United States Prevention, Pesticides EPA 738-R-08-0002
Environmental Protection and Toxic Substances March 2008
Agency (7508P)
vvEPA
Reregistration
Eligibility Decision
for Triforine
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Reregistration Eligibility Decision (RED) for
Triforine
ListB
Case No. 2720
Approved by: g
Steven Bradbury, Ph.D.
Director, Special Review and Reregistration Division
/
Date:
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Table of Contents
Table of Contents 5
EPA Triforine Team 6
I. Introduction 8
II. Chemical Overview 9
A. Regulatory History 9
B. Chemical Identification 9
C. Use Profile 11
III. Summary of Triforine Risk Assessments 12
A. Human Health Risk Assessment 12
1. Toxicity of Triforine 12
2. Exposure/Risk Pathway 14
B. Environmental Risk Assessment 17
1. Environmental Fate and Transport 17
2. Environmental Effects and Risk 17
IV. Risk Management and Reregistration Decision 20
A. Determination of Reregistrati on Eligibility 20
B. Requirements for Reregistrati on 21
1. Required Data 21
2. Risk Mitigation 21
C. Regulatory Rationale 21
1. Human Health and Ecological Risk 21
2. Endocrine Screening 22
3. Endangered Species 22
V. What Registrants Need to Do 23
A. Manufacturing Use Products 23
1. Additional Generic Data Requirements 23
2. Labeling for Manufacturing-Use Products 25
B. End-Use Products 25
1. Additional Product-Specific Data Requirements 25
2. Labeling for End-Use Products 25
C. Labeling Changes Summary Table 25
Appendix A: Use Patterns Subject to Reregistrati on 29
Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision 30
Appendix C. Technical Support Documents 33
Appendix D. Citations Considered to be Part oflhe DataBase SuppordnglheReregislralionEligibilily Decision ...34
Appendix E. List of Available Related Documents and Electronically Available Forms 38
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EPA Triforine Team
Environmental Fate and Effects Division
Keara Moore
Stephen Carey
Stephanie Syslo
Health Effects Division
Christine Olinger
Linda Taylor
Toiya Goodlow
Jeff Dawson
Kit Farwell, D. V.M.
Registration Division
Mary Waller
Special Review and Reregistration Division
Cathryn O'Connell
Nikhil Mallampalli
Tom Myers
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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
ESTAC Endocrine Disrupter Screening and Testing Advisory Committee
ED WC Estimated Drinking Water Concentration
EEC Estimated Environmental Concentration
EPA Environmental Protection Agency
ESA Endangered Species Act
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)
GRAS Generally Recognized As Safe
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.
LOC 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
WP S 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 triforine. 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 triforine 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-2008-0196.
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II.
Chemical Overview
A. Regulatory History
Triforine was first registered in the United States by American Cyanamid in 1976 for
use as a fungicide on ornamentals and a variety of food crops. All food uses were voluntarily
cancelled in 1996 and the associated tolerances were revoked in a final rule published on July
23, 2004 (69 FR 43918) (FRL-7358-6). Outside the United States, triforine continues to be
used on food crops, turf, and ornamentals. Summit Agro acquired the one technical product in
May 2005.
A DCI was issued to the technical registrant in January 1991. Because of the many crop
uses of triforine this DCI included data requirements for ecological, environmental fate,
toxicology, and residue chemistry. In the registrant's response to the DCI, they indicated that
they were no longer going to support the food uses of triforine and only maintain the non-food
uses. All indoor food uses and terrestrial food uses were removed from their labels. In 1995, a
DCI was mailed to the remaining registrants of triforine to allow them the opportunity to
support these uses by submitting the required data. In subsequent responses to the DCI, all
registrants removed food uses and only non-food uses now remain on the triforine labels. In
October 1995 a DCI was mailed to the registrants which included data requirements for re-entry
exposure.
There are currently four active Section 3 registrations for triforine. No tolerance exists
for commodities treated with triforine. Table 1 presents the supported registrations that contain
triforine as an active ingredient.
Table 1: Supported Registrations for Triforine
Registration #
82534-1
239-2435
239-2476
239-2594
Product Name
Triforine Technical
Ortho Rose Disease Control
Ortho Systemic Rose & Floral Spray
Orthenex Insect & Disease Control
Formula III
Active Ingredients (AI)
Triforine
Triforine
Triforine
Resmethrin
Acephate
Triforine
Fenbutatin-oxide
Acephate
%AI
97
6.5
0.1
0.1
0.25
3.25
0.75
4
B.
Chemical Identification
Triforine is a systemic fungicide with protectant, eradicant, and curative characteristics.
Chemical information about the structure and physiochemical properties of triforine are
presented in Tables 2 and 3.
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Table 2: Test Compound Nomenclature-Triforine
Chemical Structure
Empirical Formula
Common Name
EPA PC Code
IUPAC name
CAS Name
CAS Registry Number
C13C N H
1 T
N 0
u
^N^ 0
Cl C-^N-^H
3 H
C10H14C16N402
Triforine
107901
[piperazine-1 ,4-diylbis(2,2,2-trichloroethane- 1 , 1 -diyl)]diformamide
N,N' -[ 1 ,4-piperazinediylbis(2
,2,2-trichloroethylidene)]bisformamide
26644-46-2
Table 3: Physiochemical Properties
Parameter
Molecular Weight
Melting point/range
pH at 20 °C
Density (g/mL at 20-26 °C)
Water solubility (g/L at 20°C)
Solvent solubility (g/100 mL at 19.5 °C)
Vapor pressure (25°C)
Dissociation constant, pKa (20 °C)
Octanol/water partition coefficient,
logKow (25°C)
UV/visible absorption spectrum
Value
434.98
151. 3-154.1 °C, color change
from white to light brown at
148.6 °C
An aqueous dispersion
varied from pH 5.57-8.33
1.554
Distilled water- 12.5 x 10"3
Water,pH5-11.3xlO-3
Water, pH 7- 9.0 x 10'3
Water, pH 9- 8.7 x 10'3
Methanol- 4.69
Toluene- 0.0 11
Tetrahydrofuran- 16.8
Hexane, flask- <0.47 x 10"3
Hexane, colum- 0.26
8.0 x 10"2 Pa
(6.0 x 10"4 mm Hg)
2.4 xlO"11 (pKa= 10.6 ±0.2)
1.6xl02, logKow=2.2in
MeOH[HPLC ratio of
equilibrium concentrations in
a 2-phase system]
Not Available
Reference
MRIDs 420 19601, -02, and
42172704
MRIDs 42795801, -02
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c.
Use Profile
Type of Pesticide:
Target Pests:
Mode of Action:
Use Sites:
Formulation Type:
Application Methods:
Application Rates:
Fungicide
Black spot, rust, and powdery mildew
Inhibition of sterol biosynthesis in fungi membranes
Registered for use on ornamentals including roses, trees,
herbaceous plants, woody shrubs and vines.
Liquid concentrate (emulsifiable concentrate) and ready-to-use
pressurized liquid (aerosol can)
Hose-end sprayers, low pressure handwand sprayers, sprinkling
cans, backpack sprayers, and aerosol cans
0.46 Ib ai/acre for liquid sprays. Reapplication can be made as
early as 3 days.
Application Timing: When first signs of disease appear.
Technical Registrant: Summit Agro (USA) Corporation
Uses Considered for Reregi strati on
Table 4 lists the labeled uses considered for reregi strati on.
Table 4: Summary of Registered Triforine Uses
Crop
Ornamentals
Target
Fungal
diseases
(powdery
mildew,
black spot,
rust)
Formulations
Liquid
concentrates
(3.25 & 6.5
percent)
Aerosol can
(0.1%)
Maximum Application Rate and
Frequency of Application
0.0021 Ib triforine/gallon of
finished spray or 0.46 Ib ai/acre for
liquid sprays
&
Aerosols are applied as needed
Retreatments can be made at 3-4 or
7-10 days depending on the product
Application
Equipment
hose-end sprayers, low
pressure handwand
sprayers, sprinkling
cans, backpacks
(limited use expected),
and aerosol cans
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III. Summary of Triforine 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. 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-
2008-0196, 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. The
human health and ecological risk assessments and supporting documents listed below and
referenced in Appendix C were used to formulate the regulatory decision for the pesticidal use
of triforine.
Triforine: REVISED HED Chapter of the Reregistration Eligibility Decision Document.
Olinger, C. et al. Dated 3-11-08.
Revised Drinking Water Assessment for Reregistration of Triforine for Use on
Ornamentals. Moore, K. Dated 03-05-08.
Revised Level I Baseline Ecological Risk Assessment for the Reregistration of Triforine.
Moore, K., and Carey, S. Dated 03-05-08.
o
o
o
A.
Human Health Risk Assessment
The human health risk assessment addressed potential exposure and risks from all
registered uses. Triforine is not registered for use on any food commodities and risk is not
expected from drinking water sources, due to its use pattern, its fate characteristics, the low
potential for drinking water exposure given the small-scale residential nature of the labeled use
and its toxicity profile. Triforine products are sold predominantly in the residential marketplace
where it is used by gardeners to control various plant diseases primarily on roses but it can be
used on other ornamental plants. For the complete human health risk assessment, refer to
Triforine: REVISED HED Chapter of the Reregistration Eligibility Decision Document
(Olinger, C. et al., Dated 3-11-08), which is available in the public docket.
1.
Toxicity of Triforine
The toxicological database for triforine is sufficient for risk assessment purposes.
Triforine has low to moderate (Category III) toxicity via the dermal route of exposure and is a
minor eye irritant (Category III). It is not acutely toxic via the oral or inhalation routes of
exposure (Category IV), it is not a dermal irritant (Category IV) and is negative for skin
sensitization. Table 5 summarizes the acute toxicity profile of triforine.
Table 5: Acute Toxicity Profile - Triforine
Guideline
No.
870.1100
870.1200
870.1300
Study Type
Acute oral [rat]
Acute dermal [rabbit]
Acute inhalation [rat]
MRID
42172701
42172702
42172703
Results
LD50 > 5000 mg/kg
LD50 = >2000 mg/kg
LC50 = >5.12mg/L
Toxicity
Category
IV
III
IV
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Table 5: Acute Toxicity Profile - Triforine
Guideline
No.
870.2400
870.2500
870.2600
Study Type
Acute eye irritation [rabbit]
Acute dermal irritation [rabbit]
Skin sensitization [guinea pig]
MRID
42380407
42380408
42380409
43396901
Results
Conjunctival redness in 1
rabbit at 24 hrs. [score 1];
cleared by 48 hrs.
Not an irritant
Not a dermal sensitizer
Toxicity
Category
III
IV
Not
Applicable
Effects observed in subchronic and chronic toxicity studies were generally not severe.
Liver effects included increased liver weights, increased cholesterol levels, and increased
alkaline phosphatase levels. A mild anemia was seen in several studies, apparently caused by
damage to red blood cells because the bone marrow responded by increasing production of red
blood cells.
No maternal or developmental toxicity was observed in the rat in the developmental
toxicity study at significant dose levels. In the rabbit, decreased maternal body weight and food
consumption and decreased fetal body weight were the only effects observed at the limit dose.
Slight reproductive effects such as decrease in testes weight, were observed in the rat
reproduction study at doses above the limit dose.
Developmental or reproductive toxic effects from triforine are not of concern. Some
reproductive toxicity effects such as decreased testes weight, decreased male fertility, were
observed at doses higher than the limit dose. No toxic reactions were observed in a 21-day
dermal toxicity study at doses up to 1100 mg/kg/day which is higher than the limit dose. It is
not a dermal sensitizer or dermal irritant. Triforine does not appear to be neurotoxic and there
are no specific concerns for pre- and post-natal exposure to triforine. Therefore, no uncertainty
factors specifically for children's pre- or post-natal exposures are included in the risk
assessment.
Triforine has been classified as, "suggestive evidence of carcinogenicity, but not
sufficient to assess human carcinogenic potential." This was based on tumors seen in both
sexes of one species (mice) only at the limit dose (liver tumors in male mice and lung tumors in
female mice). Therefore, there is no quantification of cancer risk for triforine.
A point of departure 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 environmentally relevant human exposures. Table 6 contains selected points of departure
for the triforine human health risk assessments.
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Table 6: Summary of Toxicological Doses and Endpoints for Triforine for Use in Human Health
Risk Assessments
Exposure/
Scenario
All Dietary
Scenarios
Incidental Oral
Short-Term (1-
30 days) and
Intermediate-
Term (1-6
months)
Dermal Short-
and
Intermediate-
Term
Inhalation
Short-Term (1-
30 days) and
Intermediate-
Term (1-6
months)
Cancer (oral,
dermal,
inhalation)
Point of
Departure
Uncertainty
Factors
Level of
Concern for
Risk
Assessment
Study and Toxicological Effects
No risk is expected from this exposure scenario as no hazard was identified in any toxicity study
for this duration of exposure. Based on the use pattern for triforine, acute and chronic dietary
exposure is not anticipated.
Based on the use pattern for triforine, incidental oral exposure is not anticipated.
No risk is expected from this exposure scenario as no hazard was identified in a 21 -day dermal
toxicity study conducted at the limit dose.
NOAEL = 23
mg/kg/day
(inhalation and
oral toxicity
are assumed to
be equivalent)
UFA= lOx
UFH=10x
Occupational
and
Residential
LOCforMOE
<100
Subchronic/chronic oral toxicity study -
dog
LOAEL = 120 mg/kg/day, based on
decreased RBC, hematocrit, hemoglobin
values, increased spleen weight, and
siderosis in the liver, spleen, and bone
marrow
Classification: "Suggestive Evidence of Carcinogenicity, but not sufficient to assess human
carcinogenic potential" based on two adequate rodent carcinogenicity studies. Quantification of
human carcinogenic risk is not required for triforine.
POD = Point of Departure. 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). MOE = margin of exposure.
LOG = level of concern.
2. Exposure/Risk Pathway
Dietary Exposure
Because the use of triforine on roses and other plants is a non-food use and all
tolerances from prior registrations have been revoked, there is no expectation of dietary
exposures through food consumption. Therefore, the only dietary exposure considered in this
assessment is from drinking water. There are Maximum Residue Limits established for
triforine in other countries, and a list is included in the Triforine RevisedHED Chapter, page
16.
Drinking Water
Triforine is moderately persistent in soil with a half-life of one to several months and it
degrades rapidly in water through hydrolysis and photolysis with half-lives of several days.
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Due to its rapid hydrolysis and aquatic photolysis, any triforine that reaches drinking water
sources would not be long-lived so there is a low probability of exposure. Triforine is intended
for small-scale use by individual homeowners; it is marketed as either 14 oz spray cans or in
volumes of one pint to one quart, which can treat a maximum of 0.3 A. Use data from the
California Department of Pesticide Regulation (CDPR) suggests that typical use by professional
applicators is at rates of <0.05 Ib a.i./application. No water monitoring data are available for
triforine.
Tier I screening level models were used to quantify the upper bound for drinking water
exposure by calculating estimated drinking water concentrations (EDWCs). EDWCs are based
on the highly conservative assumption that an entire watershed has been treated with triforine at
the maximum application rate, so these values likely overestimate potential exposure. The
EDWC for annual average exposure (from surface or ground water sources) is less than one
ppb. Considering the toxicity profile for triforine, the fate characteristics, the use pattern, and
the very low EDWC, there is no concern from dietary exposure in drinking water.
Residential (Non-Occupational) Handler Exposure and Risk
Triforine is available as a consumer product used predominantly on roses for control of
black spot, powdery mildew, and rust. Triforine can also be used on various ornamental and/or
shade trees as well as ornamental herbaceous plants, woody shrubs and vines. The residential
risk assessment addresses inhalation exposures that individuals receive through their use of
consumer products that contain triforine and through inhalation exposures they could receive
from frequenting areas that have been previously treated with triforine such as park or home
ornamental gardens. No quantitative dermal assessment has been conducted because there were
no systemic effects observed in the 21-day dermal toxicity study at the limit dose. Based on the
use pattern no incidental oral exposure is expected.
Non-cancer risk estimates are expressed as a margin of exposure (MOE) which is a ratio
of the dose from a toxicological study selected for risk assessment, typically a NOAEL, to the
predicted exposure. Estimated MOEs are compared to a level of concern which reflects the
dose selected for risk assessment and uncertainty factors (UFs) applied to that dose. The
standard UF is 100X, which includes 10X for interspecies extrapolation (to account for
differences between laboratory animals and humans) and 10X for intraspecies variation (to
account for differences among humans). For triforine, MOEs greater than 100 for inhalation
exposure do not exceed the Agency's level of concern.
The anticipated use patterns and current labeling indicate several residential exposure
scenarios, based on the types of equipment and techniques, in which homeowners can be
exposed to triforine during the application process. Intermediate- and long-term exposures are
not expected and were not calculated for residential handlers, because of the sporadic nature of
applications by homeowners.
The quantitative inhalation risk assessment developed for residential handlers is based
on a number of scenarios that include handling liquid concentrates with various hand-held
application equipment as well as application with aerosol cans. Although there is information
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to suggest that triforine is not typically used in greenhouses, there is nothing on labels to
prohibit this use. Since the rate of triforine used in greenhouses would be the same as the
outdoor use of triforine, the estimated risk would be the same as well. All of the residential
short-term handler inhalation scenarios have MOEs that are greater than the target MOE of 100
by a wide margin. MOEs are greater than 50,000; therefore, the risks are below EPA's level of
concern. EPA evaluated both Pesticide Handlers Exposure Database (PHED) and Outdoor
Residential Exposure Task Force (ORETF) data for several of the handler scenarios. Both sets
of data result in a similar risk conclusion in that triforine risks are not of concern and by a
similar wide margin.
Residential (Non-Occupational) Post-application Exposure Assessment
The term "post-application" describes exposure to individuals who enter areas
previously treated with pesticides. For triforine, a quantitative post-application risk assessment
was not conducted because (1) incidental oral exposure was not expected since the primary uses
of triforine are for disease control on roses and other ornamental plants where children would
not be expected to routinely contact treated plants and engage in mouthing behaviors; and (2)
triforine is relatively not volatile which, coupled with the dilution expected outdoors and the
small amounts of active ingredient used, diminish the possibility of post-application inhalation
exposure. Therefore, there is no concern for post-application exposures to triforine.
Aggregate Exposure and Risk
There are no registered food uses for triforine and all tolerances for triforine have been
revoked. Due to the use of triforine and its environmental fate properties, significant drinking
water exposure is not expected. All the residential exposures do not exceed the Agency's level
of concern. Therefore, there is no concern for aggregate exposure to triforine.
Cumulative Risk Characterizing/Assessment
EPA has not identified a common mechanism for triforine and any other substances.
Triforine does not appear to produce a toxic metabolite produced by other substances.
Occupational Exposure and Risk
Although the primary marketplace for triforine is for residential gardeners, an
occupational assessment was conducted to ensure that if use by professionals did occur that the
anticipated higher daily use rates and frequency for occupational users would be considered.
Occupational exposures can occur because people have contact with triforine residues while
using commercial products containing triforine (handlers) or by being in areas that have been
previously treated (post-application workers). The only occupational exposure route included
in this risk assessment is the inhalation route. Effects from dermal exposures are not expected.
The scenarios associated with triforine use were classified as having short-term (from 1
to 30 days) and intermediate-term (from 30 days to several months) exposures. However,
intermediate-term exposures for triforine are unlikely because of its limited use pattern, low
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historic use, and low frequency of use by commercial applicators. Long-term exposures are
also not expected to occur for the same reasons.
The quantitative inhalation risk assessment developed for occupational handlers is based
on a number of scenarios that include handling liquid concentrates with various hand-held
application equipment as well as application with aerosol cans. Although there is information
to suggest that triforine is not typically used in greenhouses, there is nothing on labels to
prohibit this use. Since the rate of triforine used in greenhouses would be the same as the
outdoor use of triforine, the estimated risk would be the same as well. All of the occupational
short- and intermediate-term handler inhalation scenarios have MOEs that are much greater
than the target MOE of 100. Without the use of a respirator, MOEs were greater than 9,000;
therefore, the risks are below EPA's level of concern. EPA evaluated both PHED and ORETF
data for several of the handler scenarios. Both sets of data result in a similar risk conclusion in
that triforine risks are not of concern and by a similar wide margin.
B. Environmental Risk Assessment
The Agency has conducted an environmental fate and effects risk assessment for
triforine for the purpose of making a reregi strati on decision. The fate database for triforine is
largely complete. The available data are sufficient to characterize the transport, mobility, and
degradation of triforine in the environment. The ecological database for triforine is largely
complete for terrestrial and aquatic animals. However, the ecological database for both aquatic
and terrestrial plants is not complete and additional data is required. A summary of the
environmental risk assessment findings and conclusions is provided below. For more detail on
the ecological exposure and risk assessment, see the Revised Level I Baseline Ecological Risk
Assessment for the Reregistration of Triforine (Moore, K., and Carey, S., Dated 03-05-08).
1. Environmental Fate and Transport
The environmental fate database for parent triforine is largely complete but there are
gaps in identifying degradates and characterizing their fate. Triforine is a moderately mobile
compound (Kocis from 99 mL/goc to 199 mL/goc) that is moderately persistent in soil, with half-
lives on the scale of weeks to months, and has rapid abiotic degradation in aquatic
environments. Aquatic exposure may be to the degradates of triforine formed through
hydrolysis and photolysis. No physical/chemical or environmental fate data are available for
these degradates and ecological toxicity from these degradates are unknown. For the purposes
of this assessment, aquatic degradates are assumed to be as persistent and to have equal toxicity
as the parent.
2. Environmental Effects and Risk
To estimate potential ecological risk, EPA integrated the results of exposure and
ecotoxicity studies using the risk quotient method. Risk quotients (RQs) are calculated by
dividing exposure estimates by ecotoxicity values, both acute and chronic, for various wildlife
species. RQs are then compared to the Agency's levels of concern (LOCs), indicating whether
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a pesticide, when used as labeled, has the potential to cause adverse effects on non-target
organisms (see Table 7 below). Generally, the higher the RQ, the greater the potential risk.
Risk characterization provides further information on the likelihood of adverse effects
occurring by considering the fate of the chemical in the environment, communities and species
potentially at risk, their spatial and temporal distributions, and the nature of the effects observed
in studies.
Table 7: EPA's Levels of Concern and Associated Risk Presumptions
Risk Presumption
Acute Risk - there is potential for acute risk
Acute Endangered Listed Species - endangered
species may be adversely affected
Chronic Risk - there is potential for chronic risk
LOC
Terrestrial Animals
0.5
0.1
1
LOC
Aquatic Animals
0.5
0.05
1
LOC
Plants
1
1
Not Assessed
Aquatic Organism Risk
The Agency used modeling to derive estimated environmental concentrations (EECs)
for triforine in surface water to represent a variety of aquatic habitats, such as ponds adjacent to
treated areas, which are relevant to risk assessment for aquatic animals.
Acute
Available acute toxicity data indicate that triforine is no more than slightly toxic to
freshwater fish at the maximum solubility limit (LCso >11 mg ai/L) and moderately toxic to
freshwater invertebrates (ECso = 8.95 mg ai/L). Since a definitive acute toxicity threshold could
not be established for freshwater fish, RQs were not quantitatively estimated. Based on the
available information there is no indication of risk for freshwater fish from acute exposure to
triforine as a result of the labeled uses. For freshwater invertebrates, RQs were estimated based
on the most conservative aquatic exposure scenario. The freshwater invertebrate RQ for acute
exposure is 0.03 and does not exceed the acute listed species LOC of 0.05.
There is a potential for acute exposure to estuarine/marine fish and invertebrates, but
acute risks were not estimated because toxicity data were not available. There are some
uncertainty regarding the potential acute risks to estuarine/marine fish and invertebrates;
however, given the limited residential use of triforine combined with the indication of minimal
risk for freshwater animals, acute risks to estuarine/marine fish and invertebrates are likely
minimal.
There is only one non-vascular plant study available for triforine. A Tier II toxicity
study with green algae indicates that triforine adversely affects cell density. Based on the most
conservative aquatic exposure scenario for triforine, which assumes 20 applications at a rate of
0.46 Ibs. a.i./A, the peak EEC is 0.23 mg ai/L, the acute RQ for non-target plants is less than
0.01, which is well below the LOC of 1. Endangered species risk to aquatic non-vascular plants
could not be calculated because the green algae NOAEC was below the lowest concentration
18
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tested and an ECos as a surrogate could not be calculated without the raw data of individual
replicate measurements.
Data are not available to evaluate the risk of triforine to aquatic vascular plants (i.e.,
duckweed). The potential impact to aquatic vascular plants from exposure to triforine is
unknown. However, data from the open literature and a history of phytotoxicity incidents to
terrestrial vascular plants suggest that triforine may pose a risk to non-target aquatic vascular
plants. Additional data are required in order to assess the potential risk of triforine to aquatic
vascular plants.
Chronic
Data were not available to evaluate the chronic risk of triforine to freshwater fish and
invertebrates or to estuarine/marine fish and invertebrates. Therefore, the potential risks to
these organisms are unknown. There is some uncertainty regarding the potential chronic risk to
these organisms. Given the limited residential use of triforine combined with the indication of
minimal acute risk for freshwater animals, chronic risk to aquatic animals are likely minimal.
Terrestrial Organism Risk
Birds
Triforine is categorized as practically non-toxic to birds based on studies using upland
game birds (bobwhite quail) and waterfowl (mallard duck) on an acute oral basis (LD50 >2000
mg ai/kg-bw) and subacute dietary route (LD50 >5000 mg ai/kg-diet). Since definitive acute
oral toxicity thresholds were not established in the submitted toxicity studies, acute avian RQs
were not estimated for birds. However, due to the high LDsos, and relatively low potential for
exposure, birds are not at risk to adverse effects of survival from acute oral exposure to triforine
as a result of the labeled uses of triforine.
For chronic exposure, bird species are potentially at risk to adverse effects of growth
and reproduction from chronic dietary exposure to triforine as a result of the labeled uses.
Results of chronic studies with triforine indicate that waterfowl and upland game birds are
equally sensitive with reproductive effects of eggshell thinning and cracked eggs being
observed at 500 mg ai/kg-diet, resulting in a NOAEC of 100 mg ai/kg-diet. Based on the most
conservative terrestrial scenario with multiple (20) applications of triforine and maximum
predicted residue levels (upper bound EECs), chronic RQs range between 3.7 and 8. This
exceeds the Chronic Risk LOG (LOG >1.0) for birds consuming short grass, tall grass,
broadleaf forage/small insects. For a single application of triforine, the Chronic Risk and
Endangered Species LOG of 1 is exceeded only for birds foraging short grass (RQ = 1.1).
Although there are exceedances of the chronic LOG, the potential for risk of adverse effects to
growth and reproduction is based on the assumption that birds are feeding exclusively within
residential areas where roses, flowers, shrubs, and shady trees are grown. These exceedances to
birds are based on the assumption that birds occupy, exclusively and permanently, the area of
registered uses, and foraging feed items with triforine residues. To the extent that those birds
19
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do not reside exclusively and permanently within the area, exposure will be less and risk is
presumably less.
Mammals
The acute LD50 (>5000 mg ai/kg bw) for mammals is greater than the highest
concentration tested, suggesting that triforine is practically non-toxic to mammals on an acute
oral basis. Since a definitive acute toxicity threshold was not established, acute mammalian
RQs were not estimated; however, mammals are not likely to be at risk from acute oral
exposure to triforine as a result of the labeled uses.
Results of chronic toxicity studies with rats indicated an NOAEC of 3000 mg ai/kg-diet
for reproductive and offspring effects. Based on the maximum application rate of triforine at
0.46 Ib ai/A and maximum predicted residue levels (upper bound EECs), the chronic risk and
endangered species LOG (LOG >1.0) is exceeded for 15 and 35 g mammals consuming short
grass at 7 and 8 applications, respectively. Although there is an exceedance of the chronic
LOG, the potential for risk of adverse effects to growth and reproduction is based on the
assumption that mammals are feeding exclusively within residential areas where roses, flowers,
shrubs, and shady trees are grown and treated with triforine. The exceedance to mammals that
weigh 15 and 35 grams is based on the assumption that small and medium sized mammals
occupy, exclusively and permanently, the area of registered uses, and foraging feed items with
triforine residues. To the extent that those mammals do not reside exclusively and permanently
within the area, exposure will be less and risk is presumably less. In addition, the RQs
calculated from average estimated environmental concentrations did not exceed LOCs.
Non-target insects
Acute contact honeybee studies indicate that triforine is practically non-toxic to honey
bees(LD50>100|ig/bee).
Terrestrial Plants
Open literature and approximately nine incidents reported impacts to terrestrial plants
from the approved non-crop uses of triforine. Given the available information the potential risk
to non-target terrestrial plants cannot be precluded at this time and there are assumed to be
direct effects from triforine. Additional data are required in order to assess the potential risk of
triforine to terrestrial plants.
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
20
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of products containing triforine 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 triforine.
The Agency has completed its assessment of the human health and ecological risks
associated with the use of pesticide products containing triforine. The Agency has determined
that triforine products are eligible for reregi strati on provided label amendments are made to
implement these mitigation measures, as outlined in Chapter V. Appendix A summarizes the
uses of triforine 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 triforine, 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 reregistration requirements identified in this document, the Agency may
take regulatory action to address these concerns.
B. Requirements for Reregi strati on
Triforine 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 label changes.
1. Required Data
Triforine products are eligible for reregi strati on provided that registrants submit data as
required by the 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 triforine uses has been
reviewed and determined to be adequate to support a reregi strati on eligibility decision, except
for data deficiencies in plant toxicity data. Additional plant toxicity data are required to better
characterize risk to non-target plants.
2. Risk Mitigation
Products containing triforine are eligible for reregi strati on provided the specific labeling
requirements required in Table 9 are reflected on the triforine labels.
C. Regulatory Rationale
The Agency has determined that triforine is eligible for reregi stration 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 triforine will not
present risks inconsistent with FIFRA.
1. Human Health and Ecological Risk
EPA has conducted human health and ecological risk assessments for triforine to
support the reregi strati on eligibility decision. EPA concluded that there are no outstanding
21
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human health risks due to the use of triforine as a pesticide product that are below the Agency's
level of concern.
In EPA's ecological risk assessment, a number of exceedances were estimated from use
of triforine, specifically concerning chronic risk to mammals and birds, as well as potential risk
for plants. Although there are exceedances of the chronic LOG for birds and mammals, the
potential for risk is based on the assumption that birds and mammals are feeding exclusively
within residential areas where roses, flowers, shrubs, and shady trees are grown. To the extent
that those birds and mammals do not reside exclusively and permanently within the area,
exposure will be less and risk is presumably less.
Since there is currently no limit on the number of times triforine may be used in a year,
a statement will be added to all labels limiting the number of applications per year to 20 for all
triforine use sites. The following statement is also required for all triforine labels in order to
reduce the opportunity for ecological exposure of triforine:
"Do not apply directly to or near water, storm drains, gutters, sewers, or drainage ditches. Do
not apply when windy. To prevent product run-off, do not over water the treated area(s) to the
point of runoff or apply when raining or when rain is expected that day. Rinse application
equipment over lawn or garden area only."
Additional required label changes for triforine are included in Table 9.
2. Endocrine Screening
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. 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 the pesticidal use of triforine.
3. 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
adversely modify designated critical habitat. To analyze the potential of registered pesticide
22
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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 the pesticidal use of triforine 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 triforine 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
triforine "may affect" listed species or their designated critical habitat, EPA will employ the
provisions in the Services regulations (50 CFR Part 402).
V. What Registrants Need to Do
The Agency has determined that the products containing triforine (PC 107901) 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 9. The Agency intends to
issue a Data Call-In (DCI) requiring generic and 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
No fate data is required. However, ecological toxicity data for plants is required as
listed below.
23
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Table 8: Generic Data Requirements for Triforine
Guideline #
850.4100
850.4150
850.4400
122-l(a)
122-l(b)
123-2
Data Requirement
Seedling Emergence - Tier I
Vegetative Vigor - Tier I
Aquatic plant acute EC50
(duckweed)
Data Justification
Data are not available to evaluate the risk of triforine to aquatic vascular plants (i.e.,
duckweed) or terrestrial plants. The potential impacts to these plants from exposure to triforine
are unknown. However, data from the open literature and a history of phytotoxicity incidents to
terrestrial vascular plants suggest that triforine may pose a risk to non-target aquatic vascular
and terrestrial plants.
Due to the potential for surface run-off or spray drift, EPA has expanded the seedling
emergence and vegetative vigor data requirements to terrestrial food and feed crops, aquatic
food crops, and residential outdoor uses. These factors trigger a data requirement for
submission of plant studies for the triforine.
During the triforine RED process, the Agency has finalized its update to the data
requirements in 40 CFR part 158. These updated data requirements were promulgated on
October 26, 2007. Tier I seedling emergence, vegetative vigor, and aquatic vascular studies are
required for terrestrial and aquatic nonfood uses. These phytotoxicity data are needed to
evaluate the level of pesticide exposure to non-target terrestrial and aquatic plants and to assess
the impact of pesticides on endangered and threatened plants.
A solid understanding of the potential risks to terrestrial plants is essential for sound
environmental management because plants form the basis of most habitats and significantly
contribute to overall environmental quality. Without plant growth data for triforine, the Agency
cannot determine the levels of triforine that result in effects to terrestrial and aquatic plants.
The Agency now requires that seedling emergence and vegetative vigor studies be
conducted using the typical end use product (TEP). The TEP that contains the highest
percentage of active ingredient, and/or is the most commonly used, would be required. In
addition, the Agency recommends the seedling emergence and vegetative vigor toxicity tests
include one of the ten lettuce cultivars (Avondefiance, Deciso, Kares, Lobjoits cos, Plucos,
Vigar, All the Year Round, Romano, Valmaine or Winter Density) that may be susceptible to
triforine.
Since EPA was unable to evaluate the potential risks to terrestrial plants in dry and
semi-aquatic areas and aquatic vascular plants in water bodies associated with the proposed
uses of triforine, risks are presumed for terrestrial and aquatic vascular plants. Data from Tier I
terrestrial and aquatic vascular plant toxicity studies will be used to estimate potential risks to
plants associated with uses of triforine. The data will reduce uncertainties associated with the
24
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current risk assessment for terrestrial and aquatic plants and will improve our understanding of
the potential effects of triforine on plants.
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 9.
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.
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 9. Generally, conditions for the distribution and sale of products bearing old
labels/labeling will be established when the label changes are approved. However, specific
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 9 describes how language on the labels should be amended.
25
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Table 9: Summary of Labeling Changes for Triforine -
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 9. Summary of Labeling Changes for Triforine
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
For all Manufacturing Use
Products
"Only for formulation into afimgicide for the following use(s) [fill blank only with
those uses that are being supported by MP registrant]."
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 supported by a
formulator or user group
"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 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)."
Directions for Use
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
"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
26
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End Use Products
PPE Requirements
Established by the RED
"All mixers, loaders, applicators, and other handlers must wear the following PPE:
- long-sleeved shirt and long pants, and
- shoes plus socks."
Immediately
following/below
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
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. 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.)
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. jf no sucn
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
27
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Application Restrictions
"Do not apply this product in a way that will contact any person or pet, either directly
or through drift. Keep people and pets out of the area during application."
Directions for Use
under General
Precautions and
Restrictions
Entry Restrictions for liquids
and aerosol formulations
"Do not allow people or pets to enter the treated area until sprays have dried.
Directions for use
under General
Precautions and
Restrictions
Environmental Hazard
Statement
"Do not apply directly to water. Do not contaminate water when disposing of
equipment wash waters or rinsate.
Precautionary
Statements
immediately
following the User
Safety
Recommendations
Other Application
Restrictions
"Do not apply directly to or near water, storm drains, gutters, sewers, or drainage
ditches. Do not apply when windy. To prevent product run-off, do not over water the
treated area(s) to the point of runoff or apply when raining or when rain is expected
that day. Rinse application equipment over lawn or garden area only.*"
* Note: Do not include the last sentence for ready-to-use products.
For all uses of triforine:
The maximum number of applications allowed per year is 20.
Directions for Use
under Other Use
Precautions
28
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Appendix A: Use Patterns Subject to Reregi strati on
Use Site
Maximum
Application Rate
Formulation2
Maximum
Number of
Applications
per Year
Minimum
Application
Interval
Application Equipment //Type
TERRESTRIAL NON-FOOD & OUTDOOR RESIDENTIAL USES
ornamental and/or shade
trees
ornamental herbaceous
plants
ornamental woody shrubs
and vines
0.46 Ib. ai/acre
Formulated as 0. 1% ai
per can
0.46 Ib. ai/acre
Formulated as 0. 1% ai
per can
0.46 Ib. ai/acre
Formulated as 0. 1% ai
per can
EC
PRL
EC
PRL
EC
PRL
20
20
20
20
20
20
7 days
7 days
3 days
7 days
3 days
7 days
Hose-end sprayer/ Tank-type
sprayer //Spray
Aerosol can //Spray
Hose-end sprayer/ Tank-type
sprayer //Spray
Aerosol can //Spray
Hose-end sprayer/ Tank-type
sprayer //Spray
Aerosol can //Spray
1 Current product labels for products containing triforine express maximum application rates equivalent to 0.0021 pounds active ingredient per gallon.
At EPA's request, the registrant converted pounds active ingredient per gallon to pounds active ingredient per acre. The assumptions used to calculate
this rate are presented in the June 20, 2007 email from Carrie Daniels to Lance Wormell.
2 EC: Emulsifiable Concentrate; PRL: Pressurized Liquid.
29
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Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregi strati on
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.
30
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APPENDIX B.
Data Requirement
New
Guideline
Number
Old
Guideline
Number
Description
Use Patterns
Citations
PRODUCT CHEMISTRY
830.1550
830.7560
830.7000
830.7200
830.7300
830.7370
830.7840
830.7860
830.7950
61-1
63-11
63-12
63-5
63-7
63-10
63-8
63-8
63-9
Product Identity and
Composition
Octanol Water Partition
coefficient
pH
Melting Point
Density
Dissociation Constants in Water
Solubility
Water solubility, generator
column method
Vapor Pressure
All
All
All
All
All
All
All
All
All
42019601,42019602,
42172704
42795802,42795801
42019601,42019602,
42172704
42019601,42019602,
42172704
42019601,42019602,
42172704
42019601,42019602,
42172704
42172704,42019601,
42019602
42019601,42019602,
42172704
42019601,42019602,
42172704
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2300
850.2300
850.1010
850.1075
850.3020
850.4100
850.4150
850.4400
850.5400
71-1A
7 1-2 A
71-2B
7 1-4 A
71-4B
72-2
72-1
141-1
122-1A
122-1B
123-2
122-2
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Freshwater Invertebrate Toxicity
Freshwater Fish Toxicity
Rainbow Trout
Honey bee acute contact LD50
Seedling Emergence - Tier I
Vegetative Vigor - Tier I
Aquatic Plant Toxicity
Aquatic Plant Growth
C
C
C
C
C
C
C
C
C
C
C
C
232695, 122589,
42428401,42380401
42380403
42380402,
43231901
43231902
42380406, 44388302
42380404, 42380405,
44388301
42453101
Data Gap
Data Gap
Data Gap
42879901,42879902
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
81-1
81-2
81-3
81-4
81-5
81-6
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Skin Irritation
Dermal Sensitization
All
All
All
All
All
All
42172701
42172702
42172703
42380407
42380408
42380409,43396901
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Data Requirement
New
Guideline
Number
870.3100
870.3150
870.3200
870.3700A
870.3700B
870.3800
870.4100A
870.4100B
870.4200
870.4300
870.5375
870.5395
870.5550
870.7485
Old
Guideline
Number
82-1A
82-1B
82-2
83-3A
83-3B
83-4
83-1A
83-1B
83-2B
83-5
84-2
84-2
84-2
85-1
Description
Subchronic Oral Toxicity: 90-
Day Study Rodent
Subchronic Oral Toxicity: 90-
Day Study Non-rodent
21 -Day Dermal - Rabbit/Rat
Developmental Toxicity - Rat
Developmental Toxicity -
Rabbit
2-Generation Reproduction -
Rat
Chronic Toxicity Study - Rodent
Chronic Feeding Toxicity Study
- Non-rodent
Carcinogenicity Mice
Combined Chronic
Toxicity /Carcinogenicity: Rats
Cytogenics- Human
Lymphocytes Chromosome
Aberration Test
In Vitro Mammalian
Cytogenetics Tests
Unscheduled DNA Synthesis in
Mammalian Cells in Culture
General Metabolism
Use Patterns
C
C
C
C
C
C
C
C
C
C
C
C
C
C
Citations
00091341
00068936, 00122575
42395201, 00091338,
00122576
42889201,43222101
43664901, 43664902,
42889202
42371801,43323301
42412001
42380410, 43222102
42412001
42454001
43508101,42251703
43508101
42251702
42428402, 00071991,
00071992, 123000,
123001
ENVIRONMENTAL FATE
835.1240
835.2120
835.2240
835.2410
835.4100
835.6100
163-1
161-1
161-2
161-3
162-1
164-1
Leaching/Adsorption/Desorption
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Terrestrial Field Dissipation
C
C
C
C
C
C
42304101
42647703, 42647702
42647701
42380411
43231903,43231904
42331501
32
-------
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket, EPA-
HQ-OPP-2008-0196
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/reregistradon
These documents include:
HEP Document:
Triforine: Revised HED Chapter of the Reregi strati on Eligibility Decision Document (RED). PC
Code 107901, DP 339610. Olinger, C., Taylor, L., Goodlow, T., and Dawson, J. Dated 03-11-
08.
Triforine: Response to Registrant Error-only Comments on HED Risk Assessment. PC Code
107901, DP 339628. Olinger, C., Taylor, L., and Dawson, J. Dated 03-11-08.
EFED Documents:
Revised Drinking Water Assessment for Reregi strati on of Triforine for Use on Ornamentals. PC
Code 107901, DP339605. Moore, K. Dated 03-05-08.
Revised Level I Baseline Ecological Risk Assessment for the Reregi strati on of Triforine. PC
Code 107901, DP339607. Moore, K., and Carey, S. Dated 03-05-08.
EFED Responses to Triforine Phase 1 Error-Only Comments. PC 107901, DP 339629. Carey,
S., and Moore, K. Dated 02-26-08.
33
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Appendix D. Citations Considered to be Part of the Data Base Supporting the Reregi strati on
Eligibility Decision
MRID
68936
71991
71992
91338
91341
122575
122576
122589
123000
123001
42019601
42019602
42172701
Citation Reference
Leuschner, F.; Leuschner, A.; Schwerdtfeger, W.; et al. (1971) 13 Weeks Oral Toxicity
Study in Beagle Dogs with W-524. (Unpub- lished study received Mar 28, 1975 under
239-2435; prepared by Laboratorium fur Pharmakologie und Toxikologie, W. Germany,
sub- mitted by Chevron Chemical Co., Richmond, Calif.; CDL232696-B)
Darda, S. (1971) Biochemical Investigations with W524 (A3IH) in Rats. (Unpublished
study received Feb 8, 1977 under 21137-4; prepared by C.H. Boehringer Sohn, West
Germany, submitted by EM Laboratories, Inc., Elmsford, N.Y.; CDL095808-C)
Darda, S. (1974) The Pharmacokinetics of the Systemic Fungicide Triforine (W524) in
the Rat. (Unpublished study received Feb 8, 1977 under 21137-4; prepared by C.H.
Boehringer Sohn, West Germany, submitted by EM Laboratories, Inc., Elmsford, N.Y.;
CDL:095808-D)
Leuschner, F.; Leuschner, A.; Schwerdtfeger, W.; et al. (1973) 21- day Toxicity Tests with
the Compound W-524 in Sprague-Dawley- rats Using Dermal Application. (Translation;
unpublished study received Mar 28, 1975 under 239-2435; prepared by Celamerck,
GmbH & Co., KG, West Germany, submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:232698-K)
Stotzer, H.; Herbst, M.; Kollmer, H.; et al. (1971) Testing of the Subacute Toxicity of the
Substance W524 in Rats following Oral Administration: Document No. T15. (Translation;
unpublished study received Mar 28, 1975 under 239-2435; prepared by C.H. Boehringer
Sohn, West Germany, submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:232698-N)
Leuschner, F.; Leuschner, A.; Schwerdtfeger, W.; et al. (1971) 13 Weeks Oral Toxicity
Study in Beagle Dogs with W-524. (Un- published study received Feb 8, 1977 under
21137-4; prepared by Laboratorium fur Pharmakologie und Toxikologie, W. Ger.,
submitted by EM Laboratories, Inc., Elmsford, NY; CDL:095805-B)
Leuschner, F.; Leuschner, A.; Schwerdtfeger, W.; et al. (1973) 21-day Toxicity Tests with
the Compound W-524 in Sprague-Dawley Rats Using Dermal Application. (Translation;
unpublished study received Feb 8, 1977 under 21137-4; prepared by Laboratorium fur
Pharmakologie und Toxikologie, W. Ger., submitted by EM Laboratories, Inc., Elmsford,
NY; CDL095805-C)
Reno, F.; Moore, S. (1979) Acute Oral LD50 in Bobwhite Quail: Triforine Technical:
Project No. 920-102. Final rept. (Un- published study received Jan 15, 1979 under
21137-4; prepared by Hazleton Laboratories America, Inc., submitted by EM Labo-
ratories, Inc., Elmsford, NY; CDL:236746-A)
Darda, S. (1974) Excretion and Metabolism of Triforine ... in the Rat. Interim rept.
(Unpublished study received Mar 28, 1975 under 239-2435; prepared by C.H. Boehringer
Sohn, W. Ger., sub- mitted by Chevron Chemical Co., Richmond, CA; CDL:232064-L)
Darda, S. (1975) Pharmacokinetics of the Systemic Fungicide Trifor- ine ... in Rats.
(Translation; unpublished study received Mar 28, 1975 under 239-2435; prepared by C.H.
Boehringer Sohn, W. Ger., submitted by Chevron Chemical Co., Richmond, CA; CDL:
232064-M)
Jungblut, H.; Mladenovic, P.; Van't Klooster-Cornelissen, A. (1990) Product Identity and
Composition: Triforine: Lab Project Number: 102AX184002. Unpublished study prepared
by Shell Agar. 97 p.
Van't Klooster-Cornelissen, A.; Jungblut, H. (1990) Analysis and Certification of Product
Ingredients: Triforine: Lab Project Number: 102AX137002. Unpublished study prepared
by Shell Agar. 54 p.
Ullman, L. (1986) Acute Oral Toxicity Study with Triforine Technical in Rats: Lab Project
Number: 076151. Unpublished study prepared by Research & Consulting Co. Ag. 29 p.
34
-------
42172702
42172703
42172704
42251702
42251703
42304101
42331501
42371801
42380401
42380402
42380403
42380404
42380405
42380406
42380407
42380408
42380409
42380410
Ullman, L; Althaus, P.; Janiak, T.; et al. (1986) Acute Dermal Toxicity Study with Triforine
Technical in Rats: Lab Project Number: 278774. Unpublished study prepared by
Research & Consulting Co. Ag. 37 p.
Ullman, L. (1986) 4-Hour Acute Inhalation Toxicity Study with Triforine Technical in Rats:
Lab Project Number: 076162. Un- published study prepared by Research & Consulting
Co. Ag. 34 p.
Cardinaals, J.; Van Helvoirt, J.; Van't Klooster-Cornelissen, A.; et al. (1989) Physical and
Chemical Characteristics of Triforine: Lab Project Number: 102AX 119 007. Unpublished
study prepared by RCC Notox B.V. 192 p.
Miltenburger, H. (1985) Unscheduled DNA Synthesis in Hepatocytes of Male Rats in vitro
(UDS Test): Triforine: Lab Project Number: 102AC-457-007. Unpublished study prepared
by Celamerck GMBH and Co. KG. 50 p.
Pistel, F. (1985) Chromosome Aberrations in Cells of Chinese Hamster Cell Line V79:
Triforine: Lab Project Number: 102AC-457-009. Unpublished study prepared by
Celamerck GMBH and Co. KG. 92 p.
Clark, R. (1988) Carbon 14-Triforine: Adsorption/Desorption in Soil: Lab Project Number:
102AX-923-002. Unpublished study prepared by Hazleton UK. 121 p.
Desai, L.; Aerts, M. (1991) Soil Field Dissipation Study of Triforine in California and New
York: Lab Project Number: FD454TR90. Unpublished study prepared by Toxikon Corp.
633 p.
McCay, C.; Hazelden, K. (1990) Triforine: Two Generation Study in Rats: Lab Project
Number: IRI 437656. Unpublished study prepared by Inveresk Research Intl. 231 p.
Hakin, B.; Rodgers, M.; Anderson, A.; et al. (1992) Triforine: Acute Oral Toxicity (LD50) to
Mallard Duck: Lab Project Number: SLL 233/920563. Unpublished study prepared by
Huntingdon Research Centre Ltd. 30 p.
Hakin, B.; Rodgers, M.; Anderson, A.; et al. (1992) Triforine: Subacute Dietary Toxicity
(LC50) to Mallard Duck: Lab Project Number: SLL 231/920446. Unpublished study
prepared by Huntingdon Research Centre Ltd. 30 p.
Hakin, B.; Rodgers, M.; Anderson, A.; et al. (1992) Triforine: Subacute Dietary Toxicity
(LC50) to Bobwhite Quail: Lab Project Number: SLL 230/920489. Unpublished study
prepared by Huntingdon Research Centre Ltd. 34 p.
Ellgehausen, H. (1987) Limit Test for 96-Hour Acute Toxicity with Triforine Technical in
the Rainbow Trout: Lab Project Number: RCC 076241. Unpublished study prepared by
RCC. 41 p.
Ellgehausen, H. (1987) Limit Test for 96-Hour Acute Toxicity with Triforine Technical in
the Bluegill Sunfish including Stability of the Active Ingredient: Lab Project Number: RCC
076230. Unpublished study prepared by RCC. 35 p.
Douglas, M.; Handley, J. (1987) The Acute Toxicity of Triforine to Daphnia magna: Lab
Project Number: CMK 26/871645. Unpublished study prepared by Huntingdon Research
Center Ltd. 40 p.
Ullman, L.; Porricello, T. (1988) Primary Eye Irritation Study with Trforine Technical in
Rabbits: Lab Project Number: 213311. Unpublished study prepared by RCC, Research &
Consulting Co., Ag. 35 p.
Ullman, L.; Porricello, T. (1988) Primary Skin Irritation Study with Triforine Technical in
Rabbits (4-Hour Semi-Occlusive Application): Lab Project Number: RCC 213300.
Unpublished study prepared by RCC. 37 p.
Ullman, L.; Suter, B. (1984) Delayed Contact Hypersensitivity in Albino Guinea Pigs, the
Maurer Optimization Test (Triforine): Lab Project Number: 033276. Unpublished study
prepared by RCC, Research and Consulting Co., AG. 33 p.
Goburdhun, R.; Greenbough, R. (1973) W524-XX (Triforine): 104 Week Oral Toxicity
Study in Dogs: Lab Project Number: 102AB-437-017. Unpublished study prepared by
Inveresk Research International. 361 p.
35
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42380411
42395201
42412001
42428401
42428402
42453101
42454001
42647701
42647702
42795801
42795802
42879901
42879902
42889201
42889202
43222101
43222102
Saxena, A. (1990) Artificial Sunlight Photodegradation of ?carbon 14|-Triforine on Soil:
Final Report: Lab Project Number: HLA 6160-114. Unpublished study prepared by
Hazleton Laboratories America, Inc. 106 p.
Fokkema, G. (1992) Triforine (Saprol TM): A 21-day Dermal Toxicity Study in Rats: Lab
Project Number: SBTR. 91.011 Unpublished study prepared by Sittingbourne Research
Centre. 237 p.
Perry, C.; Mulhern, M.; Finch, J. (1991) Triforine: 104 Week Dietary Carcinogenicity
Study in Rats Incorporating 52 Week Toxicity Study: Lab Project Number: IRI 437504.
Unpublished study prepared by Inveresk Research Intl. 1195 p.
Hakin, B.; Rodgers, M.; Anderson, A.; et al. (1992) Triforine: Acute Oral Toxicity (LD50) to
Bobwhite Quail: Lab Project Number: SLL 232/920562. Unpublished study prepared by
Huntingdon Research Centre, Ltd. 30 p.
Hawkins, D.; Wood, S.; John, B.; et al. (1992) Metabolic Fate of ?carbon 14| Triforine in
Sprague Dawley Rats: Lab Project Number: HRC/SLL203/920212. Unpublished study
prepared by Huntingdon Research Centre, Ltd. 139 p.
Gilbert, J.; Harrison, E. (1992) Triforine (Saprol TM): A Laboratory Study to Determine the
Oral and Topical Toxicity to the Honey Bee Apis mellifera L: Lab Project Number: 5517:
SBTR. 92.008. Unpublished study prepared by Sittingbourne Research Centre. 26 p.
Heath, J.; Mulhearn, M.; Perry, C. et al. (1991) Triforine: 105 Week Dietary
Carcinogenicity Study in Mice: Lab Project Number: 437483: 7746. Unpublished study
prepared by Inveresk Research International. 815 p.
Waring, A. (1993) Photodegradation in Sterile, Aqueous Solution: (carbon 14)-Triforine:
Lab Project Number: 579/107: 579/107-1015. Unpublished study prepared by Hazleton
UK. 143 p.
Bass, R. (1993) Determination of the Rate of Hydrolysis and Investigation of the
Structures of Products of Hydrolysis: (carbon 14)-Triforine: Lab Project Number: 579/108:
579/108-1012. Unpublished study prepared by Hazleton UK. 155 p.
Stapersma, J.; Kroner, M. (1993) Triforine: Description of Beginning Materials and
Manufacturing Process: Lab Project Number: TF-61200. Unpublished study prepared by
Shell International Chemical Co. 128 p.
van T Klooster-Cornelissen, A. (1988) Determination of the Partition Coefficient of
Triforine Using High Performance Liquid Chromatography: Lab Project Number:
0844/C544: 102AF-114-008. Unpublished study prepared by RCC NotoxB.V. 17 p.
Ellgehausen, H. (1985) Acute Toxicity of Triforine Technical to Scenedesmus subspicatus
(OECD: Algae Growth Inhibition Test): Lab Project Number: 046034: TF-521-001:
102AC-443-006. Unpublished study prepared by Research & Consulting Co. AG. 17 p.
Wuthrich, V. (1990) Acute Toxicity of DC Formulation of Triforine Containing 180 g/L
(SAG 10249) to Scenedesmus subspicatus (OECD: Algae growth Inhibition Test): Lab
Project Number: 263788: TF-560-014: 10249-443-010. Unpublished study prepared by
RCC Unweltchemie AG. 60 p.
Fuchs, A. (1993) Triforine-Oral (gavage) Teratogenicity study in the Rat: Final Report:
Lab Project Number: 1032-121-006: 121-006. Unpublished study prepared by Hazleton
Deutschland GmbH. 229 p.
Fuchs, A. (1993) Triforine-Oral (gavage) Teratogenicity study in the Rabbit: Final Report:
Lab Project Number: 1098-121-004: 121-004. Unpublished study prepared by Hazleton
Deutschland GmbH. 189 p.
Fuchs, A. (1993) Triforine: Oral (Gavage) Teratogenicity Study in the Rat: Lab Project
Number: 1032-121-006. Unpublished study prepared by Hazleton Deutschland GmbH. 9
P-
Goburdhun, R.; Greenbough, R. (1973) W524-XX (Triforine): 104 Week Oral Toxicity
Study in Dogs: Lab Project Number: IRI 640526: 5893. Unpublished study prepared by
Inveresk Research International. 37 p.
36
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43231901
43231902
43231903
43231904
43323301
43396901
43508101
43664901
43664902
44388301
44388302
Redgrave, V. (1994) Triforine: Effects on Reproduction in Bobwhite Quail After Dietary
Administration: Lab Project Number: SLL 229/931327. Unpublished study prepared by
Huntingdon Research Centre Ltd. 254 p.
Redgrave, V. (1994) Triforine: Effects on Reproduction in Mallard Duck After Dietary
Administration: Lab Project Number: SLL 227/931326. Unpublished study prepared by
Huntingdon Research Centre Ltd. 253 p.
Rainford, F.; Lewis, C.; Clark, R. (1990) Triforine: Metabolism in Soil: Lab Project
Number: 6124-460/35. Unpublished study prepared by Hazleton UK. 151 p.
Wyss-benz, M. (1993) (Carbon 14)-Triforine: Degradation and Metabolism in One Soil
Incubated Under Aerobic Conditions: Lab Project Number: 305291. Unpublished study
prepared by RCC Umweltchemie AG. 122 p.
Hazelden, K. (1994) Triforine Registration Standard: Response to Review of Two-
Generation Reproduction Study in Rats: Lab Project Number: 437656: 11125.
Unpublished study prepared by Inveresk Research International. 124 p.
Ullman, L. (1994) Delayed Contact Hypersensitivity to Triforine Technical in Albino
Guinea Pigs: The Maurer Optimization Test: Second Amendment to Report: Lab Project
Number: 033276. Unpublished study prepared by RCC, Research & Consulting Co. Ltd.
7 p.
Little, D. (1994) Triforine Mutagenicity Studies: Mouse Micronucleus Assay: In vitro
Chromosome Studies Using Cultured Chinese Hamster Ovary (CHO) Cells: Lab Project
Number: 026256: 031037: SBTR/93/065. Unpublished study prepared by Research &
Consulting Co. AG and Shell Research Ltd. 92 p.
Muller, W. (1995) Oral (Gavage) Teratogenicity Study in the Rabbit: Triforine Fungicide:
Revised Final Report: Lab Project Number: 460/29: HLD 460/29. Unpublished study
prepared by Hazleton Labs Deutschland GmbH. 145 p.
Muller, W. (1995) Triforine: Preliminary Oral (Gavage) Embryotoxicity Study in the Rabbit:
Revised Final Report: Lab Project Number: 121-003: HLD 121-003. Unpublished study
prepared by Hazleton Labs Deutschland GmbH. 132 p.
Drottar, K.; Kendall, T.; Olivieri, C. (1997) AC 902194: Acute Toxicity of Triforine
Technical to Rainbow Trout, Oncorhynchus mykiss, Under Flow-Through Test
Conditions: (Final Report): Lab Project Number: 954-97-230: 130A-114: ECO 97-230.
Unpublished study prepared by Wildlife International Ltd. 72 p. {OPPTS 850.1075}
Drottar, K.; Kendall, T.; Olivieri, C. (1997) AC 902194: Acute Toxicity of Triforine
Technical to Daphnia magna Under Flow-Through Test Conditions: (Final Report): Lab
Project Number: 954-97-229: 130A-115: ECO 97-229. Unpublished study prepared by
Wildlife International Ltd. 77 p. {OPPTS 850.1010}
37
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Appendix E. 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 wiUiams.nicole(q),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.zov/opprdOOl/forms/85 7 0-1. pdf
http://www.epa.zov/opprd001/forms/8570-4.pdf
http://www. epa.zov/opprdOOl/forms/85 70-5. pdf
http://www. epa.zov/opprdOOl/forms/85 70-1 7.pdf
http://www.epa.zov/opprd001/forms/8570-25.pdf
http://www. epa.zov/opprdOOl/forms/85 70-2 7.pdf
http://www. epa.zov/opprdOOl/forms/85 70-28.pdf
http://www. epa.zov/opprdOOl/forms/85 70-30. 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.zov/opppmsdl/PR Notices/pr98-l . pdf
38
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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/PRNotices
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.
39
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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.nets.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.
40
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