02-113. 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 control number PF-1010, must be received on or before February 4, 2002.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-1010 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Carol E. Frazer, Ph.D., Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

Categories	NAICS codes	Examples of potentially affected entities
Industry	111	Crop production
	112	Animal production
	311	Food manufacturing
	32532	Pesticide manufacturing

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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have 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 Additional Information, Including Copies of This Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

2. In person. The Agency has established an official record for this action under docket control number PF-1010. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-1010 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number PF-1010. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want To Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified 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 control 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 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
• Biopesticides
• Feed additives
• Food additives
• Pesticides and pests
• Pollution prevention
• Reporting and recordkeeping requirements

Dated: December 20, 2001.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

Summary of Petition

The petitioner summary of the pesticide petition is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petition was prepared by the petitioners and represents the view of the petitioners. 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.

EPA has received a pesticide petition 1F6244 from Nutra-Park Inc., 8383 Greenway Blvd., Suite 520, Middleton, WI 53562, 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 Lysophosphatidylethanolamine (LPE) in or on all food commodities.

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Nutra-Park Inc. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Nutra-Park Inc. 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.

I. Nutra-Park Inc.

PP 1F6244

A. Product Name and Proposed Use Practices

The commercial name for the end use product containing Lysophosphatidylethanolamine (LPE) is LPE E94; 10% Aqueous, EPA File Symbol 70515-R. Presently, the product is being registered for use as a pre-harvest and post-harvest ripening and shelf life enhancer for fruits and vegetables. As a pre-harvest spray, 100 400 parts per million (ppm) of the active ingredient is sprayed on the raw agricultural commodities until run-off. As a post-harvest treatment, the raw agricultural commodities are dipped into or sprayed with a solution containing 25 100 ppm and air dried prior to storage.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. The active ingredient LPE is a phospholipid derived from phosphatidylethanolamine (PE) by the enzymatic removal of one fatty acid. The residues in or on raw agricultural commodities are likely to be primarily the LPE. Small amounts of free fatty acid, phosphate and ethanolamine may be present. However, none of the residues would be distinguishable from the naturally occurring moieties.

2. Magnitude of residue at the time of harvest and method used to determine the residue. The current analytical methodology cannot distinguish between naturally occurring residues and those residues resulting from the application of LPE. LPE is found in large quantities in egg yolk and meat. LPE is naturally present in small amounts in plant tissues and other biological matrices and can account for up to 10% of the phospholipid content of cell membranes. The additional amount of LPE as a result of its use as a ripening agent and shelf life enhancer will not significantly add to the amount of naturally occurring residues.

3. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed. As stated above, the current analytical methodology cannot distinguish between naturally occurring residues present in or on the raw agricultural commodities and the residues resulting from application of the product. Based on the natural occurrence of the chemical, its favorable toxicological profile and inconsequential exposure resulting from label-directed uses, measuring of the residues is not warranted.

C. Mammalian Toxicological Profile

Based on the available acute toxicity data, LPE technical and its 20% formulation, do not pose any acute toxicity risks. The acute toxicity studies place LPE technical in acute toxicity category IV for acute oral (LD₅₀>5,000 milligrams/kilograms (mg/kg) male and female), inhalation (LC₅₀>2.5mg/L male and female), skin irritation (dermal irritation index is 0.0), and eye irritation (no irritation at 72 hours) and toxicity category III for acute dermal (LD₅₀>2,000 mg/kg male and female). The acute toxicity studies place the LPE 10% formulation in acute toxicity category IV for acute oral (LD₅₀>5,000 mg/kg male and female), eye irritation (no irritation at 72 hours), skin irritation (dermal irritation index is 0.0), and inhalation (LC₅₀>4.63 mg/L male and female) and toxicity category III for acute dermal (LD₅₀>2,000 mg/kg male and female). Both LPE technical and its 10% formulation cause skin sensitization in the guinea pig.

Information on the chronic effects of LPE is obtained from the open literature. LPE and related phospholipids, such as phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol, phosphatidic acid, phosphatidylglycerol, lysophosphatidylcholine, and lysophosphatidylserine, are synthesized by microorganisms, plants and animals. These important biomolecules are ubiquitous in nature and have multifunctional properties in living cells. Lysophospholipids are continuously generated in microbial, plant and animal systems and are readily utilized in various cell functions or used in synthesizing new phospholipids. All phospholipids have specific roles in executing certain cellular functions and maintaining the integrity of cellular membranes. Furthermore, these biomolecules are of immense importance to various food and non-food industries as safe multifunctional natural additives/ingredients. Presence of hydrolytic enzymes, known as lipases, phospholipases and lysophospholipases, in microbial (including soil microorganisms), plant and animal (including humans) systems ensures the biodegradation of phospholipids and their lyso counterparts into harmless metabolites/by-products.

D. Aggregate Exposure

1. Dietary exposure—i. Food. LPE is a member of the phospholipids. Phospholipids are a heterogeneous group of compounds that are classed together partially on the basis of solubility and partially on the basis of the ester phosphorus present in the compounds. Phospholipids are found in all cellular organisms as part of the structure of the cellular membrane.

The framework of membranes surrounding the cell and intracellular organelles is composed of a bilayer of lipid. The basic unit of the bilayer is a composite of phospholipids (phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol). LPE is a phospholipid derived from phosphatidylethanolamine by the enzymatic removal of one fatty acid. Residues of LPE naturally occur in raw agricultural commodities and are consumed daily. The level of residues of LPE in raw agricultural commodities through the use of this product will not be significantly increased over the level naturally occurring.

ii. Drinking water. Because of the benign nature of the compound and because it is composed of moieties that are consumed by all organisms, dissipation of LPE in the environment will, in all likelihood, be through microbial mediated degradation. There is little or no possibility of LPE leaching into the ground water. LPE may get into surface water during a run-off event. However, microbial degradation will rapidly remove the residues. The levels of residues that might get into ground or surface water used for drinking water will not be significant compared to the exposure from naturally occurring residues of LPE.

2. Non-dietary exposure. The potential for non-dietary exposure to the general population, including infants and children, is unlikely as the potential use sites are commercial, agricultural, and horticultural settings. However, non-dietary exposure would not be expected to pose any quantifiable risk due to a lack of residues or a level of residues present that are of no toxicological concern.

E. Cumulative Exposure

Based on its abundance in nature and long history of use by humans without deleterious effects, there is reasonable certainty that no harm will result from aggregate exposure to the U.S. population, including infants and children, to residues of LPE. This includes all anticipated dietary exposures and all other exposures for which there are reliable information. The exposure to LPE as a result of its label directed use on raw agricultural food or feed commodities will not result in a significant increase in the cumulative exposure over the present exposure, daily consumption by the human population from both naturally occurring sources and from processed foods.

F. Safety Determination

1. U.S. population. LPE is naturally present in small amounts in plant tissues and other biological matrices and can account for up to 10% of the phospholipid content of cell membranes. LPE is found in many food or feed commodities such as human breast milk, cow milk, corn grain and starch, oats and wheat. Large quantities are present in egg yolk and meat. Based on its abundance in nature and long historical use of the ingredient by the human population without deleterious effects, there is reasonable certainty that no harm will result from aggregate exposure to the U.S. population.

2. Infants and children. LPE is found in mother's milk and in cow milk. It is also present in egg yolk and meat and corn, oats, and wheat. These commodities do constitute a significant percentage of infant and children diets. Based on its long consumption by infants and children without deleterious effects, there is reasonable certainty that no harm will result from this additional inconsequential exposure to infants and children.

G. Effects on the Immune and Endocrine Systems

LPE is a naturally occurring residue in raw agricultural food and feed commodities and in processed food. To date, there is no evidence to suggest that LPE affects the immune system, functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor.

H. Existing Tolerances

LPE is a constituent naturally found in eggs and various animal tissue derived products (e.g., fish meal, fish oil, lard, meat meal) already exempted from regulation under section 25(b)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act. There is a temporary exemption from the requirement of a tolerance established specific to LPE (40 CFR 180.1199).

I. International Tolerances

Nutra-Park Inc. is not aware of any tolerance, exemption from tolerance, or maximum residue level issued for LPE.