United States Prevention, Pesticides EPA738-R-96-33
Environmental Protection And Toxic Substances July 1996
Agency (7508W)
4»EPA Reregistration
Eligibility Decision (RED)
Strychnine
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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 strychnine. The
enclosed Reregi strati on 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. It may also include requirements for additional
data (generic) on the active ingredients 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
receipt of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
Please note that this RED was finalized and signed prior to August 3, 1996. On that
date, the Food Quality Protection Act of 1996 ("FQPA") became effective, amending portions
of both the pesticide law (FIFRA) and the food and drug law (FFDCA). This RED does not
address any issues raised by FQPA, and any tolerance-related statements in the RED did not
take into account any changes in tolerance assessment procedures required under FQPA. To
the extent that this RED indicates that a change in any tolerance is necessary, that
determination will be reassessed by the Agency under the standards set forth in FQPA before
a proposed tolerance is issued. To the extent that the RED does not indicate that a change in
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the tolerance is necessary, that tolerance, too, will be reassessed in the future pursuant to the
requirements of FQPA.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregi strati on Division representative Ed
Setren at (703) 308-8166. Address any questions on required generic data to the Special
Review and Reregi strati on Division representative Bonnie Adler at (703) 308-8523.
Sincerely yours,
Lois Rossi, Division Director
Special Review
and Reregi strati on Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms) You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response. All data waiver and time extension requests must be
accompanied by a full justification. All waivers and time extensions must be granted by EPA
in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You
must submit the following items for each product within eight months of the date of this
letter (RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as
formulation changes, or labeling changes not related to reregi strati on) separately. You may,
but are not required to, delete uses which the RED says are ineligible for reregi strati on. For
further labeling guidance, refer to the labeling section of the EPA publication "General
Information on Applying for Registration in the U.S., Second Edition, August 1992"
(available from the National Technical Information Service, publication #PB92-221811;
telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI)
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d Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e Certification With Respect to Data Compensation Requirements Complete
and sign EPA form 8570-31 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are
not complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregi strati on determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
STRYCHNINE
LISTC
CASE 3133
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
STRYCHNINE REREGISTRATION ELIGIBILITY DECISION TEAM i
ABSTRACT v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 4
D. Data Requirements 4
E. Regulatory History 4
III. SCIENCE ASSESSMENT 10
A. Physical Chemistry Assessment 10
B. Human Health Assessment 11
1. Toxicology Assessment 11
a. Acute Toxicity 12
b. Other Toxicological Considerations 12
(1) Poisoning Incidents 12
c. Toxicological Endpoints for Risk Assessment 13
2. Exposure Assessment 14
a. Dietary Exposure 14
b. Occupational and Residential Exposures 14
3. Risk Assessment 15
a. Dietary 15
b. Occupational and Residential 15
C. Environmental Assessment 16
1. Ecological Toxicity Data 16
a. Toxicity to Terrestrial Animals 16
2. Environmental Fate 21
a. Environmental Fate Assessment 21
b. Environmental Fate and Transport 21
c. Water Resources 22
3. Exposure and Risk Characterization 22
a. Ecological Exposure and Risk Characterization 22
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 23
A. Determination of Eligibility 23
B. Determination of Eligibility Decision 24
1. Eligibility Decision 24
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2. Eligible and Ineligible Uses 25
C. Regulatory Position 26
1. Restricted Use Classification 26
2. Child-Resistant Packaging 26
3. Personal Protective Equipment 26
V. ACTIONS REQUIRED OF REGISTRANTS 29
A. Manufacturing-Use Products 29
1. Additional Generic Data Requirements 29
2. Labeling Requirements for Manufacturing-Use Products 29
B. End-Use Products 29
1. Additional Product-Specific Data Requirements 30
2. Labeling Requirements for End-Use Products 30
a. Products Intended Primarily for Occupational Use 30
b. Products Intended Primarily for Homeowner Use 32
3. Other Labeling Requirements 33
a. Products Intended Primarily for Occupational Use 33
b. Products Intended Primarily for Home Use 33
c. All End-Use Products 34
C. Existing Stocks 34
VI. APPENDICES 35
APPENDIX A. Table of Use Patterns Subject to Reregistration 36
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 47
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of 3133 53
APPENDIX D. Generic Data Call-In 61
Attachment 1. Chemical Status Sheet 81
Attachment 2. Generic DCI Response Forms Inserts (Form A) plus
Instructions 85
Attachment 3. Requirements Status and Registrants' Response Forms
Inserts (Form B) plus Instructions 89
Attachment 4. List of Registrant(s) sent this DCI (insert) 98
APPENDIX E. Product Specific Data Call-In 99
Attachment 1. Product Specific Data Call-In Response Forms (Form
A inserts) Plus Instructions 113
Attachment 2. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 115
Attachment 3. EPA Batching of End-UseProducts for Meeting Data
Requirements for Reregistration 121
Attachment 4. List of Registrant(s) sent this DCI (insert) 125
Attachment 5. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions .... 126
Attachment 6. List of Available Related Documents 135
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STRYCHNINE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Eric Maurer
Gabe Patrick
William Gross
Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Environmental Fate and Effects Risk Assessment
Mary Powell
John Jordan
Jim Goodyear
Health Effects Risk Assessment
Jane Smith
John Redden
Tom Myers
John Leahy
Jerome Blondell
Registration Support Assessment
Shyam Mathur
Bill Jacobs
Risk Management
Bonnie Adler
Kathy Davis
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Risk Characterization and Analysis Branch
Risk Characterization and Analysis Branch
Risk Characterization and Analysis Branch
Occupational and Residential Exposure Branch
Occupational and Residential Exposure Branch
Registration Support Branch
Insecticide-Rodenticide Branch
Accelerated Reregi strati on Branch
Accelerated Reregi strati on Branch
Office of General Counsel:
Phil Ross
Pesticides Branch
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The 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
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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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ABSTRACT
The U. S. Environmental Protection Agency has completed its reregi strati on eligibility
decision for the pesticide strychnine. This decision includes a comprehensive reassessment of
the required target data for only the below-ground uses of strychnine. Strychnine products
labeled for uses above-ground have been temporarily cancelled by the Agency as part of a U.S.
District Court injunction. The use of strychnine above-ground is not considered in this eligibility
assessment and decision.
Certain products containing strychnine are classified as restricted-use for use only by or
under the direct supervision of certified applicators. Other products are available for use by the
general public. Strychnine is used primarily to control pocket gophers in their below-ground
tunnels. The Agency has concluded that the restricted-use products used below-ground by
certified applicators, as prescribed in this document, will not cause unreasonable risks to humans
or the environment and therefore, these products are eligible for reregi strati on. To mitigate risks
of potential toxicity to handlers, the Agency is requiring, among other changes, the use of
personal protective equipment.
For the unclassified general use products, the Agency has determined that a decision of
reregi strati on eligibility cannot be made at this time. More information on product-specific acute
toxicity, poisoning incidents, and benefits is needed before a determination can be made. Also,
the Agency is requiring a dermal subchronic toxicity study on technical strychnine to confirm the
presumption of low absorbency.
Before reregistering the restricted-use strychnine products labeled for below-ground uses,
the Agency is requiring that product specific data and revised Confidential Statements of Formula
(CSF) be submitted within eight months of the issuance of this document. These data include
product chemistry and acute toxicity testing for each product registration. Revised labeling to
reflect the changes required by this RED will be required at a later date. After reviewing these
data and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will
reregister a product.
Before the Agency will make a determination of eligibility for the unclassified below-
ground uses of strychnine products by the general public, the additional data mentioned above
are required. This information includes poison control center data for products used by
homeowners, incident reports for poisoning of children, and end-use product acute toxicity. A
Data Call-In for this information is included with this document. Upon review of this information
and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will
consider whether to reregister these products.
v
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregi strati on of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregi strati on process to be completed in
nine years. There are five phases to the reregi strati on process. The first four phases of the
process focus on identification of data requirements to support the reregi strati on of an active
ingredient and the generation and submission of data to fulfill the requirements. The fifth phase
is a review by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data
submitted to support reregi strati on.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregi strati on" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregi strati on involves a thorough review of the scientific data base underlying
a pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
Because strychnine products labeled for uses above-ground are temporarily cancelled by
the Agency as part of a U.S. District Court injunction, these uses were excluded from this
eligibility assessment and decision. This document presents the Agency's decision regarding the
reregi strati on eligibility of the currently registered below-ground uses of strychnine. The
document consists of six sections. Section I is the introduction. Section II describes strychnine,
its uses, data requirements and regulatory history. Section III discusses the human health and
environmental assessment based on the data available to the Agency. Section IV presents the
reregi strati on decision for strychnine. Section V discusses the reregi strati on requirements for
strychnine. Finally, Section VI is the Appendices which support this Reregi strati on Eligibility
Decision. Additional details concerning the Agency's review of applicable data are available on
request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregi strati on Eligibility
Decision:
• Chemical Name: Strychnine; strychnine alkaloid
• CAS Registry Number: 57-24-9
• OPP Chemical Code: 076901
• Empirical Formula: C21H22N2O2
B. Use Profile
The following is information on the currently registered below-ground uses with
an overview of use sites and application methods. A detailed table of these uses of
strychnine is in Appendix A. All end-use strychnine products are classified as Restricted-
use pesticides except for those products which contain strychnine at nominal
concentrations no greater than 0.5% and which are limited by their labels to manual,
below-ground applications only. For purposes of this classification, use of hand-operated
mechanical probes which dispense bait is considered to be a manual application.
Restricted-use products are limited to sale and/or use by or under the supervision of
certified pesticide applicators.
Type of Pesticide: Poison, single dose
Mode of Action: Chemical blocks inhibitory neurons causing
excessive excitation which manifests itself as
convulsions.
Use Groups and Sites:
The use categories listed below for strychnine include food and feed crop
sites. Because strychnine products are allowed for use only below-ground,
exposure to food and feed crops is not expected.
Terrestrial Food Crop Sites: orchards
Terrestrial Food+Feed Crop Sites: agricultural crops/soils
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Terrestrial Feed Crop Sites: grass (forage/fodder/hay), pastures, rangeland,
and alfalfa.
Terrestrial Non-Food Sites: nonagricultural rights-of-way (fencerows and
hedgerows), and non agricultural uncultivated areas (soils).
Aquatic Food Sites: irrigation systems
Forestry: forest trees (all or unspecified)
Outdoor Residential: household/domestic dwellings (outdoor premises)
and residential lawns.
Use Site unspecified: site not specified on label. Labeling amendments to
specify sites are addressed in Section V.
Target Pest: pocket gopher
Formulations Types Registered:
Technical Grade Active Ingredient: Dust/Powder (100%)
Manufacturing-Use Product: Dust/Powder (98.4%)
End-Use Product: Bait/Solid (0.44-1.8%), Granular (0.5%) and Paste
Concentrate (3.2-10.0%).
Methods of Application:
Type of Treatment: bait application; paste is mixed with cabbage to use
as a bait.
Equipment:
Manual: Spoon, manually operated bait dispensing probe
Mechanical: "Burrow builder" - Burrow builders create tunnels
which intersect pocket gopher tunnels and 'plant' the
bait below ground.
Timing: as needed
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C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
strychnine. Due to the use pattern of strychnine, data have been collected at the pest level
rather than at the different sites of application. Usage data provided by the United States
Department of Agriculture, Animal and Plant Health Inspection Service (USD A/APHIS),
from 1989 to 1991 show that 1,000 to 1,500 pounds of strychnine (active ingredient) were
used annually to control gophers, ground squirrels, prairie dogs and voles. Currently,
only products to control pocket gophers are registered. A trend towards reduced use has
been noted over the years, possibly as a result of the 1988 injunction against the above-
ground uses of strychnine.
D. Data Requirements
The Agency applied the data requirements specified in 40 CFR §158 and the
Reregi strati on Phase II Guidance to the active ingredient in this chemical case. Studies
on the active ingredient (generic) were generated and submitted to the Agency. The data
from these studies along with other available information form the basis for the Agency's
scientific assessment and regulatory decisions. Appendix B includes the generic data
requirements to support reregi strati on of currently registered uses.
E. Regulatory History
1. Origin and Early Use
Strychnine alkaloid is obtained from the seeds of Strychnos nux
vomica, a small tree found in India, North Australia, Sri Lanka, and
Vietnam. Although seeds of the plant were used "at least as early as 1640"
to kill birds, cats, and dogs in Europe, strychnine alkaloid itself was not
discovered until 1817. In one form or another, strychnine has been used
for centuries to poison vertebrate animals in many parts of the world.
(Clark, 1975)
2. U.S. Regulatory History of Strychnine
The first Federal registrations for strychnine alkaloid products were
issued in 1947, the year in which the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) was passed to require that pesticides be
registered. Strychnine had been used in the U.S. to control vertebrate
animals for many years prior to 1947. As many as 35 strychnine sulfate
and 717 strychnine alkaloid registrations (including transfers, and intrastate
and Special Local Needs products) have been known to exist in the U.S.
However, in 1996, less than 50 active strychnine alkaloid registrations
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remain.
(a) Classification of Strychnine Products
In 1978, EPA classified all strychnine products as Restricted Use
pesticides except for baits containing strychnine alkaloid at concentrations
of 0.5% or less which were labeled for manual below-ground applications
only (40_CER, §152.175).
(b) Uses to Control Predators
All uses of strychnine to control predators in the U.S. were
canceled in 1972 following the issuance of PR Notice 72-2 with a
cancellation order. This PR Notice was issued shortly after a report on
predator control and an executive order banning use of toxicants to control
predators on Federal lands were issued.
In 1973, EPA issued the first of many emergency exemptions under
§18 of FIFRA to permit use of strychnine alkaloid egg baits to control
skunks in rabies epizootic areas in Montana. Other emergency exemptions
were issued for this use in Wyoming and South Dakota through the mid
1980's. Applications for §3 federal registrations of strychnine for use in
egg baits to control skunks were submitted to EPA in the 1970s and the
1980s.
In 1986 and 1987, EPA held Subpart D hearings concerning use of
strychnine in egg baits to control skunks. On June 18, 1987,
Administrative Law Judge Marvin E. Jones issued an Initial Decision
modifying the 1972 executive order:
"to permit registration of strychnine to reduce populations of
skunks as a means of suppressing the spread of rabies to humans
and domestic animals." (Jones, 1987)
Applications for §3 registrations which would permit use of
strychnine in egg baits in Montana and Wyoming remain pending. Most
potential placement locations for strychnine egg baits would be above-
ground and, therefore, are prohibited by an injunction against above-
ground uses of strychnine, discussed below.
(c) Above-ground Uses
On December 1, 1976, EPA issued a "Rebuttable Presumption
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Against Registration" (RPAR) notice concerning all above-ground,
outdoor uses of strychnine covered by registrations in existence at that
time. This initial position document (PD 1) was followed by a PD 2/3
issued on November 5, 1980, to note EPA's preliminary findings in the
RPAR (now called Special Review) of the above-ground uses of
strychnine. Following receipt of responses from concerned parties and
reconsideration of certain issues, EPA issued a PD 4 document on
September 30, 1983. The PD 4 noted the conclusions that EPA reached
during its Special Review of above-ground uses of strychnine. On October
19, 1983, a Federal Register notice was published in which EPA
summarized the conclusions reached in the strychnine PD 4 document and
announced the Agency's intent to cancel certain outdoor, above-ground
uses of strychnine and to impose additional conditions and limitations on
others. On October 28, 1983, EPA sent "Notice of Intent to Cancel"
(NOIC) letters to certain strychnine registrants pursuant to the Agency's
decisions summarized in the PD 4 document.
Many parties requested hearings on the conclusions expressed in
the strychnine PD 4. A process of negotiated settlement was initiated.
Several environmental groups left the settlement discussions and, in
August of 1986, filed suit against EPA in U.S. District Court in Minnesota,
charging that the manner in which the Agency was handling registrations
for above-ground uses of strychnine products was in violation of several
Federal statutes.
On March 4, 1987, EPA announced the results of the negotiated
settlement reached with parties other than the groups which had filed suit.
This negotiated settlement included modification of certain conditions of
the strychnine PD 4 to allow above-ground uses of strychnine to control
voles and prairie dogs and to expand the scope of permissible uses to
control ground squirrels.
On April 11, 1988, the U.S. District Court in Minnesota issued an
injunction against above-ground uses of strychnine compounds, ruling that
such uses were in violation of the Migratory Bird Treaty Act, the Bald and
Golden Eagle Protection Act, and the Endangered Species Act; and that
EPA violated the Administrative Procedures Act by accepting labels which
permitted above-ground uses of strychnine. On April 25, 1988, EPA filed
a motion with U.S. District Court in Minnesota seeking clarification of the
order of April 11, 1988 and other relief. On May 4, 1988, EPA notified
registrants of strychnine products registered for above-ground uses that
they must comply with the court's order. On May 25, 1988, a Federal
Register Notice was issued which publicized and published the District
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Court's Decision and stated that compliance with the decision was
required.
On July 18, 1988, the U.S. District Court in Minnesota denied
requests by EPA and others for a stay of imposition of the injunction
against above-ground uses of strychnine pending appeal. On September
30, 1988, EPA sent "Notice of Temporary Cancellation" letters pursuant
to the injunction to registrants of strychnine products labeled for above-
ground uses. On October 5, 1988, the "Notice of Temporary Cancellation"
was published in the Federal Register.
EPA, the Department of the Interior, and the American Farm
Bureau Federation appealed the U.S. District Court's decision on October
17, 1988. On August 16, 1989, the appellate court "affirmed in part and
reversed in part" the decision of the U.S. District Court in Minnesota
(Fagg, 1989). The lower court was reversed on its findings pertaining to
the Administrative Procedures Act, the Migratory Bird Treaty Act, and the
Bald and Golden Eagle Protection Act. The lower court's decision with
respect to the Endangered Species Act (ESA) was upheld, leaving the
injunction in place. The appellate court found that a citizen's suit provision
in the ESA meant that the environmental groups could proceed against
EPA under that statute, that above-ground uses of strychnine had been
reported to have resulted in the taking of endangered species, and that EPA
had not obtained from the U.S. Fish and Wildlife Service (FWS) written
authorization for incidental takings of endangered species at the time that
the reported takings occurred.
Acknowledging that incidental taking statements were included in
biological opinion documents issued by FWS subsequent to the imposition
of the injunction, the appellate court wrote,
"If the EPA can show that it now has obtained authorization
for the incidental takings and has acted in compliance with
the requirements of the taking statement, the court should
lift the ESA injunction."
Since the injunction was instituted, FWS has issued several
biological opinion documents pertaining to above-ground uses of
strychnine. The dates of these documents are listed below, along with
brief descriptions of their contents.
May 25, 1988: Pertained to most above-ground uses of strychnine. Issued in response to
request made by EPA (in 1987) before injunction decision was rendered.
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June 24, 1988:
May 10, 1989:
August 30, 1990:
July 9, 1991:
July 28, 1992:
March 30, 1993:
July 15, 1994:
Opinion concentrated on reasonable and prudent measures to be taken to
avoid jeopardy to black-footed ferrets.
Amended and extended 1988 biological opinions pertaining to strychnine.
Pertained to use of strychnine alkaloid in egg baits to control rabid striped
skunks in Montana and Wyoming. FWS concluded that it would have to
approve on a case-by-case basis all proposed strychnine egg bait
applications in certain areas of Montana and Wyoming (where grizzly
bears and/or gray wolves occur) and that applications could not be made
within 1/2 mile of any prairie dog colony, unless a search for evidence of
black-footed ferrets was conducted by a biologist trained in a FWS-
approved workshop, or within 2.5 miles of bald eagle nests between
February 1 and August 15, within 1/4 mile of bodies of water used by
summer nonbreeding bald eagles, within 2.5 miles of bald eagle wintering
concentration areas from December 1 through February 19, or anywhere
in Montana or Wyoming during November or from February 20 to April
30.
FWS informed EPA that a plan proposed by Montana Department of
Livestock (MDL) pertaining to possible reinstatement of above-ground use
of strychnine to control of ground squirrels in Montana was too complex
to be workable, adding that EPA could elect to initiate formal consultation
on the plan.
Pertained to Endangered Species consultation on impacts of Animal
Damage Control (ADC) program of the Animal and Plant Health
Inspection Service (APHIS), U.S. Department of Agriculture. Considered
use of strychnine by ADC program including the "temporarily cancelled"
above-ground uses claimed on labels for APHIS's own strychnine
registrations.
FWS assessed revised plan from MDL and found jeopardy to bald eagles
and black-footed ferrets for 0.5% strychnine alkaloid use to control ground
squirrels in Montana. FWS forbade use within 0.5 miles of prairie dog
colonies and within 4.35 miles of prairie dog colonies where FWS had
confirmed presence of a black-footed ferret. Otherwise, FWS accepted
Montana's proposed maps and restrictions (including prohibition of
applications from November 1 of one year through April 30 of the next).
"Draft" biological opinion issued in response to EPA's consultation request
pertaining to use of strychnine alkaloid baits to control certain passerine
birds in California.
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The biological opinions issued since the injunction against above-
ground uses of strychnine was imposed include provisions for incidental
takings, although the levels of incidental take permitted were
"unquantifiable" for certain endangered species and zero for others. Prior
to the injunction, FWS issued biological opinions pertaining to above-
ground uses of strychnine on March 30, 1979, and on November 9, 1984.
The biological opinion issued in 1979 was broad in scope. The 1984
opinion concentrated upon the use of ferret searches to avoid risks posed
by strychnine to black-footed ferrets.
As of the date of this document, EPA has not approached the U.S.
District Court in Minnesota since 1988 with proposals to lift or modify the
strychnine injunction. Above-ground pesticidal uses of strychnine remain
prohibited in the U.S.
(d) Data Call-Ins
Following completion of the strychnine Special Review, EPA
issued several Data Call-Ins (DCIs) for data which were needed to
complete assessments of the risks and benefits associated with the various
uses of pesticide products containing strychnine compounds. On August
8, 1984, EPA issued a DCI requiring efficacy studies to be performed on
strychnine baits which were claimed to control ground squirrels.
The Agency issued a second DCI on October 10, 1986, in which a
broad spectrum of data were required. A third DCI was issued on
December 15, 1987. In it the Agency required submission of
environmental fate data pertaining to strychnine compounds. On
December 17, 1987, EPA revised compliance schedules for DCIs
previously issued.
On October 6, 1988, EPA sent letters of notice of intent to suspend
(NOIS) registrations to the affected registrants with products containing
strychnine alkaloid because their responses to the DCIs had been untimely.
Many affected registrants requested hearings. EPA entered settlement
discussions with the registrants who comprised a strychnine data
submitters' consortium which had been formed. By March of 1989, a
negotiated settlement agreement was accepted by all parties and by the
Administrative Law Judge. The Strychnine Settlement Agreement of 1989
modified and imposed new schedules for meeting data requirements
covered under prior data call-ins and included certain requirements and
limitations affecting the labeling of strychnine products. Any modification
of labeling for registered strychnine alkaloid products currently is
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governed by the language of the Strychnine Settlement Agreement of
1989, as modified by Judge Greene's September 27, 1996, Order.
The consortium supported the continued registration of strychnine
alkaloid but not strychnine sulfate. No individual registrants or other
parties submitted the data needed to retain strychnine sulfate as a Federally
registered pesticide chemical. On September 11, 1990, the last remaining
strychnine sulfate registrations were cancelled.
In September 1992, under the current reregistration program (Phase
IV) EPA issued a DCI that required data for physical chemistry, ecological
effects, additional environmental fate and residue chemistry data. The
residue chemistry data requirements were later waived because the
products are used below-ground and exposure to food and feed crops is
unlikely.
(e) Current Status of Strychnine Registrations
Currently, the only strychnine alkaloid pesticide products which
may be used in the U.S. are end-use products labeled only for below-
ground uses and manufacturing use products that are used to manufacture
such end-use products. The primary use pattern for strychnine end-use
products applied below-ground is the control of pocket gophers. The last
remaining strychnine alkaloid product claimed to control moles was
cancelled in 1995. The last remaining strychnine alkaloid product for
control of house mice was cancelled in 1989, thereby fully cancelling all
indoor uses of strychnine products.
Above-ground uses of strychnine remain "temporarily cancelled"
because of the District Court's injunction. The registrations for some of
these products still exist (i.e., they are not cancelled under FIFRA), but the
products may not be sold, distributed, or used. Other products for which
above-ground uses were claimed were voluntarily cancelled by their
registrants after the injunction was imposed.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
TGAI: Strychnine alkaloid
Molecular weight: 334.40
10
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Color:
White
Physical state:
Odor:
Melting point:
Specific gravity:
Solubility:
Vapor pressure:
Dissociation constant:
Octanol-water partition
coefficient:
Solid crystalline powder
Odorless
273°C
0.25 at25°C
Very insoluble in water (0.0115 g/100 ml) but
fairly soluble (20%) in chloroform.
Being solid with a high melting point, the vapor
pressure is negligible.
5.49x ID'9
5
7
9
0.9 + 0.13
4.0 + 0.2
114.0 + 4.0
pH: 9.5
Stability: Stable
B. Human Health Assessment
1. Toxicology Assessment
Strychnine is a powerful convulsant. Glycine, an important inhibitory
transmitter to motorneurons and interneurons in the spinal cord, is affected by
strychnine. Strychnine acts as a selective competitive antagonist to block the
inhibitory effects of glycine at all glycine receptors. The convulsant action of
strychnine results from interference with postsynaptic inhibition normally
mediated by glycine.
The human health assessment for strychnine is based on the acute toxicity
for the technical and is described below. Because of the high acute toxicity via the
oral and ocular routes, subchronic and chronic data were not required. In the
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absence of inhalation data and based on the high acute oral and ocular toxicity, a
default toxicity category of I was assigned for acute inhalation. A confirmatory
21-day dermal study is required to describe the dermal absorption. Additional
data are also required to describe the acute toxicity of the end-use products
intended for homeowner use.
a. Acute Toxicity
The generic acute toxicological database for strychnine is adequate
and is summarized below in Table 1.
Table 1. Acute Mammalian Toxicity
Guideline
81-1
Acute Oral LD50, rat
81-2
Acute Dermal LD50,
rabbit
81-3
Acute LC50 inhalation
81-4
Primary eye irritation,
rabbit
81-5
Primary dermal
irritation, rabbit
Results
6.4 mg/kg males
2.2 mg/kg females
Death occurred within 1 hr.
2000 mg/kg. No signs of toxicity
observed.
WAIVED
Irritation and mortality
No irritation, mortality or signs of
toxicity were observed.
Toxicity
Category
I
III
I*
I
IV
MRID #s
40908901
41210701
40908902
41210702
40908904
41210704
40908903
41010703
All studies performed with Strychnine Alkaloid Technical (Purity = 99.42%)
* Assigned Toxicity Category I as a default based on high acute toxicity from other routes of exposure.
b. Other Toxicological Considerations
(1) Poisoning Incidents
Approximately 100 cases of accidental exposure to strychnine
rodenticides are reported annually to U.S. Poison Control Centers (Litovitz
et al. 1986-1994). However, EPA believes this number of accidental
exposures is low based on comparisons with other data sources which
show that Poison Control Center data generally underestimate the true
extent of poisoning.
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During a nine-year period (1985 - 1993), 1,359 exposures to
strychnine were recorded by the U.S. Poison Control Centers. About one
third of these cases were categorized as intentional exposures, such as
suicide or homicide, or of unknown intent. Of the accidental exposure
cases, where the age of the exposed individuals was available, nearly half
of those exposed were under six years old.
Of the accidental cases where medical outcome was determined
(from 1985 through 1992), there were nineteen cases which had a
moderate outcome, five cases that were major, and one fatality. Among
these twenty-five cases with medical outcome, two were confirmed to be
children. Age was unknown for some of the cases. None of the twenty-five
exposures were described as occupational.
Estimates of lethal dose for strychnine baits as currently formulated
(0.5% active ingredient) suggest that a single swallow by a 10 kg child
could be lethal. For a typical one-year old child weighing 10 kg, this
would mean a dose of 1.1-1.8 mg/kg of strychnine, which is in the
potentially lethal range.
The available information from various sources on human
poisoning incidents is conflicting and unclear as it relates to accidental
exposure to strychnine products. This problem and the uncertainty of the
amounts of end-use products which could result in significant toxicity to
humans, especially children, do not enable the Agency to determine with
confidence the magnitude and seriousness of poisonings from the use of
strychnine in the U.S. Additional information to clarify these issues is
required.
c. Toxicological Endpoints for Risk Assessment
Because of the high acute toxicity and the current limited use
pattern for strychnine, only acute studies for the active ingredient have
been required. Previously all normally required subchronic and chronic
study requirements have been waived. The risk assessment is, therefore,
based on the acute toxicity data and acute concerns. A subchronic dermal
toxicity study is required to confirm the presumed low level of dermal
absorption.
Based on the severe oral toxicity of this chemical and the nonfood
use status, a reference dose and carcinogenicity classification has not been
determined at this time. Strychnine has not been reviewed by the Joint
FAO/WHO pesticide committee.
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2. Exposure Assessment
a. Dietary Exposure
Given the below-ground use pattern, the Agency believes there is
no opportunity for strychnine residues on/in food/feed crops when it is
applied underground at crop sites. Therefore, the Agency waived the
requirements for residue data for the continued registration of the below-
ground uses of strychnine. For this reason, a dietary exposure assessment
is not appropriate. Appropriate label restrictions and/or residue data will
be required for above-ground uses if they become reinstated.
b. Occupational and Residential Exposures
For the purposes of this document, the term "occupational" will
represent those persons who are working under the direct supervision of
a certified applicator, and the term "homeowner" represents those persons
who reside in homes and are not using pesticide products in a professional
capacity.
The Agency normally conducts an occupational and/or residential
exposure assessment for an active ingredient if (1) certain active ingredient
toxicological criteria are triggered and (2) there is potential for exposure
to handlers (mixers, loaders, applicators, etc.) during use or to persons
entering treated sites after application is complete; or, if incidence data
(acute poisonings) indicate use concerns.
For strychnine all these factors are present: its high acute toxicity
by oral, eye, and presumably inhalation routes of exposure; the potential
for exposure during mixing and applying end-use products; and, reported
incidents as summarized above. Due to these factors, there are concerns
for both occupational and residential users.
Occupational-use and Homeowner-use Products
Products containing strychnine are intended for both occupational-
use and homeowner-use (i.e., for pocket gopher control in agricultural
work areas or residential areas). All products containing a nominal
concentration of more than 0.5% strychnine are classified as Restricted-
Use pesticides and sale and application are limited to certified pest control
operators. Formulations available to homeowners are at nominal
concentrations of 0.5%. In this document, the Agency uses the term
"occupational-use" to describe those products that are classified as
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restricted-use products. Those products which are unclassified are referred
to as "homeowner-use" or "residential-use" products.
Handler Exposures
The Agency recognizes four primary exposure scenarios for
strychnine: (1) mixing and applying bait formulations; (2) mixing and
applying paste formulations; (3) mixing/loading for burrow building
applications; and, (4) applying baits using burrow builder equipment.
However, due to the absence of exposure data which would be adequate
for the Agency to estimate exposures for these four scenarios, a quantified
exposure assessment could not be conducted.
While EPA does not have, nor is it requiring, appropriate data for
reliable exposure estimates from the use of strychnine products, the
Agency believes the minimal poisoning incident information suggests
there are exposures. Supplemental incident data should provide at least
additional quantitative information about these exposures. Also, the
Agency assumes unit exposure from occupational-use products may be
less than that from homeowner-use products as the former products are
limited to certified applicators who have received training on the
appropriate and safe use of pesticides. Also, through this document,
labeling is being required to include the use of personal protective
equipment (chemical resistant gloves, protective eyewear, and a dust
mask).
Post-Application Exposures & Assumptions
Because strychnine use is currently limited to below-ground
applications the Agency considers the potential for post-application
exposure to be negligible when products are used properly.
3. Risk Assessment
a. Dietary
As explained above, there are no expected dietary exposures from
the below-ground use pattern of strychnine. For this reason, a dietary risk
assessment is not appropriate.
b. Occupational and Residential
For both occupational and residential uses of strychnine products,
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the Agency has concerns for risks to human health. These concerns are
based on (1) the high acute toxicity of technical strychnine through the
oral, ocular, and inhalation (presumed) routes; (2) data for domestic pets
which suggest a very low margin of exposure for young children, as do
calculations of potential dose based on a single swallow; (3) the number
and severity of poisoning incidents reflected in incident data; (4) the
potential for exposure to both occupational and residential handlers of
strychnine products; and (5) the absence of exposure data for all exposure
scenarios considered and the need for better incident data.
Based on these concerns, personal protective equipment, such as
chemical resistant gloves, protective eyewear and dust mask would reduce
the potential for occupational-use exposures. EPA is also particularly
concerned about potential exposures to homeowners and others in
residential settings. The need for additional information including
poisoning incident data, end-use product acute toxicity, and benefits
information and pest control alternatives is discussed further in the Risk
Management and Reregi strati on Decision, Section IV.
C. Environmental Assessment
1. Ecological Toxicity Data
The Agency's ecological toxicity data base for strychnine contains data
submitted for above- and below-ground uses of strychnine. However, only
acceptable data supporting below-ground uses were considered in the eligibility
decision. The above-ground data are provided here only for informational
purposes.
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
The Agency waived the requirement for an acute oral
toxicity study (71-1) because it has already been proven that a bird
receiving an acute dose of strychnine would die. It will be assumed
that strychnine is very highly toxic to birds on an acute basis.
Two subacute dietary studies using the technical grade of
strychnine (99-100%) were submitted and provide data to establish
the toxicity to birds. Data submitted include the preferred test
species, mallard duck (waterfowl) and bobwhite quail (upland
gamebird) (MRIDs 41322602 and 41322601). Results of these
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tests are tabulated below in Table 2.
Table 2. Avian Subacute Dietary Toxicity
Species
Northern bobwhite quail
(Colinus virginianus )
Mallard duck
(Anas platyrhynchos )
Black-billed magpie
(Pica pica)
American kestrel
(Falco sparverius )
LC 50 (ppm)
3536
NOEC 1250
212
NOEC 78
99
(65-130)
234
Toxicity Category
Slightly Toxic
Highly Toxic
Highly Toxic
Highly Toxic
These results indicate that strychnine ranges from slightly
to highly toxic to avian species on a subacute dietary basis. The
guideline requirement (71-2) is fulfilled (MRIDs 41322601 and
41322602).
(2) Birds, Chronic
Avian reproduction studies using the technical grade of
strychnine were required. Strychnine, known to be stable in the
environment may pose a threat to birds who may be subject to
repeated or continuous exposure from spills. It is possible that
potentially toxic amounts of strychnine may persist from spills and
be available as food for wild birds. The studies submitted consisted
of tests done with the preferred species, the mallard duck and
bobwhite quail (MRIDs 42716801 and 42716802). Results of
these tests are in Table 3.
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Table 3. Avian Reproduction
Species
Northern bobwhite quail
(Colinus virginianus )
Mallard duck
(Anas platyrhynchos )
%ai
100
100
NOEC/LOEC (ppm)
1,114/1,200
not reported/3 3
Endpoints
Affected
none
testes
There were no treatment related effects in the bobwhite
quail. In the mallard duck, testes were smaller at the LOEC of 33
ppm (low-dose). Also, chick body weights were reduced on day 1
in the 68.9 ppm group (mid-dose) and day 14 in the 140.9 ppm
group (high-dose). Egg production and adult female body weight
were also reduced at 140.9 ppm.
(3) Mammals
Wild mammal testing was required because of the potential
exposure of wild mammals during baiting with strychnine. Acute
oral toxicity values from laboratory rat studies (MRIDs 40908901
and 41210701), as reported above in the Human Health
Assessment, are included with studies on other mammalian species
(MRIDs 40296501, 40296502 and 40296503). The toxicity values
and test results are reported in Table 4 below.
Table 4. Mammalian Toxicity
Species
Laboratory rat
(Rattus norvegicus )
Striped skunk
(Mephitis mephitis )
European ferret
(Mustella putorius )
Red fox
(Vulpes fulva)
%ai
99
unknown
99
99
99
Test Type
Acute oral
Acute oral
Acute, mg per egg bait
Dietary
5 -day
Dietary
5 -day
Endpoint
LD50 ? = 2.2 mg/kg LD50
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is considered typical of strychnine.
(4) Terrestrial Field Testing
Pocket gopher (Thomomys bottae) control.
In one study, strychnine bait was applied with a burrow
builder, a device that creates an artificial burrow, places the
poisoned bait underground, and seals the burrow. Strychnine
residues were found in the muscle tissue. The mean residue was
approximately 0.5 ppm, and residues ranged as high as 5.4 ppm.
It was also found in the gastrointestinal tract at a mean of
approximately 5 ppm and as high as 35.8 ppm.
Three non-target species were found dead: Horned lark
(Eremophila alpestris), Brewer's blackbird (Euphagus
cyanocephalus), and Striped skunk (Mephitis mephitis). Residues
in the lark were 0.35 ppm in the muscles and 1.61 ppm in the
gastrointestinal tract. Residues in the blackbird were 0.56 ppm in
the muscle and 23.3 ppm in the gastrointestinal tract. Tissue
samples from the skunk were not analyzed.
The results of this study show that:
• Hazards to non-target avian species (and possibly
mammals) occur when using the burrow builder
because of spillage of the poisoned baits when the
builder is removed from the ground or goes around
a corner (e.g., at the end of a row). These results are
similar to those reported in previous studies (Hegdal
and Gatz, 1978; Fagerstone etal, 1980; Matschke
etal., 1991, and Evans and Campbell, 1989).
• Residues of strychnine in the gastrointestinal tract of
pocket gophers exceed the Agency's unacceptable
risk criteria for non-target organisms. Residues at
those levels could kill secondary consumers.
• There are sufficient data to presume that the
proposed use poses a "may effect" situation to
endangered species, and exposure to endangered
species is expected if the baiting operation is
conducted in their currently occupied habitats.
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b.
However, recent instructions for the burrow builder state
that operators are to collect spilled bait; therefore, the underground
use of strychnine to control pocket gophers does not pose an
unacceptable risk to non-target wildlife (MRID 42488601).
In another study, hand baiting of burrows was used to
control gophers. The baiting controlled the gophers, but there was
non-target mortality that would be of concern in areas inhabited by
endangered species (MRID 41478501).
These field studies indicate that strychnine use could pose
a risk to non-target and endangered species when the application
rate, and other conditions of the studies are used. However, the
Agency believes that the risks to non-target terrestrial animals are
minimal when strychnine is used below-ground, and according to
label directions.
Toxicity to Freshwater Aquatic Animals
(1) Freshwater Fish
Two freshwater fish toxicity studies using the technical
grade of the active ingredient were submitted (MRIDs 41126502
and 41126501) and provide data to establish the toxicity to fish.
The preferred test species are rainbow trout (a coldwater fish) and
bluegill sunfish (a warmwater fish). Table 5 lists the results of
these studies.
Table 5. Freshwater Fish Acute Toxicity
Species
Rainbow trout
(Oncorhynchus mykiss )
Bluegill sunfish
(Lepomis macrochirus )
%ai
99.9
99.9
LC50 ppm
2.3
(1.7-3.2)
0.76
(0.61-0.96)
Toxicity Category
Moderately Toxic
Highly Toxic
These results indicate that strychnine ranges from
moderately to highly toxic to freshwater fish on an acute basis.
(2) Freshwater Invertebrates
A freshwater aquatic invertebrate toxicity test using the
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technical grade of the active ingredient (99.9%) was submitted.
The Daphnia magna LC50/EC50 value is 10 ppm (MRID 41126503).
The results indicate that strychnine is moderately toxic to aquatic
invertebrates on an acute basis.
2. Environmental Fate
The environmental fate data available at this time are limited and are not
sufficient for a full-scale environmental fate assessment. Acceptable fate data
supporting below-ground uses were considered in the eligibility decision. These
data satisfy the requirements for below-ground uses only. The majority of these
data indicate that strychnine is persistent, but not mobile. The hydrolysis and soil
photolysis studies reveal that neither process produces a significant transformation
of the parent molecule.
Aerobic soil metabolism data, which are not acceptable, suggest that
metabolism can sometimes not occur, or can occur rapidly under as yet undefined
conditions which include a significant lag period. It has been suggested that a
specific microorganism or an adaptive enzyme system may be responsible.
Metabolism may also be very slow, and this process may not be a consistent and
dependable means of breakdown. The acceptable batch adsorption/desorption
study demonstrates strong binding to a number of soils. With the present below-
ground use pattern, strychnine is not likely to reach ground or surface water. For
these reasons the Agency's concerns are minimal, in that soil and ground or
surface water do not seem likely to be materially affected by the below-ground use
of strychnine.
a. Environmental Fate Assessment
Available data satisfy the environmental fate requirements for
below-ground uses. In the event that above-ground uses are restored by
modification of the existing court order, additional data appropriate to
support continued registration of these uses will be required.
b. Environmental Fate and Transport
(1) Degradation
The strychnine molecule (parent) does not hydrolyze at pH
5, 7, or 9 (MRID 41122301). Parent is stable to soil photolysis.
Photolysis data indicate that this process does not significantly
degrade the parent. The projected half-life is ca. 180 days based on
first-order kinetics, which may not apply. The actual kinetic model
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could not be determined with confidence, since only a minimal
amount of strychnine is transformed within the experimental
period. No products of the transformation could be detected
(MRID 42973401).
(2) Mobility
The data indicate that strychnine is immobile; the parent is
adsorbed to organic matter and clay. Using batch equilibrium
techniques, strychnine had Freundlich Kads in loamy sand, sandy
loam, loam, and sandy clay loam soils of 39.79, 94.65, 118.87, and
168.97, respectively. Adsorption increased with increasing CEC.
Kdes values were 55.0 for the loamy sand, 89.4 for the sandy loam,
114.6 for the loam, and 146.1 for the sandy clay loam soils.
Mobility of unaged parent was satisfied (MRID 42366501). The
data requirement for aged parent is reserved.
(3) Aerobic Soil Metabolism
Aerobic soil metabolism data are not required for below-
ground uses, but one study was submitted. This study is not
acceptable because it does not provide a half-life for strychnine,
and there is no accounting for material balance. However, the data
suggest that aerobic soil metabolism may be limited to
microorganisms capable of adaptive enzyme formation; some soils
do not appear to have the specific microbes necessary for
metabolism. There is a considerable lag period preceding
metabolism in those soils that metabolize parent (MRID
42234201).
c. Water Resources
(1) Ground Water and Surface Water
Neither ground water nor surface water seem to be at risk
from contamination under the current use pattern of applying
strychnine into specific below-ground burrows. Also, as
summarized above, strychnine is essentially immobile.
3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
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(1) Exposure and Risk to Non-target Terrestrial Animals
Field studies have shown that above-ground use of
strychnine could pose a threat to non-target and endangered
species. However, the Agency believes that the risks to non-target
terrestrial animals are minimal when strychnine is used below-
ground. When the recommended precautions are followed, below-
ground use of strychnine does not constitute a risk to non-target or
endangered species.
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 discussed earlier in this
document the need for more comprehensive information about human poisoning incidents
and the acute toxicity of strychnine products. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing strychnine for the below-ground uses only,
for the reasons described above. The Agency has completed its review of these generic
data, and has determined that the data are sufficient to support reregistration of the
Restricted-use products for below-ground uses under the conditions specified in this RED.
The use of these products are currently limited to certified pesticide applicators who are
required to wear certain personal protective equipment (PPE) according to the product
labeling that would mitigate exposure. Additional PPE are required as described in
Section V of this document.
The Agency has decided that a determination of reregistration eligibility for the
homeowner-use, or unrestricted, strychnine products cannot be made at this time. The
Agency is uncertain as to whether these products should be classified as restricted use
and/or if other stringent measures are appropriate. Certain measures are considered by
the Agency as impractical, problematic, or difficult to implement for products that are
used in the homeowner setting. EPA will consider additional required information to
reach an eligibility decision and appropriate risk reduction measures.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, etc. and the data identified
in Appendix B. Although the Agency has found that the occupational below-ground uses
of restricted use strychnine products are eligible for reregistration, it should be understood
23
-------
that the Agency may take additional appropriate regulatory action, and/or require the
submission of additional data to support the registration of these uses and products if new
information comes to the Agency's attention or if the data requirements for registration
(or the guidelines for generating such data) change. Should the Court injunction requiring
temporary cancellation of above-ground uses be modified, the Agency will initiate the
reregi strati on process for any affected uses that could be allowed to resume.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the generic data reviews for strychnine and the use of products
below-ground, the Agency has concluded it has sufficient information about
strychnine's potential to cause adverse effects to humans or the environment. The
Agency has concluded that the use of the products classified as restricted use,
labeled and used as specified in this Reregi strati on Eligibility Decision, will not
pose unreasonable adverse effects to humans or the environment. Therefore, these
products are eligible for reregi strati on.
However, for the remaining products, those unclassified and available for
use by the general public, EPA has concluded that it does not have sufficient
information regarding the risks to humans to make a decision of eligibility. This
additional information is important for EPA to reach a decision on eligibility. For
this reason the Agency is requiring, through a DCI notice included with this
document, that strychnine product registrants provide poison control center data
for products used by homeowners, incident reports on poisonings of children, and
end-use product acute toxicity.
Upon receipt, EPA will review the additional information from the DCI
and decide whether additional practical measures are prudent to protect the general
public users from the risks of poisonings or whether other regulatory action is
appropriate. At that time the Agency will reach a decision on reregi strati on
eligibility and determine any further action.
Regarding environmental risks, the Agency is able to conclude that the use
of these products underground by the general public would not result in
unreasonable adverse risks to the environment.
The following summary statements support the Agency's decisions on
reregi strati on eligibility at this time:
a. Strychnine is useful to control pocket gophers and therefore there
are benefits to farmers from the use of strychnine restricted use
24
-------
products to protect agricultural areas. Benefits of strychnine
products for use by the general public at residential sites are not
available at this time.
b. Technical strychnine is highly acutely toxic to humans through the
oral and ocular routes of exposure; inhalation toxicity is presumed
to be high.
c. Adequate acute toxicity data are unavailable for end-use strychnine
products that are available to the general public. Thus, EPA is
unable to accurately estimate toxicity values to people, especially
children, who may be exposed to these products.
d. Various sources of information about poisoning incidents in
humans give a conflicting and incomplete description of the
magnitude and characteristics of poisonings associated with the use
of strychnine products.
e. Strychnine is highly toxic to non-target wildlife as shown in the
toxicity data for birds, mammals, fish, and invertebrates. However,
the Agency believes that the use of strychnine below-ground
adequately limits exposure to non-target animals, and risk is,
therefore, minimal under this condition.
The following requirements are based on the Agency's decision:
a. Personal protective equipment is required for handlers of
strychnine products. Long-sleeved shirt and long pants, chemical-
resistant gloves, shoes plus socks and protective eyewear are
required for all persons who handle paste formulations.
Occupational handlers of grain baits must also wear a dust mask.
b. EPA is allowing strychnine end-use products formulated as ready-
to-use grain baits to be sold to and used by homeowners at levels
of no greater than 0.5% strychnine concentration for manual
baiting only. However, such end-use products must be contained
in child-resistant packaging during sale and storage.
2. Eligible and Ineligible Uses
The Agency has determined that the restricted use products for the below-
ground use are eligible for reregistration when labeled and used as specified in this
25
-------
Reregistation Eligibility Decision. The Agency can not make a determination of
eligibility at this time for the unclassified products for below-ground use by the
general public. Further data are being required.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for
strychnine. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1. Restricted Use Classification
Strychnine is highly acutely toxic to humans and other non-target
mammalian and avian species, and poses potential risks to these populations.
Consequently, all strychnine products are classified as restricted use pesticides
except for ready-to-use bait formulations which contain strychnine at nominal
concentrations no greater than 0.5%, and which are labeled only for below-ground
manual applications. This classification determination was made in 1978 and is
not altered by this RED document.
2. Child-Resistant Packaging
Because EPA has concerns about potential risks of acute poisonings to
children from products available to the general public, the Agency believes the use
of child-resistant packaging for these products is prudent as a precautionary
measure. Rather than wait until the receipt and review of required additional
information for these products, the Agency is imposing this requirement now
through this document. Specifically, unclassified ready-to-use grain baits must be
contained in child-resistant packaging based on concerns for exposures to children
and strychnine's high acute toxicity.
3. Personal Protective Equipment
The Agency establishes handler safety requirements when risk assessments
or general concerns suggest such requirements are appropriate. Although the
Worker Protection Standard (WPS) of 1994 was developed for agricultural
pesticides, the measures in this standard for addressing worker protection are
applicable to the uses of strychnine.
a. Personal Protective Equipment/Engineering Controls for
Handlers
For each end-use product, PPE requirements for pesticide handlers
26
-------
are set during reregi strati on in one of two ways:
1. If EPA determines that no regulatory action must be taken as the
result of the acute effects or other adverse effects of an active
ingredient, the PPE for pesticide handlers will be based on the
acute toxicity of the end-use product. For occupational-use
products, PPE must be established using the process described in
PR Notice 93-7 or more recent EPA guidelines.
2. If EPA determines that regulatory action on an active ingredient
must be taken as the result of very high acute toxicity or to certain
other adverse effects, such as allergic effects or delayed effects
(cancer, developmental toxicity, reproductive effects, etc.):
• In the RED for that active ingredient, EPA may establish minimum
or "baseline" handler PPE requirements that pertain to all or most
end-use products containing that active ingredient.
• These minimum PPE requirements must be compared with the PPE
that would be designated on the basis of the acute toxicity of the
end-use product.
• The more stringent choice for each type of PPE (i.e., bodywear,
hand protection, footwear, eyewear, etc.) must be placed on the
label of the end-use product.
Personal protective equipment requirements usually are set by
specifying one or more pre-established PPE units — sets of items that are
usually required together. For example, if chemical-resistant gloves are
required, then long-sleeve shirts, long pants, socks, and shoes are assumed
and are also included in the required minimum attire. If the requirement
is for two layers of body protection (coveralls over a long- or short-sleeve
shirt and long or short pants), the minimum must also include (for all
handlers) chemical-resistant footwear and chemical-resistant headgear for
overhead exposures and (for mixers, loaders, and persons cleaning
equipment) chemical-resistant aprons.
(1) Occupational-Use Products
EPA has determined that regulatory action regarding the
establishment of active-ingredient-based minimum PPE
requirements for occupational handlers must be taken for
strychnine when formulated as a grain bait because of its presumed
27
-------
high acute inhalation toxicity and potential exposure concerns from
open-pouring such formulations. Dust masks are required PPE for
occupational users of strychnine grain baits. Dust masks are
appropriate for the mixer because the remnants of the mix are
100% strychnine.
EPA has determined that regulatory action regarding the
establishment of active-ingredient-based minimum PPE
requirements for occupational handlers must be taken for
strychnine when formulated as a paste due to its high acute oral and
ocular toxicity. The Agency is requiring the use of chemical-
resistant gloves and protective eyewear for all persons who handle
such paste formulations.
(2) Homeowner-Use Products
EPA is not establishing minimum (baseline) handler PPE
for strychnine end-use products that are intended primarily for
homeowner use at this time, because the Agency has not completed
its risk assessment for these products and PPE may not be practical
for homeowners.
b. Post-Application/Entry Restrictions
EPA is not establishing entry restrictions at this time for strychnine
end-use products, since strychnine currently is registered for use only
below-ground in pocket gopher tunnels. Post-application exposures are
unlikely following applications below-ground.
c. Other Labeling Requirements
The Agency believes it is appropriate to retain the restricted use
classification for these products and to add to the products' label the reason
for this classification — acute toxicity. Refer to Section V below for the
specific wording of this label statement. The Agency is also requiring
other use and safety information to be placed on the labeling of all end-use
products containing strychnine. For the specific labeling statements, refer
to the following section.
4. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse
28
-------
impacts on endangered and threatened species and to implement mitigation
measures that will eliminate the adverse impacts. The program would require use
restrictions to protect endangered and threatened species at the county level.
Consultations with the Fish and Wildlife Service may be necessary to assess risks
to newly listed species or from proposed new uses. In the future, the Agency
plans to publish a description of the Endangered Species Program in the Federal
Register and have available voluntary county-specific bulletins. Because the
Agency is taking this approach for protecting endangered and threatened species,
it is not imposing label modifications at this time through the RED. Rather, any
requirements for product use modifications will occur in the future under the
Endangered Species Protection Program.
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 strychnine for
occupational below-ground uses has been reviewed and determined to be
substantially complete. A subchronic dermal study is required to confirm the
Agency's assumption that dermal absorption of strychnine is low. If and when
reinstatement of the above-ground use for strychnine occurs, the Agency may
require additional generic data necessary to characterize potential risks from the
above-ground uses.
2. Labeling Requirements for Manufacturing-Use Products
In order 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. The MP labeling must bear the following
statement under Directions for Use:
"This product may be used only to formulate end-use rodenticide
concentrates of ready-to-use baits which are limited by labeling to below-
ground applications to control pocket gophers."
B. End-Use Products
29
-------
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. The product specific data requirements are listed in Appendix G, the
Product Specific Data Call-In Notice. In addition, product-specific data are being
requested prior to making a determination for the use of strychnine products by
homeowners. This information includes poison control center data, incident
reports for poisoning of children, benefits and usage information, end-use product
acute toxicity data, and information concerning pest control alternatives. A DCI
to all end-use product registrants for this information is included with this
document.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then study MRID numbers should be cited
according to the instructions in the Requirement Status and Registrants Response
Form provided for each product.
2. Labeling Requirements for End-Use Products
In order to remain in compliance with FIFRA, end-use products labeling
must be revised to comply with all current EPA regulations, PR Notices and
applicable policies. The EP labeling must bear the following statement under
Directions for Use:
"This product may be used as end-use rodenticide concentrates of ready-
to-use baits which are limited by labeling to below-applications to control
pocket gophers."
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain
strychnine, the product labeling must be revised to adopt the handler
personal protective equipment/engineering control requirements set forth
in this section. Any conflicting PPE requirements on the current labeling
must be removed.
a. Products Intended Primarily for Occupational Use
(1) Restricted Use Classification and Statement
30
-------
EPA is retaining the restriction of the use of end-use
products containing 0.5% or more strychnine intended for use in a
burrow-builder or impinger to certified applicators. All restricted
use products must bear the following statement in a prominent
location on the front panel of the end-use product labeling:
"RESTRICTED USE PESTICIDE
ACUTE ORAL TOXICITY
For retail sale and use only by Certified Applicators or
persons under the direct supervision of a Certified
Applicator, and only for those uses covered by the Certified
Applicator's certification. Sale to or use by the general
public is prohibited."
(2) Minimum (Baseline) PPE/Engineering Control
Requirements
The minimum (baseline) PPE for strychnine end-use
products formulated as a paste is:
"Applicators and other handlers must wear:
—long-sleeved shirt and long pants,
—chemical-resistant gloves*,
—shoes plus socks, and
—protective eyewear.
The minimum (baseline) PPE for strychnine end-use
products formulated as grain-based baits is:
"Applicators and other handlers must wear:
—long-sleeved shirt and long pants,
—chemical-resistant gloves*,
—shoes plus socks, and
—dust mask.
* For the glove statement, use the statement established for
strychnine through the instructions in Supplement Three of
PR Notice 93-7. Although this PR Notice addresses
agricultural pesticides, the basis for our decisions for
strychnine are similar.
31
-------
(3) Determining PPE Requirements for End-use Product
Labels
The PPE that would be established on the basis of the acute
toxicity category of the end-use product must be compared to the
active-ingredient-based minimum (baseline) personal protective
equipment specified above. The more protective PPE must be
placed on the product labeling. For guidance on which PPE is
considered more protective, see PR Notice 93-7.
(4) Placement in Labeling
The personal protective equipment requirements must be
placed on the end-use product labeling in the location specified in
PR Notice 93-7, and the format and language of the PPE
requirements must be the same as is specified in PR Notice 93-7.
b. Products Intended Primarily for Homeowner Use
(1) Child-Resistant Packaging
Homeowner-use baits must be contained in child-resistant
packaging during sale and storage.
(2) Minimum (baseline) PPE Requirements
EPA is not establishing active-ingredient-based minimum
(baseline) handler PPE for strychnine end-use products that are
intended primarily for homeowner use because the Agency is
uncertain as to whether these products should be classified as
restricted use and/or if other stringent measures are appropriate.
(3) Determining PPE Requirements for End-Use Product
Any necessary PPE for each strychnine end-use product
intended primarily for homeowner use will be established on the
basis of the end-use product's acute toxicity category.
(4) Placement in Labeling
The personal protective equipment requirements, if any,
must be placed on the end-use product labeling immediately
following the precautionary statements in the labeling section
32
-------
"Hazards to Humans (and domestic animals)."
3. Other Labeling Requirements
a. Products Intended Primarily for Occupational Use
The Agency is requiring the following labeling statements to be
located on all end-use products containing strychnine that are intended
primarily for occupational use.
Application Restrictions
"Do not apply this product in a way that will contact
workers, other persons, pets, or domestic animals.
User Safety Requirements
"Follow manufacturer's instructions for
cleaning/maintaining PPE. If no such instructions for
washables, use detergent and hot water. Keep and wash
PPE separately from other laundry."
User Safety Recommendations
"Users should wash hands before eating, drinking,
chewing gum, using tobacco, or using the toilet."
"Users should remove clothing immediately if
pesticide gets inside. Then wash thoroughly and put
on clean clothing."
"Users should remove PPE immediately after
handling this product. Wash the outside of gloves
before removing. As soon as possible, wash
thoroughly and change into clean clothing."
b. Products Intended Primarily for Home Use
Application Restrictions
"Do not apply this product in a way that will contact
any person or pet. Keep people and pets out of the
area during application."
33
-------
User Safety Recommendations
"Users should wash hands before eating, drinking,
chewing gum, using tobacco, or using the toilet."
"Users should remove clothing immediately if
pesticide gets inside. Then wash thoroughly and put
on clean clothing."
c. All End-Use Products
In addition, use sites must be listed on the label. All use sites must
be clearly specified on the label, such as orchards, forests, nurseries, and
agricultural crop areas.
C. Existing Stocks
Registrants of manufacturing use products may generally distribute and sell
products bearing old labels/labeling for 26 months from the date of the issuance of this
Reregistration Eligibility Decision (RED). Persons other than the registrant may generally
distribute or sell such products for 50 months from the date of the issuance of this RED.
However, existing stocks time frames will be established case-by-case, depending on the
number of products involved, the number of label changes, and other factors. Refer to
"Existing Stocks of Pesticide Products; Statement of Policy;" Federal Register. Volume
56, No. 123, June 26, 1991. Registrants of end-use products containing strychnine will
be subject to these time frames based on the date of resolution of the labeling modification
issue from the Strychnine Settlement Agreement.
34
-------
VI. APPENDICES
35
-------
APPENDIX A
Case 3133[Strychnine] Chemical 076901[Strychnine]
4444444444444444444444444444444444444
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
)))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
))))))))))))))))
AGRICULTURAL CROPS/SOILS (UNSPECIFIED)
Bait application, When needed, By hand
Bait application, When needed, Hand probe B/S
Use Group: TERRESTRIAL FOOD+FEED CROP
B/S
B/S
B/S
B/S
B/S
B/S
B/S
B/S
B/S
B/S
B/S
B/S
G
RTU
B/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.015
Ib A
.005 Tsp
burrow
.054
.015
.108
.01
.0125
.054
.01
.01
.054
.01
.01
Ib A
UC
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
UC
Ib A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
B/S
.005 Ib A
36
-------
APPENDIX A
Case 3133[Strychnine] Chemical 076901[Strychnine]
4444444444444444444444444444444444444
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
i))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
))))))))))))))))))))))»;
AGRICULTURAL CROPS/SOILS (UNSPECIFIED) (con't)
Bait application, When needed, Mechanical B/S
burrow builder
Bait application, When needed, Spoon
GRASS FORAGE/FODDER/HAY
Bait application, When needed, Mechanical B/S
burrow builder
Bait application, When needed, Spoon
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re- Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Intv. Codes
otherwise) Dose cycle /crop /year cycle
Use Group: TERRESTRIAL FOOD+FEED CROP (con't)
B/S
B/S
B/S
B/S
G
P/T
RTU
B/S
B/S
B/S
B/S
B/S
B/S
B/S
B/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.005
.005
.005
.005
.005
.005
.001
.01
.001
.001
.01
.01
.001
.001
Ib
Ib
Ib
Ib
Ib
Ib
Us
Ib
Ib
Ib
Ib
Us
Ib
Ib
Ib
Ib
A *
A *
A *
A *
A *
A *
UC *
e Group:
A *
A *
A *
A *
e Group:
A *
A *
A *
A *
NS
NS
NS
NS
NS
NS
NS
TERRE
NS
NS
NS
NS
TERRE
NS
NS
NS
NS
N
N
N
N
N
N
N
s
N
N
N
N
s
N
N
N
N
s
s
s
s
s
s
s
TRIAL
S
s
s
s
TRIAL
S
s
s
s
NS
NS
NS
NS
NS
NS
NS
FEED CROP
NS
NS
NS
NS
FEED CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
C92, CAC
CAC
C20, C66, CAC
C20, CAC
C20, C66, CAC
CAU
C20, CAC
37
-------
APPENDIX A
Case 3133[Strychnine] Chemical 076901[Strychnine]
4444444444444444444444444444444444444
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
I))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
))))))))))))))))))))
IRRIGATION SYSTEMS
Bait application, When needed, Pliers RTU
ORCHARDS (UNSPECIFIED)
Bait application, When needed, Mechanical B/S
burrow builder
Bait application, When needed, Spoon
PASTURES
Bait application, When needed, By hand
RTU
Bait application, When needed, Hand probe B/S
B/S
Bait application, When needed, Mechanical B/S
burrow builder
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re- Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Intv. Codes
otherwise) Dose cycle /crop /year cycle
Use Group: AQUATIC FOOD CROP
UC * NS NS NS NS NS NS
Use Group: TERRESTRIAL FOOD CROP
.01 Ib A * NS NS NS NS NS NS
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.01
.001
.001
.054
.01
.0125
.054
.01
.01
.054
.01
Ib
Ib
Ib
Us
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A *
A *
A *
e Group:
UC *
A *
UC *
A *
A *
A *
A *
A *
A *
A *
NS
NS
NS
TERRE
NS
Geo.Ol
NS
NS
NS
NS
NS
NS
NS
NS
NS
N
N
N
s
s
s
NS
NS
NS
NS
NS
NS
NS
NS
NS
N:
N:
N:
STRIAL FEED CROP
N
N
N
N
N
N
N
N
N
N
s
s
s
s
s
s
s
s
s
s
NS
Humboldt Count
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
y only
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
38
-------
APPENDIX A
Case 3133[Strychnine] Chemical 076901[Strychnine]
4444444444444444444444444444444444444
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
i))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
))))))))))))))))))
PASTURES (con't)
Bait application, When needed, Spoon
RANGELAND
Bait application, When needed, By hand
Bait application, When needed, Hand probe B/S
Bait application, When needed, Mechanical B/S
burrow builder
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re- Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Intv. Codes
otherwise) Dose cycle /crop /year cycle
Use Group: TERRESTRIAL FEED CROP (con't)
RTU
B/S
B/S
B/S
B/S
G
P/T
RTU
B/S
RTU
B/S
B/S
B/S
B/S
B/S
B/S
B/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.005
.005
.005
.005
.005
.005
.005
.054
.01
.0125
.054
.01
.01
Ib
Ib
Ib
Ib
Ib
Ib
Us
Ib
Ib
Ib
Ib
Ib
Ib
Ib
UC *
A *
A *
A *
A *
A *
A *
UC *
e Group:
A *
UC *
A *
UC *
A *
A *
A *
A *
A *
NS
NS
NS
NS
NS
NS
NS
NS
TERRE
NS
NS
Geo.Ol
NS
NS
NS
NS
NS
NS
NS
N
N
N
N
N
N
N
N
s
s
s
s
s
s
s
s
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
N:
N:
N:
N:
N:
N:
N:
N:
STRIAL FEED CROP
N
N
N
N
N
N
N
N
N
s
s
s
s
s
s
s
s
s
NS
NS
Humboldt Count
NS
NS
NS
NS
NS
NS
NS
NS
NS
y only
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
N:
N:
N:
N:
N:
N:
N:
N:
N:
C20, CAC
C20, C66, CAC
CAC
C20, C66, CAC
C20, CAC
C20, C66, CAC
CAU
C20, CAC
39
-------
APPENDIX A
Case 3133[Strychnine] Chemical 076901[Strychnine]
4444444444444444444444444444444444444
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
i))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
)))))))))))))))))))
RANGELAND (con't)
Bait application, When needed, Mechanical B/S
burrow builder
Bait application, When needed, Spoon
NON- FOOD/NON- FEED
)))))))))))))))))))))))))))))))))))))))))
FOREST TREES (ALL OR UNSPECIFIED)
Bait application, When needed, Hand probe B/S
Bait application, When needed, Mechanical B/S NA
burrow builder
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re- Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Intv. Codes
otherwise) Dose cycle /crop /year cycle
Use Group: TERRESTRIAL FEED CROP (con't)
B/S
G
RTU
B/S
B/S
B/S
B/S
B/S
G
P/T
RTU
i))))»:
B/S
B/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
)))))))))))))))
NA
NA
.054
.01
.01
.005
.005
.005
.005
.005
.005
I)))))))))))))
.015
.005
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
'))
Us
Ib
A *
A *
UC *
A *
A *
A *
A *
A *
A *
A *
UC *
))))))))
e Group:
A *
Tsp *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
N
N
N
N
N
N
N
N
N
N
N
s
s
s
s
s
s
s
s
s
s
s
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
))))))))))))))))))))))))))))))))))))))))
FORESTRY
NS
NS
2/1
N
yr
S
NS
NS
NS
NS
120
NS
N:
N:
burrow
C20, C66, CAC
CAC
C20, C66, CAC
C20, CAC
C20, C66, CAC
CAU
C20, CAC
40
-------
APPENDIX A
Case 3133[Strychnine] Chemical 076901[Strychnine]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Form(s) Min. Appl.
Rate (AI un-
less noted
otherwise)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
))))))))))))))))))))))))))))
FOREST TREES (ALL OR UNSPECIFIED) (con't)
Bait application, When needed, Spoon B/S
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES
Bait application, When needed, Hand probe B/S
B/S
B/S
B/S
B/S
P/T
NONAGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS
Bait application, When needed, Pliers RTU
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS
Bait application, When needed, By hand RTU
B/S
B/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re- Geographic Limitations
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year cycle
Use Group: FORESTRY (con't)
.005 Ib A * NS NS NS
Use Group: OUTDOOR RESIDENTIAL
.005 Ib A * NS NS NS
UC * NS NS NS
UC * NS NS NS
.005 Ib A *
.005 Ib A *
UC *
.005 Ib A *
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
.054 Ib A
UC
C20, C66, C67, CAC
C66, CAC
CAC
CAU
41
-------
APPENDIX A
Case 3133[Strychnine] Chemical 076901[Strychnine]
4444444444444444444444444444444444444
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
i))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
))))))))))))))))))))))))))))
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS (con't)
Bait application, When needed, Mechanical B/S
burrow builder
Bait application, When needed, Mechanical B/S
burrow builder
Bait application, When needed, Pliers RTU
Bait application, When needed, Spoon B/S
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re- Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Intv. Codes
otherwise) Dose cycle /crop /year cycle
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.108
.01
.01
.0125
.054
.01
.01
.054
.01
.01
.001
.005
.005
.005
.005
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A
A
A
A
A
A
A
A
A
UC
A
UC
A
A
A
A
A
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
s
s
s
s
s
s
s
s
s
s
s
s
s
s
s
s
s
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
.108 Ib
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
CAC
C20, C66
C20, C66, CAC
C20, CAC
CAC
C20, C66, CAC
C20, CAC
C20, C66
C20, C66, CAC
C20, CAC
CAC
C20, CAC
C20, C66
C20, C66, CAC
C92, CAC
CAC
C20, C66, CAC
42
-------
APPENDIX A
Case 3133[Strychnine] Chemical 076901[Strychnine]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re- Geographic Limitations
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed
less noted unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
))))))))))))))))))))))))))))
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS (con't)
B/S
G
P/T
RTU
RESIDENTIAL LAWNS
Bait application, When needed, Hand probe B/S
B/S
Bait application, When needed, Injection B/S
equipment
Bait application, When needed, Spoon B/S
NOT SPECIFIED
))))))))))))))))))))))))))))))))))))))))))))))))))
SITE NOT SPECIFIED
Bait application, When needed, Hand probe B/S
B/S
B/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
)))))))))))
NA
NA
NA
.005 Ib A *
.005 Ib A *
.005 Ib A *
UC *
Use Group:
.005 Ib A *
UC *
UC *
.005 Ib A *
.005 Ib A *
UC *
.005 Ib A *
))))))))))))))))))))))))
Use Group:
.005 Ib A *
.005 Ib A *
1.953E-05 *
NS
NS
NS
NS
NS
NS
NS
NS
OUTDOOR RE
NS
NS
NS
NS
NS
NS
NS
))))):
USE
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
»)))»:
GROUP
NS
NS
NS
NS
NS
NS
NS
SIDENTIAL
NS
NS
NS
NS
NS
NS
NS
»))))))»:
FOR SITE
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
»)))))»:
00000
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
I)))))
NS
NS
NS
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
N:
)))
N:
N:
N:
C20, CAC
C20, C66, CAC
CAU
C20, CAC
C20, C66, C67, CAC
C 6 6, CAC
CAC
CAU
gal burrow
43
-------
APPENDIX A
Case 3133[Strychnine] Chemical 076901[Strychnine]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
I))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NOT SPECIFIED (con't)
)))))))))))))))))))))»:
SITE NOT SPECIFIED (con't)
Bait application, When needed, Mechanical B/S
burrow builder
Bait application, When needed, Spoon
Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry
less noted unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year cycle
NA
NA
NA
NA
NA
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
44
-------
APPENDIX A
Case 3133[Strychnine] Chemical 076901[Strychnine]
4444444,
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).
: Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per
years" is expressed as "4/3 yr"
: Maximum dose applied to a site over a single crop cycle or year. System calculated.
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days)
Re-Entry Intv.
PRO Report Date
Minimum Interval between Applications (days)
Reentry Intervals
LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
B/S : BAIT/SOLID
G : GRANULAR
P/T : PELLETED/TABLETED
RTU : LIQUID-READY TO USE
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"
45
-------
APPENDIX A
Case 3133[Strychnine] Chemical 076901[Strychnine]
4444444444444444444444444
USE LIMITATIONS CODES
020 : Endangered species restriction.
066 : Underground application only.
Do not broadcast product over crops grown for food, feed or other purposes.
Do not apply in residential areas.
For terrestrial uses, do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high water mark.
Keep out of lakes, streams, and ponds.
Do not apply where runoff is likely to occur.
Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES
013 : Other
Arizona
California
Nevada
Washington
46
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active ingredients
within the case 3133 covered by this Reregi strati on Eligibility Decision Document. It contains generic data
requirements that apply to 3133 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.
47
-------
48
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Strychnine
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-7 Density
63-8 Solubility
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
40213901, 40937002, 41499202, 40799301,
41320601
42120401, 40799301, 40937002, 41499201
41499201,40799301, 40937002, 40213901,
41499202
41513901, 41499203, 41320601, 41299301,
40799302
40799302, 41299301, 41320601,
41499203,40799301
40213901, 40799303, 40880701
40880701, 40799303, 40213901
40213901, 40799303, 40880701
42817102,40799303
40213901, 40799303, 40880701
40213901, 40799303, 40880701
40213901, 40799303, 40880701
43079801,40670501, 40864701, 40880701,
43079801
41696201
40213901, 41268501, 40880701
49
-------
Data Supporting Guideline Requirements for the Reregistration of Strychnine
REQUIREMENT
USE PATTERN
CITATION(S)
63-17 Storage stability
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral - Quail/Duck
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
71-3 Mammalian Toxicity
71-4A Avian Reproduction - Quail
71-4B Avian Reproduction - Duck
71-5B Terrestrial Field Study
72-1A Fish Toxicity Bluegill
72-1C Fish Toxicity Rainbow Trout
72-2A Invertebrate Toxicity
72-4A Early Life Stage - Fish
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation -
Rabbit
ALL
WAIVED
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
WAIVED
ALL
ALL
WAIVED
ALL
ALL
41623201,40928901
41322602
41322601
40908901, 41210701, 40296501, 40296502,
40296503
42716801
42716802
42488601,41478501
41126501
41126502
41126503
41210701,40908901
41210702,40908902
41210704, 40908904
41210703,40908903
50
-------
Data Supporting Guideline Requirements for the Reregistration of Strychnine
REQUIREMENT
USE PATTERN
CITATION(S)
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A Foliar Residue Dissipation
132-1B Soil Residue Dissipation
133-3 Dermal Passive Dosimetry
Exposure
ENVIRONMENTAL FATE
160-5 Chemical Identity
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
163-1 Leaching/Adsorption/Desorption
165-1 Confined Rotational Crop
165-2 Field Rotational Crop
165-4 Bioaccumulation in Fish
RESIDUE CHEMISTRY
171-4A Nature of Residue - Plants
171-4B Nature of Residue - Livestock
171-4C Residue Analytical Method -
ALL
WAIVED
ALL
ALL
WAIVED
ALL
WAIVED
RESERVED
RESERVED
WAIVED
WAIVED
WAIVED
RESERVED
RESERVED
RESERVED
41122301
42973401
42234201
42366501
Plants
51
-------
Data Supporting Guideline Requirements for the Reregistration of Strychnine
REQUIREMENT USE PATTERN CITATION(S)
171-4D Residue Analytical Method - WAIVED
Animal
171-4E Storage Stability WAIVED
171-4J Magnitude Meat/Milk/Poultry WAIVED
171-4K Alfalfa WAIVED
171-4L Alfalfa WAIVED
52
-------
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:
53
-------
(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.
54
-------
BIBLIOGRAPHY
MRID CITATION
40213901 H.R. Harkins, Inc. (1987) Product Chemistry: "Strychnine Alkaloid N.F." Unpublished
compilation. 18 p.
40296501 Record, C. (1987??) Test To Determine the Lowest Effective Dose of Strychnine Alkaloid in
Whole Chicken Eggs to Striped Skunks (Mephitus mephitus): Laboratory ID. No. 111. Unpublished study
prepared by Summit Laboratories. 14 p.
40296502 Record, C. (1987??) Tests To Determine the Dietary LC-50 of Strychnine Alkaloid to European
Ferrets (Mustela putorius furo): Laboratory ID. No. 112. Unpublished study prepared by Summit
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40296503 Record, C. (1987??) Tests To Determine the Dietary LC-50 of Strychnine Alkaloid to Red Foxes
(Vulpes fulva): Laboratory I.D. No. 113. Unpublished study prepared by Summit Laboratories. 19 p.
40670501 R.V. Briggs & Co., Private Ltd. (1988) Product Chemistry: Strychnine Alkaloid N.F.
Unpublished study. 3 p.
40799301 Hoffman, J. (1988) Strychnine-Product Identity. Unpublished study prepared by H. Interdonati,
Inc. 5 p.
40799302 Hoffman, J. (1988) Strychnine—Analysis and Certification of Product Ingredients. Unpublished
study prepared by H. Interdonati, Inc. 4 p. 0 40799303 Hoffman, J. (1988) Strychnine-Physical and
Chemical Properties. Unpublished study prepared by H. Interdonati, Inc. 4 p.
40864701 Hoffman, J. (1988) Strychnine—Physical and Chemical Properties. Unpublished study. 5 p.
40880701 Noris Chemical Co. (1988?) Strychnine Alkaloid NFX Product Chemistry. Unpublished study. 4
P-
40908901 Cerven, D. (1988) Strychnine Alkaloid Technical: Oral Toxicity in Albino Rats: Proj. ID MB
88-9165 A. Unpublished study prepared by MB Research Laboratories, Inc. 22 p.
40908902 Cerven, D. (1988) Strychnine Alkaloid Technical: Acute Dermal Toxicity in Albino Rabbits: Lab.
Proj. ID MB 88-9165 B. Unpublished study prepared by MB Research Laboratories, Inc. 12 p.
40908903 Cerven, D. (1988) Strychnine Alkaloid Technical: Primary Dermal Irritation in Albino Rabbits:
Lab. Proj. ID MB 88-9165 C. Unpublished study prepared by MB Research Laboratories, Inc. 8 p.
40908904 Cerven, D. (1988) Strychnine Alkaloid Technical: Eye Irritation in Albino Rabbits: Lab. Proj. ID
MB 88-9165 D. Unpublished study prepared by MB Research Laboratories, Inc. 9 p.
40928901 Karnani, S. (1988) Storage Stability Test on Strychnine Alkaloid NF. Unpublished study
55
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prepared by H.R. Harkins, Inc. 4 p.
40937002 Fagerstone, K. (1988) Strychnine Alkaloid N.F.X-Product Identity and Disclosing of Ingredients
Report. Denver Wildlife Research Center, Denver, Colorado, 4 pp.
41122301 Mishalanie,E.; Griffin, D.; Bullard, R. (1989) Environmental Fate Study: Strychnine Alkaloid
Hydrolysis: Laboratory Project ID: QA-57. Unpublished study prepared by Denver Wildlife Research
Center. 42 p.
41126501 Bowman, J. (1989) Acute Toxicity of Strychnine to Bluegill Sunfish (Lepomis macrochirus):
Project ID: 37645. Unpublished study prepared by Analytical Bio-chemistry Laboratories, Inc. 79 p.
41126502 Bowman, J. (1989) Acute Toxicity of Strychnine to Rainbow Trout (Salmo gairdneri): Project ID:
37646. Unpublished study prepared by Analytical Bio-chemistry Laboratories, Inc. 89 p.
41126503 Forbis, A. (1989) Acute Toxicity of Strychnine to Daphnia magna: Project ID: 37647.
Unpublished study prepared by Analytical Bio-chemistry Laboratories, Inc. 80 p.
41210701 Cerven, D. (1988) Strychnine Alkaloid Technical: Single Dose Oral Toxicity in Rats/LD 50 in
Rats: Revised Final Report: Laboratory Project ID 88-9165 A. Unpublished study prepared by MB Research
Laboratories, Inc. 24 p.
41210702 Cerven, D. (1988) Strychnine Alkaloid Technical: Acute Dermal Toxicity in Rabbits/LD 50 in
Rabbits: Revised Final Report: Laboratory Project ID MB 88-9165 B. Unpublished study prepared by MB
Research Laboratories, Inc. 14 p.
41210703 Cerven, D. (1988) Strychnine Alkaloid Technical: Primary Dermal Irritation in Albino Rabbits:
Laboratory Project ID MB 88-9165 C. Unpublished study prepared by MB Research Laboratories, Inc. 10 p.
41210704 Cerven, D. (1988) Strychnine Alkaloid Technical: Primary Eye Irritation/Corrosion in Rabbits:
Laboratory Project ID MB 88-9165 D. Unpublished study prepared by MB Research Laboratories, Inc. 13
P-
41268501 Hoffman, J. (1988) Strychnine-Physical and Chemical Properties [Stability Data]. Unpublished
study prepared by H. Interdonati, Inc. 4 p.
41299301 Bullard, R. (1989) Strychnine Alkaloid Technical: Certification of Ingredient Limits.
Unpublished study prepared by Denver Wildlife Research Center for Strychnine Consortium. 4 p.
41320601 Shutt, R. (1989) Strychnine Alkaloid NFX Technical: [Product Chemistry]. Unpublished study
prepared by Kothari Pyrochemical Int'l in association with Noris Chemical Corp. 14 p.
41322601 Pedersen, C. (1989) Strychnine: Avian Dietary LC50 (8 Day) in Mallard Ducklings: Lab Project
56
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Number: 89/DC/128. Unpublished study prepared by Bio-Life Associates, Ltd. 76 p.
41322602 Pedersen, C. (1989) Strychnine: Avian Dietary LC50 (8 Day) in Bobwhite Quail: Lab Project
Number: 89/QC/131. Unpublished study prepared by Bio-Life Associates, Ltd. 78 p.
41478501 Evans, I; Campbell, D. (1990) Strychnine Laboratory and Field Data Collection for Continued
Registration of Strychnine Grain Bait for Forest Pocket Gopher (Thomomys spp.) Control. [Part] II: Radio
Telemetry Field Trial: Lab Project Number: QA-44. Denver Wildlife Research Center. 26 p.
41499201 Bullard, R. (1990) Strychnine Alkaloid Technical: Description of Beginning Materials and
Manufacturing Process. Unpublished study prepared by Denver Wildlife Research Center. 8 p.
41499202 Bullard, R. (1990) Strychnine Alkaloid Technical: Discussion of Formation of Impurities.
Unpublished study prepared by Denver Wildlife Research Center. 12 p.
41499203 Bullard, R. (1990) Strychnine Alkaloid Technical: Analytical Method for Enforcement of Limits.
Unpublished study prepared by Denver Wildlife Research Center. 18 p.
41513901 Bullard, R. (1990) Strychnine Alkaloid Technical: Preliminary Analysis of Product Samples.
Unpublished study prepared by Denver Wildlife Research Center. 5 p.
41623201 Bullard, R. (1990) Product Chemistry Study: Storage Stability of Strychnine Technical Product:
Lab Project Number. Unpublished study prepared by Denver Wildlife Research Center. 8 p.
41696201 Bullard, R. (1990) Strychnine Alkaloid Technical: pH. Unpublished study prepared by Denver
Wildlife Research Center. 5 p.
42120401 Bullard, R. (1991) Strychnine Alkaloid Technical.... Unpublished study prepared by Denver
Wildlife Research Center, lip.
42234201 Starr, R.; Hurlbut, D.; Timm, R. (1992) The Aerobic Degradation of Strychnine in Soil Under an
Optimum Incubation Temperature and Moisture Regimen: Lab Project Number: QA-128. Unpublished
study prepared by Denver Wildlife Research Center. 167 p.
42366501 Timm, R.; Starr, R.; Hurlbut, D.; et al. (1992) Mobility of Strychnine in Soil: The
Sorption/Desorption of the Parent Compound in Four Soil Systems: Lab Project Number: QA-190.
Unpublished study prepared by Denver Wildlife Research Center. 353 p.
42488601 Poche, R. (1992) Field Evaluation of Three Concentrations of Strychnine Baits (0.5, 1.15, and
1.8% Strychnine) to Control the Valley Pocket Gopher (Thomomys bottae) in California Using an Artificial
Burrow Builder: Lab Project Number: 91001. Unpublished study prepared by Genesis Labs. 108 p.
42716801 Pedersen, C.; DuCharme, D.; Lesar, C. (1993) Strychnine Alkaloid: Toxicity and Reproduction
57
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Study in Bobwhite Quail: Lab Project Number: 89 QR 37: QA-207. Unpublished study prepared by Bio-Life
Associates, Ltd. 1053 p.
42716802 Pedersen, C.; Lesar, C. (1993) Strychnine Alkaloid: Toxicity and Reproduction Study in Mallard
Ducks: Lab Project Number: 89 DR 33: QA-206. Unpublished study prepared by Bio-Life Associates, Ltd.
1342 p.
42817102 Volz, S. (1992) Strychnine Alkaloid: Melting Point: Lab Project Number: QA-278. Unpublished
study prepared by Denver Wildlife Research Center. 18 p.
42973401 Timm, R.; Starr, R.; Goodall, M. (1993) Photodegradability of Strychnine Alkaloid Technical on
a Sandy Loam Soil: A Supplemental Study: Lab Project Number: QA-316. Unpublished study prepared by
Strychnine Consortium. 124 p.
43079801 Okuno, I. (1994) Product Chemistry-Octanol/Water Partition Coefficient of Strychnine Alkaloid:
Lab Project Number: QA-342. Unpublished study prepared by Denver Wildlife Research Center. 56 p.
Additional References:
Cain, S.A., Kadlec, J.A., Allen, D.A., Cooley, R.A., Hornocker, M.G., Leopold, A.S., and Wagner, F.H.
(1972) Predator Control - 1971. Report to the Council on Environmental Quality and the Department of the
Interior by the Advisory Committee on Predator Control. 207 pp.
Clark, D.M. (1975) Strychnine. In: Clark, D.M. (ed.) Vertebrate Pest Control Handbook. Division of Plant
Industry, California Department of Food and Agriculture, Sacramento, CA. 303-1-2.
Clay, J.A. (1983) Intent to cancel registrations of pesticide products containing Strychnine; denial of
applications for registration of pesticide products containing Strychnine; determination concluding the
rebuttable presumption against registration; availability of position document. Federal Register. 48:203.
48522-48530.
Fagg (1989) Appeals from the United States District Court for the District of Minnesota Nos. 88-5242 and
88-5243. Defenders of Wildlife; the Sierra Club; and Friends of Animals and the Environment vs.
Administrator, U.S. Environmental Protection Agency; Secretary, U.S. Department of the Interior; and
American Farm Bureau Federation, August 16, 18 pp.
Greene, J.F. (1989) "Accelerated Decision and Order" pursuant to negotiated settlement of issues pertaining
to NOIS letters of 10/6/88. March 10, 2 pp. (Settlement agreement itself is 38 pp. plus attachments.)
Jones, M.E. (1987) Initial decision in the matter of Wyoming et al.. petitioners. FIFRA Docket No. 560, U.S.
Environmental Protection Agency, 47 pp.
Jones, D.V., Work, C.E. (1961) Volume of a swallow. American Journal of Diseases in Children 102:173.
58
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Litovitz, T.L., Normann, S.A., Veltri, J.C. (1986) 1985 Annual report of the American Association of Poison
Control Centers National Data Collection System. American Journal of Emergency Medicine 4:427-458.
Litovitz, T.L., Martin, T.G., Schmitz, B. (1987) 1986 Annual report of the American Association of Poison
Control Centers National Data Collection System. American Journal of Emergency Medicine 5:405-445.
Litovitz, T.L., Schmitz, B.F., Matyunas, N., Martin, T.G. (1988) 1987 Annual report of the American
Association of Poison Control Centers National Data Collection System. American Journal of Emergency
Medicine 6:479-515.
Litovitz, T.L., Schmitz, B.F., Holm, K.C. (1989) 1988 Annual report of the American Association of Poison
Control Centers National Data Collection System. American Journal of Emergency Medicine 7:495-545.
Litovitz, T.L., Schmitz, B.F., Bailey, K.M. (1990) 1989 Annual report of the American Association of
Poison Control Centers National Data Collection System. American Journal of Emergency Medicine 8:394-
442.
Litovitz, T.L., Bailey, K.M., Schmitz, B.F., et al. (1991) 1990 Annual report of the American Association of
Poison Control Centers National Data Collection System. American Journal of Emergency Medicine 9:461-
509.
Litovitz, T.L., Holm, K.C., Bailey, K.M., et al. (1992) 1991 Annual report of the American Association of
Poison Control Centers National Data Collection System. American Journal of Emergency Medicine 10:452-
505.
Litovitz, T.L., Holm, K.C., Clancy, C., et al. (1993) 1992 Annual report of the American Association of
Poison Control Centers Toxic Exposure Surveillance System. American Journal of Emergency Medicine
11:494-555
Litovitz, T.L., Clark, L.R, Soloway, R.A. 1994. 1993 Annual report of the American Association of Poison
Control Centers Toxic Exposure Surveillance System. American Journal of Emergency Medicine 12:546-584
Maso, A.E. (ed.) (1995) Protection of Environment. Title 40, Code of Federal Regulations, edition of July 1,
1995 National Archives and Records Administration, U.S. Government Printing Office, Washington, DC,
720 pp.
Moore, J.A. (1987) Strychnine; intent to cancel; partial withdrawal of prior cancellation notice. Federal
Register. 52:42, 6762-6768.
Moore, J.A. (1988) Strychnine; notification of District Court order withdrawal of prior cancellation notice.
Federal Register. 53:101. 18952-18962.
Morgan, D.P. (1989) Recognition and Management of Pesticide Poisonings. U.S. Environmental Protection
59
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Agency, Washington, DC.
Murphy, D.E. (1988) Memorandum opinion and order, Civil 4-86-687, United States District Court, District
of Minnesota, 4th Division. Defenders of Wildlife, the Sierra Club, and Friends of Animals and the
Environment vs. Administrator, U.S. Environmental Protection Agency; Secretary, U.S. Department of the
Interior; and American Farm Bureau Federation, April 11, 51 pp.
National Center for Health Statistics. 1984-1992. Vital Statistics of the United States [for the years 1984
through 1990]. Volume II. Part A. U.S. Government Printing Office, Washington, D.C.
Nixon, R.M. (1972) Executive Order 11643.
Perper, J.A. (1985) Fatal strychnine poisoning — A case report and review of the literature. Journal of
Forensic Science 30(4): 1248-1255.
Ray, D.E. (1991) Pesticides Derived from Plants and other Organisms. Chapter 13 (pp. 615-619) in
Handbook of Pesticide Toxicology, Volume 2. Edited by WJ Hayes and ER Laws. Academic Press, San
Diego.
Ruckelshaus, W.D. (1972) Suspension of registration for certain products containing Sodium Fluoroacetate
(1080), Strychnine and Sodium Cyanide. PR Notice 72-2. Issued, March 9, 1972. Also published on March
18, 1972, in Federal Register. 3.7:54, 5718-5720.
Smith, B.A. (1990) Strychnine poisoning. The Journal of Emergency Medicine 8:321-325.
Thomas, L.M. (1988) Strychnine; notice of temporary cancellation. Federal Register. 53.:193, 39132-39133.
Timm, R.M. (1994) Description of active ingredients: Strychnine. In: Hyngstrom, S.E., Timm, R.M., and
Larson, G.E. (eds.), Prevention and Control of Wildlife Damage (Third Edition), University of Nebraska
Cooperative Extension, U.S. Department of Agriculture Animal and Plant Health Inspection Service, and
Great Plains Agricultural Council Wildlife Committee. G-54-55.
U.S. Environmental Protection Agency (1976) Strychnine Position Document 1, December 1.
U.S. Environmental Protection Agency (1980) Strychnine Position Document 2/3, November 5.
U.S. Environmental Protection Agency (1983) Strychnine Position Document 4, September 30, 57 pp.
60
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet.
to submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your product(s)
containing this active ingredient(s). Within 90 days after you receive this Notice you must
respond as set forth in Section III below. Your response must state:
1. how you will comply with the requirements set forth in this Notice and its Attachments
1 through 4; or,
2. why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section III-B);
or,
3. why you believe EPA should not require your submission of data in the manner specified
by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a
list of all registrants who were sent this Notice (Attachment 4).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
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information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 3-31-99).
This Notice is divided into six sections and five Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment 1 - Data Call-In Chemical Status Sheet
Attachment 2 - Data Call-In Response Form
Attachment 3 - Requirements Status And Registrant's Response Form
Attachment 4 - List Of All Registrants Sent This Data Call-In Notice
SECTION! WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because you
have product(s) containing the subject active ingredient(s).
SECTION II. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The data required by this Notice are specified in Attachment 3, Requirements
Status and Registrant's Response Form. Depending on the results of the studies required
in this Notice, additional testing may be required.
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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.
C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel:
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD-recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR §
158.70). When using the OECD protocols, they should be modified as appropriate so that
the data generated by the study will satisfy the requirements of 40 CFR § 158. Normally,
the Agency will not extend deadlines for complying with data requirements when the
studies were not conducted in accordance with acceptable standards. The OECD
protocols are available from 2001 L Street, N.W., Washington, D.C. 20036 (Telephone
number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or
change the requirements of any previous Data Call-In(s). or any other agreements entered
into with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their
affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A. SCHEDULE FOR RESPONDING TO THE AGENCY
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The appropriate responses initially required by this Notice must be submitted to
the Agency within 90 days after your receipt of this Notice. Failure to adequately respond
to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS
due to failure to comply with this Notice are presented in Section IV-A and IV-B.
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B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete
use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements
imposed by this Notice or (5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option,
the Delete Use(s) option or the Generic Data Exemption option is presented below. A
discussion of the various options available for satisfying the data requirements of this
Notice is contained in Section III-C. A discussion of options relating to requests for data
waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the
Data-Call-in Response Form (Attachment 2) and the Requirements Status and Registrant's
Response Form (Attachment 3). The Data Call-In Response Form must be submitted as
part of every response to this Notice. Please note that the company's authorized
representative is required to sign the first page of the Data Call-In Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial
any subsequent pages. The forms contain separate detailed instructions on the response
options. Do not alter the printed material. If you have questions or need assistance in
preparing your response, call or write the contact person identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice
by requesting voluntary cancellation of your product(s) containing the active
ingredient(s) that is the subject of this Notice. If you wish to voluntarily cancel
your product, you must submit a completed Data Call-In Response Form.
indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this is the only form
that you are required to complete.
If you choose to voluntarily cancel your product, further sale and
distribution of your product after the effective date of cancellation must be in
accordance with the Existing Stocks provisions of this Notice which are contained
in Section IV-C.
2. Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses of your product to which the requirements apply. If you wish
to amend your registration to delete uses, you must submit the Requirements
Status and Registrant's Response Form, a completed application for amendment,
a copy of your proposed amended labeling, and all other information required for
processing the application. Use deletion is option number 7 on the Requirements
Status and Registrant's Response Form. You must also complete a Data Call-In
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Response Form by signing the certification, item number 8. Application forms for
amending registrations may be obtained from the Registration Support and
Emergency Response Branch, Registration Division, (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to
specific data requirements, further sale, distribution, or use of your product after
one year from the due date of your 90 day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an applicant
for registration of a product is exempt from the requirement to submit or cite
generic data concerning an active ingredient(s) if the active ingredient(s) in the
product is derived exclusively from purchased, registered pesticide products
containing the active ingredient(s). EPA has concluded, as an exercise of its
discretion, that it normally will not suspend the registration of a product which
would qualify and continue to qualify for the generic data exemption in section
3(c)(2)(D) of FIFRA. To qualify, all of the following requirements must be met:
a. The active ingredient(s) in your registered product must be present
solely because of incorporation of another registered product which
contains the subject active ingredient(s) and is purchased from a source not
connected with you; and,
b. every registrant who is the ultimate source of the active
ingredient(s) in your product subject to this DCI must be in compliance
with the requirements of this Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current
"Confidential Statement of Formula" for each of your products to which
this Notice applies.
To apply for the Generic Data Exemption you must submit a completed
Data Call-In Response Form. Attachment 2 and all supporting documentation.
The Generic Data Exemption is item number 6a on the Data Call-In Response
Form. If you claim a generic data exemption you are not required to complete the
Requirements Status and Registrant's Response Form. Generic Data Exemption
cannot be selected as an option for product specific data.
If you are granted a Generic Data Exemption, you rely on the efforts of
other persons to provide the Agency with the required data. If the registrant(s)
who have committed to generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer in compliance with this
Data Call-In Notice, the Agency will consider that both they and you are not in
compliance and will normally initiate proceedings to suspend the registrations of
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both your and their product(s), unless you commit to submit and do submit the
required data within the specified time. In such cases the Agency generally will
not grant a time extension for submitting the data.
4. Satisfying the Data Requirements of this Notice - There are various
options available to satisfy the data requirements of this Notice. These options are
discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and option 6b and 7 on the
Data Call-In Response Form. If you choose option 6b or 7, you must submit both
forms as well as any other information/data pertaining to the option chosen to
address the data requirement.
5. Request for Data Waivers. Data waivers are discussed in Section III-D of
this Notice and are covered by options 8 and 9 on the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must submit
both forms as well as any other information/data pertaining to the option chosen
to address the data requirement.
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy
the data requirements (i.e. you select option 6b and/or 7), then you must select one of the
six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first
six options discussed under item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form. These six options are listed immediately below
with information in parentheses to guide registrants to additional instructions provided in
this Section. The options are:
1. I will generate and submit data within the specified time frame
(Developing Data),
2. I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing),
3. I have made offers to cost-share (Offers to Cost Share),
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),
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6. I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study).
Option 1. Developing Data —
If you choose to develop the required data it must be in conformance with
Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the
Pesticide Assessment Guidelines (PAG), and be in conformance with the
requirements of PR Notice 86-5. In addition, certain studies require Agency
approval of test protocols in advance of study initiation. Those studies for which
a protocol must be submitted have been identified in the Requirements Status and
Registrant's Response Form and/or footnotes to the form. If you wish to use a
protocol which differs from the options discussed in Section II-C of this Notice,
you must submit a detailed description of the proposed protocol and your reason
for wishing to use it. The Agency may choose to reject a protocol not specified
in Section II-C. If the Agency rejects your protocol you will be notified in writing,
however, you should be aware that rejection of a proposed protocol will not be a
basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from
the date you are required to commit to generate or undertake some other means to
address that study requirement, such as making an offer to cost-share or agreeing
to share in the cost of developing that study. A 90-day progress report must be
submitted for all studies. This 90-day progress report must include the date the
study was or will be initiated and, for studies to be started within 12 months of
commitment, the name and address of the laboratory(ies) or individuals who are
or will be conducting the study.
In addition, if the time frame for submission of a final report is more than
1 year, interim reports must be submitted at 12 month intervals from the date you
are required to commit to generate or otherwise address the requirement for the
study. In addition to the other information specified in the preceding paragraph,
at a minimum, a brief description of current activity on and the status of the study
must be included as well as a full description of any problems encountered since
the last progress report.
The time frames in the Requirements Status and Registrant's Response
Form are the time frames that the Agency is allowing for the submission of
completed study reports or protocols. The noted deadlines run from the date of
the receipt of this Notice by the registrant. If the data are not submitted by the
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deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by
this Notice and intend to seek additional time to meet the requirement(s), you must
submit a request to the Agency which includes: (1) a detailed description of the
expected difficulty and (2) a proposed schedule including alternative dates for
meeting such requirements on a step-by-step basis. You must explain any
technical or laboratory difficulties and provide documentation from the laboratory
performing the testing. While EPA is considering your request, the original
deadline remains. The Agency will respond to your request in writing. If EPA
does not grant your request, the original deadline remains. Normally, extensions
can be requested only in cases of extraordinary testing problems beyond the
expectation or control of the registrant. Extensions will not be given in submitting
the 90-day responses. Extensions will not be considered if the request for
extension is not made in a timely fashion; in no event shall an extension request
be considered if it is submitted at or after the lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data —
If you choose to enter into an agreement to share in the cost of producing
the required data but will not be submitting the data yourself, you must provide the
name of the registrant who will be submitting the data. You must also provide
EPA with documentary evidence that an agreement has been formed. Such
evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the
terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of
the agreement they may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development —
If you have made an offer to pay in an attempt to enter into an agreement
or amend an existing agreement to meet the requirements of this Notice and have
been unsuccessful, you may request EPA (by selecting this option) to exercise its
discretion not to suspend your registration(s), although you do not comply with
the data submission requirements of this Notice. EPA has determined that as a
general policy, absent other relevant considerations, it will not suspend the
registration of a product of a registrant who has in good faith sought and continues
to seek to enter into a joint data development/cost sharing program, but the other
registrant(s) developing the data has refused to accept your offer. To qualify for
this option, you must submit documentation to the Agency proving that you have
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made an offer to another registrant (who has an obligation to submit data) to share
in the burden of developing that data. You must also submit to the Agency a
completed EPA Form 8570-32, Certification of Offer to Cost Share in the
Development of Data. In addition, you must demonstrate that the other registrant
to whom the offer was made has not accepted your offer to enter into a cost
sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must,
in addition to anything else, offer to share in the burden of producing the data
upon terms to be agreed or failing agreement to be bound by binding arbitration
as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this offer. The
other registrant must also inform EPA of its election of an option to develop and
submit the data required by this Notice by submitting a Data Call-In Response
Form and a Requirements Status and Registrant's Response Form committing to
develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not
withdraw your offer to share in the burdens of developing the data. In addition,
the other registrant must fulfill its commitment to develop and submit the data as
required by this Notice. If the other registrant fails to develop the data or for some
other reason is subject to suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame.
In such cases, the Agency generally will not grant a time extension for submitting
the data.
Option 4. Submitting an Existing Study —
If you choose to submit an existing study in response to this Notice, you
must determine that the study satisfies the requirements imposed by this Notice.
You may only submit a study that has not been previously submitted to the
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:
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a. You must certify at the time that the existing study is submitted that
the raw data and specimens from the study are available for audit and
review and you must identify where they are available. This must be done
in accordance with the requirements of the Good Laboratory Practice
(GLP) regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(7) " raw
data means any laboratory worksheets, records, memoranda, notes, or
exact copies thereof, that are the result of original observations and
activities of a study and are necessary for the reconstruction and evaluation
of the report of that study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been transcribed verbatim,
dated, and verified accurate by signature), the exact copy or exact
transcript may be substituted for the original source as raw data. Raw data
may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded
data from automated instruments." The term "specimens", according to 40
CFR 160.3(7), means "any material derived from a test system for
examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control information,
pursuant to the requirements of 40 CFR Part 160. Registrants must also
certify at the time of submitting the existing study that such GLP
information is available for post-May 1984 studies by including an
appropriate statement on or attached to the study signed by an authorized
official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for
the Guideline relevant to the study provided in the FIFRA Accelerated
Reregi strati on Phase 3 Technical Guidance and that the study has been
conducted according to the Pesticide Assessment Guidelines (PAG) or
meets the purpose of the PAG (both available from NTIS). A study not
conducted according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which
states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including copies of any
supporting information or data. It has been the Agency's experience that
studies completed prior to January 1970 rarely satisfied the purpose of the
PAG and that necessary raw data are usually not available for such studies.
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If you submit an existing study, you must certify that the study
meets all requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are
submitting, you must identify any action taken by the Agency on the
protocol and must indicate, as part of your certification, the manner in
which all Agency comments, concerns, or issues were addressed in the
final protocol and study.
If you know of a study pertaining to any requirement in this Notice
which does not meet the criteria outlined above but does contain factual
information regarding unreasonable adverse effects, you must notify the
Agency of such a study. If such a study is in the Agency's files, you need
only cite it along with the notification. If not in the Agency's files, you
must submit a summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study —
If a study has been classified as partially acceptable and upgradeable, you
may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the
requirement is not satisfied, you may still be required to submit new data normally
without any time extension. Deficient, but upgradeable studies will normally be
classified as supplemental. However, it is important to note that not all studies
classified as supplemental are upgradeable. If you have questions regarding the
classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing
study you must satisfy or supply information to correct all deficiencies in the study
identified by EPA. You must provide a 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.
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The criteria for submitting an existing study, as specified in Option 4
above, apply to all data submissions intended to upgrade studies. Additionally
your submission of data intended to upgrade studies must be accompanied by a
certification that you comply with each of those criteria as well as a certification
regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studies —
If you choose to cite a study that has been previously submitted to EPA,
that study must have been previously classified by EPA as acceptable or it must
be a study which has not yet been reviewed by the Agency. Acceptable
toxicology studies generally will have been classified as "core-guideline" or "core
minimum." For ecological effects studies, the classification generally would be
a rating of "core." For all other disciplines the classification would be
"acceptable." With respect to any studies for which you wish to select this option
you must provide the MRID number of the study you are citing and, if the study
has been reviewed by the Agency, you must provide the Agency's classification
of the study.
If you are citing a study of which you are not the original data submitter,
you must submit a completed copy of EPA Form 8570-31, Certification with
Respect to Data Compensation Requirements.
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request
for a low volume/minor use waiver and the second is a waiver request based on your
belief that the data requirement(s) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver — Option 8 on the Requirements Status
and Registrant's Response Form. Section 3(c)(2)(A) of FIFRA requires EPA to
consider the appropriateness of requiring data for low volume, minor use
pesticides. In implementing this provision EPA considers as low volume
pesticides only those active ingredient(s) whose total production volume for all
pesticide registrants is small. In determining whether to grant a low volume,
minor use waiver the Agency will consider the extent, pattern and volume of use,
the economic incentive to conduct the testing, the importance of the pesticide, and
the exposure and risk from use of the pesticide. If an active ingredient(s) is used
for both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient(s) are low volume and the combined
volumes for all uses are also low, then an exemption may be granted, depending
on review of other information outlined below. An exemption will not be granted
if any registrant of the active ingredient(s) elects to conduct the testing. Any
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registrant receiving a low volume minor use waiver must remain within the sales
figures in their forecast supporting the waiver request in order to remain qualified
for such waiver. If granted a waiver, a registrant will be required, as a condition
of the waiver, to submit annual sales reports. The Agency will respond to requests
for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the
following information, as applicable to your product(s), as part of your 90-day
response to this Notice:
a. Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredient(s). If applicable to the active
ingredient(s), include foreign sales for those products that are not
registered in this country but are applied to sugar (cane or beet), coffee,
bananas, cocoa, and other such crops. Present the above information by
year for each of the past five years.
b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site. Present the above information by
year for each of the past five years.
c. Total direct production cost of product(s) containing the active
ingredient(s) by year for the past five years. Include information on raw
material cost, direct labor cost, advertising, sales and marketing, and any
other significant costs listed separately.
d. Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredient(s)
by year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredient(s), such as costs of initial
registration and any data development.
e. A list of each data requirement for which you seek a waiver.
Indicate the type of waiver sought and the estimated cost to you (listed
separately for each data requirement and associated test) of conducting the
testing needed to fulfill each of these data requirements.
f A list of each data requirement for which you are not seeking any
waiver and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill
each of these data requirements.
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g. For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct production
costs of product(s) containing the active ingredient(s) (following the
parameters in item c above), indirect production costs of product(s)
containing the active ingredient(s) (following the parameters in item d
above), and costs of data development pertaining to the active
ingredient(s).
h. A description of the importance and unique benefits of the active
ingredient(s) to users. Discuss the use patterns and the effectiveness of the
active ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to the active
ingredient(s), providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then
present the reasoning used to derive your estimates. To assist the Agency
in determining the degree of importance of the active ingredient(s) in terms
of its benefits, you should provide information on any of the following
factors, as applicable to your product(s):
(1) documentation of the usefulness of the active ingredient(s)
in Integrated Pest Management, (b) description of the beneficial impacts
on the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
ingredient(s) after use and on its persistence in the environment, and (d)
description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume minor use waiver will result in denial of the request
for a waiver.
2. Request for Waiver of Data —Option 9 on the Requirements Status and
Registrant's Response Form. This option may be used if you believe that a
particular data requirement should not apply because the corresponding use is no
longer registered or the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You must
also submit the current label(s) of your product(s) and, if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice do not apply to your
product(s), you will not be required to supply the data pursuant to section
3(c)(2)(B). If EPA determines that the data are required for your product(s). you
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must choose a method of meeting the requirements of this Notice within the time
frame provided by this Notice. Within 30 days of your receipt of the Agency's
written decision, you must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
A. NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this
Notice due to failure by a registrant to comply with the requirements of this Data Call-In
Notice, pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt
of this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on
a study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by
this Notice.
5. Failure to take a required action or submit adequate information pertaining
to any option chosen to address the data requirements (e.g., any required
action or information pertaining to submission or citation 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:
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a. inform EPA of intent to develop and submit the data required by
this Notice on a Data Call-In Response Form and a Requirements Status
and Registrant's Response Form: or,
b. fulfill the commitment to develop and submit the data as required
by this Notice; or,
c. otherwise take appropriate steps to meet the requirements stated in
this Notice, unless you commit to submit and do submit the required data
in the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at
any time following the issuance of this Notice.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend.
The grounds for suspension include, but are not limited to, failure to meet any of the
following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of required studies. Such
requirements include, but are not limited to, those relating to test material, test
procedures, selection of species, number of animals, sex and distribution of
animals, dose and effect levels to be tested or attained, duration of test, and, as
applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner
of reporting, the completeness of results, and the adequacy of any required
supporting (or raw) data, including, but not limited to, requirements referenced or
included in this Notice or contained in PR 86-5. All studies must be submitted in
the form of a final report; a preliminary report will not be considered to fulfill the
submission requirement.
C. EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
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EPA has statutory authority to permit continued sale, distribution and use of
existing stocks of a pesticide product which has been suspended or cancelled if doing so
would be consistent with the purposes of the Federal Insecticide, Fungicide, and
Rodenticide Act.
The Agency has determined that such disposition by registrants of existing stocks
for a suspended registration when a section 3(c)(2)(B) data request is outstanding would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
product(s) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may be suspended for failure to comply with this Notice
should be permitted, you have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. You must also explain why an
"existing stocks" provision is necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale, distribution, and use. Unless
you meet this burden the Agency will not consider any request pertaining to the continued
sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this
Notice and your product is in full compliance with all Agency requirements, you will
have, under most circumstances, one year from the date your 90 day response to this
Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency will allow
persons other than the registrant such as independent distributors, retailers and end users
to sell, distribute or use such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products containing an active
ingredient(s) for which the Agency has particular risk concerns will be determined on
case-by-case basis.
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.
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SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form (Attachment 2) and
a completed Requirements Status and Registrant's Response Form (Attachment 3) and any other
documents required by this Notice, and should be submitted to the contact person identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only the
Data Call-In Response Form need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance
(OECA), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois Rossi, Division Director
Special Review
and Reregi strati on Division
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3133 DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Data Call-In Notice because you hold a registration(s) of products
containing strychnine.
This attachment, the Data Call-In Chemical Status Sheet, contains the supporting
information regarding the special requirements of this Data Call-In, why the requirements are
being imposed and the contact person for inquiries. This attachment is to be used in conjunction
with (1) the Data Call-In Notice, (2) Attachment 2, the Data Call-In Response Form. (3)
Attachment 3, the Requirements Status and Registrant's Response Form, and (4) the Cost Share
and Data Compensation Forms in replying to this strychnine Data Call-In. Instructions and
guidance accompany each form.
INCIDENT HISTORY
Approximately 100 cases of accidental exposure to strychnine rodenticides are reported
annually to U.S. Poison Control Centers (Litovitz et al. 1986-1994). However, EPA believes this
number of accidental exposures is low based on comparisons with other data sources which show
that Poison Control Center data generally underestimate the true extent of poisoning.
During a nine-year period (1985-1993), 1,359 exposures to strychnine were recorded by
the U.S. Poison Control Centers. Of the accidental exposure cases, where the age of the exposed
individuals was available, nearly half of those exposed were under six years old. In addition, in
25 cases where medical outcome was determined to be serious (a moderate, major or fatal
outcome from 1985 through 1992), two were confirmed to be children. Estimates of lethal dose
for strychnine baits as currently formulated (0.5% active ingredient) suggest that a single swallow
by a 10 kg child could be lethal. For a typical one-year old child weighing 10 kg, this would
mean a dose of 1.1-1.8 mg/kg of strychnine, which is in the potentially lethal range.
The available information from various sources on human poisoning incidents is
conflicting and unclear as it relates to accidental exposure to strychnine products. This problem
and the uncertainly of the amounts of end-use products which could result in significant toxicity
to humans, especially children, do not enable the Agency to determine with confidence the
magnitude and seriousness of poisonings from the use of strychnine in the U.S. Additional
information to clarify these issues is required by this notice.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for 3133 are:
(1) poison control center data.
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This information is to include specific incident data about products used by
homeowners, and incident reports on poisoning incidents involving children;
This information requirement is contained in the Requirements Status and Registrant's
Response. Attachment C. These data are needed to fully complete the reregi strati on of all
eligible 3133 products.
WHY THESE REQUIREMENTS ARE BEING IMPOSED
Due to the limited data available to the Agency concerning strychnine poisoning incidents
EPA believes that the data required by this Notice will assist in more fully understanding the risks
associated with the use of strychnine. Since the incident data currently available to the Agency
contains some gaps, the Agency is requiring the registrants to provide data to fully assess the
risks associated with strychnine use. EPA believes that children may be at risk from the presence
of strychnine in and around the treatment site and/or from its storage in the home.
Data to be collected include poison control center data for products used by homeowners;
incident reports on poisoning of children; and end-use product acute toxicity.
This information on incidents from strychnine exposure, along with the product-specific
acute toxicity data required through the product reregistration, will be used to form the basis of
our regulatory decision for the homeowner uses of strychnine.
82-3-SS Human Incident Data:
Data Required
The types of data the Agency is requiring are described below. These data are available from
the Toxic Exposure Surveillance System of the American Association of Poison Control Centers
(AAPCC) database, which provides an annual compilation of poisoning statistics from around
the U.S. The AAPCC database is the most comprehensive, independently generated national
poisoning database known to the Agency. The AAPCC can be contacted at 3201 New Mexico
Avenue, Suite 310, NW, Washington, DC 20016; phone: 202-362-3867.
Approximately 80 percent of the U.S. population have access to the Poison Control Centers
represented in the most recent AAPCC annual report. Reports are indexed by both product brand
name (if given by the caller) and by active chemical ingredient (e.g., strychnine, etc.). Each
registrant is required to prepare a summary report on its individual products by active ingredient,
which will include a summary listing by product of the number of incidents reported. A second
summary report will be required providing the same tables and cross-tabulations for all cases
involving the active ingredient regardless of whether the registrant was the manufacturer of that
particular active chemical ingredient. However, individual product brand names will not be listed
in this second report. Where more than one company is involved in the manufacture of an active
chemical, they are encouraged to share costs when producing this latter report. Each registrant
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is required to submit the following data elements (for each incident listed by the AAPCC) in the
format of the tables found in the AAPCC annual report:
1. specific product brand name and active ingredient with concomitant pesticide exposures
(exclude cases involving exposure to non-pesticide products),
2. exposure type (e.g., acute, chronic),
3. reason for exposure (e.g., accidental, occupational, adverse reaction, misuse), as defined
by AAPCC. Registrants must include all categories of accidental exposure and intentional
misuse, (exclude intentional suicide/homicide),
4. exposure site (e.g., residence, work place, school,
5. route of exposure (oral, inhalation, dermal, ocular),
6. initial symptom assessment (present or absent, related; cholinesterase depression, if
available),
7. management of patient site (health care facility or not),
8. disposition of patient (treated and released, hospitalized),
9. decontamination provided (e.g., ipecac, charcoal),
10. therapy provided (e.g., oxygen, atropine),
11. medical outcome (none, minor, moderate, major, fatal, unknown), as defined by AAPCC,
12. age and sex of individual involved in each case, and physical and mental state, if
available, and,
13. symptoms reported for 1993-1995.
All available incidents involving strychnine listed in this DCI must be provided for the
period of 1990 through 1992, in one report and 1993 through 1995 in a second report. The data
must be in listing and cross-tabular form (e.g., reason by age, route of exposure by medical
outcome - the standard set of cross-tabulations provided by AAPCC), which will facilitate
analysis for factors that affect potential exposure or risk. In addition, there must be a one-line
summary of each case that resulted in a minor, moderate, major, or fatal outcome. The one-line
summary must give case number, date, age, sex, reason, exposure route, and a separate listing
by substance or product brand name that indicates the number of times each particular product
occurs. It is important to associate incidents with use sites. Data for the years 1990 through 1992
and 1993 through 1995 should be provided in two combined reports, not separately year-by-year.
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INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Bonnie Adler at (703) 308-8523.
All responses to this Notice for the generic data requirements should be submitted to:
Bonnie Adler, Chemical Review Manager
Accelerated Reregi strati on Branch
Special Review and Registration Division (7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460
RE: 3133
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM
This Form is designed to be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
Rodenticide Act. Fill out this form each time you are responding to a data call-in for which EPA
has sent you the form entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed by
the registrant as appropriate Items 8 through 11 must be completed by the registrant
before submitting a response to the Agency.
Public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggesting for reducing this burden, to Chief, Information Policy
Branch, PM-223, U S Environmental Protection Agency, 401 M St, S W , Washington, D C
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, DC 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and address.
Item 2. This item identifies the ease number, ease name, EPA chemical number
and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations relevant to the data
call-in. Please note that you are also responsible for informing the Agency
of your response regarding any product that you believe may be covered
by this data call-in but that is not listed by the Agency in Item 4. You must
bring any such apparent omission to the Agency's attention within the
period required for submission of this response form.
Item 5. Cheek this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of
that request. You do not need to complete any item on the Requirements
Status and Registrant's Response Form for any product that is voluntarily
cancelled.
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Item 6a. Check this item if this data call-in is for generic data as indicated in Item
3 and if you are eligible for a Generic Data Exemption for the chemical
listed in Item 2 and used in the subject product. By electing this
exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that
you use in your product.
Typically, if you purchase an EPA-registered product from one or more
other producers (who, with respect to the incorporated product, are in
compliance with this and-any other outstanding Data Call-In Notice), and
incorporate that product into all your products, you may complete this item
for all products listed on this form If, however, you produce the active
ingredient yourself, or use any unregistered product (regardless of the fact
that some of your sources are registered), you may not claim a Generic
Data Exemption and you may not select this item.
Item 6b. Check this Item if the data call-in is a generic data call-in as indicated in
Item 3 and if you are agreeing to satisfy the generic data requirements of
this data call-in. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing
use product for which you agree to supply product-specific data. Attach
the Requirements Status and Registrants' Response Form that indicates
how you will satisfy those requirements.
Item 7b. Check this item if this call-in is a data call-in for an end use product (EUP)
as indicated in Item 3 and if your product is an end use product for which
you agree to supply product-specific data. Attach the Requirements Status
and Registrant's Response Form that indicates how you will satisfy those
requirements.
Item 8. This certification statement must be signed by an authorized representative
of your company and the person signing must include his/her title.
Additional pages used in your response must be initialled and dated in the
space provided for the certification.
Item 9. Enter the date of signature.
Item 10. Enter the name of the person EPA should contact with questions regarding
your response.
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Item 11. Enter the phone number of your company contact.
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to call-in- for generic and
product-specific data as part of EPA's reregi strati on program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for both product specific and
generic data, instructions for completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1) deletion of uses or (2) request for
a low volume/minor use waiver. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-in addressed to each registrant, and
has preprinted this form with a number of items. DO NOT use this form for any other active
ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all other
items on this form by typing or printing legibly.
Public reporting burden for this collection of information is estimated to average 30 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to Chief, Information Policy Branch,
PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction Project 2070-0107, Washington,
D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2. This item identifies the case number, case name, EPA chemical number and
chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to support
the product(s) being reregistered. These guidelines, in addition to requirements
specified in the Data Call-In Notice, govern the conduct of the required studies.
Item 5. This item identifies the study title associated with the guideline reference number
and whether protocols and 1,2, or 3-year progress reports are required to be
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submitted in connection with the study. As noted in Section III of the Data Call-In
Notice, 90-day progress reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to
this guideline reference number to the Requirements Status and
Registrant's Response Form.
Item 6. This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food crop
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
Item 7. This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP End-Use Product
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical Grade
Active Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Ingredient or Pure Active Ingredient
Radiolabelled
PAIRA Pure Active Ingredient Radiolabelled
P AIRA/M Pure Active Ingredient Radiolabelled and Metabolites
PAIRA/PM Pure Active Ingredient Radiolabelled and Plant
Metabolites
TEP Typical End-Use Product
TEP _ * Typical End-Use Product, Percent Active Ingredient
Specified
TEP/MET Typical End-Use Product and Metabolites
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TEP/PAI/M Typical End-Use Product or Pure Active Ingredient
and Metabolites
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
TGAI Technical Grade Active Ingredient
TGAI/TEP Technical Grade Active Ingredient or Typical
End-Use Product
TGAI/PAI Technical Grade Active Ingredient or Pure Active
Ingredient
MET Metabolites
IMP Impurities
DEGR Degradates
*See: guideline comment
Item 8. This item identifies the time frame allowed for submission of the study or protocol
identified in item 2. The time frame runs from the date of your receipt of the Data
Call-In Notice.
Item 9. Enter the appropriate Response Code or Codes to show how you intend to comply
with each data requirement. Brief descriptions of each code follow. The Data Call-
in Notice contains a fuller description of each of these options.
1. (Developing Data) I will conduct a new study and submit it within the time
frames specified in item 8 above. By indicating that I have chosen this
option, I certify that I will comply with all the requirements pertaining to
the conditions for submittal of this study as outlined in the Data Call-In
Notice and that I will provide the protocol and progress reports required in
item 5 above.
2. (Agreement to Cost Share) I have entered into an agreement with one or
more registrants to develop data jointly. By indicating that I have chosen
this option, I certify that I will comply with all the requirements pertaining
to sharing in the cost of developing data as outlined in the Data Call-In
Notice.
3. (Offer to Cost Share) I have made an offer to enter into an agreement with
one or more registrants to develop data jointly. I am submitting a copy of
the form "Certification of Offer to Cost Share in the Development of Data"
that describes this offer/agreement. By indicating that I have chosen this
option, I certify that I will comply with all the requirements pertaining to
making an offer to share in the cost of developing data as outlined in the
Data Call-In Notice.
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4. (Submitting Existing Data) I am submitting an existing study that has
never before been submitted to EPA. By indicating that I have chosen this
option, I certify that this study meets all the requirements pertaining to the
conditions for submittal of existing data outlined in the Data Call-In Notice
and I have attached the needed supporting information along with this
response.
5. (Upgrading a Study) I am submitting or citing data to upgrade a study that
EPA has classified as partially acceptable and potentially upgradeable. By
indicating that I have chosen this option, I certify that I have met all the
requirements pertaining to the conditions for submitting or citing existing
data to upgrade a study described in the Data Call-In Notice. I am
indicating on attached correspondence the Master Record Identification
Number (MRID) that EPA has assigned to the data that I am citing as well
as the MRID of the study I am attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that has
not yet been reviewed by the Agency. I am providing the Agency's
classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In Notice
and I request a low-volume minor use waiver of the data requirement. I
am attaching a detailed justification to support this waiver request
including, among other things, all information required to support the
request. I understand that, unless modified by the Agency in writing, the
data requirement as stated in the Notice governs.
9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than low volume minor-use data waivers in the Data Call-In
Notice and I request a waiver of the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to
support this waiver request. The justification includes, among other things,
all information required to support the request. I understand that, unless
modified by the Agency in writing, the data requirement as stated in the
Notice governs.
Item 10. This item must be signed by an authorized representative of your company. The
person signing must include his/her title, and must initial and date all other pages
of this form.
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Item 11. Enter the date of signature.
Item 12. Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
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s? UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
p* 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 product(s) subject to this Notice will be subject to suspension. We have provided a list of
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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 03-31-99).
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 VI - 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.
II-B. SCHEDULE FOR SUBMISSION OF DATA
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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(s). or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
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 as well as any other information/data pertaining to the option chosen to address the
data requirement.
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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 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
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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 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
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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 Reregistration 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 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
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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.
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
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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.
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.
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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:
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.
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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.
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
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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.
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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,
Lois Rossi, Division Director
Special Review and
Reregistration Division
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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3133 DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing 3133.
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 3133. 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 3133 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 3133 are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency
has concluded that additional data on 3133 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 3133 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 Ed Setren at (703) 308-8166.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Ed Setren
Chemical Review Manager Team 81
Product Reregi strati on Branch
Special Review and Reregi strati on Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: 3133
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your 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 information that 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 FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned 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 Document unless
EPA determines that a longer time period is necessary.
Item 9 Enter only one of the following response codes for each data requirement
to 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 only if EPA indicates in an attachment to this Notice that my
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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 offer to 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) and (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
Study). 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 review indicating that the
study may be upgraded and what information is required to do so. I will
provide the MRID or Accession number of the study at the due date. I
understand that the conditions for this option outlined Option 5 in the Data
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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 information that 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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EPA'S BATCHING OF PRODUCTS CONTAINING STRYCHNINE AS THE ACTIVE
INGREDIENT FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregi strati on of products containing the active ingredient
strychnine (also known as strychnine alkaloid) the Agency has batched products which can be
considered similar in terms of acute toxicity. Factors considered in the sorting process
include each product's active and inert ingredients (identity, percent composition and
biological activity), product form (liquid, paste, solid, etc.), and labeling (e.g., signal word,
precautionary labeling, etc.). Note that the Agency is not describing batched products as
"substantially similar" since some products within a batch may not be considered chemically
similar or have identical use patterns.
Using available information, batching has been accomplished by the process described
in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the
right to require, at any time, acute toxicity data for an individual product should the need
arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see
acceptance criteria attached), the formulation tested is considered by EPA to be similar for
acute toxicity, and the formulation has not been significantly altered since submission and
acceptance of the acute toxicity data. PRS must approve any new formulations (that were
presented to the Agency after the publication of the RED) before data derived from them can
be used to cover other products in a batch. Regardless of whether new data is generated or
existing data is referenced, registrants must clearly identify the test material by EPA
Registration Number. If more than one confidential statement of formula (CSF) exists for a
product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must
follow the directions given in the Data Call-In Notice and its attachments appended to the
RED. The DCI Notice contains two response forms which are to be completed and submitted
to the Agency within 90 days of receipt. The first form, "Data Call-In Response," asks
whether the registrant will meet the data requirements for each product. The second form,
"Requirements Status and Registrant's Response," lists the product specific data required for
each product, including the standard six acute toxicity tests. A registrant who wishes to
participate in a batch must decide whether he/she will provide the data or depend on someone
else to do so. If a registrant supplies the data to support a batch of products, he/she must
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select one of the following options: Developing Data (Option 1), Submitting an Existing
Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study
(Option 6). If a registrant depends on another's data, he/she must choose among: Cost
Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If
a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6.
However, a registrant should know that choosing not to participate in a batch does not
preclude other registrants in the batch from citing his/her studies and offering to cost share
(Option 3) those studies.
Table 1 displays the batches for the active ingredient strychnine
Table 1.
Batch
1
Registration
Number
2935-507
27995-1
37295-1
Percent Active Ingredient
Strychnine ... 99.9%
Strychnine ... 99.9%
Strychnine ... 99.9%
Form
powder
powder
powder
2
30-27
299-212
299-213
322-1
322-7
641-1
641-2
814-4
909-2
2935-508
2935-524
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.54%
Strychnine ... 0.50%
Strychnine ... 0.50%
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
122
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4271-10
4271-17
5042-32
10031-1
10031-2
10031-3
10031-4
10031-5
10140-4
10140-5
10140-7
10140-8
35380-1
35380-3
36029-1
36029-7
36029-8
36029-9
36029-11
56228-8
56228-11
56228-12
56228-19
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.39%
Strychnine ... 0.44%
Strychnine ... 0.50%
Strychnine ... 0.44%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.35%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.43%
Strychnine ... 0.50%
Strychnine ... 0.50%
Strychnine ... 0.50%
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
granular
123
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56228-20
NV93000300
Strychnine... 0.51%
Strychnine ... 0.50%
granular
granular
Table 2 lists the products the Agency was unable to batch. These products were not batched
because they were not considered to be similar to other products in terms of acute toxicity or
because there was insufficient information about the product's formulation. Registrants of
these products are responsible for meeting the acute toxicity data requirements for each
product individually. These products may not cite acute toxicity/ irritation data derived from
any other products in this RED. The registrant may cite pre-existing data conducted on their
individual product if it exists and it meets current Agency standards.
Table 2.
Registration Number
56228-27
NV92000500
NV83000900
WA90000400
Percent Active Ingredient
Strychnine ...
Strychnine ...
Strychnine ...
Strychnine ...
1.6%
10.0%
3.2%
4.90%
124
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125
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126
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127
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128
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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.
129
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130
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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.
Compimv Name
Product Name
Company Number
EPA Keg. 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'
Name and Title (Pleaae
s Authorized Representative
Date
Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
-------
132
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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)(l)(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)(l)(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 exten
required by FIFRA section 3(c)(l)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
133
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134
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The following is a list of available documents for 3133 that may further assist you in responding to this
Reregi strati on Eligibility Decision document. These documents may be obtained by the following methods:
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible reader.
Electronic copies can be downloaded from the Pesticide Special Review and Reregi strati on
Information System at 703-308-7224. They also are available on the Internet on EPA's
gopher server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using WWW (World
Wide Web) on WWW.EPA.GOV., or contact Ed Setren at (703)-308-8166.
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 313 3.
The following documents are part of the Administrative Record for 3133 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
135
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