Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58091

‘‘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 22, 2004.

Lois Rossi,

Director, Registration Division, Office of 

Pesticide Programs.

■ Therefore, 40 CFR part 180 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 180.516 is amended as 

follows:

a. By alphabetically adding 

commodities to the table in paragraph 

(a).

b. By removing the commodities 

‘‘Apricot,’’ ‘‘Caneberry,’’ ‘‘Nectarine,’’

‘‘Peach,’’ and ‘‘Plum’’ in the table in 

paragraph (b).

§ 180.516 Fludioxonil; tolerances for 

residues.

(a) * * *

Commodity Parts per 

million 

Bean, dry .................................. 0.4

Bean, succulent ........................ 0.4

*** * *

Citrus, crop group 10 ................ 10

*** * *

Fruit, pome, group 11 ............... 5.0

*** * *

Grapefruit, oil ............................ 500

*** * *

Kiwifruit ..................................... 20

Leafy greens subgroup 4A, except spinach .......................... 30

*** * *

Melon subgroup 9A .................. 0.03

*** * *

Yam, true .................................. 8.0

* * * * *

[FR Doc. 04–21803 Filed 9–28–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0312; FRL–7681–6]

Methoxyfenozide; Pesticide Tolerances

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

tolerance for residues of 

methoxyfenozide (benzoic acid, 3-

methyl-2-methyl-,2-(3,5-

methylbenzoyl)-2-(1,1-dimethylethyl) 

hydrazide) in or onblack sapote; 

canistel; coriander, leaves; mamey 

sapote; mango; papaya; pea and bean, 

succulent shelled, subgroup 6B; 

peppermint; sapodilla; spearmint; star 

apple; strawberries; vegetable, foliage of 

legume (except soybean), subgroup 7A; 

vegetable, leaves of root and tuber, 

group 2; vegetable, legume, edible 

podded, subgroup 6A; vegetable, root, 

subgroup 1A. Interregional Research 

Project Number 4 (IR-4) and Dow 

AgroSciences are requesting these 

tolerances 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 29, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 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–

0312. 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:

Joseph 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:

58092 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

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) 

• Animal production (NAICS 112) 

• Food manufacturing (NAICS 311) 

• Pesticide manufacturing (NAICS 

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 at E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

In the Federal Register of August 18, 

2004 (69 FR 51298) (FRL–7361–1), 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 PP 3E6768, PP 

3E6784, PP 3E6790, PP 3E6796, and PP 

3E6801) by IR-4, 681 U.S. Highway #1 

South, North Brunswick, NJ 08902–

3390. The petition requested that 40 

CFR 180.544 be amended by 

establishing a tolerance for residues of 

the insecticide methoxyfenozide, 

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

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

dimethylethyl) hydrazide, in or on the 

following raw agricultural commodities: 

Spearmint, tops at 7.0 parts per million 

(ppm); peppermint, tops at 7.0 ppm; and 

dill at 7.0 ppm (PP 3E6768); strawberry 

at 1.5 ppm (PP 3E6784); vegetable, root, 

subgroup 1A at 0.5 ppm, and vegetable, 

leaves of root and tuber, group 2 at 30 

ppm (PP 3E6790); papaya; star apple; 

sapote, black; mango; sapodilla; 

canistel; and sapote, mamey at 0.5 ppm 

(PP 3E6796); coriander, leaves at 30 

ppm (PP 3E6796); and vegetable, 

legume, edible podded, subgroup 6A at 

1.5 ppm; pea and bean, succulent 

shelled, subgroup 6B at 0.2 ppm; and 

vegetable, foliage of legume, except 

soybean, subgroup 7A at 35 ppm (PP 

3E6801). That notice included a 

summary of the petition prepared by 

Dow AgroScience, 9330 Zionsville 

Road, Indianapolis, IN 46268, the 

registrant. There were no comments 

received in response to the notice of 

filing.

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 

methoxyfenozide, benzoic acid,3-

methoxy-2-methyl, 2-(3,5-

dimethylbenzoyl)-2-(1,1-

dimethylethyl)hydrazide, in or on 

edible podded legumes (Crop Group 

6A), mint, root vegetables (Crop Group 

1A), strawberries, succulent shelled pea 

and bean (Crop Group 6B), and tropical/

subtropical fruit crop: black sapote, 

canistel, mamey sapote, mango, papaya, 

sapodilla, and star apple) at 1.5, 7.0, 0.5, 

1.5, 0.2, 0.5 ppm respectively. EPA’s 

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 methoxyfenozide 

as well as the no observed adverse effect 

level (NOAEL) and the lowest observed 

adverse effect level (LOAEL) from the 

toxicity studies reviewed are discussed 

in the Federal Register of September 20, 

2002 (67 FR 59193) (FRL–7198–5).

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 

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 data base 

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’’

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58093

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 methoxyfenozide used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of September 20, 

2002 (67 FR 59193) (FRL–7198–5).

C. 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. 

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 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. 

Acute dietary risk assessments are 

performed for a food use pesticide if a 

toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a one day or 

single exposure. No appropriate 

toxicological endpoint attributable to a 

single exposure was identified in the 

available toxicology studies on 

methoxyfenozide. Thus, the risk from 

acute exposure is considered negligible. 

A summary of the acute dietary risk 

assessment for methoxyfenozide used 

for human risk assessment is discussed 

in Unit III.C.1.i. of the final rule 

published in the Federal Register of 

September 20, 2002 (67 FR 59193).

ii. Chronic exposure. 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 USDA 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: A 

Tier 1 (assumptions: tolerance level 

residues and 100 percent crop treated) 

chronic dietary risk assessment was 

conducted via DEEM-FCID. The 

established tolerances of 40 CFR 

180.544 and the proposed tolerances 

were included in the analysis. DEEM 

default processing factors (from DEEM 

Version 7.76) were used for all 

processed commodities that do not have 

individual tolerances. Tolerances are 

not being recommended for animal 

commodities as a result of the proposed 

uses. 

iii. Cancer. Methoxyfenozide is 

classified as a ‘‘not likely’’ human 

carcinogen. Therefore this risk is 

considered negligible.

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 FQPA Index 

Reservoir Screening Tool (FIRST) or the 

Pesticide Root Zone Model/Exposure 

Analysis Modeling System (PRZM/

EXAMS), to produce estimates of 

pesticide concentrations in an index 

reservoir. The Screening Concentration 

in Ground Water (SCI-GROW) model is 

used to predict pesticide concentrations 

in shallow ground water. For a 

screening-level assessment for surface 

water EPA will 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. Both FIRST and PRZM/

EXAMS incorporate an index reservoir 

environment, and both models include 

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 

methoxyfenozide, they are further 

discussed in the aggregate risk section 

Unit III.E.

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

58094 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

methoxyfenozide for acute exposures 

are estimated to be 43 parts per billion 

(ppb) for surface water and 3.5 ppb for 

ground water. The EECs for chronic 

exposures are estimated to be 30 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 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 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 data base 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. 

The toxicology data base for 

methoxyfenozide included acceptable 

developmental toxicity studies in both 

rats and rabbits as well as a 2-generation 

reproductive toxicity study in rats. The 

data provided no indication of increased 

sensitivity of rats or rabbits to in utero 

and/or postnatal exposure to 

methoxyfenozide.

3. Conclusion. There is a complete 

toxicity data base for methoxyfenozide 

and exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. The 

10X FQPA factor was removed and 

reduced to 1X as discussed in the final 

rule published in theFederal Register of 

September 20, 2002 (67 FR 59193).

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, EPA concludes 

with reasonable certainty that exposures 

to the pesticide 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 residues of the pesticide in 

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. Accordingly, no acute risk 

is expected from exposure to 

methoxyfenozide.

TABLE 1.—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 0.102 22.9 30 3.5 2800

All Infants (less than 1 year old) 0.102 37.3 30 3.5 290

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58095

TABLE 1.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO METHOXYFENOZIDE—Continued

Population Subgroup cPAD mg/

kg/day 

% cPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

Children (1-2 years old) 0.102 71.3 30 3.5 2900

Children (3-5 years old) 0.102 50.1 30 3.5 2900

Children (6-12 years old) 0.102 27.1 30 3.5 2900

Youth (13-19 years old) 0.102 18.1 30 3.5 2900

Adults (20-49 years old) 0.102 18.6 30 3.5 2900

Females (13-49 years old) 0.102 19.1 30 3.5 2500

Adults (50+ years old) 0.102 18.8 30 3.5 2900

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 22.9% of the cPAD for 

the U.S. population, 37.3% of the cPAD 

for all infants (less than 1 year old), and 

71.3% of the cPAD for children, 1-2 

years old. There are no residential uses 

for methoxyfenozide that result in 

chronic residential exposure to 

methoxyfenozide. 

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). 

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 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). 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 

do not exceed the Agency’s level of 

concern.

5. Aggregate cancer risk for U.S. 

population. The Agency has classified 

methoxyfenozide as a ‘‘not likely’’

human carcinogen according to the 

‘‘EPA Proposed Guidelines for 

Carcinogen Risk Assessment (April 10, 

1996).’’ This 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, 

methoxyfenozide is not expected to 

pose a 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 

methoxyfenozide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methods are 

available for determination of 

methoxyfenozide residues in plant 

commodities. The available Analytical 

Enforcement Methodology was 

previously reviewed in the Federal 

Register of September 20, 2002 (67 FR 

59193)

B. International Residue Limits

There are no Codex or Canadian 

MRLs established for residues of 

methoxyfenozide. Mexican MRLs are 

established for residues of 

methoxyfenozide in cottonseed (0.05 

ppm) and maize (0.01 ppm). The U.S. 

tolerances on these commodities are 2.0 

ppm and 0.05 ppm, respectively. Based 

on the current use patterns, the U.S. 

tolerance levels cannot be reduced to 

harmonize with the Mexican MRLs, so 

incompatibility will exist. 

V. Conclusion

Therefore, tolerances are established 

for residues of methoxyfenozide, in or 

on black sapote; canistel; coriander, 

leaves; mamey sapote; mango; papaya; 

pea and bean succulent shelled, 

subgroup 6B; peppermint; sapodilla; 

spearmint; star apple; strawberries; 

vegetable, foliage of legume (except 

soybean), subgroup 7A; vegetable, 

leaves of root and tuber, group 2; 

vegetable, legume, edible podded, 

subgroup 6A; vegetable, root, subgroup 

1A at 0.5, 0.5, 30, 0.5, 0.5, 0.5, 0.2, 7.0, 

0.5, 7.0, 0.5, 1.5, 35, 30, 1.5, 0.5, 

respectively. 

The original petition submitted by the 

petitioner requested a tolerance for dill, 

but data was not provided to the Agency 

to support the establishment of a 

tolerance.

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–2004–0312 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 29, 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 

58096 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

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–2004–0312, 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, 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, 

entitledFederalism (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 

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

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58097

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 theFederal 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 22, 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 180.544 is amended by 

alphabetically adding the following 

commodities to the table in paragraph (a) 

to read as follows:

§ 180.544 Methoxyfenozide; tolerances for 

residues.

(a) * * *

Commodity Parts per million 

*****

Black sapote ......... 0.5

*****

Canistel ................. 0.5

*****

Coriander, leaves 30

*****

Mamey sapote ...... 0.5

Mango ................... 0.5

*****

Papaya .................. 0.5

Pea and bean, 

succulent 

shelled, subgroup 6B ........... 0.2

*****

Peppermint ........... 7.0

*****

Sapodilla ............... 0.5

*****

Spearmint ............. 7.0

Star apple ............. 0.5

Strawberries .......... 1.5

*****

Vegetable, foliage 

of legume, (except soybean)subgroup 

7A ...................... 35

Commodity Parts per million 

Vegetable, leaves 

of root and 

tuber, group 2 ... 30

Vegetable, legume, 

edible podded, 

subgroup 6A ...... 1.5

Vegetable, root, 

subgroup 1A ...... 0.5

* * * * *

[FR Doc. 04–21804 Filed 9–28–04; 8:45 am] 

BILLING CODE 6560–50–S

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 0 

[DA 04–2923] 

Commission Organization

AGENCY: Federal Communications 

Commission.

ACTION: Final rule.

SUMMARY: This document amends part 0 

of the Commission’s rules to update the 

geographical coordinate locations of the 

Commission’s protected field 

installations where radio spectrum 

monitoring operations are conducted to 

delete the Commission’s Anchorage, 

Alaska monitoring facility.

DATES: Effective September 29, 2004.

FOR FURTHER INFORMATION CONTACT:

Gabriel Collazo, Enforcement Bureau, 

Spectrum Enforcement Division, (202) 

418–1160.

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Order, 

DA 04–2923, adopted on September 8, 

2004, and released on September 13, 

2004. The complete text of this Order is 

available for inspection and copying 

during normal business hours in the 

FCC Reference Information Center, 445 

12th Street, SW., Room CY–A257, 

Washington, DC 20554. In addition, the 

complete text may be retrieved from the 

FCC’s Web site at http://www.fcc.gov. 

The text may also be purchased from the 

Commission’s duplicating contractor, 

Best Copy and Printing, Inc., 445 12th 

Street, SW., Room CY–B402, 

Washington, DC 20554, telephone (202) 

488–5300, or (800) 378–3160. 

The Order amends § 0.121(b) of the 

rules to update the geographical 

coordinate locations of the 

Commission’s protected field 

installations where radio spectrum 

monitoring operations are conducted. 

Specifically, the Order deletes the 

geographical coordinates of the 

Commission’s Anchorage, Alaska 

monitoring facility from the list of 

protected field installations set forth in 

§ 0.121(b) of the rules. These locations 

are protected from harmful radio 

frequency interference to the 

Commission’s monitoring activities that 

could be produced by the proximity of 

any nearby radio transmitting facilities. 

Pursuant to the authority contained in 

sections 4(i) and (5) of the 

Communications Act of 1934, as 

amended, and § 0.231(b) of the rules, 

part 0 of the rules is amended as set 

forth in the rule changes. 

As the rule amendment adopted in 

the Order pertains to agency 

organization, procedure and practice, 

the notice and comment provision of the 

Administrative Procedure Act contained 

in 5 U.S.C. 553(b) is inapplicable. 

The Commission will not send a copy 

of this Order pursuant to the 

Congressional Review Act, see 5 U.S.C. 

801(a)(1)(A), because the adopted rule 

are rules of agency organization, 

procedure, or practice that do not 

‘‘substantially affect the rights or 

obligations of non-agency parties.’’

The rule amendment set forth in the 

rule changes will become effective 

September 29, 2004.

List of Subjects in 47 CFR Part 0 

Organization and functions 

(Government agencies).

Federal Communications Commission. 

Joseph P. Casey. 

Spectrum Enforemtion Division Enforcement 

Bureau

Rule Changes 

For the reasons discussed in the 

preamble, the Federal Communications 

Commission amends 47 CFR part 0 as 

follows:

PART 0—COMMISSION 

ORGANIZATION

■ 1. The authority citation for part 0 

continues to read as follows:

Authority: Secs. 5, 48 Stat. 1068, as 

amended; 47 U.S.C. 155.

§ 0.121 [Amended]

■ 2. Section 0.121 is amended by 

revising paragraph (b) to read as follows:

* * * * *

(b) Protected field offices are located 

at the following geographical 

coordinates (coordinates are referenced 

to North American Datum 1983 

(NAD83)):

Allegan, Michigan, 42°36′20.1′′ N. 

Latitude, 85°57′20.1′′ W. Longitude 

Belfast, Maine, 44°26′42.3′′ N. Latitude, 

69°04′56.1′′ W. Longitude 

Canandaigua, New York, 42°54′48.2′′ N. 

Latitude, 77°15′57.9′′ W. Longitude