&EPA
United States Prevention, Pesticides EPA 738-R-05-006
Environmental Protection and Toxic Substances September 2005
Agency (7508C)
Reregistration Eligibility
Decision (RED) for
Ametryn
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REREGISTRATION ELIGIBILITY DECISION (RED)
for
AMETRYN
(2-ethylamino)-4-(isopropylamino)-6-(methylthio)-^-triazine,
CASE 2010
Approved by:
Debra Edwards, Ph. D.
Director
Special Review and Reregistration Division
Date:
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Table of Contents
Ametryn Team List iv
Glossary of Terms and Abbreviations v
Executive Summary 1
I. Introduction 4
II. Chemical Overview 5
A. Regulatory History 5
B. Chemical Identification 6
C. Use Profile 6
D. Estimated Usage of Pesticide 8
III. Summary of Ametryn Risk Assessment 8
A. Human Health Risk Assessment 9
1. Toxicity Assessment of Ametryn 9
a. Acute Toxicity Profile for Ametryn 9
b. FQPA Safety Factor Considerations for Ametryn 10
c. Carcinogenicity 10
d. Toxicological Endpoints for Ametryn 11
e. Ametryn Metabolites and Degradates 12
f Endocrine Effects 13
2. Dietary Exposure and Risk from Food 13
3. Dietary Risk from Drinking Water 14
4. Residential Exposure and Risk 15
5. Aggregate Risk 15
6. Occupational Exposure and Risk 16
a. Occupational Handler Risk 16
b. Occupational Post-Application Risk 18
7. Incident Reports 18
B. Environmental Risk Assessment 18
1. Environmental Fate and Transport 19
2. Environmental Effects (Ecotoxicity) 19
a. Toxicity to Terrestrial Organism 19
b. Toxicity to Aquatic Organisms 21
3. Exposure and Risk Assessment 21
a. Fish and Aquatic Invertebrates Exposure and Risk 22
b. Terrestrial Organism Exposure and Risk 23
c. Non-Target Plant Exposure and Risk 25
4. Ecological Incidents 27
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 27
A. Determination of Reregistration Eligibility 27
B. Public Comments and Responses 28
C. Regulatory Position 28
1. Food Quality Protection Act Findings 28
a. "Risk Cup" Determination 28
b. Determination of Safety to U.S. Population 29
c. Determination of Safety to Infants and Children 29
2. Endocrine Disrupter Effects 29
3. Cumulative Risks 30
D. Tolerance Reassessment Summary 30
1. Codex/NAFTA Harmonization 32
2. Residue Analytical Methods 32
E. Regulatory Rationale 32
1. Human Health Risk Management 32
a. Dietary and Aggregate Risk Summary 32
b. Occupational Risk Mitigation 33
2. Environmental Risk Mitigation 33
3. Significance of Ametryn 35
F. Other Labeling Requirements 35
1. Endangered Species Considerations 35
2. Spray Drift Management 36
G. Mitigation Summary 36
V. What Registrants Need to Do 37
A. Manufacturing-Use Products 38
B. End-Use Products 39
C. Labeling Changes Summary Table 39
VI. Related Documents and How to Access Them 47
List of Appendices: 47
Appendix A. Food/Feed Use Patterns Eligible for Reregistration for Ametryn Al
Appendix B. Data Supporting Guideline Requirements for the Reregistration of Ametryn Bl
Appendix C. List of EPA's Technical Support Documents For Ametryn Cl
Appendix D. Citations Considered to be Part of the Database Supporting the Reregistration Decision
(Bibliography) Dl
Appendix E. Batching of Ametryn Products El
in
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Appendix F. List of Registrants to be sent the Data Call-In Fl
Appendix G. List of Available Related Documents and Electronically Available Forms Gl
IV
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Ametryn Team List
Office of Pesticide Programs:
Health Effects Risk Assessment
William Donovan
John Doherty
Robert Travaglini
Environmental Fate Risk Assessment
Kevin Costello
John Ravenscroft
Roxolana Kashuba
Brian Kiernan
Biological and Economics Division
Julie Heflin
Nicole Zinn
Steve Smearman
Registration Division
Jim Tompkins
Risk Management
Mark Howard
Neil Anderson
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Glossary of Terms and Abbreviations
AGDCI
ai
aPAD
AR
ASAE
BCF
CFR
cPAD
CSF
CSFIIUSDA
DCI
DEEM
DFR
DWLOC
EC
EEC
EPA
EUP
FAO
FDA
FIFRA
FFDCA
FQPA
G
GLN
HAFT
IR
LC50
LD,
LOC
LOD
LOAEL
mg/kg/day
mg/L
MOE
MRID
MUP
NA
NAWQA
NPDES
NOAEL
OPP
OPPTS
Agricultural Data Call-In
Active Ingredient
Acute Population Adjusted Dose
Anticipated Residue
American Society of Agricultural Engineers
Bioconcentration Factor
Code of Federal Regulations
Chronic Population Adjusted Dose
Confidential Statement of Formula
Continuing Surveys for Food Intake by Individuals
Data Call-In
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Drinking Water Level of Comparison.
Emulsifiable Concentrate Formulation
Estimated Environmental Concentration
Environmental Protection Agency
End-Use Product
Food and Agricultural Organization of the United Nations (UN)
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Granular Formulation
Guideline Number
Highest Average Field Trial
Index Reservoir
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.
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.
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
Micrograms Per Gram
Micrograms Per Liter
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
Manufacturing-Use Product
Not Applicable
USGS National Water Quality Assessment
National Pollutant Discharge Elimination System
No Observed Adverse Effect Level
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
VI
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PAD
PCA
PDF
PHED
Pffl
ppb
PPE
ppm
PRZM/EXAMS
Qi*
RAC
RED
REI
RfD
RQ
SCI-GROW
SAP
SF
SLC
SLN
TGAI
USDA
USGS
UF
UV
WHO
WPS
Population Adjusted Dose
Percent Crop Area
USDA Pesticide Data Program
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Tier II Surface Water Computer Model
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
Raw Agriculture Commodity
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Risk Quotient
Tier I Groundwater Computer Model
Science Advisory Panel
Safety Factor
Single Layer Clothing
Special Local Need (Registrations Under Section 24(c)) of FIFRA)
Technical Grade Active Ingredient
United States Department of Agriculture
United States Geological Survey
Uncertainty Factor
Ultraviolet
World Health Organization of the United Nations (UN)
Worker Protection Standard
vn
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Executive Summary
EPA has completed its review of public comments on the revised ametryn risk assessments and
is issuing its risk management decision for ametryn. There are currently 14 tolerances being reassessed
for ametryn. The revised risk assessments are based on review of the required target data base
supporting the use patterns of currently registered products and additional information received. After
considering the risks identified in the revised risk assessment, comments, and mitigation suggestions
from interested parties, EPA developed its risk management decision for uses of ametryn that pose
risks of concern. As a result, the Agency has determined that ametryn containing products are eligible
for reregistration provided that data needs are addressed, risk mitigation measures are adopted, and
labels are amended accordingly. The decision is discussed fully in this document.
Ametryn was first registered for use to control broadleaf weeds and annual grasses in
sugarcane fields in 1964. In 1969, use for general weed control in corn fields, currently the largest use
of ametryn, was added. Other crop uses added to the registration include bananas, grapefruit, oranges,
pineapple, plantains, and potatoes for broadleaf weed, annual grass, and general weed control and as a
desiccant. Ametryn has also been used as a general herbicide in uncultivated areas, rights of way, and
industrial areas and aquatic weeds. Over time, the uses of ametryn have been cancelled so that only
four use sites remain: field corn, popcorn, pineapple, and sugarcane. EPA estimates up to 380,000 Ibs
of ametryn active ingredient are used per year. Sixty percent of the annual use of ametryn is used with
corn, 20% with pineapple, and 20% with sugarcane. However, in terms of percent crop treated, nearly
100% of the pineapple crop is treated, 30% of sugarcane, and less than 1% of corn is treated.
Ametryn is a member of the broad class of triazine herbicides. However, EPA has determined
that there is no known mechanism of toxicity that would support grouping ametryn, a thiomethy-s-
triazine, with the chloro-s-triazines (atrazine, simazine, propazine and their chloro-s-triazine
metabolites). In addition to a different functional group attached to the triazine ring, (i.e., thiomethyl
versus chloro), ametryn does not exhibit the same toxicity profile as the chloro-s-triazines. Therefore,
for the purposes of tolerance reassessment and a decision on reregistration eligibility, EPA is assuming
that ametryn does not share a common mechanism of toxicity with other compounds.
Overall Risk Summary
Ametryn occupational and dietary risks from food and drinking water sources are low and not
of concern. Since there are no registered residential uses of ametryn, no residential risks were assessed.
Aggregate risks, based on combined food and drinking water exposures are low and not of concern.
For ecological risks, ametryn poses some chronic risk to birds, mammals, estuarine/marine
invertebrates, and acute risk to plants, which will be reduced with various application reductions.
Dietary Risk
Acute and chronic dietary (food only) risk from ametryn from all sources are low and below
the Agency's level of concern. Estimated concentrations of ametryn and its metabolites, in surface and
groundwater sources of drinking water, are low resulting in risks below EPA's level of concern.
1
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Residential Risk
The Agency is not considering residential exposures from ametryn, since there are no existing
or proposed residential or other non-occupational sources of exposure, and ametryn is not used in or
around public buildings, schools or recreational areas where children or others might be exposed.
Aggregate Risk
Aggregate risk for ametryn refers to the combined risk from food and drinking water.
Aggregate risk estimates are also negligible, therefore, no mitigation measures are needed.
Occupational Risk
Workers can be exposed to ametryn through mixing, loading, and/or applying (handlers) the
pesticide to field corn, popcorn, pineapple, and sugarcane. The lowest margin of exposure (MOE)
from handling ametryn wearing baseline clothing is 250. Based on the acute toxicity studies, a 12-hour
REI is required for ametryn use, although the ametryn use patterns make early re-entry unlikely.
Ecological Risk
For terrestrial species, short-term or acute ametryn risks are low to mammals, birds, and non-
target insects. However, the screening-level ecological risk assessment for terrestrial species indicates
some risk quotient (RQ) exceedance of the chronic levels of concern (LOCs), especially to mammals
that rely on grasses and broadleaf plants/insects for their diet and birds that rely on short grasses.
In aquatic species acute and chronic risks are low, with the exception of the chronic risk for
estuarine/marine invertebrates. Both the estuarine/marine fish and invertebrates chronic values
estimates are based on extrapolation using a acute to chronic ratio from the test data on the freshwater
species. The Agency is requiring additional chronic estuarine/marine species toxicity data and vascular
plant studies as a part of this RED to address these data gaps.
Consistent with its chemical use as an herbicide, ametryn is toxic to plants, including dicots
which are much more sensitive to ametryn than monocots. The RQs for dicot plants all exceed the
LOCs for uses of ametryn in all exposure scenarios (adjacent areas, semi-aquatic, and spray drift). The
RQs for monocots also exceed in almost all uses in the adjacent areas and semi-aquatic exposure. For
aquatic plants, based on limited data, the RQs exceed the level of concern for both vascular and non-
vascular plants for uses of ametryn.
Therefore, to be more protective of plants and the mammals, birds, and the aquatic species that
may be exposed on a chronic basis, the technical registrant has agreed to additional label changes to
reduce potential risk, including reducing maximum application rates and maximum number of
applications to all the remaining crops.
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Endangered Species
Based on available screening-level information, there is a potential concern for acute and
chronic effects on listed mammals; chronic effects on listed birds; and effects to terrestrial and aquatic
listed plants should exposure actually occur. These findings are based solely on EPA's screening-level
assessment and do not constitute "may affect" findings under the Endangered Species Act (ESA) for
any specific listed species. If the Agency determines use of ametryn "may affect" listed species or their
designated critical habitat, EPA will employ the provisions in the Services regulations (50 CFR Part
402).
Mitigation Summary
To address assessed risks of concern, the following mitigation measures will be implemented:
Corn:
- Reduce field corn and popcorn maximum single application rate from 2.0 to 1.6 Ibs ai/A
- Eliminate sweet corn use
Sugarcane:
- Reduce sugarcane maximum single application rate from 7.2 to 2.4 Ibs ai/A in HI
- Reduce sugarcane maximum seasonal rate from 12.0 to 7.2 Ibs ai/A in HI
- Reduce sugarcane maximum application rate from 2.4 to 1.2 Ibs ai/A in FL, LA, & TX
- Reduce sugarcane maximum number of applications from < 5 to 2 per year in FL, LA, & TX
- Reduce sugarcane maximum season rate from 11.6 to 2.4 Ibs ai/A in FL, LA, & TX
- Eliminate aerial application on sugarcane in HI, LA, & TX
- Eliminate (sugarcane) use of ametryn in PR
Pineapple:
- Reduce pineapple maximum single application rate from 2.4 to 1.2 Ibs ai/A (HI)
- Reduce pineapple maximum seasonal rate from 7.2 to 3.2 Ibs ai/A (HI)
- Reduce pineapple maximum application number from unlimited to 2 per year (HI)
Other:
- Eliminated use on bananas, plantains, and non-cultivated areas
- Restrict application methods to reduce spray drift
Next Steps
The Agency is issuing this RED document for ametryn as announced in a Notice of
Availability published in the Federal Register. In the future, EPA will issue the generic DCI for
additional data necessary to confirm the conclusions of this RED for the active ingredient ametryn.
EPA will also issue a product-specific DCI for data necessary to complete product reregistration for
products containing ametryn.
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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, henceforth 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 the pesticide
meets the "no unreasonable adverse effects" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law.
This Act amends FIFRA and the Federal Food Drug and Cosmetic Act (FFDCA) to require
reassessment of all existing tolerances for pesticides in food. FQPA also requires EPA to review all
tolerances in effect on August 2, 1996 by August 3, 2006. In reassessing these tolerances, the Agency
must consider, among other things, aggregate risks from non-occupational sources of pesticide
exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of
pesticides with a common mechanism of toxicity. When a safety finding has been made that aggregate
risks are not of concern and the Agency concludes that there is a reasonable certainty of no harm from
aggregate exposure, the tolerances are considered reassessed. EPA decided that, for those chemicals
that have tolerances and are undergoing reregistration, tolerance reassessment will be accomplished
through the reregistration process.
As mentioned above, FQPA requires EPA to consider "available information" concerning the
cumulative effects of a particular pesticide's residues and "other substances that have a common
mechanism of toxicity" when considering whether to establish, modify, or revoke a tolerance. Potential
cumulative effects of chemicals with a common mechanism of toxicity are considered, because low-
level exposures to multiple chemicals causing a common toxic effect by a common mechanism could
lead to the same adverse health effect as would a higher level of exposure to any one of these individual
chemicals. For information regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy
statements released by the EPA's Office of Pesticide Programs concerning common mechanism
determinations and procedures for cumulating effects from substances found to have a common
mechanism on EPA's website at http://epa.gov/pesticides/cumulative/.
The Agency has found no information indicating ametryn shares a common mechanism of
toxicity with other substances. Based on the Agency's review of the available toxicity information,
EPA has determined that there is no known mechanism of toxicity that would support grouping
ametryn with chloro-s-triazines (atrazine, simazine, propazine and their chloro-s-triazine metabolites).
Ametryn has a different functional group attached to the triazine ring, i.e., thiomethyl versus chloro.
Further, ametryn does not exhibit the same toxicity profile as the chloro-s-triazines. Although there
were several tumors induced by ametryn in a rat bioassay, they were only at an excessive dose which
confounds the interpretation of this response. Moreover, the Agency has found no information
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indicating ametryn shares a common mechanism of toxicity with other substances, nor does ametryn
appear to produce a toxic metabolite produced by other substances. Therefore, for the purposes of
tolerance reassessment and a decision on reregistration eligibility, EPA has not assumed that ametryn
shares a common mechanism of toxicity with other compounds. In the future, if additional information
suggests ametryn shares a common mechanism of toxicity with other compounds, additional testing
may be required and a cumulative assessment may be necessary. Information specific to the grouping
of triazines for cumulative risk assessment including the March 2002 report, "The Grouping of a Series
of Triazine Pesticides Based on a Common Mechanism of Toxicity" can be found at:
http://www.epa.gov/oppsrrdl/cumulative/triazines/triazinescommonmech.pdf.
This document presents EPA's revised human health and ecological risk assessments, its
progress toward tolerance reassessment, and the reregistration eligibility decision for ametryn. The
document consists of six sections. Section I contains the regulatory framework for reregistration/
tolerance reassessment. Section II provides a profile of the use and usage of the chemical. Section III
gives an overview of the revised human health and environmental effects risk assessments based on
data, public comments, and other information received in response to the preliminary risk assessments.
Section IV presents the Agency's reregistration eligibility and risk management decisions. Section V
summarizes label changes necessary to implement the risk mitigation measures outlined in Section IV.
Section VT provides information on how to access related documents. Finally, the Appendices list
related information, supporting documents, and studies evaluated for the reregistration decision. The
preliminary and revised risk assessments for ametryn are available in the Public Docket, under docket
number OPP-2004-0411 and on the Agency's web page, http://www.epa.gov/edockets.
n. Chemical Overview
A. Regulatory History
Ametryn was first registered for use to control broadleaf weeds and annual grasses in
sugarcane fields in 1964. In 1969, use for general weed control in corn fields, currently the largest use
of ametryn, was added. Other food crop uses added to the registration include bananas, grapefruit,
oranges, pineapple, plantains, and potatoes for broadleaf weed, annual grass; general weed control; and
as a desiccant. Ametryn has also been used as a general herbicide in uncultivated areas, rights of way,
industrial areas, and aquatic weeds.
Ametryn has been subject to several data call-ins (DCIs), including: 1983 Toxicology DCI;
1984 Groundwater DCI; 1989 FIFRA 88 Reregistration Process (Phase l-III) DCI; 1991
Reregistration Phase 4 DCI; and 1992 Hexachlorobenzene/Pentachlorobenzene Special DCI.
In response to the 1983 Toxicology DCI, a number of technical products and their associated
end-use products were cancelled. In addition, the use of ametryn on grapefruit, oranges, and as a vine
desiccant on potatoes was no longer supported by the remaining technical registrant. Adequate data
was provided for all the subsequent DCIs.
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In 2003, technical registrant Syngenta Crop Protection decided to no longer support uses on
bananas, plantains, and the non-agricultural/general herbicide uses (uncultivated fields, rights of ways,
and industrial areas). These uses were voluntarily cancelled in 2004 (see 69 FR 39467, June 30, 2004).
In addition, neither the technical registrant nor the USDA's IR-4 program are supporting tolerances on
cassava, taniers, and yams, nor regional uses for these crops in Puerto Rico.
B. Chemical Identification
Chemical Name:
Common Name:
Chemical family:
Case number:
CAS registry number:
OPP chemical code:
Empirical formula:
Molecular weight:
Trade & other names:
Basic manufacturer:
(2-ethylamino)-4-(isopropylamino)-6-(methylthio)-5-triazine
Ametryn '
methylthio-5-triazine
2010
834-12-8
080801
N CH,
HC
S N N
H
227.35
Evik, Ametryne, Ametrex
Syngenta Crop Protection, Inc. (formerly Ciba-Geigy)
Technical grade ametryn (95% pure) is a white powder with a melting point of 84-85°C,
octanol/water partition coefficient (Kow) of 676 at pH 7 (log P 2.63), and vapor pressure of 2.74 x 10"6
mm Hg at 25° C. Ametryn is slightly soluble in water (185 mg/100 mL), and soluble in most organic
solvents (56.9 g/100 mL in acetone, 61.4 g/100/mL in methylene chloride, 51.6 g/100 mL in methanol,
46.0 g/100 mL in toluene, 24.2 g/100 mL in n-octanol, and 1.4 g/lOOmL in n-hexane).
C. Use Profile
The following information is based on current registered uses of ametryn:
Type of Pesticide: Herbicide
Mode of Herbicidal Action: Like other triazines, ametryn inhibits photosynthesis and other
enzymatic processes. It is a selective systemic herbicide, absorbed by the leaves and roots, with
translocation acropetally in the xylem, and accumulation in the apical meristems.
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Summary of Use Sites: Corn (field & pop), Pineapple, and Sugarcane
Public Health Uses: None
Target Pests: Weeds consisting of: Agemtum, alexandergrass, amaranth, annual broadleaf
weeds, annual grasses, annual sowthistle, barnyardgrass, Bmchiaria, broadleaf carpetgrass,
broadleaf weeds, browntop panicum, cocklebur, common duckweed, common lambsquarters,
common purslane, crabgrass, dallisgrass, fall panicum, fingergrass, fireweed, flora's paintbrush,
Florida pusley, foxtail species, goosegrass, grasses, guineagrass, henbit, itchgrass, Japanese tea,
junglerice, kukaipuaa, lambsquarters, milkweed, morning glory, nutsedge, paleseed plantain,
panicum, paspalum, pigweed, proso millet, purpletop, purslane, ragweed, raoulgrass, rattlebox,
richardia, sandbur, shattercane, signalgrass, smartweed, sowthistle, spanishneedles, spreading
dayflower, sunflower, swinecress, swollen fingergrass, texas millet, texas panicum, velvetleaf,
wild mustard, wild pea bean, and wild proso millet.
Formulation Types Registered: Ametryn is formulated as a 80% water dispersible granule
(WDG), which is also referred to as dry flowable (DF).
Method of Application: Ametryn can be applied by groundboom sprayers and by aerial
equipment (in FL for sugarcane only). For corn (field and pop), ametryn is used as a directed
spray for soil treatment (post-emergence). For sugarcane, ametryn is used as a band treatment
(ratoon) or as a broadcast spray (pre-emergence, ratoon, and post-emergence). For pineapple,
ametryn is used as a blanket (i.e., broadcast) spray.
Application Equipment: Groundboom sprayers (all uses) and aircraft (sugarcane only in FL).
Application Rates: At the time of preparation and release of the preliminary risk assessments
for Phase 3 public comment, the use pattern information in Table 1, including maximum
application rates and number of applications, specified on the labels were used to assess
ametryn risks.
Table 1. Maximum Application Rates Used for Preliminary Risk Assessment
Crop
Corn (Field, Sweet, Pop)
Pineapple (HI)
Sugarcane (FL, LA, TX)
Sugarcane (HI)
Sugarcane (PR)
Maximum Single
Application Rate
(Ibs ai/A)
2.0
7.2
1.2-2.4
7.2
8.0
Applications per Year
1
NS
3-5
3
o
J
Maximum Seasonal
Application Rate
(Ibs ai/A)
2.0
7.2
3.6-11.6
12.0
16.0
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Table 1. Maximum Application Rates Used for Preliminary Risk Assessment
Crop
Maximum Single
Application Rate
(Ibs ai/A)
Applications per Year
Maximum Seasonal
Application Rate
(Ibs ai/A)
* NS - Not specified
In June 2005, the technical registrant amended its master product label to eliminate ametryn
use on sweet corn and use on sugarcane in Puerto Rico, and reduce the application rates and number of
applications to the levels specified in Table 2. This label was stamped and approved in August 2005.
Table 2. Proposed Revised Maximum Use Patterns
Crop
Corn (Field and Pop)
Pineapple (HI)
Sugarcane (FL, LA, TX)
Sugarcane (HI)
Maximum Single
Application Rate
(Ibs ai/A)
1.6
1.6
1.2
2.4
Applications per Year
1
2
2
o
J
Maximum Seasonal
Application Rate
(Ibs ai/A)
1.6
3.2
2.4
7.2
The Agency has revised its risk assessment to reflect the reduction of risk based on the revised
application rates and use patterns. The risk assessment summarized and presented in this RED
document reflects the reduced application rates and sites specified in Table 2.
Application Timing: Post emergence; post harvest; post plant; pre-emergence; ratoon.
Use Classification: General use
D. Estimated Usage of Pesticide
This section summarizes available pesticide usage information for the current supported uses of
ametryn. EPA estimates up to 380,000 Ibs of ametryn active ingredient are used per year. In terms of
pounds active ingredient (ai) applied annually in the U.S., ametryn usage is allocated to corn (60%),
sugarcane (20%), and pineapple (20%). However, in terms of percent crop treated, nearly 100% of
the pineapple crop is treated, 30% of sugarcane, and less than 1% of corn is treated. Uses are
concentrated in, but not limited to, the following regions: GA, SC, & NC (corn); FL, HI, LA, & TX
(sugarcane); and HI (pineapple).
HI. Summary of Ametryn Risk Assessment
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The following is a summary of EPA's human health and ecological effects risk findings and
conclusions for the herbicide, ametryn as presented fully in the documents: Revised Memo to
Incorporate Responses to Phase 3 Public Comments. Ametryn: HED Chapter of the Reregistration
Eligibility Decision Document (RED)., dated June 15, 2005 and the Environmental Fate and
Ecological Risk Assessment for the Re-registration of Ametryn, dated June 9, 2005.
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 RED document,
they are available from the Office of Pesticide Programs (OPP) Public Docket: OPP-2004-0411 and
may also be accessed on the Agency's website at http://www.epa.gov/edockets. Paper copies of these
documents may be found in the OPP public docket. The OPP public docket is located in Room 119,
Crystal Mall II, 1801 South Bell Street, Arlington, VA. The public docket is open Monday through
Friday, excluding Federal holidays, from 8:30 AM to 4:00 PM.
As part of the public participation process for the RED, EPA released its preliminary dietary,
occupational, and environmental risk assessments for ametryn for public comment on February 25,
2005 (Phase 3 of the public participation process). In response to comments received and new studies
submitted during Phase 3, the human health and environmental risk assessments were updated and
refined. A complete listing of support documents used in preparation of this RED can be found in
Appendix C.
Major revisions to the human health and environmental and ecological risk assessments as a
result of the Phase 3 public comments include the following:
A change in the cancer determination.
A reduction in crop application rates, which result in lower dietary, occupational, and
environmental exposures.
Eliminating the use on sweet corn.
Removing aerial application on sugarcane in Hawaii and eliminating use in Puerto
Rico.
A reduction in the soil half-life calculation, resulting in lower environmental and
drinking water exposure estimates.
A. Human Health Risk Assessment
The human health risk assessment incorporates potential exposure risks from all sources, which
include food, drinking water, residential (if applicable), and occupational scenarios. Aggregate
assessments combine food, drinking water, and any residential or other non-occupational (if applicable)
exposures to determine exposures to the U.S. population.
1. Toxicity Assessment of Ametryn
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Toxicity assessments are designed to predict if a pesticide could cause adverse health effects in
humans (including short-term or acute effects, such as skin or eye damage, and lifetime or chronic
effects such as cancer, development and reproduction deficiencies, etc.) and the level or dose at which
such effects might occur. The Agency has reviewed all toxicity studies submitted for ametryn and has
determined that the lexicological database is sufficient for reregistration. Further details on the toxicity
of ametryn can be found in the technical support documents cited in Appendix C. For the purposes of
this RED, ametryn and its degradates are assumed to be of equal toxicity.
a. Acute Toxicity Profile for Ametryn
The toxicology data base is adequate to characterize the toxicity of ametryn. Ametryn is of
low acute toxicity with respect to acute oral and dermal exposure (Toxicity Category III for both) and
the acute inhalation exposure (Category IV). Ametryn is also non-irritating to the eye (Category III)
and skin (Category IV) and did not demonstrate sensitization. The acute toxicity profile for ametryn is
summarized in Table 3.
Table 3. Acute Toxicity Profile - Ametryn
Guideline
870.11
870.12
870.13
870.24
870.25
870.26
Study Type
Acute oral - rat
Acute dermal - rabbit
Acute inhalation - rat
Acute eye irritation - rabbit
Acute dermal irritation - rabbit
Skin sensitization - guinea pig
MRID(s)
40995814
40995815
42470902
40995817
40995818
40995819
Results
LD50= 1356 (1164-1581) mg/kg a*
LD50= 1009 (829-1229) mg/kg ?
LD50>2020 mg/kg
LC50>5.03 mg/L
No cornea! involvement, mild
conjunctiva irritation (redness,
chemosis and discharge) reversed
by 72 hours in washed eyes.
Essentially non-irritating.
Not a sensitizer
Tox Cat
III
III
IV
III
IV
N/A
LD50 or LC50 = Median Lethal Dose or Concentration. A statistically derived single dose or concentration that can be
expected to cause death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation).
b. FQPA Safety Factor Considerations for Ametryn
The Federal Food, Drug, and Cosmetics Act, as amended by the Food Quality Protection Act
(FQPA), directs the Agency to use an additional tenfold (10X) safety factor to take into account the
potential for pre- and post-natal toxicity, and the completeness of data with respect to the toxicity and
exposure to infants and children. This is referred to as the Special FQPA Safety Factor (SF). The
statute authorizes EPA to reduce or remove this default 10X FQPA SF only if, based on reliable data,
the resulting margin would be safe for infants and children.
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EPA reduced the ametryn Special FQPA SF to IX based on the following: (1) there are no
concerns and no residual uncertainties with regard to pre- and post-natal toxicity based on the rat and
rabbit developmental toxicity studies and the rat two-generation reproduction study; (2) there were no
indications of immunotoxicity or direct neurotoxicity in the standard studies with rats, dogs, mice or
rabbits; (3) the quality of the dietary exposure data (crop field trial data); and (4) the conservatism in
the drinking water models are also considered adequately protective to infants and children to support
the reduction of the Special FQPA SF to IX.
c. Carcinogenicity
In the ametryn risk assessments initially made available for public comment, the Agency
determined that it would be appropriate to estimate, on a trial basis, the cancer risk to humans
associated with the various uses of ametryn by using a, provisional Qx* based on the mammary tumors
seen in a rat carcinogenicity study. That decision was made in part because of some uncertainty around
the high doses of ametryn which elicited the formation of tumors. Upon review of comments and
additional data, EPA has reconsidered the carcinogenicity issues associated with ametryn.
EPA conducted another review of the available information in the rat chronic/cancer study,
considered additional information provided by the registrant, and also considered cancer information on
structurally similar analogues. As a result of this EPA review, the rat carcinogenicity study has now
been determined to have been assessed at an adequate dose, an additional rat cancer study is not
necessary for ametryn, and a Qt* approach for risk assessment is no longer considered appropriate.
The Agency reconsidered the data from the 500 ppm dose in the rat study; effects seen at various dose
levels in the recently received 90-day subchronic (conducted on ametryn in 1998 and submitted to the
Agency in March 2005); and the cancer reviews of two structurally similar methylthio-s-triazines,
prometryn and terbutryn.
In reviewing the chronic/cancer study data and the additional 90-day subchronic toxicity study,
there are minimal effects (slight decrease in body weight gain) at the 500 ppm dose level. Although
there were no statistical differences reported at 500 ppm, the males were from about 2.6% to 6%
lower in weight than the controls for each week of the 13 weeks of the study. The females were also
similarly lower in weight (from about 3.2% to 6.3%) for each week of the 13 weeks of the study.
The cancer studies on prometryn and terbutryn support the conclusion that methylthio-s-
triazines either do not induce tumors in rats (prometryn) or do so only at higher doses where the body
weight is more drastically affected (terbutryn). Terbutryn is thus similar to ametryn (2-(ethylamino)-4-
isopropylamino-6-methylthio-s-triazine), since both chemicals show liver, thyroid and testicular tumors
at doses that have excessive body weight reductions. EPA's Science Advisory Panel in December 23,
1987 did not advise that the Qt* approach for risk assessment was appropriate for terbutryn because
"positive tumor data occurred only at a dose that exceeded the MTD." Similarly, since the positive
tumor data for ametryn occur only at a dose considered excessive, a Qt* quantitative risk assessment
is not appropriate for ametryn.
d. Toxicological Endpoints for Ametryn
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The lexicological endpoints used in the human health risk assessment for ametryn are listed in
Table 4. Also included in the table are the uncertainty factors (UFs) used in the ametryn risk
assessments to account for interspecies extrapolation (10X), intraspecies variability (10X), and the
Special FQPA SF (IX). An endpoint attributable to a single dose for females age 13 - 49 and the
general population was not identified from available oral studies including the developmental toxicity
studies. Therefore, an acute dietary endpoint was not selected.
Table 4. Summary of Toxicological Doses and Endpoints for Ametryn for Use in Human
Risk Assessments
Exposure
Scenario
Acute Dietary
(females 13-49) &
(general pop.)
Chronic Dietary
(all populations)
Dermal
Short-Term
(1 - 30 days) &
Intermediate-Term
(1-6 months)
Inhalation
Short-Term
(1 - 30 days) &
Intermediate-Term
(1-6 months)
Cancer (oral, dermal,
inhalation)
Dose Used in Risk
Assessment and
UF/MOE
FQPA SF and Level of
Concern for Risk
Assessment
Study and Toxicological Effects
No lexicological effect attributable to a single dose was identified.
NOAEL = 7.2
mg/kg/day
UF = 100 (inter and
intraspecies)
Chronic RfD =
0.072 mg/kg/day
NOAEL = 100
mg/kg/day
MOE = 100
NOAEL = 10
mg/kg/day
MOE = 100
FQPA SF = IX
cPAD = Chronic RfD
FQPA SF
cPAD = 0.072
mg/kg/day
FQPA SF = IX
LOC = 100
FQPA SF = NA
LOC = 100
Dog chronic feeding study
LOAEL = 70 mg/kg/day with
indications of degenerative and
inflammatory liver effects.
Rabbit 21 -day dermal toxicity study.
LOAEL = 1000 mg/kg/day with body
weight gain decrease.
Oral rabbit developmental toxicity.
LOAEL = 60 mg/kg/day with body
weight and decreased feed consumption
and increased liver weight.
Assume 100% absorption from
inhalation exposure.
Carcinogenic responses occur only at doses exceeding the maximum tolerated dose.
(No quantitative carcinogenicity risk assessment is required.)
UF = uncertainty factor; FQPA SF = Special FQPA Safety Factor; NOAEL = no observed adverse effect level;
LOAEL = lowest observed adverse effect level; PAD = population adjusted dose (a = acute, c = chronic);
RfD = reference dose; MOE = margin of exposure; LOC = level of concern; NA = Not Applicable
e. Ametryn Metabolites and Degradates
The food and occupational risk estimates summarized in this document are for ametryn per se.
However, risk estimates for drinking water include ametryn per se and the degradates 2-amino-4-
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isopropylamino-6-methylthio-s-triazine (GS-11354) and 2-ethylamino-4-amino-6-methylthio-s-triazine
(GS-11355). These degradates are formed primarily by soil metabolism and therefore are only likely to
be found in drinking water sources from run off to streams or leaching to groundwater . These
degradates are significantly similar in structure to the parent ametryn and are found to be present in
sufficient abundance in some environmental degradation studies to warrant inclusion as residues of
concern in the risk assessment. In addition, estimated contributions from the sulfoxide [NOA423271]
and sulfone [NOA428383] forms of ametryn were also considered to account for possible reformation
of ametryn from these two degradates through reduction reactions. No degradates of concern were
found in the crop metabolism studies. As a result, no degradates are expected in food items from
treated crops. A summary of the ametryn metabolites and degradates used in the human health risk
assessment and tolerance expression is provided in Table 5.
Table 5. Summary of Metabolites and Degradates Included in the Risk Assessment and
Tolerance Expression
Matrix
Plants
Livestock
Primary Crop
Rotational Crop
Ruminant
Poultry
Drinking Water
Residues included in Risk
Assessment
ametryn per se
ametryn per se
Not Applicable - no residues
expected
Not Applicable - no residues
expected
ametryn, GS-11354,
GS-1 1355, NOA423271*, and
NOA428383*
Residues included in Tolerance
Expression
ametryn per se
ametryn per se
Not Applicable - no tolerances
required
Not Applicable - no tolerances
required
Not Applicable
* Oxidized forms of ametryn: NOA423271 = N-ethyl-N-isopropyl-6-methanesulfmyl-[l,3,5]triazine-2,4-diamine;
NOA428383 = 4-ethylamino-6-isopropyl-6-isopropylamino-[l,3,5]triazine-2-sulfmic acid sodium salt (D307097 &
D307105, K. Costello, 07-JUN-2005)
f. Endocrine Effects
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 recommendations of its Endocrine
Disrupter and Testing Advisory Committee (EDSTAC), EPA determined that there was a scientific
basis for including, as part of the program, the 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 extent that effects in wildlife may help determine whether a substance may have an effect in
humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources
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allow, screening of additional hormone systems may be added to the Endocrine Disrupter Screening
Program (EDSP).
In the available toxicity studies on ametryn, there was no estrogen, androgen, and/or thyroid
mediated toxicity. When additional appropriate screening and/or testing protocols being considered
under the Agency's EDSP have been developed, ametryn may be subjected to further screening and/or
testing to better characterize effects related to endocrine disruption.
2. Dietary Exposure and Risk from Food
Dietary (food) exposure assessments were conducted for ametryn using Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID™, Version 2.0)
and Lifeline™ (ver. 2.0) for the general U.S. population and all population sub-groups. Both of these
models use food consumption data from the USDA's Continuing Surveys of Food Intake by
Individuals (CSFII) from 1994-1996 and 1998. Since the toxicity database for ametryn did not indicate
any potential acute effects in the available short-term studies, an acute dietary risk assessment was not
conducted. Furthermore, for the revised risk assessment, a cancer dietary exposure assessment was
not conducted in light of the change in the Agency's view of the carcinogenicity of ametryn.
Therefore, only a chronic dietary (food) risk assessment was conducted for ametryn.
Estimated dietary (food) risks less than 100% of the Population Adjusted Dose (PAD), either
acute (aPAD) or chronic (cPAD), are not of concern to the Agency. The PAD is the reference dose
(RfD) adjusted for the FQPA safety factor (PAD = RfD/FQPA SF). The cPAD is the dose at which an
individual could be exposed over the course of a lifetime and not expect an adverse health effect.
Chronic Dietary Risk from Food
The Lifeline™ and DEEM-FCID™ chronic exposure estimates were less than 0.1% of the
cPAD for all population subgroups (including children ages 1-2, the highest potentially exposed
population). These exposures are well below EPA's level of concern. Table 6 summarizes the results
of the chronic dietary analyses. A refined chronic analysis was conducted for ametryn using average
residue levels from applicable field trials, percent crop treated information and DEEM (ver. 7.76)
default processing factors. Maximum application rates have been reduced and anticipated residues are
not expected to increase as a result of the new, lower use rates. Residue levels at the old higher rates
were all < 0.02 ppm, which is less than the level of quantitation (LOQ).
Table 6. Summary of Chronic Dietary (Food) Exposure and Risk Estimates for Ametryn
Population Subgroup
General U.S. Population
Children 1-2 years old
Dietary Exposure (mg/kg/day)
DEEM-FCID™
0.000004
0.000018
Lifeline™
0.000004
0.000018
% cPAD
DEEM-FCID™
<0.1
<0.1
Lifeline™
<0.1
<0.1
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3. Dietary Risk from Drinking Water
Drinking water exposure to pesticides can occur through surface and groundwater
contamination. EPA considers chronic (lifetime) drinking water risks and uses modeling to estimate
those exposures, or monitoring data, if available. For ametryn, estimated drinking water
concentrations (EDWCs) were generated using the screening-level computer models PRZM/EXAMS-
Index Reservoir for surface water and SCI-GROW2 for groundwater sources of drinking water.
Potential contaminants of concern considered in the drinking water exposure assessment are parent
ametryn, the degradates 2-amino-4-isopropylamino-6-methylthio-s-triazine (GS-11354), 2-ethylamino-
4-amino-6-methylthio-s-triazine (GS-11355), NOA-423271, andNOA-428383.
Given its persistence and mobility, transport of ametryn to surface and groundwater is expected
from normal agricultural use. However, based on the new reduced maximum use patterns (rates and
number of applications) supported by the registrant and a revised half-life, modeled EDWCs have been
reduced from those presented in the preliminary risk assessments initially made available for public
comment. The EDWCs for ametryn in groundwater and surface water based on the reduced
application rates are summarized in Table 7.
Table 7. Ametryn EDWCs for Surface Water and Groundwater
Exposure Duration
Chronic
Ametryn
Surface Water Cone., ppb a
14
Groundwater Cone., ppb b
1.4
a From the Tier IIPRZM-EXAMS - Index Reservoir model. Input parameters are based on the physical properties of
ametryn, and assuming 2 separate applications of ametryn to sugarcane in LA, for a total rate of 2.4 Ib ai/A/year.
b From the SCI-GROW model assuming a maximum seasonal use rate of 3.2 Ib ai/A [pineapple in HI], a K^ of 96, and
a half-life of 40.1 days.
Monitoring of ametryn concentrations in groundwater and surface water is limited. Ametryn
was not included among analytes in the US Geological Survey's National Water-Quality Assessment
(NAWQA) program, for instance. Monitoring in Hawaii of groundwater in pineapple use areas in the
mid-1990s resulted in a maximum concentration similar in magnitude to that predicted with the
groundwater screening model SCI-GROW. In addition, quarterly surface water monitoring on the
borders of the Everglades Agricultural Area (EAA) has resulted in surface water concentrations well
below those estimated from maximum application rates by the PRZM/EXAMS models.
4. Residential Exposure and Risk
Ametryn uses are being supported only for the following agricultural crops: field corn,
popcorn, sugarcane, and pineapple. There are no residential uses and there are no anticipated
exposures in or around homes or recreational areas. Therefore, a residential risk assessment was not
conducted.
5. Aggregate Risk
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The FQPA amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA, Section
408(b)(2)(A)(ii)) require "that there is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, including all anticipated dietary exposures and other
exposures for which there are reliable information." Aggregate exposure will typically include
exposures from food, drinking water, residential uses of a pesticide, and other non-occupational
sources of exposure.
In accordance with the FQPA, the Agency must consider and aggregate (combine) pesticide
exposures and risks from three major sources or pathways: food, drinking water and, if applicable,
residential or other non-occupational exposures. For aggregate risk, EPA combines exposures from
food and residential sources and calculates a drinking water level of comparison (DWLOC), which
represents the maximum allowable exposure through drinking water after considering food and
residential exposures. If the EDWCs are less than the DWLOCs, EPA does not have concern for
aggregate exposure. If EDWCs are greater than DWLOCs, EPA will conduct further analysis to
characterize the potential for aggregate risk of concern.
In the case of ametryn, the aggregate risk estimates only consider combined food and drinking
water exposures because there are no registered residential uses. An acute aggregate risk assessment
was not conducted because an endpoint of concern attributable to a single dose was not identified.
Chronic Aggregate Risk
A long-term (chronic) aggregate risk assessment was conducted for ametryn. The chronic
assessment considered exposures from food and drinking water only. As indicated in Table 8, the
EDWCs for chronic exposures for the U.S. general population or for the most highly exposed group
(Children ages 1-2 years old) are less than the corresponding DWLOCs; therefore, estimated
aggregate risks for these exposure durations are below EPA's level of concern.
Table 8. Ametryn Chronic Aggregate Risk Assessment
Population
Subgroup
U.S. Population
Children 1-2 years
Groundwater EDWC*
(ppb)
1.4
Surface Water EDWC*
(ppb)
14
Chronic DWLOC
(ppb)
2520
720
*The EDWC levels are based on the reduced rates: 1.6 Ibs ai/acre, 2X per crop cycle for pineapple use in HI
(groundwater) and 1.2 Ibs ai/acre, 2X per year for sugarcane use in LA (surface water).
6. Occupational Exposure and Risk
Workers can be exposed to a pesticide through mixing, loading, or applying the pesticide, and
re-entering a treated site. For dermal and inhalation exposures, worker risk is measured by a Margin of
Exposure (MOE), which determines how close the occupational exposure comes to the No Observed
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Adverse Effect Level (NOAEL) selected from animal toxicity studies. For ametryn, MOEs that are
greater than 100 do not exceed the Agency's level of concern.
Ametryn exposures occurs in a variety of patterns. Occupational exposures to ametryn can
occur for a single day, or up to weeks at a time for commercial applicators that are completing a
number of applications for several different clients. This is an upper bound assessment, which presents
handler risk estimates for both short-term (1 to 30 days) and intermediate-term (1 month to 6 months)
exposure durations. No long-term exposure (>6 months) is expected from applications of ametryn.
a. Occupational Handler Risk
EPA determines potential exposures to pesticide handlers by identifying exposure scenarios
from various types of application equipment that are recommended on ametryn labeling. Based on the
product labeling, agricultural use patterns specific to ametryn are associated with the following types of
application equipment: groundboom sprayers for sugarcane, pineapple, and corn and aerial (sugarcane
in FL only). As a result, EPA has identified 9 occupational handler scenarios for which short-term (1 -
30 days) and intermediate-term (1-6 months) exposures to ametryn may occur. Exposure estimates
were conducted using the reduced maximum application rates for each of the crops.
In the absence of chemical-specific handler data, EPA used unit exposure values from the
Pesticide Handlers Exposure Database (PFLED) to estimate exposures for a variety of occupational
scenarios and combinations of personal protective equipment (PPE) and engineering controls. For
most handler scenarios, EPA used standard assumptions for the number of acres treated, body weight,
and hours worked. EPA derived information about use patterns, application methods, and the range of
application rates used in the exposure assessment from the current ametryn labels. The dermal and
inhalation lexicological endpoints used in assessing the risks from occupational exposures to ametryn
and the target MOEs are listed in Table 4. The application rates specified on the ametryn labels range
from 1.6 to 2.4 Ibs a.i./A in agricultural settings. The Agency typically uses acres treated per day
values that are thought to represent eight hours of application work for specific types of application
equipment. Table 9 summarizes the exposure scenarios, use patterns assessed and associated risk
estimates (MOEs) for occupational handlers wearing baseline attire when handling ametryn products.
All scenarios for occupational handlers wearing baseline attire (long-sleeved shirts, long pants, shoes
and socks, no gloves, and no respirator) have combined dermal and inhalation MOEs greater than 100
and, therefore, are not of concern. The PPE on the current product label includes: long-sleeve shirt
and long pants; chemical resistant gloves made of any waterproof material; and shoes plus socks.
Table 9. Summary of Occupational Handler Exposure Estimates - Baseline PPE*
Exposure Scenario
(Scenario #)
Crop
App. Rate
(Ibai/A)
Daily
Area
Treated
(acres)
Dermal
MOE
Inhalation
MOE
Total
MOE
Mixer/Loader
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Table 9. Summary of Occupational Handler Exposure Estimates - Baseline PPE*
Exposure Scenario
(Scenario #)
Mixing/Loading Dry
Flowables for
Groundboom application
(1)
Mixing/Loading Dry
Flowables for
Groundboom application
(2)
Mixing/Loading Dry
Flowables for
Groundboom application
(3)
Mixing/Loading Dry
Flowables for Aerial
application (4)
Crop
Corn
Pineapple
Sugarcane
Sugarcane
App. Rate
(Ibai/A)
1.6
1.6
2.4
1.2
Daily
Area
Treated
(acres)
200
40
80
350
Dermal
MOE
330
1700
550
250
Inhalation
MOE
2800
14000
4700
2200
Total
MOE
300
1500
490
230
Applicator
Sprays for Groundboom
application (5)
Sprays for Groundboom
application (6)
Sprays for Groundboom
application (7)
Sprays for Aerial
application (8)
Corn
Pineapple
Sugarcane
Sugarcane
1.6
1.6
2.4
1.2
200
80
80
350
1600
3900
2600
No Data
3000
7400
4900
No Data
1000
2600
1700
No Data
Flagger
Flagging for Sprays
application (9)
Sugarcane
1.2
350
1500
4800
1100
* Baseline PPE = All handlers are wearing long-sleeved shirts, long pants, socks & shoes, no gloves, and no respirator.
b. Occupational Post-Application Risk
Ametryn product labeling specifies application as either a directed spray at weeds or as a pre-
emergent broadcast spray, and includes instructions to avoid application to the crop foliage.
Additionally, for corn and pineapples, the label specifies the last ametryn application be made 30 and
160 days prior to harvesting, respectively. For sugarcane, the label specifies "Avoid wetting sugarcane
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foliage, or injury may occur" and also recommends against application after "close-in" - when the
sugarcane grows over the planting beds, generally months prior to harvesting. For these reasons, EPA
does not anticipate any foliar residues on the ametryn treated crops. Therefore, the Agency does not
expect there to be any post-application foliar exposures to occur and post-application occupational
exposures were not assessed.
7. Incident Reports
Relatively few incidents of illness (four) have been reported due to ametryn. Four exposures to
ametryn products were reported to Poison Control Centers from 1993 through 2001. Two of the four
cases, all adults, involved minor symptoms. One of the cases was seen in a health care facility and was
not hospitalized and another case reported diarrhea and drowsiness/lethargy. There were no other
reports of incidences in the other poisoning databases.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment for ametryn is presented below.
More detailed information associated with the environmental risk from the use of ametryn can be found
in the Final EFED Chapter for Ametryn, dated June 9, 2005. The complete environmental risk
assessment is not included in this RED document, but may be accessed in the OPP Public Docket
OPP-2004-0411 and on the Agency's website at
http ://www. epa. gov/pesticides/reregistration/status.htm.
Aquatic and terrestrial organisms may be exposed to ametryn residues from areas on or
adjacent to treated fields. The Tier II screening-level model PRZM/EXAMS was used to estimate
surface water concentrations of ametryn to assess risks to aquatic organisms. Terrestrial organisms
may be exposed to ametryn from consuming plants, seeds, and insects with ametryn residues. Only the
toxicity of the ametryn parent is assessed, as no toxicity data is available to assess the degradates
separately. However, additional risk from potential degradates is covered by the conservative
assumptions built into the model for assessing risk to terrestrial organisms and is not expected to
significantly change the RQs for aquatic organisms.
To estimate potential ecological risk, EPA integrates the results of exposure and ecotoxicity
studies using the risk quotient method. Risk quotients (RQs) are calculated by dividing acute and
chronic exposure estimates by ecotoxicity values for various animal and plant species. RQs are then
compared to levels of concern (LOCs); the higher the RQ, the greater the potential risk. Risk
characterization provides further information on potential adverse effects and the possible impact of
those effects by considering the fate of the chemical and its degradates in the environment, organisms
potentially at risk, and the nature of the effects observed. A summary of the Agency's environmental
risk assessment for ametryn is presented below.
1. Environmental Fate and Transport
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The environmental fate database is sufficient to characterize the environmental exposure
associated with ametryn use. However, an anaerobic aquatic metabolism study and a foliar dissipation
study will be required to verify assumptions about risk. These studies will be part of a Data Call-in
(DCI) EPA intends to issue as a result of this RED for the parent ametryn and its degradates, to
address areas of uncertainty. These data are expected to confirm the conclusions of this environmental
risk assessment.
The environmental fate of ametryn varies based on the site-specific properties of the soil to
which it is applied. Based on packed soil column leaching studies, ametryn per se and its degradates
exhibit moderate to high mobility in most sandy to loamy soils, except for clay where its mobility is
low. The major route of degradation of ametryn per se is aerobic soil metabolism, with an observed
half-life range of 9.6 days to 38 days. Ametryn per se is stable to hydrolysis, with an observed half-life
of 368 days. Ametryn has a low vapor pressure at room temperature, and is unlikely to significantly
volatilize from soil surfaces. Ametryn degradates of concern include NOA-423271, NOA428383, GS-
11354, and GS-11355. The total amount of ametryn degradate residues can vary depending on
environmental conditions. In the case of NOA-423271 and NOA-428383, environmental conditions
conducive to redox reactions can allow the oxidized forms of degradates to reduce back to the ametryn
parent. Similar to the parent, ametryn's degradation products are persistent and relatively mobile in
many soils. Given its persistence and mobility, transport of ametryn per se and its degradates to
surface water and groundwater is expected from labeled agricultural uses. Additional information on
the environmental fate of ametryn can be found in the supporting documents referenced in Appendix C.
2. Environmental Effects (Ecotoxicity)
a. Toxicity to Terrestrial Organism
Ametryn is slightly toxic to mammals on an acute oral exposure basis (LD50 =1162 mg/kg
body weight); following chronic exposure, reduced growth (NOEC =13 mg/kg) was observed.
Ametryn is practically nontoxic to bees based on an acute contact study. No mortality was observed in
subacute dietary toxicity studies with mallard ducks and bobwhite quail (LC50 >5620 ppm). Both
surrogate species responded similarly (NOEC = 300 mg/kg diet) with reduced growth and
reproduction following chronic exposure (Table 10).
Table 10. Summary of Acute and Chronic Toxicity Data for Terrestrial Organisms Exposed to
Ametryn.
Species
Birds
Honey bees
Acute Toxicity
LD50
(mg/kg bw)
>2250
>0.1 (mg/bee
contact)
Acute Oral
Toxicity
practically
non-toxic
practically
non-toxic
5-day LC50
(ppm)
>5620
-
Subacute
Dietary Toxicity
practically
non-toxic
-
Chronic Toxicity
NOEC/LOEC
300 / 900
ppm
-
Affected Endpoints
growth and
reproduction
-
20
-------
Table 10. Summary of Acute and Chronic Toxicity Data for Terrestrial Organisms Exposed to
Ametryn.
Species
Rat
Acute Toxicity
LD50
(mg/kg bw)
1162
Acute Oral
Toxicity
slightly toxic
5-day LC50
(ppm)
-
Subacute
Dietary Toxicity
-
Chronic Toxicity
NOEC/LOEC
13 / 130
mg/kg/d
Affected Endpoints
pup weights and
reduced weight gain
LD50 or LC50 = Median Lethal Dose or Concentration. NOEC/LOEC = No/lowest observed effect concentration
Consistent with its chemical use as an herbicide, ametryn is toxic to terrestrial plants; dicots are
more sensitive to ametryn than monocots, with lettuce (EC25= 0.006 Ib ai/acre) and cucumbers (EC25 =
0.002 Ib ai/acre) being the most sensitive indicators in the vegetative vigor and seedling emergence
tests, respectively. Table 11 summarizes the most sensitive toxicity endpoints calculated or observed in
terrestrial plant toxicity studies.
Table 11. Summary of Nontarget Terrestrial Phytotoxicity Using Both Monocotyledon and
Dicotyledon Plant Species Exposed to Ametryn."
Study Type
Vegetative
Vigor
Seedling
Emergence
Seed
Germination
Species
Monocot - onion
Dicot - lettuce
Monocot - oat
Dicot - cucumber
Dicot - lettuce
Monocot - onion
Dicot - cabbage
EC25
(Ibai/A)
0.105
dw
0.006
dw
0.083
dw
0.002
pe
0.027
dw
25.9
Pg
ND
Pg
EC50
(Ibai/A)
0.209
ph
0.015
dw
0.335
dw
0.016
pe
0.093
dw
644
Pg
ND
Pg
NOEC
(Ibai/A)
0.05
dw
<0.006
dw
0.05
dw
<0.002
pe
0.013
ph, dw
2.0
Pg
>8.0
all
^ = Effect concentration to 50%/25% of the test population.
" For each toxicity endpoint, the parameter in which these concentrations were observed are listed, dw = dry weight;
ph = plant height; pr = phytotoxicity rating; pe = percentage of seedlings emerged; rl = radicle length measurements;
pg = percentage of seed germinated; all = all parameters measured; ND = not determined.
b. Toxicity to Aquatic Organisms
21
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Ametryn is slightly to moderately toxic to freshwater fish and invertebrates, and moderately
toxic to estuarine/marine fish and invertebrates on an acute exposure basis. Following chronic
exposure, freshwater fish exhibited reduced growth (NOEC = 0.7 mg/L) while freshwater invertebrates
exhibited reduced reproduction (Daphnia NOEC = 0.24 mg/L). Table 12 summarizes the most
sensitive endpoints used in the hazard assessment of aquatic animals.
No chronic toxicity data were required or made available for estuarine/marine fish. A chronic
toxicity value for sheepshead minnow is estimated from the results of the acute toxicity study,
assuming that the acute/chronic toxicity ratio (ACR) is the same as that seen in the freshwater fathead
minnow study (16 mg L~V0.7 mg L"1 = 22.9). Based on this ACR, the estimated chronic toxicity to
sheepshead minnow is 0.25 mg/L. Similarly, the ACR from the freshwater invertebrate study is used to
estimate a chronic toxicity for estuarine/marine invertebrates. Using the ACR from the Daphnia
studies (28 mg L~V0.24 mg L"1 = 116.7), a chronic toxicity value of 0.02 mg/L is estimated for mysid
shrimp.
Table 12. Summary of Acute and Chronic Aquatic Toxicity Estimates Using Ametryn.
Species
Rainbow trout
Fathead minnow
Water flea
Sheepshead minnow
Mysid shrimp
Acute Toxicity
96-hr LC50
(mg/L)
3.6
16
-
5.8
2.3
48-hr EC50
(mg/L)
-
-
28
-
-
Acute Toxicity
moderately toxic
slightly toxic
slightly toxic
moderately toxic
moderately toxic
Chronic Toxicity
NOEC/LOEC
(mg/L)
-
0.7/1.4
0.24/0.32
0.25*
0.02**
Affected
Endpoints
-
Growth
Reduced
reproduction
-
-
* based on fathead minnow ACR of 22.9
** based on daphnid ACR of 116.7
Only one submitted study was available to evaluate the toxicity of ametryn to nonvascular
aquatic plants, which is summarized in Table 13. Also, toxicity information from a study available from
the ECOTOX (Ecotoxicology Database System) on-line database of ametryn and other herbicides on
their effects on duckweek Lemna perspusilla were used to assess non-endangered vascular plants
(EC50 = 10
Table 13. Summary of the Toxicity of Ametryn to Aquatic Plants
Species
Green algae
Pseudokirchneriella subcapitatum
EC50 ftig/L)
3.67
(NOEC= 1.14)
Acute toxicity
very highly toxic
22
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3. Exposure and Risk Assessment
The pesticide use profile, exposure data, and toxicity information are used to determine risk
estimates to non-target aquatic and terrestrial organisms. The estimated environmental concentration
(EEC) is calculated based on the maximum single application rate(s) of ametryn, which would yield the
maximum exposure estimate. To calculate acute risk exposure, the EEC is then divided by the LC50 or
LD50, which is a statistically-derived lethal concentration or dose of chemical that can be expected to
cause death in at least 50% of test animals. To calculate chronic risk exposure, the EEC is divided by
the No Observed Adverse Effect Level or No Observed Effects Concentration, NOAEL or NOEC,
respectively. The EECs calculated for the ecological risk assessment are based solely on data for
ametryn per se, as no ecotoxicity data is available for the degradates. However, the addition of
degradates is not expected to significantly increase the RQs for ametryn. The EECs are used to
calculate RQs. An RQ is the estimated ratio of exposure concentration (EEC) to the toxicity endpoint
(LC50/LD50 or NOAEL/NOEC). The RQ is then compared to the LOG to determine if exposure to
ametryn would pose a risk to non-target organisms. Table 14 outlines the Agency's LOCs and the
corresponding risk presumptions.
Table 14. Agency's LOCs and Risk Presumptions
If RQ > LOC value given below
Terrestrial
Organisms
0.5
0.2
0.1
1
Aquatic
Organisms
0.5
0.1
0.05
1
Plants
1
N/A
1
N/A
Then EPA presumes
Risk Presumption
Acute Risk - there is potential for acute risk; regulatory action may
be warranted in addition to restricted use classification.
Acute Restricted Use - there is potential for acute risk, but may be
mitigated through restricted use classification.
Acute Endangered Species - endangered species may be adversely
affected; regulatory action may be warranted.
Chronic Risk - there is potential for chronic risk; regulatory action
may be warranted.
a. Fish and Aquatic Invertebrates Exposure and Risk
For exposure to fish and aquatic invertebrates, EPA considers potential concentrations of
ametryn in surface water. The Tier IIPRZM/EXAMS models were used to estimate surface water
concentrations of ametryn in freshwater and estuarine/marine environment. Exposure to aquatic
invertebrates in sediment is not assessed, since a benthic invertebrate toxicity study was not required
nor voluntarily submitted to the Agency for ametryn. This model was also used to derive EECs to
measure potential exposures to aquatic organisms in surface water. The peak EECs for ametryn are
calculated based on the reduced application rates of a single application at 1.6 Ib a.i./A for corn, and
two applications of 1.2 Ib a.i./A sugarcane (total applied 2.4 Ibs a.i./A), which are the highest labeled
application rates that would yield the maximum EECs. All modeled EECs for fish and aquatic
23
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invertebrates are less than those presented in the preliminary risk assessments because those in the
preliminary assessments were based on maximum use patterns which are no longer supported by the
technical registrant. The available acute and chronic toxicity data on ametryn and the EECs for
ametryn residues in surface water indicate that RQs for both freshwater organisms are below the
Agency's LOCs. The highest freshwater acute RQ for fish or invertebrates is 0.02. This is well below
the Agency's 0.5 threshold for a level of concern. The highest chronic RQ for freshwater fish or
invertebrates is 0.31, which is also well below the Agency's 1.0 chronic level of concern.
For all application scenarios, acute toxicity to estuarine/marine organisms is below the
Agency's LOG. The highest acute RQs are 0.014 for fish and 0.034 for invertebrates. There were no
estuarine/marine fish or invertebrates chronic toxicity studies required and none were voluntarily
submitted to assess the chronic toxicity of ametryn. Estuarine/marine fish and invertebrates chronic
toxicity studies will be required in the Data Call-in (DCI) resulting from this RED. The chronic
assessment was based on the assumption that the acute-to-chronic NOEC ratio for estuarine/marine
organisms is the same as that for freshwater organisms. There is potential chronic risk to
estuarine/marine invertebrates for all corn and sugarcane scenarios modeled, with RQs ranging from
1.2 to 3.8. Some uncertainty exists in the chronic assessment for estuarine/marine organisms, because
quantifiable taxonomic sensitivity factors between the two organism categories do not exist. The
available acute and chronic RQs for estuarine/marine organisms are outlined in Table 15 below.
Table 15. Chronic RQs for Estuarine/Marine Organisms Exposed to Ametryn in Surface
Water
- Crop, State
- Application Rate
Corn, NC (east)
1.6 Ibs a.i./A
Corn, NC (west)
1.6 Ibs a.i./A
Sugarcane, FL
1.2 Ibs a.i./A
(2 applications)
Sugarcane, LA
1.2 Ibs a.i./A
(2 applications)
EECs (wg/L)
- 21-day Average
- 60-day Average
24
23
26
24
75
67
50
48
Chronic RQs
Fish
NOEC = 250 A
-------
The Agency assessed potential risk to non-target terrestrial organisms based on residues on
different types of food items that may be sources of exposure. The Agency expects exposure to
residues of ametryn on food and forage items, because treated fields provide a habitat rich in food
sources attractive to various avian and mammalian species. All modeled EECs for terrestrial organisms
are less than those presented in the preliminary risk assessments because those in the preliminary risk
assessments were based on maximum use patterns which are no longer supported by the technical
registrant. Additional information on the terrestrial organism exposures can be found in the supporting
documents referenced in Appendix C.
Avian Exposure and Risk
Based on no observed mortality from the highest test dosage on birds, acute risks for birds
were assessed, but RQs were not calculated, as there were not acute risks of concern for birds. The
chronic RQs are based on the highest labeled application rates that would yield the maximum EECs.
Chronic LOCs were exceeded for some feed items in the modeled crops, with the greatest exceedance
resulting from use on sugarcane in Hawaii. Mean EECs were also used to calculate chronic RQs.
Table 16 details the maximum chronic avian exposures for each use site for both the maximum and
mean EECs, based on the short grass food item only (other food items result in lower chronic risk).
Table 16. Chronic RQs for Avian Species Exposed to Ametryn*
Site
Application Rate (state)
Ibs a.i./A
Food Item
EEC (ppb)
Chronic
RQs
MAXIMUM EECs
Corn
Pineapple
Sugarcane
1.6
1.6
(2 apps., 30 day interval)
1.2 (FL, LA, TX)
(2 apps., 30 day interval)
2.4 (HI)
(3 apps., 30 day interval)
Short grass
Short grass
Short grass
Short grass
384
596
447
1070
1.28
1.99
1.49
3.57
MEAN EECs
Corn
Pineapple
Sugarcane
1.6
1.6
(2 apps., 30 day interval)
1.2 (FL, LA, TX)
(2 apps., 30 day interval)
2.4 (HI)
(3 apps., 30 day interval)
Short grass
Short grass
Short grass
Short grass
136
211
158
379
0.45
0.7
0.53
1.26
25
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Table 16. Chronic RQs for Avian Species Exposed to Ametryn"
Site
Application Rate (state)
Ibs
Food Item
EEC (ppb)
Chronic
RQs
Bolded text indicates exceedance of chronic LOG (1.0) for avian species.
* Based on a bobwhite quail NOEC of 300 ppm.
Mammalian Exposure and Risk
Ametryn is practically nontoxic to mammals on an oral acute basis, so RQs do not exceed the
LOG for acute exposures. The highest acute RQ is 0.4 from short grass exposure to small mammals in
Hawaii. However, consumption of food and forage items treated with ametryn may pose chronic risks
to mammalian species. The chronic risk assessment is based on maximum EECs and a 2-generation rat
reproduction study with a NOAEL of 13 mg/kg/day, based on reduction in growth in the F2
generation. Resulting RQs exceed chronic LOCs for some feed items from all modeled uses of
ametryn. See Table 17 for a summary of the maximum chronic mammalian exposure for each use site,
based on the short grass food item only (other food items result in lower chronic risk). Mean EECs
were not used to calculate chronic mammalian risks, but would result in RQ reductions similar to those
shown for avian chronic risks.
Table 17. Chronic RQs for Mammalian Species Exposed to Ametryn*
Site
Corn
Pineapple
Sugarcane
Application Rate (state)
Ibs a.i./A
1.6
1.6
(2 apps., 30 day interval)
1.2 (FL, LA, TX)
(2 apps., 30 day interval)
1.6 (HI)
(3 apps., 30 day interval)
Body Weight
(grams)
15
35
1000
15
35
1000
15
35
1000
15
35
1000
Food Item
Short grass
Short grass
Short grass
Short grass
Chronic RQs
13
11
6
20
17
9
5
5
2
36
31
16
Bolded text indicates exceedance of chronic LOG (1.0) for mammalian species.
* Based on a 2-generation rat reproduction study with a NOAEL =13 mg/kg/day and maximum EECs.
26
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c. Non-Target Plant Exposure and Risk
Terrestrial plants inhabiting dry and semi-aquatic areas may be exposed to pesticides from run-
off, spray drift, or volatilization. Like terrestrial plants, non-target aquatic plants may be exposed to
pesticides from the same routes. EECs were calculated using the highest estimated surface water
concentrations based on the reduced maximum use patterns for ametryn. As with the other organisms
assessed in the environmental risk assessment, estimated RQs are lower than those presented in the
preliminary risk assessments because of the reduced maximum use patterns.
Terrestrial Plant Exposure and Risk
Acute RQs for terrestrial plant exposure were calculated using the TerrPlant model. Currently,
the Agency is not assessing chronic effects on plants. Consistent with its use as an herbicide, ametryn
may pose a risk of concern to terrestrial plants. Spray drift exposure risk estimates using AgDrift
modeling indicates potential risk to plants. Table 18 details acute risks to terrestrial plants. Note that
the predicted risk to semi-aquatic plants appears approximately 10 times higher than the risk to plants
in adjacent area or exposed to spray drift. However, the model input for the surface watershed for the
semi-aquatic areas is 10 hectares as compared to an input of one hectare for the watershed for adjacent
areas. Unlike runoff from an adjacent area, semi-aquatic areas (i.e., wetlands) tend to be low lying
areas and would typically collect field runoff from a larger area.
Table 18. Acute RQs for Terrestrial Plants Exposed to Ametryn
Crop
Corn
Pineapple
Sugarcane
Application Rate
(Ibs a.L/A)
1.6
1.6
1.2 (FL, LA, TX)
(2 apps.,
30 day interval)
2.4 (HI)
(3 apps.,
30 day interval)
Application
Method
Ground spray
Ground spray
Ground spray
Aerial Spray
Ground Spray
Acute RQs
Adjacent Area
Monocot1
1.16
1.16
0.87
1.16
1.73
Dicot2
48
48
36
48
72
Semi-Aquatic Area
Monocot1
9.83
9.83
7.37
5.06
14.75
Dicot2
408
408
306
210
612
Spray Drift
Monocot3
0.15
0.15
0.11
0.57
0.23
Dicot3
2.67
2.67
2
10
4
1 Seedling Emergence EC^: Monocot = 0.083 Ib ai/A (oat) 2 Seedling Emergence EC^: Dicot = 0.002 Ib ai/A (cucumber)
3 Vegetative Vigor EC^: Monocot = 0.105 Ib ai/A (onion); Dicot = 0.006 Ib ai/A (lettuce)
Bolded text indicates exceedance of acute LOG (1.0) for terrestrial plants.
Acute endangered terrestrial nontarget plant RQs in adjacent and semi-aquatic areas (see Table
19) exceed the LOG for all crops modeled. Endangered species dicot spray drift RQs exceeded the
LOG in all uses. As indicated in Table 11, the actual NOEC for the most sensitive dicot (cucumber) in
both vegetative vigor and seedling emergence studies is lower than the lowest treatment level tested.
27
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As a result, actual RQs for dicot endangered species are greater than the values reported in Table 19.
Endangered species monocot spray drift RQs are less than the LOG for all application scenarios, except
for aerial sugarcane applications of ametryn.
Fable 19. Acute RQs for Terrestrial Endangered Plants Exposed to Ametryn
Crop
Corn
Pineapple
Sugarcane
Application Rate
(Ibs a.L/A)
1.6
1.6
1.2 (FL, LA, TX)
(2 apps.,
30 day interval)
2.4 (HI)
(3 apps.,
30 day interval)
Application
Method
Ground spray
Ground spray
Ground spray
Aerial Spray
Ground Spray
Acute RQs
Adjacent Area1
Monocot
1.92
1.92
1.44
1.92
2.88
Dicot
>48
>48
>36
>48
>72
Semi-Aquatic Area1
Monocot
16.32
16.32
12.20
8.40
24.48
Dicot
>408
>408
>306
>210
>612
Spray Drift2
Monocot
0.32
0.32
0.24
1.2
0.48
Dicot
>2.67
>2.67
>2.0
>10
>4.0
1RQ = EEC/Seedling Emergence NOEC
2 RQ = Drift EEC/Vegetative Vigor NOEC
Aquatic Plant Exposure and Risk
Acute RQs for aquatic plant exposure were calculated using the Tier IIPRZM/EXAMS
model. Currently, the Agency is not assessing chronic effects on plants. Consistent with its use as an
herbicide, ametryn may pose a risk to both vascular and non-vascular aquatic plants from all modeled
crop scenarios. Acute risk to endangered vascular plants is not assessed, as no data is available. Plant
testing will be required in the Data Call-In as part of this RED. Based on the higher application rate, it
is possible that RQs for aquatic endangered vascular plants in Hawaii would be higher. Table 20
summarizes acute risks to aquatic plants.
Table 20. Acute RQs for Non-Endangered and Endangered Aquatic Plants
Crop
State
Corn
NC (east)
Corn
NC (west)
Application
Rate
(Ibs a.i./A)
1.6
1.6
EECs
Peak (wg/L)
25
27
Acute RQs
Non-Endangered
Vascular
EC50 =
lO^g/L
3
3
Non-vascular
EC50 =
3.67 ,wg/L
7
7
Acute RQs
Endangered
Vascular
—
Non-vascular
NOEC =
l.U/^g/L
22
24
28
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Table 20. Acute RQs for Non-Endangered and Endangered Aquatic Plants
Crop
State
Sugarcane
FL
Sugarcane
LA
Application
Rate
(Ibs a.L/A)
1.2
(2 applications)
1.2
(2 applications)
EECs
Peak (wg/L)
81
52
Acute RQs
Non-Endangered
Vascular
EC50 =
10/^g/L
8
5
Non-vascular
EC50 =
3.67 ,wg/L
22
14
Acute RQs
Endangered
Vascular
—
—
Non-vascular
NOEC =
1.14,wg/L
71
46
Bolded text indicates exceedance of acute LOG (1.0) for aquatic plants.
4. Ecological Incidents
EPA's Ecological Incident Information System contains no reports of wildlife poisoning
incidents attributed to ametryn.
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration 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 reregistration. The Agency has previously identified and required the submission of the
generic (i.e., active ingredient-specific) data to support reregistration of products containing ametryn as
an active ingredient. The Agency has completed its review of these generic data, and has determined
that the data are sufficient to support reregistration of all products containing ametryn.
The Agency has completed its assessment of the dietary, occupational, residential, and
ecological risk associated with the use of pesticide products containing the active ingredient ametryn.
Based on a review of these data and on public comments on the Agency's assessments for the active
ingredient ametryn, the Agency has sufficient information on the human health and ecological effects of
ametryn to make decisions as part of the tolerance reassessment process under FFDCA and
reregistration process under FIFRA, as amended by FQPA. The Agency has determined that ametryn
containing products are eligible for reregistration provided that: (i) current data gaps and confirmatory
data needs are addressed; (ii) the risk mitigation measures outlined in this document are adopted; and
(iii) label amendments are made to reflect these measures. Label changes are described in Section V.
Appendix A summarizes the uses of ametryn that are eligible for reregistration. Appendix B identifies
the generic data that the Agency reviewed as part of its determination of reregistration eligibility of
ametryn, 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.
29
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Based on its evaluation of ametryn, the Agency has determined that ametryn products, unless
labeled and used as specified in this document, would present risks inconsistent with FIFRA.
Accordingly, should a registrant fail to implement any of the risk mitigation measures identified in this
document, the Agency may take regulatory action to address the risk concerns from the use of
ametryn. If all changes outlined in this document are incorporated into the product labels, then all
current risks for ametryn will be adequately mitigated for the purposes of this determination.
B. Public Comments and Responses
Through the Agency's public participation process, EPA worked extensively with stakeholders
and the public to reach the regulatory decisions for ametryn. During the public comment period on the
risk assessments, which closed on April 26, 2005, the Agency received 6 submissions of public
comments, one from Syngenta Crop Protection, Inc., three from commodity and research groups, one
from a private citizen, and one from the University of Hawaii. These comments in their entirety are
available in the public docket (OPP-2004-0411) at http ://www. epa. gov/edockets. An individual
response to these comments is being prepared by EPA and will be made available in the public docket
(OPP-2004-0411).
C. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
this pesticide. EPA has determined that risk from dietary (food sources only) exposure to ametryn is
within its own "risk cup." An aggregate assessment was conducted for exposures through food and
drinking water (ametryn has no registered residential uses). The Agency has determined that the
human health risks from these combined exposures are within acceptable levels. In other words, EPA
has concluded that the tolerances for ametryn meet FQPA safety standards. In reaching this
determination, EPA has considered the available information on the potential sensitivity of infants and
children, as well as aggregate exposure from food and drinking water.
b. Determination of Safety to U.S. Population
The Agency has determined that the established tolerances for ametryn, with amendments and
changes as specified in this document, meet the safety standards under the FQPA amendments to
section 408(b)(2)(D) of the FFDCA, and that there is a reasonable certainty no harm will result to the
general population or any subgroup from the use of ametryn. In reaching this conclusion, the Agency
has considered all available information on the toxicity, use practices and exposure scenarios, and the
environmental behavior of ametryn.
As discussed in Section III, acute dietary risk was not assessed as no acute oral endpoint was
observed. Further, the ametryn chronic dietary risk for the U.S. general population from both food and
30
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drinking sources is not of concern. Screening-level models were used to estimate concentrations of
ametryn in surface water and groundwater sources of drinking water. All drinking water model
estimates were low and below the Agency's level of concern.
c. Determination of Safety to Infants and Children
EPA has determined that the established tolerances for ametryn, with amendments and changes
as specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants and children.
The safety determination for infants and children considers factors on the toxicity, use practices and
environmental behavior noted above for the general population, but also takes into account the
possibility of increased dietary exposure due to the specific consumption patterns of infants and
children, as well as the possibility of increased susceptibility to the toxic effects of ametryn residues in
this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic effects
from exposure to residues of ametryn, the Agency considered the completeness of the hazard database
for developmental and reproductive effects, the nature of the effects observed, and other information.
Based on this information, EPA reduced the ametryn Special FQPA SF to Ix. There are no concerns
and no residual uncertainties with regard to pre- and post-natal toxicity based on the rat and rabbit
developmental toxicity studies and the rat two-generation reproduction study. There were no
indications of immunotoxicity or direct neurotoxicity in the standard studies with rats, dogs, mice or
rabbits. Further, the quality of the dietary exposure data (crop field trial data and the conservatism in
the drinking water models) are also considered adequately protective to infants and children to support
the reduction of the Special FQPA SF to Ix.
2. Endocrine Disrupter Effects
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
endocrine effects as the Administrator may designate." Following recommendations of its Endocrine
Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in
addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that EPA
include evaluations of potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the
extent that effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine Disrupter Screening Program
(EDSP).
In the available toxicity studies on ametryn, there was no estrogen, androgen, and/or thyroid
mediated toxicity. When additional appropriate screening and/or testing protocols being considered
31
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under the Agency's EDSP have been developed, ametryn may be subjected to further screening and/or
testing to better characterize effects related to endocrine disruption.
3. Cumulative Risks
Risks summarized in this document are those that result only from the use of ametryn. The
FQPA requires that the Agency consider "available information" concerning the cumulative effects of a
particular pesticide's residues and "other substances that have a common mechanism of toxicity." The
reason for consideration of other substances is due to the possibility that low-level exposures to
multiple chemical substances that cause a common toxic effect by a common toxic mechanism could
lead to the same adverse health effect as would a higher level of exposure to any of the substances
individually.
The Agency has found no information indicating ametryn shares a common mechanism of
toxicity with other substances. Based on the Agency's review of the available toxicity information,
EPA has determined that there is no known mechanism of toxicity that would support grouping
ametryn with chloro-s-triazines (atrazine, simazine, propazine and their chloro-s-triazine metabolites).
Ametryn has a different functional group attached to the triazine ring, i.e., thiomethyl versus chloro.
Further, ametryn does not exhibit the same toxicity profile as the chloro-s-triazines. Although there
were several tumors induced by ametryn in a rat bioassay, they were only at an excessive dose which
confounds the interpretation of this response. Moreover, the Agency has found no information
indicating ametryn shares a common mechanism of toxicity with other substances, nor does ametryn
appear to produce a toxic metabolite produced by other substances.
Therefore, for the purposes of tolerance reassessment and a decision on reregistration
eligibility, EPA has not assumed that ametryn shares a common mechanism of toxicity with other
compounds. In the future, if additional information suggests ametryn shares a common mechanism of
toxicity with other compounds, additional testing may be required and a cumulative assessment may be
necessary. Information specific to the grouping of triazines for cumulative risk assessment including
the March 2002 report, "The Grouping of a Series of Triazine Pesticides Based on a Common
Mechanism of Toxicity" can be found at:
http://www.epa.gov/oppsrrdl/cumulative/triazines/triazinescommonmech.pdf.
D. Tolerance Reassessment Summary
The tolerances listed in 40 CFR §180.258 (a and c) are currently expressed in terms of ametryn
(2-ethylamino)-4-(isopropylamino)-6-(methylthio)-5-triazine/'er se. The Agency has determined that
the residues of concern for the tolerance expression consists of ametryn per se. The current tolerance
expression allowing for residues of ametryn are established under 40 CFR §180.258, as listed in Table
21 below.
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Tolerances Listed Under 40 CFR §180.258 (a and c):
Adequate residue data are available to reassess the established tolerances on corn, pineapples,
and sugarcane. The available residue data indicate that tolerances can be lowered for all commodities.
Tolerances on corn grain, forage, and stover should be split to include field and pop corn (e.g. Corn,
field, grain and Corn, pop, grain)
Based on the available livestock metabolism and feeding studies, there is no reasonable
expectation of finite residues occurring in livestock commodities. Therefore, tolerances for livestock
commodities are not currently required.
The tolerances on forage and fodder of pineapples and sugarcane should be revoked as these
commodities are no longer regulated; and the tolerances on sweet corn, banana, cassava, tanier, and
yams should be revoked as uses on these crops are not being supported.
Table 21. Tolerance Reassessment Summary for Ametryn.
Commodity
Current
Tolerance
(ppm)
Tolerance Reassessment (ppm)
Comment
Tolerances Listed Under 40 CFR §180.258(a):
Banana
Corn, forage
Corn, grain
Corn, stover
Corn, fresh, kernel plus
cob with husks removed
Pineapple
Pineapple, fodder
Pineapple, forage
Sugarcane, cane
Sugarcane, fodder
Sugarcane, forage
Tanier
Yam, true, tuber
0.25
0.5
0.25
0.5
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
-
Corn, field, forage
Corn, pop, forage
Corn, field, grain
Corn, pop, grain
Corn, field, stover
Corn, pop, stover
—
—
—
Revoke
0.1
0.05
0.05
Revoke
0.05
Revoke
0.05
Revoke
Revoke
Technical registrant is deleting this
use from the label (use is not being
supported).
Field corn and pop corn should
have separate tolerances for grain,
forage, and stover.
Technical registrant is deleting this
use from the label (use is not being
supported).
—
Commodity is no longer regulated
livestock feed items.
—
Commodity is no longer regulated
livestock feed items.
No active registrations include this
use (technical registrant does not
support this use).
Tolerances Listed under 40 CFR 180.258(c):
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Table 21. Tolerance Reassessment Summary for Ametryn.
Commodity
Cassava, root
Current
Tolerance
(ppm)
0.1
Tolerance Reassessment (ppm)
—
Revoke
Comment
No active registrations include this
use (technical registrant does not
support this use).
1. Codex/NAFTA Harmonization
There are no ametryn Maximum Residue Limits (MRLs) in the FAO/WHO Codex
Alimentarius nor are there MRLs for ametryn in Canada.
2. Residue Analytical Methods
Adequate methods are available for enforcing tolerances and/or collecting data on ametryn
residues in/on plant and livestock commodities. Two gas chromotomgraphy (GC) methods are
available for enforcing tolerances of ametryn in plant commodities and are listed as Methods I and A in
PAM Vol. II (section 180.258). Method I is a GC/microcoulometric (MC) detection method for
determining ametryn per se, with a limit of quantitation (LOQ) of 0.05 ppm. Method A is a GC/flame
photometric detection (sulfur mode, FPD-S) method for determining residues of ametryn and its three
thiomethyl metabolites (GS-11354, GS-11355, and GS-26831), with a LOQ of 0.05 ppm for parent
and 0.1 ppm for each metabolite.
E. Regulatory Rationale
The Agency has determined that ametryn containing products are eligible for reregistration
provided that: current data gaps and confirmatory data needs be addressed; the risk mitigation
measures outlined in this document are adopted; and label amendments are made to reflect these
measures.
Based on the following mitigation measures agreed to by the technical registrant and certain
commodity groups including, reduced maximum use patterns and other use restrictions, risks from
ametryn exposures to humans and the environment have been reduced.
Reduction in maximum application rates and number of applications (see Table 22).
Cancellation of the use on sweet corn.
Prohibition of aerial application on sugarcane in Hawaii, Louisiana, and Texas.
Cancellation of use in Puerto Rico.
Cancellation of use in non-crop areas such as uncultivated areas, rights of way, and
industrial areas.
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The following is a summary of the rationale for managing risks associated with the use of
ametryn. Where labeling revisions are warranted, specific language is set forth in Table 23 in Section V
of this document.
1. Human Health Risk Management
a. Dietary and Aggregate Risk Summary
In the case of ametryn, an acute dietary risk assessment was not conducted because an
endpoint of concern attributable to a single dose was not identified. Therefore, only a chronic (non-
cancer) dietary risk assessment was conducted. Chronic dietary (food only) estimates are less than
0.1% of the cPAD for all population subgroups and are therefore, not of risk concern. Also, ametryn
drinking water concentrations from both groundwater and surface water sources based on screening-
level models are low and not of risk concern.
Aggregate risk estimates for ametryn only consider combined food and drinking water
exposures because there are no registered residential uses. A long-term (chronic) aggregate risk
assessment was conducted for ametryn. As indicated in Table 8, the EDWCs for chronic exposures for
the U.S. general population and the most highly exposed group (Children ages 1-2 years old) are less
than the corresponding DWLOCs. Therefore, estimated chronic aggregate risk is below EPA's level
of concern, and no measures are necessary to mitigate dietary risks from food and drinking water.
b. Occupational Risk Mitigation
Handler Exposure
Handler exposure assessments are completed by EPA using a baseline (long-sleeved shirt; long
pants; and shoes and socks) exposure scenario and, if required, increasing levels of mitigation (Personal
Protective Equipment (PPE) and engineering controls) to achieve an adequate margin of exposure
(MOE). For ametryn, the target MOE for workers is 100. The calculations indicate that the MOEs
for all occupational handler scenarios are above 100 at the baseline level and are not of concern.
Therefore, no additional measures are needed to mitigate risks to handlers.
Post-application Risk Mitigation
Ametryn product labeling specifies application as either a directed spray at weeds or as a pre-
emergent broadcast spray, and includes instructions to avoid application to the crop foliage.
Additionally, for corn and pineapples, the label specifies the last ametryn application be made 30 and
160 days prior to harvesting respectively. For sugarcane, the label specifies "Avoid wetting sugarcane
foliage, or injury may occur" and also recommends against application after "close-in" - when the
sugarcane grows over the planting beds prior to harvesting. For these reasons, EPA does not
anticipate any foliar residues on the ametryn treated crops. Therefore, the Agency does not expect any
post-application foliar exposures to occur and post-application occupational exposures were not
assessed. As a result, no mitigation measures are necessary.
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2. Environmental Risk Mitigation
It is the Agency's policy to mitigate ecological risks to the greatest extent necessary and
feasible. Mitigation measures may include lowering application rates, reducing the number of
applications, restricting the timing of applications, minimizing runoff potential, and others.
Fish and Aquatic Invertebrate Risk
EPA has low risk concerns about the potential acute or chronic risk to freshwater aquatic
organisms (fish and invertebrates) or the acute risk to estuarine/marine aquatic organisms potentially
exposed to ametryn via runoff or drift.
EPA completed a high end screening-level assessment incorporating the reduced maximum use
patterns to predict chronic risk to estuarine/marine aquatic invertebrates. There were no chronic
toxicity studies available to assess the chronic toxicity of ametryn to estuarine/marine invertebrates or
fish. Therefore, an extrapolation of available data from freshwater aquatic organisms was used to
estimate risks for estuarine/marine organisms which resulted in slight chronic risk for estuarine/marine
invertebrates. There is uncertainty associated with this extrapolation, therefore, chronic studies for
estuarine/marine fish (Guideline # 850.1400) and invertebrates (Guideline #850.1350) will be required
as part of this RED.
Avian Risk
There are low acute risk concerns for avian species. Minimal predicted chronic risks to birds
were based on maximum modeled EECs using high-end exposure feed items. When mean EECs are
used to assess potential chronic risk to birds, only one use scenario, sugarcane grown in Hawaii, and
one feed item, short grass, resulted in an RQ in excess of the LOG (RQ = 1.26).
The Agency had to rely on default assumptions when predicting foliar dissipation of ametryn
residues on feed items. Refinement of the exposure estimate with actual foliar dissipation data for
ametryn would replace the conservative default assumption utilized in the assessment and is expected
to lead to a significant reduction in predicted risk to birds through ingestion of feed items contaminated
with ametryn residues. Therefore, a foliar dissipation study (Guideline # 860.1500) is required in order
to refine the assumptions used for assessing risks to birds.
Mammalian Risk
Although ametryn is practically nontoxic to mammals on an acute oral exposure basis,
screening-level EECs slightly exceed acute restricted use and acute endangered species LOCs for some
feed items on several modeled uses. Acute RQ values range from 0.06 to 0.4 with the highest values
resulting from mammals feeding on short grass.
Estimated chronic risks to mammals from ametryn exposures exceed LOCs for some feed
items from all modeled use patterns for ametryn. Based on maximum EECs, chronic RQ values range
36
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from 0.04 to 36 with the highest values also resulting from mammals feeding on short grass. Use of
mean EECs to assess chronic mammalian risks would result in lower RQs.
As with the avian risk estimates, EPA had to rely on default assumptions when predicting foliar
dissipation of ametryn residues on feed items. Refinement of the exposure estimate with actual foliar
dissipation data (Guideline # 860.1500) for ametryn would replace the conservative default assumption
utilized in the screening-level assessment and is expected to lead to a significant reduction in predicted
acute and chronic risk to mammals through ingestion of feed items contaminated with ametryn
residues.
Non-Target Terrestrial and Aquatic Plant Risk
Based on high end screening-level assessments for ametryn exposures via runoff or drift, RQs
for non-target and endangered/threatened aquatic plants range from 3 to 71. RQs for terrestrial non-
target plants range from 0.11 to 612, while RQs for endangered or threatened non-target plants range
from 0.24 to >612. As stated previously, the registrant had agreed to reduced maximum application
rates and other use pattern restrictions (see Table 22) which reduced environmental exposure,
including exposures to plants. As an example, RQs for terrestrial non-target plants, based on the
previous higher rates, were as high as 4080. With the agreed to mitigation measures, this RQ was
significantly reduced to 612, with similar results for the other plant risk estimates.
In general, monocot species are less sensitive to ametryn than dicot species. For terrestrial
non-target plants, including endangered and threatened species, RQs estimated from spray drift
exposures were not of concern for monocot species from all modeled scenarios except for aerial
application to sugarcane where the RQ for endangered/threatened plants was 1.2.
Ametryn is applied to corn only as a post-emergence directed spray below the leaf canopy in
order to prevent injuring the corn plant. This type of application procedure minimizes the opportunity
for sprays to drift off-site. Similarly, when used as a directed spray on sugarcane the likelihood for off-
site drift is also minimized. Furthermore, the product label directs that aerial applications to sugarcane
have a minimum upwind distance of 800 feet to sensitive non-target plants. These restrictions to the
application methods are not reflected in the screening-level risk assessment and, therefore, the Agency
believes that the RQs summarized above may be overestimates.
Nevertheless, to further minimize the potential for drift, the Agency is requiring that strict use
restrictions to minimize spray drift be placed on the labels for all ametryn products. These include:
limits to droplet size, wind speed limitations, and spray boom heights. The Agency believes that the
specific drift language amendments proposed in this RED will further reduce potential risks to all non-
target plants below that already achieved through rate reductions.
3. Significance of Ametryn
Ametryn is widely used within certain regions. In Hawaii it is used on nearly 100% of the
pineapple and sugarcane crops. In the southeastern US ametryn is used extensively on sugarcane in
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Florida and up to 15% on the field corn in South Carolina, North Carolina and Georgia. Ametryn use
on popcorn is minimal. Ametryn has some niche uses in Texas and Louisiana for sugarcane.
There are several other herbicides that are also registered for the same use sites (field corn,
popcorn, pineapple, and sugarcane) as ametryn. In terms of price, ametryn is at the lower end of cost
measured in dollars/acre. In terms of weed control, ametryn, when compared to its competitors, often
has similar effectiveness in controlling weeds but controls a different spectrum of weeds than many of
its competitors. Ametryn is more effective in controlling grasses than some of the alternatives. In
pineapple, it is the only herbicide available to control morning glory species. Nevertheless, herbicides
such as ametryn are commonly mixed with other herbicides to achieve a broader spectrum of weed
control than with a single active ingredient. It is not unusual for ametryn to be tank mixed with
complementary herbicides such as 2,4-D, atrazine, or diuron.
F. Other Labeling Requirements
In order to be eligible for reregistration, various use and safety information will be included in
the labeling of all end-use products containing ametryn. For the specific labeling statements and a list
of outstanding data, refer to Section V of this RED document.
1. Endangered Species Considerations
Based on available screening level information there is a potential concern for ametryn's
chronic effects on listed birds; acute and chronic effects on listed mammals; and effects on listed
terrestrial and aquatic plants should exposures actually occur. The Agency expects ametryn poses a
low acute risk to nontarget insects because ametryn is practically nontoxic to honeybees (acute contact
LD50 was greater than the highest dose tested (>100 //g/bee)). However, the Agency does not assess
risk to bees using RQs because a screening-level RQ assessment method for estimating the risk to bees
is not available. These findings are based solely on EPA's screening-level assessment and do not
constitute "may affect" findings under the Endangered Species Act (ESA) for any listed species.
The Agency has developed the Endangered Species Protection Program to identify pesticides
whose use may cause adverse impacts on federally listed endangered and threatened species, and to
implement mitigation measures that address these impacts. The 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 uses that may affect any particular
species, EPA uses basic toxicity and exposure data developed for the REDs and considers ecological
parameters, pesticide use information, the geographic relationship between specific pesticide uses and
species locations and biological requirements and behavioral aspects of the particular species. When
conducted, this analysis will consider regulatory changes recommended in this RED that are being
implemented at that time. 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, or consultations with the Fish and Wildlife Service or National Marine Fisheries Service as
appropriate. If the Agency determines use of ametryn "may affect" listed species or their designated
critical habitat, EPA will employ the provisions in the Services regulations (50 CFR Part 402). Until
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that species specific analysis is completed, the risk mitigation measures being implemented through this
RED will reduce the likelihood that endangered and threatened species may be exposed to ametryn at
levels of concern.
2. Spray Drift Management
The Agency has been working closely with stakeholders to develop improved approaches for
mitigating risks to human health and the environment from pesticide spray and dust drift. As part of
the reregistration process, we will continue to work with all interested parties on this important issue.
From its assessment of ametryn, as summarized in this document, the Agency concludes that
certain drift mitigation measures are needed to address the risks from off-target drift for ametryn.
Label statements implementing these measures are listed in the "spray drift management" section of the
label table (Table 24) in Chapter V of this RED document. In the future, ametryn product labels may
need to be revised to include additional or different drift label statements.
G. Mitigation Summary
At this time EPA is not specifying additional specific mitigation measures for ametryn other
than the spray drift reduction measures mentioned above and acceptance of the reduced maximum use
patterns submitted by the technical registrant. A comparison of the previous (old) and reduced (new)
rates are summarized below in Table 22. The registrant has also agreed to voluntarily cancel the use on
sweet corn; aerial application to sugarcane in Hawaii, Louisiana, and Texas; and all use in Puerto Rico.
Table 22. Pre-RED and Post-RED Maximum Use Patterns for Ametryn1
Crop
Corn (Field and Pop)
Corn (sweet)
Pineapple (HI)
Sugarcane (FL, LA, TX)
Sugarcane (HI)
Sugarcane (PR)
Sugarcane (FL)
Max Single Rate
(Ibs ai/A)
Old
2.0
2.0
7.2
1.2-2.4
7.2
8.0
1.2
New
1.6
Cane
1.6
1.2
2.4
Cane
1.2
Applications
per Yr
Old
1
1
NS
3-5
3
3
3
New
1
Cane
2
2
3
Cane
2
Maximum Seasonal
Rate (Ibs ai/A/Yr)
Old
2.0
2.0
7.2
3.6-11.6
12.0
16.0
3.6
New
1.6
Cane
3.2
2.4
7.2
Cane
2.4
Application
Method
Ground
Ground
Ground
Ground
Ground
Ground
Aerial
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Table 22. Pre-RED and Post-RED Maximum Use Patterns for Ametryn1
Crop
Sugarcane (LA, TX)
Max Single Rate
(Ibs ai/A)
Old
1.2-2.4
New
Cane
Applications
per Yr
Old
3-5
New
Cane
Maximum Seasonal
Rate (Ibs ai/A/Yr)
Old
3.6-11.6
New
Cane
Application
Aerial
1 Information taken from Syngenta letters of April 26, 2005; June 22, 2005, and August 16, 2005 with revised label
language.
NS = Not Specified
Cane = Use Cancelled
V. What Registrants Need to Do
The Agency has determined that ametryn is eligible for reregistration provided that: (i)
additional data are submitted to confirm this decision; (ii) the risk mitigation measures outlined in this
document are adopted; and (iii) label amendments are made to reflect these measures. To implement
the risk mitigation measures, the registrants will be required to amend their product labeling to
incorporate the label statements set forth in the Label Changes Summary Table (Table 24) in Section C
below. In the near future, the Agency intends to issue Data Call-In Notices (DCIs) requiring product-
specific data and additional generic (technical grade) data. Generally, registrants will have 90 days
from receipt of a DCI to complete and submit response forms or request time extension and/or waiver
requests with a full written justification. For product-specific data, the registrant will have eight
months to submit data and amended labels. For generic data, due dates can vary depending on the
specific studies being required. Below are tables of additional generic data and label amendments that
the Agency intends to require for ametryn to be eligible for reregistration.
A. Manufacturing-Use Products
Additional Generic Data Requirements
The generic data base supporting the reregistration of ametryn for the above eligible uses has
been reviewed and determined to be substantially complete. However, the data listed below in Table
22 are necessary to confirm the reregistration eligibility decision documented in this RED.
Table 23. Generic Data Requirements for the Reregistration Eligibility Decision on Ametryn
Test Series
Health Effects/
Toxicology
OPPTS
Number
870.5300
Study Title
In vitro mammalian cell gene mutation test
40
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Table 23. Generic Data Requirements for the Reregistration Eligibility Decision on Ametryn
Test Series
Product Use Chemistry
Residue Chemistry
Environmental Fate
Ecological Effects
OPPTS
Number
830.1550
830.1700
830.1750
830.1800
830.6314
830.6315
830.6318
830.6319
830.6321
830.7370
860.1200
860.1500
860.1520
old 160-5
835.4300
835.4400
850.1350
850.1400
850.4400
Study Title
Product identity and composition
Preliminary analysis
Certification of limits
Analytical method
Oxidation/Reduction Potential
Flamability
Viscosity
Miscibility
Dielectrict breakdown voltage
Dissociation constants in water
Directions for use
Foliar dissipation: there is no set guidance for this test at this time; a
modified protocol of EPA's magnitude of residue study is the preferred
baseline. The registrant is encouraged to consult with EPA regarding
the appropriate modifications to ensure suitability.
Processed food/feed
Chemical identity
Aerobic aquatic metabolism
Anaerobic Aquatic Metabolism
Estuarine/marine Mysid chronic toxicity test
Estuarine/marine fish early life stage toxicity test
Aquatic plant toxicity test using Lemna sp., Tiers I and II
Labeling for Manufacturing-Use Products
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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 24.
B. End-Use Products
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 MRTD 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.
Labeling for End-Use Products
To be eligible for reregistration, labeling changes are necessary to implement measures outlined
in Section IV above. Specific language to incorporate these changes is specified in Table 24.
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 reregistration, amend all product labels to incorporate the risk
mitigation measures outlined in Section IV. The following table (Table 24) describes how language on
the labels should be amended.
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Table 24. Summary of Labeling Changes for Ametryn
Description
Amended Labeling Language
Placement on Label
For all Manufacturing Use
Products
"Only for formulation into an water dispersible granule, herbicide for the following
uses: field corn, popcorn, pineapple, and sugarcane."
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
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Table 24. Summary of Labeling Changes for Ametryn
Description
Amended Labeling Language
Placement on Label
End Use Products Intended for Occupational Use
PPE Requirements
Established by the RED1
for water-dispersible
granules
Formulations
"Personal Protective Equipment (PPE):"
"Some materials that are chemical-resistant to this product are" (registrant inserts
correct chemical-resistant material). "If you want more options, follow the
instructions for category" [registrant inserts A,B,C,D,E,F,G,or H] "on an EPA
chemical-resistance category selection chart."
"All mixers, loaders, applications and other handlers must wear:
- long-sleeved shirt,
- long pants,
- shoes and socks"
"See engineering controls for additional options and requirements"
"Human flagging is prohibited"
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
Engineering Control
Requirements:
"Engineering Controls: Pilots must use an enclosed cockpit that meets the
requirements listed in the Worker Protection Standard (WPS) for agricultural
pesticides [40 CFR §170.240(d)(6)]r
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals.
(Immediately following PPE and User
Safety Requirements.)
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If 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
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Table 24. Summary of Labeling Changes for Ametryn
Description
Amended Labeling Language
Placement on Label
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.)
Environmental Hazards
Statements Required by
the RED and Agency
Label Policies
"This pesticide is toxic aquatic organisms. Do not apply directly to water, or to
areas where surface water is present, or to inter-tidal areas below the mean high
water mark. Do not contaminate water when cleaning equipment or disposing of
equipment washwaters or rinsate. Apply this product only as specified on the
label.
Precautionary Statements immediately
following the User Safety
Recommendations
Restricted-Entry Interval
for products with
directions for use within
scope of the Worker
Protection Standard for
Agricultural Pesticides
(WPS)
Do not enter or allow worker entry into treated areas during the restricted-entry
interval (REI) of 12 hours.
PPE required for early entry to treated areas that is permitted under the Worker
Protection Standard and that involves contact with anything that has been treated,
such as plants, soil, or water is:
• Coveralls
• Chemical-resistant gloves made of any waterproof material
• Shoes plus socks
Direction for Use
Agricultural Use Requirements box
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 directly
above the Agricultural Use Box.
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Table 24. Summary of Labeling Changes for Ametryn
Description
Amended Labeling Language
Placement on Label
Other Application
Restrictions
(Note: The maximum
allowable application
rate and maximum
allowable rate per year
must also be listed as
pounds of formulated
product per acre, not just
as pounds active
ingredient per acre.)
Corn (Field and Pop) - Maximum application rate is 1.6 Ib ai/acre; 1 application
per year.
Directions for Use
Other Application
Restrictions
(Note: The maximum
allowable application
rate and maximum
allowable rate per year
must also be listed as
pounds of formulated
product per acre, not just
as pounds active
ingredient per acre.)
Pineapple - Maximum application rate is 1.6 Ib ai/acre; 2 applications per crop
cycle; maximum 3.2 Ibs ai/acre/crop cycle;
For use in HI only
Directions for Use
46
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Table 24. Summary of Labeling Changes for Ametryn
Description
Other Application
Restrictions
(Note: The maximum
allowable application
rate and maximum
allowable rate per year
must also be listed as
pounds of formulated
product per acre, not just
as pounds active
ingredient per acre.)
Other Application
Restrictions
Amended Labeling Language
Sugarcane -
FL, LA, TX - 1.2 Ib ai/acre, 2 applications per crop cycle;
maximum 2.4. Ibs ai/acre/crop cycle.
HI - 2.4 Ib ai/acre 3 applications per crop cycle;
maximum 7.2 Ibs ai/acre/crop cycle.
Aerial application is prohibited except for use on sugarcane in FL.
Placement on Label
Directions for Use
Directions for Use
47
-------
Table 24. Summary of Labeling Changes for Ametryn
Description
Amended Labeling Language
Placement on Label
Spray Drift Label
Language for Products
Applied as a Spray
"SPRAY DRIFT MANAGEMENT"
"A variety of factors including weather conditions (e.g., wind direction, wind
speed, temperature, relative humidity) and method of application (e.g., ground,
aerial, airblast, chemigation) can influence pesticide drift. The applicator must
evaluate all factors and make appropriate adjustments when applying this
product."
Wind Speed
"Do not apply at wind speeds greater than 10 mph."
"Controlling Droplet Size"
"Use a nozzle type according to manufacturer's specifications that is designed for
the intended application and produces a Medium or coarser spray (ASAE standard
572) or a volume mean diameter of 300 microns or greater for spinning atomizer
nozzles under application conditions. Applicators must consider nozzle
orientation, nozzle pressure, and flight speed in determining droplet size. Nozzles
should always be oriented in the manner that minimizes the effects of air shear.
Solid stream nozzles oriented straight back produce the largest droplets and the
lowest drift."
"Do not exceed the nozzle manufacturer's recommended pressures. When higher
flow rates are needed, use a higher-capacity nozzle instead of increasing pressure."
"Temperature Inversions"
"If applying at wind speeds less than 2 mph, the applicator must determine if a)
conditions of temperature inversion exist, or b) stable atmospheric conditions exist
at or below nozzle height. Do not make applications into areas of temperature
inversions or stable atmospheric conditions."
Directions for Use under General
Precautions or Restrictions and/or
Application Instructions
48
-------
Table 24. Summary of Labeling Changes for Ametryn
Description
Amended Labeling Language
Placement on Label
Spray Drift Label
Language for Products
Applied as a Spray
"Equipment"
"All aerial and ground application equipment must be properly maintained and
calibrated using appropriate carriers or surrogates."
"Additional requirements for aerial applications:"
1. "The boom length must not exceed 75% of the wingspan or 90% of the rotor
blade diameter."
2. "Release spray at the lowest height consistent with efficacy and flight safety.
Do not release spray at a height greater than 10 feet above the crop canopy unless
a greater height is required for aircraft safety."
3. "When applications are made with a crosswind, the swath must be displaced
downwind. The applicator must compensate for this displacement at the up and
downwind edge of the application area by adjusting the path of the aircraft
upwind."
"Additional requirements for groundboom application:"
1. "Do not apply with a nozzle height greater than 4 feet above the crop canopy."
2. "Use low drift nozzles with a maximum pressure of 40 psi."
"Other State and Local Requirements"
"Applicators must follow all state and local pesticide drift requirements regarding
application of ametryn. Where states have more stringent regulations, they must
be observed."
Directions for Use under General
Precautions or Restrictions and/or
Application Instructions
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.
49
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50
-------
VI. Related Documents and How to Access Them
A list of technical support documents for the ametryn RED is provided in Appendix C.
All technical support documents for this RED may be viewed on paper in the Office of Pesticides
Program Public Docket or electronically via the Internet. These documents may be found on the
Agency's web page at www.epa.gov.edockets under docket OPP-2004-0411 (Documents from
May 2002 to the present). Hard copies of these documents may be found in the OPP public
docket, also under docket numbers OPP-2004-0411. The OPP public docket is located in Room
119, Crystal Mall II; 1801 South Bell Street; Arlington, VA. The docket is open Monday
through Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
List of Appendices:
Appendix A. Table of Use Patterns Eligible for Reregistration for Ametryn
Appendix B. Generic Data Requirements and Studies Utilized to Make the RED for Ametryn
Appendix C. Technical Support Documents Utilized to Make the RED for Ametryn
Appendix D. Citations Supporting the RED for Ametryn (Bibliography)
Appendix E. Batching of Ametryn Products
Appendix F. List of Registrants to be sent the Data Call-In
Appendix G. List of Available Related Documents and Electronically Available Forms
51
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Appendix A. Food/Feed Use Patterns Eligible for Reregistration for Ametryn
Use Site
Application Timing
Application Type
Application Equipment
Formulation
Max Single
App Rate
(Ibs ai/acre)
Max No.
of App
Per Year
Minimum
Retreatment
Interval
(days)
Max Annual
Rate
(Ibs ai/
cc or year)
Preharvest
Interval
(Days)
Use Directions and Limitations
Food/Feed Uses
Corn (Pop & Field)
Postemergence
Directed Spray
Groundboom
80% WDG
1.6
1
Not
Applicable
1.6
30
Apply directed spray to weeds after smallest corn is at least
12 in tall.
Keep spray or drift from contacting leaves or whorl of corn.
Apply at 30 psi to avoid spray from bouncing back and
settling on corn leaves.
Pineapple
Postplant, postharvest,
broadcast/blanket spray
Groundboom
80% WDG
1.6
2
30
3.2
160
HI
Sugarcane
Preplant
broadcast, band,
interline
Groundboom &
aerial [FL only]
80% WDG
[100-786]
1.2
2.4 [HI]
2
3 [HI]
30
2.4
7.2 [HI]
NS
Aerial application permitted only permitted in FL
Al
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Appendix B. Data Supporting Guideline Requirements for the Reregistration of Ametryn
Guide to Appendix B
Appendix B contains listing of data requirements which support the reregistration for
active ingredients within the case ametryn covered by this RED. It contains generic data
requirements that apply to ametryn 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 by Guideline Number.
The Guideline Numbers accompanying each test refer to the test protocols set in the
Pesticide Assessment Guidance 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 H. Greenhouse Food
B. Terrestrial Feed I. Greenhouse Non-Food
C. Terrestrial Non-Food J. Forestry
D. Aquatic Food K. Residential
E. Aquatic Non-Food Outdoor L. Indoor Food
F. Aquatic Non-Food Industrial M. Indoor Non-Food
G. Aquatic Non-Food Residential N. Indoor Medical
O. Indoor Residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this
column list the identify number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
Bl
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of Ametryn
REQUIREMENT
Use Patterns
CITATION(S)
PRODUCT CHEMISTRY
Guideline Number
New
830.1550
830.1600
830.1620
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.6313
830.700
830.7050
830.7200
830.7220
830.7300
830.7370
830.7550
830.7840
830.7950
830.6314
830.6315
830.6316
830.6317
830.6318
830.6319
830.6320
830.6321
Old
61-1
6 1-2 A
61-2B
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-13
63-12
None
63-5
63-6
63-7
63-10
63-11
63-8
63-9
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Product Identity and Composition
Description of materials used to produce the
product
Description of production process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Stability to normal and elevated temperatures,
metals, and metal ions
pH
UV/Visable Absorption
Melting Point
Boiling Point
Density
Dissociation constants in water
Partition coefficient, shake flask method
Solubility
Vapor Pressure
Oxidizing/Reduction Potential
Flamability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectrict Breakdown Voltage
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
408447-01, CSF 8/19/85, Data gap
408447-01
408447-01, 433359-01
408447-01
4 10679-01, Data Gap
40844701, 41067901,
CSF 8/19/85, Data Gap
410679-01, Data Gap
408773-01
408773-01
408773-01
40877301, 42470901, 42631501
408773-01
408773-01
408773-01
N/A
408773-01
408773-01
408773-01
408773-01
408773-01
Data Gap
Data Gap
408773-01, In Review
408773-01, In Review
Data Gap
Data Gap
408773-01, In Review
Data Gap
B2
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of Ametryn
REQUIREMENT
Use Patterns
CITATION(S)
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2300
850.2300
850.1075
850.1075
850.1075
850.1010
850.1075
850.1025
850.1035
850.1300
850.1350
850.1400
850.1400
850.4100
850.5400
850.4225
850.4250
850.4400
850.3020
71-1A
7 1-2 A
71-2B
7 1-4 A
71-4B
72-1A
72-1A
72-1C
72-2A
72-3A
72-3B
72-3C
72-4B
72-4B
72-4A
72-4D
122-1A
122-2
123-1A
123-1B
123-2
141-1
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Fathead Minnow
Fish AcuteToxicity Rainbow Trout
Invertebrate Acute Daphnid Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity - Mollusk
Estuarine/Marine Acute Toxicity - Shrimp
Daphnid Chronic Toxicity (life cycle)
Estuarine/Marine Invertebrate chronic (Mysid
Shimp, Life Cycle)
Freshwater Fish- Early Life Stage
Eustarine Fish- Early Life Stage
Terrestrial Plant Toxicity, Seedling Emergence
Aquatic Plant Growth
Seedling Germination &
Seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
Honey Bee Acute Contact
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A, B
A, B
A, B
A, B
A, B
A, B
A,B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
409958-01
409958-03
409958-02
415476-01
415476-02
409958-04 (supplemental)
428616-01
428616-02
409958-05 (supplemental)
409958-06
411149-02
411149-03
411149-01
411897-02,423252-01
Data Gap
411897-03,423252-03
Data Gap
N/A
409958-10
409958-07
409958-08
409958-09
Data Gap
409958-11
B3
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of Ametryn
REQUIREMENT
Use Patterns
CITATION(S)
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
870.3150
870.3200
870.6200
870.4100
870.3700
870.3700
870.3800
870.4300
870.4200
870.5395
870.5100
870.5375
870.7485
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-1B
82-2
81-8
82-7
83-1A
83-1B
83 -2 A
83-3A
83-3B
83-4
83-5
83-2B
84-2
84-2
84-2B
85-1
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit/Rat
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
Subchronic Oral Toxicity: 90-Day Study Rodent
Subchronic Oral Toxicity: 90-Day Study Non-
rodent
21 -Day Dermal - Rabbit/Rat
Neurotox screening battery
Acute & 90-Day Neurotox-mammal
Chronic Tox-Rodent
Chronic Feeding Toxicity - Non-Rodent
Oncogenicity - Rat
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Combined Chronic Toxicity/ Carcinogenicity: Rats
Carcinogenicity Mice
erthrocyte (mouse) micronucleus
Bacterial Reverse Gene Mutation
Cytogenetics chromosome aberration study
General Metabolism
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A, B
A,B
A, B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A, B
40995814
40995815
42470902, 40995816
40995817
40995818
40995819
See 870.4300
See 870.4100
92002019
Reserved
92002020
403499-02
40349906, 41184201, 92002020
00153215 and 92002024
00153214, 92002025
403499-05
403499-06, 411842-01, 403820-01
403499-04
410679-03
409958-29,411897-01
41067903
41463301, 41463302, 41463303
B4
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of Ametryn
REQUIREMENT
Use Patterns
CITATION(S)
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2100
875.2200
875.2400
875.2500
132-1A
132-1B
133-3
133-4
Dislodgable Foliar residue dissipation
Soil residue dissipation
Dermal Passive Dosimetry Exposure
Inhalation Passive Dosimetry Exposure
A, B
A, B
A, B
A, B
Reserved
Reserved
Reserved
Reserved
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.4100
835.4200
835.4400
835.4300
835.1240
835.1410
835.6100
None
160-5
161-1
161-2
161-3
161-4
162-1
162-2
162-3
162-4
163-1
163-2
164-1
165-1
165-4
165-5
166-1
Chemical identity
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Photodegradation - air
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/ Adsorption/Desorption
Laboratory Volatilization
Terrestrial Field Dissipation
Confined Rotational crop
Bioaccumulation in Fish
Bioaccumulation in aquatic organisms
Groundwater - small prospective
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A, B
Data Gap
408858-12
411696-01
411696-02,411696-03
Waived
417524-01, 465338-01
417524-01
428616-03, Data Gap
Data Gap
409958-13,411696-04,
waived (low vapor pressure)
417524-02, 418723-02, 418723-01
419863-02, 433424-01
420619-01
Reserved
Reserved
B5
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of Ametryn
REQUIREMENT
Use Patterns
CITATION(S)
RESIDUE CHEMISTRY
860.1200
860.1300
860.1300
860.1340
860.1340
860.1360
860.1380
860.1380
860.1480:
860.1500
860.1500
860.1500
860.1520
860.1520
860.1520
860.1650
860.1850
860.1900:
171-2
171-4A
171-4B
171-4C
171-4D
171-4E
171-4E
171-4J
171-4K
171-4K
171-4K
171-4L
171-4L
171-4L
165-2
Directions for Use
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method - Plants
Residue Analytical Method - livestock
Multiresidue Method
Storage Stability - Plants
Storage Stability - Livestock
Magnitude of the Residue - Meat, Milk, Poultry,
Eggs
Crop Field Trials (corn)
Crop Field Trials (pineapple)
Crop Field Trials (sugarcane)
Processed Food/Feed (corn)
Processed Food/Feed (pineapple)
Processed Food/Feed (sugarcane)
Submittal of Analytical Reference Standards
Confined Accumulation in Rotational Crops
Field Accumulation in Rotational Crops
A, B
A, B
A,B
A,B
A, B
A, B
A,B
A, B
A,B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
A, B
Data Gap
41662301 41662302
41662303 41662304
41662306 43931001
41557102,41557103,
42391601
44107901
41662305
41872304
44477701, 44477702
41397201, 41423401
41557101 43335902
447837017
43342401
44477704
44477705, 44477706
41909501
41909502
41846601
42391602
41909502
41846601
Not Required
41986301, 41986302,
43342401
42391602, 44783702
OTHER
840.1100
840.1200
201-1
202-1
Droplet Size Spectrum
Drift Field Deposition Evaluation
A,B
A, B
Reserved
Reserved
N/A = Not Applicable
B6
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Appendix C. List of EPA's Technical Support Documents For Ametryn
Additional documentation in support of this RED is maintained in the OPP docket, located
in Room 119, Crystal Mall #2, 1801 South Bell Street, Arlington, VA. The docket is open
Monday through Friday, excluding Federal holidays, from 8:30 am to 4:00 pm.
The preliminary and revised risk assessments for ametryn are available in the Public
Docket, under docket number OPP-2004-0411 on the Agency's E-Dockets web page,
http ://www. epa. gov/edockets.
EPA released the preliminary risk assessments for ametryn on February 25, 2005. During
and after the public comment period, the registrant submitted additional voluntary data for
ametryn. EPA reviewed there data and incorporated them into the final revised risk assessments
for ametryn. These final revised risk assessments form the basis of the regulatory decision
described in the RED.
All final revised risk assessment and technical support documents may be viewed in the
OPP docket room, in hard copy form, or downloaded or viewed electronically via the Internet at
the following site: www.epa.gov/edockets. These documents include the following:
Human Health Risk Assessment Documents
• Revised Memo to Incorporate Responses to Phase 3 Public Comments. Ametryn: HED
Chapter of the Reregistration Eligibility Decision Document (RED). June, 15, 2005.
William H. Donovan, Ph.D. and John Doherty, Ph.D.
• Revised Memo to Incorporate Responses to Phase 3 Public Comments. Ametryn.
Chronic Dietary Exposure Assessments for the Reregistration Eligibility Decision.
May 24, 2005. William H. Donovan, Ph.D.
• Corrected Ametryn ORE Chapter to Incorporate Responses to Phase 3 Public Comments-
Ametryn. HED Occupational and Residential Exposure Chapter of the Reregistration
Eligibility Decision Document. June 13, 2005. Robert Travaglini.
• Review of Ametryn Incident Reports. Aug 26, 2004. Jerome Blondell, Ph.D. and Monica
S. Hawkins, M.P.H.
• Ametryn. Health Effects Division (HED) Phase 4 Response to Phase 3 Public Comments
on the Ametryn Preliminary Reregistration Eligibility Decision (RED) and Supporting
Memos. May 25, 2005. William H. Donovan, Ph.D., John Doherty, Ph.D., and Robert
Travaglini.
• Revised Memo to Incorporate Responses to Phase 3 Public Comments. Ametryn.
Residue Chemistry Considerations for Reregistration Eligibility Decision. May 25, 2005.
William H. Donovan, Ph.D.
• AMETRYN: Report of the Cancer Assessment Review Committee. September 17, 2004.
Cl
-------
• Revised as per 30-day Error Only Registrant Comments. Ametryn RED - Reregistration
Eligibility Decision. Product Chemistry Considerations. December 22, 2004. William
H. Donovan, Ph.D.
Environmental Fate and Ecological Effects Assessment Documents
• Drinking Water Exposure Assessment for Proposed Reregistration of Ametryn Use on
Corn, Pineapple and Sugarcane (Revised). June 9, 2005. Kevin Costello.
• Environmental Fate and Ecological Risk Assessment for the Re-registration of Ametryn
June 9, 2005. Costello et al.
Use and Usage / Economic Analysis Documents
Use Closure Memo for Ametryn; PC Code: 080801; RED Case No.: 2010; CAS No.:
834-12-8 February 27, 2003. Mark Howard.
• Alternatives Analysis for Ametryn on Sugarcane, Pineapple, Field Corn, and Popcorn
June 23, 2005. Nicole Zinn and Stephen Smearman.
C2
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Appendix D. Citations Considered to be Part of the Database Supporting the
Reregistration Decision (Bibliography)
GUIDE TO APPENDIX D
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the
Reregistration Eligibility Document. Primary sources for studies in this bibliography have been the
body of data submitted to EPA and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the published literature, in those instances
where they have been considered, are included.
UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted. The
resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional bibliographic citation. The Agency
has also attempted to unite basic documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation, and should
be used whenever a specific reference is required. It is not related to the six-digit "Accession
Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4)
below for further explanation). In a few cases, entries added to the bibliography late in the review
may be preceded by a nine character temporary identifier. These entries are listed after all MRID
entries. This temporary identifying number is also to be used whenever specific reference is
needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a
citation containing standard elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic conventions used reflect the standard
of the American National Standards Institute (ANSI), expanded to provide for certain special
needs.
1. Author. Whenever the author could confidently be identified, the Agency has chosen
to show a personal author. When no individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When no author or laboratory could
be identified, the Agency has shown the first submitter as the author.
2. Document date. The date of the study is taken directly from the document. When the
date is followed by a question mark, the bibliographer has deduced the date from the
Dl
-------
evidence contained in the document. When the date appears as (1999), the Agency was
unable to determine or estimate the date of the document.
3. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
4. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
A. Submission date. The date of the earliest known submission appears
immediately following the word "received."
B. Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the earliest
known submission.
C. Submitter. The third element is the submitter. When authorship is defaulted
to the submitter, this element is omitted.
D. Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit accession
number follows the symbol "CDL," which stands for "Company Data
Library." This accession number is in turn followed by an alphabetic suffix
which shows the relative position of the study within the volume.
PRODUCT CHEMISTRY:
MRID # Study Citations
40844701 Lail, L. (1988) Product Chemistry: Technical Ametryn: Study No. PC-88-018.
Unpublished study prepared by Ciba-Geigy Corp. 205 p.
40877301 Lail, L. (1988) Technical Ametryn: Product Chemistry: Study No. PC- 88-018.
Unpublished study prepared by Ciba-Geigy Corp. 136 p.
41067901 Lail, L. (1989) Technical Ametryn: Product Chemistry: Study No. PC-89-002.
Unpublished study prepared by Ciba-Geigy Corp. 108 p.
42470901 Stubbs, D. (1992) Product Chemistry: Ametryn Technical: Lab Project Number:
PC-92-027. Unpublished study prepared by CIBA-GEIGY Corp. 5 p.
D2
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42583102 Lail, L.; Verma, M. (1992) Product Chemistry: Technical Ametryn: Lab Project
Number: PC-92-039. Unpublished study prepared by CIBA-GEIGY Corp.,
Agricultural Division. 19 p.
42631501 Stubbs, D. (1993) Product Chemistry (Stability): Technical Ametryn: A
Supplement. Unpublished study prepared by Ciba-Geigy. 17 p.
43335901 McCain, P. (1994) Technical Ametryn Product Chemistry (Manufacturing
Process): Addendum: Lab Project Number. Unpublished study prepared by
Ciba-Geigy Corp. 8 p.
Ecological Effects
MRID # Study Citations
40995801 Grimes, J.; Jaber, M. (1988) Ametryn: An Acute Oral Toxicity Study with the
Bobwhite: Final Report: Project No. 108-291. Unpublished study prepared by
Wildlife International Ltd. 20 p.
40995802 Grimes, J.; Jaber, M. (1988) Ametryn: A Dietary LC50 Study with the Mallard:
Project No. 108-290A. Unpublished study prepared by Wildlife International Ltd.
19 p.
40995803 Grimes, J.; Jaber, M. (1988) Ametryn: A Dietary LC50 Study with the Bobwhite:
Project No. 108-289. Unpublished study prepared by Wildlife International Ltd.
18 p.
41547601 Beavers, J. (1990) Ametryn Technical: A One-Generation Reproduction Study
with the Northern Bobwhite (Colinus virginianus): Lab Project Number: 108-303.
Unpublished study prepared by Wildlife International Ltd. 116 p.
41547602 Beavers, J. (1990) Ametryn Technical: A One-Generation Reproduction Study
with the Mallard (Anas platryhyncos): Lab Project Number: 108-304. Unpublished
study prepared by Wildlife International Ltd. 119 p.
40995804 Surprenant, D. (1989) Ametryn: Acute Toxicity of Ametryn Technical to Bluegill
(Lepomis macrochirus) Under Static Conditions: Study No. 89-1-2917.
Unpublished study prepared by Springborn Life Sciences, Inc. 43 p.
40995805 Surprenant, D. (1989) Ametryn: Acute Toxicity of Ametryn Technical to Rainbow
Trout (Salmo gairdneri) Under Static Conditions: Study No. 89-1-2919.
Unpublished study prepared by Springborn Life Sciences, Inc. 42 p.
D3
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42861601 Ward, T.; Kowalski, P. (1993) Acute Toxicity of Ametryn Technical to the
Fathead Minnow, Pimephales promelas: Lab Project Number: 219-CG.
Unpublished study prepared by T.R. Wilbury Labs, Inc. 31 p.
42861602 Ward, T.; Kowalski, P. (1993) Acute Toxicity of Ametryn Technical to the
Rainbow Trout, Oncorhynchus mykiss: Lab Project Number: 220-CG.
Unpublished study prepared by T.R. Wilbury Labs, Inc. 31 p.
40995806 Surprenant, D. (1989) Ametryn: Acute Toxicity of Ametryn Technical to Daphnids
(Daphnia magna) under Static Conditions: Study No. 89-1-2912. Unpublished
study prepared by Springborn Life Sciences, Inc. 44 p.
41114901 Surprenant, D. (1989) Acute Toxicity of Ametryn Technical To Mysid Shrimp
(Mysidopsis bahia) under static Conditions: Study No. 893-2960. Unpublished
study prepared by Springborn Life Sciences, Inc. 47 p.
41114902 Surprenant, D. (1989) Acute Toxicity of Ametryn Technical To Sheepshead
Minnow (Cyprinodon variegatus) under Static Conditions: Study No. 89-4-2967.
Unpublished study prepared by Springborn Life Sciences, Inc. 43 p.
41114903 Surprenant, D. (1989) Acute Toxicity of Ametryn Technical to Quahog Clam
(Mercenaria mercenaria) Embryos-Larvae under Static Conditions: Study No. 89-
4-2971. Unpublished study prepared by Springborn Life Sciences, Inc. 47 p.
41189702 McNamara, P. (1989) Ametryn: The Chronic Toxicity of Ametryn Technical to
Daphnia Magna Under Flow-through Conditions: Study No. 89-6-3002.
Unpublished study prepared by Springborn Laboratories, Inc. 50 p.
41189703 Surprenant, D. (1989) Ametryn: The Toxicity of Ametryn Technical to Fathead
Minnow (Pimephales Promelas) Embryo and Larvae: Study No. 89-7-3022.
Unpublished study prepared by Springborn Laboratories, Inc. 48 p.
42325202 McNamara, P. (1989) Supplement to the Chronic Toxicity of Ametryn Technical
to Daphnia magna under Flow-through Conditions. Unpublished study prepared
by Ciba-Geigy Corp. 55 p.
42325203 Surprenant, D. (1989) Supplement to the Toxicity of Ametryn Technical to
Fathead Minnow (Pimephales promelas) Embryos and Larvae. Unpublished study
prepared by Ciba-Geigy, Inc. 36 p.
40995807 Canez, V. (1988) Ametryn: Nontarget Phytotoxicity Test: Seed Germination Tier
2: Study No. LR88-55B. Unpublished study prepared by Pan-Agricultural Labs,
Inc. 72 p.
D4
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40995808 Canez, V. (1988) Ametryn: Nontarget Phytotoxicity Test: Seedling Emergence
Tier 2: Study No. LR88-55C. Unpublished study prepared by Pan-Agricultural
Labs, Inc. 281 p.
40995809 Canez, V. (1989) Ametryn: Nontarget Phytotoxicity Test: Vegetative Vigor Tier
2: Study No. LR 88-55A. Unpublished study prepared by Pan-Agricultural Labs,
Inc. 281 p.
40995810 Hughes, J. (1989) Ametryn: The Toxicity of Ametryn Technical to Selenastrum
capricornutum: Study No. 0267-42-1100-1. Unpublished study prepared by
Malcolm Pirnie, Inc. 38 p.
40995811 Hoxter, K.; Jaber, M. (1988) Ametryn: An Acute Contact Toxicity Study with the
Honey Bee: Project No. 108-288. Unpublished study prepared by Wildlife
International Ltd. 15 p.
92002034 Plautz, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 40995811. Acute
Contact Toxicity of Ametryn Technical to the Honey Bee: Report No. 108-288.
Prepared by WILDLIFE INTERNATIONAL LTD. 13 p.
TOXICOLOGY
MRID # Study Citations
00034843 Roulet, ? (1961) Toxicology of Ametryne. (Unpublished study received Jan 6,
1964 under 100-473; prepared by J.R. Geigy, S.A. and Rheinisch
Friedrich-Wilhelms-Univ., Pharmacological Institute, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL: 000473-H)
00048226 Stenger, ?; Planta, V. (1961) Oral Toxicity in Rat: Experiment No. 10331.
(Unpublished study received Aug 1, 1968 under 100-473; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 222957-A)
00048227 Stenger, ?; Scharer, ? (1959) Oral Toxicity on Mice: Experiment No. 8797.
(Unpublished study received Aug 1, 1968 under 100-473; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 222957-B)
00048230 Stenger, ?; Planta, V. (1961) Oral Toxicity Rats: Experiment No. 10312.
(Unpublished study received Aug 1, 1968 under 100-473; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 222957-E)
D5
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00060310 Consultox Laboratories, Limited (1974) Ametryne: Acute Oral and Dermal
Toxicity Evaluation: CL74: 46: 996F. (Unpublished study received Dec 19, 1977
under 33660-8; submitted by Industria Prodotti Chimici, S.p.A., Novate Milanese,
Italy; CDL:232507-A)
00068171 Stenger, ?; Scharer, ?; Von Planta, ?; et al. (1964) Acute Oral Toxicity in
Rat—Summary. A translation of: Akute Toxizitat— Ratte per Os
(Zusammenfassung). (Unpublished study, including German text, received Jul 20,
1977 under 100-579; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:230872-E)
40995814 Kuhn, J. (1988) Ametryn Technical: Acute Oral Toxicity Study in Rats: Study No.
5566-88. Unpublished study prepared by Still-meadow, Inc. 22 p.
43682302 Kuhn, J. (1995) Acute Oral Toxicity Study in Rats: Final Report: G-34162
80WDG: Lab Project Number: 1690-94. Unpublished study prepared by
Stillmeadow, Inc. 31 p.
92002013 Gillis, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 40995814. Acute
Oral Toxicity Study in Rats: Study No. 5566-88. Prepared by STILLMEADOW,
INC. 10 p.
00060310 Consultox Laboratories, Limited (1974) Ametryne: Acute Oral and Dermal
Toxicity Evaluation: CL74: 46: 996F. (Unpublished study received Dec 19, 1977
under 33660-8; submitted by Industria Prodotti Chimici, S.p.A., Novate Milanese,
Italy; CDL:232507-A)
00068172 Sachsse, K.; Bathe, R. (1976) Acute Dermal LDI50A in the Rat of Technical G
34162: Project No. Siss 5665. (Unpublished study received Jul 20, 1977 under
100-579; prepared by Ciba-Geigy, Ltd., Switzerland, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:230872-F)
40995815 Kuhn, J. (1988) Ametryn Technical: Acute Dermal Toxicity Study in Rabbits:
Study No. 5567-88. Uunpublished study prepared by Stillmeadow, Inc. 12 p.
43682303 Kuhn, J. (1995) Acute Dermal Toxicity Study in Rabbits: Final Report: G-34162
80WDG: Lab Project Number: 1691-94. Unpublished study prepared by
Stillmeadow, Inc. 13 p.
92002014 Gillis, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 40995815. Acute
Dermal Toxicity Study in Rabbits: Study No. 5567-88. Prepared by
STILLMEADOW, INC. 10 p.
00060313 Kapp, R.W. (1975) Final Report: Acute Inhalation Toxicity Study in Rats: Project
No. M915-103. (Unpublished study received Dec 19, 1977 under 33660-8;
D6
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prepared by Hazleton Laboratories America, Inc., submitted by Industria Prodotti
Chemici, S.p.A., Novate Milanese, Italy; CDL:232507-E)
40995816 Holbert, M. (1988) Ametryn Technical: Acute Inhalation Toxicity Study in Rats:
Study No. 5571-88. Unpublished study prepared by Stillmeadow, Inc. 18 p.
42470902 Holbert, M. (1992) Acute Inhalation Toxicity Study in Rats: Lab Project Number:
8988-92. Unpublished study prepared by CIBA-GEIGY Corp. 32 p.
43682304 Holbert, M. (1995) Acute Inhalation Toxicity Study in Rats: Final Report:
G-34162 80WDG: Lab Project Number: 1817-95. Unpublished study prepared by
Stillmeadow, Inc. 28 p.
92002015 Gillis, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 40995816. Acute
Inhalation Toxicity Study in Rats: Study #5571-88. Prepared by
STILLMEADOW, INC. 10 p.
00060311 Kapp, R.W. (1975) Final Report: Acute Eye Irritation Potential Study in Rabbits:
Project No. 915-104. (Unpublished study re- ceived Dec 19, 1977 under 33660-8;
prepared by Hazleton Labo- ratories America, Inc., submitted by Industria Prodotti
Chimici, S.p.A., Novate Milanese, Italy; CDL:232507-B)
00060312 Reno, F.E. (1976) Final Report: Acute Eye Irritation Study in Rabbits: Project No.
915-118. (Unpublished study received Dec 19, 1977 under 33660-8; prepared by
Hazleton Laboratories Amer- ica, Inc., submitted by Industria Prodotti Chimici,
S.p.A., Novate Milanese, Italy; CDL:232507-C)
00068173 Sachsse, K.; Ullman, L. (1977) Eye Irritation in the Rabbit of Technical G 34162:
Project No. Siss 5665. (Unpublished study received Jul 20, 1977 under 100-579;
prepared by Ciba-Geigy, Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:230872-G)
00088018 Dean, W.P. (1977) Eye Irritation Study in Albino Rabbits: Study No. 382-019.
(Unpublished study received Dec 29, 1977 under 100-473; prepared by
International Research and Development Corp., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL; 232549-F)
40995817 Kuhn, J. (1988) Ametryn Technical: Primary Eye Irritation Study in Rabbits: Study
No. 5568-88. Unpublished study prepared by Stillmeadow, Inc. 18 p.
43682305 Kuhn, J. (1995) Primary Eye Irritation Study in Rabbits: Final Report: G-34162 80
WDG: Lab Project Number: 1692-94. Unpublished study prepared by
Stillmeadow, Inc. 19 p.
D7
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92002016 Gillis, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 40995817. Primary
Eye Irritation Study in Rabbits: Study No. 5568-88. Prepared by
STILLMEADOW, INC. 10 p.
00068174 Sachsse, K.; Ullmann, L. (1977) Skin Irritation in the Rabbit after Single
Application of Technical G 34162: Project No. Siss 5665. (Unpublished study
received Jul 20, 1977 under 100-579; prepared by Ciba-Geigy, Ltd., Switzerland,
submitted by Ciba- Geigy Corp., Greensboro, N.C.; CDL:230872-H)
00073738 Kapp, R.W. (1975) Final Report: Primary Skin Irritation Study in Rabbits: Project
No. 915-105. (Unpublished study received Dec 19, 1977 under 33660-8; prepared
by Hazleton Laboratories Amer- ica, Inc., submitted by Industria Prodotti Chimici,
S.p.A., Novate Milanese, Italy; CDL:232507-D)
40995818 Kuhn, J. (1988) Ametryn Technical: Primary Dermal Irritation Study in Rabbits:
Study No. 5569-88. Unpublished study prepared by Stillmeadow, Inc. 13 p.
43682306 Kuhn, J. (1995) Primary Dermal Irritation Study in Rabbits: Final Report:
G-34162 80 WDG: Lab Project Number: 1693-94. Unpublished study prepared by
Stillmeadow, Inc. 12 p.
92002017 Gillis, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 40995818. Primary
Dermal Irritation Study in Rabbits: Study No. 5569-88. Prepared by
STILLMEADOW, INC. 10 p.
00068175 Sachsse, K.; Ullmann, L. (1977) Skin Sensitizing (Contact Aller- genie) Effect in
Guinea Pigs of Technical G 34162: Project No. Siss 5665. (Unpublished study
received Jul 20, 1977 under 100-579; prepared by Ciba-Geigy, Ltd., Switzerland,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:230872-I)
40995819 Kuhn, J. (1988) Ametryn Technical: Dermal Sensitization Study in Guinea Pigs:
Study No. 5570-88. Unpublished study prepared by Stillmeadow, Inc. 18 p.
92002018 Gillis, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 40995819. Dermal
Sensitization Study in Guinea Pigs: Study No. 5570-88. Prepared by
STILLMEADOW, INC. 10 p.
00034838 Domenjoz, R. (1961) Ametryne: Toxicity in Long-Term Administration.
(Unpublished study received Jan 6, 1964 under 100-473; prepared by Rhenish
Friedrich-Wilhelm Univ., Pharmacological Institute, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:000473-C)
D8
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00034843 Roulet, ? (1961) Toxicology of Ametryne. (Unpublished study re- ceived Jan 6,
1964 under 100-473; prepared by J.R. Geigy, S.A. and Rheinisch
Friedrich-Wilhelms-Univ., Pharmacological Insti- tute, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL: 000473-H)
00048228 Stenger, ?; Planta, V. (1961) Subchronic Toxicity: Subchronic Tox- icity Test No.
257. (Unpublished study received Aug 1, 1968 under 100-473; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:222957-C)
00048229 Roulet, ?; Fiechter, ?; Stutz, ? (1961) Subchronic Toxicity on Rat: Toxicity Test
No. 257. (Translation; unpublished study received Aug 1, 1968 under 100-473;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:222957-D)
00048231 Stenger, ?; Planta, V. (1961) Subchronic Toxicity: Subchronic Toxicity Test No.
256. (Unpublished study received Aug 1, 1968 under 100-473; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:222957-F)
00048232 Roulet, ?; Fiechter, ?; Stutz, ? (1961) Subchronic Toxicity, Rat: Toxicity Test No.
256. (Unpublished study received Aug 1, 1968 under 100-473; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:222957-G)
00048233 Roulet, ?; Fiechter, ?; Stutz, ? (1961) Subchronic Toxicity, Rat: Toxicity Test No.
256. (Unpublished study received Aug 1, 1968 under 100-473; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:222957-H)
00048234 Roulet, ?.; Fiechter, ?; Schultz, ? (1961) Subchronic Toxicity, Rat: Exper. Path.
Test No. 140. (Unpublished study received Aug 1, 1968 under 100-473;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:222957-I)
00048235 Roulet, ?.; Fiechter, ?; Schultz, ? (1961) Subchronic Toxicity, Rat: Exper. Path.
Test No. 143. (Unpublished study received Aug 1, 1968 under 100-473;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:222957-J)
00068169 Piccirillo, VJ. (1977) Final Report: 28-day Pilot Feeding Study in Mice: Project
No. 483-126. (Unpublished study received Jul 20, 1977 under 100-579; prepared
by Hazleton Laboratories America, Inc., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:230872-B)
00080624 Domenjoz, R. (1961) A 1093 (G-34162) Ametryne: Toxicity in Long- term
Administration. (Unpublished study, including submitter summary, received Dec
19, 1968 under 8F0638; prepared by Rhein- ish Friedrich-Wilhelm Univ.,
Pharmacological Institute, West Germany, submitted by Geigy Chemical Corp.,
New York, N.Y.; CDL:091109-R)
D9
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00080625 Geigy Chemical Corporation (1961) ?Toxicity of A 1093 in Rats|. (Unpublished
study received Mar 27, 1967 under 8F0638; CDL: 091109-S)
40349903 Piccirillo, V. (1977) Ametryn: 28-day Pilot Feeding Study in Mice: Laboratory
Study No. 483-126. Unpublished study prepared by Hazleton Laboratories
America, Inc. 25 p.
40382001 Tai, C.; McCormick, G.; Green, J. (1987) Ametryn: 4-week Oral Range-finding
Study in Rats: Laboratory Study No. 842084, Report No. 213-84. Unpublished
study prepared by Ciba-Geigy Corp. 256 p.
92002019 Atherton, N. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 41067902.
21-Day Dermal Toxicity Study in Rabbits: Study No. 882215. Prepared by
CIBA-GEIGY CORP. 10 p.
00033709 Palazzolo, RJ. (1965) Report to Geigy Research Laboratories: Five- Day
Subacute Dermal Toxicity of Ametryne 25E. (Unpublished study received Mar
12, 1965 under 100-480; prepared by Indus- trial Bio-Test Laboratories, Inc.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:000486-A)
00034843 Roulet, ? (1961) Toxicology of Ametryne. (Unpublished study received Jan 6,
1964 under 100-473; prepared by J.R. Geigy, S.A. and Rheinisch
Friedrich-Wilhelms-Univ., Pharmacological Insti tute, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL: 000473-H)
00080615 Palazzolo, RJ. (1964) Report to Geigy Research Laboratories: Re- peated Dermal
Toxicity of Ametryne SOW. (Unpublished study, including submitter summary,
received Mar 27, 1967 under 8F0638; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by Geigy Chemical Corp., New York, N.Y.;
CDL:091109-F)
00034843 Roulet, ? (1961) Toxicology of Ametryne. (Unpublished study re- ceived Jan 6,
1964 under 100-473; prepared by J.R. Geigy, S.A. and Rheinisch
Friedrich-Wilhelms-Univ., Pharmacological Insti- tute, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL: 000473-H)
00042795 Plank, J. (1974) Report to Geigy Chemical Corporation: 24-Month Chronic Oral
Toxicity of Ametryne SOW: Albino Rats: IBT No. B4715. (Unpublished study
received Oct 7, 1977 under 100- 566; prepared by Industrial Bio-Test
Laboratories, Inc., submit- ted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:231965-D)
00080612 Wolf, C. (1967) Report to Geigy Chemical Corporation: Two-year Chronic Oral
Toxicity of Ametryne 80-W: Albino Rats (90-day Re- suits): IBT No. B4715.
D10
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(Unpublished study, including submitter summary, received Mar 27, 1967 under
8F0638; prepared by Industrial Bio-Test Laboratories, Inc., submitted by Geigy
Chemical Corp., New York, N.Y.; CDL:091109-B)
00080613 Baran, J. (1967) Report to Geigy Chemical Corporation: Status Re- port:
Two-year Chronic Oral Toxicity of Ametryne SOW—Beagle Dogs: IBT No.
C4716. (Unpublished study, including submitter summary, received Mar 27, 1967
under 8F0638; prepared by Industrial Bio-Test Laboratories, Inc., submitted by
Geigy Chemical Corp., New York, N.Y.; CDL:091109-C)
00082781 Plank, J. (1968) Report to Geigy Chemical Corporation: 24-month Chronic Oral
Toxicity of Ametryne SOW: Albino Rats: IBT No. B4715. (Unpublished study
received May 15, 1970 under OF0903; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by Geigy Chemical Co., Ardsley, N.Y.;
CDL:091557-A)
00082782 Carlson, D.; Suckow, E.E.; Richter, W.R. (1968) Report to Geigy Agricultural
Chemicals, Division of Geigy Chemical Corporation: Two-year Chronic Oral
Toxicity of Ametryne SOW in Beagle Dogs: IBT No. C4716. (Unpublished study
received May 15, 1970 under OF0903; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by Geigy Chemical Co., Ardsley, N.Y.;
CDL:091557-B)
40349902 O'Connor, D. (1987) Ametryn: Chronic Toxicity Study in Dogs: Laboratory Study
No. 842118. Unpublished study prepared by Ciba-Geigy Corp. 665 p.
92002020 Atherton, N.; Tisdel, M. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID
40349906. Combined Chronic Toxicity/Oncogenicity Study in Rat: Study
#842119. Prepared by CIBA-GEIGY CORP. 13 p.
92002021 Atherton, N.; Tisdel, M. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID
40349902. Chronic Toxicity in Dogs: Study No. 842118. Prepared by
CIBA-GEIGY CORP. 12 p.
40349903 Piccirillo, V. (1977) Ametryn: 28-day Pilot Feeding Study in Mice: Laboratory
Study No. 483-126. Unpublished study prepared by Hazleton Laboratories
America, Inc. 25 p.
40349904 Burdock, G. (1981) Ametryn Technical: Oncogenicity Study in Mice: Laboratory
Study No. 483-128. Unpublished study prepared by Hazleton Laboratories
America, Inc. 626 p.
Dll
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40349906 Hazelette, 1; Green, J. (1987) Ametryn: Combined Chronic Toxicity/
Oncogenicity Study in Rats: Laboratory Study No. 842119. Unpub- lished study
prepared by Ciba-Geigy Corp. 4305 p.
41184201 Hazelette, J.; Green, J. (1987) Ametryn: Supplement to Combined Chronic
Toxicity/Oncogenicity Study in Rats: MIN 842119. Un- published study prepared
by Ciba Geigy Corp. 12 p.
92002020 Atherton, N.; Tisdel, M. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID
40349906. Combined Chronic Toxicity/Oncogenicity Study in Rat: Study
#842119. Prepared by CIBA-GEIGY CORP. 13 p.
92002022 Atherton, N.; Tisdel, M. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID
40349904. 102-Week Carcinogenicity Study in Mice: Study #HLA-483-128.
Prepared by HAZLETON LABS AMERICA, INC. 12 p.
92002023 Gillis, J.; Tisdel, M. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID
00068169 and Related MRIDs 40349903. 28-Day Pilot Feeding Study in Mice:
Study No. 483-126. Prepared by HAZLETON LABS AMERICA, INC. 11 p.
92002041 Piccirillo, V. (1990) Ciba-Geigy Corp. Phase 3 Reformat of MRID 00068169 and
Related MRIDs 40349903. 28-Day Pilot Feeding Study in Mice: Study No.
483-126. Prepared by HAZLETON LABORATORIES AMERICA, INC. 26 p.
00153213 Infurna, R. (1984) Rabbit-Segment II: Dose Range Teratology Study Pilot (P-l):
Ametryn Technical. Unpublished study prepared by Ciba-Geigy Corp. 8 p.
00153214 Infurna, R.; Youreneff, M.; Wallace, P.; et. al (1985) Ametryn Technical: A
Teratology Study in Rabbits: Report 85063. Unpub- lished study prepared by
Ciba-Geigy Corp. 302 p.
00153215 Infurna, R.; Wimbert, K.; Arthur, A. (1985) Ametryn Technical: A Teratology
Study in Rats: Report 85140. Unpublished study pre- pared by Ciba-Geigy Corp.
337 p.
92002024 Gillis, J.; Tisdel, M. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID
00153215. A Teratology Study in Rats: Study No. 852054. Prepared by
CIBA-GEIGY CORP. 11 p.
92002025 Gillis, J.; Tisdel, M. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID
00153214. A Teratology Study in Rabbits: Study 842107. Prepared by
CIBA-GEIGY CORP. 11 p.
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00024473 Arnold, D. (1968) Report to Geigy Agricultural Chemicals Division of Geigy
Chemical Corporation: Three-Generation Reproduction Study in Albino
Rats-Ametryne SOW: Final Report: IBT No. P4709. (Unpublished study received
Oct 7, 1977 under 100-566; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by Ciba- Geigy Corp., Greensboro, N.C.; CDL:231966-D)
00080614 Kennedy, G. (1967) Report to Geigy Chemical Corporation: Three- generation
Reproduction Study in Albino Rats on Ametryne SOW: Results through Weaning
of Fib Litters (First Generation): IBT No. P4709. (Unpublished study, including
submitter summary, received on unknown date under 8F0638; prepared by
Industrial Bio-Test Laboratories, Inc., submitted by Geigy Chemical Corp., New
York, N.Y.; CDL:091109-D)
0082783 Arnold, D. (1968) Report to Geigy Agricultural Chemicals, Division of Geigy
Chemical Corporation: Three-generation Reproduction Study in Albino
Rats—Ametryne SOW: IBT No. P4709. Final rept. (Unpublished study received
May 15, 1970 under OF0903; prepared by Industrial Bio-Test Laboraties, Inc.,
submitted by Geigy Chemical Co., Ardsley, N.Y.; CDL:091557-C)
40349905 Hummel, H.; Youreneff, M.; Yau, E. (1987) Ametryn Technical: Two- generation
Reproduction Study in Rats: Laboratory Study No. 852048. Unpublished study
prepared by Ciba-Geigy Corp. 1405 p.
92002026 Atherton, N. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 40349905.
Two-Generation Reproduction Study in Rats: Study #852048. Prepared by
CIBA-GEIGY CORP. 11 p.
00060642 Simmon, V.F.; Poole, D. (1977) Final Report-In vitro~and~in vivo-
Microbiological Assays of Six Ciba-Geigy Chemicals: SRI Project LSC-5686.
(Unpublished study received Dec 29, 1977 under 100- 542; prepared by Stanford
Research Institute, submitted by Ciba- Geigy Corp., Greensboro, N.C.;
CDL:232550-B)
00078333 Simmon, V.F.; Poole, D. (1977)~In Vitro~and~In Vivo-Microbiological Assays of
Six Ciba-Geigy Chemicals: SRI Project LSC-5686. Final rept. (Unpublished
study received Aug 13, 1981 under 7F1983; prepared by Stanford Research
Institute, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:070213-I)
40995820 Deparade, E. (1984) Ametryn Technical: Gene Mutations Test: Salmo-
nella/Mammalian-Micro some Mutagenicity Test: Study No. 840802. Unpublished
study prepared by Ciba-Geigy Corp. 25 p.
41067903 Hertner, T. (1989) Ametry Technical: Structural Chromosomal Aberra- tion Test:
Micronucleus Test, Mouse: Study No. 881548. Unpub- lished study prepared by
Ciba-Geigy Limited. 38 p.
D13
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41067904 Hertner, T. (1989) Ametryn Technical: Tests for other Genotoxic Effects:
Autoradiographic DNA-Repair Test on Rat Hepatocytes: Study No. 881549.
Unpublished study prepared by Ciba-Geigy Ltd. 98 p.
41189701 Deparade, E. (1984) Ametryn Technical: Gene Mutations Test: Salmo-
nella/Mammalian-Micro some Mutagenicity Test: Study No. 840802. Unpublished
study prepared by Ciba-Geigy Ltd. 23 p.
42861703 van de Waart, E.; Enninga, I. (1987) Evaluation of the Mutagenic Activity of
(Inert Ingredient) in the Ames Salmonella/Micro some Test. Unpublished study
prepared by Notox C. V. 38 p.
42861704 Gollapudi, B.; Linscombe, A.; Verschuuren, H. (1988) Evaluation of (Inert
Ingredient) in an In Vitro Chromosomal Abberation Assay Utilizing Chinese
Hamster Ovary (CHO) Cells: Lab Project Number: TXT:K-005474-007.
Unpublished study prepared by Health and Environmental Sciences-Texas. 17 p.
42861705 Linscombe, A.; Verschuuren, H. (1991) Evaluation of (Inert Ingredient) in an In
Vitro Chromosomal Assay Utilizing Chinese Hamster Ovary (CHO-K1,S1B) Cell
Line: Lab Project Number: TXT:K-005474-008. Unpublished study prepared by
Health and Environmental Sciences-Texas. 18 p.
42861706 McClintock, M.; Gollapudi, B.; Verschuuren, H. (1988) Evaluation of (Inert
Ingredient) in the Mouse Bone Marrow Micronucleus Test: Lab Project Number:
TXT:K-005474-006. Unpublished study prepared by Health and Environmental
Sciences-Texas. 28 p.
92002027 Breckenridge, C. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 40995820.
Salmonella/Mammalian-Micro some Mutagenicity Test: Study #840802. Prepared
by CIBA-GEIGY LTD. 11 p.
92002028 Breckenridge, C. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 41067903.
Micronucleus Test, Mouse: Ametryn: Study No. 881548. Prepared by
CIBA-GEIGY LIMITED. 11 p.
92002029 Breckenridge, C. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 41067904.
Autoradiographic DNA-Repair Test on Rat Hepatocytes: Ametryn: Study No.
881549. Prepared by CIBA-GEIGY LIMITED. 12 p.
00055672 Ciba-Geigy Chemical Corporation (1971) Metabolism of~s—Triazine Herbicides.
(Unpublished study including letter dated Dec 29, 1971 from J.R. Forsythe to
Harold G. Alford, received Dec 29, 1971 under 100-437; CDL:231915-A)
D14
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00085223 Murphy, R.T. (1972) Response to EPA Comments on Igran Sorghum Pesticide
Petition #1F1048: Report No. GAAC-72079. (Unpublished study received on
unknown date under IF 1048; submitted by Geigy Chemical Corp., New York,
N.Y.; CDL:093362-B)
41463301 Wu, D. (1990) Analysis, Quantitation, and Structure Elucidation of Metabolites in
Urine and Feces from the Rat Dosed with ?Carbon 14|-Ametryn: XRL Report No.:
RPT0022. Unpublished study prepared by Xenobiotic Laboratories, Inc. 215 p.
41463302 Reynolds, J. (1990) Ametryn Metabolism of ?Carbon 14|-Ametryn in Rats-Phase I
Preliminary Study: XBL Report No.: RPT0007. Unpublished study prepared by
XenoBiotic Laboratories, Inc. 41 p.
41463303 Braun, R. (1990) Absorption, Distribution and Excretion Studies of ?Carbon
14|-Ametryn in the Rat: ETC Protocol No.: P01744. Unpublished study prepared
by Biological Test Center. 169 p.
92002042 Schabacker, D. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 41463301.
Analysis, Quantification and Structure Elucidation of Metabolites in Urine and
Feces from the Rat Dosed with (Triazine (U)-Carbonl4 Ametryn: Report No.
RPT0022. Prepared by XENOBIOTIC LABS, INC. 20 p.
Environmental Fate
MRID # Study Citations
40995812 Spare, W. (1988) Hydrolysis of ?carbon 14|-Ametryn: Final Report: Project No.
12135. Unpublished study prepared by Agrisearch Inc. 94 p.
41169601 Spare, W. (1989) Aqueous Photolysis of ?carbon 14|-Ametryn: Final Report:
Study No. 12136. Unpublished study prepared by Agrisearch Inc. 125 p.
41169602 Spare, W. (1989) Soil Photolysis of Ametryn by Natural Sunlight at Vero Beach,
Florida: Final Report: Study No. 12137. Unpublished study prepared by Arisearch
Inc. 85 p.
41169603 Spare, W. (1989) Soil Photolysis of Ametryn by Natural Sunlight and Artificial
Light: Final Report: Study No. 12137. Unpublished study prepared by Agrisearch
Inc. 141 p.
41752401 Spare, W. (1990) Ametryn: Aerobic and Anaerobic Soil Metabolism of ?Carbon
14|-Ametryn: Lab Project Number: 12138. Unpublished study prepared by
Agrisearch Inc. 166 p.
D15
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46533801 Glanzel, A. (1999) Metabolism and Rate of Degradation of (Carbon 14)-Labelled
G 34162 under Aerobic, Anaerobic and Aerobic/Anaerobic Laboratory Conditions
in Soil at 20 Degrees Celsius and 10 Degrees Celsius: Final Report. Project
Number: 97AGO 1. Unpublished study prepared by Novartis Crop Protection, AG.
152 p..
41752401 Spare, W. (1990) Ametryn: Aerobic and Anaerobic Soil Metabolism of ?Carbon
14|-Ametryn: Lab Project Number: 12138. Unpublished study prepared by
Agrisearch Inc. 166 p.
40995813 Spare, W. (1988) Adsorption/Desorption of [carbon 14]-Ametryn: Final Report:
Project No. 12141. Unpublished study prepared by Agrisearch, Inc. 100 p.
41169604 Spare, W. (1989) Leaching Characteristics of [carbon 14]-Ametryn: Final Report:
Study No. 12139. Unpublished study prepared by Agrisearch Inc. 81 p.
41752402 Judy, D.; Jacobson, B.; Gresham M. (1991) Ametryn: Terrestrial Field Dissipation
for Evik 80W-Crop Application, Louisiana Site: Final Report: Lab Project
Number: 37894. Unpublished study prepared by Analytical Bio-Chemistry
Laboratories in assoc. with Pest Management Enterprises, Inc. 267 p.
41872301 Jacobson, B.; Gresham, M. (1991) Terrestrial Field Dissipation for Evik 80W-
Bareground Application, Illinois Site: Ametryn: Final Report: Lab Project Number:
38184. Unpublished study prepared by ABC Laboratories, Inc., & Agri-Research
Associates, Inc. 247 p.
41872302 Rice, F.; Jacobson, B.; Gresham, M. (1991) Terrestrial Field Dissipation for Evik
80W-Crop Application, Illinois Site: Ametryn: Final Report: Lab Project Number:
38183. Unpublished study prepared by ABC Laboratories, Inc., & Agri-Research
Association, Inc. 256 p.
RESIDUE CHEMISTRY
MRID # Study Citations
41397201 Yokley, R. (1990) Determination of Ametryn, Prometryn, and Metabolites by U.
S. Food and Drug Administration Multiresidue Method Testing: Lab Project
Number: ABR-89064: ABR-77060: 102065. Unpublished study prepared by
Ciba-Geigy Corp. 78 p.
D16
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41423401 Williams, R. (1990) Multiresidue Method Testing of Atrazine, Simazine, and their
Chloro- and Hydroxy-traizine Metabolites in Crops and Animal Tissues: Lab
Project ID: ABR-89010. Unpublished study prepared by Ciba-Geigy Corp. 130 p.
41557101 Beidler, W. (1990) Ametryn: Storage Stability of Ametryn and Selected
Metabolites in Crops Under Freezer Storage Conditions (Six Month Interim
Report): Lab Project Number: ABR-90058. Unpublished study prepared by Ciba-
Geigy Corp. 94 p.
41557102 Vargo, J. (1990) Analytical Method for the Determination of Ametryn and
Metabolites GS-11354, GS-11355, and GS-26831 in Crops and Crop Fractions by
Gas Chromatography: Lab Project No: AG-563. Unpublished study prepared by
Ciba-Geigy Corp. 57 p.
41557103 Morris, A.; Clayton, F. (1990) Method Validation Ruggedness Trial for Ciba-
Geigy Method AG-563, Analytical Method for the Determination of Ametryn and
Metabolites GS-26831 in Crop Fractions by Gas Chromatography: Final Report:
Lab Project Number: 90-0078 CGAG. Unpublished study prepared by EN-CAS
Analytical Laboratories. 19 p.
41662301 Detra, R.; Chib, J. (1990) Ametryn: Metabolism of Triazine carbon-14 Ametryn in
Sugarcane: Lab Project Number: N/0963/1800. Unpublished study prepared by
Battelle Columbus Div. 94 p.
41662302 Detra, R.; Chib, J. (1990) Ametryn: Metabolism of Triazine-carbon-14-Ametryn in
Corn: Lab Project Number: N/0963/1800. Unpublished study prepared by Battelle.
130 p.
41662303 Liu, D. (1990) Ametryn: Metabolism of carbon 14-Ametryn in Laying Hens:
Analysis and Quantitation of Metabolites in Eggs, Edible Tissues, and Excreta:
Lab Project Number: RPT0024. Unpublished study prepared by Xenobiotic
Laboratories, Inc. 350 p.
41662304 Lin, P. (1990) Metabolism Study in Laying Hens Feeding carbon 14-Ametryn: Lab
Project Number: P01736. Unpublished study prepared by Biological Test Center.
43 p.
41662305 Liu, D. (1990) Ametryn: Metabolism of carbon 14-Ametryn in Lactating Goats:
Analysis and Quantitation of Metabolites in Milk, Edible Tissues, and Excreta: Lab
Project Number: RPT0023. Unpublished study prepared by Xenobiotic
Laboratories, Inc. 142 p.
D17
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41662306 Lin, P. (1990) Metabolism Study in Lactating Goat Feeding carbon- 14-Ametryn:
Lab Project Number: P01734. Unpublished study prepared by Biological Test
Center. 53 p.
41846601 Selman, F. (1991) Ametryn-Magnitude of Residues in Sugarcane Forage , Stripped
Cane, and Stripped Cane Processed Fractions Resulting from Applications of Evik
SOW: Lab Project Number: ABR-91002. Unpublished study prepared by Ciba-
GeigyCorp. 417 p.
41872303 Selman, F. (1991) Ametryn-Magnitude of Residues in Whole Bananas, Banana
Peel, and Banana Pulp Resulting From Application of Evik SOW: Lab Project
Number: ABR-91003. Unpublished study prepared by Ciba-Geigy Corp. 159 p.
41872304 Vargo, J. (1991) Validation of Analytical Method AG-563 for the Determination
of Ametryn, GS-11354, GS-11355, and GS-26831 in Corn and Sugarcane: Lab
Project Number: ABR-90049. Unpublished Study prepared by Ciba-Geigy Corp.
50 p.
41909501 Selman, F. (1991) Ametryn: Magnitude of Residues in Field Corn Forage, Fodder,
Grain, and Processed Corn Grain Fractions Resulting From Applications of EVIK
SOW: Lab Project Number: ABR-91001. Unpublished study prepared by Ciba-
Geigy Corporation. 507 p.
41909502 Wong, L. (1991) Ametryn: Pineapple Residue Study: Lab Project Number: 36-
5294: PGA-ES 91-5294: 96-20-26. Unpublished study prepared by Hawaiian
Sugar Planters' Association. 208 p.
41986301 Thede, B. (1991) Uptake and Metabolism in Greenhouse Grown Rotational Crops
Grown after Triazine-Carbon 14-Ametryn-Treated Sugarcane: Lab Project
Number: ABR-91043. Unpublished study prepared by Ciba-Geigy Corp. 114 p.
41986302 Kazee, B. (1991) Analytical Report: Uptake and Metabolism of in Greenhouse
Grown Rotational Crops Grown after Triazine-Carbon-14-Treated Sugarcane: Lab
Project Number: N0963-18R. Unpublished study prepared by Battelle, Columbus
Div. 63 p.
42391601 Vargo, J. (1991) Analytical Method for the Determination of Ametryn, Prometryn
and Metabolites GS-11354, GS-11355 and GS-26831 in Corn Soapstock and
Cottonseed Soapstock by Gas Chromatography including Validation Data: Lab
Project Number: METHOD AG-581. Unpublished study prepared by Ciba-Geigy
Corp. 38 p.
42391602 Selman, F. (1992) Ametryn: Magnitude of the Residues in Field Corn Forage,
Silage-Stage Fodder, Fodder, Grain and Processed Corn Grain Fractions Resulting
from Application of Evik SOW: Amendment 1: Lab Project Number ABR-91001.
D18
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Unpublished study prepared by Ciba-Geigy Corp. in coop with ABC Labs, Inc.;
EN-CAS Analytical Labs; Harris Labs, Inc. and others. 1335 p.
43335902 Eudy, L. (1994) Storage Stability of Ametryn and Selected Metabolites in Crops
Under Freezer Storage Conditions: Lab Project Number: ABR-94020: 102925:
248-89. Unpublished study prepared by Ciba-Geigy Corp. 159 p.
43342401 Ciba-Geigy Corp. (1994) Sample Storage of Greenhouse Grown Rotational Crops
Grown After Triazine-(carbon 14)-Ametryn Treated Sugarcane: Response to EPA
Review: Lab Project Number: N-0963-18R: ABR-91043. Unpublished study. 6 p.
43931001 Wu, J. (1995) Ametryn: Storage Stability on Ametryn: Goat and Hen Metabolism:
(Supplement): Lab Project Number: RPT0023: RPT0024: 88085. Unpublished
study prepared by Xenobiotic Labs, Inc. 27 p.
44107901 Thalacker, F.; Ash, S. (1996) (Carbon 14)-Ametryn: Nature of the Residue in
Bananas: Lab Project Number: HWI 6117-270: 318-94: 94.255. Unpublished
study prepared by Hazleton Wisconsin, Inc. 141 p.
44477701 Lin, K. (1997) Determination of Residues of Ametryn, GS-11354, GS-11355, and
GS-26831 in Animal Tissue, Milk, and Egg: Lab Project Number: AG-649: 632-
95: 102925. Unpublished study prepared by Novartis Crop Protection, Inc. 55 p.
(OPPTS 860.1340}
44477702 Lin, K. (1997) Validation of Analytical Method AG-649 for Determination of
Ametryn, GS-11354, GS-11355, and GS-26831 in Animal Tissues, Milk, and
Poultry Eggs by Capillary Gas Chromatography: Lab Project Number: ABR-
97127: 631-95: ANPHI-96003. Unpublished study prepared by Novartis Crop
Protection, Inc. 133 p. {OPPTS 860.1340}
44477703 Hayworth, C. (1997) Stability of Ametryn and Selected Metabolites in Processed
Fractions Under Freezer Storage Conditions: 6-Month Interim Report: Lab Project
Number: ABR-97124: 213-96: 102925. Unpublished study prepared by Novartis
Crop Protection, Inc. 107 p. {OPPTS 860.1380}
44477704 Hayworth, C. (1997) Stability of Ametryn and Selected Metabolites in Meat, Milk,
and Eggs Under Freezer Storage Conditions: 14-Month Interim Report: Lab
Project Number: ABR-97126: 222-96: 102925. Unpublished study prepared by
Novartis Crop Protection, Inc. 98 p. {OPPTS 860.1380}
44477705 Hamilton, L. (1997) Ametryn—Magnitude of the Residues in Meat and Eggs
Resulting from the Feeding of Three Levels to Poultry: Lab Project Number:
ABR-96110: 134-95: BIOL-95005. Unpublished study prepared by Novartis Crop
Protection, Inc. 187 p. {OPPTS 860.1480}
D19
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44477706 Boyette, S. (1997) Ametryn-Magnitude of the Residues in Meat and Milk
Resulting from the Feeding of Three Levels to Dairy Cattle: Lab Project Number:
ABR-96046: 144-95: BIOL-95006. Unpublished study prepared by Novartis Crop
Protection, Inc. 186 p. (OPPTS 860.1480}
44783701 Hayworth, C. (1999) Stability of Ametryn and Selected Metabolites in Processed
Fractions Under Freezer Storage Conditions: Final Report: Lab Project Number:
213-96. Unpublished study prepared by Novartis Crop Protection, Inc. 100 p.
{OPPTS 860.1380}
44783702 Lin, K. (1999) Ametryn-Field Rotational Crops Following Bare Ground
Application of Evik SOW: Final Report: Lab Project Number: 80-95: 102925: 80-
95-A. Unpublished study prepared by Novartis Crop Protection, Inc. 107 p.
{OPPTS 860.1900}
ECONOMIC ANALYSIS
Keitt, G., November 16, 1989, Transmittal of Summary Preliminary Benefit Analysis of Atrazine
Use on Sugarcane, USEPA.
Rainbolt, C., A. C. Bennett, and J. A. Dusky, 2005, Weed Management in Sugarcane - 2005,
Web address: http://edis.ifas.ufl.edu/WG004
Smith, Dudley. Weed Control Practices in U.S. Sugarcane - A report for the Southern Regional
Pesticide Impact Assessment Program at the Univ. of Florida. December 1997.
Tarutani, C., Department of Plant and Environmental Protection Sciences, University of Hawai'i,
June 2005, Personal communication with Nicole Zinn.
USDA Crop Profile for Pineapples in Hawaii, 2000, Web address:
http://www.ipmcenters.org/cropprofiles/docs/hipineapples.html.
USDA Crop Profile for Corn (Sweet) in Wisconsin, 1999, Web address:
http://www.ipmcenters.org/cropprofiles/docs/wicorn-sweet.html
USDA Crop Profile for Sugarcane in Hawaii. June, 2000. Web address:
http://pestdata.ncsu.edu/cropprofiles/docs/hisugarcane.html
USDA Crop Profile for Sugarcane in Louisiana. April 26, 1999. Web address:
http://pestdata.ncsu.edu/cropprofiles/docs/LAsugarcane.html
USDA Crop Profile for Sugarcane in Texas. Revised July 2003. Web address:
http://pestdata.ncsu.edu/cropprofiles/docs/txsugarcane.html
D20
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USDANASS, 2004, Agricultural Statistics, Web address:
http://www.usda.gov/nass/pubs/agr04/acro04.htm
Whalen, S., April 25, 2005, President and Director, Experiment Station, Hawaii Agriculture
Research Center, Letter to M. Howard.
York, A., 2005a, Professor of Crop Science and Extension Specialist, North Carolina State
University, Personal communication with Nicole Zinn on May 26, 2005.
York, A., 2005b, Crop Science Dept, 2005b, Chemical Weed Control in Corn, 2005 North
Carolina Agricultural Chemicals Manual, NC State University, Web address:
http://ipm.ncsu.edu/agchem/chptr8/801.pdf
D21
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Appendix E. Batching of Ametryn Products
There is only one ametryn technical product and only one ametryn end use product.
Therefore no batching is required.
El
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Appendix F. List of Registrants to be sent the Data Call-In
There is only one registrant, Syngenta Crop Protection, Inc. for both the remaining
ametryn technical (100-579) and remaining end use product (100-786). The contact information
is:
Mr. John Abbot
Syngenta Crop Protection, Inc.
PO Box 18300
Greensboro, NC 27419-8300
www. syngenta. com
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Appendix G. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO 1 /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 hardcopy 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@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
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
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.sov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.sov/opprd001/forms/8570-17.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
Gl
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8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
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.sov/opprd001/forms/8570-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www.epa.sov/opprd001/forms/8570-32.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
Pesticide Registration Kit
Dear Registrant:
www. epa. sov/pesticides/resistrationkit/
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
G2
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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 Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
f 40 CFR Part 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.
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
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: http://npic.orst.edu..
G3
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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:
a. Date of receipt;
b. EPA identifying number; and
c. 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.
Documents Associated with this RED
The following documents are part of the Administrative Record for this RED document and may
be included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not
available electronically, but may be obtained by contacting the person listed on the respective Chemical
Status Sheet.
1. Health Effects Division and Environmental Fate and Effects Division Science Chapters,
which include the complete risk assessments and supporting documents.
2. Detailed Label Usage Information System (LUIS) Report.
G4
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