Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55761 

Commodity Parts per million 

Goat, liver ....................... 1.0 

Goat, meat ...................... 0.01 

Goat, meat byproducts, 

except liver .................. 0.10 

Hog, fat ........................... 0.01 

Hog, liver ........................ 0.10 

Hog, meat ....................... 0.01 

Hog, meat byproducts, 

except liver .................. 0.01 

Horse, fat ........................ 0.01 

Horse, liver ..................... 1.0 

Horse, meat .................... 0.01 

Horse, meat byproducts, 

except liver .................. 0.10 

Milk ................................. 0.01 

Sheep, fat ....................... 0.01 

Sheep, liver ..................... 1.0 

Sheep, meat ................... 0.01 

Sheep, meat byproducts, 

except liver .................. 0.10 

Poultry, liver .................... 0.10 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

indirect or inadvertent residues of 

amicarbazone [4-amino-4, 5-dihydro-N- 

(1,1-dimethylethyl)-3-(1-methylethyl)-5- 

oxo-1H-1,2,4-triazole-1-carboxamide] 

and its metabolites DA amicarbazone 

[N-(1,1-dimethylethyl)-4,5-dihydro-3-(1- 

methylethyl)-5-oxo-1H-1,2,4-triazole-1- 

carboxamide] and iPr-2-OH DA 

amicarbazone [N-(1,1-dimethylethyl)- 

4,5-dihydro-3-(1-hydroxy-1- 

methylethyl)-5-oxo-1H-1,2,4-triazole-1- 

carboxamide], calculated as parent 

equivalents, in or on the following 

commodities when present therein as a 

result of application of amicarbazone to 

the growing crops in paragraph (a) of 

this section: 

Commodity Parts per million 

Alfalfa, forage ................. 0.05 

Alfalfa, hay ...................... 0.10 

Cotton, gin byproducts ... 0.30 

Cotton, undelinted seed 0.07 

Soybean, forage ............. 1.50 

Soybean, hay .................. 5.0 

Soybean, seed ................ 0.80 

Wheat, forage ................. 0.50 

Wheat, grain ................... 0.10 

Wheat, grain, milled byproducts ...................... 0.15 

Wheat, hay ..................... 1.0 

Wheat, straw ................... 0.50 

[FR Doc. 05–18951 Filed 9–22–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0267; FRL–7738–6] 

Pyridaben; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyridaben in 

or on hop, dried cones; papaya; star 

apple; sapote, black; mango; sapodilla; 

sapote, mamey; canistel, fruit, stone, 

group 12; strawberry; and tomato. 

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). 

EPA is also deleting certain pyridaben 

tolerances that are no longer needed as 

result of this action. 

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–

0267. 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: 

Barbara Madden, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6463; e-mail address: 

madden.barbara@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 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 at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings 

In the Federal Register of July 3, 2003 

(68 FR 39942) (FRL–7315–4), EPA 

issued a notice pursuant to section 

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

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

pesticide petitions (0E6068, 1E6226, 

1E6303, 2E6457, and 2E6460) from IR4, 681 U.S. Highway #1 South, North 

Brunswick, NJ 08902–3390. The 

55762 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

petitions requested that 40 CFR 180.494 

be amended by establishing tolerances 

for residues of pyridaben, 2-tert-butyl-5- 

(4-tert-butylbenzylthio)-4- 

chloropyridazin-3(2H)-one in or on the 

following raw agricultural commodities: 

Strawberry at 2.5 parts per million 

(ppm) (PP 0E6068); hop, dried cones at 

10.0 ppm (PP 1E6226); tomato at 0.2 

ppm (PP 1E6303); fruit, stone, group at 

2.5 ppm (PP 2E6457); papaya, black 

sapote, canistel, mamey sapote, mango, 

sapodilla, and star apple at 0.1 ppm (PP 

2E6460). The tomato petition was 

subsequently amended to propose a 

tolerance at 0.15 ppm. Registration for 

tomato will be limited to greenhouse 

grown tomato based on the available 

residue data. The petitioner also 

proposed that established tolerances for 

nectarine, peach, plum, and prune at 2.5 

ppm be deleted since they will be 

superceded by the tolerance for fruit, 

stone, group 12 at 2.5 ppm. That notice 

included a summary of the petition 

prepared by BASF Corporation, the 

registrant. The Agency received one 

comment expressing support for this 

action. 

EPA is also deleting the apricot, sweet 

cherry and tart cherry tolerances in 

§ 180.494(a) since they expired on June 

30, 2004, and will also be superceded by 

the tolerance for fruit, stone, group 12. 

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) at http://www.epa.gov/fedrgstr/EPAPEST/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 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 

pyridaben, 2-tert-butyl-5-(4-tertbutylbenzylthio)-4-chloropyridazin3(2H)-one in or on hop, dried cones at 

10.0 ppm; papaya at 0.10 ppm; star 

apple at 0.10 ppm; sapote, black at 0.10 

ppm; mango at 0.10 ppm; sapodilla at 

0.10 ppm; sapote, mamey at 0.10 ppm; 

canistel at 0.10 ppm; fruit, stone, group 

12 at 2.5 ppm; strawberry at 2.5 ppm; 

and tomato at 0.15 ppm. 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 pyridaben are 

discussed in Table 1 of this unit as well 

as the no observed adverse effect level 

(NOAEL) and the lowest observed 

adverse 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--rats NOAEL in males: = 4.94 mg/kg/day and NOAEL in females: 2.64 mg/kg/day 

LOAEL = 11.55 mg/kg/day based on decreased body weight (bwt) gain, food consumption, food efficiency and altered clinical pathology parameters in males and a 

LOAEL of 5.53 mg/kg/day based on decreased body weight gain and food efficiency in females 

870.3100 90–Day oral toxicity mice NOAEL = males: 4.07 and females: 4.92 mg/kg/day 

LOAEL = males: 13.02 and females: 14.65 mg/kg/day based on decreased body 

weight gain 

870.3150 90–Day oral toxicity--nonrodents NOAEL = 1.0 mg/kg/day 

LOAEL = 4.0 mg/kg/day based on increased incidence of clinical signs and decreased body weight gain in both sexes 

870.3150 90–Day oral toxicity--nonrodents NOAEL = < 2.4 mg/kg/day 

LOAEL ≤ 2.4 mg/kg/day based on increased incidence of clinical signs and depletion 

of fat in all treated animals 

870.3200 21–Day dermal toxicity NOAEL = 100 mg/kg/day 

LOAEL = 300 mg/kg/day based on decreased body weight gain observed in females 

870.3465 30–Day inhalation toxicity NOAEL = 0.001 mg/L 

LOAEL = 0.003 mg/L based on increased incidence of clinical signs and clinical 

chemistry changes in both sexes and decreased body weight gain in females 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55763 

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

Guideline No. Study Type Results 

870.3700 Prenatal developmental 

oral toxicity - rodents 

Maternal NOAEL = 4.7 mg/kg/day 

Maternal LOAEL = 13 mg/kg/day based on decreased body weight, body weight 

gain and food consumption 

Developmental NOAEL = 13 mg/kg/day 

Developmental LOAEL = 30 mg/kg/day based on deceased fetal body weight and 

incomplete ossification of bones 

870.3700 Prenatal developmental 

dermal toxicity - nonrodents 

Maternal NOAEL = 70 mg/kg/day 

Maternal LOAEL = 170 mg/kg/day based on deceased body weight and food consumption 

Developmental NOAEL = 170 mg/kg/day 

Developmental LOAEL = 450 g/kg/day based on increased incidence of fetuses with 

retarded growth (incompletely ossified skull) 

870.3700 Prenatal developmental 

oral toxicity - nonrodents 

Maternal NOAEL = 5 mg/kg/day 

Maternal LOAEL = 15 mg/kg/day based on decreases in body weight, body weight 

gain, food consumption and abortions 

Developmental NOAEL = 15 mg/kg/day (HDT). No toxicity was observed at any 

dose, therefore, the NOAEL is equal to or greater than highest dose tested 

Developmental LOAEL = > 15 mg/kg/day 

870.3800 Reproduction and fertility 

effects 

Parental/Systemic NOAEL = males: 2.20 and females: 2.41 mg/kg/day 

Parental/Systemic LOAEL = males: 6.31 and females: 7.82 mg/kg/day based on decreased body weight, body weight gains, and food efficiency 

Offspring NOAEL = 2.2 mg/kg/day 

Offspring LOAEL = 6.3 mg/kg/day based on decreased pup body weight and body 

weight gain 

Reproductive NOAEL = males: 6.31 and females: 7.82 mg/kg/day (HDT). No reproductive toxicity was observed at any dose 

Reproductive LOAEL = males: > 6.31 and > 7.82 mg/kg bwt/day (HDT) 

870.4100 Chronic toxicity-dogs NOAEL = Not established 

LOAEL = 0.5 mg/kg/day based on increased clinical signs of toxicity in both sexes 

and decreased body weight gain in females 

870.4100 Chronic toxicity--dogs NOAEL = Not established 

LOAEL = 1.0 mg/kg/day based on increased clinical signs of toxicity in both sexes 

and decreased body weight gain in females 

870.4200 Carcinogenicity--rats NOAEL = males: 1.13 and females: 1.46 mg/kg/day 

LOAEL = males: 5 and females: 6.52 mg/kg/day based on decreased body weight 

and body weight gain observed in males and females, and decreased alanine 

transferase in males 

There was no evidence of carcinogenicity 

870.4300 Carcinogenicity--mice NOAEL = 2.78 mg/kg/day (males and females) 

LOAEL = males: 8.88 and females: 9.74 mg/kg/day) based on decreased body 

weight gain, decreased food efficiency and changes in organ weights and 

histopathology (males) 

No evidence of carcinogenicity 

870.5100 Gene mutation - Salmonella Negative 

870.5300 Gene mutation in Chinese 

hamster cultured V-79 

Negative 

870.5380 Mutagenic- structural 

chromosome aberration 

-in vitro cytogenetics - 

Chinese hamster 

Negative 

870.5385 Mutagenic - structural 

chromosome aberration 

- micronucleus - mouse 

Negative 

870.5500 Mutagenic- DNA damage/ 

repair- E. Coli 

Negative 

55764 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 

870.6200 Acute oral neurotoxicity - 

rat 

NOAEL = 44 mg/kg (both sexes) 

LOAEL = 80 mg/kg/day based on increased incident of piloerection, hypoactivity, 

tremors, partially closed eyes, and decreases in body weight gain and food consumption 

No neuropathological effects were observed 

870.6200 Subchronic neurotoxicity 

screening battery 

NOAEL = males: 8.5 and females: 9.3 mg/kg/day 

LOAEL = males: 28.8 and females: 31.1 mg/kg/day based on decreased body 

weight, body weight gain, food consumption and food efficiency in both sexes 

No neuropathological effects were observed 

870.7485 Metabolism and pharmacokinetics Rapidly metabolized. Gastrointestinal tract was the major site for distribution, and 

elimination. Highest residues were found in liver, pancreas, spleen, kidney, lymph 

node and fat. Parent compound was metabolized to 20 - 30 metabolites and were 

resolved in urine and feces 

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 pyridaben used for human 

risk assessment is shown in Table 2 of 

this unit: 

TABLE 2.— SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PYRIDABEN 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 (all populations) NOAEL = 44 mg/kg/day 

UF = 100 

Acute Reference Dose (RfD) 

= 0.44 mg/kg/day 

Special FQPA SF = 1X 

Acute Population Adjusted 

Dose (aPAD) = acute 

RfD/Special FQPA SF = 

0.44 mg/kg/day 

Acute Neurotoxicity-Rat 

LOAEL = 80 mg/kg/day based on an increased incidence of piloerection, 

hypoactivity, tremors and partially closed 

eyes, decreased body weight gain and food 

consumption 

Chronic dietary (all populations) LOAEL = 0.5 mg/kg/day 

UF = 100 

Chronic RfD = 0.005 mg/kg/ 

day 

Special FQPA SF = 1X 

cPAD = chronic RfD/Special FQPA SF = .005 

mg/kg/day 

Chronic Feeding-Dog 

LOAEL = 0.5 mg/kg/day based on an increased incidence of ptyalism, emesis and 

soft stools, and decreased body weight gain 

in females. EPA determined that this LOAEL 

could be used in risk assessment without an 

additional safety factor because the effects 

seen were minimal 

Cancer (oral, dermal, inhalation) Pyridaben has been classified as a Group E chemical (i.e. evidence of non-carcinogenicity for humans) 

based on the lack of evidence of carcinogenicity in male and female rats as well as in male and female mice 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.494) for the 

residues of pyridaben, in or on a variety 

of raw agricultural commodities 

including nectarine, peach, plum, and 

prune at 2.5 ppm. Tolerances have also 

been established for milk and fat, meat, 

and meat byproducts for cattle, goat, 

hog, horse, and sheep. Risk assessments 

were conducted by EPA to assess 

dietary exposures from pyridaben in 

food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and 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 1–day or single 

exposure. The Dietary Exposure 

Evaluation Model (DEEMTM) analysis 

evaluated the individual food 

consumption as reported by 

respondents in the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII) and accumulated 

exposure to the chemical for each 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55765 

commodity. The following assumptions 

were made for the acute exposure 

assessments: A Tier 3, acute dietaryexposure assessment (probabilistic) was 

conducted for pyridaben. The 

probabilistic assessment was based 

upon residue distribution files or 

anticipated-residue estimates derived 

from crop field trial data for most 

commodities; processing factors from 

processing studies were utilized for 

most processed commodities; and 

percent crop-treated estimates and 

projected market-share estimates were 

utilized for most crops. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEM-FCIDTM), which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 nationwide CSFII, 

and accumulated exposure to the 

chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: A 

Tier 2, partially-refined, chronic dietaryexposure assessment was conducted for 

pyridaben. Anticipated-residue 

estimates were utilized to account for 

the residues of concern for risk 

assessment derived from proposed and 

established tolerance levels; and percent 

crop-treated estimates and projected 

market-share estimates were utilized for 

most crops. 

iii. Cancer. Pyridaben has been 

classified as not likely to be 

carcinogenic to humans. Therefore, a 

quantitative exposure assessment was 

not conducted to assess cancer risk. 

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 CallIns 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 PCT information as 

follows: 

4% almonds, 20% apples, 34% 

apricots, 25% cherries, 10% cranberry, 

35% grapefruit, 10% grapes, 4% 

lemons, 8% oranges, 8% peaches, 22% 

pears, 8% plums and prunes, 15% 

nectarines, 1% pistachios, 25% 

strawberry, 25% tangerines, 8% 

tomatoes, and 35% for meat and milk. 

The following PCT data were used in 

the chronic dietary exposure analysis: 

2.5% almonds, 10% apples, 34% 

apricots, 2.5% cherries, 10% cranberry, 

15% grapefruit, 5% grapes, 2.5% 

lemons, 5% oranges, 5% peaches, 15% 

pears, 5% plums and prunes, 19% 

strawberry, 15% tangerines, and 4% 

tomatoes. 

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 

the maximum. 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 USDA/ 

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 

three latest available years. The PCTs 

included in the average may be each 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. These 

factors have been considered for this 

insecticide new use, and they indicate 

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 

pyridaben 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 

pyridaben. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

Based on the EPA’s Pesticide Root 

Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS) and 

Screening Concentrations in Ground 

Water (SCI-GROW) models, the 

estimated environmental concentrations 

(EECs) of pyridaben for acute exposures 

are estimated to be 12 parts per billion 

(ppb) for surface water and 0.007 ppb 

for ground water. The EECs for chronic 

exposures are estimated to be 2.2 ppb 

55766 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

for surface water and 0.007 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). Pyridaben 

is not registered for use on any sites that 

would result in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

pyridaben and any other substances and 

pyridaben does not appear to produce a 

toxic metabolite produced by other 

substances. EPA has also evaluated 

comments submitted that suggested 

there might be a common mechanism 

among pyridaben and other named 

pesticides that cause brain effects. EPA 

concluded that the evidence did not 

support a finding of common 

mechanism for pyridaben and the 

named pesticides. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that pyridaben has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative/. 

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. 

There is no quantitative and/or 

qualitative evidence of increased 

susceptibility of rat or rabbit fetuses to 

in utero exposure to pyridaben. There is 

no evidence of increased quantitative 

and/or qualitative susceptibility to 

pyridaben following prenatal exposure 

in a 2–generation reproduction study in 

the rat. There are no concerns or 

residual uncertainties for prenatal/ 

postnatal toxicity. 

Pyridaben elicited weak clinical signs 

(piloerection, hypoactivity, tremors) in 

an acute neurotoxicity study and a 

transient effect on the righting reflex in 

a subchronic feeding study. These signs 

were initially judged to be evidence of 

neurotoxicity and a Developmental 

Neurotoxicity (DNT) study was 

required. However, further evaluation of 

the entire weight of evidence has led to 

the conclusion that these signs are nonspecific in nature and not indicative of 

a direct effect on the nervous system. 

Pyridaben has weak neurotoxicity 

signs as demonstrated in the acute 

neurotoxicity study in rats. Piloerection, 

hypoactivity, tremors, and partially 

closed eyes were observed in animals in 

the 100 mg/kg bwt group. In the 

subchronic neurotoxicity study, 

transient poorly coordinated righting 

reflex was observed in high dose males 

(28.8 mg/kg bwt/day) in the absence of 

other neurotoxicity or neuropathology 

in the subchronic neurotoxicity study. 

Inhibition of plasma cholinesterase 

activity occurred at the highest dose 

(27.68 mg/kg bwt/day) in females only 

in the 90–day rat feeding study. 

The Agency has determined that the 

DNT study is no longer required based 

on the following: 

• The lack of evidence for 

abnormalities in the development of the 

fetal nervous system including the 

prenatal developmental toxicity studies 

in either rats (oral gavage up to 1,000 

mg/kg/day) or rabbits (oral greater than 

15 mg/kg/day and dermal up to 450 mg/ 

kg/day) and the 2–generation 

reproduction study in rats (up to 6.31 

mg/kg/day). 

• The levels at which effects occurred 

in the acute and subchronic 

neurotoxicity studies were the highest 

doses tested where significant toxicity, 

other than neurotoxic signs were noted. 

Transient piloerection and hypoactivity 

were noted in the mid dose males (100 

mg/kg/day) and piloerection, 

hypoactivity, tremors and partially 

closed eyes were observed in animals in 

the 200 mg/kg bwt group (highest dose 

tested) in the acute neurotoxicity study 

in rats. There was also transient (only 1 

week), poorly coordinated righting 

reflex in highest dose tested (28.8 mg/ 

kg/day) in males only in the subchronic 

neurotoxicity study. No neuropathology 

was noted in either study. 

• Inhibition of plasma (butyryl and 

acetyl) cholinesterase activity at the 

highest dose tested (27.68 mg/kg/day, 

females) in the standard 90–day rat 

feeding study, this was not seen in the 

reversibility phase of the study. 

Pyridaben may have some flexibility 

and charge characteristics which would 

allow it to interact with the 

cholinesterase receptor in some tissues, 

but this response is not indicative of a 

neurotoxic mode of action. 

• Only transient (appearing at only 

week 8, but not at weeks 4 or 13), poorly 

coordinated righting reflex in high dose 

males (28.8 mg/kg bwt/day) was 

observed in the absence of neurotoxicity 

in the subchronic neurotoxicity study. 

• No other study of any duration 

showed evidence of neurotoxic effects 

(clinical signs, organ weights, 

histopathology) and the studies were 

tested high enough to elicit frank 

toxicity (other than neurotoxicity). 

• The 2–generation reproduction 

study in rats included developmental 

and neurotoxicity assessments. The 

observations included a comprehensive 

evaluation of clinical signs, onset and 

completion of pinna (ear) unfolding, 

hair growth, tooth eruption, eye 

opening, auditory and visual function 

assessed using the startle response and 

examination of pupil closure along with 

assessment of the visual placement 

response. No effects were noted up to 

and including the highest dose tested 

(6.31 mg/kg/day). No effects were noted 

on reproductive parameters. The 

observed effects in the 2–generation 

reproduction study were minimal in 

nature involving only body weight and 

food consumption. 

3. Conclusion. There is a complete 

toxicity data base for pyridaben and 

exposure data are complete. There is no 

quantitative or qualitative evidence of 

increased susceptibility of rat and rabbit 

fetuses to in utero exposure to 

pyridaben in developmental studies. 

There is no quantitative or qualitative 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55767 

evidence of increased susceptibility to 

pyridaben following prenatal/postnatal 

exposure in a 2–generation reproduction 

study incorporating neurotoxicity 

measurements. There is no concern for 

developmental neurotoxicity resulting 

from exposure to pyridaben. Since there 

was no observed evidence of potential 

developmental neurotoxicity in shortand long-term toxicity studies in rats, 

mice, and dogs, a DNT study is not 

required. 

The dietary exposure scenarios 

includes metabolites and/or degradates 

of concern and the dietary food 

exposure assessment is refined for acute 

food exposure and partially refined for 

chronic food exposure. Although 

refined, the assessments are based on 

reliable data and will not underestimate 

exposure/risk. The dietary drinking 

water assessment (Tier 2 estimates) 

utilizes values generated by models and 

associated modeling parameters which 

are designed to provide conservative, 

health protective, high-end estimates of 

water concentrations. There are no 

residential uses of pyridaben. 

Based on these data, the Agency has 

reduced the FQPA Safety Factor to 1X 

and a developmental neurotoxicity 

study will not be required. 

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 

EECs. 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 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 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. When new uses are added EPA 

reassesses the potential impacts of 

residues of the pesticide in drinking 

water as a part of the aggregate risk 

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 water and 

ground water EECs 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. 

There are no existing or proposed 

uses for pyridaben that would result in 

residential non-dietary exposure, 

therefore aggregate acute and chronic 

risks are based solely on exposure from 

food and water, which are as follows: 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food to pyridaben will 

occupy 3% of the aPAD for the U.S. 

population, 2% of the aPAD for females 

13 years and older, 4% of the aPAD for 

all infants < 1 year old, and 6% of the 

aPAD for children 1–2 years old, the 

children subpopulation at greatest 

exposure. In addition, there is potential 

for acute dietary exposure to pyridaben 

in drinking water. To estimate total 

aggregate exposure to a pesticide from 

food and drinking water the Agency 

calculated DWLOCs which are used as 

a point of comparison against EECs. 

After calculating DWLOCs and 

comparing them to the EECs for surface 

water and ground water, EPA does not 

expect the aggregate exposure to exceed 

100% of the aPAD, as shown in Table 

3 of this unit: 

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO PYRIDABEN

Population Subgroup aPAD (mg/ 

kg) 

% aPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Acute 

DWLOC 

(ppb) 

U.S. population 0.44 3 12 0.007 15,000 

Females (13-49 years old) 0.44 2 12 0.007 12,900 

Children (1-2 years old) 0.44 6 12 0.007 4,100 

All infants (< 1 year old) 0.44 4 12 0.007 4,200 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to pyridaben from food 

will utilize 13% of the cPAD for the 

U.S. population, 29% of the cPAD for 

all infants < 1 year old, and 47% of the 

cPAD for children 1–2 years old the 

subpopulation at greatest exposure. In 

addition, there is potential for chronic 

dietary exposure to pyridaben in 

drinking water. After calculating 

DWLOCs and comparing them to the 

EECs for surface water and ground 

water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD, as shown in Table 4 of this 

unit: 

55768 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO PYRIDABEN

Population/Subgroup cPAD/mg/ 

kg/day 

% cPAD/ 

(Food) 

Surface 

Water EEC/ 

(ppb) 

Ground/ 

Water EEC/ 

(ppb) 

Chronic/ 

DWLOC 

(ppb) 

U.S. population 0.005 13 2.2 0.007 150 

Children (1-2 years old) 0.005 47 2.2 0.007 27 

All infants (< 1 year old) 0.005 29 2.2 0.007 40 

3. Short-term and Intermediate-term 

risks. Short-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Intermediate-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Pyridaben 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. Aggregate cancer risk for U.S. 

population. Pyridaben has been 

classified as not likely to be 

carcinogenic to humans. Therefore, 

pyridaben 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 pyridaben 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(GC/ECD method, BASF D9312) 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 MRLs for 

pyridaben on hops, tropical fruit, stone 

fruit, strawberry, and tomatoes. 

Therefore, no compatibility questions 

exist with respect to Codex. 

C. Response to Comments 

The Agency received one comment 

expressing support for this action. 

V. Conclusion 

Therefore, tolerances are established 

for residues of pyridaben, 2-tert-butyl-5- 

(4-tert-butylbenzylthio)-4- 

chloropyridazin-3(2H)-one in or on hop, 

dried cones at 10.0 ppm; papaya at 0.10 

ppm; star apple at 0.10 ppm; sapote, 

black at 0.10 ppm; mango at 0.10 ppm; 

sapodilla at 0.10 ppm; sapote, mamey at 

0.10 ppm; canistel at 0.10 ppm; fruit, 

stone, group 12 at 2.5 ppm; strawberry 

at 2.5 ppm; and tomato at 0.15 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–2005–0267 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–2005–0267, 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 

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 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55769 

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 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, 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. 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 180.494 is amended by 

removing the entries for ‘‘apricot’’; 

‘‘cherry, sweet’’; ‘‘cherry, tart’’; 

‘‘nectarine’’; ‘‘peach’’; ‘‘plum’’; and 

‘‘prune’’ from the table in paragraph (a) 

and by alphabetically adding the 

following commodities to the table in 

paragraph (a) to read as follows: 

§ 180.494 Pyridaben; tolerance for 

residues. 

(a) * * * 

Commodity Parts per million 

Revocation/expiration 

date 

* * * * * 

Canistel ........ 0.10 None 

* * * * * 

Fruit, stone, 

group 12.

2.5 None 

* * * * * 

Hop, dried 

cones.

10.0 None 

55770 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

Commodity Parts per million 

Revocation/expiration 

date 

* * * * * 

Mango .......... 0.10 None 

* * * * * 

Papaya ......... 0.10 None 

* * * * * 

Sapodilla ....... 0.10 None 

Sapote, black 0.10 None 

Sapote, 

mamey.

0.10 None 

* * * * * 

Star apple ..... 0.10 None 

Strawberry .... 2.5 None 

Tomato ......... 0.15 None 

* * * * * 

[FR Doc. 05–19058 Filed 9–22–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 228 

[FRL–7973–8] 

Ocean Dumping; Site Designation 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA today designates a new 

Ocean Dredged Material Disposal Site 

(ODMDS) in the Atlantic Ocean offshore 

Port Royal, South Carolina, as an EPAapproved ocean dumping site for the 

disposal of suitable dredged material. 

This action is necessary to provide an 

acceptable ocean disposal site for 

consideration as an option for dredged 

material disposal projects in the greater 

Port Royal, South Carolina, vicinity. 

This site designation is for an indefinite 

period of time, but the site is subject to 

continuing monitoring to insure that 

unacceptable adverse environmental 

impacts do not occur. 

DATES: This rule is effective on October 

24, 2005. 

ADDRESSES: The file supporting this 

designation is available for public 

inspection at the following location: 

EPA Region 4, Sam Nunn Atlanta 

Federal Center, 61 Forsyth Street, SW., 

Atlanta, Georgia 30303. 

FOR FURTHER INFORMATION CONTACT: Gary 

W. Collins, (404) 562–9395. 

SUPPLEMENTARY INFORMATION: 

A. Background 

Section 102(c) of the Marine 

Protection, Research, and Sanctuaries 

Act (MPRSA) of 1972, as amended, 33 

U.S.C. 1401 et seq., gives the 

Administrator of EPA the authority to 

designate sites where ocean disposal 

may be permitted. On October 1, 1986, 

the Administrator delegated the 

authority to designate ocean disposal 

sites to the Regional Administrator of 

the Region in which the sites are 

located. This designation is being made 

pursuant to that authority. 

The EPA Ocean Dumping Regulations 

promulgated under MPRSA (40 CFR 

Chapter I, Subchapter H, § 228.4) state 

that ocean dumping sites will be 

designated by promulgation in this part 

228. This site designation is being 

published as final rulemaking in 

accordance with § 228.4(e) of the Ocean 

Dumping Regulations, which permits 

the designation of ocean disposal sites 

for dredged material. 

B. Regulated Entities 

Entities potentially affected by this 

action are persons, organizations, or 

government bodies seeking to dispose of 

dredged material into ocean waters 

offshore Port Royal, South Carolina, 

under the MPRSA and its implementing 

regulations. This final rule is expected 

to be primarily of relevance to parties 

seeking permits from the U.S. Army 

Corps of Engineers (COE) to transport 

dredged material for the purpose of 

disposal into ocean waters and to the 

COE itself for its own dredged material 

disposal projects. Potentially regulated 

categories and entities that may seek to 

use the proposed dredged material 

disposal site may include: 

Category Examples of potentially regulated entities 

Federal Government ................................................................................. U.S. Army Corps of Engineers Civil Works Projects, U.S. Marine 

Corps, and Other Federal Agencies. 

Industry and General Public ..................................................................... Port Authorities, Marinas and Harbors, Shipyards, and Marine Repair 

Facilities, Berth Owners. 

State, local and tribal governments .......................................................... Governments owning and/or responsible for ports, harbors, and/or 

berths, Government agencies requiring disposal of dredged material 

associated with public works projects. 

This table is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. To determine 

whether your organization is affected by 

this action, you should carefully 

consider whether your organization is 

subject to the requirement to obtain an 

MPRSA permit in accordance with 

Section 103 of the MPRSA and the 

applicable regulations at 40 CFR Parts 

220 and 225, and whether you wish to 

use the site subject to today’s action. 

EPA notes that nothing in this final rule 

alters the jurisdiction or authority of 

EPA or the types of entities regulated 

under the MPRSA. Questions regarding 

the applicability of this final rule to a 

particular entity should be directed to 

the contact person listed in the 

preceding FOR FURTHER INFORMATION

CONTACT section. 

C. EIS Development 

Section 102(2)(C) of the National 

Environmental Policy Act (NEPA) of 

1969, as amended, 42 U.S.C. 4321 et 

seq., requires that Federal agencies 

prepare an Environmental Impact 

Statement (EIS) on proposals for 

legislation and other major federal 

actions significantly affecting the 

quality of the human environment. The 

object of NEPA is to build into the 

agency decision making process careful 

consideration of all environmental 

aspects of proposed actions. While 

NEPA does not apply to EPA activities 

of this type, EPA has voluntarily 

committed to prepare NEPA documents 

in connection with ocean disposal site 

designations. (See 63 FR 58045 [October 

29, 1998], ‘‘Notice of Policy and 

Procedures for Voluntary Preparation of 

National Environmental Policy Act 

(NEPA) Documents.’’) 

EPA, in cooperation with the 

Charleston District COE, has prepared a 

Final EIS (FEIS) entitled ‘‘Final 

Environmental Impact Statement for the 

Port Royal Ocean Dredged Material 

Disposal Site Designation.’’ On June 25, 

2004, the Notice of Availability of the 

FEIS for public review and comment 

was published in the Federal Register 

(69 FR 35597 [June 25, 2004]). Anyone 

desiring a copy of the EIS may obtain 

one from the address given above. The 

public comment period on the FEIS 

closed on July 26, 2004. 

EPA received one comment letter on 

the FEIS from the South Carolina