Ethoxy Dodecyl Phenol; 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-2004-0016, must be received on or before March 22, 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:

Driss Benmhend, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9525; e-mail address: benmhend.driss@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 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS 32532)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket ID number OPP-2004-0016. 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, 1921 Jefferson Davis Hwy., 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 EPA's 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 in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.

1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an 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-2004-0016. 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-2004-0016. 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-2004-0016.

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, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP-2004-0016. 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

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 the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

Cal Agri Products, LLC

PP 3F6778

EPA has received a pesticide petition 3F6778 from Cal Agri Products, LLC, 10720 McCune Avenue, Los Angeles, CA 90034, proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for the biochemical pesticide ethoxy dodecyl phenol in or on growing crops and raw agricultural commodities.

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Cal Agri Products, LLC has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Cal Agri Products, LLC and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

A. Product Name and Proposed Use Practices

Cal Agri Products, LLC (CAP) has filed a petition for the exemption from the requirement of tolerance for residues in growing crops and raw agricultural foods for ethoxy dodecyl phenol (EDP), when used as a pesticide active ingredient. EDP is a common component in industrial and consumer products with considerable data demonstrating its safety for use in and around foods (21 CFR 178.3400). EDP is also a common inert ingredient in agricultural pesticides and has been categorized by EPA as a List 4B inert ingredient, identifying it as a compound of minimal toxicological concern. EDP is also currently listed under 40 CFR 180.1001(c) and (e) and 21 CFR 172.710 as exempt from the requirement of a food tolerance when used as an inert ingredient or occasionally as an active ingredient. EDP is formulated as a pesticide active ingredient and has been shown to operate as an effective non-toxic control agent of a number of agriculturally important insect pests and pathogens. The formulation utilizing EDP operates through a non-toxic, physical mode of action that effects the insects' protective coating making them more vulnerable to desiccation from a secondary formulation ingredient. Extensive field trials have shown this formulation to be commercially effective against a number of soft-bodied insect pests and a potential substitute for more toxic pesticides such as the organophosphates which remain the primary pesticides used against some of these pests. The formulation is intended for use primarily against soft-bodied insect pests, such as aphids and whiteflies, and foliar pathogens, such as powdery mildew. Proposed uses include foliar applications to food and non-food crops and soil applications for the control of soil dwelling pests and pathogens. The formulation will be diluted with water for use at a rate of 2,000 to 4,000 parts per million (ppm) (600 to 1,200 ppm of EDP). Use patterns will include application on field and greenhouse grown food crops and on ornamental and nursery crops.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Ethoxy dodecyl phenol (CAS No. 9014-92-0) is in the ethoxylated alkyl phenol chemical family (alpha-(p-dodecylphenyl)-omega-hydroxypoly (oxyethylene) and described by the empirical formula C₁₈ H₂₅-C₆ H₄-O(CH₂ CH₂ O)₇ CH₂ CH₂ OH. EDP is produced by adding an alpha-olefin to a phenol molecule resulting in an alkyl phenol, which is subsequently ethoxylated by adding ethylene oxide. EDP is commercially available as a viscous clear liquid and is a common surfactant used in many products as a wetting agent, antifoaming agent, detergent, dispersant, or emulsifier. EDP is listed as an inert ingredient of minimal concern (List 4B) by EPA and is exempt from the requirement of a food tolerance (40 CFR 180.1001(c) and (e)) when used as an inert (or occasionally active) ingredient in pesticide formulations. Furthermore, EDP is approved for use as an indirect food additive (21 CFR 178.3400).

2. Magnitude of residue at the time of harvest and method used to determine the residue. At harvest time, residues of EDP are projected to be negligible because this compound degrades rapidly in aerobic environments and even more rapidly when sunlight is present, due to photodegradation of the phenolic ring. Moreover, EDP is an approved food additive established by the Food and Drug Administration (FDA) under 21 CFR 172.710, which permits its use in and around the use of foods, such as a component of food packaging material.

3. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed. EPA in granting an exemption from tolerance for EDP as an inert ingredient has previously determined that no harm will result from aggregate exposure to EDP when used as an inert ingredient in pesticide formulations. Therefore, no analytic method for detecting residues have been required.

C. Mammalian Toxicological Profile

Ethoxyl dodecyl phenol (synonym: dodecyl phenol ethoxylate) and other very similar alkylphenol ethoxylates (APEs) (e. g., octylphenol ethoxylate and nonylphenol ethoxylates) are common inert ingredients in many pesticide products in the United States and other nations. In 1995, EPA concluded that the current use patterns of EDP in pesticide products will not adversely affect public health or the environment and reclassified EDP from the list of inert ingredients of unknown toxicity (List 3) to its current classification of minimal risk inert ingredients (List 4B). EDP is also exempt from the requirement of food tolerances by EPA under 40 CFR 180.1001(c) and (e) when used in accordance with good agricultural practice as an inert and occasionally as an active ingredient in pesticide formulations when applied to growing crops or to raw agricultural commodities after harvest.

1. Acute toxicity. EDP has been studied extensively in animal testing. Studies have demonstrated an acute oral toxicity, lethal dose (LD)₅₀ = 2,590 milligrams/kilogram (mg/kg) and 3,300 mg/kg in rats (toxicity category III) and an acute dermal toxicity of LD₅₀ = 1,260 mg/kg and 5,000 mg/kg in rabbits (toxicity category III). Occular exposure in rabbits yielded moderate eye irritation at 100 μL/24 hours. Dermal testing in rabbits determined EDP is a primary dermal irritant. Dermal patch tests in humans produced no positive reactions after 15 repeated applications.

2. Genotoxicity. There is no evidence of genotoxicity from exposure to EDP. APEs, such as EDP, as a surfactant group are considered non-genotoxic based on a wide variety of in vivo and in vitro tests.

3. Developmental toxicity and teratogenicity. There is no evidence of reproductive or developmental toxicity from exposure to EDP. No effects on reproduction or teratogenicity were found in studies testing daily consumption of EDP at a rate between 50 and 100 mg/kg/day. Acute studies demonstrated no teratogenic effects at doses below 500 mg/kg.

4. Subchronic toxicity. Animal studies have demonstrated that daily doses of EDP over 90 days at 100 mg/kg/day resulted in no toxicological effects. Results indicated that the risk of subchronic effects are minimal, particularly from “low-dose” exposure.

5. Chronic toxicity. There is no evidence of chronic toxicity from exposure to EDP. EDP's low mammalian toxicity and the lack of any reported negative effects by producers and consumers of EDP, indicate that chronic toxicity at the proposed rates of use would pose minimal concern.

6. Animal metabolism. EDP is quickly metabolized and excreted in mammals. No effect on metabolism has been noted, except at very high exposure levels. Further, EDP's low mammalian toxicity and the lack of reported effects by users of EDP in a variety of pesticide and consumer products indicate metabolic effects would be unlikely at the proposed use rates.

7. Metabolite toxicology. No evidence of metabolite toxicity in mammals from exposure to EDP has been found or suspected. Based on the low mammalian toxicity of EDP and the lack of reported effects by users of EDP in a variety of pesticide and consumer products suggests that metabolite toxicity would be unlikely at proposed use rates

8. Endocrine disruption. No evidence of endocrine disruption from EDP has been indicated, except at high exposure levels. EDP's low mammalian toxicity and the lack of reported effects by users of EDP in a variety of pesticide and consumer products indicate EDP would be of minimal concern at the proposed use rates.

D. Aggregate Exposure

1. Dietary exposure—i. Food. EDP is an approved food additive established by the FDA under 21 CFR 172.710, which permits its use in and around the use of foods, such as a component of food packaging material. Use of EDP on food crops is unlikely to enhance consumer exposure given its wide-spread use in consumer products, its rapid biodegradability and the low end-use concentrations when applied to plants as a pesticide at the proposed use rates.

ii. Drinking water. There is no significant human exposure to EDP in drinking water due to the small amounts and low proposed use rates in the pesticide formulation. Additionally, EDP is rapidly degraded in aerobic environments and even more rapidly when sunlight is present, due to photodegradation of the phenolic ring.

2. Non-dietary exposure. EDP and other APEs are high production chemicals found in many food and consumer cleaning products. As a result there are numerous routes of non-dietary exposure. The relatively small amount of EDP contained in the pesticide formulation and its limited use (crop protection) is unlikely to influence non-dietary exposure to children or other consumer groups.

E. Cumulative Exposure

EDP and other APEs are high production chemicals found in many food and consumer cleaning products. Due to the low concentrations of EDP used in the pesticide formulation and the rapid degradation of EDP in the environment, EDP presents a minimal risk for cumulative effects in humans or in the environment.

F. Safety Determination

1. U.S. population. Research and practical experience using EDP in consumer products have resulted in no reports of adverse effects to human health or the environment. Given the relatively low concentration of EDP in the pesticide formulation and its rapid degradation when applied to crops, there is every reason to believe that no additional risk to the U.S. population will result from aggregate exposure to EDP.

2. Infants and children. Given the low-risk profile of EDP, its' widespread use in consumer products and the relatively low concentration of EDP in the proposed pesticide formulation when applied to food crops, EDP is unlikely to pose additional risks to infants and children. In addition, substitution of the pesticide formulation containing EDP in place of more toxic pesticides, such as organophosphates, may reduce infants and children's overall exposure to residual toxins in and on foods.

G. Effects on the Immune and Endocrine Systems

No evidence of immune or endocrine effects from EDP in mammals have been found or suspected, based on its low mammalian toxicity and the lack of reported effects by users of EDP in a variety of pesticide and consumer products.

H. Existing Tolerances

EDP is listed as exempt from the requirement of a tolerance under 40 CFR 180.1001 (c) and (e) and 21 CFR 172.710 when used as an inert ingredient in pesticide formulations. EDP is also approved for use as an indirect food additive under 21 CFR 178.3400.

I. International Tolerances

There are no known Codex maximum residue levels established for EDP.Archives of Environmental Contamination and Toxicology 26: 540-548.