Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 49599

II. Background

A. What Action is the Agency Taking?

EPA has reassessed the uses of 

procymidone, and on July 7, 2005, 

reached a tolerance reassessment 

decision for this pesticide. Procymidone 

is a fungicide used to treat wine grapes 

outside of the United States. A tolerance 

of 5 parts per million for wine grapes 

has been established, with no U.S. 

registrations, to permit the import of 

wine produced from procymidone 

treated grapes. Currently, procymidone 

exposures to the U.S. general population 

exist only through drinking imported 

wine made from procymidone treated 

grapes. Since there are no registered 

uses of procymidone in the U.S., no 

occupational, residential, or drinking 

water exposures are expected. EPA has 

not made a common mechanism of 

toxicity finding and therefore, has not 

assumed that procymidone has a 

common mechanism of toxicity with 

other substances for the purposes of this 

tolerance action.

The Agency is now issuing for 

comment the resulting Report on Food 

Quality Protection Act (FQPA) 

Tolerance Reassessment Progress and 

Risk Management Decision for 

procymidone, known as a TRED, as well 

as related risk assessments and 

technical support documents. EPA 

developed the procymidone TRED 

through a modified, streamlined version 

of its public process for making 

tolerance reassessment and 

reregistration eligibility decisions. 

Through these programs, the Agency is 

ensuring that pesticides meet current 

standards under the Federal Food, Drug, 

and Cosmetic Act (FFDCA) and the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), as amended 

by FQPA. EPA must review tolerances 

and tolerance exemptions that were in 

effect when the FQPA was enacted, to 

ensure that these existing pesticide 

residue limits for food and feed 

commodities meet the safety standard 

established by the new law. Tolerances 

are considered reassessed once the 

safety finding has been made or a 

revocation occurs. EPA has reviewed 

and made the requisite safety finding for 

the procymidone tolerance included in 

this notice.

EPA is applying the principles of 

public participation to all pesticides 

undergoing reregistration and tolerance 

reassessment. The Agency’s Pesticide 

Tolerance Reassessment and 

Reregistration; Public Participation 

Process, published in the Federal 

Register of May 14, 2004 (69 FR 26819) 

(FRL–7357–9), explains that in 

conducting these programs, the Agency 

is tailoring its public participation 

process to be commensurate with the 

level of risk, extent of use, complexity 

of issues, and degree of public concern 

associated with each pesticide. EPA can 

expeditiously reach decisions for 

pesticides like procymidone, which 

pose no risk concerns and require no 

risk mitigation. Once EPA assesses uses 

and risks for such pesticides, the 

Agency may go directly to a decision 

and prepare a document summarizing 

its findings, such as the procymidone 

TRED.

The tolerance reassessment program 

is being conducted under 

Congressionally mandated time frames, 

and EPA recognizes the need both to 

make timely decisions and to involve 

the public in finding ways to effectively 

mitigate pesticide risks. Procymidone, 

however, poses no risks that require 

mitigation. The Agency therefore is 

issuing the procymidone TRED, its risk 

assessments, and related support 

documents simultaneously for public 

comment. The comment period is 

intended to provide an opportunity for 

public input and a mechanism for 

initiating any necessary amendments to 

the TRED. All comments should be 

submitted using the methods in Unit I. 

of the SUPPLEMENTARY INFORMATION, and 

must be received by EPA on or before 

the closing date. These comments will 

become part of the Agency Docket for 

procymidone. Comments received after 

the close of the comment period will be 

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

consider these late comments.

EPA will carefully consider all 

comments received by the closing date 

and will provide a Response to 

Comments Memorandum in the Docket 

and electronic EDOCKET. If any 

comment significantly affects the 

document, EPA also will publish an 

amendment to the TRED in the Federal 

Register. In the absence of substantive 

comments requiring changes, the 

decisions reflected in the TRED will be 

implemented as presented. 

B. What is the Agency’s Authority for 

Taking this Action?

Section 408(q) of the FFDCA, 21 

U.S.C. 346a(q), requires EPA to review 

tolerances and exemptions for pesticide 

residues in effect as of August 2, 1996, 

to determine whether the tolerance or 

exemption meets the requirements of 

section 408(b)(2) or (c)(2) of FFDCA. 

This review is to be completed by 

August 3, 2006.

List of Subjects

Environmental protection, Pesticides 

and pests.

Dated: August 15, 2005.

Debra Edwards,

Director, Special Review and Reregistration 

Division, Office of Pesticide Programs.

[FR Doc. 05–16685 Filed 8–23–05; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

[OPP–2005–0206; FRL–7726–3]

Fipronil; 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–

0206, must be received on or before 

September 23, 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: Ann 

Sibold, Registration Division (7505C), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 703 

305–6502; e-mail 

address:sibold.ann@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by 

this action if you 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 

49600 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 

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–

0206. 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 

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. 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–2005–0206. 

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–

2005–0206. 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.

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 49601

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–2005–0206.

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–2005–0206. 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 

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 15, 2005.

Donald R. Stubbs,

Acting 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.

BASF Corporation

5F6948 and 2E6490

EPA has received a pesticide petition 

(5F6948) from BASF Corporation, P.O. 

Box 13528, Research Triangle Park, NC 

27709 proposing, pursuant to section 

408(d) of the Federal Food, Drug, and 

Cosmetic Act (FFDCA), 21 U.S.C. 

346a(d), to amend 40 CFR 180.517 by 

establishing a tolerance for residues of 

mixture comprising fipronil, 5-amino-1-

[2,6-dichloro-4-

(trifluoromethyl)phenyl]-4-[(1R,S)-

(trifluoromethyl)sulfinyl]-1H-pyrazole3-carbonitrile and its metabolites 5-

amino-1-[2,6-dichloro-4-

(trifluoromethyl)phenyl]-4-

[(trifluoromethyl) sulfonyl]-1Hpyrazole-3-carbonitrile and 5-amino-1-

[2,6-dichloro-4-

(trifluoromethyl)phenyl]-4-

[(trifluoromethyl)thio]-1H-pyrazole-3-

carbonitrile and its photodegradate 5-

amino-1-[2,6-dichloro-4-

(trifluoromethyl)phenyl]-4-[(1R,S)-

(trifluoromethyl)]-1H-pyrazole-3-

carbonitrile in or on the raw agricultural 

commodity corm vegetables (crop group 

1-C at 0.04 parts per million (ppm), and 

indirect and inadvertent residues on 

wheat, grain at 0.005 and wheat, forage 

at 0.02 ppm and wheat, hay and straw 

at 0.03 ppm. EPA has received a 

pesticide petition 2E6490 from The 

Interregional Research Project No. 4 (IR4), Technology Centre of New Jersey, 

Rutgers, the State University of New 

Jersey, 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 180.517 by establishing a tolerance 

for residues of mixture comprising 

fipronil, 5-amino-1-[2,6-dichloro-4-

(trifluoromethyl)phenyl]-4-[(1R,S)-

trifluoromethyl)sulfinyl]-1H-pyrazole-3-

carbonitrile) and its metabolites 5-

amino-1-[2,6-dichloro-4-

(trifluoromethyl)phenyl]-4-

[(trifluoromethyl) sulfonyl]-1Hpyrazole-3-carbonitrile and 5-amino-1-

[2,6-dichloro-4-

(trifluoromethyl)phenyl]-4-

[(trifluoromethyl)thio]-H-pyrazole-3-

carbonitrile and its photodegradate 5-

amino-1-[2,6-dichloro-4-

(trifluoromethyl)phenyl]-4-[(1R,S)-

(trifluoromethyl)]-1H-pyrazole-3-

carbonitrile in or on the raw agricultural 

commodities onion (dry bulb), garlic, 

shallot (dry bulb) at 0.02 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 metabolism 

of fipronil is adequately understood. 

Adequate data on the nature of the 

residues in both plant and animals, 

including identification of major 

49602 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 

metabolites and degradates of fipronil, 

are available. In plants and animal the 

metabolism of fipronil proceeds via 

oxidation of the sulfoxide to yield 

sulfone and hydrolysis of nitrile to yield 

the amide. Fipronil and its sulfone and 

amide constitute greater than 75% of the 

identified residues in all studies. A 

limited amount of reduction of 

sulfoxide to yield the sulfide occurs in 

some cases. Further transformation of 

primary metabolites affords minor 

amounts of carboxylic acid, the amide 

and the 4-protopyrazole.

2. Analytical method. Validated 

analytical methods are available for 

detecting and measuring levels of 

fipronil and its metabolites in onion, 

dry bulb, potato (corm vegetables) and 

its processing fractions and wheat grain, 

forage, hay, and straw. The Method 

utilizes Capillary Gas Chromatography 

equipped with a Ni electron capture 

detector. The Limit of Quantitation 

(LOQ) for all potato matrices is 0.003 

ppm for all analytes. The LOQ for onion 

is 0.005 for all analytes.

3. Magnitude of residues. Field trials 

were carried out in order to determine 

the magnitude of residue in potato. 

Field trials were conducted in the 

required regions. Field trials were 

carried out using the maximum label 

rate of 0.1 lbs active ingredient (a.i.) per 

acre applied in furrow followed by four 

sequential foliar applications at 0.05 lbs 

a.i. per acre. The results demonstrate 

that any residue present would originate 

from the in-furrow not the foliar 

applications. In addition a processing 

study was conducted on potatoes. 

Onion field trials were conducted in the 

required regions. The application was 

by seed treatment at 25 grams of active 

ingredient/kilogram (g a.i./Kg) of seed. 

Twelve field trials were conducted 

where wheat was planted following 

application to primary crops. 

Applications rates were 0.13 lbs a.i. per 

acre in-furrow for six corn trials and 0.2 

lbs a.i. per acre foliar for six cotton 

trials.

B. Toxicological Profile

1. Acute toxicity. For technical 

fipronil:

Oral LD50 Rat LD50 = 97 mg/kg b.w. category II/(moderately toxic)

Dermal LD50 Rat LD50 >2,000 mg/kg b.w. 

(HDT)

category III (slightly toxic)

Dermal LD50 Rabbit LD50 = 354 mg/kg b.w. category II(moderately toxic)

Inhalation LC50 Rat LC50 = 0.39 mg/L category II(moderately toxic)

Eye Irritation Rabbit slight irritation category III

Skin Irritation Rabbit slight irritation category IV

Skin Sensitization (Maximization Test) Guinea pig Not sensitizing

Acute Neurotoxicity Rat NOAEL = 2.5 mg/kg/day (for 

general toxicity)

2. Genotoxicity. Fipronil was negative 

in both in vitro and in vivo assays 

conducted to investigate gene 

mutations, DNA damage, and 

chromosomal aberrations.

3. Reproductive and developmental 

toxicity. The developmental toxicity 

NOELs in the rat and rabbit were 20 mg/

kg/day (HDT) and 1 mg/kg/day (HDT), 

respectively. Maternal toxicity was 

observed in the rat at the HDT as 

evidenced by decreased body weight 

gain and food efficiency. In the rabbit, 

the maternal toxicity NOAEL was less 

than 0.1 mg/kg/day, based on reduced 

body weight gain and food efficiency at 

all dose levels tested. In a twogeneration rat study, the NOEL for 

parental (systemic) toxicity was 3 ppm 

(0.26 mg/kg/day for both sexes 

combined), based on increased weight 

of the thyroid glands and liver in males 

and females, decreased weight of the 

pituitary gland in females, and an 

increased incidence of follicular 

epithelial hypertrophy in females at 30 

ppm. The NOEL for reproductive 

toxicity was 30 ppm (2.64 mg/kg/day for 

both sexes combined), based on clinical 

signs of toxicity in pups, decreased litter 

size, decreased pup body weights, 

decreased mating, decreased fertility 

index, reduced pre- and postnatal 

survival, and delays in physical 

development at 300 ppm (26.03 and 

28.40 mg/kg/day for males and females, 

respectively).

In a developmental neurotoxicity 

study in the rat, the NOAEL for 

maternal toxicity was 10 ppm (0.91 mg/

kg/day), based on decreased body 

weights and body weight gain at 200 

ppm (HDT; 15 mg/kg/day). Considerable 

maternal toxicity at the HDT prevented 

adequate neurotoxicity evaluation of 

pups at this dose level. There was no 

evidence of neurotoxicity at 10 ppm 

(0.91 mg/kg/day), which was the 

NOAEL for developmental 

neurotoxicity. The NOAEL for general 

developmental toxicity was 0.5 ppm 

(0.05 mg/kg/day), based on systemic 

effects consisting of decreases in pup 

weights during lactation and increases 

in time of preputial separation in males 

at 10 ppm.

4. Subchronic toxicity. The NOAEL 

for systemic toxicity in rat was 5 ppm 

(0.35 mg/kg/day for both sexes 

combined), based on alterations in 

serum protein values and increased 

weight of the liver and thyroid at 30 

ppm (1.93 and 2.28 mg/kg/day for males 

and females, respectively). The NOAELs 

in the dog were 2 and 0.5 mg/kg/day for 

male and female, respectively, based on 

clinical signs of toxicity in males at 10 

mg/kg/day and clinical signs of toxicity 

and decreased body weight gain in 

females at 2 mg/kg/day. The NOAEL for 

mice was 10 ppm (1.27 and 1.72 mg/kg/

day for males and females, respectively), 

based on a possible decreased body 

weight gain at 25 ppm (3.2 and 4.53 mg/

kg/day for males and females, 

respectively). A repeated dose dermal 

study in the rabbit had a systemic 

NOAEL of 5 mg/kg/day, based on 

decreased body weight gain and food 

consumption at 10 mg/kg/day, and a 

dermal irritation NOEL of 10.0 mg/kg/

day (HDT).

In a subchronic neurotoxicity study in 

rats, the NOEL was 5 ppm (0.301 and 

0.351 mg/kg/day for males and females, 

respectively), based on results of the 

functional observational battery (FOB) 

at 150 ppm (8.89 and 10.8 mg/kg/day for 

males and females, respectively).

5. Chronic toxicity. The NOAEL for 

systemic toxicity in a 1–year feeding 

study in the dog was 0.3 mg/kg/day in 

females and 1 mg/kg/day in males, 

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 49603

based on clinical signs of neurotoxicity 

at 1 and 2 mg/kg/day in females and 

males, respectively. The NOAEL for 

systemic toxicity in mice was 0.5 ppm 

(0.06 mg/kg/day) based on decreased 

body weight gain, decreased food 

conversion efficiency in males, 

increased liver weights, and liver 

histopathology at 10 ppm (1.3 mg/kg/

day). Fipronil was not carcinogenic 

when administrated to mice at dose 

levels up to 60 ppm. The NOAEL in a 

2–year dietary study in the rat was 0.5 

ppm (0.019 and 0.025 mg/kg/day for 

males and females, respectively) based 

on clinical signs of toxicity and 

alterations in clinical chemistry and 

thyroid parameters at 1.5 ppm (0.059 

and 0.078 mg/kg/day for males and 

females, respectively). The EPA’s Health 

Effects Division Carcinogenicity Peer 

Review Committee classified fipronil in 

Group C - Possible Human Carcinogen, 

based on thyroid tumors observed in 

rats at 300 ppm (HDT). Mechanistic data 

indicate that these tumors are related to 

a disruption in the thyroid-pituitary 

status and are specific to the rat. In 

addition, there was no apparent concern 

for mutagenic activity. Thus, it was 

recommended that RfD methodology, 

i.e. non-linear or threshold, be used for 

the estimation of human risk.

6. Animal metabolism. The 

metabolism of fipronil is adequately 

understood. Adequate data on the 

nature of residues in both plants and 

animals, including identification of 

major metabolites and degradates of 

fipronil, are available. In plants and 

animals the metabolism of fipronil 

proceeds via oxidation of the sulfoxide 

to yield sulfone and hydrolysis of nitrile 

to yield the amide. Fipronil and its 

sulfone and amide constitute greater 

than 75% of the identified residues in 

all studies. A limited amount of 

reduction of sulfoxide to yield the 

sulfide occurs in some cases. Further 

transformation of the primary 

metabolites affords minor amounts of 

the carboxylic acid, the amide and the 

4-protiopyrazole.

7. Metabolite toxicology. MB46513 

photodegradate acute oral toxicity:

Oral LD50 Rat LD50 = 

16 mg/kg 

b.w.

category I 

(highly 

toxic)

Dermal LD50 Rabbit 

LD50 >

2,000 

mg/kg 

b.w. 

(HDT)

category 

III 

(slightly 

toxic)

i. Acute neurotoxicity. The NOEL was 

2 mg/kg, based on decreases in body 

weight gain and food consumption in 

males and females during the week 

following treatment, decreases in 

locomotor activity, hind-limb splay and 

rectal temperature 6–hour post dosing 

in males and females, and decreases in 

the proportion of males with an 

immediate righting reflex on days 7 and 

14, at 12 mg/kg/day.

In a rat developmental toxicity study, 

the NOEL was 1 mg/kg/day, based on 

the slight increase in fetal and litter 

incidence of reduced ossification of 

several bones at 2.5 mg/kg/day.

ii. Subchronic toxicity. The NOAEL in 

the rat was 3 ppm (0.18 and 0.21 mg/

kg/day in males and females, 

respectively), based on clinical signs of 

toxicity in both sexes and decreased 

body weight and body weight gain in 

males at 10 ppm. The NOEL for the 

mouse was 0.5 ppm (0.08 mg/kg/day), 

based on the aggressive and irritable 

behavior with increased motor activity 

in males at 2 ppm. The NOEL for the 

dog was 9.5 ppm (0.29 mg/kg/day), 

based on behavioral changes in females 

at 35 ppm (1.05 mg/kg/day).

The rat chronic/carcinogenicity study 

was negative for carcinogenicity. The 

LOAEL for females was 0.5 ppm (0.032 

mg/kg/day), based on clinical signs of 

toxicity. There was no NOEL 

established. For males, the NOAEL was 

2 ppm (0.098 mg/kg/day), based on 

clinical signs of toxicity, and stomach 

and lung histopathology at 10 ppm 

(0.497 mg/kg/day). No thyroid effects 

are observed in any of the rat, mouse or 

dog studies with MB46513, supporting 

the conclusion that there is no concern 

for cancer due to exposure to MB46513.

8. Endocrine disruption. Data from the 

reproduction/ developmental toxicity 

and short- and long-term repeated dose 

toxicity studies with fipronil in the rat, 

rabbit, mouse, or dog, do not suggest 

any endocrine disruption activity. This 

information is based on the absence of 

any treatment-related effects from the 

histopathological examination of 

reproductive organs as well as the 

absence of possible effects on fertility, 

reproductive performance, or any other 

aspect of reproductive function, or on 

growth and development of the 

offspring. Evidence of offspring toxicity 

was observed only in the presence of 

significant parental toxicity. Fipronil 

disrupts the thyroid-pituitary axis. 

However, mechanistic studies have 

demonstrated that fipronil decreases 

thyroid hormone levels in long-term 

studies via increased clearance, rather 

than a direct effect on the thyroid. 

Concerns related to long-term exposure 

of fipronil are addressed in human risk 

estimates, as the chronic RfD (0.0002 

mg/kg/day) is based on endpoints that 

include thyroid hormone related effects 

in rats.

C. Aggregate Exposure

1. Dietary exposure. An assessment 

was conducted to determine the acute 

and chronic exposure of all population 

sub-groups to residues of fipronil. 

Tolerance values have previously been 

established and are listed in 40 CFR 

180.517.

This analysis included all crops with 

established tolerance values and the 

proposed new crops of white potato, 

sweet potato, onion bulb, garlic, shallot 

bulb and the inadvertent residue 

tolerance on wheat grain. The dietary 

exposure assessment for crops with 

established tolerances was conducted by 

the U.S. Environmental Protection 

Agency in 2001 (PP# 7F04832. Fipronil 

in/on Cotton. HED Risk Assessment. 

Barcode D248827; PC Code 129121; 

Case 288765 ; submission S547814). 

Using these dietary exposure values is 

conservative because the registration for 

fipronil on cotton was withdrawn, and 

the dietary exposure assessment 

conducted by HED included all 

currently registered uses and the 

proposed cotton use. Using the HED 

exposure values is conservative 

(overestimates actual exposure) because 

the cotton use and all requested 

modifications to existing tolerances 

were included in the dietary exposure 

assessment.

The dietary exposure assessment for 

white potato, sweet potato, onion bulb, 

garlic, and shallot bulb were conducted 

using tolerance level residues, default 

processing factors, and 100% crop 

treated factors. These assumptions are 

conservative because it assumes all 

commodities will be at tolerance level 

and 100% of the crop has been treated 

with fipronil. The dietary exposure 

assessment for the inadvertent residues 

in wheat grain was conducted using 

tolerance level residues, default 

processing factors, and a 7% crop 

treatment factor. The U.S. EPA used a 

7% crop treatment factor for corn in the 

dietary exposure assessment. The 

tolerance for wheat grain is from 

inadvertent residues that would occur 

when wheat is planted following a 

fipronil treatment of corn. Therefore, the 

7% crop treatment factor applies to 

wheat inadvertent residues.

The dietary exposure assessments 

were conducted using the Dietary 

Exposure Evaluation Model software 

with Food Commodity Intake Database 

(DEEM-FCID).

i. Food—a. Acute dietary exposure 

assessment. The acute population 

adjusted dose (aPAD) used was 0.025 

mg/kg bw/day. Using the exposure 

49604 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 

assumptions discussed above, the 

maximum fipronil acute dietary 

exposure from food is 11% aPAD. The 

results of the acute dietary assessment 

are presented in Table 1.

TABLE 1.—COMBINATION OF THE

ACUTE DEEMTM DIETARY ANALYSIS AT 95TH PERCENTILE FOR

FIPRONIL CONDUCTED BY THE US 

EPA FOR EXISTING USES AND

BASF FOR THE USE ON WHITE AND

SWEET POTATOES

Subgroups Exposure (mg/

kg bw/day) % aPADa

U.S. Population 0.001495 6

All Infants 

(<1 year 

old) 0.002502 10

Children 

(1–6 

years 

old) 0.002859 11

Children 

(7–12 

years 

old) 0.001814 7

Females 

(13–50 

years 

old) 0.0009342 4

Males (13–

19 years 

old) 0.001332 5

Males (20+ 

years 

old) 0.000962 4

Seniors 

(55+ 

years 

old) 0.0007642 3

a The aPAD = 0.025 mg/kg bw/day.

b. Chronic dietary exposure 

assessment. The chronic population 

adjusted dose (cPAD) used was 0.0002 

mg/kg bw/day. Using the exposure 

assumptions discussed above, the 

maximum fipronil chronic dietary 

exposure from food is 56% cPAD. The 

results of the chronic dietary assessment 

are presented in Table 2.

TABLE 2.—COMBINATION OF THE

CHRONIC DEEM TM DIETARY ANALYSIS FOR FIPRONIL CONDUCTED BY

THE U.S. EPA FOR EXISTING USES

AND BASF FOR THE USE ON WHITE

AND SWEET POTATOES

Subgroups 

Exposure 

(mg/kg bw/

day) 

% cPADa

U.S. Population 0.0000546 27

All Infants (< 1 

year old) 0.0000685 34

Children (1–6 

years old) 0.0001114 56

Children (7–

12 years 

old) 0.0000738 37

Females (13–

50 years 

old) 0.0000420 21

Males (13–19 

years old) 0.0000619 31

Males (20+ 

years old) 0.0000494 25

Seniors (55+ 

years old) 0.0000425 21

a The cPAD = 0.0002 mg/kg bw/day.

ii. Drinking water. The drinking water 

values used for comparison to the 

DWLOC (Drinking Water Level of 

Comparison) can be calculated from 

model estimates or actual monitoring 

data. When modeling was conducted, 

the currently registered corn use 

resulted in the highest predicted 

estimated water concentrations. If 

monitoring data is available it can be 

used instead of model predictions. A 

drinking water monitoring study for 

fipronil and relevant metabolites in 

surface water from the corn growing 

regions has beenconducted (MRID 

45526101). Therefore, these actual 

measured drinking water values will be 

used in the drinking water assessment. 

The ground water values model by the 

EPA when the cotton use was examined 

will also be used for comparison. Based 

on the tier I screening model SCI-GROW 

(screening concentration in ground 

water), the acute ground water value 

will not exceed 0.061 ppb (0.032 μg/L 

for fipronil, 0.012 μg/L for MB46136, 

0.016 μg/L for MB46513, and 0.001 μg/

L for MB45950). This value of 0.061 ppb 

is also used for chronic ground water 

comparisons.

In the drinking water monitoring 

study, water samples were collected 

from 12 municipal water treatment 

facilities. The water treatment facilities 

were selected based on the source of 

water and the previousdocumented use 

of fipronil in the watershed area. Raw 

and finished water samples were collect 

at each water treatment site. The 

samples were collected on regular 

intervals between April and August. 

The water samples wereanalyzed for 

firponil and metabolites: MB45950, 

MB46136, and MB46513. The LOQ for 

the method was 10 parts per trillion 

(ppt) and the LOD was 4 ppt. No 

residues were detected in any of the 

finished water samples and no 

confirmed fipronil-related residues were 

found in any of the raw samples. This 

study showed that the use of fipronil in 

corn production does not pose a risk to 

surface drinking water.

a. Acute aggregate exposure and risk 

(food and water). The acute dietary risk 

associated with the existing fipronil 

uses and the proposed use of white and 

sweet potatoes does not exceed a level 

of concern. The estimated exposure at 

the 95th percentile uses ≤ 11% of the 

aPAD (Table 1). The surface water and 

ground water estimated concentrations 

were used to compare to the DWLOC. 

The estimated water concentrations are 

less than the calculated DWLOC (Table 

3). Therefore, it can be concluded with 

reasonable certainty that residues of 

fipronil and metabolites in drinking 

water do not contribute significantly to 

the acute aggregate human health risk.

TABLE 3.—ACUTE AGGREGATE EXPOSURE FOR THE USE OF FIPRONIL ON WHITE POTATOES, SWEET POTATOES, AND ALL

EXISTING USES

Population Subgroup aPAD mg/

kg/day 

Dietary Exposure1, 

mg/kg/day 

Allowable 

Drinking 

Water Exposure2, mg/

kg/day 

DWLOC, 

ppb 

Surface 

Water3, ppb 

Ground 

Water EEC, 

ppb 

U.S. Population 0.025 0.001495 0.023505 823 0.04 0.061

All Infants (< 1 year old) 0.025 0.002502 0.022498 225 0.04 0.061

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 49605

TABLE 3.—ACUTE AGGREGATE EXPOSURE FOR THE USE OF FIPRONIL ON WHITE POTATOES, SWEET POTATOES, AND ALL

EXISTING USES—Continued

Population Subgroup aPAD mg/

kg/day 

Dietary Exposure1, 

mg/kg/day 

Allowable 

Drinking 

Water Exposure2, mg/

kg/day 

DWLOC, 

ppb 

Surface 

Water3, ppb 

Ground 

Water EEC, 

ppb 

Children (1-6 years old) 0.025 0.002859 0.022141 221 0.04 0.061

Children (7-12 years old) 0.025 0.001814 0.023186 232 0.04 0.061

Females (13-50 years old) 0.025 0.0009342 0.024066 722 0.04 0.061

Males (13-19 years old) 0.025 0.001332 0.023668 828 0.04 0.061

Males (20+ years old) 0.025 0.000962 0.024038 841 0.04 0.061

Seniors (55+ years old) 0.025 0.0007642 0.024236 848 0.04 0.061

1 The dietary exposure values are from Table 1. 2 Allowable Drinking Water Exposure (mg/kg/day) = aPAD (mg/kg/day) - Acute Dietary Exposure (mg/kg/day). 3 The surface water concentration is the sum of the LOQ for fipronil, and metabolites: MB45950, MB46136, and MB46513 (0.04 μg/L = 0.01 + 

0.01 + 0.01 + 0.01).

b. Short- and intermediate-term 

aggregate exposure and risk (food, water 

and residential exposure). Short- and 

intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure from food and 

water. Aggregation of systemic oral, 

dermal and inhalation exposure from 

the residential use is not appropriate 

due to differences in the toxicity 

endpoints observed between oral 

(neurotoxicity and alterations in clinical 

chemistry and thyroid parameters), 

dermal (decrease in body weight gain 

and food consumption) and inhalation 

(developmental effects including 

decreases in pup weights during 

lactation and increases in time of 

preputial separation) routes. Also, there 

is no significant post-application 

exposure to adults. However, postapplication exposure to children is 

included in the exposure assessment.

Post-application exposure of children 

can occur from three scenarios: (1) 

Incidental ingestion of fipronil pellets or 

granules; (2) incidental ingestion of soil 

(hand to mouth) from fipronil treated 

residential areas; and (3) incidental 

ingestion (hand to mouth) of fipronil 

from treated pets. EPA’s OPP Health 

Effects Division believes that exposure 

from scenario 1 is episodic and is only 

a one time occurrence and episodic 

exposure is not aggregated with food 

and water. Exposure from scenario #3 (3 

x 10-5 mg/kg/day) is greater that 

scenario #2 (1.2 x 10-6 mg/kg/day) and 

therefore this exposure will be 

aggregated with food and water 

exposure.

The short- and intermediate-term 

exposure risk assessment was only 

determined for the most highly exposed 

subpopulation which is children 1-6 

years old (Table 4). The target MOE for 

short- and intermediate- term exposure 

risk assessment is 300 and therefore, the 

maximum allowable exposure is 

0.00033 mg/kg bw/day (LOAEL, 0.1/300 

safety factor). The short- and 

intermediate term MOE for children 1-

6 years of age is 707 which is greater 

than 300. Also, the calculated DWLOC 

is greater than the predicted chronic 

surface and ground water 

concentrations. Therefore, taking into 

account all registered uses and the 

white and sweet potato uses, it can be 

concluded with reasonable certainty 

that residues of fipronil and metabolites 

in drinking water will not result in 

short- and intermediate-term aggregate 

human health risks.

TABLE 4.—SHORT- AND INTERMEDIATE-TERM AGGREGATE EXPOSURE AND DWLOC CALCULATIONS FOR CHILDREN 1–6 

YEARS OLD FOR THE USE OF FIPRONIL ON WHITE POTATOES, SWEET POTATOES, AND ALL EXISTING USES

Max Exposure1, mg/kg/day 

Chronic 

Food Exposure2, mg/

kg/day 

Residential 

Exposure3, 

mg/kg/day 

Short-and 

IntermediateTerm Aggregate 

MOE(food 

and Residential)4

Maximum 

Water Exposure, mg/kg/

day5

DWLOC, 

ppb 

Surface 

Water6, 

ppb 

Ground 

Water 

EEC, ppb 

0.00033 0.0001114 0.00003 707 0.0001886 1.886 0.04 0.061

1 Maximum Exposure (mg/kg/day) = LOAEL / Targer MOE (0.1 / 300). 2 Chronic food exposure for children 1–6 years of age is from Table 2. 3 Residential exposure is for incidental ingestion (hand to mouth) of fipronil from treated pets. 4 Aggregater MOE = [LOAEL/(chronic food exposure + residential exposure)]. 5 ;Maximum water exposure (mg/kg/day) = Target maximum exposure - (Food exposure and Residential exposure). 6 The surface water concentration is the sum of the LOQ for fipronil, and metabolites: MB45950, MB46136, and MB46513 (0.04 μg/L = 0.01 + 

0.01 + 0.01 + 0.01).

c. Chronic aggregate exposure and 

risk (food and water). The chronic 

dietary risk associated with the existing 

fipronil uses and the proposed use of 

white and sweet potatoes does not 

exceed a level of concern. The estimated 

exposures for all subpopulations are ≤

56% of the cPAD (Table 2). The surface 

water and ground water estimated 

49606 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 

concentrations were used to compare to 

the DWLOC. The estimated water 

concentrations are less than the 

calculated DWLOC (Table 5). Therefore, 

it can be concluded with reasonable 

certainty that residues of fipronil and 

metabolites in drinking water do not 

contribute significantly to the chronic 

aggregate human health risk.

TABLE 5.—CHRONIC AGGREGATE EXPOSURE FOR THE USE OF FIPRONIL ON WHITE POTATOES, SWEET POTATOES, AND

ALL EXISTING USES

Population Subgroup cPAD,/mg/

kg/day 

Dietary Exposure 1, 

mg/kg/day 

Allowable 

Drinking 

Water Exposure 2, mg/

kg/day 

DWLOC, 

ppb 

Surface 

Water 3, 

ppb 

Ground 

Water EEC, 

ppb 

U.S. Population 0.0002 0.0000546 0.0001454 5.09 0.04 0.061

All Infants (< 1 year old) 0.0002 0.0000685 0.0001315 1.32 0.04 0.061

Children (1–6 years old) 0.0002 0.0001114 0.0000886 0.89 0.04 0.061

Children (7–12 years old) 0.0002 0.0000738 0.0001262 1.26 0.04 0.061

Females (13–50 years old) 0.0002 0.0000420 0.0001580 4.74 0.04 0.061

Males (13–19 years old) 0.0002 0.0000619 0.0001381 4.83 0.04 0.061

Males (20+ years old) 0.0 002 0.0 000494 0.000 1506 5. 27 0.04 0.061

Seniors (55+ years old) 0.0002 0.0000425 0.0001575 5.51 0.04 0.061

1 The dietary exposure values are from Table 2. 2 Allowable Drinking Water Exposure (mg/kg/day) = aPAD (mg/kg/day) - Acute Dietary Exposure (mg/kg/day). 3 The surface water concentration is the sum of the LOQ for fipronil, and metabolites: MB45950, MB46136, and MB46513 (0.04 μg/L = 0.01 

+ 0.01 + 0.01 + 0.01)]

2. Non-dietary exposure. The 

residential exposure for fipronil 

products was assessed by the U.S. EPA 

in the cotton risk evaluation in 2001.

i. Pet products. The residential 

exposure for the Frontline pet 

products was assessed. The residential 

exposure for the Frontline pet 

products was determined based on the 

following submitted studies: (1) Dermal 

and Inhalation Exposure of Commercial 

Pet Groomers During the Application of 

Frontline Spray Treatment (MRID 

#44433302), (2) Dermal Exposure of 

Commercial Pet Groomers During the 

Application of Frontline and Top 

Spot (MRID 44433303), and four 

studies examining the dislodgeable 

residues of fipronil following the spray 

and spot treatment application to dogs 

and cats (MRID 4443330–09). Based on 

these studies, HED determined the 

dermal and inhalation exposure for 

residential applicators were 3.0 x 10-3

mg/kg bw/day and 1.78 x 10-6 mg/kg 

bw/day, respectively. The non-dietary, 

oral (hand to mouth) was estimated to 

be no greater than 3.0 x 10-5 mg/kg bw/

day. The post-application dermal 

exposure for toddlers was estimated to 

be 1.0 x 10-3 mg/kg bw/day. The MOEs 

for all exposure scenarios evaluated 

were greater than 1500.

ii. Fire ant products. The applicator 

exposure was determine using the 

‘‘Draft Standard Operating Procedures 

for Residential Exposure’’ (December 18, 

1997). The greatest homeowner 

applicator exposure was calculated from 

the application of the granular product 

with a drop spreader. The average daily 

dose for dermal and inhalation exposure 

were 6.0 x 10-4 mg/kg bw/day and 1.3 

x 10-6 mg/kg bw/day, respectively. The 

MOEs for all exposure scenarios were ≥

8,000.

Post-application from the fire ant 

granular products can occur from 

dermal exposure and ingestion of 

granules from treated soil and/or 

ingestion of treated soil by children. 

Based on a submitted dislodgeable foliar 

residue study (MRID 44506901), HED 

concluded that fipronil cannot be 

dislodged from treated turf and postapplication exposure from turf will not 

occur. HED calculated exposure to 

children from the ingestion of granules 

in the treated area to be 2.8 x 10-3 mg/

kg bw/day which resulted in a MOE of 

890. The post-application exposure to 

children from ingestion of treated soil 

was calculated to be 1.2 x 10-6 mg/kg 

bw/day which resulted in a MOE of 

83,000.

HED concluded that there are no risk 

concerns for fipronil from the 

residential uses.

D. Cumulative Effects

Section 408(b)(2)(D)(v) 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.

The EPA is currently developing 

methodology to perform cumulative risk 

assessments. At this time, there are no 

available data to determine whether 

fipronil has a common mechanism of 

toxicity with other substances or how to 

include this pesticide in a cumulative 

risk assessment.

E. Safety Determination

1. U.S. population. Based on this risk 

assessment, BASF concludes that there 

is a reasonable certainty that no harm 

will result to the general population 

from the aggregate exposure to fipronil.

2. Infants and children. Based on this 

risk assessment, BASF concludes that 

there is a reasonable certainty that no 

harm will result to infants or children 

from the aggregate exposure to fipronil 

residues.

F. International Tolerances

The following maximum residue 

levels (MRLs) have been established by 

the Codex Alimentarius Commission 

(CODEX) for fipronil residues on the 

following plant commodities: banana, 

0.005 mg/kg; barley 0.002 mg/kg; 

cabbage, head, 0.02 mg/kg; flowerhead 

brassicas, 0.02 mg/kg; maize 0.01 mg/kg; 

maize fodder 0.1 mg/kg; maize forage 

0.1; oats, 0.002 mg/kg; potato 0.02 mg/

kg; rice 0.01 mg/kg; rice, straw and 

fodder, dry, 0.2 mg/kg; rye 0.002 mg/kg; 

sugar beet 0.2 mg/kg; sugar beet leaves 

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 49607

or tops, 0.2 mg/kg; sunflower seed, 

0.002 mg/kg; triticale, 0.002 mg/kg; 

wheat 0.002 mg/kg.

The following maximum residue 

levels (MRLs) have been established by 

the Codex Alimentarius Commission 

(CODEX) for fipronil residues on the 

following animal commodities: cattle, 

kidney 0.02 mg/kg; cattle liver 0.1 mg/

kg; cattle meat 0.05 mg/kg; eggs 0.02 

mg/kg; poultry meat 0.01 mg/kg; 

poultry, edible offal, 0.02 mg/kg.

[FR Doc. 05–16807 Filed 8–23–05; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

[OPP–2005–0212; FRL–7728–3]

Emamectin; 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–

0212, must be received on or before 

September 23, 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:

Thomas Harris, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9423; e-mail 

address:harris.thomas@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to:

• Crop production (NAICS code 

111)

• Animal production (NAICS code 

112)

• Food manufacturing (NAICS code 

311) 

• Pesticide manufacturing (NAICS 

code 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–

0212. 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 

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. 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 on 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