications were made that would not 

negatively affect the performance of the 

method. Adequate recovery data for 

sweet potato root samples (fortified with 

tebufenozide) were provided. Method 

TR 34–94–41 has been conditionally 

approved by the Agency as an analytical 

enforcement method, pending 

incorporation of the corrections noted 

during the Analytical Chemistry 

Branch/BEAD’s PMV trial. This method 

is considered adequate for the 

enforcement of tebufenozide residues 

in/on sweet potato roots. The LOD for 

tebufenozide in/on sweet potato was 

0.005 ppm. The LOQ for tebufenozide 

in/on sweet potato was 0.015 ppm.

Field Accumulation in Rotational Crops

Quantitative analysis of tebufenozide 

and RH–1788 residues in/on foliage of 

cereal grains and foliage of legumes (as 

well as cereal grain and legume seeds) 

was performed via the (HPLC/mass 

spectroscopy (MS)/MS) method, 

Determination of Residues of 

Tebufenozide and Metabolite in Low 

Moisture Rotational Crops by Liquid 

Chromatography with Tandem Mass 

Spectrometry, Dow AgroSciences 

Analytical Method GRM 02.20, 2002. As 

stated in the Dow AgroSciences method 

validation report, the LOD was 0.006 

ppm (for both tebufenozide and RH–

1788) in low-moisture foliage samples 

and the LOQ, as demonstrated by the 

lowest acceptable recovery level, was 

0.020 ppm. Fortified samples were 

analyzed over a validation range of 

0.020 ppm (LOQ) to 1.00 ppm. The 

recovery results from these samples 

indicate the method’s acceptability as a 

data-gathering method, at minimum. 

The original proposed analytical 

method for the enforcement of 

tebufenozide residues in/on rotated 

crops is Rohm and Haas Analytical 

Method TR 34–99–10. This HPLC/MS 

method has been validated with LOQs 

for tebufenozide and its metabolite in 

low moisture plant commodities at 0.02 

ppm; the reported LODs for the analytes 

were 0.002 ppm. The results of the PMV 

trial demonstrated that, although the 

third validation attempt was successful 

for the parent compound, the method 

trial was unsuccessful for the 

metabolite, RH–1788, due to excessive 

interferences in the chromatograms. 

EPA recommended that the method be 

returned to the petitioner for 

modifications to improve the cleanup 

step and recovery of the metabolite. As 

EPA considers DAS Method GRM 02.20 

to be the superior technique for 

quantitation of tebufenozide and RH–

1788 residues in low-moisture rotational 

crops, the registrant has proposed it as 

the tolerance enforcement method, 

rather than Rohm and Haas Method TR 

34–99–10. EPA will review the method; 

an independent method validation (ILV) 

or PMV or possibly both could be 

required before DAS Method GRM 02.20 

is deemed acceptable for tolerance 

enforcement purposes.

These methods may be requested 

from: Chief, Analytical Chemistry 

Branch, Environmental Science Center, 

701 Mapes Rd., Ft. Meade, MD 20755–

5350; telephone number: (410) 305–

2905; e-mail address: 

residuemethods@epa.gov.

B. International Residue Limits 

No Canadian or Mexican maximum 

residue limits (MRL) have been 

established for tebufenozide residues. 

Codex MRLs have been established for 

grapes at 2.0 ppm. The Codex MRL for 

grapes was based on data from France 

and Australia. No U.S. data was 

submitted to Codex.

V. Conclusion

Therefore, the tolerance is established 

for residues of tebufenozide on tuberous 

and corm vegetables (except potato) 

subgroup 1D, grape, citrus (crop group 

10), and citrus oil at 0.015, 3.0, 0.80, 

and 15.0 ppm and indirect or 

inadvertent combined residues of 

57222 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

tebufenozide , benzoic acid, 3,5-

dimethyl-1-(1,1-dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide and its 

metabolite benzoic acid, 3,5-dimethyl-1-

(1,1dimethylethyl)-2-[4-(1-

hydroxyethyl)benzoyl]hydrazide in or 

on forage, fodder, hay and straw of ceral 

grain; forage, fodder, straw and hay of 

non-grass animal feed; forage, fodder 

and hay of grass and foliage of legume 

vegetables at 1.0, 1.0, 1.0, and 0.20 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of FFDCA, as 

amended by 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 FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of 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 FFDCA, as was 

provided in the old sections 408 and 

409 of 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–2004–0209 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 November 23, 2004.

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 issues(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 

your request to the Office of the Hearing 

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

Washington, DC 20005. 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 VI.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 docket ID number 

OPP–2004–0209, 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 email 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 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32).

VII. Statutory and Executive Order 

Reviews

This final rule establishes a tolerance 

under section 408(d) 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 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, entitled 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 petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 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 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57223

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 

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.

VIII. 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.

Dated: September 16, 2004.

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 180.482 is amended by 

alphabetically adding commodities to 

the table in paragraph (a)(1) and by 

revising paragraph (d) to read as follows:

§ 180.482 Tebufenozide; tolerances for 

residues.

(a) * * *

(1) * * *

Commodity Parts per million 

*****

Citrus oil ................................................................................................................... 15.0

*****

Fruit, citrus, group 10 .............................................................................................. 0.80

*****

Grape ....................................................................................................................... 3.0

*****

Vegetable, tuberous and corm (except potato), subgroup 1D ................................ 0.015

*****

* * * * *

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

indirect or inadvertent combined 

residues of tebufenozide, benzoic acid, 

3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide and its 

metabolite benzoic acid, 3,5-dimethyl-1-

(1,1dimethylethyl)-2-[4-(1-

hydroxyethyl)benzoyl]hydrazide in or 

on the raw agricultural commodities 

when present therein as a result of the 

application of tebufenozide to growing 

crops listed in paragraph (a) of this 

section to read as follows:

Commodity Parts per million 

Forage, fodder, hay and straw of grain, cereal, group 16 ...................................... 1.0

Forage, fodder, straw and hay of non-grass animal feed, group 18 ...................... 1.0

Grass, forage, fodder and hay, group 17 ................................................................ 1.0

Vegetable, foliage of legume, group 7 .................................................................... 0.20

[FR Doc. 04–21499 Filed 9–23–04; 8:45 am]

BILLING CODE 6560–50–S