58166 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Notices 

product to be used on all food 

commodities.

2. File Symbol: 70950–U. Applicant: 

AVA Chemical Ventures, L,L.C. Product 

Name: Avachem Sorbitol Octanoate 

Manufacturing Use Product. Insecticide. 

Active ingredient: Sorbitol Octanoate at 

90.35%. Proposed classification/Use: 

None. For manufacturing use only.

List of Subjects

Environmental protection, Pesticides 

and pest.

Dated: September 17, 2004.

Janet L. Andersen,

Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs.

[FR Doc. 04–21805 Filed 9–28–04; 8:45am] 

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

[OPP–2004–0311; FRL–7679–1]

Sorbitol Octanoate; 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–2004–

0311 must be received on or before 

October 29, 2004.

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:

Denise Greenway, Biopesticides and 

Pollution Prevention Division (7511C), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8263; e-mail address: 

greenway.denise@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 identification (ID) number 

OPP–2004–0311. 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.1. EPA 

intends to work towards providing 

electronic access to all of the publicly 

available docket materials through 

EPA’s electronic public docket.

For public commenters, it is 

important to note that EPA’s policy is 

that public comments, whether 

submitted electronically or 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.

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Notices 58167

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–2004–0311. 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–

2004–0311. 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–2004–0311. 

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–2004–0311. 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: September 16, 2004.

Janet L. Andersen,

Director, Biopesticides and Pollution 

Prevention 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 AVA Chemical Ventures, 

58168 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Notices 

L.L.C. 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.

AVA Chemical Ventures, L.L.C.

PP 2E6389

EPA has received a peticide petition 

(PP 2E6389) from AVA Chemical 

Ventures, L.L.C., 80 Rochester Avenue, 

Suite 214, Portsmouth, NH 03801. This 

petition proposes, 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 the residues 

of the insecticide sorbitol octanoate in 

or on all food agricultural commodities.

A. Product Name and Proposed Use 

Practices

Sorbitol octanoate is a fatty acid ester 

made with sorbitol and caprylic acid 

derived from edible oils and fats. It is a 

contact insecticide that is effective 

against soft-bodied insects and mites. 

The modes of action are physical, 

whereby the surfactant effect of sorbitol 

octanoate either causes rapid 

suffocation or de-waxes the cuticle of 

the target insect, causing it to lose body 

fluids and dessicate.

Sorbitol octanoate is sprayed in a 

water solution at a rate of 0.5–1.0% 

volume/volume throughout the growing 

season to control soft-bodied insects and 

mites. Treatments may be applied up to 

the day of harvest.

B. Product Identity/Chemistry 

1. Identity of the pesticide and 

corresponding residues. Sorbitol 

octanoate is manufactured by the 

esterification of sorbitol, a food-grade 

sweetener, and caprylic acid derived 

from 21 CFR-approved edible oils or 

fats. Sorbitol is a hexahydric alcohol 

with about half the sweetness of sucrose 

that occurs naturally in many plants, 

including cherries, plums, pears, apples 

and seaweeds. Caprylic acid (octanoic 

acid) is obtained from coconut oil or 

palm kernel oil where it is present in 

concentrations of 5.8% and 3–4.5%, 

respectively.

Sorbitol octanoate is chemically 

similar to certain sorbitan esters which 

are approved by the Food and Drug 

Administration (FDA) for direct 

addition to food for human 

consumption (21 CFR 172.836, 172.838, 

172.840 and 172.842). The only 

difference between the sorbitan esters 

and sorbitol octanoate is in the degree 

that water has been removed from the 

main sorbitol structure.

Following use as a plant insecticide, 

sorbitol octanoate hydrolyzes rapidly 

into its starting ingredients, sorbitol and 

caprylic acid which biodegrade rapidly 

in the environment.

2. Magnitude of residue at the time of 

harvest and method used to determine 

the residue. Rapid hydrolysis and 

biodegradation ensure that the residue 

of sorbitol octanoate at time of harvest 

will be minor.

3. A statement of why an analytical 

method for detecting and measuring the 

levels of the pesticide residue are not 

needed. An analytical method for 

residues is not applicable as this 

petition proposes an exemption from 

the requirement of a tolerance.

C. Mammalian Toxicological Profile 

Sorbitol octanoate is chemically 

similar to certain sorbitan esters and 

sucrose fatty acid esters which are 

approved for use as food emulsifiers and 

post-harvest protective fruit coatings. 

Both sorbitan esters and sucrose fatty 

acid esters have been examined in a 

number of toxicological studies 

prepared in connection with their 

approval by the FDA and other 

regulatory bodies. 

1. Acute toxicity. Sorbitan esters, 

sucrose fatty acid esters and 

sucroglycerides were evaluated by the 

World Health Organization (WHO) for 

acceptable daily intake (ADI) for man in 

1969, 1973, 1976, 1980, and 1982.

WHO Food Additive Series No. 17 

(1982), titled, ‘‘Sorbitan Monoesters of 

Palmitic, Stearic, Oleic and Lauric 

Acids and Triesters of Stearic Acid,’’

examined available animal feeding 

studies and concluded that a daily 

intake in the diet of the rat of 50,000 

parts per million (ppm) (5%) causes no 

toxicological effect. This level of intake 

is equivalent to 2,500 milligrams/

kilogram (mg/kg) of body weight (bwt). 

An estimate of acceptable daily intake 

in man is 0–25 milligrams/kilogram 

(mg/kg) of body weight. 

WHO Food Additive Series No. 15 

(1980), titled, ‘‘Toxicological Evaluation 

of Certain Food Additives,’’ reports on 

the results of sucrose fatty acid esters 

administered in short-term feeding 

studies to dogs and a long-term feeding 

study of rats. No effects attributable to 

the ingestion of sucrose fatty acid esters 

were found in any of the studies. The 

WHO concluded the ingestion level in 

rat to be 10,000 ppm (1.0%) in the diet, 

equivalent to 500 mg/kg of bwt.

The American Chemical Council’s 

Aliphatic Esters Panel evaluated the 

mammalian toxicity of the sorbitan 

esters that are approved for food and 

cosmetic ingredient use. The Panel 

concluded that metabolism of the 

sorbitan esters in animals occurs via 

enzymatic hydrolysis to sorbitan and 

the corresponding natural fatty acids. 

These substances in turn metabolize 

further to either smaller and more polar 

water-soluble metabolites excretable in 

the urine or as carbon dioxide exhaled 

in the lungs.

Primary eye irritation studies were 

performed on rabbits by AVA Chemical 

Ventures, L.L.C. with manufacturing use 

product (MUP) sucrose octanoate fatty 

acid esters and with MUP sorbitol 

octanoate. MUP sucrose fatty acid esters 

were found to be severely irritating to 

the eye and sorbitol octanoate was 

found to cause substantial but 

temporary eye injury.

Primary skin irritation studies 

performed on rabbits by AVA Chemical 

Ventures, L.L.C. with MUP and end use 

product (EUP) sucrose octanoate fatty 

acid esters were submitted to EPA in 

connection with the registration of that 

compound as a pesticide active 

ingredient. Both the MUP and the EUP 

were found to be slightly irritating to the 

skin.

The Cosmetic Ingredient Review 

Expert Panel published a 

comprehensive review of sorbitan fatty 

acid esters titled, ‘‘Final Report on the 

Safety Assessment of Sorbitan 

Caprylate, Sorbitan Cocoate, Sorbitan 

Diiostearate, Sorbitan Dioleate, Sorbitan 

Distearate, Sorbitan Isostearate, Sorbitan 

Olivate, Sorbitan Sesquiiostearate, 

Sorbitan Sesquistearate and Sorbitan 

Triiostearate,’’ International Journal of 

Toxicology. (2002). The study 

concluded that the sorbitan fatty acid 

esters were generally minimal to mild 

skin irritants in various animal studies 

and were generally not ocular irritants. 

The Expert Panel concluded that the 

sorbitan fatty acid esters are safe as used 

in cosmetic formulations at 

concentrations of up to 20%.

2. Genotoxicity. The components of 

sorbitol octanoate (sorbitol and caprylic 

acid) already have regulatory approval 

and are commonly consumed in foods. 

Caprylic acid (octanoic acid) is 

approved by the FDA as a generally 

recognized as safe (GRAS) substance 

and direct food additive. (21 CFR 

184.1025 and 21 CFR 172.860). Sorbitol 

has been affirmed as GRAS by the FDA 

and is widely used as a sweetener in 

foods (21 CFR 184.1835).

3. Reproductive and developmental 

toxicity. Sorbitol octanoate is 

chemically similar to sucrose fatty acid 

esters. In 1976, in WHO Food Additive 

Series No. 10, the WHO reported on the 

results of a reproduction study over 

three generations of rats using sucrose 

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Notices 58169

fatty acid esters at 0 and 1% of the diet 

for control and test groups, respectively. 

Mean litter size, physical appearance 

and growth of litter were comparable 

among test and control groups.

A 1986 study concluded that sorbitol 

administered in the diet to three 

successive generations of rats at levels 

up to 10% had no adverse effect on 

growth or reproductive performance in 

either sex.

4. Subchronic toxicity. WHO Food 

Additive Series No. 15 (1980) reports 

the findings of a study in which sucrose 

fatty acid esters made from beef tallow 

were fed to beagle dogs at 

concentrations of 3,000, 10,000, or 

30,000 ppm for 26 weeks. A control 

group was fed an identical diet with the 

exception of the sucrose fatty acid 

esters. Body weight changes, food 

intake, and water consumption were not 

affected by the administration of the 

esters. The opthalmic and haemotologic 

examinations, urinalysis, organ weights, 

and macroscopic examinations revealed 

no adverse effects which could be 

attributed to the intake of the sucrose 

fatty acid esters. The blood chemistry 

studies showed that the majority of 

parameters measured were within 

acceptable limits.

5. Chronic toxicity. An unpublished 

paper titled ‘‘Study of Chronic Toxicity 

of a Sucrose Ester of Fatty Acids’’

(undated) was submitted to the FDA in 

connection with the registration of 

sucrose fatty acid esters as food 

additives. For up to 76, weeks mice and 

rats were fed standard feed to which 

had been added up to 3.0% sucrose fatty 

acid esters. Animals were examined for 

body weight, feed consumption, 

hematological findings, organ weights, 

and histopathology of organs. No 

particular changes resulting from 

administration of sucrose fatty acid 

esters were found.

6. Animal metabolism. Sorbitol 

octanoate is manufactured from fatty 

acids produced from 21 CFR-approved 

edible fats and oils.

7. Metabolite toxicology. The 

components of sorbitol octanoate 

(sorbitol and caprylic acid) already have 

regulatory approval and are commonly 

used in foods. Caprylic acid (octanoic 

acid) is obtained from coconut oil or 

palm kernel oil where it is present at 

concentrations of 5.8% and 3.0–4.5%, 

respectively. Caprylic acid (octanoic 

acid) is approved by the FDA as a GRAS 

substance and direct food additive (21 

CFR 184.1025 and 21 CFR 172.860).

D. Aggregate Exposure

1. Dietary exposure—i. Food. Sorbitol 

octanoate is chemically similar to 

certain sorbitan esters which are FDAapproved for direct addition to food for 

human consumption (21 CFR 172.842, 

172 836, 172.838, 172.840) and to 

sucrose fatty acid esters which are FDAapproved as food emulsifiers and as 

coatings for certain fruits (21 CFR 

172.859). 

The FAO/WHO Joint Expert 

Committee on Food Additives has 

evaluated sorbitan monoesters of 

palmitic, stearic, oleic and lauric acids, 

and triesters of stearic acids and has 

established an acceptable ADI of 0–25 

mg/kg bwt/day. The FAO/WHO has 

established an acceptable ADI of 10 mg/

kg of bwt for sucrose fatty acid esters.

Current world consumption of 

sucrose fatty acid esters in food 

applications is estimated to be 7,000 

metric tons and consumption of sorbitan 

esters in food applications is estimated 

to be 50,000 metric tons. Pesticide use 

of sorbitol octanoate and sucrose fatty 

acid esters would increase usage by 

approximately 2,000 metric tons. As the 

ester bond is one of the weakest in 

nature, the sorbitol octanoate applied to 

crops will hydrolyze into its constituent 

ingredients which will themselves 

biodegrade prior to consumption of the 

crops to which it is applied.

ii. Drinking water. No drinking water 

exposure is anticipated as sorbitol 

octanoate is not soluble in water and 

biodegrades rapidly following use. 

2. Non-dietary exposure. Nonoccupational, non-dietary exposure is 

highly unlikely given that inhalation or 

dermal absorption of sorbitol octanoate 

are not feasible. 

E. Cumulative Exposure 

Sorbitol octanoate is a non-toxic 

material made from edible starting 

materials (sorbitol and caprylic acid), 

which are commonly consumed in 

foods. Sorbitol octanoate biodegrades 

rapidly following use. A cumulative risk 

assessment is therefore not necessary. 

F. Safety Determination 

1. U.S. population. Sorbitol octanoate 

is manufactured from raw materials 

(sorbitol and caprylic acid) that are 

affirmed as GRAS and are commonly 

used in foods. Sorbitol octanoate is 

chemically similar to sorbitan esters 

which are FDA-approved under 21 CFR 

172.842, 172.836, 172.838, and 172.840 

for direct addition to food for human 

consumption and to sucrose fatty acid 

esters which are approved as food 

emulsifiers and fruit coatings under 21 

CFR 172.859 and to certain sorbitan 

esters which are approved under 21 CFR 

172.842, 172.836, 172.838, and 172.840 

for direct addition to food for human 

consumption. Based on these materials’

low-risk profiles, there is reasonable 

certainty that no harm to the U.S. 

population will result from aggregate 

exposure to sorbitol octanoate used as 

an insecticide.

2. Infants and children. Sorbitol 

octanoate is manufactured from edible 

raw materials that are widely used in 

foods. Sorbitol octanoate is chemically 

similar to sorbitan esters which are 

approved for direct addition to food for 

human consumption and to sucrose 

fatty acid esters that are approved for 

use as food emulsifiers and as protective 

coatings applied to fruits. Due to the 

extensive data base documenting the 

low toxicity of the sorbitan esters and 

the sucrose fatty acid esters, AVA 

Chemical Ventures, L.L.C. does not 

believe a safety factor analysis is 

necessary in assessing the risk of 

sorbitol octanoate used as an 

insecticide. For the same reason, AVA 

Chemical Ventures, L.L.C. believes an 

additional safety factor analysis is 

unnecessary. 

G. Effects on the Immune and Endocrine 

Systems

Sorbitol octanoate is not derived from 

nor contains any compounds which are 

known to be, or suspected to be, 

endocrine disruptors. 

H. Existing Tolerances

Sorbitol octanoate esters are 

chemically similar to sorbitan esters 

which are approved for direct addition 

to food for human consumption and to 

sucrose fatty acid esters which are 

approved for use as food emulsifiers and 

as protective fruit coatings under 21 

CFR 172.859 and to certain sorbitan 

esters which are approved under 21 CFR 

172.842, 172.836, 172.838, and 172.840 

for direct addition to food for human 

consumption. 

An exemption from the requirement 

of a tolerance has been established for 

residues of sucrose octanoate esters in 

or on all food commodities when used 

in accordance with good agricultural 

practies. (40 CFR 180.1222).

I. International Tolerances

Sorbitol octanoate esters are 

chemically similar to sorbitan esters and 

to sucrose fatty acid esters. Sucrose fatty 

acid esters are approved for use as food 

emulsifiers in Europe under E–470 and 

by the Joint FAO Expert Committee on 

Food Additives at an ADI of 10 mg/kg 

bwt/day. Sorbitan esters are approved in 

Europe for use as food emulsifiers under 

various E numbers and are also 

approved by the joint FAO/WHO Expert 

Committee on Food Additives at an ADI 

of up to 25 mg/kg bwt/day. 

58170 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Notices 

There are no CODEX maximum 

residue levels established for residues of 

sorbitol octanoate.

[FR Doc. 04–21588 Filed 9–28–04; 8:45 am] 

BILLING CODE 6560–50–S

FEDERAL MARITIME COMMISSION

Notice of Agreements Filed 

The Commission hereby gives notice 

of the filing of the following agreements 

under the Shipping Act of 1984. 

Interested parties may obtain copies of 

agreements by contacting the 

Commission’s Office of Agreements at 

(202) 523–5793 or via e-mail at 

tradeanalysis@fmc.gov. Interested 

parties may submit comments on an 

agreement to the Secretary, Federal 

Maritime Commission, Washington, DC 

20573, within 10 days of the date this 

notice appears in the Federal Register. 

Agreement No.: 008493–024. 

Title: Trans-Pacific American Flag 

Berth Operators Agreement. 

Parties: American President Lines, 

Ltd., and A.P. Moller-Maersk A/S. 

Filing Party: Howard A. Levy, Esq.; 

120 Wall Street, Suite 2020; New York, 

NY 10005–4001. 

Synopsis: The amendment updates 

Maersk’s corporate name. 

Agreement No.: 010714–037. 

Title: Trans-Atlantic American Flag 

Liner Operators Agreement. 

Parties: A.P. Moller-Maersk A/S; 

American President Lines, Ltd.; 

American Roll-On Roll-Off Carrier, LLC; 

Farrell Lines Incorporated; Lykes Lines 

Limited, LLC; and P&O Nedlloyd 

Limited. 

Filing Party: Howard A. Levy, Esq.; 

120 Wall Street, Suite 2020; New York, 

NY 10005–4001. 

Synopsis: The amendment updates 

Maersk’s corporate name. 

Agreement No.: 011117–034. 

Title: United States/Australasia 

Discussion Agreement. 

Parties: A.P. Moller-Maersk A/S; 

Australia-New Zealand Direct Line; 

CMA CGM, S.A.; Compagnie Maritime 

Marfret, S.A.; Fesco Ocean Management 

Limited; Hamburg-Sud; Lykes Lines 

Limited, LLC; P&O Nedlloyd Limited; 

Safmarine Container Lines NV; and 

Wallenius Wilhelmsen Lines AS. 

Filing Party: Wayne R. Rohde, Esq.; 

Sher & Blackwell; 1850 M Street, NW., 

Suite 900; Washington, DC 20036. 

Synopsis: The amendment adds 

Safmarine as a party to the agreement 

and clarifies that Maersk and Safmarine 

will act as a single party under the 

agreement.

Agreement No.: 011223–029. 

Title: Transpacific Stabilization 

Agreement 

Parties: APL Co. Pte. Ltd.; American 

President Lines, Ltd.; CMA CGM, S.A.; 

COSCO Container Lines Ltd.; Evergreen 

Marine Corp. (Taiwan) Ltd.; Hanjin 

Shipping Co., Ltd.; Hapag-Lloyd 

Container Linie GmbH; Hyundai 

Merchant Marine Co., Ltd.; Kawasaki 

Kisen Kaisha, Ltd.; Mitsui O.S.K. Lines, 

Ltd.; Nippon Yusen Kaisha; Orient 

Overseas Container Line Limited; P&O 

Nedlloyd B.V.; P&O Nedlloyd Limited; 

and Yangming Marine Transport Corp. 

Filing Party: David F. Smith, Esq.; 

Sher & Blackwell; 1850 M Street, NW., 

Suite 900; Washington, DC 20036. 

Synopsis: The amendment deletes 

A.P. Moller-Maersk A/S as a party to the 

agreement.

Agreement No.: 011275–016. 

Title: Australia/United States 

Discussion Agreement 

Parties: A.P. Moller-Maersk A/S; 

Australia-New Zealand Direct Line; 

FESCO Ocean Management Inc.; 

Hamburg-Sud; LauritzenCool AB; Lykes 

Lines Limited, LLC; P&O Nedlloyd 

Limited; Safmarine Container Lines NV; 

and Seatrade Group NV. 

Filing Party: Wayne R. Rohde, Esq.; 

Sher & Blackwell; 1850 M Street, NW., 

Suite 900; Washington, DC 20036. 

Synopsis: The amendment adds 

Safmarine as a party to the agreement 

and clarifies that Maersk and Safmarine 

will act as a single party under the 

agreement.

Agreement No.: 011427–002. 

Title: Japanese-U.S. Carrier Discussion 

Agreement. 

Parties: Kawasaki Kisen Kaisha, Ltd; 

Mitsui O.S.K. Lines, Ltd.; Nippon Yusen 

Kaisha; and American President Lines, 

Ltd. 

Filing Party: David F. Smith, Esq.; 

Sher & Blackwell; 1850 M Street, NW., 

Suite 900; Washington, DC 20036 and 

Charles F. Warren, Esq.; Warren & 

Associates, P.C.; 1100 Connecticut 

Avenue, NW.; Washington, DC 20036. 

Synopsis: The amendment deletes 

A.P. Moller-Maersk Sealand as a party 

to the agreement.

Agreement No.: 011515–010. 

Title: Steamship Line Cooperative 

Chassis Pool. 

Parties: Atlantic Container Line AB; 

China Shipping Container Lines Co., 

Ltd.; COSCO Container Lines Company, 

Ltd.; CMA CGM, S.A.; Compania Sud 

Americana de Vapores, S.A.; Evergreen 

Marine Corp. (Taiwan) Ltd.; Hanjin 

Shipping Co., Ltd.; Kawasaki Kisen 

Kaisha, Ltd.; Mediterranean Shipping 

Company, S.A.; Safmarine Container 

Lines, NV; Yangming Marine Transport 

Corporation; and Zim Integrated 

Shipping Services, Ltd. 

Filing Party: David F. Smith, Esq.; 

Sher & Blackwell LLP; 1850 M Street, 

NW.; Suite 900; Washington, DC 20036. 

Synopsis: The amendment deletes 

American President Lines, Ltd. and 

adds Evergreen Marine Corp. (Taiwan) 

Ltd. as parties to the agreement; updates 

Zim’s corporate name; and deletes 

unnecessarily repetitive language.

Agreement No.: 011527–009. 

Title: East Coast Americas Service. 

Parties: Hanjin Shipping Co., Ltd.; 

Kawasaki Kisen Kaisha, Ltd.; Mitsui 

O.S.K. Lines, Ltd.; and Zim Integrated 

Shipping Services Ltd. 

Filing Party: Howard A. Levy, Esq.; 

120 Wall Street, Suite 2020; New York, 

NY 10005–4001. 

Synopsis: The amendment reflects 

Zim’s new corporate name.

Agreement No.: 011660–003. 

Title: Administrative Housekeeping 

Agreement. 

Parties: A.P. Moller-Maersk A/S; 

American President Lines, Ltd.; 

American Roll-On Roll-Off Carriers, 

LLC; and Farrell Lines Incorporated; 

and P&O Nedlloyd Limited. 

Filing Party: Howard A. Levy, Esq.; 

120 Wall Street, Suite 2020; New York, 

NY 10005–4001. 

Synopsis: The amendment updates 

Maersk’s corporate name, indicates that 

P&O Nedlloyd and Farrell Lines are 

acting as one party, and adds American 

Roll-On Roll-Off Carriers.

Agreement No.: 011710–001. 

Title: TAAFC/USSEC Housekeeping 

Services Agreement. 

Parties: A.P. Moller-Maersk A/S and 

P&O Nedlloyd Limited, as parties to the 

U.S. South Europe Conference, and 

Trans-Atlantic Associated Conferences 

(London). 

Filing Party: Wayne R. Rohde, Esq.; 

Sher & Blackwell; 1850 M Street, NW., 

Suite 900; Washington, DC 20036. 

Synopsis: The amendment updates 

Maersk’s corporate name.

Agreement No.: 011810–001. 

Title: GUMEX-Brasil Cooperative 

Working Agreement. 

Parties: CMA CGM, S.A. and HapagLloyd Container Linie GmbH. 

Filing Party: Wayne R. Rohde, Esq.; 

Sher & Blackwell; 1850 M Street, NW., 

Suite 900; Washington, DC 20036. 

Synopsis: The amendment deletes 

authority for the parties to discuss and 

agree on rates.

Agreement No.: 011852–011. 

Title: Maritime Security Discussion 

Agreement. 

Parties: Australia-New Zealand Direct 

Line; China Shipping Container Lines, 

Co., Ltd.; Canada Maritime; CMA CGM, 

S.A.; Contship Container Lines; COSCO 

Container Lines Company, Ltd.; CP