[Federal Register Volume 69, Number 188 (Wednesday, September 29, 2004)]
[Notices]
[Pages 58166-58170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21588]


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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.

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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: <a href="/cdn-cgi/l/email-protection#fd9a8f9898938a9c84d3999893948e98bd988d9cd39a928b"><span class="__cf_email__" data-cfemail="4c2b3e2929223b2d3562282922253f290c293c2d622b233a">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111)
    <bullet> Animal production (NAICS code 112)
    <bullet> Food manufacturing (NAICS code 311)
    <bullet> 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 <greek-i>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.

[[Page 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 e-mail 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 <a href="/cdn-cgi/l/email-protection#f39c8383de979c90989687b3968392dd949c85"><span class="__cf_email__" data-cfemail="cea1bebee3aaa1ada5abba8eabbeafe0a9a1b8">[email protected]</span></a>, 
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 
<greek-i>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,

[[Page 58168]]

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

[[Page 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 FDA-approved 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 FDA-
approved 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. Non-occupational, 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.

[[Page 58170]]

     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


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