[Federal Register Volume 70, Number 100 (Wednesday, May 25, 2005)]
[Notices]
[Pages 30105-30109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10340]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0121; FRL-7713-1]


Pythium Oligandrum DV 74; 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 identification (ID) number OPP-
2005-0121, must be received on or before June 24, 2005.

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: Tessa Milofsky, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-0455; 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:
     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-2005-0121. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (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 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

[[Page 30106]]

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-2005-0121. 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-2005-0121. 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-2005-0121.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2005-0121. 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 30107]]


    Dated: May 16, 2005.
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 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.

Biopreparaty Co. Ltd.

PP 4F6877

    EPA has received a pesticide petition (4F6877) from Biopreparaty 
Co., Ltd. (EPA Company No. 81606), Tylisovska 1, Prague 6, Czech 
Republic, 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 
the microbial pesticide pythium oligandrum DV 74 in or on all food 
commodities.
    Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, 
Biopreparaty Co., Ltd., has submitted the following summary of 
information, data, and arguments in support of their pesticide 
petition. This summary was prepared by Biopreparaty Co., Ltd., 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

    Pythium oligandrum DV 74 is the active ingredient in the proposed 
end-use product ``Polyversum.'' The end-use product polyversum is for 
the stimulation of plant growth, the enhancement of plant strength, and 
the prevention of fungal attack. Polyversum mobilizes plant defense 
mechanisms, increases plant resistance to pathogenic fungal attack, 
increases rate of growth, and increases overall crop strength and 
yield. Polyversum can be applied as a seed dressing, pre-plant soak, 
overhead spray or soil drench, or irrigation application to 
agricultural crops, ornamental plants, and turf grasses.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Pythium 
oligandrum, originally described by Charles Drechsler in 1943. Isolate 
to be registered was discovered in 1972, in the Czech Republic. The 
pythium oligandrum DV 74 isolate is on deposit at the American Type 
Culture Collection (ATCC) as ``Pythium oligandrum, ATCC 38472.'' The 
microorganism pythium oligandrum is naturally found in soil, and is 
often associated with other mycoparasites and fungal species. It is 
widely distributed around the world, including the United States for 
example, pythium oligandrum was isolated from 74 of 93 soil samples 
collected from 40 different counties in California that represented a 
wide range of environmental conditions.
    The pythium family has 100 varieties, of which pythium oligandrum 
is one of four mycoparasites. The microorganism lives parasitically on 
plant pathogenic fungi, and works to induce/stimulate the internal 
defense systems of plants. Testing has shown pythium oligandrum is 
parasitic to 20 species of plant pathogenic fungi, including: 
Alternaria, Botrytis, Fusarium, Gaeumannonyces, Ophiostoma, Phoma, 
Pseudocercosporella, Pythium, Sclerotinia, and Sclerotium.
    The active ingredient pythium oligandrum DV 74 colonizes the 
surroundings of treated and sown seeds, and the rhizosphere of treated 
plants. Because of its strong mycoparasitical and competitive 
abilities, the active ingredient suppresses the growth and antagonistic 
effects of many soil borne pathogenic fungi, which cause damping-off 
and seed, and root rots such as phytophthora, rhizoctonia, fusarium, 
etc. The active ingredient also induces a defense reaction in the newly 
emerged plant, through stimulation of the phytohormones, which are 
involved in the resistance mechanisms of the plant against diseases. 
Pythium oligandrum DV 74 does not produce any antibiotics and therefore 
is considered a true plant growth promoter for the induction of plant 
resistance. The mycoparasitic action and stimulation of plant 
resistance by pythium oligandrum are both associated with positive 
effects on plant health and viability.
    2. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. An 
analytical method for detecting and measuring levels of pesticide 
residues is not applicable. It is expected that, when used as proposed, 
pythium oligandrum DV 74 would not result in residues that are of 
toxicological concern. Further, the application of pythium oligandrum 
DV 74 to seeds, foliage, or soil will not result in an increase in 
concentration in the environment. The level of pythium oligandrum DV 74 
in the environment following application is expected to decrease to 
levels similar to naturally occurring concentrations, because the 
organism does not thrive in the absence of sufficient nutrients.

C. Mammalian Toxicological Profile

    Studies to evaluate the safety to mammals were conducted on the 
technical grade active ingredient (tgai) and are summarized as follows:
    1. Acute oral toxicity. No adverse effects were seen on either rats 
or mice that received an oral gavage dose of 5,000 milligrams/kilogram/
body weight (mg/kg/bwt) of the technical grade active ingredient. No 
effects on appearance, behavior, or body weight were observed in any 
rats or mice any time after dosing. No rats or mice died during the 14-
day observation period, and no gross pathological changes were found in 
organs in the thoracic or abdominal cavities at necropsy. An 
LD50 >5,000 mg/kg was established.
    2. Acute dermal toxicity. No adverse effects were seen in rats that 
received a dermal dose of 5,000 mg/kg/bwt of the technical grade active 
ingredient. No effects on appearance, behavior, or body weight were 
observed in any rats any time after exposure. No rats died during the 
14-day observation period, and no gross pathological changes were found 
in organs in the thoracic or abdominal cavities at necropsy. An 
LD50 >5,000 mg/kg was established.
    3. Acute inhalation toxicity. No adverse effects were seen in rats 
that were exposed by inhalation for 4 hours to a concentration of 5 mg/
liters of the technical grade active ingredient. No effects on 
appearance, behavior, or body weight were observed in any rats any time 
after exposure. No rats died during the 14-day observation period, and 
no gross pathological changes were found in organs in the thoracic or 
abdominal cavities at necropsy. Histological analysis of the lungs and 
trachea taken from two males and two females revealed no pathogenic 
response to inhalation of the test article. An LD50 >5 mg/l 
was established.
    4. Primary eye irritation. In the primary eye irritation study on 
the technical grade active ingredient, 3 rabbits received 100 mg of 
test article in 0.1 milliliter (ml) of water in the right eye. Redness 
of the conjunctiva and swelling of the eyelids occurred during

[[Page 30108]]

the first 24-48 hours after exposure, both were rated as high as 2 on a 
scale of 1 to 3 in some animals. The edema resolved in all animals 
within 48-hours after test article administration and the redness 
resolved in all animals within 72 hours. No changes in the cornea or 
iris of any animals occurred. Pythium oligandrum DV 74 was rated 
``moderately irritating'' to eyes.
    5. Primary dermal irritation. No adverse effects were seen in 
rabbits that received a subcutaneous injection of an extract of the 
technical grade active ingredient. In this study 3 rabbits received 0.2 
ml of an extract of the test article by subcutaneous injection at 2 
injection sites. No reaction was observed between 45 minutes and 72 
hours after the subcutaneous injection. Pythium oligandrum DV 74 was 
rated ``non irritant'' to skin.
    6. Hypersensitivity incidents. The registrant has noted that no 
incidents of hypersensitivity or any other adverse effects have 
occurred through the research, develop, or testing of the active 
ingredient and its related end-use product. Should any incidents occur, 
they will be reported per the Federal Insecticide, Fungicide and 
Rodenticide Act (FIFRA) section 6(a)(2).
    A literature search on pythium oligandrum demonstrates that this 
microorganism is not infective to mammals. The literature search 
indicated that pythium oligandrum has been studied for over 20 years, 
and the only biological effects attributed to the organism are 
parasitic effects on fungal species and stimulation of resistance to 
parasitic infection in plants. The mycoparasitic mode of action of 
pythium oligandrum is initiated by a specific affinity for the cells of 
the pathogenic fungus, followed by tight binding to the host hyphae and 
local penetration. Pythium oligandrum stimulates disease resistance in 
plants by production of a small proteinaceous molecule that serves as a 
biochemical signal in the plant. Neither the mechanism of mycoparasitic 
action nor the stimulation of plant resistance is associated with 
adverse affects in mammals.
    Further, pythium oligandrum DV 74 is the active ingredient in a 
variety of over the counter products sold in parts of Europe (including 
the Czech Republic, Slovakia, and Poland). These products include: A 
footbath to control itching and odor (brand name: Biodeur Deodorant); a 
fingernail treatment preparation to control nail fungus (brand name: 
BioBlock); a mouthwash rinse to control yeast infections (brand name: 
BioPlus); and a bath additive (brand name: Biodelta) and a skin cream 
(brand name: Biogama) to control psoriasis and dermatitis. These 
products have been marketed since 1999 without reports of adverse 
effects.
    A waiver has been requested for acute oral, dermal, pulmonary, and 
IV/IP toxicity/pathogenicity; dermal sensitization; and the 
conditionally required Tier 1 data for cell culture and immune 
response. In general, the waiver requests are based on the rationale 
that the active ingredient:
     Produced no adverse effects in mammalian toxicity studies.
     Is ubiquitous as a naturally occurring soil colonizer 
whose level in the environment will not significantly increase with the 
use of products that contain this strain.
     Has modes of action that are not consistent with toxicity 
or pathogenicity to mammals.
     In an extensive literature search yielded no reports of 
adverse effects in humans or other mammals.
     Is marketed in Europe as the active ingredient in over the 
counter products, including mouth rinses, bath additives, and skin 
creams, with no reports of adverse effects.
    The results of toxicity testing indicate there is no risk to human 
health or the environment from pythium oligandrum DV 74. There are no 
reports of ecological or human health hazards caused by pythium 
oligandrum in general or the strain pythium oligandrum DV 74 in 
specific. It does not produce recognized toxins, enzymes, or virulence 
factors normally associated with mammalian invasiveness or toxicity. 
The absence of acute toxicity or pathogenicity in laboratory animals 
demonstrates the benign nature of this strain. The limited survival of 
pythium oligandrum DV 74 and the lack of acute toxicity indicate that 
both the hazard and the exposure associated with the use of pythium 
oligandrum DV 74 are low. Non-dietary exposures would not be expected 
to pose any quantifiable risk due to a lack of residues of 
toxicological concern.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Dietary exposure from use of pythium 
oligandrum DV 74, as proposed, is minimal. The major intended use of 
pythium oligandrum DV 74 is application to growing plants and crops for 
the purposes of disease control and stimulating plant defense 
mechanisms. Pythium oligandrum is widely distributed around the world, 
including the U.S. application of pythium oligandrum DV 74 to seeds, 
foliage, or soil will not result in a substantial increase in 
concentration in the environment. The level of pythium oligandrum DV 74 
in the environment following application will decrease to levels 
similar to naturally occurring concentrations, because the organism 
does not thrive in the absence of sufficient nutrients. Limited 
survivability once its nutrient source is exhausted will limit any 
dietary exposure.
    ii.Drinking water. Similarly, exposure to humans from residues of 
pythium oligandrum DV 74 in consumed drinking water would be unlikely. 
Pythium oligandrum DV 74 is not known to grow or thrive in aquatic 
environments. Potential exposure to surface water would be negligible 
and exposure to drinking water (well or ground water) would be 
impossible to measure. The major intended use of pythium oligandrum DV 
74 is to treat growing plants and crops for the purpose of disease 
control. Pythium oligandrum DV 74 has limited survivability once its 
nutrient source is exhausted. The risk of the microorganism passing 
through the soil to ground water is minimal to unlikely. Additionally, 
the fungus would not tolerate the conditions water is subjected to in a 
drinking-water facility (including: Chlorination, pH adjustments, high 
temperatures, and/or anaerobic conditions).
    2. Non-dietary exposure. The potential for non-dietary exposure to 
the general population, including infants and children, is unlikely as 
the proposed use sites are application to growing plants or crops. 
Further, pythium oligandrum DV 74 has limited survivability once its 
nutrient source is exhausted.
    3. Conclusion. The results of toxicity testing indicate there is no 
risk to human health or the environment from pythium oligandrum DV 74. 
There are no reports of ecological or human health hazards caused by 
pythium oligandrum in general or the strain pythium oligandrum DV 74 in 
specific. It does not produce recognized toxins, enzymes, or virulence 
factors normally associated with mammalian invasiveness or toxicity. 
The absence of acute toxicity or pathogenicity in laboratory animals 
demonstrates the benign nature of this strain. The limited survival of 
pythium oligandrum DV 74 and the lack of acute toxicity indicate that 
both the hazard and the exposure associated with the use of pythium 
oligandrum DV 74 are low. Non-dietary exposures would not be expected 
to pose any quantifiable risk due to a lack of residues of 
toxicological concern.

[[Page 30109]]

E. Cumulative Exposure

    It is not expected that, when used as proposed, pythium oligandrum 
DV 74 would result in residues that are of toxicological concern. 
Pythium oligandrum DV 74 is applied to growing plants and crops for the 
purposes of disease control and stimulating plant resistance. Pythium 
oligandrum is widely distributed around the world, including the U.S. 
application of pythium oligandrum DV 74 to seeds, foliage, or soil will 
not result in a substantial increase in concentration in the 
environment. The level of pythium oligandrum DV 74 in the environment 
following application will decrease to levels similar to naturally 
occurring concentrations because the organism does not thrive in the 
absence of sufficient nutrients. The results of toxicity testing 
indicate there is no risk to human health or the environment from 
pythium oligandrum DV 74. There are no reports of ecological or human 
health hazards caused by pythium oligandrum in general or the strain 
pythium oligandrum DV 74 in specific. It does not produce recognized 
toxins, enzymes, or virulence factors normally associated with 
mammalian invasiveness or toxicity. The absence of acute toxicity or 
pathogenicity in laboratory animals demonstrates the benign nature of 
this strain. The limited survival of pythium oligandrum DV 74 and the 
lack of acute toxicity indicate that both the hazard and the exposure 
associated with the use of pythium oligandrum DV 74 are low.

F. Safety Determination

    1. U.S. population. Acute toxicity studies have shown that pythium 
oligandrum DV 74 is not toxic, pathogenic, or infective to mammals. The 
major intended use of pythium oligandrum DV 74 is applied to growing 
plants and crops for the purposes of disease control and stimulating 
plant resistance. The level of pythium oligandrum DV 74 in the 
environment following application will decrease to levels similar to 
naturally occurring concentrations because the organism does not thrive 
in the absence of sufficient nutrients. The results of toxicity testing 
indicate there is no risk to human health or the environment from 
pythium oligandrum DV 74. There are no reports of ecological or human 
health hazards caused by pythium oligandrum in general or the strain 
pythium oligandrum DV 74 in specific. It does not produce recognized 
toxins, enzymes, or virulence factors normally associated with 
mammalian invasiveness or toxicity. The absence of acute toxicity or 
pathogenicity in laboratory animals demonstrates the benign nature of 
this strain. The limited survival of pythium oligandrum DV 74 and the 
lack of acute toxicity indicate that both the hazard and the exposure 
associated with the use of pythium oligandrum DV 74 are low. There is a 
reasonable certainty of no harm to the general U.S. population from 
exposure to this active ingredient.
    2. Infants and children. It is not expected that, when used as 
proposed, pythium oligandrum DV 74 would result in residues that are of 
toxicological concern. There is a reasonable certainty of no harm for 
infants and children from exposure to pythium oligandrum DV 74 from the 
proposed uses.

G. Effects on the Immune and Endocrine Systems

    To date there is no evidence to suggest that pythium oligandrum DV 
74 functions in a manner similar to any known hormone, or that it acts 
as an endocrine disrupter.

H. Existing Tolerances

    There is no EPA tolerance for pythium oligandrum DV 74.

I. International Tolerances

    A Codex Alimentarium Commission Maximum Residue Level (MRL) is not 
required for pythium oligandrum DV 74.

[FR Doc. 05-10340 Filed 5-24-05; 8:45 am]
BILLING CODE 6560-50-S