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 

49608 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 

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–2005–0212. 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–

2005–0212. 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–2005–0212.

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–2005–0212. 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 9, 2005.

Lois Rossi,

Director, Registration Division, Office of 

Pesticide Programs.

Summary of Petition

The petitioner’s summary of the 

pesticide petition is printed below as 

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

The summary of the petition was 

prepared by Syngenta Crop Protection, 

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 

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 49609

measurement of the pesticide chemical 

residues or an explanation of why no 

such method is needed.

Syngenta Crop Protection

PP 3F6574

EPA has received a pesticide petition 

(3F6574) from Syngenta Crop 

Protection, Inc., P.O. Box 18300, 

Greensboro, NC 27419 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 part 

180 by establishing tolerances for 

residues of emamectin benzoate, 4’-epimethylamino- 4’-deoxyavermectin B1

benzoate (a mixture of a minimum of 

90% 4’-epi-methylamino-4’- 

deoxyavermectin B1a and a maximum of 

10% 4’-epi-methlyamino4’deoxyavermectin B1b benzoate), and 

its metabolites 8,9 isomer of the B1a and 

B1b component of the parent insecticide 

in or on the raw agricultural 

commodities pome fruit at 0.02 parts 

per million (ppm).

A. Residue Chemistry

1. Plant metabolism. The metabolism 

of emamectin benzoate in plants has 

been studied and the nature of the 

residue has been determined in lettuce, 

cabbage, and sweet corn. The major 

portion of the residue is parent 

compound and its delta 8,9-

photoisomer. The metabolism of 

emamectin has also been investigated in 

goats and poultry to characterize the fate 

of residues that may be present in 

animal feed items.

2. Analytical method. Adequate 

analytical methods (High Production 

Liquid Chromatography -fluorescence 

methods) are available for enforcement 

purposes.

3. Magnitude of residues. The 

appropriate number of residue trials has 

been conducted for the representative 

commodities of the pome fruit crop 

group (Crop Group 11). Those 

representative commodities are apples 

and pears. These trials were conducted 

in the major U.S. growing areas for these 

crops. Processing studies were 

conducted to provide wet apple pomace 

and juice for analysis and to determine 

if a tolerance in these commodities is 

necessary.

B. Toxicological Profile

A full description of the studies 

describing the toxicity, animal 

metabolism, metabolite toxicology, and 

endocrine disruption of emamectin 

benzoate can be found in the posting for 

its first tolerances in the Federal 

Register. (64 FR 27192–27200, May 19, 

1999).

C. Aggregate Exposure

1. Dietary exposure. A Tier III acute 

and chronic dietary exposure evaluation 

was made using the Dietary Exposure 

Evaluation Model (DEEMTM, version 

7.76 from Exponent. Empirically 

derived processing studies for apple 

juice (0.27X), apple wet pomace (3.79X), 

cottonseed meal (0.12X), cottonseed oil 

(0.43X), tomato puree (0.32X), and 

tomatoes after washing (0.53X) were 

used in these assessments. The apple 

juice processing factor was used as a 

surrogate for pear juice; all other 

processing factors used DEEMTM

defaults. All consumption data for these 

assessments were taken from the 

USDA’s Continuing Survey of Food 

Intake by individuals (CSFII) with the 

1994–96 consumption database and the 

Supplemental CSFII children’s survey 

(1998) consumption database. These 

exposure assessments included all 

registered and pending uses on crops, 

including leafy vegetables (crop group 

4), head and stem Brassica vegetables 

(crop group 5A), Brassica leafy 

vegetables (crop group 5B), fruiting 

vegetables (crop group 8), pome fruit 

(crop group 11), cotton, and turnip tops. 

Secondary residues in animal 

commodities were estimated based on 

theoretical worst-case, yet nutritionally 

adequate, animal diets and transfer 

information from feeding studies.

i. Food. For the purposes of assessing 

the potential dietary exposure under the 

proposed tolerances, Syngenta Crop 

Protection has estimated aggregate 

exposure from all crops for which 

tolerances are established or proposed. 

These assessments utilized residue data 

from field trials where emamectin 

benzoate was applied at the EPAapproved maximum use rate and 

samples were harvested at the minimum 

pre-harvest interval to maximize 

anticipated residues. Percent of crop 

treated values were estimated based 

upon economic, pest and competitive 

pressures. The values used in these 

assessments were: Turnip tops 100%, 

celery 100%, Brassica vegetables 100%, 

tomatoes 11%, head lettuce 52%, leafy 

vegetables 5.9%, peppers 20%, cotton 

2.3%, and pome fruit 35%.

a. Acute exposure. An acute reference 

dose (aRfD) for emamectin benzoate of 

0.00025 milligrams/kilogram body 

weight/day (mg/kg bwt/day) for infants, 

children, and females 13 years and older 

was based upon a 0.075 mg/kg bwt/day 

NOAEL from a 15–day neurotoxicity 

study in mice, using an uncertainly 

factor of 100X. An additional Food 

Quality Protection Act (FQPA) safety 

factor of 3X was also applied. For the 

purpose of aggregate risk assessment, 

the exposure value was expressed in 

terms of margin of exposure (MOE), 

which was calculated by dividing the no 

observable effect level (NOAEL) by the 

exposure for each population subgroup. 

In addition, exposure was expressed as 

a percent of the acute reference dose (% 

aRfD). Acute exposure to the most 

exposed sub-population (children 1 and 

2 years old) resulted in a MOE of 403 

(74% of the aRfD of 0.00025 mg/kg bwt/

day). Since the benchmark MOE for this 

assessment was 300, and since EPA 

generally has no concern for exposures 

below 100% of the RfD, Syngenta 

believes that there is a reasonable 

certainty that no harm will result from 

dietary (food) exposure to residues 

arising from the current uses and the 

proposed pome fruit use for emamectin 

benzoate.

b. Chronic exposure. A chronic 

reference dose (cRfD) for emamectin 

benzoate of 0.000083 mg/kg bwt/day for 

infants, children, and females 13 years 

and older was based upon a 0.075 mg/

kg bwt/day NOAEL from a 15–day 

neurotoxicity study in mice, using an 

uncertainly factor of 100X. An FQPA 

safety factor of 3X was also applied, 

plus an additional 3X safety factor for 

use of a toxicology study of short 

duration. The emamectin benzoate Tier 

III chronic dietary exposure assessment 

was based upon residue field trial 

results. For the purpose of aggregate risk 

assessment, the exposure values were 

expressed in terms of MOE, which was 

calculated by dividing the no observable 

effect level (NOAEL) by the exposure for 

each population subgroup. In addition, 

exposure was expressed as a percent of 

the reference dose %RfD. Chronic 

exposure to the most exposed subpopulation (children 1 and 2 years old) 

resulted in a MOE of 4,411 (21% of the 

cRfD of 0.000083 mg/kg bwt/day). Since 

the benchmark MOE for this assessment 

was 900, and since EPA generally has 

no concern for exposures below 100% 

of the RfD, Syngenta believes that there 

is a reasonable certainty that no harm 

will result from dietary (food) exposure 

to residues arising from the current and 

proposed uses for emamectin benzoate.

ii. Drinking water—a. Chronic 

exposure. The estimated maximum 

concentrations of emamectin benzoate 

in surface and ground water are 0.02 

parts per billion (ppb), (Pesticide Root 

Zone Model/Exposure Modeling System 

(PRZM/EXAMS)) and 0.0005 ppb 

(screening concentration in ground 

water (SCI-GROW)), respectively. The 

chronic PAD for emamectin benzoate is 

0.000083 mg/kg bwt/day for the females 

13+ years, infants’ and children’s 

subgroups and 0.00025 mg/kg bwt/day 

for all other population subgroups. 

49610 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 

From the chronic dietary exposure 

analysis, the highest exposure estimate 

of 0.000017 mg/kg bwt/day was 

determined for the children’s (1–2 years 

old) subgroup. Based on EPA’s ‘‘Interim 

Guidance for Conducting Drinking 

Water Exposure and Risk Assessments’’ 

document (December 2, 1997), chronic 

drinking water levels of comparisons 

(DWLOCs) for emamectin benzoate were 

calculated to be 0.7 ppb for the 

children’s (1–2 years old) subgroup. 

Based on this analysis, emamectin 

benzoate estimated environmental 

concentrations (EECs) do not exceed the 

calculated chronic DWLOC.

b. Acute exposure. The estimated 

maximum concentrations of emamectin 

benzoate in surface and ground water 

are 0.1 ppb PRZM/EXAMS and 0.0005 

ppb SCI-GROW, respectively. The acute 

population adjusted dose (aPAD) for 

emamectin benzoate is 0.00025 mg/kg 

bwt/day for the females 13+ years, 

infants’ and children’s subgroups and 

0.00075 mg/kg bwt/day for all other 

population subgroups. From the acute 

dietary exposure analysis, the highest 

acute food exposure from the uses of 

emamectin benzoate was 0.000186 mg/

kg/day (children 1–2 years old) at the 

99.9th percentile of exposures. Using 

this information, acute DWLOC for 

emamectin benzoate was calculated to 

be 0.6 ppb for the children’s (1–2 years 

old) subgroup. Based on this analysis, 

emamectin benzoate EECs do not exceed 

the calculated acute DWLOC.

2. Non-dietary exposure. No products 

containing emamectin benzoate are 

registered under the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

for any non-food use. No significant 

non-dietary, non-occupational exposure 

is anticipated.

3. Aggregate Exposure. Based on the 

completeness and reliability of the 

toxicity data supporting these petitions, 

Syngenta believes that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to 

residues arising from all current and 

proposed emamectin benzoate uses, 

including anticipated dietary exposure 

from food, water, and all other types of 

non-occupational exposures.

D. Cumulative Effects

Emamectin benzoate is synthetically 

derived from avermectin, which is 

derived from Streptomyces avermitilus.

Streptomyces avermitilus produces the 

insecticide avermectin, which is a 

mixture of two homologs, avermectin 

B1a and B1b, each having equal 

biological activity. Currently, the only 

other member of this class that is 

registered for agricultural uses is 

abamectin. Abamectin and ivermectin 

are structurally similar to emamectin. 

EPA does not have, at this time, data to 

determine whether emamectin benzoate 

has a common mechanism of toxicity 

with other substances or the means to 

include this pesticide in a cumulative 

risk assessment. Unlike other pesticides 

for which EPA has followed a 

cumulative risk approach based upon a 

common mechanism of toxicity, 

emamectin benzoate does not appear to 

produce a toxic metabolite that is 

produced by other substances. For the 

purpose of this tolerance action; 

therefore, Syngenta has assumed that 

emamectin benzoate does not have a 

mechanism of toxicity common to these 

other substances.

E. Safety Determination

1. U.S. population—i. Acute risk.

Exposure to emamectin benzoate 

residues in food will occupy no more 

than 74% of the aPAD for the most 

sensitive population subgroup (children 

1–2 years old). Residue values used for 

these dietary risk assessments were from 

field trials and did incorporate percent 

of crop treated information. Acute 

dietary exposure estimates were 

determined at the 99.9th percentile of 

acute exposures. Estimated 

concentrations of emamectin residues in 

surface and ground water are lower than 

the DWLOC. Therefore, Syngenta does 

not expect acute aggregate risk to 

emamectin benzoate residues from food 

and water sources to exceed the level of 

concern for acute dietary exposure.

ii. Chronic risk. The chronic dietary 

exposure to emamectin residues in food 

is no more than 21% for the most 

sensitive population subgroup (children 

1–2 years old). Residue values used for 

these dietary risk assessments were from 

field trials and did incorporate percent 

of crop treated information, as indicated 

above. The estimated concentrations of 

emamectin residues in surface and 

ground water are lower than the 

DWLOC. The expected chronic 

aggregate risk to emamectin residues 

from food and water sources would not 

be expected to exceed the level of 

concern for chronic dietary exposure.

Syngenta has considered the potential 

aggregate exposure from food, water and 

non-occupational exposure routes and 

concluded that aggregate exposure is not 

expected to exceed 100% of the acute 

and chronic reference doses. Thus there 

is a reasonable certainty of no harm to 

infants and children from the aggregate 

exposure to residues of emamectin 

benzoate in food and water.

2. Infants and children. For 

emamectin benzoate, the Agency has 

determined that the 10x safety factor for 

the protection of infants and children 

should be reduced to 3x. The rationale 

for reducing the FQPA Safety Factor is 

based on the fact that no increased 

susceptibility was demonstrated in rats 

or rabbits following in utero and/or 

postnatal exposure to emamectin.

Although, increased susceptibility 

was demonstrated in a developmental 

neurotoxicity study in rats, the EPA 

determined that the 10x factor should be 

reduced to 3x based on the following 

weight-of-the-evidence considerations 

in the developmental neurotoxicity 

study:

i. The LOAEL was based on a single 

effect/end point (i.e., decrease in open 

field motor activity).

ii. The effect at the LOAEL was seen 

only on postnatal day 17 and was not 

seen either on earlier day 13 or later day 

21 evaluations whereas at the high dose 

(3.6/2.5 mg/kg/day), this effect was seen 

on postnatal days 13 and 17;

iii. The effect at the LOAEL was not 

accompanied with other toxicity 

whereas at the high dose, tremors and 

hind limb splay were also seen.

iv. The decreased performance was 

lower only when compared to the 

concurrent control, and;

v. There were limited (only 2 studies) 

historical control data available for 

comparison.

Syngenta believes that the clinical 

signs of avermectin-family based 

neurotoxicity seen in neonatal rats are 

unlikely to be useful predictors of 

human risk. Young rats are considerably 

more sensitive to avermectin-type 

compounds than either adult rats or 

humans and other primates. (In neonatal 

rats, unlike humans, the P-glycoprotein 

levels are only a small fraction of the 

levels seen in adult rats.) Moreover, data 

from clinical experience with 

ivermectin, a related human drug, and 

studies on ivermectin and abamectin, a 

related pesticide, demonstrate that both 

the neonatal rat and the CF–1 mouse 

overpredict the toxicity of the 

avermectin-type compounds to humans 

and to non-human primates.

3. Conclusion. There is a complete 

toxicity database for emamectin 

benzoate and exposure data is complete 

or is conservatively estimated based on 

data that reasonably accounts for 

potential exposures. Based on these risk 

assessments, Syngenta concludes that, 

there is a reasonable certainty that no 

harm will result to infants and children 

from aggregate exposure to emamectin 

benzoate residues.

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 49611

F. International Tolerances

No codex maximum residue levels 

(MRLs) have been established for 

residues of emamectin benzoate.

[FR Doc. 05–16806 Filed 8–23–05; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–7958–5] 

Florida Petroleum Reprocessors 

Superfund Site; Notice of Proposed 

Settlement

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Notice of proposed de minimis 

settlement. 

SUMMARY: Under section 122(g)(4) of the 

Comprehensive Environmental 

Response Compensation and Liability 

Act (CERCLA), the Environmental 

Protection Agency has offered a de 

minimis settlement at the Florida 

Petroleum Reprocessors Superfund Site 

(Site) located in Davie, Florida. EPA 

will consider public comments until 

September 23, 2005. EPA may withdraw 

from or modify the proposed settlement 

should such comments disclose facts or 

considerations which indicated the 

proposed settlement is inappropriate, 

improper, or inadequate. Copies of the 

proposed settlement are available from: 

Ms. Paula V. Batchelor, U.S. 

Environmental Protection Agency, 

Region 4, Superfund Enforcement & 

Information Management Branch, Waste 

Management Division, 61 Forsyth 

Street, SW., Atlanta, Georgia 30303, 

(404) 562–8887, E-mail: 

Batchelor.Paula@EPA.gov.

Written or e-mail comments may be 

submitted to Paula V. Batchelor at the 

above address within 30 days of the date 

of publication.

Dated: August 10, 2005. 

Rosalind H. Brown, 

Chief, Superfund Enforcement & Information 

Management Branch, Waste Management 

Division.

[FR Doc. 05–16812 Filed 8–23–05; 8:45 am] 

BILLING CODE 6550–60–P

FEDERAL COMMUNICATIONS 

COMMISSION 

Public Information Collections 

Approved By Office of Management 

and Budget 

August 9, 2005.

SUMMARY: The Federal Communications 

Commission (FCC) has received Office 

of Management and Budget (OMB) 

approval for the following public 

information collections pursuant to the 

Paperwork Reduction Act of 1995, 

Public Law 104–13. An agency may not 

conduct or sponsor and a person is not 

required to respond to a collection of 

information unless it displays a 

currently valid control number.

FOR FURTHER INFORMATION CONTACT: Paul 

J. Laurenzano, Federal Communications 

Commission, 445 12th Street, SW., 

Washington, DC 20554, (202) 418–1359 

or via the Internet at plaurenz@fcc.gov.

SUPPLEMENTARY INFORMATION: 

OMB Control No.: 3060–0806. 

OMB Approval date: 11/12/2004. 

Expiration Date: 11/30/2007. 

Title: Universal Service—Schools and 

Libraries Universal Service Program. 

Form No.: FCC 470. FCC 471. 

Estimated Annual Burden: 60,000 

responses; 480,000 total annual burden 

hours; approximately .166–4.5 hours 

average per respondent. 

Needs and Uses: In 1997 the 

Commission adopted rules providing 

support for the Universal Service 

Schools and Libraries Support 

Mechanism (E-rate Program). FCC 

Forms 470 and 471 are required to 

determine eligibility by schools and 

libraries for discounts under the 

program, so that they can purchase 

telecommunications services, internet 

access, internal connections, and 

maintenance services. Pursuant to 

suggestions from the Department of 

Justice, the Commission is now 

implementing changes to its FCC Forms 

470 and 471 in an effort to prevent 

waste, fraud and abuse in the program. 

The changes made to the FCC Forms 

470 and 471 will make the E-Rate 

process more transparent, and will make 

transgressions of the law easier to detect 

and prosecute.

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary.

[FR Doc. 05–16335 Filed 8–23–05; 8:45 am] 

BILLING CODE 6712–01–P

FEDERAL COMMUNICATIONS 

COMMISSION 

Notice of Public Information 

Collection(s) Being Reviewed by the 

Federal Communications Commission 

for Extension Under Delegated 

Authority 

August 10, 2005.

SUMMARY: The Federal Communications 

Commission, as part of its continuing 

effort to reduce paperwork burden 

invites the general public and other 

Federal agencies to take this 

opportunity to comment on the 

following information collection(s), as 

required by the Paperwork Reduction 

Act of 1995, Public Law 104–13. An 

agency may not conduct or sponsor a 

collection of information unless it 

displays a currently valid control 

number. No person shall be subject to 

any penalty for failing to comply with 

a collection of information subject to the 

Paperwork Reduction Act (PRA) that 

does not display a valid control number. 

Comments are requested concerning (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

Commission, including whether the 

information shall have practical utility; 

(b) the accuracy of the Commission’s 

burden estimate; (c) ways to enhance 

the quality, utility, and clarity of the 

information collected; and (d) ways to 

minimize the burden of the collection of 

information on the respondents, 

including the use of automated 

collection techniques or other forms of 

information technology.

DATES: Persons wishing to comment on 

this information collection should 

submit comments October 24, 2005. If 

you anticipate that you will be 

submitting comments, but find it 

difficult to do so within the period of 

time allowed by this notice, you should 

advise the contact listed below as soon 

as possible.

ADDRESSES: You may submit your 

Paperwork Reduction Act (PRA) 

comments by email or U.S. postal mail. 

To submit you comments by e-mail send 

them to: PRA@fcc.gov. To submit your 

comments by U.S. mail, mark it to the 

attention of Leslie F. Smith, Federal 

Communications Commission, 445 12th 

Street, SW., Room 1–A804, Washington, 

DC 20554.

FOR FURTHER INFORMATION CONTACT: For 

additional information about the 

information collection(s) send an email 

to PRA@fcc.gov or contact Leslie F. 

Smith at (202) 418–0217.

SUPPLEMENTARY INFORMATION: 

OMB Control Number: 3060–0532. 

Title: Scanning Receiver Compliance 

Exhibit, Section 2.1033 (b)(10) and 

Section 15.121. 

Form Number: N/A. 

Type of Review: Extension of a 

currently approved collection. 

Respondents: Not-for-profit 

institutions; Business or other for-profit; 

and State, Local or Tribal Government. 

Number of Respondents: 40. 

Estimated Time per Response: 1 hour. 

Frequency of Response:

Recordkeeping, On occasion reporting 

requirement; Third party disclosure.