51802 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices 

and risk from drinking water are well 

within acceptable levels. 

c. Cancer. The DWLOC for the cancer 

risk assessment was calculated to be 

0.12 ppb. Surface water and ground 

water EECs of 0.052 ppb and 0.02 ppb, 

respectively, were used for comparison 

with the DWLOC. The EECs are below 

the DWLOC, indicating that the cancer 

risk would generally be considered 

negligible. 

2. Non-dietary exposure. Ethalfluralin 

is not currently registered for use on any 

residential non-food sites, and thus, it is 

not expected that non-occupational, 

non-dietary exposures will occur. 

D. Cumulative Effects 

EPA at this time has not established 

methodologies to resolve the complex 

issues concerning common mechanism 

of toxicity in a meaningful way. 

Although, ethalfluralin is a member of 

the dinitroaniline class of herbicides, 

there is no information available at this 

time to determine whether ethalfluralin 

has a common mechanism of toxicity 

with other substances or how to include 

this pesticide in a cumulative risk 

assessment. Based on the metabolic 

profile, the registrant concludes that 

ethalfluralin does not appear to produce 

a toxic metabolite produced by other 

substances. Therefore, only aggregate 

exposure and risk were considered. 

E. Safety Determination 

1. U.S. population. Using conservative 

exposure assumptions previously 

described, chronic dietary exposure to 

residues of ethalfluralin from current 

and proposed uses was estimated to 

occupy only 0.2% of the RfD for the 

general U.S. population. EPA generally 

has no concern for exposures below 

100% of the RfD since the RfD 

represents the level at or below which 

daily exposure over a lifetime will not 

pose appreciable risks to human health. 

Additionally, the chronic DWLOC was 

found to be substantially greater than 

EECs for ethalfluralin in surface water 

or ground water, indicating risk is well 

within acceptable levels. Cancer risk 

resulting from potential exposure to 

ethalfluralin through food and drinking 

water was estimated. Cancer risk from 

potential dietary and drinking water 

exposure for the general U.S. population 

was found to be within a range that EPA 

has generally considered negligible. 

Thus, based on the completeness and 

reliability of the toxicity data and the 

conservative exposure assessment, it is 

concluded that, there is a reasonable 

certainty that no harm will result to the 

general U.S. population from aggregate 

exposure to ethalfluralin residues from 

current and proposed uses. 

2. Infants and children. Risk for 

developmental toxicity from acute 

exposure to ethalfluralin was evaluated 

for females 13+ years old. As indicated 

in the previous discussion, risk from 

aggregate acute exposure to ethalfluralin 

through food and drinking water is well 

within acceptable levels. It can be 

concluded that there is a reasonable 

certainty that no harm will result for 

both females 13+ years old and for the 

pre-natal development of infants from 

aggregate acute exposure to 

ethalfluralin. 

Chronic aggregate exposure and risk 

was evaluated for non-nursing infants, 

the population subgroup predicted to be 

most highly exposed. As indicated 

previously, risk from aggregate chronic 

exposure through food and drinking 

water is well within acceptable levels. 

Thus, based on the completeness and 

reliability of the toxicity data and the 

conservative exposure assessment, it 

can be concluded with reasonable 

certainty that no harm will result to 

infants and children from chronic 

aggregate exposure to ethalfluralin 

based on current and proposed uses. 

F. International Tolerances 

There are no Codex, Canadian or 

Mexican maximum residue limits 

established for ethalfluralin. 

[FR Doc. 05–17124 Filed 8–30–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[OPP–2005–0235; FRL–7733–1] 

Fenarimol; Notice of Filing a Pesticide 

Petition to Establish a Tolerance for a 

Certain Pesticide Chemical in or on 

Food 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice announces the 

initial filing of a pesticide petition 

proposing the establishment of 

regulations for residues of a certain 

pesticide chemical in or on various food 

commodities. 

DATES: Comments, identified by docket 

identification (ID) number OPP–2005–

0235, must be received on or before 

September 30, 2005. 

ADDRESSES: Comments may be 

submitted electronically, by mail, or 

through hand delivery/courier. Follow 

the detailed instructions as provided in 

Unit I. of the SUPPLEMENTARY

INFORMATION. 

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) 

• Animal production (NAICS 112) 

• Food manufacturing (NAICS 311) 

• Pesticide manufacturing (NAICS 

32532) 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Copies of this 

Document and Other Related 

Information? 

1. Docket. EPA has established an 

official public docket for this action 

under docket ID number OPP–2005–

0235. The official public docket consists 

of the documents specifically referenced 

in this action, any public comments 

received, and other information related 

to this action. Although a part of the 

official docket, the public docket does 

not include Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

The official public docket is the 

collection of materials that is available 

for public viewing 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. 

2. Electronic access. You may access 

this Federal Register document 

electronically through the EPA Internet 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices 51803 

under the ‘‘Federal Register’’ listings at 

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

An electronic version of the public 

docket is available through EPA’s 

electronic public docket and comment 

system, EPA Dockets. You may use EPA 

Dockets at http://www.epa.gov/edocket/ 

to submit or view public comments, 

access the index listing of the contents 

of the official public docket, and to 

access those documents in the public 

docket that are available electronically. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Unit I.B.1. Once in 

the system, select ‘‘search,’’ then key in 

the appropriate docket ID number. 

Certain types of information will not 

be placed in the EPA Dockets. 

Information claimed as CBI and other 

information whose disclosure is 

restricted by statute, which is not 

included in the official public docket, 

will not be available for public viewing 

in EPA’s electronic public docket. EPA’s 

policy is that copyrighted material will 

not be placed in EPA’s electronic public 

docket but will be available only in 

printed, paper form in the official public 

docket. To the extent feasible, publicly 

available docket materials will be made 

available in EPA’s electronic public 

docket. When a document is selected 

from the index list in EPA Dockets, the 

system will identify whether the 

document is available for viewing in 

EPA’s electronic public docket. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Unit I.B.1 EPA 

intends to work towards providing 

electronic access to all of the publicly 

available docket materials through 

EPA’s electronic public docket. 

For public commenters, it is 

important to note that EPA’s policy is 

that public comments, whether 

submitted electronically or in paper, 

will be made available for public 

viewing in EPA’s electronic public 

docket as EPA receives them and 

without change, unless the comment 

contains copyrighted material, CBI, or 

other information whose disclosure is 

restricted by statute. When EPA 

identifies a comment containing 

copyrighted material, EPA will provide 

a reference to that material in the 

version of the comment that is placed in 

EPA’s electronic public docket. The 

entire printed comment, including the 

copyrighted material, will be available 

in the public docket. 

Public comments submitted on 

computer disks that are mailed or 

delivered to the docket will be 

transferred to EPA’s electronic public 

docket. Public comments that are 

mailed or delivered to the docket will be 

scanned and placed in EPA’s electronic 

public docket. Where practical, physical 

objects will be photographed, and the 

photograph will be placed in EPA’s 

electronic public docket along with a 

brief description written by the docket 

staff. 

C. How and to Whom Do I Submit 

Comments? 

You may submit comments 

electronically, by mail, or through hand 

delivery/courier. To ensure proper 

receipt by EPA, identify the appropriate 

docket ID number in the subject line on 

the first page of your comment. Please 

ensure that your comments are 

submitted within the specified comment 

period. Comments received after the 

close of the comment period will be 

marked ‘‘late.’’ EPA is not required to 

consider these late comments. If you 

wish to submit CBI or information that 

is otherwise protected by statute, please 

follow the instructions in Unit I.D. Do 

not use EPA Dockets or e-mail to submit 

CBI or information protected by statute. 

1. Electronically. If you submit an 

electronic comment as prescribed in this 

unit, EPA recommends that you include 

your name, mailing address, and an email address or other contact 

information in the body of your 

comment. Also include this contact 

information on the outside of any disk 

or CD ROM you submit, and in any 

cover letter accompanying the disk or 

CD ROM. This ensures that you can be 

identified as the submitter of the 

comment and allows EPA to contact you 

in case EPA cannot read your comment 

due to technical difficulties or needs 

further information on the substance of 

your comment. EPA’s policy is that EPA 

will not edit your comment, and any 

identifying or contact information 

provided in the body of a comment will 

be included as part of the comment that 

is placed in the official public docket, 

and made available in EPA’s electronic 

public docket. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. 

i. EPA Dockets. Your use of EPA’s 

electronic public docket to submit 

comments to EPA electronically is 

EPA’s preferred method for receiving 

comments. Go directly to EPA Dockets 

at http://www.epa.gov/edocket/, and 

follow the online instructions for 

submitting comments. Once in the 

system, select ‘‘search,’’ and then key in 

docket ID number OPP–2005–0235. The 

system is an ‘‘anonymous access’’

system, which means EPA will not 

know your identity, e-mail address, or 

other contact information unless you 

provide it in the body of your comment. 

ii. E-mail. Comments may be sent by 

e-mail to opp-docket@epa.gov, 

Attention: Docket ID Number OPP–

2005–0235. In contrast to EPA’s 

electronic public docket, EPA’s e-mail 

system is not an ‘‘anonymous access’’

system. If you send an e-mail comment 

directly to the docket without going 

through EPA’s electronic public docket, 

EPA’s e-mail system automatically 

captures your e-mail address. E-mail 

addresses that are automatically 

captured by EPA’s e-mail system are 

included as part of the comment that is 

placed in the official public docket, and 

made available in EPA’s electronic 

public docket. 

iii. Disk or CD ROM. You may submit 

comments on a disk or CD ROM that 

you mail to the mailing address 

identified in Unit I.C.2. These electronic 

submissions will be accepted in 

WordPerfect or ASCII file format. Avoid 

the use of special characters and any 

form of encryption. 

2. By mail. Send your comments to: 

Public Information and Records 

Integrity Branch (PIRIB) (7502C), Office 

of Pesticide Programs (OPP), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001, Attention: Docket ID 

Number OPP–2005–0235. 

3. By hand delivery or courier. Deliver 

your comments to: Public Information 

and Records Integrity Branch (PIRIB), 

Office of Pesticide Programs (OPP), 

Environmental Protection Agency, Rm. 

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

Arlington, VA, Attention: Docket ID 

Number OPP–2005–0235. Such 

deliveries are only accepted during the 

docket’s normal hours of operation as 

identified in Unit I.B.1. 

D. How Should I Submit CBI to the 

Agency? 

Do not submit information that you 

consider to be CBI electronically 

through EPA’s electronic public docket 

or by e-mail. You may claim 

information that you submit to EPA as 

CBI by marking any part or all of that 

information as CBI (if you submit CBI 

on disk or CD ROM, mark the outside 

of the disk or CD ROM as CBI and then 

identify electronically within the disk or 

CD ROM the specific information that is 

CBI). Information so marked will not be 

disclosed except in accordance with 

procedures set forth in 40 CFR part 2. 

In addition to one complete version of 

the comment that includes any 

information claimed as CBI, a copy of 

51804 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices 

the comment that does not contain the 

information claimed as CBI must be 

submitted for inclusion in the public 

docket and EPA’s electronic public 

docket. If you submit the copy that does 

not contain CBI on disk or CD ROM, 

mark the outside of the disk or CD ROM 

clearly that it does not contain CBI. 

Information not marked as CBI will be 

included in the public docket and EPA’s 

electronic public docket without prior 

notice. If you have any questions about 

CBI or the procedures for claiming CBI, 

please consult the person listed under 

FOR FURTHER INFORMATION CONTACT. 

E. What Should I Consider as I Prepare 

My Comments for EPA? 

You may find the following 

suggestions helpful for preparing your 

comments: 

1. Explain your views as clearly as 

possible. 

2. Describe any assumptions that you 

used. 

3. Provide copies of any technical 

information and/or data you used that 

support your views. 

4. If you estimate potential burden or 

costs, explain how you arrived at the 

estimate that you provide. 

5. Provide specific examples to 

illustrate your concerns. 

6. Make sure to submit your 

comments by the deadline in this 

notice. 

7. To ensure proper receipt by EPA, 

be sure to identify the docket ID number 

assigned to this action in the subject 

line on the first page of your response. 

You may also provide the name, date, 

and Federal Register citation. 

II. What Action is the Agency Taking? 

EPA has received a pesticide petition 

as follows proposing the establishment 

and/or amendment of regulations for 

residues of a certain pesticide chemical 

in or on various food commodities 

under section 408 of the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 21 

U.S.C. 346a. EPA has determined that 

this petition contains data or 

information regarding the elements set 

forth in FFDCA section 408(d)(2); 

however, EPA has not fully evaluated 

the sufficiency of the submitted data at 

this time or whether the data support 

granting of the petition. Additional data 

may be needed before EPA rules on the 

petition. 

List of Subjects 

Environmental protection, 

Agricultural commodities, Feed 

additives, Food additives, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 19, 2005. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Summary of Petition 

The petitioner summary of the 

pesticide petition is printed below as 

required by FFDCA section 408(d)(3). 

The summary of the petition was 

prepared by the petitioner and 

represents the view of the petitioner. 

The petition summary announces the 

availability of a description of the 

analytical methods available to EPA for 

the detection and measurement of the 

pesticide chemical residues or an 

explanation of why no such method is 

needed. 

Interregional Research Project Number 

4 

PP 5E4573 

EPA has received a pesticide petition 

(PP 5E4573) from Interregional Research 

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

Highway #1 South, North Brunswick, NJ 

08902–3390 proposing, pursuant to 

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

346a(d), to amend 40 CFR part 180 by 

establishing a tolerance for residues of 

fenarimol [alpha-(2-chlorophenyl)- 

alpha-(4-chlorophenyl)-5- 

pyrimidinemethanol] in or on the raw 

agricultural commodity filbert at 0.02 

parts per million (ppm). EPA has 

determined that the petition contains 

data or information regarding the 

elements set forth in section 408(d)(2) of 

the FFDCA; however, EPA has not fully 

evaluated the sufficiency of the 

submitted data at this time or whether 

the data supports granting of the 

petition. Additional data may be needed 

before EPA rules on the petition. 

A. Residue Chemistry 

1. Plant metabolism. The nature of the 

residue in fenarimol-treated filbert has 

not been directly determined. 

Radioactive metabolism studies with 

apples and cherries indicate that 

fenarimol is the only significant 

component of the residue in apples and 

cherries. The residue of concern in 

filbert is fenarimol. 

2. Analytical method. Analytical 

methodology used for filbert is a slight 

modification of the basic Pesticide 

analytical manual (PAM II) method for 

fenarimol (Method R039). Residues are 

extracted with methanol. Aqueous 

sodium chloride (5%) is added and the 

extract is partitioned with 

dichloromethane. Residues are cleaned 

up on a Florisil column and detected by 

Gas chromatography/electron capture 

detector (GC/ECD). Recoveries ranged 

from 84% to 97% in samples fortified 

with fenarimol at 0.02 ppm to 0.2 ppm. 

The limit of detection via this method 

is <0.02 ppm. 

3. Magnitude of residues. IR-4 data 

from 4 residue trials show residues of 

fenarimol were <0.02 ppm in composite 

samples of filbert treated at 0.09 pound 

of active ingredient per acre (lb ai/A) 

and composite samples treated at 0.18 lb 

ai/A or two times the proposed 

maximum application rate. The data 

indicates that fenarimol residues would 

not be expected to accumulate to 

significant levels in filbert. Based on 

these results and for purposes of this 

petition, it is appropriate to base the 

magnitude of total terminal residues and 

proposed tolerance only on residues of 

the parent compound, fenarimol. 

B. Toxicological Profile 

1. Acute toxicity. The acute oral lethal 

dose (LD50) in the rat is 2,500 milligrams 

per kilogram (mg/kg) and the acute 

dermal LD50 in the rabbit is >2,000 mg/ 

kg. The inhalation lethal concentration 

(LC50) in the rat is >2.04 mg/liter of air, 

which is the highest obtainable 

respirable aerosol concentration. 

Fenarimol produced no indications of 

dermal irritation in rabbits or 

sensitization in the guinea pig. End use 

formulations of fenarimol have similar 

low acute toxicity profiles. 

2. Genotoxicity. Fenarimol tested 

negative in several assay systems for 

gene mutation, structural chromosome 

aberration, and other genotoxic effects. 

In a micronucleus test in the mouse, 

fenarimol did produce a significant 

increase in the percent of polychromatic 

erythrocytes with micronucleus at 24 

hours but not at 48 or 72 hours. 

Moreover, a second test run at a higher 

dosage, which produced significant 

toxicity including death, was 

unequivocally negative. 

3. Reproductive and developmental 

toxicity. A developmental toxicity study 

in rabbits was negative for teratogenic 

effects at all doses tested (0, 5, 10, and 

35 mg/kg). A developmental toxicity 

study in rats demonstrated 

hydronephrosis at 35 mg/kg (doses 

tested were 0, 5, 10, and 35 mg/kg). A 

second developmental toxicity study in 

rats, with a postpartum evaluation, 

again demonstrated hydronephrosis at 

35 mg/kg. Maternal toxicity (decreased 

body weight) was also observed at the 

35 milligrams/kilogram/day (mg/kg/day) 

dose level. The no observed effect level 

(NOEL) for hydronephrosis and 

maternal toxicity is 13 mg/kg. 

4. Chronic toxicity. A 2–year chronic 

toxicity and carcinogenicity study in 

rats fed diets containing 0, 50, 130, or 

350 ppm (equivalent to 2.5, 6.5, or 17.5 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices 51805 

mg/kg/day) resulted in a systemic NOEL 

of 130 ppm, equivalent to 6.5 mg/kg/ 

day. An increase in fatty liver changes 

was observed in rats fed diets 

containing 350 ppm. There were no 

carcinogenic effects observed under the 

conditions of the study. 

A second 2–year carcinogenicity 

study was conducted in rats fed diets 

containing 0, 12.5, 25, or 50 ppm, 

equivalent to 0, 0.63, 1.25, or 2.5 mg/kg/ 

day. There was no apparent effect on 

survival, which was reduced in all 

treatment groups due to chronic 

respiratory disease. An increased 

incidence of fatty changes in the liver 

was observed at the top dose level of 50 

ppm, and the NOEL was established as 

25 ppm (1.2 mg/kg/day) in this study. A 

third 2–year carcinogenicity study was 

conducted at the same dose levels as 

above. The incidence of liver lesions 

was similar in the treated and control 

groups; thus the NOEL for liver effects 

in this study was greater than 50 ppm 

(2.5 mg/kg/day). 

A 2–year feeding study was 

conducted in mice fed diets containing 

concentrations of 0, 50, 170, or 600 

ppm, equivalent to 0, 7, 24.3, or 85.7 

mg/kg/day. The 600 ppm dose level was 

shown to increase liver weight. There 

was no increase in cancer, and no 

toxicologically significant treatment 

related effects were observed at any 

dose level. The NOEL was determined 

to be 600 ppm (85.7 mg/kg/day). 

In a 1–year chronic toxicity study, 

dogs were fed diets containing 0, 1.25, 

12.5, or 125 mg/kg/day. The NOEL was 

12.5 mg/kg/day based upon an increase 

in serum alkaline phosphatase, 

increased liver weights, an increase in 

p-nitroanisole o-demethylase activity, 

and mild hepatic bile stasis at the high 

dose level (125 mg/kg/day). 

Based on the chronic toxicity data, the 

chronic Reference Dose (RfD) for 

fenarimol is established at 0.0006 mg/ 

kg/day. The RfD for fenarimol is based 

on a 2–year chronic feeding study in 

rats with a NOEL of 6.5 mg/kg/day and 

an uncertainty factor of 1,000. For shortterm <35 day risk assessments to 

females 13-50 years old, the Agency 

selected a LOAEL of 35 mg/kg/day 

based upon decreased fertility and 

dystocia in rats and an uncertainty 

factor of 3,000. 

5. Animal metabolism. Metabolism 

studies conducted in rats show 

fenarimol is rapidly metabolized and 

excreted. Major metabolic pathways 

were oxidation of the carbinol-carbon 

atom, the phenyl rings and the 

pyrimidine ring. 

6. Endocrine disruption. In a 3–

generation reproduction study with rats 

and in subsequent special studies, 

fenarimol was determined to be a weak 

inhibitor of aromatase. Rats dosed at 0, 

12.5, 25, or 50 ppm (equivalent to 0, 

0.625, 1.25, or 2.5 mg/kg/day) 

demonstrated decreased fertility in 

males at 25 ppm and delayed 

parturition and dystocia in females at 25 

and 50 ppm. The NOEL for reproductive 

effects was 12.5 ppm (0.625 mg/kg/day). 

The infertility effect in males is 

considered to be a species-specific effect 

mediated by the inhibition of aromatase, 

an enzyme which catalyzes the 

conversion of testosterone to estradiol. 

Estradiol plays an essential role in the 

developmental and maintenance of 

sexual behavior in rats. 

Multi-generation reproduction studies 

in guinea pigs and mice were negative 

for reproductive effects at the highest 

dose levels tested, 35 mg/kg/day and 20 

mg/kg/day, respectively. A NOEL of 35 

mg/kg/day for reproductive effects 

relevant to humans was established 

based on the NOEL from the multigeneration reproduction study in guinea 

pigs. 

C. Aggregate Exposure 

1. Dietary exposure—i. Food. For the 

purposes of assessing the potential 

dietary exposure from use on filbert, an 

estimate of aggregate exposure is 

determined by basing the TMRC from 

previously established tolerances and 

the proposed tolerance on filbert for 

fenarimol at 0.02 parts per million 

(ppm) and assuming the 100% of the 

filbert crop has a residue of fenarimol at 

the tolerance level. 

Exposure of humans to residues could 

also result if such residues are 

transferred to meat, milk, poultry, or 

eggs. Since there is no livestock feed 

commodity associated with filbert, there 

is no reasonable expectation that 

measurable secondary residues of 

fenarimol will occur in meat, milk, 

poultry, or eggs under the terms of the 

proposed use. Other established 

tolerances for fenarimol on food or feed 

crops in the United States are 

established under 40 CFR 180.421. The 

use of a tolerance level and 100% of 

crop treated clearly results in an 

overestimate of human exposure and a 

safety determination for use on filbert 

that is based on conservative exposure 

assessment. 

ii. Drinking water. Based upon the 

available environmental studies 

conducted with fenarimol wherein its 

properties show little potential for 

mobility in soil and extremely rapid 

photolysis in water, there is no 

anticipated exposure to residues of 

fenarimol in drinking water. 

2. Non-dietary exposure. The 

proposed use on filbert involves 

application of fenarimol to a crop grown 

in an agricultural environment. Thus, 

the potential for non-occupational, nondietary exposure to the general 

population is not expected to be 

significant. There are no residential uses 

of fenarimol. 

D. Cumulative Effects 

There is no evidence that there is a 

common mechanism of toxicity with 

any other chemical compound or that 

potential toxic effects of fenarimol 

would be cumulative with those of any 

other pesticide chemical. Thus it is 

believed that it is appropriate to 

consider only the potential risks of 

fenarimol in its exposure assessment. 

E. Safety Determination 

1. U.S. population. It is concluded 

that aggregate exposure to fenarimol 

will utilize less than 2% of the chronic 

RfD for the U.S. general population and 

less than 14% of the acute RfD for 

females 13-50 at the 99.9 percentile 

level. EPA generally has no concern for 

exposures below 100% of the RfD 

because the RfD represents the level at 

or below which daily aggregate dietary 

exposure over a lifetime will not pose 

appreciable risks to human health. It is 

concluded that there is a reasonable 

certainty that no harm will result from 

aggregate exposure to fenarimol residues 

in or on filbert. 

2. Infants and children. In assessing 

the potential for additional sensitivity of 

infants and children to residues of 

fenarimol, data from developmental 

toxicity studies in rats and rabbits and 

a multigeneration reproduction study in 

the rat are considered. The 

developmental toxicity studies are 

designed to evaluate adverse effects on 

the developing organism resulting from 

pesticide exposure during prenatal 

development to one or both parents. 

Reproduction studies provide 

information relating to effects from 

exposure to the pesticide on the 

reproductive capability and potential 

systemic toxicity of mating animals and 

on various parameters associated with 

the well-being of offspring. 

FFDCA section 408 provides that EPA 

may apply an additional safety factor for 

infants and children in the case of 

threshold effects to account for pre- and 

post-natal toxicity and the completeness 

of the data base. Based on the current 

toxicological data requirements, the data 

base for fenarimol relative to pre- and 

post-natal effects for children is 

complete. Further, for fenarimol, the 

NOEL in the chronic feeding study 

which was used to calculate the RID (6.5 

mg/kg/day used by EPA or 1.2 mg/kg/ 

day used by The World Health 

51806 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices 

Organization) is already lower than the 

NOELs from the developmental studies 

in rats and rabbits. 

Concerning the multi-generation 

reproduction study, the effects on 

reproduction are considered to be 

specific effect caused by aromatase 

inhibition. The aromatase enzyme 

promotes normal sexual behavior in rats 

and mice, but not in guinea pigs or 

primates, including humans. A NOEL of 

35 mg/kg/day for reproductive effects 

relevant to humans was established 

based on the NOEL from the multigeneration reproduction study in guinea 

pigs. In addition, a NOEL of 13 mg/kg/ 

day for developmental effects was 

established based upon the NOEL from 

the teratology study in rats. Therefore, it 

is concluded that an additional 

uncertainty factor is not needed and that 

the RfD at 0.065 mg/kg/day is 

appropriate for assessing risk to infants 

and children. 

F. International Tolerances 

There is no Codex or national 

maximum residue level established for 

fenarimol on filbert. 

[FR Doc. 05–17195 Filed 8–30–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[OPP–2005–0223; FRL–7730–2] 

Pesticide Emergency Exemptions; 

Agency Decisions and State and 

Federal Agency Crisis Declarations 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: EPA has granted or denied 

emergency exemptions under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) for use of 

pesticides as listed in this notice. The 

exemptions or denials were granted 

during the period April 1, 2005 to June 

30, 2005 to control unforseen pest 

outbreaks. 

FOR FURTHER INFORMATION CONTACT: See 

each emergency exemption or denial for 

the name of a contact person. The 

following information applies to all 

contact persons: Team Leader, 

Emergency Response Team, Registration 

Division (7505C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–9366. 

SUPPLEMENTARY INFORMATION: EPA has 

granted or denied emergency 

exemptions to the following State and 

Federal agencies. The emergency 

exemptions may take the following 

form: Crisis, public health, quarantine, 

or specific. EPA has also listed denied 

emergency exemption requests in this 

notice. 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS 111) 

• Animal production (NAICS 112) 

• Food manufacturing (NAICS 311) 

• Pesticide manufacturing (NAICS 

32532) 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Copies of this 

Document and Other Related 

Information? 

1. Docket. EPA has established an 

official public docket for this action 

under docket identification (ID) number 

OPP–2005–0223. The official public 

docket consists of the documents 

specifically referenced in this action, 

any public comments received, and 

other information related to this action. 

Although a part of the official docket, 

the public docket does not include 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. The official public 

docket is the collection of materials that 

is available for public viewing at the 

Public Information and Records 

Integrity Branch (PIRIB), Rm. 119, 

Crystal Mall #2, 1801 South 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. 

2. Electronic access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

An electronic version of the public 

docket is available through EPA’s 

electronic public docket and comment 

system, EPA Dockets. You may use EPA 

Dockets at http://www.epa.gov/edocket/ 

to submit or view public comments, 

access the index listing of the contents 

of the official public docket, and to 

access those documents in the public 

docket that are available electronically. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Unit I.B.1. Once in 

the system, select ‘‘search,’’ then key in 

the appropriate docket ID number. 

II. Background 

Under FIFRA section 18, EPA can 

authorize the use of a pesticide when 

emergency conditions exist. 

Authorizations (commonly called 

emergency exemptions) are granted to 

State and Federal agencies and are of 

four types: 

1. A ‘‘specific exemption’’ authorizes 

use of a pesticide against specific pests 

on a limited acreage in a particular 

State. Most emergency exemptions are 

specific exemptions. 

2. ‘‘Quarantine’’ and ‘‘public health’’

exemptions are a particular form of 

specific exemption issued for 

quarantine or public health purposes. 

These are rarely requested. 

3. A ‘‘crisis exemption’’ is initiated by 

a State or Federal agency (and is 

confirmed by EPA) when there is 

insufficient time to request and obtain 

EPA permission for use of a pesticide in 

an emergency. 

EPA may deny an emergency 

exemption: If the State or Federal 

agency cannot demonstrate that an 

emergency exists, if the use poses 

unacceptable risks to the environment, 

or if EPA cannot reach a conclusion that 

the proposed pesticide use is likely to 

result in ‘‘a reasonable certainty of no 

harm’’ to human health, including 

exposure of residues of the pesticide to 

infants and children. 

If the emergency use of the pesticide 

on a food or feed commodity would 

result in pesticide chemical residues, 

EPA establishes a time-limited tolerance 

meeting the ‘‘reasonable certainty of no 

harm standard’’ of the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

In this document: EPA identifies the 

State or Federal agency granted the 

exemption or denial, the type of 

exemption, the pesticide authorized and 

the pests, the crop or use for which 

authorized, number of acres (if 

applicable), and the duration of the 

exemption. EPA also gives the Federal 

Register citation for the time-limited 

tolerance, if any.