04-21588. 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: [phone]; e-mail address: [e-mail].

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 [phone].

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.

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 [e-mail], 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, 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 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.

There are no CODEX maximum residue levels established for residues of sorbitol octanoate.