United States Prevention, Pesticides EPA 738-R-96-020
Environmental Protection And Toxic Substances September 1996
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Polyhedral Inclusion Bodies of GYPSY MOTH
(Lymantria dispar)
and
DOUGLAS FIR TUSSOCK MOTH
(Orgyia pseudotsugata)
NUCLEAR POLYHEDROSIS VIRUSES
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical case 4106 which
includes the active ingredients polyhedral inclusion bodies of gypsy moth (Lymantria dispar)
and Douglas fir tussock moth (Orgyiapseudotsugata). The enclosed Reregistration Eligibility
Decision (RED) contains the Agency's evaluation of the data base of these chemicals, its
conclusions of the potential human health and environmental risks of the current product uses,
and its decisions and conditions under which these uses and products will be eligible for
reregi strati on. The RED includes the data and labeling requirements for products for
reregi strati on. No additional data (generic) on the active ingredients are needed to confirm the
risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED." This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses The first set of required responses is due 90 days from the
receipt of this letter. The second set of required responses is due 8 months from the date of
this letter. Complete and timely responses will avoid the Agency taking the enforcement action
of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Biopesticide and Pollution Prevention Division representative, Glenn
Williams, at (703) 308-8287.
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 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and product
specific data are required, a combined Generic and Product Specific DCI letter will be enclosed
describing such data. However, if you are an end-use product registrant only and have been
granted a generic data exemption (GDE) by EPA, you are being sent only the product specific
response forms (2 forms) with the RED. Registrants responsible for generic data are being sent
response forms for both generic and product specific data requirements (4 forms). You must
submit the appropriate response forms (following the instructions provided) within 90
days of the receipt of this RED/DCI letter; otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data should
be submitted in the 90-day response. Requests for data waivers must be submitted as part of the
90-day response. All data waiver and time extension requests must be accompanied by a full
justification. All waivers and time extensions must be granted by EPA in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregi strati on) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregi strati on. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S., Second Edition, August 1992" (available from the National
Technical Information Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers. Before citing these studies, you must make sure that they meet the
Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
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You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
§158.175) or (2) provide certified limits that are supported by the analysis of five batches. If
you choose the second option, you must submit or cite the data for the five batches along with a
certification statement as described in 40 CFR §158.175(e). A copy of the CSF is enclosed;
follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
Bv U.S. Mail:
Document Processing Desk (RED-BPPD)
Office of Pesticide Programs (7501W)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-BPPD)
Office of Pesticide Programs (7501W)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data waiver
and time extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregi strati on determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
Polyhedral Inclusion Bodies of GYPSY MOTIUfymantria dispar)
and
DOUGLAS FIR TUSSOCK MOTKQrgyiapseudotsugata)
NUCLEAR POLYHEDROSIS VIRUSES
LISTD
CASE 4106
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
POLYHEDRAL INCLUSION BODIES OF GYPSY MOTH (LYMANTRIA DISPAK)
AND DOUGLAS FIR TUSSOCK MOTH (ORGYIA PSEUDOTSUGATA)
NUCLEAR POLYHEDROSIS VIRUSES
REREGISTRATION ELIGIBILITY DECISION TEAM I
EXECUTIVE SUMMARY V
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 3
C. Estimated Usage of Pesticide 4
D. Data Requirements 5
E. Regulatory History 5
F. Food Quality Protection Act 9
III. SCIENCE ASSESSMENT 9
A. Physical Chemistry Assessment 10
B. Human Health Assessment 11
C. Environmental Assessment 18
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 24
A. Determination of Eligibility 24
B. Determination of Eligibility Decision 25
1. Eligibility Decision 25
2. Eligible and Ineligible Uses 25
C. Regulatory Position 26
1. Food Quality Protection Act 26
2. Tolerance Reassessment 26
3. Endangered Species Statement 26
4. Labeling Rationale 27
5. Spray Drift Advisory 27
V. ACTIONS REQUIRED OF REGISTRANTS 28
A. Manufacturing-Use Products 28
1. Additional Generic Data Requirements 28
2. Labeling Requirements for Manufacturing-Use Products 28
B. End-Use Products 29
1. Additional Product-Specific Data Requirements 29
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2. Labeling Requirements for End-Use Products 30
C. Tolerance Revocation and Import Tolerances 31
D. Existing Stocks 31
VI. APPENDICES 33
APPENDIX A. Table of Use Patterns Subject to Reregistration 35
APPENDIX B. Table of the Generic Data Requirements andStudies Used to
Make the Reregistration Decision 40
APPENDIX C. Citations Considered to be Part of the Data Base Supportig
the Reregistration of 4106 44
APPENDIX D. Product Specific Data Call-In 55
Attachment 1. Chemical Status Sheets 68
Attachment 2. Product Specific Data Call-In Response Forms (Fom
A inserts) Plus Instructions 69
Attachment 3. Product Specific Requirement Status and Registrant
Response Forms (Form B inserts) and Instructions 71
Attachment 4. EPA Batching of End-Use Products for Meeting Da*
Requirements for Reregistration 77
Attachment 5. List of All Registrants Sent This Data Call-In (inserjt
Notice 78
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 79
APPENDIX E. List of Available Related Documents 87
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POLYHEDRAL INCLUSION BODIES OF GYPSY MOTHI(YMANTRIA DISPAR)
AND DOUGLAS FIR TUSSOCK MOTH QRGYIA PSEUDOTSUGATA )
NUCLEAR POLYHEDROSIS VIRUSES
REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Ghulam All Economic Analysis Branch
William Gross, Jr. Biological Analysis Branch
Gabe Patrick Biological Analysis Branch
Biopesticides and Pollution Prevention Division
Julie Fry Microbial Pesticides Branch
John Kough Microbial Pesticides Branch
Glenn Williams Pollution Prevention Staff
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The D WEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO/WHO Food and Agriculture Organization/World Health Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It i s
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Hg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No effect concentration
III
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GLOSSARY OF TERMS AND ABBREVIATIONS
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
RUP Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
ug/L Micrograms per liter
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The U. S. Environmental Protection Agency has completed its reregi strati on eligibility
decision (RED) for the biopesticide active ingredients (ais) Polyhedral Inclusion Bodies of
Lymantria dispar and Orgyiapseudotsugata Nuclear Polyhedrosis Viruses (PIBs of LdNPV and
OpNPV) for the products Gypchek ta, Lymantrin tm, and TM Biocontrol-1 *•. PIBs of LdNPV and
OpNPV are viral insecticides used as aerial sprays on forest trees to manage gypsy moth and
Douglas fir tussock moth, respectively.
These naturally occurring insect viruses belong to the family Baculoviridae, genus
Baculovirus, subgenus A, and infect host insects, gypsy moth and Douglas fir tussock moth.
Within the nuclei of the infected cells of the hosts, the viruses are occluded within polyhedrally
shaped lattices of protein; i.e, polyhedral protein bodies that include virus particles within cell
nuclei. Hence, the terminology is derived: nuclear polyhedral viruses (NPV) and polyhedral
inclusion bodies (PIBs).
Although these two strains of NPVs are distinguishable by restriction endonuclease
profiles, fragment profiles, and natural insect host range, biochemical characteristics and
taxonomy indicate that both NPVs are closely related. For the purpose of assessing mammalian
and ecological toxicity for reregi strati on of the ais, the PIBs of LdNPV and OpNPV may be
considered the same. Study data on one strain are equally applicable for assessing the other
strain. Consequently, the Agency determined that it would be appropriate in its assessment to
bridge the test data between the two strains in determining the eligibility of the ais for
reregi strati on.
This reregi strati on eligibility decision (RED) document includes a comprehensive
reassessment of the required data and use patterns of the currently registered ais.
The Agency has concluded that all uses, as prescribed in this document, will not cause
unreasonable risks to humans or the environment and, therefore, all appropriately labelled
products are eligible for reregi strati on. The results of eye irritation testing indicate that a
Toxicity Category I classification on the label is appropriate as defined in 40CFR156.10. The
results of the other acute tests show no results that would cause undue concern for these ais.
Acute toxic effects will be addressed by appropriate labeling. The Agency does not have
subchronic or chronic concerns for the ais under the intended uses. Revised Precautionary,
Personal Protective Equipment, Practical Treatment, and Note to Physician Label statements may
be required depending on justifications and/or studies submitted and reviewed in the
Reregi strati on Phase 5 review of pesticide products containing the ais.
At this time, submission of additional generic data are not being required to confirm the
Agency's risk assessment and conclusions for the ais. The Agency does not expect any risk to
humans or the environment from use of these biopesticides; therefore all uses are eligible for
reregi strati on. The bases of this decision are:
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o evaluation of the submitted data and published scientific literature for the RED indicate
the bridged data base is complete and acceptable for all data requirements;
o the fact that PIBs of OpNPV and LdNPV are naturally-occurring pathogens of gypsy
moth and Douglas fir tussock moth and are selective for Lymantriids with no known
adverse effects to any species other than the hosts, gypsy moth and Douglas fir tussock
moth; and
o the fact that in approximately 20 years of use, there have been no reports of adverse
human health and ecological effects, with the exception of possible dermal sensitivity and
eye irritation in exposed humans during manufacture.
Before reregistering the products containing the ais PIBs of LdNPV and OpNPV, the
Agency is requiring that product specific data, revised Confidential Statements of Formula (CSF)
and revised labeling be submitted within eight months of the issuance of this document. These
data include product chemistry for each registrationand acute toxicity testing. 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 other ais will be
eligible for reregistration only when the other ais are determined to be eligible for reregi strati on.
VI
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregi strati on of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregi strati on process to be completed in
nine years. There are five phases to the 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.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-
170) was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went into effect immediately. Among
other things, FQPA amended the FFDCA by establishing a new safety standard for the
establishment of tolerances, but FQPA does not obligate the Agency to consider the factors set
forth in the new section 408 of the FFDCA when making decisions under FIFRA with respect
to pesticides that do not have any food uses. However, the FQPA did not amend any of the
existing reregistration deadlines in section 4 of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of polyhedral inclusion bodies (PIBs) of Lymantria dispar and Orgyia
pseudotsugata nuclear polyhedrosis viruses (NPVs). The document consists of six sections.
Section I is the introduction. Section II describes PIBs of Lymantria dispar and Orgyia
pseudotsugata NPVs, their uses, data requirements and regulatory histories. Section III discusses
the human health and environmental assessment based on the data available to the Agency.
Section IV presents the reregistration decision. Section V discusses the reregistration
requirements. 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 ingredients are covered by this Reregi strati on Eligibility
Decision:
Common Name:
1) Polyhedral inclusion bodies ofLymantria dispar
nuclear polyhedrosis virus (PIBs of LdNPV)
2) Polyhedral inclusion bodies of Orgyia
pseudotsugata nuclear polyhedrosis virus (PIBs of
OpNPV)
Biological Name:
1) Polyhedral inclusion bodies ofLymantria dispar
nuclear polyhedrosis virus
2) Polyhedral inclusion bodies of Orgyia
pseudotsugata nuclear polyhedrosis virus
Biological Family:
Baculoviridae
CAS Registry Number: Not applicable
OPP Chemical Code:
1)107303
2)107302
Empirical Formula:
Not applicable
Trade and Other Names:
1) PIBs of LdNPV:
Gypchek Biological Insecticide for the
Gypsy Moth; and
Lymantrin Insecticide.
2) PIBs of OpNPV:
TMBiocontrol-1.
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Basic Manufacturer:
!)PIBsofLdNPV:
USDA Forest Service/Animal and Plant
Health and Inspection Service (APHIS);
American Cyanamid Company; and
NPP Inc.
2)PIBsofOpNPV:
USDA Forest Service.
B.
Use Profile
The following is information on the currently registered uses with an overview of
use sites and application methods. A detailed table of these uses of Polyhedral inclusion
bodies of Lymantria dispar and Orgyiapseudotsugata Nuclear Polyhedrosis Viruses
(NPVs) are in Appendix A.
For polyhedral inclusion bodies of Lymantria dispar and Orgyia pseudotsugata
Nuclear Polvhedrosis Viruses (PIBs of LdNPV and QpNPVV
Type of Pesticide:
Mode of Action:
Use Sites:
Target Pests:
Microbiological pest control agent (viral insecticide)
When PIBs of LdNPV and OpNPV are ingested by
larvae of the hosts, chemical action in the gut
releases viral rods from PIBs causing host-specific
general viral infection and death of larvae.
1) PIBs of LdNPV:
Forestry: Forest trees, including oak, hickory,
basswood, birch, cherry, elm, blackgum, larch,
sassafras, hemlock, cedar, spruce, black walnut,
American chestnut, willow, poplar, ash boxelder,
hawthorn, butternut, catalpa, American holly, locust,
and sycamore.
2) PIBs of OpNPV:
Forestry: Forest trees, including Douglas fir, true
fir, willow, and cedar.
1) PIBs of LdNPV: Gypsy Moth
2) PIBs of OpNPV: Douglas Fir Tussock Moth
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Formulation Types Registered: PIBs of LdNPV and OpNPV: End Use Product
1) PIBs of LdNPV:
o Wettable powder
o Soluble concentrate
o Flowable concentrate
2) PIBs of OpNPV
o Wettable powder
Method and Rates of Application:
Types of Treatment- PIBS of LdNPV and OpNPV: Low volume spray
(concentrate); Spray
Equipment -
PIBs of LdNPV and OpNPV: Aircraft with boom
and nozzle systems designed to result in droplets
150-400mmd.
Method and Rate - 1) PIBs of LdNPV:
One application of at least 400 billion gypsy moth
polyhedral inclusion bodies or two or more
applications two to four days apart at the rate of 200
to 500 billion gypsy moth polyhedral inclusions
bodies /per 1 gal finished spray per acre or
Two applications seven to ten days apart of 25 to
125 million gypsy moth potential units (MGMPU)
per 1 gal finished spray per acre
2) PIBs of OpNPV:
0.3 Ig product per 1-2 gals finished spray per acre or
.93 billion Activity Units (AU) per 1-2 gals finished
spray per acre.
C.
Timing - Spring foliar
Estimated Usage of Pesticide:
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This section summarizes the best estimates available for the pesticide uses of
polyhedral inclusion bodies Lymantria dispar and Orygia pseudotsugata Nuclear
Polyhedral Viruses (NPVs). 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.
For PIBs of LdNPV, federal and state cooperative applications to control gypsy
moth, USD A Forest Service/Forest Pest Management estimates a total of 3000 acres
treated in 1995 and an average annual total treatment from 1990 to the present of @ 3000
acres. (Rappaport, FS, 1996: Private communication based on: "Forest Health
Technology Enterprise Team Update"). For federal applications, the U.S. Forest Service
estimates @500 acres (less than 1% of forest acreage) were treated with 247 trillion
polyhedral inclusion bodies (PIBs) applied/acre in 1994. (Thomas, 1995)
For PIBs of OpNPV, for federal applications, the U.S. Forest Service estimates
@500 acres (less than 1% of forest acreage) are treated with 247 trillion polyhedral
inclusion bodies (PIBs) applied/acre in 1994. (Thomas, 1995).
D. Data Requirements
In Phase 4 of the Reregi strati on Process data gaps for polyhedral inclusion
bodies of Orgyiapseudotsugata and Lymantria dispar Nuclear Polyhedrosis Viruses
(NPVs) were identified and Data Call-Ins (DCIs) were issued on September 1993 for
studies on ecological effects. These test data were required to assure that the data base
for reassessing the potential for unreasonable risks to human health and the environment
is complete and supports the uses of the active ingredients. Appendix B includes all data
requirements identified and reviewed by the Agency in determining eligibility for
reregi strati on.
E. Regulatory History
1 Polyhedral inclusion bodies of Orgyia pseudotsugata Nuclear
Polyhedrosis Viruses (PIBs of OpNPV)
On August 11, 1976, the EPA approved the U.S. Forest Services' (USFS)
application for registration of PIBs of OpNPV as a viral insecticide for controlling
the Douglas fir tussock moth. The PIBs of OpNPV are the ai of the product TM
Biocontrol-1 tm, EPA Registration Number 27586-1, used for aerial applications
on forest lands.
During Phase 4 of the Reregistration Process, the data base for OpNPV was
evaluated and determined to be inadequate in satisfying certain data requirements
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for the ai. The following studies for assessing microbial pest control agents
(MPCAs) were identified as data gaps, and a DCI was issued:
154A-16a Avian oral tox/path~quail
154A-16b Avian oral tox/path~duck
154A-19a Freshwater fish tox/path—trout
154A-20 Freshwater invertebrate tox/path~benthic
154A-22 Nontarget plant studies
154A-23 Nontarget insect tox/path
154A-24 Honey bee tox/path
Based on the 90-day response to the DCI and additional publicly available
literature provided by the USFS, the Agency determined the following: 1) the data
requirements had been acceptably met for 154A-23 Nontarget insect tox/path and
154A-24 Honey bee tox/path, and 2) data requirements should be waived for
154A-16a Avian oral path/tox—quail, 154A-16b Avian oral path/tox~duck, 154A-
19a Freshwater fish tox/path—trout, 154A-20 Freshwater invertebrate tox/path—
benthic. (See Section III.C.I) The only remaining outstanding data requirement
was for 154A-22 Nontarget plant studies for which a waiver was pending after the
DCI response. During the analysis and development of the reregi strati on
eligibility decision (RED), wherein the databases for OpNPV and LdNPV were
combined, the data requirement of non-target plant studies was reexamined and
waived because of the absence of toxicity in the "bridged" data set. OpNPV
appears to not cause adverse effects on avian, mammalian, aquatic, insect and
plant wildlife.
On November 29, 1988, the USFS submitted studies to California
Department of Food and Agriculture (CDFA) (information-only copies to EPA)
supporting a request for registration of PIBs of OpNPV in California, where the
product's registration had lapsed. The studies submitted were:
152A-10 Acute Oral tox/path-rat
152A-11 Primary Dermal Irritation study—rabbit
152-33 Intraperitoneal study—mouse
Additional mammalian toxicity studies for 152A-10 Acute Oral tox/path,
152-32 Acute Pulmonary (inhalation) tox/path and 152-39 Tissue culture were
submitted to CDF A in July 1991. All submitted studies were determined
unacceptable. In addition, study data indicated a Toxicity Category I for Eye
Irritation. USFS has not yet addressed these issues with the state; PIBs of OpNPV
has not been reregistered in California.
On April 18, 1996, the USFS submitted a label amendment for "Use
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Practice Limitation," substituting the language "For use in only wide-area
government sponsored pest control programs" for the original language on the
label "For use by or under the supervision of U.S. Forest Service." On May 7,
1996, the amendment was accepted by EPA.
2. Polyhedral inclusion bodes ofLymantria dispar Nuclear Polyhedrosis
Viruses (PIBs of LdNPV)
The U.S. Forest Service (USFS) developed PIBs of LdNPV, "Hamden
strain," as a viral insecticide under EPA Experimental Use Permit (EUP) number
27856-EUP-8, and applied for registration December 22, 1976, while continuing
research and testing in response to EPA's Data Requirements. EPA approved the
USFS's application for registration of PIBs of LdNPV on April 11, 1978. The
PIBs of LdNPV are the ai of the product Gypchek", EPA Registration Number
27586-2, used for aerial applications on forest lands to control gypsy moth.
During Phase 4 of the Reregistration Process, the data base for LdNPV was
evaluated and determined to be inadequate in satisfying certain test data
requirements for the ai. The following studies for MFC As were identified as data
gaps, and a DCI was issued:
154A-19a Freshwater fish tox/path—trout
154A-20 Freshwater invertebrate tox/path~benthic
154A-22 Nontarget plant studies
154A-23 Nontarget insect tox/path
154A-24 Honey bee tox/path
Based on the 90-day response to the DCI and publicly available literature,
the Agency determined that the data requirements for 154A-19a Freshwater fish
tox/path—trout, 154A-20 Freshwater invertebrate tox/path—benthic, 154A-22
Nontarget plant studies, 154A-23 Nontarget insect tox/path, and 154A-24 Honey
bee tox/path may be waived. (See Section III.C.I.) During the analysis and
development of the reregistration eligibility decision (RED), wherein the databases
for OpNPV and LdNPV were combined, these data requirements were reexamined
and waived because of the absence of toxicity in the "bridged" data set. LdNPV
appears to not cause adverse effects on avian, mammalian, aquatic, insect and
plant wildlife.
On January 8, 1990, the U.S. Department of Agriculture (USDA),
Agricultural Research Service (ARS), initiated correspondence with EPA
concerning the development of a more virulent strain "Abington strain "of LdNPV
for use as an insecticide against gypsy moth. ARS intended to use a trivalent
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pesticide containing three of the most virulent Abington isolates, which would
replace the Hamden strain of PIBs of LdNPV. During March through June 1990,
correspondence between EPA and ARS established Product Identity Data
Requirements for demonstrating similarities between the Abington and Hamden
strains that would support utilization of data already submitted for current
registration of Hamden strain for an EUP, FIFRA Section 3 registration, or FIFRA
Section 3 amendment applications for the Abington strain. As of the date of this
RED, neither ARS nor USFS has submitted the Product Identity studies for the
Abington strain or an EUP, registration, or amendment application. Therefore,
this reregi strati on eligibility decision is only for NPV inclusion bodies from L.
dispar, Hamden strain.
On September 25, 1990, NPP, Inc. submitted Application for Pesticide
Registration for a "Me Too" registration of the ai of PIBs of LdNPV (Hamden
strain), identical to the USFS registered product, EPA Reg. No. 27586-2. USFS
authorized the complete use of all the necessary data base originally submitted by
the USFS. The product, Lymantrin Insecticide tm, was registered October 30,
1991, EPA Registration No. 62343-1. On January 10, 1994, NPP Inc. submitted
a label Amendment to comply with PR Notice 93-7 (Worker Protection
Standards), which was approved by EPA on March 22, 1994.
On March 27, 1992, American Cyanamid Company submitted Application
for Pesticide Registration for a "Me Too" registration of the ai of PIBS of LdNPV
(Hamden strain) identical to the USFS registered product, EPA Reg. No. 27586-2.
USFS authorized the complete use of all the necessary data base originally
submitted by the USFS. The product, Gypchek tm, was registered June 5, 1992,
EPA Registration No. 241-347.
On May 4, 1993, USFS submitted Application for Pesticide and
Confidential Statement of Formula for amending its registration for Gypchek tm to
include an alternative production facility, the Forest Pest Management Institute
(FPMI) in Saulte Sainte Marie, Ontario, Canada—EPA Establishment Number
#66989-CN-001. However, as of the date of this RED, this facility has not been
used to manufacture Gypchektm for the USFS.
On April 26, 1996, the USFS submitted a label amendment for changing
"Use Practice Limitation," interval between treatments, and dosage. The amended
label substitutes the language "For use in only wide-area government sponsored
pest control programs" for the original language on the label "For use by or under
the supervision of U.S. Forest Service." Interval between treatments changes from
7-10 days to 2-4 days; application rates change from "2 applications 7 to 10 days
apart at the rate of 25.0 to 125.0 million gypsy moth potency units per acre" to "1
application of at least 400 billion gypsy moth polyhedral inclusion bodies per
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acre," or "make 2 or more applications 2 days apart at the rate of 200 to 500
billion gypsy moth polyhedral inclusion bodies per acre. Percentages of
ingredients change for ai from 20% to 14.6% and for inerts from 80% to 85.4%.
On May 7, 1996, the label amendment was accepted by EPA.
F. Food Quality Protection Act
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law
104-170) was signed into law. EPA is embarking on an intensive process, including
consultation with registrants, States, and other interested stakeholders, to make decisions
on the new policies and procedures that will be appropriate as a result of enactment of
FQPA. This process will include a more in depth analysis of the new safety standard and
how it should be applied to both food and non-food pesticide applications. However, in
light of the unaffected statutory deadlines with respect to reregi strati on, the Agency will
continue its ongoing reregi strati on program while it continues to determine how best to
implement FQPA.
III. SCIENCE ASSESSMENT
EPA has thoroughly reviewed the scientific data base for polyhedral inclusion bodies of
O. pseudotsugata and L. dispar Nuclear Polyhedrosis Viruses (PIBs of OpNPV and LdNPV).
The review relied primarily on studies submitted by the registrant, including studies conducted
by the registrant and studies published in the open literature. All studies were evaluated in
relation to the various guideline requirements, and only those studies that were determined to be
acceptable formed the data basis for this review. These studies are cited in Appendix B and the
Bibliography. For the purpose of evaluating test data for health and ecological endpoints, the
Agency's review of data indicates that both PIBs of OpNPV and LdNPV are so closely related
that data from both ais may be considered interchangeable (see discussion below in section
III. A.). Therefore, the combined database for both ai's may be used in determining the eligibility
for reregi strati on of each NPV.
As forest use biopesticides, the PIBs of OpNPV/LdNPV qualify for a reduced set of
generic data requirements for reregi strati on as specified in 40 CFR 158.740, Guidelines for
Microbial Control Agents—Tier I—for non-food/feed uses, and EPA Microbial Pesticide Test
Guidelines 885.1000 series.
The Agency concludes that the existing data base adequately satisifies the data
requirements. No additional studies are required at this time. The Agency does not expect any
risk to humans or the environment from use of these biopesticides; therefore, all uses are eligible
for reregi strati on. The bases of this decision are:
-------
o evaluation of the submitted data and published scientific literature for the RED indicate
the data base is complete and acceptable for all data requirements;
o the fact that PIBs of OpNPV and LdNPV are naturally-occurring pathogens of gypsy
moth and Douglas fir tussock moth and are selective for Lymantriids with no known
adverse effects to any species other than the hosts, gypsy moth and Douglas fir tussock
moth; and
o the fact that in approximately 20 years of use, there have been no reports of adverse
human health and ecological effects, with the exception of possible dermal sensitivity and
eye irritation in exposed humans during manufacture.
A. Physical Chemistry Assessment
1. Product Identity
The ais of the MFC As are PIBs of OpNPV and LdNPV, naturally-
occurring insect viruses belonging to the family Baculoviridae, genus Baculovirus,
subgenus A. Baculoviruses are double-stranded DNA containing viruses that have
no vectors and only infect arthropods, especially insects. The majority of
baculoviruses characterized to date have been isolated from Lepidopteran hosts.
PIBs of OpNPV and LdNPV are members of the morphological subgroup having
multiple bacilliform shaped virions containing double-stranded DNA. The virions
are embedded within a membrane and enclosed in a polyhedrin protein matrix,
producing characteristic occlusion bodies, termed polyhedral inclusion bodies
(PIBs), in the nuclei of infected host's cells. Both NPVs are described by the
cryptogram D/2:50/15:U/(E):I/O.
While all NPVs have some conserved traits such as the polyhedrin protein,
distinguishable traits include host range and responses to certain biochemical tests.
The registrant has submitted biochemical data consisting of general product
chemistry, restriction endonuclease (REN) profiles, protein analysis, serological
tests and buoyant density and isopycnic centrifugation data that are specific to
OpNPV and LdNPV (MRID numbers OpNPV: 49098, 49099, 49100, 49102,
49104; LdNPV: 68398, 68399, 68402, 66093, 66097). By employing these
techniques, these NPVs may be distinguished from each other (REN analysis) and
easily distinguished from other insect viruses, such as Helicoverpa (Heliothis) zea
NPV reregistered by EPA in 1990. The Helicoverpa zea NPV has a different
Lepidopteran host range and is a single embedded baculovirus.
PIBs of OpNPV and LdNPV can, therefore, be distinguished. Biological
activity suggests, however, that both share more similarities than differences.
First, both NPVs only infect species of forest pests in the Lymantriidae family.
10
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Although the NPV of L. dispar has been shown incapable of infecting O.
pseudotsugata larva, both strains of NPV have been shown to infect and replicate
in embryonic and fat body cell lines of L. dispar (Barber et al. 1993; Lynn et al.
1988). Moreover, where studies on PIBs of OpNPV and LdNPV overlap in their
test data, comparison of these data points demonstrates the same health or eco-
toxicological responses. Consequently, for the purpose of evaluating health and
ecological test data to make a reregi strati on eligibility decision, both PIBs of
OpNPV and LdNPV are so closely related that the Agency considers data for one
to be applicable for the other ai.
2. Other Physical and Chemical Characteristics
The physical and chemical characteristics of pesticides are usually
requested to identify unique hazards of a synthetic chemical such as flammability
and flash point. No such information regarding the physical and chemical
parameters has been requested nor deemed necessary for assessing these
baculoviruses for eligibility for reregi strati on.
3. Conclusion of Physical Chemistry Assessment
Product identification and chemistry data requirements were not subject to
the Reregistration Phase 4 Data Call In. The Agency is not requiring any further
information regarding product identity, physical and chemical characteristics. All
product characterization data requirements have been satisfied.
B. Human Health Assessment
1. Toxicology Assessment
In general, the Agency's major toxicological concerns for microbial pest
control agent (MPCA) ai's are the following endpoints:
o pathogenicity of the MPCA and of microbial contaminants;
o infectivity/unusual persistence of the MPCA and of microbial
contaminants; and
o toxicity of the MPCA, of microbial contaminants, and of preparation by-
products.
The Tier I battery of tests in CFR 158.740 (c) and the EPA Microbial Pesticide
Test Guidelines OPPTS 885.3000 series, allow for a reasonable assessment of the
potential risks of the MPCA for these three endpoints.
11
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Adequate acute mammalian toxicology data for assessing the potential Tier
I toxic effects of PIBs of OpNPV and LdNPV are available and support a
reregi strati on eligibility decision.
a. Acute Mammalian Toxicity
The acute mammalian toxicity studies conducted with the two
strains of NPVs adequately satisfy the data requirements. A summary of
the bridged Tier I acute toxicity data for these NPV inclusion bodies is
found in Table I below. The specific test results for each NPV inclusion
body are not listed separately for each guideline; instead the most
significant adverse response for each test guideline from the bridged data
set is listed as the result of the test.
12
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TABLE I: ACUTE MAMMALIAN TOXICITYREQUIREMENTS FOR THE NPVs CF
LYMANTRIA DISPAR AND ORGYIA PSEVDOTSVGATA
GUIDELINE
NO.
1 52-30 /
OPPTS
885.3050
1 52-31 /
OPPTS
885.3100
1 52-327
OPPTS
885.3150
1 52-33 /
OPPTS
885.3200
152-34
1 52-35 /
OPPTS
885.3300
1 52-37 /
OPPTS
885.3400
STUDY
Acute Oral
Toxicity/
Pathogenicity
Acute Dermal
Toxicity
Acute
Pulmonary
(Inhalation)
Toxicity/
Pathogenicity
Acute I.V.,
i.e., IP.
Injection
Toxicity/
Pathogenicity
Primary
Dermal
Irritation
Primary
Eye
Irritation
Hyper-
sensitivity
incidents
RESULTS
LD50 >5g/kg in
rats
LD50>3.16
g/kg or>l
g/kg in rabbits
LC50>6.12
mg/Lor>0.68
mg/L
LD50>2.5
mg/kg (107
PIBs) in rats
Not a dermal
irritant
Irritation with
corneal
involvement
not cleared by
day 14
None
Reported*
TOX
CATEGORY
IV
III
IV
N/A
IV
I
N/A
MRID/
AccessionNo.
49114
417387-01
49262
68401
60702
49116
49263
60703
66101
54189
49266
60695
66102
66105
49113
417387-03
66103
66109
49117
417387-02
49265
66104
49114
49264
91124
60696
68403
68404
60704
N/A
PIBs of NPVs
OpNPV
LdNPV
LdNPV
LdNPV
LdNPV
OpNPV
LdNPV
LdNPV
LdNPV
OpNPV
LdNPV
LdNPV
LdNPV
LdNPV
OpNPV
OpNPV
LdNPV
LdNPV
OpNPV
OpNPV
LdNPV
LdNPV
OpNPV
LdNPV
LdNPV
LdNPV
LdNPV
LdNPV
LdNPV
N/A
13
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752-397
OPPTS
885.3500
Tissue
Culture
None
submitted;
Requirement
has been
waived
N/A
N/A
N/A
All incidents must be reported to the Agency. However, see discussion.
Significant mortality was noted in the acute intraperitoneal injection
tests (152-33) with OpNPV at a dose level of 10 mg per animal (MRID
417387-03). All animals injected with the 10 mg of material died within
four hours of dosing, clearly indicating a toxic response. However,
animals injected with smaller doses (1.0 mg or 0.1 mg) survived the 21 day
duration of the test and showed no signs of lesions or toxicity at gross
necropsy. The 1.0 mg dose represents a 107 PIB dose, which conforms to
the dose level required by Guideline 152-33 / OPPTS 885.3200, and is
adequate for addressing the infectivity endpoint. While the mortality at the
10 mg dose is significant, a high dose causing nonspecific toxicity is not
unexpected, and is not relevant to the hazard assessment in compliance
with the Guidelines. This nonspecific toxicity is also found, for example,
in intraperitoneal injection assays with the bacterium, Bacillus
thuringiensis when administered above the 107 CPU dose suggested in the
Guidelines.
There have been no instances of hypersensitivity (152-37) reported
to the Agency related to use of these active ingredients. The Agency
believes the baculovirus particles by themselves are no more likely than
any other proteinaceous substance to induce hypersensitivity. However,
there are published reports in the medical literature (Shama et al. 1982) as
well as anecdotal accounts of hypersensitivity relating to exposure to setae
(hairs) of the larval stages of the target host insects. Since these active
ingredients are produced using host larvae, it is incumbent on producers
to insure that larval hairs are removed to a suitable level during processing.
This method of larval processing will be examined during the product
specific phase of reregi strati on.
The required data set for reregi strati on does not include immune
response studies. The Agency reviewed supplemental studies conducted
in immune-depressed animals. Oral, footpad injection and nasal and eye
instillation studies were conducted with PIBs of LdNPV on immune-
depressed mice, and dermal studies with the same ai were performed on
immune-depressed guinea pigs (MRID Nos. 60700 and 60703). The
studies showed no adverse reactions although the seriological response to
14
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the virus varied with the level of immune suppression as would be
expected. These negative results add further weight to the conclusions that
PIBs of LdNPV and OpNPV are neither infective nor pathogenic to
mammalian species.
Additionally, for current registration of baculoviruses, producers
are required to submit studies examining the infectivity of the purified viral
agent against mammalian cell lines in tissue culture assays (159-39). The
OpNPV has been tested against amphibian and fish cell lines for infectivity
and replication (Banowetz etal. 1976; Wolf 1975). While no effects were
found against these vertebrate cell lines, these viral agents have not been
tested against mammalian cell lines. Strictly following the OPPTS 885
series Guidelines, producers for both these active ingredients would be
required to submit infectivity/toxicity tests with mammalian cell cultures.
However, numerous baculoviruses have been tested against more than 50
cell lines without any detrimental effects (Groner 1986). In addition, the
sum total of the toxicity/pathogenicity data on these NPVs and the
subchronic and chronic feeding studies discussed below, which showed no
adverse effects, can be used to satisfy the tissue culture study's
requirement. These data do not indicate a concern for infectivity. Based
on the available data, the tissue culture studies are considered satisfied and
the requirement waived.
b. Subchronic Toxicity Studies
The Agency does not currently require the submission of
subchronic studies for MPCAs that do not show adverse effects in the Tier
I toxicology tests. Consequently, Tier II subchronic studies are not
required but are reviewed and considered as supplementary studies in
determining eligibility for reregi strati on.
Subchronic and chronic feeding studies (152-42 and 152-50) for
LdNPV were reviewed in connection with the initial registration process
(Accession Nos. 84340 and 84578, respectively). No adverse effects were
noted in a 90-day feeding study with beagle dogs given daily oral doses of
0, 107, 108 or 109 PIBs of LdNPV. A two-year oncogenicity study (152-
51) involving daily oral administration of 107 or 108 PIBs of LdNPV to
Dublin rats showed no adverse effects. Since the longer-term studies were
originally performed to assess the possible effects of repeated exposure to
NPV, these tests provide information relevant to assessing mammalian cell
culture endpoints currently required for viral pesticides. These longer-
term studies demonstrate no infectivity/pathogenicity, cell transformation,
or viral toxicity in mammals.
15
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c. Conclusion of Toxicology Assessment
Tier I toxicology tests were not the subject of the Phase 4 Data Call
In because the data base was considered satisfactory. In the evaluation of
the toxicology data base for the reregi strati on eligibility decision for the
PIBs ofLymantria dispar and Orgyiapseudotsugata NPVs, the guideline
requirements have been fulfilled or adequately addressed by the studies
already submitted. No further information for the active ingredients is
required.
Eye irritation remains an area of concern for the final products.
Irritation with corneal involvement did not clear by day 14 of the
observation period, which indicates a Toxicity Category I response for the
TGAI of PIBs of L. dispar NPV. Based on the available results of eye
irritation studies, the clinical literature on irritation caused by larval hairs
and the presence of microbial contaminants and added inerts in the final
products, studies or a scientifically sound justification will be required
prior to making final decisions on the Phase 5 reregi strati on of pesticides
products containing these ais.
Dermal toxicity, primary dermal irritation and hypersensitivity are
also areas of concern based on studies in the reregi strati on data base and
the open literature. These issues and the appropriate Label statements will
be examined in making final decisions on the Phase 5 reregi strati on of
pesticide products.
2. Exposure and Risk Assessments
a. Dietary Exposure and Risk Assessment
Since PIBs of OpNPV and LdNPV are applied to forested areas, the
Agency considers these non-food uses which do not require a tolerance.
Any exposures to wild food plants or adjacent croplands are incidental to
the intended use and are not expected to present a significant dietary
exposure. Given the lack of adverse effects presented by existing
mammalian toxicology data, there is no reason to expect any dietary risks
from residues of the NPVs in these incidental exposures.
b. Occupational Exposure and Risk Assessment
Based on the application methods which involve spraying and
aerial applications, the potential for dermal, eye and inhalation exposures
16
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to the pesticide for pesticide handlers exists. However, spraying of the
PIBs of OpNPV and LdNPV will not significantly increase exposure to
larval hairs, microbes, or other by-products that occur in the preparation
of the ais. Pest densities that necessitate spraying have a natural high
background of these factors; moreover, dilution of the ais in the spraying
preparation and its sticking to the forest foliage reduce the likelihood of
exposure to a negligible level. Finally, the lack of human pathogenicity
demonstrated by the test results on hand and the absence of any record that
indicates human health effects from occupational exposures, leads the
Agency to conclude that worker exposure data to the active ingredients are
not required.
(1). Dermal
However, due to the Acute Dermal response (Toxicity Category III)
and reports in the published literature of dermal sensitivity to the larval
hairs of the host species, the Agency will require product precautionary
label statements that include proper warning about the presence of insect
parts being a potential dermal sensitizer (Shama et al. 1982). (See Section
V of this RED.) This label statement is necessary until proper quality
control procedures are documented to reduce the likelihood that significant
levels of insect hairs are present in the product. If production methods are
employed which eliminate the use of larva and/or the potential exposure
to larval hairs, these precautionary statements may be removed.
(2). Eye
The eye irritation studies submitted to date have produced
equivocal results (Accession nos. 49114, 49264, 91124, 60696, 68403,
68404). Several animals in each test have shown corneal effects which did
not clear by the end of the 14 day observation period (Accession No.
68404). These results would require that the labels have a toxicity rating
of Toxicity Category I as a severe eye irritant. Although it was
subsequently shown that the eye irritation was not associated with the virus
particles themselves (MRID No. 60704), nevertheless, until an acceptable
eye irritation study is submitted to show otherwise, a label statement
indicating the products are severe eye irritants and specifying appropriate
eye protection is required. (See Section V of this RED.) Unlike the
dermal sensitization where exposure to larval hairs is the likely cause, this
effect may be tied to other factors such as bacterial contaminants or by-
products. Therefore, this study cannot be waived based on altered
manufacturing methods alone. Presently, a Toxicity Category I for
primary eye irritation would require products containing the active
17
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ingredients to be labeled with the signal word "Danger" and the
appropriate Statements of Precaution and Personal Protective Equipment,
Practical Treatment and Note to Physician.
C. Environmental Assessment
Part III. A. "Product Identity/Chemistry Assessment" and B. "Human Health
Assessment" of this Reregi strati on Eligibility Decision Document discuss the biological
similarities of the two NPVs, LdNPV and OpNPV, that allow the Agency to consider the
data as one data set for both NPV active ingredients (ai). This approach holds true as well
for ecological toxicity data assessment for non-target organisms, enabling the
environmental assessment to bridge data between the two NPVs for evaluating their
eligibility for reregi strati on.
Since their registration, PIBs of OpNPV and LdNPV have been used for
approximately 20 years as MFC As, and there have been no reported adverse ecological
effects in that time period. Moreover, during natural outbreaks, when large numbers of
these viruses are released into the environment, no adverse ecological effects are known
to occur other than to the host species, gypsy moth and Douglas fir tussock moth. These
facts support the evaluation of ecotoxicity studies summarized below in determining that
the two ai's, PIBs of LdNPV and OpNPV, are eligible for reregi strati on without
submission of any other environmental assessment data.
1. Ecological Toxicity to Terrestrial and Aquatic Organisms
The purpose of nontarget organism testing is to develop data necessary to
assess potential hazards of MFC As to terrestrial wildlife, aquatic animals, plants
and beneficial insects. Tier I non-target organism and environmental expression
data requirements, specified in CFR 158.740 (d) and in EPA's Microbial Pesticide
Test Guidelines OPPTS Series 885, provide a battery of tests that allow the
assessment of pathogenicity and toxicity to terrestrial and aquatic organisms
exposed to MPCAs. The guidelines in Tier I reflect a maximum hazard approach
to testing. Negative results provide a high degree of confidence that no
unreasonable adverse effects are likely to occur from the actual use of the MFC A.
The review of available data follows.
a. Summary of Ecotoxicity Studies
The available terrestrial and aquatic data and other relevant
scientific information show that the PIBs of LdNPV and OpNPV do not
cause adverse pathogenic or toxics effects on avian, mammalian and
aquatic wildlife. They are host specific, infecting only forest insect pests
18
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in the Lymantriidae family. Available data will support a Reregi strati on
Eligibility Decision. The ecological effects data submitted in support of
these NPVs are summarized in Table II.
In reviewing the Table, note that the studies identified by an
asterisk next to the MRID, Acession number or literature citation were
reviewed as supplemental studies since they do not follow protocols that
would allow them to be substituted in their entirety for basic data
requirements. However, the Agency believes that these studies provide
sufficient information on the toxicity of direct exposure of NPVs to non-
target species to make an environmental risk assessment and a
reregi strati on decision.
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TABLE II: NON-TARGET ORGANISM AND ENVIRONMENTAL EXPRESSION DATA SUPPORTING TH
REREGISTRATION DECISION FOR THENUCLEAR POLYHEDROSIS VIRUS OTLYMANTRIA DISPAR
AND ORGYIA PSEVDOTSVGATA.
Guidelines
PIBs of NPVs
Study Type
Results
MRID, Accession # or
Literature citation
154-16 /OPPTS 885.4050
Avian Acute Oral
Pathogenicity/Toxicity test
OpNPV
English sparrow
LD50> l,969mg/kg
Hudson et al. (1984)*
154-16/OPPTS 885.4050
Avian Acute Oral
Pathogenicity/
Toxicity test
LdNPV
feeding study bobwhite quail
no signs of toxicity /
pathogenicity 3.73 x 103
PIB/g/bird
LdNPV
8 -day dietary feeding study
mallard
LC50> 16000ppm
LdNPV
feeding study black capped
chickadee and house sparrow
birds fed larvae infected with
3x 107to2xl08PIBs:no
short term effects found
00091447*
accession # 231360
accession # 231360*
154-17/OPPTS 885.4100
Avian respiratory
pathogenicity test
LdNPV OpNPV
Waived
Waived
Waived
154-18/OPPTS 885.4150
Wild Mammal toxicity and
pathogenicity test
LdNPV
mammal dietary study on white
footed mouse, short tailed
shrew, Virginia opossum
mammals fed larvae infected
with 4 x 108to6xl08PIBs:
no short term effects found
00134314*
00060707*
00068412*
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154-19 /OPPTS 885.4200
Freshwater fish toxicity and
pathogenicity test
(waived for OpNPV)
154-20 /OPPTS 885.4240
Fresh H2O aquatic invertebrate
(waived for OpNPV)
154-22 /OPPTS 885.4300
Non-target Plants
154-23 /OPPTS 885.4340
Non-Target Insects
154-24 /OPPTS 885.4380
Honey Bee Toxicity,
Pathogenicity Test
LdNPV
LdNPV
LdNPV
OpNPV
LdNPV
OpNPV
LdNPV
OpNPV
Brown Trout and Bluegill
Sunfish
96hr LC 50
an exposure study w/ Daphnia
magna, Notonecta undulata ,
& Chironomus thummi
waived based on known insect
species specificity
waived based on known host
range
4 month feeding study
LC50 > 1.5xl09PIB/g
LC 50 > 250 PIB/ml
= to 1012PIB/acre
waived requirement
waived requirement
no effects on egg laying, brood
rearing and honey production
10,850 AUOL/bee**
0005465
00060709
waived requirement
waived requirement
Knox, 1970*
* These studies were reviewed and are supplemental in that they do not follow protocols that would allow them to be substituted in their entirety for basic data requirements .
However, the Agency believes that these studies provide sufficient information on the toxicity of direct exposure of NPVs to non-target species to make an environmental risk
assessment and a reregistration decision.
** AUOL = activity unit or the potency of each production lot and because the activity unit was based on the response of insect strain GL-1, its symbol is AU OL
21
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In addition to the studies cited above, PIBs of OpNPV has been tested against
amphibian and fish cell lines for infectivity and replication. No effects were found against
these vertebrate cell lines (Banowetz, G.M., J.L. Fryer, PJ. Iwai, and M. E. Martignoni.
1976. Effects of the Douglas-fir tussock moth nucleopolyhedrosis virus (baculovirus) on
three species of salmonid fish. USDA For. Serv. Res. Pap. PNW-214, 6 p. Pac.
Northwest For. and Range Exp. Stn., Portland, OR.)
Further studies were conducted and submitted to examine the effects of PIBs of
LdNPV on wildlife following aerial application at the rate of 2.5 x 1012 PIBs/ha on
woodland plots in Pennsylvania. Comparison of necropsy or organ weights and
histopathological data taken on 297 mammals (including major gypsy moth predators)
and seventy-six birds either free living or caged in the study plots indicated no significant
difference between controls and treated mammals or birds. Further prespray and post
spray censuses of the dominant mammals and resident songbirds taken on control and
treated plots indicated no population changes could be attributed to NPV treatment.
(MRID #s 00066108, 00060712, 00060711, 00060706). Mammals and birds are
important natural predators of gypsy moth larvae, and natural occurrences of both
mammals and birds passing NPV's through their alimentary tracts is documented (Groner.
1976). The negative results of these studies add further weight to the conclusions that this
NPV is neither infective nor pathogenic to non-target species.
Avian respiration for baculovirus products are associated with inhalation of the
larval setae (spiny hairs) which result from production in vivo. However, EPA has waived
the Avian respiratory pathogenicity test, Subdivision M Guideline 154A-17/OPPTS
885.4100 for both PIBs of LdNPV and OpNPV. The Agency bases its decision on several
considerations. Mammalian inhalation test for both NPVs showed no signs of toxicity or
pathogenicity, and there is no reason to believe that the avian inhalation test would show
different results. These products are typically applied by air. Natural dispersion as the
product settles to the ground and foliage is not expected to result in high avian respiratory
exposure. In addition, annual use of these baculoviruses is limited by their production in
vivo and in vitro resulting in relatively low use and exposure compared to other products.
To date, insect viruses have never been known to have any adverse avian effects.
b. Toxicity to Nontarget Plants
The NPVs of L. dispar and O. pseudotsugata are species-specific, infecting only
insects. Therefore, all nontarget plant testing data requirements have been waived.
c. Toxicity to Nontarget Insects
Non-target insect testing was waived based on the known host specificity of both
LdNPV and OpNPV to a limited number of related Lepidoptera, infecting and debilitating
species of forest pests only in the Lymantriidae family. Groner (1986) in his review of
22
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studies on susceptibility of alternativie hosts to NPVs found that infectivity is restricted
to the family or at least to the order of the original host. The NPV of L. dispar has been
shown incapable of infecting O. pseudotsugata larva (Barber et al. 1993). The NPV of
O. pseudotsugata is known to infect three other species in the genus Orygia and has been
shown to infect and replicate in embryonic and fat body cell lines of L. Dispar (Lynn et
al. 1988).
2. Environmental Fate of NPV
Naturally occurring NPVs of L. dispar and O. pseudotsugata are important in bringing
about the epizootic collapse of gypsy moth and Douglas fir tussock moth populations. During
natural outbreaks of the moths, large amounts of these viruses are released into the environment
with no known or reported adverse ecological effects to species other than the target insect host.
An environmental fate study was reviewed in connection with the initial registration to determine
NPV persistence after natural epizootics and how introduction of the virus as a MFC A affects its
natural accumulation and persistence in the environment. Results from bioassays in leaf, bark,
litter and soil showed that a much greater amount of virus is released into the environment by
the collapse of the pest population than is released through application of NPVs as a biopesticide
control measure (Podgwaite et al. 1979). Additional study results found that the natural levels
of NPV did not increase after an application of 2.5 x 1012 Pffis/ha to a test plot already supporting
high levels of naturally occuring NPV. Similarly, application of NPV at 5 x 1012 to a test plot
supporting low levels of naturally occuring NPV did not result in a significant increase of virus
levels over those in the control plot.
The Agency does not currently require the submission of environmental fate studies for
microbial pesticides that adequately pass the Tier I tests; however, these data support the
conclusion thatPIBs of LdNPV and OpNPV are natural components of the hosts' environments
and that pesticidal uses would not raise the levels of NPV above that which might naturally occur.
3. Environmental Exposure and Risk Assessment
The application of aerially applied NPVs to forest ecosystems can be expected to result
in exposure to a wide variety of birds, mammals, fish and aquatic invertebrates. The available
avian and aquatic data and other relevant literature and information show that PIBs of OpNPV
and LdNPV do not cause adverse effects on avian, mammalian and aquatic wildlife. No
mortalities were seen when these viruses were fed to mallard ducks, house sparrows, bobwhite
quail and black-capped chickadees. No mortalities or other adverse effects were seen in brown
trout, bluegill sunfish, and a variety of aquatic invertebrates. Similarly, tests with mule deer,
Virginia opposums, short-tailed shrews and white-footed mice, resulted in no evidence of
pathogenicity or toxicity. Known insect host range and scientific literature on honey bee
mortality demonstrate that these baculoviruses do not have adverse effects on honeybees and
should not pose a significant risk to nontarget insects (Cantwell et al. 1972; Knox 1970). NPV
23
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effects on endangered species are considered a low risk based on the absence of threat to
nontarget organisms.
4. Conclusion
Due to the lack of adverse effects on avian, mammalian and aquatic wildlife, plants and
nontarget insects documented in the submitted studies and scientific literature after 20 years of
use, the Agency finds that the PIBs of L. dispar and O. pseudotsugata NPVs pose minimal or no
risk to nontarget wildlife, including endangered species. The toxicology data base for the
reregi strati on eligibility decision for the PIBs of L. dispar and O. pseudotsugata NPVs are
adequate for a risk assessment. The guideline requirements have been fulfilled or adequately
addressed by the submitted studies. No further information is required.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant data
concerning an active ingredient, whether products containing the active ingredients are eligible for
reregi strati on. The Agency has previously identified and required the submission of the generic (i.e.,
active ingredient specific) data required to support reregi strati on of products containing the active
ingredients of PIBs of gypsy moth (Lymantria dispar) and Douglas fir tussock moth (Orgyia
pseudotsugata) NPVs. The Agency has completed its review of these generic data, and has determined
that the data are sufficient to support reregi strati on of all products containing PIBs of gypsy moth
(Lymantria dispar) and Douglas fir tussock moth (Orgyiapseudotsugata) NPVs. Product specific data
required for reregistering products include product chemisttry and acute toxicity data. Generic data for
these data requirements are satisfactory for product reregi strati on. Therefore the Agency expects the
registrants to cite these previously submitted data in the "Eight-Month Response.' Appendix B identifies
the generic data requirements that the Agency reviewed as part of its determination of reregi strati on
eligibility of PIBs of gypsy moth (Lymantria dispar) and Douglas fir tussock moth (Orgyia
pseudotsugata) NPVs, and lists the submitted studies that the Agency found acceptable.
In summary, the Agency concludes that the existing data base adequately satisfies the data
requirements. No additional studies are required at this time. The Agency does not expect any risk to
humans or the environment from use of these biopesticides; therefore, all uses are eligible for
reregi strati on. The bases of this decision are:
o evaluation of the submitted data and published scientific literature for the RED indicate the
data base is complete and acceptable for all data requirements;
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o the fact that PIBs of OpNPV and LdNPV are naturally-occurring pathogens of gypsy moth and
Douglas fir tussock moth and are selective for Lymantriids with no known adverse effects to any
species other than the hosts, gypsy moth and Douglas fir tussock moth; and
o the fact that in approximately 20 years of use, there have been no reports of adverse human
health and ecological effects, with the exception of possible dermal sensitivity and eye irritation
in exposed humans during manufacture.
The data identified in Appendix B were sufficient to allow the Agency to assess the registered
uses of PIBs of gypsy moth (Lymantria dispar) and Douglas fir tussock moth (Orgyiapseudotsugatd)
NPVs and to determine that PIBs of gypsy moth (Lymantria dispar) and Douglas fir tussock moth
(Orgyiapseudotsugata) NPVs can be used without resulting in unreasonable adverse effects to humans
and the environment. The Agency therefore finds that all products containing PIBs of gypsy moth
(Lymantria dispar) and Douglas fir tussock moth (Orgyiapseudotsugata) NPVs as the active ingredients
are eligible for reregi strati on. The reregi strati on of particular products is addressed in Section V of this
document.
The Agency made its reregi strati on eligibility determination based upon the target data base
required for reregi strati on, 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 PIBs of gypsy moth (Lymantria dispar) and Douglas fir tussock moth (Orgyia
pseudotsugata) NPVs are eligible for reregistration as specified in this RED, 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 PIBs of gypsy moth (Lymantria dispar) and Douglas fir
tussock moth (Orgyia pseudotsugata) NPVs, if new information comes to the Agency's attention or if
the data requirements for registration (or the guidelines for generating such data) change.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients PIBs of gypsy moth
(Lymantria dispar) and Douglas fir tussock moth (Orgyia pseudotsugata) NPVs, the Agency has
sufficient information on the health effects of PIBs of gypsy moth (Lymantria dispar) and
Douglas fir tussock moth (Orgyiapseudotsugata) NPVs and on its potential for causing adverse
effects in fish and wildlife and the environment. The Agency has determined that PIBs of gypsy
moth (Lymantria dispar) and Douglas fir tussock moth (Orgyiapseudotsugata) NPVs 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 PIBs of gypsy moth (Lymantria dispar) and Douglas fir
tussock moth (Orgyiapseudotsugata) NPVs for all uses are eligible for reregistration as specified
in this RED.
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2. Eligible and Ineligible Uses
The Agency has determined that all Forest Uses of PIBs of gypsy moth (Lymantria
dispar) and Douglas fir tussock moth (Orgyiapseudotsugata) NPVs to manage gypsy moth and
Douglas fir tussock moth, respectively, are eligible for reregi strati on and use as specified in this
RED. No other uses are currently registered.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for PIBs of gypsy moth
(Lymantria dispar} and Douglas fir tussock moth (Orgyia pseudotsugata) NPVs. Where labeling
revisions are imposed, specific language is set forth in Section V of this document.
1. Food Quality Protection Act
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-
170) was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went into effect immediately.
EPA is embarking on an intensive process, including consultation with registrants, States,
and other interested stakeholders, to make decisions on the new policies and procedures that will
be appropriate as a result of enactment of FQPA. This process will include a more in depth
analysis of the new safety standard and how it should be applied to both food and non-food
pesticide applications. However, in light of the unaffected statutory deadlines with respect to
reregi strati on, the Agency will continue its ongoing reregi strati on program while it continues to
determine how best to implement FQPA.
In deciding to continue to make reregi strati on determinations during the early stages of
FQPA implementation, EPA recognizes that it will be necessary to make decisions relating to
FQPA before the implementation process is complete. In making these early, case-by-case
decisions, EPA does not intend to set broad precedents for the application of FQPA to its
regulatory determinations. Rather, these early decisions will be made on a case-by-case basis and
will not bind EPA as it proceeds with further policy development and any rulemaking that may
be required.
If EPA determines, as a result of this later implementation process, that any of the
determinations described in this RED are no longer appropriate, the Agency will consider itself
free to pursue whatever action may be appropriate, including but not limited to reconsideration
of any portion of this RED.
2. Tolerance Reassessment
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PIBs of gypsy moth (Lymantria dispar) and Douglas fir tussock moth (Orgyia
pseudotsugata) NPVs are used exclusively for aerial spray control on Forests. This application
is a non-food/non-feed use; therefore, neither a tolerance nor an exemption from tolerance is
required.
3. Endangered Species Statement
Based on the Agency's assessment of health and environmental test data as well as studies
in the literature, PIBs of gypsy moth (Lymantria dispar} and Douglas fir tussock moth (Orgyia
pseudotsugata) NPVs, pose minimal to no adverse effects to plant and animal endangered
species.
4. Labeling Rationale
a. Precautionary Labeling
The Agency has reexamined the data base for PIBs of gypsy moth (Lymantria
dispar) and Douglas fir tussock moth (Orgyiapseudotsugata) NPVs and concludes that
the current precautionary labeling (i.e., Signal Word, Statement of Practical Treatment,
and other label statements associated with mitigating risks) require amendment as
specified in Section V. Until acceptable studies, data, and/or written justifications show
otherwise, it is prudent to label products containing PIBs of LdNPV and OpNPV in such
a way as to assure mixers, loaders, applicators, and sensitive populations are adequately
protected from both dermal sensitization (Toxicity Category III) and eye irritation
(Toxicity Category I) health effects.
b. Directions for Use
The Agency has reexamined the label for PIBs of gypsy moth (Lymantria dispar)
and Douglas fir tussock moth (Orgyia pseudotsugata) NPVs and concludes that the
current use directions for the ais must be amended. The current label requires the identity
of the use-site to be inferred. The label shall be amended to include the identity of the use
site "Forest Trees," as specified in Section V.B.2.d. The RED recognizes the label
amendments accepted by EPA on May 7, 1996. However, as the exposure and risk
assessments indicate (See Section III.B.2.), the Agency has both dermal and eye irritation
concerns, based on available data. Consequently, the pesticide must be applied in a
manner to avoid spraying—either directly or through drift—sensitive, populated areas such
as residential areas, schools, playgrounds, or similar sites where people or pets may be
present.
Label statments for use directions are not required for "restricted-entry" or
"notification-to-workers." Infestations of gypsy moth and Douglas fir tussock moth larval
populations in forests that necessitate spraying PIBs of LdNPV and OpNPV have a
27
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natural high background density of larval hairs and insect body parts—the inert elements
which are currently found in the TGAIs and thought to cause the dermal and eye concerns
(see Section III.2.b.). Spraying products containing the ais would not significantly
increase exposures to these elements. Moreover, dilution of the ais in the spray
preparation and the sticking of the preparation to forest foliage reduce the likelihood of
exposures to these elements to a negligible level on the ground.
5. Spray Drift Advisory
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices
and State Lead Agencies for pesticide regulation to develop the best spray drift management
practices. The Agency is now requiring interim measures that must be placed on product
labels/labeling as specified in Section V. Once the Agency completes its evaluation of the new
data base submitted by the Spray Drift Task Force, a membership of U.S. pesticide registrants,
the Agency may impose further refinements in spray drift management practices to further reduce
off-target drift and risks associated with this drift.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregi strati on of both
manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of the active ingredients, PIBs of gypsy
moth (Lymantria dispar) and Douglas fir tussock moth (Orgyiapseudotsugata) NPVs, for the
above eligible uses has been reviewed and determined to be substantially complete. At this time,
no additional data is required.
2. Labeling Requirements for Manufacturing-Use Products
The Agency reviewed and approved the labels for both ais/products on May 7, 1996.
Statements for Environmental Hazard, and Storage and Disposal shall remain as approved on the
May 7, 1996 label. Certain precautionary statements for the labels are to be amended to remain
in compliance with FIFRA. Manufacturing use product (MP) labeling must be revised to comply
with all current EPA regulations, PR Notices and applicable policies.
To the Directions for Use statement, the MP labeling must add the following statement:
"Only for formulation into a biological insecticide for wide-area government sponsored
pest control programs on Forest Trees."
28
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In addition, because of acute dermal response and reports in the published literature of
dermal sensitivity to the larval hairs of the host species, the Agency will require a product
precautionary label statement that includes proper warning about the presence of insect parts
being a potential dermal sensitizer. This label statement is necessary until proper quality control
procedures are documented to reduce the likelihood that significant levels of insect hairs are
present in the product. The statement shall read:
"Avoid contact with skin, eyes or clothing, Wash thoroughly with soap and water after
handling. Wear long-sleeved shirt and long pants, socks, shoes, and protective gloves.
Prolonged or frequently repeated skin contact may cause allergic reactions in some
individuals."
Regarding primary eye irritation, until an acceptable eye irritation study is submitted that
shows eye irritation is not a significant concern, a label statement is required indicating the
products are severe eye irritants and specifying appropriate eye protection. Toxicity Category
I for primary eye irritation requires products containing the ais to be labeled with the signal word
"Danger" and the appropriate Statements of Precaution and Personal Protective Equipment,
Practical Treatment, and Note to Physician.
Statements of Precaution and Personal Protective Equipment: "Primary eye irritation
studies indicate pesticide is a severe eye irritant and may cause irreversible eye damage.
An emergency eye flushing apparatus shall be present where mixing/loading/application
take place. Do not get pesticide in eyes or on clothing. Wear goggles or face shield.
Wash thorougly with soap and water after handling. Remove contaminated clothing and
wash clothing before reuse."
Statement of Practical Treatment: "If in eyes, hold eyelids open and flush with a steady,
gentle stream of water for 15 minutes. Get medical attention."
Note to Physician: "Product is a severe eye irritant, possibly causing irreversible damage
to cornea."
Until acceptable studies, data, and written justification show that dermal sensitization and
eye irritation are not a significant concern, both the dermal and eye irritation demonstrated by the
test data make it prudent to avoid spraying the ais on sensitive populated areas. Consequently,
products containing the ais must be labeled as follows:
Statement for aerial spraying: "Avoid spraying sensitive populated areas. This pesticide
must be applied in a manner to avoid spraying—either directly or indirectly through drift--
sites such as residential areas, schools, playgrounds, or similar sites where people or pets
may be present."
B. End-Use Products
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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. Registrants must
review previous data submissions to ensure that they meet current EPA acceptance criteria and
if not, commit to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to the instructions
in the Requirement Status and Registrants Response Form provided for each product.
2. Labeling Requirements for End-Use Products
a. Worker Protection Standard
Worker Protection Standard (WPS) Labeling is not applicable to Gypchek (EPA
Registration # 27586-2) and TM Biocontrol-1 (EPA Registration # 27586-1) because they
are labeled "For use in only wide-area government sponsored pest-control programs" and
are, therefore, according to PR Notice 93-7 exempt from the labeling provisions of the
WPS. Lymantrin Insecticide (EPA Registration # 62343-1) is subject to the labeling
provisions of the WPS.
Products that are controlled by the WPS and whose labeling permits use in the
production of an agricultural plant on any farm, forest, nursery, or greenhouse, must
comply with the labeling requirements of PR Notice 93-7, "Labeling Revisions Required
by the Worker Protection Standard (WPS), and PR Notice 93-11, "Supplemental
Guidance for PR Notice 93-7, which reflect the requirements of EPA' s labeling
regulations for worker protection statements (40 CFR part 156, subpart K). These labeling
revisions are necessary to implement the Worker Protection Standard for Agricultural
Pesticides (40 CFR part 170) and must be completed in accordance with, and within the
deadlines specified in, PR Notices 93-7 and 93-11. Unless otherwise specifically directed
in this RED, all statements required by PR Notices 93-7 and 93-11 are to be on the
product label exactly as instructed in those notices.
After April 21, 1994, except as otherwise provided in PR Notices 93-7 and 93-11,
all products within the scope of those notices must bear WPS PR Notice complying
labeling when they are distributed or sold by the primary registrant or any supplementally
registered distributor.
After October 23, 1995, except as otherwise provided in PR Notices 93-7 and
93-11, all products within the scope of those notices must bear WPS PR Notice
complying labeling when they are distributed or sold by any person.
The labels and labeling of all products must comply with EPA's current regulations
and requirements as specified in 40 CFR §156.10 and other applicable notices.
30
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b. Effluent Discharge Labeling Statements
Refer to subsection A.2. above: "Labeling Requirements for Manufacturing-Use
Products."
c. Statement of Precaution, Personal Protective Equipment, Practich
Treatment, and Note to Physician.
Refer to subsection A.2. above: "Labeling Requirements for Manufacturing-Use
Products" for Precautionary Statements.
d. Use Labeling
The Agency's review conducted in preparation of the Reregi strati on Eligibility
Decision Document indicates that the Use Sites on the product labels for PIBs of LdNPV
and OpNPV are not clearly specified. The Directions of Use section on the label shall be
amended to indicate the following:
For PIBs of LdNPV: "This product is registered only for the management of gypsy moth
and shall only be used on forests trees, including oak, hickory, basswood, birch, cherry,
elm, blackgum, larch, sassafras, hemlock, cedar, spruce, black walnut, American chestnut,
willow, popular, ash, boxelder, hawthorn, butternut, catalpa, American holly, locust, and,
sycamore."
For PIBs of OpNPV: "This product is registered only for the management of Douglas fir
tussock moth and shall only be used on forest trees, including Douglas-fir, true fir, spruce,
larch, pine, hemlock, willow, and cedar."
C. Tolerance Revocation and Import Tolerances
Not applicable for PIBs of LdNPV and OpNPV for forestry use.
D. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26 months
from the date of the issuance of this Reregi strati on Eligibility Decision (RED). Persons other than the
registrant may generally distribute or sell such products for 50 months from the date of the issuance of
this RED. However, existing stocks time frames will be established case-by-case, depending on the
number of products involved, the number of label changes, and other factors. Refer to "Existing Stocks
of Pesticide Products; Statement of Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell PIBs of gypsy moth
(Lymantria dispar) and Douglas fir tussock moth (Orgyiapseudotsugatd) NPVs products bearing old
31
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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.
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VI. APPENDICES
33
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34
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APPENDIX A. TABLE OF USE PATTERNS SUBJECT TO REREGISTRATION
Report Run Date: 08/29/96 ) Time 10:18
PRO Report Date: 09/14/95
LUIS 3.02 - Page:
APPENDIX A REPORT
Case 4106[NPV inclusion b] Chemical 107302[Inclusion bodies of Douglas fir tussock moth nucleopolyhedrosi]
44444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Re- 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) Intv. Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year
cycle
))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED
Low volume spray (concentrate), Foliar, WP NA
Aircraft
FOREST TREES (SOFTWOODS, CONIFERS)
.93 billion
WIDE AREA/GENERAL OUTDOOR TREATMENT (QUARANTINE/ERADICATION USE)
Low volume spray (concentrate), Foliar, WP NA
Aircraft
.93 billion * NS NS
Use Group: FORESTRY
NS NS NS NS
AU A
Use Group: TERRESTRIAL NON-FOOD CROP
NS NS NS NS
AU A
C79, CAC
35
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Report Run Date: 08/29/96 ) Time 10:18 LUIS 3.02 - Page: 2
PRD Report Date: 09/14/95
APPENDIX A REPORT
Case 4106[NPV inclusion b] Chemical 107302[Inclusion bodies of Douglas fir tussock moth nucleopolyhedrosi]
444444444
LEGEND
444444
Sort: Uses Eligible or Ineligible for Re-registration, Food/Feed or Non-Food/Non-Feed Uses, Alpha Site Name, Use Group Name, Alpha Application Type/Timing/Equipment
Description, Formulation, Maximum Application Rate Unit/Area Quantity, Minimum Application Rate
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)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps ® Max. Rate : 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"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Re-Entry Intv. : Reentry Intervals
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
WP : WETTABLE POWDER
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 : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
U : Unknown whether PPM is given by weight or by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
AU : Activity Units
USE LIMITATIONS CODES
C79 : For use by or under the supervision of U.S. Forest Service.
36
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Report Run Date: 08/29/96 ) Time 10:18 LUIS 3.02 - Page: 3
PRD Report Date: 09/14/95
APPENDIX A REPORT
Case 4106[NPV inclusion b] Chemical 107302[Inclusion bodies of Douglas fir tussock moth nucleopolyhedrosi]
44444444444444444444444444444444444
USE LIMITATIONS CODES (Cont.)
CAC : Keep out of lakes, streams, and ponds.
NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
Report Run Date: 07/02/96
PRD Report Date: 09/14/95
) Time 14:50
LUIS 3.02 - Page:
APPENDIX A REPORT
Case 4106[NPV inclusion b] Chemical 107303[Polyhedral inclusion bodies of gypsy moth nucleopolyhedrosis v]
44444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Re- 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) Intv. Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year
cycle
))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
u
NON-FOOD/NON-FEED
FOREST TREES (ALL OR UNSPECIFIED)
Low volume spray (concentrate), Foliar, WP
NA
Spray, Foliar, Aircraft
Aircraft
FOREST TREES (HARDWOODS, BROADLEAF TREES)
FM/S NA 125 MGMPU A * NS 2/1 yr
F1C NA 125 MGMPU A * NS 2/1 yr
Use Group: FORESTRY
125 MGMPU A * NS 2/1 yr NS NS
Use Group: FORESTRY
NS NS 7 NS
NS NS 7 .5
CAC
CAC
37
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Report Run Date: 07/02/96 ) Time 14:50 LUIS 3.02 - Page: 2
PRD Report Date: 09/14/95
APPENDIX A REPORT
Case 4106[NPV inclusion b] Chemical 107303 [Polyhedral inclusion bodies of gypsy moth nucleopolyhedrosis v]
444444444
LEGEND
444444
Sort: Uses Eligible or Ineligible for Re-registration, Food/Feed or Non-Food/Non-Feed Uses, Alpha Site Name, Use Group Name, Alpha Application Type/Timing/Equipment
Description, Formulation, Maximum Application Rate Unit/Area Quantity, Minimum Application Rate
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)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps ® Max. Rate : 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"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Re-Entry Intv. : Reentry Intervals
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
FM/S : FORM NOT IDENTIFIED/SOLID
F1C : FLOWABLE CONCENTRATE
WP : WETTABLE POWDER
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 : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
U : Unknown whether PPM is given by weight or by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
MGMPU : Million Gypsy Moth Potency Units
38
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Report Run Date: 07/02/96 ) Time 14:50 LUIS 3.02 - Page: 3
PRD Report Date: 09/14/95
APPENDIX A REPORT
Case 4106[NPV inclusion b] Chemical 107303[Polyhedral inclusion bodies of gypsy moth nucleopolyhedrosis v]
144444444444444444444444444
USE LIMITATIONS CODES
CAC : Keep out of lakes, streams, and ponds.
NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
REENTRY INTERVAL ABBREVIATIONS
.5 : day
39
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active ingredients
within the case 4106 covered by this Reregi strati on Eligibility Decision Document. It contains generic data
requirements that apply to 4106 in all products, including data requirements for which a "typical
formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they appear
in 40 CFR Part 158. the reference numbers accompanying each test refer to the test protocols set in the
Pesticide Assessment Guidelines, which are available from the National Technical Information Service,
5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data requirements
apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this column lists
the identifying number of each study. This normally is the Master Record Identification (MRID) number,
but may be a "GS" number if no MRID number has been assigned. Refer to the Bibliography appendix for a
complete citation of the study.
40
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APPENDIX B
APPENDIX B
Data Requirements for Reregistration of
Lymantria dispar NPV and Orgyia pseudotosugata NPV
DATA REQUIREMENTS BY GUIDELINES
PRODUCT CHARACTERIZATION
GUIDELINES:
151-20/885.1100 Product identity
151-21 / 885. 1200 Manufacturing process
151-22 7885.1300 Discussion of formation of
unintentional ingredients
151-23 7885.1400 Analysis of samples
151-25 7 885. 1500 Certification of limits
151-25 Analytical Methods
151-26 Physical and chemical properties
TOXICOLOGY TIER I:
USE
PATTERN
S
J
J
J
J
J
J
J
CITATIONS:
MRID,
ACCESSION
#,
LITERATURE
CITATION
00066097
00049098
00049099
000490100
000490102
000490104
00068398
00068399
00068402
00066093
BACUL
O-
VIRUS
LdNPV
OpNPV
OpNPV
OpNPV
OpNPV
OpNPV
LdNPV
LdNPV
LdNPV
LdNPV
PHASE
III
STATUS
ACCEPT
ACCEPT
ACCEPT
ACCEPT
ACCEPT
ACCEPT
ACCEPT
41
-------
152-30 7885.3050 Acute oral Toxicity /
Pathogenicity
152-31 7885.3100 Acute dermal Toxicity
152-32 7885.3150 Acute Pulmonary (inhalation)
Toxicity 7 Pathogenicity
152-33 7 885.3200 I.V., I.C., IP. injection Toxicity
7 Pathogenicity
152-34 Primary dermal Irritation
152-35 Primary eye Irritation
152-36 Hypersensitivity study
152-37 7 885.3400 Hypersensitivity incidence
152-38 Immune response
152-39 Tissue culture
Supplemental Studies: Immune depressed animals
Supplemental Studies: Subchronic feeding study
J
J
J
J
J
J
J
J
J
J
J
J
00049114
000417387-01
00049262
00068401
00060702
00049116
00049263
00060703
00066101
00054189
00049266
00060695
00066102
00066105
00049113
00417387-03
00066103
00066109
00049117
000417387-02
00049265
00066104
00049114
00049264
00091124
00060696
00068403
00068404
00060704
NA
NA
NA
00060700
00060703
00084340
OpNPV
LdNPV
LdNPV
LdNPV
LdNPV
OpNPV
LdNPV
LdNPV
LdNPV
OpNPV
LdNPV
LdNPV
LdNPV
LdNPV
OpNPV
OpNPV
LdNPV
LdNPV
OpNPV
OpNPV
LdNPV
LdNPV
OpNPV
LdNPV
LdNPV
LdNPV
LdNPV
LdNPV
LdNPV
NA
NA
NA
LdNPV
LdNPV
LdNPV
ACCEPT
ACCEPT
ACCEPT
ACCEPT
ACCEPT
ACCEPT
NA
NA
NA
NA
42
-------
Supplemental Studies: Chronic feeding study
ECOLOGICAL EFFECTS TIER I
154-16 7 885.4050 Avian oral Pathogenicity 7
Toxicity Tests
Supplemenatal Studies: Avian oral
Pathogenicity/Toxicity Tests
154-17 Avian injection
154-18/885.4150 Wild Mammal Testing
Suppelmental Studies: Wild mammal toxicity and
pathogenicity test
154-19 7885.4200 Freshwater fish toxicity and
pathogenicity test
154-20 / 885. 4240 Freshwater aquatic
invertebrate test
154-22 / 885.4300 Nontarget plant
154-23 / 885. 4340 Nontarget insect
154-24 / 885. 4380 Honey bee toxicity /
pathogencity test
J
J
J
J
J
J
J
J
J
J
J
00084578
000231360
Tucker/Crabtree
1979
Tucker 1967
00091447
000231360
Tucker/Crabtree
1970
00134314
00060707
00068412
0005465
00060709
NA
NA
Knox 1970
LdNPV
LdNPV
OpNPV
OpNPV
LdNPV
LdNPV
OpNVP
LdNPV
LdNPV
LdNPV
LdNPV
LdNPV
NA
NA
OpNPV /
LdNPV
NA
WAIVE
D
WAIVE
DFOR
LdNPV
WAIVE
DFOR
OpNPV
WAIVE
DFOR
OpNPV
WAIVE
D
WAIVE
D
ACCEPT
FOR
OpNPV
43
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered
relevant by EPA in arriving at the positions and conclusions stated elsewhere in the Reregi strati on
Eligibility Document. Primary sources for studies in this bibliography have been the body of data
submitted to EPA and its predecessor agencies in support of past regulatory decisions. Selections from
other sources including the published literature, in those instances where they have been considered, are
included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of published
materials, this corresponds closely to an article. In the case of unpublished materials submitted to the
Agency, the Agency has sought to identify documents at a level parallel to the published article from
within the typically larger volumes in which they were submitted. The resulting "studies" generally
have a distinct title (or at least a single subject), can stand alone for purposes of review and can be
described with a conventional bibliographic citation. The Agency has also attempted to unite basic
documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by Master
Record Identifier, or "MRID number". This number is unique to the citation, and should be used
whenever a specific reference is required. It is not related to the six-digit "Accession Number" which
has been used to identify volumes of submitted studies (see paragraph 4(d)(4) below for further
explanation). In a few cases, entries added to the bibliography late in the review may be preceded by a
nine character temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a
citation containing standard elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic conventions used reflect the standard of the
American National Standards Institute (ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to show a
personal author. When no individual was identified, the Agency has shown an identifiable
laboratory or testing facility as the author. When no author or laboratory could be identified, the
Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the date is
followed by a question mark, the bibliographer has deduced the date from the evidence
contained in the document. When the date appears 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:
44
-------
(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.
45
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Polyhedral Inclusion Bodies
Gypsy Moth (Lymantria dispar)
Nuclear Polyhedrosis Viruses (NPVs)
References in Open Literature
Banowetz, G.M., J.L. Fryer, PJ. Iwai & M.E. Martignoni, 1976, Effects of the Douglas-fir tussock moth
nucleopolyhedrosis virus (Baculovirus) on three species of salmonid fish. USDA For. Ser. Res. Pap. PNW-
214, 6p. Pac. Northwest For. and Range Exp. Stn., Portland, OR.
Barber, K.W., WJ. Kaupp & S.B. Holmes, 1993, Specificity testing of the nuclear polyhedrosis virus of the
gypsy moth, Lymantria dispar (L.) (Lepidoptera: Lymantriidae), Canadian Entomologist 125: 1055-1066).
Cantwell, G.E., T. Lehnert, and J. Fowler. 1972. Are biological insecticides harmful to the honey bee? Am.
Bee J. 112(7):255-258, (8): 294-296.
Groner, A. 1986, Specificity and safety of baculoviruses. In eds. Granados, R.R., Frederici, B.A. The
Biology of Baculoviruses. Vol. II. CRC Press: Boca Raton , FL. pp. 117-202).
Hudson, H., R.K. Tucker, M.A. Haegle. 19984. Handbook of toxicity of pesticides to wildlife. U.S. Dept. of
Inter., U.S. Fish and Wild. Serv., Resource Publ. 153, 90pp.
Knox, D.A. 1970. Tests of certain insect viruses on colonies of honeybees. J. Invertebr. Pathol. 16(1):152).
Lynn, D.E., E.M. Doughetry, J.T. McClintock and M. Loeb. 1988. Development of cell lines from various
tissues of Lepidoptera, In: invertebrates and Fish Tissue Culture, Y. Kuroda, E. Durstak & K. Maramorosch
(eds.) Japan Scientific Societies, Tokyo.
Podgwaite, J.D., K. S. Shields, R.T. Zerillo, and R.B. Bruen. 1979. Environmental persistence of the
nucleopolyhedrosis virus of the gypsy moth, Lymantria dispar L. Environ.Entomol. 8:523-536.
Shama, S.K., P.H. Etkind, T.M. Odel, A.T. Canada, A.M. Finn, andN.A. Soter, 1982, N.E. J. of Med.
306:1300-1301.
Thomas, D.F. 1995. Biopesticides in the Forest Service: research, development and application. USDA
Forest Service. Washington, DC.
Tucker, R.K. 1967. Subacute oral treatment, mallard hens. Virus (Hemerocampa pseudotsugata). U.S. Dep.
Inter. Fish and Wildl. Serv., Denver Wildl. Res. Cent., Denver, Colo. Intern. Rep. Supplementl, lp..
(unpublish)
Wolf, K. 1975, Evaluation of the exposure offish and wildlife to nuclear polyhedrosis and granulosis
viruses In Baculoviruses for Insect Pest Control: Safety Considerations, p. 109-111, M. Summers, R. Engler,
L.A. Falcon and P.V. Vail, eds. Am. Soc. Microbiol., Washington, D.C.
46
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ENVIRONMENTAL PROTECTION AGENCY
PROGRAM MANAGEMENT AND SUPPORT DIVISION
PESTICIDE DOCUMENT MANAGEMENT SYSTEM (PDMS)
GUIDELINE SEQUENCE BIBLIOGRAPHY
EXPANDED FORMAT
00049262 Hart, E.R.; Thornett, H.D. (1975) Final Report: Acute Oral Toxicity-Rats: LBI Project No.
2515. (Litton Bionetics, Inc. for U.S. Dept. of Agriculture, Forest Service, NEFES, Forest
Insect and Disease Laboratory, unpublished study; CDL:223573-C)
00049263 Hart, E.R.; Thornett, H.D. (1975) Final Report: Acute Dermal Toxicity-Guinea Pigs: LBI
Project No. 2515. (Litton Bionetics, Inc.for U.S. Dept. of Agriculture, Forest Service,
NEFES, Forest Insect and Disease Laboratory, unpublished study; CDL:223573-D)
00049264 Hart, E.R.; Thornett, H.D. (1975) Final Report: Eye Irritation-Rabbits: LBI Project No. 2515.
(Litton Bionetics, Inc. for U.S. Dept. of Agriculture, Forest Service, NEFES, Forest Insect and
Disease Laboratory, unpublished study; CDL:223573-E)
00049265 Hart, E.R.; Thornett, H.D. (1975) Final Report: Primary Skin Irritation-Rabbits: LBI Project
No. 2515. (Litton Bionetics, Inc.for U.S. Dept. of Agriculture, Forest Service, NEFES, Forest
Insect and Disease Laboratory, unpublished study; CDL:223573-F)
00049266 Thornett, H.D. (1975) Final Report: Inhalation Toxicity Study-Rats: Contract No.
12-14-110-4145-33; LBI Project No. 2241. (Litton Bionetics, Inc. for U.S. Dept. of
Agriculture, Forest Service, NEFES, Forest Insect and Disease Laboratory, unpublished
study; CDL:223573-G)
00054565 Moore, R.B. (1977) Determination of the Effects of Nuclear Polyhedrosis Virus in Trout and
Bluegill Sunfish under Laboratory Conditions: Cooperative Agreement No. 42-213.
(Unpublished study received Aug 18, 1977 under 27582-2; prepared by Essex Marine
Laboratory, Inc. and U.S. Forest Service, Northeastern Area, State and Private Forestry,
submitted by Parker Livestock Supply, Inc., Fremont, Nebr.; CDL:231361-A)
00060695 Brown, R.M. (1976) Acute Inhalation Toxicity of~L. dispar~NPV Lot # 33 (Insect Virus):
Laboratory No. 6E-2619. (Cannon Laboratories, Inc. for U.S. Forest Service; unpublished
study; CDL:230162-F)
00060696 Becker, I; Parke, G.S.E. (1976) Report: The Effects of Insect Virus~L. dispar-N.P.V.
Bioserv Lot # 33 on the Eye Mucosa of New Zealand Albino Rabbits: Laboratory No.
6E-2616. (Cannon Laboratories, Inc. for U.S. Forest Service, Insect & Disease Laboratory;
unpublished study; CDL:230162-G)
00060703 Hart, E.R.; Thornett, H.D.; Valerio, M.G. (1975) Final Report:Acute Dermal
Toxicity—Guinea Pigs: LBI Project No. 2515.(Litton Bionetics, Inc. for U.S. Forest Service,
Northeastern Forest Experiment Station, Forest Insect and Disease Laboratory; unpublished
study; CDL:230162-O)
47
-------
00060704 Hart, E.R.; Thornett, H.D. (1975) Final Report: Eye Irritation-Rabbits: LBI Project No. 2515.
(Litton Bionetics, Inc. for U.S. Forest Service, Northeastern Forest Experiment Station, Forest
Insect and Disease Laboratory; unpublished study; CDL:230162-P)
00060706 Galipeau, P.R. (1975) A Progress Report on the Effect of Nuclear Polyhedrosis Virus (NPV)
on Selected Avian Predators of the Gypsy Moth. (Unpublished study received Jan 11, 1977
under 7586-EX-8; submitted by U.S. Dept. of Agriculture, Forest Service; CDL:230162-S)
00060711 Lautenschlager, R.A.; Rothenbacher, H.; Podgwaite, J.D. (1976) The Response of Small
Mammals to an Aerial Application of the Nuclear Polyhedrosis Virus of the Gypsy
Moth,~Lymantria dispar~L. (Unpublished study received Jan 11, 1977 under 27586-EX-8;
prepared by Northeastern Forest Experiment Station, Forest In-sect and Disease Laboratory in
cooperation with Pennsylvania State Univ., Dept. of Veterinary Pathology, submitted by U.S.
Dept. of Agriculture, Forest Service, Washington, D.C.; CDL: 230162-Z)
00060712 Lautenschlager, R.A.; Rothenbacher, H.; Podgwaite, J.D. (1976) The Response of Birds to
Aerially Applied Nuclear Polyhedrosis Virus of the Gypsy Moth,~Lymantria dispar~L.
(Unpublished study received Jan 11, 1977 under 27586-EX-8; prepared by Northeastern
Forest Experiment Station, Forest Insect and Disease Laboratory in cooperation with
Pennsylvania State Univ., Dept. of Veterinary Pathology, submitted by U.S. Dept. of
Agriculture, Forest Service, Washington, D.C.; CDL:230162-AA)
00066093 Mazzone, H.M.; Tignor, G.H.; Shope, R.E.; et al. (1974?) A Serological Comparison of the
Nucleopolyhedrosis Viruses of the Gypsy Moth and the European Pine Sawfly with
Arthropod-Borne and Other Viruses. (U.S. Forest Service, Northeastern Forest Experiment
Station, Forest Insect and Disease Lboratory and others for USFS; unpublished study;
CDL:227336-F)
00066097 U.S. Department of Agriculture, Forest Service (19??) Complete Composition Including
Impurities. (Unpublished study; CDL:227336-J)
00066101 Becker, J.; Parke, G.S.E.; Offenkrantz, F.M. (1976) Dermal Toxicity Study of Insect Virus
(L~dispar~N. PV Bioserv Lot 33) in New Zealand Rabbits: Laboratory No. 6E-2617.
(Cannon Laboratories, Inc. for U.S. Forest Service; unpublished study; CDL:227336-Q)
00066102 Brown, R.M. (1976) Acute Inhalation Toxicity of L.~dispar~NPV Lot #33: Laboratory No.
6E-2619. (Cannon Laboratories, Inc. for U.S. Forest Service; unpublished study;
CDL:227336-R)
00066103 Terrell, Y.; Parke, G.S.E. (1976) Report on Acute IP. Single Dose Toxicity in Mice:
Laboratory No. 6E-2873. (Cannon Laboratories, Inc. for U.S. Forest Service, Insect &
Disease Laboratory; unpublished study; CDL:227336-T)
00066104 Hart, E.R.; Thornett, H.D. (1975) Final Report: Primary Skin Irritation-Rabbits: LBI Project
No. 2515. (Litton Bionetics, Inc.for U.S. Forest Service, Northeastern Forest Experiment
Station, Forest Insect and Disease Laboratory; unpublished study; CDL:227336-U)
48
-------
00066105 U.S. Department of Agriculture, Forest Service (19??) Persistence of~L.
dispar-Nucleopolyhedrosis Virus following Inhalation to Rats: Bioassay of Lung and Tracha
[sic]. (Unpublished study; CDL:227336-Y)
00066108 Lautenschlager, R.A.; Rothenbacher, H.; Podgwaite, J.D. (1976) The Response of Birds to
Aerially Applied Nuclear Polyhedrosis Virus of the Gypsy Moth,~Lymantria dispar~L. (U.S.
Forest Service, Northeastern Forest Experiment Station, Forest Insect and Disease Laboratory
and Pennsylvania State Univ., Dept. of Veterinary Pathology for USFS; unpublished study;
CDL:227336-AN)
00066109 Terrell, Y.; Parke, G.S.E. (1976) Report on Acute IP. Single Dose Toxicity in Mice:
Laboratory No. 6E-2874. (Cannon Laboratories, Inc. for U.S. Forest Service, Insect &
Desease Laboratory; unpublished study; CDL:227336-AO)
00068398 Mazzone, H.M.; Breillatt, I; Bahr, G. (19??) Studies on the Rod Forms and Isolated
Deoxyribonucleic Acid from the Nucleopolyhedrosis Virus of the Gypsy Moth (-Porthetria
dispar~L.). (U.S. Forest Service, Oak Ridge National Laboratry and Armed Forces Institute of
Pathology; unpublished study; CDL:231360-B)
00068399 McCarthy, W.J.; Liu, S.Y. (19??) The Structural Proteins of~Por-|i~thetria dispar-Nuclear
Polyhedrosis Virus. (Unpublished study received Aug 18, 1977 under 27582-2; prepared by
Pennsylvania State Univ., Pesticide Research Laboratory and Graduate Study Center,
submitted by Parker Livestock Supply, Inc., Fremont, Nebr.; CDL:231360-C)
00068402 Parker Livestock Supply, Incorporated (1976) Serological Investigations of~L.
dispar~NPV-Methods. (Unpublished study received Aug 18, 1977 under 27582-2;
CDL:231360-F)
00068403 Becker, I; Parke, G.S.E. (1976) Report: The Effects of Insect Virus~L. dispar-N.P.V.
Bioserv Lot #33 on the Eye Mucosa of New Zealand Albino rabbits: Laboratory No. 6E-2872.
(Cannon Laboratories, Inc. for U.S. Forest Service, Insect & Disease Laboratory; unpublished
study;CDL:231360-H)
00068404 Gordon, E.B.; Kinsel, D.A. (1977) Final Report: Primary Eye Irritation and Corrosiveness
Study in Rabbits: LBI Project No. 2802. (Litton Bionetics, Inc. for U.S. Forest Service,
Northeastern Forest Experiment Station, Forest Insect & Disease Laboratory; unpublished
study ;CDL:2313 60-1)
00091124 Imlay, P.; Terrell, Y. (1978) The Effects of LDP 53 on the Eye Mucosa of New Zealand
Albino Rabbits: Laboratory Nos. 7E-9563 & 7E-9562. (Cannon Laboratories, Inc. for U.S.
Forest Service; unpublished study; CDL:232889-A)
00091447 Roberts, S. (1978) Acute Oral Toxicity of LDP 53 (3.75 x 10A34/g)in Bobwhite Quail:
Laboratory No. 7E-9564. (Cannon Laboratories, Inc. for U.S. Forest Service; unpublished
study; CDL:232890-A)
41893401 Adamson, A. (1991) Gypchek: Product Identity; Manufacturing Process and Quality Control.
Unpublished study prepared by Espro, Inc. 7 p.
49
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50
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Polyhedral Inclusion Bodies
Douglas fir tussock moth (Orgyia pseudotsugata)
Nuclear polyhedrosis viruses (NPVs)
References in Open Literature
Banowetz, G.M., J.L. Fryer, PJ. Iwai & M.E. Martignoni, 1976, Effects of the Douglas-fir tussock moth
nucleopolyhedrosis virus (Baculovirus) on three species of salmonid fish. USDA For. Ser. Res. Pap. PNW-
214, 6p. Pac. Northwest For. and Range Exp. Stn., Portland, OR.
Barber, K.W., WJ. Kaupp & S.B. Holmes, 1993, Specificity testing of the nuclear polyhedrosis virus of the
gypsy moth, Lymantria dispar (L.) (Lepidoptera: Lymantriidae), Canadian Entomologist 125: 1055-1066).
Cantwell, G.E., T. Lehnert, and J. Fowler. 1972. Are biological insecticides harmful to the honey bee? Am.
Bee J. 112(7):255-258, (8): 294-296.
Groner, A. 1986, Specificity and safety of baculoviruses. In eds. Granados, R.R., Frederici, B.A. The
Biology of Baculoviruses. Vol. II. CRC Press: Boca Raton , FL. pp. 117-202.
Hudson, H., R.K. Tucker, M.A. Haegle. 19984. Handbook of toxicity of pesticides to wildlife. U.S. Dept. of
Inter., U.S. Fish and Wild. Serv., Resource Publ. 153, 90pp.
Knox, D.A. 1970. Tests of certain insect viruses on colonies of honeybees. J. Invertebr. Pathol. 16(1):152).
Lynn, D.E., E.M. Dougherty, J.T. McClintock & M. Loeb, 1988, Development of cell lines from various
tissues of Lepidoptera, In: Invertebrate and Fish Tissue Culture, Y. Kuroda, E. Kurstak & K. Maramorosch
(eds.) Japan Scientific Societies, Tokyo).
Podgwaite, J.D., K. S. Shields, R.T. Zerillo, and R.B. Bruen. 1979. Environmental persistence of the
nucleopolyhedrosis virus of the gypsy moth, Lymantria dispar L. Environ.Entomol. 8:523-536.
Shama, S.K., P.H. Etkind, T.M. Odel, A.T. Canada, A.M. Finn, andN.A. Soter, 1982, N.E. J. of Med.
306:1300-1301.
Thomas, D.F. 1995. Biopesticides in the Forest Service: research, development and application. USDA
Forest Service. Washington, DC.
Tucker, R.K. 1967. Subacute oral treatment, mallard hens. Virus (Hemerocampa pseudotsugata). U.S. Dep.
Inter. Fish and Wildl. Serv., Denver Wildl. Res. Cent., Denver, Colo. Intern. Rep. Supplementl, lp..
(unpublish)
Wolf, K. 1975, Evaluation of the exposure offish and wildlife to nuclear polyhedrosis and granulosis
viruses In Baculoviruses for Insect Pest Control: Safety Considerations, p. 109-111, M. Summers, R. Engler,
L.A. Falcon and P.V. Vail, eds. Am. Soc. Microbiol., Washington, D.C.
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ENVIRONMENTAL PROTECTION AGENCY
PROGRAM MANAGEMENT AND SUPPORT DIVISION
PESTICIDE DOCUMENT MANAGEMENT SYSTEM (PDMS)
GUIDELINE SEQUENCE BIBLIOGRAPHY
EXPANDED FORMAT
00049098 Hughes, K.M.; Addison, R.B. (1970) Two nuclear polyhedrosis viruses of the Douglas-fir
tussock moth. Journal of Invertebrate Pathology 16(2): 196-204. (Also~In~unpublished
submission received May 9, 1974 under 27586-EX-2; submitted by U.S. Dept. of Agriculture,
Forest Service, Washington, D.C.; CDL:223569-A)
00049099 Hughes, K.M. (1972) Fine structure and development of two polyhedrosis viruses. Journal of
Invertebrate Pathology 19(2): 198-207. (Also~In~unpublished submission received May 9,
1974 under 27586-EX-2; submitted by U.S. Dept. of Agriculture, Forest Service, Washington,
D.C.; CDL:223569-B)
00049100 Martignoni, M.E. (1972) A rapid method for the identification of nucleopolyhedron types.
Journal of Invertebrate Pathology 19(2):281-283. (Also~In~unpublished submission received
May 9,1974 under 27586-EX-2; submitted by U.S. Dept. of Agriculture, Forest Service,
Washington, D.C.; CDL:223569-C)
00049102 Carnegie, J.W. (1970) Isolation and Characteristics of the DNA from Nuclear Polyhedrosis
Virus. Doctoral dissertation, Oregon State Univ. (Abstract; unpublished study received May
9, 1974 under 27586-EX-2; submitted by U.S. Dept. of Agriculture, Forest Service,
Washington, D.C.; CDL:223569-E)
00049104 Martignoni, M.E.; Iwai, P.J.; Breillatt, J.P. (1971) Heterogeneous buoyant density in batches
of viral nucleopolyhedra. Journal of Invertebrate Pathology 18(2):219-226.
(Also~In~unpublished submission received May 9, 1974 under 27586-EX-2; submitted by
U.S. Dept. of Agriculture, Forest Service, Washington, D.C.; CDL:223569-G)
00049113 U.S. Department of Agriculture (1971) Acute Tests: Intramuscular, Intravenous, and
Intradermal Injections in Rabbits and Guinea Pigs. (Forest Service, Forestry Sciences
Laboratory, unpublished study; CDL:223569-P)
00049114 Weir, R.J. (1967) Final Report: Acute Oral Administration-Rats; Acute Eye
Application—Rabbits: Projects No. 183-119 and No. 183-140. (Hazleton Laboratories, Inc.
for U.S. Dept. of Agriculture, unpublished study; CDL:223569-Q)
00049116 Weir, R.J. (1967) Final Report: Acute Dermal Application-Rabbits: Project No. 183-163.
(Hazleton Laboratories, Inc. for U.S. Dept. of Agriculture; CDL:223569-S)
00049117 Weir, R.J. (1968) Final Report: Primary Skin Irritation-Rabbits: Project No. 183-169.
(Hazleton Laboratories, Inc. for U.S. Dept. of Agriculture, unpublished study;
CDL:223569-T)
00054189 Thornett, H.D. (1975) Final Report: Inhalation Toxicity-Rats: LBI Project No. 2492;
Contract No. 527-COR-72. (Litton Bionetics for U.S. Forest Service, Forestry Sciences
Laboratory, CDL: 226053-J)
52
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00054193 Tucker, R.K. (1966) Virus (-Hemerocampa pseudotsugata-). (U.S.Fish and Wildlife Service,
Denver Wildlife Research Center, Section of Chemical, Physiological & Pesticide-Wildlife
Studies, unpublished study; CDL:226053-N)
41738701 Lilja, H. (1989) Acute Oral Limit Study: TM-Biocontrol-1: [on Rats]: Lab Project Number:
89G-0387. Unpublished study prepared by Toxikon Corp. 9 p.
41738702 Lilja, H. (1989) Primary Dermal Irritation Study: TM-Biocontrol-1:[on Rabbits]: Lab Project
Number: 89G-0386. Unpublished study prepared by Toxikon Corp. 13 p.
41738703 Lilja, H. (1980) Acte Toxicity/Pathogenicity Study with Microbial Pesticide:
TM-Biocontrol-1: [on Mice]:Lab Project No: 90G-0355. Unpublished study prepared by
Toxikon Corp. 12 p.
53
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s? UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
•^ WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you
must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
2. Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section
III-B); or
3. Why you believe EPA should not require your submission of product specific data
in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of your
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product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a list
of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 03-31-96).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VT - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms
SECTION! WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional generic
data requirements are being imposed. You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
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II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service (NTIS),
Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified in
the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD protocols,
they should be modified as appropriate so that the data generated by the study will satisfy the
requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for complying with
data requirements when the studies were not conducted in accordance with acceptable standards.
The OECD protocols are available from OECD, 2001 L Street, N.W., Washington, D.C. 20036
(Telephone number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B} NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the
requirements of any previous Data Call-In(sX or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the requirements of all Notices to
avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must be
submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent to
Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to failure
to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
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The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or (c)
request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is presented
below. A discussion of the various options available for satisfying the product specific data
requirements of this Notice is contained in Section III-C. A discussion of options relating to
requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form. Attachment 2 and
Attachment 3. The Data Call-In Response Form must be submitted as part of every response to this
Notice. In addition, one copy of the Requirements Status and Registrant's Response Form must be
submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form in Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do not
alter the printed material. If you have questions or need assistance in preparing your response, call
or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5 on
the Data Call-In Response Form. If you choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with the Existing Stocks provisions of
this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options are
discussed in Section III-C of this Notice and comprise options 1 through 6 on the Requirements
Status and Registrant's Response Form and item numbers 7a and 7b on the Data Call-In Response
Form. Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both forms
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as well as any other information/data pertaining to the option chosen to address the data
requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the product
specific data requirements (i.e. you select item number 7a or 7b), then you must select one of the
six options on the Requirements Status and Registrant's Response Form related to data production
for each data requirement. Your option selection should be entered under item number 9,
"Registrant Response." The six options related to data production are the first six options discussed
under item 9 in the instructions for completing the Requirements Status and Registrant's Response
Form. These six options are listed immediately below with information in parentheses to guide
registrants to additional instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1. Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the Agency
which includes: (1) a detailed description of the expected difficulty and (2) a proposed schedule
including alternative dates for meeting such requirements on a step-by-step basis. You must
explain any technical or laboratory difficulties and provide documentation from the laboratory
performing the testing. While EPA is considering your request, the original deadline remains. The
Agency will respond to your request in writing. If EPA does not grant your request, the original
deadline remains. Normally, extensions can be requested only in cases of extraordinary testing
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problems beyond the expectation or control of the registrant. Extensions will not be given in
submitting the 90-day responses. Extensions will not be considered if the request for extension is
not made in a timely fashion; in no event shall an extension request be considered if it is submitted
at or after the lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data — Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the attached
data tables that your product and at least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for just one of the products in the group.
The registration number of the product for which data will be submitted must be noted in the
agreement to cost share by the registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be submitting the data. You must
also provide EPA with documentary evidence that an agreement has been formed. Such evidence
may be your letter offering to join in an agreement and the other registrant's acceptance of your
offer, or a written statement by the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement between the parties or the mechanism
to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the
agreement they may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer to
pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product of a registrant
who has in good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to accept your offer.
To qualify for this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share in the burden of
developing that data. You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data, Attachment 7. In addition, you
must demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition to
anything else, offer to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and
must not qualify this offer. The other registrant must also inform EPA of its election of an option
to develop and submit the data required by this Notice by submitting a Data Call-In Response Form
and a Requirements Status and Registrant's Response Form committing to develop and submit the
data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer to
share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
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to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4. Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency or
previously cited by anyone. Existing studies are studies which predate issuance of this Notice. Do
not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a study is not valid and needs to
be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with the requirements of
the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in 40
CFR 160.3(j) " 'raw data' means any laboratory worksheets, records, memoranda,
notes, or exact copies thereof, that are the result of original observations and
activities of a study and are necessary for the reconstruction and evaluation of the
report of that study. In the event that exact transcripts of raw data have been
prepared (e.g., tapes which have been transcribed verbatim, dated, and verified
accurate by signature), the exact copy or exact transcript may be substituted for the
original source as raw data. 'Raw data' may include photographs, microfilm or
microfiche copies, computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments." The term
"specimens", according to 40 CFR 160.3(k), means "any material derived from a test
system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregi strati on Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
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NTIS). A study not conducted according to the PAG may be submitted to the
Agency for consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which states the
Agency's policy regarding acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG are met by the study,
clearly articulate the rationale why you believe the study meets the purpose of the
PAG, including copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January 1970 rarely satisfied the
purpose of the PAG and that necessary raw data are usually not available for such
studies.
If you submit an existing study, you must certify that the study meets all requirements of the
criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet the
criteria outlined above but does contain factual information regarding unreasonable adverse effects,
you must notify the Agency of such a study. If such study is in the Agency's files, you need only
cite it along with the notification. If not in the Agency's files, you must submit a summary and
copies as required by PR Notice 86-5.
Option 5. Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you must
satisfy or supply information to correct all deficiencies in the study identified by EPA. You must
provide a clearly articulated rationale of how the deficiencies have been remedied or corrected and
why the study should be rated as acceptable to EPA. Your submission must also specify the MRID
number(s) of the study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade a
study, but has not yet been reviewed by the Agency. You must provide the MRID number of the
data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those criteria
as well as a certification regarding protocol compliance with Agency requirements.
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Option 6. Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it must
be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core minimum." For all other disciplines
the classification would be "acceptable." With respect to any studies for which you wish to select
this option you must provide the MRID number of the study you are citing and, if the study has
been reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must submit a
completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the Requirements
Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical reasons,
data and references to relevant EPA regulations, guidelines or policies. (Note: any supplemental
data must be submitted in the format required by PR Notice 86-5). This will be the only
opportunity to state the reasons or provide information in support of your request. If the Agency
approves your waiver request, you will not be required to supply the data pursuant to section
3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an option for
meeting the data requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the Requirements Status and Registrant's
Response Form. Product specific data requirements for product chemistry, acute toxicity and
efficacy (where appropriate) are required for all products and the Agency would grant a waiver
only under extraordinary circumstances. You should also be aware that submitting a waiver request
will not automatically extend the due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will remain in force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
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2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure
of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-In Response Form and a Requirements Status and Registrant's
Response Form:
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of the following:
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1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
to, those relating to test material, test procedures, selection of species, number of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting, the
completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or contained
in PR 86-5. All studies must be submitted in the form of a final report; a preliminary report
will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks. Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such existing stocks until
the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular risk concerns will be
determined on case-by-case basis.
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Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate to
the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall submit the information to the
Agency. Registrants must notify the Agency of any factual information they have, from whatever
source, including but not limited to interim or preliminary results of studies, regarding unreasonable
adverse effects on man or the environment. This requirement continues as long as the products are
registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Janet L. Andersen, Acting Director
Biopesticides and Pollution
Prevention Division (7501W)
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Attachments
1 - Data Call-in Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form
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4106 DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing 4106.
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregi strati on of 4106.
This attachment is to be used in conjunction with (1) the Product Specific Data Call-In Notice,
(2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the Requirements
Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use Products for
Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance Criteria
(Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and (7) the Cost Share
and Data Compensation Forms in replying to this 4106 Product Specific Data Call-In
(Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for 4106 are contained
in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional data on 4106 are needed for specific products. These data are required
to be submitted to the Agency within the time frame listed. These data are needed to fully
complete the reregi strati on of all eligible 4106 products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and
procedures established by this Notice, please contact Glenn Williams at (703) 308-8287.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Glenn Williams
Chemical Review Manager Team 81
Biopesticides and Pollution Prevention Division (H7501W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: 4106
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMFOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancelyour product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice
and you will not have to complete any other forms. Further sale and distribution
of your product after the effective date of cancellation must be in accordance with
the Existing Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if
your product is identical to another product and you qualify for a data
exemption, you must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this
form, provide the EPA registration numbers of your source(s;)you would not
complete the "Requirements Status and Registrant's Response" form. Examples of
such products include repackaged products and Special Local Needs (Section
24c) products which are identical to federally registered products.
Item 7a. For each manufacturing use product(MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product(EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with
Option 7 (Waiver Request) for each study for which you are requesting a waiver.
See Item 6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional informationthat does not fit on this form in a
signed letter that accompanies this form. For example, you may wish to report
that your product has already been transferred to another company or that you
have already voluntarily canceled this product. For these cases, please supply all
relevant details so that EPA can ensure that its records are correct.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMFOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier numberassigned by EPA in
Item 3 This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements, all
use patterns are covered by the data requirements. In the case of efficacy data, the
required studies only pertain to products which have the use sites and/or pests
indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documentnless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codesfor each data requirementto
show how you intend to comply with the data requirements listed in this
table. Fuller descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in
the Data Call-In Notice. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29)and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4)
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement I understand
that this option is available only for acute toxicity or certain efficacy data and
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only if EPA indicates in an attachment to this Notice that my product is similar
enough to another product to qualify for this option. I certify that another party in
the agreement is committing to submit or provide the required data; if the required
study is not submitted on time, my product may be subject to suspension. By the
specified due date, I will also submit: (1) a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29)
and (2) two completed and signed copies of the Confidential Statement of
Formula (EPA Form 8570-4)
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Data Call-In Notice that
my product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offerto another registrant (who has an
obligation to submit data) to share in the cost of that data. I am also submitting a
completed "Certification of Offer to Cost Share in the Development Data"
form. I am including a copy of my offer and proof of the other registrant's receipt
of that offer. I am identifying the party which is committing to submit or provide
the required data; if the required study is not submitted on time, my product may
be subject to suspension. I understand that other terms under Option 3 in the Data
Call-In Notice (Section III-C.l.) apply as well. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29)md (2) two
completed and signed copies of the Confidential Statement of Formula (EPA
Form 8570-4)
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (Submitting an Existing Stud$.
I certify that this study will meet all the requirements for submittal of existing data
outlined in Option 4 in the Data Call-In Notice (Section III-C.l.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify
that I have determined that this study will fill the data requirement for which I
have indicated this choice. By the specified due date, I will also submit a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29)to show what data compensation
option I have chosen. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29)and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4)
5. By the specified due date, I will submit or cite data to upgrade a study classified
by the Agency as partially acceptable and upgradable (Upgrading a Study). I
will submit evidence of the Agency's reviewindicating that the study may be
upgraded and what information is required to do so. I will provide the MRID or
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Accession number of the study at the due date. I understand that the conditions
for this option outlined Option 5 in the Data Call-In Notice (Section III-C.l.)
apply. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form
(EPA Form 8570-29)and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4)
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not
reviewed by the Agency (Citing an Existing Study). If I am citing another
registrant's study, I understand that this option is available only for acute toxicity
or certain efficacy data and only if the cited study was conducted on my product,
an identical product or a product which EPA has "grouped" with one or more
other products for purposes of depending on the same data. I may also choose this
option if I am citing my own data. In either case, I will provide the MRID or
Accession number(s)for the cited data on a "Product Specific Data Report" form
or in a similar format. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29)and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4)
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request,
including technical reasons, data and references to relevant EPA regulations,
guidelines or policies. [Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. I understand that this is my only
opportunity to state the reasons or provide information in support of my request.
If the Agency approves my waiver request, I will not be required to supply the
data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency denies my waiver
request, I must choose a method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I must, within 30 days of my
receipt of the Agency's written decision, submit a revised "Requirements Status
and Registrant's Response" Form indicating the option chosen. I also understand
that the deadline for submission of data as specified by the original data call-in
notice will not change. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29)and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4)
Items 10-13. Self-explanatory.
NOTE: You may provide additional informationthat does not fit on this form in a
signed letter that accompanies this form. For example, you may wish to report
that your product has already been transferred to another company or that you
73
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have already voluntarily canceled this product. For these cases, please supply all
relevant details so that EPA can ensure that its records are correct.
74
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75
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76
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No toxicology batching is required for this case.
77
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Attachment a. List of All Registrants Sent This Data Call-In (insert) Notice
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product specific data submission must
also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source product's
label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
79
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Maine
Company Number
Product Name
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
83
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84
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
'
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
3(c)(1 )(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
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The following is a list of available documents for 4106 that my further assist you in
responding to this Reregi strati on Eligibility Decision document. These documents may be
obtained by the following methods:
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies can be downloaded from the Pesticide Special
Review and Reregi strati on Information System at 703-308-7224. They also are
available on the Internet on EPA's gopher server, GOPHER.EPA.GOV, or
using ftp on FTP.EPA.GOV, or using WWW (World Wide Web) on
WWW.EPA.GOV., or contact glenn williams at (703)-308-8287.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for 4106.
The following documents are part of the Administrative Record for 4106 and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person
listed on the Chemical Status Sheet.
1.Health and Environmental Effects Science Chapters.
2.Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
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