United States Prevention, Pesticides EPA 738-R-07-013
Environmental Protection and Toxic Substances September 27, 2007
Agency (7508P)
&EPA
Reregistration
Eligibility Decision
for 4-aminopyridine
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Reregistration Eligibility Decision (RED) for
4-aminopyridine
List A
Case No. 0015
Approved by: j;
Steven Bradbury, Ph.D.
Director, Special Review and Reregistration Division
Date: lO 7
I / '
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Table of Contents
I. Introduction 6
II. Chemical Overview 7
A. Regulatory History 7
B. Chemical Identification 7
C. Use Profile 8
D. Estimated Usage of Pesticide 9
III. Summary of 4-Aminopyridine Risk Assessments 12
A. Human Health Risk Assessment 12
1. Toxicity of 4-Aminopyridine 12
2. Residential (Non-Occupational) Exposure and Risk 15
3. Aggregate Exposure and Risk 16
4. Occupational Exposure Assessment 16
5. Endocrine Disruption 18
B. Environmental Risk Assessment 18
1. Environmental Fate and Transport 18
2. Ecological Exposure and Risk 19
IV. Risk Management and Reregistration Decision 32
A. Determination of Reregistrati on Eligibility 32
B. Requirements for Reregistrati on 32
C. Public Comments and Responses 34
D. Regulatory Rationale 35
V. What Registrants Need to Do 39
A. Manufacturing Use Products 39
B. End-Use Products 39
C. Labeling Changes Summary Table 40
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EPA 4-Aminopyridine Team
Ecological Fate and Effects Division
Lucy Shanaman
Pamela Hurley
Stephanie Syslo
James Hetrick
Karen Whitby
Health Effects Division
James Scott Miller
Abdallah Khasawinah
Yan Donovan
Ray Kent
Registration Division
Dan Peacock
John Hebert
Meredith Laws
Special Review and Reregistration Division
Katie Weyrauch
Tom Myers
Margaret Rice
Biological Economics and Analysis Division
Nicole Zinn
Sunil Ratnayake
Andrew Lee
Timothy Kiely
Arnet Jones
Office of General Counsel
Amber Aranda
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Glossary of Terms and Abbreviations
ae Acid Equivalent
ai Active Ingredient
CFR Code of Federal Regulations
CSF Confidential Statement of Formula
DCI Data Call-In
ED WC Estimated Drinking Water Concentration
EEC Estimated Environmental Concentration
EPA Environmental Protection Agency
EUP End-Use Product
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
GENEEC Tier I Surface Water Computer Model (Estimated Aquatic Environmental Concentrations)
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or
volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in
50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.
LOG Level of Concern
LOAEL Lowest Observed Adverse Effect Level
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MUP Manufacturing-Use Product
N/A Not Applicable
NOAEL No Observed Adverse Effect Level
OPP EPA Office of Pesticide Programs
ppb Parts per Billion
PPE Personal Protective Equipment
ppm Parts per Million
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RQ Risk Quotient
TGAI Technical Grade Active Ingredient
UV Ultraviolet
WPS Worker Protection Standard
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act calls for the development and submission of data to support the
reregistration of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency (referred to as EPA or "the Agency"). Reregistration
involves a thorough review of the scientific database underlying a pesticide's registration. The
purpose of the Agency's review is to reassess the potential risks 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 or not the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document summarizes EPA's human health and ecological risk assessments and
reregistration eligibility decision (RED) for 4-aminopyridine (4-AP). The document consists of
six sections. Section I contains the regulatory framework for reregistration; Section II provides
an overview of the chemical and a profile of its use and usage; Section III gives an overview of
the human health and environmental effects risk assessments; Section IV presents the Agency's
decision on reregistration eligibility and risk management; and Section V summarizes the label
changes necessary to implement the risk mitigation measures outlined in Section IV. Finally,
the Appendices list related information, supporting documents, and studies evaluated for the
reregistration decision. The risk assessments for 4-AP and all other supporting documents are
available in the Office of Pesticide Programs (OPP) public docket at
http://www.regulations.gov under docket number EPA-HQ-OPP-2007-0400.
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II. Chemical Overview
A. Regulatory History
4-Aminopyridine (4-AP) was originally registered in the United States in January 1972.
A Registration Standard Guidance Document was issued in September 1980, which
summarized the regulatory conclusions based on available data, and specified the additional
data required for reregi strati on purposes. At the time of the Registration Standard, 4-AP was
used on food crops as well as nesting and feeding areas to control nuisance birds. Several
ecological toxicity, mammalian, environmental fate, and residue chemistry studies were
required in a September 1980 data call-in.
In February 1991, a data call-in was issued for ecological fate and effect data,
mammalian toxicity data, and crop field trial data. In October 1995 through the agricultural re-
entry data call-in, dermal and inhalation passive dosimetry exposure studies and a foliar residue
dissipation study were called in.
On October 27, 2004, a Federal Register Notice was published that cancelled 4-AP
products with food uses (69 FR 62666) (FRL-7683-7) based on a request from the registrant. A
Federal Register Notice published September 21, 2005 announced the revocation of all 4-AP
tolerances. The effective date for these revocations was January 15, 2006.
Subsequent to the revocation of 4-AP tolerances, the registrant requested a waiver for
the outstanding data requirements based on low volume and minor use classification of the
subject active ingredient and its use pattern. Based on the low potential for workers reentering
the treated area to experience dermal contact with the residues of 4-AP, the Agency granted the
waiver request.
In 2007 the 4-AP registrant requested voluntary cancellation of all labels for products
formulated as powder. Additionally, the registrant has requested voluntary cancellation for the
only two 4-AP registrations remaining with uses around growing crops, and the only 4-AP
registration with gull species as target pests. Thus, only the 4-AP labels for products
formulated as bait have been considered for reregi strati on. Additionally, the previously
required residue chemistry, environmental fate, and toxicity studies are no longer required
based on the limited use pattern for the remaining 4-AP products.
B. Chemical Identification
4-AP is registered with the EPA as an avicide. It is a member of the pyridine family. 4-
AP is a nervous system toxicant and is highly toxic to most vertebrates. Chemical information
and the structure for 4-AP is presented in Table 1.
Table 1. Physical-Chemical Properties of 4-Aminopyridine
PC Code
Chemical Name
069201
4-aminopyridine
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Table 1. Physical-Chemical Properties of 4-Aminopyridine
Structure
CAS Number
Empirical Formula
Chemical Class
Molecular Weight
Vapor pressure (20 °C)
Water Solubility (20 °C)
NH2
rS
^
504-24-5
C5H6N2
Pyridine
94.1
2.09xlO-4mmHg
112g/L
c.
Use Profile
Type of Pesticide:
Target Pests:
Mode of Action:
Use Sites:
Use Classification:
Formulation Types:
Application Methods:
Avici de
Pigeons; house sparrows; crows; grackles; cowbirds; starlings;
red-winged, yellow-headed, rusty, and Brewers blackbirds; gulls.
Note: Registrant has requested voluntarily cancellation for EPA
Reg. # 11649-11, the only label that identified gulls as a target
pest.
4-AP blocks potassium ion channels in nerve fibers.
Registered for use in nesting, feeding, loafing and roosting sites
on or in the area of structures, feedlots, landfills, and airports.
Restricted Use Pesticide due to acute avian toxicity.
Impregnated bait: whole corn, chopped corn, and mixed grains.
Powder: powder mix and concentrate; the registrant has
requested voluntary cancellation for all powder uses.
Bait: Birds are conditioned over a period of time by the
applicator to accept untreated bait. This conditioning is called
"prebaiting." Once birds have been conditioned to accept the
untreated bait, the applicator will mix 4-AP-treated bait with
untreated bait of the same composition in a 1:2 to 1:29 treated
bait to untreated bait ratio. The applicator will distribute the mix
in the same way as the untreated bait. On some labels applicators
are required to use gloves and scoops during application. The
bait is sometimes placed in bait trays.
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Application Rates:
Application Timing:
Registrants:
Application rates are dependent on the size of the flock treated.
Application rates are estimated to range from 0.0001 pound of
active ingredient per acre (Ib ai/A) to 0.002 Ib ai/A.
Labels recommend that the best time to treat birds is early in the
morning when birds have their heaviest feeding.
At this time, the sole registrant for 4-AP avicide products is
Avitrol Corporation.
D. Estimated Usage of Pesticide
The majority of 4-AP is applied in urban areas to control nuisance pigeons and
sparrows, with smaller usage in cattle feedlots for sparrows. Based on usage information
provided by the registrant, total annual domestic usage of 4-AP is under 250 pounds. Pigeons
are the most frequently targeted species, followed in frequency by starlings, crows, grackles,
blackbirds, and sparrows.
Uses Submitted for Voluntary Cancellation
In letters dated May 30, 2007 and September 25, 2007, the 4-AP registrant requested
voluntary cancellation of all remaining powder formulations, outlined below in Table 2.
Additionally, the registrant has requested voluntary cancellation for the only two labels with
uses around growing crops, CA780131 and CA 780132, and the only label with gulls as a target
pest, Reg. No. 11649-10.
Table 2. 4-Aminopyridine Registrations Submitted for Voluntary Cancellation.
Formulation
Avitrol
Concentrate
Avitrol Powder
Mix
Avitrol Mixed
Grains - Special
Local Need
Avitrol Mixed
Grains - Special
Local Need
EPA reg. #
11649-10
11649-11
CA780131
CA780132
%ai
25
50
0.5
0.5
Target pest
Starlings
Gulls
House finch, horned
larks, and crowned
sparrows in addition to
the birds already listed
on label 11649-4:
pigeon, house sparrows,
red-winged, yellow-
headed, Brewers, and
rusty blackbirds,
grackles, cowbirds, and
starlings
House finch in addition
to the birds already listed
on label 11649-4:
Use Site
In, or in the vicinity of
feedlots.
In, on, or in the vicinity
of landfills, airports, and
structures where gulls
feed, nest, loaf or roost.
Sprouting crops
Grape vineyards
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Table 2. 4-Aminopyridine Registrations Submitted for Voluntary Cancellation.
Formulation
Avitrol Powder
Mix - Special
Local Need
EPA reg. #
PR020001
%ai
50
Target pest
pigeon, house sparrows,
red-winged, yellow-
headed, Brewers, and
rusty blackbirds,
grackles, cowbirds, and
starlings
Greater Antillean grackle
Use Site
Around hotels and
industrial facilities
Uses Considered for Reregi strati on
Table 3 lists the labels and uses considered for reregi strati on.
Table 3. 4-Aminopyridine Formulations and Registered Uses.
Formulation
Avitrol Mixed
Grains (CA. only)
Avitrol Double
Strength Corn
Chops
Avitrol Corn
Chops
Avitrol Whole
Corn
Avitrol Double
Strength Whole
Corn
EPA reg. #
11649-4
11649-5
11649-6
11649-7
11649-8
%ai
0.5
1.0
0.5
0.5
1.0
Target pest
Pigeons, house sparrows,
red-winged, yellow-
headed, Brewers, and
rusty blackbirds,
grackles, cowbirds, and
starlings
Red-winged, yellow-
headed, rusty and
Brewers blackbirds,
grackles, cowbirds, and
starlings
House sparrows, red-
winged, yellow-headed,
rusty and Brewers
blackbirds, grackles,
cowbirds, and starlings
Feral pigeons
Crows
Use Site
In, on, or in the area of
structures used for
nesting, feeding, loafing,
and roosting sites.
Feedlots, and structures
used for nesting,
roosting, and feeding
sites.
On or in the area of
structures used for
feeding, nesting, and
roosting sites.
Structures used for
feeding, nesting, loafing,
and roosting sites.
In, on, or in the area of
structures used for
feeding, nesting, and
roosting sites.
Yellow-headed, red-winged, rusty, and Brewer's blackbirds, grackles, cowbirds, and
crows are protected species under the Migratory Bird Treaty Act (MBTA). The MBTA
established a Federal Prohibition, unless permitted by regulations, to "pursue, hunt, take,
capture, kill, attempt to take, capture, or kill.. .any migratory bird" (16 U.S.C. 703). 50 CFR
21.43 established a depredation order under MBTA for blackbirds, cowbirds, grackles, and
crows that states, "a Federal permit shall not be required to control yellow-headed, red-winged,
rusty, and Brewer's blackbirds, cowbirds, and all grackles, crows, and magpies, when found
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committing or about to commit depredations upon ornamental or shade trees, agricultural crops,
livestock, or wildlife, or when concentrated in such numbers and manner as to constitute a
health hazard or other nuisance..." Thus, red-winged, yellow-headed, Brewer's and rusty
blackbirds, cowbirds, grackles, and crows may be listed as target pests on 4-aminopyridine
product labels. The pesticide user must determine whether target birds are committing or about
to commit depredation, or constitute a health hazard or other nuisance.
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III. Summary of 4-Aminopyridine Risk Assessments
The purpose of this summary is to assist the reader by identifying the key features and
findings of these risk assessments, and to help the reader better understand the conclusions
reached in the assessments. The human health and ecological risk assessments and supporting
documents referenced in Appendix C were used to formulate the regulatory decision for the
pesticidal use of 4-AP.
While the risk assessments and related addenda are not included in this document, they
are available in the OPP Public Docket, docket number EPA-HQ-OPP-2007-0400, and may be
accessed through http://www.regulations.gov/. Hard copies of these documents may also be
found in the OPP public docket under this same docket number.
4-Aminopyridine: HED Chapter of the Reregistration Eligibility Decision Document (RED).
Dated August 6, 2007.
4-Aminopyridine: Re-registration Ecological Risk Assessment for 4-Aminopyridine Products.
Dated February 27, 2007.
A. Human Health Risk Assessment
The human health risk assessment addressed potential exposure risks from all registered
sources. Because 4-AP is no longer registered on any food commodities, nor is exposure
expected from drinking water sources, the Agency only assessed potential exposures in
occupational and residential settings. For the complete human health risk assessment, refer to
4-Aminopyridine: HED Chapter of the Reregistration Eligibility Decision Document (RED),
Dated August 6, 2007, which is available in the public docket.
1. Toxicity of 4-Aminopyridine
The human health risk assessment utilized both animal and human toxicity studies to estimate
risk to humans exposed to 4-AP. When considered together, the animal and human
toxicological data are sufficient for selecting toxicity endpoints for risk assessment. The
Agency's use of human studies for 4-AP risk assessment is in accordance with the Agency's
Final Rule promulgated on January 26, 2006, related to Protections for Subjects in Human
Research, which is codified in 40 CFR Part 26.
a. Toxicity Profile
4-AP has high acute toxicity to mammals via the oral route of exposure (Category I) and
the dermal and inhalation routes of exposure (Category II). The acute and subchronic
toxicological effects of 4-AP are manifested as hyperexcitability, hyperirritability, salivation,
tremors, and muscular incoordination. 4-AP acts by blocking potassium ion channels in nerve
fibers. Adverse effects in humans ingesting low levels of 4-AP (5-30 mg/day) were
nervousness, giddiness or dizziness, memory alteration, cramps, arterial vasospasm and
peripheral paraesthesia. Higher doses in an accidental poisoning case (one-time estimated dose
of 60 mg) produced additional effects including weakness, intense diaphoresis, feeling of
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impending doom, dyspnea, agitation and combative behavior, and profound thirst. Human
studies demonstrated that 4-AP is eliminated quickly from the body and effects did not
accumulate with continuous exposure. Table 4 describes the acute toxicity profile of 4-AP.
Table 4. Acute Toxicity Profile of 4-Aminopyridine
Guideline
Number
870.1100
870.1200
870.1300
Study Type
Acute oral - rat
Acute dermal - rabbit
Acute inhalation
MRID(s)
NCI 2006
NCI 2006
00096481
Results
LD50 =20 mg/kg
LD50 = 327
mg/kg
0.53mg/L
Toxicity Category
I
II
II
Animal Studies
4-AP animal studies conducted in 1968 were reviewed for use in risk assessment (oral
subchonic rat studies, MRIDs 00004026 and 00131328, and oral subchronic dog studies MRIDs
00004027 and 00131329). Both sets of studies are deemed unacceptable/non-guideline and do
not meet the current guideline requirements for 90-day studies in rodents and non-rodents due
to deficiencies regarding the test substance characterization. While the endpoints found in these
studies were not used in the 4-AP human health risk assessment, these studies were used to
provide qualitative information regarding the toxic effects of 4-AP in experimental animals.
Human Studies
There are several clinical human studies that investigated the efficacy and safety of 4-
aminopyridine in spinal cord injury or multiple sclerosis patients. Three such studies were
presented to the HSRB on June 28, 2007 for ethical and scientific evaluation. The HSRB
concluded that these studies were ethically sound but had reservations on the adequacy of
reporting of the adverse effects findings in these studies. The studies emphasized the
therapeutic effects of 4-aminopyridine and tended to minimize the adverse effects in these
select patients. Nevertheless, HSRB left it to the discretion of EPA whether or not to use these
studies in the risk assessment of 4-aminopyridine.
EPA determined that the three studies provided the best information available to the
Agency for human health risk assessment. The three studies used in human health risk
assessment are listed below:
MRID 47093602. Safety and efficacy of 4-AP in humans with cord injury (SCI): a long-term,
controlled trial. Segal et a/, 1999.
MRID 47093601. Efficacy and Safety of 4-AP in patients with long-term spinal cord injury
(SCI): a randomized, double-blind, placebo-controlled trial. Grijalva etal, 2003.
MRID 47093603. 4-Aminopyridine in patients with multiple sclerosis: dosage and serum level
related to efficacy and safety. Van Diemen etal, 1993.
For more information on these studies, refer to the 4-AP human health risk assessment
available in the 4-AP public docket.
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No human or animal data for assessing the carcinogenic potential of 4-AP were available.
Based on the lack of this data and the weight of evidence, the Integrated Risk Information
System (IRIS) (1993) classified the carcinogenic potential of 4-AP as "not classifiable to
human carcinogenicity." 4-AP was found to be negative in reverse mutation assays.
b. Endpoint Selection
A point of departure (POD) is the data point or an estimated point that is derived from
observed dose-response data and used to mark the beginning of extrapolation to determine risk
associated with lower environmentally relevant human exposures. The Lowest Observed
Adverse Effects Level (LOAEL) of 5 mg daily dose (0.07 mg/kg/day) is selected as a minimal
LOAEL for a POD based on the human clinical studies conducted with 4-AP listed above. The
LOAEL is used to measure incidental oral, dermal, and inhalation risk. To account for
individual variability (intraspecies) in the human population, a 10X uncertainty factor (UF) is
applied. An additional uncertainty factor of 3X is applied to account for the use of POD based
on a minimal LOAEL. The level of concern MOE is 30. A summary of the toxicity endpoints
used in the 4-AP human health risk assessment is listed in Table 5.
Table 5. Summary of Toxicological Doses and Endpoints for 4-aminopyridine for Use in Occupational
and Residential Risk Assessment
Exposure/
Scenario
Incidental
oral, dermal,
and
inhalation.
Short-Term
(1-30 days)
Cancer (oral,
dermal,
inhalation)
Point of
Departure
LOAEL=
0.07
mg/kg/day
Uncertainty
Factors
UFA= Ix
UFH=10x
UFL=3x
Level of
Concern for
Risk
Assessment
LOG for
MOE = 30
Study and Toxicological Effects
Segal et al 1 999 (MRID 00004026),
Van Diemen et al 1993 (MRID
47093603),
and Grijalva et al 2003 (MRID
47093601) clinical human studies.
LOAEL = 0.07 mg/kg/day based on
mild adverse effects of
paresthesias/dysethesthesias,
dizziness/light-headedness, gait
instability, nausea/vomiting,
restlessness/anxiety.
Classification: There is no animal carcinogenicity data or human data to evaluate the
carcinogenic potential of 4-AP. For this reason, IRIS maintained a classification of D
(not classifiable as to human carcinogenicity) (IRIS, 2006).
NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty
factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. MOE =
margin of exposure. LOG = level of concern. N/A = not applicable.
Dietary Exposure
Drinking Water Exposure
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For more detail on the Agency's drinking water determination, refer to the 4-Aminopyridine:
HED Chapter of the Reregistration Eligibility Decision Document (RED), Dated August 6,
2007.
EPA expects 4-AP to be both mobile and persistent in the open environment. The main
route of dissipation for 4-AP in the environment is thought to be through aerobic metabolism.
The prediction of mobility for 4-AP is based upon high aqueous solubility, a low octanol/water
partition coefficient value, and a low modeled soil/water distribution coefficient value. Since 4-
AP is thought to be a mobile compound, it may have the potential to reach ground water. On
the other hand, there exists the possibility that 4-AP might also be susceptible to aged sorption,
which would decrease the possibility that 4-AP could reach ground water. No reports of
surface water or ground water monitoring studies that included 4-AP were found in searches of
the United States Geological Survey (USGS) online National Water Quality Assessment Data
Warehouse (NAWQA) database, the EPA publication, "EPA Pesticides in Ground Water, A
Compilation of Monitoring Studies 1971-1991 National Summary", or the Google internet
search engine. Abiotic half-life values could not be derived from submitted data, and the
assumption of stability has been made for both hydrolysis and photolysis of 4-AP for the
purpose of exposure modeling.
Although 4-AP has outdoor use patterns which could lead to potential 4-AP run-off into
surface waters, the low amount of 4-AP used (less than 250 Ibs/year) in the United States is
expected to limit widespread contamination of surface source drinking water. Additionally,
while some of the existing labels permit 4-AP to be placed in discrete piles on the bare ground,
others indicate that 4-AP be used in areas above ground, such as elevated bait stations.
Generally, some 4-AP bait labels recommend that the applicator pick up and remove any
remaining product at the end of the dosing period. As a result of reregi strati on all labels will
include this requirement. Additionally, as a result of reregi strati on, a 25 foot buffer will be
required around permanent bodies of water. Therefore, long-term environmental exposure of 4-
AP is expected to minimal, and no drinking water exposure is expected.
Other Dietary Exposure
4-AP is not registered for any food uses in the US. Additionally, the only two 4-AP
labels (CA780131 and CA780132) that permit use around agricultural areas (sprouting plants
and grape vineyards, respectively) have been submitted for voluntary cancellation by the
registrant. Because drinking water exposure to 4-AP is not expected, and there are no 4-AP
food uses registered in the U.S., no dietary exposure assessment was conducted for 4-AP.
2. Residential (Non-Occupational) Exposure and Risk
Residential exposure assessments consider all potential non-occupational pesticide
exposure, other than exposure due to residues in food and drinking water. For non-occupational
exposure, EPA calculates a margin of exposure (MOE), which is then compared to a LOG to
estimate potential risk. The UF for 4-AP is SOX, to account for individual variability
(intraspecies) in the human population (10X), and 3X to account for a minimal LOAEL in the
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human toxicity studies from which the short-term endpoint for 4-AP is selected. For 4-AP,
estimated MOEs greater than the target MOE of 30 would not pose risks of concern.
a. Residential Handler Exposure Assessment
4-AP can be applied to residential settings by certified applicators. Since all 4-AP
products are restricted use products, no residential handler exposure scenario is expected.
b. Residential Post-application Exposure Assessment
Post-application residential exposures to 4-AP may result from application in residential
settings. 4-AP can be used in and around residential structures such as high rise apartment
buildings and condominium complexes. Some 4-AP labels instruct applicators to place treated
bait in areas that are inaccessible to the public. This statement will be required in all post
reregi strati on labels. It is unlikely that adults will be exposed to the bait through dermal
exposure, inhalation exposure, or through incidental oral exposure. However, to ensure that
children are adequately protected from accidental ingestion, an episodic incidental oral
ingestion exposure scenario was assessed.
Granule Ingestion Assessment
EPA does not believe that children will be routinely exposed to 4-AP. However, it is
possible that small children or toddlers could accidentally ingest treated granules when 4-AP is
applied in residential or public areas. EPA's review of the Poison Control Center data base
found incidents of accidental ingestion by children 6 years old and younger during the years
1993 through 2004. Toddlers in a number of states were reported as having been exposed. The
majority of the reported incidents occurred in the child's own residence.
In order to characterize the potential for harm to children, EPA conducted a granule
ingestion exposure assessment. This assessment found that a small child accidentally
consuming 1-2 treated corn seeds could experience mild adverse effects such as dizziness and
nausea. The assumptions used in this assessment can be found in the HED risk assessment.
Based on the assessment and incident information EPA believes that additional
measures and labeling is warranted to reduce the likelihood of accidental ingestion by children.
These measures are discussed in Section IV of this document.
3. Aggregate Exposure and Risk
With the exception of potential granule ingestion exposure, no residential exposures are
expected. Also, dietary exposures from food and drinking water are not expected. Therefore,
no aggregate risk assessment is needed.
4. Occupational Exposure Assessment
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Workers can be exposed when loading and applying baits treated with 4-AP. Based on the 4-
AP use pattern, post-application exposure to workers is not expected. The Agency assessed risk
to occupational handlers and workers by using the MOE approach. The target MOE of 30
reflects the ratio of the estimated exposure divided by the LOAEL. MOEs greater than 30 are
not of concern to the Agency.
a. Occupational Handler/Applicator Assessment
The Agency has determined that there is potential for exposure to occupational handlers
and applicators of products containing 4-AP. To assess the handler risks, the Agency used
surrogate unit exposure data from the Pesticide Handler Exposure Database (PHED) to address
seed treatment scenarios. In this PHED exposure scenario, the individual who opens the
container of treated product, loads the product into bait stations or otherwise dispenses the
treated product is considered a "handler." There are currently no registered manufacturing use
products of 4-AP; all baits come pre-treated. Thus, the handler will only "load" (combine the
treated bait with untreated bait to achieve the desired application rate) and "apply" (place the
treated bait in the desired location) 4-AP products. No mixing of 4-AP active ingredient with
bait material occurs at the time of application.
The registrant has requested voluntary cancellation of the 4-AP powder end-use
products and associated special local need registrations (SLNs) (registration numbers 11649-10,
11649-11, CA78131, CA78132, and PR020001). Thus, no occupational risk assessment was
completed for the 4-AP powder products.
To assess occupational handler and applicator exposures, the Agency used exposure
data based on seed treatment scenarios. Seed treatment exposure scenarios are protective of
occupational exposures to 4-AP treated baits because of the high quantity of product treated.
Two seed treatment scenarios were used to assess handler exposures for bait products: 1)
load/apply, and 2) multiple activities. The following assumptions were used to estimate risks to
occupational handlers exposed to 4-AP:
• The body weight of an adult handler is 70 kg.
• The exposure duration was short-term only.
• The worker will handle 100 pounds of product a day, with a maximum exposure of 1 pound
ai per day. This is a highly conservative assumption, considering that less than 250 pounds
ai of 4-AP are used a year. Additionally, this assessment assumes that the entire amount of
product used in a season is handled in one day, which is a high-end exposure.
• Unit exposures are from ExpoSAC Policy Number 14.
Based on the assessed occupational exposure scenarios, all of the MOEs are greater than
the LOG of 30 with baseline personal protective equipment (PPE) plus gloves. Thus, these
exposures do not pose any risks of concern to the Agency. A summary of the MOEs is shown
in Table 6.
Table 6: Summary of 4-Aminopyridine Occupational Handler Risks
17
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Exposure
Scenario
Loading and
Applying
Flowable
Concentrate
(used liquid
scenario)
Multiple
Activities
Flowable
Concentrate
(used liquid
scenario)
Source
Commercial
Seed
treatment
Commercial
Seed
treatment
Formulation
concentration
1%
1%
Amount
handled
(Ibs seed/
season)
100
100
Amount
handled
(Ib ai/
season)
1
1
PPE
Baseline
(long-sleeved
shirt, long
pants, shoes,
and socks),
gloves
Baseline
(long-sleeved
shirt, long
pants, shoes,
and socks),
gloves
MOE
210
120
b. Occupational Post-application Exposures
No post-application occupational exposures are expected based on the 4-AP use pattern.
5.
Endocrine Disruption
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other such endocrine effects as the Administrator may designate. "
Following the recommendations of its Endocrine Disrupter Screening and Testing Advisory
Committee (EDSTAC), EPA determined that there were scientific bases for including, as part
of the program, androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program include evaluations
of potential effects in wildlife. When the appropriate screening and/or testing protocols being
considered under the Agency's Endocrine Disrupter Screening Program (EDSP) have been
developed and vetted, 4-AP may be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption.
B.
Environmental Risk Assessment
Available 4-AP ecotoxicity and fate data were insufficient for a standard, quantitative
deterministic assessment of ecological risk. Instead, a risk description was developed by
applying quantitative methods to label information, use patterns, fate and ecotoxicity data,
models and other information to assist in framing the potential risk. The full assessment, Re-
Registration Ecological Risk Assessment for 4-Aminopyridine End-Use Products, February 27,
2007 is available on the internet and in the public docket at www.regulations.gov (EPA-HQ-
OPP-2007-0400).
1. Environmental Fate and Transport
18
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EPA expects 4-AP to be both mobile and persistent in the open environment. The main
route of dissipation for 4-AP in the environment is thought to be through aerobic metabolism.
The prediction of mobility for 4-AP is based upon high aqueous solubility, a low octanol/water
partition coefficient value, and a low soil/water distribution coefficient value estimated with
structure activity relationship (SAR) modeling. 4-AP is likely a mobile compound and has the
potential to reach ground water. However, 4-AP may also be susceptible to aged sorption,
which would decrease its mobility. No surface water or ground water monitoring data were
found in searches of the United States Geological Survey (USGS) online National Water
Quality Assessment Data Warehouse (NAWQA) database, the EPA monitoring publication,
"EPA Pesticides in Ground Water, A Compilation of Monitoring Studies 1971-1991 National
Summary", or the Google internet search engine.
Abiotic half-life values could not be derived from submitted data, and the assumption of
stability has been made for both hydrolysis and photolysis of 4-AP for purposes of exposure
modeling. 4-AP has been shown to be stable under anaerobic conditions. Under aerobic
conditions, half-life values ranged between 3 and 32 months. These biotic half-lives are
consistent with model predictions. The EPI Suite level III fugacity model half-life predicts an
aerobic metabolism half-life of 75 days, and an anaerobic metabolism half-life of about one
year for 4-AP.
Model calculations for volatility predict 4-AP partitioning into the air and sediment
would be slightly greater than 0.1% for both environmental compartments combined. This is
consistent with available data. Both the vapor pressure and the Henry's Law Constant are
relatively high for this pesticide, and aqueous solubility is unusually high at the grams per liter
range. This high aqueous solubility along with the low octanol/water partition coefficient
suggests that 4-AP has a low potential to bioaccumulate in the fatty tissues offish.
Except for carbon dioxide, no data concerning the quantity, the identity or the
environmental fate properties of any potential degradation products of 4-aminopyridine are
available.
2. Ecological Exposure and Risk
The pesticide use profile, exposure data, and toxicity information were used to
determine risk estimates to non-target aquatic and terrestrial organisms. Because a maximum
application rate could not be calculated from the label at the time the ecological risk assessment
was completed, and the lack of some ecotoxicity information for 4-AP, a qualitative ecological
risk assessment was completed.
As applicable, acute and chronic terrestrial toxicity studies are required to establish the
potential toxicity (hazard) of 4-AP to non-target species. Estimated Environmental
Concentrations (EECs) are estimates of potential residue concentrations, derived from the
maximum or typical application rate of 4-AP, to which an organism may be exposed. A risk
quotient (RQ) is the ratio of the EECs to the organism's toxicity endpoint, which would yield
19
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the deterministic risk estimates. The RQ is then compared to the level of concern (LOG) to
determine if that particular exposure scenario would pose a risk to the non-target organism.
Table 7 outlines the Agency's LOCs and the corresponding risk presumptions.
Table 7. Agency's LOCs and Risk Presumptions
Risk Presumption
Acute Risk - there is potential for acute risk
Acute Endangered Species - there is potential for
endangered species risk
Chronic Risk - there is potential for chronic risk
LOG
Terrestrial
Animals
0.5
0.1
1
LOG
Aquatic
Animals
0.5
0.05
1
LOG
Plants
1
1
N/A
Terrestrial Organisms
Exposure
4-AP treated and/or untreated bait is manually placed either directly on the ground or
onto protected and/or elevated structural sites, with, or without, the use of bait trays. Pre-
baiting with the carrier matrix is always recommended to ensure efficacy by teaching birds to
associate effects of the avicide with the location rather than with the bait, and to assist in
restricting exposure of non-target species to 4-AP. After feeding patterns have been established
through pre-baiting, treated bait is mixed with untreated bait in ratios ranging from 1:2 to 1:29
parts treated bait to parts untreated bait. Labels do not specify the number of times the treated
bait can be replaced at any one use site, which might result in locally higher concentrations of
4-AP. Birds that consume the treated bait will normally react by flapping their wings erratically
and issuing audible distress calls which are supposed to frighten away the remainder of the
flock. Reactions of individual birds are expected to vary. In most cases, the labels advise the
user to dispose of any dead birds that are found. Bait used at any location should be replaced
after being exposed to a rainfall event, but the labels do not specify the number of times the
treated bait can be replaced at any one use site.
Terrestrial animals (birds, mammals, reptiles, and terrestrial-phase amphibians) may
come in contact with baits treated with 4-AP. Although 4-AP is generally used around heavily
managed and/or densely populated areas and there are labeling instructions and precautions
designed to minimize exposure to non-target species, the ecological risk assessment and the
incidence data, described below, indicate acute risk to local non-target terrestrial animal
populations (including secondary poisoning to predatory species), as well as acute risk to
migrating species if they come in contact with the baits. Incident data from the Ecological
Incident Information System (EIIS) indicate that many birds can potentially be killed from a
single exposure event. Terrestrial animals may also be exposed to 4-AP if they come in contact
with water contaminated with 4-AP. 4-AP has a high aqueous solubility, it is possible that
flooded bait trays could contain contaminated water, which local animals may utilize as
drinking water.
20
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Gross estimates of the oral dose of bait needed to reach the LD50 for the most sensitive
bird and mammal were calculated by utilizing the percent active ingredient per weight of the
bait, the recommended dilution rates of treated bait with untreated bait, the reported LDsos for
birds and mammals and the assumed mean body weights for each of the surrogate species.
Adjusted LD50s for different sized animals was not possible with the current models. The
results were expressed as weight in milligrams of bait that can be consumed per surrogate bird
or surrogate mammal. The amount of active ingredient per seed was also estimated for canary
and rape seed, wheat, sorghum, chopped corn and whole corn. Since the chopped corn
formulation does not contain complete kernels, the amounts were based on the weight of an
individual piece of corn chop (20 mg). With the mg a.i./seed values, the number of seeds that
can be consumed to reach the LDso for each surrogate species was estimated. These estimations
are explained in detail in the Risk Description Section for terrestrial animals.
1. Avian and Mammalian Assessment
Toxicity to Birds
A variety of acute oral toxicity studies are available on birds with acute LD50 values
ranging from 2.4 mg/kg for red winged blackbirds and black- and yellowbilled magpies to 15.0
mg/kg for bobwhite quail.
Acute and subchronic dietary studies are available for a variety of birds with the number
of exposure days ranging from 7 to 40 days. In general, LCsoS and in many cases, NOAECs
and LOAECs were reported for these studies. The LC50 value for an 8 day study with mallard
ducks is 681 ppm. Sublethal effects included decreases in body weight gain and food
consumption and depression and lower limb weakness prior to death. The NOAEC for
sublethal effects (decreased body weight gain and food consumption) was < 464 ppm, the
lowest concentration tested. The LCsos for other dietary studies with additional species and
varying exposure periods ranged from 316 to 479 ppm.
In two separate studies, 4-aminopyridine was administered to coturnix quail (Coturnix
coturnix) via the diet to determine potential reproductive effects (MRTD 05003186). The first
test was conducted to determine the effects of chronic dietary exposure on reproduction in
breeding pairs and the second test was conducted to determine the effects of chronic exposure
to the parents on reproduction in the FI generation. The overall NOAEC for both studies is
31.6 ppm and the LOAEC is 100 ppm based on reduced body weight gain in males at 100 ppm
and above. There were reduced food consumption and clinical signs of toxicity at 316 ppm and
above. No reproductive parameters were affected; however, not all guideline parameters were
measured. Single mortalities were observed at 31.6 and 100 ppm; however, it is uncertain as to
whether or not this was related to treatment since a single mortality was observed in the control
group in the second dietary study. Table 8 summarizes the results of the avian toxicology
studies.
Table 8. Acute, Short-Term Dietary, and Chronic Toxicity of 4-AP to Birds
Test Organism
Test Substance
Test Type
Endpoint
Value mg/kg
or ppm
MRID
Classification
Acute endpoint
21
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Table 8. Acute, Short-Term Dietary, and Chronic Toxicity of 4-AP to Birds
Test Organism
Red Winged
blackbird
Agelaius phoeniceus
Blackbilled and
Yellowbilled
magpies Pica pica
and Pica nuttalli
Test Substance
4-aminopyridene
4-aminopyridine
Test Type
Acute oral
Acute oral
Endpoint
LD50
LD50
NOAEL
Value mg/kg
orppm
2.4 mg/kg
2.4 mg/kg
(95% CI could
not be
calculated)
1.8 mg/kg
MRID
Classification
05003191
Supplemental
00004001
Short-term dietary endpoint
Mallard duck
Anas platyrhynchos
4-aminopyridene
8-Day
Dietary
LC50
NOAEC
68 1(95% C.I. :
5 17-896) ppm
< 464 ppm
00147985
Chronic endpoint
Coturnix quail
Coturnix coturnix
4-aminopyridene
NOAEC
LOAEC
31.6 ppm
100 ppm for
sublethal
effects
05003186
Toxicity to Mammals
An acute oral toxicity study with rats reports an LDso of 28.7 mg/kg with a high increase
in mortality over a short dosing range. 4-AP is even more toxic to dogs when administered by
capsule, with an LD50 of 3.7 mg/kg reported. Clinical signs were observed, starting at the
lowest dose administered (2.0 mg/kg). Table 9 below summarizes the results of the studies.
No chronic toxicity studies were available for mammals.
Table 9. Acute Toxicity of 4-AP to Mammals
Test
Organism
Rat
Rattus
norvegicus
Dog
Mongrel
Test
Substance
Compound
1861
Hydrochloride
(purity not
reported)
Compound
1861
Hydrochloride
(purity not
reported)
Test Type
Acute oral
Gavage
Acute oral
Capsule
Endpoint
LD50
LD50
Value (mg/kg)
28.7
3. 7 ±0.2. Range of doses:
2.0 - 6.8 mg/kg. Clinical
signs (ataxia, hyperactivity)
observed at two lowest dose
levels (2.0 and 3.0),
beginning !/2 hour following
dosing and persisting to 8
hours post-dosing. Normal
by 24 hours. More severe
clinical signs at higher dose
levels. No gross pathologic
lesions.
MRID
00004024
00004024
22
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Acute Risk to Birds and Mammals
At the time the ecological risk assessment for 4-AP was completed it was not possible to
determine accurate potential dietary exposure from the labels, which were very general. For
risk description purposes, rough estimates of the oral dose of bait needed to reach the LDso for
the most sensitive bird (blackbird), small mammal (rat) and large mammal (dog) were
calculated. Potential dietary exposure for terrestrial species was calculated, based on the
percent active ingredient per weight of the bait and the recommended dilution rates. The
reported LDsoS for blackbirds, rats and dogs are 2.4, 28.7 and 3.7 mg/kg body weight,
respectively. The assumed mean body weights for blackbirds, rats and dogs are 0.07, 0.40 and
10 kg, respectively. Therefore, the estimated amount of 4-aminopyridine that can be consumed
by these three species to reach the respective LD50s are 0.168 mg/blackbird, 11.5 mg/rat and 37
mg/dog. Table 10 summarizes the various available baits, the percentages of 4-AP per weight
of medium in each bait and the estimated quantity that must be eaten to reach the LD50 for the
most sensitive bird (blackbird), small mammal (rat) and large mammal (dog). The table shows
that based on the reported LD50s it takes very few seeds to reach the LD50 level for birds. For
small and large mammals significantly more seeds need to be ingested. However, when
expressed as total grams of bait, the amounts are within the capability for mammals to consume
in a short period of time.
The mixed grain bait consists of a mixture of sorghum, wheat and corn chops
(http://www.Avitrol.com/Product/index.php). The following seed weights were used to
estimate the number of seeds needed to reach the LD50 for each species:
Canary seed: 58,000 seeds/pound: 8 mg/seed
Rapeseed: 115,000 seeds/pound: 3.9 mg/seed
Wheat and sorghum: 45-90 mg/seed (from 10,000 - 20,000 seeds/pound)
Corn chops: 20 mg/chop
Whole corn: 350 mg/seed (from 1300 seeds/pound)
The amount of 4-AP (mg) per seed was estimated by using the equations below with
10,000 seeds/pound and a 0.5% formulation diluted 1:3 with untreated bait as an example.
1 pound/10,000 seeds x 0.45 kg/pound = 0.000045 kg/seed = 45 mg/seed
10,000 seeds/pound x 1 pound/0.45 kg = 22,222.22 seeds/kg
0.5% formulation = 0.5 g a.i./lOO g = 5 g a.i./kg or 5000 mg a.i./kg
5000 mg a.i./kg bait diluted 1:2 with untreated seed = 1700 mg a.i./ kg diluted bait.
1700 mg a.i./kg bait x 1 kg bait/22,222.22 seeds = 0.08 mg a.i./seed
LD50 = 0.168mga.i./bird
0.168 mg a.i./0.08 mg a.i./seed = 2 seeds
Table 10. Acute Risk to Birds and Mammals. Approximations of Amount of Bait Consumed to Reach
LD50 Levels for Birds and Small and Large Mammals
23
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Product Name
(EPA Reg.
No.)
Avitrol Mixed
Grains (0.5%)
(11649-4)
Avitrol Mixed
Grains
(11649-4)
Avitrol Corn
Chops (0.5%)
(11649-6)
Avitrol Double
Strength Corn
Chops (1%)
(11649-5)
Avitrol Whole
Corn (0.5%)
(11649-7)
Avitrol Whole
Corn (0.5%)
(11649-7)
Avitrol Mixed
Grains (0.5%)
(11649-4)
Avitrol Mixed
Grains (0.5%)
(11649-4)
Avitrol Double
Strength Whole
Corn(l%)
(11649-8)
Bait Type
Rape seed/canary
seed 1:3 (pre-mixed)
Mixed grains
(pre-mixed):
sorghum, wheat and
specified corn chops
Corn chops
Corn chops
Whole corn
Whole corn
Mixed grains:
sorghum, wheat and
specified corn chops
Mixed grains:
sorghum, wheat and
specified corn chops
Whole corn
Dilution Ratio with Bait
Medium/Estimation of mg
4-AP/kg Bait
1 :2 treated to untreated
seed/1700 mg 4-AP/kg bait
1 :2-l :9 treated to untreated
seed/500 - 1700 mg 4-AP/kg
bait
1:5-1:9 treated to untreated
corn chops.
500 - 800 mg 4-AP/kg bait
1:4-1:9 treated to untreated
1000 - 2000 mg 4-AP/kg bait
Maximum 1:9 treated to
untreated
500 mg 4-AP/kg bait
Maximum 1:9 treated to
untreated.
500 mg 4-AP/kg bait
1:5-1:9 treated to untreated.
500 - 800 mg/kg bait
1:5-1:9 treated to untreated.
500 - 800 mg/kg bait
At least 1 :9 treated to
untreated
At least 1000 mg/kg bait
Quantity Required to Reach Most
Sensitive LD50
Blackbird: 98 mg or 12 seeds
Rat: 6.8 g or 800 seeds
Dog: 22 g or 2700 seeds
Blackbird: 98- 336 mg or 1-20 seeds
Rat: 6.8 - 23 g or 70-1 15 seeds
Dog: 22 - 74 g or 250 - 4000 seeds
Blackbird: 210 - 336 mg or 10-20 seeds
Rat: 15 - 25 g or 700 - 1400 seeds
Dog: 46 - 74 g or 2300 - 3700 seeds
Blackbird: 84 - 168 mg or 4 - 8 seeds
Rat: 6 - 15 g or 290 - 600 seeds
Dog: - 19 - 37 g or 900 - 1800 seeds
Blackbird: 336 mg or 1 seed
Rat: 25 g or 70 seeds
Dog: 74 g or 200 seeds
Blackbird: 336 mg or 1 seed
Rat: 25 g or 70 seeds
Dog: 74 g or 200 seeds
Blackbird: 210 - 336 mg or 10-20 seeds
Rat: 15 - 25 g or 700 - 1400 seeds
Dog: 46 - 74 g or 2000 - 4000 seeds
Blackbird: 210 - 336 mg or 10-20
seeds
Rat: 15 - 25 g or 700 - 1400 seeds
Dog: 46 - 74 g or 2000 - 4000 seeds
Blackbird: 168 mg or < 1 seed
Rat: 15 g or 35 seeds
Dog: 37 g or 100 seeds
Chronic Risk to Birds
In a chronic study with coturnix quail, observed effects were reduced body weight gain,
reduced food consumption, clinical signs of toxicity and mortalities. No reproductive
parameters were affected (egg production, eggshell thinning, hatchability and chick mortality)
up to a concentration level of 316 ppm. At 1000 ppm, all birds died within 3 weeks. The
overall NOAEC for both studies is 31.6 ppm and the LOAEC is 100 ppm based on reduced
body weight gain in males at 100 ppm and above. There were reduced food consumption and
clinical signs of toxicity at 316 ppm and above. Comparing these concentration levels to the
estimated amounts in the baits, the baits have 4-AP concentration levels higher than the bird
chronic NOAEC and LOAEC. Some types of treated bait have concentration levels higher than
1000 ppm, which resulted in complete mortality in the chronic study after 3 weeks. It is
possible that some birds may eat less than the amount that would result in mortality and then
come back for multiple days to eat similar amounts if the baits are left in the same place each
day. Reproductive effects may not be as significant a risk for these birds as sublethal effects;
however, the data are not sufficiently complete for an estimate that would cover all the current
24
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reproductive parameters. The repeated dose studies with birds indicate that 4-AP does not have
cumulative effects in birds (MRID 00004083). Therefore, daily feeding may not necessarily
result in death of these birds; however, death may occur from reduced feeding and the clinical
signs of toxicity would make the birds more vulnerable to predators. It is more likely that the
amounts eaten will result in quick mortality, thus providing minimal opportunities for chronic
exposure. In addition, this chemical is designed to scare away birds, thus reducing the
probability of chronic exposure.
Chronic Risk to Mammals
There are no reproduction or developmental toxicity studies conducted with mammals. There
are two subchronic toxicity studies conducted with 4-AP hydrochloride with rats (MRID
00004026) and dogs (MRID 00004027) which indicate some neurological symptoms
(hyperirritability to noise and touch in rats at 300 ppm (15 mg/kg bw/day)), and salivation and
muscular weakness in dogs at 2.0 - 3.25 mg/kg bw/day. There were also some changes in brain
weights (increased in rat, decreased in dog) and liver weights (increased in rat). The NOAELs
of these two studies were 30 ppm (1.5 mg/kg bw/day) and 1.0 mg/kg bw/day for rats and dogs,
respectively. Using the same calculations as in the acute risk section, the estimated amount of
4-AP that can be consumed by rats and dogs to reach the respective NOAEL/LOAELs for the
studies are 0.5/5 mg/rat and 10/20 mg/dog. Although the effects observed in these two studies
cannot be quantitatively linked to reproduction, growth or survival, these studies represent the
only data beyond acute toxicity studies for mammals and they provide some sublethal data.
The listed effects are similar to the sublethal effects observed in the acute toxicity studies.
Again, it is more likely that sufficient amounts will be eaten such that quick mortality will
result, thus providing minimal opportunities for chronic exposure.
2. Terrestrial and Semi-aquatic Plant Assessment
Toxicity to Terrestrial Plants
Terrestrial and semi-aquatic plants around the treated area may be exposed to 4-AP if there are
rain events followed by runoff. Terrestrial plant ecotoxicity data are limited. The results of a
toxicity test on corn are described in Table 11 below.
Table 1 1 . Toxicity of 4-AP to Terrestrial Plants
Test
Organism
Corn (Zea
may)
Pioneer
3956
Hybrid
Test
Substance
4-AP purity
unspecified
Test Type
Phytotoxicity
to seeds and
seedlings
Endpoint
NOAEC
Value
ppm
10 ppm
<0.1 ppm
following
2 apps.
Affected Endpoint
Germination (no effect up
to 1.0 ppm)
Fresh weights of seedlings
(no effect up to 10 ppm
following single
application,
slight effect at all
concentrations (5-12%
reduction) following 2
applications up to 100 ppb
MRID
Classification
00004124
00004037
Supplemental
25
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Risk to Terrestrial Plants
A phytotoxicity study with corn showed that 4-AP had no effect on germination up to
1.0 ppm and no effect on fresh weights of seedlings up to 10 ppm following a single
application. Following 2 applications, there was a slight effect at all concentrations (5-12%
reduction) up to 100 ppb. This effect (5-12%) falls below the Agency's LOG of 25% effect. A
translocation study was conducted with the same variety of corn seeds. The authors of the
studies stated that the observations of the phytotoxicity and translocation studies suggest
smaller single doses of 4-AP can be assimilated by the plants resulting in little to no adverse
affects; furthermore, increasing the number of plants in a unit diminishes adverse effects. As
with terrestrial animals, the fact that 4-AP is used in either heavily managed areas and/or areas
densely populated by humans and that less than 250 pounds active ingredient were used in
2005, impacts to terrestrial plants are not expected.
b. Aquatic Organisms
Aquatic ecosystems potentially at risk include water bodies adjacent to 4-AP bait
stations. Since 4-AP has the potential to be used in coastal areas, adjacent marine water bodies
are also potentially at risk. Risks will be discussed for aquatic animals (fish, invertebrates,
amphibians) and plants, which are assumed to occur in small, static ponds that receive runoff
from areas adjacent to the baits. Additionally, the proposed labels do not specify the number of
times the treated bait can be replaced at any one use site, which might result in locally higher
concentrations of 4-AP.
The estimated environmental concentrations (EECs) for surface water could not be
calculated for 4-AP in the absence of both fully acceptable environmental fate data and an
application rate in terms of pounds per acre. The open literature, SAR modeling, and
conservative assumptions were used to supplement the sparse environmental fate data. The
Tier 1 surface water model, GENEEC2, was used to estimate the application rate for 4-AP, in
terms of pounds per acre, which could be applied without exceeding levels of concern for
representative species. Normally, the Agency assesses risk by integrating both EECs and
toxicity endpoints from the most sensitive species and estimating the likelihood of adverse
ecological effects to non-target species. This approach utilizes the ratio of the exposure
estimate divided by a single point estimate of toxicity to calculate an RQ. The RQ is then
compared to the respective LOCs, which serve as criteria for categorizing potential risk to non-
target organisms. For 4-AP, the fate and environmental effects data are insufficient to
determine RQ values with reasonable associated uncertainties. Therefore, for risk description
purposes, the reported toxicity values for fish, amphibians and aquatic invertebrates were
utilized to determine EECs and associated application rates which may potentially approach
LOCs for aquatic species.
1. Fish and Invertebrates
Freshwater and Marine/Estuarine Fish and Invertebrates
26
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Similar to RQs calculated for terrestrial organisms, aquatic acute RQs are derived by
dividing the peak EECs by the LCso to estimate acute hazard. Chronic RQs for freshwater
invertebrates are derived by dividing the 21-day EECs by the NOAEC values. However, for 4-
AP, the EECs for surface water could not be precisely calculated in the absence of both fully
acceptable environmental fate data and an application rate in terms of pounds per acre at the
time of the ecological risk assessment.
The endangered fish and aquatic invertebrate species LOG is 0.05. For endangered
freshwater fish and frog larvae, the EEC for endangered species must be less than 0.05 times
the respective LCsoS of 2.4 ppm or 0.12 ppm. In the absence of fully acceptable environmental
fate data, conservative assumptions were made in order to derive model input values, tabulated
below.
No data were available to estimate the application rate that would trigger acute or
chronic concern for marine/estuarine invertebrates. Additionally, no chronic data were
available to estimate the application rate that would trigger chronic concern for freshwater
invertebrates or marine/estuarine vertebrates.
While no data exists to address chronic risk for freshwater invertebrates and
marine/estuarine vertebrates and invertebrates, use patterns are such that it is unlikely that
sufficient amounts of 4-AP will be available in the aquatic environment to generate significant
chronic exposure. Some uncertainty remains over how the replacement and renewal rates for
the baits would affect chronic exposure for these taxa. The estimated application rates needed
to exceed aquatic levels of concern for 4-AP are found in Table 12.
27
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Table 12. Tier I, GENEEC2, Estimated Application Rates Needed to Exceed Aquatic Levels of
Concern for 4-Aminopyridine
Taxonomic
Group and Most
Sensitive Test
Species
Freshwater
vertebrates
Freshwater fish:
Channel catfish
Ictulurus
Punctutus
Frog larvae:
Southern leopard
frog larvae
Rana
sphenocephala
Freshwater
vertebrates
Frog eggs:
Southern leopard
frog eggs and
larvae
Rana
sphenocephala
Freshwater
invertebrates
Juvenile glass
shrimp
Palaemonetes
kadiakensis
Marine/estuarine
vertebrates
Cowfish
Lactophyrs
tricornis
Globe fish
Chilomycterus sp.
Marine/estuarine
invertebrates
Toxicity Endpoint
MRID
Classification
2.4 ppm (LC50)
00004083,
00003985,
00004101
Supplemental
ECOTOX Ref. #
7412
Supplemental
l.Oppm(NOAEC)
2.0 ppm (LOAEC)
ECOTOX Ref. #
7412
Supplemental
0.37 ppm (EC50)
ECOTOX Ref. #
7412
Supplemental
7.6 ppm (LC50)
00004111
Supplemental
ND
Estimated
Single
Application
Rate to Trigger
a Concern
>23 Ib. ai/acre
>2.3 Ib. ai/acre
>19.31b. ai/acre
>38.6 Ib. ai/acre
>3.6 Ib. ai/acre
>0.37 Ib. ai/acre
>73 Ib. ai/acre
>15 Ib. ai/acre
>7.3 Ib. ai/acre
ND
Targeted 1 -in- 10-year annual exceedence probability
Estimated Peak EEC to
Trigger a Concern3
>1 .2 ppm (acute risk)
>0.12ppm
(endangered species)
ND
ND
>0. 1 9 ppm (acute risk)
>0.019ppm
(endangered species)
>3.8 ppm (acute risk)
>0.76 ppm (restricted
use)
>0.38 ppm
(endangered species)
ND
Estimated 21-
day EEC to
Trigger
Concern3
ND
>1.0ppmb
>2.0 ppmb
ND
ND
ND
Estimated 60-
day EEC to
Trigger
Concern3
ND
ND
ND
ND
ND
ND
ND = no data for class of organism and/or endpoint value
a = LOG (acute risk (0.5), restricted use (0.1), endangered species (0.05) or chronic (1.0)) -=- toxicity endpoint
b = exposure period of amphibian study was less than 21 days but greater than 1 day
0 = estimated application rates presented are for a single application, replacement of bait after rainfall event was not
considered
2. Aquatic Plants
No ecotoxicity data are available for either freshwater or marine/estuarine plants. Risk
to aquatic plants cannot be assessed due to a lack of data. Risk to aquatic plants is not expected
because of the impracticality of using large amounts of the bait in a single drainage area, thus
providing limited opportunities for significant aquatic exposure.
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3. Aquatic Animals
Based on the current use patterns and labels, acute risk to aquatic animals is not
expected; however, uncertainty exists for local populations because the labels do not specify the
number of times the treated bait can be replaced at any one use site, which might result in
locally higher concentrations of 4-AP. Chronic data are not available for aquatic animals. Risk
to aquatic animals is not expected because of the impracticality of using large amounts of the
bait in a single drainage area, thus providing limited opportunities for significant aquatic
exposure.
b. Secondary Exposures to Birds and Mammals
Although labeling precautions are provided, use of 4-AP in densely populated areas does not
preclude exposure of non-target terrestrial species. 4-AP is targeted for ground-feeding
granivorous birds. Other non-target granivores and omnivores with similar feeding patterns
might consume the bait. Predators and scavengers that consume pigeons and other birds are
also at risk of exposure if their prey has fed on 4-AP. Non-target species with these feeding
patterns have been observed in highly populated urban areas, some of which may also be
habituated to consuming food provided by humans.
The incident data from Ecological Incident Information System (EIIS) indicate that predatory
birds have been exposed to 4-AP-poisoned prey birds. Four predatory bird deaths are listed in
EIIS. One of the predatory birds was a peregrine falcon, which was a listed species at the time
of the incident report (1998). The reports contain necropsy and chemical analysis records
which indicate that the predatory bird deaths were due to ingestion of poisoned birds. The
secondary hazard studies were conducted with poisoned red-wing blackbirds, the most sensitive
bird tested (LD50: 2.4 mg/kg). The ingested birds found in the dead predatory birds included a
house sparrow (LD50:7.5 mg/kg), pigeon (LD50: 7 mg/kg) and starling (LD50: 4.9 mg/kg).
Secondary Toxicity and Risk to Birds and Mammals
A secondary hazard study was conducted where 4-aminopyridine-killed blackbirds were
fed to canines, rats, sparrow hawks, and red-tailed hawks, among other species. In some cases,
the blackbirds were fed treated bait and in other cases, they were administered the test material
by gavage. No effects were observed in any of the predatory species; however, for those
animals which were fed birds that had died from consuming a bait formulation, the amount of
the treated corn that the blackbirds ate was either not measured or not reported. However, the
amount of 4-AP needed to kill blackbirds was not sufficient to kill predators through secondary
ingestion. Less sensitive birds could pose a greater risk, as they would presumably have
consumed more 4-AP before they died. The ecological incident report, as described below,
indicates that there is some risk to predators due to secondary effects from 4-AP. Table 13
summarizes the results of the secondary hazard study.
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Table 13. Secondary Toxicity of 4-aminopyridine to Predatory Birds and Mammals
Test Organism
Canine
Canis familiaris-Canis
latrans mix and Canis
familiaris
Rats
Rattus norvegicus
Rats
Rattus norvegicus
Sparrow hawk
Falco sparverius
Red-tailed hawk
Buteo jaraicansis
Test Substance
4-Aminopyridine
(purity not reported)
4-Aminopyridine
(purity not reported)
4-Aminopyridine
(purity not reported)
4-Aminopyridine
(purity not reported)
4-Aminopyridine
(purity not reported)
Endpoint
Chronic
Feeding
NOAEC
Acute
Feeding
NOAEC
Chronic
Feeding
NOAEC
Chronic
Feeding
NOAEC
Chronic
Feeding
NOAEC
Value
0.4 mg/kgbw/
day
67.5 mg/kgbw
1.23 mg/kgbw/
Day
6.05 mg/kg
bw/day
1.06 mg/kg
bw/day
Comments and Affected Endpoints
1 female beagle-coyote cross & 1 male beagle fed
175 g of mixture containing 75% ground 4-AP
poisoned blackbird & 25% dog chow 2x/day for 8
days. Additional dog chow ad lib. between
feedings. 0.39-0.4 mg/kg/day 4-AP. No effects;
however, birds had been fed mixture of 1 part 3.0%
4-AP treated cracked corn with 99 parts untreated
cracked corn. Unclear on how many pieces of
treated corn birds ate, so unclear on how much dogs
received.
5 rats fed 1 ground bird dosed with 100-300 mg/kg
by gavage. Treated feed mixed with oatmeal and
consumed within 3 hours. Mg/kg bw dose of 4-AP
from birds ranged from 14.3 1-67.49. No effects.
10 rats fed ad lib mixture containing 75% ground 4-
AP poisoned blackbird & 25% oatmeal for 21 days.
Mean 1.23 mg/kg/day 4-AP. No effects; however,
unclear on how many pieces of treated corn birds
ate, so unclear on how much rats received.
For 7, 21, 45 days, 3 sparrow hawks were fed
poisoned birds. One control bird. Up to 6.05 mg 4-
AP/kg bw/day tested. No observed effects; however,
see comment under chronic feeding dog.
One hawk received field poisoned birds (4%
solution of 4-AP sprayed on husked ripening ears of
corn) for 2 weeks. Amounts of 4-AP present/bird
unknown but was enough to kill them. Based on
LD50 of 2.4 mg/kg, authors surmised that hawk
received > 0. 17 mg 4-AP/bird. No lexicological
symptoms.
MRID
Classification
0004001
0004006
Supplemental
0004001
0004006
Supplemental
0004001
0004006
Supplemental
0004001
0004006
Supplemental
0004001
0004006
Supplemental
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d. Ecological Incidents
Ecological incidents are reported to the Agency by local, state, other federal agencies, or
at times, submitted under FIFRA sec. 6(a)2. The Ecological Incident Information System (EIIS)
was accessed on in November 2006 to review the reported incidences for 4-AP.
Aquatic Organisms
No incidences involving aquatic organisms were reported; however, two incidences
involving terrestrial birds around aquatic areas were reported. One was reported in 1987 in
Saratoga New York where 2 ring-billed gulls were killed after ingesting bait. This was recorded
as a misuse (intentional) and was determined to be probable. A residue analysis was conducted.
The second was 2 mallards that were killed in Wisconsin in 1995. The legality was
undetermined. A residue analysis was conducted. The certainty was highly probable.
Terrestrial Organisms
One hundred twenty-one incident reports involving exposure of terrestrial animals are
available from 1971 to 2005. The certainty index classification was given for all reported
incidents: 5 possible, 40 probable and 76 highly probable. All reported 4-aminopyridine
incidents for terrestrial species involve exposures to wild birds, which included Cooper's hawks
(1), starlings, American crows, rock doves, doves, red-tailed hawks (2), song sparrows, grackles,
red-winged blackbirds, house sparrows, mourning doves, ring-billed gulls, white-throated
sparrows, peregrine falcons (1 in 1998, which was a listed species at the time of the report),
Canada goose and blue jays. The majority of reported incidents involved direct toxicity to birds
listed as target species on 4-AP labels. For the predatory birds, the individual incidence reports
provided necropsy evidence and chemical analyses that indicated that these birds were killed by
ingesting poisoned birds. The weight of evidence suggests that such secondary effects can occur,
although the frequency with which they could occur is not clear.
During the reporting period, a total of 121 calls were made regarding possible exposure
of birds to 4-aminopyridine; of these, 3 reported that animals were either having seizures or
incapacitated, 1 had no report and the remainder reported death of animals.
The treatment sites include barns, buildings, corn, granary, hardware store, home,
municipal operation, parks, parking lot, residential areas, rooftop, street and urban areas. Many
of the reports involved treated baits.
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IV. Risk Management and Reregi strati on Decision
A. Determination of Reregi strati on Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregi strati on. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support reregi strati on of
products containing 4-AP as an active ingredient. The Agency has completed its review of these
generic data, and has determined that the data are sufficient to support reregi strati on of all
products containing 4-AP.
The Agency has completed its assessment of the human health and ecological risks
associated with the use of pesticide products containing 4-AP. The Agency has determined that 4-
AP-containing products are eligible for reregi strati on provided the risk mitigation measures
outlined in this document are adopted and label amendments are made to implement these
mitigation measures, as outlined in Chapter V. Appendix A summarizes the uses of 4-AP that are
eligible for reregi strati on. Appendix B identifies the generic data that the Agency reviewed as
part of its determination of reregi strati on eligibility of 4-AP, and lists the submitted studies that
the Agency found acceptable. Data gaps are identified as generic data requirements that have not
been satisfied with acceptable data. Should a registrant fail to implement any of the reregi strati on
requirements identified in this document, the Agency may take regulatory action to address these
concerns.
B. Requirements for Reregi strati on
4-AP-containing products are eligible for reregi strati on provided that registrants comply
with the requirements outlined in this document including the following: (1) submit required data
and (2) implement risk mitigation measures.
1) Required Data
4-AP-containing products are eligible for reregi strati on provided that registrants submit
data as required by the generic and product-specific data call-ins that EPA intends to issue as a
result of this RED (see Section V).
The generic database supporting the reregi strati on of 4-AP uses has been reviewed and
determined to be adequate to support a reregi strati on eligibility decision; however, generic data
will be required to confirm acute toxicity information of the 4-AP technical formulation.
2) Risk Mitigation
Products containing 4-AP are eligible for reregi strati on provided the measures presented in
Table 14 are implemented. Specific labeling requirements to implement these measures are
presented in Table 15 (see Section V).
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Table 14. Risk Mitigation Measures for 4-Aminopyridine
Risk of Concern or
Potential Risk
Mitigation Measures
Potential for dietary
exposure through
drinking water
A certified applicator (or a person under their supervision) must remove 4-
AP-treated blend at the end of the application period.
The following statement will be required on all 4-AP end-use product labels:
"Do not apply treated bait within 25 feet of permanent bodies of water."
Potential for risk to
occupational handlers
All occupational handlers must wear the following PPE: long-sleeved shirt,
long pants, shoes plus socks, and chemical-resistant gloves.
The registrant has requested voluntary cancellation for all 4-AP products
formulated as powders. The remaining products, all formulated as baits, have
a much lower potential for inhalation exposure.
Potential for
exposure to children
The following statement is required on all 4-AP end-use product labels:
"DO NOT apply treated bait in areas accessible to children."
In populated areas and areas open to the public, baiting must be performed at
elevated sites.
Where baiting at elevated sites cannot be accomplished, a certified applicator
or someone under his/her direct supervision (authorized handler) must ensure
children, pets, and non-target species do not come in contact with the blend.
The authorized handler must not leave the site until all dead/dying birds and
unused bait are retrieved from the site.
All 4-AP end-use product labels will require that the product is not stored or
even temporarily placed in locations accessible to children, pets, or domestic
animals.
Potential for food or
feed contamination
The following statements are required on all 4-AP end-use product labels:
"Do not feed to livestock or poultry. Do not mix with grain for livestock or
poultry feed."
"Do not apply where livestock and/or poultry may be exposed."
"Do not apply to growing food crops."
"Do not apply baits made from this product in any way that could
contaminate materials to be used as human food or animal feed."
"Do not use treated baits as food or feed."
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Table 14. Risk Mitigation Measures for 4-Aminopyridine
Risk of Concern or
Potential Risk
Mitigation Measures
Potential for risk to
non-target organisms
4-AP end-use product labels will require that a certified applicator or
someone under his/her direct supervision ensures that non-target species do
not come in contact with the blend during the entire application period. That
authorized handler must stay on the site during the entire application period
(from the time the 4-AP treated bait is placed in the application site to the
time treated bait and any dead or dying birds are removed). The authorized
handler must ensure that children, pets, and non-target species do not come in
contact with the blend.
Birds killed during treatment must be disposed of by burial or incineration.
Prebaiting target birds will also be required on all 4-AP end-use product
labels. Prebaiting will promote feeding by target species and will provide an
opportunity to assess potential exposure to non-target species. Application of
4-AP treated bait will be prohibited if non-target species are observed feeding
on the pre-bait.
The only label with gulls listed as a pest, label number 11649-11, has been
requested for voluntary cancellation by the registrant. This will preclude
gulls from being targeted for use with 4-AP.
All 4-AP end-use product labels will require both the common names and the
scientific names of target birds to clearly distinguish target species from non-
target species, including those protected under the Endangered Species Act
and the Migratory Bird Treaty Act.
C. Public Comments and Responses
When making its reregi strati on decision, the Agency considered all comments received
in the docket during the public participation phase, and worked with stakeholders and the public
to reach the regulatory decisions for 4-AP. During the public comment period on the 4-AP
ecological risk assessment which began on May 30, 2007, the Agency received from the
Humane Society of the United States, the Animal Protection Institute, and other environmental
stakeholder groups for an extension to the comment period. Based on this request, the 60-day
comment period was extended an additional three weeks. EPA received comments in favor of
the reregi strati on of 4-AP products from the National Pest Management Association, the
National Sunflower Association, and contacts within the USDA Extension Service. EPA
received comments expressing concerns about the reregi strati on of 4-AP products from the
Humane Society of the United States, the Animal Protection Institute, People for the Ethical
Treatment of Animals, the American Bird Conservancy, and other members of the public.
Public comments in their entirety are available in the public docket (EPA-HQ-OPP-
2007-0400) at http://www.regulations.gov. The RED document, supporting documents for 4-
AP, and the Agency's response to received comments are also available in the docket. In
addition, the 4-AP RED document may be downloaded or viewed through the Agency's
website at http://www.epa.gov/pesticides/reregistration/status.htm.
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D. Regulatory Rationale
The Agency has determined that 4-AP is eligible for reregi strati on provided that the
requirements for reregi strati on outlined in this document are implemented. Provided that
registrants comply with the requirements of this RED, EPA believes that 4-AP will not present
risks inconsistent with FIFRA and that 4-AP's benefits to public health and safety outweigh the
remaining risks. A summary of EPA's rationale for reregistering and managing risks associated
with 4-AP is presented below.
Benefits and Alternatives
4-AP is a pesticide with killing and flock alarming properties. Birds are pre-baited with
untreated grain so that they are accustomed to eating at the treatment site. A blend of treated
and untreated grain is then used to replace the untreated pre-bait. The flock feeds on the blend.
Since not all of the grains are treated with 4-AP, each member of the flock may or may not eat a
particle of treated grain. Consumption of 4-AP-treated baits will cause a reduction in motor
control in the affected birds brought on by over stimulation of the nervous system. The birds
that have consumed treated bait will exhibit tremors, erratic behavior, periods of inactivity,
vocalization, and in many cases will die. Neighboring birds observe this behavior and leave the
area. Some species of birds are more reactive than other species upon eating 4-AP-treated bait.
Less reactive species are less noticeable to their neighbors. Additionally, some types of birds
respond to distress signals of their neighbors, and other species do not respond to the distress
signals. In general, crows, blackbirds, and other black species respond well to the distress
signals of their neighbors, and pigeons and sparrows do not respond as well to distress signals.
Thus, birds that consume 4-AP-treated bait react in such a way that the remainder of the flock is
frightened away. Birds that consume the 4-AP-treated bait usually die. Mortality levels depend
on the ratio of treated to untreated grain applied, the reactivity of the targeted species, and how
responsive the rest of the flock is in reacting to the distress called of its members.
In general 4-AP is used to control "nuisance" species of birds in situations where they
may endanger public health and safety (see EPA Pesticide Registration Notice 2002-1) or cause
damage to structures. Overpopulation of birds can spread and harbor diseases such as
salmonellosis, histoplasmosis, arboviral encephalitis, and West Nile virus. Bird roosts can be
infested with flies as well as mites and ticks which can act as disease-spreading vectors as well.
Overpopulation of birds may also cause economic losses in urban and agricultural
environments. Bird droppings cause damage to automobile paint, buildings, statues, and
electrical systems. Registrant-reported information indicates that in Tulsa, Oklahoma crows
caused damage to a roof by pecking holes in a soft roofing substance. USDA Animal and
Plant Health Inspection Service (APHIS) Wildlife Services reports using 4-AP products in its
integrated wildlife management approach to protect human health and safety, and to limit
damage to property, equipment and machinery, aviation, livestock feed, buildings, crops,
electrical utilities, and livestock. The National Pest Management Association reported use of 4-
AP-treated baits by their members to manage bird overpopulation and prevent disease and
unsanitary conditions. It was reported that in Massachusetts 4-AP-treated baits are used
primarily around office buildings, public transportation buildings, and industrial buildings.
Finally, 4-AP-treated baits are used around feedlots where birds are attracted by feed. This can
35
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cause economic losses to producers. Birds may also spread E. coli bacteria present in cattle
manure.
4-AP containing products are most frequently used to control nuisance pigeons,
starlings, crows, grackles, blackbirds, and sparrows. Non-chemical alternatives to 4-AP include
exclusion, habitat modification, frightening devices, devices with spikes, and trapping.
Chemical alternatives include Starlicide (3-chloro-p-toluidine hydrochloride), nicarbazin, and
methyl anthranilate. Starlicide is a restricted use avicide used to control crows, ravens, and
magpies that prey on Federally threatened or endangered species, prey on newborn livestock, or
that damage and feed on the contents of sillage bags. Birds that consume Starlicide baits die
without eliciting distress signals that frighten away the rest of the flock. Thus, flocks that feed
on Starlicide-treated bait would have a higher mortality rate than flocks feeding on 4-AP-
treated baits. Nicarbazin is a restricted use pesticide that reduces egg hatchability. Nicarbazin
is currently only registered for use on Canadian geese and pigeons. In order to be efficacious,
nicarbazin-treated bait must be fed daily to the target species and be consistently consumed by
the target species. Daily feedings must continue throughout the entire nesting period, which
can last all year. Methyl anthranilate is a bird repellent used on crops as well as on and around
structures. Methyl anthranilate has been found to be efficacious in some situations, but it is
usually recommended for use as part of an integrated pest management to reduce bird damage
in crops. Effectiveness of chemical and non-chemical bird control methods varies depending
on the type of device, site, skill of the user, and type of bird species involved in the problem.
2. Human Health and Ecological Risk
4-AP is currently formulated as a treated bait and a powder. The registrant has
requested voluntary cancellation of the remaining products formulated as powders. Through
the requirements of this RED and associated product reregi strati on, EPA intends to minimize
the potential adverse effects to human health and the environment from the bait formulation.
Because there are relatively few bird control tools available and in most cases they are
not direct substitutes for one another, EPA concludes that continued registration of 4-AP
products formulated as treated bait, subject to the requirements of this RED, would provide
benefit to public health and safety in controlling unwanted bird species in agricultural and
urban/suburban areas and that risks to non-target species are not unreasonable.
EPA has conducted human health and ecological risk assessments for 4-AP to support
the reregi strati on eligibility decision. In its assessments, EPA concluded that many risks are
below the Agency's level of concern but also identified potential risks that, if left unmitigated,
may pose unreasonable risks or adverse effects to humans or the environment.
As a result of this RED, EPA is requiring registrants to implement risk mitigation
measures to address ecological risks from unintended exposure and human health risks from
accidental exposure and from handling 4-AP. To mitigate risk to non-target organisms, the
Agency is requiring that applicators pre-bait the intended target area and observe target birds'
feeding habits to determine the optimum time of application and evaluate potential hazards
associated with the application. 4-AP-treated bait may not be applied if non-target species are
36
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observed feeding on the pre-bait. To mitigate risk to non-target species during ground
applications, a certified applicator or someone under his/her direct supervision (authorized
handler) must ensure that pets and non-target species do not come in contact with the blend
during the entire application period. The application period starts when treated bait is placed in
the application site and ends when the blend and any dead/dying birds are removed. Birds that
die as a result of application must be disposed of by burial or incineration in order to minimize
secondary poisoning to predatory species. In order to mitigate risk to predatory species, the
authorized handler must not leave the site until all dead or dying birds and unused bait are
retrieved from the site. All 4-AP labels must list both the common name and the scientific
name of target species to avoid confusion of which species are permitted to be controlled.
To reduce the potential for risk to children, the Agency is requiring that treated bait not
be applied in areas accessible to children. In addition, EPA is requiring that in populated areas
and areas open to the public, baiting be performed at elevated sites. Where it is not feasible to
bait at elevated sites and ground applications are necessary, the certified applicator or someone
under his/her direct supervision (authorized handler) must ensure that children do not come in
contact with the blend during the entire application period. Also, that authorized handler must
not leave the site until all dead/dying birds and unused bait are retrieved and removed from the
site. In order to reduce potential risk of food or feed contamination from 4-AP applications,
EPA is requiring that 4-AP not be applied where livestock and/or poultry may be exposed, that
4-AP baits not be used as feed, and that 4-AP not be applied to growing food crops. Finally,
EPA is requiring that handlers of 4-AP products wear additional personal protective equipment.
3. Endocrine Screening
EPA is required under the Federal Food Drug and Cosmetic Act (FFDCA), as amended
by FQPA, to develop a screening program to determine whether certain substances (including
all pesticide active and other ingredients) "may have an effect in humans that is similar to an
effect produced by a naturally occurring estrogen, or other such endocrine effects as the
Administrator may designate." Following the recommendations of its Endocrine Disrupter
Screening and Testing Advisory Committee (EDSTAC), EPA determined that there were
scientific bases for including, as part of the program, androgen and thyroid hormone systems, in
addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that
the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA
will use FIFRA and, to the extend that effects in wildlife may help determine whether a
substance may have an effect in humans, FFDCA authority to require the wildlife evaluations.
When the appropriate screening and/or testing protocols being considered under the Agency's
Endocrine Disrupter Screening Program (EDSP) have been developed and vetted, there may be
additional screening and/or testing required for 4-AP.
4. Endangered Species
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on endangered and threatened species and to
implement mitigation measures that address these impacts. The Endangered Species Act (ESA)
requires federal agencies to ensure that their actions are not likely to jeopardize listed species or
37
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adversely modify designated critical habitat. To analyze the potential of registered pesticide
uses that may affect any particular species, EPA uses basic toxicity and exposure data and
considers ecological parameters, pesticide use information, geographic relationship between
specific pesticide uses and species locations, and biological requirements and behavioral
aspects of the particular species. When conducted, these analyses take into consideration any
regulatory changes recommended in this RED being implemented at that time.
The ecological assessment that EPA conducted for this RED does not, in itself,
constitute a determination as to whether specific species or critical habitat may be harmed by
the pesticide. Rather, this assessment serves as a screen to determine the need for any species-
specific assessment that will evaluate whether exposure may be at levels that could cause harm
to specific listed species and their critical habitat. The species-specific assessment refines the
screening-level assessment to take into account information such as the geographic area of
pesticide use in relation to the listed species and the habits and habitat requirements of the listed
species. If the Agency's specific assessments for 4-AP result in the need to modify use of the
pesticide, any geographically specific changes to the pesticide's registration will be
implemented through the process described in the Agency's Federal Register Notice (54 FR
27984) regarding implementation of the Endangered Species Protection Program.
Risk findings are based solely on EPA's qualitative assessment for 4-AP and do not
constitute "may affect" findings under the ESA. A determination that there is a likelihood of
potential effects to a listed species may result in limitations on the use of the pesticide, other
measures to mitigate any potential effects, and/or consultations with the Fish and Wildlife
Service or National Marine Fisheries Service, as necessary. If the Agency determines use of 4-
AP "may affect" listed species or their designated critical habitat, EPA will employ the
provisions in the Services regulations (50 CFR Part 402). To reduce potential effects to non-
target endangered species, EPA is requiring various mitigation measures.
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V. What Registrants Need to Do
The Agency has determined that the products containing 4-AP (PC 069201) are eligible
for reregi strati on provided that the mitigation measures and label changes identified in this
RED are implemented. Registrants will need to amend their product labeling to incorporate the
label statements set forth in the Label Changes Summary Table 15. The Agency intends to
issue a Data Call-In (DCI) requiring product-specific data. Generally, the registrant will have
90 days from receipt of a DCI to complete and submit response forms or request time
extensions and/or waivers with a full written justification. For product-specific data, the
registrant will have eight months to submit data and amended labels.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregi strati on of the 4-AP treated bait formulation
has been reviewed and determined to be substantially complete. No generic data requirements
will be required at this time.
2. Labeling for Manufacturing-Use Products
To ensure compliance with FIFRA, manufacturing-use product (MUP) labeling should
be revised to comply with all current EPA regulations, PR Notices, and applicable policies.
The MUP labeling should bear the labeling contained in Table 15.
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 Registrant
must review previous data submissions to ensure that they meet current EPA acceptance criteria
and if not, commit to conduct new studies. If a registrant believes that previously submitted
data meet current testing standards, then the study MRID numbers should be cited according to
the instructions in the Requirement Status and Registrants Response Form provided for each
product. The Agency intends to issue a separate product-specific data call-in (PDCI), outlining
specific data requirements. For any questions regarding the PDCI, please contact Moana
Appleyard at (703) 308-8175.
2. Labeling for End-Use Products
To be eligible for reregi strati on, labeling changes are necessary to implement measures
outlined in Section IV above. Specific language to incorporate these changes is specified in
Table 15. Generally, conditions for the distribution and sale of products bearing old
labels/labeling will be established when the label changes are approved. However, specific
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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.
C. Labeling Changes Summary Table
In order to be eligible for reregi strati on, amend all product labels to comply with the
following table. Table 15 describes how language on the labels should be amended.
40
-------
Labeling Changes Summary Table
In order to be eligible for reregi strati on, amend all product labels to incorporate the risk mitigation measures outlined in Section IV.
The following table describes how language on the labels should be amended.
Table 15: Summary of Labeling Changes for 4-aminopyridine
Description
Amended Labeling Language for Manufacturing Use Products*
Placement on Label
For all Manufacturing
Use Products
"Only for formulation into an avicide for the following use(s) [fill blank
only with those uses that are being supported by MP registrant]."
"Only for formulation into products classified as restricted use."
"Only for formulation into end-use products that are formulated onto bird
bait at a maximum of one percent active ingredient in the bait."
"Formulation into powder is prohibited."
Note to registrant: All species the product targets must be stated on the
label. The common and scientific names of each targeted species must be
included on the label. For example, if the product targets pigeons, the
label would state: "Used for the control of feral pigeons (Columba
livid).."
Directions for Use
One of these statements
may be added to a label
to allow reformulation
of the product for a
specific use or all
additional uses
"This product may be used to formulate products for specific use(s) not
listed on the MP label if the formulator, user group, or grower has
complied with U.S. EPA submission requirements regarding support of
such use(s)."
"This product may be used to formulate products for any additional
Directions for Use
41
-------
supported by a
formulator or user
group
use(s) not listed on the MP label if the formulator, user group, or grower
has complied with U.S. EPA submission requirements regarding support
of such use(s)."
Environmental Hazards
Statements Required
by the RED and
Agency Label Policies
"This product is extremely toxic to mammals and birds. This product is
toxic to invertebrates. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or other waters unless in
accordance with the requirements of a National Pollution Discharge
Elimination System (NPDES) permit and the permitting authority has
been notified in writing prior to discharge. Do not discharge effluent
containing this product to sewer systems without previously notifying the
local sewage treatment plant authority. For guidance contact your State
Water Board or Regional Office of the EPA."
Precautionary Statements
End Use Products Intended for Occupational Use
RUP
"Restricted Use Pesticide"
"Due to acute oral and acute dermal toxicity and due to toxicity to birds
and mammals."
"For retail sale to and use by only Certified Applicators or persons under
their direct supervision and only for those uses covered by the Certified
Applicator's certification."
This statement must appear at the very
top of the label's front panel [see 40 CFR
156.10(j)(2)(i) for more information].
No other wording or symbols may
appear above the RUP statement.
Note to Registrant
All species the product targets must be stated on the label. The common
and scientific names of each targeted species must be included on the
label. For example, if the product targets pigeons, the label would state:
"Used for the control of feral pigeons (Columba livid)..."
PPE Requirements
Established by the
RED1
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" [EUP
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
42
-------
For Bait
Formulations
registrant, insert correct chemical-resistant material}. "If you want
more options, follow the instructions for category" [EUP registrant,
insert A, B, C, D, E, F, G, or H] "on an EPA chemical-resistance
category selection chart."
"All mixers, loaders, applicators, persons picking up dead birds and
unused bait, and other handlers must wear the following PPE:
- long-sleeved shirt and long pants,
- shoes plus socks, and
- chemical-resistant gloves."
Note: application continues until the dead birds and unused bait are
retrieved - all participants in the application are pesticide handlers.
User Safety
Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. jf no
such instructions for washables exist, use detergent and hot water. Keep
and wash PPE separately from other laundry."
Precautionary Statements: Hazards to
Humans and Domestic Animals
immediately following the PPE
requirements
User Safety
Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing.
Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible, wash
thoroughly and change into clean clothing."
Precautionary Statements under:
Hazards to Humans and Domestic
Animals immediately following
Engineering Controls
(Must be placed in a box.)
Environmental Hazards
"Do not apply directly to water, or to areas where surface water is present
Precautionary Statements immediately
43
-------
or to intertidal areas below the mean high water mark.
This pesticide is extremely toxic to mammals and birds. This product is
toxic to invertebrates. Wildlife and pets feeding on treated bait may be
killed. Do not contaminate water by cleaning equipment or disposal of
waste."
following the User Safety
Recommendations
Entry Restrictions
"Keep persons (other than authorized handlers) as well as pets and
livestock, away from the treated bait and dead or dying birds at all times.
Only protected handlers may be in the area during bait application until
all dead birds and unused bait is retrieved."
Directions for Use Under General
Precautions and Restrictions
General Application
Restrictions
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may be
in the area during application."
Place in the Direction for Use
Other Application
Restrictions (Risk
Mitigation)
"Do not feed to livestock or poultry. Do not mix with grain for livestock
or poultry feed."
"Do not apply where livestock and/or poultry may be exposed."
"Do not apply to growing food crops."
"DO NOT apply treated bait in areas accessible to children."
"Do not apply more than 0.4 Ib treated bait per protected acre per
application."
"Baits must be prepared and applied as specified on this label. Do not
apply baits made from this product by air or any mechanical equipment
designed to broadcast baits or other pesticides. Users of this product
must follow all limitations indicated on this label regarding the
Directions for Use
44
-------
placement, monitoring, and retrieval of treated baits."
"Before baits made with this product are applied, sites that are to be
treated must be observed for evidence of non-target activity and must be
pre-baited (see specific instructions for these activities)."
"In populated areas, and areas open to the public, where feasible, baiting
must be performed at elevated sites."
"Where baiting at elevated sites is not feasible and ground baiting is
required, a certified applicator or someone under his/her direct
supervision (authorized handler) must ensure children, pets, and non-
target species do not come in contact with the blend during the entire
application period. That authorized handler must not leave the site until
all dead/dying birds and unused bait are retrieved from the site. All
dead/dying birds must be disposed of by burial or incineration."
"Do not apply treated baits within 25 feet of permanent bodies of water."
"Do not apply baits made from this product in any way that could
contaminate materials to be used as human food or animal feed. Do not
use treated baits as food or feed. Do not store or even temporarily place
treated bait in locations accessible to children, pets, or domestic animals."
"Before applying treated baits in any problem area, carefully observe
target birds' feeding habits to locate their preferred feeding sites,
determine the optimum time of application, and evaluate options to
reduce potential hazards of the application to desirable and/or protected
animal species."
"Pre-baiting with untreated bait materials is required to promote feeding
by target species and to assess potential for exposure of non-target
species. Do not apply treated bait if non-target species are observed
feeding on the pre-bait."
45
-------
* At the time of reregistration, there are no registered 4-aminopyridine manufacturing use products. If in the future, 4-aminopyridine
manufacturing use products are registered, label statements from the manufacturing use products section of the Labeling Changes table will be
required on those labels.
1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document.
The more protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
46
-------
Appendix A: Use Patterns Subject to Reregistration of 4-Aminopyridine (PC Code 069201)
Target Birds
Pigeons; house sparrows; red-
winged, yellow-headed,
Brewers, and rusty blackbirds;
grackles; cowbirds; and
starlings
[Bird species must be specified
on label with both common and
latin species names]
Site
In, on or in
the area of
structures,
nesting,
loafing, and
roosting
sites.
Application Rate
Restrictions
Maximum rate:
Ratio 1 part treated
bait: 5 parts
untreated bait;
0.4 Ib treated bait
per protected acre
per application
Formulation
Bait
Directions for Use
See Table 15 in
Section V of the 4-
Aminopyridine
RED.
47
-------
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision
GUIDE TO APPENDIX B
Appendix B contains a listing of data requirements which support the reregi strati on for
active ingredients within the 4-AP case covered by this RED. It contains generic data
requirements that apply 4-AP in all products, including data requirements for which a "typical
formulation" is the test substance.
The data table is organized in the following formats:
1. Data requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR 158. The reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidance, which is 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 is no MRID number has been assigned. Refer to
the Bibliography appendix for a complete citation of the study.
48
-------
APPENDIX B.
Data Supporting Guideline Requirements for the Reregistration of 4-Aminopyridine
New
Guideline
Number
Old
Guideline
Number
Study Description
Use
Pattern
Citation(s)
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2300
850.1300
850.2500
850.4025
71-1A
7 1-2 A
71-2B
7 1-4 A
72-4
71-5
121-1
Avian Acute Oral Toxicity - Quail
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Avian Reproduction - Quail
Daphnid Chronic Toxicity
Field Testing for Terrestrial Wildlife
Phytotoxicity
All
All
All
All
All
All
All
00003999
00004101
00003998
00147985
05003186
00003985
00004083
00004111
00086682
00004001
00004037
00004124
00004132
00004147
00109573
00109577
00109579
00131325
05003440
TOXICOLOGY
870.1100
870.1200
870.3100
870.3150
None
Non-
Guideline
81-1
81-2
82-1A
84-4
None
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit
Repeated dose 28-day/
90-Day Feeding - Rodent
90-Day Oral Toxicity - Dog
Other Genotoxic Effects
Human Clinical Study
All
All
All
All
All
All
00004024
00004025
00004028
00004265
00021901
00021902
00004024
00131328
00004026
00021907
00131329
00004027
00021904
Ogawaetal, 1986
Wakabayashi et al, 1982
Sugimura et al, 1982 as
summarized in EPA IRIS
2003 and NIC 2005
47093602, Segal et al 1999
47093 60 l,Grijalvaetal
2003
47093603, van Diemen et al,
1993
49
-------
Data Supporting Guideline Requirements for the Reregistration of 4-Aminopyridine
New
Guideline
Number
Old
Guideline
Number
Study Description
TTsp
\J 3C
Pattern
Citation(s)
ENVIRONMENTAL FATE
835.4100
162-1
Aerobic Soil Metabolism
All
00109579
05003407
OTHER
None
None
Non-Guideline
All
00003963
00003964
00003965
00003966
00003967
00003968
00003969
00003970
00003971
00003972
00003973
00003974
00003976
00003977
00003979
00003980
00003981
00003984
00003986
00003987
00003988
00003989
00003991
00003992
00003994
00003995
00003996
00003997
00004000
00004002
00004003
00004006
00004008
00004013
00004014
00004015
00004031
00004032
00004033
00004034
00004035
00004036
50
-------
Data Supporting Guideline Requirements for the Reregistration of 4-Aminopyridine
New
Guideline
Number
Old
Guideline
Number
Study Description
Use
Pattern
Citation(s)
00004041
00004042
00004043
00004044
00004045
00004046
00004047
00004051
00004052
00004053
00004054
00004056
00004057
00004058
00004059
00004060
00004061
00004062
00004063
00004064
00004065
00004067
00004068
00004069
00004070
00004071
00004072
00004073
00004074
00004075
00004076
00004077
00004078
00004079
00004082
00004084
00004085
00004086
00004087
00004090
00004091
00004092
00004093
00004094
00004097
00004098
00004099
51
-------
Data Supporting Guideline Requirements for the Reregistration of 4-Aminopyridine
New
Guideline
Number
Old
Guideline
Number
Study Description
Use
Pattern
Citation(s)
00004102
00004103
00004104
00004105
00004108
00004109
00004113
00004114
00004115
00004116
00004117
00004120
00004122
00004123
00004126
00004127
00004128
00004130
00004131
00004133
00004138
00004139
00004140
00004141
00004142
00004143
00004144
00004145
00004146
00004267
00004269
00014378
00021884
00021886
00021887
00021888
00021889
00021894
00021895
00021896
00021898
00021899
00022550
00022560
00027851
00030610
00030611
52
-------
Data Supporting Guideline Requirements for the Reregistration of 4-Aminopyridine
New
Guideline
Number
Old
Guideline
Number
Study Description
Use
Pattern
Citation(s)
00030613
00030614
00030617
00030618
00033899
00050977
00050978
00050979
00050981
00050982
00050983
00050985
00050986
00050987
00050988
00050989
00050991
00052582
00055447
00074912
00090078
00090081
00107008
00109578
00109580
00131327
00131331
00134510
00134511
00145584
00150203
00150204
00158101
00158103
00158104
05003185
05003191
05003193
40603600
41107900
41107901
41107902
41107903
46789600
46789601
05003185
40603603
53
-------
Data Supporting Guideline Requirements for the Reregistration of 4-Aminopyridine
New
Guideline
Number
Old
Guideline
Number
Study Description
Use
Pattern
Citation(s)
00003999
00004101
00003998
00147985
05003186
00086682
00003985
00004083
00004111
00067838
00085360
00004001
00004037
00004124
00004132
00004147
00109573
00109577
00109579
00131325
05003440
00003991
00003997
00004006
00004015
00004032
00004105
00004131
00004269
00021886
00021887
00150203
05003191
54
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Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket, EPA-
HQ-OPP-2007-0400.
It is open Monday through Friday, excluding legal holidays, from 8:30 am to 4 pm.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site: www.epa.gov/pesticides/reregistration
These documents include:
HEP Document:
4-Aminopyridine: HED Chapter of the Reregi strati on Eligibility Decision Document (RED).
Donovan, Y., Khasawinah, A., and Miller, 1, D336326, 08/06/2007.
EFED Documents:
Re-registration Ecological Risk Assessment for Avitrol (4-Aminopyridine) End-Use Products.
Shanaman, L., Hurley, P., 01/05/2007.
Transmittal of the Environmental Fate and Effect's Division's (EFED) Re-registration Science
Chapter for the Ecological Risk Assessment of the Restricted Use Avicide, Avitrol. Shanaman,
L., Hurley, P., D336332, 02/27/2007.
55
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Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Eligibility Decision
MRID
00003999
00004101
00003998
00147985
05003186
00003985
00004083
00004111
00086682
00004001
00004037
00004124
Citation Reference
Schafer, E.W.; Lockyer, N. (19??) The Effects of DRC-1327 Baits on Mourning Doves.
(Unpublished study received Dec 18, 1970 under 224-EX-3; prepared by U.S. Fish and
Wildlife Service, Denver Wildlife Research Center, submitted by Phillips Petroleum Co.,
Bartlesville, Okla.; CDL:122744-E)
Besser, J.F. (1968) Compilation of Information on the Chronic Toxicity of 4-Aminopyridine
to Pheasant, Quail and Starlings. (Unpublished study received Mar 2, 1973 under 11649-12;
prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research Center, submitted by
Avitrol Corp., Tulsa, Okla.; CDL:120117-A)
Schafer, E.W., Jr.; Brunton, R.B.; Lockyer, N. (1970) The Chronic Toxicity of DRC-1327 to
Mourning Doves: Preliminary Report No. 16--W. J. DF-102.2. (Unpublished study received
Dec 18, 1970 under 224-EX-3; prepared by U.S. Fish and Wildlife Ser- vice, Denver
Wildlife Research Center, submitted by Phillips Petroleum Co., Bartlesville, Okla.;
CDL:122744-D)
Fink, R.; Reno, F. (1976) Eight-day Dietary LC50 - Mallard Duck 4-Aminopyridine: Final
Report: Project No. 684-105. Unpublished study prepared by Hazleton Laboratories
America, Inc. 10 p.
Schafer, E.W.; Brunton, R.B.; Lockyer, N.F. (1975) The effects of subacute and chronic
exposure to 4-aminopyridine on reproduction in coturnix quail. Bulletin of Environmental
Contamination and Toxicology 13(6):758-764.
U.S. Fish and Wildlife Service, Denver Research Laboratory (19??) Toxicity of Avitrol to
Bluegill and Channel Catfish at Selected Water Qualities and Temperatures: Table.
(Unpublished study received May 18, 1971 under 224-EX-3; prepared in cooperation with
La Crosse Fish Control Laboratory, submitted by Phillips Petroleum Co., Bartlesville, Okla.;
CDL:122743-F)
Schafer, E.W., Jr.; Marking, L.L. (1974?) Long Term Effects of 4- Aminopyridine Exposure
to Birds and Fish. (Unpublished study received Nov 11, 1975 under 11649-15; prepared by
U.S. Fish and Wildlife Service, Wildlife Research Center in cooperation with Fish Control
Laboratories, submitted by Avitrol Corp., Tulsa, Okla.; CDL:225255-C)
Palazzolo, R.J. (1963) Report to Phillips Petroleum Company: Toxic- ity to Salt Water Life
of Compound 1861 Hydrochloride. (Unpublished study received Jan 2, 1968 under 224-12;
prepared by Industrial Bio-Test Laboratories, Inc., submitted by Phillips Pe- troleum Co.,
Bartlesville, Okla.; CDL:229844-F)
Knittle, C.E.; Besser, J.F.; Guarino, J.L.; et al. (1981) Further Evaluations of 1:29 Avitrol
Treatments To Protect Ripening Sun- flower from Blackbird Damage in North Dakota: Bird
Damage Research Report No. 202. (U.S. Fish and Wildlife Service, Denver Wildlife
Research Center; unpublished study; CDL: 246228-A)
Starr, R.I.; Cunningham, D.J. (1970) Translocation and Degradation of 4-Aminopyridine in
Corn Plants-Its Movement and Degradation in Soil Systems: Third Periodic Report, Avitrol
Concentrate|. (Unpublished study received Apr 24, 1970 under 224-EX-3; pre- pared by U.S.
Fish and Wildlife Service, Denver Wildlife Re- search Center, submitted by Phillips
Petroleum Co., Bartlesville, Okla.; CDL:122744-H)
Starr, R.I.; Cunningham, D.J. (19??) Phytotoxicity. (Unpublished study received Jan 3, 1973
under 1F1013; prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research
Center, submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL:091757-R)
Starr, R.; Cunningham, D.; Brunton, R. (1966?) Absorption and Translocation of 4-
Aminopyridine by Corn Plants. (Unpublished study received Apr 15, 1969 under 224-EX-3;
prepared by U.S. Fish and Wildlife Service, Denver Research Center, submitted by Phillips
Petroleum Co., Bartlesville, Okla.; CDL:122745-H)
56
-------
00004132
00004147
00109573
00109577
00109579
00131325
05003440
00004024
00004025
00004028
00021901
00004265
00021902
00131328
00004026
Starr, R.I.; Cunningham, DJ. (1972) Fate of 4-Aminopyridine in Corn, Sorghum, and Soil
Systems: A Summary of Research Findings. (Unpublished study received Apr 16, 1973
under 3G1320; prepared by U.S. Fish and Wildlife Service, Bureau of Sport Fisheries and
Wildlife, submitted by Avitrol Corp., Tulsa, Okla.; CDL:093548- A)
Matlock, R.S.; Oswalt, R.M. (1963?) Report of Sunflower Research in Oklahoma.
(Unpublished study received Jun 16, 1972 under un- known admin, no.; prepared by
Oklahoma State Univ., Dept. of Agronomy, submitted by Avitrol Corp., Tulsa, Okla.;
CDL:210151-I)
Avitrol Corp. (1973) ?Efficacy of 4-Aminopyridine Baits and Other Products Used To
Control Blackbird Damage to Sunflowers|. (Compilation; unpublished study received Oct 17,
1973; Mar 5, 1973 under 11649-EX-2; CDL:248060-A)
Avitrol Corp. (1974) ?Efficacy Testing of Avitrol-Sunflowers|. (Compilation of reports by
various government agencies; unpublished study; CDL:248063-A)
Starr, R.; Cunningham, D. (19??) Fate of 4-Aminopyridine in Corn, Sorghum, and Soil
Systems. A Summary of Research Findings. (Unpublished study received Nov 27, 1972
under 11649-EX-5; submitted by Avitrol Corp., Tulsa, OK; CDL:248064-B)
Starr, R. (1972) The absorption, translocation, and metabolism of 14C-4-aminopyridine in
corn and sorghum: Its movement and de- gradation in soil systems. Dissertation Abstracts
International (XXIII)6. (Also In unpublished submission received Feb 11, 1974 under
3G1384; submitted by Avitrol Corp., Tulsa, OK; CDL: 071822-A)
Starr, R.I.; Cunningham, DJ. (1974) Phytotoxicity, absorption, and translocation of 4-
aminopyridine in corn and sorghum growing in treated nutrient cultures and soils. Journal of
Agricultural and Food Chemistry 22(3):409-413.
Ives, M. (1962) Report to Phillips Petroleum Company: Toxicity Studies on Compound 1861
Hydrochloride. (Unpublished study received Dec 30, 1968 under 1F1013; prepared by
Industrial Bio- Test Laboratories, Inc., submitted by Phillips Petroleum Co., Bartlesville,
Okla.; CDL:091756-B)
Ives, M. (1962) Report to Phillips Petroleum Company: Acute Oral Toxicity Studies on
Compound 1861 Admixed on Grain. (Unpublished study received Dec 30, 1968 under
1F1013; prepared by Industrial Bio-Test Laboratories, Inc., submitted by Phillips Petroleum
Co., Bartlesville, Okla.; CDL:091756-C)
Lifestream Laboratories, Incorporated (1968) Determination of the Maximum Tolerated
Dose of Compound 1861~Mongrel Dogs. (Unpublished study received Dec 30, 1968 under
1F1013; submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL:091756-I)
Ives, M. (1962) Report to Phillips Petroleum Company: Toxicity Studies on Compound 1861
Hydrochloride. (Unpublished study received Mar 18, 1975 under 11649-12; prepared by
Industrial Bio- Test Laboratories, Inc., submitted by Avitrol Corp., Tulsa, Okla.;
CDL:094800-U)
Palazzolo, R.J. (1962) Report to Phillips Petroleum Company: Special Acute Toxicity Study
on Compound 1861 Hydrochloride. (Unpublished study received Dec 30, 1968 under
1F1013; prepared by Industrial Bio-Test Laboratories, Inc., submitted by Phillips Petroleum
Co., Bartlesville, Okla.; CDL:091756-D)
Ives, M. (1962) Report to Phillips Petroleum Company: Acute Oral Toxicity Studies on
Compound 1861 Admixed on Grain. (Unpublished study received Mar 18, 1975 under
11649-12; prepared by Industrial Bio-Test Laboratories, Inc., submitted by Avitrol Corp.,
Tulsa, Okla.; CDL:094800-Z)
Kohn, F.; Cervenka, H.; Kay, D.; et al. (1968) Report to Phillips Petroleum Company: 90-
Day Subacute Oral Toxicity of Compound 1861 (4-aminopyridine)~Albino Rats: Lifestream
Laboratories Project No. 888. (Unpublished study received Apr 13, 1973 under 3G1384;
prepared by Lifestream Laboratories, Inc., submitted by Avitrol Corp., Tulsa, OK;
CDL:071822-G)
Kohn, F.E.; Cervenka, H.; Kay, D.L.; Vega, S.M. (1968) 90-Day Sub- acute Oral Toxicity of
Compound 1861 (4-Aminopyridine): Albino Rats: Project Number 888. (Unpublished study
received Dec 30, 1968 under 1F1013; prepared by Lifestream Laboratories, Inc., submitted
by Phillips Petroleum Co., Bartlesville, Okla.; CDL: 091756-F)
57
-------
00021907 Kohn, F.E.; Cervenka, H.; Kay, D.L.; Vega, S.M. (1968) Report to Phillips Petroleum
Company: 90-Day Subacute Oral Toxicity of Compound 1861 (4-Aminopyridine): Albino
Rats: Project No. 888. (Unpublished study received Jan 5, 1973 under 11649-12; prepared by
Lifestream Laboratories, Inc., submitted by Avitrol Corp., Tulsa, Okla.; CDL:004572-B)
00131329 Cervenka, H.; Vega, S. (1968) Report to Phillips Petroleum Company: Ninety-day Subacute
Oral Toxicity Study of Compound 1861 (4- aminopyridine)~Beagle Dogs: Lifestream
Laboratories Project No. 777. (Unpublished study received Apr 13, 1973 under 3G1384;
prepared by Lifestream Laboratories, Inc., submitted by Avitrol Corp., Tulsa, OK;
CDL:071822-H)
00004027 Cervenka, H.; Vega, S.M. (1968) Ninety-Day Subacute Oral Toxicity of Compound 1861 (4-
Aminopyridine)~Beagle Dogs: Project Number 777. (Unpublished study received Dec 30,
1968 under 1F1013; prepared by Lifestream Laboratories, Inc., submitted by Phillips
Petroleum Co., Bartlesville, Okla.; CDL:091756-G)
00021904 Cervenka, H.; Vega, S.M. (1968) Ninety-Day Subacute Oral Toxicity Study of Compound
1861 (4-Aminopyridine)~Beagle Dogs: Project No. 777. (Unpublished study received Mar
18, 1975 under 11649-12; prepared by Lifestream Laboratories, Inc., submitted by Avitrol
Corp., Tulsa, Okla.; CDL:094800-AD)
47093602 Segal, I; Pathak, M.; Hernandez, I; et. al. (1999) Safety and Efficacy of 4-Aminopyridine in
Humans with Spinal Cord Injury: A Long term, Controlled Trial. Pharmacotherapy 19(6):
713-723.
47093601 Grijalva, S.; Sahagun, G.; Hernandez, G.; et. al. (2003) Efficacy and Safety of 4-
Aminopyridine in Patients With Long-Term Spinal Cord Injury: A Randomized, Double-
Blind, Placebo-Controlled Trial. Pharmacotherapy 23(7): 823-834.
47093603 Diemen, V.; Polman, C.; Koetsier, I; et al. (1999) 4-Aminopyridine in Patients With
Multiple Sclerosis: Dosage and Serum Level Related to Efficacy and Safety. Clinical
Neuropharmacology. 3(16): 195-204.
00109579 Starr, R.; Cunningham, D. (19??) Fate of 4-Aminopyridine in Corn, Sorghum, and Soil
Systems. A Summary of Research Findings. (Unpublished study received Nov 27, 1972
under 11649-EX-5; submitted by Avitrol Corp., Tulsa, OK; CDL:248064-B)
05003407 Betts, P.M.; Giddings, C.W.; Fleeker, J.R. (1976) Degradation of 4-aminopyridine in soil.
Journal of Agricultural and Food Chemistry 24(3):571-574.
00003963 Avitrol Corporation (1975) Avitrol FC Corn Chops~99 Baits for Protecting Sweet Corn
from Blackbirds in Ulster County, New York. (Unpublished study including letter dated Sep
12, 1975 from J.E. Forbes to Kelly Swindle, received Feb 18, 1976 under 11649-12;
prepared in cooperation with U.S. Fish and Wildlife Service; CDL:224248-A)
00003964 Avitrol Corporation (19??) Introduction and Summary: ?50 Documented Reports on Bird
Species andBaits|. (Unpublished study received Apr 10, 1975 under 11649-10;
CDL:115276-A)
00003965 Schafer, E.W., Jr.; Brunton, R.B.; Lockyer, N.F. (1974) Hazards to animals feeding on
blackbirds killed with 4-Aminopyridine baits. Journal of Wildlife Management 38(3):424-
426. (Also in unpublished submission received Apr 10, 1975 under 11649-10; submitted by
Avitrol Corp., Tulsa, Okla.; CDL:115276-B)
00003966 Avitrol Corporation (1974) Avitrol: Summary Test Results-Gulls. Summary of studies
115276-D and 115276-F. (Unpublished study received Apr 10, 1975 under 11649-10;
CDL:115276-C)
00003967 Hext, D.D. (1965) Experimental Gull Control Utilizing Avitrol 200 at Oakland International
Airport. (Unpublished study received Apr 10, 1975 under 11649-10; submitted by Avitrol
Corp., Tulsa, Okla.; CDL: 115276-D)
00003968 Ware, J.E. (1971) Report on Avitrol Gull Repellency Test: Salem, Massachusetts, 1971.
(Unpublished study received Apr 10, 1975 under 11649-10; prepared by U.S. Bureau of
Sport Fisheries and Wildlife, Div. of Wildlife Services, submitted by Avitrol Corp., Tulsa,
Okla.; CDL: 115276-E)
00003969 Avitrol Corporation (1974) Avitrol: Summary Test Results-Star- lings, Blackbirds in
Feedlots. (Unpublished study received Apr 10, 1975 under 11649-11; CDL:115277-C)
58
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00003970 Avitrol Corporation (1974) Avitrol: Summary Test Results-Sparrows. (Unpublished study
received Apr 10, 1975 under 11649-6; CDL: 119808-C)
00003971 Newson, J.D.; Wilson, R.C.; Murray, M. (1973) An Assessment of Crow Control Techniques
in Pecan Orchards in Louisiana: Project Number: LW-56-WU. (Unpublished study received
Jul 26, 1973 under 11649-8; prepared by Louisiana State Univ., submitted by Avitrol Corp.,
Tulsa, Okla.; CDL:227059-A)
00003972 Dolbeer, R.A.; Ingram, C.R.; Seubert, J.L.; Stickley, A.R., Jr.; Mitchell, R.T. (1976) 4-
Aminopyridine effectiveness in sweet corn related to blackbird population density. Journal of
Wildlife Management 40(3):564-570. (Also in unpublished submission received Jun 21,
1977 under 11649-12; submitted by Avitrol Corp., Tulsa, Okla.; CDL:230665-A)
00003973 De Grazio, J.W.; Besser, J.F.; DeCino, T.J.; Guarino, J.L.; Schafer, E.W., Jr. (1972)
Protecting ripening corn from black- birds by broadcasting 4-Aminopyridine baits. Journal of
Wild- life Management 38(4):1316-1320. (Also In unpublished submission received Jun21,
1977 under 11649-12; submitted by Avitrol Corp., Tulsa, Okla.; CDL:230665-B)
00003974 Stickley, A.R., Jr.; Mitchell, R.T.; Heath, R.G.; Ingram, C.R.; Bradley, E.L., Jr. (1972) A
method for appraising the bird repellency of 4-Aminopyridine. Journal of Wildlife
Management 36(4): 1313-1316. (Also In unpublished submission received Jun 21, 1977
under 11649-12; submitted by Avitrol Corp., Tulsa, Okla.; CDL:230665-C)
00003 976 Avitrol Corporation (1965) The Control of Gulls with Avitrol 200 on and Near the
Metropolitan Oakland International Airport. (Un- published study received Apr 10, 1975
under 11649-10; CDL: 115276-F)
00003977 Avitrol Corporation (1974) Avitrol: Summary Test Results-Pigeons. (Unpublished study
received Apr 10, 1975 under 11649-6; CDL: 119808-E)
00003979 Lee, J.O. (1963) Starling Control: Bait Acceptance Tests, Winter 1962-63. (Unpublished
study received on unknown date under 224- EX-1; prepared by U.S. Fish and Wildlife
Service, Branch of Predator and Rodent Control, submitted by Phillips Petroleum Co.,
Bartlesville, Okla.; CDL:122741-B)
00003980 Held, L.J. (1963) A Report of the Animal Control Program, Fiscal Year 1963. (Unpublished
study received Aug 13, 1963 under 224- EX-1; prepared by U.S. Fish and Wildlife Service,
Branch of Predator and Rodent Control in cooperation with the Illinois Pork Council,
submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL:122741-C)
00003981 De Grazio, J.W.; Stone, C.P. (1972) Project DF-102: Bird Damage Control Research:
Second Periodic Report-Avitrol. (Unpublished study received Mar 27, 1972 under 224-EX-
3; prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research Center in
cooperation with Sand Lake National Wildlife Refuge, submitted by Phillips Petroleum Co.,
Bartlesville, Okla.; CDL:122743-B)
00003984 Walls, D.T. (1971) Field Demonstration of Avitrol 200 for Repelling Blackbirds in
Minnesota Field Corn: Third Periodic Report- Avitrol Concentrate. (Unpublished study
received May 18, 1971 under 224-EX-3; prepared by U.S. Fish and Wildlife Service, Den-
ver Wildlife Research Center in cooperation with Minnesota, Dept. of Agriculture and
Agricultural Extension Service, submitted by Phillips Petroleum Co., Bartlesville, Okla.;
CDL: 122743-E)
00003986 Coon, R.A. (1971) Avitrol Program: Ohio-Michigan, 1970. (Unpub- lished study received
Apr 19, 1971 under 224-EX-3; prepared by U.S. Fish and Wildlife Service, Div. of Wildlife
Services, Ohio Office, submitted by Phillips Petroleum Co., Bartlesville, Okla.;
CDL:122743-G)
00003987 Hanson, R.V. (1970) Field Test Project on 4-Amino-pyridine (DRC-1327, Avitrol 200).
(Unpublished study received Apr 19, 1971 under 224-EX-3; prepared by U.S. Fish and
Wildlife Service, Div. of Wildlife Services, North Dakota Office, submitted by Phillips
Petroleum Co., Bartlesville, Okla.; CDL:122743-H)
00003988 Hanson, R.V. (1971) North Dakota Field Tests: First Periodic Report -Avitrol Concentrate.
(Unpublished study received Nov 19, 1971 under 224-EX-3; prepared by U.S. Fish and
Wildlife Ser- vice, Div. of Wildlife Services, North Dakota Office, Submitted by Phillips
Petroleum Co., Bartlesville, Okla.; CDL:122748-A)
59
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00003989 De Grazio, J.W.; Stone, C.P. (1971) South Dakota Field Tests: Avitrol FC Corn Chips.
(Unpublished study received Nov 19, 1971 under 224-EX-3; prepared by U.S. Fish and
Wildlife Service, Denver Wildlife Research Center, submitted by Phillips Petroleum Co.,
Bartlesville, Okla.; CDL:122748-B)
00003991 Phillips Petroleum Company (19??) Toxicity Data Summary: 4-Aminopyridine (Compound
1861; DRC-1327): (Active Component-Avitrol 200 Bird Management). (Unpublished study
received Apr 22, 1969 under 224-EX-3; CDL:122747-C)
00003992 Phillips Petroleum Company (1969) Effectiveness Data: 4-Aminopyridine (Avitrol 200).
(Unpublished study received Apr 22, 1969 under 224-EX-3; CDL: 122747-F)
00003994 U.S. Fish and Wildlife Service. (1968) ?Avitrol 200|. (Un- published study received Apr 22,
1969 under 224-EX-3; submitted by Phillips Petroleum Co., Bartlesville, Okla.;
CDL:122747-K)
00003995 De Grazio, J.W.; Besser, J.F.; Cunningham, DJ. (1969) Project DF- 102: Bird Damage
Control Research. (Unpublished study received Dec 18, 1970 under 224-EX-3; prepared by
U.S. Fish and Wildlife Service, Denver Wildlife Research Center, Section of Birds in
cooperation with Sand Lake National Wildlife Refuge, submitted by Phillips Petroleum Co.,
Bartlesville, Okla.; CDL:122744-A)
00003996 Besser, J.F.; Mott, D.F. (1970) Field Work with 4-Aminopyridine in Idaho Cornfields.
(Unpublished study received Dec 18, 1970 under 224-EX-3; prepared by U.S. Fish and
Wildlife Service, Denver Wildlife Research Center, submitted by Phillips Petroleum Co.,
Bartlesville, Okla.; CDL:122744-B)
00003997 Schafer, E.W., Jr. (1970) A Summary of the Acute Toxicity, Chronic Toxicity, and
Secondary Hazards of 4-Aminopyridine (DRC-1327) to Birds and Mammals. Summary of
studies 122744-D and 122744-E. (Unpublished study received Dec 18, 1970 under 224-EX-
3; prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research Center, submitted
by Phillips Petroleum Co., Bartlesville, Okla.; CDL:122744-C)
00004000 Nelson, J. W. (19??) Field Tests of Avitrol in Virginia. (Unpublished study received Dec 18,
1970 under 224-EX-3; prepared by Virginia Dept. of Agriculture, State Bird Control,
submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL:122744-G)
00004002 De Grazio, J.W.; Besser, J.F.; West, R.R. (1969) Annual Progress Report: Denver Wildlife
Research Center, Calendar Year 1969: DF-102.3-9. (Unpublished study received Jan 20,
1970 under 224- EX-3; prepared by U.S. Fish and Wildlife Service, Denver Wild- life
Research Center, Section of Birds in cooperation with Sand Lake National Wildlife Refuge,
submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL:122744-I)
00004003 Seubert, J.L.; Mitchell, R.T.; Stickley, A.R., Jr.; Francis, W.J.; Dyer, M.I.; Meanley, B.;
Hardy, J.W. (1969) Project: P-F-33: Studies on Methods of Reducing Blackbird and Starling
Popula- tions. (Unpublished study received Jan 20, 1970 under 224-EX-3; prepared by U.S.
Fish and Wildlife Service, Patuxent Wildlife Research Center, submitted by Phillips
Petroleum Co., Bartlesville, Okla.; CDL:122744-J)
00004006 Schafer, E.W., Jr.; Brunton, R.B. (1970) Secondary Hazard Studies with 4-Aminopyridine-
Killed Blackbirds on Avian and Mammalian Predators. (Unpublished study received Jan 20,
1970 under 224- EX-3; prepared by U.S. Fish and Wildlife Service, Denver Wildlife
Research Center, submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL: 122744-M)
00004008 Phillips Petroleum Company (1969) Field Tests, Avitrol FC Corn Chops: First Periodic
Report, Avitrol Concentrate. (Unpublished study received Oct 20, 1969 under 224-EX-3;
prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research Center; CDL:
122744-O)
00004013 Reinert, A. J.; Cantrel, K.E. (1965) Crow Control Tests with Avitrol 200 at Leonard Bend,
Texas. (Unpublished study received on Jul 17, 1970 under 224-EX-2; submitted by Phillips
Petroleum Co., Bartlesville, Okla.; CDL:122742-B)
00004014 Reinert, A. J. (1965) Crow Control Tests with Avitrol 200 at Fulton, Arkansas. (Unpublished
study received Jul 17, 1970 under 224-EX-2; submitted by Phillips Petroleum Co.,
Bartlesville, Okla.; CDL: 122742-D)
00004015 Phillips Petroleum Company (1969) Toxicity Data: ?4-Aminopyridine|. (Unpublished study
received Jul 17, 1970 under 224-EX-3; CDL: 122743-1)
60
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00004031 Besser, J.F. (1970) A Discussion of the Problem of Blackbird Damage to Field Corn.
(Unpublished study received Jan 3, 1973 under 1F1013; prepared by U.S. Fish and Wildlife
Service, Denver Wildlife Research Center, submitted by Phillips Petroleum Co., Bartlesville,
Okla.; CDL:091757-E)
00004032 Phillips Petroleum Company (19??) Laboratory Evaluation of 4-Amino- pyridine Toxicity
and Bait Formulations. (Unpublished study received Jan 3, 1973 under IF 1013; prepared in
cooperation with U.S. Fish and Wildlife Service, Denver Wildlife Research Center;
CDL:091757-F)
00004033 Hanson, R.V. (1969) Field Test Project on 4-Aminopyridine (DRC 1327). (Unpublished
study received Jan 3, 1973 under 1F1013; prepared by U.S. Fish and Wildlife Service,
Denver Wildlife Research Center in cooperation with North Dakota Game and Fish Dept,
submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL:091757-J)
00004034 Hanson, R.V.; Pfeifer, W.K. (1968) Field Test Project on 4-Amino- pyridine (DRC 1327):
North Dakota, 1968. (Unpublished study received Jan 3, 1973 under 1F1013; prepared by
U.S. Fish and Wildlife Service, Denver Wildlife Research Center in coopera- tion with North
Dakota Game and Fish Dept., submitted by Phillips Petroleum Co., Bartlesville, Okla.;
CDL:091757-K)
00004035 Smith, R.N. (1968) Summary: Field Evaluation of Avitrol 200 Used to Protect Large Areas
of Field Corn from Blackbird Depredation in Ohio and Michigan, 1968. (Unpublished study
received Jan 3, 1973 under 1F1013; prepared by U.S. Bureau of Sport Fisheries and Wildlife,
submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL:091757-M)
0000403 6 Winters, R.O. (1969) Field Evaluation of Avitrol 200 Used to Pro- tect Large Areas of Field
Corn from Blackbird Depredations in Ohio, Michigan, and Indiana during Summer 1969.
(Unpublished study received Jan 3, 1973 under 1F1013; prepared by U.S. Fish and Wildlife
Service, submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL:091757-O)
00004041 Winters, R.O. (1969) Field Evaluation of Avitrol 200 Used to Protect Large Areas of Field
Corn from Blackbird Depredations in Ohio, Michigan, and Indiana during Summer 1969.
(Unpublished study received Jan 3, 1973 under 1F1013; prepared by U.S. Fish and Wildlife
Service, submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL:091757-O)
00004042 Besser, J.F. (1973) 4-Aminopyridine Baits for Protecting Sunflowers from Blackbirds in
Tennessee: (Report of Study No. 47, Work Unit DF-102.3). (Unpublished study received
Apr 30, 1974 under 4F1498; prepared by U.S. Fish and Wildlife Service, Denver Wildlife
Research Center, submitted by Avitrol Corp., Tulsa, Okla.; CDL:094836-L)
00004043 Guarino, J.L. (1974) 4-Aminopyridine for Protecting Sunflowers from Blackbirds in Steele
County, North Dakota: (Report of study No. 45, Work Unit DF-102.3). (Unpublished study
including un- dated letter from J.L. Guarino and C.P. Stone to Landowner, received Apr 30,
1974 under 4F1498; prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research-
Center, submitted by Avitrol Corp., Tulsa, Okla.; CDL:094836-M)
00004044 Hanson, R.N. (1969) Field Test Project on 4-Amino-pyridine (ORC 1327, Avitrol 200).
(Unpublished study received Apr 30, 1974 under 4F1498; prepared by U.S. Fish and
Wildlife Service, Div. of Wildlife Services, submitted by Avitrol Corp., Tulsa, Okla.;
CDL:094836-N)
00004045 Hanson, R.V. (1970) Supplemental Test. (Unpublished study received Apr 30, 1974 under
4F1498; prepared by U.S. Fish and Wildlife Services, Div. of Wildlife Services, submitted
by Avitrol Corp., Tulsa, Okla.; CDL:094836-P)
00004046 U.S. Fish and Wildlife Service, Division of Wildlife Services (1971) Field Test Project on 4-
Aminopyridine (DRC-1327, Avitrol 200). (Unpublished study received Apr 30, 1974 under
4F1498; submitted by Avitrol Corp., Tulsa, Okla.; CDL:094836-R)
00004047 U.S. Fish and Wildlife Service, Division of Wildlife Services (1972) Field Test Project on 4-
Aminopyridine (DRC-1327, Avitrol 200). (Unpublished study received Apr 30, 1974 under
4F1498; submitted by Avitrol Corp., Tulsa, Okla.; CDL:094836-S)
00004051 Newsom, J.D.; Wilson, R.C. (1973) An Assessment of Crow Control Techniques in Pecan
Orchards in Louisiana: Project Number LW-56- WU. (Unpublished study including project
no. LW-57-WU, received May 3, 1973 under 11649-8; prepared by Louisiana State Univ.
and Agricultural and Mechanical College in cooperation with U.S. Fish and Wildlife Service,
submitted by Avitrol Corp., Tulsa, Okla.; CDL:220289-A)
61
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00004052 Avitrol Corporation (1973) Avitrol Survey: Bird Damage in Pecans. (Unpublished study
received May 3, 1973 under 11649-8; CDL: 220289-B)
00004053 Reinert, A.J. (19??) Field Tests on Starlings with 1861 at Beardstown, Illinois. (Unpublished
study received Oct 17, 1973 under 11649-1; prepared by Phillips Petroleum Co., submitted
by Avitrol Corp., Tulsa, Okla.; CDL:011002-A)
00004054 Avitrol Corporation (19??) Pigeon Control with 1861 on a Dewey, Oklahoma, School
Building. (Unpublished study received Oct 17, 1973 under 11649-1; CDL:011002-B)
00004056 Marquardt, R.E. (19??) Control of Sparrows and Blackbirds at the Jenkins Rice Mill,
Anahuac, Texas. (Unpublished study received Oct 17, 1973 under 11649-1; prepared by
Phillips Petroleum Co., submitted by Avitrol Corp., Tulsa, Okla.; CDL:011002-D)
0000405 7 Marquardt, R.E. (1962) Use of 1861 for Bird Control at Pantex Storage, Amarillo, Texas.
(Unpublished study received Oct 17, 1973 under 11649-1; prepared by Phillips Petroleum
Co., submitted by Avitrol Corp., Tulsa, Okla.; CDL:011002-E)
00004058 Stansbury, R.E. (1962) Test with 1861 on Pigeons at the University of Arkansas.
(Unpublished study received Oct 17, 1973 under 11649-1; prepared by Phillips Petroleum
Co., submitted by Avitrol Corp., Tulsa, Okla.; CDL:011002-G)
00004059 Reinert, A.J. (1963) Field Tests on Starlings with 1861 near Columbus, Ohio. (Unpublished
study received Oct 17, 1973 under 11649-1; prepared by Phillips Petroleum Co. in
cooperation with U.S. Fish and Wildlife Service, submitted by Avitrol Corp., Tulsa, Okla.;
CDL:011002-H)
00004060 Marquardt, R.E. (1962) Use of Chemical 1861 for Control of Black- birds in Rice fields in
Chambers County, Texas. (Unpublished study received Oct 17, 1973 under 11649-1;
prepared by Phillips Petroleum Co., submitted by Avitrol Corp., Tulsa, Okla.; CDL: 011002-
I)
00004061 Stansbury, R.E. (1962) Use of Chemical 1861 Hydrochloride to Control Crows Menacing
Air Traffic at Standiford Field Airport, Louisville, Kentucky. (Unpublished study received
Oct 17, 1973 under 11649-1; prepared by Phillips Petroleum Co. in cooperation with
Louisville and Jefferson County Air Board, submitted by Avitrol Corp., Tulsa, Okla.;
CDL:011002-J)
00004062 Marquardt, R.E.; Cantrel, K.E. (1963) Herring Gull Tests in New Hampshire, 1962-1963.
(Unpublished study received Oct 17, 1973 under 11649-1; prepared by Phillips Petroleum
Co., submitted by Avitrol Corp., Tulsa, Okla.; CDL:011002-K)
00004063 Avitrol Corporation (1963) Gull Tests in Florida, 1963. (Unpublished study received Oct 17,
1973 under 11649-1; CDL:011002-L)
00004064 Marquardt, R.E.; Cantrel, K.E. (1963) Bird Control Tests with Chemical 1861 at the Martin
Farm, Independence, Kansas, 1962-1963. (Unpublished study received Oct 17, 1973 under
11649-1; prepared by Phillips Petroleum Co., submitted by Avitrol Corp., Tulsa, Okla.;
CDL:011002-M)
00004065 Stansbury, R.E. (1963) Demonstration of 1861 on Gulls at Common- wealth Pier in Boston,
Massachusetts. (Unpublished study received Oct 17, 1973 under 11649-1; prepared by
Phillips Petroleum Co., submitted by Avitrol Corp., Tulsa, Okla.; CDL: 011002-N)
00004067 Baumgartner, P.M. (1962) Report on House Sparrow Management at Southern Great Plains
Field Station, Woodward, Oklahoma, August 16-17, 1962. (Unpublished study received Oct
17, 1973 under 11649-1; prepared by Oklahoma State Univ., Research Foundation,
submitted by Avitrol Corp., Tulsa, Okla.; CDL:011002-T)
00004068 Baumgartner, P.M. (1962) Bird Management Project Progress Report for September, 1962.
(Unpublished study received Oct 17, 1973 under 11649-1; prepared by Oklahoma State
Univ., Research Foundation, submitted by Avitrol Corp., Tulsa, Okla.; CDL:011002-U)
00004069 Baumgartner, P.M. (1962) Report to Phillips Petroleum Company: Bird Management Tests,
January-February, 1962. (Unpublished study received Oct 17, 1973 under 11649-1;
prepared by Oklahoma State Univ., Research Foundation, submitted by Avitrol Corp., Tulsa,
Okla.;CDL:011002-V)
00004070 Baumgardner, R.K. (1962) Chemical Control of House Sparrows in Sunflower Fields.
(Unpublished study received Oct 17, 1973 under 11649-1; prepared by Oklahoma State
Univ., Research Foundation, Bird Management Project, submitted by Avitrol Corp., Tulsa,
62
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Okla.;CDL:011002-W)
00004071 North, C.A. (19??) Evaluation of Selected Chemicals as Bird Management Agents.
(Unpublished study received Oct 17, 1973 under 11649-1; prepared by Oklahoma State
Univ., submitted by Avitrol Corp., Tulsa, Okla.; CDL:011002-X)
00004072 Baumgartner, P.M. (1962) Annual Report to Phillips Petroleum Company July, 1961 -June,
1962: Bird Management Tests. (Unpublished study received Oct 17, 1973 under 11649-1;
prepared by Oklahoma State Univ., Dept. of Zoology, submitted by Avitrol Corp., Tulsa,
Okla.;CDL:011002-Y)
00004073 North, C.A. (1962) Summary of Field Studies, July, 1962-August, 1962 to Phillips
Petroleum Company: Bird Management Tests. (Unpublished study received Oct 17, 1973
under 11649-1; prepared by Oklahoma State Univ., submitted by Avitrol Corp., Tulsa, Okla.;
CDL:011002-Z)
00004074 Avitrol Corporation (1972?) Reasonable Ground sic in Support of the Petition: 4-
Aminopyridine . (Unpublished study received Apr 11, 1973 under 11649-EX-3;
CDL:095015-D)
00004075 Winters, R.O. (1972) Report on Field Trial Use of Avitrol 200 to Protect Sweet Corn.
(Unpublished study received Jun 8, 1972 under 11649-EX-l; prepared by U.S. Fish and
Wildlife Service, Div. of Wildlife Services, submitted by Avitrol Corp., Tulsa, Okla.;
CDL:223541-D)
00004076 Hickman, G.L. (1968) Blackbird-Corn Damage Briefing for SW Idaho and SE Oregon.
(Unpublished study received Jun 8, 1972 under 11649-EX-l; prepared by U.S. Fish and
Wildlife Service, Div. of Wildlife Services, submitted by Avitrol Corp., Tulsa, Okla.;
CDL:223541-F)
00004077 Mott, D.F.; Besser, J.F. (1970?) Project DF-102: Bird Damage Control Research: DF-102.3-
20. (Unpublished study received Jun 8, 1972 under 11649-EX-l; prepared by U.S. Fish and
Wildlife Service, Denver Wildlife Research Center, submitted by Avitrol Corp., Tulsa,
Okla.; CDL:223541-G)
00004078 Guarino, J.L.; Stone, C.P.; Royall, W.C.; Bray, O.E. (1973) DF- 102.3-45~4-Aminopyridine
for Protecting Sunflowers from Blackbirds in Steele Co., North Dakota. (Unpublished study
received Nov 11, 1975 under 11649-15; prepared by U.S. Fish and Wildlife Service, Denver
Wildlife Research Center, submitted by Avitrol Corp., Tulsa, Okla.; CDL:223451-B)
00004079 Besser, J.F.; Cummings, J.L. (1975) Avitrol FC Corn Chops-99 Baits for Protecting
Sunflowers from Blackbirds in North Dakota, Minnesota, and South Dakota: (Report of
Study No. 59, Work Unit DF-102.3). (Unpublished study received Nov 11, 1975 under
11649-15; prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research Center,
submitted by Avitrol Corp., Tulsa, Okla.; CDL:223451-I)
00004082 Besser, J.F. (1975) Relationship of Bird Pressure to the Effectiveness of AvitrolA(R)I FC
Corn Chops-99 for Protecting Cropfields from Blackbirds. Summary of studies 223451-B,
223451-1, 223451- J, 223451-K, 225255-A, 225255-J through 225255-L. (Unpublished study
received Nov 11, 1975 under 11649-15; prepared by U.S. Fish and Wildlife Service, Denver
Wildlife Research Center, submitted by Avitrol Corp., Tulsa, Okla.; CDL:225255-B)
00004084 Dolbeer, R.A.; Stickley, A.R., Jr.; Ingram, C.R. (1974) Efficacy of 4-Aminopyridine in
Protecting Sunflowers from Blackbirds in Ohio: Progress Report: January 1, 1973--
DecemberSl, 1973, Work Unit P-F-33.10. (Unpublished study received Jul 22, 1974 under
11649-15; prepared by U.S. Fish and Wildlife Service, Patuxent Wildlife Research Center,
Section of Animal Depredations Control Studies, submitted by Avitrol Corp., Tulsa, Okla.;
CDL:226529-A)
00004085 Besser, J.F.; Cummings, J.L. (1975) Avitrol FC Corn Chops-99 Baits for Protecting
Sunflowers from Blackbirds in North Dakota, Minnesota, and South Dakota: (Report of
Study No. 59, Work Unit DF-102.3). (Unpublished study including draft, received Apr 28,
1975 under 11649-15; prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research
Center, submitted by Avitrol Corp., Tulsa, Okla.; CDL:225254-A)
00004086 Besser, J.F.; Cunningham, D.J. (1974) 1974 Test Results. (Un- published study received Apr
28, 1975 under 11649-15; prepared by U.S. Fish and Wildlife Service, Denver Wildlife
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63
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00004087
00004090
00004091
00004092
00004093
00004094
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00004098
00004099
00004102
00004103
00004104
00004105
00004108
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Avitrol Corporation (1975) Crop Economics. (Unpublished study received Apr 28, 1975
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Avitrol Corporation (1974) Avitrol: Summary Test Results-Pigeons. (Unpublished study
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Avitrol Corporation (1974) Avitrol on Sparrows and Pigeons. (Unpublished study received
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Barber, E.H. (1974) Report of the Results Obtained in Pigeon Control at the Port of New
Orleans. (Unpublished study received Apr 10, 1975 under 11649-7; prepared by Barber
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Avitrol Corporation (1974?) Introduction: 4-Aminopyridine. (Unpublished study received
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Stickley, A.R., Jr.; Ingram, C.R. (1975) 1974 Test of 4-Aminopyridine (Avitrol) Efficacy in
Preventing Bird Damage to Sweet Corn in New York: Progress Report: January 1, 1974-
December 31, 1974: Work Unit P-F-33.12. (Unpublished study received Mar 18, 1975 under
11649-12; prepared by U.S. Fish and Wildlife Service, Patuxent Wildlife Research Center,
Section of Animal Depradations Control Studies, Ohio Field Station, submitted by Avitrol
Corp., Tulsa, Okla.; CDL:094799-F)
Mitchell, R.T.; Linehan, J.T.; Ingram, C.R.; Meanley, B.; Martin, P.S. (1975) 1974 Test of 4-
Aminopyridine (Avitrol) Efficacy in Preventing Bird Damage to Sweet Corn in Maryland:
Progress Report: January l-December31, 1974: WorkUnitP-F-II-33.13. (Unpublished
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Dolbeer, R.A.; Ingram, C.R. (1975) 1974 Test of 4-Aminopyridine (Avitrol) Efficacy in
Preventing Bird Damage to Sweet Corn in Ohio: Progress Report: January 1, 1974-
December 31, 1974: Work Unit P-F-3 3.11. (Unpublished study received Mar 18, 1975 under
11649-12; prepared by U.S. Fish and Wildlife Service, Patuxent Wildlife Research Center,
Section of Animal Depradations Control Studies, Ohio Field Station, submitted by Avitrol
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Mott, D.F.; Guarino, J.L. (1972) Investigation of Blackbirds and the Damage They Cause
during the Peanut Damage Season in South- central Oklahoma, 1972: (Technical Report No.
6, Work Unit DF- 102.3). (Unpublished study received Feb 15, 1973 under 11649-12;
prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research Center, submitted by
Avitrol Corp., Tulsa, Okla.; CDL: 008284-A)
Mott, D.F.; Besser, J.F.; West, R.R.; De Grazio, J.W. (1972?) Bird Damage to Peanuts and
Methods for Alleviating the Problem. By U.S. Fish and Wildlife Service, Denver Wildlife
Research Center. Washington, D.C.: Dept. of the Interior. (Proceedings, 5th Vertebrate Pest
Control Conference, Mar 7-9, 1972, Fresno, Calif.; also In unpublished submission received
Feb 15, 1973 under 11649-12; submitted by Avitrol Corp., Tulsa, Okla.; CDL:008284-B)
West, R.R.; Besser, J.F.; De Grazio, J.F. (1969) Project DF-102: Bird Damage Control
Research: DF-102.3-10. (Unpublished study received Feb 15, 1973 under 11649-12;
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Schafer, E.W. (1972?) Acute Toxicity of 4-Aminopyridine to 40 Animal Species.
(Unpublished study received Feb 15, 1973 under 11649-12; submitted by Avitrol Corp.,
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Yates, J. (1967) Use of Avitrol Process for Pigeon Control. (Un- published study received
Jan 2, 1968 under 224-12; prepared by Redd Pest Control Co., submitted by Phillips
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Parmenter, R.E. (1967) Final Report: Investigations of the Usability of Avitrol 200-D29 as a
Pigeon Repellent. (Unpublished study including preliminary report, received Jan 2, 1968
under 224-12; prepared by Abalene Pest Control Service, Inc., submitted by Phillips
64
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Petroleum Co., Bartlesville, Okla.; CDL:229844-D)
00004113
00004114
00004115
00004116
00004117
00004120
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00004123
00004126
00004127
00004128
00004130
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Custom Chemical Specialties (1968) Avitrol Field Tests. (Unpublished study received 1968
under unknown admin, no.; prepared in cooperation with Brown & Bryant, Inc. and Soilserv,
Inc., submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL: 221959-C)
De Grazio, J.W.; Besser, J.F.; Guarino, J.L.; West, R.R. (1967) Annual Progress Report:
Wildlife Research Work Unit: Denver Wildlife Research Center: Calendar Year 1967: Work
Unit F-4.1: Control of Blackbird Damage to Corn in South Dakota. (Unpublished study
received Apr 23, 1968 under 224-EX-3; prepared by U.S. Fish and Wildlife Service, Denver
Wildlife Research Center, Section of Birds in cooperation with Sand Lake National Wildlife
Refuge and South Dakota Dept. of Game, Fish and Parks, submitted by Phillips Petroleum
Co., Bartlesville, Okla.; CDL: 122746-A)
Hanson, R.V. (1968) Field Test Project on 4-Amino-pyridine (DRC 1327, Avitrol 200),
Season 1967. (Unpublished study received Apr 23, 1968 under 224-EX-3; prepared by U.S.
Fish and Wild- life Service, Div. of Wildlife Services in cooperation with Denver Wildlife
Research Center and North Dakota Game and Fish Dept., submitted by Phillips Petroleum
Co., Bartlesville, Okla.; CDL:122746-B)
De Grazio, J.W.; Schafer, E.W., Jr.; Besser, J.F. (1967) Baiting Experiments. (Unpublished
study received May 22, 1967 under 224-EX-3; prepared by U.S. Fish and Wildlife Service,
Denver Wildlife Research Center, submitted by Phillips Petroleum Co., Bartlesville, Okla.;
CDL:122746-C)
Phillips Petroleum Company (19??) Results of a Laboratory Test to Determine the Rate of
Degradation of 4-Aminopyridine in Soil: Good-67-66R. (Unpublished study received May
16, 1966 under 224-EX-3; CDL:122746-D)
Phillips Petroleum Company (1969) Field Test Project on 4-Aminopyridine (DRC-1327).
(Unpublished study received Apr 24, 1970 under 224-EX-3; prepared in cooperation with
U.S. Fish and Wildlife Service, Div. of Wildlife Services, Denver Wildlife Re- search Center
and North Dakota Game and Fish Dept.; CDL: 122745-D)
Phillips Petroleum Company (1968) Ohio Field Evaluation of Avitrol 200 Used to
Discourage Blackbird Depredation to Field Corn. (Unpublished study including summary
report, received Apr 15, 1969 under 224-EX-3; CDL:122745-F)
Hanson, R.V.; Pfeifer, W.K. (1969) Field Test Project on 4-Aminopyridine (DRC 1327,
Avitrol 200). (Unpublished study received Apr 15, 1969 under 224-EX-3; prepared by U.S.
Fish and Wild- life Service, Div. of Wildlife Services in cooperation with Denver Wildlife
Research Center and North Dakota Game and Fish Dept., submitted by Phillips Petroleum
Co., Bartlesville, Okla.; CDL:122745-G)
Starr, B. (19??) Thin-Layer Chromatography~Avitrol. (Unpublished study received Apr 15,
1969 under 224-EX-3; prepared by U.S. Fish and Wildlife Service, Denver Research Center,
submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL:122745-J)
Avitrol Corporation (1975) Avitrol: Summary Test Results-Star- lings, Blackbirds in
Feedlots. (Unpublished study received Apr 10, 1975 under 11649-5; prepared in cooperation
with Ag Pest Control, Inc., Loyal Pest Control and American Fertilizer, Inc.; CDL: 119811-
C)
De Grazio, J.W.; Besser, J.F.; Guarino, J.L.; West, R.R. (1969) Annual Progress Report:
Denver Wildlife Research Center: Calendar Year 1968: Project DF-102: Bird Damage
Control Research: Work Unit DF-102.3. (Unpublished study received Jan 9, 1969 under 224-
EX-3; prepared by U.S. Fish and Wildlife Service, Den- ver Wildlife Research Center,
Section of Birds in cooperation with Sand Lake National Wildlife Refuge and South Dakota
Dept. of Game, Fish and Parks, submitted by Phillips Petroleum Co., Bartlesville, Okla.;
CDL:122745-K)
Phillips Petroleum Company (1968) Periodic Report for Avitrol FC Corn Chops
Concentrate. (Unpublished study received Sep 30, 1968 under 224-EX-3; CDL:122745-O)
Avitrol Corporation (19??) Toxicity Data Summary: 4-Aminopyridine (Compound 1861;
DRC-1327). (Unpublished study received Sep 28, 1972 under 11649-EX-5; CDL:222250-D)
65
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00004133 U.S. Fish and Wildlife Service, Division of Wildlife Services (1972) Field Test Project on 4-
Amino-pyridine. (Unpublished study received Mar 5, 1973 under 3G1297; submitted by
Avitrol Corp., Tulsa, Okla.; CDL:094671-K)
0000413 8 Larson, B. (1966) Starling Control Using Avitrol 200 Concentrate and Sugar Mixture.
(Unpublished study received Aug 24, 1966 under 224-EX-4; prepared by Paramount Pest
Control, Inc., submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL: 122749-A)
00004139 Hyatt, H.W. (1966) Starling Control Using Avitrol 200 Concentrate Sugar Mixture.
(Unpublished study received Aug 24, 1966 under 224-EX-4; submitted by Phillips Petroleum
Co., Bartlesville, Okla.; CDL:122749-B)
00004140 Hyatt, H.W. (1965) Starling Control Using Avitrol 200 Concentrate Sugar Mixture.
(Unpublished study received Aug 24, 1966 under 224-EX-4; submitted by Phillips Petroleum
Co., Bartlesville, Okla.; CDL:122749-C)
00004141 Paramount Pest Control Service (1965) Resume of Avitrol Bird Management Process for
Hales Brothers Building Service Performed City of Oakland, California. (Unpublished study
including let- ter dated Sep 15, 1965 from E.W. Bushing to Phillips Petroleum Co. and letter
dated Sep 20, 1965 from H.W. Hilts to Phillips Petroleum Co., received Jun 27, 1967 under
224-EX-6; submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL:122751-A)
00004142 Scott, J.F.R., Jr. (1964) Report of Crow Infestation at Friendship International Airport,
Baltimore, Maryland. (Unpublished study received on unknown date under unknown admin.
no.; prepared by City of Baltimore, Dept. of Aviation, Friendship International Airport;
submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL:122739-A)
00004143 Goodhue, L.D. (19??) 4-Aminopyridine (AvitrolA(R)I): Toxicology Report. (Unpublished
study received Jun 16, 1972 under unknown admin, no.; submitted by Avitrol Corp., Tulsa,
Okla.; CDL: 210151-B)
00004144 Hanson, R.V.; Pfeifer, W.K. (1969) Field Test Project on 4-Aminopyridine (DRC 1327,
Avitrol 200). (Unpublished study received Jun 16, 1972 under unknown admin, no.; prepared
by U.S. Fish and Wildlife Service, Div. of Wildlife Services, submitted by Avitrol Corp.,
Tulsa, Okla.; CDL:210151-F)
00004145 Hanson, R.V. (1970) Field Test Project on 4-Amino-pyridine (DRC-1327, Avitrol 200).
(Unpublished study including supplement data, received Jun 16, 1972 under unknown
admin, no.; prepared by U.S. Fish and Wildlife Service, Div. of Wildlife Services, submitted
by Avitrol Corp., Tulsa, Okla.; CDL:210151-G)
00004146 Hanson, R. (1970) Field Test Project on 4-Amino-pyridine (DRC-1327, Avitrol 200).
(Unpublished study received Jun 16, 1972 under unknown admin, no.; prepared by U.S. Fish
and Wildlife Service, Div. of Wildlife Services, submitted by Avitrol Corp., Tulsa, Okla.;
CDL:210151-H)
00004267 Avitrol Corporation (19??) Pesticidal Safety: (4-Aminopyridine). (Unpublished study
received Feb 15, 1973 under 11649-12; CDL: 008284-E)
00004269 Goodhue, L.D. (19??) Toxicity Data Summary: 4-Aminopyridine (Compound 1061; DRC-
1327) (Active Component-Avitrol 200 Bird Management). (Unpublished study received on
unknown date under 3G1384; submitted by Avitrol Corp., Tulsa, Okla.; CDL:097036-B)
00014378 Phillips Petroleum Company (19??) Compound 1861 Hydrochloride. (Unpublished study
received on unknown date under 1F1013; CDL: 098629-D)
00021884 Trott, R.L. (1974?) Introduction and Summary: Avitrol FC Corn Chops-99|. (Unpublished
study received Mar 18, 1975 under 11649-12; submitted by Avitrol Corp., Tulsa, Okla.;
CDL: 094800-A)
00021886 Avitrol Corporation (19??) Laboratory Evaluation of 4-Aminopyridine Toxicity and Bait
Formulations. (Unpublished study received Mar 18, 1975 under 11649-12; CDL:094800-C)
00021887 Goodhue, L.D. (19??) 4-Aminopyridine (AvitrolA(R)I Toxicology Re- port. (Unpublished
study received Mar 18, 1975 under 11649-12; submitted by Avitrol Corp., Tulsa, Okla.;
CDL:094800-D)
00021888 Avitrol Corporation (19??) 4-Aminopyridine (Compound 1861; DRC- 1327). (Unpublished
study received Mar 18, 1975 under 11649-12; CDL:094800-E)
00021889 Bray, O.E. (1973) Telemetry Study of Red-Winged Blackbirds Damaging Sunflowers in
North Dakota, 1972. (Unpublished study received Mar 18, 1975 under 11649-12; prepared
66
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00021894 Besser, J.F. (1973) 4-Aminopyridine Baits for Protecting Sunflowers from Blackbirds in
Tennessee. (Unpublished study received Mar 18, 1975 under 11649-12; prepared by U.S.
Fish and Wildlife Ser- vice, Denver Wildlife Research Center, submitted by Avitrol Corp.,
Tulsa, Okla.; CDL:094800-K)
00021895 Guarino, J.L. (1974) 4-Aminopyridine for Protecting Sunflowers from Blackbirds in Steele
County, North Dakota. (Unpublished study received Mar 18, 1975 under 11649-12; prepared
by U.S. Fish and Wildlife Service, Denver Wildlife Research Center, submitted by Avitrol
Corp., Tulsa, Okla.; CDL:094800-L)
00021896 Hanson, R.V.; Pfeifer, W.K. (1971) Field Test Project on 4-Aminopyridine (DRC-1327,
Avitrol 200). (Unpublished study received Mar 18, 1975 under 11649-12; prepared by U.S.
Fish and Wildlife Service, Div. of Wildlife Services, submitted by Avitrol Corp., Tulsa,
Okla.; CDL:094800-M)
00021898 Avitrol Corporation (1970?) Pesticidal Safety: (4-Aminopyridine). (Unpublished study
received Mar 18, 1975 under 11649-12; CDL: 094800-Q)
00021899 Avitrol Corporation (19??) Toxicology: Mathematical Approach: Consumer Safety from
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00022550 U.S. Environmental Protection Agency (1979) Summary or Reported Pesticide Incidents
Involving Aminopyridine: Pesticide Incident Monitoring System Report No. 137. (U.S. EPA,
Office of Pesticide Programs, Benefits and Field Studies Div., Human Ef- fects Monitoring
Branch; unpublished report.)
00022560 U.S. Fish and Wildlife Service, Division of Wildlife Services (1972) Avitrol 200: Toxicity to
Birds). (Unpublished report.)
00027851 Heinrichs, L.; Maher, J. (1976) Determination of Prometon and Simazine in
PramisA(TM)I80WDG Formulation by Gas Chromatography. Method no. PA-91A-T dated
Jan 20, 1976. (Unpublished study received Oct 10, 1978 under 100-602; submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:235343-B)
00030610 De Grazio, J.W.; Besser, J.F.; Guarino, J.L.; et al. (1969) A method for appraising blackbird
damage to corn. Journal of Wildlife Management 33(4): 988-994. (Also In unpublished
submission received Jan 3, 1973 under 1F1013; submitted by Phillips Petroleum Co.,
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00030611 De Grazio, J.W.; Besser, J.F.; Guarino, J.L. (1969) Winter distribution of blackbirds as
related to corn damage control in Brown County, South Dakota. Pages 131-136, in
Transactions of the Thirty-Fourth North American Wildlife and Natural Resources
Conference; Mar 2-5, 1969. Washington, D.C.: Wildlife Management Institute. (Also in
unpublished submission received Jan 3, 1973 under 1F1013; submitted by Phillips Petroleum
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0003 0613 Maryland Board of Natural Resources (1967) A Report on the Problem of Damage to
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00030614 Avitrol Corporation (19??) Crop Economics. (Unpublished study received Sep 28, 1972
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00030617 Jensma, J.R. (1973) International conference reflects ascendancy of the sunflower. World
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00030618 Kinnear, H. (1973) Keep an eye on the sunflower. American Farmer ? (?/Feb):4-5. (Also In
unpublished submission received on un- known date under 3G1297; submitted by Avitrol
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00033899 Hagen, D. (1968) Sunflowers: New threat to soybeans. Farm Journal, Western Edition
92(12):31,36. (Also In unpublished submission received Jul 20, 1972 under 3G1297;
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00050977 Swindle, K.F. (1973) Letter sent to James M. Rea dated Jul 24, 1973 Supporting use of
Avitrol to control crows in pecan orchards. (Unpublished study received Jul 26, 1973 under
67
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11649-8; submitted by Avitrol Corp., Tulsa, Okla.; CDL:227059-B)
00050978 Brady, K.L. (1971) Letter sent to A. Merrill Schnitzer dated Oct 13, 1971 Data on use of
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00050979 Ogden, R.D. (1971) Letter sent to A. Merrill Schnitzer dated Nov 11, 1971 Data on the use
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00050981 Ogden, R.D. (1971) Letter sent to A. Merrill Schnitzer dated Nov 11, 1971 Data on the use
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00050982 Hayenga, R.V. (1972) Letter sent to Fred Rauscher dated Jun 9, 1972 Avitrol for use in bird
control|. (Unpublished study received Apr 30, 1974 under 4F1498; prepared by Minnesota
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00050983 Duitsman, W.W. (1963) Letter sent to Richard E. Marquardt dated Apr 12, 1963 Bird
Control|. (Unpublished study received Oct 17, 1973 under 11649-1; prepared by Kansas
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00050985 Besser, J.F. (1975) Letter sent to Richard Trott dated Mar 11, 1975 Relationship between
blackbird pressure and protection|. (U.S. Fish and Wildlife Service, unpublished study; CDL:
094799-C)
00050986 Pfeifer, W.K. (1968) Letter sent to A. Merrill Schnitzer dated Dec 23, 1968: Periodic Report,
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00050987 Gnegy, D.C. (1968) Letter sent to A. Merrill Schnitzer dated Dec 23, 1968 Toxicity of
Avitrol to non-target species of birds). (U.S. Fish and Wildlife Service, Div. of Wildlife
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00050988 MacLachlan, J. (1967) Letter sent to Fred C. Oberst dated Jun 12, 1967 Outline of bird
control program at Utica Public Library . (Unpublished study received Jun 27, 1967 under
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00050989 Haggerty, C.C. (1965) Letter sent to Gene Jackson dated Sep 14, 1965 Use of Avitrol in
pigeon control|. (Unpublished study received Jun 27, 1967 under 224-EX-6; prepared by
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00050991 Fisher, C.W. (1965) Letter sent to Kenneth W. Seed dated Sep 15, 1965: Technical
information exchange. (Unpublished study received Jun 27, 1967 under 224-EX-4; prepared
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00134510
00134511
00145584
00150203
00150204
00158101
00158103
00158104
05003185
05003191
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46789600
46789601
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US EPA (1989) Submission of Pesticide Use Data in Support of the 4-Aminopyridine
Registration Standard. Transmittal of 3 studies.
US EPA (1980) EPA Index to Pesticide Chemicals: 4-Aminopyridine: c069201. Unpublished
study. 34 p.
US EPA (1980) Preliminary Quantitative Usage Analysis of Avitrol. Unpublished study. 7 p.
US EPA (1979) Pesticide Chemical Use Pattern Profile for 4-Aminopyridine. Unpublished
study. 20 p.
IR-4 (2006) Submission of Pesticide Use Data in Support of the Amended Registration of
Crop Group 20 - Oilseed Group. Transmittal of 1 Study.
Chen, H. (2006) Crop Group 20 - Oilseeds, Technical Amendment (Addition) to 40 CFR
180.41 (c). Unpublished study prepared by Interregional Research Project No. 4. 334 p.
69
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05003185 Starr, R.I.; Cunningham, DJ. (1975) Leaching and degradation of 4-aminopyridine-14C in
several soil systems. Archives of Environmental Contamination and Toxicology 3(l):72-83.
40603603 Pesselman, R.; Kennedy, G.; Hofman, M.; et al. (1987) 4-Aminopyri- dine~Physical and
Chemical Characteristics: HLA 6001-170: HLA 6001-197. Unpublished study prepared by
Hazleton Laboratories America, Inc. 259 p.
00003999 Schafer, E.W.; Lockyer, N. (19??) The Effects of DRC-1327 Baits on Mourning Doves.
(Unpublished study received Dec 18, 1970 under 224-EX-3; prepared by U.S. Fish and
Wildlife Service, Denver Wildlife Research Center, submitted by Phillips Petroleum Co.,
Bartlesville, Okla.; CDL:122744-E)
00004101 Besser, J.F. (1968) Compilation of Information on the Chronic Toxicity of 4-Aminopyridine
to Pheasant, Quail and Starlings. (Unpublished study received Mar 2, 1973 under 11649-12;
prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research Center, submitted by
Avitrol Corp., Tulsa, Okla.; CDL:120117-A)
00003998 Schafer, E.W., Jr.; Brunton, R.B.; Lockyer, N. (1970) The Chronic Toxicity of DRC-1327 to
Mourning Doves: Preliminary Report No. 16--W. J. DF-102.2. (Unpublished study received
Dec 18, 1970 under 224-EX-3; prepared by U.S. Fish and Wildlife Ser- vice, Denver
Wildlife Research Center, submitted by Phillips Petroleum Co., Bartlesville, Okla.;
CDL:122744-D)
00147985 Fink, R.; Reno, F. (1976) Eight-day Dietary LC50 - Mallard Duck 4-Aminopyridine: Final
Report: Project No. 684-105. Unpublished study prepared by Hazleton Laboratories
America, Inc. 10 p.
05003186 Schafer, E.W.; Brunton, R.B.; Lockyer, N.F. (1975) The effects of subacute and chronic
exposure to 4-aminopyridine on reproduction in coturnix quail. Bulletin of Environmental
Contamination and Toxicology 13(6):758-764.
00086682 Knittle, C.E.; Besser, J.F.; Guarino, J.L.; et al. (1981) Further Evaluations of 1:29 Avitrol
Treatments To Protect Ripening Sun- flower from Blackbird Damage in North Dakota: Bird
Damage Research Report No. 202. (U.S. Fish and Wildlife Service, Denver Wildlife
Research Center; unpublished study; CDL: 246228-A)
00003985 U.S. Fish and Wildlife Service, Denver Research Laboratory (19??) Toxicity of Avitrol to
Bluegill and Channel Catfish at Selected Water Qualities and Temperatures: Table.
(Unpublished study received May 18, 1971 under 224-EX-3; prepared in cooperation with
La Crosse Fish Control Laboratory, submitted by Phillips Petroleum Co., Bartlesville, Okla.;
CDL:122743-F)
00004083 Schafer, E.W., Jr.; Marking, L.L. (1974?) Long Term Effects of 4-Aminopyridine Exposure
to Birds and Fish. (Unpublished study received Nov 11, 1975 under 11649-15; prepared by
U.S. Fish and Wildlife Service, Wildlife Research Center in cooperation with Fish Control
Laboratories, submitted by Avitrol Corp., Tulsa, Okla.; CDL:225255-C)
00004111 Palazzolo, R.J. (1963) Report to Phillips Petroleum Company: Toxicity to Salt Water Life of
Compound 1861 Hydrochloride. (Unpublished study received Jan 2, 1968 under 224-12;
prepared by Industrial Bio-Test Laboratories, Inc., submitted by Phillips Petroleum Co.,
Bartlesville, Okla.; CDL:229844-F)
00067838 Baumgartner, P.M. (1962) Phillips Petroleum Company Project: Secondary Poisoning of
Cats and Dogs by Eating Birds Affected by Chemically Treated Baits. (Unpublished study
received Jun 14, 1962 under unknown admin, no.; submitted by Phillips Petroleum Co.,
Bartlesville, Okla.; CDL:103064-A)
00085360 Baumgartner, P.M. (1962) Phillips Petroleum Company Project: Secondary Poisoning of
Cats and Dogs by Eating Birds Affected by Chemically Treated Baits. (Unpublished study
received May 2, 1962 under unknown admin, no.; submitted by Phillips Petroleum Co.,
Bartlesville, Okla.; CDL:103071-A)
00004001 Starr, R.I.; Cunningham, D.J. (1970) Translocation and Degradation of 4-Aminopyridine in
Corn Plants-Its Movement and Degradation in Soil Systems: ?Third Periodic Report,
Avitrol Concentrate|. (Unpublished study received Apr 24, 1970 under 224-EX-3; pre- pared
by U.S. Fish and Wildlife Service, Denver Wildlife Re- search Center, submitted by Phillips
Petroleum Co., Bartlesville, Okla.; CDL:122744-H)
70
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00004037 Starr, R.I.; Cunningham, DJ. (19??) Phytotoxicity. (Unpublished study received Jan 3, 1973
under 1F1013; prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research
Center, submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL:091757-R)
00004124 Starr, R.; Cunningham, D.; Brunton, R. (1966?) Absorption and Translocation of 4-
Aminopyridine by Corn Plants. (Unpublished study received Apr 15, 1969 under 224-EX-3;
prepared by U.S. Fish and Wildlife Service, Denver Research Center, submitted by Phillips
Petroleum Co., Bartlesville, Okla.; CDL:122745-H)
00004132 Starr, R.I.; Cunningham, DJ. (1972) Fate of 4-Aminopyridine in Corn, Sorghum, and Soil
Systems: A Summary of Research Findings. (Unpublished study received Apr 16, 1973
under 3G1320; prepared by U.S. Fish and Wildlife Service, Bureau of Sport Fisheries and
Wildlife, submitted by Avitrol Corp., Tulsa, Okla.; CDL:093548- A)
00004147 Matlock, R.S.; Oswalt, R.M. (1963?) Report of Sunflower Research in Oklahoma.
(Unpublished study received Jun 16, 1972 under un- known admin, no.; prepared by
Oklahoma State Univ., Dept. of Agronomy, submitted by Avitrol Corp., Tulsa, Okla.;
CDL:210151-I)
00109573 Avitrol Corp. (1973) Efficacy of 4-Aminopyridine Baits and Other Products Used To
Control Blackbird Damage to Sunflowers. (Compilation; unpublished study received Oct 17,
1973; Mar 5, 1973 under 11649-EX-2; CDL:248060-A)
001095 77 Avitrol Corp. (1974) Efficacy Testing of Avitrol-Sunflowers|. (Compilation of reports by
various government agencies; unpublished study; CDL:248063-A)
00109579 Starr, R.; Cunningham, D. (19??) Fate of 4-Aminopyridine in Corn, Sorghum, and Soil
Systems. A Summary of Research Findings. (Unpublished study received Nov 27, 1972
under 11649-EX-5; submitted by Avitrol Corp., Tulsa, OK; CDL:248064-B)
00131325 Starr, R. (1972) The absorption, translocation, and metabolism of 14C-4-aminopyridine in
corn and sorghum: Its movement and de- gradation in soil systems. Dissertation Abstracts
International (XXIII)6. (Also In unpublished submission received Feb 11, 1974 under
3G1384; submitted by Avitrol Corp., Tulsa, OK; CDL: 071822-A)
05003440 Starr, R.I.; Cunningham, DJ. (1974) Phytotoxicity, absorption, and translocation of 4-
aminopyridine in corn and sorghum growing in treated nutrient cultures and soils. Journal of
Agricultural and Food Chemistry 22(3):409-413.
00003991 Phillips Petroleum Company (19??) Toxicity Data Summary: 4-Aminopyridine (Compound
1861; DRC-1327): (Active Component-Avitrol 200 Bird Management). (Unpublished study
received Apr 22, 1969 under 224-EX-3; CDL:122747-C)
00003997 Schafer, E.W., Jr. (1970) A Summary of the Acute Toxicity, Chronic Toxicity, and
Secondary Hazards of 4-Aminopyridine (DRC-1327) to Birds and Mammals. Summary of
studies 122744-D and 122744-E. (Unpublished study received Dec 18, 1970 under 224-EX-
3; prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research Center, submitted
by Phillips Petroleum Co., Bartlesville, Okla.; CDL:122744-C)
00004006 Schafer, E.W., Jr.; Brunton, R.B. (1970) Secondary Hazard Studies with 4-Aminopyridine-
Killed Blackbirds on Avian and Mammalian Predators. (Unpublished study received Jan 20,
1970 under 224- EX-3; prepared by U.S. Fish and Wildlife Service, Denver Wildlife
Research Center, submitted by Phillips Petroleum Co., Bartlesville, Okla.; CDL: 122744-M)
00004015 Phillips Petroleum Company (1969) Toxicity Data: 4-Aminopyridine|. (Unpublished study
received Jul 17, 1970 under 224-EX-3; CDL: 122743-1)
00004032 Phillips Petroleum Company (19??) Laboratory Evaluation of 4-Amino- pyridine Toxicity
and Bait Formulations. (Unpublished study received Jan 3, 1973 under IF 1013; prepared in
cooperation with U.S. Fish and Wildlife Service, Denver Wildlife Research Center;
CDL:091757-F)
00004105 Schafer, E.W. (1972?) Acute Toxicity of 4-Aminopyridine to 40 Animal Species.
(Unpublished study received Feb 15, 1973 under 11649-12; submitted by Avitrol Corp.,
Tulsa, Okla.; CDL: 008284-D)
00004131 Avitrol Corporation (19??) Toxicity Data Summary: 4-Aminopyridine (Compound 1861;
DRC-1327). (Unpublished study received Sep 28, 1972 under 11649-EX-5; CDL:222250-D)
00004269 Avitrol Corporation (19??) Toxicity Data Summary: 4-Aminopyridine (Compound 1861;
DRC-1327). (Unpublished study received Sep 28, 1972 under 11649-EX-5; CDL:222250-D)
71
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00021886 Avitrol Corporation (19??) Laboratory Evaluation of 4-Aminopyridine Toxicity and Bait
Formulations. (Unpublished study received Mar 18, 1975 under 11649-12; CDL:094800-C)
00021887 Goodhue, L.D. (19??) 4-Aminopyridine (AvitrolA(R)I Toxicology Re- port. (Unpublished
study received Mar 18, 1975 under 11649-12; submitted by Avitrol Corp., Tulsa, Okla.;
CDL:094800-D)
00150203 Schwemley, J. (1980) Toxicity Data [Avitrol]. Unpublished study prepared by Avitrol
Corporation. 15 p.
05003191 Schafer, E.W., Jr.; Brunton, R.B.; Lockyer, N.F.; De Grazio, J.W. (1973) Comparative
toxicity of seventeen pesticides to the Quelea, house sparrow, and red-winged blackbird.
Toxicology and Applied Pharmacology 26(1): 154-157.
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Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available via the Agency's website at
http://www.epa.gov/opprd001/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on your
computer then printed).
2. The completed form(s) should be submitted in hard copy in accord with the existing policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA regulations
covering your request, to the address below for the Document Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551 or by
e-mail at Williams.nicole(a),epa.gov.
The following Agency Pesticide Registration Forms are currently available via the Internet at the
following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution
of a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (PR
Notice 98-5)
Data Matrix (PR Notice 98-5)
Summary of the Physical/Chemical Properties (PR
Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (PR Notice 98-1)
http://www.epa.Kav/opprd001/forms/8570-l.pdf
http://www.epa.sov/opprd001/forms/8570-4.pdf
http://www. epa.sov/opprdOOl/forms/85 70-5. pdf
http://www. epa.sov/opprdOOl/forms/85 70-1 7.pdf
http://www.epa.zov/opprd001/forms/8570-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www. epa.sov/opprdOOl/forms/85 70-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www.epa.zov/opprd001/forms/8570-32.pdf
http://www. epa.zov/opppmsdl/PR Notices/pr98-5.pdf
http://www. epa.zov/opppmsdl/PR Notices/pr98-5.pdf
http://www.epa.zov/opppmsdl/PR Notices/pr98-l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-l.pdf
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Pesticide Registration Kit http://www. epa.gov/pesticides/registrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug
and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of
1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is
in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR Notices
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will
require the Acrobat reader).
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require the
Acrobat reader).
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF
format)
e. 40 CFR §156, Labeling Requirements for Pesticides and Devices (PDF format)
f. 40 CFR § 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional
sources of information. These include:
1. The Office of Pesticide Programs' website.
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2. The booklet "General Information on Applying for Registration of Pesticides in the United
States," PB92-221811, available through the National Technical Information Service (NTIS)
at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161-0002
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center
for Environmental and Regulatory Information Systems. This service does charge a fee for
subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614
or through their website.
4. The National Pesticide Information Center (NPIC) can provide information on active
ingredients, uses, toxicology and chemistry of pesticides. You can contact NPIC by
telephone at (800) 858-7378 or through their website at http:/Avww.ncis.orst.edu.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
encloses with his submission a stamped, self-addressed postcard. The postcard must contain the
following entries to be completed by OPP:
• Date of receipt;
• EPA identifying number; and
• Product Manager assignment.
Other identifying information may be included by the applicant to link the acknowledgment of
receipt to the specific application submitted. EPA will stamp the date of receipt and provide the
EPA identifying file symbol or petition number for the new submission. The identifying number
should be used whenever you contact the Agency concerning an application for registration,
experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind"
codes used when a sample was submitted for testing by commercial or academic facilities).
Please provide a chemical abstract system (CAS) number if one has been assigned.
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