United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-96-026
April 1997
R.E.D. FACTS
Pesticide
Reregistration
Co lie to trich um
gloeosporioides f.sp
aeschynomene
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered before November 1, 1984, be
reregistered to ensure that they meet today's more stringent standards.
In evaluating pesticides for reregi strati on, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregi strati on, EPA explains the basis
for its decision in a Reregi strati on Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregi strati on case 4103, Colletotrichum gloeosporioides f.sp.
aeschynomene (C.g.a.) ATCC strain 20358.
US6 Profile Colletotrichum gloeosporioides f.sp. aeschynomene (C.g.a.} ATCC
strain 20358 is a mycoherbicide used to control Northern Jointvetch (NJV)
The sole registered product is College™
Colletotrichum gloeosporioides f sp. aeschynomene ATCC 20358 is
applied by air and ground equipment.
Use practice limitations include: no applications to be made
(a) after rice heads emerge from the boot or after pods form on the
lower nodes of soybeans.
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Regulatory
History
(b) when rice and soybeans are under stress for moisture or when
drying conditions are likely to occur.
(c) to NJV previously treated with phenoxy herbicides.
Do not apply fungicides for at least three weeks following application
of C.g.or. ATCC20358.
C.g.a. ATCC 20358 was first registered as a pesticide in the U.S. in
1982. A September 1993 Data Call-In (DCI) required additional product
chemistry, acute mammalian, avian and freshwater fish and invertebrate
toxicity/pathogenicity data as well as some information to assess the effects
of its use on some non-target plants and insects. The sole registered
product, Collego™, has been mainly used for control of NJV on rice in
Arkansas.
Human Health
Assessment
Toxicity
No unreasonable adverse effects to human health are expected from
the use of Colletotrichum gloeosporioides f. sp. aeschynomene ATCC
20358. Adequate mammalian toxicology data on C.g.a. ATCC 20358 are
available and will support a Reregi strati on Eligibility Decision (RED). In
studies using laboratory animals, C.g.a. ATCC 20358 generally has been
shown to be of low acute toxicity. On the basis of acute oral, acute dermal,
and acute pulmonary toxicity/pathogenicity tests, it was rated as a Toxicity
Category IV mycoherbicide. It is neither a dermal irritant, nor a dermal
sensitizer and is considered a Toxicity Category III primary eye irritant.
These tests demonstrate that the active ingredient is practically non-toxic to
mammalian species.
Dietary Exposure and Risk
The RED document permits limited use of the pesticide on two crops,
rice and soybeans, in three states, Arkansas (AR), Louisiana (LA) and
Mississippi. Currently available data demonstrate the use of the
mycoherbicide on less than 0.1 percent of acreage of rice under cultivation
in Arkansas. Potential residues of the mycoherbicide are likely to be
removed from treated raw agricultural commodities by processing.
Therefore, exposure and risk of human infants, children and adults to
residues of C.g.a. ATCC strain 20358 through the diet is expected to be
minimal.
Exemptions from tolerances were established for the microbial
pesticide on rice grain and soybeans in 40 CFR 180.1075. EPA has
reassessed these exemptions from tolerances and found that there is no need
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to change them at this time. If data become available to necessitate any
changes to these exemptions from tolerances, the Agency will take
appropriate regulatory action.
Acute and Chronic Dietary Risks for Sensitive
Subpopulations, Particularly Infants and Children
The general population may be exposed to naturally occurring C.g.a
ATCC 20358, as a plant pathogenic fungus, with low or no specificity for
animals and human beings. The pesticidal use is not expected to increase
exposure to this microorganism above the natural levels of the fungus. The
Agency considers the toxicity database, together with the low volume use
and the removal of the pesticide during processing, sufficient to perform a
risk assessment for this mycoherbicide. To date, none of the active
ingredients of the microbial pesticides registered by the Agency have
required subchronic or chronic exposure studies. Also, for food uses of the
microbial pesticides, the acute toxicity/pathogenicity studies have allowed
for the conclusion that an exemption from the requirement of a tolerance is
appropriate and adequate to protect human health, including that of infants
and children. The results of testing done with Colletotrichum
gloeosporioides f.sp. aeschynomene ATCC 20358 agree with this
conclusion.
Effects on the Immune and Endocrine Systems
The active ingredient is a plant pathogenic fungus. No known
metabolite that acts as an "endocrine disrupter" is produced by this
microorganism. The submitted toxicity/pathogenicity studies in the rodent
indicated that the intact immune system was able to process and clear the
active microbial ingredient, as is expected of challenge from non-
pathogenic micro-organisms.
Potential for the Transfer of the Pesticide to Drinking Water
C.g.a ATCC 20358 is a naturally occurring plant pathogen. Although
the potential exists for some minimal amount of the applied microorganism
to enter ground water or other drinking water sources, the amounts present
would in all probability be undetectable or at least several orders of
magnitude lower than those levels tested for safety. Also, drinking water is
not screened for this fungus as a potential indicator of microbial
contamination or as a direct pathogenic contaminant. Both percolation
through soil and municipal treatment of drinking water would reduce the
possibility of exposure to the microbe through drinking water. Therefore,
the Agency considers the potential of significant transfer of Colletotrichum
gloeosporioides f.sp. aeschynomene ATCC 20358 to drinking water is
minimal to nonexistent.
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Cumulative Exposure From Multiple Routes Including Oral and
Inhalation
Skin would primarily be a route of exposure for mixer/loader
applicators. Unbroken skin is a natural barrier to microbial invasion of the
human body. The only way in which skin could be a significant route for
exposure would be if the skin were cut, or the microbe were a pathogen
with mechanisms for entry through or infection in the skin, or if metabolites
were produced that could not be absorbed dermally. Since the submitted
toxicology studies demonstrated no adverse effects in animals, even cut
skin should not pose a risk to health via entry of Colletotrichum
gloeosporioides f.sp. aeschynomene ATCC 20358 into the body.
Inhalation would also be a route of exposure for mixer/loader
applicators. Because the pulmonary study showed no adverse effects, the
risks anticipated for this route of exposure are considered minimal.
Oral exposure would occur primarily from eating treated produce but
minimal risk is expected because of the active ingredient's exemption from
the requirement of a tolerance.
Occupational and Residential Exposure
This is a low toxicity category III or IV mycoherbicide, which is to be
applied in three states by ground and air at low rates to the raw agricultural
commodities, rice and soybeans. Based on current use patterns, the
exposure and risk to handlers (mixers, loaders, and applicators) using this
pesticide is likely to be minimal.
The Agency recommends that handlers wear long-sleeved shirts, long
pants, socks, and shoes. Post-application reentry workers will be required
to observe a 4-hour Restricted-entry Interval (REI). During this REI, the
Agency recommends that the reentry workers wear long-sleeved shirts, long
pants, socks, and shoes and a dust/mist filtering respirator MSHA/NIOSH
approval number prefix TC-21C.
Environmental The database in support of the ecological effects of this
AsSGSSITIGnt mycoherbicide establishes that Colletotrichum gloeosporioides f.sp.
aeschynomene (C.g.a.) ATCC strain 20358 is a plant pathogen with a great
degree of host specificity for the Northern Joint Vetch (NJV), the target
pest.
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Risks Posed by Potential Residential, School or Daycare
Exposure
No residential, school or daycare uses currently appear on the label.
Both use sites, rice and soybeans, are agricultural for control of the northern
jointvetch weed. Therefore, under current agricultural practice, nondietary
exposure to sites where children are present is minimal to nonexistent.
Environmental Effects and Risk Assessment
After application to soybeans and rice, no spores were isolated from either
raw agricultural commodity. Infested host plant debris, buried in the soil for
more than 8 weeks under field conditions did not yield any colony forming units.
After application, fungus spores remain airborne for a period of less than 5
minutes. Laboratory tests indicate that the fungus can survive in field water for at
least 90 days, but its population gradually declines due to either microbial
degradation/predation. Irrigation water, assayed after aerial application of the
fungus at label rates contained less than 1 colony forming unit. Further studies
demonstrated a short half-life of the fungal spores in the aquatic system. Thus
appreciable build-up of the fungal spores in the air, soil and water is not
anticipated.
Ecological Effects and Risk Assessment
Studies were submitted and reviewed to establish the effects of the
mycoherbicide on the required invertebrates, vertebrates, and non-target plants.
Adverse effects on non-target insects, mammals and other aquatic and terrestrial
vertebrates and invertebrates are not expected. There is some potential for
phytopathogenicity to sweet peas and to NJV, which is an endangered species in
the Northeastern United States. However, peas are not grown as an agricultural
crop in Louisiana, Arkansas and Mississippi, where NJV is the target pest.
Risk Mitigation
To lessen the risks of potential phytopathogenicity to peas posed by
C.g. a. ATCC 20358, EPA is requiring the following risk mitigation
measures.
1 . Peas are not to be planted in rotation to crops treated with the
mycoherbicide.
2. This microbial pesticide is to be applied only to rice and soybeans in
Arkansas, Louisiana and Mississippi.
Additional Data EPA is requiring revised Confidential Statements of Formula (CSFs),
certification of nominal limits and revised labeling for reregi strati on.
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Product Labeling
Changes
Required
All end-use products containing Colletotrichum gloeosporioides f.sp.
aeschynomene (C.g.a.) ATCC strain 20358 must comply with EPA's
current pesticide product labeling requirements and with the following. For
a comprehensive list of labeling requirements, please see the RED
document.
For products containing Colletotrichum gloeosporioides f.sp.
aeschynomene (C.g.a.) ATCC strain 20358, the Personal Protective
Equipment (PPE) recommended by the WPS are: long sleeved shirt, long
pants, socks, and shoes for the mixer/loader and applicator. In addition the
mixer/loaders should wear a dust/mist filtering respirator MSHA/NIOSH
approval number prefix TC-21C. Early entry workers should wear long
sleeved shirt, long pants, shoes and socks for postapplication activities
during the four (4) hour Restricted-entry Interval (REI).
Products containing Colletotrichum gloeosporioides f.sp.
aeschynomene (C.g.a.) ATCC strain 20358 may not be applied to peas, nor
should peas be planted in rotation to crops treated with this mycoherbicide.
Use is restricted to Arkansas, Louisiana, and Mississippi.
Regulatory
Conclusion
The use of currently registered products containing Colletotrichum
gloeosporioides f.sp. aeschynomene (C.g.a.) ATCC strain 20358 in
accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of these
products as specified in the RED document are eligible for reregi strati on.
Products containing Colletotrichum gloeosporioides f.sp.
aeschynomene (C.g.a.) ATCC strain 20358 will be reregistered once the
required product-specific data, revised Confidential Statements of Formula,
and revised labeling are received and accepted by EPA.
For More
Information
EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for Colletotrichum gloeosporioides f.sp.
aeschynomene (C.g.a.) ATCC strain 20358 during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
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Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregi strati on Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the Colletotrichum gloeosporioides
f.sp. aeschynomene (C.g.a.) ATCC strain 20358 RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregi strati on program,
the Colletotrichum gloeosporioides f.sp. aeschynomene (C.g.a.) ATCC
strain 20358 RED, or reregi strati on of individual products containing
Colletotrichum gloeosporioides f.sp. aeschynomene (C.g.a.) ATCC strain
20358, please contact the Biopesticides and Pollution Prevention Division
(7501W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8712.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
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