Pythium Oligandrum DV 74; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 30105-30109 [05-10340]
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Federal Register / Vol. 70, No. 100 / Wednesday, May 25, 2005 / Notices
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[FR Doc. E5–2622 Filed 5–24–05; 8:45 am]
BILLING CODE 6717–01–P
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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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:
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(703) 308–0455; e-mail address:
milofsky.tessa@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS
32532)
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Copies of this
Document and Other Related
Information?
1. Docket. EPA has established an
official public docket for this action
under docket ID number OPP–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
https://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 https://www.epa.gov/edocket/
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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
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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 email 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 https://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 opp-docket@epa.gov,
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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
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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.
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Federal Register / Vol. 70, No. 100 / Wednesday, May 25, 2005 / Notices
Dated: May 16, 2005.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
application to agricultural crops,
ornamental plants, and turf grasses.
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 enduse 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
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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 dampingoff 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,
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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
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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
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(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
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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.
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25MYN1
Federal Register / Vol. 70, No. 100 / Wednesday, May 25, 2005 / Notices
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
VerDate jul<14>2003
17:52 May 24, 2005
Jkt 205001
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
FEDERAL COMMUNICATIONS
COMMISSION
Notice of Public Information
Collection(s) Being Reviewed by the
Federal Communications Commission
for Extension Under Delegated
Authority
May 13, 2005.
SUMMARY: The Federal Communications
Commission, as part of its continuing
effort to reduce paperwork burden
invites the general public and other
Federal agencies to take this
opportunity to comment on the
following information collection(s), as
required by the Paperwork Reduction
Act of 1995, Pub. L. 104–13. An agency
may not conduct or sponsor a collection
of information unless it displays a
currently valid control number. No
person shall be subject to any penalty
for failing to comply with a collection
of information subject to the Paperwork
Reduction Act (PRA) that does not
display a valid control number.
Comments are requested concerning (a)
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
30109
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
Commission, including whether the
information shall have practical utility;
(b) the accuracy of the Commission’s
burden estimate; (c) ways to enhance
the quality, utility, and clarity of the
information collected; and (d) ways to
minimize the burden of the collection of
information on the respondents,
including the use of automated
collection techniques or other forms of
information technology.
DATES: Persons wishing to comment on
this information collection should
submit comments by July 25, 2005. If
you anticipate that you will be
submitting comments, but find it
difficult to do so within the period of
time allowed by this notice, you should
advise the contact listed below as soon
as possible.
ADDRESSES: Direct all Paperwork
Reduction Act (PRA) comments to
Judith B. Herman, Federal
Communications Commission, 445 12th
Street, SW., Room 1–C804, Washington,
DC 20554 or via the Internet to JudithB.Herman@fcc.gov.
FOR FURTHER INFORMATION CONTACT: For
additional information or copies of the
information collections contact Judith B.
Herman at 202–418–0214 or via the
Internet at Judith-B.Herman@fcc.gov.
SUPPLEMENTARY INFORMATION: OMB
Control No.: 3060–0881.
Title: Section 95.861, Interference.
Form No.: N/A.
Type of Review: Extension of a
currently approved collection.
Respondents: Business or other for
profit.
Number of Respondents: 460.
Estimated Time Per Response: .50
hours.
Frequency of Response: On occasion
reporting requirement, recordkeeping
requirement and third party disclosure
requirement.
Total Annual Burden: 230 hours.
Annual Cost Burden: $13,800.
Privacy Act Impact Assessment: N/A.
Needs and Uses: The Commission
will be submitting this information
collection after the 60 day public
comment period in order to obtain the
full three year clearance from OMB. We
are requesting an extension (no change)
to the information collection
requirements. Section 95.861 requires
218–219MHz licensees to notify all
households located both within a TV
Channel 13 Grade B contour and a 218–
219 MHz system service area of
potential interference to Channel 13 TV
reception. This requirement is intended
to prevent interference from 219–219
E:\FR\FM\25MYN1.SGM
25MYN1
]]>Agencies
[Federal Register Volume 70, Number 100 (Wednesday, May 25, 2005)]
[Notices]
[Pages 30105-30109]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10340]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: milofsky.tessa@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-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 https://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 https://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 https://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 opp-docket@epa.gov,
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
