United States Prevention, Pesticides EPA-738-R-96-026
Environmental Protection And Toxic Substances May 1997
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Colletotrichum
gloeosporioides f.sp.
aeschynomene
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical case 4103, which
includes the active ingredient Colletotrichum gloeosporioides f.sp. aeschynomene ATCC
20358. The enclosed Reregi strati on Eligibility Decision (RED) contains the Agency's
evaluation of the data base of this chemical, its conclusions of the potential human health and
environmental risks of the current product uses, and its decisions and conditions under which
these uses and products will be eligible for reregi strati on. The RED includes the data and
labeling requirements for products for reregi strati on. It may also include requirements for
additional data (generic) on the active ingredient to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED." This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses The first set of required responses is due 90 days from the
receipt of this letter. The second set of required responses is due 8 months from the date
of this letter. Complete and timely responses will avoid the Agency taking the enforcement
action of suspension against your products.
Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3, 1996, amending portions of both the pesticide law (FIFRA) and the food and drug
law (FFDCA). This RED takes into account the new safety standard set by the FQPA for
establishing and reassessing tolerances. However, it should also be noted that in continuing to
make the reregi strati on determinations during the early stages of FQPA implementation, EPA
recognizes that it will be necessary to make decisions relating to FQPA before the
implementation process is complete. In making these early case-by-case decisions, EPA does
not intend to set broad precedents for the application of FQPA. Rather, these early
determinations will be made on a case-by-case basis and will not bind EPA as it proceeds
with further policy development and any rule-making that may be required.
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If EPA determines, as a result of this later implementation process, that any of the
determinations described in the RED are no longer appropriate, the Agency will pursue
whatever action may be appropriate, including but not limited to reconsideration of any
portion of this RED.
If you have questions on the generic and product specific data requirements or wish to
meet with the Agency, please contact the Biopesticides and Pollution Prevention Division
representative, Shanaz Bacchus, at (703) 308-8097.
Sincerely yours,
Janet L. Andersen, Ph. D., Director
Biopesticides and Pollution
Prevention Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms) You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response. All data waiver and time extension requests must be
accompanied by a full justification. All waivers and time extensions must be granted by EPA
in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You
must submit the following items for each product within eight months of the date of this
letter (RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as
formulation changes, or labeling changes not related to reregi strati on) separately. You may,
but are not required to, delete uses which the RED says are ineligible for reregi strati on. For
further labeling guidance, refer to the labeling section of the EPA publication "General
Information on Applying for Registration in the U.S., Second Edition, August 1992"
(available from the National Technical Information Service, publication #PB92-221811;
telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI)
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d Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e Certification With Respect to Data Compensation Requirements Complete
and sign EPA form 8570-31 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-BPPD)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-BPPD)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are
not complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregi strati on determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Colletotrichum gloesoporioides f. sp. aeschynomene
LISTD
CASE 4103
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
Colletotrichum gloeosporioides f. sp. aeschynomene
REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 4
D. Data Requirements 4
E. Regulatory History 4
III. SCIENCE ASSESSMENT 5
A. Product Identity and Characterization 5
B. Human Health Assessment 8
1. Toxicology Assessment 8
a. Acute Toxicity 9
b. Subchronic Toxicity 10
2. Exposure Assessment 10
a. Dietary Exposure 10
b. Occupational/Residential Exposure 11
3. Risk Assessment 11
a. Dietary 11
b. Occupational and Residential 11
c. Food Quality Protection Act Considerations 12
C. Environmental Assessment 14
1. Ecological Toxicity 14
a. Toxicity to Terrestrial Animals 15
b. Toxicity to Aquatic Animals 16
c. Toxicity/Pathogenicity to Plants 17
2. Environmental Fate 19
a. Environmental Fate and Transport 19
3. Exposure and Risk Characterization 21
a. Ecological Exposure and Risk Characterization 21
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 22
A. Determination of Eligibility 22
1. Eligibility Decision 23
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2. Eligible and Ineligible Uses 23
B. Regulatory Position 23
1. Food Quality Protection Act Considerations 23
2. Tolerance Reassessment 24
3. Endangered Species 25
4. Labeling Rationale 25
5. Spray Drift Advisory 26
V. ACTIONS REQUIRED OF REGISTRANTS 26
A. Manufacturing-Use Products 26
1. Additional Generic Data Requirements 26
B. End-Use Products 26
1. Additional Product-Specific Data Requirements 26
2. Labeling Requirements for End-Use Products 27
C. Existing Stocks 32
VI. APPENDICES 33
APPENDIX A. Table of Use Patterns Subject to Reregistration 34
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 39
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of Colletotrichum gloeosporioides f.sp.
aeschynomene ATCC strain 20358 45
APPENDIX D. Generic Data Call-In 53
Attachment 1. Chemical Status Sheet 73
Attachment 2. Generic DCI Response Forms Inserts (Form A) plus
Instructions 75
Attachment 3. Requirements Status and Registrants' Response Forms
Inserts (Form B) plus Instructions 79
Attachment 4. List of Registrants sent this DCI (Insert) 85
APPENDIX E. List of Available Related Documents 87
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Colletotrichum gloeosporioides f. sp. aeschynomene
REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Gabe Patrick
Neil Anderson
Sandra Zavolta
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Biooesticides and Pollution Prevention Division
Robert Torla
Robert I. Rose
Phil Hutton
Roy Sjoblad
John Kough
Cindy Schaffer
Mike Mendelsohn
Gail Tomimatsu
Shanaz Bacchus
John Tice
Biochemicals Team
Biochemicals Team
Microbials and Plant
Microbials and Plant
Microbials and Plant
Microbials and Plant
Microbials and Plant
Microbials and Plant
Microbials and Plant
Pollution Prevention
Pesticides
Pesticides
Pesticides
Pesticides
Pesticides
Pesticides
Pesticides
Team
Team
Team
Team
Team
Team
Team
Team
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e.
drinking water) lifetime exposure at which adverse, non carcinogenic health effects are not
anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO/WHO Food and Agriculture Organization/World Health Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and
other organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of
substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in
50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It
is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Hg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
Ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
N/A Not Applicable
NOEC No effect concentration
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
Pa pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
RUP Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
ug/L Micrograms per liter
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The U. S. Environmental Protection Agency has completed its reregi strati on eligibility
decision on the active ingredient, Colletotrichum gloeosporioides f. sp. aeschynomene
(referred to as C.g.a.) American Type Culture Collection (ATCC) 20358. This decision
includes a comprehensive reassessment of the required target data and the use patterns of the
currently registered active ingredient. This decision also considered the requirements of the
of the recently enacted "Food Quality Protection Act of 1996" which amended the Federal
Food and Drug and Cosmetic Act and the Federal Insecticide, Fungicide and Rodenticide Act,
the two Federal statutes that provide the framework for pesticide regulation in the United
States. FQPA became effective immediately upon signature and all reregi strati on eligibility
decisions (REDs) signed subsequent to August 3, 1996 are accordingly being evaluated under
the new standards imposed by FQPA.
In establishing or reassessing tolerances, FQPA requires the Agency to consider
aggregate exposures to pesticide residues, including all anticipated dietary exposures and
other exposures for which there is reliable information, as well as the potential for cumulative
effects from a pesticide and other compounds with a common mechanism of toxicity. The
Act further directs EPA to consider the potential for increased susceptibility of infants and
children to the toxic effects of pesticide residue.
The Agency has reassessed the food and feed tolerances for C.g.a. ATCC 20358 under
the standards of FQPA and determined that, based on available information, there is a
reasonable certainty that no harm will result to infants and children or to the general
population from aggregate exposure to the microbial pesticide residues. EPA evaluated only
dietary and drinking water exposure in the aggregate assessment, since other non-
occupational exposures to C.g.a. ATCC 20358 are unlikely. EPA has no information to
indicate that the toxic effects produced by the microbial pesticide would be cumulative with
those of any other compound, and therefore has considered only C.g.a. ATCC 20358
exposures in the aggregate assessment.
Pesticidal products whose sole active ingredients qualify as biological agents may be
exempt from certain generic data requirements necessary for conventional chemical
pesticides. The data requirements relating to toxicology, residue chemistry, human exposure,
ecological effects and environmental fate of the active ingredient are outlined in 40 CFR §
158.740 — Guidelines for Microbial Control Agents.
C.g.a. ATCC 20358, a fungus, has been registered and used as a herbicide on rice and
soybeans since 1982, the sole registered product being Collego™. An exemption from the
requirement of a tolerance for C. gloeosporioides f.sp. aeschynomene ATCC 20358 on rice
and soybeans has been established (40 CFR §180.1075). In reaching the determination of
safety for infants and children, the Agency found that the toxicity database for this microbial
pesticide is complete based on current requirements. Moreover, because of its limited usage
v
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on two crops in three states, and the potential for loss of residues during processing of these
raw agricultural commodities, dietary exposure to human infants, children and adults is
expected to be minimal. EPA has reassessed the tolerances for C.g.a. ATCC 20358 as
required by FIFRA 4(g)(2)(E) and considers these reassessed tolerances to be qualifying
Federal determinations under FFDCA 408(n)(2).
Species in the genus Colletotrichum are common in the environment and frequently
parasitize higher plants, causing anthracnose disease. There are no indications, however, that
C.g.a. ATCC 20358 presents any pathogenic potential to animal species. No adverse effects
have been reported as required by section 6(a)2 of FIFRA. Recreational areas are not
registered for this microbial pesticide. The pesticide is short-lived in the environment and is
not likely to persist in aquatic systems. Although the potential exists for some minimal
amount of the 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 microorganism as a potential indicator of microbial contamination or as a direct
pathogenic contaminant.
Geographical limitations are not stated on the current label of the sole registered
product Collego. However, there is some concern about the potential phytopathogenicity if
this microbial herbicide is directly applied to peas or to certain non-target species of plants as
discussed in this RED document. For these reasons, the use of all products containing this
active ingredient is limited to Arkansas, Louisiana and Mississippi. In addition, the Agency
recommends that C.g.a ATCC 20358 must not be applied to peas and peas must not be
planted in rotation to crops which have been treated with products containing the active
ingredient C.g.a ATCC 20358. On the basis of data currently available, the Agency has
concluded that those registered uses, as described in this document, will not cause
unreasonable risks to human infants, children or adults or the environment and, therefore, the
currently registered products, containing this active ingredient, are eligible for reregi strati on.
Label revisions and a revised Confidential Statement of Formula (CSF) to reflect the
current reregi strati on status and nominal limits of C.g.a. ATCC 20358 are required as part of
this RED document. Workers exposed to this low acute and low subchronic toxicity
microbial are not likely to be at risk. To comply with the Worker Protection Standards (WPS)
for pesticides used on agricultural crops, the Agency is requiring, among other changes, the
use of Personal Protective Equipment (PPE) for handlers and early-entry workers. A four (4)
hour Restricted-entry Interval (REI) is required for early-entry workers engaged in
postapplication activities following treatment of agricultural crops with this pesticide. If
necessary, other WPS requirements will be set during the product reregi strati on process.
VI
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregi strati on of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregi strati on process to be
completed in nine years. There are five phases to the reregi strati on process. The first four
phases of the process focus on identification of data requirements to support the reregi strati on
of an active ingredient and the generation and submission of data to fulfill the requirements.
The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregi strati on.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregi strati on" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus, reregi strati on involves a thorough review of the scientific data base
underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the
need for additional data on health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criterion of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law
104-170) was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went into effect immediately. Among
other things, FQPA amended the FFDCA by establishing a new safety standard for the
establishment of tolerances, but FQPA does not obligate the Agency to consider the factors
set forth in the new section 408 of the FFDCA when making decisions under FIFRA with
respect to pesticides that do not have any food uses. However, the FQPA did not amend any
of the existing reregi strati on deadlines in section 4 of FIFRA. Therefore, the Agency will
continue its ongoing reregi strati on program while it continues to determine how best to
implement FQPA.
This document presents the Agency's decision regarding the reregi strati on eligibility of
the registered uses of Colletotrichum gloeosporioides f. sp. aeschynomene ATCC 20358. The
document consists of six sections. Section I is the introduction. Section II describes C.g.a.
ATCC 20358, its uses, data requirements and regulatory history. Section III discusses the
human health and environmental assessment based on the data available to the Agency.
Section IV presents the reregi strati on decision for C.g.a. ATCC 20358. Section V discusses
the reregi strati on requirements for C.g.a. ATCC 20358. Finally, Section VI contains the
Appendices which support this Reregi strati on Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregi strati on Eligibility
Decision:
• Common Name: College, C.g.a. ATCC 20358.
• Biological Name: Colletotrichum gloeosporioides f. sp.
aeschynomene ATCC strain 20358
• Biological Family: Melanconiaceae
• OPP Chemical Code: 226300
• Trade and Other Names: College™, C.g.a. ATCC 20358
• Basic Manufacturer: University of Arkansas
Office of Research and Sponsored Programs
120 Ozark Hall, Fayetteville, Arkansas 72701
B. Use Profile
The following is information on the currently registered uses with an overview
of use sites and application methods. A detailed table of these uses of C.g.a. is in
Appendix A.
ForCg.a. ATCC 20358:
Type of Pesticide: Herbicide (microbial control agent)
Use Sites: Rice, soybean. This RED limits use to Arkansas, Louisiana, and
Mississippi to protect non-target plants.
Target Pests: Weeds: northern jointvetch
Formulation Types Registered: A two component product consisting of:
Component A: a water-soluble rehydrating agent, which is a nutrient solution,
and
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Component B: a dried fungal spore preparation of Colletotrichum
gloeosporioides f. sp. aeschynomene ATCC 20358. This component can be
suspended in water and contains fermentation solids, mycelial fragments and
inerts.
Method and Rates of Application: See Appendix A: post emergence,
flooded area treatment; air, ground applications; high volume spray (dilute);
low volume spray (concentrate). (See Appendix A for details)
Equipment - fixed wing aircraft, helicopter; high volume ground
sprayer; low volume ground sprayer
Method and Rate - To treat 10 acres: One quart of Component A and 2
parts of water to make the rehydrating solution for 1 bag of Component
B (75.7 x 1010 viable spores).
Timing - post emergent, when northern jointvetch are 8 to 24 inches tall.
Use Practice Limitations:
On the current label:
Apply when the leaves of northern jointvetch are moist and can be
expected to remain so for at least 12 hours.
The pesticide is not to be applied under the following conditions:
(a) after rice heads emerge from the boot or after pods form on
the lower nodes of soybeans.
(b) when rice and soybeans are under stress for moisture or when
drying conditions are likely to occur.
(c) to northern jointvetch previously treated with phenoxy
herbicides
Do not apply fungicides for at least three weeks following application of
C.g.or. ATCC 20358.
Proposed label amendments
Additional Agency-proposed use practice limitations resulting from the
evaluation of the data for this RED and to comply with the Worker
Protection Standards are discussed in Sections IV and V.
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C. Estimated Usage of Pesticide
C.g.a. ATCC 20358 is registered in the United States as a sole product,
College™, for control of Northern jointvetch (NJV) in rice and soybeans. The current
label does not place any geographical limitation on the use of C.g.a. ATCC 20358
NJV, the target pest, is endemic to Arkansas (AR), Louisiana (LA) and Mississippi
(MS).
Prior to 1993, Collego was applied to 1,000 to 10,000 acres of rice annually in
Arkansas to control Northern joint vetch. Spradley and Windham, 2-CA-95, report the
use in Arkansas as less than 0.1 percent of acres of treated rice. Soybeans is the other
registered site for Collego; however, no usage data were found on soybeans.
In this RED, because of potential phytotoxicity to non-target plants (as
discussed under Ecological Exposure and Risk Characterization in Section III) the
Agency is limiting the use of C.g.a. ATCC 20358 to AR, LA and MS. Appendix A
summarizes the currently registered pesticide uses by agricultural site.
D. Data Requirements
A Data Call-In, which was issued in September, 1993, for reregi strati on of
C.g.a. required additional product chemistry, acute mammalian, avian and freshwater
fish and invertebrate toxicity/pathogenicity data, as well as information to assess the
effects of its use on some non-target plants and insects. All data were reviewed as
summarized in this RED document. Appendix B includes all data requirements
identified by the Agency to support reregi strati on of currently registered uses. The
Agency obtained additional information on the host range specificity of C.g.a for the
reregi strati on process. This information was useful in evaluating the
phytopathogenicity of the fungus to non-target plants. No further generic data are
required for reregi strati on of C.g.a. as currently marketed.
E. Regulatory History
The sole registered product, Collego™, contains the active ingredient
Colletotrichum gloeosporioides f. sp. aeschynomene ATCC strain 20358. It is a post-
emergent herbicide for control of Northern jointv etch (NJV) in rice and soybeans.
There is no technical or manufacturing use product registered.
Collego™ was conditionally registered in June 1982, with unconditional
registration depending on resolution of issues regarding avian toxicity and freshwater
fish and freshwater invertebrate toxicity/pathogenicity. An unconditional registration
was granted to Tuco Products Co., a Division of Upjohn, for the use of the
microbiological pesticide in the United States in October, 1982.
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The registration for this microbiological herbicide was transferred to AGREVO
USA Co., in April, 1985, and later in January of 1989 to Ecogen. The current
registrant as of June, 1996, is the University of Arkansas (EPA Reg. No. 69843-1).
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public
Law 104-170) was signed into law. EPA is embarking on an intensive process,
including consultation with registrants, States, and other interested stakeholders, to
make decisions on the new policies and procedures that will be appropriate as a result
of enactment of FQPA. This process will include a more in depth analysis of the new
safety standard and how it should be applied to both food and non-food pesticide
applications. However, in light of the unaffected statutory deadlines with respect to
reregistration, the Agency will continue its ongoing reregi strati on program while it
continues to determine how best to implement FQPA.
The Agency has found that the uses of Colletotrichum gloeosporioides f. sp.
aeschynomene ATCC strain 20358 are eligible for reregistration under the conditions
specified in this RED. However, it should be understood that the Agency may take
additional appropriate regulatory action, and/or require submission of additional data
to support the registration of products containing this active ingredient, if new
information comes to the Agency's attention or if the data requirements for registration
(or the guidelines for generating such data) change.
III. SCIENCE ASSESSMENT
A. Product Identity and Characterization
The product identity and characterization information for Colletotrichum
gloeosporioides f.sp. aeschynomene (also known as C.g.a.) ATCC strain 20358 shows
that this microorganism is a naturally occurring fungus, originally isolated from
diseased northern jointvetch (Aeschynomene virginicd) growing as weeds in Arkansas
rice fields. The fungus is an imperfect or asexual fungus in theMelanconiaceae
family, producing slipper-shaped, hyaline non-septate phialospores (approximately
15.8 x 5.5|im in size) from thickened, brown pseudoparenchyma that develops into
stromatic tissue under the host epidermis. The conidia are produced in a slimy exudate
which is pink to orange in color and arise from an acervulus which lacks setae. Spores
landing on suitable host tissue become two-celled, then germinate to form an
appressorium and infect the host tissue causing the typical anthracnose or leaf spot
disease under proper conditions. No sexual stage of this fungus is known in nature,
but other strains of Colletotrichum gloeosporioides have been related to the perithecial
ascomycete Glomerella cingulata. The active ingredient has been deposited in the
American Type Culture Collection as strain 20358.
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The taxonomy of fungal plant pathogens is unusual in that description of the
organism beyond the species level is possible only by designating the range of plants
that can be infected. This is especially important in imperfect fungi such as C.
gloeosporioides which have a very wide described host range. Fungi are allowed by
the rules of botanical nomenclature to employ the "formae speciales" (f. sp.)
designation to specify this added information. Consequently, the microbe causing the
anthracnose disease in northern jointvetch is named C. gloeosporioides f.sp.
aeschynomene to refer to its restricted host range for the plant genus Aeschynomene
(MRID 00083879, 00084478, 00084340, 00084481, 00084482, 00084483,
00084484). The studies performed to demonstrate the restricted host range impinge on
both the proper taxonomic description of the active ingredient and the hazards posed
to non-target plants. Therefore, some of the discussion will be cross referenced
between the two sections.
To verify the restricted host range of C.g.a., data on individual host plant
response after inoculation were provided to circumscribe the potential host range using
the centrifugal phylogenetic testing scenario. This method first tests those plant
species most closely related to the known target plant, (in this case other
Aeschynomene species, members in the tribe Hedysareae and other legume species)
then proceeds with testing of more distantly related species until plant immunity is
generally found. For the original submission this included thirteen species in the
genus Aeschynomene and another member of a taxonomically related group
(Lespedeza stipulacea also in the Hedysareae tribe). Nine other species in the
Leguminosae were tested including 22 cultivars of soybean (Glycine max) and 6
cultivars of cowpea (Vicia unguiculatd). In addition, 26 agronomic or horticultural
species with from 1 to 3 cultivars within each species were tested. This testing group
comprised 16 families with 32 genera and included pot marigold (Calendula
officinalis), a plant species known to be infected by C. gloeosporioides (no formae
speciales designation and a broader host range for this fungal strain). The immunity of
the species tested except for Aeschynomene virginica, A. indica, A. evenia, A.
pratensis, A. rudis, A. scabra and A. sensitiva allowed the determination of safety to
non-target plant species to be made for the original registration (MRID 00083879,
00084478,00084340, 00084481, 00084482, 00084483, 00084484).
Subsequent to this original submission, the published literature has indicated
that the host plant range for C.g.a. is greater than described in the original submission.
To identify further the host range of C.g.a. within the Leguminosae, 82 species from
47 genera and 24 tribes within the Leguminosae were tested by inoculation (MRID
43965601). These tests suggest the host range of C.g.a. includes several other species
in the Leguminosae including Lupinus arboreus, L. nanus, Vicia ervilia and the
Mammoth Melting Sugar, Sweet Snap, Mars, Snowbird, Thomas Laxton and Venus
cultivars ofPisum sativum, all of which show more than 50% of the leaf tissue
infected (MRID 43965601). Lupinus alba and Pisum sativum cultivar Little Marvel
-------
were tested in the original host range determination and found to be immune to C.g.a..
Other species (Lupinus alba, L. polyphyllus, L. regalis, L. densiflorus, L. subcarnosus,
Indigofera hirsuta, I. tinctoria, Lotus tetragonolobus, Lathyrus odorata, Lens
esculenta, Vicia benghalensis, V. faba, V. narboensis, V. pannoiae and V. sativa) were
found to sustain lesser degree of infection upon inoculation. It is important to note that
the results of the individual inoculation tests indicate that only A. virginica is killed
outright by C.g.a..
While these results do not significantly alter the host range of plants that are
expected to be exposed to C.g.a. in use, it does call into question the selection of
species and cultivars during phylogenetic centrifugal testing for non-target plant
effects. It is also important to consider that the testing of numerous cultivars within a
species such as Pisum sativa implies the sampling of a larger range of genotypes
within the susceptible population. In the absence of selection for host resistance
during cultivar development, it could be expected that some cultivar variation in
pathogen susceptibility will be displayed if any potential for infection was in the
genetic background of that plant species. The importance of this susceptibility and the
biological meaning of low levels of virulence expressed under artificial inoculation is
unclear, but it does not alter the original findings for reregi strati on purposes. Host
range specificity with regards to Pisum sativa is further discussed in the Ecological
Effects Section under Toxicity to Plants.
The proof that C.g.a. is genetically stable is cogent to the determination that the
demonstrated host range cannot be drastically altered. To verify this claim, the ability
of C.g.a. to form heterokaryons, diploids and undergo mitotic recombination was
examined using auxotrophic mutants of C.g.a. and Colletotrichum gloeosporioides
f.sp.jussiaeae (C.g.j.), a specific fungal strain infecting Ludwigia decurrens. The use
ofC.g.j. is relevant due to its occurrence in the same habitat as northern jointvetch.
All of the environmental C.g.a. isolates, including the registered active ingredient,
were in the same vegetative compatibility group, which indicates that they can form
anastomoses and possibly undergo asexual or mitotic recombination. None of the
C.g.a. auxotrophs were able to form heterokaryons with C.g.j. which supports the fact
that these strains are genetically separate. Even between mutants derived from the
same C.g.a. parent, stable heterokaryons were rarely formed (<10"4 heterokaryotic
colonies per colony plated) and none of these heterokaryons displayed reversion to
prototrophy, indicating diploid formation and mitotic recombination were not
occurring (MRID 43965601).
Further experimental evidence showed that C.g.a. isolate Clar-5a and
Colletotrichum gloeosporioides isolated from pecans (and capable of infecting apples)
in Louisiana or from Ludwigia decurrens (referred to as C.g.j. above) were able to
form fertile Gomerella cingulata-type perithecia. C.g.a. Clar-5a was unable to form
perithecia with 21 isolates of C. gloeosporioides from 8 other host plants (including
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the C.g.a. strain used as the active ingredient) or with 19 isolates from other
Colletotrichum species (MRID 43965601). The single ascosporic colonies dissected
from these perithecia displayed outcrossing, not homothallic perithecial formation,
with characters segregating for both parental types. However, there was a much lower
frequency of fertile perithecia in these crosses than normally occurs with Glomerella
cingulata. The asci present were few, rarely had 8 ascospores and displayed low
germination rates (about 33%). These results indicate that C.g.a. is probably not
solely an asexual fungus and should probably be more properly described as
Glomerella cingulata but that the sexual state is probably very rare and produces few
viable ascospores.
These results also do not indicate the biological significance of this potential
for gene exchange by sexual recombination in nature. The colonies resulting from the
laboratory crosses had reduced pathogenicity on A. virginica and variable
pathogenicity to apples. Although C.g.a. and these two C. gloeosporioides strains
occur in the same habitats, C.g.a. has been shown to be relatively stable and
homogenous by pathogenicity and DNA analyses (43965601). Examination of 174
isolates from the Arkansas area, and several from Louisiana, indicated that none
differed when probed with markers for glyceraldehyde-3-phosphate dehydrogenase,
ribosomal DNA and mitochondrial DNA. These isolates were also not discernably
different by pathogenicity testing on A. virginica. There were distinguishable banding
patterns to identify individuals within the 174 isolates produced using a telomeric
DNA probe from Fusarium oxysporum or a DNA probe consisting of repetitive DNA
from C.g.a. itself. Based on these results, if the sexual stage of C.g.a. (Glomerella
cingulata) is occurring in nature, it is not having the same effect on C.g.a. that occurs
in culture (i.e., loss of pathogenicity to A virginica and recombination of traits).
The new information generated on the host range of this fungus (discussed
above), represents a more thorough analysis of the host range within the family
Leguminosae, rather than an entirely new and unexpected shift of this pathogen's host
range.
B. Human Health Assessment
1. Toxicology Assessment
Adequate mammalian toxicology data on Colletotrichum
gloeosporioides f.sp. aeschynomene are available and will support a
Reregi strati on Eligibility Decision (RED).
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a. Acute Toxicity
Certain mammalian toxicity studies conducted with
Colletotrichum gloeosporioides f.sp. aeschynomene ATCC 20358 have
been submitted and adequately satisfy the requirements as set forth in
40 CFR § 158.740 -- Microbial Pest Control Agents. All studies were
conducted with the technical grade of the active ingredient (Table 1).
TABLE 1: Acute Mammalian Toxicity For
Colletotrichum gleosporioides f.sp. aeschynomene ATCC 20358
Guideline
Number
152A-10 OPPTS
885.3050 OECD
152A-12 OPPTS
885. 3150 OECD
152A-13 OPPTS
885.3200 OECD
152A-15 OPPTS
885.3400
OECD"
81-2 OPPTS
870. 1200 OECD
81-4 OPPTS
870.2400
OECD"
81-5 OPPTS
870.2500
OECD"
81-6 OPPTS
870.2600
OECD"
Study
Acute Oral Toxicity/
Pathogenicity
Acute Pulmonary
(Inhalation) Toxicity/
Pathogenicity
Acute Intra-
peritoneal Toxicity/
Pathogenicity
Hyper-sensitivity
Incidents
Acute Dermal
Toxicity
Primary Eye Irritation
Primary Dermal
Irritation
Dermal Sensitization
(Modified Buehler)
Results
LD50 > 5g/kg
Fungal Clearance was observed
by day 7; and LD50 >8.6 X 106
spores
LD50 > 6.0 mg/L or 1.8x 106
spores/L
Viable spores were no longer
present by day 10
None reported*
LD50 > 5g/kg in rats; > 21.4 g/kg
in rabbits
Corneal opacity and irritation
cleared by day 4
Not a dermal irritant
No sensitizing potential
Toxicity
Category
IV
IV
N/A
N/A
IV
III
IV
N/A
MRIDs
84551
84552
84553
84568
99072
84555
84556
84557
98376
N/A
84554
99073
84558
84559
84560
99075
84560
84561
99074
84565
84562
84563
84564
*
**
All incidents must be reported to the Agency.
Not required for the active ingredient, but reported here since the tests were conducted with the technical
and the formulated product. The test for OPPTS guideline 81-6 (OECD 870.2600) was conducted with the
technical only. There is one registered product and no separate registration for the technical active
ingredient.
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In the evaluation of the toxicology data base for the
reregi strati on eligibility decision for Colletotrichum gloeosporioides
f.sp. aeschynomene ATCC 20358, the guidelines have been fulfilled and
no further information is required.
b. Subchronic Toxicity
The Agency does not currently require the submission of
subchronic studies for Microbial Pesticides. However, two subchronic
oral toxicity studies in the dog for Colletotrichum gloeosporioides f.sp.
aeschynomene ATCC 20358 were reviewed in connection with the
initial registration process. No toxicity or signs of disease were
observed when dogs were fed 3 x 108 spores/lb per week for six months
(84340, 84578). These two studies provide adequate information to
determine that the fungus does not have the potential to produce
mycotoxins.
2. Exposure Assessment
a. Dietary Exposure
Since C.g.a ATCC 20358 is applied to rice and soybeans for
weed control, a food tolerance determination is required. An exemption
from the requirement of tolerances for residues of Colletotrichum
gloeosporioides f.sp. aeschynomene (40 CFR 180.1075) on rice grain
and soybeans has been established.
There is limited usage of this microbial, which is registered for
use on rice and soybeans only. Current literature shows that C.g.a.
ATCC 20358 has been used as a pesticide in Arkansas on less than 0.1
percent of the acres of rice grown (Spradley and Windham, 2-CA-95).
The trend is for a low-volume use of the microbial herbicide. The
pesticide is applied at low rates as a preemergent treatment. Residues of
C.g.a ATCC 20358 are not likely to remain on the two treated crops
because the microbial pesticide is likely to be removed from the crops
during processing. Moreover, no hypersensitivity incidents have been
reported and the microbe is a plant pathogen with minimal adverse
effects on animals. Therefore, dietary exposure to human infants,
children and adults is likely to be minimal.
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b. Occupational/Residential Exposure
Handlers: On the basis of a lack of human toxicity concerns (Table 1),
there is no trigger for quantitative estimates of worker exposure data as
determined by Subparts U and K of the Pesticide Assessment
Guidelines. Based on the application methods which involve ground
sprays and aerial applications, there will be potential for dermal and
inhalation exposure to handlers. The unit of exposure to the workers
who use high and low volume ground sprayers is likely to be moderate.
The mixer/loader and the pilot for aerial applications generally treat
large acreages. However, because of the low rates of application,
exposure to workers who use all types of equipment is likely to be low.
Postapplication (Early-Entry) Workers: Potential exposure to
postapplication (early-entry) workers is likely to be low because the
herbicide is applied at low rates to short weeds such that foliar
dislodgeable residues are likely to be minimal.
3. Risk Assessment
a. Dietary
Given the low acute and subchronic toxicity/pathogenicity
potential, the low volume use of the microbial, and the probable lack of
residues on the treated crops, the Agency concluded that the potential
risk to human infants, children and adults, and to mammals from dietary
exposure is expected to be minimal.
b. Occupational and Residential
This microbial is considered an acute Toxicity Category III
herbicide on the basis of primary eye irritation studies. It was classified
as a Toxicity Category IV microbial on the basis of acute dermal and
acute inhalation studies. It shows no potential for dermal sensitization
and no hypersensitivity incidents were reported (see Table 1).
Handlers: Occupational risk is likely to be minimal because of the low
toxicity, and the potentially low to moderate exposure of handlers
exposed to this microbial herbicide.
Postapplication workers: Risk to postapplication (early-entry)
workers is also expected to be low because of the low toxicity profile of
this pesticide. A Restricted-entry Interval (REI) of 4 hours is required
11
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for C.g.a. ATCC 20358 It is recommended that during that interval
early-entry workers can conduct postapplication activities if they wear
long sleeve shirt, long pants, socks, and shoes.
The proposed precautionary product labeling for a low
acute/sub chronic toxicity microbial as recommended and required in
Section V of this RED document will adequately mitigate the minimal
risks to all categories of workers.
c. Food Quality Protection Act Considerations
The Food Quality Protection Act of 1996 (FQPA) amended the
FFDCA by setting a new safety standard for the setting of tolerances. In
determining whether a tolerance meets the new safety standard, Section
408(b)(2)(C) directs EPA to consider information concerning the
susceptibility of infants and children to pesticide residues in food, and
available information concerning aggregate exposure to infants and
children of such residues, as well as the potential for cumulative effects
from pesticide residues and other substances that have a common
mechanism of toxicity.
The FQPA amendments to section 408(b)(2)(C) also required
EPA to apply an additional 10-fold uncertainty (safety) factor unless
reliable data demonstrate that the additional factor is unnecessary to
protect infants and children.
Section 408(b)(2)(D) establishes factors that the Agency must
consider in determining whether the safety standard is met in deciding
to issue or reassess the exemptions from tolerances. These factors
include the consideration of available information on the aggregate
exposures to the pesticide from dietary sources, including drinking
water, as well as from non-occupational exposures such as those derived
from pesticides used in and around the home. The Agency must also
consider the potential cumulative effects of the pesticide for which the
exemption from tolerance is being sought as well as other substances
that have a common mechanism of toxicity.
Because C.g.a. ATCC 20358 has food uses, specific
consideration of the risks to infants and children, as well as aggregate
exposures and potential cumulative effects is warranted.
In determining whether a safety factor different from the
additional 10-fold factor is or is not appropriate for assessing risks to
12
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infants and children, EPA considers all reliable data and makes a
decision using a weight of evidence approach taking into account the
completeness and the adequacy of the toxicity database.
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 man. The pesticidal use is not expected to
increase exposure to this microorganism above the naturally occurring
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. For this
mycoherbicide, no toxicity or signs of disease were observed in dogs
studied under subchronic test conditions (see Subchronic Toxicity).
Effects on the Immune and Endocrine Systems
The active ingredient is a microorganism. 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 expected, with 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
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of significant transfer of Colletotrichum gloeosporioides f.sp.
aeschynomene ATCC 20358 to drinking water is minimal to
nonexistent.
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 intravenous study demonstrated no adverse effects,
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 be the primary 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 raw
agricultural commodities but minimal risk is expected because residues
of the active ingredient are not likely to be present after washing,
processing, and cooking treated food, and the acute oral
toxicity/pathogenicity study indicates no concern at limit doses.
Risks posed by Potential Residential, School or Daycare Exposure
No residential, school or daycare uses currently appear on the label,
which allows use of the mycoherbicide on rice and soybeans for
agricultural control of the northern jointvetch (NJV) weed. Therefore,
under current agricultural practice, nondietary exposure to sites where
children are present is minimal to nonexistent.
C. Environmental Assessment
1. Ecological Toxicity
The database supporting the ecological effects and the environmental
fate of Colletotrichum gloesporioides f.sp. aeschynomene (C.g.a. ATCC strain
20358) when used as a microbial herbicide is sufficient to allow reregi strati on
of the pesticide. The potential effects of the microbial on certain non-target
14
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plants which led the Agency to restrict the use of C.g.a. ATCC 20358 to AR,
LA and MS are discussed in this section (see Toxicity to plants and
Endangered species).
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
The study to establish the acute toxicity to the mallard
duck (MRID 00091001) is considered to be acceptable. Mallard
ducks which were intubated with a dose of 2 grams (5 x 106
spores) per bird once a week for 5 weeks demonstrated no
treatment-related effects (MRID 00091001)
The bobwhite quail study (MRID 00091002) has been
found to be supplemental. No adverse effect was observed in
bobwhite quail which consumed water containing 2 x 106
spores/ml for 40 days (MRID 00091002).
While the latter study does not meet guideline
requirements, the Agency feels that there is sufficient
information contained in both studies for the risk assessment.
Adverse effects to nontarget avian species would not be expected
and further testing for these guidelines is not necessary.
(2) Mammals
Based on toxicity studies submitted for health effects
assessment, C.g.a. ATCC 20358 is not likely to have acute or
subchronic toxic or pathogenic effects on mammals.
(3) Insects
Non-target insect testing was waived because C.g.a. is a
known plant pathogen and currently available data do not
indicate pathogenicity to insects.
(4) Other non-target terrestrial invertebrates
Little, if any, adverse effects were observed in
earthworms which consumed approximately 4 x 108 C.g.a.
ATCC strain 20358 spores over a 40 day period (MRID
15
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00091006). This study was considered supplemental but
supports reregi strati on of the mycoherbicide.
b. Toxicity to Aquatic Animals
Currently available data on this ATCC strain 20358 of C.g.a
demonstrate that there is no confirmed treatment-related
toxicity/pathogenicity effects on aquatic animals.
(1) Freshwater Fish
Both the bluegill (MRID 00091003) and the channel
catfish (MRID 00091004) showed no confirmed treatment
related effects when they were exposed to 4 x 106 C.g.a. ATCC
20358 spores in 60 gallons of water for 30 days. These data,
though supplementary, when taken together were sufficient to
indicate the likelihood of low or no adverse effects on freshwater
fish. Therefore, data requirements in support of acute toxicity to
the rainbow trout were waived.
(2) Freshwater Invertebrates
Exposure for three weeks to water containing a spore
concentration of 2 x 106 spores/ml C.g.a. ATCC strain 20358
produced no treatment related effects in Crayfish (MRID
00091005). This study was considered supplementary.
Data in support of OPPTS Subdivision M Guideline
154A-20 (885.4240 OECD) to evaluate the effects of C.g.a.
ATCC 20358 on the freshwater aquatic invertebrate, Daphnia,
were waived because adverse effects would not be expected.
(3) Estuarine and Marine Animals
These studies are conditionally required or required for
direct applications of the pesticide to estuarine or marine water
or if the pesticide is expected to enter those environments in a
high enough concentration to cause concern. The volume of the
microbial now in use is very low. Moreover, the fungus has
been shown to have a short half-life in water (see
Environmental Fate). These data requirements were, therefore,
waived.
16
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c. Toxicity/Pathogenicity to Plants
(1) Effects on Target Pest
Nontarget plant testing has been satisfied via data from
open literature and other information in the referenced
submissions (MRIDs 43965601, 43965602). The disease has
been reported to be an endemic anthracnose which occurs
naturally each year on the leaves of the native populations of its
leguminous host, but it rarely kills this herbaceous, hard-seeded
annual. It is much more pathogenic on leaves of the original
host than on those of alternative crops (Alahakoon etal., 1994).
Peak levels of the pathogen occur as the weed matures when
seeds become infected as pods are shed. In addition to seed
infection, the fungus may overwinter as mycelium in dead stems
in natural weed colonies. Infected weed debris, a source of
primary inoculum, is destroyed in agricultural lands by tillage
practices that return the plant refuse to the soil where it is
colonized and assimilated by saprobes (G.E. Templeton, et. al.,
1979).
The original testing demonstrated that ATCC strain
20358 only affected certain members of the genus to which
northern jointvetch belonged (Aeschynomene). Although C.g.a.
ATCC 20358 is endemic to the rice growing regions of
Arkansas, and to a much lesser degree, in Mississippi and
Louisiana, the fungal spore carryover from season to season is
not sufficient to control the NJV. Thus, annual applications of
C.g.a. ATCC 20358, as registered, or other pest control measures
are necessary for control of NJV.
(2) Effects on Nontarget Species
The species Colletotrichum gloeosporioides is a
ubiquitous plant pathogen with a wide host range (see Product
Identity and Characterization) In addition to northern
jointv etch, the target weed of the sole registered microbial, the
following crops are affected by this species of pathogen:
Pea, Olive, Nutmeg, Papaya, Statice, Grape, Guava, Mango,
Pepper, Strawberry, Rubber, Clove, Okra, Apple, Tomato,
Rambutan, Lavatera species, Cocoa, Conifer Seedlings,
Muscadine Grape, Blackberry, Blueberry, Banana Fruit, Lesser
17
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Yam (Diosorea esculenta), Water Yam (Diosorea alata),
Soybeans, Betel Nut Palm, Avocado, Citrus, Peach & Pecans,
Wild Oats (Clidemia hinto) [Weed], Bitter Gourd, Round-
Leaved Mallow (f. sp. malvae) [Weed], St. Johns Wort [Weed],
Velvet Leaf (f. sp. malvae} [Weed], Stylosanthes guianesis &
Stylosanthes scabra, Water Primrose [pest].
(3) Effects of the Actual Strain, ATCC 20358, on
Nontarget Plants
In spite of the wide host range of Colletotrichum
gloeosporioides, the actual host range of this specific strain of
Colletotrichum gloeosporioides f. sp. aeschynomene ATCC
strain 20358, is undoubtedly much more narrow.
Some adverse effects of this strain, C.g.a. ATCC 20358,
were observed on certain pea and soybean varieties in the
Leguminosae family. These hosts were not tested during the
initial registration process, but have recently been the subject of
plant inoculation tests (MRIDs 43965601, 43965602). On the
basis of the data provided, peas were the only significant
agronomic species affected and the exposure of soybeans to the
mycoherbicide is not likely to be an environmental hazard.
While C.g.a. ATCC strain 20358 did reduce seed
germination of soybeans in glass culture plates, infested sand
and soil did not affect soybean seed germination (Cerkauskas,
1988). The Agricultural Resources Environmental Indicators
(AREI) Updates: Seeds (1995, No. 4) indicates that the majority
of soybean seeds planted in Arkansas and the majority of the
U.S. is not pretreated with pesticide. Thus, most of the soybean
seeds are not protected by a fungicide seed treatment and the
potential for fungal infestations of soybeans prior to germination
exists. However, since infested sand and soil did not affect
soybean seed germination, a hazard to soybeans in the field does
not appear to exist.
(4) Genetic Stability and Potential Pathogenicity
Genetic stability affects the potential pathogenicity of
C.g.a. ATCC strain 20358 on a wider range of hosts.
18
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Individual isolates of Colletotrichum gloeosporioides
have a very restricted host range. Those isolates which share the
same host range are genetically discrete and can be sexually
compatible. Alternatively, recombination can occur between
strains that are pathogenic to distantly related hosts (MRIDs
43965601,43965602).
With regards to C.g.a. ATCC strain 20358, the sexual
state is probably very rare and produces few viable ascospores,
as discussed under Product Identity and Characterization. It
has also been shown to be stable and homogenous by
pathogenicity and DNA analysis. Although Cerkauskas' paper
demonstrated the latent infection of soybean by this strain, C.g.a.
ATCC strain 20358 appears quite stable genetically. Thus the
potential for selection of a more virulent strain due to carryover
of strain 20358 populations from year to year and mating with
other C. gloeosporioides strains appears to be minimal.
2. Environmental Fate
Environmental fate data are required since adverse effects to nontarget
plants have been observed in laboratory/greenhouse studies. Most of the
environmental fate data in support of C.g.a. ATCC strain 20358 were submitted
and evaluated in 1982 (Agency Ecological Effects Review, J. Tice, 1982).
Additional literature and pre-publication literature reports have been submitted
and evaluated for reregi strati on.
a. Environmental Fate and Transport
Literature reports (some submitted under MRID No. 43965602)
suggest that C.g.a. ATCC strain 20358 is spread by wind and splashing
rain, frogs, grasshoppers and northern jointvetch seeds. In high density
rice fields the dispersal of C.g.a. ATCC 20358 per rain event was shown
to be about 1.5 meters. Frog, grasshopper, and seedborne dispersal
were not quantified (MRID 43965602). However, based on the data,
the organism still appears to be limited in its ability to spread in the
environment.
In Yang and TeBeesf s 1994 paper regarding distribution and
grasshopper transmission of northern jointvetch anthracnose in rice,
they indicate that the natural occurrence of the disease is much greater
than observed in a survey done in the early 1970s (MRID 43965602).
However, the authors speculate that this was due to frequent use of
19
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C.g.a. ATCC strain 20358 as a mycoherbicide in the survey area. They
further stated that despite the high incidence in the survey, disease
severity was low in most fields. Natural dispersal mechanisms may not
spread inoculum from one patch to other distant patches efficiently
enough to provide high levels of natural infections early in the season.
This was made evident by the patchy and uneven distribution of disease
and the low disease severity in individual fields.
Cerkauskas, in his 1988 paper regarding latent colonization by
Colletotrichum species, has reported the phenomenon of latent
colonization of soybean tissue by C.g.a. ATCC 20358. This strain was
recovered on symptomless plants after surface-disinfestation with
bleach and subsequent treatment with paraquat. Thus, dispersal of
C.g.a. ATCC strain 20358 may not be limited to sites where disease is
observed.
However, 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 (MRID 00091007).
(1) Degradation
Laboratory tests indicated that the fungus can survive in
field water for at least 90 days. However, the population
numbers declined continually and the survival rate in field water
was much lower than sterile water. This suggested microbial
degradation/ predation. Irrigation water assayed after aerial
application of the fungus at label rates contained less than 1
colony forming unit/ml. Further studies demonstrated a short
half life of the fungal spores in the aquatic system. Thus,
appreciable build up of the fungal spores in water after
application is not anticipated (Agency Ecological Effects
Review, J. Tice, 1/29/82).
20
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3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
(1) Exposure and Risk to Nontarget Terrestrial Animals
C.g.a. is a well-known plant pathogen, endemic to areas
where northern jointvetch occurs. From the above review of the
data submitted, the Agency has concluded that C.g.a. ATCC
strain 20358 is not likely to cause adverse effects to mammalian,
avian, aquatic and insect species.
(2) Exposure and Risk to Nontarget Aquatic Animals
The potential risk of aquatic animals exposed to this
microbial is likely to be low because this RED limits the use sites
to three states only: Mississippi (MS), Arkansas (AR), and
Louisiana (LA). There are only two target crops, rice and
soybeans, in these states. Less than 1 percent of the rice under
cultivation in Arkansas is expected to be treated with the
microbial (Spradley, J. Pies etal., 2-CA-95). Only a few
growers in Arkansas have reported their use of the pesticide.
Moreover, the organism appears to be limited in its ability to
spread in the environment and has a short half-life in the aquatic
system. Therefore, the total environmental residues which will
be available to aquatic nontarget animals is likely to be very low.
Consequently, the potential risk to non-target aquatic animals,
such as freshwater fish, freshwater invertebrates, and estuarine
and marine animals is likely to be minimal.
(3) Exposure and Risk to Nontarget Plants
The primary risks are to 1) crops other than soybeans and
rice planted in the field and 2) plants outside of the treated field.
Colletotrichum gloeosporioides f. sp. aeschynomene is a
potential pathogen of certain species within the pea family.
Provided peas are not planted subsequent to soybeans or rice
treated with this microbial, the use of this pesticide should pose
minimal risk to nontarget plants including endangered species.
21
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(4) Endangered Species
C.g.a. ATCC strain 20358 is not likely to cause adverse
effects to endangered mammalian, avian, aquatic and insect
species. Several endangered species within the Leguminosae
may be at risk if the pesticide is used in states other than AR, LA
and MS. Price's Potato-Bean, an endangered legume found in
Mississippi, is susceptible to C.g.a. infection. However, this
endangered legume is not found in or around rice or soybean
production areas. A list of the at-risk endangered species is on
file and should be consulted in the event of additional
registrations.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether products
containing the active ingredients are eligible for reregi strati on. The Agency has
previously identified and required the submission of the generic (i.e. active ingredient
specific) data required to support reregi strati on of products containing the active
ingredient Colletotrichum gloeosporioides f. sp. aeschynomene (C.g.a.) ATCC 20358.
The Agency has completed its review of these generic data, and has determined that
the data are sufficient to support reregi strati on of all products containing
Colletotrichum gloeosporioides f. sp. aeschynomene ATCC 20358 for use in
Arkansas, Louisiana and Mississippi. Appendix B identifies the generic data
requirements that the Agency reviewed as part of its determination of reregi strati on
eligibility of C.g.a., and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of C.g.a. ATCC 20358 and to determine that this active ingredient
can be used without resulting in unreasonable adverse effects to humans and the
environment. The Agency therefore finds that all products containing C.g.a. ATCC
20358 as the active ingredients are eligible for reregi strati on as specified in this RED.
The reregi strati on of particular products is addressed in Section V of this document.
The Agency made its reregi strati on eligibility determination based upon the
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, etc. and the data identified
in Appendix B. Although the Agency has found that all uses of C.g.a. ATCC 20358
are eligible for reregistration, it should be understood that the Agency may take
appropriate regulatory action, and/or require the submission of additional data to
22
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support the registration of products containing C.g.a. ATCC 20358, if new information
comes to the Agency's attention or if the data requirements for registration (or the
guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients
C.g.a. ATCC 20358, the Agency has sufficient information on the health
effects of C.g.a. ATCC 20358 and on its potential for causing adverse effects in
fish and wildlife and the environment. The Agency has determined that C.g.a.
ATCC 20358 products, labeled and used as specified in this Reregi strati on
Eligibility Decision, will not pose unreasonable risks or adverse effects to
humans or the environment. Under the Food Quality Protection Act of 1996,
the Agency has determined that there is a reasonable certainty that no harm will
result to infants, children or to the general population from aggregate exposure
to C.g.a. ATCC 20358. Therefore, the Agency concludes that products
containing C.g.a. ATCC 20358 for all uses described herein are eligible for
reregi strati on and use in Arkansas, Louisiana and Mississippi.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of Colletotrichum
gloeosporioides f. sp. aeschynomene ATCC 20358, as described in this RED
document, are eligible for reregi strati on and use on rice and soybeans in
Arkansas, Louisiana and Mississippi.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for C.g.a.
ATCC 20358. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1. Food Quality Protection Act Considerations
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA)
(Public Law 104-170) was signed into law. FQPA amends both the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amended the FFDCA by establishing a new safety standard for
the establishment of tolerances. The FQPA did not, however, amend any of the
existing reregi strati on deadlines in section 4.
23
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In determining whether a tolerance meets the new safety standard,
section 408(b)(2)(C) directs EPA to consider information concerning the
exposure of infants and children to pesticides in food, available information
concerning the susceptibility of infants and children to pesticide residues in
food, and available information concerning cumulative effects on infants and
children of such residues and other substances that have a common mechanism
of toxicity. Section 408(b)(2)(D) establishes factors that the Agency must
consider in determining whether the safety standard is met; these factors
include the consideration of available information on the cumulative effects of
the pesticide for which a tolerance is sought as well as other substances that
have a common mechanism of toxicity and consideration of available
information on the aggregate exposure levels of the population and of major
subgroups of the population to the pesticide and related substances.
EPA is embarking on an intensive process, including consultation with
registrants, States, and other interested stakeholders, to make decisions on the
new policies and procedures that will be appropriate as a result of enactment of
FQPA. This process will include a more in depth analysis of the new safety
standard and how it should be applied to both food and non-food pesticide
applications. However, in light of the unaffected statutory deadlines with
respect to reregistration, the Agency will continue its ongoing reregi strati on
program while it continues to determine how best to implement FQPA.
In deciding to continue to make reregistration determinations during the
early stages of FQPA implementation, EPA recognizes that it will be necessary
to make decisions relating to FQPA before the implementation process is
complete. In making these early, case-by-case decisions, EPA does not intend
to set broad precedents for the application of FQPA to its regulatory
determinations. Rather, these early decisions will be made on a case-by-case
basis and will not bind EPA as it proceeds with further policy development and
any rulemaking that may be required.
If EPA determines, as a result of this later implementation process, that
any of the determinations described in this RED are no longer appropriate, the
Agency will consider itself free to pursue whatever action may be appropriate,
including but not limited to reconsideration of any portion of this RED.
2. Tolerance Reassessment
There is an existing food tolerance exemption for residues of
Colletotrichum gloeosporioides f.sp. aeschynomene (40 CFR § 180.1075) on
rice grain and soybeans. EPA has reassessed this exemption from tolerance as
24
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required by FIFRA § 4(g)(2)(E) and considers these reassessed exemptions
from tolerances to be qualifying federal determinations under FFDCA §
408(n)(2).
3. Endangered Species
Currently, the Agency is developing a program ("The Endangered
Species Protection Program") to identify all pesticides whose use may cause
adverse impacts on endangered and threatened species and to implement
mitigation measures that will eliminate the adverse impacts. The program
would require use restrictions to protect endangered and threatened species at
the county level. Consultations with the Fish and Wildlife Service may be
necessary to assess risks to newly listed species or from proposed new uses. In
the future, the Agency plans to publish a description of the Endangered Species
Program in the Federal Register and have available voluntary county-specific
bulletins. Because the Agency is taking this approach for protecting
endangered and threatened species, it is not imposing label modifications at this
time through the RED. Rather, any requirements for product use modifications
will occur in the future under the Endangered Species Protection Program.
4. Labeling Rationale
C.g.a. ATCC 20358 is to be applied to rice and soybean, which are
agricultural use sites under the scope of the Worker Protection Standards
(WPS) 40 CFR § 170 and PR Notices 93-7, "Labeling Revisions Required by
the Worker Protection Standard (WPS)", and PR Notice 93-11, "Supplemental
Guidance for PR Notice 93-7". These label revisions include Personal
Protective Equipment (PPE) based on the acute toxicological profile, the
method of application and the volume of use of the microbial pesticide.
For this low toxicity microbial the reduced Restricted-entry Interval
(REI) of four hours is applicable according to PR Notice 95-3, "Reduction of
Worker Protection Standard (WPS) Interim Restricted Entry Intervals (REIs)
For Certain Low Risk Pesticides".
To avoid potential phytopathogenicity to peas and certain non-target
plants, the Agency is requiring the following limitations on the use of this
microbial pesticide. C.g.a. ATCC 20358 can be used only in Arkansas,
Louisiana and Mississippi where the target pest, NJV, is endemic and peas are
not grown. Also, peas must not be treated with C.g.a. ATCC 20358 and must
not be planted in rotation to crops treated with C.g.a. ATCC 20358.
25
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For details of these required label amendments, the Personal Protective
Equipment (PPE) and the Restricted-entry Interval for limited use of the sole
registered product, College™, see Section V under Labeling Requirements.
5. Spray Drift Advisory
The Agency has been working with the Spray Drift Task Force, EPA
Regional Offices and State Lead Agencies for pesticide regulation to develop
the best spray drift management practices. The Agency is now requiring
interim measures that must be placed on product labels/labeling as specified in
Section V. Once the Spray Drift Task Force completes their studies, submits
data, and the Agency evaluation is completed, there may be further refinements
in spray drift management practices.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregi strati on of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
While there is currently no registered Manufacturing-Use Product, the
generic data base supporting the reregi strati on of C.g.a. ATCC 20358 for the
above eligible uses has been reviewed and determined to be substantially
complete, except for the following standard confirmatory data requirements:
1. Guideline 151A-15 OPPTS r885.1500 OECDV Certification of Limits. The
registrant must provide information to certify that the limits are within the
standards required by the Subdivision M Guidelines.
In the event of a change in the manufacturing process or reformulation
of the sole registered product, the registrant must submit the relevant data
required by the Subdivision M Guidelines and the 40 CFR.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
26
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has been made. The product specific data requirements are listed in Appendix
D, the Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria (Appendix F; Attachment E) and if not,
commit to conduct new studies. If a registrant believes that previously
submitted data meet current testing standards, then study MRID numbers
should be cited according to the instructions in the Requirement Status and
Registrants Response Form provided for each product.
2. Labeling Requirements for End-Use Products
a. Worker Protection Standard
Any product whose labeling reasonably permits use in the
production of an agricultural plant on any farm, forest, nursery, or
greenhouse must comply with the labeling requirements of PR Notice
93-7, "Labeling Revisions Required by the Worker Protection Standard
(WPS), and PR Notice 93-11, "Supplemental Guidance for PR Notice
93-7, which reflect the requirements of EPA' s labeling regulations for
worker protection statements (40 CFR part 156, subpart K). These
labeling revisions are necessary to implement the Worker Protection
Standard for Agricultural Pesticides (40 CFR part 170) and must be
completed in accordance with, and within the deadlines specified in, PR
Notices 93-7 and 93-11. Unless otherwise specifically directed in this
RED, all statements required by PR Notices 93-7 and 93-11 are to be on
the product label exactly as instructed in those notices.
After April 21, 1994, except as otherwise provided in PR Notices
93-7 and 93-11, all products within the scope of those notices must bear
WPS PR Notice complying labeling when they are distributed or sold
by the primary registrant or any supplementally registered distributor.
After October 23, 1995, except as otherwise provided in PR
Notices 93-7 and 93-11, all products within the scope of those notices
must bear WPS PR Notice complying labeling when they are distributed
or sold by any person.
The labels and labeling of all products must comply with EPA's
current regulations and requirements as specified in 40 CFR §156.10
and other applicable notices.
27
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For Collego™ 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).
b. Other
1. Since C.g.a. ATCC 20358 has been shown to have a wider host
range than the target weed, modify the directions for use by
replacing "Collego is a selective postemergent mycoherbicide
which is a specific biological weed control agent." to read
"Collego is a postemergent mycoherbicide which is a biological
weed control agent."
2. Add the statement "Do not apply to peas".
3. In the Crop Rotation section of the directions for use, modify the
statement "Food, feed and forage crops may be sown in Collego-
treated fields immediately after harvest of rice or soybeans." to
read "Any food, feed and forage crops except peas may be sown
in Collego -treated fields immediately after harvest of rice or
soybeans. Peas may be planted following the harvesting of a
non-Collego-treated crop."
4. At the beginning of the Directions for Use section, add the
statement "THIS PRODUCT MAY ONLY BE APPLIED IN
THE STATES OF ARKANSAS, LOUISIANA &
MISSISSIPPI."
5. Insert the current EPA registration and EPA Establishment
numbers on the front panel.
c. Spray Drift Labeling
To avoid potential pathogenicity to peas via spray drift, the
following language must be placed on each product label for products
that can be applied aerially:
28
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Avoiding spray drift at the application site is the responsibility of
the applicator. The interaction of many equipment-and-weather-related
factors determine the potential for spray drift. The applicator and the
grower are responsible for considering all these factors when making
decisions.
The following drift management requirements must be followed
to avoid off-target drift movement from aerial applications to
agricultural field crops. These requirements do not apply to forestry
applications, public health uses or to applications using dry
formulations.
1. The distance of the outer most nozzles on the boom must not
exceed 3/4 the length of the wingspan or rotor.
2. Nozzles must always point backward parallel with the air stream
and never be pointed downwards more than 45 degrees.
Where states have more stringent regulations, they should be observed.
The applicator should be familiar with and take into account the
information covered in the Aerial Drift Reduction Advisory
Information.
The following aerial drift reduction advisory information must
be contained in the product labeling:
[This section is advisory in nature and does not supersede the
mandatory label requirements.]
INFORMATION ON DROPLET SIZE
The most effective way to reduce drift potential is to apply large
droplets. The best drift management strategy is to apply the largest
droplets that provide sufficient coverage and control. Applying larger
droplets reduces drift potential, but will not prevent drift if applications
are made improperly, or under unfavorable environmental conditions
(see Wind, Temperature and Humidity, and Temperature Inversions).
29
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CONTROLLING DROPLET SIZE
• Volume - Use high flow rate nozzles to apply the highest
practical spray volume. Nozzles with higher rated flows produce
larger droplets.
• Pressure - Do not exceed the nozzle manufacturer's
recommended pressures. For many nozzle types lower pressure
produces larger droplets. When higher flow rates are needed,
use higher flow rate nozzles instead of increasing pressure.
• Number of Nozzles - Use the minimum number of nozzles that
provide uniform coverage.
• Nozzle Orientation - Orienting nozzles so that the spray is
released parallel to the airstream produces larger droplets than
other orientations and is the recommended practice. Significant
deflection from horizontal will reduce droplet size and increase
drift potential.
• Nozzle Type - Use a nozzle type that is designed for the
intended application. With most nozzle types, narrower spray
angles produce larger droplets. Consider using low-drift nozzles.
Solid stream nozzles oriented straight back produce the largest
droplets and the lowest drift.
BOOM LENGTH
For some use patterns, reducing the effective boom length to less
than 3/4 of the wingspan or rotor length may further reduce drift without
reducing swath width.
APPLICATION HEIGHT
Applications should not be made at a height greater than 10 feet
above the top of the largest plants unless a greater height is required for
aircraft safety. Making applications at the lowest height that is safe
reduces exposure of droplets to evaporation and wind.
SWATH ADJUSTMENT
When applications are made with a crosswind, the swath will be
displaced downward. Therefore, on the up and downwind edges of the
30
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field, the applicator must compensate for this displacement by adjusting
the path of the aircraft upwind. Swath adjustment distance should
increase, with increasing drift potential (higher wind, smaller drops,
etc.)
WIND
Drift potential is lowest between wind speeds of 2-10 mph.
However, many factors, including droplet size and equipment type
determine drift potential at any given speed. Application should be
avoided below 2 mph due to variable wind direction and high inversion
potential. NOTE: Local terrain can influence wind patterns. Every
applicator should be familiar with local wind patterns and how they
affect spray drift.
TEMPERATURE AND HUMIDITY
When making applications in low relative humidity, set up
equipment to produce larger droplets to compensate for evaporation.
Droplet evaporation is most severe when conditions are both hot and
dry.
TEMPERATURE INVERSIONS
Applications should not occur during a temperature inversion
because drift potential is high. Temperature inversions restrict vertical
air mixing, which causes small suspended droplets to remain in a
concentrated cloud. This cloud can move in unpredictable directions
due to the light variable winds common during inversions. Temperature
inversions are characterized by increasing temperatures with altitude
and are common on nights with limited cloud cover and light to no
wind. They begin to form as the sun sets and often continue into the
morning. Their presence can be indicated by ground fog; however, if
fog is not present, inversions can also be identified by the movement of
smoke from a ground source or an aircraft smoke generator. Smoke that
layers and moves laterally in a concentrated cloud (under low wind
conditions) indicates an inversion, while smoke that moves upward and
rapidly dissipates indicates good vertical air mixing.
SENSITIVE AREAS
The pesticide should only be applied when the potential for drift
to adjacent sensitive areas (e.g. residential areas, bodies of water, known
31
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habitat for threatened or endangered species, non-target crops) is
minimal (e.g. when wind is blowing away from the sensitive areas).
C. Existing Stocks
Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this Reregi strati on
Eligibility Decision (RED). Persons other than the registrant may generally distribute
or sell such products for 50 months from the date of the issuance of this RED.
However, existing stocks time frames will be established case-by-case, depending on
the number of products involved, the number of label changes, and other factors. Refer
to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register.
Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell
Colletotrichum gloeosporioides f. sp. aeschynomene ATCC 20358 products bearing
old labels/labeling for 26 months from the date of issuance of this RED. Persons other
than the registrant may distribute or sell such products for 50 months from the date of
the issuance of this RED. Registrants and persons other than registrants remain
obligated to meet pre-existing Agency imposed label changes and existing stocks
requirements applicable to products they sell or distribute.
32
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VI. APPENDICES
33
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34
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APPENDIX A REPORT
Case 4103[Colletotrichum gloeosporioi] Chemical 226300[Colletotrichum gloeosporioides spores]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re- Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Intv. Codes
otherwise) Dose cycle /crop /year
cycle
USES ELIGIBLE FOP FEPEGI3TFATIO1
FOOD/FEED USES
F ICE
SOYBEANS (UNSPECIFIED)
llll 11 * II1- 113 II1-
C'j-3 A
U e Gr ill: TEPFE^TFI-L F OD+FEED '_P' 'E
NS NS NS NS
NS
NS
Use Group: TERRESTRIAL FOOD+FEED CROP
NS NS NS NS
NS
-------
APPENDIX A REPORT
Case 4103[Colletotrichum gloeosporioi] Chemical 226300[Colletotrichum gloeosporioides spores]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re- Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Intv. Codes
otherwise) Dose cycle /crop /year
cycle
USES ELIGIBLE FOP FEPEGI3TFATIO1
FOOD/FEED USES (con't)
iEEMI3 i UN 'EB.IFIED1 .c n'tl
U e. Gr ill: TEPFE^TFI-L F OD+FEED '_P' 'E I Dli't)
II1- 113 II1- II1- 1L. I
llll u
C'j-3 t-
36
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Report Run Date: 07/12/96 ) Time 09:55 LUIS 3.02 - Page:
PRD Report Date: 03/13/95
APPENDIX A REPORT
Case 4103[Colletotrichum gloeosporioi] Chemical 226300[Colletotrichum gloeosporioid.es spores]
4444444^
LEGEND
444444
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
: Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
: Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
: Maximum dose applied to a site over a single crop cycle or year. System calculated.
: Minimum Interval between Applications (days)
: Reentry Intervals
: LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
FM? : FORM NOT IDENTIFIED
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station (s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
: Dosage Can Not be Calculated
: No Calculation can be made
: PPM calculated by weight
: PPM Calculated by volume
: Unknown whether PPM is given by weight or by volume
: Hundred Weight
37
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38
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the case Colletotrichum gloeosporioides f.sp. aeschynomene ATCC 20358
covered by this Reregi strati on Eligibility Decision Document. It contains generic data
requirements that apply to Colletotrichum gloeosporioides f.sp. aeschynomene in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
39
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40
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration ofColletotrichumgloeosporioides
f.sp. aeschynomene ATCC strain 20358
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
885.1100 Chemical Identity All
885.1200 Start. Mat. & Mfg. Process All
885.1300 Formation of Unintentional All
Ingredients
TIER I TOXICOLOGY
885.3050 Acute Oral Toxicity/Pathogenicity All
870.1200 Acute Dermal Toxicity - Rabbit/Rat All
885.3150 Acute Pulmonary All
Toxicity/Pathogenicity
885.3200 Acute Intravenous - All
Toxicity/Pathogenicity
870.2400 Primary Eye Irritation - Rabbit All
885.3400 Hypersensitivity Incidents All
83879; 84480; 43965601; Weidemann et
al., 1988; D.O. TeBeest, 1988.
83879,43965601
84340, 84578
84551, 84552, 84553, 84568, 99072
84554, 99073
84555, 84556, 84557
98376?
84558,84559, 84560, 99075
None reported
41
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Data Supporting Guideline Requirements for the Reregistration ofColletotrichumgloeosporioides
f.sp. aeschynomene ATCC strain 20358
REQUIREMENT
USE PATTERN
CITATION(S)
TIER II TOXICOLOGY
885.3600 Subchronic tox/pathogenicity1
All
84340, 84578
NON-TARGET ORGANISMS - TIER I
885.4050 Avian oral pathogenicity/toxicity - ABD
bobwhite quail
885.4050 Avian oral pathogenicity/toxicity - ABD
mallard duck
885.4200 Freshwater Fish toxicity/pathogenicity ABD
- trout
885.4200 Freshwater Fish toxicity/pathogenicity ABD
- bluegill
00091002
00091001
Waived
00091003, 00091004 (channel catfish)
885.4240 Freshwater Invertebrate
toxicity/pathogenicity
885.4280 Estuarine and Marine animal
toxicity/pathogenicity
ABD
ABD
00091005
Waived
These studies were not required by the new guideline requirements, but were submitted for registration of the pesticide.
They are reported here to demonstrate the low subchronic toxicity of the mycoherbicide.
42
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Data Supporting Guideline Requirements for the Reregistration ofColletotrichumgloeosporioides
f.sp. aeschynomene ATCC strain 20358
REQUIREMENT USE PATTERN CITATION(S)
885.4300 Nontarget plant studies ABD 43965601,43965602; P. W. Alahakoon
etal., 1994; R.F. Cerkauskas, 1988;
C. R. Cisar et al., 1994;
G. E. Templeton et al., 1979.
885.4340 Nontarget insect testing ABD Waived
885.4380 Honey bee testing ABD Waived
OCCUPATIONAL/RESIDENTIAL EXPOSURE
All Occupational Exposure data requirements were waived based on the low toxicity profile of this active ingredient.
RESIDUE CHEMISTRY
All residue chemistry data requirements have been waived because of the agricultural patterns of use and the potential lack of
residues on treated crops, which are exempt from the requirements of a tolerance for this microbial
43
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44
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregi strati on Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes
of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
45
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as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative position of the study
within the volume.
46
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MRID
BIBLIOGRAPHY
CITATION
00083879 Upjohn Company (1974) College™, a Biological Herbicide: Over-all
Summary. (Unpublished study received Sep 16, 1981 under 1023-63;
CDL:070349-B).
00084340 Upjohn Company (1980) Sub-acute Oral Study in Dogs. (Unpublished study
received Sep 16, 1981 under 1023-63; CDL:070347-B)
00084476 Upjohn Company (1976) Environmental Fate & Safety Summary.
(Unpublished study received Sep 16, 1981 under 1023-63; CDL:070352-A)
00084478 Upjohn Company (19??) Stability of Spray Dried Colletotrichum
gloeosporioid.es f. sp. aeschynomene-spores. (Unpublished study received Sep.
16, 1981 under 1023-63; CDL 07353-C).
00084480 Upjohn Company (1979?) Biological Properties of the Pathogen
Colletotrichum gloeosporioides f. sp. aeschynomene. (Compilation;
unpublished study, including published data, received Sep 16, 1981 under
1023-63; CDL:070353-E)
00084481 Lenle, J.M.; Sonoda, R. M. (1978). Colletotrichum spp. on tropical forage
legumes. Plant Disease Reporter 62 (9): 813-817. U.S. Agricultural Research
Administration, Bureau of Plant Industry, soils and Agricultural Engineering,
Division of Mycology and Disease Survey generated, published study:
CDL:070353-F).
00084482 TeBeest, D.O.; Templeton, G.E.; Smith, R.J., Jr. (1977) Histopathology of
Northern Jointvetch Anthracnose. Taken from: Proceedings of the American
Phytopathological Society 4:157-158. (Abstract No. 349). Also in published
submission received Sep 16, 1981 under 1023-63; submitted by Upjohn Co.,
Kalamazoo, Mich., CDL:070353-G).
00084483 TeBeest, D.O.; Templeton, G.E.; Smith, R.J., Jr. (1978) Histopathology of
Colletotrichum gloeosporioides f. sp. aeschynomene on northern Jointvetch.
Phytopathology 68 (Sep): 1271-1275. Also in published submission received
Sep 16, 1981 under 1023-63; submitted by Upjohn Co., Kalamazoo, Mich.,
CDL:070353-H).
47
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BIBLIOGRAPHY
MRID
CITATION
00084484 TeBeest, D.O.; Templeton, G.E.; Smith, R.J., Jr. (1978) Temperature and
moisture requirements for development of anthracnose on Northern jointvetch.
Phytopathology 68 (Mar) 389-393. (Also, in unpublished submission received
Sep. 16, 1981 under 1023-63; submitted by Upjohn Co., Kalamazoo, Mich.,
CDL:070353-G).
00084485 TeBeest, D.O.; Templeton, G.E.; Smith, R.J., Jr. (1978) Decline of a biocontrol
fungus during winter. Arkansas Farm Research 27 (1): 12. (Also in
unpublished submission received Sep. 16, 1981 under 1023-63; submitted by
Upjohn Co., Kalamazoo, Mich., CDL:070353-J).
00084488 Upjohn Company (1976) Residue Summary. (Unpublished study received Sep
16, 1981 under 1023-63; CDL:070356-A)
00084551 Raczniak, T.J.; Wood, D.R.; Kakuk, T.J.; et al. (1980) Oral LD50 Screen in
Upj:TUC(SD)spf Rats with Colletotrichum gloeosporioides f. sp.
aeschynomene (CGA) Spores: Technical Report No. 404-9610-80-007.
(Unpublished study received Sep 16, 1981 under 1023-63; submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:070346-B)
00084552 Beasley, J.N. (1976) Acute Oral Study in Rats: EUP 1/77. (Unpublished study
received Sep 16, 1981 under 1023-63; prepared by Univ. of Arkansas, Animal
Science Dept, submitted by Upjohn Co., Kalamazoo, Mich.; CDL:070346-C)
00084553 University of Arkansas (1973) Acute Oral Toxicological Study: #EUP-l-74.
(Unpublished study received Sep 16, 1981 under 1023-63; submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:070346-D)
00084554 Raczniak, T.J.; Wood, D.R.; Kakuk, T.J.; et al. (1980) Acute Dermal Toxicity
Screen in New Zealand White Rabbits with Colletotrichum gloeosporioides f.
sp. aeschynomene (CGA) Spores: Technical Report No. 404-9610-80-005.
(Unpublished study received Sep 16, 1981 under 1023-63; submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:070346-E)
00084555 Leong, B.K.J.; Seaman, W.J.; Powell, D.J.; et al. (1980) Acute 4-hour
Inhalation Exposure to the Aerosols of Colletotrichum gleosporioides f. sp.
aeschynomene (CGA) Spores in Rats: Technical Report 404-9610-80-001.
(Unpublished study received Sep 16, 1981 under 1023-63; submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:070346-F)
48
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MRID
BIBLIOGRAPHY
CITATION
00084556 Beasley, IN. (1977) Rat Inhalation Exposure Study: EUP 5/77. (Unpublished
study received Sep 16, 1981 under 1023-63; prepared by Univ. of Arkansas,
Animal Science Dept, submitted by Upjohn Co., Kalamazoo, Mich.;
CDL:070346-G)
00084557 University of Arkansas (1974) Inhalation Evaluation of CGA
Spores:EUP-3-74. (Unpublished study received Sep 16, 1981 under 1023-63;
submitted by Upjohn Co., Kalamazoo, Mich.; CDL:070346-H)
00084558 Raczniak, T.J.; Wood, D.R.; Kakuk, T.J.; et al. (1980) Primary Eye Irritation
Study in New Zealand White Rabbits with Colletotrichum gloeosporioides f.
sp. aeschynomene (CGA) Spores: Technical Report No. 404-9610-80-004.
(Unpublished study received Sep 16, 1981 under 1023-63; submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:070346-I)
00084559 University of Arkansas (19??) Ocular Inoculation Study of CGA Spores in the
Rabbit: EUP 7/77. (Unpublished study received Sep 16, 1981 under 1023-63;
submitted by Upjohn Co., Kalamazoo, Mich.; CDL:070346-J)
00084560 University of Arkansas (1973?) Eye Irritation and Dermal Irritation Study:
EUP-2-74. (Unpublished study received Sep 16, 1981 under 1023-63;
submitted by Upjohn Co., Kalamazoo, Mich.; CDL:070346-K)
00084561 Raczniak, T.J.; Wood, D.R.; Kakuk, T.J.; et al. (1980) Primary Dermal
Irritation Study in New Zealand White Rabbits with Colletotrichum
gloeosporioides f. sp. aeschynomene (CGA) Spores: Technical Report No.
404-9610-80-006. (Unpublished study received Sep 16, 1981 under 1023-63;
submitted by Upjohn Co., Kalamazoo, Mich.; CDL:070346-L)
00084562 Raczniak, T.J.; Wood, D.R.; Kakuk, T.J.; et al. (1980) Dermal Sensitization
Study in the Male Albino Guinea Pig with Colletotrichum gloeosporioides f.
sp. aeschynomene (CGA) Spores:Technical Report No. 404-9610-80-002.
(Unpublished study received Sep 16, 1981 under 1023-63; submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:070346-M)
00084563 University of Arkansas (1973?) Skin Sensitization of Guinea Pig:EUP 14/77.
(Unpublished study received Sep 16, 1981 under 1023-63; submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:070346-N)
49
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MRID
BIBLIOGRAPHY
CITATION
00084564 University of Arkansas (1973?) Skin Sensitization Study-Guinea Pigs: EUP
6/77. (Unpublished study received Sep 16, 1981 under 1023-63; submitted by
Upjohn Co., Kalmazoo, Mich.; CDL:070346-O)
0008456 University of Arkansas (1973?) Sensitization Potential in Rabbits: EUP-4/76.
(Unpublished study received Sep 16, 1981 under 1023-63; submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:070346-P)
00084568 University of Arkansas (1973?) Viability of CGA in the Digestive Tract of the
Rat: EUP 2/76. (Unpublished study received Sep 16, 1981 under 1023-63;
submitted by Upjohn Co., Kalamazoo, Mich.; CDL:070346-S)
00084578 University of Arkansas (1977) Sub-acute Oral Study in Dogs: EUP 13/77.
(Unpublished study received Sep 16, 1981 under 1023-63; submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:070346-AD)
00091001 Beasley, J.N. (1977) Oral Inoculation of Mallard Ducks. (Unpublished study
received Sep 16, 1981 under 1023-63; prepared by Univ. of Arkansas, Animal
Science Dept, submitted by Upjohn Co., Kalamazoo, Mich.; CDL:070351-B)
00091002 Beasley, J.N. (1977) Inoculation of Bobwhite Quail. (Unpublished study
received Sep 16, 1981 under 1023-63; prepared by Univ. of Arkansas, Animal
Science Dept., submitted by Upjohn Co., Kalamazoo, Mich.; CDL:070351-C)
00009100 Beasley, J.N. (1977) Inoculation of Bluegill. (Unpublished study received Sep
16, 1981 under 1023-63; prepared by Univ. of Arkansas, Animal Science
Dept., submitted by Upjohn Co., Kalamazoo, Mich.; CDL:070351-D)
00091004 Beasley, J.N. (1977) Inoculation of Channel Catfish. (Unpublished study
received Sep 16, 1981 under 1023-63; prepared by Univ. of Arkansas, Animal
Science Dept., submitted by Upjohn Co., Kalamazoo, Mich.; CDL:070351-E)
00091005 Upjohn Company (1973) Continuous Immersion Study — Crayfish.
(Unpublished study received Sep. 16, 1981 under 1023-63; CDL:070351-F).
00091006 Upjohn Company (19??) Feeding Study - Earthworm. (Unpublished study
received Sep 16, 1981 under 1023-63; CDL:070351-G
50
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MRID
BIBLIOGRAPHY
CITATION
00091007 Raczniak, T.J.; Wood, D.R. (1981) Literature Review and Toxicological Profile
of Colletotrichum gloeosporioides f. sp. aeschynomene (College™): Technical
Report No. 404-9610-81-001. Rev. Summary of studies 0703 51-B through
070351-G. (Incomplete; unpublished study received Sep 16, 1981 under
1023-63; submitted by Upjohn Co., Kalamazoo, Mich.; CDL:070351-H)
00098376 Raczniak, T.J.; Wood, D.R.; Kakuk, T.J; et al. (1982) Single-dose
Intraperitoneal Infectivity Potential Study in immunodepressed and Non-
immunodepressed B6C3F, Hybrid Mice with Colletotrichum gloeosporioides f.
sp. aeschynomene (C.g.a.) Spores: 14 day Interim Report: Technical Report
No. 404-9610-82-001. (Unpublished study received Apr 7, 1982 under
1023-63; submitted by Upjohn Co., Kalamazoo, Mich.; CDL:247187-A)
00099070 Henderson, S.L. (1981) Letter sent to T.A. Coleman dated Oct 5, 1981:
Stability of CGA spores at 23° C. (Unpublished study received Nov 25, 1981
under 1023-63; submitted by Upjohn Co., Kalamazoo, Mich.; CDL:246276-B)
00099072 Tompkins, B.C.; Harris, G.L. (1981) Acute Oral Toxicity Study:TRL Study No.
002-005; 404-9610-81-004. (Unpublished study received Nov 25, 1981 under
1023-63; prepared by Toxicity Research Laboratories, Ltd., submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:246276-D)
00099073 Tompkins, B.C.; Harris, G.L. (1981) 14-day Acute Dermal Toxicity Study in
Rabbits: TRL Study No. 002-004; 404-9610-81-005. (Unpublished study
received Nov 25, 1981 under 1023-63; prepared by Toxicity Research
Laboratories, Ltd., submitted by Upjohn Co., Kalamazoo, Mich.;
CDL:246276-E)
00099074 Tompkins, B.C.; Harris, G.L. (1981) Primary Skin Irritation Study:TRL Study
No. 002-002; 404-9610-81-002. (Unpublished study received Nov 25, 1981
under 1023-63; prepared by Toxicity Research Laboratories, Ltd., submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:246276-F)
00099075 Tompkins, B.C.; Harris, G.L. (1981) Primary Eye Irritation Study: TRL Study
No. 002-003; 404-9610-81-003. (Unpublished study received Nov 25, 1981
under 1023-63; prepared by Toxicity Research Laboratories, Ltd., submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:246276-G)
51
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MRID
BIBLIOGRAPHY
CITATION
43965601
43965602
Tebeest, D., et al. (1996) Published Studies in Support of Product Identity:
"The use of Vegetative Compatibility and Heterokaryosis to Determine
Potential Asexual Gene Exchange in Colletotrichum gloeosporioides";
Evidence for Mating Between Isolates of C. gloeosporioides with Different
Host Specificities"; "Host Specificity and Sexual Compatibility in C.
gloeosporioides"; "Biological Properties: the Pathogen C. gloeosporioides f. sp.
aeschynomene". Unpublished study prepared by University of Arkansas. 65 p.
Tebeest, D., et al. (1996) Published Studies in Support of Non-Target Plant
Studies: "Host Specificity of Colletotrichum gloeosporioides f. sp.
aeschynomene and C. truncatum in the Leguminosae"; Additions to Host
Range of C. gloeosporioides..."; Evidence for mating Between Isolates of C.
gloeosporioides with Different Host specificities": "Host Specificity and
Sexual Compatibility in C. gloeosporioides"; Distribution of Grasshopper
Transmission of Northern Anthracnose in Rice"; Green Treefrogs as Vectors
of C. gloeosporioides". Unpublished Study prepared by University of
Arkansas.
REVIEWS
Tice, J. (1982) Ecological Effects Review, United States Environmental Protection Agency
PUBLICATIONS
Alahakoon, P.W. et. al., (February 1994) "Cross-infection potential of genetic groups of
Colletotrichum gloeosporioides on tropical fruits."Physiological and Molecular
Plant Pathology. V 44 (2), in AGRIGOLA abstract, 93-103.
Agricultural Resources Environmental Indicators (AREI) Updates: Seeds. (1995, No. 4)
Cerkauskas, R.F. (1988) "Latent colonization by Colletotrichum spp.: Epidemiological
considerations and implications for mycoherbicides," Canadian Journal of Plant
Pathology. V 10, pp. 297-310.
Spradley, J. Pies and Windham, Tony E. Document Number 2-CA-95. The Biologic and
Economic Assessment of Pest Management in Rice. United States Department
of Agriculture, National Agricultural Pesticide Impact Assessment Program.
Templeton et al. (1979). Biological Control with Mycoherbicides. Ann. Rev.
Phytopathology. V 17, p. 305.
52
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment 1 of this Notice, the Data Call-In Chemical Status
Sheet, to submit certain data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient(s). Within 90 days after you receive this Notice
you must respond as set forth in Section III below. Your response must state:
1. how you will comply with the requirements set forth in this Notice and its Attachments
1 through 4; or,
2. why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section Hi-
fi); or,
3. why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list
of all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 4).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
53
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information is authorized under the Paperwork Reduction Act by OMB Approval No.
2070-0107 and 2070-0057 (expiration date 3-31-99).
This Notice is divided into six sections and five Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment 1 - Data Call-In Chemical Status Sheet
Attachment 2 - Data Call-In Response Form
Attachment 3 - Requirements Status And Registrant's Response Form
Attachment 4 - List Of All Registrants Sent This Data Call-In Notice
SECTION! WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the
continued use of products containing this active ingredient(s). You have been sent this Notice
because you have product(s) containing the subject active ingredient(s).
SECTION II. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The data required by this Notice are specified in Attachment 3, Requirements
Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in Attachment 3, Requirements Status and Registrant's Response Form.
within the time frames provided.
54
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C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with
test standards outlined in the Pesticide Assessment Guidelines for those studies for
which guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel:
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD-recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR §
158.70). When using the OECD protocols, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements of 40 CFR § 158.
Normally, the Agency will not extend deadlines for complying with data requirements
when the studies were not conducted in accordance with acceptable standards. The
OECD protocols are available from 2001 L Street, N.W., Washington, D.C. 20036
(Telephone number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-
in Notice must be in accordance with Good Laboratory Practices [40 CFR Part
160.3(a)(6)].
D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede
or change the requirements of any previous Data Call-In(s). or any other agreements
entered into with the Agency pertaining to such prior Notice. Registrants must comply
with the requirements of all Notices to avoid issuance of a Notice of Intent to Suspend
their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice must be submitted
to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for
issuance of NOIS due to failure to comply with this Notice are presented in Section
IV-A and IV-B.
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B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2)
delete use(s), (3) claim generic data exemption, (4) agree to satisfy the data
requirements imposed by this Notice or (5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option,
the Delete Use(s) option or the Generic Data Exemption option is presented below. A
discussion of the various options available for satisfying the data requirements of this
Notice is contained in Section III-C. A discussion of options relating to requests for
data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon
your response, one or both must be used in your response to the Agency. These forms
are the Data-Call-in Response Form (Attachment 2) and the Requirements Status and
Registrant's Response Form (Attachment 3). The Data Call-In Response Form must be
submitted as part of every response to this Notice. Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response
Form and Requirements Status and Registrant's Response Form (if this form is
required) and initial any subsequent pages. The forms contain separate detailed
instructions on the response options. Do not alter the printed material. If you have
questions or need assistance in preparing your response, call or write the contact
person identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice
by requesting voluntary cancellation of your product(s) containing the active
ingredient(s) that is the subject of this Notice. If you wish to voluntarily cancel
your product, you must submit a completed Data Call-In Response Form.
indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this is the only
form that you are required to complete.
If you choose to voluntarily cancel your product, further sale and
distribution of your product after the effective date of cancellation must be in
accordance with the Existing Stocks provisions of this Notice which are
contained in Section IV-C.
2. Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses of your product to which the requirements apply. If you
wish to amend your registration to delete uses, you must submit the
Requirements Status and Registrant's Response Form, a completed application
for amendment, a copy of your proposed amended labeling, and all other
information required for processing the application. Use deletion is option
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number 7 on the Requirements Status and Registrant's Response Form. You
must also complete a Data Call-In Response Form by signing the certification,
item number 8. Application forms for amending registrations may be obtained
from the Registration Support and Emergency Response Branch, Registration
Division, (703)308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject
to specific data requirements, further sale, distribution, or use of your product
after one year from the due date of your 90 day response, must bear an
amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an
applicant for registration of a product is exempt from the requirement to submit
or cite generic data concerning an active ingredient(s) if the active ingredient(s)
in the product is derived exclusively from purchased, registered pesticide
products containing the active ingredient(s). EPA has concluded, as an
exercise of its discretion, that it normally will not suspend the registration of a
product which would qualify and continue to qualify for the generic data
exemption in section 3(c)(2)(D) of FIFRA. To qualify, all of the following
requirements must be met:
a. The active ingredient(s) in your registered product must be
present solely because of incorporation of another registered product
which contains the subject active ingredient(s) and is purchased from a
source not connected with you; and,
b. every registrant who is the ultimate source of the active
ingredient(s) in your product subject to this DCI must be in compliance
with the requirements of this Notice and must remain in compliance;
and
c. you must have provided to EPA an accurate and current
"Confidential Statement of Formula" for each of your products to which
this Notice applies.
To apply for the Generic Data Exemption you must submit a completed
Data Call-In Response Form. Attachment 2 and all supporting documentation.
The Generic Data Exemption is item number 6a on the Data Call-In Response
Form. If you claim a generic data exemption you are not required to complete
the Requirements Status and Registrant's Response Form. Generic Data
Exemption cannot be selected as an option for product specific data.
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If you are granted a Generic Data Exemption, you rely on the efforts of
other persons to provide the Agency with the required data. If the registrant(s)
who have committed to generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer in compliance with
this Data Call-In Notice, the Agency will consider that both they and you are
not in compliance and will normally initiate proceedings to suspend the
registrations of both your and their product(s), unless you commit to submit
and do submit the required data within the specified time. In such cases the
Agency generally will not grant a time extension for submitting the data.
4. Satisfying the Data Requirements of this Notice - There are various
options available to satisfy the data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6
on the Requirements Status and Registrant's Response Form and option 6b and
7 on the Data Call-In Response Form. If you choose option 6b or 7, you must
submit both forms as well as any other information/data pertaining to the option
chosen to address the data requirement.
5. Request for Data Waivers. Data waivers are discussed in Section III-D
of this Notice and are covered by options 8 and 9 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must
submit both forms as well as any other information/data pertaining to the option
chosen to address the data requirement.
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to
satisfy the data requirements (i.e. you select option 6b and/or 7), then you must select
one of the six options on the Requirements Status and Registrant's Response Form
related to data production for each data requirement. Your option selection should be
entered under item number 9, "Registrant Response." The six options related to data
production are the first six options discussed under item 9 in the instructions for
completing the Requirements Status and Registrant's Response Form. These six
options are listed immediately below with information in parentheses to guide
registrants to additional instructions provided in this Section. The options are:
1. I will generate and submit data within the specified time frame
(Developing Data),
2. I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing),
3. I have made offers to cost-share (Offers to Cost Share),
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4. I am submitting an existing study that has not been submitted previously
to the Agency by anyone (Submitting an Existing Study),
5. I am submitting or citing data to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study),
6. I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study).
Option 1. Developing Data —
If you choose to develop the required data it must be in conformance
with Agency deadlines and with other Agency requirements as referenced
herein and in the attachments. All data generated and submitted must comply
with the Good Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted
according to the Pesticide Assessment Guidelines (PAG), and be in
conformance with the requirements of PR Notice 86-5. In addition, certain
studies require Agency approval of test protocols in advance of study initiation.
Those studies for which a protocol must be submitted have been identified in
the Requirements Status and Registrant's Response Form and/or footnotes to
the form. If you wish to use a protocol which differs from the options
discussed in Section II-C of this Notice, you must submit a detailed description
of the proposed protocol and your reason for wishing to use it. The Agency
may choose to reject a protocol not specified in Section II-C. If the Agency
rejects your protocol you will be notified in writing, however, you should be
aware that rejection of a proposed protocol will not be a basis for extending the
deadline for submission of data.
A progress report must be submitted for each study within 90 days from
the date you are required to commit to generate or undertake some other means
to address that study requirement, such as making an offer to cost-share or
agreeing to share in the cost of developing that study. A 90-day progress report
must be submitted for all studies. This 90-day progress report must include the
date the study was or will be initiated and, for studies to be started within 12
months of commitment, the name and address of the laboratory(ies) or
individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more
than 1 year, interim reports must be submitted at 12 month intervals from the
date you are required to commit to generate or otherwise address the
requirement for the study. In addition to the other information specified in the
preceding paragraph, at a minimum, a brief description of current activity on
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and the status of the study must be included as well as a full description of any
problems encountered since the last progress report.
The time frames in the Requirements Status and Registrant's Response
Form are the time frames that the Agency is allowing for the submission of
completed study reports or protocols. The noted deadlines run from the date of
the receipt of this Notice by the registrant. If the data are not submitted by the
deadline, each registrant is subject to receipt of a Notice of Intent to Suspend
the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required
by this Notice and intend to seek additional time to meet the requirement(s),
you must submit a request to the Agency which includes: (1) a detailed
description of the expected difficulty and (2) a proposed schedule including
alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your
request, the original deadline remains. The Agency will respond to your
request in writing. If EPA does not grant your request, the original deadline
remains. Normally, extensions can be requested only in cases of extraordinary
testing problems beyond the expectation or control of the registrant.
Extensions will not be given in submitting the 90-day responses. Extensions
will not be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it is submitted
at or after the lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data —
If you choose to enter into an agreement to share in the cost of
producing the required data but will not be submitting the data yourself, you
must provide the name of the registrant who will be submitting the data. You
must also provide EPA with documentary evidence that an agreement has been
formed. Such evidence may be your letter offering to join in an agreement and
the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not
specify all of the terms of the final arrangement between the parties or the
mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the parties
cannot resolve the terms of the agreement they may resolve their differences
through binding arbitration.
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Option 3. Offer to Share in the Cost of Data Development —
If you have made an offer to pay in an attempt to enter into an
agreement or amend an existing agreement to meet the requirements of this
Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although
you do not comply with the data submission requirements of this Notice. EPA
has determined that as a general policy, absent other relevant considerations, it
will not suspend the registration of a product of a registrant who has in good
faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation
to the Agency proving that you have made an offer to another registrant (who
has an obligation to submit data) to share in the burden of developing that data.
You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data. In addition,
you must demonstrate that the other registrant to whom the offer was made has
not accepted your offer to enter into a cost sharing agreement by including a
copy of your offer and proof of the other registrant's receipt of that offer (such
as a certified mail receipt). Your offer must, in addition to anything else, offer
to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section
3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the data required
by this Notice by submitting a Data Call-In Response Form and a Requirements
Status and Registrant's Response Form committing to develop and submit the
data required by this Notice.
In order for you to avoid suspension under this option, you may not
withdraw your offer to share in the burdens of developing the data. In addition,
the other registrant must fulfill its commitment to develop and submit the data
as required by this Notice. If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as well as that of
the other registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit, and do submit the required data in
the specified time frame. In such cases, the Agency generally will not grant a
time extension for submitting the data.
Option 4. Submitting an Existing Study —
If you choose to submit an existing study in response to this Notice, you
must determine that the study satisfies the requirements imposed by this Notice.
You may only submit a study that has not been previously submitted to the
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Agency or previously cited by anyone. Existing studies are studies which
predate issuance of this Notice. Do not use this option if you are submitting
data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not
acceptable, the Agency will require you to comply with this Notice, normally
without an extension of the required date of submission. The Agency may
determine at any time that a study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing
study, all of the following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted
that the raw data and specimens from the study are available for audit
and review and you must identify where they are available. This must
be done in accordance with the requirements of the Good Laboratory
Practice (GLP) regulation, 40 CFR Part 160. As stated in 40 CFR
160.3(7) " raw data means any laboratory worksheets, records,
memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event
that exact transcripts of raw data have been prepared (e.g., tapes which
have been transcribed verbatim, dated, and verified accurate by
signature), the exact copy or exact transcript may be substituted for the
original source as raw data. Raw data may include photographs,
microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated
instruments." The term "specimens", according to 40 CFR 160.3(7),
means "any material derived from a test system for examination or
analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control
information, pursuant to the requirements of 40 CFR Part 160.
Registrants must also certify at the time of submitting the existing study
that such GLP information is available for post-May 1984 studies by
including an appropriate statement on or attached to the study signed by
an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria
for the Guideline relevant to the study provided in the FIFRA
Accelerated Reregi strati on Phase 3 Technical Guidance and that the
study has been conducted according to the Pesticide Assessment
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Guidelines (PAG) or meets the purpose of the PAG (both available from
NTIS). A study not conducted according to the PAG may be submitted
to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40
CFR 158.70 which states the Agency's policy regarding acceptable
protocols. If you wish to submit the study, you must, in addition to
certifying that the purposes of the PAG are met by the study, clearly
articulate the rationale why you believe the study meets the purpose of
the PAG, including copies of any supporting information or data. It has
been the Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary raw
data are usually not available for such studies.
If you submit an existing study, you must certify that the study
meets all requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are
submitting, you must identify any action taken by the Agency on the
protocol and must indicate, as part of your certification, the manner in
which all Agency comments, concerns, or issues were addressed in the
final protocol and study.
If you know of a study pertaining to any requirement in this
Notice which does not meet the criteria outlined above but does contain
factual information regarding unreasonable adverse effects, you must
notify the Agency of such a study. If such a study is in the Agency's
files, you need only cite it along with the notification. If not in the
Agency's files, you must submit a summary and copies as required by
PR Notice 86-5.
Option 5. Upgrading a Study —
If a study has been classified as partially acceptable and upgradeable,
you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides
the requirement is not satisfied, you may still be required to submit new data
normally without any time extension. Deficient, but upgradeable studies will
normally be classified as supplemental. However, it is important to note that
not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be
upgraded, call or write the contact person listed in Attachment 1. If you submit
data to upgrade an existing study you must satisfy or supply information to
correct all deficiencies in the study identified by EPA. You must provide a
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clearly articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your
submission must also specify the MRID number(s) of the study which you are
attempting to upgrade and must be in conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study
classified as unacceptable and determined by the Agency as not capable of
being upgraded.
This option should also be used to cite data that has been previously
submitted to upgrade a study, but has not yet been reviewed by the Agency.
You must provide the MRID number of the data submission as well as the
MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4
above, apply to all data submissions intended to upgrade studies. Additionally
your submission of data intended to upgrade studies must be accompanied by a
certification that you comply with each of those criteria as well as a
certification regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studies —
If you choose to cite a study that has been previously submitted to EPA,
that study must have been previously classified by EPA as acceptable or it must
be a study which has not yet been reviewed by the Agency. Acceptable
toxicology studies generally will have been classified as "core-guideline" or
"core minimum." For ecological effects studies, the classification generally
would be a rating of "core." For all other disciplines the classification would
be "acceptable." With respect to any studies for which you wish to select this
option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's
classification of the study.
If you are citing a study of which you are not the original data
submitter, you must submit a completed copy of EPA Form 8570-31,
Certification with Respect to Data Compensation Requirements.
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a
request for a low volume/minor use waiver and the second is a waiver request based
on your belief that the data requirement(s) are inapplicable and do not apply to your
product.
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1. Low Volume/Minor Use Waiver — Option 8 on the Requirements
Status and Registrant's Response Form. Section 3(c)(2)(A) of FIFRA requires
EPA to consider the appropriateness of requiring data for low volume, minor
use pesticides. In implementing this provision EPA considers as low volume
pesticides only those active ingredient(s) whose total production volume for all
pesticide registrants is small. In determining whether to grant a low volume,
minor use waiver the Agency will consider the extent, pattern and volume of
use, the economic incentive to conduct the testing, the importance of the
pesticide, and the exposure and risk from use of the pesticide. If an active
ingredient(s) is used for both high volume and low volume uses, a low volume
exemption will not be approved. If all uses of an active ingredient(s) are low
volume and the combined volumes for all uses are also low, then an exemption
may be granted, depending on review of other information outlined below. An
exemption will not be granted if any registrant of the active ingredient(s) elects
to conduct the testing. Any registrant receiving a low volume minor use waiver
must remain within the sales figures in their forecast supporting the waiver
request in order to remain qualified for such waiver. If granted a waiver, a
registrant will be required, as a condition of the waiver, to submit annual sales
reports. The Agency will respond to requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the
following information, as applicable to your product(s), as part of your 90-day
response to this Notice:
a. Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredient(s). If applicable to the active
ingredient(s), include foreign sales for those products that are not
registered in this country but are applied to sugar (cane or beet), coffee,
bananas, cocoa, and other such crops. Present the above information by
year for each of the past five years.
b. Provide an estimate of the sales (pounds and dollars) of the
active ingredient(s) for each major use site. Present the above
information by year for each of the past five years.
c. Total direct production cost of product(s) containing the active
ingredient(s) by year for the past five years. Include information on raw
material cost, direct labor cost, advertising, sales and marketing, and
any other significant costs listed separately.
d. Total indirect production cost (e.g. plant overhead, amortized
plant and equipment) charged to product(s) containing the active
ingredient(s) by year for the past five years. Exclude all non-recurring
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costs that were directly related to the active ingredient(s), such as costs
of initial registration and any data development.
e. A list of each data requirement for which you seek a waiver.
Indicate the type of waiver sought and the estimated cost to you (listed
separately for each data requirement and associated test) of conducting
the testing needed to fulfill each of these data requirements.
f. A list of each data requirement for which you are not seeking
any waiver and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to
fulfill each of these data requirements.
g. For each of the next ten years, a year-by-year forecast of
company sales (pounds and dollars) of the active ingredient(s), direct
production costs of product(s) containing the active ingredient(s)
(following the parameters in item c above), indirect production costs of
product(s) containing the active ingredient(s) (following the parameters
in item d above), and costs of data development pertaining to the active
ingredient(s).
h. A description of the importance and unique benefits of the active
ingredient(s) to users. Discuss the use patterns and the effectiveness of
the active ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to the active
ingredient(s), providing information that is as quantitative as possible.
If you do not have quantitative data upon which to base your estimates,
then present the reasoning used to derive your estimates. To assist the
Agency in determining the degree of importance of the active
ingredient(s) in terms of its benefits, you should provide information on
any of the following factors, as applicable to your product(s):
(1) documentation of the usefulness of the active
ingredient(s) in Integrated Pest Management, (b) description of the
beneficial impacts on the environment of use of the active ingredient(s),
as opposed to its registered alternatives, (c) information on the
breakdown of the active ingredient(s) after use and on its persistence in
the environment, and (d) description of its usefulness against a pest(s) of
public health significance.
Failure to submit sufficient information for the Agency to make a
determination regarding a request for a low volume minor use waiver will result in
denial of the request for a waiver.
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2. Request for Waiver of Data —Option 9 on the Requirements Status and
Registrant's Response Form. This option may be used if you believe that a
particular data requirement should not apply because the corresponding use is
no longer registered or the requirement is inappropriate. You must submit a
rationale explaining why you believe the data requirements should not apply.
You must also submit the current label(s) of your product(s) and, if a current
copy of your Confidential Statement of Formula is not already on file you must
submit a current copy.
You will be informed of the Agency's decision in writing. If the
Agency determines that the data requirements of this Notice do not apply to
your product(s), you will not be required to supply the data pursuant to section
3(c)(2)(B). If EPA determines that the data are required for your product(s).
you must choose a method of meeting the requirements of this Notice within
the time frame provided by this Notice. Within 30 days of your receipt of the
Agency's written decision, you must submit a revised Requirements Status and
Registrant's Response Form indicating the option chosen.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
A. NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this
Notice due to failure by a registrant to comply with the requirements of this Data Call-
in Notice, pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your
receipt of this Notice.
2. Failure to submit on the required schedule an acceptable proposed or
final protocol when such is required to be submitted to the Agency for
review.
3. Failure to submit on the required schedule an adequate progress report
on a study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required
by this Notice.
5. Failure to take a required action or submit adequate information
pertaining to any option chosen to address the data requirements (e.g.,
any required action or information pertaining to submission or citation
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of existing studies or offers, arrangements, or arbitration on the sharing
of costs or the formation of Task Forces, failure to comply with the
terms of an agreement or arbitration concerning joint data development
or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of
submitted studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in
the cost of developing data and provided proof of the registrant's receipt
of such offer, or failure of a registrant on whom you rely for a generic
data exemption either to:
a. inform EPA of intent to develop and submit the data required by
this Notice on a Data Call-In Response Form and a Requirements Status
and Registrant's Response Form: or,
b. fulfill the commitment to develop and submit the data as
required by this Notice; or,
c. otherwise take appropriate steps to meet the requirements stated
in this Notice, unless you commit to submit and do submit the required
data in the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above,
at any time following the issuance of this Notice.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to
Suspend. The grounds for suspension include, but are not limited to, failure to meet
any of the following:
1. EPA requirements specified in the Data Call-In Notice or other
documents incorporated by reference (including, as applicable, EPA Pesticide
Assessment Guidelines, Data Reporting Guidelines, and GeneTox Health
Effects Test Guidelines) regarding the design, conduct, and reporting of
required studies. Such requirements include, but are not limited to, those
relating to test material, test procedures, selection of species, number of
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animals, sex and distribution of animals, dose and effect levels to be tested or
attained, duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner
of reporting, the completeness of results, and the adequacy of any required
supporting (or raw) data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR 86-5. All studies must be
submitted in the form of a final report; a preliminary report will not be
considered to fulfill the submission requirement.
C. EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of
existing stocks of a pesticide product which has been suspended or cancelled if doing
so would be consistent with the purposes of the Federal Insecticide, Fungicide, and
Rodenticide Act.
The Agency has determined that such disposition by registrants of existing
stocks for a suspended registration when a section 3(c)(2)(B) data request is
outstanding would generally not be consistent with the Act's purposes. Accordingly,
the Agency anticipates granting registrants permission to sell, distribute, or use
existing stocks of suspended product(s) only in exceptional circumstances. If you
believe such disposition of existing stocks of your product(s) which may be suspended
for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with
the Act. You must also explain why an "existing stocks" provision is necessary,
including a statement of the quantity of existing stocks and your estimate of the time
required for their sale, distribution, and use. Unless you meet this burden the Agency
will not consider any request pertaining to the continued sale, distribution, or use of
your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this
Notice and your product is in full compliance with all Agency requirements, you will
have, under most circumstances, one year from the date your 90 day response to this
Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency will
allow persons other than the registrant such as independent distributors, retailers and
end users to sell, distribute or use such existing stocks until the stocks are exhausted.
Any sale, distribution or use of stocks of voluntarily cancelled products containing an
active ingredient(s) for which the Agency has particular risk concerns will be
determined on case-by-case basis.
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Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result in the Agency granting any additional time to
sell, distribute, or use existing stocks beyond a year from the date the 90 day response
was due unless you demonstrate to the Agency that you are in full compliance with all
Agency requirements, including the requirements of this Notice. For example, if you
decide to voluntarily cancel your registration six months before a 3 year study is
scheduled to be submitted, all progress reports and other information necessary to
establish that you have been conducting the study in an acceptable and good faith
manner must have been submitted to the Agency, before EPA will consider granting
an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the
information to the Agency. Registrants must notify the Agency of any factual information
they have, from whatever source, including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person listed in Attachment 1, the Data Call-In Chemical Status
Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic
data exemption claims) must include a completed Data Call-In Response Form (Attachment
2) and a completed Requirements Status and Registrant's Response Form (Attachment 3) and
any other documents required by this Notice, and should be submitted to the contact person
identified in Attachment 1. If the voluntary cancellation or generic data exemption option is
chosen, only the Data Call-In Response Form need be submitted.
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The Office of Compliance (OC) of the Office of Enforcement and Compliance
Assurance (OECA), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Janet L. Andersen, Ph. D., Director
Biopesticides and Pollution
Prevention Division
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DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing Colletotrichum gloeosporioides f.sp. aeschynomene.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregi strati on of
Colletotrichum gloeosporioides f.sp. aeschynomene. This attachment is to be used in
conjunction with (1) the Generic Data Call-In Notice, (2) the Generic Data Call-In Response
Form (Attachment 2), (3) the Requirements Status and Registrant's Form (Attachment 2), (4)
a list of registrants receiving this DCI (Attachment 4), (5) the EPA Acceptance Criteria
(Attachment 5), and (6) the Cost Share and Data Compensation Forms in replying to this
Colletotrichum gloeosporioides f.sp. aeschynomene Generic Data Call In (Attachment F).
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for
Colletotrichum gloeosporioides f.sp. aeschynomene are contained in the Requirements Status
and Registrant's Response. Attachment C. The Agency has concluded that additional product
chemistry data on Colletotrichum gloeosporioides f.sp. aeschynomene are needed. These data
are needed to fully complete the reregi strati on of all eligible Colletotrichum gloeosporioides
f.sp. aeschynomene products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Shanaz Bacchus at (703) 308-8097.
All responses to this Notice for the generic data requirements should be submitted to:
Shanaz Bacchus, Regulatory Action Leader
Microbes and Plant Pesticides Team
Biopesticides and Pollution Prevention Division (7501W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M St., S.W.
Washington, D.C. 20460
RE: Colletotrichum gloeosporioides f.sp. aeschynomene
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE
FORM
This Form is designed to be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
Rodenticide Act. Fill out this form each time you are responding to a data call-in for which
EPA has sent you the form entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed
by the registrant as appropriate Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
Public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect
of this collection of information, including suggesting for reducing this burden, to Chief,
Information Policy Branch, PM-223, U S Environmental Protection Agency, 401 M St, S W ,
Washington, D C 20460; and to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D C 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and address.
Item 2. This item identifies the case number, case name, EPA chemical number
and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations relevant to the data
call-in. Please note that you are also responsible for informing the
Agency of your response regarding any product that you believe may be
covered by this data call-in but that is not listed by the Agency in Item
4. You must bring any such apparent omission to the Agency's attention
within the period required for submission of this response form.
Item 5. Cheek this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which
you previously requested voluntary cancellation, indicate in Item 5 the
date of that request. You do not need to complete any item on the
Requirements Status and Registrant's Response Form for any product
that is voluntarily cancelled.
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Item 6a. Check this item if this data call-in is for generic data as indicated in Item
3 and if you are eligible for a Generic Data Exemption for the chemical
listed in Item 2 and used in the subject product. By electing this
exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient
that you use in your product.
Typically, if you purchase an EPA-registered product from one or more
other producers (who, with respect to the incorporated product, are in
compliance with this and-any other outstanding Data Call-In Notice),
and incorporate that product into all your products, you may complete
this item for all products listed on this form If, however, you produce
the active ingredient yourself, or use any unregistered product
(regardless of the fact that some of your sources are registered), you
may not claim a Generic Data Exemption and you may not select this
item.
Item 6b. Check this Item if the data call-in is a generic data call-in as indicated in
Item 3 and if you are agreeing to satisfy the generic data requirements
of this data call-in. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a
manufacturing use product for which you agree to supply
product-specific data. Attach the Requirements Status and Registrants'
Response Form that indicates how you will satisfy those requirements.
Item 7b. Check this item if this call-in is a data call-in for an end use product
(EUP) as indicated in Item 3 and if your product is an end use product
for which you agree to supply product-specific data. Attach the
Requirements Status and Registrant's Response Form that indicates how
you will satisfy those requirements.
Item 8. This certification statement must be signed by an authorized
representative of your company and the person signing must include
his/her title. Additional pages used in your response must be initialled
and dated in the space provided for the certification.
Item 9. Enter the date of signature.
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Item 10. Enter the name of the person EPA should contact with questions
regarding your response.
Item 11. Enter the phone number of your company contact.
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS
AND REGISTRANTS RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to call-in- for generic and
product-specific data as part of EPA's reregi strati on program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for both product specific and
generic data, instructions for completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1) deletion of uses or (2) request
for a low volume/minor use waiver. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-in addressed to each
registrant, and has preprinted this form with a number of items. DO NOT use this form for
any other active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must
complete all other items on this form by typing or printing legibly.
Public reporting burden for this collection of information is estimated to average 30
minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect
of this collection of information, including suggesting for reducing this burden, to Chief,
Information Policy Branch, PM-223, U.S. Environmental Protection Agency, 401 M St.,
S.W., Washington, D.C. 20460; and to the Office of Management and Budget, Paperwork
Reduction Project 2070-0107, Washington, D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2. This item identifies the case number, case name, EPA chemical number and
chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to
support the product(s) being reregistered. These guidelines, in addition to
requirements specified in the Data Call-In Notice, govern the conduct of the
required studies.
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Item 5. This item identifies the study title associated with the guideline reference
number and whether protocols and 1, 2, or 3-year progress reports are required
to be submitted in connection with the study. As noted in Section III of the
Data Call-In Notice, 90-day progress reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's
Response Form.
Item 6. This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food crop
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
Item 7. This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP End-Use Product
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical Grade
Active Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Ingredient or Pure Active Ingredient
Radiolabelled
PAIRA Pure Active Ingredient Radiolabelled
PAIRA/M Pure Active Ingredient Radiolabelled and
Metabolites
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PAIRA/PM Pure Active Ingredient Radiolabelled and Plant
Metabolites
TEP Typical End-Use Product
TEP _ * Typical End-Use Product, Percent Active
Ingredient Specified
TEP/MET Typical End-Use Product and Metabolites
TEP/PAI/M Typical End-Use Product or Pure Active
Ingredient and Metabolites
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
TGAI Technical Grade Active Ingredient
TGAI/TEP Technical Grade Active Ingredient or Typical
End-Use Product
TGAI/PAI Technical Grade Active Ingredient or Pure Active
Ingredient
MET Metabolites
IMP Impurities
DEGR Degradates
*See: guideline comment
Item 8. This item identifies the time frame allowed for submission of the study or
protocol identified in item 2. The time frame runs from the date of your receipt
of the Data Call-In Notice.
Item 9. Enter the appropriate Response Code or Codes to show how you intend to
comply with each data requirement. Brief descriptions of each code follow. The
Data Call-In Notice contains a fuller description of each of these options.
1. (Developing Data) I will conduct a new study and submit it within the
time frames specified in item 8 above. By indicating that I have chosen
this option, I certify that I will comply with all the requirements
pertaining to the conditions for submittal of this study as outlined in the
Data Call-In Notice and that I will provide the protocol and progress
reports required in item 5 above.
2. (Agreement to Cost Share) I have entered into an agreement with one or
more registrants to develop data jointly. By indicating that I have
chosen this option, I certify that I will comply with all the requirements
pertaining to sharing in the cost of developing data as outlined in the
Data Call-In Notice.
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3. (Offer to Cost Share) I have made an offer to enter into an agreement
with one or more registrants to develop data jointly. I am submitting a
copy of the form "Certification of Offer to Cost Share in the
Development of Data" that describes this offer/agreement. By
indicating that I have chosen this option, I certify that I will comply with
all the requirements pertaining to making an offer to share in the cost of
developing data as outlined in the Data Call-In Notice.
4. (Submitting Existing Data) I am submitting an existing study that has
never before been submitted to EPA. By indicating that I have chosen
this option, I certify that this study meets all the requirements pertaining
to the conditions for submittal of existing data outlined in the Data
Call-in Notice and I have attached the needed supporting information
along with this response.
5. (Upgrading a Study) I am submitting or citing data to upgrade a study
that EPA has classified as partially acceptable and potentially
upgradeable. By indicating that I have chosen this option, I certify that I
have met all the requirements pertaining to the conditions for submitting
or citing existing data to upgrade a study described in the Data Call-In
Notice. I am indicating on attached correspondence the Master Record
Identification Number (MRID) that EPA has assigned to the data that I
am citing as well as the MRID of the study I am attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that
has not yet been reviewed by the Agency. I am providing the Agency's
classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In
Notice and I request a low-volume minor use waiver of the data
requirement. I am attaching a detailed justification to support this
waiver request including, among other things, all information required
to support the request. I understand that, unless modified by the Agency
in writing, the data requirement as stated in the Notice governs.
9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than low volume minor-use data waivers in the Data
Call-In Notice and I request a waiver of the data requirement. I am
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attaching an identification of the basis for this waiver and a detailed
justification to support this waiver request. The justification includes,
among other things, all information required to support the request. I
understand that, unless modified by the Agency in writing, the data
requirement as stated in the Notice governs.
Item 10. This item must be signed by an authorized representative of your company.
The person signing must include his/her title, and must initial and date all other
pages of this form.
Item 11. Enter the date of signature.
Item 12. Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
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Attachment 4. List of Registrants sent this DCI (Insert)
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The following is a list of available documents for Colletotrichum gloeosporioides f.sp.
aeschynomene ATCC 20358 that may further assist you in responding to this Reregi strati on
Eligibility Decision document. These documents may be obtained by the following methods:
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies 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., or contact Phil Hutton at (703)-308-8260.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for Colletotrichum gloeosporioides f.sp. aeschynomene
ATCC strain 20358.
The following documents are part of the Administrative Record for Colletotrichum
gloeosporioides f.sp. aeschynomene ATCC strain 20358 and may be included in the EPA's
Office of Pesticide Programs Public Docket. Copies of these documents are not available
electronically, but may be obtained by contacting the person listed on the Chemical Status
Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may
be obtained by contacting the person listed on the Chemical Status Sheet of this RED
document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
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