United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7503CS
EPA 738-R-04-Q04
DATE January 2003
Interim Reregistration
Eligibility Decision (IRED)
Atrazine
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** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
g U WASHINGTON, D.C. 20460
¦z.
lU
<$. p OFFICE OF
i PROl- PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Errata/Addendum Sheet for Changes to the Atrazine Interim Reregistration
Eligibility Decision.
/ /''
FROM: Anne Overstreet (/i J[nT)'; / i.'/-?/C#
Special Review Branch '
Special Review and Reregistration Divsion
TO: Public Docket for Atrazine
Listed below are changes/clarifications added to the Atrazine Interim Reregistration
Eligibility Decision (1RED) which was published in January. 2003. The regulatory decision of
the IRED did not change as a result of these clarifications.
1) The occupational and non-occupational mitigation areas were updated to reflect more recent
data. Because the Agency recently updated several scenarios using ORTEF data, a respirator is
no longer necessary for backpack sprayers.
2) Appendices A-H were added to the IRED. They are as follows:
- Appendix A: Atrazine Use Patterns Eligible for Reregistration
- .Appendix B: Studies Used to Support the Reregistration of Atrazine
- Appendix C: Technical Support Documents
- Appendi x D: Citations Considered to Be Part of the Database Supporting the Interim
Reregistration Decision (Bibliography)
- Appendix E: Generic Data Call-In
- Appendix F: Product Specific Data Call-In
- Appendix G: CPA's Batching of Atrazine Products for Meeting Acute Toxicity Data
Requirements For Reregistration
- Appendix H: Atrazine Monitored Watersheds
Appendix B was previously posted on the web. It has been subsequently been amended to
accurately reflect the data gaps and studies used in support of reregistration.
3) The Label Table in Section IV has been added to the FRED. In order to be eligible for
1
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reregistration, all product labels are to be amended to incorporate the risk mitigation measures
outlined in Section IV. Table 29 has been added to the IRED and describes how language on the
labels should be amended
4) Clarification was made relating to the atrazine cancer assessment language. The findings of
the 2000 SAP meeting were included.
5) Corrections were made pertaining to the baseline attire for occupational scenarios. Baseline
clothing typically includes: long-sleeved shirt and long pants, shoes and socks. For scenario 5
(Table 14 of the TRF.D), application of liquids via groundboom. baseline assessments also
included gloves. This clarification was made in both the text and footnotes of Table 14.
6) In Table 15, for scenarios 10&11 (application of liquids via backpack sprayer and low-
pressure handwand), the number of acres treated changed from 1 to 5 based on further
refinements to input parameters.
7) In Table 15 for the following scenarios:
-12(a) - application of liquid via handgun and compressed air sprayer
- 12(b) - WDG via lawn handgun
- 12(c) - WSP via lawn handgun
-13 - application of granular via push-type spreader
- 7 - application of liquids via handgun
A footnote was added which specified that these scenarios considered baseline attire plus gloves.
8) There has been harmonization between Sections IV and V with the MOA.
9) The Atrazine Water Management Information Center (AWMIC) has been changed to the
Atrazine Water Information Center (AWIC). It has been changed in Chapters four and five of the
IRED.
10) In Section IV of the IRED, an updated name was listed as the contact for the generic DCI.
T
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^O S7-/; ,
vT <5?
UNITED STATES ENVIRONMENTAL- PROTECTION AGENCY
WASHINGTON. D.C. 20460
PRO^°
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
MAR 1 6 20
Dear Registrants:
This is to inform you that the Environmental Protection. Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments received
related to the preliminary and revised risk assessments for the pesticide atrazine. The public
comment period on the revised risk assessment phase of the reregistration process is closed.
Based on comments received during the public comment period and additional data received
from the registrants, the Agency revised the human health and environmental effects risk
assessments and made them available to the public on May 6, 2002. Additionally, the Agency
held a Technical Briefing on April 16, 2002. where the results of the revised human health and
environmental effects risk assessments were presented to the general public. This Technical
Briefing concluded Phase 4 of the Public Participation Pilot Process developed by the Tolerance
Reassessment Advisory Committee (TRAC), and initiated Phase 5 of that process. During Phase
5, all interested parties were invited to participate and provide comments and suggestions on
ways the Agency might mitigate the estimated risks presented in the revised risk assessments.
This public participation and comment period commenced on May 6. 2002, and closed on July 5.
Based on its review, EPA has identified risk mitigation measures that the Agency
believes are necessary to address the human health and environmental risks associated with the
current use of atrazine. The EPA is now- publishing its interim decision on the reregistration"
eligibility of and risk management decision for the current uses of atrazine and associated human
health and environmental risks. The reregistration eligibility and tolerance reassessment
decisions for atrazine will be finalized once the cumulative assessment for all of the triazine
herbicides is complete. The enclosed "Interim Reregistration Eligibility Decision for Atrazine"
was approved on January 31. 2003, and contains the Agency's decision on the individual
chemical atrazine.
The Agency is aware that several pertinent studies are being performed at this time by
2002.
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researchers that may reduce some of the uncertainties in understanding potential atrazine effects
on amphibian endocrinology and reproductive and developmental responses. The Agency has
committed to provide these studies along with other available studies, a summary of the available
data and methodologies and various data analyses for an external scientific review by the Federal
insecticide, Fungicide and Rodenticide Act (FIFRA) Science Advisory Panel (SAP) at a public
meeting which is scheduled for June. 2003. The Agency anticipates that the results from this
SAP meeting will provide significant input to enable it publish an amendment to this IRED in
October 2003 which will address the issue of the potential effects of atrazine on amphibian
endocrinology and development.
A Notice of Availability for this Interim Reregistration Eligibility Decision (interim
RED) is being published in the Federal Register. To obtain a copy of the interim RED
document, please contact the OPP Public Regulatory Docket (7502C), US EPA. Ariel Rios
Building, 1200 Pennsylvania Avenue NW, Washington. DC 20460, telephone (703) 305-5805.
Electronic copies of the interim RED and all supporting documents are available on the Internet.
See http:www.epa.gov/pesticides.
The interim RED is based on the updated technical information found in the atrazine
public docket. The docket includes background information and comments on the Agency's
preliminary risk assessments, the Agency's April 2002 revised risk assessments for atrazine. and
a document summarizing the Agency's Response to Comments. The Response to Comments
document addresses corrections to the preliminary risk assessments submitted by chemical
registrants and responds to comments submitted by the general public and stakeholders during
the comment period on the risk assessment. The docket also includes comments on the revised
risk assessment, and any risk mitigation proposals submitted during Phase 5. For atrazine. a
proposal was submitted by Syngenta Crop Protection, Inc. (Syngenta), a technical registrant.
Comments on mitigation or mitigation suggestions were submitted by growers, agricultural
extension agents, environmental organizations, university scientists, and various other
organizations.
This document and the process used to develop it are the result of a pilot process to
facilitate greater public involvement and participation in the reregistration and/or tolerance
reassessment decisions for pesticides. As part of die Agency's effort to involve the public in the
implementation of the Food Quality Protection Act of 1996 (FQPA), the Agency is undertaking a
special effort to maintain open public dockets on pesticides and to engage the public in the
reregistration and tolerance reassessment processes for these chemicals. This open process
follows the guidance developed by TRAC, a large multi-stakeholder advisor)' body that advised
the Agency on implementing the new provisions of the FQPA. The reregistration and tolerance
reassessment reviews for atrazine are following this new process.
Please note that the atrazine risk assessment and the attached interim RED concern only
4
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this particular triazine. This interim RED presents the Agency's conclusions on the dietary and
residential risks posed by exposure to atrazine alone. The Agency has also concluded its
assessment of the ecological risk, with die exception of the potential atrazine effects on
amphibian endocrinology and reproductive and developmental responses, and worker risks
associated with the use of atrazine. Because the FQP.A directs the Agency to consider available
information on cumulative risk from substances sharing a common mechanism of toxicity, such
as the toxicity expressed by the triazine herbicides through a common biochemical mechanism,
the Agency will evaluate the cumulative risk posed by the entire triazine class of chemicals after
considering the risks for the individual triazines. The Agency is working towards completion of
a methodology to assess cumulative risk and the individual risk assessments for each triazine are
likely to be necessary elements of any cumulative assessment. The Agency has decided to move
forward with individual assessments and to identify mitigation measures necessary to address
those human health and environmental risks associated with the current uses of atrazine. The
Agency will issue the final tolerance reassessment decision for atrazine and finalize decisions on
reregistration eligibility once the cumulative risks for all of the triazines are considered.
This document contains a generic and/or a product-specific Data Call-In(s) (DC1) that
outline(s) further data requirements for this chemical. Note that a complete DCI, with all
pertinent instructions, is being sent to registrants under a separate cover. Additionally, for
product-specific DCTs, the first set of required responses is due 90 days from the receipt of the
DCI letter. The second set of required responses is due eight months from the date of the DCI.
The Agency has determined that atrazine is eligible for reregistration provided that all the
conditions identified in this document are satisfied, including implementation of the interim risk
mitigation measures outlined in Section IV of the document. This determination does not include
consideration of the cumulative risk from the use of the triazines. The Agency believes that
certain current uses of atrazine pose unreasonable adverse effects to human health and the
environment, and that such effects can be mitigated with the risk mitigation measures identified
in this interim RED. Accordingly, the Agency recommends that registrants implement these
interim risk mitigation measures immediately. Section V of this interim RED describes labeling
amendments for end-use products and data requirements necessary to implement these interim
mitigation measures. Instructions for registrants on submitting revised labeling and the time
frame established to do so can be found in Section VT of this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency v/iiL undertake appropriate action to address concerns about the risks
posed by atrazine. Where the Agency has identified any unreasonable adverse effect to human
health or the environment, the Agency must take action to address this concern. At that time, any
affected person(s) may challenge the Agency's action.
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If you have questions on this document or the label changes necessary for reregistration,
please contact the Chemical Review Manager, Kimberly Nesci at (703) 308-8059. For questions
about product reregistration and/or the Product DCI that accompanies this document, please
contact Bonnie Adler at (703) 308-8523.
Sincerely,
(J ¦
Lois A. Rossi. Director
Special Review and
Reregistration Division
Attachment
4
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Interim Reregistration Eligibility Decision
for
Atrazine
Case No.
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TABLE OF CONTENTS
Air2zine Team v
Glossary of Terms and Abbreviations vii
Executive Summary 1
I. Introduction 7
II. Chemical Overview 9
A. Regulatory History 9
B. Chemical Identification 11
C. Use Profile 12
D. Estimated Usage of Pesticide 13
III. Summary of Atrazine Risk Assessments 15
A. Human Health Risk Assessment 15
1. Dietary Risk From Food 16
a. Toxicity and Carcinogenicity 16
1) Atrazine and the Chlorinated Metabolites .... 16
2) Hydroxyatrazine 17
b. FQPA Safety Factor 17
1) Atrazine and the Chlorinated Metabolites 17
2) Hydroxyatrazine 18
c. Population Adjusted Dose : 19
d. Exposure Assumptions 20
e. Food Risk Characterization 20
1) Atrazine and Its Chlorinated Metabolites 21
2) Hydroxyatrazine 21
2. Dietary Risk from Drinking Water 21
a. Drinking Water Levels of Comparison (DWLOC) 22
1) Community Water Systems (CWS) Using Surface
Water 23
2) Groundwater 25
3) Domestic Rural Wells 26
2. Residential Risk 26
a. Toxicity 27
b. Exposure Assumptions 28
c. Residential Applicator Risk 29
d. Post-Application Residential Risk 30
3. Aggregate Risk 32
a. Acute Aggregate Exposure and Risk Estimates 32
l
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33
n
j.i
o -»
34
35
36
36
38
39
39
50
52
52
53
53
56
57
58
60
61
61
63
65
69
69
70
70
71
72
73
75
75
76
78
78
78
79
84
84
85
b. Intermediate-Term and Chronic Aggregate Exposure and
Risk Estimates
c. Short-Term Aggregate Exposure and Risk Estimates . . .
1) Adult Handlers
2) Adult Post-Application
3) Child Post-Application
4. Occupational Risk
a. Toxicity
b. Occupational Exposure
c. Occupational Handler Risk Summary
1) Agricultural Handler Risk
2) Lawn Care Operator Handler Risk
3) Post-Application Occupational Risk
4) Epidemiology Data
Environmental Risk Assessment
1. Environmental Fate and Transport
2. Risk to Terrestrial Organisms
a. Toxicity (Hazard) Assessment
b. Exposure and Risk - Birds and Mammals
c. Exposure and Risk - Terrestrial Plants
3. Risk to Aquatic Species
a. Toxicity (Hazard) Assessment
b. Exposure and Risk
5. Refined Aquatic Assessment
a. Ponds
b. Lakes and Reservoirs
c. Streams
d. Estuaries
6. Risk to Endangered Species
7. Ecological Incident Reports
8. Endocrine Disruption
Interim Risk Management and Reregistration Decision
Determination of Interim Reregistration Eligibility
Summary of Phase 5 Comments and Responses
Regulatory Position
1. FQPA Assessment
a. "Risk Cup" Determination
b. Tolerance Summary
3. Codex Harmonization
4. Endocrine Disruptor Effects
5. Labels
li
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a. Agricultural Use Exposure Reduction Measures 85
1) Mixing/Loading Scenarios: 86
2) Applicator and Flagger Scenarios: 86
b. Non-Agricultural Use Exposure Reduction Measures 87
1) Non-Agricultural Products including Lawns and
Turf (not Sod Farms) 87
2) Residential 87
c. Label Harmonization . . 87
D. Regulator} Rationale 89
1. Human Health Risk Mitigation 89
a. Dietary (Food) 89
b. Dietary (Drinking Water) 89
1) Community Water Systems (CWS) 89
2) Rural Drinking Water Wells 92
b. Residential Risk Mitigation 93
1) Residential Handler Risk 93
2) Residential Post-Application Risk 93
c- Aggregate Risk Mitigation 93
1) Acute Exposure 94
2) Intermediate-Term and Chronic Exposure .... 94
3) Short-Term Aggregate Exposure 94
d. Occupational Risk Mitigation 95
1) Mixing/Loading Scenarios 96
2) Applicator and Flagger Scenarios 96
3. Non-Agricultural Products including Lawns and Turf (not Sod Farms) 97
2. Environmental Risk Mitigation 98
3. Other Labeling 9S
a. Endangered Species Statement 99
b. Spray Drift Management 99
V. What Registrants Need to Do 100
A. Manufacturing Use Products 100
1. Additional Generic Data Requirements 100
2. Labeling for Manufacturing Use Products 102
B. End-Use Products 102
1. Additional Product-Specific Data Requirements 102
2. Labeling for End-Use Products 102
C. Existing Stocks 102
D. Labeling Changes Summary Table 103
iii
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Appendix A: ATRAZ1NE USE PATTERNS ELIGIBLE FOR
RE REGISTRATION 127
Appendix B: STUDIES USED TO SUPPORT THE REREGISTRATION OF
ATRAZINE 153
Appendix C: TECHNICAL SUPPORT DOCUMENTS m
Appendix D: CITATIONS CONSIDERED TO BE PART OF THE DATA BASE
SUPPORTING THE INTERIM REREGISTRATION DECISION
(BIBLIOGRAPHY) 173
Appendix E: PRODUCT SPECIFIC DATA CALL-IN AND A LIST OF
REGISTRANTS SENT TUTS DCI 265
Appendix G: EPA'S BATCHING OF ATRAZINE PRODUCTS FOR MEETING
ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION 275
Appendix H: ATRAZINE MONITORED WATERSHEDS 285
Appendix I: LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS 287
IV
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Atrazine Team
Office of Pesticide Programs:
Health Effects Risk Assessment
Gan? Bangs
Vicki Dellarco
Catherine Eiden
Ar.ensie Flowers
I .inda Taylor
Environmental Fate Risk Assessment
Tim Bargar
Kevin Costello
Marjr Frankenberry
James Lin
William Rabert
Thomas Siceger
Douglas Urban
Use and Usage Analysis
Neil Anderson
Nicole Mosz
Steve Smearmari
Philip Villnnueva
Virginia Werling
Registration Support
Philip Errico
Edith Minor
Jim Tompkins
Risk Management
Mark Hartrnan
Kimberly Nesci
v
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Intentionally Blank Page
vi
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Glossary of Terms and Abbreviations
ah
2..1.
A GDC I
ai
aPAD
AR
ARC
BCF
CAS
CI
CNS
cPAD
CSF
CFR
CSFII
DCT
DEEM
DFR
DRES
DWEL
DWLOC
EC
EEC
F,P
EPA
FAO
FDA
FIFRA
FFDCA
FQPA
FOB
G
GENEEC
GLC
GLN
GM
GRAS
Acid Equivalent
Active ingredient
Agricultural Data Call-in
Active Ingredient
Acute Population Adjusted Dose
Anticipated Residue
Anticipated Residue Contribution
Bioconcentration Factor
Chemical Abstracts Service
Cation
Central Nervous System
Chronic Population Adjusted Dose
Confidential Statement of Formula
Code of Federal Regulations
USD A Continuing Surveys for Food Intake by Individuals
Data Call-in
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
Drinking Water Equivalent Level (DWF,T,) The DWEL represents a medium
specific (i.e., drinking water) lifetime exposure at which adverse, noncarcinogenic
health effects are not anticipated to occur.
Drinking Water Level of Comparison.
Emulsifiable Concentrate Formulation
Estimated Environmental Concentration. The estimated pesticide concentration in
an environment, such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Agriculture Organization
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Functional Observation Battery
Granular Formulation
Tier I Surface Water Computer Model
Gas Liquid Chromatography
Guideline Number
Geometric Mean
Generally'Recognized as Safe as Designated by FDA
vii
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HA
11 AFT
HDT
IR
LC,(i
LD
50
LEL
LOC
LOD
LOAEL
MAT'C
MCLG
mg/kg/day
mg/I.
MOE
MP
MPI
MRID
NA
N/A
NAWQA
NOEC
NOEL
NOAEL
NPDES
NR
OP
OPP
OPPTS
Pa
PAD
PADI
Health Advisory (HA). The HA values are used as informal guidance to
municipalities and other organizations when emergency spills or contamination
situations occur.
Highest Average Field Trial
Highest Dose Tested
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.
Lowest Effect Level
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
.Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal. The MCLG is used by the Agency to
regulate contaminants in drinking water under the Safe Drinking Water Act.
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
Manufacturing-Usc Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
Not Applicable
Not Applicable
USGS National Water Quality Assessment
No Observable Effect Concentration
No Observed Effect Level
No Observed Adverse Effect Level
National Pollutant Discharge Elimination System
Not Required
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention. Pesticides and Toxic Substances
Pascal, the pressure exerted by a force of one newton acting on an area of one
square meter.
Population Adjusted Dose
Provisional Acceptable Daily Intake
VI11
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PAG
Pesticide Assessment Guideline
PAM
Pesticide Analytical Method
PCA
Percent Crop Area
PCO
Pest Control Operator
FDP
USDA Pesticide Data Program
PHED
Pesticide Handler's Exposure Data
PHI
Preharvcst Interval
Ppb
Parts Per Billion
PPE
Personal Protective Equipment
ppm ¦
Parts Per Million
PRN
Pesticide Registration Notice
PRZM./
EXAMS
Tier 11 Surface Water Computer Model
Qi*
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RAC
Raw Agriculture Commodity
RBC
Red Blood Cell
RED
Reregistration Eligibility Decision
REI
Restricted Entry Interval
RID
Reference Dose
RQ
Risk Quotient
RS
Registration Standard
RHP
Restricted Use Pesticide
SAP
Science Advisory Panel
SCT-GROW
Tier I Ground Water Computer Model
sr
Safety Factor
SLC
Single Layer Clothing
SLN
Special Local Need (Registrations Under Section 24(c) of FIFRA)
TC
Toxic Concentration. The concentration at which a substance produces a toxic
effect.
TD
Toxic Dose. The dose al which a substance produces a toxic effect.
TEP
Typical End-Use Product
j'GAI
Technical Grade Active Ingredient
TLC
Thin Layer Chromatography
TMRC
Theoretical Maximum Residue Contribution
torr
A unit of pressure needed to support a column of mercury 1 mm high under
standard conditions.
TRR
Total Radioactive Residue
LJF
Uncertainty Factor
jig/g
Micrograms Per Gram
fig/L
Micrograms Per Liter
USDA
United States Department of Agriculture
USGS
United States Geological Survey
IX
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UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
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Executive Summary
EPA has completed ils review of public comments concerning the revised atrazine risk
assessments and is issuing its interim risk management decision for atrazine. The revised risk
assessments arc based on the Agency's review of available data on the currently registered uses
of atrazine and public comments received during the reregistration process. The Agency invited
stakeholders to provide proposals, ideas or suggestions on appropriate mitigation measures
before the Agency issued its risk mitigation decision for atrazine. After considering the risks
identified, public comments, and mitigation options proposed by several entities, the Agency
developed its interim risk management decision for atrazine. This decision is discussed fully in
this document and in a January 31, 2003. Memorandum of Agreement between the Agency and
the primary technical registrant, Syngenta Crop Protection, Inc. The Agency expects the atrazine
technical registrants to agree to adopt the risk management measures presented in the IRED and
in the MOA. Neither the risk assessments nor the interim risk management measures include
consideration of cumulative risks posed by all of the triazines and amphibian risk issues.
Atrazine is a triazine herbicide currently registered for use against broadleaf and some
grassy weeds. Atrazine is currently registered for use on corn (field and sweet); guavas;
macadamia nuts; sorghum; sugarcane; range grasses for the establishment of permanent grass
cover on rangeiands and pastures under USDA's Conservation Reserve Program (CRP) in OK,
NE, TX, and OR; wheat (where application is to wheat stubble on fallow land following wheat
harvests; wheat is not the target crop); conifer forests; Christmas tree farms; sod farms; golf
courses and residential lawns (Southern turfgrasses). Given the specific nature of the lawn uses,
much of atrazine's use on lawns is confined to Florida and the Southeast. Atrazine degrades into
hydroxy compounds and chlorotriazine degradates. Atrazine was first registered in 1958 as an
herbicide. Use data from 1990 to 1997 indicate that approximately 76.5 million pounds of
atrazine active ingredient are used domestically each year.
The Food Quality- Protection Act of 1996 (FQPA) requires that, when considering
whether to establish, modify, or revoke a tolerance, 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 with other pesticides. The Agency has classified the
triazine herbicides (atrazine, simazine, and propazine) and their common chlorinated degradates
as having a common mechanism of toxicity. The Agency has not yet completed its cumulative
risk assessment for the triazine class, but the cumulative risks of these chemicals will be
considered in the future. At that time, the Agency's final tolerance reassessment decision for
atrazine and the other triazines will be issued. The Agency may need to pursue further risk
mitigation for atrazine to address any risks identified in the cumulative assessment for the
triazines.
1
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Overall Risk Summary
The Agency's human health risk and ecological risk assessments Tor atrazine indicate
risks of concern. Intermediate-term (seasonal) dietary risk from drinking water exceeds the
Agency's level of concern (>100% cPAD) at the 99.9th exposure percentile for infants, children
1-6 years of age. and adults in 34 community water systems (CWS) primarily in the Midwest.
Acute dietary drinking water risks, and acute and chronic dietary food risks (alone) arc below the
Agency's level of concern for the U.S. population and all population subgroups.
Further, there are some concerns for workers who mix, load and apply atrazine to
agricultural and turf sites and for homeowners who apply atrazine products to home lawns. In
addition, there are risks of concern for adults and children exposed to atrazine treated lawns after
applications.
For ecological effects, the Agency has conducted a screening level assessment for
terrestrial impacts and a refined exposure assessment for aquatic impacts of atrazine use. These
assessments indicate that atrazine is likely to result in community- and population-level risk at 10
to 20 ppb. The ecological assessment does not address the potential for effects on amphibians
endocrinology and reproductive and developmental responses. The Agency will consider
amphibian risk after the Agency obtains further data and will address any risks identified in a
revision to the IRED to be published by October 31, 2003.
To mitigate risks of concern posed by the uses of atrazine, the Agency considered the
mitigation proposal submitted by the technical registrants, as well as comments and mitigation
ideas from other interested parties, and has decided on a number of label amendments to address
the dietary (drinking water), worker, and residential concerns. In addition, to further address
drinking water concerns and to address ecological concerns, the Agency and the technical
registrants have agreed to a performance standard for atrazine that must be met. in community
water systems, prohibition of use in watersheds if the standard is not met, and monitoring data
requirements as described in the Memorandum of Agreement. Results of the risk assessments,
the necessary label amendments to mitigate those risks, and information on the Agreement
between the Agency and the technical registrants are presented in this IRED.
Dietary Risk (Food)
Acute risk estimates for food and drinking water and chronic food risk estimates do not
exceed the Agency's level of concern; therefore, mitigation measures are not needed to address
acute dietary risks or chronic food risk estimates.
Dietary Risk (Drinking Water)
Intermediate-term (seasonal) drinking water risk estimates do exceed the Agency's level
of concern in 34 CWS primarily in the Midwest. The registrant has added three CWS to these 34
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io make a total oi'37 CWS thai are of concern. To mitigate these risks, the Agencv has
determined thai a performance standard thai must be met in these CWS and prohibiting use in the
watershed if the performance standard is not met is necessary to avoid unreasonable adverse
effects. In addition, the Agency is requiring extensive monitoring data on these CWS and other
CWS that are in atrazine use areas.
To confirm that risks from atrazine in rural wells is not a concern, the Agency is requiring
monitoring data for atrazine levels in rural wells in atrazine use areas.
Residential Risk
Residential and turf use results in risks of concern for children reentering treated atrazine
turf and for homeowners applying product to turf using a bellygrinder.
Restrict the application of granular lawn products when using hand-held devices (e.g. belly
grinder) to spot applications only.
Prohibit applications of granular lawn products by hand
Reduce the maximum single application rate for liquid formulations on residential lawns
and turf to 1 lb ai/A from 2 lb ai/A (liquid products containing >4% ai are restricted use)
Require that granuiar!awn products be watered in
Occupational Risk
Occupational exposure to atrazine is of concern to the Agency. For agricultural and turf
lawn care operator uses of atrazine. several mixer/loader/applicator risk scenarios currently
exceed the Agency's level of concern at baseline PPE or label PPE. The Agency has determined
that a number of measures are needed to mitigate these risks, as follows:
Agricultiirat Uses
1) Mixing/Loading Scenarios:
Liquids:
require closed systems for mixing/loading to support aerial applications at
greater than 3 lb ai/A
all mixers/loaders (including using engineering controls) must wear long-
sleeve shirt, long pants, shoes, socks, chemical-resistant gloves and
chemical resistant apron
Wettable Powders:
require water-soluble packaging for all WP formulations
ail mixers/loaders must wear long-sleeve shirt, long pants, shoes, socks,
chemical-resistant gloves and chemical resistant apron
Dry Flowabies:
water-soluble packaging optional
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if in water-soluble packaging, all mixcrs/loadcrs must wear long-sleeve
shirt, long pants, shoes, socks, chemical-resistant gloves and chemical
resistant apron
if not in water-soluble packaging, mixers/loaders must wear coveralls over
long-sleeve shirt and long pants, chemical-resistant gloves, chemical-
resistant footwear, and chemical-resistant apron plus a NIOSH-approved
dust/mist filtering respirator with any N, R, P, or HE filter.
if not in water-soluble packaging, aerial application is prohibited.
Granular Products:
Loaders must wear long-sleeve shirt, long pants, shoes, and socks.
2) Applicator and Flaggcr Scenarios:
Pilots must use enclosed cockpits (40 CFR 170.240(d)(6)) for aerial applications.
Human flaggers supporting aerial applications must used enclosed cabs (40 CFR
170.240(d)(5)).
Applicators applying sprays with motorized ground equipment (i.e., groundboom
or rights-of-way sprayers) must wear long-sleeve shirt, long pants, shoes, socks,
and chemical-resistant gloves.
Applicators applying granular products or impregnated fertilizer must wrear long-
sleeve shirt, long pants, shoes, and socks.
Restrict the impregnation of bulk fertilizer to commercial facilities (prohibit on-
farm impregnation)
Restrict the impregnation of dry bulk fertilizer to 500 tons per day for no more
than 30 days per calender year per facility
Reduce the maximum application rate for handlers applying liquids with rights-of-
way sprayers to 1.0 lb ai/A
Reduce the maximum application rate for liquids for chemical follow to 2.25 lb
ai/A
Require a 60-day PI II for field corn forage uses
Require a 45-day PHI for sweet com forage uses
Require a 60-day PHI for preemergent uses and a 45-day PIII for postemergent
sorghum forage uses
Non-Agricultural Products including Law ns and Turf (not Sod Farms)
Require that all wettable powder products be packaged in water soluble bags.
Granular formulations: loaders, applicators, and other handlers must wear long-
sleeve shirt, long pants, shoes, and socks.
Liquid, wettable powder, dry llowable (water-dispersible granule) formulations:
applicators using spray equipment mounted on their backs must wear coveralls
worn over long sleeved shirt and long pants, chemical-resistant gloves and
chemical-resistant footwear plus socks.
all other mixers, loaders, applicators, and other handlers must wear long-sleeved
4
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shirt and long pants, shoes and socks, and chemical resistant gloves.
Reduce the maximum single application rate for liquid formulations on residential lawns
and turf to 1 lb ai/A from 2 lb ai/A (liquid products containing >4% ai are restricted use)
Require that granular lawn products be watered in
The Agency does not have risks of concern for workers reentering treated fields;
therefore, no mitigation is needed.
Ecological Risk
Ecological risks are also of concern to the Agency. The environmental risk assessment
suggests that exposure to atrazine could result in community-level and population-level effects in
aquatic communities at concentrations of 10-20 ppb atrazine.
To address these risks, the Agency has determined that an ecological assessment process
to identify v/aterbodies at risk and monitor these waterbodies for atrazine concentrations. In
addition, it may be necessary lo undertake mitigation in these vulnerable ecosystems. The
specifics of this ecological program will be negotiated with the technical registrants and agreed to
by April 30.2003.
The ecological assessment docs not address the potential for effects on amphibian
endocrinology and reproductive and developmental responses. The Agency will consider
amphibian risk after the Agency obtains further data on this issue. Any risks identified will be
addressed by the Agency in a revision to the IRED to be published by October 31, 2003.
Conclusions
The Agency is issuing this interim Reregistration Eligibility Decision (IRED) for atrazine.
as announced in a Notice of Availability published in the Federal Register. This IRED includes
guidance and time frames for implementing label changes for products containing atrazine. Note
that the Agency has shortened the time period for implementation of risk mitigation measures
outlined in this document and to establish monitoring programs so that the risks identified herein
are addressed as quickly as possible. There is a 60-day comment period on this document. With
the mitigation measures detailed in this document, the Agency has determined that, until the
cumulative risks from all the triazines has been considered, most of the currently registered uses
of atrazine may continue. Neither the tolerance reassessment nor the reregistration eligibility
decision for atrazine can be considered final until the cumulative risk for all triazines is
considered.
5
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Intentionally Blank Page
6
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I. Introduction
The Federal Insecticide. Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products containing active ingredients originally 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 (EPA or "the Agency"). Reregistration involves a
thorough review of the scientific database supporting a pesticide's registration. The purpose of
the Agency's review is to reassess the potential hazards and benefits arising from the currently
registered uses of the pesticide; to determine if there is a need for additional data on benefits,
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 the Federal Food. Drug and Cosmetics Act (FFDCA) to require
reassessment of all existing tolerances. The Agency had decided that, for those chemicals that
have tolerances and are undergoing reregistration, the tolerance reassessment will be initiated
through this reregistration process. It also requires that by 2006, EPA must review all tolerances
in effect as of August 2, 1996 (the day before FQPA was enacted). FQPA also amends the
FFDCA to require a safety finding in tolerance reassessment based on several factors, including
an assessment of cumulative effects of chemicals with a common mechanism of toxicity.
Atrazine belongs to a group of systemic herbicides called triazincs that share a common
mechanism of toxicity. Agency is continuing its reregistration program while it resolves the
remaining issues associated with the implementation of FQPA.
This document presents the Agency's revised human health and ecological risk
assessments; its progress toward tolerance reassessment; and the interim decision on the
reregistration eligibility of atrazine. It is intended to be only the first phase in the reregistration
process for atrazine. The Agency will eventually proceed with its assessment of the cumulative
risk of the triazine pesticides and issue a final reregis tration eligibility decision for atrazine.
The implementation of FQPA has required the Agency to revisit some of its existing
views relating to the determination and regulation of dietary risk, and has also raised a number of
new issues that need to be addressed. These issues were refmed and developed through
collaboration between the Agency and the Tolerance Reassessment Advisory Committee
(TRAC), a committee that was composed of representatives from industry, environmental
groups, and other interested parties.
This interim Reregistration Eligibility Decision 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 resulting from public
comments and other information. Section IV presents the Agency's interim decision on
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reregistration eligibility and risk management decisions. Section V summarizes the label
changes necessary to implement the risk mitigation measures outlined in Section IV. Section VI
provides information on how to access related documents. Finally, the Appendices list Data
Call-In (DC!) information. The revised risk assessments and related addenda are not included in
this document, but are available on the Agency's web page:
"www.epa.gov/pesticides/reregistration,"" and in the Public Docket.
8
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II. Chemical Overview
A. Regulatory History
Atrazine was first registered in 1958 as an herbicide. On November 10. 1983. a '
Registration Standard for atrazine was issued. This document noted the Agency's concern about
the dietary carcinogenic risk from ground and surface water contamination. The Registration
Standard also required the submission of generic and product-specific data to support the
continued registration of atrazine products. Since the Registration Standard was issued in 1983,
there have been a total of 4 DCIs issued (September 1990, September 1992. March 1995,
October 1995).
In 1988, EPA issued a preliminary notification of the Agency's intention to initiate
Special Review under FIFRA based on concerns regarding the carcinogenic potential of atrazine
and possible risks resulting from exposure to atrazine in the diet from treated food and drinking
water.
In the early 1990s, atrazine's occurrence in the environment prompted the Environmental
Protection Agency's Office of Water (OW) to regulate atrazine under the Sale Drinking Water
Act (SDWA). In 1991 OW established a Maximum Contaminant Level (MCL) of 3 parts per
billion (ppb) for atrazine. Under the SDWA, atrazine has been subject to compliance
monitoring. OW has also established a one-day Health Advisory Level (HAL) for atrazine of
100 ppb.
In the early 1990s, the registrant voluntarily instituted several risk reduction measures to
address concerns raised about surface water and groundwater contamination by atrazine. In
1990, the following measures were undertaken by the registrant to address groundwater exposure
concerns:
Reduction of the application rate for corn and sorghum to 3.0 lbs ai/acre from 4.0
lbs ai/acre.
Reduction of the maximum rate for non-cropland and total vegetation control to
10 lbs ai/acre from 40 lbs ai/acre.
Require that postemergence applications to corn and sorghum be made before
they reach 12 inches in height.
¦ Deletion of rangeland, proso millet, and pineapple uses.
Prohibition of chemigation (applying atrazine through irrigation systems).
Institution of a well-head protection plan requiring 50 foot setbacks around all
wells for mixing, loading, or applying atrazine-containing products.
Institution of construction requirements for bulk storage facilities to prevent point
source contamination from spills
Classification of all atrazine-containing products (except for the lawn care, turf,
and conifer uses) as Restricted Use Pesticides (RUPs).
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In 1992, the following additional measures were undertaken to address concerns about
atrazine contamination of surface water sources:
Further reduction of the total seasonal application rates for corn and sorghum to
2.5 lbs ai/acre per year. This rate includes a 1.5 lbs ai/acre per year pre-cmergence
use and a 1.0 lbs ai/acre per year post-emergence use.
Deletion of all uses for total vegetation control in non-cropland.
Expansion of restricted use criteria to include surface water concerns.
Expansion of the setback requirements, including: a 50 foot setback around
surface water sources when workers are mixing and loading atrazine-containing
products; a 66 foot application (ground and aerial) setback from points of entry
where field surface water runoff enters surface water sources; and. a 200 foot
application setback around lakes and reservoirs.
In November 1994, EPA initiated a Special Review for the triazine pesticides (atrazine,
simazine and cyanazine; 59 FR 60412) based on cancer risk concerns for people potentially
exposed to atrazine through consumption of food and drinking water, and lawn treatments. The
basis for the Special Review also included cancer risk concerns for workers exposed to atrazine
in various agricultural settings and application scenarios. At the time that the Special Review-
was initiated, atrazine and the other triazines were classified as Group C carcinogens (possible
human carcinogens).
Further labeled use restrictions in 1996 reduced environmental exposure from tile-
terraced fields containing standpipes, as follows:
Restrictions against application within 66 feet of standpipes.
A requirement that applications be incorporated to a depth of 2 to 3 inches.
Restrictions against application to no-till fields unless practicing high crop residue
management.
In August 2002, the Agency and NRDC! jointly agreed to request that the court extend the
deadline for the IRED to January 31, 2003 (Consent Decree (as amended) entered in Natural
Resources Defense Council v. Whitman. Case Number C -99-3701 CAT., N. D. California
(2002)). The new schedule includes the completion of an IRED by January 31. 2003 (this _
document), and a revised IRED by October 31. 2003, to consider a number of additional new
studies on potential amphibian risk. The Agency also agreed to bring to the FIFRA Scientific
Advisory Panel issues regarding amphibian effects and carcinogenicity.
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B. Chemical Identification
Chemical Structure:
C-UCH
' CH-
Common name:
Chemical name:
Chemical family:
Case number:
Atrazine
6-chloro-N2-ethyl-N4-isopropyl-1.3,5-tria7,ine-2,4-
di amine
Triazines
0062
CAS registry number: 1912-24-9
OPP chemical code:
Empirical formula:
Molecular weight:
Vapor Pressure:
Technical registrants:
080803
CH;jC1N5
215.7
40 zvPa at 20 °C
Agan Chemical Manufacturing. LTD.
Dow AgroSciences
Drexel Chemical Company
Oxon Italia S.P.A.
Platte Chemical Company Inc.
Syngenta Crop Protection Inc.
Atrazine is a white crystalline solid with a melting point of 172-175° C, density of 0.35
g/'mL, octanol/watcr partition coefficient (log Pov) of 2.7645. and vapor pressure of 40 uPa at 20c
C. Atrazine is moderately soluble in water (33 ppm at 25c C), and is soluble in octanol (0.82
g/100 mL). ether (0.86 g/100 mL). methanol (1.4 g/100 ml), ethyl acetate (2.5 g/100 ml ). and
chloroform (7.8 g/100 mL) at 20° C. Atrazine has four hydroxyatrazine compounds and three
chlorinated atrazine compounds as metabolites. The three chlorinated metabolites are
desethylated atrazine. desisopropyl alrazine, and diaminochlorotriazine (DACT).
11
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C. Use Profile
Atrazine is a systemic triazine herbicide registered for the control of broadleaf weeds and
some grassy weeds. Currently, atrazine is one of the two most widely used agricultural pesticides
in the United States. An estimated average of approximately 64 to 76 million pounds of active
ingredient are applied per year. Annually, 75% of all field corn, 58.5% of all sorghum, and 76%
of all sugarcane grown are treated with atrazine. Most of atrazine applied to corn and sorghum is
applied pre-emergence. The following information is based on the currently registered uses of
atrazine that were originally being supported for reregistration. Appendix A at the end of this
document presents a summary of eligible uses and revised use conditions.
Type of Pesticide: Triazine Herbicide
Summary of Use Sites:
Food: Atrazine is used on corn (field and sweet), guavas, macadamia nuts,
sorghum, sugarcane, range grasses under USDA's Conservation Reserve Program
(CRP), and wheat (where application is to wheat stubble on fallow land following
wheat harvests; wheat is not the target crop)
Other Agricultural Sites: Atrazine is also used in conifer forests, on Christmas tree
farms and on sod farms.
Residential: Atrazine is used on golf courses and residential lawns. Given the
specific nature of the lawn uses, much of atrazine's use on lawns is confined to
Florida and the Southeast.
Other Sites: Atrazine in used on range grasses for the establishment of permanent
grass cover on rangelands and pastures under the Conservation Reserve Program
(CRP) in four states: OK, NE, TX, and OR.
Public Health: None
Targct Pests: Broadleaf and some grassy weeds.
Formulation Types Registered:
Formulated as a flowable concentrate, a water dispensable granular (dry flowable).
a ready-to-use product, and a granular.
Method and Rates of Application:
Equipment: Atrazine may be applied by groundboom sprayer, aircraft.
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tractor-drawn spreader, rights-of-way sprayer, low pressure handwand,
backpack sprayer, lawn handgun, push-type spreader, and bellvgrinder.
Rates: Maximum application rates range from 0.4 lb ai/A or lb ai/gal to
4.0 lb ai/A or lb ai/gal (conifer forests, sugarcane, Christmas tree farms,
sod farms (FL), Bermuda grass highway rights-of-way). The number of
maximum allowable applications ranges between 1 and 4 per season or
year, when specified.
Timing:
Sugarcane: Applications to sugarcane are usually at planting (fall), in the spring
after emergence, and an additional post-emergence application (often at layby
(canopy closure)). However, these later applications are only used if pest pressure
dictates need. Also, raloon crops may face heavier weed pressure, and therefore
additional applications are more likely during ratoon crops.
Com: Applications to com are most often pre-emergence (mid-April through
mid-May in the major corn growing areas). Post-emergence applications arc most
likely to occur up to the end of June, until com reaches 12" in height. There will
be some variability in timing based on geographical regions.
Sorghum: Applications to corn are most often pre-emergence (mid-June to mid-
July in the major sorghum growing areas). Post-emergence applications are most
likely to occur up to the end of August. There will be some variability in timing
based on geographical regions.
Use Classification: Most atrazine products are restricted use pesticides.
D. Estimated Usage of Pesticide
This section summarizes the best estimates of available pesticide usage information for
atrazine from 1990 to 1997. A full listing of all uses of atrazine, with the corresponding use and
usage data for each site, has been completed and is in the January 10, 2001 "Quantitative Usage
Analysis for Atrazine" document available in the public docket and on the internet. The data,
reported on an aggregate and site basis, reflect annual fluctuations in use patterns as well as the
variability in using data from various information sources.
Estimates for total annual domestic use of atrazine averages approximately 76.5 million
pounds of active ingredient. Crops with the highest weighted average percent crop treated are
com (75%). sugarcane (76%), sorghum (58.5%), sweet corn (processed) (58%) and sweet com
(fresh) (49%). In terms of pounds applied, corn (83%), sorghum (10%), and sugarcane (3%)
account for the greatest use. Less than 2% of atrazine is believed to be applied in forestry, turf or
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other non-agricultural uses.
Tahle 1. Atrazinc Estimated Usage for Representative Sites
Crop
Pounds Arrive
Ingredient Applied
(000) (Wl. Ave.)'
Estimated
Maximum %
Crop Treared
Weighted Average
Percent Crop
Treated
Food Crops
Sweet Com, Fresh
160
59.9
49.5
Sweet Com, Processed
250
64.6
58.2
Sorghum
7,790
73.7
58.5
Com
63.800
84.0
75.0
Winter Wheat
300
1.1
0.6
Sugar Cane
2550
95
76.0
Non-Food Crops
Hay
150
0.7
0.4
Pasture
46
0.1
0.0
Summer Fallow
8
0.1
0.1
Woody Ornamentals
140
na
na
Forestry
48
na
na
Turf - Lawn Care Operators
600
na
na
Sod
160
na
na
Golf Courses
78
na
na
1 Weighted Average is based on data for 1990-1997; the most recent years and more reliable data are weighted more
heavily. Based on USDA/NASS and EPA proprietary data.
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111. Summary of Atrazine Risk Assessments
The following is a summary of F.PA's revised human health and ecological risk findings
and conclusions for the triazine herbicide atrazine. These findings and conclusions are fully
presented in the following documents, available on EPA's web page at www.epa.gov/pesticides
and in the public docket:
Reregistration Eligibility Science Chapter for Atrazine - Environmental Fate and
Effects Chapter (April 22. 2002);
Atrazine: HED's Revised Human Health Risk Assessment for the Reregistration
Eligibility Decision (April 16, 2002);
Addendum and corrections to Occupational and Residential Exposure Chapter for
Atrazine (May 23, 2002); and
Atrazine: Addendum to Revised Human Health Risk Assessment for the
Reregistration Eligibility Decision (RED) (January 31. 2003).
These risk assessments for atrazine were presented at a Technical Briefing held on April
16, 2002, and followed by an opportunity for public comment on risk management. The risk
assessments presented here form the basis of the Agency's risk management decision for atrazine
only; the Agency must consider a cumulative assessment of the risks of all triazine pesticides
before any final decisions can be made.
A. Human Health Risk Assessment
EPA issued its preliminary human health risk assessment for atrazine and its metabolites
on February 14, 2001 (Phase 3 of the TRAC process). In response to comments and studies
submitted during Phase 3, the risk assessment was updated and refined, and released on May 6.
2002. In addition, any new Agency policies were incorporated as appropriate. Major revisions to
the human health risk assessment are listed below:
Revisions to the occupational and residential risk assessments to incorporate more
recent data and information received in the response to comments.
Revisions to the dietary drinking water risk assessment to include additional
monitoring data received from the registrant.
A decision not to require tolerances for hydroxyatrazine.
Exposure scenarios considered in the human health assessment arc acute, intermediate-
term, and chronic dietary exposure through food plus drinking water; short-term residential
exposures from residential applications of atrazine; acute, chronic, and short-term aggregate
exposure from all sources (food, drinking water, and residential); and short and intermediate-
term occupational exposures.
In the risk assessments presented in this document, the toxicity of atrazine and its
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chlorinated metabolites arc considered to be equivalent: therefore, the risks associated with
exposure to atrazine and its chlorinated metabolites arc presented together. The toxicity of the
metabolite hydroxyatrazine is considered to be independent of the effects of atrazine; thus, the
risks from exposure to hydroxyatrazine are presented independently.
1. Dietary Risk From Food
a. Toxicity and Carcinogenicity
1) Atrazine and the Chlorinated Metabolites
The atrazine toxicity database is extensive. The Agency lias reviewed these toxicity
studies and has a liigh degree of confidence in the scientific quality of the toxicity studies
conducted with atrazine. Special studies examining the toxicology of atrazine have been
performed by the registrant in addition to the required guideline studies. Additionally, EPA's
National Health and Environmental Effects Laboratory (NHEERL) has performed studies
investigating atrazine's neuroendocrine mode of action and related reproductive and
developmental effects.
For the purposes of this risk assessment, the toxicity of atrazine's chlorotriazine
metabolites is considered to be equivalent to that of parent atrazine and exposure to those
metabolites may occur. Therefore, the chlorotriazine metabolites are included in the atrazine
human health risk assessment.
In accordance with the 1999 Interim Guidelines for Carcinogen Risk Assessment. EPA's
Cancer Assessment Review Committee (CARC) classified atrazine as "not likely to be
carcinogenic to humans". As summarized by the FIFRA Scientific Panel (SAP), "there are
considerable differences between hypothalamic-pituitarv-ovarian function in rats and humans,
and the effects of aging on the function of the axis also is quite dissimilar. Therefore, it is
unlikely that the mechanism by which atrazine induces mammary gland tumors in female SD rats
could be operational in humans. Nevertheless, it is not unreasonable to expect that atrazine
might cause adverse effects on hypothalamic-pituitary function in humans" (SAP, 2000).
Although the cancer mode of action may not be operative in humans, the SAP further to state that
the same endocrine perturbations that induce tumors also appear to play a role in at least some
reproductive developmental effects (not associated with reproductive aging) which may be
relevant to humans. The Agency also concluded that the cancer mode of action is not relevant to
humans. Consequently, a quantitative cancer risk assessment was not conducted for atrazine.
However, EPA agreed in the August 2002 amendment to the Consent Decree in NRDC v.
W?iitman to present to the SAP data concerning atrazine exposure and prostrate or other cancers
in humans that had been received by EPA after the May 2002 risk assessment but prior to
February 28. 2003. Any risks identified will be addressed in the revised Atrazine IRED to be
issued by October 31, 2003.
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As indicated above, the cascade of events triggered by atrazine leading to mammary gland
tumors in female SD rats are not expected to occur in humans given the species difference in
reproductive aging. However, the potential for disruption of the hypothalamic pituitary axis and
consequent attenuation of the LH surge leading to other health consequences not associated with
reproductive aging (e.g.. delay in pubertal development) can not be dismissed. Thus, EPA has
determined that the triazine pesticides (with a common mechanism group of atrazine, propamine,
simazine and their chlorometaboliies) have common mechanism of suppression of LII surge and
consequent developmental and reproductive effects. It is expected that EPA will complete a
preliminary cumulative risk assessment in the winter of 2005; this is contingent on completion of
the IREDs for the individual chemicals.
2) Hydroxyatrazine
Atrazine is metabolized to hydroxyatrazine by plants and bacteria. Animals do not
metabolize atrazine to hydroxyatrazine; however, they may receive hydroxyatrazine in their diets
through forages and fodders.
A limited toxicology database for hydroxyatrazine compounds is available.
Hydroxyatrazine appears to be less acutely toxic than the parent atrazine. The only effects seen
in any of the submitted studies that may be attributable to a single dose were developmental
alterations in the developmental rat study. The developmental alterations seen in this study were
seen only at the high dose, were few in number, and were deemed to be not of toxicological
significance. Thus, the Agency did not select an acute endpoint for hydroxyatrazine, and
concludes that no toxicologically significant endpoint to represent a single exposure can be found
in the toxicology database for hydroxyatrazine. Hydroxyatrazine has not been classified as to its
carcinogenic potential by the Agency.
Further details on the toxiciLy of atrazine and its chlorinated and hydroxy metabolites can
be found in the April 16, 2002, Revised Human Health Risk Assessment; the January 31. 2002,
Addendum to the Revised Human Health Risk Assessment; and all supporting documents. An
ovemew of the studies and safety factors used for the dietary risk assessment is outlined in Table
2.
b. FQPA Safety Factor
The FQPA safety factor is intended to provide up to an additional 10-fold safety factor
(1 OX) to account for potential pre- and post-natal toxicity and the completeness of the data with
respect to exposure and toxicity to infants and children.
1) Atrazine and the Chlorinated Metabolites
The FQPA Safety Factor of lOx was retained for atrazine and its chlorinated metabolites
to protect the safety" of infants and children in assessing risk from dietary (food and drinking
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water) exposures.
The Agency concluded that, as to dietary risk, the default 10.x FQPA safety factor is
required because of the absence of reliable evidence showing that a different safety factor would
be protective of infants and children. The principal grounds for this conclusion are:
residual concerns for the effects of the neuroendocrine mode of action described for
atrazine on the development of the young. These concerns could not be accounted for in
the determination of toxicity endpoints and traditional uncertainty factors to be used in
risk assessment; and,
residual concerns with regard to the drinking water exposure assessment. The various
water monitoring data sources that exist for atrazine and its chlorinated metabolites
indicate that exposure via drinking water sources is high in some of the systems that have
been monitored. In addition, widespread low levels are commonly detected. Limitations
in the extent, frequency, and compounds tested for in the monitoring data raise significant
uncertainties regarding the level of exposure to atrazine and its metabolites.
The 10X FQPA safety factor is being applied across all aggregate risk assessments based
on estimated dietary exposures for all populations considered in these risk assessments.
For residential exposures, the FQPA safety factor was reduced to 3x. This is considered
adequate to protect the safety of infants and children in assessing residential exposure and risks
because the exposure concerns for drinking water included in the 1 Ox FQPA safety factor for
dietary exposure do not apply to residential exposure scenarios, although the concerns for the
effect of the neuroendocrine mode of action on the development of the young remain. The
assumptions inherent to the Agency's residential risk estimates based on screening-level
procedures are conservative and protective. The 3x FQPA safety factor is being applied across
all aggregate risk assessments based on estimated residential exposures for all populations
considered in these risk assessments.
2) Hydroxyatrazine
The FQPA Safety Factor of 1 Ox was removed for atrazine"s hydroxymetabolites for the
following reasons:
There was no evidence of increased susceptibility in the prenatal developmental toxicity
study in rats with hydroxyatrazine;
There is no evidence of neurotoxicity from the submitted toxicity studies;
The neuroendocrine effects described for atrazine arc postulated to be part of a cancer
mode of action for atrazine. Because hydroxyatrazine is non-carcinogenic, the current
18
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belief is that the neuroendocrine effects described for atrazine are not occurring following
hydroxyatrazine exposure;
The dietary and non-dietary exposure assessments do not underestimate the potential
exposures for infants and children; and
The drinking water exposure concerns expressed for atrazine and the chlorinated
metabolites do not apply to hydroxyatrazine, given its dissimilar toxicological profile and
environmental fate properties that indicate that hydroxyatrazine is less mobile in
soil/water systems.
c. Population Adjusted Dose
The population adjusted dose (or PAD) is a term that characterizes the dietary risk of a
chemical. The PAD reflects the Reference Dose (RfD), either acute or chronic, that has been
adjusted to account for the FQPA safety factor (i.e., RfD/FQPA safety factor). The RfD is
calculated by talcing the no observed adverse effect level (NOAEL) from an appropriate study
and dividing it by an uncertainty factor (i.e., NOAEL/IJF). Acute and chronic PADs are
equivalent to the acute and chronic RfDs divided by 10, respectively. A risk estimate that is less
than 100% of the acute PAD (aPAD) or chronic PAD (cPAD) does not exceed the Agency's
level of concern. Tn the case of atrazine, the FQPA safety factor of lOx was retained for dietary
exposures: therefore, the RfD is ten times greater than the PAD. The PADs are presented in
Tables 2 and 3 below for atrazine and hydroxyatrazine, respectively.
Table 2. Summary of Toxicological Endpoints and Other Factors Used in the Dietary
Risk Assessment of Atrazine and Its Chlorinated Metabolites
Exposure
Scenario
Dose
(mg/kg/day)
UF
FQPA
SF
Endpoint
Study
Acute
Dietary
(females 13
to 50 yrs old)
NOAL.L= 10
LOAEL = 70
100
10
Delayed ossification of certain
cranial bones in fetuses, decreased
body weight gain in adult
Developmental
toxicity study in rat
& rabbit (weight of
evidence from four
studies)
Acute RfD = 0.1 mg/kg/day
Acute PAD ~ 0.01 mg/kg/day
intermediate
and
Chronic
NOAEL = 1.8
LOAEL = 3.65
100
10
Attenuation of pre-ovulatory
lutenizing hormone (LH) surge, as a
biomarker indicative of
hypothalamic function disruption
Six-month LH surge
study-Ral
Chronic RID = 0.018 mg/kg/day
Chronic PAD = 0.0018 mg/kg/day
UF = Uncertainty Factor (100 is the result of a !0x for interspecies variability and I0.\ for intraspccics extrapolation): SF=Safety Factor;
PAD = Population Adjusted Dose
19
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Tabic 3. Summary of Toxicological Endpoints and Other Factors Used in the Human
Dietary (Food) Risk Assessment of Hydroxyatrazine, a Metabolite of Atrazine
Exposure
Scenario
Dose
(mg/kg/dav)
IJF1
FQPA
SF'
F.ndpoint
Study
Acute
Dietary
None selected
na
na
An appropriate endpoint
attributable to a single dose was
not identified (no toxic effect seen)
None selected
Acute RfT) = Not Established
Chronic
Dietary
NOAEL. = 1.0
LOAEL = 7.75
100
1
Histopathological lesions of the
kidneys
Combined chronic
toxicity/
carcinogenicity -Rat
Chronic RfD = 0.01
Chronic PAD = 0.01 mg/kg/day
UP = Uncertainty Factor (100 is the result of a lOx for interspecies variability and 10.x for intraspecies extrapolation). SF-Safety Factor:
PAD = Population Adjusted Dose
d. Exposure Assumptions
The Agency conducts dietary (food) risk assessments using the Dietary Exposure
Evaluation Model (DEF.M). DEEM incorporates consumption data generated in USDA's
Continuing Survey of Food Intake by Individuals (CSFII), 1989-92. For the assessment of
dietary exposure to residues of atrazine, monitoring data generated through the USDA Pesticide
Data Program (PDP) and through the Food and Drug Administration (FDA) Surveillance
Monitoring Program were used for wheat grain. Anticipated residue values from crop residue
field trial studies and information from metabolism studies were used for most crops. For guava,
tolerance level residues were used.
For acute probabilistic dietary (food) risk assessments, the entire distribution of single-
day food consumption events is combined with a distribution of residues to obtain a distribution
of exposure in mg/kg/dav. Chronic dietary (food) risk assessments use the three day average of
consumption for each subpopulation combined with residues in commodities to determine
average exposure in mg/kg/'day.
e. Food Risk Characterization
Generally, a dietary (food) risk estimate that is less than 100% of the acute or chronic
PAD docs not exceed the Agency's risk concern. Acute and chronic risk estimates from
exposures to food associated with the use of atrazine did not exceed the Agency's level of
concern.
20
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1) Atrazine and Its Chlorinated Metabolites
The percent acute PAD value for the relevant population subgroup considered under the
acute risk assessment, females 13 to 50 years old, is less than 1 at the 99.9th percentile of
exposure. The percent chronic PAD values for all exposed population subgroups were less than
L as well. These estimates of risk based on one-day and long-term exposures to atrazine and its
chlorinated metabolites from residues on food alone are below the Agency's level of concern.
2) Hydroxyatrazine
No acute toxicological endpoint was identified for hydroxyatrazine: therefore, an acute
risk assessment for hydroxyatrazine and the hydroxylated metabolites was not conducted. The
percent chronic PAD values were less than 1 for all population subgroups considered in the risk
assessment. Therefore, estimates of risk based on long-term exposures to hydroxyatrazine from
residues on food alone are below the Agency's level of concern.
2. Dietary Risk from Drinking Water
Exposure to pesticides from drinking water can occur through residues in ground water
and surface water. In the assessment for atrazine, EPA considers both acute (one day),
intermediate-term (seasonal), and chronic (annual) exposures to residues in drinking water risks
and uses actual monitoring data to characterize those risks.
Drinking water risk from the application of atrazine is assessed based on exposures to
combined residues of atrazine and the chlorinated metabolites. These are the only atrazine-
related compounds expected to occur in drinking water in significant quantities. Extensive
monitoring data are available for atrazine parent in finished drinking water, and some monitoring
data are available for the chlorinated metabolites. This monitoring data is the basis for the
Agency's drinking water risk assessment. To estimate the levels of chlorinated metabolites in
areas where monitoring data is not available for those metabolites, the Agency developed a
model based on the available monitoring data which the Agency believes provides a reasonable
estimate of the levels of the chlorinated metabolites that could be expected in drinking water.
A qualitative assessment of exposure to the hydroxy metabolites of atrazine in drinking
water has been conducted by the Agency. Exposure to these compounds is expected to be
significantly less than exposure to atrazine and the chlorinated metabolites based on the
characteristics of these metabolites. Therefore, the Agency has not included the hydroxy
metabolites in its quantitative risk assessment for drinking water
Risk estimates for exposures to residues of atrazine and its chlorinated metabolites in
drinking water are provided for populations receiving their drinking water from community water
systems (CWS) using surface water, CWS using groundwater; and individual rural wells located
in atrazine use areas. Exposure assessments were conducted for about 33 percent of the CWS
using surface water in the United States, serving approximately 65 million people in 31 atrazine
21
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use states. These CWS represent about 99% of atrazine use. The Agency uses monitoring data
for finished (i.e.. treated) drinking water in the assessment presented here.
The Agency initially conducted a deterministic (screening-level) drinking water risk
assessment for atrazinc and its chlorinated metabolites. The initial assessment identified specific
CY\ S and rural wells as having concentrations of atrazine and its chlorinated metabolites above
the Agenc) "s level of concern. The CWS of concern were assessed probabilistically to refine the
risk estimates: insufficient data were available to refine the risk estimates for rural wells.
a. Drinking Water Levels of Comparison (l)WLOC)
'1 o determine the maximum allowable contribution of water containing pesticide residues
permitted in the diet. HPA first looks at how much of the overall allowable risk is contributed by
food (and if appropriate, residential uses) then determines a "drinking water level of comparison"
(DWLOC) to determine whether modeled or monitoring levels exceed this level. The Acer.e\
uses the DWLOC as a surrogate to capture risk associated with exposure from pesticides in
drinking water. The DWLOC is the maximum concentration in drinking water that, when
considered together with dietary (food) exposure, does not exceed a level of concern.
Calculated 1 )WLOCs arc presented in Table 4 below.
"1 he results of the Agency's drinking water analysis arc summarized here. Details of this
analysis are found in the HF.D Human Health Risk Assessment dated April 16. 2002, the If FED
Environmental Risk Assessment dated April 20. 2002.
Table 4. Summary of Lowest DWLOC Values for Alrazine and lis Chlorinated
Metabolites
IJVVLOC (ppb)
Copulation Subgroup
Acute (One Day)
Hxpo.su re
Intermediate (Seasonal) and
Chronic (Annual) Exposure
Genera! Population
not available
68
infants * 1 year old
not available
12.5
Children ! to 6
not available
23
Children 7 to 12
nor available
53
Females 13 to 50
298
60
Males 13 to !9
not available
68
Vtaies 20 and over
not available
68
Seniors
not available
68
99
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1) Community Water Systems (CWS) Using Surface
Water
a) Acute Risk
Based on the Agency's deterministic assessment, the measured maximum one-day
concentrations of atrazine plus estimates of the chlorinated metabolites in drinking water do not
exceed the Agency's level of concern for acute effects, regardless of source, for any relevant
population subgroup.
Based on the Agency's screening-level deterministic assessment, one-day concentrations
less than the DWLOC of 298 ppb do not exceed the level of concern for acute effects. The
maximum measured concentration of atrazine and its chlorinated metabolites in any CWS
monitoring for atrazine from 1993 to 1998 was 89 ppb.
b) Intermediate-Term (Seasonal) and Chronic
(Annual) Risk
As stated previously, the drinking water concerns expressed for atrazine and its
chlorinated metabolites do not apply to hydroxyatrazine because of its toxicology profile and
environmental fate profile.
Under the Agency's screening-level assessment for intermediate-term and chronic
exposures to atrazine and its chlorinated metabolites, 34 out of the 3670 CWS assessed were
above the Agency's level of concern based on a comparison of average seasonal concentrations
to the chronic infant DWLOC of 12.5 ppb. These CWS were identified with quarterly average
concentrations of chlorotriazines above levels of concern for infants in one, two, or three years
between 1993 ana 2001. In addition, several of the 34 had annual average concentrations above
the levels of concern for children 1 to 6 years old and adults.
A probabilistic exposure assessment was conducted for 39 CWS. most of which were
identified as being of concern under the screening-level assessment, as listed above. Risk
estimates based on a probabilistic exposure assessment that estimated 90-day average exposures
to atrazine and the chlorinated metabolites indicate that 34 CWS have seasonal concentrations
that exceed levels of concern for infants at the 99.9th percentile of exposure.
In total, 34 CWS serving -230.000 to 240.000 people had 90-day average exposures that
exceeded levels of concern for infants in one, two, three, or four years between 1993 and 2001.
Risk estimates for these CWS ranged from 100% to 670% of the chronic PAD for infants at the
99.9th percentile of exposure, and several exceeded levels of concern for children 1 to 6 years old
and adults as well. The CWS identified and the cPADs for these systems are listed in Table 5
below.
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Table 5. Risk Estimates for High Seasonal Exposures to Atrazinc in Finished Drinking
Water at the 99.9'h Percentile of Exposure* (Calandex)
Community Water System (City/State)
Infant
% cPAD
Children 1 - 6
% cPAD
Adult
% cPAD
Chariton. IA
235
<100
<100
Sorento. 1L
183
<100
<100
Flora. IL
211
<100
<100
W. Salem, IL
189
100
<100
Farina. IL
189
<100
<100
White Hall. IL
278
117
<100
Carlinviik. IL
128
<100
<100
Gillespie. IL
550
222
172
llcttick. IL
544
222
172
Shipman. IL
<100
<100
<100
Palmyrn-Modcsto. IL
350
155
111
N Otter Tup ADGPTV. IL
189
<100
<100
Kinmundy. IL
150
<100
<100
Salerr.. IL
528
267
200
Centraha. IL
255
100
<100
llillsboro. 11.
272
117
<100
Louisville, IL
344
122
<100
North Vemon, IN
200
117
<100
Omaha. IL
250
111
<100
Holland. IN
244
128
<100
Balesvilte, IN
261
111
<100
Scottsburg. IN
267
150
105
Ixwisburg, K Y
317
128
<100
Marion. K.Y
317
128
<100
Iberville. LA
261
117
<100
Dearborn. MO
555
228
155
Buckiin. MO
250
100
<100
Vandalia, MO
189
105
<100
Sardinia, OH
667
305
205
24
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Community Water System (City/State)
Infant
% cPAD
Children 1-6
% cPAD
Adult
% cPAD
Delaware, OH
155
<100
<100
Clermont Count}'. OH
144
<100
<100
Williamsburg, OH
289
122
<100
Mt. Orah, OH
200
<100
<100
Newark, OH
111
<100
<100
The Agency notes that the Shipman reservoir no longer serves as a drinking water source:
in 1999 the town of Shipman was switched to an alternative source of drinking water. The
drinking water source at White Hall was switched from surface water to groundwater in 1997. It
is the Agency's understanding that Hettick, IT, is also in the process of defining a new source for
their drinking water needs and will close down the Hettick reservoir in the next couple of years.
The seasonal pulses of atrazine and the chlorinated metabolites detected in monitoring
data that resulted in exposures above the Agency's level of concern spanned from several weeks
to several months. Typically, for the year with exposures of concern, pulses lasted from early-
spring through the summer and into the fall, and some CWS had high pulses almost all year long.
The higher concentrations occurring in the spring and early summer influence the 90-day average
concentrations all year long.
2) Groundwater
Risk estimates based on screening-level assessments for 14,500 CWS using groundwater
(~33 percent of groundwater CWS in the U.S.) do not exceed the Agency's level of concern for
acute or chronic effects.
Data to estimate concentrations of the chlorinated metabolites of atrazine in these CWS
using groundwater in 21 major atrazine use states have been developed. The highest
concentration of atrazine and the chlorinated metabolites measured in any CWS in the data set
was ~11 ppb. The 99th percentile concentration value for chlorotriazines in CWS with prior
detections of atrazine was 1.9 ppb. Both the maximum measured value and the 99th percentile
value are less than the acute DWLOC of 298 ppb, and do not exceed the Agency's level of
concern for acute effects.
The 50th percentile concentration value was 0.180 ppb for CWS with prior detections.
The mean concentration value at the 95 percent upper confidence bound was 0.55 ppb for CWS
with prior detections. Both are less than the lowest intermediate-term to chronic DWLOC of
12.5 ppb, and do not exceed the Agency's level of concern for chronic effects.
The Agency believes that CWS using groundwater are not impacted as heavily by
atrazine use as CWS using surface water.
25
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3) Domestic Rural Wells
Approximately 10% of the U.S. population receives their drinking water from rural well
cisterns or springs. These sources of drinking water are not regulated under the SDWA. Acute
exposures to atrazine and the chlorinated metabolites in drinking water from rural wells do not
exceed the Agency's level of concern. The maximum measured concentration of atrazine plus
the chlorinated metabolites in the rural drinking water wells in atrazine use areas monitored by
the registrant was 18 ppb: much less than the acute DWLOC (females 13 to 50) of 298 ppb. In
addition, chronic exposures of adult populations using rural wells for drinking water do no:
exceed the Agency 's level of concern.
However, Ihe Agency has some concerns for chronic exposures of infants and children
drawing drinking water from rural wells located directly in atrazine use areas, i.e., adjacent to
fields where atrazine was used. Eight wells out of 1505 wells monitored had residues of atrazin
and the chlorinated metabolites approaching, equal to. or greater than the chronic DWLOC
(infants <1 year old) of 12.5 ppb. The 1505 wells monitored were selected based on their
location in areas with high atrazine use. Of these, eight wells were resampled in March 2001.
one sample per well. All samples showed concentrations of atrazine and the chlorinated
metabolites less than the DWLOC of 12.5 ppb.
Although the data indicate that levels are decreasing in these wells over time, the Agency
continues to have uncertainty regarding subchronic and chronic exposures of infants using
private rural wells in close proximity to atrazine use areas for the several reasons. It is difficult
to interpret typical exposures ir. rural wells close to atrazine use areas based on two samples
taken many years apart. 1 here are approximately 13 million drinking water wells in the U.S.,
thus, the rural well survey (1,505 wells) is inadequate to fully assess exposures to the entire I '.S
population that uses rural wells for drinking water. And finally, limited sampling from the well,
in the survey results in a high level of uncertainty regarding exposures to atrazine and the
chlorotriazine metabolites for the population using rural wells for drinking water.
2. Residential Risk
Atrazine is registered for use by homeowners to control weeds in turf grass.
Homeowners mixing, loading, and applying atrazine products to their lawns may be exposed lo
atrazine through their skin and by inhaling dusts or sprays during application. Residential
exposures are only applicable for those regions of the United States where atrazine is used on tu
grass, generally the Southeast (including Florida).
Adults or children can also be exposed to atrazine after application has occurred through
contact with treated lawns or other turf areas (i.e., golf courses). In this instance, inhalation
exposures are not expected: however, post-application dermal exposures for homeowners and
children (yard work, walking, playing, crawling) and incidental oral exposure for toddlers are
possible. Exposure data are not available on atrazine's chlorinated metabolites and hydroxy
metabolites; however, residues of the chlorinated metabolites and hydroxy metabolites are hot
26
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expected to occur on the surfaces of plants. Therefore, any residential exposure to these
metabolites would be minimal, and risks were not assessed.
The Agency recognizes that there may be concerns for the potential for children's
exposure in the home as a result of agricultural uses of atrazine. Environmental concentrations
of atrazine in homes may result from spray drift, track-in. or from redistribution of residues
brought home on the farmworkers clothing. Potential routes of exposure for children may
include incidental ingestion and dermal contact with residues on carpcts/hard surfaces. Studies
are currently being pilot-tested that will look for sources of major pesticide exposure (including
exposure to atrazine) and will attempt to quantify these exposures.
Risk for all of the potentially exposed populations is measured by a Margin of Exposure
(MOE). A MOE determines how close the amount of residue that individuals are exposed to
come to a No Observed Adverse Effect Level (NOAEL), whether exposures are from the use of a
pesticide or from pesticide residues after application. For atrazine, MOEs greater than 300 (10
interspecies uncertainty x 10 intraspecies variability x 3 FQPA) do not exceed the Agency's level
of concern.
a. Toxicity
The toxicity of atrazine is integral to assessing the residential risk. The toxicological
endpoints and other factors used in the residential risk assessment for atrazine are described
below and summarized in Table 6.
As mentioned earlier, the FQPA safety factor for residential exposures was reduced to 3x.
This is considered adequate to protect the safety of infants and children in assessing residential
exposure and risks because the uncertainties relating to drinking water exposure and the existing
monitoring data included in the 10x FQPA. safety factor for dietary exposure do not apply to
residential exposure scenarios. Concerns for the effect of the neuroendocrine mode of action on
the development of the young remain. The assumptions inherent to the Agency's residential risk
estimates based on screening-level procedures are conservative and protective. The 3x FQPA
safety factor is being applied across all aggregate risk assessments based on estimated residential
exposures for all populations considered in these risk assessments.
Table 6. Summary of Toxicological Endpoints and Other Factors Used in the Atrazine
Residential Human Health Risk Assessment
Exposure Dose
Scenario (mg/ky/dny)
UF1
FQPA
Safety
Factor
F.ndpoint
Study
Oral, NOAEL= <3.25
ShortrTerm |LOAEL^12.5
100
3
Delayed preputial separation in
male offspring after 30 days of
dosing.
Pubertal assay (30-
day) NHEERL
published literature
27
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Table 6. Summary of Toxicological Endpoints and Other Factors Used in the Atrazine
Residential Human Health Risk Assessment
Exposure-
Scenario
Dose
(mg/kg/day)
UF'
FQPA
Safety
Factor
Endpoint
Study
Oral,
Intermediate-
Term
NOAEL = 1.8
LOAEL - 3.65
100
**
J
Attenuation of pre-ovulatory
lutenizing hormone (LI I) surge, as a
biomarker indicative of
hypothalamic function disruption
Six-month LH
surge- Rat
Dermal.
Short-Term1
NOAEL - 6.25
LOAEL = 12.5
100
**
Delayed preputial separation in
male offspring after 30 days of
dosing. Use of the dermal
penetration factor yields a dose of
104 mg/kg/day.
Pubertal assay (30-
day) NHEERL
published literature
Dermal,
Intermediate-
and
Long-Term1'
NOAEL- 1.8
LOAEL = 3.65
100
3
Attenuation of pre-ovulatory
lutenizing hormone (LH) surge, as a
biomarker indicative of
hypothalamic function disruption
Six-month LH
surge- Rat
Inhalation,
Short-Term L
NOAEL= 6.25
LOALL = 12.5
100
-t
J
Delayed preputial separation in
male offspring after 30 days of
dosing.
Pubertal assay (30-
day) NI1EERL
published literature
Inhalation,
Intermediate
and
Long-Term1-
NO A EI ,= 1.8
LOAEL = 3.65
100
3
Attenuation of pre-ovulatory
lutenizing hormone (LH) surge, as a
biomarker indicative of
hypothalamic function disruption
Six-month LH
surge-Rat
]UK= Uncertainty Factor (100 is the result of a I Ox for interspecies variability and lOx for intraspecies extrapolation)
a = The N0AJE1, of 6.25 mp/kpj'day is multiplied hy a 3.6 dermal penetration factor.
b = 6% dermal absorption factor for route-io-routc extrapolation.
c "" 100% absorption faetor for route-to-ronrc extrapolation
Residenri.il = A MOI- of 300 is required and includes the 3x FQPA Safety Factor
b. Exposure Assumptions
Residential exposures to atrazine. are expected to be short-term in duration (1 to 30 days),
based on label direetions that specify no more than two applications of atrazine to home lawns.
Exposures greater than 30 days arc not expected because no currently registered residential use
products would result in exposures of this duration due to the use pattern and turf residue
dissipation data on atrazine.
Chemical-specific exposure data, including a Turf Transferable Residue study on
atrazine, and data on residential handlers applying granular and liquid formulations submitted by
the Outdoor Residential Exposure Task Force (ORETF) were used to assess the exposure to
atrazine as a result of residential application. In addition, analyses were performed using the unit
exposure values in the Pesticide Handlers Exposure Dalabase (PHED), Version 1.1 (August
28
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1998) and using standard assumptions (average body weight, work day, daily areas treated,
volume of pesticide used, etc.).
The quality of the data and exposure factors represents the best sources of data currently
available to the Agency for completing these kinds of assessments. For example, if appropriate
chemical-specific exposure data are available lor atrazine, those data are used instead of the more
generic PHED data. The quality of the data used for each scenario assessed, standard procedures,
and any assumptions made are further discussed in the April 16. 2002, Revised Human Health
Risk Assessment: the August 2002 Revised Occupational and Residential Risk Assessment: and
the January 31, 2003. Addendum to the Revised Human Health Risk Assessment available in the
public docket and online.
Anticipated use patterns and application methods, range of application rates, and area of
lawn treated per day were derived directly from current atrazine labels for residential products.
Application rates specified on atrazine labels for residential uses range up to 2 pounds of active
ingredient per acre on residential turf.
The Agency also considered exposure to adults or children entering or playing on treated
lawns or entering homes after application of atrazine products (post-application exposure).
These activities are expected to result in short-term exposure (1 to 30 days), based on atrazine
turf residue dissipation data and atrazine's residential use pattern. These data show that atrazine
has a half-life on turf of up to 5 days after spraying or 9 days after granular application, and
requires several weeks to dissipate. However, the Agency docs not expect exposures greater than
30 days, even considering the slow dissipation rates, because the label prohibits application more
than twice per year.
Residential post-application exposure assessments assumed residents wear the following
attire: short sleeved shirt, short pants, shoes and socks, and no gloves.
c. Residential Applicator Risk
The anticipated use patterns and current labeling for atrazine homeowner products
indicate 5 major exposure scenarios for residential applicators, as follows:
(1) mixing/loading/applying liquid formulations using a backpack sprayer,
(2) mixing/loading/applying liquid formulations for application with a low pressure
handwand,
(3) mixing/loading/applying liquid formulations for hose-end sprayer,
(4) loading/applying granular formulations with a push type spreader, and
(5) loading/applying granular formulations with a bellygrinder.
The Agency does not believe the addition of personal protective equipment (PPE) to
residential handlers (as used for assessing occupational handler risk) is appropriate for
homeowner handier exposure assessments. Homeowners often lack access to PPE and do not
29
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possess expertise in the proper use of PPE. As a result, homeowner handler assessments are
completed using a single scenario based on the use of short-sleeved shirts and short pants,
common homeowner attire during the pesticide application season. In addition, as mentioned
above, only short-term exposures were assessed, as the Agency does not believe homeowners
who apply atrazinc will be exposed for more than a few consecutive days.
All of the residential handler exposure scenarios considered in the risk assessment, with
the exception of the scenario for application of granular formulations via a bellygrinder as a
broadcast application, were below the Agency's level of concern (MOEs > 300). MOEs
calculated for each homeowner handler scenario are presented in Table 7, as follows:
Table 7. Homeowner Uses and Risk Concerns (combined dermal & in
lalation MOEs)
Scenario
Rale
(lb ai/A)
Short-Term MOE
(1) Mixing, loading, and applying liquid formulations via backpack
sprayer
2
28,000
(2) Mixing, loading, and applying liquid formulations via low pressure
handwand
2
1,600
(3) Mixing, loading, and applying liquid formulations via hose-end
sprayer
2
640a
(4) Loading and applying granular formulations via push type spreader
2
1,100'
(5) Loading and applying granular formulations via bellygrinder
2
65 (broadcast)
1,400 (spot
treatment)
' Calculated using ORRTF linil Exposure Values
d. Post-Application Residential Risk
Atrazine can be used on home lawns, golf courses, and on other turf areas where exposure
to adults and children may occur. Dermal exposure to atrazine may result from entering the
treated area, performing yard work (e.g., mowing), playing or performing other recreational
activities (e.g., golfing) on the treated areas. In addition, incidental oral post-application exposure
to children may occur from "hand-to-mouth" (i.e., ingestion of grass, soil and/or granular pellets;
or hand-to-mouth contact) exposure when reentering treated lawns.
The Agency does not expect post-application inhalation exposure to atrazine to occur
because of low chemical vapor pressure and dilution of vapor outdoors. Thus, this exposure was
not assessed. Handler study data support this conclusion.
Representative turf reentry activities include, but are not limited to:
(1) Adults involved in a low exposure activity, such as golfing or walking on treated turf.
(2) Adults mowing or other moderate contact activity, for 1-2 hours.
30
-------
(3) Adults involved in a high exposure activity, such as heavy yard work (doses similar to
occupational scenarios for cutting and harvesting sod).
(4) Children involved in high exposure activities on turf.
The Agency has risk concerns for post-application residential exposures to children from
incidental oral contact. In children exposed to treated lawns after application of liquid atrazine
formulations, hand-to-mouth activities and combined oral exposures result in MOEs above the
Agency's level of concern. MOEs are 210 for hand-to-mouth activities and 200 for combined
oral exposures. In addition, for children exposed to treated lawns after granular applications, the
Agency has concerns for incidental ingestion of granules. The MOEs for this scenario range
from 16 to 110.
Table 8: Residential Short-Term Post-Application Risk Estimates from Atrazine
Application to Lawns
Scenario
Application
Rate
(lb ai/A)
MOE
Lie
uid
Granular
GA
NC
GA1
FL1
Adull
Dermal
Turf Contact
2
510
4300
1200
Walking, Golfing
"9
7400
62,000
17,000
Push Mowing Lawn
2
15,000
120,000
34,000
Child
Dermal
Turf Contact
2
310
2.600
690
Oral
Hand to Mouth Activity
2
210
950
T urfgrass/Objcct
Mouthing
2
3300
Ingestion of Soil
2
62,500
Combined"
2
200
730
Ingestion of Granules
2
n/a
16-31 (1.5% ai)
57-110 (0.42% ai)
The MOEs presented here represent non-irrigated turf. As these MOEs were acceptable, irrigated turi'
MOEs, generally higher than non-irrigated, were not presented.
Combined includes Haiid-to-mouth activity, turfgrass/object mouthing; and ingestion of soil. Ingestion of
granules is not included because this is considered an infrequent, episodic event.
Adults may reasonably be expected to perform more than one activity on treated lawns in
a single day, but an eight-hour duration of exposure is unlikely. Therefore, it is reasonable to
aggregate the exposures from playing/gardening (highest exposure rate), walking, and mowing
31
-------
(lower exposure rate) for a single MOE. The MOE for all post-application adult exposures
combined is 460 and is above the Agency's level of concern. It is also possible that an adult
would apply herbicide spray to a lawn and then play on it or mow it later that day. In such an
event, the aggregated dermal MOF, for the day would be slightly lower than the target 300 for
that day (MOE=270). based on the liquid application study values, but not based on the granular
residue data. However, this not very likely and is considered a high-end estimate of exposure.
It is likely that dermal and oral incidental exposures may occur in the same day for
children playing on atrazine-treated lawn. It can be seen from the MOEs presented in Table 8 that
the incidental hand-to-mouth (licking fingers) exposure estimate constitutes most of this oral
exposure. The overall MOF. of 200 is only slightly less than the MOE of 210 for the hand-to-
mouth estimate. The individual dermal and oral routes of exposure each exceed the level of
concern, and aggregating these estimates results in an even lower MOE. Ingestion of granules is
not aggregated because it is considered an infrequent, episodic event.
3. Aggregate Risk
Aggregate risk assessments have been conducted for acute, short-term, and intermediate-
term to chronic exposures to atrazine and the chlorinated metabolites. Aggregate risk
assessments look at the combined risk from dietary exposure (food and drinking water) and non-
occupational (e.g., residential, golfers, etc...). The acute aggregate risk assessment combines
exposures to atrazine and the chlorinated metabolites in food and drinking water. The short-term
aggregate risk assessment combines exposures to atrazine and the chlorinated metabolites in food
and drinking water with residential exposures to atrazine,per se, occurring between 1 and 30
days after use of atrazine products at home. The intermediate-term and chronic aggregate risk-
assessment combines exposures to atrazine and the chlorinated metabolites in food and drinking
water alone because intermediate-term (30 days to several months) and chronic (several months
to lifetime) exposure scenarios for the registered non-occupational uses of atrazine arc not
expected.
Although a risk assessment for exposures to atrazine's hydroxylated metabolites in food
was conducted, risk assessments aggregating exposures to atrazine's hydroxylated metabolites in
food, drinking water, and in residential settings were not. There is limited data on
hydroxyatrazine in water, and exposure to the hydroxy metabolites of atrazine in drinking water
is not expected to be significant relative to the chlorinated metabolites. In addition, the Agency
does not expect exposure to hydroxyatrazine from applications of atrazine to turf because
hydroxyatrazine is formed within plant tissues, not on plant surfaces.
a. Acute Aggregate Exposure and Risk Estimates
The aggregate risk assessment for acute exposures to atrazine and the chlorinated
metabolites combines high-end one-day exposures through food and drinking water alone. The
Agency does not believe that high-end exposures through food, drinking water, and residential
use will all occur on the same day. Therefore, acute aggregate risk estimates are the same as
-------
those presented for acute drinking water risks. Exposure to atrazine from food sources and
drinking water do not exceed the Agency's level of concern for acute dietary risk for any relevant
subgroup, as described previously in Section III.A.2.a.3.
b. Intermediate-Term and Chronic Aggregate Exposure and Risk
Estimates
The aggregate risk assessment for intermediate-term and chronic exposures to atrazine
and the chlorinated metabolites combines estimates of high-end seasonal or long-term average
exposures to atrazine in drinking water with long-term average exposures to atrazine in food.
Neither intermediate-term nor long-term (chronic) exposures are expected to occur in the home
from residential uses of atrazine. Therefore, intermediate-term and chronic aggregate risk-
estimates are the same as those presented for intermediate-term and chronic drinking water risks
(see section III.A.2.a.3). Infants and children are potentially at risk from exposures to combined
residues of atrazine plus its chlorinated metabolites from 34 CWS using surface water based on
available monitoring data. Aggregate intermediate-term and chronic exposures in CWS using
groundwater are not of concern.
c. Short-Term Aggregate Exposure and Risk Estimates
Short-term estimates of aggregate risk were calculated for adult applicators and children
and adults exposed to residues of atrazine after application to home lawns. Short-term aggregate
risk estimates that include residential exposures are only applicable for those regions of the
United States where atrazine is used on turf grass (residential and golf courses), generally the
Southeast (including Florida).
The theoretical upper limit in drinking water for short-term exposures is referred to as a
short-term DWLOC and is based on exposure estimates for adults and children from average
residues of atrazine in food and exposure to high-end atrazine residues during application or
immediately after application of anazine to lawns. If the short-term DWLOC values are greater
than the measured average concentrations for atrazine residues in surface water and groundwater,
there is no concern for short-term aggregate exposures to atrazine residues through food, drinking
water, and non-occupational uses. Measured concentrations of atrazine residues in surface water
and groundwater from monitoring data (as presented earlier in this document) were compared to
the calculated short-term DWLOCs.
1) Adult Handlers
Short-term estimates of aggregate risk to adults applying atrazine products to the lawn
and garden combines exposures through the dermal, dietary' (food and drinking water), and
inhalation routes. These exposures have a common toxic effect, delayed puberty as a biomarker
for neuroendocrine effects.
Table 9 below presents the results of the Agency's short-term aggregate risk assessment
-------
for adult handlers of atrazine. Of the five exposure scenarios evaluated, only applieations of
granular formulations of atrazine applied over 0.5 acres with a belly-grinder results in aggregate
exposures that exceed the Agency's level of concern.
Aggregate short-term DWLOC values are presented for the five adult handler scenarios in
Table 9. The first four DWLOCs presented are greater than the measured maximum weekly
concentration of 89 ppb atrazine and the chlorotriazines in finished drinking water; thus, these
scenarios are not of concern to the Agency. A DWLOC of 0 is assigned for adults applying via
belly grinder because this residential scenario alone exceeds the Agency's level of concern; thus,
this scenario is also of concern when aggregated with dietary and drinking water routes of
exposure.
Table 9. Short Term Aggregate DWLOCs - Adults applying atrazine at 2 lb ai/A to lawns.
Exposure Scenario
Aggregate MOE
(Dermal and Inhalation)
Short Term
DWLOC (ppb)
(1) Mixing, loading, and applying liquid formulations via
backpack sprayer
28,000
219
(2) Mixing, loading, and applying liquid formulations via
low pressure handwand
1.600
273
(3) Mixing, loading, and applying liquid formulations via
hose-end sprayer
640
105
(4) Loading and applying granular formulations via push-
type spreader
11,000
159
(5) Loading and applying granular formulations via belly
grinder
65
0
2) Adult Post-Application
Short-term estimates of aggregate risk lor adults from post-application exposures
combine dietary exposure and post-application dermal exposures after atrazine lawn treatment.
Short-term dermal and dietary exposures have a common toxic effect: delayed puberty as a
biomarker for neuroendocrine effects.
Table 10 summarizes the results of the Agency's aggregate risk assessment for short-term
exposures of adults exposed to atrazine-treated lawns immediately after application. Short-tern;
aggregate risk estimates do not exceed the Agency's level of concern. Weekly concentrations of
atrazine and the chlorotriazine metabolites have been measured in drinking water up to 89 ppb:
since this concentration is less than the remaining DWLOCs, the aggregate risk is acceptable.
34
-------
Table 10. Short Term Aggregate DYVLOCs - Adults exposed to atrazine after
application to lav/us at 2 lb ai/A.
Exposure Scenario (formulation)
Dermal MOE
Short Term DWLOC
(Ppb)
Derma! Turf Contact (liquid)
510
130
Dermal Turf Contact (granular)
1200
157
Dermal Contact Walking/Playing Golf (liquid)
7,800
210
Dermai Contact Walking/Playing Golf (granular)
16,000
215
Dermal Contact Pushing Lawn Mower (liquid)
16,000
214
Derma! Contact Pushing T,awn Mower (granular)
35,000
217
3) Child Post-Application
Short-term estimates of aggregate risk to toddlers from post-application residential
exposure to atrazine combine dietary exposures with post-application dermal and incidental oral
exposures after atrazine lawn treatment.
Aggregate risk estimates for short-term exposures to toddlers playing on liquid atrazine-
treatcd lawns exceed EPA's level of concern. Risks to children from aggregated oral residential
post-application exposures (hand-to-mouth transfer of residues, grass and soil ingestion activities
by toddlers on grass) are of concern for liquid formulations (MOE = 200); therefore, any
aggregation through the dermal. inhalation or dietary pathways would result in risk estimates that
further exceed the Agency's level of concern.
Toddlers" risk estimates from individual or aggregated (combined) pathways for
incidental oral exposures based on granular formulations do not exceed the Agency's levels of
concern; i.e., a MOE of 730. Toddlers' risk estimates from dermal exposures based on granular
formulations also do not exceed the Agency's levels of concern: i.e., MOEs of 690 (for
applications that are not_watered-in immediately after application and 2000 for applications that
arc watered-in immediately after application). Combined dermal and incidental oral exposures
for toddlers result in a MOE of 350 or greater and also do not exceed the Agency's level of
concern. Short-term DWLOCs for toddlers' post application aggregate exposures, inclusive of
dermal, incidental oral, and dietary (food - drinking water) exposures, do not exceed HED's
level of concern for granular formulations watered-in after application to turf. Short-term
DWLOCs for toddlers"' post application aggregate exposures exceed the Agency's level of
concern for granular formulations.
Exposure to atrazine through ingestion of granules by toddlers result in MOEs of 16 to
110. Granule ingestion by toddlers is considered an episodic event (a stand alone incident) and
has not been aggregated with either other incidental oral exposures or dermal and dietary
35
-------
exposures.
Table 11 below presents the short-term aggregate MOEs and DWLOCs for toddlers
exposed to atrazine after lawn applieations.
Table 11. Short-Term Aggregate DWLOCs - Toddlers exposed to atrazine after liquid
and granular applications to lawns.
Type of Exposure
Formulation/Application
Kate (Ihs ai/acre)
Dermal MOE
Aggregate
Incidental Oral
MOE
Short-Term
DYVLOC (ppb)
Dermal Contact on Turf
2 lb ai/acre (liquid)
310
200
zero
Dermal Contact on Turf
1 lb ai/acre (liquid)
610
390
zero
Dermal Contact on Turf
2 lb ai/acre (granular)
without watering-in
690
730
12-14
Dermal Contact on Turf
2 lb ai/acre (granular)
with watering-in
2000
730
35-39
4. Occupational Risk
Workers handling pesticide products can be exposed to atrazine through mixing, loading,
and/or applying this pesticide, and through reentering treated sites. Occupational handlers of
atrazine include: individual farmers and other growers who mix, load, and/or apply pesticides:
commercial, professional, or custom agricultural applicators; commercial pest control operators:
and lawn care and turf management professionals. The post-application occupational risk
assessment considered exposures to workers entering treated sites in agriculture. Risk for all of
these potentially exposed populations is measured by a Margin of Exposure (MOE) which
determines how close the occupational or residential exposure comes to a No Observed Adverse
Effect Level (NOAEL)- Generally, MOEs greater than 100 do not exceed the Agency's risk
concern.
a. Toxicity
The toxicity of atrazine is integral to assessing the occupational risk. The Agency has
conducted short-term and intermediate-term dermal and inhalation exposure assessments for the
occupational handler. In addition, the Agency has conducted short-term post-application dermal
and inhalation exposure assessments. Long-term (chronic) occupational exposures are not
anticipated based on atrazine?s use pattern.
All risk estimates are based on the most current toxicity information available for
atrazine, including a 21 -day dermal toxicity study. The toxicological endpoints. and other factors
used in the occupational risk assessments for atrazine are summarized in Table 12 below. Please
note that the occupational dermal and inhalation endpoints are the same as those used in the
36
-------
dietary drinking water assessment and in the residential risk assessment.
A dermal absorption factor of 6% (rounded up from 5.6%) was selected, based on a
human study in which 10 volunteers were exposed to a single topical dose of atrazine. An
inhalation absorption factor of 100% is applied. The FQPA Safety Factor is not applicable to the
Occupational Risk Assessment.
Table 12. Summary of Toxicological Endpoints and Other Factors Used in the
Atrazine Occupational Risk Assessment
Exposure
Scenario
Dose
(mg/kg/day)
UF1
Endpoint
Study
Dermal.
Short-Term"
NOAEL= 6.25
LOAEL = 12.5
100
Delayed preputial separation in
male offspring after 30 days of
dosing. Use of the dermal
penetration factor yields a dose of
104 mg/kg/day.
Pubertal assay (30-
day) NHEERL
published literature
Dermal.
Intermediate-
Term1'
NOAEL= 1.8
LOAEL - 3.65
100
Attenuation of pre-ovulatory
lutenizing hormone (LH) surge, as a
biomarker indicative of
hypothalamic function disruption
Six-month LH
surge- Rat
Inhalation.
Short-Term r
NOAEL= 6.25
LOAEL - 12.5
100
Delayed preputial separation in
male offspring after 30 days of
dosing.
Pubertal assay (30-
day) NKEERL
published literature
Inhalation.
Intermediate-
Term'
NOAEL= 1.8
LOAEL = 3.65
100
Attenuation of pre-ovulatory
lutenizing hormone (LII) surge, as a
biomarker indicative of
hypothalamic function disruption
Six-month I.H
surge-Rat
'UF - Uncertainty Factor (!00 is the result of a 1 Ox for interspecies variability and I Ox for intraspecies
extrapolation)
a = The NOAEL of 6.25 mg/kg/day is multiplied by a 3.6 dermal penetration factor,
b 6% derma! absorption factor for route-to-route extrapolation,
c = 100% absorption factor for route-to-rouie extrapolation.
Atrazine has low acute dermal and inhalaiion toxicity. It is non-irritating to skin,
minimally irritating to the eyes and is not a skin sensitizer. It is classified under Category III for
acute oral toxicity. Table 13 summarizes the acute toxicity of atrazine.
37
-------
Table 13. Summary of Results from Acute Toxicity Studies of Technical Atrazine
Guideline
No.
Test
Results
Toxic Category
81-1
Acute Oral I .Dsc - rat
LD50 > 1,869 mg/kg (M&.F
combined)
III
81-2
Acute Dermal LD55 - rat
LDSC > 2,000 mg/kg (M&F
combined)
II]
81-3
Acute Inhalation LC,0 -
rat
LC,n > 5.8 mg/L (M&F combined)
IV
81-4
Eye Irritation - rabbit
Non-irritant
IV
81-5
Dermal Irritation - rabbit
Non-irritant
IV
81-6
Dermal Sensitization
Non-sensitizer
b. Occupational Exposure
Several chemical-specific studies that were submitted to the Agency by the technical
registrant were used together were used to assess the occupational handler risks from use of
atrazine for most exposure scenarios. Exposure studies submitted to the Agency by the Outdoor
Residential Exposure Task Force (ORETF) were also used in the occupational (and non-
occupational) risk assessments for applicators.
In addition, the Agency generated MOEs to assess risk to commercial handlers engaged
in impregnating atrazine onto dry bulk fertilizer using dermal and inhalation unit exposure data
from the Pesticide. Handlers Exposure. Database. (PHED), Version 1.1 (August 1998). The
PHED scenario for mixing/loading liquids using a closed system were used as a surrogate to
estimate these exposures. However, such an exposure surrogate is less appropriate for
estimating exposures due to transferring the treated dry bulk fertilizer from an auger truck to the
application equipment. There are no data or reasonable surrogate available for this operation.
Three chemical-specific studies, one of dislodgeable foliar residue on corn, and two of
transferable turf residues (TTR), were submitted to the Agency and used in the post-application
occupational risk assessment. In addition, transfer coefficients used were based on data
submitted by the Agricultural Reentry Task Force (ARTF), where possible. Most of the atrazine
used in agriculture is applied to corn and sorghum early in the season, either before weeds
emerge or when the crops are quite small, generally less than 12 inches high. This, and the
degree of mechanization in cultivating these crops, leads the Agency to conclude that post-
application exposure to workers is low.
Anticipated use patterns and application methods, range of application rates, and daily
amounts treated were derived from current labeling. Maximum application rates specified on
atrazine labels were 2.0 lb ai-'A, with a few exceptions. Maximum label rates were used to
estimate handler exposure. The Agency uses acres treated per day values that are thought to
38
-------
represent an eight-hour workday for a particular type of application equipment or a specific crop.
Occupational handler exposure assessments arc conducted by the Agency using different
levels of personal protection. The Agency typically evaluates all exposures with baseline
protection and then adds additional protective measures using a tiered approach to obtain an
appropriate MOE (i.e.. going from minimal to maximum levels of protection). The lowest suite
of personal protective equipment (PPE) is baseline PPE. If required (i.e., MOEs are less than
100). increasing levels of risk mitigation PPE arc applied. If MOEs are still less than 100,
engineering controls (EC) are applied. The levels of protection that formed the basis for
calculations of exposure from atrazine activities include:
Baseline: Long-sleeved shirt and long pants, shoes and socks (includes
gloves for the applicator in scenario 5).
PPE: Baseline + coveralls, chemical-resistant gloves, and a dust/mist
respirator (see table for specifics by scenario)
Engineering controls: Engineering controls, such as closed cab tractor for application
scenarios, or a closed mixing and loading system such as a farm
closed mechanical transfer system for liquids or a package based
system. Some engineering controls arc not feasible for certain
scenarios. Some formulation types qualify as engineering controls
for the purpose of controlling exposure during mixing and loading,
such as water soluble packets.
c. Occupational Handler Risk Summary
Inhalation and dermal exposure to alrazine can result from occupational use. The Agency
assessed dermal and inhalation risks (MOEs) for each crop currently registered for atrazine. For
atrazine, occupational MOEs greater than 100 are not of risk concern to the Agency.
1) Agricultural Handler Risk
The Agency has determined that there is potential atrazine exposure to mixers, loaders,
applicators, and other handlers using atrazine in accordance with the current use patterns.
Fourteen major agricultural handler exposure scenarios were identified for atrazine, as listed
below. The major handler scenarios involved multiple crops and application rates, resulting in
several different exposure estimates. The largest agricultural use of atrazine involves the mixing,
loading and application of alrazine to row crops and results in the largest potentially exposed
occupational population.
(la) mixing/loading liquid formulations for aerial application,
(lb) mixing/loading liquid formulations for groundboom application,
(1 c) mixing/loading liquid formulations for rights-of-way sprayer application to
roadside,
(le) mixing/Ioading/incorporating liquid formulations into liquid and dry bulk
-------
fertilizer (commercial & on-farm techniques),
(2a) mixing/loading dry flowabie formulations for aerial application,
(2b) mixing/loading dry flowabie formulations for groundboom application,
(2c) mixing/loading dry flowabie formulations for rights-of-way sprayer application to
roadside,
(3) loading granular formulations.
(4) applying liquids with aircraft,
(5) applying liquids with groundboom sprayer.
(6) applying liquids to roadsides with rights-of-way sprayer,
(8) applying impregnated dry bulk fertilizer with a tractor-drawn spreader,
(9) applying granular formulations with a tractor-drawn spreader,
(15) flagging for aerial spray applications
(16a) mixing/loading wettable powder formulations for aerial application; and
(16b) mixing/loading wettable powder formulations for groundboom application.
PPE requirements on current atrazine labels are typically long-sleeved shirt, long pants,
shoes, socks and waterproof gloves. Mixers and loaders must also wear protective eyewear,
(mixers/loaders).
As summarized in Table 14, occupational risks are of concern (i.e MOEs < 100) for some-
scenarios even when maximum PPE are utilized. Handler risks are also of concern for a few
scenarios with engineering controls. Engineering controls are considered to be the maximum
feasible mitigation. These involve several scenarios for the incorporation of atrazine into liquid
or dry bulk fertilizer, handlers mixing and loading wettable powders for application to 350 acres
of sugarcane at 4 lb ai/A, and handlers applying liquids with a right of way sprayer to 40 acres of
roadsides at 2 lb ai/A.
40
-------
Tabic 14. Occupational Handler Aggregate (Dermal pins Inhalation) Margins of Exposure (PIIED)
Scenario
Crnp/lJse Site
Rate'
Acres
Levels of Protection
Baseline
pprc-
EC's
Short Term
Inter-
mediate
Term
Short Term
Inter-
mediate
Term
Short Term
Inter-
mediate
Tcrin
Mixer/Loader
(la) Liquid
formulations for
aerial application
Conifer forests
Christmas tree farms
4
350
2 .
0.4
248
61
520
130
Sugarcane
4
350
2
0.4
248
61
520
130
2.6
3
0.7
381
94
800
200
Chemical fallow
3
1200
1
n a
96
na
200
na
350
2
0.6
330
82
690
170
1.4
1200
1
n a
206
na
430
n a
350
5
1.3
708
170
1500
370
CRP or grasslands
2
1200
1
na
144
na
300
n a
350
4
0.9
495
120
1000
260
Corn
Sorghum
2
1200
1
na
144
na
300
na
350
4
0.9
495
120
1000
260
1
1200
2
n a
289
na
610
na
350
7
2
991
240
2100
520
Sod Farms
4 (FL)
350
2
0.4
248
61
520
130
2
350
4
1
495
120
1000
260
41
-------
Scenario
f'rop/t'sc Silt*
Rate'
\crcs
Levels of Protection
Baseline
ITfc1
ECs
Slturt Term
Inter-
mediate
Term
Short Term
Inter-
mediate
Term
Short Term
Inter-
mediate
Term
(lb) Liquid
formulations for
gnumdboom
application
MauKlamia nuts
C iiio%a
Cnnifcrs
4
80
8
2
1084
270
2300
560
Sugnrcane
4
80
8
2 ¦
1084
270
230!!
560
2.6
SO
12
3
1667
410
3500
870
l.'licmical I'altov,
3
450
2
m
257
na
540
!!»
200
1
1
578
140
1201)
300
1,1
450
4
nu
550
nil
1200
tin
200
9
->
1238
310
2600
640
l,RP or giasslands
2
450
3
na
385
na
810
na
200
6
2
867
210
1800
4 50
Com
Sorghum
2
450
3
na
385
na
RIO
na
200
6
2
867
210
1800
450
1
450
6
na
771
na
1600
na
200
12
3
1734
430
3600
900
Roadsides
1
40
62
15
8669
2100
18.000
4500
n
3!
8
4335
1100
9100
2300
Sod farms
4 (FU
80
8
o
1084
270
2300
560
2
HO
16
4
2167
540
4600
1 mo
-------
.Scenario
Crop/lJsc Site
Rate1
Acres
Levels of Protection
Baseline
PPF/
KCs
Sliort Term
Inter-
mediate
Term
Short Term
Inter-
mciliute
Term
Short Term
Intcr-
mr.ilinte
Term
(Id Liquid
formulations tor
rights-of-way
sprayer
Roadsides
1
40
62
15
8669
2100
18,000
4500
Bermuda grass rights-of-way
2
31
8
4335
1100
9100
2300
(1c) Incorporating
liquid
formulations into
liquid or dry bulk
fertilizer
Commercial fertilizer for corn,
sorghum (PHBD data)
2
960 tons
sec engineering controls
64
ii a
500 tons
120
36
1
960 tons
120
na
500 tons
230
72
Commercial fertilizer for corn,
sorghum (Helix study data)
2
500 tons
see engineering controls
170
67
1
see engineering controls
350
130
On-farm fertilizer for corn,
sorghum
2
160
8
na
700
na
1900
nn
1
160
15
na
1400
na
3 B00
na
(2a) Dry flowablc
for aerial
application
Conifer forests
Christmas tree farms
4
350
66
16
105
26
380
130
Sugarcane
4
350
66
16
105
26
380
130
2.6
350
100
25
161
40
580
140
Chemical fallow
3
1200
26
na
4)
nn
150
na
350
88
22
140
35
500
120
1.4
1200
55
na
87
na
320
na
350
190
47
300
74
1100
270
CRT or grasslands
2
1200
38
na
61
na
220
na
43
-------
Levels of Protection
Scenario
Crop/Use Site
Rate1
Acres
Baseline
PPE:
fx:s
Short Terin
Inter-
mediate
Term
Short Term
Inter-
mediate
Term
Short Term
Inter-
mediate
Term
350
130
33
210
52
750
190
Corn
Sorghum
2
1200
38
na
61
na
220
n a
350
130
33
210
52
750
190
1
1200
77
n a
122
na
440
na
350
260
65
420
100
1500
370
Sod farms
4 (FL)
350
66
16
105
26
380
130
2
350
130
33
210
52
750
190
(2b) Dry flowable
for groundboom
application
Macadamia nuts
Guava
Conifers
4
80
290
71
459
110
1600
410
Sugarcane
4
80
290
71
459
110
1600
410
2.6
80
440
110
706
170
2500
630
Chemical fallow
3
450
68
na
109
na
400
na
200
150
38
245
61
880-
220
1.4
450
150
na
233
na
840
na
200
330
82
525
130
1900
470
CRP or grasslands
2
450
100
n a
163
na
580
na
200
230
57
367
91
1300
330
Corn
Sorghum
2
450
100
na
163
na
580
na
200
230
57
367
91
1300
330
44
-------
Scpnnrin
Crop/Use Site
Rale1
Acres
Levels of Protection
BnsL'litic
PPE2
ECs
Short Term
Inlcr-
nicdiatr
Term
Short Term
Inter-
mediate
Term
Short Term
Infor-
med bit t
Term
1
450
210
na
326
im
1200
nn
200
460
110
734
180
2600
650
Koailstdcs
1
40
2300
570
3672
910
13,000
3300
2
40
1200
290
1836
450
6600
1600
Sod farms
4(1-'L)
80
290
71
459
110
1600
410
2
80
580
140
91S
230
3300
820
(2clDry flowablc
for rights-of-way
Roadsides
1
40
2300
570
3672
910
13,000
3300
2
40
1200
290
1836
450
6600
1600
(3) Granular
formulations
Sod farms
2
80
1200
310
5023
1200
62,000
15,000
(16a) Wctlablc
powders fur aerial
application
Sugarcane
4
350
1,2
5.2
17
4.1
580
93
2,6
1.8
3
26
6.3
380
140
Chemical Fallow
3
1200
0.5
tin
6,5
n a
150
na
1/1
1
na
14
na
.110
nn
Corn, Sorghum
2
1200
0.7
na
9.7
nn
220
na
350
2.4
4
33
8.2
750
190
1
1200
1.4
na
19
na
440
na
350
4,7
7
66
16
1500
370
45
-------
Scenario
Crop/llsc Site
Rate'
Acres
Levels of Protection
Baseline
PPF.!
EC's
Short Term
Inter-
mediate
Term
Short Term
Inter-
mediate
Term
Short Term
Inter-
mediate
Term
(16b) Wcttable
powders lor
groundboom
application
Nlacadamia nuls
4
40
10
16
150
36
3300
820
Sugarcane
4
200
2.1
3
29
7.2
660
160
Sod farms (FL)
4
80
5.2
8
73
18
1600
410
Applicator
(4) Applying
liquids with
aircraft
Conifer forests
Christmas tree farms
4
350
See engineering controls
850
210
Sugarcane
4
350
Sec engineering controls
850
210
2.6
35
1300
320
Chemical fallow
3
1200
See engineering controls
330
na
350
1100
280
1.4
1200
710
na
350
2400
600
CRI' or grasslands
2
1200
See engineering controls
500
na
350
1700
420
Corn
Sorghum
2
1200
See engineering controls
500
na
350
1700
420
1
1200
990
na
350
3400
840
Sod farms
4 (FL)
350
See engineering controls
850
210
46
-------
Levels nf Protection
Scenario
Crop/Use Site
Rate'
Acres
Baseline
PPE-
EC's
Short Term
Inter-
mediate
Term
Sliort Term
Inter-
mediate
Term
Short Term
Inter-
mediate
Term
2
350
1700
420
(5) Applying
liquids by
groundboom'
Macadamia nuts
Guava
Conifers
4
80
860
210
1690
420
4000
980
Sugarcane
4
80
860
210
1690
420
4000
980
2.6
80
1300
330
2600
640
6100
1500
Chemical fallow
3
450
200
n a
401
99
940
na
200
460
110
901
220
2100
520
1.4
450
440
n a
858
210
2000
na
200
990
240
1931
480
4500
1100
CRP or grasslands
2
450
310
na
601
150
1400
na
200
690
170
1352
330
3200
790
Corn
2
450
310
n a
601
150
1400
n a
Sorghum
200
690
170
1352
330
3200
790
1
450
610
n a
1202
300
2800
n a
200
1400
340
2704
670
6400
1600
Roadsides
2
40
3500
850
6759
1700
16,000
3900
1
40
6900
1700
13519
3300
32,000
7900
Sod farms
4(FL)
80
860
210
1690
420
4000
980
2
80
1700
430
3380
840
8000
2000
47
-------
Scenario
Crop/Use Site
Rate'
Acres
Levels of Protection
Baseline
PPE:
FXs
Short Term
Inter-
mediate
Term
Short Term
Inter-
mediate
Term
Short Term
Inter-
mediate
Term
(6) Applying
liquids with a right
of way sprayer
Roadsides
2
40
67
16
300
74
not feasible
1
40
130
33
601
150
not feasible
(8) Applying
impregnated
fertilizer with a
tractor-drawn
spreader
Corn
Sorghum
2
320
190
n a
660
na
1000
na
160
380
n a
1300
na
1900
na
1
320
380
na
1300
n a
1900
na
160
900
na
2600
na
4000
n a
(9) Applying
granular product
with a tractor-
drawn spreader
Oil-farm fertilizer for corn,
sorgh uni
2
200
610
150
2221
550
3200
790
80
1500
380
5553
1400
7900
2000
1
200
1200
300
4442
1100
6400
1600
80
3000
750
11,100
2700
16,000
4000
Flagger
(15) Flagging
sprays
Conifer forest
Christinas tree farms
4
350
310
76
466
120
910
220
Sugarcane
4
350
310
76
466
120
910
220
2.6
350
480
120
717
180
1400
350
Chemical fallow
3
350
410
100
621
150
1200
300
1.4
350
880
220
1331
330
2600
640
CRP or grasslands
2
350
620
150
931
230
1800
450
Corn
2
350
620
150
931
230
1800
450
Sorghum
48
-------
Scenario
Crop/lJse Site
Rntc'
Acres
Levels of Protection
Rasclinc
PPE2
ECs
Short Term
Inter-
mediate
Term
Short Term
Inter-
mediate
Term
Short Tcnn
Inter-
mediate
Term
1
350
1200
310
1863
460
3600
900
Sod farms
4 (FL)
350
310
76
466
120
910
220
2
350
620
150
931
230
1800
450
lb ai/A or lb ai/gal
PPE Includes long-sleeved shirt and long pants, coveralls, chemical resistant gloves, and a respirator.
(16a) and (16b) are listed using minimum ppe (single layer, gloves, dust/mist respirator),
pounds of fertilizer treated per day
Scenario #5, Applying Liquids by Groundboom: the baseline assessment includes gloves.
I
49
-------
2) Lawn Care Operator Handler Risk
The Agency has determined that there is potential lor atrazine exposure to Lawn Care
Operators (LCOs) and other handlers mixing, loading and/or applying atrazine to turf in
accordance with the current use pattern. Fifteen major exposure scenarios have been identified
and are listed below.
(lb) mixing/loading liquid formulations for groundboom application,
(Id) mixing/loading liquid formulations for lawn handgun application (LCO),
(2b) mixing/loading dry flowable for groundboom application,
(3) loading granular formulations,
(5) applying liquids with groundboom sprayer.
(7) applying with a lawn handgun or compressed air sprayer,
(9) applying granular formulations with a tractor-drawn spreader,
(10) mixing/loading/applying with a backpack sprayer,
(11) mixing/loading/applying liquid formulations with a low pressure handwand.
(12a) mixing/loading/applying liquids with a lawn handgun or compressed air sprayer,
(12b) mixing/loading/applying WDG formulations with a lawn handgun,
(12c) mixing/loading/applying water soluble powder formulations with a lawn handgun,
(13) loading/applying granular formulations with a push type spreader, and
(14) loading/applying granular formulations with a bellygrinder.
The risk assessments for these scenarios are summarized in Table 15 below. With the use
of PPE, all scenarios are acceptable.
Table 15. Lawn Care Operator Margins of Exposure
Scenario
Crop/
Use
Site
Rale,
(lb
ai/A)
Acres
Levels of Protertion
Baseline
PFE
ECs
Short
term
Inter-
mediate
term
Short
term
Inter-
mediate
term
Short
term
Inter
mediate
term
Mixer/Loader
(lb) Liquid
formulations for
groundboom
application
golf
course
turf
2
40
31
8
4335
1100
9100
2300
(1 d) Liquid
formulations for
lawn handgun
application
lawn,
golf
courses
2
100
12
3
1734
430
3600
900
50
-------
Scenario
Crop/
Use
Site
Rale
(lb
ai/A)
Acres
Levels of Protection
Baseline
PPF.
ECs
Shorl
term
Inter-
mediate
term
Short
term
inter
rrudiiitc
term
Short
tern!
Inter-
mediate
. tern:
(2b) Dry flowabk for
groundboom
application
golf
course
turf
2
40
1200
290
1836
450
6600
1600
(3) Granular
formulations (loading)
golf
course
turf
2
40
2S00
610
10,047
2500
120K
31,000
Mixer/Loader/ Applicator
(10) Liquid via
backpack sprayer
lawns.
golf
courses
2
5
see PPE
428
110
not feasible
(11) Liquid via low-
pressure handwand
lawns,
golf
courses
2
5
7
1549
380
not feasible
(12a) Liquid via lawn
handgun and
compressed air sprayer1
lawns,
golf
courses
2
5
see PPE.
1400
gloves
340
gloves
not feasible
(12b) WDCt via lawn
haidgun1
lawns,
golf
courses
2
5
see PPE
1100
gloves
290
gloves
not feasible
(12c) WSP via lawn
handgun1
lawns,
golf
courses
2
5
see PPii
920
gloves
230
gloves
not feasible
(13) Granular via push
type spreader
(ORETF)1
lawns,
golf
courses
2
5
1500
380
2100
gloves
520
gloves
not feasible
(14) Granular via belly
j grinder
lawns.
golf
courses
2
1
330
82
616
ISO
not feasible
Applicator
(5) Applying liquids by
grautidboom
golf
course
turf
40
3500
850
6759
1700
16.000
3900
(7) Applying liquids
with a handgun
fOREll )' *"
lav.) Li.
golf
courses
2
5
see PPE
980
gloves
240
gloves
not feasible
51
-------
Scenario
Crop/
Use
Site
Rate
(lb
ai/A)
Acres
Levels of Protection
Baseline
PPI
ECs
Short
term
Inter-
mediate
term
Short
term
Inter-
mediate
term
Short
term
Inter-
mediate
term
(9) Applying granular
formulations with a
tractor-drawn spreader
golf
course
turf
T
X.
40
3000
750
11,100
2700
16,000
4000
Footnote:
PPE for scenarios 12(a), 12(b). 12(c), 13 and 7, include baseline (long-sleeved shirt, pants, shoes and socks)
plus gloves.
3) Post-Application Occupational Risk
Post-application exposure to workers through entry into agricultural fields treated with
atrazine was also considered in the occupational risk assessment. These activities result in
potential short-term exposures. All post-application risk estimates were below the Agency's
level of concern. MOEs ranged from 100 to 220,000.
4) Epidemiology Data
An epidemiology study was conducted of workers at the Syngenta St. Gabriel plant where
atrazine is manufactured. That study reported a statistically significant increase in the incidence
of prostate cancer among plant workers. The Agency, upon review of this study, requested
additional information on the exposure profile of the employees diagnosed with prostate cancer
and this information was provided and reviewed. Based on this review, it appears that most of
the increase in prostate cancer incidence at the St. Gabriel plant is likely due to intensive prostate
specific antigen (PSA) screening of employees conducted as part of the company's "Wellness
Program." The study was insufficiently large and has limitations that prevent ruling out atrazine
as a potential contributor to the increase observed. On balance, however, a role for atrazine
seems unlikely because prostate cancer was found primarily in active employees who received
intensive PSA screening; there was no increase in advanced tumors or mortality; and proximity
to atrazine manufacturing did not appear to be correlated with risk.
Atrazine has also been tied to inflammation of the prostate in laboratory animals and
changes in testosterone levels at high doses. However, neither condition has been tied to the
increased risk of prostate cancer and the Agency concludes the animal data do not provide
biologically plausible evidence to support atrazine as a cause of prostate cancer.
Other cancers besides prostate were found to have an elevated, though not statistically
significant, increase in risk at the St. Gabriel plant. Other studies have suggested an increased
risk lor ovarian, breast, and other cancers, including non-IIodgkin's lymphoma. However, these
studies are at best preliminary and should not serve as a basis for implicating atrazine as a human
carcinogen due to their methodological limitations.
52
-------
In addition, the Agency understands that Syngenta will be conducting a case control study
on male employees at the St. Gabriel plant to examine the relationship between atrazine exposure
estimates and the presence or absence of prostate cancer among cases and controls. We expect to
receive and review this study during the third quarter of 2003 and to incorporate the results into
the October revision to the IRED.
Further, the National Cancer Institute's (NCI) preliminary analysis of the National
Institute of Environmental Health Sciences (NIEIIS) Agricultural Health Study has found no
association between prostate cancer and atrazine in one of the largest and best-designed
epidemiological studies ever conducted. NCI expects to publish a final analysis this summer.
The Agency will fully consider additional results from the NCI analysis when it becomes
available.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For
detailed discussions of all aspects of the environmental risk assessment, see the April 22, 2002,
Reregistratior. Eligibility Science Chapter for Atrazine - Environmental Fate and Effects Chapter
and the "Steeger Document'" available in the public docket and on the internet at
www.epa.gov/pesticides/reregistration. There were no major revisions to the ecological risk
assessment.
1. Environmental Fate and Transport
Atrazine is mobile and persistent in the environment and, as such, atrazine is expected to
be present in surface water and groundwater. This is confirmed by widespread detection in
surface water and groundwater. The main route of dissipation is microbial degradation under
aerobic conditions.
Atrazine can reach nearby non-target plants, soil, and surface water via spray drift during
application. Atrazine is applied directly to target plants during foliar application or directly to
soil during the more frequent pre-plant and pre-emergent applications. Atrazine cars be
transported indirectly to soil due to incomplete interception during foliar application and washoff
subsequent to foliar application. Atrazine is unlikely to undergo rapid degradation on foliage
because atrazine is resistant to abiotic hydrolysis (stable at pHs 5, 7, and 9), resistant to direct
aqueous photolysis (stable under sunlight at pH 7), and is only moderately susceptible to
degradation in soil (aerobic laboratory half-lives of 3-4 months). For aquatic environments
reported half-lives were much longer. In an anaerobic aquatic study, atrazine's overall half-life,
water half-life, and sediment hall-life were given as 60S, 578, and 330 days, respectively.
Atrazine is also unlikely to undergo rapid volatilization from foliage because it has a
relatively low Henry's Law constant (2.6 X 10"' atm-mVmol). But this may be offset by atrazine;s
relatively low octanol/water coefficient (Log K0,v ~ 2 .7), and soil/water partitioning coefticents
(Freundlich K_,d5 values < 3 and often < 1). In addition, atrazine has relatively low adsorption
53
-------
characteristics; this indicates that atrazine may undergo substantial washoff from foliage.
In terrestrial field dissipation studies performed in Georgia, California, and Minnesota,
alrazine dissipated with half lives of 13, 58, and 261 days, respectively. The differences between
these reported half-lives could be attributed to the temperature variation between the studies in
which atrazine was seen to be more persistent in colder climate. Long term field dissipation
studies also indicated that atrazine could persist over a year in such climatic conditions. A
forestry field dissipation study in Oregon (aerial application of 4 lb ai/A) estimated an 87 day
half-life for atrazine on exposed soil, a 13 day half-life in foliage, and a 66 day half-life on leaf
litter.
Atrazine metabolites, desethylatrazine (DEA) and desisopropylatrazine (DIA) were
detected in all anaerobic aquatic metabolism studies submitted, and hydroxyatrazine and
diaminochloroatrazine (DACT) were detected in all but one of the anaerobic aquatic metabolism
studies submitted. Desethylhydoxyatrazine (DEHA) and desisopropylhydroxyatrazine (DIHA)
were also delected in one of the aerobic studies. All of the chlorinated metabolites and hydroxy
compounds detected in laboratory metabolism studies were present at much less than 10% of
applied atrazine; thus, are not considered by the Agency to be "major degradates."
For studies limited to several months, the relative concentrations of the metabolites in soil
were generally as follows: DEA>DIA>DACT~hydroxyatrazine. However, lor an aerobic soil
metabolism study and an anaerobic aquatic metabolism study both lasting a year, the
concentration of hydroxyatrazine was comparable to that of DEA over the last few months of the
studies. In addition, some literature indicates that higher quantities of hydroxyatrazine can be
formed in soil and in sediment under acidic conditions. Other hydroxy compounds have only
rarely been detected in lab studies.
The soil/water partitioning of atrazine, DEA, DIA, and DACT are relatively low as shown
by Frcundlicli adsorption coefficients of < 3 and often < 1 for 4 different soils. The Freundlich
adsorption constants for hydroxyatrazine are substantially greater, being approximately 2 for
sand, but 6.5. 12.1. and 390 for a sandy loam, loam, and clay soil, respectively. No
adsorption/desorption data are available for other hydroxy-triazine degradates. However, the
higher soil/water partitioning exhibited by hydroxyatrazine compared to atrazine suggests that the
other hydoxy-triazines are likely to exhibit higher soil/water partitioning than corresponding
chloro-triazine degradates.
In a limited study on atrazine and its chlorodegradates in surface water source CWS, the
detection of all was relatively widespread. However, atrazine predominated with the relative
order of concentrations generally being as follows; atrazine»DEA>DIA~DACT.
In a 1999 study of rural wells, the four hydroxy compounds were detected.
Hydroxyatrazine was detected the most frequently and generally at the highest level, but not to
the same extent as atrazine or the chlorinated metabolites. Unlike in surface water, where
atrazine concentrations were generally much greater than chlorotriazinc concentrations, the DEA
54
-------
and DACT concentrations in rural wells were often comparable to those of atrazine. The relative
order of concentrations found in rural wells was generally
atrazine -DEA~DACT>DlA>hyaroxyatrazinc .
The relatively widespread detection of atrazine and various chlorinated metabolites in the
surface water study on metabolites and in the ! 999 rural well study is consistent with the
widespread use of atrazine, the persistence of atrazine and the mobility of atrazine and its
chlorinated metabolites. The lower frequency of detection and generally lower levels of the
hydroxyatrazinc in the rural well study is consistent with its higher soil/water partitioning than
atrazine and the chlorinated metabolites.
The available fate and ground water data indicate that hydroxy compounds are unlikely to
significantly contaminate surface water. They are not appreciably formed in soil, and they are
likely to exhibit higher soil/water partitioning than corresponding chlorinated metabolites. In
addition, they were detected much less frequently and at much lower levels than the chlorinated
metabolites in rural wells. However, hydroxyatrazinc was detected at concentrations up to 6.5
ppb in 6% of rural wells sampled. Also, there have been reported concentrations of
hydroxyatrazine in soil sometimes approaching and possibly in some cases (e.g.. acidic soils)
exceeding that of DEA.
Atrazine should be somewhat persistent in groundwater and in surface water with
relatively long hydrologic residence times where advective transport is limited. The reasons for
this are the resistence of atrazine to abiotic hydrolysis and to direct aqueous photolysis, its only
moderately susceptibility to biodegradation. and its limited volatilization potential as indicated
by a relatively low Henry's Law constant. Atrazine has been observed to remain at elevated
concentrations longer in some reservoirs than in flowing surface water or in other reservoirs with
presumably much shorter hydrologic residence times in which advective transport greatly limits
its persistence.
The relatively low soil/water partitioning of atrazine and chlorinated metabolites indicates
that their concentrations in or on suspended and bottom sediment will be in equilibrium with the
residues in the water column. However, despite relatively low soil/water partitioning, limited
data indicated that activated carbon can be effective in reducing atrazine and its triazine
metabolite concentrations by several fold, depending upon the frequency and conditions of its
use.
Volatility as a route of field dissipation raises concerns about the atmospheric fate of
atrazine, its aerial transport and whether aerial deposition poses the potential for risks to non-
target terrestrial plants. The potential for adverse effects on sensitive, non-target crops and
plants from atmospheric deposition is uncertain. Atrazine has been widely detected in rainfall,
with the highest concentrations occurring in the Midwestern corn belt during the application
season (mid-April through mid- July). In addition, DEA and DTA were also detected in rainfall
together with atrazine. High ratios of DEA to atrazine were attributed to atmospheric
degradation. Mass deposition of atrazine and its metabolites is higher in the midwestem com
55
-------
belt, and decreases with distance away from the corn belt.
2. Risk to Terrestrial Organisms
The Agency's ecological risk assessment compares toxicity endpoints from ecological
studies to estimated environmental concentrations (EECs) based on environmental fate
characteristics and pesticide use data. To evaluate the potential risk to non-target organisms from
the use of atrazine products, the Agency calculates a Risk Quotient (RQ) by determining the ratio
of the EEC to the toxicity endpoint values, such as the median lethal dose (LD50) or the median
lethal concentration (LC50). These RQ values are then compared to the Agency's levels of
concern (LOCs) to determine whether or not a chemical, when used as directed, has the potential
to cause adverse effects to non-target organisms. In general, the higher the RQ, the greater the
concern. When the RQ exceeds the LOC for a particular category (e.g., endangered species), the
Agency presumes a risk of concern to that category of non-target organisms. The LOCs and the
corresponding risk presumptions are presented in Table 16.
Table 16. LOCs and Associated Risk Presumptions
If...
Then (he Agenry presumes....
Birds and Mammals
Acute RQ > LOC of 0.5
acute risk
Acute RQ > l.OC of 0.2
risk that may be mitigated through restricted use classification
Endangered Species
Acute RQ > LOC of 0.1
acute effects may occur in endangered species
Chronic RQ > LOC of I
chronic risk and chronic effects may occur in non-target organisms
Aquatic Animals
Acute RQ > l.OC of 0.5
acute risk
Acute RQ > LOC of 0.1
risk that may be mitigated through restricted use classification
Endangered Species
Acute RQ > LOC of 0.05
acute effects may occur in endangered species
Chronic RQ " LOC of 1
chronic risk and chronic effects- may occur in non-target organisms
Terrestrial and Semi-Aquatic Plants
Acute RQ > LOC of 1
acute risk
Acute RQ > l.OC of 1
risk that may he mitigated through restricted use classification
Endangered Species
Acute RQ > LOC of 1
acute effects may occur in endangered species
Chronic RQ > l.OC of i
chronic risk and chronic effects may occur in non-target organisms
56
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a. Toxicity (Hazard) Assessment
Atrazine is practically non-toxic to slightly toxic to birds and mammals, and relatively
non-toxic to honey bees.
As expected for a herbicide, alxazine is toxic to non-target plants. Terrestrial plant
seedling germination tests indicate that cucumber is the most sensitive dicot and oats is the most
sensitive monocot. Terrestrial plant seedling emergence tests indicate that the dicot most
sensitive to atrazine is carrot, and the monocots most sensitive to atrazine are oats and ryegrass.
Terrestrial plant vegetative vigor tests indicate that the most sensitive dicot is cucumber and the
most sensitive monocot is onion.
The acute and chronic toxicity values used to assess risks are presented in Tables 17 and
18 below.
Table 17. Summary of Toxicity Data for Terrestrial Aoimals
Species
Acute Toxicity (ppm)
Chronic Toxicity (ppm)
LD50
Acute
Oral
Toxicity
5-day
LD5,000
practically
non-toxic
225/675
decreased egg
production, increase
in defective eggs,
decreased embryo
viability, decreased
body weight
Honey bee
Apis meliferus
96.69
relatively
non-toxic
-
--
-
-
Laboratory rat (mg/kg)
1.869 -
3,080
practically
non-toxic
--
-
50
See health effects
endpoints
Tabic 18. Summary of Toxicity Data for Non-Target Terrestrial Plants
Species
Seedling Germination
Toxicity
Seedling Emergence
Toxicity
Vegetative Vigor
Toxicity
EC25/
ECUS
Endpoint
EC25/
NOAEC
Endpoint
EC25/
NOAEC
Endpoint
Monocots
Oat - A vena sattva j 1.8/0.12
i i
reduction in { 0.0004/ reduction
radical length 0.0025 j in dry wt.
2.4/2.0
reduction
in dry wt.
57
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Table 18. Summary of Toxicity Data for Non-Target Terrestrial Plants
Species
Seedling Germination
Toxicity
Seedling Emergence
Toxicity
Vegetative Vigor
Toxicity
1;X'25/
F.C05
Emlpoint
EC25/
N O AF C
Endpoint
EC25/
NO AFC
Endpoint
Onion - Allium cepa
<4.0/<4.0
no effect
0.009/
0.005
reduction
in dry wt.
0.61/0.5
reduction
in dry wt.
Dicots
Carrot - Dauctis carota
<4.0/<4.0
no effect
0.003/
0.0025
reduction
in dry wt.
1.7/2.0
reduction
in plant
height
Cucumber - Cucumis sativus
0.80/0.60
reduction in
radical length
0.013/
0.005
reduction
in dry wt.
0.008/
0.005
reduction
in dry
weight
b. Exposure and Risk - Birds and Mammals
The Agency's acute ecological risk assessment for terrestrial wildlife considers exposure
to atrazinc from the ingestion of residues on food. Terrestrial EECs were derived for the three
major crops using the maximum labeled use rates (4 lb ai/A for sugarcane and 2 lb ai/A for corn
and sorghum) and the highest value measured for foliar dissipation half-life from the application
of atrazine to turf in the Southeastern United States: 17 days. Since foliar dissipation half-lives
are used in estimating these EECs, the EECs better represent post-emergent applications than
pre-plant and pre-emergence applications made directly to soil.
No acute LOCs are exceeded for mammals; however, in some scenarios, restricted use
and endangered species LOCs are exceeded. RQ values for small mammals are cited in the table
below. Acute endangered species LOCs are exceeded for small herbivorous mammals (RQ
range: 0.0092 - 0.13) at 1.1 and 1.2 lb ai/A. All acute avian RQs are significantly below all
LOCs indicating that there is negligible potential for acute risks to birds
The chronic LOC is exceeded for birds (RQ range: 0.08 - 4.3) and mammals (RQ range:
1.6 - 96) suggesting the potential for chronic risks to mammals and birds from atrazine applied at
typical and maximum use rates.
It is important to consider that exposure of birds and mammals to atrazine applied as a
pre-plant or pre-emergent herbicide is primarily a result of ingestion of earthworms and other soil
organisms that can serve as a food source and inadvertent ingestion of soil. Methods are not
available to determine the levels of atrazine that could occur in soil and in earthworms and other
soil organisms that are used as food sources by birds and mammals. The resulting levels of
atrazine in soil and soil organisms thai can serve as a source of food for birds and mammals are
58
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expected to be considerably lower than estimated levels in plants used as food sources. As such.
risk quotients based on EECs from maximum foliar dissipation half-life data, as presented in this
document, are over-estimates for birds and mammals that are exposed from ingestion of soil
organisms.
The primary effects of concern for herbicides and wildlife are indirect.
Table 19. Acute and Chronic Risk Quotients for Terrestrial Organisms
Organism
Size of
Organism
(grams)
Range of EEC
(ppm)
Acute RQ
Subacute
Dietary RQ
Chronic
RQ (Repro)
Sugarcane: 1 Preplant Aerial Application 4 lb ai/A (maximum labeled use rate)
Mammalian Herbivores
15
60-960
0.031-0.49
1.2-19.2
Mammalian Insectivores
15
60 - 540
0.031 -0.27
Mammalian Granivores
15
60
0.0067
Avian Species
60-960
-
<0.012-<0.19
0.27-4.3
Sugarcane: 1 Preplant Aerial Application 2.6 lb ai/A (typical use rate)
Mammalian Herbivores
15
39 - 624
0.020 - 0.32
0.78 - 12.48
Mammalian Insectivores
15
39- 151
0.020 - 0.08
Mammalian Granivores
15
39
0.0044
Avian Species
39 - 624
-
<0.0078 -
<0.12
0.17-2.8
Corn and Sorghum: 1 Preplant Aerial Application at 2.0 lb ai/A (maximum labeled rate)
Mammalian Herbivores
15
30-480
0.015-0.24
0.6-9.6
Mammalian Insectivores
15
30-270
0.015-0.14
Mammalian Granivores .
15
30
0.34
Avian Species
30 - 480
-
<0.0060 -
<0.096
0.13-2.1
Corn: 1 Preplant Aerial Application at 1.1 lb ai/A (typical use rate)
Mammalian Herbivores
15
16.5-264
0.0084-0.13
0.3-5.28
Mammalian Insectivores
15
16.5- 14S.5
0.0084 - 0.075
Mammalian Granivores
15
16.5
0.0019
Avian Species
16.5-264
-
<0.0033 -
<0.053
0.73 - 1.2
59
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Table 19. Acute and Chronic Risk Quotients for Terrestrial Organisms
Organism
Size of
Organism
(grams)
Range of EEC
(ppm)
Acute RQ
Subacute
Dietary RQ
Chronic
RQ (Rcpro)
Sorghum: 1 Preplant Aerial Application at 1.2 lb ai/A (typical use rate)
Mammalian Herbivores
15
18-288
0.0092 -0.15
0.36 - 5.76
Mammalian lnsectivores
15
18 - 162
0.0092 - 0.082
Mammalian Granivores
15
18
0.0020
Avian Species
18-288
-
<0.0036 -
<0.058
0.08 - 1.1
c. Exposure and Risk - Terrestrial Plants
Atrazine applications to crop and non-crop areas result in exposure to non-target plants in
areas adjacent to treated fields via spray drift and/or runoff. The Agency's assessment compares
standard residue values for runoff and drift for exposure and compares these exposure values to
toxicity data available for non-target species. Spray drift levels for ground and aerial applications
are 1 and 5 percent, respectively. Atrazine is highly mobile in soils and has a low soil-water
partitioning coefficient and a water solubility value of about 33 ppm. Its runoff is estimated at 2
percent. The scenario for plants growing in dry areas receive runoff from 1 hectare to 1 hectare,
while a 1-hectare wet area receives runoff from 10 hectares. All plant toxicity values are present
as pounds active ingredient per acre (lbs ai/A). The EC25 values are used to calculate risk
quotients for the typical non-target plants and the NOAEC values are used for endangered and
threatened plant species. Although the Agency currently only has data on crop species, the
results are assumed to represent a range of wild plants. The assessment assumes that terrestrial
plants living in wetter habitats arc at greater risk because they are exposed to runoff more than
drier areas. The assessment resulted in cxccedences for ground and aerial applications of
atrazine at typical and maximum labeled rates. RQs based on the maximum labeled use rate are
presented in Table 20 below.
RQs from three test species exceed the typical plant LOC from spray drift alone
(cucumber, soybeans, and cabbage), 8 test species (in dry areas) or 9 test species (in wetter areas)
exceeded the LOC from spray drill plus runoff. Both monoeot and dicot species have exceeded
the level of concern.
Endangered species exceedences for direct effects on terrestrial plants indicate potential
risks to endangered species. RQs from 9 test species exceeded the endangered species LOC from
spray drift alone or from spray drift plus runoff. The level of concern for endangered terrestrial
plant species is exceeded for both monocots and dicots. These results indicate concern for
endangered plant species growing in areas adjacent to atrazine-treated fields from combined
spray drift and runoff.
60
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A ground application of 2 lbs ai/A poses a diminished risk to adjacent crops compared to
4 lb ai/A applications, but only one of these species (i.e.. soybeans from spray drill) would no
longer exceed the acute level of concern. At the typical com use rate of 1.1 lbs ai/A, the non-
target crops at risk are cucumbers from spray drift, 7 out of 9 non-target species growing in dry
habitats, and all 9 non-target species, if grown in semi-aquatic habitats. Risk quotients for
endangered plant species indicate concern for endangered species growing in areas adjacent to
atrazine-treated fields from combined spray drift and runoff.
Table 20. Risk Quotients for Terrestrial Plants
Crop
4 lbs ai./A; Aerial Application
4 lbs ai./A; Ground Application
Spray Drift
(5%)
Spray Drift + Runoff
Spray Drift
(1%)
Spray Drift + Runoff
Typ
ES1
Dry Areas
Wet Areas
Typ
ES
Dry Areas
Wet Areas
Typ
ES
Typ
ES
Typ
ES
Typ
ES
Carrot
0.12
0.10
83
99
230
270
0.024
0.02
40
48
280
340
Oats
0.083
0 10
62
99
170
270
0.017
0.02
30
48
210
340
Ryegrass
<0.05
<0.05
62
50
170
140
<0.01
<0.0 i
30
24
210
170
Lettuce
0.61
0.80
50
50
140
140
¦0.12
0.16
24
24
170
170
Onion
0.33
0.40
28
50
76
140
0.066
0.08
13
24
93
170
Cucumber
25
40
19
50
52
140
5.0
8.0
9.2
24
65
170
Soybean
7.7
10
1.3
9.9
3.5
27
1.5
2.0
0.63
4.8
4.4
34
Cabbage
14
40
18
25
49
68
2.9
8.0
8.6
12
60
84
Tomato
0.28
0.40
7.3
25
20
68
0.056
0.08
3.5
12
25
84
Corn
<0.05
<0.05
<0.06
<0.06
<0.17
<0.17
<0.01
<0.01
<0.03
<0.03
<0.21
<0.21
1 F.S - Endangered Species; Typ. - typical Species
3. Risk to Aquatic Species
To assess the risks to aquatic plants and animals from the use of atrazine, the Agency first
conducted a screening-level RQ assessment similar to that described above for terrestrial
organisms. This screening-level assessment was conducted only for freshwater species. The
Agency also conducted a refined assessment to further evaluate the potential risks to aquatic
organisms and local communities and populations. Estuarine and saltwater species were
assessed as part of the refined assessment.
a. Toxicity (Hazard) Assessment
Atrazine is slightly to moderately toxic to freshwater fish and slightly to highly toxic to
61
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freshwater invertebrates. Atrazine is slightly to moderately toxic to estuarine/marine fish and
slightly to very highly toxic to estuarine/marine invertebrates. Tables 21 and 22 summarizes the
endpoints used in the screening-level risk assessment of aquatic animals and plants.
Table 21. Summary of Toxicity Data for Aquatic Organisms
Species
Acute Toxicity (ppb)
Chronic Toxicity (ppb)
96-hr
LCso
Acute Toxicity
NOAEC/
LOAEC
Affected Endpoints
Freshwater Fish
Rainbow trout - Oncor'nynchus my kiss
5,300
moderately toxic
-
-
Brook troul - Salvclimts tontinalis
6,300
moderately toxic
65/120
reduced mean
length, mean body-
weight
Freshwater Invertebrates
Midge - Chironomv.s tentans
720
highly toxic
110/230
reduction in
pupation and adult
emergence
Scud - Gaminarus fasciatus
5700
moderately toxic
60/140
reduction in
development
Mysid shrimp - Amcricamysis bahia
1000
highly toxic
80/190
reduction in adult
survival
5400
moderately toxic
Table 22. Summary of Toxicity Data for Non-Target Aquatic Plants
Species
Short Term Exposure
(10 days or less)
Longer Term Exposure
(>10 days)
Concen-
tration
(PPb)
Response
Concen-
tration
(PPb)
Response
Freshwater Vascular Plants
Duckweed - f^mria gihba
170
50% reduction in
growth
37
50% reductio in growth
(l.OAEC = 3.4, i~9%
reduction in growth;
NOAEC < 3.4)
43
50% reduction in growth
(NOAEC = 10)
Freshwater Non-Vascular Plants
Chlorophyceae - Kirchneria
subcapitata (Selenasirvm
capricornutum)
49
50% reduction in cell
growth (NOAEC =
16)
62
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b. Exposure and Risk
For the screening-level assessment, to assess potential risk to aquatic animals and plants
in ponds, the Agency uses a computer model to predict the EECs of atrazine in water. Peak
EECs are compared to acute toxicity endpoints to derive acute RQs. Normally, chronic RQs are
derived using 96-hour and 21- to 90-day EECs, corresponding to the duration of the test. For
atrazine, 21-day EECs were generally used for chronic exposures, because the difference in EEC
values is small. To estimate chronic risk to fish, both 21-day and 90-day EECs were used: EECs
are presented in Table 23 below. Calculated RQs of concern are summarized below and
presented in Table 23.
Table 23. EECs Used in the Atrazine Aquatic Risk Assessment for Ponds
Crop
l.se Rates
(lb ai/A)
Atrazine EEC Values ppb (fig/L)
Peak Cone.
96-bour Average
21-day
Avernge
60-day
Avernge
90-dav
Average
Sugarcane
4.0
205
204
202
198
194
2.6
133
133
131
129
126
Corn
2.0
38.2
38.0
37.2
35.5
34.2
1.1
21.0
20.9
20.5
17.7
18.8
Sorghum
2.0
72.7
72.3
70.6
67.7
65.9
1.2
43.6
43.4
42.4
40.6
39.5
For the sugarcane scenarios, atrazine applied at either the 2.6 lbs/ai/A or 4.0 lbs ai/A rate
exceeds the levels of concern for acute toxicity to aquatic plants, restricted use for aquatic
invertebrates, and endangered species for aquatic invertebrates and aquatic vascular plants. In
addition, the chronic LOC is exceeded for aquatic plants, fish and aquatic invertebrates resulting
from both the maximum use rate and the typical use rate for sugarcane.
For the 2.0 lb rate corn scenario, atrazine exceeds the levels of concern for acute toxicity
for aquatic plants and for endangered species for aquatic invertebrates and aquatic vascular
plants. The acute RQs for freshwater fish, and the chronic RQs for freshwater fish and aquatic
invertebrates do not exceed levels of concern. For the 1.1 lb. rate com scenario, atrazine
exceeds the LOC for endangered species for aquatic vascular plants. The remaining calculated
RQs do not exceed levels of concern.
For the 2.0 lb rate sorghum scenario, atrazine exceeds the LOC for acute toxicity for
aquatic plants, restricted use for aquatic invertebrates, endangered species for aquatic
invertebrates,, and aquatic vascular plant species. The levels of concern for chronic effects are
exceeded by chronic RQs for aquatic plants, fish and aquatic invertebrates. For the 1.2 lb. Rate
sorghum scenario, atrazine exceeds the LOC for acute toxicity for vascular plants, endangered
species for aquatic invertebrates, and endangered species for aquatic vascular plaints. The acute
and chronic RQs for freshwater fish and aquatic invertebrates do not exceed levels of concern.
63
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Table 24. Acute and Chronic Risk Quotients for Freshwater Aquatic Species
Organism
Acute
Chronic
EEC
f ppb) J RQ
EEC (ppb) RQ
Sugarcane: 1 Preprint Aerial Application at 4.0 lb ai/A
Freshwater Fish
205
0.039
194 - 202
2,9-3.1
Aquatic Invertebrate
0.28
202
3.4
Freshwater Vascular Plant
5.5
--
Freshwater Vascular Plant
(NOECf
>60.3
--
-
Freshwater Algae
4.2
~
..
Sugarcane: 1 Preplan! Aerial Appliation at 2.6 lb ai/A
Freshwater 1 ish
133
0.025
126- 133
1.9-2.0
Aquatic Invertebrate
0.18
131
2.2
Freshwater Vascular Plant
3.6
-
freshwater Vascular Plant
(NOECJ*
>39,1
--
--
Freshwater Algae
2.7
--
Corn: I Preplant Aerial Application at 2.1) lb ai/A
Freshwater 1 ish
38.2
0.0072
34.2 - 37.2
0.53-0.58
Aquatic Invertebrate
38.2
0.053
37.2
0.63
Freshwater Vascular Plant
37.2
1.0
Freshwater Vascular Plant
(NOECy
37.2
>11
-
-
Freshwater Aigac
38.2
0.78
-
Corn: 1 Preplant Aerial Application at 1.1 lb ai/A
Freshwater Fish
21.0
0.0040
18.8-20.5
0.29 - 0.32
Aquatic Invertebrate
21.0
0.029
20.5
0.34
Freshwater Vascular Plant
20.5
0,56
-
-
Freshwater Vascular Plant
CNOF.Cr
20.5
>6.0
-
64
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Table 24. Acute and Chronic Risk Quotients for Freshwater Aquatic Species
Organism
Acute
Chronic
EEC
(PPb)
RQ
EEC (ppb)
RQ
Freshwater .Algae
21.0
0.43
~
Sorghum: 1 Preplan! Aerial Application at 2.0 lb a21
-
--
Freshwater Algae
72.7
1.5
~
--
Sorghum: 1 Pi eplant Aerial Application at 1.2 lb ai/A
Freshwater Fisli
43.6
0.0082
39.5-42.4
0.61 -0.65
Aquatic Invertebrate
43.6
0.061
42.4
0.71
Freshwater Vascular Plant
43.6
1.2
--
-
Freshwater Vascular Plant
(NOEC)*
43.6
>13
-
-
Freshwater Aigae
43.6
0.89
»
-
-
* Endangered species RQ calculation
In addition to the risks described above, indirect effects on fish and aquatic invertebrates
may be severe due to the loss of up to 60 to 95 percent of the vegetative cover, which provides
habitat to conceal young fish and aquatic invertebrates from predators. Numerous studies have
described atrazine's ability to inhibit photosynthesis, change community structure, and cause the
mortality of aquatic flora at concentrations between 20 and 500 ppm.
5. Refined Aquatic Assessment
The refined atrazine aquatic risk assessment focuses on aquatic plants and invertebrates
and the potential for effects on sensitive plant species to result in community-level impacts that
affect a range of aquatic organisms. The assessment is broken down by the type of water body
(i.e.. small static fresh water bodies such as ponds, flowing fresh water such as streams and
rivers, larger bodies of fresh water such as lakes and reservoirs, and estuarine and marine
habitats). Exposure for these three types of aquatic environments was estimated using PRZM-
F.XAMS modeling simulations (ponds) and monitoring data (streams, lakes and reservoirs, and
estuarine/marine environments - relined aquatic assessment). The April 22, 2002, Environmental
Fate and Effects Chapter presents figures that plot atrazine concentrations against exccedence
65
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probabilities to illustrate the effects that are likely or estimated to occur in these aquatic
environments.
The Agency's refined aquatic risk assessment is based on ecotoxicological data,
microcosm and mesocosm studies, and the monitoring data described above. A large number of
laboratory, microcosm, mesocosm, and actual field studies found in the literature suggest that
atrazine concentrations measured in the environment could reach levels that are likely to have
negative impact on sensitive aquatic species and communities.
Tables 25, 26 and 27 summarize the toxicological endpoints used in the refined risk
assessment.
Table 25. Key Endpoints for the Lentic Freshwater Environment (e.g., reservoirs, lakes).
The Endpoints Chosen for Use in the Refined Risk Assessment are Bolded.
key (.roup of
Non-larget
Organisms
Type of Study
Measurement Fndpoint
1 est Organisms /
EITllt
Assessment bndpnint
Fish
Lab
Acute Fish (%-hours) LC50 =
5.300 pg/L
Rainbow trout /
Mortality
fish Mortality Estimated to Occur a!
5300 pg/L
Lab
Chronic Fisil (44-weeks)
NOAEC = 65 pg/L LOAEC=
120 ug'L, MAI C 88 pg/L
Brook trout / [7.2
% red. mean
length. 16 % red.
mean body
weight]
Reduction in Fish Growth Estimated to
Occur at 88 pg/L
Distribution of
1 .ah Data
10"' ccntile value - 62 pg/L
Freshwater
Aquatic Animal
Chronic Data
Fish Papulation Reductions Estimated
to Occur at 62 pg/L
Field
(me.socosms)
96% Reduction in H of Young
fish Occurred at 20 |ig/L
(Caused by Loss of hood and
Habitat)
Blttegill sunfish
Fish Populations Likely In be
Reduced at 20 p<>/L due to Loss- or
Fuod and Habitat
Invpilehrstos
Lab
Acute Invertebrate (48-hour)
LCS0 - 720 pg/L
Midge / Mortality
Invertebrate Mortality- L'stimated to
Occur at 720 pg/L
Lab
Chronic Invertebrate (48-hour)
NOAEC = 60 pg/L: L()AHC=
140 pg/L; MATC- 92 pg/L
Scud / [25 % red.
in development of
F, to seventh
instar]
Reduction in Invertebrate Populations
Estimated to Occur at 92 pg/I.
Distribution of
Lab Data
10'k ccntiie value = 62 pg'L
Freshwater
Aquatic Animal
Chronic Data
Reduction in Invertebrate
Populations Estimated to Occur at
62 ns/f
field
i'9-65% Reduction in Daphnid
population growth occurred at
10 an/I, over 18-days
Daphnids
Invertebrate Populations Likely to he
Reduced at 10 ug/L
\on~Vasrulai
Plants
Lab
Acute Algae (1-week) EC5- = 1
pg/L
four species
[41-93%
reduction in
chlorophyll
production]
Reduction in Primary Production
Estimated to Occur al 1 pg/1
66
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Key Group of
Nun-targei
Onanisms
Type of Study
Measuremcnt Lndpoint
Test Organisms /
Effect
Assessment Endnoint
Distribution of
I.ab Data
10"' cetitile value - 32 jig/L for
acute effects on phytophnkton.
and 2.3 ug/L for chronic effects
or. plants
Freshwater
Aquatic Plant
Data
Acute Effects on Plivtoplanktun
Estimated at 32 pg/I. and Reductions |
in Primary Production Estimated to i
Occur at 23 pg/L
Microcosm
23% Reduction ir gross primary
production 10 ug/L (at day 2);
recovery by day 7
phytoplankton
Reduction in Primary Production
Estimated to Occur at 10 pg/I.
Field
42% Reduction in
phytoplankton biomass (at days
2-7) occurred at 20 pg/L
phytoplankton
Reduction in Primary Production
Likely to Occur at 20 pal.
Vascular Placts
Lab
Acute (14-days) HC^ = 37 ug/L
Duckweed [50%
reduction in
growth]
Reduction in Macrophytes Estimated to
Occur at 37 pg/I.
Distribution of
Dala
lO'1 centile value -18 pg/L for
acute effect on macrophytes,
and 2.3 pg/L for chronic effects
oil plants
Freshwater
Aquatic Plant
Data
Acute Effects on Macrophytes
F.stimated at 18 p^/I. and Reductions
in Macrupfcytc Populations Estimated
to Occur at 2.3 ug/L
Mesocosm
60% Reduction of macrop'nvte
vegetation occurred at 20 pg/L;
by May uf following year, 95%
Reduction of macrophytes
Macrophytes
Reduction in Macrophytes (number &
diversity) Likely to Occur at 20 pg/1.
Table 26. Key Endpoints for the IiOtic Freshwater Environment (e.g., streams). The
Cndpoiots Chosen for Use in the Refined Risk Assessment are Rolded.
Key Group of
Non-target
Organisms
Type of Study
Measurement Endpoim
Test
Organisms /
Effect
Assessment l.ndpoint
Fish
Lab
Acute Fish (96-liours) LC50
5,300 pg/L
Rainbow trout I
Mortality
Fish Mortality Estimated to Occur at
5,300 pal.
Lab
Clironic Fi-fi (44-vvesks)
NOACC = 65 ppl.; LOAEC=
120 pg/L; MATC= 83 ug/L
Brook trout / [7.2
% red. mean
length, 16 % red.
mean body
weight!
Reduction in Fish Growth Estimated to
Occur at 8S pg'L
Distribution of
Lab Data
10'1' centile value = 62 pg/I.
Freshwater
Aquatic Animal
Chronic Data
Fish Population Reductions Estimated
to Occur at 62 pg/L
Invertebrate
Lab
Acute Invertebrate (48-hour)
I .C-, - 720 p?A.
Midge / Mortality
Invertebrate Mortality Estimated to
Occur at 720 pg/I
lab
Chronic Invertebrate (48-hour)
NOAEC - 60 pg/L; LOAEC=
140 pg/L: MATC- 92 pg/L
Scud / r25 % red.
in development of
F, to seventh
instar]
Reduction in Invertebrate Populatioas
Estimated to Occur at V2 pg/L
Distribution of
Lab Data
10s ccntilc value = 62 ug'L
Freshwater
Aquatic Animal
C.hmr.ic Data
Invertebrate Population Reductions
Estimated to Occur at 62 ug/L
:
67
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Key Group of
Non-target
Organisms
Type of Sturiy
Measurement Lndpoint
T est
Oi gnnisms /
Effect
Assessment F.nripoint
Outdoor Sttenni
Significant Increase in daytime
and nighttime invertebrate drift
occurred a! 2.2 |ig/', due to
increased orcdatior,
various species of
stream dwelling
invertebrates
Invertebrate Populations Likely to be
Reduced at 22 pg/I.
Non-Vascular
Plants
Lab
Acute Algae (1-wcelO ECW = 1
pg/L
Four species
[41-93%
reduction in
chlorophyll
production]
Reduction in Primary Production
Estimated to Occur at 1 pg/L
Distribution of
Lab Data
10"' tenuis; value - 32 pg/'L for
acute effect"; on phytoplankton.
and 2.3 pg/L for chronic effects
on plants
Freshwater
Aquatic Plant
Data
Acute Effects on Phytoplankton
Estimated at 32 ng/L and reductions
in primary production estimated to
occur at 23 ng/L
Stream (first
order adjacent to
corn field in
Canada)
79% (mean) Reduction in Total
Phytoplankton Counts at 2.62
pg/L (mean, range 0.211 -
13.9)
phytoplankton
Reduction in Primary Production
Likely to Occur at 2.62 (0.211 - 13.9)
Mg/L
Outdoor
Artificial
Streams
Depression of Photosynthesis at
10 ug/I.
Various species of
stream algae.
Photosynthesis
reduction
measured by open
water oxygen
methods
Reduction in Primary Production
Likely to Occur at 10 pg/I.
Vascular Plants
Lab
Acute (14-days) EC;,, = 37 pg/L
Duckweed [50%
reduction in
growl h]
Reduction in Macrophytes Estimated to
Occur at 37 pg/L
Distribution ot
I ,aii Data
I0: ' ccmilc value = 18 pg/L for
acute effects on macrophytes.
and 2.3 pg/L for chronic effects
on plants
Freshwater
Aquatic Plant
Data
Acute Effects on Ylscrophvtcs
Estimated at 18 fig/L and Reductions
in Macrophytes Estimated to Occur
at 2.3 (ir/L
Table 27. Key Endpoints for the Estuarine/Marine Environment (e.g., estuaries, tidal,
marshes). Endpoints Chosen for Use in the Refined Risk Assessment are Bolded.
Key Croup of
Non-target
Organisms
Type of Study
Measurement F.ndpoint
Test
Organisms /
Effect
Assessment Endpoint
Fish
Lab
Acute Fish (96-hours) LC50 =
2.000 pg/L
Sheepshead
minnow /
Mortality
Fish Mortality Estimated to Occur a!
2,000 p»/L
Lab
Chronic Fish NOALC = 1,900
pg'L; i.OAl C 3400 pg/L;
MATC= 2542 pp7L
Sheepsheari
minnow [89 %
red Juv. survival]
Reduction in Fish Populations Estimated
to Occur at 2542 ug/L
Distribution of
Lab Data
10"1 cemile value = 23 pg/L
Saltwater Aquatic
Animal Chronic
Data
Fisb Population Reductions Estimated
to Occur at 23 jig/I
Invertebrates
Lab
Acute Invertebrate LC; - 94
pg/I.
Copepod (Acartia
tonsil)
Invertebrate Mortality Estimated to
Occur at 94 ng/L
68
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Key Group of
Non-target
Organisms
Type of Study
Measurement Endpoint
Test
Organisms /
Effect
Assessment Endpoint
Distribution of
[ ah Data
!0C centile value = 23 jig/L
Saltwater Aquatic
Animal Chronic
Data
Invertebrate Population Reductions
Estimated to Occur at 23 fig/L
lib
Chronic Invertebrate N04FC -
80 ^g/L: LOAEO 190 ng/L;
MATO 123 iisO,
My sir! [37% red.
Adult survival]
Reduction in Invertebrate Populations
Estimated to Occur at 123 jis'I.
Non-VasruJnr
Plants
Lab
Acute (120-hours) Alcae T.CX, =
22 iig/L
Alsae
(Chrysophyceac;
Isochrysis
galbana)
Algae Mortality Estimated to Occur at
22 Hg/L
Distribution of
Lab Data
10* ccntilc value = 27 jig/L for
acute effects on phytoplankton,
and 9.1 (jg/T. for chronic effects
.on plants
Saltwater Aquatic
Plant Data
Acute Effects on Phytoplanlcton
Estimated at 27 jig/L and Reductions
in Primary Production Estimated to
Occur at 9.1 fig/L
Vasruiar Plants
Lab
Significant reduction in dry
weight occurred at 10 ^°/L
(calculated MATC from
N0AEO7.5 and
LOAEC- 14.3)
Sago Pondweed
Reduction in Mucrophyles Estimated to
Occur at 10 p%fL
Distribution of
Lab Data
10ft centile value = 9.1 ^ig/L for
chronic effects an plants
Saltwater Aquatic
Plant Data
Reductions in Macrophytes
Estimated to Occur at 9.1 n?/L
Microcosm
16% Reduction in Tuber
formation; 55% Reduction in
Biomass over reproductive
season at 4 \i%!L
Wild Celery
(yallisneria
Americana)
Reduction in Macrophytes Likely to
Occur at 4 fig/L
a. Ponds
Based on modeling simulations, it is possible that for months every year, atrazine
concentrations in ponds from use on sorghum and sugarcane exceed the levels at which studies
have shown reductions in fish and invertebrate populations, macrophytes, and primary
production (>20ppb). For corn, modeling simulations indicate that atrazine concentrations in
ponds exceed the levels at which studies have shown reductions in fish populations, invertebrate
populations, macrophytes, and primary production in 70 to 83% of the years. From 70 to 75% of
the years, atrazine concentrations in ponds from use on sugarcane exceed the levels at which
reproduction studies have shown reductions in invertebrate populations and fish growth. For
sorghum, the percentage of exceedences are from 2.8 and <5% of the years.
b. Lakes and Reservoirs
Monitoring data in lakes and reservoirs have indicated that a number of drinking water
sites have atrazine concentrations greater than 20 ppb in the finished water. This is the level at
which reductions in fish populations, invertebrate populations, macrophytes. and primary
production has been observed in simulated field studies.
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c. Streams
The highest atrazine concentrations occur in brief pulses following rain events and are
usually associated with the next rain event after an application. Atrazine concentrations in
streams vary frequently, depending on usage and rainfall patterns, and vary from watershed to
watershed, depending on the size of the watershed, the intensity of agricultural activity, and the
flow volume and location of the watershed.
Reductions in invertebrate populations and primary production were likely to occur in 12
to 34% of the 129 Midwestern streams sampled following atrazine applications in 1989. In
addition, based on simulated field testing and laboratory testing macrophytes may be reduced in
52 to 63% of the streams sampled in the weeks following atrazine applications. Reduction in
primary production is also possible at these levels. Later in the season, concentrations that would
affect primary production and macrophytes were seen in only 1% of the 143 streams sampled.
Based on sampling in 1995, reduction in invertebrate populations are primary production are
likely to occur in 17 to 35% of the 50 Midwestern streams sampled following atrazine
applications. In addition, based on laboratory testing, macrophytes may be reduced in 64% of the
streams sampled following atrazine applications.
The highest pulse concentrations seen in streams exceed many of the assessment
endpoints for non-target organisms. While the duration of these high concentrations is not likely
to be long since pulses of runoff tend to move quickly downstream, they may last for hours,
especially during the Spring and during runoff events when many fields in a watershed are being
treated with atrazine around the same time. Thus, it is possible that reductions in invertebrate
populations and primary production could occur as a result of post-application stream
contamination from the Spring application of atrazine. The frequency of such reductions
occurring may be low considering the frequency of the pulses above 10 ppb and depending upon
the flow volume of each stream. The frequency of similar reductions occurring in rivers is
probably lower than for streams since the peaks and average concentrations of atrazine are lower
in rivers.
Based on NAWQA monitoring data for 40 agricultural sites, 11 to 35% of the 40 sites
exceed atrazine concentrations at which invertebrate populations and primary production occur,
based on the maximum atrazine concentrations seen. NAWQA monitoring data, however, were
not designed to time monitoring to correspond with atrazine treatment and may underestimate
concentrations likely to be present in streams.
d. Estuaries
Based on maximum atrazine concentrations in Louisiana, 77% of the sites sampled
exceed concentrations at which reductions in macrophytes occur. This Tails to 26 to 61% for the
mean concentration. About 30% of the sites based on maximum concentrations and about 7%
based on mean concentrations exceed the concentrations at which reductions in fish and
invertebrate populations occur.
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Maximum atrazine concentrations in the Chesapeake Bay exceed levels that are likely to
reduce macrophytes for 8% of the site and year combinations sampled. Atrazine eould be
contributing to reductions in submerged aquatic vegetation at certain sites in the Bay. It is
possible that atrazine and other herbicides are a source of stress to aquatic vegetation. This,
combined with eroding sediment could negatively affect estuarine ecosystems.
6. Risk to Endangered Species
Endangered species LOCs are exceeded for terrestrial plants, birds and small mammals
from the agricultural uses of atrazine. However, risks to endangered birds and mammals are not
anticipated from the dietary residues based on the methods and timing of atrazine applications.
The risk exceedences for endangered terrestrial plants are based on spray drift and runoff into the
habitats for terrestrial and scmi-aquatic plants.
Endangered aquatic species LOCs are exceeded for some agricultural uses of atrazine.
Acute risks to endangered freshwater invertebrates and aquatic vascular plants are exceeded for
all crop uses except for the typical use rate on com (1.1 lb ai/A.) Chronic levels of concern for
endangered species are exceeded for fish and aquatic invertebrate reproduction for all use rates,
except for com and the typical use rate on sorghum.
Atrazine was included in the formal Section 7 consultations with FWS for the
rangeland/pastureland and the forest cluster reviews in 1984. The Biological Opinions for both
reviews stated that these uses of atrazine would jeopardize the continued existence of over 60
species of plants associated with rangeland and ten species of plants associated with forests.
Atrazine was also included in the sorghum cluster review in 1983. and the Biological Opinion
found possible jeopardy to several species offish plus one insect (loss of habitat) and one plant
species.
In addition, atrazine was one of 109 active ingredients included in the reinitiated
Biological Opinion of 1989 from the FWS. This Opinion was primarily for aquatic species. In
this Opinion. FWS found jeopardy to nine species of freshwater fish, two freshwater crustaceans,
four amphibians and twelve species of plants for its uses on field crops, rangeland and forests.
FWS provided "Reasonable and Prudent Alternatives'7 (RPAs) for each jeopardized species and
"Reasonable and Prudent Measures" (RPMs) for 43 non-jeopardized species to minimize
incidental take of these latter species. These consultations and the findings expressed in the
Opinions, however, are based on old labels and application methods, less refined risk assessment
procedures and an older approach to consultation which is currently being revised through
interagency collaboration.
When the regulator}' changes recommended in this ERED are implemented and the
ecological effects and environmental fate data are submitted and accepted by the Agency, the
Reasonable and Prudent Alternatives and Reasonable and Prudent Measures in the Biological
Opinion(s) may need to be reassessed and modified based on the new information.
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The Agency is currently engaged in a Proactive Conservation Review with FWS and the
National Marine Fisheries Service under section 7(a)(1) of the Endangered Species Act. The
objective of this review is to clarify and develop consistent processes for endangered species risk
assessments and consultations. Subsequent to the completion of this process, the Agency will
reassess the potential effects of atrazine use to federally listed threatened and endangered species.
At that time the Agency will also consider any regulatory changes recommended in the IRED that
are being implemented. Until such time as this analysis is completed, the overall environmental
effects mitigation strategy articulated in this document and any County Specific Pamphlets
described in Section IV which address atrazine, will serve as interim protection measures to
reduce the likelihood that endangered and threatened species may be exposed to atrazine at levels
of concern.
The potential adverse effects of atrazine on homing and reproduction in endangered
salmon and other anadromous fish species is currently uncertain. The laboratory study of
olfactory function in mature Atlantic salmon parr and the effect of atrazine in the range of 0.5
jig/L for sensing female hormones in urine and behavior to ground salmon skin is notable. This
is so especially if the effects are significant on salmon reproduction at such a low atrazine
concentration, because existing concentrations in streams inhabited by endangered salmonids
may exceed this level for prolonged periods. Atrazine concentrations are likely to be their highest
in the late spring and early summer following applications, at a time when salmon are returning
from the ocean to spawn. It is unclear from the results of the test by Moore and Waring (1998)
whether the effect on olfactory function is manifested in mature adult salmon and what effect it
might have on reproduction and recruitment. These data are preliminary and additional studies
are necessary to determine if there are adverse atrazine effects on adult salmon homing and adult
male milt production responses to female hormones in ovulating female urine. Further study is
also needed on whether those effects could be significant to reproduction and recruitment.
7. Ecological Incident Reports
The Agency received 109 ecological incident reports on atrazine between 1991 and 2001.
Of the 109 incidents, thirteen are classified as "Unlikely,'" 50 are listed as "Possible," and two are
"Unrelated." In only one case, a 1996 cotton use in Louisiana, were casualties (fish) analyzed for
atrazine residues. Shad and carp tested positive for atrazine. but the conclusion was that atrazine
was unlikely to be the cause of mortality. Forty of the 109 incidents are considered "Probable,"
and four incidents are listed as "Highly Probable." The 4 incidents listed as "Highly Probable"
include 3 home lawn use incidents and 1 corn use incident, llie corn use incident reported
affecting 100 bass and 100 bream resulting from a registered use. The three home lawn incidents
were lawn applications that affected the turf itself; two were concluded to be accidental misuse,
and the third was a registered use that affected grass and non-target plants.
The forty "Probable" incidents include: 16 cases affecting com; 11 affecting grass; 11 fish
kills; 1 bird kill; and affects on ornamentals, fruit trees, berries, garden, oats, vegetation around
an atrazine/cyanazine-treated field (runoff), and greenhouse plants (pond irrigation water). Four
"probable" incidents are classified as accidental misuse: two cases from com use, pears,
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raspberry and oats and grass and ornamentals: and two lawn misuse cases affecting grass and
bluegrass.
Atrazine alone is not very toxic to the birds, mammals, and aquatic animals cited in most
of these incidents. In none of these cases has evidence been provided that firmly demonstrate
that atrazine has produced the reported effects. In many cases, the inference of these reported
incidents to atrazine effects is likely due to the wide spread use of atrazine and the proximity of
the atrazine application and timing to the occurrence to the incident. About 60 percent of the
reported fish kills listed under atrazine in the incident record occur during the Spring when
atrazine is applied, soils are saturated and heavy rainfall is frequent. Heavy- runoff may carry
atrazine. other pesticides and organic loads into surface waters. The high volume and wide-
spread use of atrazine increases the probability of co-occurrence of fish kills with atrazine
applications.
8. Endocrine Disruption
Atrazine has been associated with sub-lethal effects in aquatic organisms and amphibians
in research presented in the open, peer-reviewed literature. These include potential effects on
endocrine-mediated processes in frogs at ~ 0.1 (ig/L and in largemouth bass at - 50 iig/L, as
well as olfactory effects in salmon at ~ 0.5 |ig/L. In addition, some studies have been conducted
to address this issue and found that these effects were not demonstrated.
The Agency's ecological risk assessment does not suggest that endocrine disruption, or
potential effects on endocrine-mediated pathways, be regarded as an regulatory endpoint at this
time. Nor does the Agency have evidence to state that there is no reliable evidence that atrazine
causes endocrine effects in the environment. Based on the existing uncertainties in the available
database, atrazine should be subject to more definitive testing once the appropriate testing
protocols have been established. The Agency is aware that several pertinent studies are being
performed at this time by researchers that may to reduce some of the uncertainties in
understanding potential atrazine effects on amphibian endocrinology and reproductive and
developmental responses. The Agency has committed to provide these studies along with other
available studies, a summary of the available data and methodologies and various data analyses
for an external scientific review by the Federal Insecticide, Fungicide and Roaenticide Act
(FIFRA) Science Advisory Panel (SAP) at a public meeting which is scheduled for June, 2003.
The Agency anticipates that the results from this SAP meeting will provide significant input to
enable it publish an amendment to this TRED in October 2003 which will address the issue of the
potential effects of atrazine on amphibian endocrinology and development.
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74
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IV.
Interim Risk Management and Reregistration Decision
A. Determination of Interns Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine whether products
containing a specific active ingredient are eligible for reregistration after submission of the
relevant data. The Agency has previously identified and required the submission of the generic
data (i.e., data specific to an active ingredient) to support reregistration of products containing
atrazinc.
The Agency has completed its assessment of the ecological and occupational risks
associated with the use of currently registered pesticides containing the active ingredient atrazine.
as well as an atrazine-specific dietary risk assessment and residential risk assessment that have
not considered the cumulative effects of the triazines, as a class. The ecological assessment does
not address the potential for effects on amphibian endocrinology and reproductive and
developmental responses. As mentioned above, the Agency will publish an amendment lo this
IRED in October 2003 which will address the issue. Based on a review of the generic data, other
special studies, and public comments on the Agency's assessments, EPA has sufficient
information on the human health and ecological effects of atrazine to make interim decisions as
part of the tolerance reassessment process under FFDCA and reregistration under FIFRA, as
amended by FQPA. The Agency has determined that atrazine products, based on currently
approved labeling, pose unreasonable dietary-, residential, occupational, and ecological risks.
However, the Agency believes that these risks can be mitigated through routine changes to
pesticide labeling and through actions designed to further prevent risks from occurring that are
described in a Memorandum of Agreement with the registrants. Accordingly, the Agency has
determined that the active ingredient atrazine is eligible for reregistration provided that: (i) the
additional data needs that the Agency has identified are addressed; (ii) the risk mitigation
measures outlined in this document are adopted, and label amendments are made to reflect these
measures; (iii) the consideration of cumulative risk for the triazines supports a final reregistration
eligibility decision; and (iv) the Memorandum of Agreement is implemented. Further mitigation
measures and additional data requirements may be warranted following the completion of the
stakeholder process outlined in this document.
Although the Agency has not yet considered the cumulative risk for the triazines. the
Agency is issuing this interim assessment now in order to identify risk reduction measures that
are necessary to support the continued use of atrazine. Based on its current evaluation of atrazine
alone, the Agency has determined that atrazine 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 use of atrazine.
At the time that a cumulative assessment is conducted, the Agency will address any
outstanding risk concerns. For atrazine, if all changes outlined in this document are incorporated
into the labels and the Memorandum of Agreement is implemented, then all currently identified
75
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risks will be mitigated. However, because this is an interim RED, the Agency may take any
necessary further actions to finalize the reregistration eligibility decision for atrazine after
assessing the cumulative risk of the triazine class. Such an incremental approach to the
reregistration process is consistent with the Agency's goal of improving the transparency of the
reregistration and tolerance reassessment processes. By evaluating each triazine in turn and
identifying appropriate risk reduction measures, the Agency is addressing the risks from use of
all of the triazines in as timely a manner as possible.
Because the Agency has not yet considered cumulative risk for all of the triazines, this
reregistration eligibility decision does not fully satisfy the reassessment of the existing atrazine
food residue tolerances as called for by the Food Quality Protection Act (FQPA). When the
Agency has completed the cumulative assessment, atrazine tolerances will be reassessed. At that
time, the Agency will reassess atrazine along with the other triazine pesticides to complete the
FQPA requirements and make a final reregistration eligibility determination for atrazine. By
publishing this interim decision on reregistration eligibility and requesting mitigation measures
now for the individual chemical atrazine, the Agency is not deferring or postponing FQPA
requirements; rather, EPA is taking steps to assure that uses that exceed FIFRA's unreasonable
risk standard do not remain on the label longer than is necessary, pending completion of the
cumulative assessment required under FQPA. This decision does not preclude the Agency from
making further FQPA determinations or tolerance-related rulemakings that may be required on
this pesticide or any other in the future.
If the Agency determines, before finalization of the interim RED, that any of the
determinations described in this interim RED arc no longer appropriate, the Agency will pursue
appropriate action, including, but not limited to, reconsideration of any portion of this interim
RED.
Label changes that are necessary to adequately mitigate the risks of atrazine use arc
described in Section V of this document. Appendix A summarizes the uses of atrazine that are
eligible for reregistration. Appendix B identifies the generic data requirements that the Agency
reviewed as part of its determination of reregistration eligibility, and lists the submitted studies
that the Agency found acceptable.
B. Summary of Phase 5 Comments and Responses
When making its interim reregistration decision, the Agency took into account all
comments received during Phases 3, 4, and 5 of the Public Participation Process for atrazine.
These comments are available in the docket in their entirety. Numerous letters were received
commenting on the atrazine risk assessments during Phase 5 of the public process. Comments
that addressed human health and ecological concerns were received from the technical registrants
(Syngenta Crop Protection, Inc., and Sipcam Agro USA); state and other regulatory agencies
(California Department of Pesticide Regulation. California Regional Water Quality Control
Board, State of New York Office of the Attorney General. Connecticut Office of the Attorney
General,U.S. Department of the Interior. Fish and Wildlife Service); environmental and advocacy
76
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groups (Natural Resources Defense Council [NRDC], People for the Ethical Treatment of
Animals, Beyond Pesticides/NCAMP, Center for Regulatory Effectiveness; universities (Yale
University; Texas Tcch University: U.C. Berkeley); grower and agricultural advocacy groups
(National Agricultural Aviation Association, Sugar Cane Growers Cooperative of Florida. Weed
Science Society of America, Triazine Network. Marion County Farm Bureau. American Farm
Bureau Federation, Illinois Farm Bureau. Louisiana Farm Bureau Federation, Ohio Farm Bureau
Federation, Minnesota Farm Bureau): water advocacy groups (American Water Works
Association); and man}' private citizens and growers. Comments were received on the following
topics:
Toxicology and Mode of Action of Atrazine and Endpoints Chosen:
Carcinogenicity of Atrazine;
Ecological Risks of Atrazine;
Exposure to Atrazine and its Degradates;
Other Atrazine Regulations;
Occupational and Residential Exposure to and Risk from Atrazine:
Atrazine Treatment Costs; and
Benefits of the Use of Atrazine.
These comments have been addressed and the assessments refined as appropriate by the
Agency. Response to Comments documents addressing most of these comments are available in
the public docket and on the Agency's web page at http://www.epa.gov/pesticides/reregistration.
Three comments that were received are being addressed in the IRED. as follows:
comments from the The New York State Office of the Attorney General (NYOAG) on the
Endangered Species Act (ESA) and consultations with the U.S. Fish and Wildlife Service
(FWS); comments from the Natural Resources Defense Council (NRDC) on the consideration of
farm worker children in the assessment; and comments from the Center for Regulator}'
Effectiveness on the new Data Quality Act (DQA)
Comment: The NYOACi commented to the Agency that EPA must initiate consultations with
the FWS because EPA's issuance of a reregi strati on decision for atrazine triggers
the ESA consultation requirement and slated that the ESA requires that the
Agency consider any existing FWS biological opinion.
Response: Atrazine has been reviewed on several occasions by the FWS as described in
Section HI above under the discussion on endangered species. Currently, the
Agency is developing a proposal to implement its Endangered Species Protection
Program (ESPP). The Agency is soliciting public opinion on this proposal
through issuance of a Federal Register Notice, Endangered Species Protection
Program Field Implementation, December 2. 2002. The Agency obtained input on
several key aspects of the program in a workshop held in September 2002 that
included the pesticide industry, pesticide user groups, and environmental
advocacy organizations. An Advance Notice of Proposal Rulemaking (ANPR).
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Endangered Species and Pesticide Regulation, was issued jointly by the Agency,
the Department of Interior and the Department of Commerce on January 24, 2003.
The ANPR is soliciting comments regarding methods to make the consultation
process more efficient.
Comment: The Center for Regulator)' Effectiveness commented on November 25, 2002,
requesting correction under the Environmental Protection Agency's (EPA)
Information Quality Guidelines. This Request for Correction was filed on behalf
of the Kansas Corn Growers Association, the Triazine Network, and the Center
for Regulatory Effectiveness. The complaint alleges that the April 22, 2002.
Environmental Risk Assessment for Atrazine does not comply with the "Data
Quality Act" because the document "states that atrazine causes endocrine effects
in various organisms including frogs." The comment requests that the
environmental risk assessment be corrected to state that there is no reliable
evidence that atrazine causes "endocrine effects" in the environment and that there
can be no reliable, accurate or useful information regarding atrazine's endocrine
effects until and unless there are test methods for those effects that have been
properly validated.
Response: After reviewing the questions raised in the request, the Agency has decided that
some minor clarifications of the April 2002 Environmental Risk Assessment for
Atrazine may help to avoid any future misunderstanding of the Agency's position
on the environmental effects of atrazine. Any such clarifications will be included
in a revised Environmerital Risk Assessment for Atrazine. This Request for
Correction is further addressed in the Agency's Response to Comments document
available in the public docket and on the Agency's web page at
http://www.epa.gov/pesticides/reregistration.
The Agency is providing a 60-day public comment period on this IRED. While all
comments are welcome, those with specific data or information bearing on the risk and benefit
assessments are most useful.
C. Regulator^7 Position
1. FQPA Assessment
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with this triazine. The assessment, was for this individual triazine, and docs not attempt to fully
reassess these tolerances as required under FQPA. FQPA requires the Agency to evaluate food
tolerances on the basis of cumulative risk from substances sharing a common mechanism of
toxicity, such as the toxicity expressed by the triazine pesticides through a common biochemical
interaction. The Agency will evaluate the cumulative risk posed by the entire class of triazines
78
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once the policy concerning cumulative assessments is fully resolved.
EPA has determined that risk from exposure to atrazine exceeds its own "risk cup" for the
currently registered uses ol'airazine. In reaching this determination, EPA has considered the
available info'filiation on the special sensitivity of infants and children, as well as dietary (food
and drinking water) and residential exposure to atrazine. However, if the use of atrazine is
modified, the Memorandum of Agreement is implemented, and any other mitigation measures
outlined in this document are implemented, the Agency believes that risks from the use of
atrazine will not exceed the Agency's level of concern (i.e., atrazine uses will "fit" within its risk
cup). Therefore, the atrazine tolerances can remain in effect until a full reassessment of the
cumulative risk from all triazines is completed.
b. Tolerance Summary
Tolerances for residues of atrazine per se are established under 40 CFR §180.220(a)(1).
Tolerances for atrazine and its chlorinated metabolites arc established under 40 CFR
§ 180.220(a)(2).
The Agency has determined that the tolerance expression in 40 CFR § 180.220(a)(1) must
be changed to reflect the combined residues of atrazine and its chlorinated metabolites, and that
all tolerances based on atrazine and its chlorinated metabolites should be placed together under
40 CFR § 180.220 (a)(1). A summary of atrazine tolerance reassessments is presented in
Table 28. Reassessments are based on tolerances redefined as atrazine and its chlorinated
metabolites.
The Agency has also determined that tolerance expressions for the combined residues of
each of the four hydroxy compounds arc not needed.
The Agency will commence proceedings to revoke and modify existing tolerances, and to
correct commodity definitions. The establishment of a new tolerance or raising tolerances will
be deferred, pending consideration of cumulative risk for the triazines. "Reassessed" does not
imply that all of the tolerances have been fully reassessed as required by FQPA, since these
tolerances may only be fully reassessed once the cumulative risk assessment of all triazinc
pesticides is considered, as required by the statute. Rather, this IRED provides reassessed
tolerances for atrazine in/on various commodities, supported by all the submitted residue data,
only for atrazine. EPA will finalize these tolerances after considering the cumulative risks for all
triazine pesticides. The Agency's tolerance summary is provided in Table 28.
Tolerances Listed Under 40 CFR §180.220fa)fi)
Tolerances for residues in/on sweet com forage and fodder can be lowered to 4.0 ppm and
2.0 ppm, respectively, to 1.5 ppm for field/'pop com forages, and to 0.5 ppm for field/pop com
fodder and the designation "fodder" should be revised to "stover." The tolerances for residues
in/on com. fresh, K+CWHR and com grain can be decreased to 0.20 ppm, each based on
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combined nondctectable residues at 0.05 ppm for atrazine and each chloro-mctabolite. The
tolerance for residues in/on macadamia nuts can be lowered to 0.20 ppm based on combined
nondetectable residues at 0.05 ppm for atrazine and each chloro-mclabolile. Tolerances for
residues in/on sorghum forage and fodder can be lowered tu 0.50 ppm, each; the designation
"fodder' should be revised to "stover." The tolerance for residues in/on sorghum grain can be
lowered lo 0.20 ppm based on combined nondctectable residues at 0.05 ppm for atrazine and
each chloro-metabolite. The tolerances for residues ia'on wheat fodder, grain, and straw can be
lowered to 1.5, 0.10, and 0.50 ppm, respectively; the designation "fodder" should be revised to
"forage.The tolerance for sugar cane can be lowered to 0.20 ppm based on combined
nondetectable residues at 0.05 ppm for atrazine and each chlorinated metabolite. The tolerances
for residues in/on sugarcane, forage and fodder, should be revoked, as these are no longer
regulated as livestock feed items. The tolerance for residues in/on guavas is adequate.
Existing tolerances for residues in commodities from cattle, goats, horses, and sheep
(0.02 ppm) must be increased to 0.10 ppm include combined residues of atrazine and chlorinated
metabolites. Tolerances have been reassessed based on animal feeding study data.
The tolerances for commodities from hogs, poultry, and eggs can be revoked as there is
no reasonable expectation of finite residues.
Syngenta proposes lowering the tolerances for sweet and field corn forages to 1.5 ppm,
and the tolerance for sorghum forage to 0.25 ppm. For postemergent treatments, the registrant
proposes a change from a 30-day PHI to a 45-day PHI for sweet corn and sorghum forages, and
from a 30-dav PHI to a 60-day PHI for field corn forage. For preemergent treatments on
sorghum, they propose a change from a 45-day PHI to a 60-day PHI. Preemergent treatments on
sweet and field corn will retain the existing 45-day and 60-day PHI, respectively. Existing labels
contain 21 and 30-day PHIs for corn and sorghum forages.
The Agency has reassessed the tolerance for sweet corn forages at 4.0 ppm based on field
trial data showing the highest chlorotriazine residues detected at 3.2 ppm after one treatment, and
a 30-day PHI. Syngenta states that a sweet corn forage tolerance of 1.5 ppm is supported by data
representing a 45-dav PHI. Maximum chlorotriazine residues on sweet corn forage harvested 45
days after postemergent treatments at the IX rate expected to result in the highest residues (0.5 +
2.0 lbs ai/A) were approximately 1.15 ppm. The Agency concludes that if labels for
postemergent sweet corn use are amended to allow a minimum PHI of 45 days, the tolerance for
sweet corn forage be lowered to 1.5 ppm.
The Agency has already reassessed the tolerance for field corn forage at 1.5 ppm based on
the highest chlorotriazine residues detected at 1.1 ppm after a IX treatment, at either a 30-dav or
a 60-day PHI. Maximum chlorotriazine residues on field com forage harvested 60 days after
postemergent treatments at the IX rate expected to result in the highest residues (0.5 + 2.0 lbs
ai/A) were approximately 1.11 ppm. The Agency concludes that all atrazine labels for
postemergent field corn should be amended to allow a minimum PHI of 60 days.
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The tolerance for sorghum forage has already been reassessed at 0.5 ppm based on field
trial data showing the highest chlorotriazine residues detected at 0.22 ppm after a IX treatment,
and a 23-day PHI. Maximum chlorotriazine residues on sorghum forage harvested 30 and 45
days al'ler postemergenl treatments ai the IX rate were approximately 0.35 ppm and 0.09 ppm.
respectively. Maximum chlorotriazine residues on sorghum forage harvested 45 and 60 days
after preemergent treatments at the IX rate were approximately 0.12 and 0.16 ppm. respectively.
The Agency concludes that if all atrazine labels for postemergent sorghum use are amended to
allow a minimum PI II of-15 days, and for preemergent sorghum use to allow a minimum PHI of
60 days, the tolerance for sorghum forage be lowered to 0.25 ppm.
The Agency has recalculated the maximum theoretical dietary burden (MTDB) for dairv
cattle based on a reassessed sweet corn forage tolerance of 1.5 ppm. The resulting MTDB for
daiiy cattle is approximately 2.0 ppm chlorotriazines. Extrapolating the results from cattle
feeding studies to this MTDB results in a reassessed milk tolerance of 0.03 ppm. If all atrazine
labels are amended to the proposed PI lis discussed above for sweet and field corn forage and
sorghum forage, the milk tolerance ear. be lowered to 0.03 ppm. based on available feeding
studies and residue data.
Tolerances Needed Under 40 CFR $ i 80.220('a)(' 1')
The Agency proposes establishing a tolerance for residues of atrazine and the chlorinated
metabolites in wheal hay based on existing wheat forage residue data, and taking into account
any concentration of residues during drying processes for hay. Alternatively, the registrant may
submit Held trials to determine an appropriate tolerance level for residues in/on wheat hay.
An additional processing study is required for sugarcane, in order to determine the need
for a separate tolerance for residues in molasses.
Tolerances Currently Listed Under 40 CFR $180.220(a1(2) To Be Placed Under 40 CFR
$180.220(aim
The Agency recommends that the established tolerances for residues of atrazine in or on
orchard grass and orchard grass, hay be revoked, as these uses are not being supported.
The Agency also recommends the revocation ofihe 15 ppm tolerance for Perennial rye grass and
that the use be cancelled. In addition, the tolerance for Grass, range should be revoked and a
crop group tolerance for Crop Group 17 (Grass, Forage. Fodder, and Hay) should be established
under 1 80.220(a}( 1). that will cover range grasses. Residue data on representative grasses to
support the crop group tolerance are recommended. This will include residue data on bermuda
grass, bluegrass, and bromegrass or fescue from 12 trials (four for each cultivar) conducted in
concordance with the current label rates. If the regislrant(s) do not wish to support a crop group
tolerance with new residue data, the existing tolerances should be revoked and the uses
cancelled.
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Table 28. Tolerance Reassessment Summary for Atrazine
Commodity
Established Reassessed Comments
Tolerance, ppni Tolerance, ppm [Correct Commodjty Uefmitioji]
Tolerances Listed Under 40 CFR § 180.220(a)(1)1
Cattle, fat
0.02
0.10
Reassessed tolerances based on reassessed sweet
com forage tolerance of 4.0 ppm. Registrant
recommended lowering tolerances for sweet com
forase to 1.5 ppm pending amendment of all
; Cattle, mbyp
0.02
0.10
Cattle, meat
0.02
0.10
atrazine labels for postemergent sweet com use to
allow a minimum PHT of 45 davs.
Com, fodder, field
15
0.5
corn, field, stover
¦ Corn, fodder, pop
15
0.5
corn, pop, stover '
; Corn, fodder, sweet
15
2.0
corn, fresh, stover
. Corn, forage, field
15
1.5
Amend all atrazine labels for postemergent and
preemergent field com use to require a minimum
PHI of 60-days.
! Com, forage, pop
!5
1.5
Com, forage, sweet
15
1.5
Amend all atrazine labels for postemergent and
preemergent sweet com use to require a minimum
PHJ of45 days. i
Com, fresh.
K+CWHR
0.25
0.20
Com, grain
0.25
0.20
: Eggs
0.02
Revoke
The Agency concludes that there is no reasonable
expectation of finding quantifiable atrazine
residues in eggs or the meat, fat, or meat
byproducts of poultry
Goats, fat
0.02
0.10
Reassessed tolerances based on reassessed sweet
corn forage tolerance of 4.0 ppm. Registrant
recommended lowering tolerances for sweet com
forage to 1.5 ppm pending amendment of all
atrazine labels for postemergent sweet com use to
allow a minimum PHI of 45 days.
Goats, mbyp
0.02
0.10
Goats, meat
0.02
0.10
Guava
0.05
0.05
Hogs, fat
0.02
Revoke
No reasonable expectation of finding quantifiable
atrazine residues in the meat, fat, or meat
byproducts of hogs.
Hogs, mbyp
Hogs, meat
0.02
0.02
Revoke
Revoke
Horses, fat
0.02
0.10
Reassessed tolerances based on reassessed sweet
com forage tolerance of 4.0 ppm. Registrant
recommended lowering tolerances for sweet com
forage to 1.5 ppm pending amendment of all
atrazine labels for postemergent sweet com use to
allow a minimum PHI of 45 davs.
: Horses, mbyp
0.02
0.10
Horses, meat
0.02
0.10
Maeadarnia nuts
025
020
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Table 2S. Toler
Commodity
; Milk
ance Reassessment Summary for Atrazice
Established Reassessed Comments
\Correct Commodity Definition]
Reassessed
_ Tolerance, ppm Tolerance, ppm
Poultry', fat
Poultry, mbyp
Poultry, meat
Rye, grasses,
: perennial
I Sheep, fat
j
! Sheep, mbyp
¦ Sheep, meat
I Sorghum, fodder
; Sorghum, forage
Sorghum, grain
Sugarcane
Sugarcane, fodder
Sugarcane, forage
Wheat, fodder
Wlieat, grain _
Wheat, straw _
Tolerances
0.02
0.02
0.02
0.0?.
15
0.02
0.02
0.02
15
15
0.25
0.25
0.25
0.25
J
0.25
5
AH atrazine labels must be amended to the
0.03 proposed PRls for sweet and fleid com forage and
: sorahum forase.
Revoke
Revoke The Agency concludes that there is no reasonable
expectation of finding quantifiable atrazine
residues in eggs or the meat, fat. or meat
Revoke byproducts of poultry.
; Uses are restricted to the Conservation Reserve
Revoke : Program (CRP) lands in OK, OR, NE, and TX.
Restrictions on grazing and cutting for hay apply.
| Reassessed tolerances based on reassessed sweet
| com forage tolerance of 4.0 ppm. Registrant
| recommended lowering tolerances for sweet com
J forage to 15 ppm pending amendment of all
I atrazine labels for postemergent sweet com use to
I allow a minimum PHI of 45 days.
0.10
0.10
0.10
0.50 ' Sorghum, stover
0.25
. Amend all atrazine labels for postemergent
! sorghum use to require a minimum PHI of 45 days,
i and for preemergent sorghum use to require a
minimum PHI of 60 days.
°.20_
0.20
Revoke
Not a significant livestock feed item
Revoke
Not a significant livestock feed item
1.5
Wheat, forage
0.10
0.50
Grasses,
orchardgrass
Grasses.
orchardings, hay
lasted Under 40 CFR §180.220(a)(2) To be Places Under 40 CFR §180.220(a)(l)!
! Uses on orchard grass are not supported by the
I basic produce
Revoke
15
Revoke
I Uses on orchard grass arc not supported by the
| basic producer
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Tabic 28. Tolerance Reassessment Summary for Atrazine
Commodity
Established
Tolerance, j)pm_
Reassessed
_Tolcrance. ppm
Grasses, range
TBD
Comments
| Correct Commodity Definition)
Uses are restricted to the Conservation Reserve
Program (CRP) lands in OK, OR, NE, and TX.
Restrictions on grazing and cutting for hay 'apply.
However, these grasses may be fed during drought
and emergencies. Registrant may establish a crop
group tolerance under Crop Group 17. Residue
data on representative crops are recommended.
Once data are submitted a crop group tolerance
should be established under 180.220(a)(1). Table
2 of OPPTS 860.1500 Crop Field Trials calls for
12 trials (four for each cultivar). Existing
tolerances are believed to be unsupportable based
on today's data requirements. If the registrant(s)
do not wish to support a crop group tolerance with
new residue data, the existing tolerances will be
revoked and the uses cancelled.
Tolerances Needed^lJnder 40 CFR §180.220(a)(l)
Simarcane molasses
none
TBD:
Wheat, hav
Additional data are required to determine the need
¦ for a separate tolerance.
This tolerance is based on residue data for wheat
: forage, taking into account concentration of
none 5 residues as forage is dried to hay. Alternatively,
; the registrants may provide residue data on wheat
: hay from field trials.
Tolerances to be Proposed Under 40 CFR §180.220(d)
[Indirect residues in
foliage of legume
vegetables!
none
TBD
Additional data are required to determine the need
for indirect residue tolerance(s).
Tolerances reassessed based on combined residues of atrazine. G30033. G-2S279. and G-2S273.
"TBD - To be determined Reassessment ol'tolernnce(s) cannot be made at this time because additional data are required
'Tolerances based on combined residues ol'2-hydroxy-4-cthylam!no-<>-isopropylamino-s-tnazmc (G-34048). 2-amino-4-hydroxy-6-
isopropylamino-s-tria^inf (GS-17794). 2-aniino-4-hydroxy-6-cthyiamino-s-triazine (GS-17792). and 2.4-diamino-6-hydroxy-s-
tria/ine (GS-17791).
3. Codex Harmonization
The Codex Alimentarius Commission has not proposed or established maximum residue
limits (MRLs) for residues of atrazine in/on agricultural commodities. Therefore, there are no
issues regarding harmonization or compatibility of U.S. tolerances with Codex MRLs.
4. Endocrine Disruptor 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
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occurring estrogen., or other such endocrine effects as the Administrator may designate."
Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory
Committee (EDSTAC), EPA determined that there were scientific bases 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
allow, screening of additional hormone systems may be added to the Endocrine Disruptor
Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
Agency's EDSP have been developed, atrazine may be subjected to additional screening and/or
testing to better characterize effects related to endocrine disruption.
5. Labels
A number of label amendments, in addition to the existing label requirements, are
necessary in order for atrazine products to be eligible for reregistration. The Agency has
determined that these measures, in addition to the existing label requirements, will adequately
reduce risks.
Provided the following risk management measures are incorporated in their entirety into
labels for atrazinc-containing products, the Agency finds that all currently registered uses of
atrazine are eligible for interim reregistration, pending consideration of cumulative risks of the
triazines. While all uses are eligible at this time, the cotton use will be phased out over five
years. The regulatory rationale for each of the risk management measures outlined below is
discussed immediately after this list of required risk management measures.
a. Agricultural Use Exposure Reduction Measures
For agricultural use, the following measures are required, in addition to the existing label
requirements to address risks of concern.
Dietary (Drinking Water)
Require the following statement:
"ANY USE OF THIS PRODUCT IN AN AREA WHERE USE IS PROHIBITED
IS A VIOLATION OF FEDERAL LAW. Before using this product, you must
consult the Atrazine Watershed Information Center (AWIC) to determine whether
the use of this product is prohibited in your watershed. AWIC can be accessed
through [website], [mailing address] or [1-800-toll-free number]. If use of this
product is prohibited in your watershed, you may return this product to your point
of purchase or contact [insert name of registrant] for a refund."
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Occupational - Agricultural Uses
1) Mixing/Loading Scenarios:
a) Liquids:
require closed systems for mixing/loading to support aerial applications at
greater than 3 lb ai/A
all mixers/loaders (including using engineering controls) must wear long-
sleeve shirt, long pants, shoes, socks, chemical-resistant gloves and
chemical resistant apron
b) Wcttable Powders:
require water-soluble packaging for all WP formulations
all mixers/loaders must wear long-sleeve shirt, long pants, shoes, socks.
chemical-resistant gloves and chemical resistant apron
c) Dry Flowables:
water-soluble packaging optional
if in water-soluble packaging, all mixers/loaders must wear long-sleeve
shirt, long pants, shoes, socks, chemical-resistant gloves and chemical
resistant apron
if not in water-soluble packaging, mixers/loaders must wear coveralls over
long-sleeve shirt and long pants, chemical-resistant gloves, chemical-
resistant footwear, and chemical-resistant apron plus a NlOSII-approved
dust/mist filtering respirator with any N, R, P, or HE filter,
if not in water-soluble packaging, aerial application is prohibited.
d) Granular Products:
Loaders must wear long-sleeve shirt, long pants, shoes, and socks.
2) Applicator and Flagger Scenarios:
a) Pilots must use enclosed cockpits (40 CFR 170.240(d)(6)) for aerial applications.
b) Human flaggers supporting aerial applications must used enclosed cabs (40 CFR
170.240(d)(5)).
c) Applicators applying sprays with motorized ground equipment (i.e., groundboom
or rights-of-way sprayers) must wear long-sleeve shirt, long pants, shoes, socks,
and chemical-resistant gloves.
d) Applicators applying granular products or impregnated fertilizer must wear long-
sleeve shirt, long pants, shoes, and socks.
Restrict the impregnation of bulk fertilizer to commercial facilities
(prohibit on-farm impregnation)
Restrict the impregnation of dry bulk fertilizer to 500 tons per day for no
more than 30 days per calender year per facility
e) Reduce the maximum application rate for handlers applying liquids with rights-of-
way sprayers to 1.0 lb ai/A
f) Reduce the maximum application rate for liquids for chemical follow to 2.25 lb
ai/A
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g) Require a 60-day PHI for field com forage uses
h) Require a 45-dav PIII for sweet corn forage uses
i) Require a 60-day PHI for pre-emergent uses and a 45-day PHI for postcmergent
sorghum forage uses
b. Non-Agricultural Use Exposure Reduction Measures
1) Non-Agricultural Products including Lawns and Turf
(not Sod Farms)
a) Require that all wettable powder products be packaged in water soluble bags.
b) Granular formulations: loaders, applicators, and other handlers must wear long-
sleeve shirt, long pants, shoes, and socks.
c) Liquid, wettable powder, dry flowable (water-dispersible granule) formulations:
applicators using spray equipment mounted on their backs must wear
coveralls worn over long sleeved shirt and long pants, chemical-resistant
gloves and chemical-resistant footwear plus socks.
all other mixers, loaders, applicators, and other handlers must wear long-
sleeved shirt and long pants, shoes and socks, and chemical resistant
gloves.
Reduce the maximum single application rate for liquid formulations on
residential lawns and turf to 1 lb ai/A from 2 lb ai/A (liquid products
containing >4% ai are restricted use)
d) Require that granular lawn products be watered in
2) Residential
a) Restrict the application of granular lawn products when using hand-held devices
(e.g. belly grinder) to spot applications only.
b) Prohibit applications of granular lawn products by hand
c) Reduce the maximum single application rate for liquid formulations on residential
lawns and turf to 1 lb ai/A from 2 lb ai/A (liquid products containing >4% ai are
restricted use)
d) Require that granular lawn products be watered in
c. Label Harmonization
As described in Section II under the discussion of the regulatory history of atrazine, a
number of risk mitigation measures have been instituted over the years to address exposure to
atrazine. While most product labels have adopted these measures there are some that continue to
reflect use patterns prior to the implementation of these risk mitigation measures. The listing
below identifies measures that are not fully implemented on all current product labels. All of
these measures, in addition to new label requirements as defined by this ERED, are needed on
atrazine labels in order for products to be eligible for reregistration.
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Atrazine products containing >4% active ingredient must be classified as restricted use
Maximum broadcast application rates for corn and sorghum must be as follows:
a) Where both a preemergence and a postemergcnce arc used, the total atrazine
applied in the preemergence PLUS postemergence treatment cannot exceed 2.5 lb
ai/A/calendar year.
b) 2.0 lb ai/A as a single preemergence application on soils that are not highly
erodible or on highly erodible soils if at least 30% of the soil is covered with plant
residues; or
c) 1.6 lb ai/A as a single preemergence application on highly erodible soils if <30%
of the surface is covered with plant residues; or
d) 2.0 lb ai/A if only applied postemergence.
e) For all tank mixtures and sequential treatment of products containing atrazine. the
total lbs. a.i. of atrazine applied cannot exceed the application limits described
above.
Maximum application rates per crop must be as follows (single application and annual
maximum):
a) Conifers 4 lb ai/A; 4 lb ai/A per year maximum
b) Sugarcane 4 lb ai/A (single application); 10 lb ai/A per year maximum
c) Rights-of-Way/Roadsides Treatment 1 lb ai/A; 1 application per year
d) Guava 4 lb ai/A (single application); 8 lb ai/A per year maximum
e) Macadamia Nuts 4 lb ai/A (single application); 8 lb ai/A per year maximum
1) Conservation Reserve Program (CRP) 2 lb ai/A
g) Chemical Fallow 2.25 lbs ai/Aa
Delete all uses for total vegetation control on non-cropland areas. 1 his docs not include
rights-of-way/roadsides or CRP
Prohibit use in chemigation systems
Prohibit use, and mixing and loading within 50 feet of all wells, including abandoned
wells, drainage wells, and sink holes
Prohibit mixing and loading within 50 feet of intermittent streams and rivers, natural or
impounded lakes and reservoirs.
Prohibit application within 66 feet of the points where field surface water runoff enters
perennial or intermittent streams and rivers. If land is highly erodible. the buffer must be
planted to the crop or seeded with grass or other suitable crop.
Prohibit application within 200 feet of natural or impounded lakes and reservoirs.
Require that one of the following restrictions be used in applying Atrazine to tiled-
outletted fields containing standpipes
a) Do not apply within 66 feet of standpipes in tile-ouilelted fields
b) Apply this product to the entire tile-outletted field and immediately incorporate it
to a depth of 2-3 inches in the entire field
c) Apply this product to the entire tile-outletted field under a no-till practice only
when a high crop residue management practice is practiced. High crop residue
management is described as a crop management practice where little or no crop
residue is removed from the field during and after crop harvest.
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D. Regulator}' Rationale
The following is a summary of the rationale for managing risks associated with the
current uses of atrazine. The Agency has discussed these measures with the technical registrants
and in all cases the registrants have agreed to the measures presented here. Where labeling
revisions are warranted, specific language is set forth in the summary tables of Section V of this
document.
1. Human Health Risk Mitigation
a. Dietary (Food)
The acute and chronic dietary risks from atrazine residues on food are well below the
Agency's level of concern at the 99.9th percentile of exposure. Therefore, no mitigation
measures are necessary at this time.
b. Dietary (Drinking Water)
1) Community Water Systems (CWS)
The Agency has identified 34 surface water CWS with levels of atrazine that have
exceeded the Agency's current DWLOC (12.5 ppb as a 90-day average) at least once since
frequent monitoring for atrazine began in 1993. The 12.5 DWLOC was used as a screening tool
to identify specific CWS that were of concern to the Agency. The registrant has since added 3
CWS to the list of CWS of concern. These 37 CWS have been targeted for intensive monitoring,
risk mitigation, and probabilistic risk assessments.
The 12.5 ppb DWLOC was also used as a tool to establish a trigger value based on
SDWA compliance monitoring data by which CWS with potential high-end seasonal exposures
could be identified in the future. The Agency considered available data from SDWA compliance
monitoring and determined that a trigger value of 2.6 TCT provides an appropriate early warning.
If annual average concentrations of atrazine and its chlorinated metabolites (total chlorotriazines
- TCT) in a surface water CWS reach 2.6 ppb, this triggers weekly (during the use season) and
biweekly (during the remainder of the year) monitoring of that CWS for TCT concentrations.
The 12.5 ppb DWLOC is based on an endpoint of 1.8 mg/kg/day and a 1000 fold
uncertainty factor. The uncertainty factor includes a lOx factor for interspecies variation; a lOx
factor for intraspeeies variability, and a lOx FQPA Safety Factor. The lOx FQPA safety factor
was applied to account for the uncertainties associated with atrazine's toxic effects on the
developing child and the extent and magnitude of exposure to atrazine in drinking water.
Community water systems found to be potentially impaired by atrazine, as predicted by
exceedences of an annual average of 2.6 ppb based on SDWA compliance monitoring data, and
the 37 CWS identified above will be subject to an intensive monitoring program that includes
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weekly sampling for atrazine during the use season and biweekly sampling for atrazine during
the remainder of the year. This monitoring program will determine the maximum 90-day average
TCT concentration with sufficient accuracy to allow removal of that portion of the 1 Ox FQPA
safety factor associated with residual uncertainties regarding the extent and magnitude of
drinking water exposure, thereby reducing the lOx FQPA safely factor to 3x for the risk
assessments conducted in those community water systems for which there is available, reliable
drinking water exposure data.
For those specific CWS undergoing or preparing to undergo intensive monitoring,
uncertainties regarding the extent and magnitude of exposure to chlorotriazines no longer exist:
this supports a reduction in the FQPA safety factor to 3x for those CWS. Based on this, the
Agency has recalculated the DWLOC using a total risk assessment 300x uncertainty factor for
those CWS currently undergoing or targeted for future intensive monitoring. For these CWS, the
DWLOC becomes 37.5 ppb for total chlorotriazines based on an endpoint of 1.8 mg/kg/day, and
a 300x uncertainty factor reflecting a 1 Ox factor for interspecies variation, a lOx factor for
intraspecies variability, and a 3x FQPA safety factor. The 3x FQPA safety factor reflects
residual uncertainties associated with atrazine's toxic effects on the developing child only. For
CWS without intensive monitoring as described above, the screening level DWLOC remains
12.5 ppb for total chlorotriazines.
As such, the Agency is establishing 37.5 ppb TCT (as a 90-day average) as a performance
standard that must be met in CWS that are being intensively monitored. The Agency believes
that its usual mitigation measures for pesticide chemicals (e.g., reduction in label rates, labeled
use restrictions, etc.) are not appropriate in the case of atrazine because of the nature of the
chemical. Exceedences do not appear to be linked to nation-wide use practices that can be
amended on the label. Based on atrazine monitoring data, the Agency's risk assessment for
atrazine has determined that drinking water risks from atrazine use are localized problems and. as
such, lend themselves to a localized mitigation plan. In addition, this localized approach is
consistent with the conclusions from a February 2000 F1FRA Scientific Advisory Panel meeting
(Partial Report May 25, 2000. Report Number 2000-01). OPP's approach is also consistent with
the intent of the Agency's recent January 2003 Water Quality Trading Policy that encourages
solutions within watersheds, provides incentives and encourages actions, and provides flexibility
to meet local challenges and accountability to ensure improvements.
The Agency's approach to these CWS is as follows:
For 2 CWS that were identified in the screening-level assessment and arc of concern to
the Agency. Shipman. IL, and Hettick, IT,, the Agency understands that these CWS will
no longer be using the reservoir that has shown unacceptable atrazine levels as a water
source for the community in the future.
For 8 CWS that were identified in the screening-level assessment (see Appendix H for a
site-specific listing), the Agency is requiring frequent monitoring data. Tf an exceedencc
of 37.5 is detected in raw drinking water (pre-treatmenl) in any of these watersheds.
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further use of atrazine \viii be prohibited in that watershed.
For all remaining CWS, the Agency is requiring frequent monitoring data if an annual
average of 2.6 total chlorotriazincs is triggered through SDWA compliance monitoring
data. If an exceedence is detected in raw drinking water (pre-treatment) twice in any
watershed, further atrazine use will be prohibited in that watershed.
» Frequent monitoring will continue annually for five years (minimum) and may only cease
if no 90-day rolling average exceeds the performance standard of 37.5 ppb total
chlorotriazines during the five year period.
Based on the monitoring programs, the registrants are being required to submit annual
reports to the Agency that include the results of that year's analysis. Atrazine registrants must
notify EPA in writing of any raw water exceedance within 30 days of date of the last water
sample included in that result.
As part of the Agency's mitigation program for atrazine, registrants are also being
required to submit to the Agency written mitigation plans for the 8 CWS of concern (or any other
CWS that has an exceedence in the future) describing mitigation measures to be implemented
and a strategy for communication with growers within the watershed and quarterly progress
reports describing the measures taken during that quarter in each CWS.
An important element of the mitigation program is the ability of the Agency to quickly
prohibit use of atrazine in watersheds that have exceeded the applicable performance standard.
This is possible because the mitigation program includes a mechanism that does not require
lengthy administrative proceeding before the use prohibition goes into effect. The principle
registrants of atrazine have agreed to this measure. Without tltis voluntary measure, it may have
been necessary for the Agency to seek immediate cancellation of atrazine.
In order to implement this agreement, if the product contains directions for use other than
for reformulation and contains greater than 4% atrazine active ingredient, the label must include
all of the following statements:
"ANY USE OF THIS PRODUCT IX AN AREA WHERE USE IS PROHIBITED
IS A VIOLATION OF FEDERAL LAW. Before using this product, you must
consult the Atrazine Watershed Information Center (AWIC) to determine whether _
the use of this product is prohibited in your watershed. AWIC can be accessed
through | website], [mailing address] or [1-800-toII-free number]. If use of this
product is prohibited in your watershed, you may return this product to your point
of purchase or contact [insert name of registrant] for a refund."
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The atrazine registrants will establish an Atrazine Watershed Information Center (AWIC)
that:
will provide detailed information on what Watershed Areas have become subject
to a prohibition on Atrazine use. Only information approved by EPA may be
included in the AWIC.
shall be accessible to the public daily, including weekends and holidays, through a
toll-free telephone number available 24 hours a day and seven days a week, a
World Wide Web site, and a regular mailing address. Contact information for the
AWIC will be included on all Atrazine product labels,
shall be updated to include, any Watershed Areas for which use is prohibited
will prominently display information regarding use prohibitions in a manner thai
is simple and convenient for users to access and understand.
This localized drinking water mitigation program will ensure that mitigation actions taken
in watersheds of concern are providing results in raw drinking water and will prevent any
exceedences from occurring or going undetected in the future. The Memorandum of Agreement
with the atrazine technical registrants provides further details on this mitigation plan, including
the specifics of the monitoring programs being established and the mechanism by which use
prohibitions will be implemented.
This program allows the Agency to make a safely finding because future exceedences in
raw water trigger use prohibitions in the watershed of concern. Since this exceedence is in raw,
not finished water, treatment of water by CWS operators to meet the MCL may prevent actual
exposures above the Agency's level of concern. In addition, the Agency does not expect future
exceedences to occur because of the responsible use programs being implemented and
coordinated by the registrants as product stewardship. The Agency feels that the risk of use
prohibitions is a strong incentive for atrazine users and the registrants to make every effort to
prevent exceedences. The performance standard approach makes the prevention of atrazine
water contamination the responsibility of the user, but will not result in unacceptable risks.
2) Rural Drinking Water Wells
To confirm that rural drinking water wells will not have atrazine levels that exceed the
Agency's level of concern, the Agency will be requiring that the registrant(s) develop and
conduct a program for the monitoring of rural wells. The Agency is requiring that the registrants
define a protocol for monitoring total chlorotriazine levels in rural wells by April 30, 2003. The
protocol must identify the number of wells to be sampled, the frequency of monitoring, the
duration and timing of monitoring, and the liming of submission of data. The Agency may take
appropriate regulatory action if EPA determines that additionai label restrictions for the
protection of rural drinking water wells are necessary.
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h. Residential Risk Mitigation
1) Residential Handler Risk
Residential handler risks were considered for homeowners who mix, load, and apply
atrazine products to home lawns.
One residential handler risk scenario was above the Agency's level of concern, the
broadcast application of granular formulations with a bellygrinder. To address these concerns,
the following risk mitigation measures are needed in order for EPA to conclude that atrazine
products are eligible for reregistration:
Restrict the application of granular lawn products when using hand-held devices
to spot applications only.
Prohibit applications of granular lawn products by hand.
2) Residential Post-Application Risk
Residential post-application risks were considered for individuals that reenter lawns and
golf courses treated with atrazine.
The Agency has risk concerns for incidental oral exposures in children to atrazine
residues. For lawns treated with liquid formulations of atrazine. the Agency has concerns for
hand-to-mouth exposures alone (MOE - 210) and for combined oral routes of exposure (hand-to-
mouth, turfgrass & object mouthing, and ingestion of soil; MOE = 200). For lawns treated with
granular formulations, the Agency has concerns for incidental ingestion of granules.
To address those concerns, the risk mitigation measures listed below are necessarv.
w j
These mitigation measures make it possible for EPA to conclude that atrazine products are
eligible for reregistration. The mitigation measures are as follows:
Reduce the maximum 1 time application rate for liquid formulations on lawns and
turf to 1 lb ai/A from 2 lb ai/A.
Require that granular lawn products be watered in.
At the 1 lb ai/A rate for liquid formulations of atrazine, the short term MOE for hand-to-
mouth and combined incidental oral exposures becomes acceptable individually (420 and 370,
respectively). If granular lawn products are watered in, the short-term MOE for ingestion of
granules is no longer appropriate since the individual granules will no longer be present in the
turf.
c. Aggregate Risk Mitigation
The Agency's aggregate risk assessment for atrazine is based on exposure estimates for
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drinking water based on monitoring data and residential exposure estimates based on chemical-
sped fie exposure data.
1) Acute Exposure
Acute aggregate exposure estimates Tor atrazine are the same as those presented for acute
drinking water risks because the Agency does not believe that high-end exposures through food,
drinking water, and residential uses will all occur on the same day. Since acute drinking water
risks do not exceed the Agency's level of concern, acute aggregate risk is also acceptable, and no
mitigation measures are necessary.
2) Intermediate-Term and Chronic Exposure
The aggregate risk assessment for intermediate-term and chronic exposures to atrazine
and the chlorinated metabolites combines estimates of high-end seasonal or long-term average
exposures to atrazine in drinking water with long-term average exposures in food. Neither
intermediate-term nor long-term exposures are expected to occur in or around the home from
residential uses of atrazine. Therefore, the intermediate-term and chronic aggregate risk for
atrazine is the same as the intermediate-term and chronic drinking water risk. As such,
mitigation measures presented above to address intermediate-term and chronic drinking water
risk also mitigates the intermediate-term and chronic aggregate risk. No additional mitigation
measures are needed to specifically address aggregate risk.
3) Short-Term Aggregate Exposure
The short-term (1-30 days) aggregate risk assessment combines short-term residential
exposures with short-term drinking water exposures. If the short-term DWLOC is less than the
measured average concentrations in surface water and groundwater, there is a risk of concern.
Short-term aggregate risk estimates that include residential exposures to atrazine are only
applicable for those regions of the United States where atrazine is used on turf, the Southeast
(including Florida).
For adult handlers applying granular formulations of atrazine via bellygrinder, both
residential exposures alone and aggregate exposures are of concern. To address the residential
concern, the Agency has concluded that the application of granular lawn products using hand-
held devices should be limited to spot applications only.
For adults exposed to atrazine after it has been applied to turf or home lawns, neither
residential exposure alone nor aggregate exposures are of concern. Therefore, no mitigation is
needed.
For children exposure to atrazine after it has been applied in liquid formulations to home
lawns, aggregate exposure is of concern. Combined dermal and incidental oral exposures for
toddlers result in a MOF, of 180 for toddlers' aggregate dermal and oral exposures, based on the
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1 lb ai/A rate necessary to address residential concerns alone. Since this is above the Agency's
level of concern, the short-term DWLOC is zero for aggregated exposures from liquid
formulations across multiple exposure routes for toddlers. However, since the lawn use of
atrazine is limited to the Southwest and Florida and the CWS of concern, with the exception of
Iberville. LA. are in the Midwest, it is highly unlikely that home lawn exposure will occur at the
same time as high-end drinking water exposures.
For children exposed to atrazine after it has been applied as a granular formulation to
home iawns, and watered-in, aggregate exposure is not of concern. Toddlers' risk estimates from
combined pathways for incidental oral exposures based on granular formulations result in an
MOE of 730 and thus do not exceed the Agency's level of concern. Toddlers' risk estimates from
dermal exposures based on granular formulations also do not exceed HED's levels of concern
(MOE = 690 if not watered-in and 2000 if granules are watered-in immediately after application).
For most CWS. short-term DWLOCs for toddlers' post application aggregate exposures do not
exceed the Agency's level of concern for granular formulations watered-in after application to
turf. Thus, mitigation measures required for residential concerns alone (i.e, requiring that
granular formulations be watercd-in) mitigate any aggregate post-application concerns. In
addition, the few CWS that have 30-day average concentrations above the DWLOC are primarily
located in the Midwest (outside of airline turf use areas), with the exception of Iberville.
Louisiana.
Further, all of the CWS with 30-day average concentrations above the DWLOC have also
been identified under the intermediate-term drinking water risk assessment as of concern,
including Iberville, Lousiana. As such, levels of atrazine in all of these CWS are being mitigated
through the Agency's localized atrazine drinking water mitigation plan described above.
d. Occupational Risk Mitigation
It is the Agency's policy to mitigation occupational risks to the greatest extent necessary
and feasible with personal protective equipment and engineering controls. In managing these
risks, EPA must take into account the economic, social, and environmental costs and benefits of
the pesticide's use. A wide range of factors is considered in making risk management decisions
for worker risks. These factors include, in addition to the calculated MOEs, incident data, the
nature and severity of adverse effect, uncertainties in the risk assessment, the cost, availability
and relative risk of alternatives, importance of the chemical in integrated pest management (IPM)
programs, and other similar factors.
Agricultural Handlers
Several occupational handler scenarios are not of concern at baseline levels of PPE (long-
sleeved shirt and long pants, shoes and socks); therefore, no risk mitigation is necessary at this
time in order for these uses to remain eligible for rercgistration. These scenarios are described in
Section III.A.4. of this document.
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For ihe remaining agricultural handlers scenarios, occupational risks are of concern when
considering the use of PPE or engineering controls (the maximum feasible mitigation). To
reduce mixer/loader and applicator risk so that atrazine products are eligible for reregistration,
risk mitigation measures are necessary. These mitigation measures arc explained in more detail
below.
1) Mixing/Loading Scenarios
Liquids:
require closed systems for mixing/loading to support aerial applications at
greater than 3 lb ai/A
all mixers/loaders (including using engineering controls) must wear long-
sleeve shirt, long pants, shoes, socks, chemical-resistant gloves and
chemical resistant apron
Wettable Powders:
require water-soluble packaging for all WP formulations
all mixers/loaders must wear long-sleeve shirt, long pants, shoes, socks,
chemical-resistant gloves and chemical resistant apron
Dry Flowablcs:
water-soluble packaging optional
if in water-soluble packaging, all mixers/loaders must wear long-sleeve
shirt, long pants, shoes, socks, chemical-resistant gloves and chemical
resistant apron
if not in water-soluble packaging, mixers/loaders must wear coveralls over
long-sleeve shirt and long pants, chemical-resistant gloves, chemical-
resistant footwear, and chemical-resistant apron plus a NIOSH-approved
dust/mist filtering respirator with any N, R, P, or HE filter.
if not in water-soluble packaging, aerial application is prohibited.
Granular Products:
Loaders must wear long-sleeve shirt, long pants, shoes, and socks.
2) Applicator and Flagger Scenarios
Pilots must use enclosed cockpits (40 CFR 170.240(d)(6)) for aerial
applications.
Human flaggers supporting aerial applications must used enclosed cabs
(40 CFR 170.240(d)(5)).
Applicators applying sprays with motorized ground equipment (i.e..
groundboom or rights-of-way sprayers) must wear long-sleeve shirt, long
pants, shoes, socks, and chemical-resistant gloves.
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Applicators applying granular products or impregnated fertilizer must wear
long-sleeve shirt, long pants, shoes, and socks.
In Addition:
Restrict the impregnation of bulk fertilizer to commercial facilities
(prohibit on-farm impregnation)
Restrict the impregnation of dry bulk fertilizer to 500 Ions per day for no
more than 30 days per calender year per facility
Reduce the maximum application rate for handlers applying Liquids with
rights-of-way sprayers to 1.0 lb ai/A
Reduce the maximum application rate for liquids for chemical follow to
2.25 lb ai/A
Require a 60-day PKI for field corn forage uses
Require a 45-day PHI for sweet corn forage uses
Require a 60-day PHI for preemergent uses and a 45-day PHL for
postemergent sorghum forage uses
3. Non-Agricultural Products including Lawns and Turf (not Sod
Farms)
For turf and LCO uses of atrazine, handler risks are of concern, but can be mitigated
through the use of PPE. To reduce this risk so that atrazine turf products are eligible for
reregistration, risk mitigation measures are necessary. These mitigation measures are explained
in more detail below.
Require that ali wettablc powder products be packaged in water soluble
bags.
Granular formulations: loaders, applicators, and other handlers must wear
long-sleeve shirt, long pants, shoes, and socks.
Liquid, wettable powder, dry flowable (water-dispersible granule)
formulations:
applicators using spray equipment mounted on their backs must
wear coveralls worn over long sleeved shirt and long pants,
chemical-resistant gloves and chemical-resistant footwear plus
socks.
all other mixers, loaders, applicators, and other handlers must wear
long-sleeved shirt and long pants, shoes and socks, and chemical
resistant gloves.
Reduce the maximum single application rate for liquid formulations on
residential lawns and turf to 1 lb ai/A from 2 lb ai/A (liquid producis
containing >4% ai are restricted use)
Require that granular lawn products be watered in
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Post-Application Occupational Risk
The Agency has not identified any post-application occupational risks from atrazine.
Therefore, no mitigation measures are needed at this time.
2. Environmental Risk Mitigation
The Agency has ecological risk concerns from the use of atrazine. The Agency has
identified the potential for community-level and population-level risk to aquatic ecosystems at
concentrations of atrazine from 10 to 20 ppb.
To mitigate these ecological risks to aquatic communities, the Agency is requiring that
atrazine registrants, in consultation with EPA, develop a program under which the registrants
monitor for atrazine concentrations and mitigate environmental exposures if EPA determines that
mitigation is necessary. The program will focus on watershed impacts of atrazine use.
The program will include an appropriate ecological level of concern (LOG), including for
endangered species, identified by EPA; development of a protocol for a monitoring program that
specifics the frequency, location, and timing of sampling, as well as an appropriate coordination
with TMDL programs; triggers for mitigation measures; and description of mitigation measures
that will he taken if triggers are exceeded. This monitoring and mitigation program would he
designed, conducted and implemented on a tiered watershed level and must be consistent with
existing state and federal water quality programs.
The requirement that this process be established is presented in the Memorandum of
Agreement between the Agency and the atrazine technical registrants. Per the Memorandum of
Agreement, the Agency and the registrants must reach an agreement on the ecological monitoring
program by April 30, 2003. If an agreement has not been reached, the Agency will identify any
requirements the Agency deems necessary in the October 31, 2003, revision to the Atrazine
IllED. The establishment of a process to address ecological risks on a watershed basis allows the
Agency to conclude that atrazine products arc eligible for rcrcgistration.
3. Other Labeling
Other use and safety information need to be placed on the labeling of all end-use products
containing atrazine, in addition to the mitigation measures listed above and other existing label
requirements. Tor the specific iabeling statements, refer to Section V of this document.
The Agency reserves the right to require additional label amendment to mitigate risks
from triazine residues. Any further amendments will be discussed in the triazine cumulative
decision.
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a. Endangered Species Statement
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on endangered and threatened species, and to
implement mitigation measures that address these impacts. The Endangered Species Act requires
federa! 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 to affect
any particular species. EPA puts basic toxicity and exposure data developed for IREDs into
context for individual listed species and their locations by evaluating important 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. This analysis will take into consideration any regulatory changes recommended in this
IRED that are being implemented at this time. A determination that there is a likelihood of
potential impact to a listed species may result in limitations on use of the pesticide, other
measures to mitigate any potential impact, or consultations with the Fish and Wildlife Service
and/or the National Marine Fisheries Service as necessary.
The Endangered Species Protection Program as described in a Federal Register notice
(54 FR 27984) is currently being implemented on an interim basis. As part of the interim
program, the Agency has developed County Specific Pamphlets that articulate many of the
specific measures outlined in the Biological Opinions issued to date. The Pamphlets are
available for voluntary use by pesticide applicators on EPA's website atwww.epa.gov/espp. A
final Endangered Species Protection Program, which may be altered from the interim program, is
scheduled to be proposed for public comment in the Federal Register before the end of 2001.
b. Spray Drift Management
The Agency is currently working with stakeholders to develop appropriate generic label
statements to address spray drill risk. Once this process has been completed, atrazine product
labels will need to be revised to include this additional language.
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V. What Registrants Need to Do
In order to be eligible for reregistration, registrants need to implement the risk mitigation
measures outlined in Section IV and V, which include, among other things, submission of the
following:
For products containing atrazine. registrants need to submit the following items for each
product within eight months of the date of the PDCI:
(1) an application for reregistration (EPA Form 8570-1, filled in, with a description
on the application, such as, "Responding to Interim Reregistration Eligibility
Decision" document);
(2) five copies of the draft label incorporating all label amendments outlined in Table
17 of this document;
(3) responses to the generic and/or product specific Data Call-Ins (DCIs) as instructed
in the enclosed DCIs;
(4) two copies of the Confidential Statement of Formula (C-SF); and
(5) a certification with respect to data compensation requirements.
Note that the first set of required responses for the product-specific DCI is due 90 days
from the receipt of the DCI. The second set of required responses is due eight months from the
date of the DCI. For questions about product reregistration and/or the product-specific DCI.
please contact Bonnie Adler at (703) 308-8523.
For the generic DCI. the following items are due:
(1) DCI response form, due 90 days from the receipt of the DCI:
(2) Registrant response form, due 90 days from the receipt of the DCI; and
(3) the actual generic data in response to the DCI.
For questions relating to the generic DCI, please contact Eric Olson at (703) 308-8067.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of atrazine for the above eligible uses
has been reviewed and determined to be substantially complete. The following data gaps remain:
Product Chemistry' Data
Product-Specific Product Chemistry data requirements have not been fulfilled ( Series
830). Please see Product-Specific Data Call-Ins.
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ioxicolosv Data
Non-Guiileiine Study
Non-Guide Iine St itd\¦
28-day inhalation toxicity study, measuring LI I surge anc
esinis cycle parameters
Assessment of C.NS alterations after atrazinc exposure
(recommended)
Occupational Data
None
Environmental Fate and Ecological Effects Data
OPPTS 850.2100 (71 -1(a))
OPPTS 850.1075 (72- 1(a))
OPPTS 850.10~5 (72-1 (c))
OPPTS 850.1010 (72-2(a))
OPPTS 850.1025 (72-3{ai)
OPPTS 850.1025 (72-3(h))
OPPTS 850.
OPPTS 850.
OPPTS 850.
OPPTS 835.
OPPTS 835.
OPPTS 850.
OPPTS 840.
OPPTS 840.
OPPTS 830.
1025
1400
1350
4300
1(10
1950
1100
1200
7050
(72-3(c))
(72-4(a)j
(7 2-4(b))
(162-4) '
f'l 63-2)
(165-5)
(201-1)
(202-1)
(NA)
Acute Avian Oral - Northern Quail (3 major degradates)
Acute Fish Toxicity Blucgill (major degradate}
Acute Fish Toxicity Rainbow Trout (major degradate)
Acute Aquatic Invertebrate Toxicity (major degradate)
Acute Estuarine/Marine Fish Toxicity (major degradate)
Acute Estuarine/Marine Mollusk Toxicity (TGAI and majo
degradate)
Acute Estuarine/Marine Shrimp Toxicity- (major degradate)
Early Life-Stage Fish (Marine) (TGAI)
Life-Cycle Marine invertebrate (TGAI)
Aerobic Aquatic Metabolism - Lab
Volatility (Lab)
Accumulation in Aquatic Xon-Targct Organisms
Spray Drift - Droplet Size Spectrum.
Spray Drift - Drift Field Evaluation
UV/Visible Absorption
Residue Chemistry Data
OPPTS 860.1380 (1 71-4e)
OPPTS 860.1900 (165-2)
OPPTS 860.1500 (171-4k)
OPPTS 860.1360 (171-4)
Storage Stability
Field Rotational Crop Study (in review)
Crop Field Trials - Crop Group 17
Muiti-Residue Method
Other Data Requirements
Non-Guideline Study
Non-Guideline Siudy
Rural Well Monitoring Program
(see MOA & DCI for details)
Surface Water CWS Monitoring Program
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(see MOA & DCI for details)
Non-Guideline Study Ecological Monitoring and Mitigation Program
(see MOA & DCI for details - specifics to be negotiated)
2. Labeling for Manufacturing Use Products
To remain in compliance with F1FRA, manufacturing use product (MUP) labeling should
be revised to comply with all current EPA regulations. PR Notices and applicable policies. The
MP labeling should bear the labeling contained in Table 17 at the end of this section.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. Registrants 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 MR1D numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product.
A product-specific data cali-in, outlining specific data requirements, accompanies this
interim RED.
2. Labeling for End-Use Products
Labeling changes are necessary to implement the mitigation measures outlined in Section
IV above. Specific language to incorporate these changes is specified in the Table 28 at the end
of this section.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Interim Reregistration Eligibility Decision
document. Persons other than the registrant may generally distribute or sell such products for 50
months from the date, of the issuance oJ" this interim RED. However, existing stocks time frames
will be established casc-by-case, depending on the number of products involved, the number of
label changes, and other factors. Refer to '"Existing Stocks of Pesticide Products; Statement of
Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may not distribute or sell atrazine products
bearing old labels/labeling after the date of cancellation or amendment unless it is for the purpose
of relabeling in accordance with the terms of this interim RED. Persons other than the registrants
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may distribute or sell such products until October 1, 2003. Registrants and persons other than the
registrants remain obligated to meet pre-existing label requirements and existing stocks
requirements applicable to products they seli or distribute. In addition, HP A. has agreed to allow
the atrazine technical registrants to re-label cancelled products with new provisions or to create
supplemental labeling that will allow distributors to provide new label language to purchasers of
atrazine products with labels that do not comply with this interim RED.
D. Labeling Changes Summary Table
In order to be- eligible for reregi strati on. amend all product labels to incorporate the risk
mitigation measures outlined in Section IV. Table 29 below describes how language on the
labels should be amended.
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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 describes how language on the labels should be amended.
Table 29: Summary of Labeling Changes for Atrazine
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
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 foimulator or user group
"Only for formulation into an herbicide for the following use(s) [fill blank only with those uses that are
being supported by MP registrant]."
Note: In addition to the uses previously classified as restricted use, all uses of products containing >4%
active ingredient must be classified as restricted use.
Uses for total vegetation control on non-cropland areas (not including rights-of-ways, roadsides, or CRP
programs) are cancelled. Uses on pineapple, rangeland, and proso millet are also cancelled. Technical
and end-use product labels must be revised to delete all references to and use-directions for these
cancelled use patterns.
Directions for Use
"This product may be used to formulate products for specific use(s) not listed on the MP label if the
foi mulator, 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
Text required from
Memorandum of Agreement
"This product may not be reformulated or repackaged into another product unless the registration of the
reformulated or repackaged product was either granted or amended after March 15, 2004, so as to be
consistent with the terms and conditions set forth in the Atrazine January 31, 2003 Interim Reregistration
Eligibility Document (1RED)."
Directions for Use
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Description
Amended Labeling Language
Placement on Label
Text required from
Memorandum of Agreement
No product (other than products containing 4% or less atrazine active ingredient) may be formulated or
repackaged from this product unless the formulated repackaged product hears a label including all.of the
following statements:
The following language must be prominently displayed in the DIRECTIONS FOR USE on the label:
"ANY USE OF THIS PRODUCT IN AN AREA WHERE USE IS PROHIBITED IS A VIOLATION OF
FEDERAL LAW. Before using this product, you must consult the Atrazine Watershed Information
Center (AWIC) to determine whether the use of this product is prohibited in your watershed. AWIC can
be accessed through www.atrazine-watershed.info, or 1-866-365-3014. If use of this product is
prohibited in your watershed, you may return this product to your point of purchase or contact [insert
name of registrant] for a refund."
"No product containing 4% or less atrazine active ingredient may be formulated or repackaged from this
product unless the registration of the resulting product includes the following terms and conditions: The
registrant of this product shall immediately: i) cease all distribution and sale to any retailer or entity
distributing or selling such product to any retailer located within all counties containing any portion of
the Watershed Area listed in the AWIC; ii) ensure the removal of such Atrazine product from the shelves
of any retailer located within all counties containing any portion of any Watershed Area listed in the
AWIC; and iii) repurchase any such Atrazine product from any of the purchasers described above. In
addition, such Registrant shall consult with the State(s) in which such counties are located to determine
whether additional territory shall be included in the area to which these requirements will apply. If the
State(s) determine that a larger area is warranted, the Registrant shall within 10 days of such
determination notify the Director ofEPA's Special Review and Reregistration Division (SRRD) (7508C),
Office of Pesticide Programs, of the specific boundaries within which the stop sale, removal, and
repurchase shall take place."
Directions for Use
Environmental Hazards
"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 Pollutant 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
immediately following the
User Safety
Recommendations
105
-------
Description
Amended Labeling Language
Placement on Label
End Use Products Intended for Occupational Use (WPS and NonWPSt
Restricted Use Pesticide
(In addition to the uses
previously restricted, all uses
of products containing >4%
active ingredient must be
classified restricted use)
"RESTRICTED USE PESTICIDE"
"Due to ground and surface water concerns. For retail sale to and use only by certified applicators or
persons under their direct supervision, and only for those uses covered by the certified applicator's
certification."
Top of front panel
Text required from
Memorandum of Agreement
"ANY USE OF THIS PRODUCT IN AN AREA WHERE USE IS PROHIBITED IS A VIOLATION
OF FEDERAL LAW. Before using this product, you must consult the Atrazine Watershed Information
Center (AWIC) to determine whether the use of this product is prohibited in your watershed. AWIC can
be accessed through [www.atrazine-watershed.info], or [1-866-365-3014], If use of this product is
prohibited in your watershed, you may return this product to your point of purchase or contact
[registrant] for a refund."
Directions for Use
PPE Requirements
Established by the IRED1
for liquid products that do
NOT contain directions for
use on lawns or other
turfgrass
"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 If] "on an EPA chemical-resistance category selection chart."
"Mixers, loaders, applicators, flaggers, and other handlers must wear:
> Long sleeved shirt and long pants,
> Chemical resistant gloves, such as (registrant insert correct chemical-resistant materials),
> Shoes plus socks, and
> Chemical-resistant apron, when mixing/loading, cleaning up spills, or cleaning equipment, or otherwise
exposed to the concentrate."
"See engineering controls for additional requirements."
Immediately
following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
106
-------
Description
Amended Labeling Language
Placement on Label
PPE Requirements
Established by the 1RED'
for liquid products that DO
contain directions for use on
lawns or other turfgrass
"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 J!] "on an EPA chemical-resistance category selection chart."
"Applicators using spray equipment mounted on their backs must wear:
> Coveralls over long-sleeved shirt and long pants,
> Chemical-resistant footwear plus socks, and
> Chemical-resistant gloves, such as (registrant insert correct chemical-resistant materials)."
"Mixers, loaders, all other applicators, flaggcrs, and other handlers must wear:
> Long sleeved shirt and long pants,
> Chemical resistant gloves, such as (registrant insert correct chemical-resistant materials),
> Shoes plus socks, and
> Chemical-resistant apron, when mixing/loading, cleaning up spills, cleaning equipment, or otherwise
exposed to the concentrate."
"See engineering controls for additional requirements."
Immediately
following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
107
-------
Description
Amended Labeling Language
Placement on Label
I'l'H Requirements
Established by the IRIID'
for wcttable powder and dry
flow able (\v;tier dispcrsiblc
granular) formulations in
water-soluble packets that do
NO'!" contain directions for
use on lawns or other
turlgrass. Note: all wcttable
powder products with IVI'S
uses on the label must he in
water soluble packets to be
eligib/e for rercgistratioii
Dryjlowahle (water
dispersible granular)
formulations are not
required to he in water-
soluble packets. However
aerial application is
prohibited unless a dry
Jlowahle (water dispersible
granular) formulation is
packaged in water-soluble
packets.
"Personal Protective Equipment (PPF.)"
"Some materials that arc chemical-resistant to this product are (registrant inserts correct chcmical-
rcsistant material). If you want more options, follow the instructions for category /registrant inserts
A.B,C.I\E,F,G.or II| "on an 1:PA chemical-resistance category selection chart."
"Mixers, loaders, applicators, daggers, and other handlers must wear:
Long sleeved shirt and long pants.
> Chemical resistant gloves, such as (registrant insert correct chemical-resistant materials),
> Shoes plus socks, and
> Chemical-resistant apron, when mixing/loading, cleaning up spills, cleaning equipment, or otherwise
exposed to the concentrate."
';See engineering controls for additional requirements."
Immediately
following/below
Precautionary Statements:
! la/.ards to 1 hiinans and
Domestic Animals
108
-------
Description
Amended Labeling Language
Placement on Label
PPE Requirements
Established by the IRED'
Cor wettable powder and dry
flovvable (water dispersible
granular) formulations
packaged in water-soluble
packets that DO contain
directions for use on lawns
or other turfgrass. Note: all
wettable powder products
with WPS uses on the label
must be in water soluble
packets to be eligible for
/({registration. Dryj1owable
(water dispersible granular)
formulations are not
required to be in water-
soluble packets. However
aerial application is
prohibited unless a dry
flowable (water dispersible
granular) formulation is
packaged in water-soluble
packets.
"Personal Protective Equipment (PPE)"
"Some materials that arc 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 I I] "on an EPA chemical-resistance category selection chart."
"Applicators using spray equipment mounted on their backs must wear:
> Coveralls over long-sleeved shirt and long pants,
> Chemical-resistant footwear plus socks, and
> Chemical-resistant gloves, such as (registrant insert correct chemical-resistant materials)."
"Mixers, loaders, applicators, daggers, and other handlers must wear:
> Long sleeved shirt and long pants,
> Chemical resistant gloves, such as (registrant insert correct chemical-resistant materials),
> Shoes plus socks, and
> Chemical-resistant apron, when mixing/loading, cleaning up spills, cleaning equipment, or otherwise
exposed to the concentrate."
"See engineering controls for additional requirements."
Immediately
following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
109
-------
Description
Amended Labeling Language
Placement on Label
PPE Requirements
Established by the IRRD'
for dry flowable (water
dispersible granule) products
NOT packaged in water
soluble packets that do NOT
contain directions for use on
lawns or other turfgrass..
Note: if not packaged in
water-soluble packets, aerial
application is prohibited.
"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.'"
"Mixers, loaders, cleaners of equipment or spills, and other handlers exposed to the concentrate must
wear:
> Coveralls over long sleeved shirt and long pants,
> Chemical-resistant gloves, such as (registrant insert correct chemical-resistant materials)
> Chemical resistant footwear plus socks,
> Chemical-resistant apron, and
> A NIOSH-approved dust/mist filtering respirator with any N, R, P or HE filter or a NIOSH-approved
dust/mist filtering respirator with approval number prefix TC-21Q."
Applicators and all other handlers exposed to the dilute must wear:
> Long sleeved shirt and long pants,
> Shoes plus socks, and
> Chemical resistant gloves, such as (registrant insert correct chemical-resistant materials).'"
"Aerial application is prohibited."
"See engineering controls for additional requirements."
Immediately
following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
110
-------
Description
Amended Labeling Language
Placement on Label
PPE Requirements
Established by the IRED1
for dry flowable (water
dispersablc granule) products
NOT packaged in water
soluble packets that DO
contain directions for use on
lawns or other turfgrass..
Note: if not packaged in
water-soluble packets, aerial
application is prohibited.
"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 11] "on an EPA chemical-resistance category selection chart."
"Mixers, loaders, cleaners of equipment or spills, and other handlers exposed to the concentrate must
wear:
> Coveralls over long sleeved shirt and long pants,
> Chemical-resistant gloves, such as (registrant insert correct chemical-resistant materials),
> Chemical resistant footwear plus socks,
> Chemical-resistant apron, and
> A NIOSH-approved dust/mist filtering respirator with any N, R, P or HE filter or a NIOSH-approved
dust/mist filtering respirator with approval number prefix TC-21C)."
"Applicators using spray equipment mounted on their backs must wear:
> Coveralls over long sleeved shirt and long pants,
> Chemical-resistant gloves, such as (registrant insert correct chemical-resistant materials), and
> Chemical resistant footwear plus socks."
"All other applicators and all other handlers exposed to the dilute must wear:
> Long sleeved shirt and long pants,
> Shoes plus socks, and
> Chemical resistant gloves, such as (registrant insert correct chemical-resistant materials)."
"Aerial application is prohibited."
"See engineering controls for additional requirements."
Immediately
following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
PPE Requirements
Established by the IRED1
for granular products
"Personal Protective Equipment (PPE)"
"Loaders, applicators and other handlers must wear:
> Long-sleeved shirt and long pants, and
> Shoes plus socks."
Immediately
following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
-------
Description
Amended Labeling Language
Placement on Label
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."
If coveralls are specified in the handler PPE section of the label, use the following in addition to the
above statement:
"Discard clothing and other absorbent materials that have been drenched or heavily contaminated with
this product's concentrate. Do not reuse them."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following the
PPE requirements
Engineering Controls for
liquid formulations that
contain directions for use
permitting aerial application.
"Engineering Controls"
"Mixers and loaders supporting aerial applications at a rate greater than 3 lbs ai/A must use a closed
system that meets the requirements for dermal protection listed in the Worker Protection Standard (WPS)
for Agricultural Pesticides [40 CFR 170.240(d)(4) and must:
-wear the personal protective equipment required for mixers and loaders,
-wear protective eyewear if the system operates under pressure, and
-be provided and have immediately available for use in an emergency, such as a spill or equipment
breakdown: chemical resistant footwear."
"Pilots must use an enclosed cockpit in a manner that is consistent with the WPS for Agricultural
Pesticides [40 CFR170.240(d)(6)]. Pilots must wear the PPE required on this labeling for applicators,
however, they need not wear chemical-resistant gloves when using an enclosed cockpit."
"Flaggers supporting aerial applications must use an enclosed cab that meets the definition on the Worker
Protection Standard for Agricultural Pesticides [ 40 CFR 170.240 (d)(5)] for dermal protection."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
(Immediately following
PPE and User Safety
Requirements.)
Engineering Controls for
wettable powders and dry
flowables (water dispersible
granules) packaged in water-
soluble packets. All wettable
powders with WPS uses must
be in water soluble packets
to be eligible for
reregistration.
"Engineering Controls"
"Water soluble packets when used correctly qualify as a closed mixing/loading system under the Worker
Protection Standard for Agricultural Pesticides [40 CFR 170.240(d)(4). Mixers and loaders using water
soluble packets must:
-wear the personal protective equipment required on this labeling for mixers and loaders, and
-be provided and have immediately available for use in an emergency, such as a broken package, spill, or
equipment breakdown, chemical resistant footwear."
Precautionary Statements:
I lazards to Humans and
Domestic Animals
(Immediately following
PPE and User Safety
Requirements.)
112
-------
Description
Amended Labeling Language
Placement on Label
Engineering Controls for
wcllable powders and dry
flowables (water dispersible
granules) packaged in water-
soluble packets that contain
directions for use permitting
aerial application. AH
wet/able powders with WPS
uses must be in water soluble
packets to be eligible for
reregistrcition.
"Pilots must use an enclosed cockpit in a manner that is consistent with the WPS for Agricultural
Pesticides [40 CFR 170.240(d)(6)]. Pilots must wear the PPE required 011 this labeling for applicators,
however, they need not wear chemical-resistant gloves when using an enclosed cockpit."
"Flaggers supporting aerial applications must use an enclosed cab that meets the definition on the Worker
Protection Standard for Agricultural Pesticides [ 40 CFR 170.240 (d)(5)] for dermal protection.
Precautionary Statements:
Hazards to Humans and
Domestic Animals
(Immediately following
the water-soluble
packaging engineering
control requirements.)
Additional Engineering
Controls Statement for all
liquid, wettable powder, and
dry flowable formulations.
"When applicators use enclosed cabs in a manner that meets the requirements listed in the Worker
Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(5), the handler PPE
requirements may be reduced or modified as specified in the WPS."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
(Immediately following
any other engineering
control requirements.)
Engineering Controls for
Granular Formulations
Note to registrants: no engineering controls statement is needed 011 labels of granular formulations.
not applicable
User Safety
Recommendations
"User Safety Recommendations"
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet."
"Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put
on clean clothing."
"Users should remove PPE immediately after handling this product. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary Statements
under: Hazards to
Humans and Domestic
Animals immediately
following Engineering
Controls
(Must be placed in a box.)
113
-------
Description
Amended Labeling Language
Placement on Label
Environmental Hazards
"Atrazine can travel (seep or leach) through soil and can enter ground water which may be used as
drinking water. Atrazine has been found in ground water. Users are advised not to apply atrazine to sand
and loamy sand soils where the water table (ground water) is close to the surface and where these soils
are very permeable; i.e., well-drained. Your local agricultural agencies can provide further information
on the type of soil in your area and the location of ground water."
"Product must not be mixed or loaded within 50 feet of intermittent streams and rivers, natural or
impounded lakes and reservoirs. Product must not be applied within 66 feet of points where field
surface water runoff enters perennial or intermittent streams and rivers or within 200 feet of natural or
impounded lakes and reservoirs. If this product is applied to highly erodible land, the 66 foot buffer or
setback from runoff entry points must be planted to crop, or seeded with grass or other suitable crop."
"Product must not be mixed or loaded, or used within 50 feet of all wells, including abandoned wells,
drainage wells, and sink holes. Operations that involve mixing, loading, rinsing, or washing of this
product into or from pesticide handling or application equipment or containers within 50 ft. of any well
are prohibited, unless conducted on an impervious pad constructed to withstand the weight of the
heaviest load that may be positioned on or moved across the pad. Such a pad shall be designed and
maintained to contain any product spills or equipment leaks, container or equipment rinse or wash water,
and rain water that may fall on the pad. Surface water shall not be allowed to either flow over or form
the pad which means the pad must be self-contained. The pad shall be sloped to facilitate material
removal. An unroofed pad shall be of sufficient capacity to contain at a minimum 110% of the capacity
of the largest pesticide container or application equipment on the pad. A pad that is covered by a roof of
sufficient size to completely exclude precipitation from contact with the pad shall have a minimum
containment of 100% of the capacity of the largest pesticide container or application equipment on the
pad. Containment capacities as described above shall be maintained at all times. The above-specified
minimum containment capacities do not apply to vehicles when delivering pesticide to the
mixing/loading sites."
"Additional State imposed requirements regarding well-head setbacks and operational area containment
must be observed."
Environmental Hazards
114
-------
Description
Amended Labeling Language
Placement on Label
Environmental Hazards
Continued
"One of the following restrictions must be used in applying atrazine to tile-outletted fields containing
standpipes:
Do not apply within 66 feet of stnndpipes in tile-outletted fields.
Apply this product to the entire tile-outletted Held and immediately incorporate it to a depth of
2-3 inches in the entire field.
Apply this product to the entire tile-outletted field under a no-till practice only when a high crop
residue management practice is practiced. High crop residue management is described as a crop
management practice where little or no crop residue is removed from the field during and after
crop harvest."
"This pesticide is toxic to aquatic invertebrates. Do not apply directly to water, to areas where surface
water is present, or to intertidal areas below the mean high water mark. Do not apply when weather
conditions favor drift from treated areas. Runoff and drift from treated areas may be hazardous to
aquatic organisms in neighboring areas. Do not contaminate water when disposing of equipment wash
water."
Environmental Hazards
Restricted-Entry Interval (for
labels with WPS uses)
"Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 12
hours."
Directions for Use,
Agricultural Use
Requirements Box
Early Reentry Personal
Protective Equipment
established by the IRED (for
labels with WPS Uses.
"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,
> shoes plus socks, and
> chemical resistant gloves, such as any waterproof material."
115
-------
Description
Amended Labeling Language
Placement on Label
Entry Restriction for
NonWPS uses
Entry Restriction for non-WPS uses applied as a spray:
"Do not enter or allow others to enter until sprays have dried."
Entry Restriction for non-WPS uses applied dry:
"Do not enter or allow others to enter until dusts have settled.''
Entry Restriction for non-WPS uses applied as a solid (i.e. granular) and watered-in (for occupational
use to home lawns):
"Do not enter or allow others to enter the treated area until dusts have settled. If soil incorporation is
required after the application, do not enter or allow others to enter the treated area (except those persons
involved in the incorporation) until the incorporation is complete. If the incorporation is accomplished by
watering-in, do not enter or allow others to enter the treated area until the surface is dry after the
watering-in."
If no WPS uses 011 the
label, place the statements
in the Directions for Use
Under General Precautions
and Restrictions.
If WPS uses arc also on
the labeling, place these
statements in a
NonAgricuItura! Use
Requirements box as
specified in PR Notice 93-
7 and 93-11.
116
-------
Description
Amended Labeling Language
Placement on Label
Other Application
Restrictions (Risk
Mitigation)
All Products/Formulations Containing Atrazine
"Do not apply this product through any type of irrigation system"
"When tank-mixing or sequentially applying atrazine or products containing atrazine to corn or sorghum,
the total pounds of atrazine applied (lbs ai/A) must not exceed 2.5 pounds active ingredient per year."
"When tank-mixing or sequentially applying atrazine or products containing atrazine to crops other than
corn or sorghum, the total pounds of atrazine applied (lbs ai'A) must not exceed the specific seasonal rate
limits as noted in the use directions."
Delete all directions for use for the following use-patterns:
>rangcland
>total vegetation control on non-cropland areas (except Conservation Reserve Program(CRP), rights-of-
ways, and roadsides)
>proso millet, and
>pineapple uses.
Products with Guava Uses:
- "Do not apply more than 4 pounds active ingredient per acre for any application."
- "Do not apply more than 8 pounds active ingredient per year."
Macndnmia Nut Uses:
- "Do not apply more than 4 pounds active ingredient per acre for any application."
- "Do not apply more than 8 pounds active ingredient per year."
Conifers Uses:
- "Do not apply more than 4 pounds active ingredient per acre for any application."
- "Do not apply more than 4 pounds active ingredient per year."
Directions for Use
117
-------
Description
Amended Labeling Language
Placement on Label
Other Application
Restrictions (Risk
Mitigation)
Sod Farm Uses
-For muck or peat soils:
> "Do not apply more than 4 pounds active ingredient per acre for any application."
> "Do not apply more than 6 pounds active ingredient per year."
-For sandy soils:
> "Do not apply more than 4 pounds active ingredient per acre for any application."
> "Do not apply more than 3 pounds active ingredient per year."
Conservation Reserve Program Uses:
- "Do not apply more than 2 pounds active ingredient per acre for any application."
Chemical Fallow Uses:
For soils in North and South Dakota with a pH of 7.5 or greater.
- "Do not apply more than 1.5 pounds active ingredient per acre for any application."
- "Do not apply more than one application per year."
Directions for Use
For soils in North and South Dakota with a pH of less than 7.5:
- "Do not apply more than 2.0 pounds active ingredient per acre for any application."
- "Do not apply more than one application per year."
For all other locations:
- "Do not apply more than 2.25 pounds active ingredient per acre for any application."
- "Do not apply more than one application per year."
118
-------
Description
Amended Labeling Language
Placement on Label
Other Application
Restrictions (Risk
Mitigation) continued
Rights-of-way Uses (applied as a spray):
- "Do not apply more tlian 1.0 pounds active ingredient per acre for any application."
- "Do not apply more than one application per year."
Sugarcane Uses:
- "Do not apply more than 4.0 pounds active ingredient per acre for any application."
- "Do not apply more than 10.0 pounds active ingredient per acre per year."
Corn anil Sorghum Uses:
-Field corn forage uses: 60-day PHI
-Sweet corn forage uses: 45-day PHI
- Preemergent sorghum forage uses: 60-day PHI
- Postemcrgent sorghum forage uses: 45-day PI II
-"Postemergence applications to com and sorghum must be made before crop reaches 12 inches in
height"
"Maximum broadcast application rates for corn and sorghum must be as follows:
> If no atrazine was applied prior to corn/sorglnim emergence, apply a maximum of 2 lb ai/A
broadcast. If a postemergence treatment is required following an earlier herbicide application,
the total atrazine applied may not exceed 2.5 lb ai/A per calendar year.
> Apply a maximum of 2.0 lb ai/A as a single preemergence application on soils that are not
highly erodible or on highly erodible soils if at least 30% of the soil is covered with plant
residues; or
> Apply a maximum of 1.6 lb ai/A as a single preemergence application on highly erodible soils
if <30% of the surface is covered with plant residues; or 2.0 lb ai/A if only applied
postemergence."
Directions for Use
119
-------
Description
Amended Labeling Language
Placement on Label
Other Application
Restrictions (Risk
Mitigation) continued
Roadsides Uses:
- "Do not apply more than 1.0 pounds active ingredient per acre for any application."
- "Do not apply more than one application per year."
Dry Bulk Fertilizer Impregnation Uses:
- "Impregnation of bulk fertilizer is restricted to commercial facilities. On-farm fertilizer impregnation is
prohibited."
- "No more than 500 tons of dry bulk fertilizer can be impregnated per day.''
- "No single facility may impregnate fertilizer with this product for more than to 30 days per calendar
year."
- "The commercial facility impregnating the dry bulk fertilizer must inform, in writing, the user
(applicator) of the dry bulk fertilizer that:
> "Applicators must wear long-sleeved shirt, long pants, shoes, and socks."
> "The restricted-entry interval is 12 hours."
Directions for Use
Application Restrictions for
Granular formulations that
contain directions for use on
turfgrass at residential sites,
including homes, daycare
facilities, schools,
playgrounds, parks,
recreational areas, and sports
fields
"Turfgrass at Residential Sites (including homes daycare facilities, schools, playgrounds, parks,
recreational areas, and sports fields:"
"This product must be watered in immediately after application. Watering-in must be performed by the
commercial applicator or the commercial applicator must provide the following instructions to the
resident or owner in writing:
> "This product must be watered in immediately.
> "Do not enter or allow others (including children or pets) to enter the treated areas (except
those involved in the watering) until the watering-in is complete and the surface is dry."
Directions for Use
120
-------
Description
Amended Labeling Language
Placement on Label
Application Restrictions for
Liquid, Wettable Powder, or
Dry Flowable (Water-
Dispersible Granule)
formulations that contain
directions for use on
turfgrass at residential sites,
including homes, daycare
facilities, schools,
playgrounds, parks,
recreational areas, and sports
fields
"Turfgrass at Residential Sites (including homes daycare facilities, schools, playgrounds, parks,
recreational areas, and sports fields):"
"Do not apply more than 1.0 pounds active ingredient per acre for any application."
- "'Do not apply more than 2.0 pounds active ingredient per acre per year."
Application Restrictions for
Dry Flowable Formulations
NOT packaged in water-
soluble packets
"Aerial application is prohibited."
Near the beginning of the
Directions for Use in bold
type and red lettering.
End Use Products Intended Primarily for Use by Homeowners
Environmental Hazards
"Atrazine can travel (seep or leach) through soil and can enter ground water which may be used as
drinking water. Atrazine has been found in ground water. Users are advised not to apply Atrazine on
sand and loamy soils where the water table (ground water) is close to the surface and where these soils
are very permeable; i.e., well drained. Your local agricultural agencies can provide further information
on the type of soil in your area and the location of ground water. This product is toxic to aquatic
invertebrates. Do not apply directly to water, to areas where surface water is present or to intertidal areas
below the mean high water mark. Runoff and drift from treated areas may be hazardous to aquatic
organisms in neighboring areas. Do not contaminate water when disposing of equipment washwaters."
Precautionary Statements
121
-------
Description
Amended Labeling Language
Placement on Label
Application Restrictions
All products:
"Do not apply this product in a way that will contact any person or pet, either directly or through drift.
Keep people and pets out of the area during application."
Granular Products Applied Dry:
'' This product must be watered in immediately after application."
Directions for Use under
General Precautions and
Restrictions
Statements must be in the
color red and in all caps.
Entry Restriction
Products Applied as a Liquid:
"Do not allow people or pets to enter the treated area until sprays have dried."
Products Applied Dry:
"Do not enter or allow others (including children or pets) to enter the treated areas (except those involved
in the watering) until the watering-in is complete and the surface is dry."
Directions for Use under
Genera! Precautions and
Restrictions
Statements must be in the
color red and in all caps.
-------
Description
Amended Labeling Language
Placement on Label
Precautionary Statements
Tor Granular Lawn Products:
"Do not apply granular lawn products by hand. Avoid contact with hands or skin."
"Broadcast applications must NOT be made using hand-held devices, such as a belly grinder or handheld
rotary applicator. Such equipment may only be used for spot treatments."
For Liquid products:
- "Maximum rate per application turfgrass (including lawns) is [registrant insert the maximum rate of the
formulated product per unit area - such as 2 pints per 1,000 square feet - that reflects an maximum
application rate of 1 pound active ingredient per acre]."
- "Maximum of two applications per year."
Immediately
foil owing/be low
Precautionary Statements:
Hazards to Humans and
Domestic Animals
123
-------
Intentionally Blank Page
-------
APPENDICES
125
-------
Intentionally Blank Page
126
-------
Appendix A: ATRAZINE USE PATTERNS ELIGIBLE FOR REREGISTRATION
Site
Applicniion Type
Application Timing
Application Ffluipmem
Formulation
Max. Single
Application Rale
(lb ai/A)
Max. It
Apps/
season
Max Annual
Application
Rate (lb ai/A)
Pre-
harvest
Interval
(davs)
Minimum
Rctreatmcnt
Interval
(davs)
Use Limitations
FOOD/FEED USE PATTERNS
Corn
Broadcast or banded
Farly Prcplnnt; pieplant surface or
incorporated, preemcrgencc, or
postemergcnce to corn .<: 12" tall
Ground or aerial applications
90% DF
4 Ib/gal FIC
Othersd
1.6
precmergence on
highly crodible
soil if < 30%
surface covered
with plant
residues
2 preemcrgencc
on not highly
erodiblc soil or if
> 30% surface
covered with
plant residues
2 postemergcncc
NS
(Not
specified)
2.5
60 for
forage
60 for
field corn
45 for
sweet
corn
NS
For prcplant surface treatments, use on
medium or fine-textured soils with reduced
tillage systems only in CO, IA, IL, IN, ICS,
ICY, MN, MO, MT, ND, NF, SD, WI and
WY, up to 45 days prcplanting; on coarse
textured soils, do not apply >2 weeks prior
to planting.
Broadcast
Fallow weed control (and continued
control in following minimum
tillage corn). Applied to stubble
ground after wheat harvest in a
wheat-corn-fallow crop rotation.
Ground or aerial applications
90% DF
4 Ib/gal FIC
3
1.5
(ND & SD soils
with pll>7.5)
2.0
(ND & SD soils
with pH<7.5)
1
NS
NS
NS
Use limited to CO, ICS, ND, NF, SD, and
WY. Whcal-corn-fallow cropping sequence
must be followed.
Do not apply following corn harvest. An 18-
month plant-back restriction is specified for
all crops other than those on the label.
Grazing or feeding of forage from treated
areas are prohibited.
127
-------
Site
Application Type
Application liming
Application Equipment
Formulation
Max. Single
Application Rate
(lb ai/A)
Max. tf
Apps/
season
Max Annual
Application
Rate (lb ai/A)
Pre-
harvest
Interval
(days)
Minimum
Retreatment
Interval
(days)
Use Limitations
Broadcast
Winter weed control in TX
Ground or aerial applications
90% DF
4 lb/gal FIC
0.8-1.0
NS
NS
NS
N/A
For postemergence control of winter w eeds
only on fall bedded land in the Gulf Coast
and Blacklands of TX. Normal weed
control programs may be used in the
follow ing corn, grain sorghum, or sorghum
forage crops the following spring. The label
prohibits planting any crops except corn,
grain sorghum, or forage sorghum in the
Spring following this treatment.
Guava
Broadcast
Ground application
90% DF
4 lb/gal FIC
4.0
3
8.0
NS
120
Use only on established guava at least 18
months old. Label states, "do not apply more
frequntly than at 4-month intervals".
"Do not apply more than 4 pounds active
ingredient per aere for any application."
"Do not apply more than 8 pounds active
ingredient per year."
Grain Sorghum or Sorghum-sudan hybrids (grain and forage types)
128
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Max. Single
Application Rate
Ob ai/A)
Max. II
Apps/
season
Max Annual
Application
Rate 0b ai/A)
Pie-
harvest
Interval
(days)
Minimum
Retreatmcnt
Interval
((lavs)
Use Limitations
Broadcast or banded
Early Preplan!; preplanl surface or
incorporated, preeincrgcnce, or
postemergence to sorghum s 12" lall
Ground or aerial applications
90% DF
¦1 Ih/gal FIC
Others'1
1.6
preemergence on
highly credible,
soil if < 30%
surface covered
with plant
residues
2 preeincrgcnce
on not highly
erodible soil or if
> 30% surface
coveted with
plant residues
2 postemergence
NS
2.5
60 for
forage
60 for
preemcrg.
use
45 for
postemer.
use
NS
A 60-day PG1 or PI II for forage is in effect.
For pieplant surface treatments, use on
medium or fine-textured soils with reduced
tillage systems only in CO, IA, II., IN, KS,
' KY, MN, MO, MT, ND, NF, SD, WI and
WY, up to 45 days preplanting; on coarse
textured soils, do not apply >2 weeks prior
to planting. Do not apply pieplant surface or
incorporated in Al., AR, FL, GA, LA, MS,
NC, NM, OK, SC, TN, or TX. Do not apply
preemergence in NM, OK, or TX, except in
northeast OK. the TX Gulf Coast and
Blaeklands areas.
Broadcast
Winter weed control ill TX
Ground or aerial applications
90% DF
4 lb/gal FIC
0.8-1.0
NS
NS
NS
NA
For postemergence control of winter weeds
only on fall bedded land in the Gulf Coast
and Blaeklands of TX. Normal weed
control programs may be used in the
following corn, grain sorghum, or sorghum
forage crops the following spring. The label
prohibits planting any crops except corn,
grain sorghum, or forage sorghum in the
spring following this treatment.
Broadcast
Fallow weed control (and continued
control in minimum tillage
sorghum) applied to stubble ground
following wheat harvest in a wheat-
sorglnim-fallow crop rotation.
Ground or aerial applications
90% DF
4 lb/gal FIC
3
1
NS
NS
NA
Whcat-sorghuni-fallow cropping sequence
must be followed.
Do not apply following sorghum harvest. An
18-month plant-back restriction is specified
for all crops other than those on the label.
Grazing or feeding of forage from treated
areas are prohibited.
129
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Max. Single
Application Rate
(lb ai/A)
Max. tt
Apps/
season
Max Annual
Application
Rate (lb ai/A)
l're-
harvest
Interval
(days)
Minimum
Retreat ment
Interval
(days)
Use Limitations
Macadainin nuts
Broadcast
Ground application
90% DF
4 Ib'gal FIC
4.0
NS
8.0
NS
NS
"Do not apply more than 4 pounds active
ingredient per acre for any applications."'
"Do not apply more than 8 pounds active
ingredient per year."
Soybeans (Unspecified)
43% EC
2.5
NS
NS
NS
NS
Sugarcane
Broadcast or banded
Precmergence (at-planting or
ratooning) followed by one
application at emergence, and up to
two interline post-emergence
directed applications prior to close-
in (lay-by).
(hound or aerial application
90% DF
4 lb/gal FIC
2-4
4
10
NS
NS
Treatments may be made applied in a
minimum of 20 gal/A of water by ground
and 5 gal/A of water by air. A reasonable
interval between lay-by and harvest would
be 120-150 days, providing a built-in PHI.
In FL and TX, 0.5-1 gal of surfactant/100 gal
of spray may be used. In LA, an application
of 2 lb ai/A may be used to control annual
weeds during summer fallow period; after-
planting applications may not exceed 8 lb
ai/A.
Fallow Wheat Stubble (Wheat is not a target crop)
Broadcast
Fallow weed control applied to
stubble ground following wheat
harvest in a wheat-fallow-wheat
crop rotation.
Ground or aerial applications
90% L)F
4 lb/gal FIC
0.5-1
1
NS
NS
NA
Use limited to CO, KS, ND, NE. SD, and
WY.
Grazing of treated areas is prohibited for 6
months, and a 12-month plant-back interval
for wheat is specified.
NON FOOD/NON FEED USE PATTERNS
Agricultural Fnllow/Idleland
130
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Max. Single
Application Rate
(lb ni/A)
Max, §
Apps/
season
Max Annual
Application
Rate (lb ai/A)
Prc-
barvesi
Interval
(days)
Minimum
Retreatment
Interval
(days)
Use Limitations
At Planting
4.1% fx:
43% SC7L
90% DF
2.25
I
2.25
NS
NS
"Do not apply more than 2,25 pounds active
ingredient per acre for any application,"
"Do not apply more than one application per
year."
Established Plantings
90% DF
I
1
NS
NS
NS
Foil
43% EC
90% DF
1
NS
NS
NS
NS
Fallow
20-9%, EC
21.92% FIC
43% EC
43% FIC
43% SC/I
80% WP
85.5% DF
90% DF
90% WP
2.25
1
2,25
NS
NS
"Do not apply more than 2.25 pounds active
ingredient per acre for any application,"'
"Do not apply more than one application per
year."
February
March
90% DF
1
NS
NS
NS
NS
Late Fall
43% FIC
85.5% DF
90% DF
0.4
1
0.4
NS
NS
Posthnrvcst
22% FIC
43% EC
90% WP
I
1
I
NS
NS
Preemcrgciicc
Preplan!
43% EC
43% SC/L
85.5% DF
90% DF
2
NS
NS
NS
NS
131
-------
Site
Application Type
Application liming
Application Equipment
Formulation
Max. .Single
Application Rale
(lb ai>'A)
Max. It
Apps/
season
Max Annual
Application
Rate (lb ai/A)
I're-
harvest
Interval
(days)
Minimum
Retrcatmcnt
Interval
(days)
Use Limitations
Renovation
Spring
43% EC
85.5% DF
90% I)F
2
NS
2
NS
NS
Stubbie
22% l-.C
22% PIC
43% EC
43% SC/1.
53.5% EC
80% WP
90% DF
90% WP
2.25
1
2.25
NS
NS
"Do not apply more than 2.25 pounds active
ingredient per acre for any application.""
"Do not apply more than one application per
year."
Bcrmudagrass
Dormant, spring
43% nc
90% DF
2
NS
NS
NS
NS
Christmas Tree Plantations
Fall, Karly Spring
21.42 KC
80% WP
4
NS
NS
NS
NS
Commercial/industrial Lawns
Early Spring
.58% G
.92% G
0.0461b 1 Kfl3
NS
NS
NS
NS
Fall
,45% G
.92% G
1.05% G
0.046 lb lKfl?
NS
NS
NS
NS
Post-plant
25% FIC
.75
NS
NS | NS
NS
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Max. Single
Application Rate
(lb ai/A)
Max. 11
Apps/
season
Max Annual
Application
Rate (lb ai/A)
Pre-
hnrvest
Interval
(days)
Minimum
Uetreatment
Interval
(days)
Use Limitations
Spring
.45% C.
0.046 lb 1 ICft1
NS
NS
NS
NS
.92% G
1.05% G
Conifers (Seed Orchard)
Dormant
43% EC
90% WP
4
NS
4
NS
NS
"Do not apply more than 4 pounds active
ingredient per acre for any applications."
"Do not apply more than 4 pounds active
ingredient per year."
Forest Plantings (Reforestation Prograins)(Tree Farms, Tree Plantations, Etc.)
Early Spring
80% WP
4
1
NS
NS
NS
Fall
80% WP
4
1
NS
NS
NS
90% WP
Forest Trees (Softwoods, Conifers)
Dormant
43% EC
43% EIC
4
1
4
NS
NS
"Do not apply more than 4 pounds active
ingredient per acre for any application."
85.5% DF
90% DF
"Do not apply more than 4 pounds active
ingredient per year."
Early Spring
I
133
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Max. Single
Application Rate
(lb ai/A)
Max. #
Apps/
season
Max Annual
Application
Rate (lb ai/A)
Prc-
harvest
Interval
(davs)
Minimum
Retreatmcnt
Interval
(days)
Use Limitations
25% F1C
90%DF
90% WP
3.96
I
NS
NS
NS
"Do not apply more than 4 pounds active
ingredient per acre for ;tny application."
"Do not apply more than 4 pounds active
ingredient per year."
Established Planting
43% EC
43.6% F.C
53-48% EC
80% WP
85.5% DF
90% DF
4
1
NS
NS
NS
"Do not apply more than 4 pounds active
ingredient per acre for any application."
"Do not apply more than 4 pounds active
ingredient per year."
Fall
25% F1C
43% EC
90% DF
90% WP
4
1
NS
NS
NS
"Do not apply more than 4 pounds active
ingredient per acre for any application."
"Do not apply more than 4 pounds active
ingredient per year.''
Post-Plant
43% DF
43% EC
4.4
I
NS
NS
NS
"Do not apply more than 4 pounds active
ingredient per acre for any application."
"Do not apply more than 4 pounds active
ingredient per year.''
Post-transplant
134
-------
Site
Application Type
Application Timinfi
Application Equipment
Formulation
Max. Single
Application Rnte
(lb ai/A)
Max. tl
Apps/
season
Max Annual
Application
Katc.(lh ai/A)
Prc-
linrvest
Interval
(days)
Minimum
Retreatment
Interval
(clays)
Use Limitations
43",, f-:c
4.1% SOI,
43,5% KC
43.6% EC
53.48% r-;c
80% WP
85.5% DF
90% DF
90% WP
4
1
NS
NS
NS
"Do not apply more than 4 pounds active
ingredient per acre for ;my application."
"Do not apply more than 4 pounds active
ingredient per year,"
Pre-plan t (Spring)
43% DF
43% EC
4,4
1
NS
NS
NS
"Do not apply more than 4 pounds active
ingredient per acre for any application."
"Do not apply more than 4 pounds active
ingredient per year."
Prc-trnnsplnnl
43% RC
43% SC/L
43,5% EC
43.6% EC
53.48% EC
80% WP
85.5% DF
90% DF
90% WP
4
1
NS
NS
NS
"Do not apply more tlian 4 pounds active
ingredient per acre for any application,"
"Do not apply more than 4 pounds active
ingredient per year."
Spring
135
-------
Site
Application Type
Application liming
Application Equipment
Formulation
Max. Single
Application Rate
(Jb ai/A)
Max. fl
Apps/
season
Max Annual
Application
Rate (lb ai/A)
Prc-
harvest
Interval
(days)
Minimum
Retrcatment
Interval
(days)
Use Limitations
43% DF
¦13% EC
4.4
1
NS
NS
NS
"Do not apply more than 4 pounds active
ingredient per acre for any application."
"Do not apply more tlian 4 pounds active
ingredient per year.''
Transplant
43% EC
43% SC/L
43.5% EC
85.5% DF
90% DF
4
1
NS
NS
NS
"Do not apply more than 4 pounds active
ingredient per acre for any application.''
"Do not apply more than 4 pounds active
ingredient per year."
Winter
43% DF
43% EC
4.4
1
NS
NS
NS
"Do not apply more than 4 pounds active
ingredient per acre for any application."
"Do not apply more than 4 pounds active
ingredient per year."
Golf Course Turf
At Planting
90% DF
099
NS
NS
NS
NS
Dormant
53.48% EC
90% DF
2.5
NS
NS
NS
NS
Early Spring
90% DF
1.98
NS
NS
NS
NS
Tail
-------
Site
Application Type
Application Timing
Application Ecminmeni
Formulation
Max. Single
Application Rnte
(lb m/A)
Max. H
Apps/
season
Max Annual
Application
Rate (lb ai/A)
Prc-
hnrvest
Interval
(clays)
Minimum
Rctrentmenl
Interval
(days)
Use Limitations
,45% (i
,6% ti
,92% G
43% HC
43% FIC
53.48% EC
89% WP
90% DF
90% WP
2
N.S
NS
NS
NS
Foliar
53.48% EC
90% DF
2.5
NS
NS
NS
NS
Late Winter
.6% 0
43% EC
43% FIC
53.48% EC
80% WP
90% DF
90,1% DF
2
NS
NS
NS
NS
Post-plant
25% FIC
.75
NS
NS
NS
NS
Spring
,45%G
.6% G
.92% O
,046 lb/1 Kit3
NS
NS
NS
NS
Winter
90% DF
1,98
2
NS
NS
NS
Grasses Grown for Seed
137
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Max, Single
Application Rate
(lb ai/A)
Max. ft
Apps/
season
Max Annual
Application
Rate (lb ai/A)
Pre-
harvest
Interval
(days)
Minimum
Retreatment
Interval
(days)
Use Limitations
Dormant
43" u I K
90% DF
1
NS
NS
NS
NS
Nonngricultiiral Rights of way/fencerows/hedgerows
Delayed Dormant
43% EC
1
1
NS
NS
NS
"Do not apply more than 1 pound active
ingredient per acre for any application,"
"Do not apply more than one application per
year,"
Dormant
43% EC
53,48 HC
2.5
NS
NS
NS
NS
"Do not apply more than 1 pound active
ingredient per acre for any application."
"Do not apply more than one application per
year,"
Early Spring
90% DF
90,1% FIC
3,96
1
NS
NS
NS
"Do not apply more than 1 pound active
ingredient per acre for any application,"
"Do not apply more than one application per
year.''
Fall
138
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Mnx. Single
Application Rnte
(lb ai/A)
Max, ii
Apps/
season
Mnx Annual
Application
Rate (lb ai/A)
Prc-
harvest
Interval
Sclavs')
Minimum
Rctrcntmcnt
Interval
(tlavsi
Use Limitations
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Max. Single
Application Rate
{lb ai/A)
Max. H
Apps/
season
Max Annual
Application
Rate (lb ai/A)
Pre-
harvest
Interval
(days)
Minimum
Retreatment
Interval
(days)
Use Limitations
43% EC
43% 1'IC
43% SOL
43,5% EC
43,6% KC
53.48% KC
80% WP
85,5% DF
90% DF
90% WP
90.1% DF
90.!% FIC
4
1
NS
NS
NS
"Do not apply more than 1 pound active
ingredient per acre for any application."
'"Do not apply more than one application per
year."
When Needed
43% EC
2
NS
NS
NS
NS
"Do not apply more than I pound active
ingredient per acre for any application.''
"Do not apply more than one application per
year."
Ornamental And/or Shade Trees
Dormant
43% KC
90% DF
4
1
NS
NS
NS
Karly Spring
53.48% EC
90.1% DF"
4
1
NS
NS
NS
Kstabli.sfied Planting
90% DF
3.96
1
NS
NS
NS
Fall
140
-------
Silc
Application Type
Application Timing
Application Ecniinment
Formulation
Max. Single
Application Rate
(lb ai/A)
Max. 11
Apps/
season
Max Annual
Application
Rate (lb ai/A!
Pre-
liarvest
Interval
(clays)
Minimum
Retreatnient
Interval
(days)
Use Limitations
53.48% KC
5)0,1% DF
4
!
NS
NS
NS
Post-transplant
43% EC
53.48% KG
90% DF
90.1% DF
4
1
NS
NS
NS
Prc-lransplant
43% EC
53.48% EC
90% DF
90.1 % DF
4
1
NS
NS
NS
Transplant
43% EC
90.1 % DF
4
I
NS
NS
NS
Ornamental Lawns and Tnrf
Dormant
23,(5% FIC
43% EC
43% FIC
43% SC/L
53.48% EC
90% DF
4
1
NS
NS
NS
" This product must be watered in
immediately utter application."
Early Spring
.58% G
,92% O
43% FIC
90% DF
1,98
NS
NS
NS
NS
"This product must be watered in
immediately after application."
Early Winter
141
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Max. Single
Application Rate
(lb ai/A)
Max. t>
Apps/
season
Max Annua!
Application
Rate (]b ai/A)
P re-
harvest
Interval
(davs)
Minimum
Retreatmciu
Interval
(davs)
Use Limitations
.92% G
.046 lb/IKft'
NS
NS
NS
NS
"This product must be watered in
immediately after application,"
Fail
042% G
,57% G
.6% G
.63% G
,79% G
,83%G
.91% G
.92% G
1.05% G
1.11%G
1.15% G
1. 16% G
1.28% G
1,41% G
1.5% G
43%EC
43% FIC
80% WP
85.5% DF
90% DF
90% WP
2
N.S
NS
NS
NS
"This product must be watered in
immediately alter application."
Foliar
142
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Max. Single
Application Rntc
(lb ai/A)
Max. If
Apps/
season
Max Annual
Application
Rate (lb ni/A)_
Pre-
hnrvest
Interval
(days)
Minimum
Rctrcsitment
Interval
(days)
Use Limitations
23.6% FlC
43% EC
43% PI43%
SC/i,
53,48% EC
80% WP
90% DF
2.5
NS
NS
NS
NS
" This product must be watered in
immediately alter application."
Late Winter
.6% G
,8% 0
i.i i%o
43% EC
43% FlC
43% SC/L
43.5% EC
43.6% EC
80% WP
90% DF
90.1% DP
4
NS
NS
NS
NS
" This product must be watered in
immediately after application."
Postplant
.42% G
.44% G
.91% G
.75
NS
NS
NS
NS
"This produet must be watered in
immediately after application."
Preemergcncc
90% DF
US
2
NS
NS
NS
"This product must be watered in
immediately after application.
Spring
143
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Max. Single
Application Rate
(lb ai/A)
Max.#
Apps/
season
Max Annual
Application
Rate [lb ai/Al
Prc-
harvcsi
Interval
(days)
Minimum
Retreatment
Interval
(davs)
Use Limitations
,42% G
.018 Ih/IKfr
NS
NS
NS
NS
"This product must be watered in
.57% G
immediately alter application."
.6% G
.63% G
.79% G
.83% G
.91% G
.92% G
1.05% G
1.11% G
1.15% G
1.16% G
1.28% G
!.5%G
Summer
.6% G
1,05% G
.046 Ib/lKft'
NS
NS
NS
NS
"This product must be watered in
immediately after application."
When Needed
08% G
.83% G
2
NS
NS
NS
NS
"This product must be watered in
immediately after application."
.92% G
1.22% G
1.41% G
43% EC
Winter
,42% G
.63% G
1.98
NS
NS
NS
NS
"This product must bo watered in
immediately after application."
.91% G
1,05% G
90% DK
144
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Max. Single
Application Rate
(lb ai/A)
Max. H
Apps/
season
Max Annual
Application
Rate (lb ai/A)
P re-
harvest
Interval
(davs'l
Minimum
Retrenlment
Interval
(clays)
Use Limitations
Ornamental Sod Farm (Turt)
At Planting
90% IDF
3.96
NS
NS
NS
NS
"For muck or peal soils: do not apply more
than 4 pounds active ingredient pu'r acre for
any application."
"Do not apply more than 6 pounds active
ingredient per year."
"For sandy soils: do not apply more than 4
pounds active ingredient per acre for any
application."
"Do not apply more than 3 pounds active
ingredient per year."
Dormant
53.48% EC
90% DF
2
NS
NS
NS
NS
"For muck or peat soils: do not apply more
than 4 pounds active ingredient per acre for
any application."
"Do not apply more than 6 pounds active
ingredient per year."
"For sandy soils: do not apply more than 4
pounds active ingredient per acre for any
application."
"Do not apply more than 3 pounds active
ingredient per year."
Early Spring
145
-------
Site
Application Type
Application l iming
Application Equipment
Formulation
Max. Single
Application Rate
(lb ai-'A)
Max. n
Apps/
season
Max Annual
Application
Rate (lb ai/Aj_
Pre-
harvest
Interval
(class)
Minimum
Retreatmcnt
Interval
«lavs)
Use Limitations
90% DF
2
NS
NS
NS
NS
"For muck or peal soils: do not apply more
than 1 pounds active ingredient per acre for
any application."
"Do not apply more than 6 pounds active
ingredient per year/'
"For sandy soils: do not apply more than 4
pounds active ingredient per acre lor any
application."
"Do not apply more than 3 pounds active
ingredient per year."
Fall
.45% G
.92% G
43% EC
43% FIC
53.48% EC
85.5% DF
90% DF
90% WP
2
NS
NS
NS
NS
"For muck or peal soils: do not apply more
than 4 pounds active ingredient per acre for
any application."
"Do not apply more than 6 pounds active
ingredient per year."
"For sanely soils: do not apply more than 4
pounds active ingredient per acre for any
application."
"Do not apply more than 3 pounds active
ingredient per year."
Foliar
43% EC
43% FIC
53.48% EC
85.5% DF
90% DF
90% WP
43% EC
4
NS
NS
NS
NS
"For muck or peal soils: do not apply more
than 4 pounds active ingredient per acre for
any application."
"Do not apply more than 6 pounds active
ingredient per year."
"For sandy soils: do not apply more than 4
pounds active ingredient per acre for any
application."
"Do not apply more than 3 pounds active
ingredient per year."
Late Winter
146
-------
Site
Application Type
Application liming
Application Equipment
Formulation
Max. Single
Applicntinn Rate
fib ai/A)
Max, il
Apps/
season
Max Annual
Application
Rate (lb ai/AL
Pre-
Inirvcst
Inlcrvnl
(days)
Minimum
Retrentment
Interval
(days)
Use Limitations
43% KG
4.1% FiC
53.48% KG
85,5% DF
90% DF
90% WP
90.1% DF
43% EC
2
NS
NS
NS
NS
"For muck or peal soils: do not apply more
than 4 pounds active ingredient per acre tor
any application."
"Do not apply more than 6 pounds active
ingredient per year/'
"For sandy soils: do not apply more than 4
pounds active ingredient per acre fur any
application."
"Do not apply more than 3 pounds active
ingredient per year."
Puss Harvest
43% EC
43% FIC
53.48% EC
85.5% DF
90% DF'
90% WP
90.1% DF
4
NS
NS
NS
NS
"For muck or peat soils: do not apply more
than 4 pounds active ingredient per acre for
any application,"
'"Do not apply more titan 6 pounds active
ingredient per year."
"For sandy sails: do not apply more than 4
pounds active ingredient per acre for any
application."
"Do not apply more than 3 pounds active
ingredient per year."
Post Plant
43% EC
43% FIC
53,4R% EC
85.5% DF
90% DF
90% WP
90.1 % DF
4
NS
NS
NS
NS
"For muck or peal soils: do not apply more
than 4 pounds active ingredient per acre for
any application."
"Do not apply more than ft pounds active
ingredient per year."
"For sandy soils: do not apply more than 4
pounds active ingredient per acre for any
application."
"Do not apply more than 3 pounds active
ingredient per year,"
Post-transplant
147
-------
Site
Application Type
Application Timing
Application EauiDment
Formulation
Max. Single
Application Rate
(lb ai/A)
Max. #
Apps/
season
Max Annual
Application
Rate lib ai/Aj_
Prc-
harvest
Interval
(davs)
Minimum
Retreatment
Interval
(davs)
Use Limitations
80% WP
4
NS
NS
KS
NS
'"For muck or peat soils: do not apply more
than 4 pounds active ingredient per acre for
any application."
'"Do not apply more than 6 pounds active
ingredient per year."
"For sandy soils: do not apply more than 4
pounds active ingredient per acre for any
application,"
"Do not apply more than 3 pounds active
ingredient per year."
Precmcrgencc, Pretranspiant and Preplan!
43% DC/L
4
NS
NS
NS
NS
"For muck or peat soils: do not apply more
than 4 pounds active ingredient per acre for
any application."
"Do not apply more than 6 pounds active
ingredient per year."
"For sandy soils: do not apply more than 4
pounds active ingredient per acre for any
application."
"Do not apply more than 3 pounds active
ingredient per year."
Spring
.455G
,92% G
.046 lb lKfl3
NS
KS
NS
NS
"For muck or peat soils: do not apply more
than 4 pounds active ingredient per acre for
any application."
"Do not apply more than 6 pounds active
ingredient per year."
"For sandy soils: do not apply more than 4
pounds active ingredient per acre for an)'
application."
"Do not apply more than 3 pounds active
ingredient per year."
When Needed
148
-------
Site
Application Type
Application Timing
Application Bqnipment
Formulation
Max. Single
Application Rale
(lb ai/A)
Max. #
Apps/
season
Max Annual
Application
Rate (lb ai/A)
Pre-
hnrvest
Interval
(days)
Minimum
Kctrcnt incut
Interval
(days)
Use Limitations
43% EC
<)()% DF
3.96
NS
NS
NS
NS
"Far muck or pent soils: do not apply more
than 4 pounds active ingredient per acre fur
any application."
"Do not apply more than 6 pounds active
ingredient per year."
"Fur sanely soils: do not apply more than 4
pounds active ingredient per acre for any
application.*'1
"Do not apply more than 3 pounds active
ingredient per year."
Rangclnnd
Established Planting
43% r-c
1
1
NS
NS
-NS
90% DF
March
90% DF
I
1
NS
NS
NS
Preemergence
43% EC 1
1
NS
NS
NS
Riicreiition Area Lawns
Dormant
43% EC
2.5
NS
NS
NS
NS
43% MC
43% SC/1,
53.48% KC
90% DF
Early Spring
43% MC
1.98
NS
NS
NS
NS
90% DF
Pull
149
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Max Single
Application Rate
(lb as/A)
Max. it
Apps/
season
Max Annual
Application
Rate (lb al'A)
I'rc-
lwrvest
Interval
(days)
Minimum
Rctrcatmenl
Interval
((lavs)
Use Limitations
1.05% (1
0.04 ft lb I Kit2
NS
NS
NS
NS
Foliar
43% He
43% F1C
43% SC/L
53.48% EC
90°/o or
2.5
NS
NS
NS
NS
Late Winter
80% Wp
90% DF
2
2
NS
NS I NS
I'osf-plnnt
25% FIC
.75
NS
NS
NS
NS
Spring
1.05% G
0.0461b IKft 2 | NS
NS
NS
NS
Recreational Areas
Fall
.45% G
,92% G
0.046 lb IKft3
NS
NS
NS
NS
Spring
.45% (i
.92% G
0.046 lb IKft2
NS
NS
NS
NS
Residential Lawns
Dormant
150
-------
Sifc
Applicntion Type
Application Timing
Application Equipment
Formulation
Max. Single
Application Rule
(lb ni/A)
Max. 11
Apps/
season
Max Annual
Application
Rate{ibai/A)
Prc-
linrvest
Interval
(dnys)
Minimum
Retrentment
Interval
(days)
Use Limitations
14% EC
23.6% FIC
-13% i-:c
43% FIC
53.48% KC
90% DF
2.5
NS
NS
NS
NS
"This product must be watered in
immediately alter application."
Enrty Spring
14% EC
43% FIC
90% DF
1.98
NS
NS
NS
NS
"This product must be watered in
immediately after applicntion."
Early Summer
14% Be
0,046 lb IK.fl1
NS
NS
NS
NS
"This product must be watered in
immediately after application."
Fall
,45% G
,6% G
,92% a
1.05% Q
14% EC
0.046 lb IKfl2
NS
NS
NS
NS
"This product must be watered in
immediately after application."
Foliar
23.6% FIC
43% EC
43% FIC
53.4H% EC
90% DF'
2.5
NS
NS
NS
NS
"This product must be watered in
immediately after application."
Laic Winter
151
-------
Site
Application Type
Application liming
Application Equipment
Formulation
Max. Single
Application Rate
(lb ai/A)
Max. H
Apps/
season
Max Annual
Application
Rate (lb ai/A)
Pre-
harvest
Interval
(days)
Minimum
Retrcatment
Interval
(days)
Use Limitations
.6% G
14% EC
80% WP
90% DI-
2
NS
NS
NS
NS
"This product must be watered in
immediately after application."
Mid-Winter
14% 1IC
0.046 lb lKft2
NS
NS
NS
NS
"This product must be watered in
immediately after application."'
Post-Plant
25% FIC
.75
NS
NS
NS
NS
"This product must be watered in
immediately after application."
Spring
.45% G
0.6% G
.92% G
1.05% G
14% EC
0.046 lb 1 Kft -
NS
NS
NS
NS
"This product must be watered in
immediately after application."
-------
Appendix B: STUDIES USED TO SUPPORT THE REREGISTRATION OF ATRAZINE
GUIDE TO APPENDIX B
Appendix B contains listing of data requirements which support the reregistration for
active ingredients within the case atrazine covered by this IRED. It contains generic data
requirements that apply to atrazine 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
0.
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 maybe a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
-------
APPENDIX B. Data Supporting Guideline Requirements for the Reregistration of Atrazine
DATA REQUIREMENT
CITATION(S)
New Guideline
Number
Old
Guideline
Nnmhor
Study Title
Use Pattern
MRU) Number
PRODUCT CHEMISTRY
830.1550
61-1
Product Identity and Composition
All
40566501,43188901,43505801
830.1600
830.1620
830.1650
61-2 A
Starting Materials and Manufacturing Process
All
40566501
830.1670
61-2B
Formation of Impurities
All
00142160,42043501, 43188901
830.1700
62-1
Preliminary Analysis
All
00142160,00164821,42043501,
42211401,42873701, 42925201,
44488801
830.1750
62-2
Certification of Limits
All
40566501,42925201,43188901
830.1800
62-3
Analytical Method
All
00142160,00164821,42873701
830.6302
63-2
Color
All
00142160
830.6303
63-3
Physical State
All
00142160
830.6304
63-4
Odor
All
00142160
830.7050
None
UV/Visible Absorption
All
data gap
830.7200
63-5
Melting Point
All
00142160. 00164822
830.7220
63-6
Boiling Point
All
not applicable
830.7300
63-7
Density
All
00023548, 43016501, 43188902
830.7840
830.7860
63-8
Solubility
All
00023497,43337901
154
-------
APPENDIX B. Data Supporting Guideline Requirements for the Rcrcgistration of Atrazinc
DATA REQUIREMENT
CIT ATION(S)
New Guideline
Number
Old
Guideline
Niimhnr
Study Title
Use Pattern
MRU) Number
830.7950
63-9
Vapor Pressure
All
00142160, 00164822
830.7370
63-10
Dissociation Constant in Water
All
00022855
830.7550
830.7560
830.7570
63-11
Partition Coefficient (Octanol/Water)
All
00142160, 00164822,43337901
830.7000
63-12
pH
All
00142160,43337901
830.6313
63-13
Stability
All
00023497,00023548, 00023963,
43337901,43796001
830.6314
63-14
Oxidizing/Reducing Action
All
43016501,43188902
830.6315
63-15
Flammability
All
not applicable
830.6316
63-16
Explodability
All
43016501,43188902
830.6317
63-17
Storage Stability
All
0023548,43395501
830.7100
63-18
Viscosity
All
not applicable
830.6319
63-19
Miscibility
All
not applicable
830.6320
63-20
Corrosion Characteristics
All
00142160,43016501,43188902
ECOLOGICAL EFFECTS
850.2100
71-1
Avian Acute Oral Toxicity Test
AI3C.IK
00024721 (parent)
data gap (3 major degradates)
850.2200
71-2
Avian Dietary Toxicity
ABC J It
00022923
155
-------
APPENDIX B. Data Supporting Guideline Requirements for the Reregistration of Atrazine
DATA REQUIREMENT
CITATION(S)
New Guideline
Number
Old
Guideline
Number
Study Title
Use Pattern
MRID Number
850.2300
71-4
Avian Reproduction
ABCJK
42547102,42547101
850.1075
72-1 (a & b)
Fish Acute Toxicity - Freshwater
ABCJK
00024717, 00024716 (parent)
data gap (major degradate)
850.1010
72-2
Acute Aquatic Invertebrate Toxicity
ABCJK
00024377 (parent)
data gap (ma jor degradate)
850.1075
72-3a
Acute Estuarine/Marine Toxicity - Fish
ABCJK
43344901 (parent),
data gap (major degradate)
850.1025
72-3 b
Acute Estuarine/Marine Toxicity - Invertebrate (Mollusk)
ABCJK
data gap(parent and major
degradate)
72-3c
Estuarine/Marine Toxicity - Invertebrate (Shrimp)
ABCJK
43344902 (parent)
data gap (ma jor degradate)
850.1400
72-4a
Early Life-Stage Fish (Freshwater)
ABCJK
45208304
72-4a
Early Life-Stage Fish (Marine)
ABCJK
data gap
45202920 (upgradable)
850.1300
72-4b
Life-Cycle Aquatic Invertebrate
ABCJK
00024377
850.1350
72-4 b
Life-Cycle Marine Invertebrate
ABCJK
45202920, data gap
850.1500
72-5
Life-Cycle Fish
ABCJK
00024377
850.4225
850.4230
123-1 a
Seedling Germination/Seedling Emergence
ABCJK
42041403
850.4250
1231b
Vegetative Vieor
ABCJK
42041402
156
-------
APPENDIX B. Data Supporting Guideline Requirements for the Reregistration of Atrazine
DATA REQUIREMENT
CITATION(S)
New Guideline
Number
Oltl
Guideline
Number
Study Title
Use Pattern
MRID Number
850.4400
123-2
Aquatic Plant Growth
ABC.IK
41065203a &b
43074801, 43074802, 43074803
850.3020
141-1
Nontarget Insect Acute Contact Toxicity (Honey Bee)
ABC.IIC
00036935
TOXICOLOGY - Parent Atrazine
870.1100
81-1
Acute Oral - Rat
All
00024706,00027097
Accession No. 230303
870.1200
81-2
Acute Dermal - Rabbit
All
00024708, 00027097
Accession Nos. 230303; 231466
870.1300
81-3
Acute Inhalation - Rat
All
42089901,43016502
870.2400
81-4
Primary Eye Irritation - Rabbit
All
Accession No. 230303
00024709
870.2500
81-5
Primary Dermal Irritation - Rabbit
All
Accession No. 230303
00024709,00024710
870.2600
81-6
Dermal Sensitization
All
00105131
870.3100
82-1
90-Day Feeding
All
44723701
870.3200
82-2
21 -Day Dermal Toxicity - Rat
All
42089902
870.3700
83-3
Developmental Toxicity
All
41065201,00143008,40566302
Accession No. 254979
00143006,40566301
870.3800
83-4
Reproduction and Fertility Effects - 2 Generation Repro
All
40431303,42743903
157
-------
APPENDIX B. Data Supporting Guideline Requirements for the Reregistration of Atrazine
DATA REQUIREMENT
CITATION(S)
New Guideline
.Number
Old
Guideline
Number
Stud}' Title
Use Pattern
MRID Number
870.4100
83-1A
Chronic Feeding Toxicity - Rodent
All
40629302,42227001. 43934402,
870.4300
83-5
Combined Chronic Toxicity/Carcinogenicity
00158930,43532001
870.4100
83-1B
Chronic Feeding Toxicity - Non-Rodent (dog)
All
40431301
870.4200
83-2A
Oncogenicity - Rat
All
40629302, 42227001. 42204401.
43934402.00158930
870.4200
83-2B
Oncogenicity - Mouse
All
40431302
non-guideline
non-guideline
Special Studies - Neurotoxicity
All
44152102,43934406, 45166902,
45166901
870.5100
84-2
Bacterial Reverse Mutation Assay
All
00060642, 40246601
870.5385
84-2
Micronucleus Assay
All
40722301
870.5450
84-2
Rodent Dominant Lethal Assay
All
42637003
870.5550
84-2
UDS Assay
All
00161790, 40722301. 42547105
870.7485
85-1
General Metabolism
All
40431304,40431305, 40431306,
42165503,44713802,40437501
870.7600
85-2
Dermal Absorption
All
43314302 (rat)
44152114 (human)
non-guideline
non-guideline
Special Studies - Assays of Direct Estrogenic Activity of
Triazines
All
43598617,43598618, 43598619,
43934403
non-guideline
non-guideline
Special Study - Estrous Cycle Alterations and LH Surge
Attenuation - Method Validation
All
43934405
158
-------
APPENDIX B. Data Supporting Guideline Requirements for the Rcrcgistration of Atrazinc
DATA REQUIREMENT
CJTATJON(S)
New Guideline
Number
Old
Guideline
. .Number
Study Title
Use Pattern
MRID Number
non-guideline
non-guideline
Special Study - Estrous Cycle Alterations and LI l Surge
Attenuation - Pilot
All
43934404
non-guideline
non-guideline
Special Study - Estrous Cycle Alterations and LH Surge
Attenuation - 28-day
All
43934406
non-guideline
non-guideline
Special Study - Estrous Cycle Alterations and LI I Surge
Attenuation - 6-month
All
44152102
non-guideline
non-guideline
Special Study - Hormone and Estrous Cycle Measurements in
SD Rats
All
42085001,42743902, 43598622
non-guideline
non-guideline
Special Study - Mammary Gland and Ovarian
Histomorphology in SD Rats
All
43598622, 42085001, 42743902
non-guideline
non-guideline
Special Study - Two-Year Bioassay in F-344 Rats
All
42146101,42743902,43598622
non-guideline
non-guideline
Special Study - Hormone and Estrous Cycle Measurements in
F-344 Rats
All
42743902,42146101, 43598622
non-guideline
non-guideline
Special Study - Mammary Gland and Ovarian
Histomorphology in F-344 Rats
All
43598622,42146101, 42743902,
44917701
non-guideline
non-guideline
Special Study - Two-year Bioassay with the SD Strain of Rate
All
42204401
non-guideline
non-guideline
Special Study - Tumor Incidence in Ovariectomized (OVX) vs
Intact Animals
All
44544701
non-guideline
non-guideline
Special Study - Sexual Maturation
All
45058702,45722401
non-guideline
non-guideline
Long-Term Estrous Cycle Measurements
All
Unaudited draft report of the interim
estrous cycle data from 44544701
159
-------
APPENDIX B. Data Supporting Guideline Requirements for the Reregistration of Atrazine
DATA REQUIREMENT
CITATION(S)
New Guideline
Number
Old
Guideline
Nnmhpr
Study Title
Use Pattern
MRU) Number
non-guideline
non-guideline
Direct Comparison of LH Surge Attenuation of Atrazine,
Simazine, and Dact
All
45471002, 45058701
non-guideline
non-guideline
Other published literature
All
Cooper et al. 1996
Shaferetal. 1999
Das et al. 2000
Cummings et al. 2000
Narotsky et al. 2000
Laws et al. 2000
Stoker et al. 2000
TOXICOLOGY - Deeradate DACT
870.1100
81-1
Acute Oral - Rat
All
43013201
870.3100
82-1A
Subchronic Oral Toxicity in Rats
All
43013207
870.3150
870.4100
82-IB
83-IB
Subchronic & Chronic Oral Toxicity in Dogs
All
41392401
870.3700
83-3
Developmental Toxicity in Rats
All
41392402
870.5100
84-2
Mutagenicity Study - Bacterial Reverse Mutation
All
40722302
870.5550
84-2
Mutagenicity Study - UDS Assay
All
40722303
TOXICOLOGY - De&radate Desisopropyl Atrazine
870.1100
81-1
Acute Oral - Rat
All
43013201
870.3100
82-1A
Subchronic Oral Toxicity in Rats
All
43013205
870.3150
82-IB
Subchronic Oral Toxicity in Does
All
43013203
160
-------
APPENDIX B. Data Supporting Guideline Requirements for the Rcrcgistration of Atrazinc
DATA REQUIREMENT
CITATION(S)
New Guideline
Number
Old
Guideline
Nnmlipr
Study Title
Use Pattern
MRIO Number
870.3700
83-3
Developmental Toxicity in Rats
All
43013208
870.5100
84-2
Mutagenicity Study - Bacterial Reverse Mutation Assay
All
43093101
870.5385
84-2
Mutagenicity Study - Mammalian Bone Marrow Chromosome
Aberration Test
All
43093103
870.5550
84-2
Mutagenicity Study - UDS Assay
All
43093105
TOXICOLOGY - Denradatc Dccthvl Atrazinc
870.1100
81-1
Acute Tox - Rat
All
43013202
870.3100
82-1A
Subchronic Oral Toxicity in Rats
All
43013206
870.3150
82-IB
Subchronic Oral Toxicity in Dogs
All
43013203
870.3700
83-3
Developmental Toxicity in Rats
All
43013209
870.5100
84-2
Mutagenicity Study - Bacterial Reverse Mutation Assay
All
43093102
870.5385
84-2
Mutagenicity Study - Mammalian Bone Marrow Chromosome
Aberration Test
All
43093104
870.5550
84-2
Mutagenicity Study - UDS Assay
All
43093106
TOXICOLOGY - Dccradate Hydroxyatrazine
870.3100
82-1A
Subchronic Oral Toxicity in Rats
All
41293501
870.3700
83-3
Developmental Toxicity in Rats
All
41065202
870.4100
870.4300
83-1A
83-5
Chronic Toxicity - Rat
All
43532001
161
-------
APPENDIX B. Data Supporting Guideline Requirements for the Reregistration of Atrazine
DATA REQUIREMENT
CITATION(S)
New Guideline
Number
Old
Guideline
Number
Study Title
Use Pattern
MRU) Number
870.5100
84-2
Mutagenicity Study - Bacterial Reverse Mutation Assay
All
40722304
870.5385
84-2
Mutagenicity Study - Mammalian Bone Marrow Chromosome
Aberration Test
All
41479401
870.5550
84-2
Other Genetic Effects
All
40722305, 40888101
EPIDEMIOLOGY
non-guideline
non-guideline
Cancer Epidemiologic Studies - Submitted to EPA
All
45152101,45518401,44008601
non-guideline
non-guideline
Cancer Epidemiologic Studies - Other Published Literature
All
Alvanja et al. 2003
Breckenridge 2002
Breckenridge 2003
MacLennan et a!. 2002
MacLennan et al. 2003
Mills 1998
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.1100
875.1300
875.1500
231
232
235
Applicator Exposure Monitoring (Dermal outdoor exposure,
Inhalation outdoor exposure, Biological monitoring)
ABCJK
43934416,43934417,43934418,
44152109,44152110,44152111,
44315403,44315404, 43598604
875.1500
235
Biological Monitoring
ABCJK
44597605
44597606
875.1100
231
Dermal Exposure
ABCJK
43016506
875.1100
875.1300
231
232
Exposure Monitoring (ORETF)
ABCJK
44972201
875.2100
132-1
Foliar Dislodeeable Residue Dissipation
ABCJ
44883601
162
-------
APPENDIX B. Data Supporting Guideline Requirements for the Reregistration of Atrazinc
DATA REQUIREMENT
CITATION(S)
New Guideline
Number
Old
Guideline
Nunihrr
Study Title
Use Pattern
MRTD Number
875.2100
132-1
Transferable Residue Dissipation: Lawn and Turf
CK
44958001,44958801, 45517301
840.1100
201-1
202-1
Droplet Size Spectrum
Drift Field Evaluation
ABC.1IC
data gap
non-guideline
non-guideline
Dermal Transfer Efficiency of Granular Atrazine Residues
From Turf to Dry and Wetted Palms
CIC
45622310,45622311
non-guideline
non-guideline
Exposure Assessments
ABCJIC
44152106, 44152108, 45399905,
44597604
ENVIRONMENTAL FATE
835.2120
161-1
Hydrolysis of Parent and Degradates
ABCJIC
40431319
835.2240
161-2
Photodegradation - Water
ABC.1IC
42089904,45545301
835.2410
161-3
Photodegradation - Soil
ABCJK
40431320
42089905
835.2370
161-4
Photodegradation - Air
ABCJIC
not applicable
835.4100
162-1
Aerobic Soil Metabolism
ABCJIC
42089906
835.4200
162-2
Anaerobic Soil Metabolism
ABCJIC
42089906
835.4400
162-3
Anaerobic Aquatic Metabolism
ABCJIC
40431323
835.4300
162-4
Aerobic Aquatic Metabolism
ABCJIC
data (jap
835.1240
163-1
Leaching/Adsorption/Desorption
ABCJIC
40431324,40431325, 40431326,
40431327, 40431328
835-1410
163-2
Volatilitv-Lab
ABCJIC
data cap
163
-------
APPENDIX B. Data Supporting Guideline Requirements for the Reregistration of Atrazine
DATA REQUIREMENT
CITATION(S)
New Guideline
Number
Old
Guideline
Nnmher
Study Title
Use Pattern
MRID Number
835.6100
164-1
Terrestrial Field Dissipation
ABCJK
42165504,42165505, 40431336.
42165506,40431337, 42165507
835.1200
164-2
Aquatic (sediment) Dissipation
ABCJK
not applicable
835.1300
164-3
Forestry Dissipation
ABCJK
40431340,42041405
835.1500
164-5
Soil, Long Term Dissipation
ABCJK
40431339,42089911. 40431337.
42089912,40431338, 42089909,
40431336, 42089910
850.1730
165-4
Bioaccumulation in Fish
ABCJK
40431344
850.1950
165-5
Bioaccumulation in Non-Target Organisms
ABCJK
data gap
ENVIRONMENTAL FATE - DRINKING WATER MONITORING DATA
non-guideline
non-guideline
Atrazine Drinking Water Monitoring Data (PLEX & VMP)
All
43598634,43934413, 43934414,
44152122,44152123,44152124,
44315414,44597601,44711001,
44856901,44997001,44997003,
45058703,45058704,45145601,
45209601, 45253401, 45475101,
45475102,45545305, 45622305
non-guideline
non-guideline
Atrazine Drinking Water Monitoring Data (ARP)
All
45728401,45730200, 45722700
Acetochlor Registration Partnership
(ARP) Final Report for the State
Monitoring Program
non-guideline
non-guideline
Atrazine Rural Well Monitoring Data
ALL
data gap
164
-------
APPENDIX li. Data Supporting Guideline Requirements for tlie Rcrcgistration of Atrazinc
DATA REQUIREMENT
CITATIONS
New Guideline
Old
Number
Guideline
Study Title
Use Pattern
MRID Number
Number
non-guidclinc
non-guideline
Alrazine Ground-Water Monitoring Data
All
43934414,44222601, 44222602,
45399906, 45545304, data cap
RESIDUE CHEMISTRY
860.1300
171-4 A
Nature of Residue - Plants
AB
00023324 00023529 00022474
00024786 00055672 00149428
00161854 00016306 41209801
42547116 42547115 43016503
43048501 43598628 43598629
44152119 44152120 44152121
44315408 44315409
860.1300
171-4B
Nature of Residue - Livestock
AB
00022857 00038297 00161854
00016306 00038294 40431352
40431353 40431354 40431355
40431356 40431357 40437502
41209802 41209803 41209804
41209806 41209807 41209808
42925601 4350850143934412
860.1340
171-4C
Residue Analytical Method - Plants
AB
00016401 00016402 00016403
00023499 00023502 00024480
00024482 00055644 00093520
40431365 41397102 42547118
42547119 43016504 44315412
43395502
165
-------
APPENDIX 13. Data Supporting Guideline Requirements for the Rcrcgistration of Atrazine
DATA REQUIREMENT
( ITATION(S)
New (Guideline
Nil in her
Old
Guideline
Number
Study Title
Use Pattern
MRU) Number
860.1340
171-41)
Residue Analytical Method - Animals
AB
00023280 00023502 00161854
40431364 40431369 40431370
40431422 40431424 41397103
42547120 42547121 42547122
42547123
860.1360
Multiresidue Methods
AB
41423401, data gap
860.1380
I71-4F-:
Storage Stability
AB
00024482 40431421 4043142.6
41258601 41258602 41258603
41397101 43395503, data gap
860.1480
171 -4.1
Magnitude of Residues - Meat, Milk, Poultry, Eggs
Milk and the Fat, Meat, and Meat Byproducts of Cattle,
Goats, Hogs, Horses, and Sheep
Eggs and the Fat, Meat, and Meat Byproducts of Poultry
AB
00026977,00080629. 00093524,
40431424
40431422,40431423
860.1500
I71-4IC
Crop Field Trials - Macadamia Nuts
AB
00024799, 40431418
860.1500
171-4 K
Crop Field Trials - Corn, field and sweet, K iCWHR
AB
00094135,00093523, 40431401,
42547117,43598630, 44152117,
44315410,44597602, 45399901
860.1500
17I-4K
Crop Field Trials - Sorghum grain
AB
00093523,40431383. 43598631,
43598632, 44152118,44315411,
44597603,45399902
860.1500
171-4K
Crop Field Trials - Wheat grain
AB
00024475,40431420, 43160502
166
-------
APPENDIX B. Data Supporting Guideline Requirements for the Rercgistration of Atrazine
DATA REQUIREMENT
CITATION(S)
New Guideline
N limber
Old
Guideline
Number..
Study Title
1 Use Pattern
MRU) Number
860,1500
17I-4K
Crop Field "['rials - Corn forage and stover
AB
00093520 00093523 00094135
40431401 43598630 44152117
44315410 44597602
860.1500
171-4 K.
Crop Field Trials - Sorghum forage and stover
AB
00093523 40431383 43598631
43598632 44315411 44597603
860,1500
171-4K
Crop Field '['rials - Wheat forage, fodder, straw, grasses, and
forage
AB
00024475 00067425 40431420
43160502
data gap
860.1500
171-4K
Crop Field Trials - Orehardgrass, orehardgrass hay, rye,
perennial
AB
00024487
860.1500
171-4 K
Crop Field Trials - RangcGrnsses
AB
00126712
data fpp
860.1500
171-4K
Crop Field Trials - Guava
AB
00055643
860.1500
171-4 K
Crop Field Trials -Sugarcane
AB
00115588,43160504
860.1520
171-4L
Processed Foods (Corn)
AB
43160505
860.1520
I71-4L
Processed Foods (Sorghum)
AB
43160503
860,1520
171-4L
Processed Foods (Sugarcane)
AB
43160504,43395504
860,1520
171-4L
Processed Foods (Wheat)
AB
43160502
860.1850
165-1
Confined Rotational Crop
AB
43016505
860.1900
165-2
Field Rotational Crop
AB
43160501
PROBABILISTIC ASSESSMENTS
167
-------
APPENDIX B. Data Supporting Guideline Requirements for the Reregistration of Atrazine
DATA REQUIREMENT
CITATION(S)
New Guideline
Number
Old
Guideline
Niimher
Study Title
Use Pattern
MRID Number
non-guideline
non-guideline
Probabilistic Drinking Water Exposure Assessment
All
45503101, 45503102. 45622306,
45629401,45711308
non-guideline
non-guideline
Probabilistic Ecological Risk Assessment
All
45299501: 45299505, 45622302,
45622303
168
-------
Appendix C: TECHNICAL SUPPORT DOCUMENTS
Additional documentation in support of this IRED is maintained in the OPP docket,
located in Room 119, Crystal Mall #2. 1921 Jefferson Davis Highway, Arlington, VA. It is open
Monday through Friday, excluding legal holidays, from 8:30 am to 4 pm.
The docket initially contained the February 14, 2001 preliminary human health risk
assessment, and the September 26, 2001 preliminary ecological fate and effects risk assessment
and related documents. EPA then considered comments on these risk assessments, revised the
risk assessments, and added the formal "Response to Comments'' documents and the revised risk
assessments to the docket in May 2002. Additional response to comments documents and
documents supporting the IRED were published in January 2003.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at the following sites:
www.epa.gov/pesticides/op
http://cascade.epa.gov/RightSite/dkjpublic_home.htm
These documents include:
SRRD Documents:
Atrazine Memorandum of Understanding. January 31, 2003
4 Atrazine Summary. May 2, 2002
Atrazine Overview. May 2, 2002
HED Documents:
IRED Supporting Documents
Atrazine: Addendum to Revised Human Health Risk Assessment for the Reregistration
Eligibility Decision (RED) dated April 16, 2002. January 31, 2003
Atrazine: Reassessment of DWLOC value for use in human health risk assessment.
January 3!, 2003
Atrazine: Addendum to Revised Occupational and Residential Exposure Assessment and
Recommendations for the Reregistration Eligibility Decision Document. January 31,
2003
Atrazine: Response to Public Comments on the EPA's April 16, 2002, Revised Human
Health Risk Assessment and Associated Documents for the Reregistration Eligibility
Decision (RED). January 31, 2003
Review of Additional Data on Potential Atrazine Exposure and Review Comments
Submitted by Syngenta and NRDC on Atrazine Cancer Epidemiology Study: "Follow-up
Study of Cancer Incidence Among Workers in Triazine-related Operations at the Novarris
169
-------
St. Gabriel Plant" by Elizabeth Delzell et al. January 15, 2003.
Atrazine: Response to Syngenta's Comments on the EPA's April 16, 2002, Revised
Human Health Risk Assessment and Associated Documents for the Reregistration
Eligibility Decision (RED). November 22. 2002
Revised Risk Assessments and Supporting Documents
Atrazine: HED's Revised Human Health Risk Assessment for the Reregistration
Eligibility Decision (RED). April 16,2002
Atrazine: Response to Public Comments on the EPA's January 19, 2001, Revised
Preliminary Human Health Risk Assessment and Associated Documents for the
Reregistration Eligibility Decision (RED). April 16,2002
Atrazine: Response to Syngenta's Comments on the EPA's January 19, 2001, Revised
Preliminary Human Health Risk Assessment and Associated Documents for the
Reregistration Eligibility Decision (RED). April 16,2002
Atrazine/DACT - Reassessment Report of the FQPA Safety Factor Committee. April 8,
2002
Atrazine/DACT - Fourth Report of the Hazard Identification Assessment Review
Committee. April 5, 2002
Atrazine: Metabolism Assessment Review Committee. Residues to be Regulated and
Residues of Concern for Dietary Assessment. November 15, 2000
Atrazine: Toxicology Chapter of the Reregistration Eligibility' Decision. Second
Revision. April 11,2002
Atrazine: HED Product and Residue Chemistry Chapters. April 16,2002
Atrazine: Revised Occupational and Residential Exposure Assessment and
Recommendations for the Reregistration Eligibility Decision Document. April 25, 2002
Response to Comments from Sipcam Agro. April 18, 2002
Atrazine: Review of Probabilistic Exposure Assessment for Drinking Water from 28
Community Water Systems. April 23, 2002.
Addendum and Corrections to Occupational and Residential Exposure Chapter for
Atrazine. May 23, 2002.
Review of Atrazine Cancer Epidemiology Studies: "A Follow-up Study of Mortality
Among Workers at the Novartis St. Gabriel Plant" "Follow-up Study of Cancer Incidence
Among Workers in Triazine-relatcd Operations at the Novartis St. Gabriel Plant" both by
Elizabeth Delzell et al. March 25. 2002.
Review of Atrazine Cancer Epidemiology Study "Follow-up Study of Cancer Incidence
Among Workers in Triazine-related Operations at the Novartis St. Gabriel Plant" by
Elizabeth Delzell et al. December 13, 2001.
Preliminary Risk Assessments and Supporting Documents
EPA's Response to Syngenta's Comments on the Preliminary Human Health Risk-
Assessment for Atrazine in Support of the Reregistration, Tolerance Reassessment, and
Special Review. January 23, 2001
170
-------
Atrazine - Drinking Water Exposure Assessment for Atrazine and Various Chloro-
Triazine and Hydroxy-Triazine Degradates. January 23, 2001
Atrazine - Toxicology Chapter of the Reregistraiion Eligibility Decision - Revised.
January 19, 2001
Atrazine - HED's Revised Preliminary Human Health Risk Assessment for the
Reregistration Eligibility Decision (RED). January 19. 2001
Atrazine - Anticipated Residues and Acute and Chronic Dietary Exposure Assessments
for Atrazine.. Revised January 2001. January 18, 2001
Atrazine - HED Product and Residue Chemistry Chapters. January ] 8, 2001
Atrazine - Occupational and Residential Exposure Assessment and Recommendations for
the Reregistration Eligibility Decision Document. January 18, 2001
Atrazine - 3 rd Report of the Hazard Identification Assessment Review Committee.
December 21, 2000
Atrazine - Evaluation of Carcinogenic Potential. December 13, 2000
Atrazine - Reevaluation by the FQPA Safety Factor Committee. November 14. 2000
Atrazine - Cancer Peer Review Committee Meetings - Provisional Conclusions.
November 1,2000
Review of Atrazine Incident Reports. October 31, 2000
Diaminochlorotriazine (DACT) - Report of the Hazard Identification Assessment Review
Committee. August 28, 2000
Hydroxyatrazine - Report of the Hazard Identification Assessment Review Committee.
August 28, 2000
EFED Documents:
IRED Supporting Documents
EPA Response to Comments from Syngenta and its Contractors, the Triazine Network,
the Center for Regulatory Effectiveness, the American Water Works Association, the
State of New York Office of Attorney General, the U.S. Department of Interior Fish and
Wildlife Service, the California Regional Water Control Board, the American Farm
Bureau Federation, and the Louisiana Farm Bureau Federation, about the EPA
Reregistration Eligibility Science Chapter for Atrazine. Environmental Fate and Effects
Chapter, dated April 22, 2002. March 2003 (Replaces January 2003 Response to
Comments document)
Reregistration Eligibility Science Chapter for Atrazine: Environmental Fate and Effects
Chapter (and Appendices). January 31, 2003
EPA Response to Comments. January' 28, 2003
Revised Risk Assessments and Supporting Documents
Reregistration Eligibility Science Chapter for Atrazine. Environmental Fate and Effects
Chapter (and appendices). April 22, 2002.
171
-------
EFED Review of Comments from Syngenta and Its Contractors About the EPA Revised
Environmental Risk Assessment for Atrazine. April 22, 2002
EFED Review of Public Comments in Reponse to the EPA Revised Environmental Risk.
Assessment for Atrazine. April 10.2002
Response to Comments Contained in Attachment 6 of Syngenta's Comments on
"Atrazine. HED's Revised Human Health Risk Assessment for the Reregistration
Eligibility Document." April 9, 2002
Preliminary Risk Assessments and Supporting Documents
Response to Syngenta's Error Corrections of EPA's Atrazine RED and Environmental
Fate and Effects Chapter (including Appendices). March 16, 2001
172
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Appendix D: CITATIONS CONSIDERED TO BE PART OF THE DATA BASE
SUPPORTING TIIE INTERIM REREGISTRATION DECISION
(BIBLIOGRAPHY)
GUIDE TO .APPENDIX D
1. CON TENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies in
support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study." In the case
of published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they
were submitted. The resulting "studies" generally have a distinct title (or at least a single
subject), can stand alone for purposes of review and can be described with a conventional
bibliographic citation. The Agency has also attempted to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. Ttie 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. Tnis temporary
identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no
author or laboratory could be identified, the Agency has shown the first submitter
as the author.
-------
b. Document date. The date of the study is taken directly from the document. When
the date is followed by a question mark, the bibliographer has deduced the date
from the evidence contained in the document. When the date appears as (1999),
the Agency was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create
or enhance a document title. Any such editorial insertions are contained between
square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) . Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for "Company
Data Library." This accession number is in turn followed by an alphabetic
suffix which shows the relative position of the study within the volume.
174
-------
BIBLIOGRAPHY
MRID
Citation
00002875 Frear, D. E. H. and J. E. Boyd. 1967. Use of Daphnia magna for the
microbioassay of pesticides. I. Development of standardized techniq ues for
rearing Daphnia and preparation of dosage-mortality curves for pesticides. J.
Econ. Entomol. 60(5):1228-1236.
00016306 Hermes, P. (1972) Diphasic Extraction of Radioactive Metabolites from Treated
Biological Material. Method no. AG-214 dated Aug 15, 1972. (Unpublished study
received Sep 26. 1974 under 5F1606; submitted by Ciba-Gcigy Corp.,
Greensboro. N.C.; CDL: 094385-Q)
00016401 Cannizzaro, R.D.; Li, C. (1972) Determination of Atrazine Residues in Dry-
Crops by Gas Chromatography. Method no. AG-145 dated Nov 29, 1972.
(Unpublished study received Feb 18,1977 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 228126-L)
00016402 Cullen, T.; Balu, K. (1972) Determination of 2-Chloro-4,6-diamino s-triazine
(G-28273) Residues in Sorghum by Gas Chromatography. Method no. AG-232 A
dated Dec 20, 1972. (Unpublished study received Feb 18, 1977 under 100-583;
submitted by Ciba-Gcigy Corp., Greensboro, N.C.; CDL:228126-M)
0001640.-)
Cheung, M.W.; Hsieh, K. (1974) Determination of Atrazine. G-30033, arid
G-28279 Residues in Rangeland Forage by Gas Chromatography. Method no.
AG-269 dated Seted by Ciba-Geigy Corp., Greensboro, Method no. AG-269 dated
Sep 12, 1974. (Unpublished study received Feb 18, 1977 under 100-583;
submitted by Ciba-Geigy Corp., Greensboro, N.C.: CDL:228126-0)
00022474 Malina, M. (1964) Dissipation of Banvel D from Bermuda Grass (Ap- plied
6/28/63 in Texas): Report No. 3. (Unpublished study re- ceived Aug 30, 1965
under 6F0466: submitted by Velsicol Chemical Corp., Chicago, 111.; CDL:090517-
Ci)
00022855 Esser. H.O.; DuPuis, G.; Ebert, E.; et al. (1974) s-Triazines. Pages 129-
20S.-4n~Without Titlej. By N.P. (Also-ln-unpub- lished submission received
Oct 7. 1977 under 100-566; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:231969-C)
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40431.325 Yu, W. C. 1986. Determination of adsorption/desorption constants of Cr-28279:
Laboratory Study No. 59-6A. Unpublished study prepared by Cambridge
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Greensboro, NC.
40431326 Yu. W. C. 1986. Dcteraaination of adsorption/desorption constants of G-34048:
Laboratory Study No. 59-7A. Unpublished study prepared by Cambridge
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Greensboro, NC.
40431327 Yu, W. C. 1986. Determination of adsorption/desorption constants of G-28273:
Laboratory Study No. 59-5A. Unpublished study prepared by Cambridge
Analytical Associates, Inc., Boston, MA; submitted by Ciba-Geigy Corp.,
Greensboro, NC.
40431328 Yu, W. C. 1986. Determination of adsorption/desorption constants of G-30033:
laboratory Study No. 59-6A. Unpublished study prepared by Cambridge
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40431330 Saxena, A. M. 1987. Determination of the mobility of soil-aged 14C-atrazine
residues by thin-layer chromatography: Laboratory Study No. HLA 6015-186.
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40431336 White, S. 1987. Field dissipation study on Aatrex Nine-0 for terrestrial uses on
bareground, Ripon, California: Laboratory Study No. 1641 -86-71-01-21H-23. 300
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40431337 White, S. 1987. Field dissipation study on Aatrex Nine-0 for terrestrial uses on
bareground, Hollandale, Minnesota: Laboratory Study No.
1641-86-7I-01-21E-25. 356 p. Unpublished study prepared by Minnesota Valley
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40431338 White. S. 1987. Field dissipation study on Aatrex Nine-0 for terrestrial uses on
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40431339 White. S. 1987. Field dissipation study on Aatrex Ninc-0 for terrestrial uses on
186
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40431340 Schofield, M. 1986. Combined field dissipation and aquatic non-target organism
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40431344 Forbis. A. 1986. Uptake, depuration, and bioconcentration and metabolite
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40431352 Caballa, S. (1973) The in vitro Metabolism of Carbon 14 -Atrazine and
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Carbon 14 -Atrazine Dosed Chickens and Goat: (Nature of
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40431355 Farrier. D. (1987) Study of Protease Released Metabolites in Selected 1'issues of
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40431357 Madrid, S. (1987) Metabolism of Carbon 14 -Atrazine in Laying Hens Dosed for
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Capillary Gas Chromatography: (Residue Analytical Method): Laboratory Study
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40431418 Bade. T. (1987) Residues of Atrazine and Its Chlorometabolites in Macadamia
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54 p.
40431420 Bade, T. (1987) Residue of Atrazine and its Chlorometabolites in Wheat and
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188
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40431422 Bade, T. (1987) Residues of Atrazine and its Chlorometabolites in Poultry Tissues
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SOW or Nine-0 Herbicide (Magnitude Atrazine in their Diet (Magnitude of
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40431424 Bade, T. (1987) Residues of Atrazine and its Chlorometabolites in Dairy Tissues
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40722301 Ceresa, C. (1988) Atrazine: Structural Chromosomal Aberration Test
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40722302 Deparade. E. (1987) Diaminochlorotriazine: Gene Mutations Test: Salmonella/
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40722303 Meyer, A. (1987) Diaminochlorotriazine: Tests for Other Genetoxic Effects:
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41065203 Hughes. J. R. 1986. The toxicity of atrazine, Lot No. FL-850612 to four species
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41065205 Balu, K. 1989. Atrazine: Summary of surface water monitoring data for atrazine.
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4 i 209804 Simoneaux, B. (1989) Atrazine - Nature of the Residue: Further Characterization
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to Man: Atrazine: Project ID ABE-89067. Unpublished study prepared by
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41223001 Chetram, R. S. 1989. Atrazine: Tier 2 seed germinalion nontarget phytotoxicity
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41258601 Cheung, M. (1989) Simazine, Atrazine, and Chlorometabolites: Residue Stability
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41293501 Rudzki. M.: McCormick. G.; Arthur, A. (1989) 90-Day Oral Toxicity Study in
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204
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43598629 Larson. J.; Ash, S. (1992) (Carbon 14)-Atrazine: Nature of the Residue in Com
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43934407 Hui, X.; Wester, R.; Maibach, H. (1995) Disposition of Atrazine in Rhesus
Monkey Following Intravenous Administration: Interim Report: Lab Project
Number: UCSF 95SU04: 333-95. Unpublished study prepared by University of
California. 63 p.
43934408 Maibach, H. (1996) Disposition of Atrazinc in Rhesus Monkey Following
Intravenous Administration: Interim Report: Lab Project Number: ABR-95131:
333-95. Unpublished study prepared by Ciba-Geigy Corp. and University of
California. 59 p.
43934411 Hackett, D.; Bray, L. (1996) Updated Dietary Exposure Assessment for Atrazine:
Lab Project Number: ABR-96009. Unpublished study prepared by Ciba-Geigy
Corp. 48 p.
206
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4J
934412 Thalacker. F. (1996) Determination of Transfer Rate and Nature of the Residue(s)
in Milk from (carbon 14)-Atrazine Treated Cows: Lab Project Number: CHW
6117-325: 287-95: AM044. Unpublished study prepared by Coming Hazleton.
Inc. 105 p.
43934413 Clarkson., J.; Goiden, K.; Tiemey, D.; et al. (1996) Human Exposure to atrazine
and Simazine via Ground and Surface Drinking Water: Update-I: Lab Project
Number. 2852.0480: 696-95. Unpublished study prepared by Montgomery
Watson. 1840 p.
43934414 Balu, K. and P. W. Holdcn. 1996. Ciba/State ground-water monitoring study for
atrazine and its major degradation products in the United States. Final Report.
Ciba Study No. 174-91. 24 p. Unpublished study prepared by Waterbome
Environmental. Inc. Leesburg. VA.; submitted by Ciba-Geigv Corp., Greensboro.
NC.
43934415 Sielken, R.; Bretzlaff, R.; Valez-Fiores, C. (1996). Prdiminary Risk
Characterization for Atrazine and Simazine: Lab Project Number: 56.
Unpublished study prepared by Sielken, Inc. 1254 p.
43934416 Brady. J.F. (1995). Analytical Method for the Scmi-Quantitativc Determination
of Atrazine Mercapturate in Urine by Enzyme Immunoassay including Validation
Study. Laboratory Project Identification Analytical Method Number AG-638.
Unpublished study prepared by Ciba-Geigy Corp. [now Syngenta] 34 p.
43934417 Evaluation of the Potential Exposure of Workers to Atrazine During
Commercial Mixing, Loading, and Spray Applications to Corn. Biological Field
Phase. Honeycutt, R., Bennet, R., and DeGeare, M. (1996). HERAC, Inc. No. 95-
501HE. Ciba Study No. 178-95. Unpublished study prepared by Ciba Crop
Protection.[now Syngenta] 839 pages.
43934418 Selman, F. (1996). Assessment of Potential Worker Exposure to Atrazine During
Commercial Mixing, Loading, and Application to Com: Interim Report: Lab
Project Number: ABR-95133: 101930: 178-95. Unpublished study prepared by
Ciba-Geigy Corp. [now Syngenta] 64 p.
43934419 Solomon, K. R., D. B. Baker. R. P. Richards, K. R. Dixon, S. J. Kline, T. W. La
Point, R. J. Kendall, C. P. Weisskopf, J. M. Ciiddings, J. P. Giesy, L, W. Hall. Jr.,
and M. Williams. Ecological risk assessment of atrazine in North American
surface waters. Environ. Toxicol. Chem. 15(1):31-76.
43934420 Ecorisk, Inc. (1995) Ecological Risk Assessment of Atrazine in North American
Surface Waters: Additional Considerations of Exposure and Ecological Effects.
Unpublished study. 35 p.
207
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43934421 Benjamin. R. (1996) Characterization of Selenastrum Capricomutum Response to
Episodic Atrazine Exposure: Lab Project Number: 09524: TIWET 09542:
TIWET-09524. Unpublished study prepared by The Institute of Wildlife and
Environmental Toxicology, Clemson University. 92 p.
43934422 Drewing, L. (1996) Supplement to Ciba's Benefits Analysis of Atrazine and
Simazine: Lab Project Number: EV-1991-3: OPP-30000-60: SS-AGR-9.
Unpublished study prepared by Ciba-Geigy Corp. 532 p.
44008601 Delzell, E, I. Brill, and C. Beall. (1996). A follow-up Study of Workers at the
Ciba-Geigy St. Gabriel Plant. Laboratory Study No. Supplemental Document No.
11181. Unpublished study prepared by Ciba-Geigy Corp.[now Syngenta] 42 p.
44008602 Gass. R. and G.A. Stalder. (1993). Atrazine: An Epidemiology Study at the
Schweizerhalle Plant. Laboratory Study No. Supplemental Document No. 11182.
Unpublished study prepared by Ciba-Geigy Corp.[now Syngenta] 36 p.
44152102 Morscth, S. (1996) Evaluation of the Luteinizing Hormone (LH) Surge in
Atrazine-Exposed Female Sprague-Dawley Rats(Final) 6-Month Interim Report:
Lab Project Number: CHV 2386-111: 2386-111: 6791E. Unpublished study
prepared by Corning Hazlcton Inc. 727 p.
44152104 Simpkins, J. (1996) Evaluation of a Hormonal Mode of Action for Mammary
Carcinogenesis of the Chlorotriazine Herbicides: Second Concensus Panel Report.
Unpublished study prepared by Ciba-Geigy Corp. 37 p.
44152105 Consensus Panel (1995) Weight of the Evidence on the Oncogenic Potential of
Atrazine: Consensus Panel Report. Unpublished study. 38 p.
44152106 An Updated Assessment of Worker Exposure for Atrazine in Response to the U.S.
Environmental Protection Agency Issuance of the "Triazine Herbicides Position
Document 1 Initiation of Special Review". Supplement to ABR-95038:
Assessment of Worker Exposure for Atrazine in Response to the U.S.
Environmental Protection Agency Issuance of the "Triazine Herbicides Position
Document - Initiation of Special Review" (MRID 435986-38). Laboratory
Project Number: ABR-96071. Unpublished study by Ciba Crop Protection.[now
Syngenta] 124 pages.
44152108 Selman, F.B. (1996). Supplemental Data and Evaluation of Exposure to Lawn
Care Operators Using Atrazine in the Southern United States. Supplement to
ABR-95038: Assessment of Worker Exposure from Atrazine in Response to the
U.S. Environmental Protection Agency Issuance of the "Triazine Herbicides
Position Document - Initiation of Special Review" (MRID 435986-38).
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44152109 Selman. F.B. and L. Rosenheck. (1996). Evaluation of the Potential Exposure of
Workers to Atrazine During Commercial Mixing, Loading, and Spray
Applications to Com: (Final Report): Lab Project Number: ABR-95133.
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44152110 Bodalbhai, L. (1996) Analytical Method for the Determination of Residues of
Atrazine. G-30033. G-28279, and G-28273 in Urine by Gas
Chromatography/Mass Selective Detection Including Validation Data: Lab Project
Number: 264-95: AG-637: 101930. Unpublished study prepared by Ciba Crop
Protection. 91 p.
44152111 Honeycutt, R.C., Bennett. R.M. and DeGeare. M.A. (1996). Evaluation of the
Potential Exposure of Workers to Atrazine during Commercial Mixing, Loading,
and Spray Application to Corn (EPA-Subpart U) Biological Field Phase: Final
Report: Lab Project Number: 178-95: 95-501HF.: 95-517. Unpublished study
prepared by Ciba Crop Protection [now Syngenta]. 687 pages. 2 volumes.
44152113 Hui. X.; Wester, R.; Simoneaux, B.: et al. (1996) Disposition of Atrazine in
Rhesus Monkey Following Oral Administration: Lab Project Number: ABR-
96094: UCSF 96SU01: 306-96. Unpublished study prepared by University of
California, San Francisco and Ciba Crop Protection. 171 p.
44152114 Hui, X.; Oilman. S.; Simoneaux. B.: ct al. (1996) In vivo Percutaneous Absorption
of Atrazine in Man: Lab Project Number: ABR-96067: BDH-081-2: H832-11835-
01. Unpublished study prepared by UCSF; UC Davis; and Ciba Crop Protection.
297 p.
44152115 Bray, L. (1996) Revised Dietary Exposure Assessment for Atrazine: Lab Project
Number: ABR-96105. Unpublished study prepared by Ciba-Geigy Corp. 97 p.
44152117 Boyette, S. (1996) AtrazineMagnitude of the Residues In or On Com: (Final
Report): Lab Project Number: ABR-96087: 25-96: 101930. Unpublished study
prepared by Ciba-Geigy Corp. 211 p.
44152118 Boyette. S. (1996) AtrazineMagnitude of the Residues In or On Grain Sorghum:
Lab Project Number: ABR-96088: 26-96: 101930. Unpublished study prepared by
Ciba-Geigy Corp. 286 p.
44152119 Thalacker. F.; Ash. S. (1996) (Carbon 14)-Atrazine: Nature of the Residues in
Corn and Sorghum: Amendment No. 3 to the Final Report: MRID 42547116: Lab
PW 6117-325: 287-95: AM044. Report: MRID 42547116: Lab Project Number:
IIWI 6117-178: 51-91. Unpublished study prepared by Ilazieton Wisconsin. Inc.
209
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31 p.
44152120 Thalacker. F.: Ash, S. (1996) (Carbon 14)-Atrazine: Nature and Magnitude of the
Hydroxy-triazine and Chlorotriazine Residues in Sorghum Following a
Pre-emergcncc Application at 2 lb. ai/A: Lab Project Number: CHW 6117-337:
229-96. Unpublished study prepared by Corning Hazleton, Inc. 65 p.
44152121 Thalacker, F.; Ash, S. (1996) (Carbon 14)-Atrazine: Nature and Magnitude of the
Hydroxy-triazine and Chlorotriazine Residues in Corn Following a
Pre-emergence Application at 2 lb. ai/A: Lab Project Number: CHW 6117-335:
228-96. Unpublished study prepared by Corning Hazleton, Inc. 65 p.
44152122 Clarkson, J.; Hines, N.; Tierney, D.; et al. (1996) Human Exposure to Atrazine
and Simazine via Ground and Surface Drinking Water: UpdateII: Supplement to
MRID No. 43934413 (and No. 43598634): Lab Project Number: 2852.0540: 696-
95. Unpublished study prepared by Montgomery Watson. 2267 p.
44152123 Tierney D and Balu K. 1996. Summary of Voluntary Atrazine Monitoring
Program at Selected Community Water Systems. October 29, 1996. Submitted by
Novartis.
44152124 Tierney, D.'; Balu, K. (1996) Summary of Sampling Methods for Estimating
Annual Mean Concentrations of Atrazine in Community Water Systems: Lab
Project Number: ABR-96103. Unpublished study prepared by Ciba Crop
Protection. 162 p.
44152125 Sielken, R.; Bretzlaff, R.; Valdez-Flores, C. (1996) Risk Characterization for
Atrazine and Simazine: Report Supplement: Lab Project Number: 56.
Unpublished study prepared by Sielken, Inc. 1245 p.
44152126 Ciiddings. J.; Hall, L.: Kendall, R.; et al. (1996) Beyond the Probabilistic
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Supplement to MRID 43934419. Unpublished study prepared by Ecorisk, Inc. 54
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44152127 Hill, E.; Crousc, K. (1996) The Role of Atrazine in Managing Weed Biotypes
Resistant to ALS-lnhibitor Herbicides. Unpublished study prepared by Ciba Crop
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44222601 Balu, K.; Holden, P. (1996) Ciba/State Ground-Water Monitoring Study for
Atrazine and Its Major Degradation Products in the United States: Amendment to
the Final ReportMRTD 43934414: Lab Project Number: ] 74-91: 242.01:
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44222602 Balu, K.; Holden, P. (1997) Ciba/State Ground-Water Monitoring Study for
Atrazine and Its Major Degradation Products in the United States: Second
Amendment to the Final ReportMRID 43934414: Lab Project Number: 174-91:
242.01: CIGNC01E-5. Unpublished study prepared by Watcrbome
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44256501 Delzell, E.; Sathiakumar, N. (1996) An Updated Follow-up Study of Workers at
the Ciba-Geigy Mcintosh Plant: Final Report. Unpublished study prepared by
University of Alabama at Birmingham. 76 p.
44256502 Delzell. E.; Sathiakumar, N. (1996) A Combined Analysis of Mortality Among
Workers at the Ciba-Geigy- Corporation's Mcintosh and St. Gabriel PlantsAn
Update. Unpublished study prepared by University of Alabama at Birmingham.
113 p.
44315401 Simpkins, J. (1997) Evaluation of a Hormonal Mode of Action for Mammary
Carcinogenesis of the Chloro-s-triazine Herbicides: Third Consensus Panel
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44315402 Safe. S.; McDougaL A.: Wilson, C. (1997) Induction of estradiol 2-hydroxylase
activity in MCF-7 human breast cancer cells by pesticides and carcinogens.
Environmental Toxicology and Pharmacology p. 1 -5.
44315403 Selman. F.B. and Rosenheck, L. (1996). Assessment of Potential Worker
Exposure to Atrazine During Commercial Mixing, Loading, and Application to
Corn (MRID 441521-09). Amendment 1. Laboratory Project Number ABR-
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44315404 Selman. F.B. and Rosenheck. L. (1996). Presentation of Data from ABR-95133
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Mixing, Loading, and Application to Corn" from Use in the Pesticide Handler's
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44315405 Simoneaux, B. (1996) Disposition of Atrazine in Rhesus Monkey Following Oral
Administration: Final Report Amendment 1: Lab Project Number: ABR-96094:
306-96. Unpublished study prepared byNovartis Crop Protection. Inc. 54 p.
44315406 Bray, L.; Boyette, S.; Breckenridge, C. ct al. (1997 ) Summary of the Nature and
Magnitude of Atrazine Residues on Com and Sorghum Grain, Forage and Fodder
and the Basis for the Dietary Risk Assessment. Unpublished study prepared by
Novartis Crop Protection. Inc. 17 p.
211
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44315407 Bray, L. (1997) Revised Dietary Assessment for Atrazine Including Two
Exposure Scenarios: Lab Project Number: ABR-97064: 396-97. Unpublished
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44315408 Thalacker, P. (1996) (Carbon-14)-Atrazine: Nature and Magnitude of the .
Hydroxy-triazine and Chlorotriazine Residues in Corn Following a
Pre-Emergence Application at 2 lb. ai/A: Amendment No. 2 to the Final Report:
Lab Project Number: 6117-335: 228-96: BIOL-97003. Unpublished study
prepared by C'ovance Labs.. Inc. 78 p. .
44315409 Thalacker, F.; Ash, S. (1996) i4C-Atrazine: Nature and Magnitude of the
Hydroxy-triazine and Chlorotriazine Residues in Sorghum Following a
Pre-Emergence Application at 2 lb. ai/A: Amendment No. 2 to the Final Report:
Lab Project Number: 6117-337: 229-96: B10L-97004. Unpublished study
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Amendment 1: Lab Project Number: ABR-96087: 25-96: 101930. Unpublished
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44315411 Bovette, S. (1996) Atrazine-Magnitudc of the Residues in or on Grain Sorghum:
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44315412 Lin, K. (1997) Validation of Analytical Method AG-484A for the Determination
of Residues of Atrazine, G-30033. G-28279 and G-28273 in or on Corn and
Sorghum: Lab Project Number: ABR-97056: 300-97: AG-484A. Unpublished
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44315413 Bray, L. (1997) Rationale for the Dairy Cattle Diet Utilized in the Revised Dietary
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44315414 Clarkson, J.; Hines, N.; Tierney, D. et al. (1997) Human Exposure to Atrazine and
Simazine via Ground and Surface Drinking Water: UpdateIll: Supplement: Lab
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44315417 Brooks, R.; Crouse, K.; Hill, E. et al. (1997) Supplement to Novartis' Benefits
Analysis of Atrazine and Simazine: Additional Information on Weed Control,
Yield and Impact to Growers and Livestock Producers June 1997. Unpublished
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44488801 Lail. L. (1998) Technical Atrazine: Product Chemistry (Preliminary Analysis):
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44518401 Van Kampen. W.; Thus, J. (1996) The Determination of Diflubenzuron and
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44597603 Clarkson .T, Hines N, Tiemey D, Christensen B, and Mattan C. 1998. Human
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44856901 Brady, J. (1999) Validation Study of an Atrazine Immunoassay for Drinking
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Novak, J. M.. T. B. Moorman and C. A. Cambardella. 1997. Atrazine sorption at the field scale
in relation to soils and landscape position. J. Environ. Qual. 26(5): 1271-1277.
Nsabimana, E.. J. Bohatier. A. Beian, D. Pepin and L. Charles. 1996. Effects of the herbicide
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O'Keliy. J. C and T. R. Deason. 1976. Deszradatior. of pesticides by algae. US EPA, Athens.
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atrazine and polar metabolites from sediments followed bv confirmation with LC-MS. Environ.
Sci. Technol. 30(6): 1822-1827.
Parshley, Thomas J. 1990. Letter: Atrazine technical, EPA Reg. No. 100-529: Additional
information on adsorption/ desorption data: Soil series names. 3 p. Submitted by Ciba-Geigy
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Tom Parshley to Office of Pesticide Programs, September 14, 2001.
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1997. A study of the temporal variability of atrazine in private well water. 2. Analysis of data.
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533-544
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110.
249
-------
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250
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251
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252
-------
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254
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Appendix E: GENERIC DATA CALL-IN
Note that a complete Data Call-in (DCI). with all pertinent instructions, will be sent to
registrants under separate cover.
255
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
DATA CALL-IN RESPONSE
OMR Approval 2070-0107
OMR Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0062 Atrazine
Chemical # and Name 080803
Atrazine
3 Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID # GDCI-080803-NNNNN
4. EPA
Product
Registration
5 1 wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
7. Product Specific Data
6a. 1 am claiming a Generic
Data Exemption because 1
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. 1 agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7a. My product is an MUP and
1 agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
1 agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
NNNNNN-NNNNN
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. 1 acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
9. Date
-------
uii/\i' i t, u r y
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMT1 Approval M7MI07
OMU Approval 207(1-01)57
INSTRUCTIONS; Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2, Case # and Name
0062 Atrazine
Chemical # and Name
Atrazine
000803
3. Date and Typo of DCI and Number
DD-MMM-YYYY
GENERIC
ID ft GDCI-000803-NNNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
B. Time
Frame
(Months)
9. Registrant
Response
Environmental Fate Data Requirements (Antimicrobial)
840.1100
840.1200
835.1410
835,4300
850.1950
830.7050
060.1360
060.1380
Spray droplet size spectrum (3)
Spray drift field deposition (4)
Environmental Fate Data Requirements (Conventional
Chemical)
Laboratory volatilization from soil
Aerobic aquatic metabolism
Field testing for aquatic organisms
Product Chemistry Data Requirements (Conventional
(11
(2)
(33 ,34 .35
,36)
Chemical)
UVA/isibie absorption
Residue Chomlstrv Data Requirements for Food Uses
(Conventional Chemical)
Multiresiclun method
Storage stability data
(40 ,41)
(42)
A, B, C, J, K
A, n. C, J, K
A, B, C, J, K
A, B, C, J, l<
A, B.C.J, K
A, B, C, J, K
A, B, C, J, K
A, B, C, J. K
TEP
TEP
TEP
TGAI or PAIRA
TEP
TGAI/PA!
TGAI; PAIRA
TEP or res of concm
12
24
12
24
12
0
24
10, Certification I certify that the statements made on this lorm and all attachments are true, accurate, and complete. I acknowledge that any
knowingly fa!se or misleading statement may bo punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
11, Date
12, Name of Company
13 Phone Number
-------
D R A F T C O P Y
Page 2 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
OMB Approval 2070-0107
OMB Approval 2070-0057
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
2 Case # and Name
3.
Date and Type of DCI and Number
SAMPLE COMPANY
0062 Atrazine
DD-MMM-YYYY
NO STREET ADDRESS
Chemical # and Name
080803
GENERIC
NO CITY, XX 00000
Atrazine
ID# GDCI-080803-NNNNN
4. Guideline
Requirement
Number
5. Study Title
P
R
O
T
O
C
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
o
L
1
2
3
860 1500
Crop field trialsfGRASS. FORAGE/
(43 .45)
A. B. C. J, K
TEP
24
860.1500
Crop field trials(GRASS, HAY)
(44 ,46)
A, B.C. J, K
TEP
24
860 1900
Field accumulation in rotational crops
'47)
A. B, C. J. K
TEP
36
Terrestrial and Aauatic Nontaraet Oraanisms Data
Requirements (Conventional Chemical)
850 1010
Aquatic invertebrate acute toxicity, test, freshwater (5 ,6 .7 ,8 ,9)
daphnids
A, B, C. J. K
COMMENT
24
850.1025
Oyster acute toxicity test (shell deposition) (10,11 ,12
,13 ,14)
A, B, C, J, K
COMMENT
12
850.1075
Fish acute toxicity test, freshwater and marine (15 ,16 ,17
.18 .19 .20
.21 ,22 ,23)
A, B, C, J, K
COMMENT
18
850.1350
Mysid chronic toxicity test
(24 ,25 ,26)
A, B, C, J, K
TGAI
12
850.1400
Fish early-life stage toxicity test
(27 ,28 ,29
.30 ,31 .32/
A, B, C, J, K
TGAI
12
850.1950
Field testing for aquatic organisms
(33 ,34 ,35
.36)
A, B, C, J, K
TEP
12
850.2100
Avian acute oral toxicity test
(37 .38 .39)
A, B, C, J, K
COMMENT
12
Initial to indicate certification as to information on this page
Date
-------
v_ r r
I oyo i
United Stales Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMR Approval 307(1-0107
OMB Approval 2070-O0S7
INSTRUCTIONS; Please type or print in ink. Please rend carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2 Case it and Name
0062 Atrazirie
Chemical # and Name
Atrazine
3. Date and Type of DCI and Number
DU-MMM-YYYY
GENERIC
ID# GDC1-0B0B03-NNNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
0. Time
Frame
(Months)
9. Registrant
Response
SS-28 Day Inh
SS-CNS altered
SS-RWM
SS-SWM
28-Day Inhalation Study
Assessment of CNR alterations after atrazine
exposure
Rural Well Monitoring Program
Surface Water CWS Monitoring Program
(48)
A, B, C, J, K
A, B, C, J, K
A, B, C, J, K
A, B, C, J, K
24
24
48
Initial to indicate certification as to Information on this pago
(full text of certification is on page one).
Date
-------
DRAFT COPY
Page 1 of 5
United States Environmental Protection
Agency Washington. D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0062 Atrazine
PCI Number: GDCI-080803-NNNNN
Key: COMMENT = See Footnote; TEP = Typical End Use Product [TEP]; TEP or res of concrn = Typical End-Use Product or Residue of Concern; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI
or PAIRA = Technical Grade of the Active Ingredient or Active Ingredient, Radio-Labelled; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient; TGAI; PAIRA = Technical Grade of
the Active Ingredient; Pure Active Ingredient, Radio-Labelled
Use Categories Key:
A - Terrestrial food crop J - Forestry use
B- Terrestrial feed crop K- Residential
C - Terrestrial nonfood crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Requirement based on use patterns and other pertinent factors including, but not limited to, Henry's Law Constant. In view of methodological difficulties with the study of photodegradation in
air, prior consultation with the Agency regarding the protocol is recommended before the test is performed.
2 Aerobic Aquatic Metabolism- Lab
3 This study is required when aerial applications (rotary and fixed winged) and mist blower or other methods of ground application are proposed and it is estimated that the detrimental effect level
of those nontarget organisms expected to be present would be exceeded. The nontarget organisms include humans, domestic animals, fish and wildlife, and nontarget plants. This requirement
may be satisfied by submittal of published or unpublished information regarding spray drift patterns that would be expected to be similar to the proposed product.
4 This study is required when aerial applications (rotary and fixed winged) and mist blower or other methods of ground application are proposed and it is estimated that the detrimental effect level
of those nontarget organisms expected to be present would be exceeded. The nontarget organisms include humans, domestic animals, fish and wildlife, and nontarget plants. This requirement
may be satisfied by submittal of published or unpublished information regarding spray drift patterns that would be expected to be similar to the proposed product.
5 For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing use products to be reformulated or to support these same end-use products when
there is no registered manufacturing use product. For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing-use products to be reformulated
into these same end-use products or to support end-use products when there is no registered manufacturing-use product.
6 Data using the TGAI are required to support all outdoor end-use product uses including turf. Data are generally not required to support end use products in the form of a gas, a highly volatile
liquid, a highly reactive solid, or a highly corrosive material.
7 Freshwater fish LC50 (the most sensitive of the species tested), freshwater invertebrate EC50 (preferably Daphnia), and acute LC50/EC50 estuarine and marine organisms studies using the
EP or TEP are required for any product which meets any of the following conditions:! (i) The end-use pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides
and mosquito larvicides) when used as directed; (ii) the maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic
environment is equal to or greater than one-half the LC50 or EC50 of the TGAI when the EP is used as directed; (iii) an ingredient in the end-use formulation other than the active ingredient is
expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
8 Data are preferred on Daphnia magna.
9 Acute aquatic invertebrate tox (major degradate)
10 Data using the TGAI are required to support all outdoor end-use product uses including turf. Data are generally not required to support end use products in the form of a gas, a highly volatile
liquid, a highly reactive solid, or a highly corrosive material.
-------
ru{|o t. 01 o
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case ft and Name: 0062 Atrazine
DC I Number: C.DCI-080803-NNNNN
Key: COMMENT = See Footnote; TEP = Typical End Use Product [TEP]; TEP or res of concrn = Typical End-Use Product or Residue of Concern; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI
or PAIRA = Technical Grade of the Active Ingredient or Active Ingredient, Radio-Labelled; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient; TGAI; PAIRA = Technical Grade of
the Active Ingredient; Pure Active Ingredient, Radio-Labelled
Use Categories Key:
A - Terrestrial food crop J - Forestry use
B - Terrestrial feed crop K - Residential
C - Terrestrial nonfood crop
Footnotes: IJlio following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
11 Freshwater fish LC50 (the most sensitive of the species tested), freshwater invertebrate EC50 (preferably Daphnia), and acute LC50/EC50 estuarine and marine organisms studies using the
EP or TEP are required for any product which meets any of the following conditions:! J(i) The end-use pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides
and mosquito larvicides) when used as directed; (ii) the maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic
environment is equal to or greater than one-half the LC50 or EC50 of the TGAI when the EP is used as directed; (iii) an ingredient in the end-use formulation other than the active ingredient is
expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
12 Data are preferred on eastern oyster (Crassostrea virginica) and oppossum shrimp (America mysis) formerly (Mysidopsis bahia) and silver side (Menidia sp.)
13 Data are generally not required for other, non-turf, outdoor residential uses, i.e., gardens and ornamentals.
14 Acute estuarine/marine fish toxicity (major degradate)
Acute Estuarine/marine mollusk toxicity (TGAI and major degradate)
Acute Estuarine/marine shrimp toxicity (major degradate)
15 For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing use products to be reformulated or to support these same end-use products when
there is no registered manufacturing use product. For greenhouse and indoor end-use products, data using the TGAI are required to support manufacturing-use products to be reformulated
into these same end-use products or to support end-use products when there is no registered manufacturing-use product.
16 Data using the TGAI are required to support all outdoor end-use product uses including turf. Data are generally not required to support end use products in the form of a gas, a highly volatile
liquid, a highly reactive solid, or a highly corrosive material.
17 Data using the TGAI are required to support all outdoor end-use product uses including turf. Data are generally not required to support end use products in the form of a gas, a highly volatile
liquid, a highly reactive solid, or a highly corrosive material.
18 Data are preferred on rainbow trout and bluegill for terrestrial, aquatic, forestry, and residential outdoor uses. For indoor and greenhouse uses, testing with either fish species is required.
However, if the TGAI is stable in the hydrolysis study, and the I.C50 value of the first fish tested is between 1 ppm and 10 ppm, then testing with both species is required.
19 Freshwater fish LC50 (the most sensitive of the species tested), freshwater invertebrate EC50 (preferably Daphnia), and acute LC50/EC50 estuarine and marine organisms studies using the
EP or TEP are required for any product which meets any of the following conditions:! >(i) The end-usa pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides
and mosquito larvicides) when used as directed; (ii) the maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic
environment is equal to or greater than one-half the LC50 or EC50 of the TGAI when the EP is used as directed; (iii) an ingredient in the end-use formulation other than the active ingredient is
expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
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DRAFT COPY
Page 3 of 5
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0062 Atrazine
PCI Number: GDCI-080803-NNNNN
Key: COMMENT = See Footnote; TEP = Typical End Use Product [TEP]; TEP or res of concrn = Typical End-Use Product or Residue of Concern; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI
or PAIRA = Technical Grade of the Active Ingredient or Active Ingredient, Radio-Labelled; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient; TGAI; PAIRA = Technical Grade of
the Active Ingredient; Pure Active Ingredient, Radio-Labelled
Use Categories Key:
A- Terrestrial food crop J- Forestry use
B- Terrestrial feed crop K- Residential
C - Terrestrial nonfood crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
20 Freshwater fish LC50 (the most sensitive of the species tested), freshwater invertebrate EC50 (preferably Daphnia), and acute LC50/EC50 estuarine and marine organisms studies using the
EP or TEP are required for any product which meets any of the following conditions;! :(i) The end-use pesticide will be introduced directly into an aquatic environment (e.g., aquatic herbicides
and mosquito larvicides) when used as directed; (ii) the maximum expected environmental concentration (MEEC) or the estimated environmental concentration (EEC) in the aquatic
environment is equal to or greater than one-half the LC50 or EC50 of the TGAI when the EP is used as directed; (iii) an ingredient in the end-use formulation other than the active ingredient is
expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms
21 Data are preferred on eastern oyster (Crassostrea virginica) and oppossum shrimp (America mysis) formerly (Mysidopsis bahia) and silver side (Menidia sp.)
22 Data are generally not required for other, non-turf, outdoor residential uses, i.e., gardens and ornamentals.
23 Aquatic fish toxicity on Rainbow Trout and Bluegill (major degradate)
24 Data are generally not required for other, non-turf, outdoor residential uses, i.e., gardens and ornamentals.
25 Data are required on estuarine species if the product is: (i) intended for direct application to the estuarine or marine environment; (ii) expected to enter this environment in significant
concentrations because of its expected use or mobility patterns, and (iii) if the acute LC50 or EC50 < 1 mg/l; or (iv) if the estimated environmental concentration in water is equal to or greater
than 0.01 of the acute EC50 or LC50 and any of the following conditions exist; (a) studies of other organisms indicate the reproductive physiology of fish and/or invertebrates may be affected;
(b) physicochemical properties indicate bioaccumulation of the pesticide; (c) the pesticide is persistent in water (e.g., half-life in water greater than 4 days).
26 Data are preferred on oppossum shrimp (America mysis) formerly (Mysidopsis bahia).
27 Data using the TGAI are required to support all outdoor end-use product uses including turf. Data are generally not required to support end use products in the form of a gas, a highly volatile
liquid, a highly reactive solid, or a highly corrosive material.
28 Data are generally not required for other, non-turf, outdoor residential uses, i.e., gardens and ornamentals.
29 Data are generally not required for other, non-turf, outdoor residential uses, i.e., gardens and ornamentals.
30 Data are preferred on rainbow trout. If fathead minnow (Pimephales promelus) is used, a 96 hour LC50 on that species must also be provided.
31 Data are required on estuarine species if the product is: (i) intended for direct application to the estuarine or marine environment; (ii) expected to enter this environment in significant
concentrations because of its expected use or mobility patterns, and (iii) if the acute LC50 or EC50 < 1 mg/l; or (iv) if the estimated environmental concentration in water is equal to or greater
than 0.01 of the acute EC50 or LC50 and any of the following conditions exist: (a) studies of other organisms indicate the reproductive physiology of fish and/or invertebrates may be affected;
(b) physicochemical properties indicate bioaccumulation of the pesticide; (c) the pesticide is persistent in water (e.g., half-life in water greater than 4 days).
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\j iv a r t i i
Kapjo a 01q
Unilcc! States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AMD KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0062 Atrazine
PCI Number: GDCI-0S0803-NNNNN
Key: COMMENT ~ See Footnote; TEP = Typical End Use Product [TEP]; TEP or res of concrn = Typical End-Use Product or Residue of Concern; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI
or PAIRA = Technical Grade of the Active Ingredient or Active Ingredient, Radio-Labelled; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient; TGAI; PAIRA = Technical Grade of
the Active Ingredient; Pure Active Ingredient, Radio-Labelled
Use Categories Key:
A - Terrestrial food crop J - Forestry use
B - Terrestrial feed crop l< - Residential
C - Terrestrial nonfood crop
Footnotes: [The following notes are referenced In column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
32 Data are preferred on sheepshead minnow (Cypinodon variegatus).
33 Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards
and procedures for independent laboratory validation are available as addenda to the guideline for this test requirement.
34 Tests are required based on the results of lower tier toxicology studies such as acute and chronic aquatic organism testing, intended use pattern, and environmental fate characteristics that
indicate potential exposure.
35 Required if significant concentrations of the active ingredient and/or its principal degradation products are likely to occur in aquatic environments and may accumulate in aquatic organisms.
36 Accumulation in aquatic non-target organisms
37 Data are preferred on redwing blackbird (Agelalus phoneiceus) and either mallard or bobwhite quail for terrestrial, aquatic, forestry, and residential outdoor uses. Data are preferred on mallard
or bobwhite quail for indoor and greenhouse uses.
38 Data using the TGAI are required to support all outdoor end-use product uses including turf. Data are generally not required to support end use products in the form of a gas, a highly volatile
liquid, a highly reactive solid, or a highly corrosive material.
39 Northern Quail; 3 major degradates
40 Data are required to determine whether FDA/USDA multiresidue methodology would detect and identify the pesticides and any metabolites.
41 Study needed for analytical methods AG484 and 596 for testing through the multi-residue methods.
42 Storage stability data are required on atrazine and chloro-metabolites to support the following samples from field trial studies: sugarcane (stored at 32 months), and wheat commodities (stored
at 35 months), and to support samples of corn processed commodities (stored 40 months), and sorghum process commodities (stored 37 months).
43 Studies using single serving samples of a raw agricultural commodity may bo needed for acutely toxic pesticides and/or their metabolites. These residue studies must be conducted using a
statistical design accepted by the Agency.
44 Studies using single serving samples of a raw agricultural commodity may be needed for acutely toxic pesticides and/or their metabolites. These residue studies must be conducted using a
statistical design accepted by the Agency.
45 Field trial data are required to support a crop group tolerance for Crop Group 17 (Grass Forage, Fodder, and Hay). Residue data from feild trials on representative crops are recommended:
Bermuda grass, bluegrass, brnniegrass, orfe3cue,
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DRAFT COPY
Page 5 of 5
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0062 Atrazine
PCI Number: GDCI-080803-NN'NNN
Key: COMMENT = See Footnote; TEP = Typical End Use Product [TEP]; TEP or res of concrn = Typical End-Use Product or Residue of Concern; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI
or PAIRA = Technical Grade of the Active Ingredient or Active Ingredient, Radio-Labelled; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient: TGAI; PAIRA = Technical Grade of
the Active Ingredient; Pure Active Ingredient, Radio-Labelled
Use Categories Key:
A- Terrestrial food crop J- Forestry use
B - Terrestrial feed crop K - Residential
C - Terrestrial nonfood crop
Footnotes: The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
46 Field trial data are required to support a crop group tolerance for Crop Group 17 (Grass Forage, Fodder, and Hay). Residue data from field trials on representative crops are recommended:
Bermuda Grass, Bluegrass, Bromegrass, or fescue.
47 Required if pesticide or metabolite residues of toxicological concern are found in crops at the appropriate plant back intervals from a confined rotational crop study (guideline 860.1850)
48 28-day inhalation toxicity study measuring LH surge and estrus cycle parameters
49 Assessment of CNS alterations after atrazine exposure (recommended)
-------
Appendix F: PRODUCT SPECIFIC DATA CALL-IN AND A LIST OF REGISTRANTS
SENT THIS DCI
Note that a complete Data Call-In (DCI), with all pertinent instructions, will be sent to
registrants under separate cover.
265
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DRAFT COPY
Pago 1 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
OMR Approval 2070-0107
OMR Approval 2070-0057
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
2. Case # and Name
3.
Date and Type of DCI and Number
SAMPLE COMPANY
0062 Atrazine
DD-MMM-YYYY
NO STREET ADDRESS
PRODUCT SPECIFIC
NO CITY, XX 00000
EPA Reg. No. NNNNNN-NNNNN
ID# PDCI-080803-NNNN
4. Guideline
Requirement
Number
5. Study Title
P
R
O
T
O
C
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
O
L
1
2
3
Product Chemistrv Data Requirements (Conventional
830.1550
Chemical)
Product Identity and composition
(1)
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
TGAI/MP/EP
8
830.160C
Description of materials used to produce the product (2)
A. B. C. D. E, F, G,
J. K, L. M. N. O
H, I,
TGAI/MP/EP
8
830.1620
Description of production process
(3)
A, B, C, D, E, F, G,
J, K, L, M, N, O
H, I,
TGAI
8
830.1650
Description of formulation process
(4)
A, B. C. D. E. F, G.
J, K. L. M, N. O
H. I,
MP/EP
8
830.1670
Discussion of formation of impurities
(5)
A, B, C, D, E, F, G,
J, K, L, M, N, O
H, I,
TGAI/MP/EP
8
830.170C
Preliminary analysis
(5 .7 .8)
A. B. C. D. E. F. G,
J. K. L. M. N. O
H, 1,
TGAI
8
830.1750
Certified limits
(9)
A, B, C, D, E, F, G,
J, K, L, M, N, O.
H, 1,
TGAI/MP/EP
8
830.1800
Enforcement analytical method
(10)
A, B. C. D, E. F. G.
J. K. L. M. N. O
H, 1,
TGAI/MP/EP
8
830.6302
Color
(11)
A, B, C, D, E, F, G,
J, K, L, M, N, O
H, 1,
TGAI/MP/EP
S
830.6303
Physical state
(12)
A, B. C. D. E, F. G,
J, K. L. M, N, O
H. 1,
TGAI/MP/EP
8
830.6304
Odor
(13)
A, B, C, D, E, F, G,
J, K, L, M, N, O
H, 1,
TGAI/MP/EP
8
10. Certification I certify tf
knowingly false or misleadinc
at the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
statement may be punishable by fine, imprisonment or both under applicable law
11. Date
Signature and Title of Company's Authorized Representative
1 O Nhmo a!
-------
United Slates Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMN Approval 2070-0107
OMR Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case 1t and Name
0062 Atrazine
EPA Reg. No. NNNNNN-NNNNN
Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID # PDCI-080803-NNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
830.6314
830.6315
830 6316
830.6317
830.6319
830.6320
B30.6321
830.7000
830,7050
830.7100
830.7300
Oxidizing or reducing action
Flammability
Explodability
Storage stability of product
Misc.ibility
Corrosion characteristics
Dielectric breakdown voltage
pH of water solutions or suspensions
UV/Vislble absorption
Viscosity
Density/relative density
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21 ,22)
(23)
(24 ,25)
A, B, C, D.
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
>), K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D
J, K, L. M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
E, F, G, H, I,
N, O
E, F, G, H, I,
N, O
E, F, G, H, I,
N, O
E, F, G, H, I,
N, O
E, F, G, H, I,
N, O
E, F, G, H, I,
N, O
E, F. G, H, I,
N, O
E,F, G, H, I,
N, O
E, F, G, H, I.
N, O
E, F, G, H, I,
N, O
E, F, G, H, I,
N, O
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
TGAI/MP/EP
TGAI/PAI
MP/EP
TGAI/MP/EP
Toxicology Data Requirements (Conventional Chemical)
Initial to indicate certification as to information on this page
(full text of certification is nn page one).
Date
-------
DRAFT COPY
Page 3 of3
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMR Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0062 Atrazine
EPA Reg. No. NNNNNN-NNNNN
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-080803-NNNN
4. Guideline
Requirement
Number
870.1100
870.1 ZOO
B7C.13Q0
870.2400
87 Q 2500
870.2600
5. Study Title
Acute Oral TQxicitv
Acute dermal toxicity
Acute inhalation toxicity
Acute eye irritation
Acute dermal irritation
Skin sensitization
(26)
(27 .28)
(29)
(30)
(31 .32)
(33 .34)
Progress
Reports
6. Use
Pattern
A, B, C, D, E, F, G. H. I,
J. K. L. M. N, O
A, B. C, D, E, F, G, H, I.
J. K. I, M, N, O
A. B.C. D, E. F.G. H, (.
J. K, L. M, N. O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A. B, C. D. E. F, G. H, i.
J, K, L M. N.'O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
7. Test
Substance
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
8, Tim9
Frame
(Months)
9. Registrant
Response
Initial to indicate certification as to information on this page
Date
-------
rago i ot 3
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case ft and Name: 0062 Atrazine
PCI Number: PDCI-080803-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical
Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
Indoor nonfood use
Indoor medical use
Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Data must be provided in accordance with the "Product Composition" Section.(158.155)
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M-
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential N-
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O-
2 Data must be provided in accordance with the "Description of Materials used to Produce the Product" Section.(158.160)
3 Data must be provided in accordance with the "Description of Production Process" Section.(150.162)
4 Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
5 Data must be provided in accordance with the "Description of Formation of Impurities" Section(158.167)
6 Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
7 Required for TGAIs and products produced by an integrated system.
8 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
g Data must be provided in accordance with the "Certified Limits" Section(158.175)
10 Data must be provided in accordance with the "Enforcement Analytical Method" Section.(150.180)
11 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
12 If the TGAI cannot be Isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient Is either an acid, base or Ionic form, and It is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
13 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient Is either an acid, base or ionic form, and it is formulated Into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
14 Required If the product contains an oxidizing or reducing agent
15 Required when the product contains combustible liquids.
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DRAFT COPY
Page 2 of 3
United States Environmental Protection
Agency Washington, DC. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0062 Atrazine
PCI Number: ¦PDC1-08P803-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient, TGAI = Technical Grade Active Ingredient (TGAI); TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical
Grade Active Ingredient; TGAl/PAl = Technical Grade Active Ingredient, Pure Active Ingredient
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
15 Required when the product is potentially explosive,
17 Please see attached "Additional Information and Reauirements Pertaining to Storage Stability {OPPTS 830,6317) and Corrosion Characteristics (QPPTS 830,6320) Data Requirements of the
Product Specific Data Call-ins issued under the Roregistration Eligibility Decision {RED)/lnterirn Rereg;stration Eligibility Decision (IRED) Documents,"
18 Required if the product is an emu'sifiahle liquid and is to be diluted with petroleum solvents,
19 Please see attached "Additional information and Requirements Pertaining to Storage Stability [OPPTS 830,6317) and Corrosion Characteristics (OPPTS 830 6320) Data Reauirements of the
Product Specific Data Call-ins issued under the Rerecjistration Eligibility Decision (REQ)/lnterim Reregisfration Eligibility Decision (IRED) Documents."
?0 Required if the end-use product is a liquid and is to be used around electrical equipment.
21 If the TGA! cannot be isolated, data are requ;red on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in tnese products must be expressed in acid equivalent or active equivalent).
22 Required if the product is dispersible with water.
23 Required if the product is a liquid.
24 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
tbe concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
25 True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
26 Not required if test material is a gas or a highly volatile liquid,
27 Not required :f test material is a gas or a highly volatile liquid,
28 No' required it test material is corrosive to skin or has a pH of less than 2 or greater than 11,5,
29 Required if the product consists of, or under conditions of use will result in, a respirabie material (e.g., gas, vapor, aerosol, or particulate).
30 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11,5.
-------
-ityur JUIO
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0062 Atrazine
DCI Number: PDCI-080803-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/MP/EP - Manufacturing-Use Product, Pure Active Ingredient and Technical
Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Footnotes: [The following notes are referenced In column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form,]
31 Not required If test material Is a gas or a highly volatile liquid.
32 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11,5.
33 Not required if test material Is corrosive to skin or has a pH of less than 2 or greater than 11.5.
34 Required if repeated dermal exposure is likely to occur under conditions of use.
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name
0062,Atrazine
Co. Nr.
Company Name
Agent For
Address
City & State
Zip
100
SYNGENTA CROP PROTECTION,
INC.
PO Box 18300
GREENSBORO
NC 274198300
239
THE ORTHO BUSINESS GROUP
PO Box 190
MARYSVILLE
OH 43040
241
BASF CORPORATION
PO Box 13528
RESEARCH
TRIANGLE PARK
NC 277093528
264
BAYER CROPSCIENCE LP
2 T.W. ALEXANDER DRIVE
RESEARCH
TRIANGLE PARK
NC 27709
352
E. I. DU PONT DE NEMOURS AND
CO., INC.
PO Box 30 STINE-HASKELL RESEARCH CENTER
NEWARK
DE 197140030
524
MONSANTO COMPANY
MONSANTO CO
600 13TH STREET, NW SUITE 660
WASHINGTON
DC 20005
534
GROWMARK INC
1701 TOWANDAAVE
BLOOMINGTON
IL 61701
538
SCOTTS COMPANY, THE
14111 SCOTTSLAWN RD
MARYSVILLE
OH 43041
769
VALUE GARDENS SUPPLY, LLC
PO Box 585
ST. JOSEPH
MO 64502
829
SOUTHERN AGRICULTURAL
INSECTICIDES, INC
PO Box 218
PALMETTO
FL 34220
1381
AGRILIANCE, LLC
PO Box 64089
ST. PAUL
MN 551640089
1386
UNIVERSAL COOPERATIVES INC
1300 CORPORATE CENTER CURVE
EAGAN
MN 55121
2749
ACETO AGRICULTURE
CHEMICALS CORP
ONE HOLLOW LANE
LAKE SUCCESS
NY 110421215
5905
HELENA CHEMICAL CO
225 SCHILLING BOULEVARD, SUITE 300
COLLIERVILLE
TN 38017
7138
SOUTHERN STATES
COOPERATIVE, INC.
6606 WEST BROAD STREET
RICHMOND
VA 23230
7401
VOLUNTARY PURCHASING
GROUP INC
BRAZOS ASSOCIATES, INC.
1806 AUBURN DRIVE
CARROLLTON
TX 750071451
7969
BASF CORPORATION
PO Box 13528 26 DAVIS DRIVE
RESEARCH
TRIANGLE PARK
NC 277093528
8660
SYLORR PLANT CORP.
PO Box 142642
ST. LOUIS
MO 631140642
9198
THE ANDERSONS LAWN
FERTILIZER DIVISION, INC.
PO Box 119
MAUMEE
OH 43537
9404
SUNNILAND CORP
H.R. MCLANE, INC.
7210 RED ROAD, SUITE 206A
MIAMI
FL 33143
9779
AGRILIANCE, LLC
PO Box 64089
ST PAUL
MN 551640089
10404
LESCO INC
15885 SPRAGUE ROAD
STRONGSVILLE
OH 44136
11603
AGAN CHEM MFG, LTD
MAKHTESHIM-AGAN OF N AMERICA INC
551 FIFTH AVE, SUITE 1100
NEW YORK
NY 10176
11715
SPEER PRODUCTS INC
4242 B.F. GOODRICH BOULEVARD
MEMPHIS
TN 381810993
11773
VAN DIEST SUPPLY COMPANY
PO Box 610
WEBSTER CITY
IA 50595
19713
DREXEL CHEMICAL CO
PO Box 13327 1700 CHANNEL AVENUE
MEMPHIS
TN 381130327
-------
United States Environmental Protection
Agency Washington, D.C. 20460
USTOF ALL
REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case // and Name: 0062,Atrazine
Co. Nr.
Company Namo
Agent For
Address
City & State
Zip
33270
UNITED SUPPLIES INC.
PO Box 530
ELDORA
IA
50627
34704
LOVELAND PRODUCTS, INC.
PO Box 1286
GREELEY
CO
806321286
35512
HOWARD FERTILIZER &
CHEMICAL CO., INC
REGISTRATIONS BY DESIGN INC.
118 1/2 E MAIN STREET, SUITE 1
SALEM
VA
24153
35915
OXON ITALIA S. P. A.
SIPCAM AGRO USA, INC
300 COLONIAL PARKWAY, SUITE 230
ROSWELL
GA
30076
42750
ALBAUGH INC
ALBAUGH, INC
1910 EXETER, SUITE 1
GERMANTOWN
TN
38138
40273
MARMAN USA INC
NUFARM CO.
1333 BURR RIDGE PARKWAY #125A
BURR RIDGE
IL
60527
51036
MICRO-FLO COMPANY LLC
PO Box 772099
MEMPHIS
TN
381172099
53083
CONTROL SOLUTIONS, INC.
5903 GENOA-RED BLUFF
PASADENA
TX
775071041
55467
TENKOZINC
100 NORTH POINT CENTER EAST, STE 330
ALPHARETTA
GA
30022
59144
GRO TEC INC
REGWEST COMPANY
30856 ROCKY ROAD
GREELEY
CO
806319375
59639
VALENT U.S.A. CORPORATION
PO Box 8025 1600 RIVIERA AVENUE, SUITE 200
WALNUT CREEK
CA
94596
60063
SIPCAM AGRO USA, INC.
300 COLONIAL PARKWAY, SUITE 230
ROSWELL
GA
30076
62719
DOW AGROSCIENCES LLC
9330 ZIONSVILLE RD 308/2E225
INDIANAPOLIS
IN
462681054
66222
MAKHTESHIM-AGAN OF NORTH
AMERICA INC
551 FIFTH AVENUE - STE 1100
NEW YORK
NY
10176
70907
GHARDA USA, INC
IPM RESOURCES LLC
660 NEWTOWN-YARDLEY RD., SUITE 105
NEWTOWN
PA
18940
71368
NUFARM, INC.
1333 BURR RIDGE PARKWAY, SUITE 125A
BURR RIDGE
II.
60527
72155
BAYER ADVANCED,
95 CHESTNUT RIDGE ROAD
MONTVALE
NJ
07645
-------
Intentionally Blank Page
274
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Appendix G:
EPA'S BATCHING OF ATRAZ1NE PRODUCTS FOR MEETING ACUTE
TOXICITY DATA REQUIREMENTS FOR RE REGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products containing ATRAZINE as the
active ingredient, the Agency has batched products which can be considered similar for purposes
of acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicologica! studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only some
of the other registrants, or only their own products within a batch, or to generate all the required
acute toxicologica! studies for each of their own products. If a registrant chooses to generate the
data for a batch, lie/she must use one of the products within the batch as the test material. If a
registrant chooses to rely upon previously submitted acute toxicity data, he/she may do so
provided that the data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the
formulation has not been significantly altered since submission and acceptance of the acute
toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than one
confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's data,
he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing
an Existing Study (Option 6). If a registrant does not want to participate in a batch, the choices
are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to participate in a
batch does not preclude other registrants in the batch from citing his/her studies and offering to
cost share (Option 3) those studies.
275
-------
One hundred and thirty-five products were found which contain Atrazine as the active
ingredient. These products have been placed into fourteen batches and a "No Batch" category in
accordance with the active and inert ingredients and type ofl'ormulation. Furthermore, the
following bridging strategies are deemed acceptable for this chemical:
Batch 11: EPA Reg. No. 524-493 and 524-497 mav cite the data generated with EPA
Reg. No. 524-510.
Batch 13: Each product in this Batch should generate their own primary eye irritation
study utilizing the fertilizer with the highest levels of nitrogen.
Batch 14: Each product in this Batch should generate their own primary eye irritation
study utilizing the fertilizer with the highest levels of nitrogen.
No Batch: Each product in this Batch should generate their own data.
NOTE: The technical acute toxicity values included in this document are for informational
purposes only. The data supporting these values may or may not meet the current acceptance
criteria.
Batch 1
EPA Reg. No.
% Active Ingredient
100-529
98.00
11603-32
98.81
19713-7
97.00
19713-375
97.00
34704-784
97.00
35915-6
98.50
62719-456
97.60
Batch 2
EPA Reg. No.
% Active Ingredient
100-585
90.0
1381-159
90.0
1386-660
90.0
2749-485
90.0
5905-522
90.0
9779-253
90.1
11773-13
90.0
276
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Batch 2
EPA Reg. No.
% Active Ingredient
19713-76
90.0
19713-499
90.0
33270-9
90.0
34704-622
90.0
34704-689
90.0
35915-3
90.0
42750-53
90.0
55467-4
90.0
59639-106
90.0
62719-313
90.0
66222-37
90.0
Batch 3
EPA Reg. No.
% Active Ingredient
9779-254
80.0
34704-490
80.0
51036-9
80.0
51036-159
80.0
Batch 4
EPA Reg. No.
% Active Ingredient
19713-80
53.48
19713-291
53.48
Batch 5
EPA Reg. No.
% Active Ingredient
100-497
43.5
534-97
43.5
829-268
43.0
277
-------
Batch 5
EPA Reg. No.
% Active Ingredient
1381-158
43.0
1386-647
43.0
2749-336
43,0
5905-470
43.0
7401-318
43.0
9404-72
43.0
9779-255
43.0
11773-1
43.6
19713-11
43.0
19713-498
43.0
33270-10
43.5
34704-69
43.0
34704-690
43.0
35915-4
43.0
42750-44
43.0
42750-45
43.0
48273-11
43.5
51036-158
43,0
55467-5
43.5
62719-312
43.0
66222-36
43.6
Batch 6
EPA Reg. No.
% Active Ingredient
100-817
Alrazine: 33.7
S-Metolachlor: 26.1
100-886
Atrazinc: 33.7
S-Metolachlor; 26.1
278
-------
Batch 7
EPA Reg. No.
% Active Ingredient
352-600
Atrazine: 28.4
Dimethcnamid: 24.8
7969-146
Atrazine: 28.4
Dimethenamid: 24.8
Batch 8
EPA Reg. No.
% Active Ingredient
7969-136
Atrazine: 22.23
Dicamba K Salt: 13.42
42750-41
Atrazine: 22.23
Dicamba K Salt: 13.42
51036-307
Atrazine: 22.23
Dicamba K Salt: 13.42
70907-16
Atrazine: 21.92
Dicamba K Salt: 13.45
Batch 9
EPA Reg. No.
% Active Ingredient
264-477
Atrazine: 21.62
Bromoxynil Octanoate: 15.74
9779-348
Atrazine: 21.62
Bromoxynil Octanoate: 15.74
51036-255
Atrazine: 21.62
Bromoxynil Octanoate: 15.74
71368-27
Atrazine: 21.62
Bromoxynil Octanoate: 15.74
279
-------
Batch 10
EPA Reg. No.
% Active Ingredient
5 i 036-363
Atrazine: 25.0
Bentazon: 27.0
60063-18
Atrazine: 25.0
Bentazon: 27.0
Batch 11
EPA Reg. No.
% Active Ingredient
524-493
Atrazine: 16.1
Acctochlor: 21.5
Glyphosate: 8.1
524-497
Atrazine: 16.2
Acetochlor: 21.6
Glyphosate: 8.2
524-510
Atrazine: 15.9
Acetochlor: 21.2
Glyphosate: 15.9
Batch 12
EPA Reg. No.
% Active Ingredient
19713-513
Atrazine; 16,6
Acetochlor: 24.8
62719-371
Atrazine: 16.6
Acetochlor: 24.8
Batch 13
EPA Reg. No.
% Active Ingredient
538-18
1.055
538-163
0.600
538-229
1.320
280
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Batch 13
EPA Reg. No.
% Active Ingredient
538-234
0.600
9198-186
1.110
Batch 14
EPA Reg. No.
% Active Ingredient
769-943
0.92
7138-14
0.90
7401-336
cn
00
o
8660-12
1.16
8660-18
1.18
8660-32
0.58
8660-41
0.92
8660-187
0.63
8660-204
0.92
8660-223
1.05
8660-224
0.91
8660-245
0.42
9198-153
0.92
9404-51
0.92
9404-55
0.79
9404-56
1.50
9404-80
0.57
9404-81
1.28
9404-82
1.15
9779-359
0.92
9779-360
0.80
10404-39
0.80
10404-94
1.05
10404-95
0.45
-------
Batch 14
EPA Reg. No.
% Active Ingredient
10404-96
0.92
34704-822
0.92
35512-14
0.80
35512-34
0.57
35512-41
1.22
35512-42
0.44
35512-46
0.92
- 59144-32
1.16
No Batch
EPA Reg. No.
% Active Ingredient
100-827
Atrazine: 28.7
S-Metolaehbr: 35.8
100-928
Atrazine; 23.3
Fluinetsulam: 1.0
S-Metolachlor: 29.1
100-956
Atrazine: 74.93
Prosulfuron: 1.78
100-962
Atrazine; 25.7
Glyphosate: 18.0
239-2618
14.0
241-353
Atrazine: 32.54
Imazethapyr: 4.36
264-573
Atrazine: 43.2
Isoxaflutolc: 3.2
264-668
Atrazine: 33.42
Glufosinate-ammonium: 10.00
270-288
23.6
352-585
Atrazine: 86.78
Nicosulfuron: 1.34
Rimsulfuron: 1.34
282
-------
No Batch
EPA Reg, No.
% Active Ingredient j
524-329
Atrazine: 16,3
Alachlor: 27.2
524-418
Atrazine: 15.3
Alachlor: 27.05
524-480
Atrazine: 18.3
Acetoc'nlor: 46.3
524-485
Atrazine: 26.9
Acetochlor: 33.4
524-509
Atrazine: 20.9
Glvphosate: 20.9
524-511
Atrazine: 14.5
Acetochlor. 29.0
3125-523
Atrazine: 50.5
Fiufenacet: 19.6
Metribuzm: 4.9
7969-192
Atrazine: 35.3
Dimethenamid-P: 18.2
7969-200
Atrazine: 29.5 |
Dimethenamid-P: 24. f !
19713-6
80.0
19713-171
Atrazine: 21.42
Simazine: 21.41
34704-728
Atrazine: 25.00
2.4-D: 16.58
42750-50
Atrazine: 21.62
Bromoxvnil: 15.74
62719-368
Atrazine: 21.1
Acetochlor: 31.6
-------
Intentionally Blank Page
284
-------
Appendix II:
ATRAZINE MONITORED WATERSHEDS
LAI047002 Iberville Water Works District #3 Louisiana
MO 1010204 Dearborn Missouri
IL1170400 Gillespie Illinois
KY0280267 Marion Water Department Kentucky
KY0710247 Lewisburg Water Works Kentucky
IA5903011 Chariton Municipal Water Works Iowa
M020i0*il2 Bucklin Missouri
IN5299001 Batesville Water Utility Indiana
285
-------
Intentionally Blank Page
286
-------
Appendix I: LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS
Pesticide Registration Forms arc available at the following EPA internet site:
htto .// www.e ca. gov/ o pardQQ i /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 atvvilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
Application for Pesticide
Registration''Amendment
http://www.eDa.aov/oDDrd001/fonns/8570-l .Ddf.
8570-4
Confidential Statement of
Formula
htto://www.epa.Gov/oDDrdOO 1 /forms/8570-4.Ddf.
8570-5
Notice of Supplemental
Registration of Distribution of a
Registered Pesticide Product
httD://www.eDa.eov/oDordOO 1 /forms/8570-5.Ddf.
8570-17
Application for an Experimental
Use Permit
httD://www.epa.eov/oDnrd001/forms/S570-17.DcLf.
287
-------
8570-25
Application for/Notification of
State Registration of a Pesticide
To Meet a Special Local Need
http://www.eoa. eov/opprdOO 1 /forms/8 5 70-25.ndf.
8570-27
Formulator's Exemption
Statement
httD://www.epa.eov/oDprd001/forms/8570-27.Ddf.
8570-28
Certification of Compliance with
Data Gap Procedures
httr://www.epa.Gov/oDprd001 /forms/8570-28.odf.
8570-30
Pesticide Registration
Maintenance Fee Filing
http://www.epa.gov/opprd001/forms/8570-30.pdf
8570-32
Certification of Attempt to Enter
into an Agreement with other
Registrants for Development of
Data
http://www.epa.Bov/opprd001/forms/8570-32.pdf.
8570-34
Certification with Respect to
Citations of Data (in PR Notice
98-5)
http://www.eDa.cov/ooDDmsdl/PR Notices/nr98-5.
pdf.
8570-35
Data Matrix (in PR Notice 98-5)
http://www.epa.gov/opppmsd 1/PR Notices/pr98-5.
Pdf.
8570-36
Summary of the
Physical/Chemical Properties (in
PR Notice 98-1)
http://www.epa.eov/opppmsd 1 /PR Notices/or98-1.
pdf.
8570-37
Self-Certification Statement for
the Physical/Chemical Properties
(in PR Notice 98-1)
htio://www.eDa.cov/oDDDinsd 1 'PR Notices/or98-1.
pdf.
Pesticide Registration Kit www. ena. govpest i ci des/re g i s tr ati n nk i t /.
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended bv 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
288
-------
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chcmigation)
e. 87-6 Inert Ingredients in Pesticide Products Poiicv Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-i Self Certification of Product Chemistry Data with Attachments ( This
document is in PDF format ana requires the Acrobat reader.)
Other PR Notices can be found at http:/AYWw.epa.&Qv/opi3prnsd 1 ''PR Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF formal 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. Diopesticides and Pollution Prevention Division (RPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952. Pesticide Registration Procedures; Pesticide Data Reuuirements
(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' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the
United States", PB92-221811. available through die National Technical Information
Sen-ice ("NTIS) at the following address;
289
-------
National Technical Information Service (NTTS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NT1S is (703) 605-6000. Please note that EPA is currently
in the process of updating this booklet to reflect the changes in the registration
program resulting from the passage of the FQPA and the reorganization of the Office
of Pesticide Programs. We anticipate that this publication will become available during
the Fall of 1998.
3. The National Pesticide Information Retrieval System (NP1RS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service docs
charge a fee for subscriptions and custom searches. You can contact NPIRS by
telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides. You
can contact NPTN by telephone at (800) 858-7378 or through their Web site:
ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or
petitioner encloses with his submission a stamped, self-addressed postcard. The
postcard must contain the following entries to be completed by OPP:
Date of receipt
EPA identifying number
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 andproviae 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 "blinH" codes used when a sample was submitted for testing by
commercial or academic facilities). Please provide a CAS number if one has been
assigned.
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