[Federal Register Volume 68, Number 216 (Friday, November 7, 2003)]
[Notices]
[Pages 63088-63092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27956]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0255; FRL-7331-7]


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.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket 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: [email protected].

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:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production on (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] 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

[[Page 63089]]

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 [email protected], 
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.


[[Page 63090]]


    Dated: October 28, 2003.
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 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

     MeloConTM WG. For purposes of marketing the product in 
the U.S.A., the name MeloConTM 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. MeloConTM 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.
    [sbull] Product name. MeloConTM WG
    [sbull] Active ingredient. Paecilomyces lilacinus strain 251
    [sbull] CAS No. Not applicable
    [sbull] Color. Pink
    [sbull] Physical state. Non-dusty, water dispersible granules
    [sbull] Odor. Odorless
    [sbull] Bulk density. 500-550 kg/cubic meter
    [sbull] pH. Before storage, the pH of PBP-01001-I was 6.86 (mean of 
two replications). After storage at a temperature of 40[deg]C for a 
period of 8 weeks, the pH of the product was 5.52 (mean of two 
replications).
    [sbull] 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 
MeloConTM 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

    MeloConTM 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.

[[Page 63091]]



                        Table 1.--Summary of Mammalian Toxicity/Pathogenicity Studies\1\
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              Study                     Animal             Dose (mg)          Dose (cfu)            Result
----------------------------------------------------------------------------------------------------------------
Acute oral, LD50                  Rat                 > 2,000 milligrams/ > 4 x 109 colony    LD50 > 2,000 mg/kg
                                                       kilogram body       forming units/
                                                       weight (mg/kg       kilogram body
                                                       bwt)                weight (cfu/kg
                                                                           bwt)
---------------------------------
Acute dermal, LD50                Rat                 > 2,000 mg/kg       > 4 x 109 cfu/kg    LD50 > 2,000 mg/kg
                                                       body.wt             body wt
---------------------------------
Acute IP injection                Rat                 > 2,000 mg/kg       > 4 x 109 cfu/kg    LD50 > 2,000 mg/kg
                                                       body.wt             body wt             Non-infectious;
                                                                                               100% clearance
---------------------------------
Acute pulmonary (intratracheal)   Rat                 > 125 mg/kg         > 2.5 x 108 cfu/kg  LD50 > 125 mg/kg
                                                       body.wt             body wt             Non-infectious;
                                                                                               100% clearance
---------------------------------
Acute skin irritation             Rabbit                                                      Non-irritant
---------------------------------
Acute eye irritation              Rabbit                                                      Non-irritant
---------------------------------
Skin sensitization (Buehler       Guinea pig                                                  Not sensitizing
 test)
----------------------------------------------------------------------------------------------------------------
\1\The end product was test substance.

     In addition, the temperature profile for this strain of P. 
lilacinus strain 251 indicates that it does not grow at 36[deg]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 
MeloConTM WG and its active ingredient is minimal to non-
existent. MeloConTM 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 MeloConTM 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 MeloConTM 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[deg]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.

[[Page 63092]]

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 
MeloConTM 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).

[FR Doc. 03-27956 Filed 11-6-03; 8:45 am]
BILLING CODE 6560-50-S