Paecilomyces Lilacinus Strain 251; 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 ID number OPP-2003-0255, must be received on or before December 8, 2003.

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:

Barbara Mandula, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-7378; e-mail address: mandula.barbara@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 on (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-2003-0255. 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 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-2003-0255. 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-2003-0255. 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-2003-0255.

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-2003-0255. 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 summary of the pesticide petition is printed below as required by FFDCA section 408(d)(3). The summary of the petition was prepared by W. F. Stoneman Company LLC 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.

W.F. Stoneman Company LLC

PP 3F6737

EPA has received a pesticide petition 3F6737 from W.F. Stoneman Company LLC (on behalf of Prophyta Biologischer Pflanzenschutz GmbH), 6307 Mourning Dove Drive, McFarland, Wisconsin 53558-9019, proposing 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, to establish an exemption from the requirement of a tolerance for residues of the microbial pesticide Paecilomyces lilacinus strain 251 (P. lilacinus).

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, W.F. Stoneman Company LLC (on behalf of Prophyta Biologischer Pflanzenschutz GmbH) has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by W.F. Stoneman Company LLC (on behalf of Prophyta Biologischer Pflanzenschutz GmbH) 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

MeloCon^TM WG. For purposes of marketing the product in the U.S.A., the name MeloCon^TM WG was chosen and a registered trademark will be sought. The same active ingredient in the same or similar formulations is sold under other trade names in other countries of the world including: Paecil, BioACT WG, and Nemachek.

Proposed use practices. MeloCon^TM WG is a biological nematicide for the control of plant parasitic nematodes. The product is sold as water dispersible granules that are then mixed with water and applied as a soil spray, initially at a rate of 4 pounds per acre. Applications are made to soil before planting, to the soil of seedlings before transplanting, and as a post-plant soil drench.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues.

• Product name. MeloCon^TM WG
• Active ingredient. Paecilomyces lilacinus strain 251
• CAS No. Not applicable
• Color. Pink
• Physical state. Non-dusty, water dispersible granules
• Odor. Odorless
• Bulk density. 500-550 kg/cubic meter
• pH. Before storage, the pH of PBP-01001-I was 6.86 (mean of two replications). After storage at a temperature of 40°C for a period of 8 weeks, the pH of the product was 5.52 (mean of two replications).
• Mode of action. Control of plant-parasitic nematodes by P. lilacinus is basically achieved by parasitism and subsequent killing of eggs, juveniles and adult females of a range of nematode species. The infective units are spores and mycelia, enabling the fungus to parasitize the host epiphytically or as an endophyte, following penetration of cell walls.

Historical Background. Plant-parasitic nematodes infect a wide range of crops and cause reduction in yield and sometimes death of the crop plant. As early as 1877 parasitism of female nematodes of the species of Heterodera schachtii by a fungus was described, but it took several decades for researchers to discover that fungi play a major role as antagonists of parasitic nematodes. Numerous fungi are known to have nematophagous activity and to act by several mechanisms, including endoparasitic, predacious, and opportunistic parasitism. As opportunistic fungi, P. lilacinus and Verticillium chlamydosporium have been extensively studied as possible biocontrol agents.

In 1979. P. lilacinus was identified as an effective parasite of Meloidogyne incognita and Globodera pallida eggs on potatoes. Further study revealed that different strains of P.lilacinus differed considerably in their nematophagous potential. Efficient P. lilacinus strains have been registered as biocontrol agents for plant-parasitic nematodes in the Philippines and South Africa, while registration is pending in Australia.

2. Magnitude of residue at the time of harvest and method used to determine the residue— Analytical method. An analytical method of residues is not applicable.

3. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed. An analytic method for residues is not applicable. Paecilomyces lilacinus strain 251 is active in the soil, applied to the soil, and incorporated into the soil prior to planting, or drenched onto the soil surrounding plants very early in the growing season. It is not applied directly to the food commodity. Residues of the active ingredient in MeloCon^TM WG are not expected on agricultural commodities.

In most of the crops envisaged for use of the active ingredient no deposit is likely to occur, since soil drench applications rule out a direct contact between the applied product and the fruit. This applies to all crops with above ground harvest, such as grapes, tomato, and tobacco. After harvest any remaining fungal spores on potato, celery and carrots will be exposed to unfavorable conditions (e.g. dryness), and are not likely to germinate and grow on the harvested crop.

Any potentially occurring residual deposits on these crops will not harm humans because the strain shows no toxicity in appropriate tests and any such residues will be very low due to the low environmental concentration in soil predicted from maximum field use of the active ingredient.

P. lilacinus is not able to enter plants and infest them. In fact, it enhances plant health and growth. As a saprophytic fungus it would use the resources of the plant host in case access was possible.

C. Mammalian Toxicological Profile

MeloCon^TM WG is the end use product of the active ingredient P. lilacinus strain 251. The active ingredient is in the end use product at a nominal concentration of 6% by weight (with a minimum concentration of 1 billion spores per gram). The active ingredient was tested for acute Toxicity/Pathogenicity through oral, dermal, IP injection, pulmonary, skin irritation, eye irritation, and skin sensitization. The results of these mammalian studies indicate no significant human health risks. The table below summarizes the results of the acute studies that were done.

In addition, the temperature profile for this strain of P. lilacinus strain 251 indicates that it does not grow at 36°C or higher, and therefore, will not be pathogenic to humans. The strain does not produce paecilotoxins or other toxins. The acute toxicity/pathogenicity studies have determined that the end use product containing the organism is not toxic, irritating or sensitizing to the test animals. Strain 251 of P. lilacinus has not been reported as a pathogen to humans or as causing any type of adverse effects to humans in the published literature or through commercial manufacture or use.

In conclusion, all submitted toxicological studies and supplemental information on P. lilacinus strain 251, prove that this fungus is non-pathogenic and non-infectious to mammals and imposes no health risk for operators, workers, or consumers.

D. Aggregate Exposure

1. Dietary exposure— i. food. Dietary exposure from use of MeloCon^TM WG and its active ingredient is minimal to non-existent. MeloCon^TM WG is applied to the soil before planting and very early in the plant-growing season. After harvest any remaining fungal spores on potato, celery and carrots will be exposed to unfavorable conditions (e.g. dryness), and are not likely to germinate and grow on the harvested crop.

Any potentially occurring residual deposits on these crops are not relevant as a human health concern in view of the toxicological profile of this strain. The amount of residue, if any, is likely to be very low.

P. lilacinus is not able to enter plants and infest them. As a saprophytic fungus it would use the resources of the plant host in case access was possible.

Residues of the active ingredient are not expected on agricultural commodities.

ii. Drinking water. Exposure to humans from residues of P. lilacinus strain 251 in drinking water is unlikely. The active ingredient of MeloCon^TM WG is not very soil mobile and will not leach to the water table. Following application of the active ingredient to the soil, spores of P.lilacinus strain 251 are likely to establish a population based on the prevailing environmental conditions of the relevant soil ecosystem. Unlimited growth is not expected, given that this species is not a “foreigner” to the naturally occurring soil micro-flora. The active ingredient is a spore and not soluble and therefore non-leaching. In addition, when the product is used as directed, the presence of spores in natural surface waters is not expected.

2. Non-dietary exposure. The potential for non dietary exposure to the general population, including infants and children, is minimal to non-existent. No approval for consumer uses is expected. The proposed uses are limited to commercial agricultural and horticultural applications. No exposure is expected to the general public during either manufacture or application of the product. If non-dietary exposures were to occur, they would not be expected to pose a risk due to a lack of pathogenicity and toxicity, as demonstrated for this strain in the studies conducted on MeloCon^TM WG. The recommendations for use of personal protective equipment (PPE) will mitigate the potential exposure of workers.

E. Cumulative Exposure

No residues are expected to remain in human food and no cumulative effects of this microbial nematicide are expected.

F. Safety Determination

1. U. S. population. There have been no reports of P. lilacinus strain 251 infecting humans, and no reports that the microbe makes toxins or secondary metabolites that might be harmful to humans.

In most of the crops envisaged for use of the active ingredient no residue is expected on the food, since soil drench applications rule out a direct contact between the applied product and the fruit. This applies to all crops with above ground harvest, such as grapes, tomato, and tobacco. After harvest, any remaining fungal spores on potato, celery and carrots will be exposed to unfavorable conditions (e.g. dryness), and are not likely to germinate and grow on the harvested crop.

P. lilacinus strain 251 does not grow at 36°C or greater, and therefore, cannot grow in humans. It has been shown to be non-toxic/pathogenic to mammals in acute studies.

2. Infants and children. Residues of P. lilacinus strain 251 are not expected to occur on agricultural commodities. There is no reason to expect harm to infants and children from exposure to the active ingredient from the proposed uses on the proposed product label.

G. Effects on the Immune and Endocrine Systems

There is no reason to expect any effects of P. lilacinus strain 251 on the human endocrine system. The active ingredient in MeloCon^TM WG does not function as a hormone nor does it produce any known hormones. P. lilacinus strain 251 in a naturally occurring, nonpathogenic soil organism.

H. Existing Tolerances

EPA no tolerance to date.

I. International Tolerances

Australia has granted a Certificate of an exemption for an active constituent (National Registration Authority, Australia 1998).