55740 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

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 19, 2005 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.510 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.510 Pyriproxyfen; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

*****

Citrus hybrids ................................................................................................................................................... 0.30 

*****

Grape ............................................................................................................................................................... 2.5 

Grass, forage, fodder, and hay, group 17, forage .......................................................................................... 0.70 

Grass, forage, fodder, and hay, group 17, hay ............................................................................................... 1.1 

*****

Onion, dry bulb ................................................................................................................................................ 0.15 

*****

Strawberry ........................................................................................................................................................ 0.30 

*****

Vegetable, legume, group 6 ............................................................................................................................ 0.20 

*****

White sapote .................................................................................................................................................... 0.30 

*****

* * * * * 

[FR Doc. 05–19059 Filed 9–22–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0133; FRL–7738–7] 

Fenpropathrin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fenpropathrin 

in or on bushberry subgroup 13B; 

lingonberry; juneberry; salal; pea, 

succulent; and vegetable, fruiting, group 

8. Interregional Research Project 

Number 4 (IR-4) requested 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 23, 2005. Objections and 

requests for hearings must be received 

on or before November 22, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0133. 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: 

Shaja R. Brothers, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–3194; e-mail address: 

brothers.shaja@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55741 

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/. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

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

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings 

In the Federal Register of March 24, 

2004 (69 FR 13833) (FRL–7347–2–), 

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 1E6261, PP 

1E6331, PP 1E6336, and PP 3E6588 by 

IR-4, 681 U.S. Highway #1 South, North 

Brunswick, NJ 08902–3390. The 

petitions requested that 40 CFR 180.466 

be amended by establishing tolerances 

for residues of the insecticide 

fenpropathrin, a-cyano-3-phenoxybenzyl 2,2,3,3-tetramethylcyclopropanecarboxylate, in or 

on currant at 3.0 parts per million (ppm) 

requested by PP 1E6261; vegetable, 

fruiting, group 8, except tomato at 1.0 

ppm requested by PP 1E6331; pea, 

succulent at 0.02 ppm requested by PP 

1E6336, and bushberry subgroup 13B, 

lingonberry, juneberry, and salal at 3.0 

ppm requested by PP 3E6588. Currant is 

a member of the bushberry subgroup, 

and will receive a tolerance at 3.0 ppm 

as requested for the bushberry subgroup. 

Therefore, a separate tolerance will not 

be established for currant under PP 

1E6261. The proposed petition (1E6331) 

for vegetable, fruiting, group 8, except 

tomato at 1.0 ppm was subsequently 

amended to establish a tolerance for 

vegetable, fruiting, group 8 at 1.0 ppm. 

The Agency will delete the existing 

tolerance for tomato at 0.6 ppm since 

tomato is covered by the vegetable, 

fruiting group 8 tolerance promulgated 

under this ruling. That notice included 

a summary of the petition prepared by 

Valent U.S.A. Corporation, the 

registrant. One comment was received. 

EPA’s response to this comment is 

discussed in Unit IV.C. below. 

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 the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

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 these 

actions. EPA has sufficient data to 

assess the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) 

ofFFDCA, for tolerances for residues of 

fenpropathrin on vegetable, fruiting, 

group 8 at 1.0 ppm; pea, succulent at 

0.02 ppm; and bushberry subgroup 13B, 

lingonberry, juneberry, and salal at 3.0 

ppm. EPA’s assessment of exposures 

and risks associated with establishing 

these tolerances 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 fenpropathrin is 

discussed in Table 1 of this unit as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies reviewed. 

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results 

870.3100 90-Day oral toxicity--rodents (Rat) NOAEL = 15 milligrams/kilogram/day (mg/kg/day) 

LOAEL = 30 mg/kg/day based on clinical signs of tremors, body weight reductions, 

decreased blood clotting time in females, and possibly increased alkaline phosphatase levels (both sexes) 

870.3150 90-Day oral toxicity--nonrodents 

(Beagle dog) 

NOAEL = < 6.2 mg/kg/day 

LOAEL = 6.2 mg/kg/day based on effects on the gastrointestinal system, tremors, 

and body weight changes 

870.3200 21-Day dermal toxicity (NZW rabbit) NOAEL = >3,000 mg/kg/day 

Only local irritation was seen. There were no systemic effects, thus the LOAEL was 

not determined 

55742 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued 

Guideline No. Study Type Results 

870.3700 Prenatal developmental--rodents(Fischer Rats) Maternal NOAEL = 3 mg/kg/day 

The maternal NOAEL for the developmental rat study was 3.0 mg/kg/day based on 

decreased food consumption and body weight gains. However, these effects are 

not characteristic of an acute exposure and are not a suitable option for this exposure scenario. One of the factors to consider in selecting an acute dietary endpoint is when the toxic effects occur. For an acute effect, a relevant endpoint 

would occur as the result of a single dose. Since the neurotoxic signs observed in 

the dams of the developmental rat study were most severe within two hours after 

dosing, the clinical effects are resultant from a single dose, and are therefore appropriate endpoints for acute exposure scenarios. 

Maternal LOAEL = 6 mg/kg/day based on decreased food consumption and body 

weight gains. At 10 mg/kg/day, 6 dams died between days 7 and 13, and one 

dam was sacrificed moribund on day 8. The remaining 23 dams survived through 

the end of gestation. Also in the high dose group, many clinical signs were observed in the dams including ataxia, sensitivity to external stimuli, spastic jumping, and tremors. These signs were most severe 2 hours post-dosing and during 

the first days of dosing. 

Developmental NOAEL = 6 mg/kg/day 

Developmental LOAEL = 10 mg/kg/day based on increased incidence of asymmetrical ossification of sternabrae and incomplete ossification of the 5th and 6th 

sternabrae. 

870.3700 Prenatal developmental--nonrodents 

(NZW rabbit) 

Maternal NOAEL = 4 mg/kg/day 

Maternal LOAEL = 12 mg/kg/day based on flicking of the forepaws 

Developmental NOAEL = >36 mg/kg/day 

No dose related effects were seen, thus the LOAEL was not determined 

870.3800 Reproduction and fertility effects 

(Sprague-Dawley rats) 

Parental/Systemic NOAEL = M:3.0; F: 3.0 mg/kg/day 

LOAEL = M: 8.9; F: 10.1 mg/kg/day based on death and clinical signs of 

neurotoxicity in females. 

Offspring NOAEL = M:3.0; F:3.4 mg/kg/day 

LOAEL = M: 8.9; F: 10.1 mg/kg/day based on increased mortality and body tremors. 

870.4100 Chronic toxicity (Beagle Dog) NOAEL = 2.5 mg/kg/day 

LOAEL = 6.25 mg/kg/day based on tremors and ataxia in both sexes 

870.4200 Carcinogenicity- CD-1 mice NOAEL = Not established 

LOAEL = M: >56.0; F: >65.2 mg/kg/day 

There was an overall lack of toxic response. However an aborted mouse carcinogenicity study demonstrated that at a slightly higher maximum tolerated dose 

(MTD) of 1,000 ppm, the test article was lethal to 15% of the mice after only 13 

weeks. Thus the maximum dose used in this completed study (600 ppm) was 

very close to the MTD. A repeat study is not justified. 

no evidence of carcinogenicity 

870.4300 Carcinogenicity-rat NOAEL = M:17.06; F: 7.23 mg/kg/day 

LOAEL = 19.45 mg/kg/day based on increase mortality and body tremors in the females 

no evidence of carcinogenicity 

870.5100 Gene mutation 

Bacterial Reverse Mutation Test 

Negative in Salmonella typhimurium TA 1535, TA1537, TA1538, TA98, and TA100 

and Escerichia coli Wp2 uvrA up to the limit concentration with evidence of compound insolubility 

870.5300 Gene Mutation 

In vitro mammalian cell gene mutation test 

There was no clear evidence (or a concentration related positive response) of induced mutant colonies over background 

870.5375 Cytogenetics 

In vitro mammalian cell chromosomal 

aberration assay 

Negative in Chinese hamster ovary (CHO) cells (cytotoxicity observed at ≥30 μg/mL 

-S9 and compound precipitation at 1,000 μg/mL +S9) 

870.5500 Other effects 

Bacterial DNA damage or repair test 

Negative in Bacillus subtilis H17 (DNA repair proficient) and M45 (DNA repair deficient) 

870.5900 Other effects 

In vitro sister chromatid exchange 

assay 

Negative in CHO cells up to the solubility limit. 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55743 

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued 

Guideline No. Study Type Results 

870.7485 Metabolism and pharmacokinetics 

(Sprague-Dawley rat) 

Greater than 99% of the administered dose was excreted within 168 hours with 

28% to 56% excreted in the urine and the remainder in the feces. Major biotransformations of the absorbed compound included the oxidation of the methyl group 

of the acid moiety, hydroxylation at the 4’-position of the alcohol moiety, cleavage 

of the ester linkage, and conjugation with sulfuric acid or glucuronic acid. Mean 

dermal absorption for the 10–hour interval was 33.3%, 20.1%, and 17.6% in the 

low, mid, and high dose groups, respectively 

870.7600 Dermal penetration-rats Dermal absorption increased with dose but not proportionally. The percentage of 

the dose absorbed decreased with the increasing administered dose. The total 

body burden could be expected to rapidly decrease due to excretion via urine and 

feces. Mean dermal absorption for the 10–hour interval was 33.3%, 20.1%, and 

17.6% in the low, mid, and high dose groups, respectively 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, 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. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

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

pesticides/health/human.htm. 

A summary of the toxicological 

endpoints for fenpropathrin used for 

human risk assessment is shown in the 

following Table 2: 

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FENPROPATHRIN FOR USE IN HUMAN RISK

ASSESSMENT

Exposure Scenario 

Dose Used in Risk Assessment, 

Interspecies and Intraspecies and 

any Traditional UF 

Special FQPA SF and Level of 

Concern for Risk Assessment Study and Toxicological Effects 

Acute Dietary (General population including infants and 

children) 

NOAEL = 6 mg/kg/day 

UF = 1,000 

Acute RfD = 0.006 mg/kg/day 

Special FQPA SF = 1X 

aPAD = acute RfD ÷ Special 

FQPA SF = 0.006 mg/kg/day 

Developmental Toxicity in Rats 

LOAEL = 10 mg/kg/day based on 

death and neurological signs 

At 10 mg/kg high dose death in 6 

out of 30 

Chronic Dietary (All populations) NOAEL= 2.5 mg/kg/day 

UF = 1,000 

Chronic RfD = 0.0025 mg/kg/day 

Special FQPA SF = 1X 

cPAD = chronic RfD ÷ Special 

FQPA SF = 0.0025 mg/kg/day 

52-Week Chronic Oral Toxicity in 

Dogs 

LOAEL = 6.25 mg/kg/day based 

on tremors and ataxia in both 

sexes 

Cancer (oral, dermal, inhalation) Classification: Not likely to be carcinogen to humans 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.466) for the 

residues of fenpropathrin, in or on the 

following raw agricultural commodities: 

Cotton; grapes; strawberries; peanuts; 

tomatoes; Brassica, head and stem, Crop 

Subgroup 5A; fruit, citrus, group 10; 

fruit, pome, group 11; eggs; milk fat; and 

the meat; meat byproducts, and fat of 

cattle, goats, hogs, horses, sheep, and 

poultry. Risk assessments were 

conducted by EPA to assess dietary 

exposures from fenpropathrin 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. In conducting the 

acute dietary risk assessment EPA used 

the Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM-FCID, Version 

2.03), 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 

acute dietary exposure analysis was a 

refined one. It was refined through the 

use of crop field trial data, Pesticide 

Data Program (PDP) monitoring data, 

anticipated residues (ARs) in animal 

commodities, processing factors, and 

percent crop treated and projected 

percent crop treated estimates. 

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the Dietary Exposure Evaluation 

55744 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

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: The 

chronic dietary exposure analysis was 

also a refined one. It was refined 

through the use of crop field trial data, 

PDP monitoring data, ARs in animal 

commodities, processing factors, and 

average percent crop treated and 

projected market share estimates. 

iii. Cancer. A cancer dietary exposure 

analysis was not performed because 

fenpropathrin was classified as ‘‘not 

likely to be carcinogenic to humans.’’

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of the FFDCA authorizes 

EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide chemicals 

that have been measured in food. If EPA 

relies on such information, EPA must 

pursuant to section 408(f)(1) require that 

data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. Following the initial data 

submission, EPA is authorized to 

require similar data on a time frame it 

deems appropriate. For the present 

action, EPA will issue such data call-ins 

for information relating to anticipated 

residues as are required by FFDCA 

section 408(b)(2)(E) and authorized 

under FFDCA section 408(f)(1). Such 

data call-ins will be required to be 

submitted no later than 5 years from the 

date of issuance of this tolerance. 

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; and 

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 maximum PCT 

information as follows: Apples 15%; 

broccoli <2.5%; brussels sprouts <2.5%; 

cabbage <1%; cantaloupes 10%; cotton 

<2.5%; grapefruit 5%; grapes 10%; 

oranges 5%; peanuts <2.5%;pears 10%; 

pumpkins <2.5%; squash 10%; 

strawberries 20%; tangerines <2.5%; 

tomatoes <2.5%; and watermelons 

<2.5%; blueberries 18%. 

The Agency used average PCT 

information as follows: Apples 10%; 

broccoli <1%; brussels sprouts <2.5%; 

cabbage <1%; cantaloupes 5%; cotton 

<1%; grapefruit 2%; grapes 5%; oranges 

2%; peanuts <1%; pears 5%; pumpkins 

<1%; squash 5%; strawberries 15%; 

tangerines <1%; tomatoes <1%; and 

watermelons <1%; peas 27%; peppers 

49%. 

The Agency used projected acreage 

PCT information as follows: Blueberries 

18%; peas 27%; peppers 49%. 

EPA uses an average PCT for chronic 

dietary risk analysis. The average PCT 

figure for each existing use is derived by 

combining available Federal, state, and 

private market survey data for that use, 

averaging by year, averaging across all 

years, and rounding up to the nearest 

multiple of five except for those 

situations in which the average PCT is 

less than one. In those cases <1% is 

used as the average and <2.5% is used 

as the maximum. The percent of crop 

treated for grapefruit and oranges is 2%. 

EPA uses a maximum PCT for acute 

dietary risk analysis. The maximum 

PCT figure is the single maximum value 

reported overall from available Federal, 

state, and private market survey data on 

the existing use, across all years, and 

rounded up to the nearest multiple of 

five. In most cases, EPA uses available 

data from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

Proprietary Market Surveys, and the 

National Center for Food and 

Agriculture Policy (NCFAP) for the most 

recent 6 years. 

EPA projects PCT for a new 

insecticide use by assuming that the 

PCT for the insecticide’s initial 5 years 

will not exceed the average PCT of the 

dominant insecticide (the one with the 

largest PCT) within all insecticides over 

the three latest available years. The 

PCTs included in the average may be for 

the same insecticide or for different 

insecticides since the same or different 

insecticides may dominate for each year 

selected. Typically, EPA uses USDA/ 

NASS as the source for raw PCT data 

because it is non-proprietary and 

directly available without computation. 

This method of projecting PCT for a 

new insecticide use, with or without 

regard to specific pest(s), produces an 

upper-end projection that is unlikely, in 

most cases, to be exceeded in actuality 

because the dominant insecticide is 

well-established and accepted by 

farmers. Factors that bear on whether a 

projection based on the dominant 

insecticide could be exceeded are 

whether the new insecticide is more 

efficacious or controls a broader 

spectrum of pests than the dominant 

insecticide, whether it is more costeffective than the dominant insecticide, 

and whether it is likely to be readily 

accepted by growers and experts. EPA 

has considered these factors for the new 

uses of this insecticide, and indicates 

that it is unlikely that actual PCT for 

this new use will exceed the PCT for the 

dominant insecticide in the next 5 

years. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

fenpropathrin 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 

fenpropathrin. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessments 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the First Index Reservior 

Screening Tool (FIRST) and Screening 

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

water concentrations (EDWC’s) of 

fenpropathrin for acute exposures are 

estimated to be 10.3 parts per billion 

(ppb) for surface water and 0.005 ppb 

for ground water. The EDWC’s for 

chronic exposures are estimated to be 

1.8 ppb for surface water and 0.005 ppb 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model (DEEMFCID). For acute dietary risk assessment, 

the peak water concentration value of 

10.3 ppb was used to access the 

contribution to drinking water. For 

chronic dietary risk assessment, the 

annual average concentration of 1.8 ppb 

was used to access the contribution to 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55745 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Fenpropathrin 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. 

Fenpropathrin is a member of the 

pyrethroid class of pesticides. Although 

all pyrethroids alter nerve function by 

modifying the normal biochemistry and 

physiology of nerve membrane sodium 

channels, EPA is not currently following 

a cumulative risk approach based on a 

common mechanism of toxicity for the 

pyrethroids. Although all pyrethroids 

interact with sodium channels, there are 

multiple types of sodium channels, and 

it is currently unknown whether they 

have similar effects on all channels. In 

addition, EPA does not have a clear 

understanding of effects on key 

downstream neuronal function, e.g., 

nerve excitability, nor does EPA 

understand how these key events 

interact to produce their compoundspecific patterns of neurotoxicity. There 

is ongoing research by both the EPA’s 

Office of Research and Development 

and the pyrethroid registrants to 

evaluate the differential biochemical 

and physiological actions of pyrethroids 

in mammals. This research is expected 

to be completed by 2007. When the 

results of this research are available, the 

Agency will make a determination of 

common mechanism of toxicity as a 

basis for assessing cumulative risk. For 

information regarding EPA’s procedures 

for cumulating effects from substances 

found to have a common mechanism of 

toxicity, see EPA’s website 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. 

The Agency has determined that there is 

no concern for pre- and/or post-natal 

toxicity resulting from exposure to 

fenpropathrin based on the submitted 

guidelines studies. There is no evidence 

(qualitative or quantitative) of increased 

susceptibility following in utero and/or 

pre- or post-natal exposure in adequate 

developmental toxicity studies in rats or 

rabbits and in a two-generation 

reproduction study in rats. In the rat 

developmental toxicity study, 

developmental effects occurred at a dose 

that was higher than the dose that 

caused maternal toxicity. In the study in 

rabbits, no developmental effects were 

seen at the highest dose tested. In the 

two-generation reproduction study in 

rats, the deaths in two pups of the F2 

generation were not considered to be 

evidence of qualitative increased 

susceptibility as (i) the deaths occurred 

at the same dose that caused severe 

maternal toxicity (i.e., maternal deaths 

and neurotoxic clinical signs) and, (ii) 

the deaths occurred during lactation 

(days 19 and 21) when these pups were 

exposed to the compound via the milk 

and the diet. The Agency has concluded 

that there are no concerns or residual 

uncertainties for pre- and post-natal 

toxicity, based on the submitted 

guideline study results. However, EPA 

is lacking acute and subchronic 

neurotoxicity studies, and a 

developmental neurotoxicity study. The 

developmental neurotoxicity study has 

been required based on neurotoxicity 

being seen in all four tested animal 

species, and the fact that no detailed 

neuropathology data were available. 

3. Conclusion. Because analysis of the 

existing database does not provide a 

reliable basis for concluding that these 

missing studies will not affect the 

regulatory endpoints for fenpropathrin, 

EPA is retaining the additional 10X 

FQPA factor for fenpropathrin, in the 

form of a database uncertainty factor, for 

the protection of infants and children. 

E. Aggregate Risks and Determination of 

Safety 

The Agency currently has two ways to 

estimate total aggregate exposure to a 

pesticide from food, drinking water, and 

residential uses. First, a screening 

assessment can be used, in which the 

Agency calculates drinking water levels 

of comparison (DWLOCs) which are 

used as a point of comparison against 

EDWCs. The DWLOC values are not 

regulatory standards for drinking water, 

but 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). 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 EDWCs for surface water and 

ground water are less than the 

calculated DWLOCs, EPA can conclude 

with reasonable certainty that exposures 

to the pesticide in drinking water (when 

considered along with other sources of 

exposures 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. When new uses are added EPA 

reassesses the potential impacts of 

residues of the pesticide in drinking 

water as a part of the aggregate 

assessment process. 

More recently the Agency has used 

another approach to estimate aggregate 

exposure through food, residential and 

drinking water pathways. In this 

approach, modeled surface and ground 

water EDWCs are directly incorporated 

into the dietary exposure analysis, along 

with food. This provides a more realistic 

estimate of exposure because actual 

body weights and water consumption 

from the CSFII are used. The combined 

food and water exposures are then 

added to estimated exposure from 

residential sources to calculate aggregate 

risks. The resulting exposure and risk 

estimates are still considered to be high 

end, due to the assumptions used in 

developing drinking water modeling 

inputs. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure and drinking water, the 

acute dietary exposure from food and 

water to fenpropathrin will occupy 50% 

of the aPAD for the U.S. population, 

43% of the aPAD for females 13 years 

55746 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

and older, 86% of the aPAD for all 

infants <1 year old, and 91% of the 

aPAD for children 3 to 5 years old, the 

subpopulation at greatest exposure. 

Therefore, EPA does not expect the 

aggregate exposure to exceed 100% of 

the aPAD. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure and drinking water, 

EPA has concluded that exposure to 

fenpropathrin from food and water will 

utilize 3.7% of the cPAD for the U.S. 

population, 6.7% of the cPAD for all 

infants < 1 year old, the subpopulation 

at greatest exposure, and 6.4% of the 

cPAD for children 1 to 2 years old. 

There are no residential uses for 

fenpropathrin. Therefore, EPA does not 

expect the aggregate exposure to exceed 

100% of the cPAD. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Fenpropathrin is not registered for use 

on any sites that would result in 

residential exposure. Therefore, the 

aggregate risks are the sums of the risks 

from food and water, which do not 

exceed the Agency’s level of concern. 

4. Aggregate cancer risk for U.S. 

population. Fenpropathrin has been 

classified as not likely to be 

carcinogenic to humans. Therefore, 

fenpropathrin is expected to pose at 

most a negligible cancer risk. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to 

fenpropathrin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An enforcement method is available 

for the analysis of fenpropathrin in 

plants. This method, Residue Method 

Number RM-22-4 (11/1/89, revised 5/3/ 

93) is entitled ‘‘Determination of 

Fenpropathrin in Crops.’’ Residues in 

crops are extracted with acetone/ 

hexane, partitioned into hexane, 

cleaned up by silica gel and C18 Sep Pak 

chromatography, and measured by gas 

chromatography equipped with an 

electron capture detector. The limit of 

detection of this method is 0.01 ppm. 

An EPA trial of this method for the 

determination of fenpropathrin residues 

in apples has been successfully 

conducted. No additional animal 

commodity tolerances are being 

established with these petitions. As a 

result, enforcement methods for animal 

commodities are not being addressed. 

Recovery of fenpropathrin was tested 

through FDA multiresidue methods, and 

fenpropathrin was found to be 

completely recovered by the PAM I 

Section 302 Method (Luke Method). 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are no Codex, Canadian, or 

Mexican MRLs for fenpropathrin in or 

on the proposed commodities. 

Therefore, harmonization of tolerances 

is not an issue. 

C. Response to Comments 

One comment was received from a 

private citizen who opposed the 

authorization to sell any pesticide that 

leaves a residue on food. The Agency 

has received this same comment from 

this commenter on numerous previous 

occasions and rejects it for the reasons 

previously stated (70 FR 1349, 1354, 

January 7, 2005). 

V. Conclusion 

Therefore, the tolerances are 

established for residues of 

fenpropathrin, a-cyano-3-phenoxybenzyl 2,2,3,3-tetramethylcyclopropanecarboxylate, in or 

on bushberry subgroup 13B; 

lingonberry; juneberry, and salal at 3.0 

ppm; pea, succulent at 0.02 ppm, and 

vegetable, fruiting, group 8 at 1.0 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–2005–0133 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 22, 2005. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issue(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

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–2005–0133, to: Public Information 

and Records Integrity Branch, 

Information Technology and Resource 

Management Division (7502C), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001. In person or by courier, bring a 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55747 

copy to the location of the PIRIB 

described in ADDRESSES. You may also 

send an electronic copy of your request 

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

Please use an ASCII file format and 

avoid the use of special characters and 

any form of encryption. Copies of 

electronic objections and hearing 

requests will also be accepted on disks 

in WordPerfect 6.1/8.0 or ASCII file 

format. Do not include any CBI in your 

electronic copy. You may also submit an 

electronic copy of your request at many 

Federal Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issue(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to petitions 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, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

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. 801et 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 19, 2005. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.466 is amended in the 

table to paragraph (a) by by removing 

the commodity ‘‘tomato’’ and by adding 

alphabetically commodities to the table 

to read as follows: 

§ 180.466 Fenpropathrin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Bushberry subgroup 13B .......... 3.0 

* * * * * 

Juneberry .................................. 3.0 

* * * * * 

Lingonberry ............................... 3.0 

55748 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

Commodity Parts per 

million 

* * * * * 

Pea, succulent .......................... 0.02 

* * * * * 

Salal .......................................... 3.0 

* * * * * 

Vegetable, fruiting, group 8 ...... 1.0 

* * * * * 

[FR Doc. 05–19062 Filed 9–22–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0017; FRL–7736–4] 

Kasugamycin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance forresidues of kasugamycin in 

or on fruiting vegetables, crop group 8. 

Arysta Lifescience North American 

Corporation (previously know as 

Arvesta Corporation), agent for Hokko 

Chemical Industry Corporation, 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 23, 2005. Objections and 

requests for hearings must be received 

on or before November 22, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of theSUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0017. 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: 

Mary L. Waller, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9354; e-mail address: 

waller.mary@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed underFOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using EDOCKET (http:// 

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

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http:// 

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

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings 

In the Federal Register of April 8, 

2005 (70 FR 17997) (FRL–7704–2), 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 3E6579) by Arysta 

Lifescience North American 

Corporation, 100 First Street, Ste. 1700; 

San Fransisco, CA 94105; agent for 

Hokko Chemical Industry Corporation 

Ltd., 4-20, Nihonbashi Hongochkucho 4 

Chome, Chuo-Ku, Tokyo 103–8341, 

Japan. The petition requested that 40 

CFR part 180 be amended by 

establishing a tolerance for residues of 

the fungicide kasugamycin, 1L-1,3,4/ 

2,5,6-1-deoxy-2,3,4,5,6-pentahydroxycyclohexyl-2-amino-2,3,4,6-tetradeoxy4-([a]-iminoglycino)-[a]-D-arabinohexapyranoside, in or on fruiting 

vegetables (Crop Group 8) at 0.04 parts 

per million (ppm), tomato juice at 0.06 

ppm, tomato puree at 0.06 ppm, and 

tomato paste at 0.25 ppm. That notice 

included a summary of the petition 

prepared by Arysta Life Science North 

American Corporation, agent for Hokko 

Chemical Industry Corporation, LLC, 

the registrant. Comments were received 

on the notice of filing. EPA’s response 

to these comments is discussed in Unit 

IV.C. below. 

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 http://