United States Prevention, Pesticides EPA 738-R-94-020
Environmental Protection And Toxic Substances September 1994
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Sodium Cyanide
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1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case for sodium cyanide.
The enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the
data base of this chemical, its conclusions of the potential human health and environmental risks
of the current product uses, and its decisions and conditions under which these uses and products
will be eligible for reregistration. The RED includes the data and labeling requirements for
products for reregistration.
To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED". This summary also refers to other enclosed documents
which include further instructions. You must follow all instructions and submit complete and
timely responses The first set of required responses are due 90 days from the date of this
letter. The second set of required responses are due 8 months from the date of this letter.
Complete and timely responses will avoid the Agency taking the enforcement action of suspension
against your products.
If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregistration Division representative Franklin
Gee at (703) 308-8008.
Sincerely yours,
Louis P. True, Jr., Acting Director
Special Review and
Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data are
required, another DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific letter will be
enclosed describing such data. Complete the two response forms provided with each DCI letter
(or four forms for the combined) by following the instructions provided. You must submit the
response forms for each product and for each DCI within 90 days of the date of this letter
(RED issuance date); 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 data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response, but
certainly no later than the 8-month response date. 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 reregistration) separately. You may delete uses which
the RED says are ineligible for reregistration. For further labeling guidance, refer to the labeling
section of the EPA publication "General Information on Applying for Registration in the U.S.,
Second Edition, August 1992" (available from the National Technical Information Service,
publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers. Before citing these studies, you must make sure that they meet the
Agency's acceptance criteria (attached to the DCI).
d Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
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.
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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 REVIEWSEPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data waiver
and time extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregistration determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
SODIUM CYANIDE
LISTC
CASE 3086
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
SODIUM CYANIDE REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements 7
D. Regulatory History 7
III. SCIENCE ASSESSMENT 9
A. Physical Chemistry Assessment 9
B. Human Health Assessment 9
1. Toxicology Assessment 9
a. Acute Toxicity 10
b. Chronic toxicity 11
c. Metabolism 11
2. Exposure Assessment 11
a. Dietary Exposure 11
b. Occupational and Residential 12
3. Risk Assessment 12
a. Toxicological Endpoints 12
b. Occupational and Residential 12
C. Environmental Assessment 12
1. Environmental Fate 12
a. Environmental Chemistry, Fate and Transport 12
b. Environmental Fate Assessment 13
2. Ecological Effects 14
a. Ecological Effects Data 14
(1) Terrestrial Animal Data 14
(2) Aquatic Data 14
(3) Nontarget Insects Data 15
(4) Nontarget Plants Data 15
b. Ecological Effects Risk Assessment 15
(1) Risk to Terrestrial Animals 16
(2) Aquatic 17
(3) Plants 17
(4) Endangered Species 17
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION 18
A. Determination of Eligibility 18
1. Eligibility Decision 18
2. Eligible Uses 19
B. Regulatory Position 19
1. Endangered Species Statement 19
2. Hazards to Nontarget Species 20
3. Risk Reduction Measures 20
4. Value of Additional Information 20
5. Labeling Rationale 21
V. ACTIONS REQUIRED BY REGISTRANTS 21
A. Manufacturing-Use Products 21
1. Additional Generic Data Requirements 21
B. End-Use Products 21
1. Additional Product-Specific Data Requirements 21
2. Labeling Requirements for End-Use Products 22
C. Existing Stocks 24
VI. APPENDICES 25
APPENDIX A. Table of Use Patterns Subject to Reregistration 27
APPENDIX B. Table of the Generic Data Requirements and Studies Used to Make
the Reregistration Decision 31
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Sodium Cyanide 37
APPENDIX D. List of Available Related Documents 45
APPENDIX E 49
PR Notice 86-5 51
PRNotice 91-2 71
APPENDIX F. Product Specific Data Call-In 77
Attachment 1. Chemical Status Sheet 89
Attachment 2. Product Specific Data Call-In Response Forms (Form A
inserts) Plus Instructions 91
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 97
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 101
Attachment 5. EPA Acceptance Criteria 105
Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
119
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 121
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APPENDIX G. U.S. Fish and Wildlife Service Biological Opinion March, 1993
pages 11-73 to 11-78 131
APPENDIX H. FACT SHEET 139
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SODIUM CYANIDE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Steve Jarboe
George Keitt
Jim Saulmon
Al Halvorson
Biological Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Environmental Fate and Effects Division
Betsy Grim
Jim Goodyear
Silvia Termes
Health Effects Division
Flora Chow
Charles Frick
Pat McLaughlin
Winston Dang
Registration Division
Bill Jacobs
Ian Blackwell
Tom Ellwanger
Sami Malak
Special Review and Reregistration Division
Kathleen Depukat
Kathy Davis
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Chemical Coordination Branch
Chemical Coordination Branch
Toxicology Branch II
Occupational and Residential Exposure Branch
Insecticide-Rodenticide Branch
Registration Support Branch
Registration Support Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Policy and Special Projects Staff
Jean Frane
Tracy Perry
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Office of Research and Development:
Vivian Williams
Office of General Counsel:
Mary Jane Angelo
Office of Compliance:
Phyllis Flaherty
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid equivalent
a.i. Active Ingredient
APHIS Animal and Plant Health Inspection Service
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium
specific (i.e. drinking water) lifetime exposure at which adverse, non carcinogenic
health effects are not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in
an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
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.
in
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GLOSSARY OF TERMS AND ABBREVIATIONS
LD
50
LDlo
LEL
LOG
LOEL
MCLG
MP
MPI
MOE
MRID
N/A
NPDES
NOEL
OPP
PADI
ppm
Q*i
RED
Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit weight
of animal, e.g., mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Level of Concern
Lowest Observed Effect Level
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to
regulate contaminants in drinking water under the Safe Drinking Water Act.
Manufacturing-Use Product
Maximum Permissible Intake
Margin Of Exposure
Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
Not Applicable
National Pollutant Discharge Elimination System
No Observed Effect Level
Office of Pesticide Programs
Provisional Acceptable Daily Intake
Parts Per Million
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
Reregistration Eligibility Decision
IV
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GLOSSARY OF TERMS AND ABBREVIATIONS
RED Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The concentration at which a substance produces a toxic
effect.
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
USD A United States Department of Agriculture
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EXECUTIVE SUMMARY
Sodium cyanide is used as a single dose poison in the M-44 ejector device to control
coyote (Canis latrans), red fox (Vulpes vulpes), gray fox (Urocyon cineoargenteus) and wild dog
(C. familiaris) populations that either prey upon (or are likely to prey upon) livestock, poultry
and federally-designated threatened or endangered species, or that are vectors of communicable
disease. This product is for use in pastures, range land and forest land only by trained and
certified applicators under the direct supervision of a government agency.
Sodium cyanide, as used in the M-44 device, is considered to be a high acute risk pesticide
for terrestrial vertebrates, including nontarget and endangered birds and mammals.
Sodium cyanide is a restricted use pesticide from which endangered species may not
currently be adequately protected. Under the Endangered Species Act of 1973 (ESA), as
amended, all federal agencies have responsibility to ensure that any action authorized, funded, or
carried out by that agency is not likely to jeopardize the continued existence of any federally listed
endangered or threatened species or result in the destruction or adverse modification of critical
habitat. Furthermore, federal agencies are required to utilize their authorities to carry out
programs for the conservation of threatened and endangered species.
The U. S. Environmental Protection Agency (referred to as "the Agency") is currently
developing a program, the Endangered Species Protection program (ESP), to identify all
pesticides whose use may cause adverse impacts on endangered and threatened species and to
implement mitigation measures that will eliminate the adverse impacts. The program will require
use modifications or a generic product label statement, requiring users to consult county-specific
bulletins. These bulletins will provide information about specific use restrictions to protect
endangered and threatened species on a county-specific basis. The Agency plans to publish a
description of the Endangered Species Program in the Federal Register in 1994 and by 1995 have
enforceable county-specific bulletins available.
The U.S. Fish and Wildlife Service (referred to as "the Service") issued a Biological
Opinion in March, 1993 for sodium cyanide and other vertebrate pesticide chemicals. The
specific Biological Opinion for sodium cyanide is included in Appendix G of this document.
Jeopardy determinations were made for the Florida panther, jaguarundi, Louisiana black bear,
ocelot, San Joaquin Kit fox, and California condor. The Service has provided "reasonable and
prudent alternatives" and "reasonable and prudent measures" for sodium cyanide, which it
believes, in their best professional judgement, will provide the appropriate level of protection to
the species listed in their jeopardy determinations.
Through this document, the Agency is requiring the registrants of sodium cyanide to
modify their labeling to include the Service's "reasonable and prudent alternatives" and/or
"measures."
VI
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The Agency has determined that all current uses of sodium cyanide are eligible for
reregistration. Labeling for all M-44 sodium cyanide capsule products must include the 26 use
restrictions currently required plus language determined to be needed to protect endangered
species likely to be jeopardized by use of M-44 devices.
Before reregistering the products containing sodium cyanide, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling be
submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and efficacy data. After reviewing these data and any revised
labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will
reregister a product.
vn
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregistration of products with active ingredients registered prior to November 1,
1984. The amended Act provides a schedule for the reregistration process to be completed in nine
years. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data to fulfill the requirements. The fifth phase is a review
by the Agency of all data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of sodium cyanide. The document consists of six sections. Section I is the
introduction. Section II describes sodium cyanide, its uses, data requirements and regulatory
history. Section III discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregistration decision for sodium cyanide.
Section V discusses the reregistration requirements for sodium cyanide. Finally, Section VI is the
Appendices which support this Reregistration Eligibility Decision. Additional details concerning
the Agency's review of applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
Common Name: Sodium Cyanide
Chemical Name: Sodium salt of Hydrocyanic acid
CAS Registry Number: 143-33-9
OPP Chemical Code: 074002
Empirical Formula: NaCN
Molecular Weight: 4910
Trade and Other Names: Cyanogran
B. Use Profile
The following is information on the currently registered uses with an overview of
use sites and application methods. A detailed table of these uses of sodium cyanide is in
Appendix A.
For Sodium Cyanide:
Type of Pesticide: Predacide/Rodenticide (single dose poison)
Mechanism of
Action: Inhibits oxidative enzyme systems and causes death
from anoxia.
Use Sites: Pastures, Rangeland, Forest (all or unspecified)
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Target Pests:
Coyote, Red Fox, Gray Fox, wild Dog
Formulation Type
Registered:
Sodium cyanide powder enclosed in polyethylene
capsules.
A voluntary action taken by the principal registrant,
United States Department of Agriculture/Animal and
Plant Health Inspection Service (USDA/APHIS), is
to color code the top of each capsule with paint per
year of manufacture. The capsules are also coded
per state of use with day- glow plastic fluorescent
markers.
Method and Rates of
Application:
For application, each capsule is loaded into a capsule
holder which is screwed onto the ejector mechanism
of an M-44 device. This device had previously been
inserted into the unit's base, which has been pounded
into the ground for use. The capsule holder is then
treated with a scent used to attract canids to the
unit. When an animal tugs at the capsule holder, a
spring-driven plunger ejects the sodium cyanide
capsule into its mouth.
Labeling use restrictions limit application rates to no
more than 10 units per 100 acres of pastureland or
12 units per square mile of open range-land. For use
in forest lands, the rangeland rate applies, unless the
forest is within an area that is fenced (or otherwise
enclosed) on all sides and serves as a pasture.
Single Active Ingredient:
Use Practice Limitations:
91.06% sodium cyanide
88.78% sodium cyanide
Sodium cyanide is a restricted use pesticide for
which the applicators must be trained and certified
specifically for the use of these capsules in M-44
devices.
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The use of sodium cyanide in the M-44 device is
currently registered in only twelve states (Arizona,
California, Idaho, Kansas, Montana, Nebraska, New
Mexico, Oregon, South Dakota, Texas,
Washington, and Wyoming). While the
USD A/APHIS holds the principal registration, four
State agencies have state-limited, FIFRA §3
registrations (Montana, Wyoming, New Mexico and
Kansas). Other area-limited registrations are held by
the Navajo Nation (Arizona) and the Texas
Department of Agriculture. The product registered
to the Kansas Fish and Game Department is the only
one which still, officially, is 88.78% sodium cyanide.
The following list of use restrictions represents the
USD A/APHIS product. The claims made for the six
other registered M-44 capsule products differ
somewhat and the 26 use restrictions differ
accordingly.
1. Use of the M-44 device shall conform to all applicable Federal, State, and
local laws and regulations.
2. Applicators shall be subject to such other regulations and restrictions as
may be prescribed from time-to-time by the U.S. Environmental Protection
Agency (EPA).
3. Each applicator of the M-44 device shall be trained in: (1) safe handling of
the capsules and device, (2) proper use of the antidote kit, (3) proper
placement of the device, and (4) necessary record keeping.
4. M-44 devices and sodium cyanide capsules shall not be sold or transferred
to, or entrusted to the care of any person not supervised or monitored by
the Animal and Plant Health Inspection Service (APHIS), Animal Damage
Control (ADC) program or any agency not working under an ADC
cooperative agreement.
5. The M-44 device shall only be used to take wild canids: (1) suspected of
preying on livestock or poultry; (2) suspected of preying on Federally
designated threatened or endangered species, or; (3) that are vectors of a
communicable disease.
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6. The M-44 device shall not be used solely to take animals for the value of
their fur.
7. The M-44 device shall only be used on or within seven miles of a ranch unit
or allotment where losses due to predation by wild canids are occurring or
where losses can be reasonably expected to occur based upon recurrent
prior experience of predation on the ranch unit or allotment. Full
documentation of livestock depredation, including evidence that such
losses were caused by wild canids, will be required before application of
the M-44 is undertaken. This use restriction is not applicable when wild
canids are controlled to protect Federally designated threatened or
endangered species or are vectors of a communicable disease.
8. The M-44 device shall not be used: (1) in areas within national forests or
other Federal lands set aside for recreational use, (2) areas where exposure
to the public and family and pets is probable, (3) in prairie dog towns, or,
(4) except for the protection of federally designated threatened or
endangered species, in National and State Parks; National or State
Monuments; federally designated wilderness areas; and wildlife refuge
areas.
9. The M-44 device shall not be used in areas where federally listed
threatened or endangered animal species might be adversely affected. Each
applicator shall be issued a map, prepared by or in consultation with the
U.S. Fish and Wildlife Service, which clearly indicates such areas.
10. One person other than the individual applicator shall have knowledge of the
exact placement location of all M-44 devices in the field.
11. In areas where more than one governmental agency is authorized to place
M-44 devices, the Agencies shall exchange placement information and
other relevant facts to ensure that the maximum number of M-44's allowed
is not exceeded.
12. The M-44 device shall not be placed within 200 feet of any lake, stream, or
other body of water, provided that natural depression areas which catch
and hold rainfall only for short periods of time shall not be considered
"bodies of water" for purposes of this restriction.
13. The M-44 device shall not be placed in areas where food crops are planted.
14. The M-44 device shall be placed at least a 50-foot distance or at such a
greater distance from any public road or pathway as may be necessary to
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remove it from the sight of persons and domestic animals using any such
public road or pathway.
15. The maximum density of M-44's placed in any 100 acre pasture land areas
shall not exceed 10; and the density in any 1 square mile of open range
shall not exceed 12.
16. No M-44 device shall be placed within 30 feet of a livestock carcass used
as a draw station. No more than four M-44 devices shall be placed per
draw station and no more than five draw stations shall be operated per
square mile.
17. Supervisors or applicators shall check the records, warning signs, and M-
44 devices of each applicator at least once a year to verify that all
applicable laws, regulations, and restrictions are being strictly followed.
18. Each M-44 device shall be inspected at least once every week, weather
permitting access, to check for interference or unusual conditions and shall
be serviced as required.
19. Damaged or nonfunctional M-44 devices shall be removed from the field.
20. An M-44 device shall be removed from an area if, after 30 days, there is no
sign that a target predator has visited the site.
21. All persons authorized to possess and use sodium cyanide capsules and M-
44 devices shall store such capsules and devices under lock and key.
22. Used sodium cyanide capsules shall be disposed of by deep burial or at a
proper landfill site. Incineration may be used instead of burial for disposal.
Place the capsules in an incinerator or refuse hole and burn until the
capsules are completely consumed. Capsules may be incinerated using
either wood or diesel fuel.
23. Bilingual warning signs in English and Spanish shall be used in all areas
containing M-44 devices. All such signs shall be removed when M-44
devices are removed.
a. Main entrances or commonly used access points to areas in which
M-44 devices are set shall be posted with warning signs to alert the
public to the toxic nature of the cyanide and to the danger to pets.
Signs shall be inspected weekly to ensure their continued presence
and ensure that they are conspicuous and legible.
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b. An elevated sign shall be placed within 25 feet of each individual
M-44 device warning persons not to handle the device.
24. Each authorized or licensed applicator shall carry an antidote kit on his
person when placing and/or inspecting M-44 devices. The kit shall contain
at least six pearls of amyl nitrite and instructions on their use. Each
authorized or licensed applicator shall also carry on his person instructions
for obtaining medical assistance in the event of accidental exposure to
sodium cyanide.
25. In all areas where the use of the M-44 device is anticipated, local medical
people shall be notified of the intended use. This notification may be
through a poison control center, local medical society, the Public Health
Service, or directly to a doctor or hospital. They shall be advised of the
antidotal and first-aid measures required for treatment of cyanide
poisoning. It shall be the responsibility of the supervisor to perform this
function.
26. Each authorized M-44 applicator shall keep records dealing with the
placement of the device and the results of each placement. Such records
shall include, but need not be limited to:
a. The number of devices placed.
b. The location of each device placed.
c. The date of each placement, as well as the date of each inspection.
d. The number and location of devices which have been discharged
and the apparent reason for each discharge.
e. Species of animals taken.
f All accidents or injuries to humans or domestic animals.
C. Data Requirements
Data required in the September 30, 1992 Data Call-In for sodium cyanide include
studies on product chemistry and ecological effects. These data were required to support
the uses listed in the Data Call-In. Appendix B includes all data requirements identified by
the Agency for currently registered uses needed to support reregistration.
D. Regulatory History
Sodium cyanide was initially registered as a pesticide on December 23, 1947, to
control ants on uncultivated agricultural and non-agricultural areas. Sodium cyanide was
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also registered to control certain bacteria, insects, and commensal rodents in human
residences; railway cars; food marketing, storage, and distribution facilities; and
commercial institutional and industrial premises. All non-predacidal uses of sodium
cyanide were canceled in 1987 pursuant to a generic data call-in issued by EPA.
The only currently registered uses of sodium cyanide are for toxicant-filled
capsules to be placed in M-44 spring-loaded ejectors used to kill wild canids: coyotes
(Canis latrans), wild dogs (C. familiaris), red foxes (Vulpes vulpes), and gray foxes
(Urocyon cineoargenteus). All currently registered products are restricted use pesticides
with specific applicator training and certification required. Use is limited to situations in
which the above named canids prey upon (or are likely to prey upon), livestock, poultry,
or Federally-designated threatened or endangered species, or where named canids are
vectors of communicable diseases. Not all of these claims appear on all registered labels.
Prior to early 1972, sodium cyanide was used to control predators in a
gunpowder-fired unit called the "Humane Coyote Getter." This use was canceled in 1972
along with all predator control uses of sodium cyanide, sodium fluoroacetate (Compound
1080), and strychnine (Ruckelshaus, 1972). The primary reasons given for cancellation of
predacidal uses of sodium cyanide in the "Humane Coyote Getter", were (1) injuries to
humans associated with the "Humane Coyote Getter" device, and (2) the occasional taking
of domestic dogs."
Use of sodium cyanide in M-44 capsules was reinstated in 1975 following Subpart
D hearings (Train, 1975). Supporting an initial decision by an Administrative Law Judge,
the EPA Administrator concluded that "substantial new evidence" had been provided
which indicated that use of sodium cyanide capsules in the M-44 device was safer and
more selective than use of the capsules in the "Humane Coyote Getter." Reinstated uses
of sodium cyanide were subject to 26 use restrictions which were believed to minimize
potential adverse impacts on man and the environment. Among other things, these
restrictions required that applicators be appropriately trained and certified for using
sodium cyanide capsules in M-44 devices, that applicators carry antidote kits with them,
and that M-44 devices not be placed in areas likely to cause adverse impacts on humans
and endangered or other nontarget species. The 1975 decision addressed uses of sodium
cyanide to control canids that prey on livestock and poultry and canids that vector
diseases. The latter use was not added to the label for any sodium cyanide product until
1992.
Subsequent hearing activities have led to adjustments to the 26 use restrictions for
M-44 capsules and authorization for use of sodium cyanide capsules to protect threatened
and endangered species (Greene, 1986). The opinion rendered regarding the protection of
threatened and endangered species addressed uses to control Arctic foxes (Alopex
lagopus), but this species claim has not been proposed formally for any M-44 capsule
product.
-------
The Agency issued a subsequent Data Call-In on September 30, 1992 for sodium
cyanide requiring additional product chemistry and ecological effects data. This
Reregistration Eligibility Decision reflects a reassessment of all data which were submitted
to support the reregistration of sodium cyanide.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Color: White granules
Physical State: Solid
Odor: Almond-like
Melting Point:
Density, Bulk Density
Specific Gravity:
Solubility:
Vapor Pressure:
Dissociation Constant:
Octanol/Water
Partition Coefficient:
pH:
Stability:
563°C
1.61 gm/cm3
34% in water at 15°C, slightly soluble in alcohol
<10-6torrat25°C
pKa for HCN = 9.31
pKb for ON' = 4.69
N/A. Inorganic polar salt
12.12 in 1 M solution
11.37 in 0.1 M solution
10.47 in 0.01 M solution
Stable under ordinary conditions of use and storage,
readily hydrolyzes to hydrogen cyanide
B. Human Health Assessment
1. Toxicology Assessment
-------
Sodium cyanide is highly toxic to warm-blooded animals. It is considered to
be Category I for oral, dermal, and inhalation toxicity. It is highly corrosive to the
skin and eyes. The toxicological data base for sodium cyanide is adequate and will
support reregistration eligibility.
Based on the use information, there are no applicator/mixer/loader or post-
applicator exposure concerns; there is limited potential for exposure because of label
restrictions specifying use by certified personnel only.
a. Acute Toxicity
Because of the corrosive properties of sodium cyanide and its toxicity,
requirements for acute toxicity were waived.
ACUTE TOXICITY DATA
TEST
Oral LD,n - rat
Dermal LD50 - rabbit
Dermal irritation - rabbit
RESULTS
7.5 mg/kg
41 mg/kg M; 50 mg/kg F
corrosive, lethal
CATEGORY
I
I
I
An acute oral toxicity study in Wistar rats found the LD50s were 7.5
mg/kg for the combined sexes, 7.5 mg/kg for males, and 7.4 mg/kg for
females. All deaths occurred within 4 hours of dosing (MRID 42610801).
An oral LD50 for rats was reported in the literature as 6.4 mg/kg (Sax and
Lewis, 1989).
An acute dermal toxicity study with New Zealand albino rabbits found
LD50s of 41 mg/kg for males, 50 mg/kg for females, and 44 mg/kg for
combined sexes (MRID 41731201).
In a primary dermal irritation study with New Zealand albino rabbits,
the application of 0.5 g of sodium cyanide resulted in the death of four out of
six rabbits. The remaining two rabbits showed severe dermal irritation with
eschar formation (MRID 42610802).
It has been reported that cyanide liquid, and possibly vapor, can be
absorbed through intact skin; vapor can be absorbed extremely rapidly
through the respiratory tract. It has been estimated that human exposure to
10
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hydrogen cyanide in air may be immediately fatal at a concentration of 0.3
mg/1 and the LC50 after 10 minutes may be 0.61 mg/1 (Clayton and Clayton,
1982).
It has been reported in the literature that 5.0 mg/kg was an LD50 for
rabbits by the ocular route (Sax and Lewis, 1989).
Low acutely toxic doses for humans by the oral route have been
reported as 0.7 mg/kg, 6.6 mg/kg, and 2.9 mg/kg (Sax and Lewis, 1989).
b. Chronic toxicity
In the literature, an experiment has been reported in which Carworth
Farms rats were given food fumigated with hydrogen cyanide for two years.
The food was shown to contain, on the average, 0, 100, or 300 ppm of
hydrogen cyanide. There was no evidence of typical cyanide toxicity, but
there were definite increases in thiocyanate concentrations found in the tissues
of the test animals (MRID 00129738).
c. Metabolism
Cyanide readily forms relatively stable complexes with some
biologically active metal ions, thus inhibiting a number of enzyme reactions.
The most important effect is the interaction of cyanide with the iron in
cytochrome oxidase. The inhibition of cytochrome oxidase prevents the
oxidation of cytochrome C, thus stopping the utilization of oxygen by cells;
this leads rapidly to loss of cellular functions and to cell death. Cyanide also
combines rapidly with methemoglobin. It has been estimated that the rate of
metabolism in humans of intravenously injected hydrogen cyanide is about
0.017 mg/kg/min. If the concentration of cyanide is not lethal, then it is
released from the combinations with metal ions, converted to thiocyanate ion,
and excreted in the urine. Very low levels of cyanide can be found in normal
human blood, and some is found in exhaled air, saliva, and sweat (Clayton and
Clayton, 1982).
2. Exposure Assessment
a. Dietary Exposure
Based on currently registered use patterns, there will be no sodium
cyanide exposure to the general population through the diet.
11
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b. Occupational and Residential
Based on the use restrictions, there are no applicator/mixer/loader or
post-application exposure concerns other than following the label restriction
for use by certified personnel only.
3. Risk Assessment
a. Toxicological Endpoints
Because of the specific nature of this registered use, the primary
concern is for the potential risk of acute toxicity.
b. Occupational and Residential
There are no currently registered uses of sodium cyanide in residential
environments.
The risk of cyanide poisoning from the current pesticidal uses to
workers is minimal because of the current label restrictions.
C. Environmental Assessment
1. Environmental Fate
No additional data are required at this time. The Agency used information
from the open chemical literature, information on biodegradative processes provided
by the registrant (MRID #00118813) and a review undertaken by the U.S.
Department of the Interior Bureau of Mines to assess the fate and transport of sodium
cyanide and degradates in the environment.
a. Environmental Chemistry, Fate and Transport
The availability of cyanide to different organisms varies with the
chemical form (speciation) of cyanide present in the environment. Speciation
in the environment is dependent on pH, exposure to light and air,
biodegradation and the presence and chemical forms of metal components in
soils capable of reacting with cyanide. Factors influencing the transport of
cyanide species are their solubilities, adsorption on soil components and clays,
and interactions with biomass.
12
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The oxidation state of carbon in cyanide is C(II). The two major
chemical forms of cyanide are "free cyanide," which refers to uncomplexed
cyanide ion (CN~) and/or molecular hydrogen cyanide (HCN) and "complexed
cyanide," which refers to cyanide bound to metal ions. Uncomplexed CN" and
HCN are related by the acid dissociation of HCN (pKa ca. 9). The
concentration of HCN relative to CN" varies as a function of pH. At pHs
above 9.0, the CN" ion is the predominant species while at pHs below 9.0,
HCN becomes the predominant species.
When dissolved in water or in contact with moisture, cyanide salts
(such as sodium cyanide) can react with atmospheric carbon dioxide (CO2)
and liberate HCN gas. This reaction is the primary reaction in the
environment. However, an additional series of reactions (nonoxidative and
oxidative) contribute to the degradation of free cyanide. The resulting reaction
products can undergo further reactions to other products. Based on
thermodynamic considerations, the ultimate fate of carbon in cyanide is CO2
or carbonates. The ultimate products for nitrogen in cyanide are determined
by the availability of oxidizing species present in the media. The resulting
nitrogen species may be ammonia (NH3), nitrogen (N2), nitrite (NO2"), or
nitrate (NO3"). Some of the reactions of the intermediates leading to these
final products may be kinetically slow.
"Free cyanide" does not absorb light in the region of 290 to 800 nm
and, therefore, it will not degrade by direct photolysis. However, cyanide
complexes of iron, cobalt, or chromium (which absorb light strongly in the
visible region) can degrade by direct photolysis. The fate of the liberated
cyanide ion is not well understood. Photo-oxidation of "free cyanide"
catalyzed by titanium dioxide has been reported. Cyanide adsorbed to metal
sites in minerals present in soil are also sensitive to photodegradation.
There is evidence that microorganisms can decompose cyanide on
soils and that the end-products of this decomposition are CO2 and NH3.
Therefore, groundwater contamination from the pesticidal use of sodium
cyanide is not expected.
b. Environmental Fate Assessment
The Agency does not anticipate significant environmental exposure
to sodium cyanide when used as an encapsulated material together with the
M-44 ejector device and when the directions specified on the label are
followed.
13
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Should an accidental spill of sodium cyanide from the capsules occur
in the field, several processes would contribute to the dissipation of cyanide.
Hydrogen cyanide formed by reaction with moisture will diffuse to the
atmosphere and be diluted into the air compartment. Reactions with soil
components (including microorganisms) will convert cyanide to carbon
dioxide and ammonia or other nitrogen containing compounds.
Groundwater contamination by cyanide from M-44 ejectors is not
anticipated.
The environmental impact of the pesticidal use of sodium cyanide is
expected to be minimal because of its mode of application (encapsulated in
ejector devices).
2. Ecological Effects
a. Ecological Effects Data
(1) Terrestrial Animal Data
(A) Avian Toxicity
Acute avian studies were waived because sodium
cyanide has been demonstrated in human toxicological
literature to be a known toxicant. In addition, conducting a
study using sodium cyanide poses a hazard to the
technicians. There is sufficient evidence to categorize
sodium cyanide as very highly toxic to birds when
administered orally on an acute basis.
(B) Toxicity to Nontarget Mammals
Again, testing was not required because sodium
cyanide is a well known toxicant. There is sufficient evidence
to categorize sodium cyanide as very highly toxic to
mammals.
(2) Aquatic Data
(A) Freshwater Fish and Invertebrates Toxicity
Only one study was evaluated on the effects to
freshwater fish. This study was done by EPA's Animal
Biology Laboratory in 1977 (MRID 13701) using the TEP
14
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"Durham's Sodium Cyanide Balls" (EPA registration # 430-
01) and rainbow trout. Sodium cyanide was categorized as
highly toxic to rainbow trout.
Freshwater Fish Acute Oral Toxicity Findings
Species
Rainbow trout
% Test Material
(TGAI)
96.5
LC50
O.llSppm
Conclusions
highly toxic
Based on the existing study and the known
characteristics of sodium cyanide, it is considered to be very
highly toxic to aquatic organisms for the purpose of risk
evaluation.
(B) Estuarine/Marine Toxicity
Estuarine and marine organisms are not expected to
be exposed to sodium cyanide from the M-44. No studies
were required.
(3) Nontarget Insects Data
Because nontarget insects are not expected to be exposed to
sodium cyanide, nontarget insect toxicity testing was not required.
(4) Nontarget Plants Data
Due to the use pattern, chemical characteristics and low
volume of use, plants are not expected to be exposed to sodium
cyanide from the M-44. No studies were required.
b. Ecological Effects Risk Assessment
Sodium cyanide is formulated into capsules for use in an M-44
device as a canid predacide. The mode of action is by conversion to
15
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hydrogen cyanide gas which poisons, by inactivation, an enzyme essential to
mammalian cellular respiration. This results in central nervous system
depression, cardiac arrest, and gross respiratory failure.
Because most animals able to activate the trigger of the cyanide
ejector device will be exposed to a lethal dose, sodium cyanide, as used in
the M-44 device, would be considered a high acute risk pesticide for
terrestrial vertebrates. This includes nontarget and endangered birds.
Therefore, labeling for M-44 cyanide capsule products, must include the list
of 26 use restrictions (See Section II.B. above) to be followed to reduce the
risk to nontarget terrestrial and aquatic animals and to endangered species.
Even with the above restrictions, some endangered species would
not be adequately protected as determined by the U.S. Fish and Wildlife
Service in their Biological Opinion (Appendix G) dated March 1993.
Jeopardy determinations have been made for the Florida panther,
jaguarundi, Louisiana black bear, ocelot, San Joaquin kit fox, and California
condor. The FWS has established their reasonable and prudent alternatives
and measures that the Agency is implementing as part of this document.
Although the above restrictions will reduce the risk to nontarget
terrestrial animals, nontarget kills will likely occur with the M-44. These
kills tend to be of predatory and scavenger animal species.
(1) Risk to Terrestrial Animals
(A) Nontarget insects
Consistent with its use pattern, no direct or indirect
effects are expected with M-44 capsules with respect to
nontarget insects.
(B) Avian and mammalian species
(i) Avian Acute Oral
Because of its low volume of production and
since sodium cyanide is well known as a poison, the
Agency waived the data requirements for avian
studies. Therefore, the Agency does not have the
basic toxicity data generally used to calculate the risk
quotients. However, sodium cyanide can be
categorized as very highly toxic to birds based on the
16
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nature of the poison. Carrion-feeding birds able to
activate the trigger of the M-44 sodium cyanide
ejector device are at risk.
(ii) Avian Dietary
Because of its use pattern and chemical
characteristics (rapid degradation), sodium cyanide is
not expected to be a dietary hazard to birds.
(iii) Nontarget Mammals
Although the restrictions described above
reduce the risk to nontarget terrestrial animals,
nontarget kills will likely occur with the M-44.
These kills tend to be of predatory and scavenger
animal species.
Evidence was submitted by USDA/APHIS
that secondary poisonings would not be expected
with sodium cyanide based on their experience in
finding nontarget kills, the distribution of sodium
cyanide in the body of a target animal, and the fate
and distribution of sodium cyanide in the
environment.
(2) Aquatic
Based on the one study reviewed, sodium cyanide was
categorized as highly toxic to rainbow trout. Because of the nature
of the product and the terrestrial use pattern, it is not expected that
fish and aquatic invertebrates will be exposed to sodium cyanide.
(3) Plants
Consistent with its use patterns, no direct or indirect effects
are expected with M-44 cyanide capsules with respect to plants.
(4) Endangered Species
The U.S. Fish and Wildlife Service Biological Opinion
(Appendix G) has outlined restrictions for specific endangered
species at risk from use of the M-44. Jeopardy determinations have
17
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been made for the Florida panther, jaguarundi, Louisiana black bear,
ocelot, San Joaquin kit fox, and California condor.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing sodium cyanide active ingredients. The
Agency has completed its review of these generic data, and has determined that the data are
sufficient to support reregistration of all products containing sodium cyanide. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of sodium cyanide, and lists the submitted studies
that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of sodium cyanide and to determine that sodium cyanide can be used
without resulting in unreasonable adverse effects to humans and the environment. The
Agency therefore finds that all products containing sodium cyanide as the active ingredient
are eligible for reregistration. The reregistration of particular products is addressed in
Section V of this document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data and the data identified in Appendix B. Although the Agency
has found that all uses of sodium cyanide are eligible for reregistration, it should be
understood that the Agency may take appropriate regulatory action, and/or require the
submission of additional data to support the registration of products containing sodium
cyanide, if new information comes to the Agency's attention or if the data requirements for
registration (or the guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient sodium
cyanide, the Agency has sufficient information on the health effects of sodium
cyanide and on its potential for causing adverse effects in fish and wildlife and the
environment. The Agency has determined that sodium cyanide products, labeled
and used as specified in this Reregistration Eligibility Decision, will not pose
unreasonable risks or adverse effects to humans or the environment. Therefore, the
18
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Agency concludes that products containing sodium cyanide for all currently
registered uses are eligible for reregistration.
2. Eligible Uses
The Agency has determined that all current uses of sodium cyanide are
eligible for reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for sodium
cyanide. Where labeling revisions are imposed, specific language is set forth in Section V
of this document.
1. Endangered Species Statement
The Agency has concerns about the exposure of threatened and endangered
animal species to sodium cyanide as discussed above in Section III.C.2.b. The U.S.
Fish and Wildlife Service Biological Opinion has outlined restrictions for specific
endangered species at risk from use of the M-44. Jeopardy determinations have
been made for the Florida panther, jaguarundi, Louisiana black bear, ocelot, San
Joaquin kit fox, and California condor. A copy of the pertinent pages (11-73
through 11-78) of the U.S. Fish and Wildlife Service Biological Opinion dated
March, 1993 for sodium cyanide is contained in Appendix G.
Currently, the Agency is developing a program, ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse
impacts on endangered and threatened species and to implement mitigation
measures that will eliminate the adverse impacts. The program would require use
modifications or a generic product label statement, requiring users to consult
county-specific bulletins. These bulletins would provide information about specific
use restrictions to protect endangered and threatened species in the county.
Consultations with the Fish and Wildlife Service will be necessary to assess risks to
newly listed species or from proposed new uses.
The Agency plans to publish a description of the Endangered Species
Program in the Federal Register in 1994 and by 1995 have enforceable county-
specific bulletins available. Any additional requirements for product use
modifications may occur in the future under the Endangered Species Protection
Program.
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2. Hazards to Nontarget Species
Sodium cyanide, as used in the M-44 device, is considered to be a high
acute risk pesticide for terrestrial vertebrates, including nontarget and endangered
birds and mammals. Animals able to activate the trigger of the cyanide ejector
device will be exposed to a lethal dose of sodium cyanide. Therefore, the labeling
for M-44 cyanide capsule products must include the list of 26 use restrictions to be
followed, in order to reduce the risk to nontarget terrestrial animals and to
endangered species. These use restrictions will also reduce risks to aquatic species.
Even with the above restrictions, endangered species are not adequately
protected. Additional restrictions for sodium cyanide have been outlined for species
at risk in the U.S. Fish and Wildlife Service Biological Opinion (Appendix G).
Jeopardy determinations have been made for the Florida panther, jaguarundi,
Louisiana black bear, ocelot, San Joaquin kit fox, and California condor.
3. Risk Reduction Measures
a. The 26 Use Restrictions, currently part of registered labeling for M-
44 sodium cyanide capsule products, will remain part of the labeling
that acompanies all of these products.
b. Label modifications are required to reflect the "reasonable and
prudent alternatives" and "measures" indicated in the March 1993
U.S. Fish and Wildlife Service Biological Opinion.
c. It is required that sodium cyanide registrants continue to supply
nontarget kill data (and all other adverse data) as a monitoring
component for the reregistration of sodium cyanide used in the M-
44 device. The current methods and report format of the annual
report are sufficient. In addition, a report that includes the number
of wild canids that are killed while attempting to control other
species and the occurrence of more than one kill at a single station
should be provided. This kill information will be used to judge the
relative magnitude of nontarget mortalities.
4. Value of Additional Information
Monitoring information, described above, will be used to judge the relative
magnitude of nontarget mortalities.
20
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5. Labeling Rationale
Endangered species jeopardy determinations have been identified above.
The retention of the current 26 use restrictions provides assurance that sodium
cyanide will continue to be used in a safe manner with negligible exposure and risk
to humans, endangered species, and the environment, as well as reduce risks to
nontarget species. The required endangered species label restrictions will
strengthen our risk reduction measures for this chemical.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products. In addition to the requirements listed below,
registrants are required to supply nontarget kill data (and all other adverse data) as a monitoring
component for the reregistration of sodium cyanide used in the M-44 device. The current methods
and report format of the annual report are sufficient. In addition, a report that includes the number
of wild canids that are killed while attempting to control other species and the occurrence of more
than one kill at a single station should be provided.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of sodium cyanide for
the above eligible uses has been reviewed and determined to be substantially
complete. No additional generic data requirements are being levied at this time.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. The product specific data requirements are listed in Appendix F, the
Product Specific Data Call-In Notice. These data requirements include product
chemistry and efficacy, although the Agency does not expect that new efficacy data
will need to be generated.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment 5) and if not, commit to
21
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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
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10 and described in the
Pesticide Reregistration Handbook. As stated in Section IV, the Agency has
determined that labeling must be changed. Sodium cyanide as used in the M-44
device, poses a high acute risk for terrestrial vertebrates, including nontarget and
endangered birds and mammals. The following label restriction statements must be
added to all end-use products:
a. "This pesticide is TOXIC TO WILDLIFE. Keep out of lakes, ponds,
or streams. Do not contaminate water by cleaning of equipment or
disposal of wastes."
b. "Restricted Use Pesticide - Inhalation Hazard to Humans" with a
footnote which states "M-44 sodium cyanide capsules may only be
used by certified applicators who have taken the required additional
training."
or
"Restricted Use Pesticide - Due to Extremely High Acute Toxicity
and the need for highly specialized applicator training."
c. All products must maintain the 26 use restrictions as described in
Section 2.B. of this document.
d. "Use of this product is prohibited in areas where such use might
jeopardize the continued existence of endangered species. Contact
the local office of the U.S. Fish and Wildlife Service to determine
the locations of habitats occupied by any endangered species listed
below which occur in or near the intended area of product use.
Florida Panther
Do not use this product within 20 miles of the boundary of any
Federal or State lands (e.g., National Wildlife Refuges, National
Parks, National Preserves, State Parks, State Preserves, State
22
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Wildlife Management Areas, etc.) and Indian Reservations that
provide suitable Florida panther habitat south of Charlotte, Glades,
and Martin Counties, Florida.
or
The use of this product is prohibited in Florida.
Jaguarundi and Ocelot
Do not use this product within three miles of occupied habitat of the
Jaguarundi and ocelot in Cameron, Hidalgo, Kleberg, Jim Wells,
Kenedy, Starr, Willacy, and Zapata Counties, Texas.
Louisiana Black Bear
Do not use this product within the geographical range of the
Louisiana black bear near the Mississippi River in Mississippi and in
the Atchafalaya and Tensas River basins in Louisiana.
or
The use of this product is prohibited in Mississippi and Louisiana.
San Joaquin Kit Fox
Do not use this product within the range of the San Joaquin kit fox
in Alameda, Contra Costa, Fresno, Kern, Kings, Merced, Monterey,
San Benito, San Joaquin, Santa Barbara, Santa Clara, Stanislaus, or
Tulare Counties, California.
California Condor
Do not use this product in habitat occupied by the California condor
in Ventura, Kern, Santa Barbara, Los Angeles, and San Luis Obispo
Counties, California."
These statements are consistent with the Biological Opinion of March, 1993
for sodium cyanide. For those M-44 capsule registrations which are currently
limited to states other than Florida, California, Texas, Mississippi, or Louisiana, no
additional specific text would be needed for these labels.
23
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The addition of these statements is consistent with the Agency's
responsibility and authority under the ESA to ensure that any federally listed
threatened or endangered species will be protected to the fullest extent possible.
The retention of the current 26 use restrictions provides assurance that sodium
cyanide will continue to be used in a manner with negligible exposure and risk to
humans, endangered species, and the environment, as well as reduced risks to
nontarget species.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for
26 months from the date of the issuance of this Reregistration Eligibility Decision (RED).
However, existing stocks time frames will be established case-by-case, depending on the
number of products involved, the number of label changes, and other factors. Refer to
"Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register. Volume 56,
No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell sodium cyanide
products bearing old labels/labeling, i.e., labels absent the modifications specified in this
RED document, except as noted below, for 26 months from the date of issuance of this
RED. Registrants and persons other than registrants remain obligated to meet preexisting
Agency imposed label changes and existing stocks requirements applicable to your
products. These preexisting requirements can include label changes and existing stock
provisions for effluent discharges or worker protection standards.
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VI. APPENDICES
25
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26
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APPENDIX A. Table of Use Patterns Subject to Reregistration
27
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28
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Date 07/22/94 ) Time 09:15
APPENDIX A ) CASE 3086, [Inorganic cyanide] Chemical 074002 [Sodium cyanide]
LUIS 1.3 ) Page 1
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max.
Rate (AI Text Apps
unless noted (Max @ Max
otherwise) Dse) Rate
Maximum Dose Min. Restr. Geographic Limitations Use
/crop cycle Interv Entry Allowed Disallowed Limitations
or /year (days) Interv Codes
[day(s) ]
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
)))))))))
PASTURES
Bait application., When needed., Ejector
device.
RANGELAND
Bait application., When needed., Ejector
device.
NON- FOOD/NON- FEED
P/T NA
P/T NA
Use Group: TERRESTRIAL FEED CROP
.01957 Ib 100 A * NS NS NS NS
.02349 Ib 1 sq.
mile
Use Group: TERRESTRIAL FEED CROP
NS NS NS NS
PASTURES IN PARTIALLY WOODED AREAS
Bait application., When needed., Ejector P/T
device.
Use Group: TERRESTRIAL FEED CROP
UC * NS NS NS NS
-------
Date 07/22/94 ) Time 09:15 APPENDIX A ) CASE 3086, [Inorganic cyanide] Chemical 074002 [Sodium cyanide] LUIS 1.3 ) Page 2
4444444
LEGEND
444444
HEADER ABBREVIATIONS
Max. Apps @ Max Rate : Maximum number of Applications at Maximum Dosage Rate
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
P/T : PELLETED/TABLETED
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
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
C20 : Endangered species restriction.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
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APPENDIX B. Table of the Generic Data Requirements and
Studies Used to Make the Reregistration Decision
31
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32
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case sodium cyanide covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to sodium cyanide 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.
33
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34
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Sodium Cyanide
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
63-9 Vapor Pressure
63-10 Dissociation Constant
63-12 pH
63-13 Stability
63-16 Explodability
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
41285601, 42223401, 42227601
41285602, 42610901
42610902
42610903
41285603, 42223402, 42227602
42610904
41394501,41285604
41285605
41285602, 42610905
41285602, 42610906
41285606
41285602, 42610907
41285602, 42610908
42610909
42610910
41285602,42610911
42610912
35
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Data Supporting Guideline Requirements for the Reregistration of Sodium Cyanide
REQUIREMENT
ECOLOGICAL EFFECTS
71-5A Simulated Field Study
71-5B Actual Field Study
72- 1C Fish Toxicity - Rainbow Trout
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity - Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation - Rabbit
83-1 A Chronic Toxicity - Rat
ENVIRONMENTAL FATE
160-5 Chemical Identity
162-1 Aerobic Soil Metabolism
USE PATTERN
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
BJ
CITATION(S)
Waived
Waived
EPABiol. Rpt. of Anal.
42610801
41731201
Waived
Waived
42610802
00129738
41285607, 42610913
00118813
36
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APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Sodium Cyanide
37
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38
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in
the Reregistration Eligibility Document. Primary sources for studies in this bibliography
have been the body of data submitted to EPA and its predecessor agencies in support of
past regulatory decisions. Selections from other sources including the published literature,
in those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case
of published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct title (or at least a single
subject), can stand alone for purposes of review and can be described with a conventional
bibliographic citation. The Agency has also attempted to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically
by Master Record Identifier, or "MRID number". This number is unique to the citation,
and should be used whenever a specific reference is required. It is not related to the six-
digit "Accession Number" which has been used to identify volumes of submitted studies
(see paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier.
These entries are listed after all MRID entries. This temporary identifying number is also
to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no
author or laboratory could be identified, the Agency has shown the first submitter
as the author.
b. Document date. The date of the study is taken directly from the document. When
the date is followed by a question mark, the bibliographer has deduced the date
from the evidence contained in the document. When the date appears as (19??),
the Agency was unable to determine or estimate the date of the document.
39
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c. Title. In some cases, it has been necessary for the Agency bibliographers to create
or enhance a document title. Any such editorial insertions are contained between
square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the earliest
known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit accession
number follows the symbol "CDL," which stands for "Company Data
Library." This accession number is in turn followed by an alphabetic suffix
which shows the relative position of the study within the volume.
40
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BIBLIOGRAPHY
MRID
CITATION
00118813 U.S. Fish and Wildlife Service (1975). Product Performance: Sodium Cyanide.
Unpublished study received July 7, 1975.
00129738 Howard, J. and Hanzal, R. (1955) Chronic Toxicity for Rats of Food Treated with
Hydrogen Cyanide. J. Agric. Food Chem. 3:325-329.
41285601 Bullard, R. (1989) M-44 Cyanide Capsules: Product Identity and Disclosure of
Ingredients. Unpublished study prepared by Denver Wildlife Research Center
15 p.
41285602 Bullard, R. (1989) M-44 Cyanide Capsules: Description of Beginning Materials
and Manufacturing Process. Unpublished study prepared by Denver Wildlife
Research Center. 22 p.
41285603 Bullard, R. (1989) M-44 Cyanide Capsules: Certification of Ingredient Limits.
Unpublished study prepared by Denver Wildlife Research Center. 32 p.
41285604 Bullard, R. (1989) M-44 Cyanide Capsules: Color. Unpublished study prepared by
Denver Wildlife Research Center. 4 p.
41285605 Bullard, R. (1989) M-44 Cyanide Capsules: Physical State. Unpublished study
prepared by Denver Wildlife Research Center. 4 p.
41285606 Starbuck, B. (1989) M-44 Cyanide Capsules: Density. Unpublished study
prepared by Denver Wildlife Research Center. 4 p.
41285607 Bullard, R. (1989) M-44 Cyanide Capsules: Chemical Identity. Unpublished study
prepared by Denver Wildlife Research Center. 4 p.
41394501 Bullard, R. (1989) M-44 Cyanide Capsules: Color. Unpublished study prepared
by Denver Wildlife Research Center. 4 p.
41731201 Cerven, D. (1990) Acute Dermal Toxicity in Rabbits/LD50 in Rabbits: Sodium
Cyanide: Lab Project Number: MB 90-16 B. Unpublished study prepared by MB
Research Laboratories, Inc. 95 p.
41
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BIBLIOGRAPHY
MRID
CITATION
42223401 Tope, K. (1992) M-44 Cyanide Capsules: Product Identity and Disclosure of
Ingredients: Lab Project Number: QA-225. Unpublished study prepared by Denver
Wildlife Research Center. 16 p.
42223402 Tope, K. (1992) M-44 Cyanide Capsules: Certificate of Ingredients Limits: Lab
Project Number: QA-225. Unpublished study prepared by Denver Wildlife
Research Center. 12 p.
42227601 Tope, K. (1992) M-44 Cyanide Capsules: Product Identity and Disclosure of
Ingredients: Lab Project Number: QA/229. Unpublished study prepared by
Denver Wildlife Research Center. 16 p.
42227602 Tope, K. (1992) M-44 Cyanide Capsules: Certification of Ingredient Limits: Lab
Project Number: QA/229. Unpublished study prepared by Denver Wildlife
Research Center. 12 p.
42610801 Cerven, D. (1990) Single Dose Oral Toxicity in Rats/LD50 in Rats: Sodium
Cyanide: Final Report: Lab Project Number: MB 90-16 A. Unpublished study
prepared by MB Research Laboratories, Inc. 60 p.
42610802 Cerven, D. (1990) Primary Dermal Irritation in Albino Rabbits: Sodium Cyanide:
Final Report: Lab Project Number: MB 90-16 C. Unpublished study prepared by
MB Research Laboratories, Inc. 41 p.
42610901 Bullard, R. (1990) Description of Beginning Materials and Manufacturing Process:
Sodium Cyanide (M-44). Unpublished study prepared by Denver Wildlife
Research Center. 8 p.
42610902 Bullard, R. (1990) Discussion of the Formation of Impurities: Sodium Cyanide
(M-44). Unpublished study prepared by Denver Wildlife Research Center. 5 p.
42610903 Bullard, R. (1990) Preliminary Analysis of Product Samples: Sodium Cyanide
(M-44). Unpublished study prepared by Denver Wildlife Research Center. 4 p.
42610904 Bullard, R. (1990) Analytical Methods to Verify Certified Limits: Sodium Cyanide
(M-44). Unpublished study prepared by Denver Wildlife Research Center. 10 p.
42
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BIBLIOGRAPHY
MRID
CITATION
42610905 Bullard, R. (1990) Odor: Sodium Cyanide (M-44). Unpublished study prepared by
Denver Wildlife Research Center. 4 p.
42610906 Bullard, R. (1990) Melting Point: Sodium Cyanide (M-44). Unpublished study
prepared by Denver Wildlife Research Center. 4 p.
42610907 Bullard, R. (1990) Solubility: Sodium Cyanide (M-44). Unpublished study
prepared by Denver Wildlife Research Center. 5 p.
42610908 Bullard, R. (1990) Vapor Pressure: Sodium Cyanide (M-44). Unpublished study
prepared by Denver Wildlife Research Center. 5 p.
42610909 Bullard, R. (1990) Dissociation Constant: Sodium Cyanide (M-44). Unpublished
study prepared by Denver Wildlife Research Center. 4 p.
42610910 Bullard, R. (1990) pH: Sodium Cyanide (M-44). Unpublished study prepared by
Denver Wildlife Research Center. 4 p.
42610911 Bullard, R. (1990) Stability: Sodium Cyanide (M-44). Unpublished study prepared
by Denver Wildlife Research Center. 5 p.
42610912 Bullard, R. (1990) Explodability: Sodium Cyanide (M-44). Unpublished study
prepared by Denver Wildlife Research Center. 4 p.
42610913 Bullard, R. (1990) Product Identity and Disclosure of Ingredients: M-44 Cyanide
Capsules. Unpublished study prepared by Denver Wildlife Research Center. 15 p.
Clayton, G.D., and Clayton, F.E., eds. (1982) Patty's Industrial Hygiene and
Toxicology. 3rd Revised Ed., Wiley Interscience, NY.
Cotton, F. A. and Wilkinson, G. Advanced Inorganic Chemistry. Fifth Edition, John
Wiley and Sons, New York, 1988.
Flynn, C.M., Jr. and McGill, S.L. Cyanide Chemistry- Precious Metals
Application. Draft Information Circular, United States Department of the Interior,
Bureau of Mines, Reno Research Center, Reno, Nevada.
43
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BIBLIOGRAPHY
MRID CITATION
Greeme, J.F. (1986) Recommended decision. In the matter of Defenders of
Wildlife, et al, FIFRA Docket No. 559, Administrative Law Office, U.S.
Environmental Protection Agency, 9pp.
Greenwood, N.N. and Earnshaw, A. Chemistry of the Elements. Pergamon Press,
Oxford, United Kingdom, 1984.
Jenks, W.R. "Cyanides (Alkali Metals)". Chapter in Kirk-Othmer Encyclopedia of
Chemical Technology. Third Edition, Volume 7, Wiley, New York, 1979.
Ruckelshaus, W.D. (1972) Suspension of registration for certain products
containing Sodium Fluoroacetate (1080), Strychnine and Sodium Cyanide. PR
Notice 82-2, March 9, Pesticides Regulation Division, U. S. Environmental
Protection Agency, 15 pp.
Sax, N.I., and Lewis, R.J. Sr., (1989) Dangerous Properties of Industrial
Materials. 7th Edition. Van Nostrand Reinhold, N. Y.
Towill, L.E., Drury, J.S., Whitfield, B.L., Lewis, E.B., Galyan, E.L., and
Hammons, A.S. Reviews of the Environmental Fate of Pollutants. V. Cyanide.
U.S. Environmental Protection Agency, Health Effects Research Laboratory,
Office of Research and Development, Cincinnati, OH; EPA 600/1-78/027; NTIS
PB 28-9920; 1978.
U.S. Environmental Protection Agency, Biological Report of Analysis, Sample No.
136703, Durham's Sodium Cyanide Balls, EPA Reg. No. 430-01, May 9, 1977.
Train, R.E. (1975) Sodium cyanide applications to register for use in the M-44
device to control predators. Federal Register. 40:189, 44726-44739.
44
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APPENDIX D. List of Available Related Documents
45
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46
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The following is a list of available documents related to sodium cyanide. It's purpose is to
provide a path to more detailed information if it is needed. These accompanying documents are
part of the Administrative Record for sodium cyanide and are included in the EPA's Office of
Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Sodium Cyanide RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
6. U.S. Fish and Wildlife Service Biological Opinion, March 1993, Section on
Sodium Cyanide, pages 11-73 through 11-78. (included in Appendix G)
47
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48
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APPENDIX E. PR Notices 86-5 and 91-2
49
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50
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PR Notice 86-5
51
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52
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Pno WASHINGTON, D.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Pers9ns responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and certain provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining
pesticide registrations, experimental use permits, tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA. These data are defined in FIFRA §10(d)(1). This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the
submitter for necessary revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in
the Federal Register (49 FR 37956) which include Requirements for
Data Submission (40 CFR §158.32), and Procedures for Claims of
Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
entire proposed regulation becomes final. Adequate lead time is
53
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being provided for submitters to comply with the new
requirements.
V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be C9mpatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen is to avoid the additional C9sts and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of applicati9n
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
deadlines for inserting int9 the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each application
for registration or other action include a list 9f all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support f9r the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party. That requirement is not altered by this notice, which
applies only to data submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements
foll9ws the index on the next page, and samples of some of the
requirements are attached. Except for the language 9f the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies . . 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
54
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D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10 (d) (1)1 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(1) ) 8 14
D. 5 Good Laboratory Practice Compliance Statement . . 9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies .... 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at
the same time f9r review in support of a single regulatory
action, along with a transmittal document and other related
administrative material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this Notice. The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims).
B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--!.e., a registration application,
petition, experimental use permit (EUPT, §3 (c)(2)(B) data
call-in, §6(a)(2) submittal, 9r a special review; the transmittal
date; and a list of all individual studies included in the
gackage in the order of their appearance, showing (usually by
uideline reference number) the data requirement(s) addressed by
each one. The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petiti9n for tolerance or an
application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40 CFR 180.7
and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
55
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When a submittal package supports a tolerance petiti9n and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study slKmld be identifiable and distinguishable by a
C9nventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with 39016 exceptions dis-
cussed in section C.I. Each study included in a submittal
Eackage must be bound as a separate entity. (See comments on
inding studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study on
each page (i.e., 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or mark and study number on each
page of the study, e g , Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
When a single study is extremely long, binding it in mul-
tiple V9lumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.1 Special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical C9ntrol data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import t9lerance petiti9n, or an end-use product
produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61, 62, and 63) for
C9nventional pesticides, or for the equivalent subject range for
biorational pesticides. The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
56
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would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
second would cover Guidelines 151-23 and 151-25; the third would
cover Guideline 151-26.
Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
§10(d)(1)(A), (B), or (C), and if so must be handled as described
in section D.3. of this notice.
c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single cr9p or from processing a
single crop. When more than one commodity is derived from a
single crop (such as beet tops and beet roots) residue data on
all such C9mmodities should be reported as a single study. When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports Iaborat9ry Page 16
work subject to GLP require-
ments
For certain t9xicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C)
CBI Attachment
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C) Page 15
Supplemental Statement Only if confidentiality is Page 14
of Data Confidentiality claimed on a basis other than
Claims FIFRA §10(d)(1)(A), (B), or (C)
57
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D.I. Title Page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study title. The study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears in
the Guidelines.
b. Data requirement addressed. Include on the title page the
Guideline number(s) of the specific requirement(s) addressed by
the study.
c. Author(s). Cite only individuals with primary intellectual
responsibility for the C9ntent 9f the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory IdentificatJ9n. If the study reports
work done by one or more laboratories,Include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include 9n the title page elements a. through d. for the
previ9usly submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers. (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary stuay. Do not include supplements to more than one
study under a single title page).
g. Facts of Publication. If the study is a reprint of a pub-
lished d9cument, identity on the title page all relevant facts of
publication, such as the J9urnal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d) (1) .
Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 (b) and (c) (See
Attachment 3). These statements apply only to claims of data
confidentiality based on FIFRA §10(d)(1)(A), (B), or (C). Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or
to waive such a claim (§158.33(c)). In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. 09 not make CBI
claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions (see NOTE Pg 13).
58
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D.3. Confidential Attachment
If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
§10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body 9f the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5).
The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment." An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet. Paginate the Confidential Attachment
separately from the body of the study, beginning with page 1 of X
on the title page. Each passage confined t9 the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
§10(d)(1) on which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §10(d)
(1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement 9f Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us t9 retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies smpuld not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed 9n one side only in
black ink, with high contrast and good res9lution. Bindings for
individual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
instructions bef9re submitting data in any medium other than
paper, such as film or magnetic media.
59
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Please be particularly attentive to the following points:
Do not include frayed or torn pages.
Do not include carbon copies, or copies in other than
black ink.
Make sure that photocopies are clear, complete, and
fully readable.
Do not include oversize computer printouts or fold-out
pages.
Do not bind any documents with glue or binding tapes.
Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence.
Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The prop9sed regulati9ns specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Stan-
dard 9r Special Review must be provided in four C9pies, fr9m one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
Remove the "Supplemental Statement of Data
Confidentiality Claims".
Remove the "Confidential Attachment".
Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d)(1)(A), (B) , or (C). Do not
close up or paraphrase text remaining after this
excision.
Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential".
V. For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
/B/
James W. Akerman
Acting Director,
Registration Divison
60
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Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality
Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample G9od Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
61
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
"Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
"Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is
submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g. experimental
use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline
No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-
smittal letter. This remains an acceptable practice so
long as all four elements are included.
* Indicate which of the J9int submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data.
Company Official:
Name Signature
Company Name
Company Contact:
Name Phone
62
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
63
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64
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(1)(A),(B), or (C).
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this
study on the basis of its falling within the scope of FIFRA
6§10(d)(1)(A), (B), or (C).
Company
Company Agent: Typed Name Date:
Title Signature
2. Claim of confidentiality under FIFRA §10(d)(1)(A), (B), or (C).
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent: Typed Name Date:
Title Signature
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method. These
analytical methods are published in the FDA Pesticide Analytical
Methods Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
65
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1)(A), (B), or (C), but for which y9u claim
C9nfidential treatment 9n another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
Identify specifically by page and line number(s) each
portion of the study for which you claim
confidentiality.
Cite the reasons why the cited passage qualifies for
confidential treatment.
Indicate the length of time--until a specific date or
event, or permanently--for which the information should
be treated as confidential.
Identify the measures taken to guard against undesired
disclosure of this information.
Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
Encl9se C9pies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
If y9u assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe th9se harmful effects and explain why
they should be viewed as substantial.
If you assert that the informati9n in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
66
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED WORDS OR PHRASED Ethvlene Glvcol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED PARAGRAPH(S):
( )
( Reproduce the deletedparagraph(s) here )
( )
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
PAGES LINES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process §10(d)(l)(A)
67
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Study Director
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1.
2 .
3.
Submitter
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
68
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
LEGEND
Study title page.
Statement of Confidentiality Claims.
. GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims
* When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
'
69
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70
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PR Notice 91-2
71
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72
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide P^gram's P9licy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CFR 158.153(1). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
9f identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting go9d manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175 (c) (3) .
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.
73
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The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
product compositi9n because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is imp9rtant for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal C9ncentrati9n expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. C9pies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to pr9vide certified limits
f9r each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) 9nly) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may n9t be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to C9ntrol pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
74
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(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
(3) All other products/applications that are not subject to
(1) and (2) ab9ve will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
X? £ -/ *
Z---£--f^--* t_ c>^i-'jt>*
Ann* E. tdndaay, Director
Registration Division (H-7505
75
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76
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APPENDIX F. Product Specific Data Call-in
77
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78
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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
ofyour 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 A through G; 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 all ofyour 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 (expiration date 12-31-92).
This Notice is divided into six sections and seven 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:
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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 Grouping or End-Use Products tor Meeting Acute Toxicology Data
Requirements tor Reregistration
EPA
5 - EPA Acceptance Criteria
6 - List or Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
SECTION I. 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
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, 1750 Pennsylvania
Avenue N.W., Washington, D.C. 20006.
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
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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
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 or 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
b 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.
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3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section 111-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.
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)
I have made offers to cost-share (Offers to Cost Share)
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
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
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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^), 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
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(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
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
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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
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:
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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:
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
UNACUEP TABLE
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.
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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 3D 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
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 CalHn Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment Z 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,
Louis P. True, Jr., Acting 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 Grouping; ot End- Use Products tor Meeting Acute Toxicology Data
Requirements tor Reregistration
EPA
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
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Attachment 1. Chemical Status Sheet
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SODIUM CYANIDE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing sodium cyanide.
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 reregistration of
sodium cyanide. 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), (o) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this sodium cyanide 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 sodium cyanide are
contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency has
concluded that additional data on sodium cyanide 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 reregistration of all eligible sodium cyanide products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of sodium cyanide, please
contact Kathleen Depukat at (703) 308-8587.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Franklin Gee at (703) 308-8008 or Emily Mitchel at
(703) 308-8583.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Emily Mitchell
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: SODIUM CYANIDE
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Attachment 2. Product Specific Data Call-In Response Forms
(Form A inserts) Plus Instructions
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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 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
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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 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
95
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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.
96
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
97
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98
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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 guidelines 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 patters (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 Documents 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.
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 on for acute toxicity or certain efficacy data and only if
EPA indicates in an attachment to this notice that my product is similar. Enough to
another product to qualify for this option. I certify that another party in the
agreement is committing to submit or provide the required data; if the required
study is not submitted on time, my product my be subject to suspension.
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
require 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.
99
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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.
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgrade (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 Call-in Notice (Section III-C.l.) apply.
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) number (s) for the cited data on a "Product Specific Data Report" form
or in a similar format. If I cite another registratrant's data, I will submit a
completed "Certification With Respect To Data Compensation Requirements" form.
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 require 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 chosen. I also understand that the deadline
for submission of data as specified by the original data cal-in notice will not change.
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 cancelled this
product. For these cases, please supply all relevant details so that EPA can ensure that its records
are correct.
100
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
101
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102
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EPA'S BATCHING OF PRODUCTS CONTAINING SODIUM CYANIDE 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 reregistration of products containing the active ingredient sodium cyanide, 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), type of formulation (e.g., emulsifiable concentrate, aerosol,
wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, 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 lexicological 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
lexicological 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. 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 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 batch for the active ingredient sodium cyanide. All seven products of this RED
were batched.
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Table 1
Batch
1
Registration
Number
33858-2
35975-2
35978-1
39260-1
39508-1
50628-1
56228-15
% Active Ingredient
sodium cyanide ... 91.06%
sodium cyanide ... 91.06%
sodium cyanide ... 91.06%
sodium cyanide ... 91.06%
sodium cyanide ... 91.06%
sodium cyanide ... 88.78%
sodium cyanide ... 91.06%
Form
powder capsules
powder capsules
powder capsules
powder capsules
powder capsules
powder capsules
powder capsules
104
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Attachment 5. EPA Acceptance Criteria
105
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106
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
107
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at _>_ 0.1% by weight
and for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present "at < 0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
Registry Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned
experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and the
parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
which may be present at _>_ 0.1% or was found at _>_ 0.1% by product analyses and (2) certain
lexicologically significant impurities (see #3).
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present the
information in items 6, Y, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and
all impurities present at > 0.1%.
2. Degree of accountability!^ closure _>_ ca 98%.
3. Analyses conducted for certain traceToxic impurities at lower than 0.1% (examples, nitrosamines in the case
of products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and
stored samples must be analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with
explanation of how the limits were determined.
8. Upper certified limit proposed for each impurity present at > 0.1% and for certain lexicologically significant
impurities at < 0.1% along with explanation of how limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if
exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy.
109
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
Reported in °C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3 or
Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if
pressure too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25 °C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
110
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SUBDIVISION F
Guideline Study Tide
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
111
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3.r Dosing, single oral may be administered over 24 hrs.
4.*^ Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.^ Vehicle control, only if toxicity of vehicle is unknown.
7.~ Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours oefore dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or
contains particles of inhalable size for man (aerodynamic diameter 15 pm or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (+_2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
respirable substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
114
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of < 2 or > 11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8. Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
;ntal and
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof <2or >11.5.
3. One offhe following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.^ Reference for test.
6.~ Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
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118
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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
119
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120
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Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
121
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122
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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.
125
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126
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
127
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128
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&EPA
United States Environmental
Washington, DC
CERTIFICATION WITH
DATA COMPENSATION
Protection
20460
Agency
RESPECT TO
REQUIREMENTS
OUI N*. 2070-0107
2070-0037
Ap*«*v*l Expire* 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington. DC 20503.
Please fill In blanks below.
Company Nam*
Product NaM
Company Number
EPA R*?. No.
I Certify that:
1. For each study cited in support of registration or reregistration under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use
study, I am the original data submitter, or I have obtained the written permission of the original data submitter, or I
have notified in writing the company(ies) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(C)(1)(D) 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(0(1 )(D) of FIFRA for the studies I have cited in support of
registration or reregistration under FIFRA.
Signature
Date
Nam* and Till* (PI**** Tjrp* or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to tne
registration or reregistration of my products, to the extent required by FIFRA sections 3(c)(i)(D) and 3(c)(2)(D).
Signature
Date
Nam* and Till* (PI**** Type or Print)
EPA Perm M70-J1 (4-90)
129
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130
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APPENDIX G. U.S. Fish and Wildlife Service Biological
Opinion March, 1993 pages 11-73 to 11-78
131
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Sodium Cyanide
Sodium cvanide
CHEMICAL INFORMATION
TYPE: Canid predacide
FORMULATION: Capsules (888 mg sodium cyanide (NaCN), 89% ai) contained in an M-44 device.
REGISTERED USES: Control of coyotes, red foxes, gray foxes and feral dogs. M-44 use is subject to 26
restrictions designed to protect the applicator, human health, livestock, and non-target wildlife. Registered for use only
by the following agencies: U.S. Department of Agriculture's Animal and Plant Health Inspection Service (Hyattsville,
MD), Texas Department of Agriculture, (Austin), Montana Department of Livestock (Helena), Wyoming Department
of Agriculture (Cheyenne), Navajo Fish and Wildlife Department (Window Rock, AZ), New Mexico Department of
Agriculture, (Las Cruces) and the Kansas Department of Wildlife and Parks (Pratt). All other NaCN products for
mammalian predator control have been canceled and uses suspended.
BACKGROUND:
Mode of action: Converts to hydrogen cyanide gas which poisons by inactivating an enzyme essential to mammalian
cellular respiration leading to central nervous system depression, cardiac arrest, and gross respiratory failure
(Ballantyne 1987).
Aquatic toxicity: NaCN is highly soluble in water (480 g/L at 10° C; Eisler 1991) but completely dissociates to give
free cyanide which, depending on pH, forms highly toxic hydrogen cyanide (HCN). HCN does not tend to
bioaccumulate in aquatic organisms. Likewise, cyanide seldom remains biologically available in soils because it is
either complexed by trace metals, metabolized by microorganisms, or lost through volatilization (Eisler 1991). Cyanide
is highly to very highly toxic to most aquatic organisms. In general, fish were the most sensitive aquatic organisms
tested under controlled conditions (Eisler 1991).
Cyanide acts rapidly in aquatic environments, does not persist for extended periods, and is highly species selective.
Organisms usually recover quickly on removal to clean water. The critical sites for cyanide toxicity in freshwater
organisms are the gills, egg capsules, and other sites where gaseous exchange and osmoregulatory processes occur
(Eisler 1991). The M-44 NaCN capsules may not be used within 200 feet of water and the number of capsules that
may be used is limited to a maximum of 20 per square mile. Therefore, cyanide from M-44 capsules should pose
negligible hazard to aquatic organisms.
Terrestrial toxicity: NaCN is highly to very highly toxic to birds and mammals. The M-44 NaCN ejector device
should be considered to have 100% efficacy. The M-44 is designed to eject a burst of crystalline NaCN into the face of
a predator tugging at the bait. On contact with mucus or saliva of the eyes, nose, and mouth, hydrogen cyanide is
immediately formed and the gas readily absorbed through the highly permeable membranes of the nose, mouth, lungs,
and stomach.
In an avian study of acute oral toxicity, three flesh-eating species (black vulture, American kestrel, and eastern screech-
owl; LD50s = 4.0-8.6 mg/kg) were more sensitive to NaCN than three species (Japanese quail, European starling, and
domestic chicken; LD50s = 9.4-21 mg/kg) that fed predominantly on plant material (Wiemeyer et al. 1986). It was also
noted that the associated dose-response curve was consistently steepest for the flesh-eaters and thereby suggests further
increase in hazard to species most likely to trip an M-44 cyanide ejector device.
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Sodium Cyanide
EPA lists a number of "may affect" mammals such as the San Joaquin kit fox, jaguar, ocelot, gray wolf, and the
Mariana crow. However, it is EPA's position that adherence to the 26 conditions effectively eliminates the non-target
hazards associated with the use of M-44 cyanide capsules. Conversely, it is clear from Connolly's (1988) list of non-
target species that any carrion feeding animal able to activate the trigger of the M-44s cyanide ejector device is at risk.
Consistent with its use pattern, no direct or indirect effects are expected with M-44 cyanide capsules with respect to
listed plants and/or plant pollinators considered in this consultation.
Wildlife incidents: EPA reported no wildlife poisoning incidents associated with NaCN. However, when the M-44 user
is in compliance with the 26 specific restrictions, the likelihood of the general public locating the carcass of a non-target
species is small. Many of the Animal Damage Control non-target listings (Connolly 1988) would have constituted
"wildlife incidents" if located first by the general public. Also, a dead California condor was exposed to NaCN from
an M-44 even through a conclusive diagnosis of death was not made (Wiemeyer et al. 1986).
The U.S. Department of Agriculture's Animal Damage Control program records mortality from M-44 cyanide ejector
use. During 1976-1986, M-44s were used in 14 western states, killing 103,255 animals. This total includes 4,868
non-target animals (Connolly 1988). Non-target species reported killed include grizzly bear, black bear, mountain lion,
badger, kit and swift fox, bobcat, ringtail cat, feral cat, skunk, opossum, raccoon, Russian boar, feral hog, javelina,
beaver, porcupine, nutria, rabbit, vulture, raven, crow, and hawk. It is reasonable to believe birds deaths are
underestimated in non-target kill reports because the bird's flight response on activation of an M-44 could easily remove
them from the vicinity of the device in a few seconds.
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Sodium Cyanide
BIOLOGICAL OPINION
CHEMICAL REFERENCE TABLE
(The following table contains only those species for which the Service provided a jeopardy or no jeopardy call. Species not included in this list are either not
affected by the chemical or have no chance for exposure. For a complete list of all species considered in this opinion, refer to the master species list on page
III-l of the species profile section.)
Species Name
MAMMALS
Florida panther
Gray wolf
Grizzly bear
Jaguarundi
Louisiana black bear
Ocelot
San Joaquin kit fox
BIRDS
Alala (Hawaiian crow)
California condor
Mariana crow
J/NJ
J
NJ
NJ
J
J
J
J
NJ
J
NJ
PAGE
83
85
85
83
84
83
85
86
85
86
RATIONALE FOR JEOPARDY DETERMINATIONS
Florida panther - The panther could be exposed to sodium cyanide when the chemical is used in an
M-44 device to control canid predators such as foxes and feral dogs. EPA requires a number of
restrictions on the use of the device, which would minimize the opportunity of an endangered species
coming in contact with the M-44 device. According to EPA, the M-44 shall not be used in areas
where endangered species may be adversely affected. However, the panther requires a large home
range, and at times will venture from that range in search of prey. Young panthers will also disperse
to establish new home range territory, consequently, there is opportunity for panthers to be exposed
to an M-44 device. Although these sodium cyanide devices are designed for canid control, there are
documented kills of bobcats and mountain lions. Because of the critically small panther population,
any poisoning event could threaten the survival of the species. Therefore, it is the Services' opinion
that the use of sodium cyanide is likely to jeopardize the continued existence of the Florida panther.
Reasonable and Prudent Alternative(s) - If implemented, the following reasonable and prudent
alternative would avoid jeopardy to the Florida panther: prohibit the use of the chemical device
within 20 miles of the boundary of any Federal and State lands (e.g., National Wildlife Refuge,
National Park, National Preserve, State Park, State Preserve, State Wildlife Management Areas,
etc.) and Indian Reservations that provide suitable panther habitat south of Charlotte, Glades
and Martin Counties, Florida.
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Sodium Cyanide
Incidental Take - Because individuals of the species may disperse beyond a given home range,
the use and toxicity of the pesticide is still a concern, consequently, the Service anticipates that
an unquantifiable level of incidental take may occur as a result of the use of the pesticide outside
of the prohibited use zone.
Reasonable and Prudent Measure(s) - The following reasonable and prudent measure for
minimizing incidental take should be adopted and implemented: prohibit the use of sodium
cyanide (M-44s) in the geographic range of the Florida panther until after the user has contacted
the local fish and Wildlife Service office and that office has determined that there are no known
panthers in the general vicinity of where the M-44's are going to be used.
Jaguarundi and Ocelot - The ocelot and jaguarundi could be exposed to sodium cyanide when the
chemical is used in an M-44 device to control canid predators such as foxes, coyote and feral dogs.
EPA required a number of restrictions on the device, which would minimize the opportunity of an
endangered species coming in contact with the M-44 device. According to EPA, the M-44 shall not
be used in areas where endangered species may be adversely affected. However, young ocelots and
jaguarundi will disperse in an attempt to establish new territories and could be exposed to an M-44
device. Although these sodium cyanide devices are designed for canid control, there are documented
kills of bobcats and mountain lions. Because of the critically small ocelot and jaguarundi populations,
any poisoning event could threaten the survival of the species. Therefore, it is the Services' opinion
that the use of sodium cyanide is likely to jeopardize the continued existence of the ocelot and
jaguarundi.
Reasonable and Prudent Alternative(s) - If implemented, the following reasonable and prudent
alternative will avoid jeopardy to the ocelot and jaguarundi: prohibit use within three miles of
occupied habitat.
Incidental Take - Despite the implementation of the reasonable and prudent alternative
described above, the Service anticipates that an unquantifiable level of incidental take of ocelot
and jaguarundi may occur as a result of sodium cyanide use within the range of these species.
Reasonable and Prudent Measure(s) - If implemented, the following reasonable and prudent
measures will minimize incidental take: prior of use of sodium cyanide in potential ocelot or
jaguarundi habitat, conduct survey to determine if habitat is occupied. If habitat is unoccupied,
no further restrictions are applicable. If habitat is occupied, prohibit use within three miles.
Louisiana black bear - The bear could be exposed to sodium cyanide when the chemical is used in
an M-44 device to control canid predators such as foxes and feral dogs. EPA required a number of
restrictions on the use of the deice, which would minimize the opportunity of an endangered species
coming in contact with the M-44 device. According to EPA, the M-44 shall not be used in areas
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Sodium Cyanide
where endangered species may be adversely affected. However, the bear requires a large home range,
and at times will venture from that range in search of additional prey. Young bears will also disperse
to establish new home range territory. The registered use of the canid control chemical permits up to
20 M-44 devices per square mile. Consequently, there is opportunity for bears to be exposed to an
M-44 device. Although these sodium cyanide devices are designed for canid control, there are
documented kills of other mammals including skunks, bobcats and mountain lions. Because of the
bear's relatively small population, any poisoning event could threaten the survival of the species.
Therefore, it is the Service's opinion that the use of sodium cyanide is likely to jeopardize the
continued existence of the Louisiana black bear.
Reasonable and Prudent Alternative(s) - If implemented, the following reasonable and prudent
alternative would avoid jeopardy to the Louisiana black bear: prohibit the use of the chemical
device within the known occupied habitat of the Louisiana black bear.
Incidental Take - Because individuals of the species may disperse beyond a given home range,
the use and toxicity of the pesticide is still a concern. Consequently, the Service anticipates that
an unquantifiable level of incidental take may occur as a result of the use of the pesticide outside
of the prohibited use zone.
Reasonable and Prudent Measure(s) - The following reasonable and prudent measure for
minimizing incidental take should be adopted and implemented: prohibit the use of sodium
cyanide (M-44s) in the geographic range of the Louisiana black bear until after the user has
contacted the local Fish and Wildlife Service office and that office has determined that there are
no known Louisiana black bears in the general vicinity of where the M-44's are going to be
used.
San Joaquin kit fox - The primary risk of exposure of San Joaquin kit foxes to sodium cyanide
would occur during use of this chemical in M-44 devices to control coyotes and other canids. M-44
devices (consisting of a stake with an attractant and spring loaded capsule containing the active
ingredient) are targeted specifically for the control of wide-ranging canid species. They are highly
attractive to such species, are highly dangerous when triggered, and are relatively non-selective.
Because of these qualities, use of M-44 devices within the San Joaquin kit fox range would pose a
significant exposure hazard to kit foxes and could have significant adverse impacts on the species. If
permitted, use of M-44 devices likely wold occur throughout the kit fox range because four potential
target species (coyotes, red foxes, grey foxes, and feral dogs,) share this area. For these reasons, it is
the Service's biological opinion that use of sodium cyanide in M-44 devices within the San Joaquin kit
fox range is likely to jeopardize the continued existence of this species.
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Sodium Cyanide
Reasonable and Prudent Alternative(s) - If implemented, the following reasonable and prudent
alternatives would avoid jeopardy to the San Joaquin kit fox: prohibit use of sodium cyanide
M-44 devices within the range of the San Joaquin kit fox.
Incidental Take - With implementation of the reasonable and prudent alternatives described
above, no incidental take is anticipated and therefore none is authorized.
California Condor - The primary exposure of sodium cyanide from registered uses can occur when a
California condor activates the M-44 device by its foraging activities. Limited reintroduction of
California condors by the Service has begun in 1991. Therefore, it is the Service's biological opinion
that use of sodium cyanide is likely to jeopardize the continued existence of this species.
Reasonable and Prudent Alternative(s) - If implemented, the following reasonable and prudent
alternatives would avoid jeopardy to the California condor: the use of sodium cyanide should
be prohibited in condor occupied habitat including Ventura, Kern, Santa Barbara, Los Angeles,
and San Luis Obispo Counties. Alternative control of canid predators must be considered to
avoid the inadvertent poisoning of California condors.
Incidental Take - With implementation of the reasonable and prudent alternative described
above, no incidental take is anticipated and therefore none is authorized.
RATIONALE FOR NO JEOPARDY DETERMINATIONS
Gray wolf and Grizzly bear - The registration of sodium cyanide capsules for use in the M-44
device for control of canid predators could result in the morality of a gray wolf or grizzly bear.
However, EPA also requires a number of restrictions, some of which should provide protection to the
gray wolf and grizzly bear. According to EPA, the M-44 shall not be used in areas where threatened
or endangered species may be adversely affected. Based on that restriction, it is the Service's opinion
that the registered use of sodium cyanide is not likely to jeopardize the continued existence of the
gray wolf or the grizzly bear.
Incidental Take - While applicators are restricted from using the M-44 in areas where a gray
wolf or grizzly bear may be adversely affected, these two species have a very wide range and
thus could be inadvertently taken in areas not mapped and/or prior to the applicator's
knowledge that the species may be in the control area. The Service, therefore, anticipates that
an unquantifiable level of incidental take may occur as a result of the use of sodium cyanide.
Reasonable and Prudent Measure(s) - The following reasonable and prudent measures should be
adopted: prohibit the application of sodium cyanide (M-44s) in the geographic range of the
gray wolf an grizzly bear until after the user has contacted the local Fish and Wildlife Service
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Sodium Cyanide
office and that office had determined that there are no known wolves or grizzly bears in the
general vicinity of where the M-44's are going to be applied.
Alala (Hawaiian crow) and Mariana crow - Both of these corvids are, in part, carrion feeders. M-
44 sodium cyanide devices may pose a potential threat due to the possibility that the crows may be
attracted to baits associated with capsule deployment. There are few incidents of feral dog predation
on livestock in these geographic areas and canid control is typically effected through shooting or
trapping. M-44 devices are not expected to be employed in Hawaii or Guam. The alala is currently
restricted to the coastal slope of Mona Loa on the island of Hawaii and only 12 birds were estimated
to occur in the wild in 1990. the Mariana Crow is currently restricted to forest areas from Ritidian
Point to Anao along the northern cliffline, in Northwest Field, and in the Convention weapons
Storage Areas of Guam and on the island of Rota. Consequently, it is the Service's biological opinion
that use of sodium cyanide as described above within or adjacent to habitat occupied by the alala and
Mariana crow is not likely to jeopardize the continued existence of these species.
Incidental take - The Service anticipates that an unquantifiable level of incidental take of the
alala and Mariana common crow may occur as a result of sodium cyanide use within the
occupied habitat of these species.
Reasonable and Prudent Measure(s) - The following reasonable and measure for minimizing
incidental take must be adopted: prohibit the use of sodium cyanide within occupied habitat on
Guam, Rota and the island of Hawaii.
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APPENDIX H. FACT SHEET
139
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United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(H-7508W)
EPA-738-F-94-016
September 1994
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Sodium Cyanide
All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered years ago be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency imposes any
regulatory controls that are needed to effectively manage each pesticide's risks.
EPA then reregisters pesticides that can be used without posing unreasonable
risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED for Case 3086, sodium
cyanide.
Sodium cyanide is a single dose poison used in the M-44 ejector device
on pastures, range and forest land to control coyote, red fox, gray fox and wild
dog populations that prey upon (or are likely to prey upon) livestock, poultry
or endangered species, or that are vectors of communicable diseases.
The sodium cyanide capsule is loaded into a capsule holder which is
screwed onto the ejector mechanism of an M-44 device. The capsule holder is
then treated with a scent formulated to attract canids. When an animal tugs at
the capsule holder, a spring-driver plunger ejects the sodium cyanide capsule
into its mouth. Sodium cyanide causes death by inhibiting enzyme reactions in
mammals that prevent oxygen flow to the blood.
A Restricted Use Pesticide, sodium cyanide may be applied only by
trained, certified applicators under the direct supervision of a government
agency, in accordance with 26 stringent use restrictions detailed in product
labeling.
The U.S. Fish and Wildlife Service issued a Biological Opinion in March
1993 that proposed additional restrictions on the use of sodium cyanide to
protect endangered species.
-------
Regulatory
History
Human Health
Assessment
Sodium cyanide was initially registered as a pesticide in 1947 to control
ants, certain bacteria, insects and rodents in residential and commercial areas.
However, all non-predicidal uses were canceled in 1987 in response to a
generic data call-in issued by EPA.
The only currently registered uses of sodium cyanide are for toxicant-
filled capsules to be placed in M-44 spring-loaded ejector devices used to kill
wild canids. Use is limited to situations where canids prey upon (or are likely
to prey upon) livestock, poultry or Federally-designated threatened or
endangered species, or where particular canids are carriers of communicable
diseases. All currently registered products are Restricted Use Pesticides with
specific applicator training and certification requirements, subject to 26 use
restrictions.
Prior to 1972, sodium cyanide was used to control predators in a
gunpowder-fired unit called the "Humane Coyote Getter." However, this use
and all other predator control uses of sodium cyanide were canceled in 1972
due to the incidence of human injuries and the occasional killing of domestic
dogs.
The use of sodium cyanide capsules in the M-44 was reinstated in 1975
when it was determined that the M-44 was safer and more selective than the
"Humane Coyote Getter." The reinstated uses of sodium cyanide are subject
to 26 use restrictions to minimize potential adverse impacts on man and the
environment. Among other things, these restrictions require that applicators be
appropriately trained and certified for using sodium cyanide capsules in M-44
devices, that applicators carry antidote kits when placing or inspecting M-44
devices, and that M-44 devices not be placed in areas likely to cause adverse
impacts on humans and endangered species or other nontarget species.
Toxicity
Sodium cyanide is highly toxic to warm-blooded animals. It has been
placed in Toxicity Category I, indicating the greatest degree of acute toxicity,
for oral, dermal and inhalation effects. It is highly corrosive to the skin and
eyes, and cyanide liquid and possibly vapor, can be absorbed through intact
skin. Vapor can be absorbed extremely rapidly through the respiratory tract.
Dietary, Occupational and Residential Exposure
Based on the pesticide's use patterns, the general population will not be
exposed to sodium cyanide. There are no applicator/mixer/loader or post-
application exposure concerns other than following the label restriction for use
by certified personnel only.
142
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Environmental
Assessment
Human Risk Assessment
Because of the specific nature of sodium cyanide's registered use pattern,
the Agency's primary concern is the potential risk of acute toxicity to non-
target animals. Sodium cyanide is not registered for use in residential
environments, so risks are not posed to the general population. Risk of acute
toxicity to applicators is mitigated by the pesticide's 26 use restrictions and its
classification as a Restricted Use Pesticide.
Environmental Fate
The Agency does not anticipate significant environmental exposure to
sodium cyanide when it is used as an encapsulated material together with the
M-44 ejector device.
Should an accidental spill of sodium cyanide capsules occur in the field,
several processes would contribute to their dissipation. Hydrogen cyanide,
which is formed by reaction with moisture, will diffuse to the atmosphere and
be diluted into the air. Reactions with soil compounds will convert cyanide
into carbon dioxide and ammonia or other nitrogen containing compounds.
Thus, the environmental impact of the pesticidal use of sodium cyanide is
expected to be minimal because of its mode of application as well as its
degradation pattern in the environment.
Ecological Effects Risk Assessment
Sodium cyanide works by converting to hydrogen cyanide gas when it
comes in contact with moisture, which inhibits an enzyme reaction that is
essential to mammalian cellular respiration. This results in central nervous
system depression, cardiac arrest and gross respiratory failure.
Any animal that is able to activate the trigger of the cyanide ejector
device will get a dose of sodium cyanide in the mouth and will die. Therefore,
it is considered a high acute risk pesticide for terrestrial vertebrates, including
nontarget and endangered birds.
While the label restrictions were designed to minimize the risk to
nontarget species, the M-44 will kill nontarget animals, including some
endangered species. Additional restrictions on the use of sodium cyanide have
been outlined for species at risk in a March 1993 U.S. Fish and Wildlife
Service Biological Opinion and are being imposed through this Reregistration
Eligibility Decision.
Based on the available information, secondary poisoning of animals that
ingest the body of the target animal is not expected from approved use of
sodium cyanide.
Additional Data EPA is requiring product-specific data including product chemistry and
Required efficacy data, revised Confidential Statements of Formula (CSF) and revised
product labeling for reregistration of products containing sodium cyanide.
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Product Labeling
Changes Required
All sodium cyanide end-use products must comply with EPA's current
pesticide product labeling requirements. The following statements also must
appear on the labels of all end-use products:
"Restricted Use Pesticide" - the 26 use restrictions must be maintained
on the labels.
"This pesticide is TOXIC TO WILDLIFE. Keep out of lakes, ponds or
streams. Do not contaminate water by cleaning of equipment or disposal
of wastes."
Additional endangered species labeling consistent with the
recommendations of the U.S. Fish and Wildlife' Biological Opinion of
March 1993.
Regulatory
Conclusion
For More
Information
The use of registered products containing sodium cyanide will not pose
unreasonable risks or adverse effects to humans or the environment, provided
that these products are used in accordance with the restrictions on product
labeling. Therefore, all uses of these products are eligible for reregistration.
Sodium cyanide products will be reregistered once the required product-
specific data, Confidential Statements of Formula and revised labeling are
received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for sodium cyanide during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Following the comment period, the sodium cyanide RED document will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program, the
sodium cyanide RED, or reregistration of individual products containing
sodium cyanide, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides Telecommunications Network (NPTN). Call toll-free 1-
800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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