United States Prevention, Pesticides EPA 738-R-95-023
Environmental Protection And Toxic Substances June 1995
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Agrobacterium
radiobacter
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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
reregistration eligibility review and decisions on the biopesticide case Agrobacterium
radiobacter. The enclosed Reregistration Eligibility Decision (RED) contains the Agency's
evaluation of the data base for this biopesticide, 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 reregistration. The RED includes the data
and labeling requirements for products for reregistration.
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. An Application for Reregistration is required to be
submitted eight months from the date of this letter. Complete and timely responses will
avoid the Agency taking the enforcement action of suspension against your products.
If you have questions about our decision or the requirements set forth in this document,
please contact the reregistration representative for Biopesticides and Pollution Prevention
Division, Richard King at (703) 308-8052.
Sincerely yours,
Janet L. Andersen, Acting Director
Biopesticides and Pollution
Prevention Division (7501W)
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO THE
REREGISTRATION ELIGIBILITY DECISION (RED)
1. 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-d 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 reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. 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. 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.
d. 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.
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5. WHERE TO SEND 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 reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Agrobacterium radiobacter
LISTD
CASE 4101
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
BIOPESTICIDES AND POLLUTION
PREVENTION DIVISION
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TABLE OF CONTENTS
Agrobacterium radiobacter 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 5
III. SCIENCE ASSESSMENT 5
A. Product Chemistry Assessment 5
B. Human Health Assessment 6
1. Acute Toxicity 6
2. Exposure and Risk Assessments 7
a. Dietary Exposure and Risk Assessment 7
b. Occupational Exposure and Risk Assessment 8
C. Environmental Assessment 8
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 9
A. Determination of Eligibility 9
B. Determination of Eligibility 10
1. Eligibility Decision 10
2. Eligible and Ineligible Uses 10
C. Regulatory Position 10
1. Tolerance Reassessment 10
2. Endangered Species Statement 10
3. Labeling Rationale 10
V. ACTIONS REQUIRED BY REGISTRANTS 12
A. Manufacturing-Use Products 12
1. Additional Generic Data Requirements 12
2. Labeling Requirements for Manufacturing-Use Products 12
B. End-Use Products 13
1. Additional Product-Specific Data Requirements 13
2. Labeling Requirements for End-Use Products 13
C. Existing Stocks 14
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VI. APPENDICES 15
APPENDIX A. Table of Use Patterns Subject to Reregistration 17
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 35
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of 4101 41
APPENDIX D. List of Available Related Documents 47
APPENDIX E. FACT SHEET 51
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Agrobacterium radiobacter REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biopesticides and Pollution Prevention Division
Phil Hutton
Richard King
John Rough
Sheryl K. Reilly
Robert I. Rose
William Schneider
Roy Sjoblad
John Tice
Robert Torla
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
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
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
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/L, 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.
pg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MOE Margin of Exposure
NOEC No effect concentration
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OP Organophosphate
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GLOSSARY OF TERMS AND ABBREVIATIONS
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PPE Personal Protective Equipment
ppb Parts Per Billion
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*j 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
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
TMRC Theoretical Maximum Residue Contribution
TLC Thin Layer Chromatography
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The Environmental Protection Agency has completed an assessment of the potential
human health and environmental risks associated with the pesticidal use of Agrobacterium
radiobacter in the United States.
Agrobacterium radiobacter is registered as a fungicide (microbial control agent) for the
prevention of Crown Gall in certain non-bearing fruit, nut and ornamental nursery stock. This
fungicide is target specific in mitigating the causative agent of Crown Gall, a bacterium
Agrobacterium tumefaciens.
The Agency has determined that the uses of A. radiobacter as currently registered will
not cause unreasonable risk to humans or the environment and that these uses are eligible for
reregistration. The Agency is not requiring additional studies.
Before reregistering the products containing A. radiobacter, the Agency is requiring
that product specific data; a revised Confidential Statements of Formula (CSF) and revised
labeling be submitted within eight months of the issuance of this document. After reviewing
these data and any revised labels and finding them acceptable in accordance with Section
3(c)(5) of FIFRA, the Agency will reregister a product. Those products which contain A.
radiobacter in combination with other active ingredients will be eligible for reregistration only
when the other active ingredients are determined to be eligible for reregistration.
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration 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 reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration 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.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of A. radiobacter. The document consists of six sections. Section I is the
introduction. Section II describes A. radiobacter, 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 reregistration decision for A. radiobacter. Section
V discusses the reregistration requirements for A. radiobacter. Finally, Section VI is the
Appendices which support this Reregistration 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 Reregistration Eligibility
Decision:
• Common Name: Agrobacterium radiobacter
• Chemical Name: Agrobacterium radiobacter (Strain Kerr-84)
• Chemical Family: Not applicable
• CAS Registry Number: Not applicable
• OPP Chemical Code: 114201
• Empirical Formula: Not applicable
• Trade and Other Names: Galltrol-A8 , Norbac 84-C8
Basic Manufacturer:
AgBioChem, Inc.
New Bioproducts, Inc.
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 the use of A. radiobacter is in
Appendix A.
Type of Pesticide: Fungicide (microbial control agent).
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Use Sites: Terrestrial and Greenhouse Non-food Crops
Non-bearing Fruit and Nut Nursery Stock:
Almonds Apples Apricots
Blueberries Caneberries* Cranberries
Cherries Kiwis Nectarines
Peaches Pears Pecans
Plums Prunes Walnuts
* Caneberries include Blackberry, Boysenberry, Raspberry, and Youngberry
Ornamental Nursery Stock:
Euonymus Rose Weeping Cherry
Target Pests: Aids in the control of Crown Gall disease (A. tumefaciens).
Formulation Types Registered: 2.25% Flowable concentrate
1.2% Solidified Agar
Method and Rates of Application:
Equipment - Hand-operated spray, drench and dip treatment equipment.
Method and Rate -
Dipping
Germinating Seed Application - 1 unit of product**/gallon of water.
Seedling Application - 1 unit of product**/gallon of water.
Cutting Application - 1 unit of product**/gallon of water.
Root and Stem Application - 1 unit of product**/gallon of water.
Spraying
Root and Stem Application - 1 unit of product**/gallon of water.
Soil Drench Application - 1 unit of product**/ 5 gallons of water;
6-8 oz of suspension per 1 gallon container or 1 foot of plant row.
**1 unit of product equals 3 x 1012 and 1.2 x 10" colony forming units per volume
of product for the flowable concentrate and solidified agar formulations, respectively.
Timing - Preplant — cutting, root and stem treatments; Immediately Prior
to Planting — germinating seed and seedling treatments; Postplant — soil
drench treatment.
Use Practice Limitations: Label limits use only to applications on certain non-
food and non-bearing plants.
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C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of A.
radiobacter. The Agency estimates that less than 1000 Ibs. a.i. are used annually. These
estimates are derived from a variety of published and proprietary sources available to the
Agency. The data, reported on an aggregate and site (crop) basis, reflect annual
fluctuations in use patterns as well as the variability in using data from various information
sources. The table below summarizes the pesticides use by site.
Annual Usage and Percent of Crop Treated in California37 in 1990 with A. radiobacter
NAME OF SITE
Fruits and Nuts:
Almond
Almond Seeds
Cherry
Walnuts
Prune
Nursery/Greenhouse:
Greenhouse Cut Flowers or Greens
Greenhouse Grown Transplants
Outdoor Containers/Field Plants
Outdoor Grown Transplants
ACRES
GROWN/HARVESTED"'
(1000)
404
NA
16
176
79
2
NA
27
NA
PERCENT OF ACRES
TREATED'7
<1
NA
<5
<1
<1
<1
NA
<1
NA
a/ National Usage data is not available.
b/ Three years average 1992 to 1994 (with some census data) are reported. For perennial crops, harvested acres are reported; for other
crops, acres grown are reported. Sources: US Dept. of Commerce. 1992 Census of Agriculture, CA, Volume 1, Part 5, September 1994:
US Dept. of Commerce. 1992 Census of Agriculture, Volume 1, Part 51, October 1994; USDA, Noncitrus Fruits and Nuts, 1994
Summary, January 1995.
c/ The relevant measure for percent of crop treated would be acres planted. Because annual estimates for planted acres are not available,
percent of crop treated is based on annual harvested acres.
NA - Not Available.
D. Data Requirements
Data requested in the Phase 3 of the Reregistration Process issued January 1989
and the DCI issued July 1993 include studies on product chemistry, ecological effects,
environmental fate, and toxicology. These data were required to support the uses of
products containing the active ingredient A. radiobacter. Appendix B includes all data
requirements identified by the Agency for currently registered uses to support
reregistration.
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E. Regulatory History
The microbial control agent/bacterial inoculant, A. radiobacter, was initially
registered in the United States in 1979 as Galltrol-A8, EPA Reg. No 40230-1, for the
prevention of Crown Gall infections in certain fruit, nut and ornamental nursery stock
(non-bearing plants only). Later in 1979 another product containing A. radiobacter,
Norbac 84-C8, was registered for these uses.
During Phase 3 of the Reregistration Process, the toxicology data base for A.
radiobacter was evaluated and determined to adequately satisfy most of the data
requirements for microbial pest control agents. The acute pulmonary toxicity/
pathogenicity, Guideline No. 152A-12, and acute intravenous toxicity/ pathogenicity,
Guideline No. 152A-13, were identified as outstanding data gaps and a Data Call-In was
issued July 1993. Since the DCI, the Agency's initial position with respect to these
guidelines was re-evaluated, and these data requirements were waived because it was
determined that A. radiobacter was a soil saprophyte and was not known to be pathogenic
to humans and animals.
This Reregistration Eligibility Decision reflects a reassessment of all data which
were submitted in response to the reregistration process.
III. SCIENCE ASSESSMENT
A. Product Chemistry Assessment
The Agency has determined that A. radiobacter meets the criteria for a select category of
pesticide active ingredients (biopesticides) for which a reduced set of generic data requirements
are appropriate for reregistration. Refer to §40 CFR 158.740 — Guidelines for Microbial Control
Agents — Tier I — for non-food/feed uses. Products in this select category of pesticides may also
be exempt from certain generic data requirements for toxicology, residue chemistry, human
exposure, ecological effects, and environmental fate on the active ingredient. In considering A.
radiobacter's eligibility for reregistration, the Agency believes that it meets these criteria for the
following reasons:
(1) Review of the available toxicology data and literature submitted in support of
reregistration indicates that adequate information is available to characterize the risks to humans
and animals; products containing A. radiobacter are not likely to produce unreasonable adverse
effects on humans. Agrobacterium radiobacter is generally understood to be non-pathogenic to
humans or animals. It has been registered and used since 1979 with no reports of adverse effects
which would have been reported as required by section 6(a) (2) of FIFRA, if they had occurred.
Although some strains of Agrobacterium have been identified in human clinical specimens, it
appears that these were sampling contaminants or incidental non-pathogenic inhabitants of the
patients. Moreover, these strains are distinguisable from the A. radiobacter Kerr 84 strain used
in these products, which has never been identified in association with clinical specimens. Most
Agrobacterium strains from clinical specimens have been identified as A. radiobacter biovar 1,
which differs from the biovar 2 Kerr 84 strain used in these products by a number of
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physiologically and metabolic factors such as the ability to grow at 35°C, and produce 3-
ketolactose, acid from ethanol, H2S, and oxidase (Kovacs method).
(2) The use patterns for A. radiobacter, applications to certain fruit, nut, and ornamental
nursery stock are considered to be non-food/feed uses. Therefore, this microbial control agent
does not require the establishment of tolerances or exemptions from tolerances under the
provisions of FIFRA and FFDCA Sections 408 and 409.
Agrobacterium radiobacter is a naturally occurring bacterium which is present in many
soil types and plant rhizospheres. Agrobacterium radiobacter is one of the best examples of a
successful microbial control agents that has been isolated from nature (first isolated from soil
surrounding a peach tree in Australia in the early 1970's) and employed in agriculture. The use
of A. radiobacter is targeted at mitigating pathogenic strains of another closely related bacteria,
A. tumefaciens. Agrobacterium tumefaciens causes crown gall infections in certain fruit, nut, and
ornamental nursery stock and is susceptible to Agrosin 84, the bacteriocin produced by A.
radiobacter.
Agrobacterium radiobacter products range in color from cream for the technical grade
active ingredient to light green for the end-use products. The physical state for A. radiobacter can
be considered to be bacterial cells cultured on an agar medium. Agrobacterium radiobacter has
a slight odor and a pH of 6.8-7.1 for both the technical grade active ingredient and the end-use
products. These bacterial cultures are miscible in water and susceptible to drying at pH's greater
than 9 and temperatures in excess of 35°C. The live bacteria cultures of A. radiobacter have a
shelf-life of 120 days under refrigeration.
B. Human Health Assessment
Adequate toxicological effects data on A. radiobacter are available to support a
Reregistration Eligibility Decision (RED).
1. Acute Toxicity
Certain acute toxicity studies for the technical grade active ingredient, A. radiobacter, have
been submitted and adequately satisfy the requirements as set forth in §40 CFR 158.740 for non-
food/feed use of microbial control agents.
GUIDELINE
No.
152A-10
152A-11
STUDY
Acute Oral
Toxicity/
Pathogenicity
Acute Dermal
Toxicity
RESULTS
LD50 > 5g/kg
Slight erythema
CATEGORY
IV
IV
MRID
00060518
00064089
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152A-12
152A-13
152A-14
152A-15
Acute
Pulmonary
Toxicity/
Pathogenicity
Acute
Intravenous
Toxicity/
Pathogenicity
Primary Eye
Irritation/
Infection
Hyper-
sensitivity
Waived*
Waived*
Irritation
None Reported**
NA
NA
III
NA
NA
00060518
00064089
41653304
41653305
1-7* Literature submitted in support of reregistration indicated that A. radiobacter is not
pathogenic to humans and animals.
** All incidents of hypersensitivity must be reported to the Agency.
In the Agency's initial evaluation of the primary eye irritation study (MRID 00060518 and
00064089), A. radiobacter was determined to be a Toxicity Category II eye irritant, based on
persistent corneal effects in 1/6 rabbits over 21 days following the instillation of the test substance
in the conjunctival sac of the eye. However, during a subsequent evaluation for the reregistration
process it appeared that the toxicity category should be reconsidered, based on the fact that all eye
irritation in 2 of the other 5 animals was resolved by 72 hours, and the remaining 3 animals by
day seven. In addition, the affected animal reportedly had only slight irritation over the 21-day
observation period. The actual ocular irritation in this animal was not described, but was scored
1 on a scale of 0-4. The eye irritation study was repeated with 4 more rabbits, and only 1 rabbit
exhibited slight irritation of the cornea for 24 hours which was resolved within 48 hours. The
Agency has reconsidered its initial position and has concluded that since there were no materials
in the test substance (composed of an agar culture media dissolved in water) that would be likely
to cause eye irritation, and only 1/10 animals tested exhibited very slight irritation beyond 7 days,
the toxicity category is more appropriate classified as Toxicity Category III for eye irritation.
Agrobacterium radiobacter occurs naturally in the environment and does not appear to be
pathogenic to humans and animals. For this reason and because of its low mammalian toxicity
(oral, dermal, and occular), the required acute pulmonary toxicity/pathogenicity and acute
intravenous toxicity/pathogenicity guideline studies have been waived. Consequently, all of the
toxicology data requirements for microbial control agents have been satisfied.
2. Exposure and Risk Assessments
a. Dietary Exposure and Risk Assessment
Although A. radiobacter is applied to certain fruit and nut crops, the
Agency considers these applications to be non-food uses because they are
made only to non-bearing nursery stock. Thus, neither a tolerance or an
exemption from tolerance is required. Additionally, the Agency has
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concluded that the dietary exposure from consuming commodities which
were treated with A. radiobacter as nursery stock are not expected.
b. Occupational Exposure and Risk Assessment
Based on the application methods (dipping of plants by hand and
spraying with a hand-held sprayer) listed on the product label, the potential
for eye, dermal and inhalation exposure to handlers and post application
nursery workers exists. Because of a lack of human toxicity concern,
worker exposure data are not required. Moreover, it is the Agency's
opinion that these occupational exposures and subsequent risks are
negligible because: (1) the proposed precautionary product labeling
stipulated in Section V will adequately mitigate the risks to applicators and
related nursery workers; and (2) the organism has been determined not to
be pathogenic to humans and animals.
C. Environmental Assessment
Agrobacterium radiobacter is a well-characterized bacterium which has
been in continuous use since 1979. The Agency is unaware of any cases where it
or related bacteria have been found in association with diseases of birds, fish,
insects or other non-target species. Agrobacterium radiobacter's mechanism of
action to control the target plant pathogen, A. tumefaciens, the causal agent of
crown gall, is well-understood. It involves direct competition with A. tumefaciens
and is enhanced by the production of a specific bacteriocin (Agrosin 84).
No ecological toxicity data requirements were required for A. radiobacter
because there are mitigating factors that support the conclusion that exposure to
non-target terrestrial and aquatic organisms is extremely minimal. The major
mitigating factor is that the registered use of A. radiobacter being supported for
reregistration is the treatment of certain nursery stock in a contained environment
(indoor use). Thus, there is little or no exposure to the environment when used
according to label directions. Because there is little or no exposure, the risk to non-
target terrestrial and aquatic organisms is expected to be minimal
Based on the previously mentioned rationale, the Agency has waived the
following Environmental and Ecological Guidelines (Tier I) for A. radiobacter.
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Guideline No.
154A-16
154A-19
154A-20
154A-22
154A-23
154A-24
Description
Avian pathogenicity/toxicity
Freshwater Fish
pathogenicity/toxicity
Freshwater invertebrate
Nontarget plant testing
Nontarget insect testing
Honeybee toxicity/pathogenicity
Conclusion
Waived
Waived
Waived
Waived
Waived
Waived
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 reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing the bacterium, A. radiobacter as an active
ingredient. The Agency has completed its review of these generic data, and has
determined that the data are sufficient to support reregistration of all products containing
A. radiobacter. Appendix B identifies the generic data requirements that the Agency
reviewed as part of its determination of reregistration eligibility of A. radiobacter, 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 A. radiobacter and to determine that A. radiobacter can be used without
resulting in unreasonable adverse effects to humans and the environment. The Agency
therefore finds that all products containing A. radiobacter as the active ingredients are
eligible for reregistration. The reregistration of particular products is addressed in Section
V of this document.
The Agency made its reregistration eligibility determination based upon the target
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 A. radiobacter 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 support the registration of
products containing A. radiobacter, if new information comes to the Agency's attention
or if the data requirements for registration (or the guidelines for generating such data)
change.
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B. Determination of Eligibility
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient A.
radiobacter, the Agency has sufficient information on the health effects of A.
radiobacter and on its potential for causing adverse effects in fish and wildlife and
the environment. The Agency has determined that A. radiobacter products,
labeled and used as specified in this Reregistration Eligibility Decision, will not
pose unreasonable risks or adverse effects to humans or the environment.
Therefore, the Agency concludes that products containing A. radiobacter for all
currently registered uses are eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all currently registered uses of A.
radiobacter are eligible for reregistration.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for A.
radiobacter. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1. Tolerance Reassessment
Although A. radiobacter is applied to certain fruit and nut crops, the
Agency considers these applications to be non-food uses, because they are only
made to non-bearing nursery stock. Therefore, neither a tolerance nor an
exemption from tolerance is required. Should one be needed in the future, the data
available are adequate to support an exemption from the requirement of a
tolerance.
2. Endangered Species Statement
Based on the current use patterns, the potential for adverse effects to plant
and animal (avian and aquatic) endangered species from applications of A.
radiobacter is not expected.
3. Labeling Rationale
Precautionary Labeling:
In the evaluation of the toxicology data base for the reregistration eligibility
decision for A. radiobacter, the Agency reexamined the acute toxicity study —
primary eye irritation (MRID 00060518 and 00064089), and concluded that the eye
10
-------
irritation potential is more appropriately reclassified Toxicity Category III. This
reduction in potential hazard prompts the revision of the precautionary labeling
statements (Signal word, Statement of Practical Treatment, and other associated
label statements mitigating risks) for all A. radiobacter products. The Agency is
now requiring that these revised precautionary labeling statements be placed on the
label/labeling of all A. radiobacter products as specified in Section V.
Worker Protection Requirements:
The 1992 Worker Protection Standards for Agricultural Pesticides (WPS)
established certain worker-protection requirements (personal protective equipment,
restricted entry intervals, etc.) to be specified on the label of all products that
contain uses within the scope of the WPS. Uses within the scope of the WPS
include all commercial (non-homeowner) and research uses on farms, forests,
nurseries, and greenhouses to produce agricultural plants (including food, feed,
and fiber plants, trees, turf grasses, flowers, shrubs, ornamental, and seedlings).
Uses within the scope include not only uses on plants, but also uses on soil or
planting medium the plants are (or will be) grown in. At this time all currently
registered uses of A. radiobacter are within the scope of the Worker Protection
Standards for Agricultural Pesticides (WPS).
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 and 93-11. Unless otherwise specifically directed in
this RED, all statements required by PR Notices 97-7 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 Notice 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.
On April 26, 1995, the Agency established a policy which allows
registrants to reduce the interim WPS restricted entry interval (REI) from 12 hours
to 4 hours for certain low risk pesticides. This policy identifies A. radiobacter as
a candidate eligible for a reduced WPS REI. The procedures for requesting a
reduction in the REI are outlined in Section V.
11
-------
Personal Protective Equipment (PPE):
All PPE labeling requirements for products containing A. radiobacter were
established using the process described in PR Notice 93-7 or more recent EPA
guidelines. This RED will not impose any changes to the PPE WPS labeling
requirements established in PR Notices 93-7 and 93-11.
Restricted-Entry Interval (REI):
Under the Worker Protection Standard (WPS), interim restricted entry
intervals (REI) for all uses within the scope of the WPS were established on the
basis of the acute toxicity of the active ingredient. The toxicity categories of the
active ingredient for acute dermal toxicity, eye irritation potential, and skin
irritation potential were used to determine the interim WPS REI. If one or more
of the three acute toxicity effects are in toxicity category I, the interim WPS REI
is established at 48 hours. If none of the acute toxicity effects are in category I, but
one or more of the three is classified as category II, the interim WPS REI is
established at 24 hours. If none of the three acute toxicity effects are in category
I or II, the interim WPS REI is established at 12 hours. The interim WPS REI for
A. radiobacter is 12 hours, since all of the acute toxicity categories are either III
or IV.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of A. radiobacter for the
above eligible uses has been reviewed and determined to be substantially complete.
At this time, no additional data are being required.
2. Labeling Requirements for Manufacturing-Use Products
Precautionary Labeling
The product labeling of each product containing A. radiobacter as an active
ingredient must bear the following revised precautionary label statements. Refer
to 40 CFR 156.10 — Labeling Requirements for Pesticides and Devices, for
additional information regarding proper placement and type size requirements for
these statement.
12
-------
CAUTION
Keep out of Reach of Children
Avoid contact with skin, eyes or clothing
STATEMENT OF PRACTICAL TREATMENT:
In case of contact immediately flush eyes or skin with plenty of water. Get medical
attention if irritation persists.
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 has
been made. However, the data base supporting the reregistration for the above
eligible end-uses of A. radiobacter products is substantially complete and no
additional product specific data is being required at this time.
2. Labeling Requirements for End-Use Products
Precautionary Labeling
Refer to subsection A. above for labeling requirements for precautionary
labeling.
Worker Protection Standard Labeling:
If registrants of A. radiobacter wish their products to be considered for
a REI reduction from 12 hours to 4 hours, they must notify EPA. For each
product, the following information must be submitted:
1. An Application for Registration (EPA Form 8570-1).
2. One copy of the current product label, clearly marked to highlight the
interim WPS REI.
3. Two copies of the revised label, clearly marked to highlight the revised
WPS REI.
4. The following certification statement:
"I certify that this notification is complete in accordance with the provisions
of EPA's reduced REI policy and that no other changes have been made to
the labeling or confidential statement of formula of this product. I further
13
-------
understand that if this notification does not comply with the terms of EPA's
reduced REI Policy, this product may be in violation of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) and I may be subject
to enforcement action and penalties under sections 12 and 14 of FIFRA. I
understand that the Agency may direct a change in the REI of a product
subject to this notice if the Agency determines that a change is appropriate,
and that products may be subject to regulatory and enforcement action if
the appropriate changes are not made."
Notifications should be sent to:
By U.S. Mail:
Document Processing Desk (WPS:95-1)(BPPD)
Office of Pesticide Programs (7504C)
Environmental Protection Agency
401 M Street, S.W.
Washington, DC 20460-0001
By express:
Document Processing Desk (WPS:95-1) (BPPD)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
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 Reregistration 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 A. radiobacter
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.
14
-------
VI. APPENDICES
15
-------
16
-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
17
-------
18
-------
Report Run Date: 05/15/95 ) Time 08:01
PRD Report Date: 02/14/95
APPENDIX A ) CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
LUIS 2.0 ) Page 1
SITE Application Type, Application Form(s)
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED
ALMOND
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant., By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Nonbearing nurserystock., By
hand.
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant., By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Spray., Nonbearing nurserystock., Sprayer.
APPLE
Dip treatment., Bare root., By hand.
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
Min. Appl. Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
UC *
Use Group
.6614 Ib IK plant *
UC *
UC *
UC *
.6614 Ib IK plant *
UC *
1.47 Ib cwt *
UC *
UC *
UC *
.6614 Ib IK plant *
UC *
.6614 Ib IK plant *
Use Group
UC *
Max . tt Apps
a Max. Rate
/crop /year
cycle
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: GREENHOUSE
NS
NS
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
CROP
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s)]
NS
NS
NS
NS
NS
NS
NS
0.5
NS
0.5
NS
0.5
NS
0.5
NS
NS
NS
0.5
NS
0.5
NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
APPLE (con't)
Seed treatment., Preplant . , By hand.
Soil drench treatment., Postplant . , By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Min. Appl . Max. Appl . Soil Max. tt Apps
Rate (AI un- Rate (AI Tex. © Max. Rate
less noted unless noted Max. /crop /year
otherwise) otherwise) Dose cycle
Use Group: GREENHOUSE
F1C
F1C
F1C
F1C
NA
NA
NA
NA
UC * NS
UC * NS
UC * NS
UC * NS
NS
NS
NS
NS
Use Group: TERRESTRIAL
Dip treatment., Bare root., By hand.
Seed treatment., Preplant., By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
APRICOT
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant., By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
F1C
F1C
F1C
F1C
F1C
NA
NA
NA
NA
NA
UC * NS
UC * NS
UC * NS
UC * NS
UC * NS
NS
NS
NS
NS
NS
Use Group: GREENHOUSE
F1C
F1C
F1C
F1C
F1C
F1C
F1C
NA
NA
NA
NA
NA
NA
NA
UC * NS
UC * NS
UC * NS
UC * NS
UC * NS
UC * NS
UC * NS
NS
NS
NS
NS
NS
NS
NS
Use Group: TERRESTRIAL
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
F1C
F1C
F1C
F1C
NA
NA
NA
NA
.6614 Ib IK plant * NS
UC * NS
UC * NS
UC * NS
NS
NS
NS
NS
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
NON -FOOD
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s)]
CROP (con't)
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
NS
0.5
NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page 3
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
APRICOT (con't)
Dip treatment., Nonbearing nurserystock . , By
hand.
Dip treatment., Seedling stage., By
Seed treatment., Preplant . , By hand
Soil drench treatment., Postplant . ,
Soil drench treatment., Postplant.,
Spray., Bare root., Sprayer.
hand.
By hand .
Sprayer.
Spray., Nonbearing nurserystock., Sprayer.
BLACKBERRY
Dip treatment., Bare root., By hand
Dip treatment., Cutting., By hand.
Dip treatment., Seedling stage., By
Soil drench treatment., Postplant.,
Soil drench treatment., Postplant.,
Spray., Bare root., Sprayer.
Dip treatment., Bare root., By hand
Dip treatment., Cutting., By hand.
Dip treatment., Seedling stage., By
Soil drench treatment., Postplant.,
Soil drench treatment., Postplant.,
Spray., Bare root., Sprayer.
hand.
By hand .
Sprayer.
hand.
By hand .
Sprayer.
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
.6614 Ib IK plant *
UC *
1.47 Ib cwt *
UC *
UC *
UC *
.6614 Ib IK plant *
UC *
.6614 Ib IK plant *
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
Max . tt Apps
© Max. Rate
/crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s)]
CROP (don't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
NS
0.5
NS
NS
NS
0.5
NS
0.5
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page 4
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
BLUEBERRY
Dip treatment
Dip treatment
., Cutting., By hand.
., Seedling stage., By
Soil drench treatment., Postplant . ,
Soil drench treatment., Postplant.,
Dip treatment
Dip treatment
., Cutting., By hand.
., Seedling stage., By
Soil drench treatment., Postplant.,
Soil drench treatment., Postplant.,
BOYSENBERRY
Dip treatment
Dip treatment
Dip treatment
. , Bare root . , By hand
., Cutting., By hand.
., Seedling stage., By
Soil drench treatment., Postplant.,
Soil drench treatment., Postplant.,
Spray. , Bare
Dip treatment
Dip treatment
Dip treatment
root . , Sprayer.
. , Bare root . , By hand
., Cutting., By hand.
., Seedling stage., By
Soil drench treatment., Postplant.,
Soil drench treatment., Postplant.,
Spray. , Bare
root . , Sprayer.
hand.
By hand .
Sprayer.
hand.
By hand .
Sprayer.
hand.
By hand .
Sprayer.
hand.
By hand .
Sprayer.
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
Min. Appl.
Rate (AI un-
less noted
otherwise)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Max. Appl. Soil
Rate (AI Tex.
unless noted Max.
otherwise) Dose
Use Group
UC *
UC *
UC *
UC *
Use Group
UC *
UC *
UC *
UC *
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
Max . tt Apps
© Max. Rate
/crop /year
cycle
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
NON -FOOD
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
CROP
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s)]
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page 5
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
CANEBERRIES
Dip treatment
Dip treatment
Dip treatment
hand.
Spray. , Bare
., Bare root., By hand.
., Cutting., By hand.
. , Nonbearing nurserystock . , By
root . , Sprayer.
Spray., Nonbearing nurserystock . , Sprayer.
CHERRY
Dip treatment
Dip treatment
Dip treatment
., Bare root., By hand.
., Cutting., By hand.
., Seedling stage., By hand.
Seed treatment., Preplant . , By hand.
Soil drench treatment., Postplant . , By hand.
Soil drench treatment., Postplant., Sprayer.
Spray. , Bare
Dip treatment
Dip treatment
Dip treatment
root . , Sprayer.
., Bare root., By hand.
., Cutting., By hand.
. , Nonbearing nurserystock . , By
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
.6614 Ib IK plant *
UC *
.6614 Ib IK plant *
.6614 Ib IK plant *
.6614 Ib IK plant *
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
UC *
Use Group
.6614 Ib IK plant *
UC *
UC *
UC *
.6614 Ib IK plant *
Max . tt Apps
© Max. Rate
/crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
NON -FOOD
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s)]
0.5
0.5
0.5
0.5
0.5
NS
NS
NS
NS
NS
NS
NS
0.5
NS
0.5
NS
0.5
hand.
Dip treatment., Seedling stage., By hand. F1C NA
Seed treatment., Preplant., By hand. F1C NA
F1C NA
UC
1.47 Ib cwt
UC
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page 6
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
CHERRY (con't)
Soil drench treatment., Postplant . , By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Spray., Nonbearing nurserystock . , Sprayer.
KIWI FRUIT
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant . , By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant., By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
UC *
UC *
.6614 Ib IK plant *
UC *
.6614 Ib IK plant *
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
UC *
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
UC *
Max . tt Apps
© Max. Rate
/crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
NON- FOOD
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s)]
CROP (con't)
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
NS
0.5
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NECTARINE
Dip treatment., Bare root., By hand. F1C NA
Use Group: GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page 7
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
NECTARINE (con't)
Dip treatment., Cutting., By hand.
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant . , By hand.
Soil drench treatment., Postplant . , By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Nonbearing nurserystock . , By
hand.
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant., By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Spray., Nonbearing nurserystock., Sprayer.
ORNAMENTAL AND/OR SHADE TREES
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
Use Group
.6614 Ib IK plant *
UC *
UC *
UC *
.6614 Ib IK plant *
UC *
1.47 Ib cwt *
UC *
UC *
UC *
.6614 Ib IK plant *
UC *
.6614 Ib IK plant *
Use Group
UC *
UC *
Max . tt Apps
© Max. Rate
/crop /year
cycle
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: GREENHOUSE
NS
NS
NS
NS
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
NON -FOOD
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s)]
CROP (con't)
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
NS
0.5
NS
0.5
NS
0.5
NS
NS
NS
0.5
NS
0.5
NS
NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL AND /OR SHADE TREES (con't)
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant . , By hand.
Soil drench treatment., Postplant . , By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Nonbearing nurserystock . , By
hand.
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant., By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Spray., Nonbearing nurserystock., Sprayer.
ORNAMENTAL WOODY SHRUBS AND VINES
Dip treatment., Bare root., By hand.
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
UC *
UC *
UC *
UC *
UC *
Use Group
3.307 Ib 5K *
plants
UC *
UC *
UC *
3.307 Ib 5K *
plants
UC *
1.102 Ib 75 Ib *
seed
UC *
UC *
UC *
3.307 Ib 5K *
plants
UC *
3.307 Ib 5K *
plants
Use Group
UC *
Max . tt Apps
© Max. Rate
/crop /year
cycle
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: GREENHOUSE
NS
NS
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
NON -FOOD
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s)]
CROP (con't)
NS
NS
NS
NS
NS
NON- FOOD+OUTDOOR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
RESIDENTIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
NS
0.5
NS
0.5
NS
0.5
NS
NS
NS
0.5
NS
0.5
NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page 9
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL WOODY SHRUBS AND VINES (con't)
Dip treatment., Cutting., By hand.
Dip treatment., Seedling stage., By hand.
Soil drench treatment., Postplant . , By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Nonbearing nurserystock . , By
hand.
Dip treatment., Seedling stage., By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Spray., Nonbearing nurserystock., Sprayer.
PEACH
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Seedling stage., By hand.
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
UC *
UC *
UC *
UC *
UC *
Use Group
3.307 Ib 5K *
plants
UC *
UC *
UC *
3.307 Ib 5K *
plants
UC *
UC *
UC *
3.307 Ib 5K *
plants
UC *
3.307 Ib 5K *
plants
Use Group
UC *
UC *
UC *
Max . tt Apps
© Max. Rate
/crop /year
cycle
: GREENHOUSE
NS NS
NS NS
NS NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: GREENHOUSE
NS
NS
NS
NS
NS
NS
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
NON -FOOD
NS
NS
NS
NS
NS
CROP (con't)
NS NS
NS NS
NS NS
NS
NS
NON- FOOD+OUTDOOR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s)]
NS
NS
NS
NS
NS
RESIDENTIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
NS
0.5
NS
0.5
NS
NS
NS
0.5
NS
0.5
NS
NS
NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page 10
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
PEACH (con't)
Seed treatment., Preplant . , By hand.
Soil drench treatment., Postplant . , By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Nonbearing nurserystock . , By
hand.
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant., By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Spray., Nonbearing nurserystock., Sprayer.
PEAR
Dip treatment., Bare root., By hand.
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant., By hand.
Soil drench treatment., Postplant., By hand.
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
UC *
UC *
UC *
UC *
Use Group
.6614 Ib IK plant *
UC *
UC *
UC *
.6614 Ib IK plant *
UC *
1.47 Ib cwt *
UC *
UC *
UC *
.6614 Ib IK plant *
UC *
.6614 Ib IK plant *
Use Group
UC *
UC *
UC *
UC *
Max . tt Apps
© Max. Rate
/crop /year
cycle
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
NON -FOOD
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s)]
CROP (con't)
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
NS
0.5
NS
0.5
NS
0.5
NS
NS
NS
0.5
NS
0.5
NS
NS
NS
NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page 11
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. © Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PEAR (con't)
Soil drench treatment., Postplant., Sprayer. F1C NA
Spray., Bare root., Sprayer. F1C NA
Dip treatment., Bare root., By hand. F1C NA
Dip treatment., Seedling stage., By hand. F1C NA
Seed treatment., Preplant., By hand. F1C NA
Soil drench treatment., Postplant., By hand. F1C NA
Soil drench treatment., Postplant., Sprayer. F1C NA
Spray., Bare root., Sprayer. F1C NA
PECAN
Dip treatment., Bare root., By hand. F1C NA
Soil drench treatment., Postplant., By hand. F1C NA
Soil drench treatment., Postplant., Sprayer. F1C NA
Spray., Bare root., Sprayer. F1C NA
Dip treatment., Bare root., By hand. F1C NA
Soil drench treatment., Postplant., By hand. F1C NA
Soil drench treatment., Postplant., Sprayer. F1C NA
Spray., Bare root., Sprayer. F1C NA
PLUM
Dip treatment., Bare root., By hand. F1C NA
Dip treatment., Cutting., By hand. F1C NA
Dip treatment., Seedling stage., By hand. F1C NA
Use Group: GREENHOUSE NON-FOOD CROP (con't)
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
Use Group: GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
Use Group: GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page 12
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
PLUM (con't)
Seed treatment., Preplant . , By hand.
Soil drench treatment., Postplant . , By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Nonbearing nurserystock . , By
hand.
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant., By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Spray., Nonbearing nurserystock., Sprayer.
PRUNE
Dip treatment., Bare root., By hand.
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant., By hand.
Soil drench treatment., Postplant., By hand.
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
UC *
UC *
UC *
UC *
Use Group
.6614 Ib IK plant *
UC *
UC *
UC *
.6614 Ib IK plant *
UC *
1.47 Ib cwt *
UC *
UC *
UC *
.6614 Ib IK plant *
UC *
.6614 Ib IK plant *
Use Group
UC *
UC *
UC *
UC *
Max . tt Apps
© Max. Rate
/crop /year
cycle
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
NON -FOOD
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s)]
CROP (con't)
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
NS
0.5
NS
0.5
NS
0.5
NS
NS
NS
0.5
NS
0.5
NS
NS
NS
NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page 13
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. © Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PRUNE (con't)
Soil drench treatment., Postplant . , Sprayer.
Spray., Bare root., Sprayer.
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Nonbearing nurserystock . , By
hand.
Dip treatment., Seedling stage., By hand.
Seed treatment., Preplant . , By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Spray., Nonbearing nurserystock., Sprayer.
RASPBERRY (BLACK, RED)
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Seedling stage., By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
UC *
UC *
Use Group
.6614 Ib IK plant *
UC *
UC *
.6614 Ib IK plant *
UC *
1.47 Ib cwt *
UC *
UC *
UC *
.6614 Ib IK plant *
UC *
.6614 Ib IK plant *
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
: GREENHOUSE
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
CROP (con't)
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
NS
0.5
0.5
NS
0.5
NS
NS
NS
0.5
NS
0.5
NS
NS
NS
NS
NS
NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page 14
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
RASPBERRY (BLACK, RED) (con't)
Dip treatment
Dip treatment
Dip treatment
., Bare root., By hand.
., Cutting., By hand.
., Seedling stage., By hand.
Soil drench treatment., Postplant . , By hand.
Soil drench treatment., Postplant., Sprayer.
Spray. , Bare
root . , Sprayer.
F1C
F1C
F1C
F1C
F1C
F1C
NA
NA
NA
NA
NA
NA
WALNUT (ENGLISH/BLACK)
Dip treatment
Dip treatment
Dip treatment
., Bare root., By hand.
., Cutting., By hand.
., Seedling stage., By hand.
Seed treatment., Preplant . , By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray. , Bare
Dip treatment
Dip treatment
Dip treatment
root . , Sprayer.
., Bare root., By hand.
., Cutting., By hand.
. , Nonbearing nurserystock . , By
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
UC *
Use Group
.6614 Ib IK plant *
UC *
UC *
UC *
.6614 Ib IK plant *
Max . tt Apps
© Max. Rate
/crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: GREENHOUSE
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
NON -FOOD
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s)]
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
NS
0.5
NS
0.5
hand.
Dip treatment., Seedling stage., By hand. F1C NA
Seed treatment., Preplant., By hand. F1C NA
F1C NA
UC
1.47 Ib cwt
UC
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page 15
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
WALNUT (ENGLISH/BLACK) (con't)
Soil drench treatment., Postplant . , By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Spray., Nonbearing nurserystock . , Sprayer.
YOUNGBERRY
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Seedling stage., By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
Dip treatment., Bare root., By hand.
Dip treatment., Cutting., By hand.
Dip treatment., Seedling stage., By hand.
Soil drench treatment., Postplant., By hand.
Soil drench treatment., Postplant., Sprayer.
Spray., Bare root., Sprayer.
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
F1C
Min. Appl.
Rate (AI un-
less noted
otherwise)
NA
NA
NA .6614
NA
NA .6614
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Max. Appl. Soil Max. tt Apps
Rate (AI Tex. © Max. Rate
unless noted Max. /crop /year
otherwise) Dose cycle
Use Group: TERRESTRIAL
UC * NS NS
UC * NS NS
Ib IK plant * NS NS
UC * NS NS
Ib IK plant * NS NS
Use Group: GREENHOUSE
UC * NS NS
UC * NS NS
UC * NS NS
UC * NS NS
UC * NS NS
UC * NS NS
Use Group: TERRESTRIAL
UC * NS NS
UC * NS NS
UC * NS NS
UC * NS NS
UC * NS NS
UC * NS NS
Max. Dose [ (AI
unless noted
otherwise) /A]
/crop /year
cycle
NON- FOOD CROP
NS NS
NS NS
NS NS
NS NS
NS NS
NON-FOOD CROP
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NON- FOOD CROP
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
Min.
Interv
(days)
(don't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s)]
NS
NS
0.5
NS
0.5
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
-------
Report Run Date: 05/15/95
PRD Report Date: 02/14/95
Time 08:01
APPENDIX A
CASE 4101, [Agrobacterium radiobacter] Chemical 114201 (Agrobacterium radiobacter)
Page 16
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.
Soil Tex. Max. Dose
Max. # Apps ® Max. Rate
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days)
Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
PRD Report Date
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
F1C : FLOWABLE CONCENTRATE
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
DCNC
No Calc
W
V
U
cwt
nnE-xx
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
nn times (10 power -xx); for instance, "1.234E-04"
is equivalent to ".0001234"
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
35
-------
36
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case 4101 covered by this Reregistration Eligibility Decision Document.
It contains generic data requirements that apply to 4101 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
0 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.
37
-------
38
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Agrobacterium radiobacter
REQUIREMENT
USE PATTERN CITATION(S)
PRODUCT CHEMISTRY:
151A-10
151A-11
151A-12
151A-15
151A-16
(a)
(b)
(c)
(d)
(e)
(0
(g)
Chemical Identity
Start. Mat. & Mnfg. Process
Discussion of Formation of
Unintention Ingredients
Certification of limits
PHYSICAL AND CHEMICAL
PROPERTIES:
Color
Physical State
Odor
Density
pH
Stability
Storage Stability
CI
CI
CI
CI
CI
CI
CI
CI
CI
CI
CI
41653301
41653302
41653302
41653303
41653303
41653303
41653303
41653303
41653303
41653303
41653303
TOXICITYTIERI:
152A-10
152A-11
152A-12
152A-13
Acute Oral Tox/Path
Acute Dermal Toxicity
Acute Pulmonary/Tox/Path
Acute Intravenous Tox/Path
CI
CI
CI
CI
00060517, 00060518, 00060519, 41653304
41653305
00064089, 41653304, 41653305
WAIVED
WAIVED
39
-------
Data Supporting Guideline Requirements for the Reregistration of Agrobacterium radiobacter
REQUIREMENT USE PATTERN CITATION(S)
152A-14 Primary Eye Irritation CI
152A-15 Hypersensitivity Incidents CI
ECOLOGICAL EFFECTS (Tier I):
All Ecological Effects data requirements have been waived.
OCCUPATIONAL EXPOSURE:
All Occupational Exposure data requirements have been waived.
ENVIRONMENTAL FATE:
All Environmental Fate data requirements have been waived.
00060517, 00060518, 00060519, 41653304,
41653305
00060517, 00060518, 00060519, 41653304,
41653305
40
-------
APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of 4101
41
-------
42
-------
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 Reregistration 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
43
-------
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.
44
-------
BIBLIOGRAPHY
MRID
CITATION
00060517 Nortell Laboratories (1977?) Introduction: Crown Gall Disease. (Unpublished
study received Jan 24, 1978 under 38087-EX-l; CDL:232741-B)
00060518 Nortell Laboratories (1977?) Toxicology Studies for Agrobacterium
radiobacter, Isolate 84, Used for Biological Control of Crown Gall.
(Unpublished study received Jan 24, 1978 under 38087-EX-l; CDL:232741-C)
00060519 Patton, N.M. (1976) Letter sent to Nortell Laboratories, Inc. dated Mar 25,
1976: Determination of LD50 in mice for Norbac 84C (Agrobacterium
radiobacter) a plant bacteria. (Unpublished study received Jan 24, 1978 under
38087-EX-l; prepared by Oregon State Univ., Laboratory Animal Resource
Center, submitted by Nortell Laboratories, Corvallis, Oreg.; CDL:232741-D)
00064089 Baltezore, M. (1978) Product Culture and Skin and Eye Irritation: Laboratory
Nos. 9861, 10056. (Technical report; unpublished study received Jun 8, 1978
under 40230-1; prepared by Unilab Research, submitted by Agbiochem, Inc.,
Orinda, Calif.; CDL: 234064-A)
41653301 Moore, L. (1990) Agrobacterium radiobacter Strain K84: Product Identity: Lab
Project Number: L.W.M.-l. Unpublished study prepared by Oregon State
University. 209 p.
41653302 Moore, L. (1990) Agrobacterium radiobacter Strain KM: Manufacturing
Process; Discussion of Formation of Unintentional Ingredient; Analysis of
Samples: Lab Project Number: L.M.W.-2. Unpublished study prepared by
New BioProducts Laboratory, Inc. 48 p.
41653303 Moore, L. (1990) Norbac 84C (A. radiobacter strain K84): Physical and
Chemical Properties: Lab Project Number: L.W.M.-3. Unpublished study
prepared by New BioProducts Laboratory, Inc. 3 p.
41653304 Moore, L. (1990) Agrobacterium radiobacter Strain K84: Tier 1 Toxicology:
Lab Project Number: L.W.M.-4. Unpublished study prepared by Oregon State
University. 14 p.
41653305 Moore, L. (1990) Agrobacterium radiobacter Strain K84: Tier 1 Tox,
Nontarget Organisms: Lab Project Number: L.W.M.-5. Unpublished study
45
-------
BIBLIOGRAPHY
MRID CITATION
prepared by Oregon State University. 74 p.
46
-------
APPENDIX D. List of Available Related Documents
47
-------
48
-------
The following is a list of available documents related to 4101. It's purpose is to
provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for 4101 and are included in the EPA's Office of
Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. 4101 RED Fact Sheet
49
-------
50
-------
APPENDIX E. FACT SHEET
51
-------
52
-------
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7504C)
EPA-738-F-95-020
June 1995
R.E.D. FACTS
Pesticide
Registration
Agrobacterium
radiobacter
All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered years ago be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregi strati on, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency imposes any
regulatory controls that are needed to effectively manage each pesticide's
risks. EPA then reregisters pesticides that can be used without posing
unreasonable risks to human health or the environment.
When a pesticide is eligible for reregi strati on, EPA announces this and
explains why in a Reregi strati on Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for reregi strati on
case 4101, Agrobacterium radiobacter., also referred to as A radiobacter.
Use Profile Agrobacterium radiobacter is a fungicide (microbial control agent) used to
control Crown Gall in certain non-bearing fruit, nut and ornamental nursery
stock.
Non-bearing Fruit and Nut Nursery Stock:
Almonds
Blueberries
Cherries
Peaches
Plums
Apples
Caneberries*
Kiwis
Pears
Prunes
Apricots
Cranberries
Nectarines
Pecans
Walnuts
Caneberries include Blackberries, Boysenberries, Raspberries, and Youngberries.
-------
Ornamental Nursery Stock:
Euonymus Rose
Weeping Cherry
Formulations include a 2.25% flowable concentrate product and a 1.2 %
solidified agar product.
Agrobacterium radiobacter is applied by hand operated spray, drench and dip
treatment equipment.
Method and Rate -
Dipping
Germinating Seed Application - 1 unit of product**/gallon of water.
Seedling Application - 1 unit of products/gallon of water.
Cutting Application - 1 unit of product**/gallon of water.
Root and Stem Application - 1 unit of product**/gallon of water.
Spraying
Root and Stem Application - 1 unit of product**/gallon of water.
Soil Drench Application - 1 unit of product**/ 5 gallons of water; 6-8 oz of
suspension per 1 gallon container or 1 foot of plant row.
**1 unit of product equals 3 x 1012 and 1.2 x 1011 colony forming units per volume
of product for the flowable concentrate and solidified agar formulations, respectively.
Timing - Preplant — cutting, root and stem treatments; Immediately Prior to
Planting — germinating seed and seedling treatments; Postplant — soil drench
treatment.
Amount- Less than 1,000 pounds of this active ingredient (a.i.) are used
annually.
Use practice limitations: Label limits use only to applications on certain non-
food and non-bearing plants.
Regulatory
Agrobacterium radiobacter was first registered as a pesticide in the U.S.
l_lj A in 1979. During Phase 3 of the Reregi strati on Process, the toxicology data
base for A. radiobacter was evaluated and determined to adequately satisfy
most of the data requirements for microbial pest control agents. Acute
pulmonary toxicity/pathogenicity studies, and acute intravenous
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toxicity/pathogenicity studies were identified as outstanding data gaps and a
Data Call-In was issued July 1993. Since the DCI, the Agency's initial
position with respect to these guidelines was re-evaluated, and these data
requirements were waived because it was determined that A. radiobacter was
a soil saprophyte and was not known to be pathogenic to humans and animals.
Currently, two A radiobacter products are registered: Galltrol-A and
Norbac 84-C.
Human Health
Assessment
Toxicity
In studies using laboratory animals, A. radiobacter generally has been
shown to be of very low acute toxicity. It's primary eye irritation/infection
toxicity places it in Toxicity Category III (the second lowest of four
categories). Agrobacterium radiobacter's oral toxicity is LD50 > 5g/Kg,
which places it in Toxicity Category IV (the lowest of four categories).
Likewise, A. radiobacter's acute dermal toxicity is in Toxicity Category IV.
Dietary Exposure
Although A. radiobacter is applied to certain fruit and nut crops, the
Agency considers these applications to be non-food uses because they are
made only to non-bearing nursery stock. Thus, neither a tolerance nor an
exemption from a tolerance is required. Additionally, the Agency has
concluded that dietary exposure from consuming commodities which were
treated with A. radiobacter as nursery stock not expected.
Occupational and Residential Exposure
Based on the application methods (dipping of plants by hand and
spraying with a hand-held sprayer) listed on the product label, the potential
for eye, dermal and inhalation exposure to handlers and post application
nursery workers exists. Because of a lack of human toxicity concern, worker
exposure data are not required. Moreover, it is the Agency's opinion that these
occupational exposures and subsequent risks are negligible because: (1) the
proposed precautionary product labeling stipulated in the RED for A.
radiobacter will adequately mitigate the risks to applicators and related
nursery workers; and (2) the organism has been determined not to be
pathogenic to humans and animals.
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Human Risk Assessment
Since exposures and subsequent risks from A. radiobacter applications
are not expected, any potential risks from exposure to treated plants will be
mitigated by the use of PPE required by the WPS, supplemented by specific
precautionary labeling required by this RED. Post-application reentry
workers will be required to observe a 12-hour Restricted Entry Interval.
Because of A. radiobacter's ubiquitous nature and low toxicity, it is a
candidate for a reduced reentry interval: from 12 hours to 4 hours.
Environmental
Assessment
Additional Data
Required
Product Labeling
Changes Required
No environmental or ecological toxicity data requirements are being
required for A radiobacter in this RED, because mitigating factors support
the conclusion that exposure to non-target terrestrial and aquatic organisms is
extremely minimal. The major mitigating factor is that the registered use of
A. radiobacter being supported for reregi strati on is the treatment of certain
nursery stock in a contained environment (indoor use). Thus, little or no
exposure to the environment results from use according to label directions.
Because there is little or no exposure, the risk to non-target terrestrial and
aquatic organisms is expected to be minimal.
EPA is requiring the following information for reregi strati on A.
radiobacter: revised Confidential Statements of Formula (CSFs), and revised
product labeling.
In the evaluation of the toxicology data base for A. radiobacter, an
acute toxicity study — primary eye irritation was re-evaluated. It was
determined that the eye irritation potential is more appropriately reclassified ,
Toxicity Category III. This reduction in potential hazard prompts revision of
the precautionary labeling statements ( Signal Word — Caution vs Warning
and Statement of Practical Treatment) for end-use products. For a
comprehensive list of labeling requirements, please see the A radiobacter
RED document.
Regulatory
Conclusion
The use of currently registered products containing A radiobacter in
accordance with approved labeling will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, all uses of these products
are eligible for reregi strati on.
Agrobacterium radiobacter products will be reregistered once the
revised Confidential Statements of Formula and revised labeling are received
and accepted by EPA.
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For More
Information
EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for A radiobacter during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregi strati on Information System at
703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using WWW
(World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone 513-
489-8190, fax 513-489-8695.
Following the comment period, the A radiobacter RED document also
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregi strati on program, the
A. radiobacter RED, or reregi strati on of individual products containing A
radiobacter, please contact the Biopesticides and Pollution Prevention
Division (7504C), OPP, US EPA, Washington, DC 20460, telephone 703-
308-8712.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-free
1-800-858-7378, between 8:00 am and 8:00 pm Eastern Standard Time,
Monday through Friday.
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