SEPA
United States Prevention, Pesticides EPA 738-R-05-002
Environmental Protection and Toxic Substances June 2005
Agency (7508C)
Reregistration
Eligibility Decision for
2,4-D
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Reregistration Eligibility Decision
for
2,4-D
List A
Case 0073
Approved By:
Debra Edwards, Ph.D.
Director, Special Review and
Reregistration Division
Date
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Table of Contents
Glossary of Terms and Abbreviations
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2,4-D Reregistration Eligibility Decision Team x
Executive Summary xi
I. Introduction 1
n. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 4
C. Use Profile 8
D. Estimated Usage of Pesticide 9
HI. Summary of 2,4-D Risk Assessment 15
A. Human Health Risk Assessment 15
1. Toxicity of 2,4-D 15
a. Toxicity Profile 15
b. Safety and Database Uncertainty Factors 18
c. Carcinogenicity 19
d. Cumulative Assessment 20
e. Endocrine Effects 20
2. Dietary Exposure and Risk from Food 23
a. Exposure Assumptions 23
b. Population Adjusted Dose 24
c. Food Risk Estimates 24
3. Dietary Exposure and Risk from Drinking Water 24
a. Surface Water 25
b. Ground Water 26
c. EDWCs Selected for Risk Assessment 27
4. Residential and Other Non-occupational Exposure 27
a. Toxicity 28
b. Residential Handler 29
1) Exposure Scenarios, Data, and Assumptions 29
2) Residential Handler Risk Estimates 31
31
c. Residential Postapplication Risk 32
1) Exposure Scenarios, Data, and Assumptions 32
2) Postapplication Risk Estimates 33
d. Recreational Swimmer Risk 34
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1) Exposure Scenarios, Data, and Assumptions 35
2) Recreational Swimmer Risk Estimates 36
5. Aggregate Exposure and Risk 38
a. Acute Aggregate Risk Assessment 38
b. Chronic Aggregate Risk Assessment 40
c. Short-term Aggregate Risk Assessments 41
d. Cancer Aggregate Risk 42
e. Aggregate Risk Characterization 42
6. Occupational Risk 43
a. Occupational Toxicity 43
b. Occupational Handler Exposure 44
c. Occupational Handler Risk Summary 45
d. Occupational Postapplication Risk 50
1) Exposure Scenarios, Data, and Assumptions 50
2) Occupational Postapplication Risk Estimates 51
7. Human Incident Data 52
8. Cancer Epidemiology Studies 52
B. Environmental Risk Assessment 53
1. Environmental Exposure 53
a. Environmental Fate and Transport 53
b. Aquatic Organism Exposure 55
1) Exposure to 2,4-D Acid in Surface Water 56
2) Surface Water Modeling of 2,4-D Esters 56
3) Modeling of Direct Application of 2,4-D for Control of Aquatic Weeds .... 56
4) Modeling of 2,4-D Use on Rice 57
c. Terrestrial Organism Exposure 57
1) Birds and Mammals 58
a) Exposure to Nongranular (Liquid) Formulations 58
b) Exposure to Granular Formulations 58
2) Non-target Terrestrial Plants 58
2. Environmental Effects (Toxicity) 59
a. Toxicity to Aquatic Organisms 59
b. Toxicity to Terrestrial Organisms 61
3. Ecological Risk Estimation (RQs) 62
a. Risk to Aquatic Organisms 63
1) Fish and Aquatic Invertebrates 63
2) Aquatic Plants 64
b. Risk to Non-target Terrestrial Organisms 65
1) Birds 65
2) Mammals 67
3) Non-Target Insects 69
4) Non-target Terrestrial Plants 69
4. Ecological Incidents 72
5. Endangered Species Concerns 72
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6. Risk Characterization 74
a. Characterization of risk to aquatic organisms from direct aquatic application . . 74
b. Characterization of risk to mammals from terrestrial use 75
c. Characterization of risk to birds from terrestrial use 76
d. Characterization of risk to non-target plants from terrestrial use 77
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 79
A. Determination of Reregistration Eligibility 79
B. Public Comments and Responses 79
C. Regulatory Position 80
1. Food Quality Protection Act Findings 80
a. "Risk Cup" Determination 80
b. Determination of Safety to U.S. Population 80
2. Endocrine Disrupter Effects 81
3. Cumulative Risks 81
4. Special Review Disposition 82
5. Dioxin Contaminants 82
D. Tolerance Reassessment Summary 84
1. Tolerances Currently Listed Under 40 CFR §180.142 84
2. Tolerances to Be Proposed Under 40 CFR §180.142 89
3. Codex Harmonization 97
4. Residue Analytical Methods - Plants and Livestock (GLN 860.1340) 97
E. Regulatory Rationale 98
1. Human Health Risk Management 98
a. Residential Risk 98
1) Residential risk summary 98
2) Residential Post-application Mitigation 99
3) Residential Swimmer Mitigation 99
b. Aggregate Risk 100
1) Aggregate Risk Summary 100
2) Acute Aggregate Risk 100
3) Short-term Aggregate Risk 101
4) Chronic (Non-Cancer) Aggregate Risk 101
5) Aggregate Risk Mitigation 102
c. Occupational Risk Mitigation 102
1) Handler Risk Mitigation 102
2) Post-application Risk Mitigation 102
2. Environmental Risk Mitigation 103
a. Birds 103
b. Mammals 104
c. Aquatic Organisms 105
d. Non-target Insects 106
e. Non-target Terrestrial Plants 106
f Summary of Environmental Risk Mitigation 106
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F. Other Labeling Requirements 106
1. Endangered Species Considerations 106
2. Spray Drift Management 107
3. Consumer Labeling Initiative 107
V. What Registrants Need To Do 108
A. Manufacturing Use Products 109
1. Additional Generic Data Requirements 109
B. End-Use Products Ill
1. Additional Product-Specific Data Requirements Ill
2. Labeling for End-Use Products Ill
C. Existing Stocks Ill
D. Required Labeling Changes Summary Table 113
VI. Appendicies 153
Appendix A. Table of 2,4-D Use Patterns Eligible for Reregistration (Case 0073) 154
Appendix B. Data Supporting Guideline Requirements for the Reregistration of 2,4-D ... 169
Appendix C. Technical Support Documents 184
Appendix D. Citations Considered to be Part of the Data Base Supporting the Reregistration
Eligibility Decision (Bibliography) for 2,4-D 187
Appendix E. Generic Data Call-In 292
Appendix F. Product Specific Data Call-In 294
Appendix G. EPA's Batching of 2,4-D Products for Meeting Acute Toxicity Data
Requirements for Reregistration 296
Appendix H. List of Registrants Sent This Data Call-In 298
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Glossary of Terms and Abbreviations
A Acre
AGDCI Agricultural Data Call-In
ae Acid Equivalent
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
BCF Bioconcentration Factor
CFR Code of Federal Regulations
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CSFn USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disruption Screening Program
EDWC Estimated Drinking Water Concentration
EEC Estimated Environmental Concentration
EPA Environmental Protection Agency
EUP End-Use Product
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLN Guideline Number
HAFT Highest Average Field Trial
HAT Hour After Treatment
IR Index Reservoir
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that
can be expected to cause death in 50% of test animals. It is usually expressed as the
weight of substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or
ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause
death in 50% of the test animals when administered by the route indicated (oral,
dermal, inhalation). It is expressed as a weight of substance per unit weight of animal,
e.g., mg/kg.
LOC Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
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MATC Maximum Acceptable Toxicant Concentration
|ig/g Micrograms Per Gram
|ig/L Micrograms Per Liter
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MRID Master Record Identification (number). EPA's system of recording and tracking
studies submitted
MSWC Maximum Swimming Water Concentration
MUP Manufacturing-Use Product
NA Not Applicable
NAWQA USGS National Water Quality Assessment
NCOD National Drinking Water Contaminant Occurrence Database
NPDES National Pollutant Discharge Elimination System
NR Not Required
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDIC Product-Specific Data Call-In
POP USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRZM/
EXAMS Tier II Surface Water Computer Model
Ql * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RAC Raw Agriculture Commodity
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
SCI-GROW Tier I Ground Water Computer Model
SAP Science Advisory Panel
SF Safety Factor
SLC Single Layer Clothing
SLN Special Local Need (Registrations Under Section 24(c)) of FIFRA)
STORET Storage and Retrieval Environmental Data System
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TGAI Technical Grade Active Ingredient
TRR Total Radioactive Residue
TWAM Time Weighted Annual Mean
USDA United States Department of Agriculture
USGS United States Geological Survey
UF Uncertainty Factor
UV Ultraviolet
WPS Worker Protection Standard
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2,4-D Reregistration Eligibility Decision Team
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Elisa Rim
Rafael Prieto
Steve Jarboe
Tim Kiely
Environmental Fate and Effects Risk Assessment
Mark Corbin
Bill Evans
James Hetrick
Sid Abel
Health Effects Risk Assessment
Bill Hazel
Timothy Dole
Linda Taylor
Felecia Fort
Toiya Jimerson
Michael Metzger
Whang Phang
Risk Management
Katie Hall
Mark Seaton
Moana Appleyard
Tom Myers
Margaret Rice
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Executive Summary
EPA has completed its review of public comments on the preliminary risk assessments and is
issuing its risk management decision for 2,4-D. The revised risk assessments are based on review of
the required target data base supporting the use patterns of the currently registered products and
additional information received from the 2,4-D Task Force IE. After considering the risks identified
in the revised risk assessment and comments and mitigation suggestions from interested parties, EPA
developed its risk management decision for uses of 2,4-D that pose risks of concern. The decision is
discussed fully in this document.
2,4-D is an herbicide in the phenoxy or phenoxyacetic acid family that is used post-emergence
for selective control of broadleaf weeds. 2,4-D is registered for use on a variety of food/feed sites
including field, fruit, and vegetable crops. 2,4-D is also registered for use on turf, lawns, rights-of-
way, aquatic and forestry applications. Residential homeowners may use 2,4-D on lawns.
Based primarily on pesticide usage information from 1992 through 2000 for agriculture and
1993 through 1999 for non-agriculture, total annual domestic usage of 2,4-D is approximately 46
million pounds, with 30 million pounds (66%) used for agriculture and 16 million pounds (34%) used
for non-agriculture. In terms of pounds, total 2,4-D usage is allocated mainly to pasture/rangeland
(24%), lawn by homeowners with fertilizer (12%), spring wheat (8%), winter wheat (7%),
lawn/garden by lawn care operators/landscape maintenance contractors (7%), lawn by homeowners
alone (without fertilizer) (6%), field corn (6%), soybeans (4%), summer fallow (3%), hay other than
alfalfa (3%) and roadways (3%). Agricultural sites with at least 10% of U.S. acreage treated include
spring wheat (51%), filberts (49%), sugarcane (36%), barley (36%), seed crops (29%), apples (20%),
rye (16%), winter wheat (15%), cherries (15%), oats (15%), millet (15%), rice (13%), soybeans
(12%), and pears (10%). For 2,4-D, rates per application and rates per year are generally less than
1.50 pounds acid equivalent (a.e.) per acre and 2.00 pounds a.e. per acre (Ibs ae/A), respectively. 2,4-
D is used predominantly in the Midwest, Great Plains, and Northwestern United States.
The Food Quality Protection Act (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." Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA has not made a common mechanism of
toxicity finding as to 2,4-D and any other substances. For the purposes of this tolerance action,
therefore, EPA has not assumed that 2,4-D has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA's Office of Pesticide Programs (OPP) concerning common mechanism
determinations and procedures for cumulating effects from substances found to have a common
mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
Dietary Risk
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Acute and chronic dietary exposures for food and drinking water do not exceed the Agency's
level of concern; therefore, no mitigation is warranted at this time for any dietary exposure to 2,4-D.
The maximum contaminant level (MCL) established by EPA's Office of Water (OW) for 2,4-D
is 70 micrograms/liter (ug/1; ppb). Further, it is important to note that an MCL is an enforceable limit
under the Safe Drinking Water Act (SDWA). To minimize the possibility that aquatic applications
will result in drinking water concentrations in excess of the MCL, registrants and the Agency have
developed label language for the direct aquatic use of 2,4-D to control aquatic weeds.
Residential Risk
Potential exposures are anticipated as a result of homeowner and commercial applications in
residential areas. Applications can be made to lawns. In addition to residential areas, there are also
potential postapplication exposure scenarios that may occur in public areas such as parks, recreational
areas, and golf courses. The Agency evaluated 2,4-D exposures to residential handlers during
mixing, loading and application to turf/ornamentals and 2,4-D postapplication exposure to residues by
adults and children on treated turf.
In preliminary versions of the risk assessment, when considered alone, acute and short-term
residential risks posed by the use of 2,4-D were not of concern to the Agency; however, when
considered as part of an aggregate exposure with food and drinking water, exposures did exceed the
Agency's level of concern. As a result, 2,4-D registrants agreed to reduce the maximum application
rate to turf and residential lawns from 2.0 Ibs ae/A to 1.5 Ibs ae/A. Chronic residential exposures to
2,4-D are not expected due to its use pattern.
Aggregate Risk
An aggregate risk assessment looks at the combined risk from dietary exposure (food and
drinking water pathways), as well as exposures from non-occupational sources (e.g., residential uses).
In the preliminary and revised risk assessments, the estimated acute and short-term exposures
exceeded the Agency's level of concern. As a result, 2,4-D registrants agreed to reduce the maximum
application rate to turf and residential lawns from 2.0 pounds acid equivalent per acre (Ibs ae/A) to
1.5 Ibs ae/A. The current risk assessment considers exposures from the reduced application rate for
residential turf.
Two methods of aggregate risk calculations were employed in assessing the aggregate risk of
2,4-D. The first method is the drinking water level of concern (DWLOC) method. OPP (Office of
Pesticide Programs) has traditionally compared estimates of concentrations of a pesticide in drinking
water to DWLOCs. A DWLOC is the portion of the acute population adjusted dose (aPAD) or
chronic population adjusted dose (cPAD) remaining after estimated dietary (food only) exposures
have been subtracted and the remaining exposure has been converted to a concentration (ug/liter or
ppb). This concentration value (DWLOC) represents the available or allowable exposure through
drinking water. The second method is the forward calculation method. In this approach, food,
drinking water, and residential exposures are aggregated and compared to an appropriate endpoint. A
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population adjusted dose, or PAD, is the reference dose (RfD) adjusted for the FQPA safety factor. A
risk estimate that is less than 100% of the acute PAD (aPAD), the dose at which an individual could
be exposed over the course of a single day and no adverse health effects would be expected, does not
exceed EPA's level of concern. Likewise, risk estimate that is less than 100% of the chronic PAD
(cPAD), the dose at which an individual could be exposed over the course of a lifetime and no
adverse health effects would be expected, does not exceed EPA's level of concern.
In the case of 2,4-D, the DWLOCs were calculated for comparison to the MCL established by
the EPA Office of Water and aggregate risks were calculated using the forward calculation approach
for comparison to the appropriate endpoint. The respective DWLOCs and aggregate risks are shown
for acute, chronic and short term exposures in the following sections.
Acute aggregate risk. The acute aggregate risk assessments address exposure to 2,4-D
residues in food and water using both the DWLOC and forward calculation approach. Acute
residential exposures from swimming in treated water bodies or playing on treated turf were not
included because exposures are unlikely to co-occur with acute dietary exposures. The acute
DWLOCs are 432 ppb or greater with the most sensitive population being females 13-49 years old.
The estimated drinking water concentrations (EDWCs) of 118 ug/liter for surface water and 15
ug/liter for groundwater are substantially less than the DWLOCs which means that the risks are not of
concern.
Acute aggregate risks were also assessed by aggregating acute food exposures and acute water
exposures using Lifeline. The acute aggregate risks are not of concern because they are less than 100
percent of the aPAD. The highest risks (58 percent of the aPAD) are for females 13-49 years old
because these risks are based upon the lower no-observed adverse effect level (NOAEL) of 25
mg/kg/day from a developmental study in rats.
Short-term aggregate risk. Short term aggregate risk assessments were conducted by
calculating DWLOCs based upon short term turf exposures, chronic food exposures and short term
endpoints. Short term exposures from swimming in treated water bodies were not included because
these exposures represent high-end unlikely scenarios. The short term DWLOCs were calculated
only for females 13-49 and children 1-6 because these population subgroups have the highest
exposure and are protective of the other subgroups. The DWLOCS range from 24 to 54 ug/liter.
These DWLOCs are all greater than the EDWCs, which range from 15 to 23 ug/liter, and indicate that
short term risks are not of concern.
Short term aggregate risks were also assessed by aggregating short term turf exposures, chronic
food exposures and chronic water exposures using the forward calculation approach. Short term
aggregate risks were calculated only for females 13-49 and children 1-6 because these population
subgroups have the highest exposure and are protective of the other subgroups. The short term
aggregate margins of exposure (MOEs) indicate that the short term risks are not of concern because
the MOEs equal or exceed the target MOE of 1000.
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Chronic (non-cancer) aggregate risk. Chronic DWLOCs were calculated based upon chronic
dietary exposures. As there are no chronic residential exposures, residential exposures were not
included in the chronic DWLOC calculations. The chronic DWLOCs are 47 ug/liter or greater with
the most sensitive populations being infants and children. The EDWCs, which range from 1.5 to 23
ug/liter, are less than the DWLOCs which means that the risks are not of concern. It should be noted
that the master label indicates that potable water consumption from a treated water body cannot begin
until the 2,4-D concentration is 70 ug/liter or below, therefore an annual average exposure at the
MCL of 70 ug/liter would not occur because dissipation would reduce the initial concentration of 70
ug/liter to an annual average concentration of 11 ug/liter.
Chronic aggregate risks were also assessed by aggregating chronic food exposures and chronic
water exposures using the forward calculation approach. The chronic aggregate risks are presented as
percent cPAD are not of concern because they are less than 100 percent of the cPAD. The highest
risks (38 percent of the cPAD) are for children 1-2 years old.
Occupational Risk
Based on current use patterns, occupational handlers (mixers, loaders, and applicators) may be
exposed to 2,4-D during and after normal use. The Agency identified 18 handler scenarios resulting
from mixing/loading and applying 2,4-D for crop and non-crop uses. For the occupational use of 2,4-
D, EPA is concerned about any Margin of Exposure (MOE) less than 100, which incorporates
uncertainty factors of lOx for interspecies variation and lOx for intraspecies variation.
With the exception of mixing/loading wettable powder, all of the short-term and intermediate-
term MOEs exceed the target of 100 with baseline personal protective equipment (PPE) (i.e., long-
sleeved shirt, long pants, shoes plus socks, no respirator) or single layer PPE (i.e., long-sleeved shirt,
long pants, shoes plus socks, gloves, no respirator) and are not of concern. The MOEs for handling
wettable powder are above 100 with engineering controls (i.e., water soluble bags).
Ecological Risk
Fish and Aquatic Invertebrates: Estimated risk quotients (RQs) from use of 2,4-D acid and
amine salts in aquatic weed control through direct subsurface application to water bodies exceed the
restricted use LOCs for freshwater invertebrates. There are no chronic LOG exceedances for this use.
Estimated RQs from use of 2,4-D BEE in weed control through direct subsurface application to water
bodies exceed the acute risk level of concern (LOG) for freshwater fish and invertebrates and chronic
risk LOG for freshwater and estuarine fish and freshwater invertebrates when compared on an acid
equivalent basis. Estimated RQs from use of 2,4-D acid and amine salts in rice paddies exceed the
acute endangered species LOCs for freshwater invertebrates.
Non-Target Aquatic Plants: For non-target aquatic plants, estimated RQs from the runoff/drift
of 2,4-D acid and amine salts from use on terrestrial crops exceed the aquatic vascular plant
endangered species LOCs for use of 2,4-D acid and amine salts on pasture and apples. Consideration
of average application rates and assuming a proportional reduction in EECs results in RQs below the
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endangered species LOG. Likewise, there are no LOG exceedances from the drift of the ester forms
to aquatic water bodies or from the runoff of the ester forms to water bodies from use on terrestrial
sites.
Estimated RQs for the scenario of direct application to water for aquatic weed control for 2,4-D
acid and amine salts exceed the acute and endangered species LOCs for aquatic vascular and acute
the LOG for non-vascular plants, while estimated RQs from use of 2,4-D BEE (the only ester
registered for aquatic weed control) for direct application to water for weed control exceed all LOCs
for vascular and the acute LOG for non-vascular plants.
Estimated RQs for use of 2,4-D acid and amine salts in rice paddies exceed the acute and
endangered species LOCs for aquatic vascular plants. Consideration of average application rates
results in RQs below the endangered species LOCs.
Birds: For non-granular spray applications of 2,4-D acid, amine salts, and esters, estimated RQs
exceed acute LOCs for most crop scenarios for short grass, tall grass, and broadleaf forage exposures.
For birds that eat fruit and large insects, acute endangered LOCs are exceeded for non-cropland,
forest, and cranberry scenarios. Chronic LOCs are exceeded for birds that forage on short grass when
the application rate of 2,4-D ranges from 2.0 to 4.0 Ibs ae/A such as with non-cropland areas,
cranberries, or asparagus. For granular broadcast applications, acute LOCs are exceeded for several
different crop scenarios and bird weights. The chronic LOC is not exceeded for granular broadcast
applications.
Mammals: For non-granular formulations of 2,4-D, estimated RQs exceed acute LOCs for
mammals feeding on plants and insects for all uses assessed for small and medium size mammals,
except potatoes and citrus. There were no exceedances for granivores exposed to non-granular
formulations of 2,4-D. LOCs for acute exposure to granular 2,4-D products are exceeded for all sites
with the following exceptions: 1000 g mammals in turf, aquatic areas, and cranberries. Mammalian
chronic RQs range from 0.05 to 200 and chronic LOCs were exceeded in all cases with the exception
of potatoes and citrus (large insects, seeds). Consideration of average application rates results in
acute RQs below the LOCs for non-granular and granular applications. However, consideration of
average application rates for non-granular and granular applications did not result in RQs below the
chronic LOC.
Insects: Since study results show that 2,4-D DMAS and 2,4-D EHE are practically non-toxic to
honey bees, the potential for 2,4-D and its salts and esters is predicted to pose minimal risk to
pollinators and other beneficial insects.
Non-Target Terrestrial Plants: Estimated RQs exceed acute LOCs for both non-endangered
and endangered plants for non-granular and granular uses at many use sites. Consideration of average
application rates did not result in RQs below LOCs.
In summary, some ecological risks are of concern on some sites for some species. The
Agency's characterization of its assessment of ecological risk is provided in section m.B.3 of this
document. The mitigation measures of (1) reducing maximum application rates, and (2) specifying a
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required spray droplet size of "Medium to Coarse" or coarser (i.e., prohibiting "fine" sprays) are
expected to lessen, but not eliminate, the risk of 2,4-D to wildlife and plants.
Summary of Mitigation Measures
EPA has determined that 2,4-D is eligible for reregistration provided the mitigation outlined in
this document is implemented.
Dietary Risk
• Acute and chronic dietary exposures for food and drinking water do not exceed the Agency's
level of concern; therefore, no mitigation is warranted at this time for any dietary exposure to
2,4-D.
Residential Risk
• Maximum turf rate is reduced from 2.0 Ibs ae/A to 1.5 Ibs ae/A.
• At the agreed-upon maximum application rate of 1.5 Ibs ae/A for residential turf, acute and
short-term residential risks posed by the use of 2,4-D are not of concern to the Agency. Due to
its use pattern, chronic residential exposures to 2,4-D are not expected.
Occupational Risk
Risks from handling wettable-powder products will be mitigated by requiring wettable powder
products to be packaged in water-soluble packaging.
• Personal protective equipment (PPE) prescribed in the exposure reduction plan set forth in 1992
will be replaced with the PPE requirements outlined in this document.
Ecological Risk
The measures to control spray drift are expected to reduce the risk of 2,4-D to non-target plants.
• Maximum turf rate is reduced from 2.0 Ibs ae/A to 1.5 Ibs ae/A.
Implementation of the application rates set forth in the Master Label will reduce rates (as
compared to current rates on existing labels) for field corn, popcorn, sweet corn, small grains,
fallowland/stubble, non-cropland, turf, aquatic applications (surface), pasture, and soybean.
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to November 1, 1984.
The amended Act calls for the development and submission of data to support the reregistration of an
active ingredient, as well as a review of all submitted data by the U.S. Environmental Protection
Agency (referred to as EPA or "the Agency"). Reregistration involves a thorough review of the
scientific database underlying a pesticide's registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently registered uses of the pesticide; to determine
the need for additional data on health and environmental effects; and to determine whether or not the
pesticide meets the "no unreasonable adverse effects" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law. This
Act amends FIFRA and the Federal Food Drug and Cosmetic Act (FFDCA) to require reassessment
of all existing tolerances for pesticides in food. FQPA also requires EPA to review all tolerances in
effect on August 3, 1996 by August 3, 2006. In reassessing these tolerances, the Agency must
consider, among other things, aggregate risks from non-occupational sources of pesticide exposure,
whether there is increased susceptibility to infants and children, and the cumulative effects of
pesticides with a common mechanism of toxicity. When a safely finding has been made that
aggregate risks are not of concern and the Agency concludes that there is a reasonable certainty of no
harm from aggregate exposure, the tolerances are considered reassessed. EPA decided that, for those
chemicals that have tolerances and are undergoing reregistration, tolerance reassessment will be
accomplished through the reregistration process.
As mentioned above, FQPA requires EPA to consider "available information" concerning the
cumulative effects of a particular pesticide's residues and "other substances that have a common
mechanism of toxicity" when considering whether to establish, modify, or revoke a tolerance.
Potential cumulative effects of chemicals with a common mechanism of toxicity are considered
because low-level exposures to multiple chemicals causing a common toxic effect by a common
mechanism could lead to the same adverse health effect as would a higher level of exposure to any
one of these individual chemicals. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by the EPA's Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects from substances found to
have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
Unlike other pesticides for which EPA has considered cumulative risk based on a common
mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for 2,4-
dichlorophenoxyacetic acid (2,4-D). Therefore, for the purposes of tolerance reassessment and a
decision on reregistration eligibility, EPA is assuming that 2,4-D does not share a common
mechanism of toxicity with other compounds. In the future, if information suggests 2,4-D shares a
common mechanism of toxicity with other compounds, additional testing may be required and a
cumulative assessment may be necessary.
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This document presents summaries of EPA's revised human health and ecological risk
assessments, tolerance reregistration decision, and the reregistration eligibility decision for 2,4-D.
The document consists of six sections. Section I contains the regulatory framework for
reregistration/tolerance reassessment. Section II provides a profile of the use and usage of the
chemical. Section in gives an overview of the revised human health and environmental effects risk
assessments based on data, public comments, and other information received in response to the
preliminary risk assessments. Section IV presents the Agency's reregistration eligibility and risk
management decisions. Section V summarizes label changes necessary to implement the risk
mitigation measures outlined in Section IV. Finally, the Appendices list related information,
supporting documents. The preliminary and revised risk assessments for 2,4-D are available in the
Public Docket, under docket number OPP-2004-0167 and on the Agency's web page,
http: //www. epa. gov/edockets.
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n. Chemical Overview
A. Regulatory History
2,4-D has been used as an herbicide since the mid-1940s. Currently over 600 end-use products
are registered for use on over 300 distinct agricultural and residential sites, and there are over 100
tolerances for 2,4-D listed in the Code of Federal Regulations. 2,4-D was the subject of a
Registration Standard and a Registration Standard Guidance Document dated February 16, 1988 and
September 9, 1988, respectively. These documents summarized the regulatory conclusions based on
available data, and specified the additional data required for reregistration purposes. Numerous data
submissions have been received and evaluated since the Registration Standard Guidance Document
was published.
Special Review
2,4-D has been in pre-Special Review status since September 22, 1986, because of
carcinogenicity concerns. More specifically, there were concerns for epidemiological links of 2,4-D
to non-Hodgkin's lymphoma from both occupational and residential exposure. A proposed decision
not to initiate Special Review was published (53 FR 9590) on March 23, 1988 based on findings that
such a link could not be established. The final decision was deferred until reregistration. In part to
address these concerns, the 2,4-D Task Force agreed to risk reduction measures in September 1992
that included an exposure reduction plan effected through modifications of technical and
manufacturing-use product labels and implementation of a user education program.
A Science Advisory Board/Scientific Advisory Panel Special Joint Committee reviewed
available epidemiological and other data on 2,4-D in 1992 and concluded that "the data are not
sufficient to conclude that there is a cause and effect relationship between exposure to 2,4-D and non-
Hodgkin's lymphoma." 2,4-D was classified as a Group D, not classifiable as to human
carcinogenicity. The Agency requested further histopathological examinations of rat brain tissues and
mouse spleen tissues in question. These exams were submitted and reviewed, and on March 16,
1999, the Agency notified the 2,4-D Task Force that the Agency would continue to classify 2,4-D as
a Group D carcinogen.
The Agency has twice recently reviewed epidemiological studies linking cancer to 2,4-D. In
the first review, completed January 14, 2004, EPA concluded there is no additional evidence that
would implicate 2,4-D as a cause of cancer (EPA, 2004). The second review of available
epidemiological studies occurred in response to comments received during the Phase 3 Public
Comment Period for the 2,4-D RED. EPA's report, dated December 8, 2004 and authored by EPA
Scientist Jerry Blondell, Ph.D., found that none of the more recent epidemiological studies
definitively linked human cancer cases to 2,4-D.
Final notice of the Agency's decision not to initiate Special Review will be issued at the
completion of the reregistration process.
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Residue Tolerances
Tolerances for residues of 2,4-D in/on plant and processed food/feed commodities, fish, and
potable water are expressed in terms of 2,4-D per se [40 CFR §180.142(a)(l-6 and 9-12) and (b)].
There are currently approximately 110 tolerances for 2,4-D.
The Industry Task Force n on 2,4-D Research Data (Task Force n) is supporting the
reregistration of 2,4-D. The members of the Task Force currently include Agro-Gor Corp (jointly
owned by Atanor, S.A. and FBI-Gordon Corp.), Dow AgroSciences, and Nufarm USA. In addition,
USDA's Interregional Project No. 4 (IR-4) is supporting the reregistration of a number of minor crop
uses for 2,4-D, and the California Citrus Quality Council (CCQC) is supporting selected uses of 2,4-
D isopropyl ester (IPE) on citrus fruits.
B. Chemical Identification
2,4-D [2,4-dichlorophenoxyacetic acid] is a List A pesticide active ingredient classified as an
herbicide, a plant growth regulator, and a fungicide. It is, however, mainly used as a selective
postemergence herbicide for the control of broadleaf weed species in a variety of food/feed sites
including field, fruit, and vegetable crops. In addition to the acid form, there are numerous salts and
esters of 2,4-D in Reregistration Case 0073, each with an assigned PC Code number, that are
presently registered as active ingredients in end-use products (EPs). Nine forms of 2,4-D are
currently supported; these forms are listed in Table 1 below. With regards to analytical methodology,
the quantitative recovery of residues of concern are enhanced by the formation of the more polar acid
form of 2,4-D. Given that results of 2,4-D analyses are typically expressed in terms of the quantified
levels of the acid form, 2,4-D concentrations in product formulations are typically referred to in terms
of acid equivalents (ae).
Chemical structures and information are presented in Tables 1 and 2 for 2,4-D acid and those
salts and esters with registered manufacturing-use and/or end-use products (MPs/EPs) being
supported by 2,4-D Task Force n and its member companies.
Table 1. Chemical Structures for Supported Forms of 2,4-D Acid, Amine Salts, and Esters
2,4-D active ingredients with registered MPs/EPs
2,4-D acid
Empirical Formula: C8H6C12O3
Molecular Weight: 221.0
CAS Registry No.: 94-75-7
PC Code: 030001
2,4-D sodium salt (Na)
Empirical Formula: C8H,Cl2NaO3
Molecular Weight: 243.03
CAS Registry No. : 2702-72-9
PC Code: 030004
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2,4-D active ingredients with registered MPs/EPs
OH
O
.Cl
O Na
O
2,4-D diethanolamine salt (PEA)
Empirical Formula: C17H17C19NO5
Molecular Weight: 326.18
CAS Registry No.: 5742-19-8
PC Code: 030016
2,4-D dimethylamine salt (DMA)
Empirical Formula: C10H13C1,NO3
Molecular Weight: 266.13
CAS Registry No.: 2008-39-1
PC Code: 030019
Cl,
Cl
O"[NH (CH CH OH) ]
O
0~[NH2(CH3)J
2,4-D isopropvlamine salt (IPA)
Empirical Formula: CUH15CLNO3
Molecular Weight: 280.04
CAS Registry No.: 5742-17-6
PC Code: 030025
2,4-D triisopropanolamine salt (TIPA)
Empirical Formula: C17H,7C1,NO6
Molecular Weight: 412.3~1
CAS Registry No.: 32341-80-3
PC Code: 030035
.Cl
O
Cl
O'[NH3CH(CH3)2]
O
O ~ NH+(CH,CHOHCH3)3
O
O
2,4-D 2-butoxyethyl ester (BEE)
Empirical Formula: C14H18C12O4
Molecular Weight: 321.20
CAS Registry No.: 1929-73-3
PC Code: 030053
2,4-D 2-ethylhexyl ester (2-EHE)'
Empirical Formula: C16H22C12O3
Molecular Weight: 333.2~7
CAS Registry No.: 1928-43-4
PC Code: 030063
Page 5 of 304
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2,4-D active ingredients with registered MPs/EPs
Cl .
Cl
0
O
CH
Cl
.Cl
o
0
,CH,
/\ CH,
^ ^
2,4-D isopropyl ester (IPE)
Empirical Formula: CUH19C19O3
Molecular Weight: 263.12
CAS Registry No.: 94-11-1
PC Code: 030066
O
CH
1 Formerly identified as the isooctyl ester.
Available data concerning identification of the active ingredients are summarized in Table 2 for
2,4-D acid, salts, and esters with registered MPs/EPs.
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Table 2. Available Data Concerning Identification of the Active Ingredient1
Active ingredient
(PC Code)
2,4-D acid
(030001)
2,4-D Na salt
(030004)
2,4-D DBA salt
(030016)
2,4-D DMA salt
(030019)
2,4-D IPA salt
(030025)
2,4-D TIPA salt
(030035)
2,4-D BEE
(030053)
2,4-D 2-EHE
(030063)
2,4-D IPE
(030066)
Color
white
white
cream
amber
amber
amber
dark
amber
dark
amber
pale
amber
Physical State
crystalline
solid
powder
powder
aqueous
liquid
aqueous
liquid
aqueous liquid
liquid
liquid
liquid
Melting Point/
Boiling Point
m.p. 138-141 C
m.p. 200 C
m.p. 83 C
m.p. 1 18-120 C
(PAI)
nip. 121 C
(PAI)
m.p, 87-1 IOC
(PAI)
b.p. 89 C
b.p. 300 C
b.p. 240 C
Density/Specific
Gravity
s.g=1.416
at25C
bulk = 42.2 lb/ft3
at25C
bulk = 0.762
g/cm3
at25C
s.g. = 1.23
at20C
s.g. = 1.15
at20C
s.g, = 1,21
at20C
s.g. = 1.225
at20C
s.g. = 1.152
at20C
s.g. = 1.252
at25C
Octanol/Water
Partition Coeff.
Log Knmf
0.001 Msol'n
pH5 2.14
pH 7 0.177
pH9 0.102
Vapor Pressure
1.4x 10'7mmHg
at25C
N/A 2; salt dissociates to acid in water
2.24 x ID'2
at25C
N/A; salt
dissociates to acid
in water
<1.33xlO-5Paat
25 C
-------
C. Use Profile
2,4-D comes in multiple chemical forms and is found in numerous end-use products intended
for use in a wide range of use patterns. 2,4-D is an ingredient in approximately 660 agricultural and
home use products, as a sole active ingredient and in conjunction with other active ingredients. 2,4-D
is formulated primarily as an amine salt in an aqueous solution or as an ester in an emulsifiable
concentrate. Chemical forms covered by this risk assessment are as 2,4-D acid, 2,4-D DMAS, 2,4-D
IPA, 2,4-D TIPA, 2,4-D EHE, 2,4-D BEE, 2,4-D DEA, 2,4-D IPE, and 2,4-D sodium salt. Copies of
all labels may be found at http://www.cdpr.ca.gov/docs/epa/m2.htm. The following is information on
the currently registered uses including an overview of use sites and application methods. A detailed
table of the uses of 2,4-D eligible for reregistration is contained in Appendix A.
Type of Pesticide: Herbicide
Target organism(s): A wide variety of broadleaf weeds and aquatic weeds
Mode of action: 2,4-D is thought to increase cell-wall plasticity, biosynthesis of proteins and the
production of ethylene. The abnormal increase in these processes is thought to result in uncontrolled
cell division and growth which damages vascular tissue.
Use Sites: Table 3 presents a summary of the registered 2,4-D uses.
Use Classification: General use
Formulation Types: Formulation types registered include emulsifiable concentrate, granular, soluble
concentrate/solid, water dispersible granules, and wettable powder.
Application Methods: 2,4-D may be applied with a wide range of application equipment including
fixed-wing aircraft, backpack sprayer, band sprayer, boom sprayer, granule applicator, ground-
directed sprayers, hand held sprayer, helicopter, injection equipment, tractor-mounted granule
applicator, and tractor-mounted sprayers.
Application Rates: For 2,4-D, rates per application and rates per year are generally less than 1.5
pounds acid equivalent (ae) per acre per year and 2.0 pounds a.e. per acre per year (Ibs ae/A),
respectively. Maximum rates are 4.0 Ibs ae/A per year for asparagus, forestry uses, and non-cropland
uses, among others. The maximum rate for aquatic uses is 10.8 Ibs ae/acre foot for submerged
aquatic plants.
Application Timing: Timing of 2,4-D application can include at emergence, before bud break,
during dormancy, to established plantings, foliar, post-emergence, pre-emergence, pre-harvest, and
pre-plant.
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Table 3. Registered 2,4-D Uses
Crop Grouping
Terrestrial food crop
Terrestrial food and feed
crop
Terrestrial feed crop
Terrestrial non-food crop
Terrestrial non-food and
outdoor residential
Aquatic food crop
Aquatic non-food
outdoor
Aquatic non-food
industrial
Forestry
Outdoor residential
Indoor non-food
Representative Crops
Pear, Pistachio, Stone fruits
Agricultural fallow/idleland; Agricultural rights-of-way/fencerows/hedgerows;
Agricultural uncultivated areas; Apple; Barley; Citrus fruits; Corn (unspecified);Corn,
field; Corn, pop; Corn, sweet; Fruits (unspecified), Grapefruit, Lemon, Oats, Orange, Pome
fruits, Rice, Rye, Small fruits, Soil, preplant/outdoor, Sorghum, Sorghum (unspecified),
Soybeans (unspecified), Sugarcane, Tangelo, Tree nuts, Wheat
Grass forage/fodder/hay, Pastures, Rangeland, Rye, Sorghum
Agricultural fallow/idleland, Agricultural rights-of-way/fencerows/hedgerows,
Agricultural uncultivated areas, Airports/landing fields, Christmas tree plantations,
Commercial/industrial lawns, Commercial/institutional/industrial, premises/equipment
(outdoor), Forest nursery plantings (for transplant purposes), Golf course turf, Grasses
grown for seed, Industrial areas (outdoor), Nonagricultural outdoor buildings/structures,
Nonagncultural rights-of-way/fencerows/hedgerows, Nonagricultural uncultivated
areas/soils, Ornamental and/or shade trees, Ornamental lawns and turf, Ornamental sod
farm (turf), Ornamental woody shrubs and vines, Paved areas (private roads/sidewalks),
Potting soil/topsoil, Recreation area lawns, Recreational areas, Soil, preplant/outdoor,
Urban areas
Fencerows/hedgerows, Nonagricultural rights-of-way/fencerows/hedgerows, Ornamental
and/or shade trees, Ornamental lawns and turf, Ornamental woody shrubs and vines,
Paths/patios, Paved areas (private roads/sidewalks), Urban areas
Agricultural drainage systems, Aquatic areas/water, Commercial fishery water systems,
Irrigation systems, Lakes/ponds/reservoirs (with human or wildlife use), Rice,
Streams/rivers/channeled water, Swamps/marshes/wetlands/stagnant water
Aquatic areas/water, Streams/rivers/channeled water,
Swamps/marshes/wetlands/stagnant water
Drainage systems, Industrial waste disposal systems, Lakes/ponds/reservoirs (without
human or wildlife use)
Conifer release, Forest plantings (reforestation programs)(tree farms, tree plantations,
etc.), Forest tree management/forest pest management, Forest trees (all or unspecified),
Forest trees (hardwoods, broadleaf trees), Pine (forest/shelterbelt)
Residential lawns
Commercial transportation facilities-nonfeed/nonfood
D. Estimated Usage of Pesticide
Based primarily on pesticide usage information from 1992 through 2000 for agriculture and
1993 through 1999 for non-agriculture, total annual domestic usage of 2,4-D is approximately 46
million pounds, with 30 million pounds (66%) used by agriculture and 16 million pounds (34%) used
by non-agriculture (see the OPP Biological and Economic Assessment Division [BEAD] quantitative
use analysis [QUA] which is available on EPA's Pesticide Docket OPP-2004-0167 located at:
Page 9 of 304
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http://www.epa.gov/edockets). In terms of pounds, total 2,4-D usage is allocated mainly to
pasture/rangeland (24%), lawn by homeowners with fertilizer (12%), spring wheat (8%), winter
wheat (7%), lawn/garden by lawn care operators/landscape maintenance contractors (7%), lawn by
homeowners alone (without fertilizer) (6%), field corn (6%), soybeans (4%), summer fallow (3%),
hay other than alfalfa (3%), and roadways (3%).
Agricultural sites with at least 10% of U.S. acreage treated include spring wheat (51%), filberts
(49%), sugarcane (36%), barley (36%), seed crops (29%), apples (20%), rye (16%), winter wheat
(15%), cherries (15%), oats (15%), millet (15%), rice (13%), soybeans (12%) and pears (10%). For
2,4-D, rates per application and rates per year are generally less than 1.5 Ibs ae/A per year and 2.0 Ibs
ae/A per year, respectively. 2,4-D is used predominantly in the Midwest, Great Plains, and
Northwestern United States (Figure 1).
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Total 2,4-D Usage on an Area-Weighted Basis
Legend
2,4-D Use(lbs/sq mile)
00
0.1 -5.0
5.1 -10.0
.-•;, 10.1 - 25.0
mm 25.1 - BO.O
0 250 500
Source of 2,4-D Use Data: Thelin, G.P., and Gianessi, L.P., 2000.
USGS Open File Report 00-250
Figure 1. Estimated 2,4-D usage (Ibs ae/square mile). The estimates are based on pesticide use rates compiled
by the National Center for Food and Agricultural Policy (NCFAP) and modified by Thelin, G.P. and Gianessi,
L.P., 2000 (USGS Open-File Report 00-250)
-------
Application Rates, Timing and Frequency of Applications
The 2,4-D master label (available in EPA docket #OPP-2004-0167) has been developed by the
2,4-D Task Force and represents the maximum supported application rates for agricultural and non-
agricultural uses. All end-use product manufacturers obtain 2,4-D starting material from companies
represented by the 2,4-D Task Force. EPA used the master label rates in the 2,4-D human health and
ecological risk assessments. Some master label rates are lower than the rates present on existing
labels. The Agency and the task force have agreed that all of the 2,4-D labels will be updated with
the new master label rates as part of the registration process. All of the registrants, including those
that are not in the 2,4-D task force, will have to conform to the master label rates. The master label
agreement is discussed in an internal Agency memo (EPA, March 18, 2003), which is available on
EPA's Pesticide Docket OPP-2004-0167 located at: http://www.epa.gov/edockets.
Typically, one to three applications are made per growing season. Applications are made to the
target weeds prior to crop emergence, after crop emergence, prior to harvest, and in the dormant
season, depending upon the crop. The label required spray volumes for ground applications range
from 0.0375 Ibs ae/A for applications to low bush blueberries to 4.0 Ibs ae/A for brush control. 2,4-D
can be applied over the top to tolerant crops such as small grains and rice, but must be directed or
shielded for the more sensitive crops such as fruits and berries.
The application rates on the master label are included in Table 4 for non-crop areas and Table 5
for agricultural crops. The average application rates from the 2,4-D QUA report (EPA BEAD 2001)
are shown for comparison. With the exception of filberts, the QUA data indicate that only one
application is made to most crops. The National Agricultural Pesticide Impact Assessment Program
(NAPIAP) report on Phenoxy Herbicides indicates that on average one 2,4-D application is made
annually to turfgrass.
Table 4. 2,4-D Application Rates for Non-Crop Areas
Aquatic Areas, Forestry, Non-Crop Areas and
Turf
Aquatic Areas - Floating Weeds
Aquatic Areas - Submerged Weeds
Tree and Brush Control - Tree Injection
Forestry - Weed and Brush Control
Forestry - Conifer Release
Irrigation Ditch Banks
Rights of Way Areas
Rangeland, Pastures
Turf- Grass Grown for Seed or Sod
Acid Equivalent Ibs (ae) Application Rates
Per Application/Per crop or Year
Master Label
2.0/4.0 per acre
10.8 per acre foot
1 to 2 ml per inch of trunk diameter
4.0/4.0 per acre
4.0/4.0 per acre
2.0/4.0 per acre
2.0/4.0 per acre
2.0/4.0 per acre
2.0/4.0 per acre
Amount Used per QUA
Report
5 12,000 lbsA
136,000 Ibs
2.1 million Ibs
35 1,000 Ibs
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Aquatic Areas, Forestry, Non-Crop Areas and
Turf
Turf- Ornamental
Acid Equivalent Ibs (ae) Application Rates
Per Application/Per crop or Year
Master Label
2.0/4.0 per acre B
Amount Used per QUA
Report
11.6 million Ibs
A. According to the NAPIAP report about 98,000 acres were treated for floating weeds and about 5,000 acres were treated for
submerged weeds by state agencies in 1993.
B. The registrants have agreed to reduce the ornamental turf rate from 2.0 to 1.5 Ibs ae per acre. The new maximum yearly rate
will be 3.0 Ibs ae per acre.
Table 5. 2,4-D Application Rates for Agricultural Crops
Agricultural Crops
Asparagus
Blueberries - Low Bush Wiper Bar
Blueberries - High Bush
Citrus (Growth Regulator)
Conifer Plantations
Corn (sweet)
Corn (field and pop)
Cranberries - granular applications
Cranberries - liquid applications
Fallowland and Crop Stubble
Filberts
Grain Sorgum
Grapes
Orchard Floors (Pome and Stone Fruits,
Tree Nuts)
Potatoes
Rice
Soybeans (Preplant burndown)
Strawberries (Except CA or FL)
Sugarcane
Cereal Grains
(Wheat, Barley, Millet, Oats and Rye)
Acid Equivalent Ibs (ae) Application Rates per Acre
Per Application/Per crop or Year
Master Label
2.0/4.0
0.0375 Ib/GA
1.4/2.8
0.1
4.0/4.0
0.5 to 1.0/1.5
0.5 to 1.5/3.0
4.0/4.0 dormant season application
1.2/2.4 growing season application
2.0/4.0
1 .0 Ib per 100 Ga/4 Apps per year
0.5 to 1.0/1.0
1.36/1.36
2.0/4.0
0.07/0.14
1.0 or 1.5/1.5
0.5 or 1.0/1.0
1.5/1.5
2.0/4.0
0.5 or 1.25/1.75
Average Rate per QUA Report
1.1/1.3
0.46/0.51
No Data
No Data
0.48/0.51
0.44/0.46
1.8/2.0
0.69/0.89
0.64/1.7
0.46/0.50
0.73/0.87
Apples = 1.2/1.4
Pears = 1.1/1. 5
0.10/0.17
0.92/0.94
0.46/0.47
1.2/1.3
0.75/0.99
Wheat= 0.44/0.48
Barley =0.46/0.47
Oats = 0.46/0.46
Rye = 0.50/0.50
Millet= 0.44/0.44
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Agricultural Crops
Wild Rice (MN only)
Acid Equivalent Ibs (ae) Application Rates per Acre
Per Application/Per crop or Year
Master Label
0.25/0.25
Average Rate per QUA Report
0.20/0.20
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HE. Summary of 2,4-D Risk Assessment
The following is a summary of EPA's human health and ecological risk findings and
conclusions for 2,4-D, as presented fully in the documents "2,4-D. HED's Revised Human Health
Risk Assessment for the Reregistration Eligibility Decision (RED) Revised to Reflect Public
Comments" dated May 12, 2005, and the "Environmental Fate and Effects Division's Risk
Assessment for the Reregistration Eligibility Decision for 2,4-D," dated October 28, 2004.
The purpose of this section is to summarize the key features and findings of the risk assessment
in order to help the reader better understand the risk management decisions reached by the Agency.
While the risk assessments and related addenda are not included in this document, they are available
in the public docket OPP-2004-0167, and on the Agency's website at
http: //www. epa. gov/pesticides/reregistration/status. htm
A. Human Health Risk Assessment
EPA released its preliminary risk assessments for 2,4-D for public comment on June 23, 2004,
thereby starting Phase 3 of a six phase public participation process. In response to comments
received during Phase 3, the human health risk assessment was updated. EPA issued the revised risk
assessments for 2,4-D for a second public comment period on January 12, 2005 (Phase 5 of the public
participation process). The risk assessments were revised again in response to Phase 5 public
comments, and are available for review.
The 2,4-D degradates detected in the various laboratory environmental fate studies were 1,2,4-
benzenetriol, 2,4-dichlorophenol (2,4-DCP), 2,4-dichloroanisole (2,4-DCA), 4-chlorophenol,
chlorohydroquinone (CHQ), volatile organics, bound residues, and carbon dioxide. The OPP
Metabolism Assessment Review Committee (MARC) determined that all residues other than 2,4-D
are not of risk concern due to low occurrence under environmental conditions, comparatively low
toxicity, or a combination thereof. Therefore, the Agency assessed risks from 2,4-D per se.
1. Toxicity of 2,4-D
With very few exceptions, the effects and relative toxicities of the salt and ester forms of 2,4-D
are quite similar to those of the acid form. Thus, the acid form was selected as being representative of
all members of the 2,4-D reregistration case (Case No. 0073). The member chemicals in the 2,4-D
case exhibit low to slight acute toxicity with the exception of the acid and salt forms being severe eye
irritants. The Agency has reviewed all toxicity studies submitted for 2,4-D and has determined that
the toxicological database is sufficient for reregistration. Further details on the toxicity of 2,4-D can
be found in the technical support documents cited in Appendix C.
a. Toxicity Profile
Major features of the toxicology profile are presented below. In acute studies, 2,4-D generally
has low acute toxicity (Toxicity Category HI or IV) via the oral, dermal and inhalation routes of
Page 15 of 304
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exposure. 2,4-D is not a skin irritant (Toxicity Category HI or IV), nor a skin sensitizer. Although
the 2,4-D ester forms are not eye irritants (Toxicity Category in or IV), the acid and salt forms are
considered to be severe eye irritants (Toxicity Category I). The acute toxicity of all 2,4-D forms is
listed in Table 6.
Table 6. Acute Toxicity Data for 2,4-D acid, 2,4-D ester forms, and 2,4-D aniine salts1.
Guideline
No
870.1100
870.1200
870.1300
870.2400
870.2500
Study Type
Acute Oral
2,4-D acid
DEA salt
DMA salt
IPA salt
IPE ester
UFA salt
BEE ester
EHE ester
Acute Dermal
2,4-D acid
DEA salt
DMA salt
IPA salt
IPE ester
UFA salt
BEE ester
EHE ester
Acute Inhalation
2,4-D acid
DEA salt
DMA salt
IPA salt
IPE ester
UFA salt
BEE ester
EHE ester
Primary Eye Irritation
2,4-D acid
DEA salt
DMA salt
IPA salt
IP ester
UFA salt
BEE ester
EHE ester
Primary Skin Irritation
2,4-D acid
DEA salt
DMA salt
IPA salt
IPE ester
UFA salt
BEE ester
EHE ester
MRID Numbers
00101605
41920901
00157512
00252291
41709901
41413501
40629801
41209001
00101596
41920911
00157513
00252291
41709902
41413502
40629802
41209002
00161660
41986601
00157514
40085501
40352701
41957601
40629803
42605202
41125302
41920902
00157515
00252291
40352702
41413504
40629804
44725303
42232701
41920903
00157516
00252291
40352703
41413505
40629805
41413505
Results
rat LD50 = 639 mg/kg
rat LD50 = 735 mg/kg
rat LD50 = 949 mg/kg
rat LD50 = 1646 mg/kg
rat LD50 = 1250 mg/kg
rat LD50 = 1074 mg/kg
rat LD50 = 866 mg/kg
rat LD50 = 896 mg/kg
rabbits LD50 >2000 mg/kg
rabbits LD50 >2000 mg/kg
rabbit LD50 1829 mg/kg
rabbits LD50 >2000 mg/kg
rabbits LD50 >2000 mg/kg
rabbits LD50 >2000 mg/kg
rabbits LD50 >2000 mg/kg
rabbits LD50 >2000 mg/kg
ratLC50>1.79mg/L
rat LC50 >3.5 mg/L
rat LC50 >3.5 mg/L
ratLCso =3.1 mg/L
rat LC50 >4.97 mg/L
rat LC50 =0.78 mg/L
rat LC50 =4.6 mg/L
ratLC50>5.4mg/L
severe eye irritant
severe eye irritant
severe eye irritant
severe eye irritant
not an eye irritant
severe eye irritant
not an eye irritant
not an eye irritant
unacceptable
slight skin irritant
slight skin irritant
slight skin irritant
slight skin irritant
slight skin irritant
very mild irritant
not a skin irritant
Toxicity Category
in
IE
in
IE
IE
IE
IE
IE
IE
IE
IE
IE
IE
IE
IE
IE
IE
IV
IV
IV
IV
IE
IV
IV
I
I
I
I
IV
I
IE
IE
N/A
IE
IV
IV
IV
IV
IV
IV
Page 16 of 304
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Guideline
Nn
870.2600
Study Type
Dermal Sensitization
2,4-D acid
DBA salt
DMA salt
IPA salt
IPE ester
UFA salt
BEE ester
EHE ester
MRID Numbers
00161659
41920904
41642805
41233701
40352704
41413506
40629806
41209006
Results
not a dermal sensitizer
not a dermal sensitizer
unacceptable
unacceptable
not a dermal sensitizer
not a dermal sensitizer
not a dermal sensitizer
unacceptable
Toxicity Category
N/A
1. The technical acute toxicity values included in this document are for informational purposes only. The data supporting these values
will be evaluated during reregistration and may or may not meet the current Agency acceptance criteria.
The mechanisms responsible for renal clearance of 2,4-D have been investigated in several
species. 2,4-D is actively secreted by the proximal tubules. This mechanism of renal clearance is
consistent with results seen with other phenoxy acids. It has been suggested that observed dose-
dependent, non-linear, pharmacokinetics of 2,4-D are primarily due to the saturation of this renal
secretory transport system. Due to a limited capacity to excrete organic acids, the dog is more
sensitive to the effects of 2,4-D than the rat with respect to repeated dosing.
In laboratory animals, following subchronic, oral exposure at dose levels of 2,4-D above the
threshold of saturation for renal clearance, the primary target organs are the eye, thyroid, kidney,
adrenals, and ovaries/testes. Changes in these organs are also observed following exposure to the
amine salts and esters of 2,4-D. Systemic toxicity was not observed following repeated dermal
exposure to 2,4-D, EHE, and TIPA at or above the limit dose or following repeated dermal exposure
to BEE and IPA at the highest dose tested. Liver toxicity was observed following repeated high-dose
dermal exposure to DEA, and one death occurred following repeated high-dose dermal exposure to
DMA.
There are no repeat-dose inhalation exposure data available on 2,4-D. The most reliable way to
characterize inhalation toxicity and to quantify inhalation risk is through the use of inhalation toxicity
studies. In general, chemicals tend to be more toxic by the inhalation route than by the oral route due
to rapid absorption and distribution, bypassing of the liver's metabolic protection (portal circulation),
and potentially serious portal-of-entry effects, such as irritation, edema, cellular transformation,
degeneration, and necrosis. An inhalation risk assessment that is based on oral data generally
underestimates the inhalation risk because it cannot account for these factors. However, in the case of
2,4-D, based on the limited metabolism of 2,4-D via the oral route, the moiety to which the body
would be exposed would be the same for both routes of exposure. With regard to portal-of-entry
effects, these can only be assessed in an inhalation study. Therefore, a subchronic (28-day) inhalation
study is required for 2,4-D.
Developmental toxicity, characterized mainly as an increased incidence of skeletal
abnormalities in the rat, was observed following exposure to 2,4-D and its amine salts and esters at
dose levels that were at or above the threshold of saturation of renal clearance. Similarly,
developmental toxicity was observed in the rabbit only following exposure to 2,4-D (abortions) and
DEA (increased number of litters with fetuses having 7th cervical ribs) at or above the threshold of
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renal clearance.
Reproductive toxicity, characterized as an increase in gestation length, was observed following
exposure to 2,4-D at a dose level above the threshold of saturation of renal clearance. A repeat 2-
generation reproduction study (using the revised EPA protocol) is required to address concerns for
endocrine disruption.
Neurotoxicity was demonstrated following exposure to 2,4-D at relatively high dose levels.
Clinical signs of neurotoxicity (ataxia, decreased motor activity, myotonia, prostration, lateral
recumbency, impaired/loss of the righting reflex, and skin cold to the touch) were observed in
pregnant rabbits following exposure to 2,4-D and its amine salts and esters. Neuropathology (retinal
degeneration) was observed following 2,4-D exposure in several studies in female rats.
Incoordination and slight gait abnormalities (forepaw flexing or knuckling) were observed following
acute dosing and increased forelimb grip strength was observed following chronic exposure to 2,4-D
at dose levels that exceeded the threshold of saturation of renal clearance. A developmental
neurotoxicity study in the rat is required for 2,4-D.
2,4-D is classified as a Group D chemical (not classifiable as to human carcinogenicity). Based
on the overall pattern of responses observed in both in vitro and in vivo genotoxicity tests, 2,4-D was
not mutagenic, although some cytogenic effects were observed. 2,4-D acid is currently considered to
be representative of all nine member chemicals of the 2,4-D case.
The toxicological endpoints that were used to complete the risk assessments are summarized in
Table 7. These endpoints were selected by the Agency from animal studies. With respect to dermal
exposures, the Agency previously selected a dermal absorption factor of 5.8 percent based on the
average absorbed dose value from a human dermal absorption study. That factor (5.8 percent) was
used in previous versions of the human health risk assessment. Based on comments received during
the Phase 5 comment period, the dermal absorption study and resulting absorption factor were
reconsidered. In order to account for the variability observed in the dermal absorption study, the
dermal absorption factor was changed from 5.8 percent to 10 percent. In their "Re-evaluation of the
Lawn and Turf Uses of 2,4-D," which was made available to the public for review, Health Canada
also selected a factor of 10 percent based upon the weight of evidence from several published studies,
taking into account the variability in the data and the limitations of the various studies. These studies
include the Feldman and Maibach study discussed above and studies from Harris and Solomon 1992,
Moody et. al. 1990, Wester et. al. 1996, and Pelletier et al. 1988.
b. Safety and Database Uncertainty Factors
The Food Quality Protection Act (FQPA) directs the Agency to use an additional tenfold (10X)
safety factor to protect for special sensitivity of infants and children to specific pesticide residues in
food, drinking water, or residential exposures, or to compensate for an incomplete database. FQPA
authorizes the Agency to modify the tenfold safety factor only if reliable data demonstrate that
another factor would be appropriate.
FQPA Special Safety Factor. After evaluating hazard and exposure data for 2,4-D, EPA
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removed the default 10X FQPA special safety factor. The toxicity database for 2,4-D includes
acceptable developmental and reproductive toxicity studies. Developmental toxicity studies were
conducted in both rats and rabbits for most 2,4-D forms. There is qualitative evidence of
susceptibility in the rat developmental toxicity study with 2,4-D acid and DEA salt where fetal effects
(skeletal abnormalities) were observed at a dose level that produced less severe maternal toxicity
(decreased body-weight gain and food consumption). There is no evidence of increased (quantitative
or qualitative) susceptibility in the prenatal developmental toxicity study in rabbits or in the 2-
generation reproduction study in rats on 2,4-D. Regarding the 2,4-D amine salt and ester forms, no
evidence of increased susceptibility (quantitative or qualitative) was observed in the prenatal
developmental toxicity study in rats and rabbits (except for 2,4-D DEA) dosed with any of the amine
salts or esters of 2,4-D. There is evidence of increased susceptibility (qualitative) in the prenatal
developmental study in rabbits for 2,4-D DEA salt.
After establishing developmental toxicity endpoints to be used in the risk assessment with
traditional uncertainty factors (lOx for interspecies variability and lOx for intraspecies variability), the
Agency has no residual concerns for the effects seen in the developmental toxicity studies. Therefore,
the 10X FQPA special safety factor was reduced to IX.
Database Uncertainty Factor. On April 8, 2003, based on the weight of evidence presented,
the Agency reaffirmed the previous conclusion that a developmental neurotoxicity (DNT) study in
rats is required for 2,4-D because there is a concern for developmental neurotoxicity resulting from
exposure to 2,4-D. There is evidence of neurotoxicity, including clinical signs such as ataxia and
decreased motor activity in pregnant rabbits following dosing during gestation days 6-15 in studies on
2,4-D itself and 2,4-D amine salts and esters, and tremors in dogs that died on test following repeat
exposure to 2,4-D. Incoordination and slight gait abnormalities (forepaw flexing or knuckling) were
also observed following dosing in the acute neurotoxicity study with 2,4-D. There is also evidence of
developmental toxicity, as discussed above in the FQPA Special Safety Factor section. In addition,
the Agency determined that a repeat 2-generation reproduction study using the new protocol is
required to address specific concerns for endocrine disruption (thyroid and immunotoxicity
measures). Therefore, the Agency determined that a 10X database uncertainty factor (UFDB) is
needed to account for the lack of these studies.
c. Carcinogenicity
A Science Advisory Board/Scientific Advisory Panel Special Joint Committee reviewed
available epidemiological and other data on 2,4-D in 1992 and concluded that "the data are not
sufficient to conclude that there is a cause and effect relationship between exposure to 2,4-D and non-
Hodgkin's lymphoma." 2,4-D has been classified as a Category D chemical (i.e., not classifiable as to
human carcinogenicity), by the EPA/OPP Cancer Peer Review Committee in 1996. The Agency
requested further histopathological examinations of rat brain tissues and mouse spleen tissues in
question. These exams were submitted and reviewed and on March 16, 1999, the Agency notified the
2,4-D Task Force that the Agency would continue to classify 2,4-D as a Group D carcinogen.
The Agency has twice recently reviewed epidemiological studies linking cancer to 2,4-D. In
the first review, completed January 14, 2004, EPA concluded there is no additional evidence that
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would implicate 2,4-D as a cause of cancer (EPA, 2004). The second review of available
epidemiological studies occurred in response to comments received during the Phase 3 Public
Comment Period for the 2,4-D RED. This report, dated December 8, 2004 and authored by EPA
Scientist Jerry Blondell, Ph.D., found that none of the more recent epidemiological studies
definitively linked human cancer cases to 2,4-D.
2,4-D Diethanolamine (PEA). The Agency recently reviewed the available toxicology data
on diethanolamine (DEA) and related compounds. The Agency concluded that it was not likely that
exposure to the DEA salt of 2,4-D resulting from occupational use would pose a carcinogenic risk to
humans. While liver tumors were observed in mice following dermal exposure to DEA, there was no
evidence of carcinogenicity in rats following dermal exposure, and there was no evidence of a
genotoxic or mutagenic concern. Although no formal assessment has been performed on the proposed
mode of action (choline deficiency), this mode of action was considered plausible for the mouse
hepatocellular tumors observed following dermal exposure to DEA, as were other confounding
factors, including the use of ethanol as a vehicle for dose administration and the fact that humans are
generally refractive to choline deficiency. Additionally, the low use pattern for 2,4-D DEA indicates
that there is no potential long-term dermal exposure to the diethanolamine salt of 2,4-D in agricultural
uses. The Agency also determined that, at this time, no carcinogenicity studies are required for the
DEA salt of 2,4-D.
d. Cumulative Assessment
FQPA requires EPA to consider "available information" concerning the cumulative effects of a
particular pesticide's residues and "other substances that have a common mechanism of toxicity"
when considering whether to establish, modify, or revoke a tolerance. Potential cumulative effects of
chemicals with a common mechanism of toxicity are considered because low-level exposures to
multiple chemicals causing a common toxic effect by a common mechanism could lead to the same
adverse health effect as would a higher level of exposure to any one of these individual chemicals.
2,4-D is a member of the alkylphenoxy herbicide class of pesticides. A cumulative risk assessment
has not been performed as part of this human health risk assessment because the Agency has not yet
made a determination whether or not phenoxy herbicides have a common mechanism of toxicity. For
information regarding EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released
by the EPA's Office of Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a common mechanism on EPA's
website at http://www.epa.gov/pesticides/cumulative/
e. Endocrine Effects
EPA is required under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the
Food Quality Protection Act (FQPA), to develop a screening program to determine whether certain
substances (including all pesticide active and other ingredients) "may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the
Administrator may designate."
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When the appropriate screening and/or testing protocols being considered under the Agency's
Endocrine Disruption Screening Program (EDSP) have been developed, 2,4-D may be subject to
additional screening and/or testing to better characterize effects related to endocrine disruption.
Based on currently available toxicity data, which demonstrate effects on the thyroid and gonads
following exposure to 2,4-D, there is concern regarding its endocrine disruption potential. There have
been no studies on 2,4-D that specifically assess its endocrine disruption potential. The Agency has
determined that a repeat 2-generation reproduction study using the most recent protocol is required to
address both the concern for thyroid effects (comparative assessment between the young and adult
animals) and immunotoxicity, as well as a more thorough assessment of the gonads and
reproductive/developmental endpoints.
f. Toxicological Endpoints for Risk Assessment
The toxicological endpoints used in the human health risk assessment for 2,4-D are listed in
Table 7. The safety factors used to account for interspecies extrapolation, intraspecies variability,
special susceptibility of infants and children, and database uncertainties are also described in Table 7
below. This table also describes any absorption factors used to extrapolate from one route of
exposure to another (e.g., oral to dermal).
Table 7. Toxicity Endpoints for Human Health Risk Assessment for 2,4-D
Exposure
Scenario
Dose Used in Risk
Assessment, UF
Special FQPA SF and Level of
Concern for Risk Assessment
Study and Toxicological Effects
Dietary Exposures
Acute Dietary
(Females 13-49
years of age)
MRID 00130407,
00130408
Acute Dietary
(General
population
including infants
and children)
MRID 431 15201
Chronic Dietary
(All populations)
MRID 436 12001
NOAEL = 25 mg/kg/day
UF = 1000
Acute RID = 0.025
mg/kg/day
NOAEL = 67 mg/kg/day
UF = 1000
Acute RID = 0.067
mg/kg/day
NOAEL= 5 mg/kg/day
UF = 1000
Chronic RID =
0.005 mg/kg/day
FQPA SF = IX
aPAD = acute RfD(0.025)
FQPA SF (1)
= 0.025 mg/kg/day
FQPA SF = IX
aPAD = acute RfD (0.067)
FQPA SF (1)
= 0.067mg/kg/day
FQPA SF = IX
cPAD = chronic RfD (0.005)
FQPA SF (1)
= 0.005 mg/kg/day
Rat Developmental Toxicity Study,
LOAEL = 75 mg/kg/day based on skeletal
abnormalities
Acute Neurotoxicity Study in Rats
LOAEL = 227 mg/kg/day based on gait
abnormalities
Rat Chronic Toxicity Study
LOAEL = 75 mg/kg/day based on
decreased body-weight gain (females) and
food consumption (females), alterations in
hematology , and clinical chemistry
parameters, decreased T4 (both sexes),
glucose (females), cholesterol (both sexes),
and triglycerides (females).
Occupational and Residential Non- Dietary Exposures
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Exposure
Scenario
Short- Term
Incidental Oral (1-
30 days)
MRID 00130407,
00130408
Intermediate-
Term
Incidental Oral (1-
6 months)
MRID 41991501
Short- Term
Dermal*
MRID
00130407,
00130408
Intermediate-
Term
Dermal*
MRID 00130407,
00130408
Long- Term
Dermal*
MRID 436 12001
Short- Term
Inhalation*
MRID
00130407,
00130408
Intermediate-
Term Inhalation*
MRID 00130407,
00130408
Long- Term
Inhalation*
MRID 436 12001
Cancer
Dose Used in Risk
Assessment, UF
NOAEL= 25 mg/kg/day
NOAEL = 15 mg/kg/day
Oral study NOAEL= 25
mg/kg/day
Oral study NOAEL =15
mg/kg/day
Oral study NOAEL= 5
mg/kg/day
Oral study NOAEL= 25
mg/kg/day
Oral study NOAEL = 15
mg/kg/day
Oral study NOAEL= 5
mg/kg/day
Special FQPA SF and Level of
Concern for Risk Assessment
Residential LOC for MOE
=1000
Occupational = NA
Residential LOC for MOE =
1000
Occupational = NA
Residential LOC for MOE
= 1000
Occupational LOC for MOE =
100
Study and Toxicological Effects
Rat developmental toxicity study
LOAEL = 75 mg/kg/day based on
decreased maternal body-weight gain
Rat Subchronic Oral Toxicity
LOAEL = 100 mg/kg/day based on
decreased body weight/body-weight gain,
alterations in some hematology, and
clinical chemistry parameters, and cataract
formation.
Rat Developmental Toxicity Study
LOAEL = 75 mg/kg/day based on
decreased maternal body-weight gain and
skeletal abnormalities
Rat Subchronic Oral Toxicity (same as for
intermediate-term incidental oral)
Rat Chronic Toxicity Study (same as for
chronic dietary)
Rat Developmental Toxicity Study (same
as for short-term dermal)
Rat Subchronic Oral Toxicity (same as
intermediate-term incidental oral)
Rat Chronic Toxicity Study (same as for
chronic dietary)
Classification: Group D [not classifiable as to human carcinogenicity]
The dermal absorption factor is 10 percent and the inhalation absorption factor is 100 percent.
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD = reference dose, MOE = margin of
exposure, LOC = level of concern, NA = Not Applicable
Dermal Absorption. A dermal absorption study utilizing human volunteers is available.
Excretion following dermal application was 5.8 ± 2.4 percent (mean ± S.D.) of the administered dose
and after intravenous administration was 100 ± 2.5 percent. The Agency previously selected a dermal
Page 22 of 304
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absorption factor of 5.8 percent based on the human dermal absorption study. This factor was used in
previous versions of this risk assessment. Based on comments received during the Phase 5 comment
period, this dermal absorption study and factor were reconsidered. In order to account for the
variability observed in the dermal absorption study, the dermal absorption factor was changed from
5.8 percent to 10 percent. In their "Re-evaluation of the Lawn and Turf Uses of 2,4-D," which was
made available to the public, Health Canada also selected a factor of 10 percent based upon the
weight of evidence from several published studies, taking into account the variability in the data and
the limitations of the various studies. These studies include the Feldman and Maibach study
discussed above and studies from Harris and Solomon 1992, Moody et. al. 1990, Wester et. al. 1996,
and Pelletier et al. 1988.
2. Dietary Exposure and Risk from Food
a. Exposure Assumptions
Acute and chronic dietary exposure and risk analyses for 2,4-D were conducted using the
Lifeline ™ Model Version 2.0 and Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID™, Version 1.33). DEEM incorporates consumption data
from USDA's Continuing Surveys of Food Intakes by Individuals (CSFH), 1994-1996 and 1998.
Lifeline ™ uses food consumption data from the United States Department of Agriculture's
(USDA's) Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.
Lifeline™ uses recipe files contained within the program to relate raw agricultural commodities
(RACs) to foods "as-eaten." Lifeline™ converts the RAC residues into food residues by randomly
selecting a RAC residue value from the "user defined" residue distribution (created from the residue,
percent crop treated, and processing factors data), and calculating a net residue for that food based on
the ingredients' mass contribution to that food item.
Lifeline™ models the individual's dietary exposures over a season by selecting a new CSFII
diary each day from a set of similar individuals based on age and season attributes. Lifeline™ groups
CSFII diaries based on the respondent's age and the season during which the food diary was
recorded. Based on analysis of the 1994-96, and 1998 CSFII consumption data, which took into
account dietary patterns and survey respondents, the Agency concluded that it is most appropriate to
report risk for the following population subgroups: the general U.S. population, all infants (<1 year
old), children 1-2, children 3-5, children 6-12, youths 13-19, adults 20-49, females 13-49, and adults
50+ years old. The most highly exposed population subgroup for 2,4-D using both DEEM and
Lifeline was children 1-2 years of age.
The acute dietary assessment was only slightly refined as the following assumptions were
made: tolerance-level exposure values for most commodities, the highest field trial residue value for
citrus commodities, and 100% crop treated (%CT). Note that half of the average level of detection
(LOD) from the United States Department of Agriculture (USD A) Pesticide Data Program (POP)
monitoring data was used as the milk residue value because no milk sample contained detectable 2,4-
D residues over several years of PDF sampling.
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The chronic dietary assessment was moderately refined, making use of the following
assumptions: tolerance-level exposure values for most commodities; averages of field trial data and
processing study factors for small grains, citrus, and sugarcane sugar and molasses; %CT information
for all commodities; and the MCL (70 ppb) as well as the highest observed groundwater monitoring
concentration (15 ppb) for drinking water in a forward calculation. As in the case of the acute
assessment, half of the average LOD from PDF monitoring data was used for milk.
b. Population Adjusted Dose
A population adjusted dose, or PAD, is the reference dose (RfD) adjusted for the FQPA safety
factor. A risk estimate that is less than 100% of the acute PAD (aPAD), the dose at which an
individual could be exposed over the course of a single day and no adverse health effects would be
expected, does not exceed EPA's level of concern. Likewise, a risk estimate that is less than 100% of
the chronic PAD (cPAD), the dose at which an individual could be exposed over the course of a
lifetime and no adverse health effects would be expected, does not exceed EPA's level of concern.
In the case of 2,4-D , the FQPA SF has been removed (equivalent to a factor of Ix), so the acute
or chronic RfD is identical to the respective aPAD or cPAD. In addition, an uncertainty factor is
determined for each chemical. In the acute and chronic dietary risk assessments for 2,4-D, the total
uncertainty factor (UF) is lOOOx; lOx for interspecies variability, lOx for intraspecies variability, and
lOx for database uncertainty.
c. Food Risk Estimates
Acute: Risk to the general U.S. population was 18% and 17% of the aPAD using both DEEM
and Lifeline, respectively. The most highly exposed population subgroup using both DEEM and
Lifeline was children 1-2 years of age; risks were 33% and 32% of the aPAD, respectively. Risk to
females 13-49 years of age was 31% of the aPAD using DEEM and 42% of the aPAD using Lifeline;
these higher calculated risks for women of child-bearing age are due to the 2.7x lower toxicological
point of departure for developmental effects applicable to Females 13-49 years of age. These acute
dietary (food) risks are all less than the Agency's level of concern (100% of the aPAD).
Chronic: Risk to the general U.S. population was 4.1% and 3.8% of the cPAD, using DEEM
and Lifeline, respectively. Risk to children 1-2 years of age, the most highly exposed population
subgroup, was 8.5% of the cPAD using DEEM and Lifeline.
3. Dietary Exposure and Risk from Drinking Water
Drinking water exposure to pesticides can occur through surface and ground water
contamination. EPA considers acute (one day) and chronic (lifetime) drinking water risks and uses
either modeling or monitoring data, if available and of sufficient quality, to estimate those exposures.
In assessing drinking water risks, EPA compares model results to concentrations that would be
acceptable in drinking water from a human health perspective (e.g., DWLOCs). If the estimated
drinking water concentrations (EDWCs) in water are less than the DWLOCs, EPA does not have
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concern from consuming drinking water. If the EDWCs are greater than DWLOCs, EPA will
conduct further analysis to characterize the potential dietary risk from drinking water. Risks from
exposure to 2,4-D in drinking water are further discussed in the section m.A.5.
2,4-D is an herbicide used in a wide variety of environments. As the major route of degradation
is aerobic microbial metabolism, 2,4-D is non-persistent (t1/2=6.2 days) in terrestrial (aerobic)
environments, moderately persistent (t1/2=45 days) in aerobic aquatic environments, and highly
persistent (t1/2= 231 days) in anaerobic terrestrial and aquatic environments. Because 2,4-D will be
anionic (X-COO" EF) under most environmental conditions, it is expected to be mobile (Koc=61.7) in
soil and aquatic environments.
The 2,4-D degradates detected in the various laboratory environmental fate studies were 1,2,4-
benzenetriol, 2,4-dichlorophenol (2,4-DCP), 2,4-dichloroanisole (2,4-DCA), 4-chlorophenol,
chlorohydroquinone (CHQ), volatile organics, bound residues, and carbon dioxide. The Agency has
determined that residues other than 2,4-D are not of risk concern due to low occurrence under
environmental conditions, comparatively low toxicity, or a combination thereof.
Estimated Environmental Concentrations (EEC) were derived through an evaluation of
monitoring data and modeling. A number of different scenarios were assessed and EECs provided
for each. Scenarios evaluated included the direct application of 2,4-D to water bodies for aquatic
weed control, a rice use scenario, and terrestrial uses including food and nonfood uses.
a. Surface Water
Modeling: The Tier n screening models, Pesticide Root Zone Model and Exposure Analysis
Modeling System (PRZM-EXAMS),with the Index Reservoir and Percent Crop Area adjustment (IR-
PCA PRZM/EXAMS) were used to estimate 2,4-D residues in surface water used for drinking water.
The Index Reservoir represents a watershed that is more vulnerable than most watersheds used
as drinking water sources. It was developed from a watershed in western Illinois that has been used
for drinking water purposes. The Index Reservoir is used as a standard watershed that, in
combination with local soils types, weather conditions, and cropping practices, represents a
vulnerable watershed that could support a drinking water supply.
For terrestrial uses of 2,4-D, EECs were calculated from aquatic exposure modeling using
PRZM/EXAMS with the Index Reservoir and a percent crop area treated (PCA) adjustment (Tier II).
Fifteen scenarios were chosen for aquatic exposure modeling, including sugarcane in Florida; turf in
Florida and Pennsylvania; spring wheat in North Dakota; winter wheat in Oregon; corn in Illinois and
California; sorghum in Kansas and Texas; soybean in Mississippi; pasture in North Carolina; apples
in North Carolina, Oregon, and Pennsylvania; and filberts in Oregon. Although this only represents a
portion of the crops for which 2,4-D has a labeled use, it does represent crops with higher application
rates and crops which have a large percentage of their total acreage treated with 2,4-D.
Surface water concentrations were modeled using PRZM version 3.12 and EXAMS version
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2.98.04. Ground water concentrations were modeled using SCIGROW version 2.2. The 15 crop
scenarios listed above were modeled using PRZM/EXAMS. Based on the maximum modeled
values, (more specifically, the North Carolina apple model scenario), the model-estimated, surface-
water-derived drinking water concentrations for the use of 2,4-D are:
118 ug/L for the 1 in 10 year annual peak concentration (acute)
64 ug/L for the 1 in 10 year 90-day average
23 ug/L for the 1 in 10 year annual mean concentration (chronic)
Monitoring: Monitoring data considered in the assessment were the United States Geological
Survey's (USGS) National Water Quality Assessment Program (NAWQA) groundwater and surface
water database, USGS/EPA reservoir monitoring database, National Drinking Water Contaminant
Occurrence Database (NCOD), and US EPA's Storage and Retrieval environmental data system
(STORET). Review of these databases was conducted to provide peak and median concentrations.
Additionally, the quality of data was evaluated for targeting pesticide use areas, detection limits, and
analytical recoveries. The monitoring data indicate that 2,4-D is detected in groundwater and surface
water. Also, 2,4-D is detected in finished drinking water. Maximum concentrations of 2,4-D in
surface source water and ambient groundwater are 58 ug/L and 14.8 ug/L, respectively. The highest
median 2,4-D concentration of 1.18 ug/L was derived from finished water samples in the NCOD
database. The highest time weighted annual mean (TWAM) concentration was 1.45 ug/L from the
NAWQA database containing nontargeted data reflecting pesticide concentrations in flowing water as
opposed to more stationary bodies of water such as ponds, lakes, and reservoirs.
The PRZM/EXAMS surface water-derived drinking water model estimate that would be
appropriate for acute exposure (118 ug/L) is approximately two times the peak concentration of 58
ug/L detected in the surface water monitoring data evaluated as part of this assessment. However,
since 70 ug/1 is the current maximum contaminant level (MCL) established under the Safe Drinking
Water Act, and is the label-prescribed 2,4-D concentration in treated water to be used for drinking
water, this MCL limit is a reasonable and practical value to be used for the surface water
concentration of 2,4-D for acute risk assessment purposes.
Note that the peak surface water concentration of 58 ug/L is consistent with the 70-ppb label
instruction (also the MCL). Although the surface water monitoring was not specifically targeted to
known 2,4-D- treated sites or even areas of high 2,4-D usage, this agreement suggests that, from a
practical standpoint, the MCL is a reasonable regulatory limit.
Although of high quality, the available monitoring data is not targeted to 2,4-D use. However,
the data provide context to model results and indicate that there is little evidence that concentrations
are likely to be found exceeding these levels.
b. Ground Water
Monitoring: The maximum 2,4-D concentration detected in ground water is 14.89 ug/L based
on the USGS NAWQA program and 8 ug/L based on the NCOD monitoring data. The next highest
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concentration detected in the NAWQA groundwater data is 4.54 ug/L which is consistent with the
NCOD-reported concentration. Therefore, the Agency is using 15 ug/L based on monitoring for the
groundwater EDWC.
c. EDWCs Selected for Risk Assessment
The EDWCs for 2,4-D in surface and ground water are listed in Table 8 below. The EDWCs
were selected from both modeling calculations and monitoring data.
Table 8. Surface and Ground Water Estimated Drinking Water Concentrations (EDWCs)
Drinking Water Source
Surface Water
Ground Water
Duration
Acute (Peak)
Short and Intermediate
Chronic
All Duration
EDWC (ppb)
(ppb = ug/liter)
70 ug/liter (aquatic
applications)
118 ug/liter (terrestrial
applications)
70 ug/liter (aquatic
applications)
64 ug/liter (terrestrial
applications)
1 1 ug/liter (aquatic
application)
23 ug/liter (terrestrial
application)
1 .5 ug/liter (terrestrial
application)
15 ug/liter
Data Source
Maximum Contaminant
Level (MCL)
Modeling - PRZM-
EXAMS (NC apple
scenario)
Maximum Contaminant
Level (MCL)
Modeling - PRZM-
EXAMS (NC apple 1 in
10 year annual average)
Modeling - Dissipation
modeling of aquatic
application
Modeling - PRZM-
EXAMS worst case
terrestrial use (NC apple
scenario)
Monitoring - Maximum
time weighted annual
mean from NAWQA
database
Monitoring - Highest
monitored value from
NAWQA database
4. Residential and Other Non-occupational Exposure
Residential exposure assessment considers all potential pesticide exposure, other than exposure
due to residues in foods or in drinking water. Exposure may occur during and after application on
lawns and turf, golf courses, parks, cemeteries, and other grass areas. Exposure may also occur to
recreational swimmers while swimming in waters treated with 2,4-D for aquatic weeds. Each route
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of exposure (oral, dermal, inhalation) is assessed, where appropriate, and risk is expressed as a
Margin of Exposure (MOE), which is the ratio of estimated exposure to an appropriate NOAEL. 2,4-
D products are marketed for homeowner use on residential lawns and turf. 2,4-D containing products
are also marketed for use by professional applicators on residential turf, golf courses, and on other
turf such as recreational or commercial areas. Based on these uses, 2,4-D has been assessed for the
residential mixing/loading/applicator (or "handler") exposure for applications by homeowners to
home lawns. For post-application exposure, 2,4-D has been assessed for toddlers playing on treated
turf, adults performing yardwork on treated turf, adults playing golf on treated turf, and children and
adults swimming in bodies of water treated with 2,4-D for aquatic weed control.
a. Toxicity
The toxicological endpoints, and associated uncertainty factors used for assessing the non-
dietary risks for 2,4-D are listed in Table 9.
In a dermal absorption study utilizing human volunteers, excretion following dermal application
was 5.8 ± 2.4% and after i.v. administration was 100 ± 2.5%. In previous risk assessments, the
Agency selected a dermal absorption factor of 5.8 percent based on the human dermal absorption
study. Based on comments received during the Phase 5 comment period, this dermal absorption
study and factor were reconsidered. In order to account for the variability observed in the dermal
absorption study, the dermal absorption factor was changed from 5.8 percent to 10 percent. In their
"Re-evaluation of the Lawn and Turf Uses of 2,4-D," which was made available to the public, Health
Canada also selected a factor of 10 percent based upon the weight of evidence from several published
studies, taking into account the variability in the data and the limitations of the various studies. These
studies include the Feldman and Maibach study discussed above and studies from Harris and
Solomon 1992, Moody et. al. 1990, Wester et. al. 1996, and Pelletier et al. 1988.
Chronic endpoints were not used in the residential assessment because chronic occupational and
residential exposures to 2,4-D are not expected to occur. Per the 2,4-D Master Label, the maximum
label frequency for application of 2,4-D to turf is two times per year. 2,4-D also rapidly dissipates
from foliage and is readily excreted from the human body.
A MOE greater than or equal to 1000 is considered adequately protective for the residential
exposure assessment. The MOE of 1000 includes lOx for interspecies extrapolation, lOx for
intraspecies variation, and lOx for a database uncertainty factor. Table 9 lists the toxicity endpoints
selected for assessing residential risk for 2,4-D.
Table 9. Toxicity Endpoints Selected for Assessing Residential Risk for 2,4-D
Exposure
Scenario
Dose Used in Risk
Assessment, UF
Level of Concern for
Risk Assessment
Study and Toxicological Effects
Occupational and Residential Non- Dietary Exposures
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Exposure
Scenario
Short- Term
Incidental Oral (1-30
days)
MRID 00130407,
00130408
Intermediate-Term
Incidental Oral (1-6
months)
MRID 41991501
Short- Term Dermal*
MRID 00130407,
00130408
Intermediate-Term
Dermal*
MRID 00130407,
00130408
Long-Term Dermal*
MRID 436 12001
Short- Term Inhalation*
MRID 00130407,
00130408
Intermediate-Term
Inhalation*
MRID 00130407,
00130408
Long-Term Inhalation*
MRID 436 12001
Cancer
Dose Used in Risk
Assessment, UF
NOAEL= 25 mg/kg/day
UFDB = 10
NOAEL = 15 mg/kg/day
Oral study NOAEL= 25
mg/kg/day
Oral study NOAEL = 15
mg/kg/day
Oral study NOAEL= 5
mg/kg/day
Oral study NOAEL= 25
mg/kg/day
Oral study NOAEL =15
mg/kg/day
Oral study NOAEL= 5
mg/kg/day
Level of Concern for
Risk Assessment
Residential LOG for
MOE =1000
Occupational = NA
Residential LOG for
MOE = 1000
Occupational = NA
Residential LOG for
MOE
= 1000
Occupational LOG for
MOE = 100
Study and Toxicological Effects
rat developmental toxicity study
LOAEL = 75 mg/kg/day based on
decreased maternal body-weight gain
subchronic oral toxicity - rat
LOAEL = 100 mg/kg/day based on
decreased body weight/body-weight gain,
alterations in some hematology, and
clinical chemistry parameters, and
cataract formation.
rat developmental toxicity study
LOAEL = 75 mg/kg/day based on
decreased maternal body-weight gain and
skeletal abnormalities
subchronic oral toxicity - rat (same as for
incidental oral)
rat chronic toxicity study (same as for
chronic dietary)
rat developmental toxicity study (same as
for short-term dermal)
subchronic oral toxicity - rat (same as
incidental oral)
rat chronic toxicity study (same as for
chronic dietary)
Classification: Group D [not classifiable as to human carcinogenicity]
*The dermal absorption factor is 10 percent and the inhalation absorption factor is 100 percent.
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD = reference dose, MOE = margin of
exposure, LOG = level of concern, NA = Not Applicable
b. Residential Handler
1) Exposure Scenarios, Data, and Assumptions
Homeowners (or others) may be exposed to 2,4-D while treating their lawns. All homeowner-
use products are available in liquid or granular form. 2,4-D is applied using hose-end sprayers, pump
sprayers, ready-to-use sprayers, broadcast spreaders, bellygrinders, and hand application, either
before or after seasonal weed emergence, at a rate up to 1.5 Ibs ae/A. A number of assumptions, or
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estimates, such as adult body weight and area treated per application, are made by the Agency for
residential risk assessment. Also, note that residential handlers are addressed somewhat differently
than occupational handlers in that homeowners are assumed to complete all elements of an
application (mix/load/apply) without use of personal protective equipment (assessments are based on
an assumption that individuals will be wearing short pants and short-sleeved shirts).
The quantitative exposure/risk assessment developed for residential handlers is based on these
scenarios:
1) Hand application of granules
2) Belly grinder application
3) Load/apply granules with a broadcast spreader
4) Mix/load/apply with a hose-end sprayer (mix your own)
5) Mix/load/apply with a hose-end sprayer (ready-to-use)
6) Mix/load/apply with hand held pump sprayer
7) Mix/load/apply with ready-to-use sprayer
Exposure estimates for these scenarios are taken from the Pesticide Handlers Exposure
Database (PHED, Version 1.1 August 1998) which is used to assess handler exposures when
chemical-specific monitoring data are not available. In addition to PHED data, the residential risk
assessment relies on data from the Outdoor Residential Exposure Task Force (ORETF) and
proprietary studies. Three turf transferable residue studies submitted by the Broadleaf Turf Herbicide
Turf Transferable Residue (TTR) Task Force. These studies measured the dissipation of several
phenoxy herbicides, including 2,4-D, using the ORETF roller technique. Scenarios #1 through #5 use
ORETF or PHED data; scenarios #6 and #7 use exposure data from the Carbaryl
Mixer/Loader/Applicator Exposure Study (EPA MRID 444598-01).
The results of a biomonitoring study (Harris and Solomon 1992) were also used to calculate
dermal MOEs for post application exposure on turf. The study was conducted with adult volunteers
who were exposed to 2,4-D while performing controlled activities for one hour on turf treated with
2,4-D. The controlled activities were conducted at 1 hour after treatment (HAT) and at 24 HAT. Ten
volunteers participated in the study. Five volunteers wore long pants, a tee shirt, socks and closed
footwear. The other five wore shorts and a tee shirt and were barefoot. The volunteers walked on the
turf for a period of 5 minutes and then sat or lay on the area for 5 minutes and then continued in this
fashion for 50 more minutes. Each volunteer collected all urine for the next 96 hours immediately
following the exposure. The MOEs for the DAT 1 volunteers who wore shorts and no shoes ranged
from 1000 to 26000 with the lowest MOE corresponding to a volunteer who removed his shirt during
the exposure period. The MOEs for the remaining volunteers ranged from 17000 to 27000.
For more information, see "2,4-D. HED's Revised Human Health Risk Assessment for the
Reregistration Eligibility Decision (RED) Revised to Reflect Public Comments. PC Code 030001;
DP Barcode D316597" dated May 12, 2005, and the "2,4-D: 3rd Revised Occupational and
Residential Exposure and Risk Assessment and Response to Public Comments for the Registration
Eligibility Decision (RED) Document" dated May 4, 2005.
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Assumptions Regarding Residential Handlers
• Clothing would consist of a short-sleeved shirt, short pants and no gloves.
• Broadcast spreaders and hose end sprayers would be used for broadcast treatments and the
other application methods would be used for spot treatments only.
• An area of 0.023 acre (1000 square feet) would be treated per application during spot treatments
and an area of 0.5 acre would be treated during broadcast applications.
• The application rate is 1.5 Ib ae/acre representing the most recent revision to the master label.
• Average body weight of an adult handler is 70 kg.
• The duration of exposure is expected to be short-term (1-30 days) for residential handlers of
2,4-D. Intermediate- and long-term exposures of residential applicators are not anticipated
based on 2,4-D 's residential use pattern.
2) Residential Handler Risk Estimates
Based on toxicological criteria and potential for exposure, the Agency has conducted both a
dermal and an inhalation exposure assessment. Risk assessment for short-term inhalation exposure is
based on a rat developmental study. An assumption is made that 100% of the estimated inhalation
dose will be absorbed. A dermal absorption factor of 10 percent was selected for converting dermal
exposures to oral equivalent doses. An MOE greater than or equal to 1000 (lOx for interspecies
extrapolation, lOx for intraspecies variation, and lOx for database uncertainty) is considered
adequately protective for this assessment. Since all residential handler MOEs are greater than 1000,
risk to residential handlers is not of concern. The 2,4-D risk estimates are presented in Table 10
below.
In preliminary versions of the risk assessment, when considered alone, acute and short-term
residential risks posed by the use of 2,4-D were not of concern to the Agency; however, when
considered as part of an aggregate exposure with food and drinking water, exposures did exceed the
Agency's level of concern. As a result, 2,4-D registrants agreed to reduce the maximum application
rate to turf and residential lawns from 2.0 Ibs ae/A to 1.5 Ibs ae/A. The revised application rate (1.5
Ibs ae/A) was used in the current risk assessment.
Table 10. 2,4-D Short Term Risk Estimates for Residential Handlers
Scenario
1 . Hand Application of Granules
2. Belly Gnnder Application
3. Load/Apply Granules with a Broadcast Spreader
4. Mix/Load/Apply with a Hose-end Sprayer (Mix your own)
5. Mix/Load/Apply with a Hose-end Sprayer (Ready to Use)
6. Mix/Load/Apply with Hand Held Pump Sprayer
Application Rate
(Ibs ae/acre)
1.5
1.5
1.5
1.5
1.5
1.5
Treated Area
(acres/day)
0.023
0.023
0.5
0.5
0.5
0.023
MOE
3,700
3,900
29,000
1,800
7,400
11,000
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Scenario
7. Mix/Load/Apply with Ready to Use Sprayer
Application Rate
(Ibs ae/acre)
1.5
Treated Area
(acres/day)
0.023
MOE
7,900
Note: 1000 square feet equals 0.023 acres
For more information, see Appendix F of "2,4-D: 3rd Revised Occupational and Residential
Exposure and Risk Assessment and Response to Public Comments for the Reregistration Eligibility
Decision (RED) Document (PC Code 030001, DP Barcode D316596)" dated May 4, 2005.
c. Residential Postapplication Risk
1) Exposure Scenarios, Data, and Assumptions
2,4-D uses in the residential setting include applications to home lawns. The following
scenarios were assessed for residential post application risks:
1) Toddlers playing on treated turf
2) Adults performing yardwork on treated turf
3) Adults playing golf on treated turf
These scenarios chosen for risk assessment represent what the Agency considers the likely
upper-end estimates of possible exposure. An MOE of 1000 (or more) is considered protective for
this assessment.
Assumptions Regarding Residential Postapplication Risk
• An assumed initial turf transferable residue (TTR) value of 5.0% of the application rate is used
for assessing hand to mouth exposures.
• An assumed initial TTR value of 20% of the application is used for assessing object to mouth
exposures.
• Soil residues are contained in the top centimeter and soil density (i.e., the ratio of the mass of
dry solids to the bulk volume of the soil occupied by those dry solids) is 0.67 gram/mL.
• Three year old toddlers are expected to weigh 15 kg.
• Hand-to-mouth exposures are based on a frequency of 20 events/hour and a surface area per
event of 20 cm2 representing the palmar surfaces of three fingers.
• Saliva extraction efficiency is 50 percent. Every time the hand goes in the mouth
approximately half of the residues on the hand are removed.
• Adults are assessed using a transfer coefficient of 14,500 cm /hour.
• Toddlers are assessed using a transfer coefficient of 5,200 cm /hour.
• Golfers are assessed using a transfer coefficient of 500 cm2/hour.
• An exposure duration of 2 hours per day is assumed for toddlers playing on turf or adults
performing heavy yardwork.
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The following assumptions that are specific to 2,4-D are used for assessing residential post
application exposures.
• The master label application rate of 1.5 Ibs ae/acre was used.
• The exposure following the application of granular formulations was not assessed because there
were no TTR data submitted for granular formulations. It was assumed this exposure would be
less than or equal to the exposure from liquid formulations.
Other residential exposure standard operating procedures (SOPs) may be viewed at the
following website: http: //www. epa. gov/oscpmont/sap/1997/september/sopindex.htm .
Calculation Method for Postapplication Exposure for Toddlers on Treated Turf
MOEs were calculated for acute toddler exposures using the maximum TTR value along with
the acute dietary NOAEL of 67 mg/kg/day. This NOAEL was adapted to acute dermal exposures by
using the dermal absorption factor of 10 percent to account for route to route extrapolation. The
MOEs for toddler short term exposures were calculated using the seven day average TTR value
because the short term NOAEL was based upon decreased body weight gain which occurred after
several days of exposure. MOEs for acute and adult short term exposures were calculated using the
maximum TTR value because the acute and short term NOAELs are the same and are based upon the
developmental effects which could have occurred following one day of exposure.
The quantitative exposure/risk assessment for postapplication risk to children is based on these
scenarios:
1) Dermal activity from treated turf: Postapplication exposure to children from the dermal
exposure of pesticide residues from activity on treated turf.
2) Hand-to-mouth activity from treated turf: Postapplication exposure to children from the
"incidental" ingestion of pesticide residues on treated turf from hand-to-mouth transfer
(i.e., those residues that end up in the mouth from children touching turf and then putting
their hands in their mouths).
3) Object-to-mouth activity from treated turf: Postapplication exposure to children from
incidental ingestion of pesticide residues on treated turf from object-to-mouth transfer
(i.e., those residues that end up in the mouth from a child mouthing a handful of treated
turf).
4) Soil ingestion activity: Postapplication exposure to children from incidental ingestion of
soil in a treated area.
For more information on formulas used for calculating occupational and residential exposures
to 2,4-D, see Appendix A of "2,4-D: 3rd Revised Occupational and Residential Exposure and Risk
Assessment and Response to Public Comments for the Reregistration Eligibility Decision (RED)
Document" dated May 4, 2005.
2) Postapplication Risk Estimates
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Risk assessment for children's postapplication exposure is based on a NOAEL of 67 mg/kg/day
from an oral study of acute neurotoxicity study in rats. A Margin of Exposure (MOE) of 1000 (lOx
for interspecies extrapolation, lOx for intraspecies variation, and lOx for database uncertainty) is
considered adequately protective for this assessment. Table 11 below presents the MOEs for Post-
Application Exposure in Children. Since all MOEs meet or exceed 1000, postapplication exposure to
children is not of concern.
Table 11. Children Post-Application Exposure to Turf Treated with 2,4-D
Application Rate
(Ibs ae/acre)
Dermal
MOE
Hand-to Mouth
MOE
Object to
Mouth MOE
Soil Ingestion
MOE
Total
MOE
Acute Toddler Risks Using the Maximum TTR (North Carolina Tnal 1 using 2,4-D DMA)
DATO
1.5
1,900
3000
12,000
>100,000
1,100
Short Term Toddlers Risks Using California TTR Data (DMA Mix, No Ram)
DAT 0 to
DAT 6
1.5
3,900
2,100
8,500
> 100,000
1,200
Short Term Toddler Risks Using North Carolina TTR Data from Trial 1 (DMA and DMA Mix, No Rain)
DAT 0 to
DAT 6
1.5
5,100
4,400
18,000
> 100000
2,100
Short Term Toddler Risks Using North Carolina TTR Data from Trial 2 (DMA Mix, Some Rain)
DAT 0 to
DAT 6
1.5
12,000
7,000
28,000
> 100000
3,900
The acute NOAEL is 67 mg/kg/day for neurotoxic effects observed in the acute neurotoxicity study.
The short term NOAEL is 25 mg/kg/day for maternal effects observed in the developmental study.
Table 12 below lists the adult acute/short term MOEs for exposure to turf treated with 2,4-D.
The acute/short term NOAEL is 25 mg/kg/day from the rat developmental toxicity study. The
LOAEL was 75 mg/kg/day based on skeletal abnormalities from a developmental toxicity study in
rats. All MOEs meet or exceed 1000, so postapplication exposure to adults is not of concern.
Table 12. Adult Acute/Short Term MOEs for Exposure to Turf Treated with 2,4-D
Exposure Scenario
Heavy Yardwork
Playing Golf
Application Rate
(Ibs ae/acre)
1.5
TTR (ug/cm2)
0.50
Acute/Short Term Dermal MOE1
on Day 0
1000
15000
1 The acute/short term NOAEL is 25 mg/kg/day for developmental effects observed in the developmental study.
d. Recreational Swimmer Risk
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1) Exposure Scenarios, Data, and Assumptions
The master label indicates that 2,4-D can be used for aquatic weed control of surface weeds
such as water hyacinth and submersed weeds such as Eurasian milfoil. Surface weeds are controlled
by foliar applications at a maximum rate of 4.0 Ib ae/acre. Submersed weeds are controlled by
subsurface injection of liquids to achieve a target concentration of 2 to 4 ppm in the water column
surrounding the weeds. This requires 5.4 to 10.8 Ib ae per acre foot of water depth (e.g., 5.4 Ibs ae
would be required to achieve 2 ppm in a one acre pond that has an average depth of 1 foot). Granular
formulations of BEE (Aquakleen and Navigate) are also used to control submersed weeds. The
granular formulations resist rapid decomposition in water and release the herbicide into the root zone.
Although many herbicide treatments are applied to aquatic areas where recreational swimming
is not likely to occur, some of the subsurface treatments are made at recreational lakes. These
treatments are made because the Eurasian milfoil interferes with recreation and other activities. This
problem is particularly prevalent in the northern states such as Minnesota and Washington and in the
New England region.
The following exposure scenarios are assessed for recreational swimmers:
1) Adult Recreational Swimmer
2) Child Recreational Swimmer
Assumptions Regarding Recreational Swimmer Risk
The following assumptions were used for the assessment of swimmer risks. Many of these
assumptions were taken from the Residential SOPs and are also used in the SWIMODEL.
fj
• The skin surface area of adults is assumed to be 21,000 cm (Residential SOPs). This is
the 95th percentile value for females (EPA Exposure Factors Handbook, 1997).
• The body weight for children is assumed to be 22 kg as cited in the Residential SOPs.
This is a mean value for 6 year old children.
• The skin surface area for children is assumed to be 9,000 cm2 as cited in the Residential
SOPs. This is the 90th percentile value for male and female children.
• The assumed mean ingestion rate is 0.05 liters per hour for both adults and children as
cited in the Residential SOP. This value may be greater for young children playing in
water and accidentally ingesting a remarkable quantity of water (U.S. EPA SAP, 1999).
• The exposure time is assumed to be 3 hours per day. This is the 90th percentile value for
time spent swimming in a freshwater pool (EPA Child Specific Exposure Factors
Handbook, 2002).
• The body weight for female adult acute exposures is assumed to be 60 kg.
• The body weight for male adult acute exposures is assumed to be 70 kg.
• The body weight for adult short term exposure is assumed to be 60 kg because the
endpoint is gender specific.
• Risks were not calculated for foliar treatments because the application rate of 2.0 Ib
ae/acre would result in water concentration of only 0.25 ppm in a three foot water column
Page 3 5 of 304
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even if all of the spray were to run off the leaves into the water.
Calculation Method for Recreational Swimmer Exposure
The Agency used the Swimmer Exposure Assessment Model (SWIMODEL) to calculate
exposures to swimmers in water treated with 2,4-D for aquatic weed control. The SWIMODEL
estimates exposure for up to six exposure routes (i.e., oral ingestion, dermal absorption, inhalation,
buccal/sublingual, nasal/orbital, and aural routes), or calculates exposure as a function of any one of
the three major exposure routes (i.e., oral ingestion, dermal absorption, or inhalation). Other factors
used in the SWIMODEL formulae for dermal and ingestion exposure which are described in
Appendix A of "2,4-D: 3rd Revised Occupational and Residential Exposure and Risk Assessment and
Response to Public Comments for the Reregistration Eligibility Decision (RED) Document" dated
May 4, 2005.
The SWIMODEL formulas for the other dermal pathways (aural, buccal/sublingual and
orbital/nasal) were not used in the 2,4-D human health risk assessment because these formulas are
based upon recreational swimmers in swimming pools who swim with their heads partially immersed.
It is anticipated that recreational swimmers in weed infested areas would be less likely to swim with
their heads immersed than recreational swimmers in weed- free swimming pools. In addition, the
formulas for the buccal/sublingual and orbital/nasal pathways contain a default absorption factor of
0.01 which is based upon the absorption of nitroglycerin. This factor would greatly overestimate the
risk of 2,4-D exposure because 2,4-D is absorbed at a much lower rate.
Because the 2,4-D water concentrations can vary depending upon the application rate and site
conditions the Maximum Swimming Water Concentration (MSWC) was calculated. The MSWC is
the water concentration at which the combined dermal and ingestion MOE meets or exceeds the
target MOE of 1000. The MSWCs were calculated for children's acute exposures using the acute
NOAEL of 67 mg/kg/day and the MSWCs for children's short term exposures were calculated using
the short term NOAEL of 25 mg/kg/day for maternal effects. The MSWCs for adult acute/short term
exposures were calculated using a NOAEL of 25 mg/kg/day that is based upon developmental effects
which could have occurred following one day of exposure.
2) Recreational Swimmer Risk Estimates
The MSWCs are summarized in Table 13 and the detailed calculations are included in
Appendix H of the 3rd Revised Occupational and Residential Exposure Assessment for 2,4-D. The
acute MSWCs range from 1.2 ppm for 2,4-D BEE to 9.8 ppm for 2,4-D acid while the short term
MSWCs range from 0.9 ppm for 2,4-D BEE to 3.6 ppm for 2,4-D acid or amine. The MSWCs for
2,4-D BEE are lower because based on its chemical properties, 2,4-D BEE is expected to have a
much higher dermal absorption value.
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Table 13. Maximum Swimming Water Concentrations for 2,4-D Aquatic Applications
Exposure Duration
NOAEL
(mg/kg/day)
2,4-D Form
2,4-D MSWC*
(ppm)
Dermal
MOE
Ingestion
MOE
Combined
MOE
Adults
Acute/Short Term
25
25
Acid or Amine
BEE
9.8
1.2
97000
1200
1000
8300
1000
1000
Children
Acute
Acute
Short Term
Short Term
67
67
25
25
Acid or Amine
BEE
Acid or Amine
BEE
9.8
2.4
3.6
0.90
425000
1300
230000
1300
1000
4100
1000
4100
1000
1000
1000
1000
* The MS WC is the concentration below which the combined MOE would be above 1000 and the risks would not be of
concern.
The Acute MSWC of 9.8 ppm for exposures to 2,4-D acid or amine is greater than the master
label application rate of 4.0 ppm, therefore, acute exposures to 2,4-D acid or amine are not of
concern. The MSWC of 3.6 ppm for short-term exposures to 2,4-D acid or amine is also not of
concern because some dissipation or dispersion is likely to occur which would cause the 7-day
average of 2,4-D concentrations to be less than 3.6 ppm. Dissipation studies submitted to EFED
indicated that the half lives following pond and lake liquid treatments ranged from 3.2 days to 27.8
days which yield 7 day average concentrations of 1.9 ppm when the half life equals 3.2 days to 3.6
ppm when the half life equals 27.8 days.
The MSWCs for 2,4-D BEE are less than the master label application rate of 4 ppm, but they
are unlikely to be of concern for the following reasons:
• 2,4-D BEE degrades rapidly by abiotic hydrolysis in sterile water to form 2,4-D acid
particularly when the pH is 7.5 or above.
• 2,4-D BEE degrades to 2,4-D acid by microbial hydrolysis with an average half life of 2.6 +
1.8 hours at a bacterial concentration of 5 x 10~8 organisms per liter. Therefore, degradation of 2,4-D
BEE to 2,4-D under typical environmental conditions will be rapid leading to significantly lower risk
estimates because the 2,4-D acid has a lower rate of dermal absorption.
• Modeling predicts direct water application of 2,4-D BEE will yield surface water concentrations
of 2,4-D BEE concentrations in the Agency standard pond of 624 ug/L for peak (24 hour average), 30
ug/L for the 21-day average, and 10 ug/L for the 60-day average.
• The existing label rates for 2,4-D BEE products are also lower than the master label rate.
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5. Aggregate Exposure and Risk
OPP has traditionally compared estimates of concentrations of a pesticide in drinking water to
DWLOCs. A DWLOC is the portion of the acute PAD or chronic PAD remaining after estimated
dietary (food only) exposures have been subtracted and the remaining exposure has been converted to
a concentration (ug/L or ppb). This concentration value (DWLOC) represents the available or
allowable exposure through drinking water. In an acute risk assessment, the remaining portion of the
aPAD is based on dietary exposures at the percentile of exposure appropriate for a given risk
assessment and depends on each relevant population subgroup considered. Estimated Drinking
Water Concentrations (EDWCs) of 2,4-D in ground and surface water that are less than the DWLOCs
do not exceed the Agency's level of concern. DWLOC values vary for population subgroups
depending on dietary exposure through foods for each subgroup, assumptions made about the volume
of drinking water consumed, and default body weights for each subgroup.
More recently, OPP has adopted the forward calculation approach for the assessment of
aggregate risks. In this approach, food, drinking water and residential exposures are aggregated and
compared to an appropriate endpoint.
In the case of 2,4-D, the DWLOCs were calculated for comparison to the MCL established by
the EPA Office of Water and aggregate risks were calculated using the forward calculation approach
for comparison to the appropriate endpoint. The respective DWLOCs and aggregate risks are shown
for acute, chronic and short term exposures in the following sections.
a. Acute Aggregate Risk Assessment
DWLOC Approach
Acute DWLOCs were calculated based upon acute dietary exposures. Acute residential
exposures from swimming in treated water bodies or playing on treated turf were not included
because exposures are unlikely to co-occur with acute dietary exposures. The acute DWLOCs are
summarized in Table 14 and are 432 ppb or greater with the most sensitive population being females
13-49 years old. The EDWCs of 118 ug/liter for surface water and 15 ug/liter for groundwater are
substantially less than the DWLOCs which means that the risks are not of concern.
Page 3 8 of 304
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Table 14. Acute DWLOC Calculations
Population
Subgroup
General U.S.
Population
All Infants (< 1
year old)
Children 1-2
years old
Children 3-5 years
old
Children 6- 12
years old
Females 13-49
years old
Body Weight
(kg)
70
10
10
10
10
60
Water
Consumption
(liters/day)
2.0
1.0
1.0
1.0
1.0
2.0
aPAD
(mg/kg/day)
0.067
0.025
Food Exp1
(mg/kg/day)
0.0118
0.0132
0.0221
0.0206
0.0147
0.0106
Max Water
Exposure
(mg/kg/day )
0.0552
0.0538
0.0449
0.0464
0.0523
0.0144
DWLOC
(^g/L)3
1932
538
449
464
523
432
1. Food exposure values are the maximum of the acute DEEM or Lifeline values.
2 . Maximum water exposure (mg/kg/day) = [(acute PAD - food exposure)]
3. DWLOC (ug/L) = [maximum water exposure x body weight] ^ [water consumption x 10"3 mg/ug].
Surface Water EDWC = 70 ug/liter (aquatic applications) or 1 18 ug/liter (terrestrial applications)
Ground Water EDWC = 15 ug/liter
Forward Calculation Approach
Acute aggregate risks were assessed by aggregating acute food exposures and acute water
exposures. The acute aggregate risks are presented in Table 15 and are not of concern because they
are less than 100 percent of the aPAD. The highest risks (58 percent of the aPAD) are for females 13-
49 years old because these risks are based upon the lower NOAEL of 25 mg/kg/day.
Table 15. 2,4-D Aggregate Acute MOEs
Population
Subgroup
General U.S.
Population
Females 13-49 yrs old
Body
Weight
(kg)
70
60
Water
Consumption
(liters/day)
2.0
2.0
Food
Exposure
(mg/kg/day)
0.0118
0.0106
Drinking
Water
Exposure"
(mg/kg/day)
0.00337
0.0039
Aggregate
Exposure
(mg/kg/day
)
0.0152
0.015
aPAD4
(mg/kg/day
)
0.067
0.025
Percent
aPAD5
23
58
Notes for Table X
1 . Food exposure values are the maximum of the DEEM or Lifeline acute values .
2. Drinking Water Exposure = (EDWC * daily water consumption) / (1000 ug/mg * Body Weight ); where the EDWC = 118 ug/liter
3. Aggregate Exposure = Food Exposure + Drinking Water Exposure
4. aPAD = NOAEL/1000; where the NOAEL is 25 mg/kg/day for females 13-49 and 67 nig/kg/day for all other population subgroups
5. Percent aPAD = (Aggregate Exposure/aPAD) * 100
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b. Chronic Aggregate Risk Assessment
DWLOC Approach
Chronic DWLOCs were calculated based upon chronic dietary exposures. As there are no
chronic residential exposures, residential exposures were not included in the chronic DWLOC
calculations. The chronic DWLOCs are summarized in Table 16 and are 46 ug/liter or greater with
the most sensitive population being children. The EDWCs, which range from 1.5 to 23 ug/liter, are
less than the DWLOCs which means that the risks are not of concern. It should be noted that the
master label indicates that potable water consumption from a treated water body cannot begin until
the 2,4-D concentration is 70 ug/liter or below, therefore an annual average exposure at the MCL of
70 ug/liter would not occur because dissipation would reduce the initial concentration of 70 ug/liter to
an annual average concentration of 11 ug/liter.
Table 16. Chronic DWLOC Calculations
Population Subgroup
General U.S. Population
All Infants (< 1 year old)
Children 1-2 years old
Children 3-5 years old
Children 6-12 years old
Youth 13-19 years old
Adults 20-49 years old
Adults 50+ years old
Females 13 -49 years old
Body
Weight
(kg)
70
10
10
10
10
60
70
70
60
Water
Consumption
(liters/day)
2.0
1.0
1.0
1.0
1.0
2.0
2.0
2.0
2.0
cPAD
(mg/kg/day)
0.005
Food Exp
(mg/kg/day)
0.00020
0.00016
0.00042
0.00037
0.00026
0.00019
0.00019
0.00018
0.00020
Max Water
Exposure
(mg/kg/day)
0.0048
0.00484
0.00458
0.00463
0.00474
0.00481
0.00481
0.00482
0.0048
DWLOC
(^g/L)3
168
48
46
46
47
144
168
169
144
1. Food exposure values are the maximum of the DEEM or Lifeline chronic dietary values.
2. Maximum water exposure (mg/kg/day) = [(chronic PAD - food exposure)]
3. DWLOC (ug/liter) = [maximum water exposure x body weight] - [water consumption x 10"3 mg/ug].
Surface Water EDWC (maximum time weighted annual mean from the NAWQA database) = 1.5 ug/liter
Surface Water EDWC (dissipation modeling of aquatic application when 70 ppb occurs at time zero) =11 ug/liter
Surface Water EDWC (worst case terrestrial use PRZM-EXAMs run) = 23 ug/liter
Ground Water EDWC (the highest monitored value from the NAWQA database) =15 ug/liter
Forward Calculation Approach
Chronic aggregate risks were also assessed by aggregating chronic food exposures and chronic
water exposures in a forward calculation approach. The chronic aggregate risks are presented as
percent cPAD in Table 17 and are not of concern because they are less than 100 percent of the cPAD.
The highest risks (38 percent of the cPAD) are for children 1-2 years old.
Table 17. 2,4-D Aggregate Chronic Risks
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Population Subgroup
General U.S. Population
Children 1-2 yrs old
Body
Weight
(kg)
70
10
Water
Consumption
(liters/day)
2.0
1.0
Food
Exposure
(mg/kg/day)
0.00020
0.00042
Drinking
Water
Exposure"
(mg/kg/day)
0.00043
0.0015
Aggregate
Exposure
(mg/kg/day
)
0.0006
0.002
cPAD4
(mg/kg/day
)
0.005
0.005
Percent
cPAD5
13
38
1. Food exposure values are from Table X and are the maximum of the DEEM or Lifeline chronic dietary values.
2. Drinking Water Exposure = (EDWC * daily water consumption)/ (1000 ug/mg * Body Weight ); where the EDWC = 15 ug/liter
3. Aggregate Exposure = Food Exposure + Drinking Water Exposure
4. cPAD = NOAEL of 5 mg/kg/day / 1000
5. Percent cPAD = (Aggregate Exposure/aPAD) * 100
c. Short-term Aggregate Risk Assessments
DWLOC Approach
Short-term aggregate risks assessments were conducted by calculating DWLOCs based upon
short term turf exposures, chronic food exposures and short term endpoints. Short-term exposures
from swimming in treated water bodies were not included because these exposures represent episodic
scenarios that are unlikely to occur the same day as an acute dietary exposure. The short-term
DWLOCs were calculated only for females 13-49 and children 1-6 because these population
subgroups have the highest exposure and are protective of the other subgroups. The DWLOCS are
listed in Table 18 and range from 24 to 54 ug/liter. These DWLOCs are all greater than the EDWCs,
which range from 15 to 23 ug/liter, and indicate that short term risks are not of concern.
Table 18. Short-Term DWLOC Calculations for 2,4-D
Pop.
Subgroup
Children 1-6
Females 13-
49
Body
Weight
(kg)
15
60
Water
Consumption
(liters/day)
1.0
2.0
NOAEL/UF
(mg/kg/day)
0.025
0.025
Turf
Exposure
(mg/kg/day)
0.021
0.024
Food Exp1
(mg/kg/day)
0.00042
0.00020
Max Water
Exposure
(mg/kg/day)2
0.00358
0.00080
DWLOC
(^g/L)3
54
24
1. Food exposure values are the maximum of the DEEM or Lifeline chronic dietary values.
2 Maximum water exposure (mg/kg/day) = [(NOAEL/UF) - (Turf exposure + food exposure)]
3. DWLOC (ug/liter) = [maximum water exposure x body weight] — [water consumption x 10"3 mg/ug].
Surface Water EDWC (worst case terrestrial use PRZM-EXAMs run) = 23 ug/liter
Ground Water EDWC (based upon the highest monitored value) =15 ug/liter
Forward Calculation Approach
Short-term aggregate risks were also assessed by directly aggregating short-term turf exposures,
chronic food exposures and chronic water exposures. Short-term aggregate risks were calculated only
for females 13-49 and children 1-6 because these population subgroups have the highest exposure and
are protective of the other subgroups. The short term aggregate MOEs are presented in Table 19 and
indicate that the short term risks are not of concern because the MOEs equal or exceed the target
MOEof 1000.
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Table 19. 2,4-D Aggregate Short-Term MOEs Including Turf Exposures
Population
Subgroup
Females 13-49
Children 1 - 6
Females 13 -49
Children 1 - 6
Turf
Application
Rate
(Ibs ae/acre)
1.5
1.5
1.5
1.5
Chronic
Food
Exposure"
(mg/kg/day)
0.000195
0.000424
0.000195
0.000424
Short-Term
Turf
Exposure
(mg/kg/day)
0.024
0.021
0.024
0.021
Chronic
EDWC4
(ug/liter)
15
15
23
23
Drinking
Water
Exposure'
(mg/kg/day)
0.00050
0.0010
0.00077
0.0015
Aggregate
Exposure
(mg/kg/day)
0.0247
0.0224
0.0250
0.0230
Aggregate
MOE7
1000
1100
1000
1100
1. Body weights are 60 kg (females) and 15 kg (children). Water consumption values are 2 liter/day (females) and 1.0 liter/day (children).
2. The food exposure for females is from Lifeline. The food exposure for children is from DEEM and is for 1-2 year old children
3. Female's turf exposures are from the dermal route only. Children's turf exposures are from the dermal and incidental oral routes.
4. ED WC is 1 5 ug/liter for ground water and 23 ug/liter for surface water.
5. Drinking Water Exposure = (EDWC * daily water consumption) / (1000 ug/mg * Body Weight )
6. Aggregate Exposure = Turf Exposure + Food Exposure + Drinking Water Exposure
7. Aggregate MOE = NO AEL/ Aggregate Exposure where the NOAEL is 25 mg/kg/day.
d. Cancer Aggregate Risk
2,4-D was classified as a Category D chemical, i.e., not classifiable as to human
carcinogenicity, by the EPA/OPP Cancer Peer Review Committee in 1996. Thus, no aggregate
cancer assessment is warranted.
e. Aggregate Risk Characterization
The highest aggregate risks are the short term risks that include the turf exposure scenarios.
For the most sensitive subpopulation (females 13 -49), these risks j ust meet the target MOE of 1000
and the turf exposure is the risk driver as it contributes 96 percent of the risk. It is important to note,
however, that the turf exposure estimate is based upon modeling and is greater than exposure
measurements obtained from biomonitoring. The results of a biomonitoring study (Harris and
Solomon 1992) were also used to calculate dermal MOEs for post application exposure on turf. The
study was conducted with adult volunteers who were exposed to 2,4-D while performing controlled
activities for one hour on turf treated with 2,4-D. The controlled activities were conducted at 1 hour
after treatment (HAT) and at 24 HAT. Ten volunteers participated in the study. Five volunteers wore
long pants, a tee shirt, socks and closed footwear. The other five wore shorts and a tee shirt and were
barefoot. The volunteers walked on the turf for a period of 5 minutes and then sat or lay on the area
for 5 minutes and then continued in this fashion for 50 more minutes. Each volunteer collected all
urine for the next 96 hours immediately following the exposure. The MOEs for the DAT 1
volunteers who wore shorts and no shoes ranged from 1000 to 26000 with the lowest MOE
corresponding to a volunteer who removed his shirt during the exposure period. The MOEs for the
remaining volunteers ranged from 17000 to 27000. If the calculated MOE of 1000 is considered in
conjunction with the biomonitoring results, it is clear that the short term risks are upper bound
estimates and not likely to be of concern.
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6. Occupational Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying a pesticide, or
re-entering treated sites. Occupational handlers of 2,4-D include workers in agricultural areas,
workers in forest areas, workers in rights-of-way and non-cropland areas, workers in lawn and turf
areas (including turf grown for seed or sod), and workers applying 2,4-D for aquatic weed control.
Occupational risk for all of these potentially exposed populations is measured by an MOE which
determines how close the occupational exposure comes to a NOAEL. In the case of 2,4-D, MOEs
greater than 100 do not exceed the Agency's level of concern. For workers entering a treated site,
MOEs are calculated for each day after application to determine the minimum length of time required
before workers can safely reenter.
Occupational risk estimates are expressed as MOEs, which are the ratio of estimated exposure
to an established dose level (NOAEL). 2,4-D MOEs are determined by a comparison of specific
exposure scenario estimates to the NOAELs for short-term assessment and intermediate-term
assessment, respectively. The NOAEL for short-term dermal and inhalation exposure is 25
mg/kg/day from a rat developmental toxicity study, and the NOAEL for intermediate-term dermal
and inhalation exposure is 15 mg/kg/day from a rat subchronic oral toxicity study. The dermal
absorption factor is 10 percent and the inhalation absorption factor is 100 percent. For 2,4-D users an
MOE of 100 has been determined to be adequately protective (for both short- and intermediate-term
exposure) based on the standard uncertainty factors of lOx for interspecies extrapolation and lOx for
intraspecies variability. Long-term worker exposure is not expected for 2,4-D.
Occupational risk is assessed for exposure at the time of application (termed "handler"
exposure) and assessed for exposure following application, or postapplication exposure. Application
parameters are generally defined by the physical nature of the formulation (e.g., formula and
packaging), by the equipment required to deliver the chemical to the use site, and by the application
rate required to achieve an efficacious dose. Post-application risk is assessed for activities such as
scouting, irrigating, pruning, and harvesting and is based primarily on dermal exposure estimates.
Occupational risk estimates are calculated based on assumptions concerning acres treated per
day and the seasonal duration of exposure. For more information on the assumptions and calculations
of potential risk of 2,4-D to workers, see the Occupational Exposure Assessment (Section 7.0) in
"2,4-D: 3rd Revised Occupational and Residential Exposure and Risk Assessment and Response to
Public Comments for the Reregistration Eligibility Decision (RED) Document," dated May 4, 2005.
a. Occupational Toxicity
Table 20 provides a listing of the toxicological endpoints used in the 2,4-D occupational risk
assessment.
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Table 20. Toxicological Endpoints for the Occupational Risk Assessment
Exposure
Scenario
Short- Term Dermal*
Intermediate-Term
Dermal*
Long- Term
Dermal*
Short- Term
Inhalation*
Intermediate-Term
Inhalation*
Long- Term
Inhalation*
Cancer
Dose Used in Risk
Assessment, UF
Oral study NOAEL=
25 mg/kg/day
Oral study NOAEL = 15
mg/kg/day
Oral study NOAEL=
5 mg/kg/day
Oral study NOAEL= 25
mg/kg/day
Oral study NOAEL = 15
mg/kg/day
Oral study NOAEL= 5
mg/kg/day
Level of Concern
for Risk
Assessment
Occupational
LOC for MOE -
100
Study and Toxicological Effects
Rat developmental toxicity study
LOAEL = 75 mg/kg/day based on decreased maternal
body-weight gain and skeletal abnormalities
Subchronic oral toxicity - rat
LOAEL =100 mg/kg/day based on decreased body
weight/body-weight gain, alterations in some
hematology, and clinical chemistry parameters, and
cataract formation.
Rat Chronic Toxicity Study
LOAEL = 75 mg/kg/day based on decreased body-
weight gain (females) and food consumption (females),
alterations in hematology , and clinical chemistry
parameters, decreased T4 (both sexes), glucose
(females), cholesterol (both sexes), and triglycerides
(females)].
Rat developmental toxicity study (same as for dermal)
Subchronic oral toxicity - rat (same as incidental oral)
Rat chronic toxicity study (same as for chronic dietary)
Classification: Group D [not classifiable as to human carcinogenicity]
*The dermal absorption factor is 10 percent and the inhalation absorption factor is 100 percent.
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse
effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD = reference dose, MOE = margin of exposure, LOG = level of concern, NA
= Not Applicable
For more occupational toxicity information, see "2,4-D: HED's Revised Human Health Risk
Assessment for the Reregistration Eligibility Decision (RED) Revised to Reflect Public Comments,"
dated January 4, 2005.
b. Occupational Handler Exposure
Occupational handler risk estimates have been assessed for both short- and intermediate-term
exposure durations. Because 2,4-D is typically applied only a few times per season and because the
agricultural scenarios occur for only a few months per year, it is anticipated that 2,4-D exposures
would primarily be short-term. Intermediate-term risk estimates are provided as an upper-bound
assessment.
Occupational handler assessments are conducted using increasing levels of protection. The
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Agency typically evaluates all exposures with minimal protection and then considers additional
protective measures using a tiered approach (going from minimal to maximum levels of protection).
The lowest tier is represented by the baseline clothing scenario (i.e., single layer clothing, socks, and
shoes), followed by, if MOEs are of concern, increasing levels of risk mitigation such as personal
protective equipment (PPE) and engineering controls (EC). With the exception of mixing and
loading wettable powders, MOEs for most occupational exposure scenarios are above 100 at baseline
PPE (long-sleeved shirt, long pants, socks, and shoes) or single layer PPE (long-sleeved shirt, long
pants, socks, shoes, and gloves). The MOEs for handling wettable powder are acceptable with
engineering controls (i.e. water soluble bags). While the generic assessment for 2,4-D as an active
ingredient does not indicate a need for additional PPE, evaluation of end-use product toxicity data
may. End-use product PPE will be assessed on a product-by-product basis.
c. Occupational Handler Risk Summary
The Agency has determined that there are potential exposures to individuals who mix, load,
apply, and otherwise handle 2,4-D during the usual use patterns associated with the pesticide's use.
Based on the use patterns, 18 major occupational handler exposure scenarios were identified as
follows:
Mixer/Loader
(la) Mix/Load Wettable Powder for Aerial Application
(Ib) Mix/Load Wettable Powder for Groundboom Application
(Ic) Mix/Load Wettable Powder for Aquatic Subsurface Application
(le) Mix/Load Wettable Powder for 10 Man Crew Backpack Application
(If) Mix/Load Wettable Powder for Row Sprayer
(Ig) Mix/Load Wettable Powder for Aquatic Foliar Application
(Ih) Mix/Load Wettable Powder for Turfgun Application
(2a) Mix/Load Liquids for Aerial Application
(2b) Mix/Load Liquids for Groundboom
(2c) Mix/Load Liquids for Aquatic Subsurface Application
(2d) Mix/Load Liquids for Airblast Application
(2e) Mix/Load Liquids for 10 Man Crew Backpack Application
(2f) Mix/Load Liquids for Row Sprayer
(2g) Mix/Load Liquids for Aquatic Foliar Application
(2h) Mix/Load Liquids for Turfgun Application
(3) Load Granules for Broadcast Spreader
Applicator
(4) Aerial Application
(5) Groundboom Application
(6) Subsurface Application of Liquids to Submersed Aquatic Weeds
(7) Airblast Application
(8) Backpack Application
(9) Rights of Way (ROW) Application
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(10) Foliar Application of Liquids to Floating Aquatic Weeds
(11) Turfgun Application
(12) Broadcast Spreader Application
Mixer/Loader/Applicator
(13) Mix/Load/Apply Wettable Powder with a Turfgun
(14) Mix/Load/Apply Liquids with a Turfgun
(15) Mix/Load/Apply Water Dispersable Granules with a Turfgun
(16) Mix/Load/Apply Liquids with a Backpack Sprayer
(17) Load/Apply Granules with a Push Spreader
(18) Flag Aerial Application
Occupational Handler Exposure Assumptions
When possible, the assumptions for daily areas treated are taken from the Health Effects
Division Science Advisory Committee on Exposure Policy 9: Standard Values for Daily Acres
Treated in Agriculture (July 5, 2000). In other instances, the daily areas treated were defined for each
handler scenario by best scientific judgement, or the best information available, as footnoted below in
Table 21.
Analyses were completed using acceptable surrogate exposure data for the scenario assessed.
Several handler assessments were completed using data from the Pesticide Handler Exposure
Database (PHED) (version 1.1). PHED data were used primarily for the large scale agricultural and
forestry scenarios. Some handler assessments (i.e., handheld handgun equipment, push-type spreader,
and other lawn care scenarios) were completed using data from the Outdoor Residential Exposure
Task Force (ORETF). California Department of Pesticide Regulation (CA DPR) data were used for
the backpack applicator forestry scenario where multiple applicators are supplied by a nurse tank.
The following assumptions and factors were used in order to complete the exposure and risk
assessments for occupational handlers and applicators:
• The average work day was 8 hours.
• A listing of application methods and amounts of acreage treated per 8 hour day is
included in Table 22 and Table 23.
• The application rate for submerged aquatic weeds is based upon the master label rate of
10.8 Ibs a.e. per acre foot times an average lake depth of 5 feet.
• Maximum application rates and daily acreage were used to evaluate short term exposures.
• Average application rates were used to evaluate intermediate term exposures.
• A body weight of 60 kg was assumed for short-term exposures because the short-term
endpoint relates to females 13-50 years of age.
• A body weight of 70 kg was assumed for intermediate-term exposures because the
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intermediate-term endpoint is not gender-specific.
• The dermal absorption rate is 10%.
• The inhalation absorption rate is 100%.
• Baseline PPE includes long sleeve shirts, long pants and no gloves or respirator.
• Single Layer PPE includes baseline PPE with gloves.
• Double Layer PPE includes coveralls over single layer PPE.
• Double Layer PPE PF5 includes above with a PF5 respirator (i.e. a dustmask).
• Double Layer PPE PF10 includes above with a PF10 cartridge respirator.
• Only closed cockpit airplanes are used for aerial application.
• There are very little exposure data to evaluate the exposure in helicopters; therefore, the
exposure data for fixed-wing aircraft are used as a surrogate.
• Airplane and helicopter pilots do not wear chemical resistant gloves.
Table 21. 2,4-D Application Methods and Assumptions
Application Method
Aenal
Groundboom
Subsurface Application of Liquids
Airblast
Backpack Sprayer - Mix/Load/Apply
Backpack Sprayer - Apply Only
Right of Way (ROW) Sprayer
Foliar Application of Liquids
Broadcast Spreader - Tractor Drawn or Boat
Mounted
Turf gun
Broadcast Spreader - Push Type
Typical Crops Treated
Small Grain, Field Corn, Sugarcane
Citrus Growth Regulation
Small Grams, Field Com, Sugarcane
Orchard/Vineyard Floors
Strawbemes
Submersed Aquatic Weeds
Citrus Growth Regulation
Christmas Tree Plantations
Conifer Release
Weed Control - 20 gallons per acre
Brush Control - 400 gallons per acre
Floating Aquatic Weeds
Turf
Submersed Aquatic Weeds
Turf
Turf
Treated Area
1200
350
200
80
80
302
40
23
44
505
2.55
106
40
507
5
5
1. Except as noted, the acres treated per day values are from ExpoSAC Policy #9 "Standard Values for Daily Acres
Treated in Agriculture", Revised 7/5/2000.
2. The area treated for aquatic application of liquids to submersed aquatic weeds is based on information provided in an
email of 12/11/03 from Dr. Kurt Getsinger of the US Army Corps of Engineers to Timothy C. Dole of the US EPA Office
of Pesticide Programs.
3. The area treated for Backpack Sprayer (Mix/Load/Apply) is 40 gallons per day from ExpoSAC Policy #9 divided by the
label recommended spray volume of 20 gallons per acre.
4. The area treated for Backpack Sprayer (Apply Only) is 4 acres per day based upon the acreage treated in CA DPR HS-
1769 normalized to an 8 hour day.
5. The area treated for ROW sprayers was determined by the dividing the daily spray volume handled (1000 gallons per
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day) from ExpoSAC Policy #9 by the label recommended spray volume of 20 gallons per acre for weed control and 400
gallons per acre for woody brush control.
6. The area treated for foliar application of liquids to floating aquatic weeds is based upon use information reported in the
HED Memorandum "Occupational and Residential Exposure Characterization/Risk Assessment for Tnclopyr
Tnethylamine for Aquatic Weed Control, DP Barcode D269448 of 7/22/2002.
7. The area treated for application of granules to submersed aquatic weeds is based upon information provided in an email
of 11/22/2000 from Jim Kannenburg of Marine Biochemists/Applied Biochemists to Troy Swackhammer of the US EPA
Office of Pesticide Programs.
Summary of Risk Concerns and Data Gaps for Handlers
The MOEs for handlers are summarized in Tables 22 and 23 below. With the exception of
mixing/loading wettable powder, all of the short-term and intermediate-term MOEs exceed the target
of 100 with baseline PPE (i.e., long-sleeved shirt, long pants, shoes plus socks, no respirator) or single
layer PPE (i.e., long-sleeved shirt, long pants, shoes plus socks, gloves, no respirator) and are not of
concern. The MOEs for handling wettable powder are adequate with engineering controls (i.e. water
soluble bags).
Exposure Scenario
Crop Type
Application
Rate
(\b ae/acre)
Acres/
Day
Base-line
Single
Layer
Eng.
Control
Mixer/Loader (M/L)
M/LWP
M/L Liquids
M/L Liquids
Load Granulars for Broadcast
Spreader
All Crops
All Crops
Submersed Weeds
Golf Courses and
Aquatic Areas
0.25 to 4
0.25 to 4
54
2 to 54
5 to 1200
5 to 1200
30
40 or 50
>1
>1
3.2
>220
>5
>89
260
>230
>260
>330
980
>1000
Applicator (APP)
Aerial Application
Groundboom Application
Subsurface Aquatic Application of
Liquids
Airblast Application
Backpack Application
ROW Application
Foliar Aquatic Application of
Liquids
Turfgun Application
Broadcast Spreader Application
All Crops
All Crops
Submersed Weeds
Citrus
Conifer Release
Weed Control
Floating Weeds
turf
Golf Courses and
Aquatic Areas
1.25 to 4.0
1.25 to 4
54
0.1
4
2
2
1.5
1.5 or 54
1200
40 to 200
30
40
4
50
10
5
40 or 50
ND
>1000
430
>1000
ND
110
280
ND
>250
ND
>1000
430
>1000
140
350
870
>1000
>290
>550
>1000
>1000
>1000
ND
ND
ND
>1000
>1000
Mixer/Loader/Applicator (M/L/A)
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Exposure Scenario
M/L/A Liquids with Backpack
Sprayer
M/L/A WD Granules with a Turfgun
M/L/A Wettable Powder with a Turf
Gun
M/L/A Liquid Flowables with a
Turfgun
Load/ Apply Granules with a Push
Spreader
Crop Type
Christmas Trees
turf
turf
turf
turf
Application
Rate
(Ib ae/acre)
4
1.5
1.5
1.5
1.5
Acres/
Day
2
5
5
5
5
Base-line
ND
ND
ND
ND
ND
Single
Layer
730
>1000
>1000
>1000
710
Eng.
Control
ND
ND
>1000
ND
ND
Flagger
Flag Aerial Liquid Application
All Crops
1.25 to 4.0
1200
>210
>200
>1000
MOEs in bold font do not exceed the target MOE of 100 and are of concern
ND not determined
Table 23. MOEs for Intermediate-Term Risk to Occupational Handlers
Exposure Scenario
Crop Type
Application
Rate
(\b ae/acre)
Acres/
Day
Base-line
Single
Layer
Eng.
Control
Mixer/Loader (M/L)
M/LWP
M/L Liquids
M/L Liquids
Load Granulars for Broadcast
Spreader
All Crops
All Crops
Submersed Weeds
Golf Courses or Aquatic
Areas
0.25 to 4
0.25 to 4
54
1.5 or 54
5 to 1200
5 to 1200
30
40 or 50
>1.1
>1.5
2.2
>150
>7.3
>130
190
>160
>360
>460
690
>1000
Applicator (APP)
Aerial Application
Groundboom Application
Subsurface Aquatic Application
Airblast Application
Backpack Application
ROW Application
Foliar Aquatic Application of
Liquids
Turfgun Application
Broadcast Spreader Application
All Crops
All Crops
Submersed Weeds
Citrus
Conifer Release
Weed Control
Floating Weeds and Wild
Rice
turf
Golf Courses and
Aquatic Areas
0.5 to 2.0
0.5 to 4
54
0.1
2
2
4 or 0.25
1.5
1.5 or 54
1200
40 to 200
30
40
4
50
10
5
40 or 50
ND
>1000
300
>1000
ND
78
>200
ND
>180
ND
>1000
300
>1000
200
240
>610
>1000
>200
>770
>1000
>1000
>1000
ND
ND
ND
ND
ND
Mixer/Loader/Applicator (M/L/A)
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Exposure Scenario
M/L/A Liquids with Backpack
Sprayer
M/L/A WD Granules with a
Turf gun
M/L/A Wettable Powder with a
Turf Gun
M/L/A Liquid Flowables with a
Turf gun
Load/ Apply Granules with a Push
Spreader
Crop Type
C onifer Plantations
turf
turf
turf
turf
Application
Rate
(Ib ae/acre)
4
1.5
1.5
1.5
1.5
Acres/
Day
2
5
5
5
5
Base-line
ND
ND
ND
ND
ND
Single
Layer
510
>1000
>1000
>1000
500
Eng.
Control
ND
ND
>1000
ND
ND
Flagger
Flag Aerial Liquid Application
All Crops
0.50 to 2.0
1200
>660
>610
>1000
MOEs in bold font do not exceed the target MOE of 100 and are of concern
d. Occupational Postapplication Risk
Post application 2,4-D exposures can occur in the agricultural environment when workers enter
fields recently treated with 2,4-D to conduct tasks such as scouting and irrigation. In the Worker
Protection Standard (WPS), a restricted entry interval (REI) is defined as the duration of time which
must elapse before residues decline to a level so entry into a previously treated area and engaging in a
specific task or activity would not result in exposures that are of concern. The WPS REI for 2,4-D is
12 hours for the ester and sodium salt forms and is 48 hours for the acid and amine salt forms.
1) Exposure Scenarios, Data, and Assumptions
Postapplication dislodgeable foliar residue (DFR) data were submittted for 2,4-D as well as turf
transferable residue (TTR) data from treated turf. Three turf transferable residue (TTR) studies were
submitted by the Broadleaf Turf Herbicide TTR Task Force. These studies are described in "2,4-D:
3rd Revised Occupational and Residential Exposure (ORE) and Risk Assessment and Response to
Public Comments for the Reregistration Eligibility Decision (RED) Document"dated May 4, 2005,
and in Appendix F of that document. These data were used in the human health risk assessment
along with standard transfer coefficients based on EPA Science Advisory Council guidance to assess
potential exposures to workers reentering treated sites.
For all other postapplication activities, EPA used the EPA Science Advisory Council for
Exposure (Exposure SAC) policy on agricultural transfer coefficients.
The following assumptions were made regarding postapplication occupational exposure:
• Short term risks were assessed using master label rates.
• Intermediate term risks were assessed using average application rates when available.
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• The transfer coefficients are from an interim transfer coefficient policy developed by HED's
Science Advisory Council for Exposure using proprietary data from the Agricultural Re-entry
Task Force (ARTF) database (US EPA, August 7, 2001). This policy will be periodically
updated to incorporate additional information about agricultural practices in crops and new data
on transfer coefficients. Much of this information will originate from exposure studies currently
being conducted by the ARTF, from further analysis of studies already submitted to the
Agency, and from studies in the published scientific literature.
• The transfer coefficients for turf harvesting and maintenance are based upon recently conducted
ARTF studies that are being reviewed by EPA.
• In cases where applications would be made in such a way as to minimize contact with crop
foliage postapplication exposures are expected to be negligible and are not assessed. These
cases are included in "2,4-D: 3rd Revised Occupational and Residential Exposure and Risk
Assessment and Response to Public Comments for the Reregistration Eligibility Decision
(RED) Document (PC Code 030001, DP Barcode D316596)", dated May 4, 2005.
• The initial percent of application rate as Dislodgeable Foliar Residue (DFR) was assumed to be
20% for all crops except turf. This is the standard value used in the absence of chemical specific
data.
2) Occupational Postapplication Risk Estimates
All short- and intermediate-term MOEs are above 100 on day zero. All occupational
postapplication risk scenarios are not of concern. Short-term and intermediate-term risk estimates are
shown in Tables 24 and 25 below.
Table 24. 2,4-D Postapplication Short-Term Worker Risks
Crop Group
Field/row crop, low/med (cereal grains)
Field/row crop, low/med (rice)
Field/row crop, tall (com)
Pre-harvest rate for field corn
Post-emergence rate for sweet corn
Field/row crop, tall (sorghum)
Sugarcane
Turf - California
Turf - North Carolina
ShortTerm MOE on Day 0
Application Rate
(Ib a.e./acre)
1.25
1.5
1.5
0.5
1.0
2.0
2.0
2.0
Low Exposure
Scenarios
6,700
5,600
5,600
17,000
8,400
NA
1,900
860
Medium
Exposure
Scenarios
450
370
1,400
4,200
2,100
420
NA
NA
High
Exposure
Scenarios
NA
NA
560
NA
NA
210
950
430
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Table 25. 2,4-D Postapplication Intermediate Term Worker Risks
Crop Group
Field/row crop, low/med (cereal grains)
Field/row crop, low/med (rice)
Field/row crop, tall (field com)
Field/row crop, tall (sweet corn)
Field/row crop, tall (sorghum)
Sugarcane
Turf -California
Turf - North Carolina
Intermediate Term MOE on Day 0
Application Rate+
(Ib a.e./acre)
0.5
0.92
0.44
0.48
0.46
0.75
2.0
2.0
Low Exposure
Scenarios
12,000
6,400
13,000
13,000
13,000
NA
1,600
610
Medium
Exposure
Scenarios
780
420
3,300
3,100
3,100
780
NA
NA
High
Exposure
Scenarios
NA
NA
1,300
NA
NA
390
810
300
+ Average application rates as reported in the QUA report or NASS report were used when available.
7. Human Incident Data
In evaluating incidents to humans, the Agency reviewed reports from the National Poison
Control Centers, the EPA OPP's Incident Data System (IDS), the California Pesticide Illness
Surveillance Program, and the National Pesticide Telecommunications Network (NPTN).
The Agency reviewed 2,4-D incident reports in January 2004. A total of 45 incidents were
reported in the OPP Incident Data System and many of these incidents involved irritant effects to the
eyes, skin and occasionally respiratory passages. Poison Control Center Incident Data (1993 to!998)
indicated that 2,4-D is generally less likely than other pesticides to cause minor, moderate or life
threatening symptoms. The most common symptoms were dermal irritation and ocular problems.
Incident data from the California Pesticide Illness Surveillance Program indicated that the number of
cases generally ranges from 0 to 3 per year and most of these cases were due to eye or skin effects.
Incident data from the National Pesticide Information Center for the years 1996 to 2002 indicated
that an average of 3 cases definitely or probably related to 2,4-D exposure were reported per year.
8. Cancer Epidemiology Studies
A Science Advisory Board/Scientific Advisory Panel Special Joint Committee reviewed
available epidemiological and other data on 2,4-D in 1992 and concluded that "the data are not
sufficient to conclude that there is a cause and effect relationship between exposure to 2,4-D and non-
Hodgkin's lymphoma" and 2,4-D was classified as a Group D, not classifiable as to human
carcinogenicity. The Agency has twice recently reviewed epidemiological studies linking cancer to
2,4-D. In the first review, completed January 14, 2004, EPA concluded there is no additional
evidence that would implicate 2,4-D as a cause of cancer (EPA, 2004). The second recent review of
available epidemiological studies occurred in response to comments received during the Phase 3
Public Comment Period during the reregistration process for 2,4-D. EPA's report, dated December 8,
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2004 and authored by Jerry Blondell, Ph.D., found that none of the more recent epidemiological
studies definitively linked human cancer cases to 2,4-D.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment for 2,4-D is presented below. The
Agency has conducted an assessment of potential risks to aquatic and terrestrial organisms resulting
from the use of 2,4-D and its associated chemical forms including 2,4-D dimethylamine salt (2,4-D
DMAS), 2,4-D isopropylamme salt (2,4-D IP A), 2,4-D tnisopropanolamme salt (2,4-D TIPA), 2,4-D
ethylhexyl ester (2,4-D EHE), 2,4-D butoxyethyl ester (2,4-D BEE), 2,4-D-diethanolamine salt (2,4-
D DEA), 2,4-D isopropyl ester (2,4-D IPE) and 2,4-D sodium salt. In this document, the term
"chemical form" is used to refer to the supported technical formulations listed above, while the term
"formulation" refers to the physical nature (e.g. granular or emulsifiable concentrate) of the applied
product, and the term "end use product" is used to refer to any formulated product including mixtures
of pesticide sold in the United States.
2,4-D has the following registered uses, which result in environmental exposures:
pasture/rangeland, turf, wheat, corn, soybeans, fallowland, hay other than alfalfa, noncropland
(roadways, rights-of-way, ditches, industrial sites, etc.), forestry, rice, sugarcane, pome fruits, stone
fruits, nut orchards, filberts, grass grown for seed and sod, aquatic weed control, potatoes, asparagus,
strawberries, blueberries, grapes, cranberries, and citrus.
This summary will present exposure estimates and hazard determinations associated with 2,4-D
and its various chemical forms. In addition, risks of concern, as determined in the environmental
assessment, will be identified and characterized. More detailed information associated with the
potential environmental risk from the use of 2,4-D can be found in the Environmental Fate and
Effects Division's Risk Assessment for the Reregistration Eligibility Document for 2,4-
Dichlorphenoxyacetic Acid, (2,4-D), dated October 28, 2004. The complete environmental risk
assessment is not included in this RED, but may be accessed in the OPP Public Docket (OPP-2004-
0167) and on the Agency's website at http://www.epa.gov/pesticides/reregistration/status.htm.
1. Environmental Exposure
a. Environmental Fate and Transport
The environmental fate database is sufficient to characterize the environmental exposure
associated with 2,4-D use. However, there are some studies that will be required as a result of the
reregistration process. An aerobic aquatic metabolism study for 2,4-D BEE in acidic aquatic
environments is required, along with several other dissipation studies. See section V.A. 1 of this
reregistration eligibility decision (RED) document for a complete list of all required studies. EPA
intends to issue a DCI as part of this RED to require submission of additional data to address areas of
uncertainty. These data are expected to confirm the conclusions of this environmental risk
assessment.
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Database
A complete database has been assembled for 2,4-D acid. The dissipation of 2,4-D appears to be
dependent on oxidative microbial-mediated mineralization, photodegradation in water, and leaching.
2,4-D is stable to abiotic hydrolysis. Photodegradation of 2,4-D was observed [half life (t1/2) =12.9
calendar days or 7.57 days of constant light] in pH 5 buffer solution. However, the 2,4-D
photodegradation half-life on soil was 68 days.
Degradation Summary
The degradation of 2,4-D was rapid (t1/2= 6.2 days ) in aerobic mineral soils. The half-life of
2,4-D in aerobic aquatic environments was 15 days. 2,4-D was moderately persistent to persistent
(t1/2 = 41 to 333 days) in anaerobic aquatic laboratory studies.
Several degradates were detected in the laboratory fate studies reviewed. The degradates
detected were 1,2,4-benzenetriol, 2,4-DCP, 2,4-DCA, chlorohydroquinone (CHQ), 4-chlorophenol,
volatile organics, bound residues, and carbon dioxide. For a complete listing of 2,4-D degradates for
each route of degradation, please see the environmental risk assessment. No degradates were
considered for further analysis in water or the terrestrial ecological assessment.
Mobility
2,4-D has a low binding affinity (Kad < 3 and Kde < 1) in mineral soils and sediment. The
mobility of 2,4-D in supplemental soil thin layer chromatography (TLC) studies was classified as
intermediately mobile (Rf=0.41) to very mobile (Rf=1.00) in "sieved" mineral soils. Aged
radiolabeled residues of 2,4-D appeared to be immobile in supplemental soil column studies. 2,4-D
was studied in sandy loam, sand, silty clay loam and loam soil. Freundlich K^ values were 0.17 for
the sandy loam soil, 0.36 for the sand soil, 0.52 for the silty clay loam soil, and 0.28 for the loam soil.
Corresponding Koc values were 70, 76, 59 and 117 mL/g.
Bridging Strategy
The 1988 2,4-D Registration Standard proposed an environmental fate strategy for bridging the
degradation of 2,4-D esters and 2,4-D amine salts to 2,4-D acid. The bridging provides information
on the dissociation of 2,4-D amine salts and hydrolysis of 2,4-D esters is included in the ecological
risk assessment. The bridging data indicate esters of 2,4-D are rapidly hydrolyzed in alkaline aquatic
environments, soil/water slurries, and moist soils. The 2,4-D amine salts have been shown to
dissociate rapidly in water. However, 2,4-D esters may persist under sterile acidic aquatic conditions
and on dry soil. These bridging data indicate under most environmental conditions 2,4-D esters and
2,4-D amines will degrade rapidly to form 2,4-D acid.
2.4-D Amine Salts
Additional data submitted subsequent to establishment of the environmental fate bridging
strategy generally support the strategy for the amine salts. Direct evidence of the stability of 2,4-D
amine salts in soil and aquatic environments is difficult due to the lack of analytical methods. Based
on maximum application rates for 2,4-D amine salts (at 4 Ibs ae/A), 2,4-D amine salts are expected to
fully dissociate in soil environments because their theoretical concentrations in soil solution does not
exceed water solubilities. Additionally, dissociation studies indicate the time for complete
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dissociation is rapid (less than 3 minutes). Although the analytical methods in the field studies for
2,4-D DMAS were not capable of separating and identifying 2,4-D DMAS from 2,4-D acid, the most
conservative half-lives of 2,4-D DMAS would be equivalent to the 2,4-D acid half-lives in field
studies. Half-lives of 2,4-D in 2,4-DMAS field studies ranged from 1.1 days to 30.5 days with a
median half-life of 5.6 days.
2.4-D Esters
The conversion of 2,4-D esters to the acid and an associated alcohol moiety is more difficult to
generalize. Unlike the physical dissociation mechanism of 2,4-D amine salts, the de-esterification of
2,4-D esters is dependent on abiotic and microbial-mediated processes. Any environmental variable
influencing microbial populations or microbial activity could theoretically influence the persistence of
the 2,4-D ester. Soil properties including clay mineralogy, organic carbon content, temperature, and
moisture content are known to influence hydrolysis rates (Wolfe, et al, 1989 and Wolfe, 1990).
Registrant-sponsored research indicates the 2,4-D esters (ethylhexyl, isopropyl, butoxyethyl)
degrade rapidly (half life less than 24 hours) in soil slurries, aerobic aquatic environments, and
anaerobic, acidic aquatic environments. In terrestrial field dissipation studies for 2,4-D EHE, the
half-lives for 2,4-D EHE ranged from 1 to 14 days with median half-life of 2.9 days. 2,4-D BEE,
applied as a granule formulation, degraded rapidly in the water column in aquatic field dissipation
studies under alkaline conditions. However, the 2,4-D BEE residues were detected in sediment
samples from Day 0 (immediately posttreatment) to 186 days posttreatment. It is unclear whether
2,4-D BEE persistence in sediment is due to the slow release of the granule formulation or to slow de-
esterification of sediment bound 2,4-D BEE. Available open-literature and registrant sponsored
laboratory data would suggest slow granule dissolution prolonged the persistence of 2,4-D BEE. In
forest dissipation studies, the 2,4-D EHE ester degraded slowly on foliage and in leaf litter.
Persistance of 2,4-D Amine Salts and 2,4-D Esters
The weight of evidence from open-literature and registrant sponsored data indicates that 2,4-D
amine salts and 2,4-D esters are not persistent under most environmental conditions including those
associated with most sustainable agricultural conditions. 2,4-D amine salt dissociation is expected to
be instantaneous (< 3 minutes) under most environmental conditions. Although the available data on
de-esterification of 2,4-D ester may not support instantaneous conversion from the 2,4-D ester to 2,4-
D acid under all conditions, it does show 2,4-D esters in normal agriculture soil and natural water
conditions are short lived compounds (< 2.9 days). Under these conditions, the environmental
exposure from 2,4-D esters and 2,4-D amines is expected to be minimal in both terrestrial and aquatic
environments.
b. Aquatic Organism Exposure
For exposure to aquatic fish and invertebrates, EPA considers surface water exposure only,
since most aquatic organisms are not found in ground water. Surface water models are used to
estimate exposure to freshwater aquatic animals. Unlike the drinking water assessment described in
the human health risk assessment section of this document, the ecological water resource assessment
does not include the Index Reservoir (IR) and Percent-Crop Area (PCA) factor refinements. The IR
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and PCA factors represent a drinking water reservoir, not the variety of aquatic habitats, such as
ponds adjacent to treated fields, relevant to a risk assessment for aquatic animals. Therefore, the EEC
values used to assess exposure to aquatic animals are not the same as the values used to assess human
dietary exposure from drinking water sources.
1) Exposure to 2,4-D Acid in Surface Water
The aquatic exposure assessment for 2,4-D has relied on a combination of monitoring data and
modeling. Both Tier I (SCIGROW and screening level models for aquatic uses) and Tier n
(PRZM/EXAMS) models have been used to estimate exposure to 2,4-D and its various chemical
forms in a variety of exposure scenarios. Concentrations used for ecological assessment are 62.8 ug
ae/L for peak, 55.1 ug ae/L for the 21-day average concentration, and 45.4 ug ae/L for the 60-day
average. The predicted 2,4-D concentrations in surface water are slightly higher than reported
monitoring data. The modeling predictions are expected to indicate upper bound concentration
ranges for 2,4-D. Model input and output files for the ecological assessment may be found in the
ecological risk assessment for 2,4-D.
2) Surface Water Modeling of 2,4-D Esters
The Agency's strategy for bridging the fate data requirements for the ester and amine salt forms
of 2,4-D to the acid form was supported by laboratory data which indicated rapid conversion of the
amine and ester forms of 2,4-D to the acid form. However, 2,4-D esters may persist under acidic
aquatic conditions. In order to account for the potential impact of the spray application of 2,4-D
esters to aquatic environments, and to account for runoff during the time in which 2,4-D EHE may
remain in the field, the Agency conducted additional modeling with PRZM/EXAMS to assess the
potential for aquatic organisms to be exposed to 2,4-D EHE through spray drift or runoff. The peak
(acute) estimated environmental concentrations (EECs) for the 2,4-D esters were estimated for each
scenario and range from 0.6 ug ae/L (CA citrus) to 7.4 ug ae/L (NC pasture). A chronic EEC was not
provided in this scenario because the hydrolysis soil slurry data indicate that dissipation in a non-
sterile water body will occur at all pHs and therefore long-term exposures are unlikely.
3) Modeling of Direct Application of 2,4-D for Control of Aquatic Weeds
Because there are no aquatic herbicide model scenarios, a first approximation of an aquatic
ecological EEC was predicted assuming direct application to the standard pond. For this assessment,
the Agency developed a simple spreadsheet model that incorporates degradation based on an
acceptable aerobic aquatic metabolism study for the EFED standard pond with no flow. In this
model, the 21-day average and 60-day average concentrations were calculated assuming first-order
dissipation from aerobic aquatic degradation, but does not assume dissipation.
The interpretation of the label for aquatic weed control is that the target rate for 2,4-D amine
(2,4-D DMAS) and ester (2,4-D BEE) use is based on concentration and not application rate. In
order to account for this scenario it was assumed that 2,4-D would be applied at a rate to meet the
target concentration of 4000 ug/1. This assumption would be applicable across all water bodies since
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the target rate is based on a rate per acre foot of water (10.8 Ibs ae/acre-foot) and would be
independent of water body geometry/volume. This scenario included the assumption of uniform
application across the entire water body; however, this application scenario will over-predict actual
concentrations because 2,4-D is not applied to more than 50% of a water body in a single treatment.
Treating more than 50% of a water body will result in oxygen depletion due to decaying plant
material. Typically, 2,4-D is applied to control aquatic weeds in littoral zones that make up less than
50% of the water body. Modeling the 2,4-D concentration that results when 100% of the water body
is treated predicts direct water application of 2,4-D will yield surface water concentrations of 2,4-D
concentrations in the EFED standard pond of 4000 ug ae/L for peak, 3417 ug ae/L for the 21-day
average, and 2610 ug ae/L for the 60-day average. Actual concentrations are expected to be less
given the conservative treatment area assumption as described above, and the likely effects of
dispersion on 2,4-D concentrations.
EFED evaluated the potential for exposure to 2,4-D BEE using a similar approach. Modeling
predicts direct water application of 2,4-D BEE will yield surface water concentrations of 2,4-D BEE
concentrations in the EFED standard pond of 624 ug/L for peak (24 hour average), 30 ug/L for the
21-day average, and 10 ug/L for the 60-day average.
4) Modeling of 2,4-D Use on Rice
Finally, the use of 2,4-D on rice was evaluated using a screening level model. 2,4-D is
registered for use in rice paddies for the acid and amine salt forms of 2,4-D (esters are not registered
for rice use) with a maximum seasonal application rate of 1.5 pounds ae per acre. Modeling of this
use rate results in an estimated acute 2,4-D concentration in the rice paddy of 1431 ug ae/L. This
value is expected to represent upper percentile concentrations for edge of paddy concentrations
because of the lack of consideration for degradation, dilution and dispersion. EFED conducted a
preliminary evaluation of the effect of degradation and holding times on EECs for the use of 2,4-D on
rice. As with the previous rice model, this refined model provides a single EEC which represents
both an acute and chronic exposure and is an approximation of the EEC at the point of release into a
receiving water body. Modeling with all three scenarios predict initial concentrations in the paddy
water between 678 ug ae/L (California) and 762 ug ae/L (Louisiana) and decreasing concentrations
with holding times based on degradation due to aerobic aquatic metabolism.
c. Terrestrial Organism Exposure
The Agency assessed exposure to terrestrial organisms by first predicting the amount of 2,4-D
residues found on animal food items and then by determining the amount of pesticide consumed by
using information on typical food consumption by various species of birds and mammals. The
amount of residues on animal feed items are based on the Fletcher nomogram (a model developed by
Fletcher, Hoerger, Kenaga, et al.)1 and the current maximum application rate as stated in the Master
Label for 2,4-D. For terrestrial uses of 2,4-D, the Master Label allows a maximum single application
of 4 Ibs ae/A and up to two 2 Ibs ae/A applications per season for a total seasonal maximum rate of 4
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Ibs ae/A. Therefore, for terrestrial uses, EPA modeled the maximum and mean residues of 2,4-D in
various food items immediately after the 4 Ib Ibs ae/A application. The Agency assumed no dilution
due to the growth of the plants or degradation of 2,4-D. EPA's estimates of 2,4-D residues on various
wild animal food items are summarized in Table 26. EPA used these EECs and standard food
consumption values to estimate dietary exposure levels for 2,4-D to birds and mammals.
Table 26. Estimated Environmental Concentrations on Avian and Mammalian Food Items
(ppm) Following a Single Application at 1 Ib ae/A
Food Items
Short grass
Tall grass
Broadleaf/forage plants and small
insects
Fruits, pods, seeds, and laree insects
EEC (ppm)
Predicted Maximum Residue1
240
110
135
15
EEC (ppm)
Predicted Mean Residue1
85
36
45
7
Predicted maximum and mean residues are for a 1 Ib ae/a application rate and are based on Hoerger and Kenaga (1972) as modified
by Fletcher etal. (1994).
1) Birds and Mammals
The Agency expects exposure to birds and mammals from residues of 2,4-D on food items.
Exposure is probable because 2,4-D is applied in many different environments that provide habitats
rich in food sources attractive to various avian and mammalian species.
a) Exposure to Nongranular (Liquid) Formulations
Toxicant concentrations on food items following multiple applications are predicted based on a
first-order residue decline using the Agency's FATES model. The FATES model allows
determination of residue dissipation over time by incorporating degradation half-life. Predicted
maximum and mean EECs resulting from multiple applications are calculated by taking into account
the maximum or mean initial EEC from the first application, the total number of applications, the time
interval between applications, and a first-order foliar degradation rate of 8.8 days.
b) Exposure to Granular Formulations
Birds and small mammals may be exposed to granular formulations through ingestion of
granules. The number of lethal doses (LD50) that are available within one square foot immediately
after application (LD50/ft2) is used as the risk quotient (RQ) for granular products. RQs are calculated
for three separate weight classes of birds (1000 g, 180 g, and 20 g) and mammals (15 g, 35 g, and
1000g,35g,andl5g).
2) Non-target Terrestrial Plants
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Due to the differences in the solubilities of the acid and amine salts when compared to the
solubilities of the esters, risks for these two groups were calculated separately for the non-target
terrestrial plant risk assessment. The terrestrial plant toxicity data for the 2,4-D acid and amine salts
were bridged as one group, while that of the esters were bridged as another group.
Terrestrial plants inhabiting dry and semi-aquatic areas may be exposed to pesticides from
runoff, spray drift or volatilization. EPA's runoff exposure estimate assumes a l-in-10 year rain event
and is based on a pesticide's water solubility and the amount of pesticide present on the soil surface
and its top one inch, characterized as "sheet runoff (one treated acre to an adjacent acre) for dry
areas, characterized as "channelized runoff (10 treated acres to a distant low-lying acre) for semi-
aquatic areas, and is based on percent runoff values of 0.01, 0.02, and 0.05 for water solubility of <10
ppm, 10-100 ppm, and >100 ppm, respectively. The modeled runoff exposure estimates likely over-
estimate actual exposures from runoff, given the conservative l-in-10 year rain event assumption, and
also given that farming practices, intended to minimize soil loss from runoff, are not taken into
account.
Spray drift exposure from ground and overhead chemigation applications is assumed to be 1%
of the application rate. Spray drift from aerial, airblast, and forced-air applications is assumed to be
5% of the application rate with an application efficiency (i.e., the amount that lands on the target area)
of 60%. The effects of multiple applications are addressed by summing the application rates from
individual applications.
Applications of granular formulations may pose risks to terrestrial plants inhabiting dry and
semi-aquatic areas. Exposure is assumed to be from runoff only, and drift is assumed not to occur
with granular applications of pesticides. Therefore, the Agency's runoff scenario is essentially the
same as that used in the non-granular scenario described above, with the exception that the drift
component is removed.
The EECs for the acid and amine salts as well as the esters to dry and semi-aquatic areas are
tabulated in Appendix F of the 2,4-D ecological risk assessment for single applications to the targeted
use sites. The percent runoff value based on water solubility is assumed to be 5% for the acid and
amines and 1% for the esters.
2. Environmental Effects (Toxicity)
a. Toxicity to Aquatic Organisms
Freshwater and Estuarine/Marine Fish
The available acute toxicity data on 2,4-D indicate that the acid and amine salts are practically
non-toxic to freshwater or marine fish. The esters are highly to slightly toxic to marine or freshwater
fish. Toxicities for the acid and amine salts range from a LC50 of >80.24 to 2244 milligrams acid
equivalent per liter (mg ae/L). The ester toxicities range from a LC50 of >0.1564 to 14.5 mg ae/L.
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Chronic toxicity, based on length and larval survival from the early life stage studies, range
from a NOEC of 14.2 to 63.4 mg ae/L for 2,4-D acid, 2,4-D DBA and 2,4-D DMAS. The NOEC
based on larval fish survival for the fish full life cycle studies ranged from 0.0555 to 0.0792 mg ae/L
for 2,4-D BEE and 2,4-D EHE.
Amphibians
Although not currently required by the Agency, freshwater amphibian studies were conducted
on frog tadpoles (Rana pipiens). Tests were conducted using the ASTM (American Society for
Testing and Materials) Standard E729-88a. Tests indicate that 2,4-D acid, 2,4-D DMA, and 2,4-D
EHE are practically non-toxic to tadpoles.
Freshwater and Estuarine/Marine Invertebrates
Acute toxicity of 2,4-D acid and amine salts to freshwater aquatic invertebrates ranges from a
LC50 of 25 to 642.8 mg ae/L (slightly toxic to practically non-toxic). The freshwater toxicities of the
esters range from 2.2 mg ae/L for the 2,4-D IPE to 11.88 mg ae/L for the 2,4-D EHE (moderately
toxic to slightly toxic). Acute toxicity of 2,4-D acid and amine salts to marine invertebrates range
from an LC50 of 49.6 for 2,4-D IPA to 830 mg ae/L for 2,4-D DMA (slightly toxic to practically non-
toxic). The marine invertebrate LC50 s range from >0.092 to >66 mg ae/L for the 2,4-D esters (highly
toxic to practically non-toxic). These toxicities indicate that the esters are more toxic than the acid and
amine salts. Although acute data are missing for some of the amine salts, these studies will not be
required because none of the RQs exceed the aquatic levels of concern for the acid amine salts.
Chronic toxicity tests for freshwater and estuarine/marine invertebrates were performed on 2,4-
D acid, 2,4-D DEA, 2,4-D DMAS, and 2,4-D BEE. The toxicity ranged from a NOEC of 16.05 mg
ae/1 for 2,4-D DEA (survival and reproduction) and 79 mg ae/L for the 2,4-D acid (number of young).
The chronic freshwater NOEC is 0.20 mg ae/L for the 2,4-D BEE (survival and reproduction). There
are no freshwater or marine chronic toxicity data for any of the other 2,4-D esters.
Although an estuarine/marine invertebrate life-cycle toxicity test using the TGAI is required to
establish the toxicity of products containing the 2,4-D acid, salts, and amines, a chronic study will not
be required. The data from the freshwater invertebrate studies will be bridged to the estuarine/marine
invertebrates for the 2,4-D acid and amine salts. The RQs for the freshwater chronic studies were
well below the levels of concern, and the chronic risk for estuarine/marine invertebrates would be
expected to be low. However, there is a risk concern for for estuarine/marine invertebrates for the
2,4-D esters. A chronic study will be required for 2,4-D BEE to reduce the uncertainty to
estuarine/marine invertebrates.
Aquatic Plants
The vascular plant ECso toxicity data for the acid and amine salts range from 0.29 mg ae/L for
2,4-D DEA to 1.28 mg ae/L for 2,4-D TTPA. The ECso toxicity data for the more toxic esters range
from 0.33 mg ae/L for 2,4-D EHE to 0.3974 mg ae/L for 2,4-D BEE. The same trend is shown for the
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non-vascular plant ECso. The nonvascular plant EC50 toxicity data range for the acid and amine salts is
3.88 to 156.5 mg ae/L for 2,4-D DMA. The range for the esters is 0.066 mg ae/L for 2,4-D EHE to
19.8 mg ae/L for 2,4-D EHE. In addition, based on the data available, it appears that the vascular
plants are more than two orders of magnitude more sensitive than the non-vascular plants.
b. Toxicity to Terrestrial Organisms
The bird and mammal toxicity values of the 2,4-D acid, salts, amine salts, and esters were
pooled because the toxicity values were within one to two orders of magnitude for all the chemical
forms.
Birds
Toxicity ranges for birds do not show distinct differences between the acid, salts, amine salts,
and esters, as indicated for aquatic animals. All studies have been conducted with the active
ingredient, and have been converted to the acid equivalent since use rates on the master label are
given in pounds acid equivalent per acre.
2,4-D is classified as moderately toxic to practically non-toxic to birds on an acute oral basis,
since the oral LD50 ranges from 500 mg ai/kg (415 mg ae/kg) for 2,4-D DMAS to >1000 mg ae/kg for
the 2,4-D acid.
The chronic NOEC of 962 ppm is based on the endpoints of eggs cracked and a decreased
number of eggs laid for the 2,4-D acid. There is no comparable study for the mallard duck and no
other avian chronic study was performed on any of the other active ingredients.
Mammals
The Agency expects exposure to mammals from residues of 2,4-D on food items, since 2,4-D is
used in many different mammalian habitats, including pasture and rangeland, and turf lawns.
Toxicity ranges for mammals do not show distinct differences between the acid, salts, amine salts,
and esters as indicated for aquatic animals. All studies have been conducted with the active
ingredient, and have been converted to the acid equivalent since all use rates on the master label are
given in pounds acid equivalent per acre. The rat LD50 ranged from 579 to 1300 mg ae/kg.
Mammalian chronic toxicity values are from rat and rabbit developmental toxicity studies for
the 2,4-D acid and all amine salts, and esters. In addition, the 2-generation rat study is also available
for the 2,4-D acid. The NOAEL in the rat chronic toxicity study was 5 mg/kg/day, with a LOAEL of
75 mg/kg/day based on decreased body-weight gain and alterations in hematology. The NOAEL in
the rabbit developmental toxicity study was 30 mg/kg/day, and the LOAEL was 90 mg/kg/day based
on clinical signs, loss of righting reflex, and abortions.
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Non-Target Insects
Available data from a honey bee acute toxicity study indicated that technical 2,4-D is practically
non-toxic to the honey bee. The LD50 in the honey bee acute toxicity study is greater than 10
micrograms per bee; see MRID 445173-04 for 2,4-D DMA and MRID 445173-01 for 2,4-D EHE.
Minimal risk is expected to non-target insects from 2,4-D use.
Terrestrial Plants
The terrestrial plant runoff exposure scenario is based on the solubility of the 2,4-D compound.
The water solubilities differ greatly between 2,4-D esters and 2,4-D acid and amine salts. The
terrestrial plant toxicity values for 2,4-D acid and amine salts is summarized in Table 27, and have
been listed as the acid equivalent. The sensitivity ranges for the monocot and dicot species are listed
for the seedling emergence and vegetative vigor studies.
Table 27. Terrestrial Plant Toxicity Summary for 2,4-D Acid and amine salts
Study Type
Seedling Emergence
Vegetative Vigor
Monocot
Dicot
Monocot
Dicot
Most sensitive Crop /
Active Ingredient
Sorghum /2,4-D DMAS
Mustard /2,4-D DBA
Onion /2,4-D Acid
Tomato /2,4-D DBA
EC25/NOEC
(Ib ae/A)
0.026/0.015
0.045 / 0.045
0.0075/0.0075
0.003/0.002
The terrestrial plant toxicity for the 2,4-D esters is summarized in Table 28. The sensitivity
ranges for the monocot and dicot species are listed for the seedling emergence and vegetative vigor
studies.
Table 28. Terrestrial Plant Toxicity Summary for 2,4-D Esters
Study Type
Seedling Emergence
Vegetative Vigor
Monocot
Dicot
Monocot
Dicot
Most sensitive Crop /
Active Ingredient
Onion/ 2,4-D WE
Lettuce / 2,4-D IPE
Com /2,4-D IPE
Lettuce /2,4-D IPE
EC25/NOEC
(Ib ae/A)
0.01/0.005628
0.00081/0.00047
0.2016/0.0252
0.00126/0.006132
3. Ecological Risk Estimation (RQs)
The Agency's ecological risk assessment compares toxicity endpoints from ecological toxicity
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 2,4-D
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products, the Agency calculates a Risk Quotient (RQ), which is the ratio of the EEC to the most
sensitive toxicity endpoint values. These RQ values are then compared to the Agency's levels of
concern (LOCs), given in Table 29, which indicate whether a pesticide, when used as directed, has
the potential to cause adverse effects on non-target organisms. When the RQ exceeds the LOG for a
particular category (e.g., endangered species), the Agency presumes a risk of concern to that category.
These risks of concern may be addressed by further refinements of the risk assessment or by
mitigation. Use, toxicity, fate, exposure, and incidents are considered when characterizing the risk,
as well as the levels of uncertainty in the assessment.
Table 29. EPA's Levels of Concern and Associated Risk Presumptions.
Risk Presumption
Acute Risk - there is potential for acute risk; regulatory action may be
warranted in addition to restricted use classification.
Acute Restricted Use - there is potential for acute risk, but may be
mitigated through restricted use classification.
Acute Endangered Species - endangered species may be adversely
affected; regulatory action may be warranted.
Chronic Risk - there is potential for chronic nsk; regulatory action
may be warranted.
LOC
terrestrial
animals
0.5
0.2
0.1
1
LOC
aquatic
animals
0.5
0.1
0.05
1
LOC Plants
1
N/A
1
N/A
For a more detailed explanation of the ecological risks posed by the use of 2,4-D, refer to
Environmental Fate and Effects Division's Risk Assessment for the Reregistration Eligibility
Document for 2,4- Dichlorophenoxyacetic Acid (2,4-D), dated October 28, 2004.
a. Risk to Aquatic Organisms
The RQs for aquatic organisms are presented in detail in Appendix F of the ecological risk
assessment for 2,4-D.
1) Fish and Aquatic Invertebrates
There were no acute or chronic Level of Concern (LOC) exceedances for aquatic organisms
through use of 2,4-D acid and amine salts due to runoff/drift from use on terrestrial sites, no acute
LOC exceedances for aquatic organisms due to drift-only of 2,4-D esters to water bodies from use on
terrestrial sites, and, there were no acute LOC exceedances for aquatic organisms due to the
runoff/drift of 2,4-D esters to water bodies from use on terrestrial sites. Chronic concerns were not
evaluated for terrestrial uses of 2,4-D esters.
Estimated risk quotients (RQs) from use of 2,4-D acid and amine salts in aquatic weed control
through direct subsurface application to water bodies exceed the restricted use LOCs for freshwater
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invertebrates. There are no chronic LOG exceedances for this use. Estimated RQs for use of 2,4-D
BEE in weed control through direct subsurface application to water bodies exceed the acute risk LOG
for freshwater fish and invertebrates and chronic risk LOG for freshwater and estuarine fish and
freshwater invertebrates when compared on an acid equivalent basis.
Additional characterization of the potential risk associated with the direct application of 2,4-D
for aquatic weed control was completed by back-calculating the target concentration needed to reduce
EECs below LOCs. This type of consideration provides context to the characterization of potential
risk and indicates that for all 2,4-D chemical forms target concentration reduction of up to 10-fold still
exceeds all LOCs for aquatic organisms.
While noting the potential risks identified above, it is important to note the benefits gained
through the direct application of 2,4-D to aquatic bodies, for the control of invasive species. The U.S
Army Corps of Engineers (USAGE), among others, has identified 2,4-D as an important tool for
protecting the nation's waters from the invasion and establishment of some of the world's worst
species of exotic nuisance vegetation. 2,4-D has a reputation as a selective and economical means to
remove invasive plants, enhance the growth and recovery of desirable native vegetation, restore water
quality, reduce sedimentation rates in reservoirs, and improve fish and wildlife habitat. 2,4-D
products are used to control invasive weeds, such as Eurasian watermilfoil (Myriophyllum spicatum)
in the northern tier states and water hyacinth (Eichhornia crassipes} in the Gulf Coast states. Effective
control of these plants can benefit public health with respect to reducing levels of mosquito habitat. In
addition, according to USAGE, no other product (or alternative technique) can control these plants in
a more cost-effective manner (K. Getsinger, USAGE, Public Comment; Docket ID# OPP-2004-0167-
0053).
Estimated RQs for use of 2,4-D acid and amine salts in rice paddies exceed the acute
endangered species LOCs for freshwater invertebrates. The rice model used to predict these EECs is
a screening level model which predicts concentration in tailwater at the point of release from the
paddy. It is anticipated that once released, the concentration will be reduced and subsequently is
expected to decrease away from the point of release. Additional characterization was conducted by
considering average application rates (average rates are presented in the quantitative usage analysis
dated August 9, 2001 prepared by the Biological and Economic Affairs Division of EPA/OPP) versus
maximum label rates and assuming a proportional reduction in EECs. Consideration of average
application rates results in EECs below the endangered species LOG.
2) Aquatic Plants
For non-target, aquatic plants, estimated RQs resulting from the runoff/drift of 2,4-D acid and
amine salts from use on terrestrial crops exceed the aquatic vascular plant endangered species LOCs
for use of 2,4-D acid and amine salts on pasture and apples. Consideration of average application
rates and assuming a proportional reduction in EECs results in RQs below the endangered species
LOG. Likewise, there are no LOG exceedances from the drift of the ester forms to aquatic water
bodies or from the runoff of the ester forms to water bodies from use on terrestrial sites.
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Estimated RQs for the scenario of direct application to water for aquatic weed control for 2,4-D
acid and amine salts indicate acute and endangered species LOG exceedances for aquatic vascular
plants and acute LOG exceedances for non-vascular plants, while estimated RQs for the use of 2,4-D
BEE for direct application to water to control aquatic weeds exceed all LOCs for vascular and one
acute LOG exceedance for non-vascular plants. Risk to endangered non-vascular plants is not
evaluated because at this time there are no listed endangered nonvascular plant species. Additional
characterization of potential risk for the direct application of 2,4-D for aquatic weed control was
completed by back-calculating the target concentration needed to reduce the RQs below LOCs. This
type of consideration provides context to the characterization of potential risk and indicates that for all
2,4-D chemical forms target concentration reduction of up to 100-fold still exceeds all LOCs for
aquatic plants.
While noting the potential risks identified above, it is important to note the benefits gained
through the direct application of 2,4-D to aquatic bodies, for the control of invasive species. The U.S
Army Corps of Engineers (USAGE), among others, has identified 2,4-D as an important tool for
protecting the nation's waters from the invasion and establishment of some of the world's worst
species of exotic nuisance vegetation. 2,4-D has a reputation as a selective and economical means to
remove invasive plants, enhance the growth and recovery of desirable native vegetation, restore water
quality, reduce sedimentation rates in reservoirs, and improve fish and wildlife habitat. 2,4-D
products are used to control invasive weeds, such as Eurasian watermilfoil (Myriophyllum spicatum)
in the northern tier states and water hyacinth (Eichhornia crassipes) in the Gulf Coast states. Effective
control of these plants can benefit public health with respect to reducing levels of mosquito habitat. In
addition, according to USAGE, no other product (or alternative technique) can control these plants in
a more cost-effective manner (K. Getsinger, USAGE, Public Comment; Docket ID# OPP-2004-0167-
0053).
Estimated RQs for use of 2,4-D acid and amine salts in rice paddies exceed the acute and
endangered species LOCs for aquatic vascular plants. Consideration of average application rates
results in RQs below the endangered species LOCs.
b. Risk to Non-target Terrestrial Organisms
1) Birds
The RQs for birds are presented in detail in Appendix F of the ecological risk assessment for
2,4-D. Potential risks were evaluated for non-granular and granular formulations applied both as
banded and broadcast applications.
EPA has relied on risk estimates from oral gavage studies on birds (LD50 of 415 mg ae/kg-bw)
to assess risk because no definitive endpoint was determined from dietary studies. Therefore, it is
likely that the risk estimates associated with the gavage studies overestimate the actual exposure of
birds in the field. For predicted maximum exposures when compared with oral gavage data there are
exceedances of acute LOCs for all use sites except potatoes and citrus for most small birds and some
medium birds. There are also exceedances of acute restricted use and endangered species LOCs for
medium and large birds feeding on short grass, tall grass, and broadleaf forage/small insects at all use
sites except potatoes and citrus. However, comparison with the lowest dietary LC50 of >5620 mg
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ae/kg-diet would result in no acute LOG exceedances. As noted previously, no definitive endpoint
was available from the avian acute dietary studies and, hence, risk was not evaluated using this
endpoint.
The RQs are presented below in Table 30 for the avian risk due to 2,4-D residues on various
food items.
Table 30. Avian Risk Quotient Summaries for Non-granular Spray Applications of 2,4-D acid,
amine salts and esters
Use Site (Acute &
Chronic Risk)
Scenario
Short Grass
Tall Grass
Broadleaf, forage,
small insects
Fruit, large insects,
Fallow areas and Crop Stubble; Turf (Golf courses, Residential Lawns, Grasses Grown for Seed, and Sod); Pastures,
Rangeland, Perennial Grassland; Sugarcane (2 Ibs ae/A/app, 2 app., ground/aerial, 30 day interval)
Acute RQ Exceedance
0.1* -1.91***
0.04-0.88***
0.04-0.78***
-
Non-Cropland (Fencerows, Hedgerows, Roadsides, Ditches, Rights-of-Way, Utility Power Lines, Railroads, Airports,
Industrial Sites, etc.); Forest Uses, Cranberry (4.0 Ibs ae/A/app, 1 app., ground/aerial,)
Acute RQ Exceedance
0.18* -3.5***
0.07-1.6***
0.07-1.43***
0.01-0.15*
Fruit, Small Grains (Except Corn), Asparagus (1.4 to 2.0 Ibs ae/A/app)
Acute RQ Exceedance
0.09-1.75***
0.04-0.81***
0.03 - 0.72***
-
Corn (1.5 Ibs ae/A/app, 2 app., 7 day interval, ground or aerial)
Acute RQ Exceedance
0.1* -2.07***
0.04-0.81***
0.03 - 0.72***
-
* indicates an exceedance of Endangered Species Level of Concern (LOC).
** indicates an exceedance of Acute Restricted Use LOC.
*** indicates an exceedance of Acute Risk LOC.
Chronic risk calculations resulted in RQ's of 1.0 to 1.1 on birds which forage on short grass
when the application rate of 2,4-D ranges from 2.0 to 4.0 Ib ae/A such as seen with rights-of-way,
cranberries or asparagus. The chronic risk LOC is 1.0.
Non-granular Banded Applications - According to the Master Label for 2,4-D, products that allow
for banded applications of sprays to row crops require all formulators to adjust the application rates
according to a formula provided. Many current labels do not advise applicators to adjust the
application rates, and the resulting treatment can be interpreted to concentrate the per acre application
rate into a narrow band. Birds, at least in theory, could be exposed to the higher concentration of
toxicant by foraging or wandering into the treated band. EPA/OPP evaluated the banded risk by
comparing the RQs from unadjusted band rates to those using the adjusted band rates to illustrate the
increased risk. OPP assumed a 6 inch band and 30 inch row space as a typical banded application.
The RQs indicate that levels of concern are not exceeded for 1000 g birds for rates adjusted due to
band widths. LOCs are also not exceeded for these adjusted rates for potatoes for all weight classes
of birds. The unadjusted band width rate, however, exceeds LOCs for all weight classes of birds for
all uses with the exception of potatoes.
Granular Broadcast Applications - Acute RQs for granular products are calculated for three separate
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weight classes of birds using the LD50/ft2: 1000 g (e.g., waterfowl), 180 g (e.g., upland gamebird), and
20 g (e.g., songbird). The acute RQs for broadcast applications of granular products are tabulated
below for the use sites from the 2,4-D Master Label which support granular formulations.
Table 31: Avian Acute Risk Quotient Calculations for Granular Broadcast A
Von-Cropland (4.0 Ibs ae/A/app, 1 app., ground/aerial,)
Aquatic areas (4.0 Ib ae/A/app. 3 wks between apps)
Cranberry (4.0 Ibs ae/A/app, 1 app., ground)
Turf (2.0 Ibs ae/A/app, 2 app., ground/ aerial, 30 day interval)
Aquatic areas - Ditchbank applications (2.0 Ib ae/A/app., 2 app.,
ground)
Aquatic areas - Surface application or subsurface injection (10.8
Ib ae/acre-foot to an average pond depth of 5 feet)
Bird Body Weight (g)
20
180
1000
20
180
1000
20
180
1000
pplications
Acute RQ
(LD^perft2)"
5.02***
0.55***
0.1*
2 5***
0.3**
0.05
13.55***
1 5***
0.27**
aRQ = App. Rate (Ibs ae) x 453,590 mg x Acre
Acre Lb 43,560 ft2
1
x 1000 g x Kg
Animal weight (g) 1 kg LD50 mg
* indicates an exceedance of Endangered Species Level of Concern (LOC).
** indicates an exceedance of Acute Restricted Use LOC.
*** indicates an exceedance of Acute Risk LOC.
Granular Banded Applications - In addition to broadcast applications of granular formulations, a
number of labels instruct the applicators to apply unincorporated banded treatments of granular
products to crops. As explained for banded spray treatments above, many labels adjust application
rates according to band width and row spaces, but many others do not. If banded granular
applications were used at the same sites as banded spray applications, the risk would be similar.
2) Mammals
Acute LOCs for mammals feeding on plants and insects were exceeded when considering non-
granular formulations, for all uses assessed for small and medium size mammals, except potatoes and
citrus. There were no exceedances for granivores. Banded applications result in exceedances of
acute LOCs at all use sites.
Mammalian chronic RQs range from 0.05 to 200 and chronic LOCs were exceeded in all cases
with the exception of potatoes and citrus (large insects, seeds). Consideration of average application
rates results in EECs below the LOCs for non-granular, granular, or banded applications. However,
consideration of average application rates for non-granular, granular and banded applications did not
result in exposure below the chronic LOC.
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Acute Exposure from Nongranular 2,4-D Products The acute RQs for broadcast applications of
nongranular products are tabulated for herbivores/insectivores and granivores in Appendix F of the
ecological risk assessment for 2,4-D. When the LD50 of 1072 mg ai/kg (579 mg ae/kg) is used for in
herbivore/insectivore RQ calculations, endangered species LOCs are exceeded at many sites for
mammals foraging on short and tall grass, broadleaf plants, and small insects. The RQs range from
1.72 for asparagus to < 0.01 for potatoes. There are no LOG exceedances for granivorous mammals.
As described above for avian risk, in addition to broadcast spray, a number of labels instruct the
applicators to apply unincorporated banded treatments of sprays to row crops. Using the same
assumptions as described above for birds, the RQs for mammals are presented in Table 32. Again,
for purposes of comparison, the unadjusted rates that appear on many of the current labels have been
included. Using the mammalian LD50 of 579 mg ae/kg, acute levels of concern are exceeded at all
use sites and for 15, 35, and 1000 g mammals when banded rates are not adjusted. When the banded
rates are adjusted, LOCs are not exceeded for 1000 g mammals. The results of these calculations are
tabulated in Appendix F of the ecological risk assessment for 2,4-D.
Acute Exposure to Granular 2,4-D Products - Mammalian species also may be exposed to granular
pesticides by ingesting granules. The number of lethal doses (LD50) that are available within one
square foot immediately after application can be used as a RQ (LD50/ft2)for the various types of
exposure to pesticides. RQs are calculated for three separate weight classes of mammals: 15 g, 35 g,
and 1000 g. The LOCs are exceeded for all sites with the following exceptions: no LOCs are
exceeded for 1000 g mammals in turf, aquatic areas (ditchbanks and surface applications), or
cranberries.
The acute RQs for broadcast applications of granular products are tabulated below for the use
sites from the master label which support granular formulations.
Table 32; Mammalian Acute Risk Quotient Calculations for Granular Broadcast Applications
Animal Body Weight (g)
Non-Cropland (4.0 Ibs ae/A/app, 1 app., ground/aerial,)
Aquatic areas (4.0 Ib ae/acre/app. 3 weeks between
applications)
Cranberry (4.0 Ibs ae/A/app, 1 app., ground)
Turf (2.0 Ibs ae/A/app, 2 app., ground/aerial, 30 day interval)
Aquatic areas - Ditchbank applications (2.0 Ib ae/acre/app., 2
app., ground
Aquatic areas - Surface application or subsurface injection
(10.8 Ib ae/acre foot to an average pond depth of 5 feet)
15
35
1000
15
35
1000
15
35
1000
Acute RQ (LD50 per ft2) 1
4.8***
2 i ***
0.1*
24 ***
1.0***
??
12.9***
5.5***
0.2**
1 RQ = App. Rate (Ibs ae) x 453,590 mg x Acre
Acre Lb 43,560 ft2
s 1 x 1000 g x Kg
Animal weight (g) 1 kg LD50 mg
* indicates an exceedence of Endangered Species Level of Concern (LOC).
** indicates an exceedence of Acute Restricted Use LOC.
*** indicates an exceedence of Acute Risk LOC.
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Chronic Exposure to Mammals - The chronic RQs for broadcast applications of nongranular
products are tabulated in Appendix F of the 2,4-D ecological risk assessment for all classes of
mammals. The parental toxicity NOAELs ranged from 5 mg/kg/day based on female body weight
gain and male renal tubule alteration for the 2,4-D acid. The FATE program was used to determine
the maximum and 56-day average residues that occur in a one year time period. The application rate,
minimum number of applications, and the interval between applications were determined from the
2,4-D Master Label and represent the highest single application rates. Levels of concern were
exceeded in all cases with the exception of potatoes and citrus (large insects, seeds) and RQs ranged
from 0.1 to 200.
3) Non-Target Insects
The Agency currently does not quantify risks to terrestrial non-target insects. RQs are therefore
not calculated for these organisms. Since the test results from one of the salts (2,4-D DMAS) and
2,4-D EHE was practically non-toxic to honey bees (LD50 of >100 jig/bee), the potential for 2,4-D
and its salts and esters is predicted to pose minimal risk to pollinators and other beneficial insects.
4) Non-target Terrestrial Plants
Acute LOCs for both non-endangered and endangered terrestrial plants were exceeded for non-
granular and granular uses at many use sites. Consideration of average application rates did not result
in exposure below LOCs.
RQs for terrestrial plants in dry and semi-aquatic areas are calculated for multiple and single
spray applications for endangered and non-endangered species. As mentioned above in the exposure
section, the runoff scenarios are based on solubility, and as a consequence, the environmental
concentrations must be calculated separately for the esters and the acid and amine salts. The
environmental concentrations for the esters were calculated separately at a percent runoff value of
0.01, while that of the acid and amine salts were calculated at a value of 0.05. A 60% efficiency
factor is also included for aerial applications. In addition, banded applications granular and non-
granular formulations are also calculated. The detailed calculations for terrestrial plants are tabulated
in Appendix F of the ecological risk assessment.
Risk Quotient (RQ) Calculations - To calculate the RQs for non-endangered plants the EC25 value of
the most sensitive species in the seedling emergence study is compared to runoff and drift exposure to
determine the RQ (EEC/toxicity value). The EC25 value of the most sensitive species in the
vegetative vigor study is compared to the drift exposure to determine the acute RQ. RQs are
calculated for the most sensitive monocot and dicot species.
RQs for Endangered Plants - To calculate the RQs for endangered plants the NOEC or EC05 value of
the most sensitive species in the seedling emergence study is compared to runoff and drift exposure
(EEC/toxicity value). The NOEC or EC05 value of the most sensitive species in the vegetative vigor
study is compared to the drift exposure to determine the acute RQ. RQs are calculated for the most
sensitive monocot and dicot species. The RQ ranges for single and multiple applications are
summarized below for non-endangered and endangered plants for the acid and amine salts, and
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separately for the esters.
• Single Spray Applications - Most use sites on the 2,4-D Master Label allow multiple
applications. However, the following use sites are labeled for maximum application rate for a
single application.
Table 33. 2,4-D Use Sites With Maximum Labeling for a Single Application
Use Site
Non-crop l, Forest Uses, Cranberry
Strawberry, Rice
Grapes
Sorghum, Soybean
Soybean
Citrus
Application Rate/Method
Ground & Aerial Applications (4.0 Ibs ae/A/app.,)
Ground & Aerial Applications (1.5 Ibs ae/ac/app.)
Ground Applications (1 .36 Ibs ae/A/app.)
Ground and Aerial Applications (1 .0 Ibs ae/A/app.)
Ground & Aerial Applications (1.0 Ibs ae/A/app.)
Ground or Aenal Applications (0. 1 Ibs ae/A/app.)
1 Woody plants in rights-of-way. Other non-crop sites may have up to 2 applications of 2 Ibs each.
The detailed RQ calculations for single applications are tabulated in detail in Appendix F of the
ecological assessment for 2,4-D, and a summary is presented below.
Table 34. Terrestrial Plant Risk Quotients for Single Applications
Chemical Group (acid / ester)
2,4-D Acid and Amine Salt
2,4-D Ester
Plant Group (non-endangered /
endangered)
non-endangered
endangered
non-endangered
endangered
Risk Quotient Range
0.18-67
0.13-136
O.01 - 543.21
0.04-936.17
Multiple spray applications - Most of the 2,4-D products on the 2,4-D Master Label allow second
applications at prescribed intervals ranging from 7 to 30 days with the exception of pome fruit which
allows a 75 day interval. The RQs for multiple applications follow a linear pattern for changes in
application rates, and since a maximum of two applications is allowed, the RQ doubles for these
applications. The detailed calculations are tabulated in detail in Appendix F of the 2,4-D ecological
risk assessment, and a summary is presented below.
Table 35. Terrestrial Plant Risk Quotients for Multiple Applications
Chemical Group (acid / ester)
Plant Group (non-endangered /
endangered)
Risk Quotient Range
2,4-D Acid and Amine Salt
non-endangered
0.19-157
endangered
0.19-272
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Chemical Group (acid / ester)
2,4-D Ester
Plant Group (non-endangered /
endangered)
non-endangered
endangered
Risk Quotient Range
0.01 - 12
0.01 -33
Banded Spray Applications - Banded spray applications are allowed on a number of labels and
instruct the applicators to apply unincorporated banded treatments of sprays to row crops. Many
labels adjust application rates according to band width and row spaces, but others do not. For the
labels which do not adjust the application rates, the treatments could be more concentrated in the
bands. Since non-target plants do not migrate from treated to untreated bands as is the case with birds
and mammals, exposure to plants is characterized as "sheet runoff (one treated acre to an adjacent
acre) for dry areas and "channelized runoff (10 treated acres to a distant low-lying acre) for semi-
aquatic areas. Therefore, the higher per acre rates in the concentrated bands do not affect the
exposure to non-target plants when label rates are not adjusted.
The 2,4-D Task Force proposal to require all formulators to adjust the application rates for
banded applications will reduce the exposure to non-target plants. If we assume use of the same 6
inch band and 30 inch row space that we used for the analysis of birds and mammals, the per acre
banded application rate would be reduced by 1/5 of the broadcast application rate. The RQs are
detailed in Appendix F of the ecological risk assessment for 2,4-D, and summarized for multiple and
single applications in the following table.
Table 36. Non-target Plant Risk Quotient Summary of Adjusted Band Applications to Selected
Row Crops.
Chemical Group (acid /
ester)
2,4-D Acid and Amrne Salt
2,4-D Ester
Plant Group (non-
endangered /
endangered)
non-endangered
endangered
non-endangered
endangered
Risk Quotient Range
(Single Applications)
0.02 - 60
0.02 - 439
O.01 - 27
O.01 - 47
Risk Quotient Range
(Multiple Applications)
0.04 - 120
0.04 - 878
O.01 - 54
O.01 - 94
Granular Applications - The only currently approved granular applications which are currently
allowed on the master label are on grass grown for seed or sod, turf, cranberries, non-crop land, and
aquatic weed control sites. The non-target terrestrial plant RQ summaries for the acid and amine salts
for the esters are presented below. Detailed RQs are presented in Appendix F of the ecological risk
assessment for 2,4-D.
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Table 37. Non-target Plant Risk Quotient Summary of Granular Applications to Selected Uses.
Chemical Group (acid /
ester)
2,4-D Acid and Amine Salt
2,4-D Ester
Plant Group (non-endangered /
endangered)
non-endangered
endangered
non-endangered
endangered
Risk Quotient Range
(Single Applications)
2.2 - 77
2.2-133
2.0- 494
3.57-851
Risk Quotient
Range (Multiple
Applications)1
4.4-154
4.4 - 266
4.0 - 987.62
7.14 -1702.12
1 Turf is only site for multiple applications of granular products.
4. Ecological Incidents
Aquatic Incidents
The EFED Ecological Incident Information System (EIIS) database reports pesticide incidents
that have been voluntarily submitted to EPA by state agencies. The report assigns a certainty index of
0 (unrelated), 1 (unlikely), 2 (possible) 3 (probable) or 4 (highly probable) to each incident. In
addition, a judgement of registered use, accidental misuse, intentional misuse, or undetermined is
assigned. There were 227 incidents reported for 2,4-D, and 24 of these incidents were reported as
aquatic incidents under the 2,4-D acid only.
The two "highly probable" registered use incidents occurred when 2,4-D was applied to corn
and a railroad right-of-way. The corn application resulted in bluegill and largemouth bass mortalities
in Missouri, while the right-of-way application resulted in a kill of 23,000 (presumably) fish.
The corn incident affected bluegill, catfish, crappie, fox squirrel, greengill, largemouth bass,
silver minnow, smallmouth bass, sunfish and watersnake. This incident was determined to be "highly
probable" and was not listed as a misuse, however, no residue analysis was obtained. Another
incident was recorded as "possible" and the use was "undetermined." The species affected included
bass, catfish, crappie, grass carp, and perch.
Results from these incidents should be regarded with caution since it is not clear exactly which
products or tank mixes might be involved. In addition, residue analysis was not available in almost
all instances.
Terrestrial Incidents
There were 227 terrestrial incidents reported for 2,4-D, and 155 of these incidents were
reported as plant incidents under the acid form only. Two incidents were reported as both terrestrial
and aquatic.
Eighty-four incidents to plants were listed as registered uses and most were considered
"probable." Crop damage was reported to have occurred on numerous crops, but most common non-
target plant damages occurred on grass and corn. However, most of these incidents resulted from
applications to lawns/turf and corn, respectively.
Results from the incident reports should be regarded with caution since it is not clear exactly
which products or tank mixes might be involved. In addition, residue analysis was not available in
almost all instances.
5. Endangered Species Concerns
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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 federal
agencies to ensure that their actions are not likely to jeopardize listed species or adversely modify
designated critical habitat. To analyze the potential of registered pesticide uses to affect any
particular species, EPA puts basic toxicity and exposure data developed for REDs 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 the RED 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
27984-28008, July 3, 1989) 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 at www.epa.gov/espp.
The preliminary risk assessment for endangered species indicates that 2,4-D exceeds the
endangered species LOCs for the following combinations of analyzed uses and species:
• Estimated risk quotients (RQs) from use of 2,4-D DMAS in weed control through direct
subsurface application to water bodies exceed the endangered species LOG for freshwater and
estuarine fish, and estuarine invertebrates. However, there are currently no endangered
estuarine/marine invertebrates.
• Estimated RQs from use of 2,4-D BEE in weed control through direct subsurface application to
water bodies exceed the endangered species LOG for freshwater fish and invertebrates and
estuarine fish.
Estimated RQs from use of 2,4-D acid and amine salts in rice paddies exceed endangered
species LOCs for freshwater invertebrates. The rice model used to predict these EECs is a
screening level model which predicts concentration in tailwater at the point of release from the
paddy. It is anticipated that once released, the concentration will be reduced and subsequently,
RQs will decrease.
• The scenario of the direct application to water for weed control for the acid and amine salts
indicates a endangered species concern for aquatic vascular plants. Estimated RQs from use of
2,4-D BEE for direct application to water for weed control exceed all LOCs for both vascular
and non-vascular plants. Potential risk to endangered non-vascular plants is not evaluated
because at this time there are no listed endangered non-vascular plant species.
• Target acute RQs for birds and mammals were exceeded for endangered species risks for
multiple crops and multiple animal weights. Banded and granular applications result in higher
RQs at more use sites.
• Target acute LOCs for both non-endangered and endangered plants were exceeded for non-
granular and granular for multiple uses, based on predicted EECs.
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In December 2004, EPA completed a refined assessment for 2,4-D's potential effects to 26
environmentally significant units (ESUs) of Pacific Salmonids (salmon and steelhead). That refined
assessment concluded that 2,4-D has "no effect" on these species when used according to label
directions on terrestrial sites. Further, that assessment concluded that use of 2,4-D on rice "may affect
but is not likely to adversely affect" 4 ESU's and will have "no effect" on 22 ESU's. That same
analysis concluded that use of 2,4-D "may affect" each of the 26 ESU's when used for aquatic weed
control purposes. As a result of that assessment, EPA is currently engaged in consultation with the
National Marine Fisheries Service regarding those scenarios that resulted in a determination that 2,4-
D "may affect but is not likely to adversely affect" the species, or "may affect" the species.
The Agency's level of concern for endangered and threatened freshwater fish and invertebrates,
estuarine invertebrates, birds, mammals, aquatic vascular plants, and terrestrial non-target plants is
exceeded for the use of 2,4-D. The Agency recognizes that there are no Federally listed
estuarine/marine invertebrates. The registrant must provide information on the proximity of Federally
listed freshwater vascular plants, birds, mammals, and non-target terrestrial plants (there are no listed
estuarine/marine invertebrates) to the 2,4-D use sites. This requirement may be satisfied in one of
three ways: 1) having membership in the FIFRA Endangered Species Task Force (Pesticide
Registration [PR] Notice 2000-2); 2) citing FIFRA Endangered Species Task Force data; or 3)
independently producing these data, provided the information is of sufficient quality to meet FIFRA
requirements. The information will be used by the OPP Endangered Species Protection Program to
develop recommendations to avoid adverse effects to listed species.
6. Risk Characterization
The Agency has considered available information on 2,4-D's toxicity, use areas, usage, fate
properties, and application methods and formulations in characterizing ecological risks related to
normal use. Upon review and synthesis of this information, the Agency concludes use of 2,4-D for
aquatic weed control presents risk to aquatic organisms, while 2,4-D use on terrestrial sites presents
the greatest potential risks to small mammals, birds, and non-target terrestrial plants.
a. Characterization of risk to aquatic organisms from direct aquatic
application
Whereas the maximum labeled target concentration for control of aquatic weeds is 4 ppm, the
typical target concentration is 2 ppm. Moreover, the risks to aquatic organisms were estimated based
on a 2,4-D application that resulted in a whole-reservoir concentration of 4 ppm. Treating 100% of
the water body would result in a large amount of decaying plant life, thereby creating an oxygen-
depleted environment that would most likely result in fish kills. To avoid that scenario, the 2,4-D
label advises the applicator to avoid treating more than 50% of a water body in a single application.
In actual practice, aquatic weeds that 2,4-D controls tend to grow in littoral zones. As a result,
generally a maximum of 20-30% of a water body is treated in a single application. Applying the
typical rate of 2 ppm, and taking into account a typical maximum treated area of 30% would decrease
calculated RQs by approximately 6-fold.
While noting the potential risks to aquatic organisms from the direct application of 2,4-D for the
control of aquatic weeds identified above, it is important to note the benefits gained through the direct
application of 2,4-D to aquatic bodies, for the control of invasive species. The U.S Army Corps of
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Engineers (USAGE), among others, has identified 2,4-D as an important tool for protecting the
nation's waters from the invasion and establishment of some of the world's worst species of exotic
nuisance vegetation. 2,4-D has a reputation as a selective and economical means to remove invasive
plants, enhance the growth and recovery of desirable native vegetation, restore water quality, reduce
sedimentation rates in reservoirs, and improve fish and wildlife habitat. 2,4-D products are used to
control invasive weeds, such as Eurasian watermilfoil (Myriophyllum spicatum) in the northern tier
states and water hyacinth (Eichhornia crassipes) in the Gulf Coast states. Effective control of these
plants can benefit public health with respect to reducing levels of mosquito habitat. In addition,
according to USAGE, no other product (or alternative technique) can control these plants in a more
cost-effective manner (K. Getsinger, USAGE, Public Comment; Docket ID# OPP-2004-0167-0053).
b. Characterization of risk to mammals from terrestrial use
All of the calculated RQs for mammalian acute risk for the non-granular use of 2,4-D were
based on maximum labeled application rates. The QUA from BEAD (Quantitative Usage Analysis
for 2,4-D, Case Number: 0073, Date: 8-9-01, A. Halvorson) suggests that the average application
rates for many crops are considerably less than the modeled maximum application rates. For non-
granular spray application mammalian acute concerns, the highest RQ was 1.72 for use on asparagus
for small mammals feeding on short grass based on a maximum application rate of 4 Ibs ae/acre;
however, the average application rate was only 1.10 Ibs ae/acre (BEAD QUA). If the modeled
application rate was reduced to the reported average application rate of 1.10 Ibs ae/acre for asparagus,
the RQ would be 1.08 which is still above the acute LOG of 0.5. However, asparagus is
representative of a minor 2,4-D use, and risk to mammals from use of 2,4-D on asparagus would be
minimal, given that fact.
To add context to the acute mammalian assessment, the effect of assuming an average
application rate was determined. Major 2,4-D crops include pasture/rangeland, turf, wheat, corn, and
soybeans. For pasture/rangeland, the highest acute RQ was 0.86 for small mammals feeding on short
grass based on a maximum application rate of 4 Ibs ae/acre. However, the average application rate
was only 0.62 Ibs ae/acre (BEAD QUA). If the modeled application rate was reduced to 0.62 Ibs
ae/acre for pasture/rangeland, the resulting RQ is 0.31 which is below the acute LOG, but above the
restricted use LOG of 0.2. Similar trends are noted for other major use sites.
Calculated chronic risks to mammals were greatest for small herbivores/insectivores. For 15 g
mammalian herbivores/insectivores, chronic RQs based on maximum residues and mean residues
ranged from <1 to 200 and <1 to 70, respectively. For major use sites, including rangeland/pasture,
RQs were approximately 100. These chronic risk estimates are likely conservative as described
below.
Exposure
The chronic RQs calculated for mammalian herbivores/insectivores are based on conservative
estimates of exposure that are not likely to occur in nature. In the example of pasture/rangeland, the
chronic RQ of approximately 100 for maximum residues (35 for mean residues) was calculated based
on an application rate of 4 Ibs ae/A. This maximum application rate was determined based on the
knowledge that the maximum rate of 2 Ibs ae/A may be applied twice per year, at a 30 day interval.
However, the Biological and Economic Analysis Division within OPP has determined that the
average application rate on pasture/rangeland is only 0.62 Ibs ae/acre (BEAD QUA). Moreover,
information from several state contacts indicate that a once per year application of less than 1 Ib ae/A
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is typical (personal communications). As the typical rate is approximately 25% of the assessed rate,
use of the typical rate would be expected to decrease the RQ for the pasture/rangeland scenario to
approximately 25 for maximum residues and 9 for mean residues.
A second example of the conservative assumptions included in the assessment of exposure to
mammalian herbivores/insectivores is the assumption that 100% of the long term diet is limited to
single food types foraged only from treated fields. The assumption of 100% diet from a single food
type may be realistic for acute exposures, but diets are likely to be more variable over longer periods
of time. Moreover, currently Agency models do not account for the uptake of 2,4-D by plants and
therefore assume that all non-dissipated pesticide applied to the field is present for exposure to
organisms. In fact, many pesticides, including 2,4-D, are systemic and are absorbed by plants in the
field so that the current approach may overestimate the amount of 2,4-D available for exposure in
terrestrial systems. Therefore, the percent of diet assumption is likely to be conservative and will tend
to overestimate potential risks for chronic exposure, especially for larger organisms that have larger
home ranges.
Hazard
The mammalian chronic risk assessment utilized a toxicity endpoint from a rat two-generation
reproduction test. This endpoint was the NO AEL of 5 mg/kg-bw/day for growth rate reductions in
Fib offspring. The agency considers that reduced growth (reductions in pup body weight gains
relative to controls) in offspring as a potentially important effect with implications for the
survivability of offspring and therefore a potential impact on fecundity. Because the endpoint is the
no effect level for this measured parameter, evaluations of the significance of any exposures above
this endpoint were conducted. From the same two-generation rat reproduction study, the LO AEL
associated with Fib pup growth rate reduction was 20 mg/kg-bw/day. This LOAEL corresponds
with body-weight gain reductions of 15 to 17 % (males and females) relative to controls. The 20
mg/kg-bw/day dose level also represents a NO AEL for increased gestational length and incidents of
skeletal anomalies and reduced ossification in Fib pups. The LOAEL for these gestational and
skeletal effects is 80 mg/kg-bw/day.
In addition to the available rat two generation reproduction study, a number of developmental
toxicity studies are available in rats and rabbits for the acid, amine salts and esters. These data are
from studies involving short-term exposures during critical periods of fetal development and are
useful to determine if long-term or short-term exposure events are necessary for the types of effects
observed in the two-generation reproduction study. MRID 41747601, developmental toxicity in
rabbits with the acid, shows a NO AEL of 30 mg/kg-bw/day for increased rate of fetal abortions, with
a LOAEL 90 mg/kg-day. Similar NO AEL and LOAEL thresholds were observed in studies in
rabbits with the amine salts and esters of 2,4-D. MRID 000251031, developmental toxicity in rats
with the acid, showed a NO AEL of 25 mg/kg-bw/day and a LOAEL of 75 mg/kg-bw/day for
increased incidence of skeletal malformations. Similar results are reported in other studies with rats
involving the amine salt and esters of 2,4-D.
c. Characterization of risk to birds from terrestrial use
The assessment of risk to birds from exposure to 2,4-D is likely conservative as follows.
Currently, Agency models do not account for the uptake of 2,4-D by plants and therefore assume that
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all non-dissipated pesticide applied to the field is present for exposure to organisms. In fact, many
pesticides, including 2,4-D, are systemic and are absorbed by plants in the field and therefore, the
current approach may overestimate the amount of 2,4-D available for exposure in terrestrial and
aquatic systems.
For non-granular spray application, the highest acute avian RQ (3.50) was from the cranberry
scenario, for birds feeding on short grass. That assessment was based on a maximum application rate
of 4 Ibs ae/acre; however, the average application rate is 1.83 Ibs ae/acre (see the BEAD QUA). If the
modeled application rate was reduced to 1.83 Ibs ae/acre for cranberries, and an assumption made that
the resulting EEC will be reduced linearly, the RQ would be 1.60.
To determine the hazard associated with acute exposures to birds, the assessment has
considered two types of data, a suite of dietary studies and a suite of gavage studies. For avian acute
exposures, the dietary studies result in non-definitive endpoints which are not appropriate for
estimating risk. Therefore, the assessment has relied on the gavage studies to estimate avian acute
risks. The Agency recognizes that this approach may overestimate risk to birds due to the fact that
birds would not typically be expected to consume 2,4-D in this manner.
Given the conservative assumptions in both exposure scenarios and hazard determinations, the
Agency finds that the acute risk to birds from 2,4-D exposure does not exceed the Agency's level of
concern.
Potential chronic risks to birds is limited to a few use sites. These include non-cropland, forest,
asparagus, and cranberry. The RQs for these sites range from 1 -1.09. Further characterization of
these use sites by evaluating average application rates versus maximum application rates lower these
RQs to below the LOCs.
d. Characterization of risk to non-target plants from terrestrial use
Acute LOCs for both non-endangered and endangered terrestrial plants were exceeded for non-
granular and granular uses at many use sites. Consideration of average application rates did not result
in exposure below LOCs. However, the exposure estimates used to develop the RQs were likely
conservative, as follows.
In the exposure calculation for non-target plants, the major contributor is run-off from the
application site. The runoff and leaching vulnerability schemes used in this assessment were adapted
from a vulnerability scheme developed by the USDA (Kellogg et al, 1998), and incorporate several
conservative assumptions. For example, a 1-in-10 year rain event is modeled, resulting in 3 cm of
runoff water. USDA identified several caveats to be considered when using this vulnerability scheme
which could contribute to the uncertainty associated with this assessment. Among these are that
estimates of runoff and leaching vulnerability are estimated through the use of algorithms (i.e. they
represent estimates of vulnerability and not actual field measurements), fate and transport processes
(i.e. dilution and recharge) are not included, farm management practices are not considered, and some
watershed estimates are based on major crops only. The effect of these factors on the vulnerability
assessment is unknown, however, there is a low probability that a l-in-10 year rain event will
coincide with the first few days following a 2,4-D application at the maximum application rate. Also,
it is likely that farm management practices would be in place to limit run-off, as run-off events are
detrimental to the farm as a whole for reasons other than pesticide damage.
Currently Agency models do not account for the uptake of 2,4-D by plants and therefore
assume that all non-dissipated pesticide applied to the field is present for exposure to organisms. In
fact, many pesticides, including 2,4-D, are systemic and are absorbed by plants in the field and
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therefore, the current approach may overestimate the amount of 2,4-D available for exposure in
terrestrial and aquatic systems.
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant
data concerning an active ingredient, whether or not products containing the active ingredient are
eligible for reregistration. The Agency has previously identified and required the submission of the
generic (i.e., active ingredient-specific) data to support reregistration of products containing 2,4-D as
an active ingredient. The Agency has completed its review of these generic data, and has determined
that the data are sufficient to support reregistration of all products containing 2,4-D .
The Agency has completed its assessment of the dietary, occupational, residential, and
ecological risk associated with the use of pesticide products containing the active ingredient 2,4-D .
Based on a review of these data and on public comments on the Agency's assessments for the active
ingredient 2,4-D , the Agency has sufficient information on the human health and ecological effects
of 2,4-D to make decisions as part of the tolerance reassessment process under FFDCA and
reregistration process under FIFRA, as amended by FQPA. The Agency has determined that 2,4-D
containing products are eligible for reregistration provided that: (i) current data gaps and confirmatory
data needs are addressed; (ii) the risk mitigation measures outlined in this document are adopted; and
(iii) label amendments are made to implement these measures. Label changes are described in
Section V. Appendix A summarizes the uses of 2,4-D that are eligible for reregistration. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of 2,4-D, and lists the submitted studies that the Agency found acceptable.
Data gaps are identified as generic data requirements that have not been satisfied with acceptable
data.
Based on its evaluation of 2,4-D, the Agency has determined that 2,4-D products, unless labeled
and used as specified in this document, would present risks inconsistent with FIFRA. Accordingly,
should a registrant fail to implement any of the risk mitigation measures identified in this document,
the Agency may take regulatory action to address the risk concerns from the use of 2,4-D . If all
changes outlined in this document are incorporated into the product labels, then all current risks for
2,4-D will be adequately mitigated for the purposes of this determination.
B. Public Comments and Responses
Through the Agency's public participation process, EPA worked extensively with stakeholders
and the public to reach the regulatory decisions for 2,4-D . During the public comment period on the
revised risk assessments, which closed on March 14, 2005, the Agency received comments from
numerous parties. These comments in their entirety are available in the public docket (OPP-2004-
0167) at http: //www. epa.gov/edockets. Individual responses to these comments are also available in
the public docket (OPP-2004-0167).
The RED and technical supporting documents for 2,4-D are available to the public through
EPA's electronic public docket and comment system, EPA Dockets, under docket identification
number OPP-2004-0167. The public may access EPA Dockets at http://www.epa.gov/edockets. In
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addition, the 2,4-D RED may be downloaded or viewed through the Agency's website at
http: //www. epa. gov/pesticides/reregistration/status. htm.
C. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
this pesticide. EPA has determined that risk from dietary (food sources only) exposure to 2,4-D is
within its own "risk cup." An aggregate assessment was conducted for exposures through food,
drinking water, and residential uses. The Agency has determined that the aggregate human health
risks from these combined exposures are within the risk cup. In other words, EPA has concluded that
the tolerances for 2,4-D meet FQPA safety standards. In reaching this determination, EPA has
considered the available information on the special sensitivity of infants and children, as well as
aggregate exposure from food, water, and residential uses.
b. Determination of Safety to U.S. Population
The Agency has determined that the established tolerances for 2,4-D , with amendments and
changes as specified in this document, meet the safety standards under the FQPA amendments to
section 408(b)(2)(D) of the FFDCA, and that there is a reasonable certainty no harm will result to the
general population or any subgroup from the use of 2,4-D. In reaching this conclusion, the Agency
has considered all available information on the toxicity, use practices and exposure scenarios, and the
environmental behavior of 2,4-D . Both the acute dietary (food alone) and chronic dietary risk from
2,4-D are not of concern.
Acute and chronic risks from drinking water exposures are not of concern. Models have been
used to estimate surface water concentrations. The surface water EECs are below the DWLOCs for
all population subgroups. Drinking water monitoring data from the USGS NAWQA Program
confirm that concentrations of 2,4-D are less than modeled estimates for surface water. The
maximum concentration detected in ground water monitoring (from USGS NAWQA) has been used
as the ground water EEC. The ground water EEC is below the DWLOCs for all populations
subgroups.
EPA has determined that the established tolerances for 2,4-D, with amendments and changes as
specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants and children.
The safety determination for infants and children considers the factors noted above for the general
population, but also takes into account the possibility of increased dietary exposure due to the specific
consumption patterns of infants and children, as well as the possibility of increased susceptibility to
the toxic effects of 2,4-D residues in this population subgroup. FQPA directs EPA, in setting
pesticide tolerances, to use an additional tenfold margin of safety to protect infants and children,
taking into account the potential for pre- and postnatal toxicity and the completeness of the toxicology
and exposure databases. The statute authorizes EPA to replace this tenfold FQPA safety factor with a
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different FQPA factor only if reliable data demonstrate that the resulting level of exposure would be
safe for infants and children.
FQPA Special Safety Factor
EPA concludes that the toxicology database for 2,4-D is substantially complete since all
required studies have been submitted. After evaluating hazard and exposure data for 2,4-D, EPA
removed the default 10X FQPA special safety factor. The toxicity database for 2,4-D includes
acceptable developmental and reproductive toxicity studies. Developmental toxicity studies were
conducted in both rats and rabbits for most 2,4-D forms. There is qualitative evidence of
susceptibility in the rat developmental toxicity study with 2,4-D acid and DEA salt where fetal effects
(skeletal abnormalities) were observed at a dose level that produced less severe maternal toxicity
(decreased body-weight gain and food consumption). There is no evidence of increased (quantitative
or qualitative) susceptibility in the prenatal developmental toxicity study in rabbits or in the 2-
generation reproduction study in rats on 2,4-D. Regarding the 2,4-D amine salt and ester forms, no
evidence of increased susceptibility (quantitative or qualitative) was observed in the prenatal
developmental toxicity study in rat and rabbits (except for 2,4-D DEA) dosed with any of the amine
salts or esters of 2,4-D. There is evidence of increased susceptibility (qualitative) in the prenatal
developmental study in rabbits for 2,4-D DEA salt.
After establishing developmental toxicity endpoints to be used in the risk assessment with
traditional uncertainty factors (lOx for interspecies variability and lOx for intraspecies variability), the
Agency has no residual concerns for the effects seen in the developmental toxicity studies. Therefore,
the 10X FQPA special safety factor was reduced to IX.
Database Uncertainty Factor
The EPA has concluded that there is a concern for developmental neurotoxicity resulting from
exposure to 2,4-D, and that a developmental neurotoxicity (DNT) study in rats is required for 2,4-D.
The Agency has also concluded that a 2-generation reproduction study is required to address both the
concern for thyroid effects and immunotoxicity, as well as a more thorough assessment of the gonads
and reproductive/developmental endpoints. EPA has determined that a 10X database uncertainly
factor (UFDB) is needed to account for the lack of these studies. This Uncertainty Factor is applied
only to exposure scenarios that are expected for children or pregnant women, and thus is not applied
to occupational exposure scenarios.
2. 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 occurring estrogen, or other
endocrine effects as the Administrator may designate." When the appropriate screening and/or
testing protocols being considered under the EDSP have been developed, 2,4-D may be subject to
additional screening and/or testing to better characterize effects related to endocrine disruption.
3. Cumulative Risks
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The Food Quality Protection Act (FQPA) requires EPA to consider "available information"
concerning the cumulative effects of a particular pesticide's residues and "other substances that have a
common mechanism of toxicity" when considering whether to establish, modify, or revoke a
tolerance. Potential cumulative effects of chemicals with a common mechanism of toxicity are
considered because low-level exposures to multiple chemicals causing a common toxic effect by a
common mechanism could lead to the same adverse health effect as would a higher level of exposure
to any one of these individual chemicals. 2,4-D is a member of the alkylphenoxy herbicide class of
pesticides. A cumulative risk assessment has not been performed as part of this human health risk
assessment because the Agency has not yet made a determination of whether 2,4-D and other
alkylphenoxy compounds have a common mechanism of toxicity. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements by the EPA's Office of Pesticide
Programs concerning common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA's website at
http: //epa. gov/pesticides/cumulative/. 1
4. Special Review Disposition
2,4-D has been in pre-Special Review status since September 22, 1986, because of
carcinogenicity concerns. In 1994 a Science Advisory Panel/Scientific Advisory Board classified
2,4-D as a Group D carcinogen (not classifiable to human carcinogenicity). The Agency requested
further histopathological examinations of rat brain tissues and mouse spleen tissues in question.
These exams were submitted and reviewed, and on March 16, 1999, The Agency notified the 2,4-D
Task Force that the Agency would continue to classify 2,4-D as a Group D carcinogen. Also, in a
1994 review of all relevant epidemiological studies, EPA found that none of the more recent
epidemiological studies definitively linked human cancer cases to 2,4-D. A final notice of the
Agency's intent not to initiate Special Review will be published in concert with the release of this
RED document.
5. Dioxin Contaminants
Exposure
In 1987, a DCI titled "Data Call-In Notice for Product Chemistry Relating to Potential
Formation of Halogenated Dibenzo-p-dioxin or Dibenzofuran Contaminants in Certain Active
Ingredients," was issued to identify pesticides that may contain halogenated dibenzo-p-dioxin and
dibenzofuran contaminants. A second DCI in 1987, "Data Call-In for Analytical Chemistry Data on
Polyhalogenated Dibenzo-p-Dioxins/Dibenzofurans (HDDs and HDFs)," was issued, under which
registrants whose products did not qualify for an exemption or waiver were required to generate and
submit analytical methods and certification limits of dioxins and furans.
The specific results of analysis of multiple 2,4-D technical products, submitted to EPA in
response to both DCIs, are considered confidential business information (CBI) and cannot be released
by EPA to the public. In summary, two of eight technical products had concentrations of 2,3,7,8-
tetrachlorodibenzo-p-dioxin (TCDD; dioxin) greater than the limit of quantitation (LOQ; LOQ = 0.1
ppb) and three of eight had concentrations of 1,2,3,7,8-pentachlorodibenzo-p-dioxin (PCDD) greater
than the LOQ (LOQ = 0.5 ppb).
In 1991, the EPA's Office of Research and Development (EPA/ORD) began an assessment of
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the health risks of exposure to dioxins. The most recent revision of that assessment has recently been
submitted to the National Academies of Science (NAS) for review. In that document and elsewhere,
a source inventory of dioxin was published. As a result of the 1987 DCI data, and the amount of 2,4-
D applied to agricultural and residential settings (approximately 50 million pounds per year), the
current draft dioxin source inventory (see The Inventory of Sources and Environmental Releases of
Dioxin-Like Compounds in the United States: The Year 2000 Update. EPA/600/P-03/002A, External
Review Draft, March 2005) identifies 2,4-D as a source of dioxin emissions (28.9 g TEQDF-
WHO98; TEQ = Toxic EQuivalent amount, or an amount of total dioxin equivalent to 28.9 g of the
most toxic dioxin congener, 2,3,7,8-TCDD). It should be noted that this estimate of dioxin release
assumes all products are contaminated and does not take into account manufacturing changes since
the DCI. Moreover, that estimate is specific for the year 1995, and therefore should not be considered
the current estimate of dioxin release.
The 1995 estimate for dioxin emissions from 2,4-D, taken together with NAS estimates for
2002/2004 releases from other sources of dioxin in the U.S., suggest that 2,4-D applications to land
ranks seventh (2.6% of all dioxin sources) behind backyard burning (57%), sewage sludge application
(6.9%), residential wood burning (5.7%), coal-fired utilities (5.4%), diesel trucks (3.2%), and
secondary aluminum smelting (2.6%) in terms of dioxin emissions (see The Inventory of Sources and
Environmental Releases of Dioxin-Like Compounds in the United States: The Year 2000 Update,
EPA/600/P-03/002A, External Review Draft, March 2005). According to 2,4-D registrants, since the
1990's, the manufacturing processes for 2,4-D and its chemical intermediate, dichlorophenol, have
been modified, and those modifications decrease the chance that TCDD and PCDD are formed during
the manufacturing process. The following description of the current 2,4-D manufacturing process
summarizes information submitted by the 2,4-D Task Force II.
A key chemical intermediate in the manufacture of 2,4-D is 2,4-dichlorophenol (2,4-DCP) and
the purity of this intermediate has a strong correlation to the purity of 2,4-D acid produced from it. In
the manufacture of 2,4-DCP, multiple positions around the phenyl ring structure may be chlorinated.
The desired positions for chlorination are carbons two and four of the phenyl ring, but the reaction
may yield small quantities of compounds chlorinated at different positions. Certain combinations of
these chlorinated structures may form precursors to the dioxin 2,3,7,8-TCDD.
Manufacture of the 2,4-DCP intermediate has been optimized by controlling processing
conditions necessary to drive the chlorination reaction to the preferred two and four carbon positions,
thereby limiting the formation of impurities that can lead to dioxin formation. Controlled temperature
and residence time during the chlorination reaction, programmed addition of the chlorinating agent,
and efficient agitation in the reaction vessel are processing factors that contribute to the purity of 2,4-
DCP. Additionally, distillation of 2,4-DCP is a technique that may be employed post-chlorination to
increase purity. Moreover, quality control sampling and analytical procedures are also utilized to
verify product quality at various steps of the 2,4-DCP process. According to Results of testing of
2,4-DCP, performed in response to the Toxic Substances Control Act (TSCA) Dioxin/Furan Test
Rule, showed no detectable concentrations of 2,3,7,8-substituted tetra- through hepta-CDD/CDFs.
In the manufacture of 2,4-D acid per se, there are additional process conditions and procedures
that must be controlled to maximize yield and purity. Details regarding these measures are dependent
on specific manufacturing methodologies and, as such, are protected under FIFRA Section 10 as
Confidential Business Information.
Anticipated Residues
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The Agency's most recent evaluations of anticipated dioxin and furan residues resulting from
2,4-D applications are based on the concentrations of dioxins and furans present in technical grade
2,4-D as determined by review of analytical data submitted in response to the 1987 DCI. In those
evaluations, completed in the early 1990's, the ratios of individual chlorodibenzo-p-dioxin (CDD;
dioxin) or chlorodibenzo-p-furan (CDF; furan) contaminant concentrations to 2,4-D acid
concentrations were calculated, and those ratios were used with 2,4-D tolerance expressions to
calculate an anticipated residue in eggs, fruits, grains, kidney (hogs), meat (hogs), milk, nuts, poultry,
and sugarcane, for each detected dioxin or furan. For each technical 2,4-D formulation for which the
Agency received data, calculation of an anticipated dietary exposure was based on a worst-case
scenario in which the highest anticipated residue was used, and an assumption was made that 100%
of the diet consisted of the food item with the highest anticipated residue.
Toxicological Significance
Based on the calculation of dietary exposures, using the worst-case scenario described above,
both the cancer and non-cancer risks from dietary exposure to dioxins and furans as contaminants of
2,4-D acid were considered to be of no toxicological concern at the time of the assessment.
Risk Management
Members of the 2,4-D Task Force n have submitted information about the current
manufacturing process for the 2,4-D intermediate, 2,4-DCP, as well as for 2,4-D acid itself, and have
included in their submissions explanatory text on how current manufacturing processes minimize the
chance of dioxin and furan formation. To confirm that the changes to the manufacturing processes
since the time of the 1987 DCI have resulted in lower concentrations of dioxin congeners in technical
2,4-D products, the Agency is requiring that five recent batches of all technical products be analyzed
for 2,3,7,8-TCDD, 2,3,7,8-TCDF and their respective higher substituted chlorinated congeners using
validated analytical methods. The Agency is specifying that the manufacturers use the most current
state-of-the art laboratory methods for measuring 2,3,7,8-TCDD and TCDF at levels less than 1 part
per trillion (EPA Method 1613, Tetra- through Octa-Chlorinated Dioxins and Furans by Isotope
Dilution HRGC/HRMS). Because 1,2,3,7,8-PeCDD is equi-potent to 2,3,7,8-TCDD in the TEF
scheme, the Agency is adding this compound to our testing requirements. The pentachloro-congener
was reported as present in 2,4-D in the 1987 Data Call-in. Registrants are encouraged to submit their
analytical methods and sampling plans to the Agency for review prior to commencing these studies.
D. Tolerance Reassessment Summary
1. Tolerances Currently Listed Under 40 CFR §180.142
Tolerances for residues of 2,4-D in/on plant RACs and processed commodities, fish, and
potable water are currently expressed in terms of 2,4-D per se [40 CFR §180.142(a)(l-6 and 9-12)
and (b)]. Tolerances for residues in livestock commodities are currently expressed in terms of 2,4-D
and/or its metabolite 2,4-dichlorophenol (2,4-DCP) [40 CFR §180.142(a)(8)]. EPA has concluded
that 2,4-D is the residue of concern and that tolerances listed in 40 CFR § 180.142 are to be defined as
residues of 2,4-D, both free and conjugated, determined as the acid.
The listing for 2,4-D tolerances in 40 CFR §180.142 should be recodified into parts (a), (b), (c),
and (d). Part (a) should be reserved for commodities with permanent tolerances reflecting at least a
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preharvest (field) or postharvest use, part (b) for Section 18 emergency exemptions, part (c) for
tolerances with regional use registrations, and part (d) for commodities bearing 2,4-D residues solely
inadvertently, including irrigated crops. A summary of 2,4-D tolerance reassessments and
recommended recodifications is presented in Table 37 along with any recommended changes in
commodity definitions.
Note that some commodities currently are the subject of two or more separate tolerances
depending on the use pattern, the 2,4-D form applied, timing of treatment (preharvest or postharvest),
or degree of intent to deposit residues (direct treatment or inadvertent). Direct treatment involves
intentional field treatment of crop sites or postharvest treatment of harvested commodities on
registered labels. Inadvertent deposition involves the incidental exposure of crops when water
passing through 2,4-D-treated irrigation ditchbanks or diverted from 2,4-D-treated bodies of water is
used to irrigate crops. EPA is proposing to remove most such use-pattern or FIFRA-related language
at 180.142. Due to the complicated nature of the routes of residue deposition, we are proposing to
subsume the lower tolerances in the highest existing or reassessed tolerance established in the same
commodity - even if that results in 180.142(a) containing some tolerances that reflect 2,4-D residues
that could potentially result from two or more exposure routes. An example is citrus which has
tolerances for 2,4-D in the RAC resulting from preharvest use + postharvest use, irrigation ditchbank
treatment (inadvertent), and direct water body treatment (also inadvertent). If there are no registered
uses on a given commodity and residues are likely to occur on that commodity solely inadvertently,
i.e., via irrigation, then the tolerance in that commodity will be located under 180.142(d). In most
cases, residues, and hence the tolerance, resulting from a direct, registered use are higher than the
residues (and the tolerance) resulting inadvertently. EPA proposes these revisions because we know
that an enforcement agency, having detected 2,4-D residues in a commodity, would: (i) not be able to
distinguish which form of 2,4-D had been applied; (ii) rarely be able to determine who applied the
pesticide, when, or for what purpose; and (iii) not know whether a sample is violative if the 2,4-D
concentration falls between two tolerance levels.
Tolerances Listed Under 40 CFR §180.142(a)(l):
Adequate data are available to reassess the established tolerances for the following
commodities: apple, apricot, citrus fruit, pear, potato and quince.
The available apple and pear residue data will support a crop group tolerance at 0.05 ppm for
pome fruits under the redesignated section 180.142(a). The separate tolerances on apple, pear, and
quince should be revoked concomitant with establishing a new pome fruit crop group tolerance.
The 5 ppm tolerance on citrus fruits should be reassessed to 3.0 ppm to reflect any combination
of the preharvest use on citrus, the postharvest use of 2,4-D on lemons in the U.S., a similar
postharvest use on oranges imported into the U.S., and any inadvertent (irrigation) residues that may
be incurred as a result of 2,4-D use in aquatic sites. The tolerances in citrus fruit of 0.1 ppm at
180.142(a)(3) and 1.0 ppm at 180.142(a)(6), both reflecting inadvertent residues, should be revoked
as they will be subsumed by the reassessed tolerance of 3.0 ppm at 180.142(a).
The tolerance for residues in/on apricots should be revoked as residues in/on apricots will be
covered by the tolerance in stone fruits.
Tolerances Listed Under 40 CFR $180.142(aĄ2):
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Adequate data are available to reassess all the tolerances listed under 180.142(a)(2). All
reassessed tolerances should be recodified under the revised section 180.142(a).
Based on the available residue data, the current tolerances on grass hay and tree nuts are
adequate. However, tolerances can be lowered on the following commodities: blueberry, sweet corn
(kernel plus cob with husks removed), corn forage and grain, cranberry, stone fruits, grape, grass
forage, pistachio, rice straw, sorghum forage, grain and stover, and sugarcane. Tolerances should be
increased on the following commodities: corn stover, rice grain, and wheat grain and forage.
The available residue data for wheat commodities will be used to reassess tolerances on similar
commodities from barley, millet, oats, and rye. Tolerances should be increased accordingly on:
barley grain; millet grain, forage and straw; oat forage and grain; and rye forage and grain.
The tolerance for residues in sugarcane forage should be revoked because it is no longer
considered a significant livestock feed item (OPPTS GLN 860.1000).
Tolerances Listed Under 40 CFR §180.142(a)(3):
Tolerances listed in 40 CFR §180.142(a)(3) are established for negligible residues of 2,4-D in
irrigated crops from application of its dimethylamine salt to irrigation ditch banks in the Western
United States in programs of the Bureau of Reclamation, U.S. Department of Interior; cooperating
water user organizations; the Bureau of Sport Fisheries, U.S. Department of Interior; Agricultural
Research Service, U.S. Department of Agriculture; and the Corps of Engineers, U.S. Department of
Defense. Where tolerances are established at higher levels resulting from other uses of 2,4-D, the
higher tolerance applies also to residues in crops from the irrigation ditch bank use cited in this
paragraph.
The tolerances in crops or crop groups listed under 40 CFR §180.142(a)(3) that do not have a
direct treatment tolerance under 180.142(a) should be recodified as 180.142(d), i.e., inadvertent
residue tolerances.
The available irrigated crop data support tolerances for inadvertent residues at 0.2 ppm in
foliage of legume vegetables (group 7) and non-grass animal feed (group 18) and at 0.05 ppm in/on
the following crops groups: bulb vegetables (group 3), legume vegetables (group 6), cucurbit
vegetables (group 9), and fruiting vegetables (group 8).
In addition, tolerances resulting from the primary use of 2,4-D on grasses, citrus fruits, and tree
nuts are high enough to cover any inadvertent residues in these crops that may result from the use of
2,4-D treated irrigation water. Therefore, separate tolerances for inadvertent residues in/on these
crops are not required.
Separate tolerances for inadvertent residues are unnecessary in pome fruits, stone fruits,
pistachios, grapes, blueberry, and strawberry as these crops all have tolerances resulting from the
direct use of 2,4-D. However, the tolerances in all of these commodities have been reassessed at 0.05
ppm, the limit of quantitation of the enforcement method, to reflect only direct treatment at this time.
It is reasonably possible that inadvertent residues resulting from irrigation with treated water could
contribute concentrations of 2,4-D in the commodities necessitating tolerances higher than 0.05 ppm.
Therefore, confirmatory irrigated crop residue data are required for a representative perennial crop
(strawberry). Also, additional residue data on sugar beets and tops irrigated with water containing
2,4-D at 0.1 ppm are required to permit reassessment of the tolerances in the Root and Tuber
Vegetables Group and the Leaves of Root and Tuber Vegetables Group resulting inadvertently due to
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irrigation with 2,4-D-treated water. These data may also be used to reassess inadvertent tolerances
established at 180.142(d) as a result of the 2,4-D RED.
Tolerance Listed Under 40 CFR § 180.142(aĄ4):
The established tolerance for residues in/on asparagus is reassessed at the current level under
the revised tolerance expression and is to be recodified as 40 CFR §180.142(a).
Tolerance Listed Under 40 CFR §180.142(a>(5)
The established tolerance for residues in/on strawberry is reassessed at the current level under
the revised tolerance expression and is to be recodified as 40 CFR §180.142(a).
Tolerances Listed Under 40 CFR $180.142(aĄ6):
Tolerances listed in 40 CFR §180.142(a)(6) are established for residues of 2,4-D from
application of its dimethylamine salt for water hyacinth control in ponds, lakes, reservoirs, marshes,
bayous, drainage ditches, canals, rivers, and streams that are quiescent or slow moving in programs
conducted by the Army Corps of Engineers or other Federal, State, or local public agencies. Where
tolerances are established at higher levels from other uses of the dimethylamine salt of 2,4-D on crops
included within these commodity groups, the higher tolerances also apply to residues from the aquatic
uses cited in this paragraph.
Based on the available residue data, the current tolerance in shellfish is adequate and the
tolerance in fish can be reduced to 0.1 ppm. Both tolerances should be recodified under the revised
section 180.142(a).
Tolerances for residues in/on the irrigated crops and crop groups at the current §180.142(a)(6)
are set at 1.0 ppm whereas the tolerances in/on the identical crops/crop groups at §180.142(a)(3) are
at 0.1 ppm for the irrigation ditchbank use. The recommended/reassessed tolerances from
§180.142(a)(3) to be recodified under sections §180.142(a) or §180.142(d) concomitantly address the
reassessments/recodifications recommended for tolerances at §180.142(a)(6), depending on whether
residues are incurred directly and/or inadvertently, as explained above.
Tolerances Listed Under 40 CFR $180.142(aĄ8V
Tolerances listed in 40 CFR §180.142(a)(8) are established for residues of 2,4-D and/or its
metabolite 2,4-DCP in livestock commodities. As indicated by the Agency, the regulated residue in
animal commodities is 2,4-D (free and conjugated). As a result of this residue definition change, all
reassessed livestock tolerances should be recodified to §180.142(a).
Based upon the available livestock feeding study, the 0.1 ppm tolerance in milk is reassessed at
0.05 ppm and the tolerances in cattle, goat, horse, and sheep commodities are reassessed at: 0.3 ppm
in fat, meat, and meat byproducts except kidney and 4.0 ppm in kidney.
The established tolerances for 2,4-D residues in hog commodities may be revoked. Based on
the MTDB for swine (1.6 ppm) and the results of the ruminant feeding study, there is no reasonable
expectation of finite 2,4-D residues occurring in hog commodities [Category 3 of 40 CFR
§180.6(a)(3)].
In addition, the established tolerances for 2,4-D residues in eggs and poultry tissues may be
revoked. Based on the results of the 2,4-D poultry metabolism study, there is no reasonable
expectation of finite residues in poultry tissues and eggs [Category 3 of 40 CFR §180.6(a)(3)].
Page 87 of 304
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Tolerance Listed Under 40 CFR §180.142(^(9):
Tolerances listed in 40 CFR §180.142(a)(9) are established for residues of 2,4-D from
applications of its dimethylamine salt or its butoxyethanol ester for Eurasian water milfoil control in
programs conducted by the Tennessee Valley Authority in dams and reservoirs of the TVA system.
The tolerance for 2,4-D residues in fish at 40 CFR §180.142(a)(9) should be revoked and this
section deleted. There is no need for two 2,4-D tolerances in fish. It has already been recommended
that the 1.0 ppm tolerance in fish currently at §180.142(a)(6) be reassessed at 0.1 ppm and that this
reassessed tolerance be recodified at the new 40 CFR §180.142(a).
Tolerance Listed Under 40 CFR §180.142(a)(10V
The tolerance listed in 40 CFR §180.142(a)(10) is a regional registration as defined in Sec.
180.1(n) and is established for the residues of 2,4-D in raspberries. The tolerance includes residues
from the application of 2,4-D and its N-oleyl-l,3-propylenediamine salt.
As the members of Task Force n are not supporting 2,4-D use on this commodity, the tolerance
for residues in/on raspberries should be revoked unless another party wishes to support a use on this
crop. 40 CFR §180.142(a)(10) should be deleted and any tolerances with regional use registration
should be established under the revised section 40 CFR §180.142(c).
Tolerance Listed Under 40 CFR §180.142(a)(l 1):
A time-limited tolerance of 0.02 ppm has been established for residues of 2,4-D resulting from
the preplant use of 2,4-D ester or amine in/on soybean seed [40 CFR §180.142(a)(l 1)], expired on
December 31, 2004. Adequate residue data are available to support permanent tolerances on soybean
commodities. Section 180.142(a)(l 1) should be deleted, and permanent tolerances for 2,4-D residues
in/on soybean seed, forage, and hay are recommended to be established under the revised section
180.142(a).
Tolerances Listed Under 40 CFR $180.142(aĄ12):
Tolerances listed at 40 CFR §180.142(a)(12) are established for residues of 2,4-D in processed
feeds. Such residues may be present therein only as a result of application to the growing crop of the
herbicides identified in this section. Tolerances formerly listed at 40 CFR §180.1450 were moved to
40 CFR §180.142(a)(12) (63 FR 34829, 6/26/98).
The tolerance for residues in sugarcane bagasse should be revoked because it is no longer
considered a significant livestock feed item and has been deleted from Table 1 (OPPTS GLN
860.1000).
40 CFR §180.142(a)(12) should be deleted. The tolerance for 2,4-D residues in milled fractions
derived from barley, oats, rye, and wheat should be revoked as the commodity definition will change
and the tolerances will be increased and recodified at the revised 40 CFR §180.142(a) for residues in
barley bran, rye bran, and wheat bran. No tolerances in other processed products of small grains are
necessary because concentration of residues does not occur in them.
Tolerances Listed Under 40 CFR §180.142(a)(13):
Tolerances listed at CFR §180.142(a)(13) are established for residues of 2,4-D in processed
foods and potable water.
Page 88 of 304
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40 CFR §180.142(a)(13) should be deleted. The tolerances for 2,4-D residues in sugarcane
molasses and in milled fractions derived from barley, oats, rye, and wheat should be revoked as
tolerances will be recodified under the revised 40 CFR §180.142(a) for residues in sugarcane
molasses, barley bran, rye bran, and wheat bran.
The established tolerance for residues of 2,4-D in potable water should be revoked as
EPA/OPPTS/OPP no longer establishes pesticide tolerances in potable water. Instead, the EPA
Office of Water establishes Maximum Contaminant Levels (MCLs). An MCL of 0.07 ppm has been
established for 2,4-D in drinking water.
Tolerances Listed Under 40 CFR $180.142(Ą):
The tolerance listed in 40 CFR §180.142(b) is a time-limited tolerance established for 2,4-D
in/on wild rice in connection with use of 2,4-D in MN under a Section 18 emergency exemption
granted by EPA. The tolerance is set to expire on December 31, 2005. As adequate residue data are
available on wild rice grown in MN, a permanent tolerance for rice, wild, grain should be established
at 0.05 ppm under 40 CFR §180.142(c).
2. Tolerances to Be Proposed Under 40 CFR §180.142
Tolerances Needed Under 40 CFR §180.142(a):
The revised section will include all permanent tolerances for residues of 2,4-D, defined as
residues of 2,4-D, both free and conjugated, determined as the acid. The section will include all plant
commodities (excluding crop commodities exposed solely inadvertently), livestock commodities,
fish, and shellfish at reassessed levels.
In addition, the available residue data indicate that new tolerances should be established for 2,4-
D residues in/on the following commodities: almond hulls; aspirated grain fractions; barley bran and
straw; oat straw; rice hulls; rye bran and straw; soybean forage, hay, and seeds; and wheat bran and
straw.
Once adequate residue data become available, new tolerances should also be established for
wheat hay. Wheat hay data will be translated to barley hay, millet hay, and oat hay.
Tolerances Needed Under 40 CFR §180.142(c):
Based on the available residue data, tolerances with regional use registrations should be
established for wild rice grain at 0.05 ppm, reflecting the use of 2,4-D on wild rice grown in MN.
Tolerances Needed Under 40 CFR §180.142(dV
Tolerances for inadvertent 2,4-D residues in irrigated crops that have no registered, direct uses
will be moved from paragraph §180.142(a)(3) to paragraph §180.142(d) and the commodity and crop
group listings will be revised to the current EPA definitions.
Table 38. Tolerance Reassessment Summary for 2,4-D.
Commodity
Tolerance Listed
Under 40 CFR
§180. 142 (ppm)
Reassessed
Tolerance (ppm)
Comment
[Corrected Commodity Definition]
Tolerances Listed Under 40 CFR §180.142 (a) (1) 2
Page 89 of 304
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Commodity
Apple
Apricot
Fruit, citrus
Pear
Potato
Quince
Tolerance Listed
Under 40 CFR
§ 180.1 42 (ppm)
5
5
5
5
0.2
5
Reassessed
Tolerance (ppm)
Revoke
Revoke
3.0
Revoke
0.40
Revoke
Comment
[Corrected Commodity Definition]
A single tolerance should be established at 0.05
ppm under 180. 142(a) for direct and inadvertent
residues in/on the Fruit, pome, group 11.
Residues in/on apricots will be covered by the
tolerance for direct and inadvertent residues in stone
fruits at 180.1 42(a).
A tolerance should be established in Fruit, citrus,
group 10, recodified as 180.142(a), that will cover
the preharvest use on citrus, the postharvest use on
lemons in the U.S., the postharvest use on citrus
imported into the U.S., and the inadvertent residues
due to irrigation with treated water.
A single tolerance should be established at 0.05
ppm under 180. 142(a) for direct and inadvertent
residues in/on the Fruit, pome, group 11.
Includes direct and inadvertent (irrigation) residues.
Recodify as 180.142(a).
Residues in/on quince will be included under the
0.05 ppm tolerance at 180.142(a) for direct and
inadvertent residues in/on the Fruit, pome, group
11.
Tolerances Listed Under 40 CFR §180.142 (a) (2) 2
Barley, grain
Blueberry
Corn, fodder
Corn, forage
Corn, fresh, sweet,
kernel plus cob with
husks removed
Corn, grain
Cranberry
Fruit, stone
Grape
Grass, hay
0.5
0.1
20
20
0.5
0.5
0.5
0.2
0.5
300
2.0
Revoke
50.0
6.0
0.05
0.05
Revoke
0.05
0.05
300
The submitted data for wheat grain may be
translated to barley grain. Recodify as 180.142(a).
To be included under the 0.2 ppm Berries group 13
tolerance to be recodified as 1 80. 142(a).
Residue data from the 7-day PHI. Recodify as
180.142(a). Corn, stover
Residue data from the 7-day PHI. Recodify as
180,142(a),
Recodify as 180. 142(a).
Residue data from 7 -day PHI. Recodify as
180.142(a).
To be included under the 0.2 ppm Berries group 13
tolerance to be recodified as 1 80. 142(a).
Recodify as 180. 142(a). This tolerance will now
cover both direct and inadvertent residues. Fruit,
stone, group 12
Residue data on grape are available for the entire
U.S. Recodify as 1 80. 142(a).
Residue data from the 7-day posttreatment interval
(PTI) for Grass, hay. Recodify as 180.142(a).
Page 90 of 304
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Commodity
Grass, pasture
Grass, rangeland
Millet, forage
Millet, grain
Millet, straw
Nut
Oat, forage
Oat, grain
Pistachio
Rice
Rice, straw
Rye, forage
Rye, grain
Sorghum, fodder
Sorghum, forage
Sorghum, grain
Sugarcane
Sugarcane, forage
Tolerance Listed
Under 40 CFR
§ 180.1 42 (ppm)
1,000
1,000
20
0.5
20
0.2
20
0.5
0.2
0.1
20
20
0.5
20
20
0.5
2
20
Reassessed
Tolerance (ppm)
360
25
2.0
50
0.2
25
2.0
0.05
0.5
10
25
2.0
0.2
0.2
0.2
0.05
Revoke
Comment
[Corrected Commodity Definition]
Recodify as 180. 142(a). Residue data from the 0-
day PTI. This new tolerance will now cover both
direct and inadvertent residues. Grass, forage
The data for wheat forage, grain, and straw may be
translated to millet forage, grain, and straw. The
required wheat hay data will be translated to millet
hay. Recodify as 180. 142(a). This new tolerance
will now cover both direct and inadvertent residues.
Recodify as 180. 142(a). This new tolerance will
now cover both direct and inadvertent residues.
Nut, tree, group 14
The data for wheat forage may be translated to oat
forage. Recodify as 180. 142(a). This new tolerance
will now cover both direct and inadvertent residues.
The data for wheat grain may be translated to oat
grain. Recodify as 180. 142(a). This new tolerance
will now cover both direct and inadvertent residues.
Recodify as 180. 142(a). This new tolerance will
now cover both direct and inadvertent residues.
Recodify as 180. 142(a). This new tolerance will
now cover both direct and inadvertent residues.
Rice, grain
Recodify as 180. 142(a). This new tolerance will
now cover both direct and inadvertent residues.
Recodify as 180. 142(a). This new tolerance will
now cover both direct and inadvertent residues. The
data for wheat forage may be translated to rye
forage.
Recodify as 180. 142(a). This new tolerance will
now cover both direct and inadvertent residues. The
data for wheat grain may be translated to rye grain.
Recodify as 180. 142(a). This new tolerance will
now cover both direct and inadvertent residues.
Sorghum, stover
Recodify as 180. 142(a). This new tolerance will
now cover both direct and inadvertent residues.
Recodify as 180. 142(a). This new tolerance will
now cover both direct and inadvertent residues.
Recodify as 180.142(a). Sugarcane, cane
Sugarcane forage is no longer considered a
significant livestock feed item.
Page 91 of 304
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Commodity
Wheat, forage
Wheat, grain
Tolerance Listed
Under 40 CFR
§ 180.1 42 (ppm)
20
0.5
Reassessed
Tolerance (ppm)
25
2.0
Comment
[Corrected Commodity Definition]
Recodify as 180. 142(a). This new tolerance will
now cover both direct and inadvertent residues. The
14-day PHI residue data on wheat forage and grain
will be used to support tolerances for residues in/on
similar commodities of barley, millet, oats, and rye.
Tolerance Listed Under 40 CFR §180.142 (a)(3) 4
Avocado
Cottonseed
Cucurbits
Fruit, citrus
Fruit, pome
Fruit, stone
Grain, crop
Grass, forage
Hop
Leafy vegetables
Legume, forage
Nut
0.1 (N)
0.1 (N)
0.1 (N)
0.1 (N)
0.1 (N)
0.1 (N)
0.1 (N)
0.1 (N)
0.1 (N)
0.1 (N)
0.1 (N)
0.1 (N)
0.05
0.05
0.05
Revoke
Revoke
Revoke
Revoke
Revoke
0,2
0.4
Group 7 - 0.2
Group 18 -0.2
Revoke
Recodify as 180. 142(d).
Recodify as 180. 142(d). Cotton, iindelinted seed
Recodify as 180.142(d). Vegetable, cucurbit, group
9
Inadvertent residues will be covered by the crop
group tolerance on citrus fruit at 180. 142(a).
Inadvertent residues will be covered by the crop
group tolerance on pome fruit at 180.142(a).
Revocation of one strone fruit tolerance is
necessary to avoid duplication. Inadvertent residues
will be covered by the stone fruit group tolerance at
1 80. 1 42(a)(2) to be recodified as 1 80. 1 42(a).
Separate tolerances in RACs of each grain will be
individually established and recodified as
180. 142(a) in/on grain, forage, fodder, stover, or
hay, as applicable, to cover both direct and
inadvertent residues. Upon formal Agency
approval, a small grains subgroup tolerance may be
established.
Inadvertent residues will be covered by the grass
forage tolerance for direct residues to be recodified
as!80.142(a).
Inadvertent residues will be covered by the hop
tolerance for direct residues upon establishment at
180. 142(a) in response to PP#2E6352.
Establish separate tolerances for inadvertent
residues in the Vegetable, leafy, except brassica,
group 4 and Vegetable, brassica, leafy, group 5 at
0.4 ppm under the revised 1 80. 1 42(d)
Establish separate tolerances for the Vegetable,
foliage of legume, group 7 and Animal feed,
nongrass, group 18 for inadvertent residues under
180.142(d).
Inadvertent residues will be covered by the
tolerance in the tree nuts crop group at 180. 142(a)
Page 92 of 304
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Commodity
Root crop vegetables
Seed and pod
vegetables
Small fruit
Vegetable, fruiting
Tolerance Listed
Under 40 CFR
§ 180.1 42 (ppm)
0.1 (N)
0.1 (N)
0.1 (N)
0.1 (N)
Reassessed
Tolerance (ppm)
Group 1 - TBD
Group 2 - TBD
Group 3 - 0.05
0.05
0.2
0.05
Comment
[Corrected Commodity Definition]
Additional data are required to determine
inadvertent residues in sugar beet roots and tops to
represent root and tuber vegetables. Establish
separate tolerances in the Vegetable, bulb, group 3.
When sugar beet data are received, establish
separate tolerances in the Vegetable, root and tuber,
group 1 and Vegetable, leaves of root and tuber,
group 2. Recodify as 180.142(a).
Establish tolerance for inadvertent residues at
180.142(d) in the Vegetable, legume, group 6.
The 0.2 ppm tolerance in the Berries group 13, to be
recodified at §180. 142(a), will also cover
inadvertent residues. Inadvertent residues in/on
blueberry and cranberry will also be covered by this
group tolerance. Inadvertent residues in/on grape
and strawberry will be covered by separate
tolerances for direct uses on these crops
§180.142(a).
Establish tolerance for inadvertent residues at 0.05
ppm in the Vegetable, fruiting, group 8 recodified
under §1 80. 142(d).
Tolerance Listed Under 40 CFR §180.142 (a)(4) 2
Asparagus
5
5.0
Recodify as §1 80. 142(a).
Tolerance Listed Under 40 CFR §180.142 (a)(5) 2
Strawberry
0.05
0.05
Recodify as § 1 80. 1 42(a). This tolerance will cover
direct and inadvertent residues.
Tolerance Listed Under 40 CFR §180.142 (a)(6) 2
Crops in paragraph
(c) of this section
Crop groupings in
paragraph (c) of this
section
Fish
Shellfish
1.0
1.0
1.0
1.0
Revoke
Revoke
0.10
1.0
The tolerances to be established under paragraphs
§ 1 80. 1 42(a) and § 1 80. 1 42(d) will be sufficient to
cover inadvertent residues in irrigated crops under
the recodified § 1 80. 1 42(a)(6).
The tolerances to be established under paragraphs
§ 1 80. 1 42(a) and § 1 80. 1 42(d) will be sufficient to
cover inadvertent residues in irrigated crops under
the recodified § 1 80. 1 42(a)(6).
Residue data for fish and shellfish are from recent
tests where fish and shellfish were exposed to 2,4-D
under static conditions at 6.0 ppm (1 ,5x). Recodify
to§180.142(a).
Tolerance Listed Under 40 CFR §180.142 (a)(8) 2
Cattle, fat
Cattle, kidney
Cattle, meat
0.2
2
0.2
0.3
4.0
0.3
Recodify as §1 80. 142(a).
Recodify as §1 80. 142(a).
Recodify as §180.1 42(a).
Page 93 of 304
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Commodity
Cattle, meat
byproducts, except
kidney
Egg
Goat, fat
Goat, kidney
Goat, meat
Goat, meat
byproducts, except
kidney
Hog, fat
Hog, kidney
Hog, meat
Hog, meat
byproducts, except
kidney
Horse, fat
Horse, kidney
Horse, meat
Horse, meat
byproducts, except
kidney
Milk
Poultry
Sheep, fat
Sheep, kidney
Sheep, meat
Sheep, meat
byproducts, except
kidney
Tolerance Listed
Under 40 CFR
§ 180.1 42 (ppm)
0.2
0.05
0.2
2
0.2
0.2
0.2
2
0.2
0.2
0.2
2
0.2
0.2
0.1
0.05
0.2
2
0.2
0.2
Reassessed
Tolerance (ppm)
0.3
Revoke
0.3
4.0
0.3
0.3
Revoke
0.3
4.0
0.3
0.3
0.05
Revoke
0.2
2.0
0.2
0.2
Comment
[Corrected Commodity Definition]
Recodify as §180.1 42(a).
Category 3 of 40 CFR §180.6(a)(3) applies.
Recodify as §1 80. 142(a).
Recodify as §1 80. 142(a).
Recodify as §180.1 42(a).
Recodify as §180.1 42(a).
Category 3 of 40 CFR §180.6(a)(3) applies.
Recodify as §180.1 42(a).
Recodify as §180.1 42(a).
Recodify as §180.1 42(a).
Recodify as §180.1 42(a).
Residues in milk increased linearly with dose;
therefore, the 0.05 ppm tolerance will be adequate
for the Ix dose level. Recodify as §180.142(a).
Category 3 of 40 CFR §180.6(a)(3) applies.
Recodify as §180.1 42(a).
Recodify as §1 80. 142(a).
Recodify as §180.1 42(a).
Recodify as §180.1 42(a).
Tolerance Listed Under 40 CFR §180.142 (a)(9) 2
Fish
1.0
Revoke
The reassessed tolerance of 0. 1 ppm at
§ 180. 142(a)(6) will be recodified as § 180. 142(a).
There is no need for duplication of tolerances.
Tolerance Listed Under 40 CFR §180.142 (a)(10) 2
Raspberry
1.0
Revoke
Although there is no indication that IR-4 or the Task
Force II is supporting a use on raspberries, it would
be covered by the 0.2 ppm tolerance in the Bemes
group!3at§180.142(a).
Page 94 of 304
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Commodity
Tolerance Listed
Under 40 CFR
§ 180.1 42 (ppm)
Reassessed
Tolerance (ppm)
Comment
[Corrected Commodity Definition]
Tolerance Listed Under 40 CFR §180.142 (a)(ll) 3
Soybean, seed
0.02
0.02
Tolerance expired on 12/31/04. Residue data
support a permanent tolerance. If established,
recodifyas§180.142(a).
Tolerance Listed Under 40 CFR §180.142 (a)(12) 2
Sugarcane bagasse
Sugarcane molasses
Milled fractions
denved from barley,
oats, rye, and wheat
to be ingested as
animal feed or
converted into animal
feed
5
5
2
Revoke
0.20
Revoke
Sugarcane bagasse is no longer considered a
significant livestock feed item.
Maximum residue value is based on HAFT residues
of 0.015 ppm in/on sugarcane and a 7x
concentration factor for molasses. Recodify as
§180.142(a). Sugarcane, molasses
Tolerances for direct and inadvertent residues of
2,4-D in barley, bran; rye, bran; and wheat, bran are
to be established under revised 40 CFR 1 80. 1 42(a).
Tolerances in other small grain processed products
are not necessary as residues do not concentrate
upon processing.
Tolerance Listed Under 40 CFR §180.142 (a)(13) 2
Sugarcane molasses
Milled fractions
derived from barley,
oats, rye, and wheat
to be ingested as
animal feed or
converted into animal
feed
Potable water
5
2
0.1 (N)
Revoke
Revoke
Revoke
The sugarcane molasses reassessed tolerance at
§ 180. 142(a)(12) will be recodifed as § 180. 142(a).
Duplication of tolerances is not necessary.
Tolerances for direct and inadvertent residues of
2,4-D in barley, bran; rye, bran; and wheat, bran are
to be established under revised 40 CFR 1 80. 1 42(a).
Tolerances in other small grain processed products
are not necessary as residues do not concentrate
upon processing.
OPP no longer establishes tolerances in drinking
water. EPA's Office of Water has established an
MCL for 2,4-D at 0.07 ppm.
Tolerances Needed Under 40 CFR §180.142 (a); this list does not include recodifications, etc. from above
Almond hulls
Aspirated grain
fractions
None
None
0.10
40
Almond, hulls
Based on FLAFT residues of 0.038 ppm for corn
grain and a 39x concentration factor, maximum
expected residues would be 1.48 ppm in aspirated
grain fractions (AGF) derived from com grain.
Based on FLAFT residues of 3.24 ppm for wheat
grain and a 1 1 ,2x concentration factor, maximum
expected residues would be 36.3 ppm in AGF
denved from wheat grain.
As sorghum and soybeans uses are early-season
uses, residue data on AGF were not generated for
these crops. Establish tolerance in AGF at 40 ppm.
Page 95 of 304
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Commodity
Barley, hay
Barley, straw
Barley, bran
Millet, hay
Oat, hay
Oat, straw
Rice, hulls
Rye, straw
Rye, bran
Soybean, forage
Soybean, hay
Soybean, seed
Wheat, hay
Wheat, straw
Wheat, bran
Tolerance Listed
Under 40 CFR
§ 180.1 42 (ppm)
None
None
None
None
None
--
None
None
None
None
None
None
None
None
None
Reassessed
Tolerance (ppm)
TBD
50
4.0
TBD
TBD
50
2.0
50
4.0
0.02
2.0
0.02
TBD
50
4.0
Comment
[Corrected Commodity Definition]
Data for wheat straw were translated to barley
straw. Required wheat wheat hay data will be
translated to barley hay.
Data for wheat bran were translated to barley bran.
Required wheat wheat hay data will be translated to
millet hay.
Data for wheat straw were translated to oat straw.
Required wheat wheat hay data will be translated to
oat hay.
Maximum residue value is based on HAFT residues
of 0.425 ppm in/on rice grain and a 3.3x
concentration factor for hulls.
Data for wheat straw were translated to rye straw.
Data for wheat bran were translated to rye bran.
Adequate residue data are available to support
permanent tolerances on soybean commodities.
Data are required on wheat hay
Maximum residue value is based on HAFT residues
of 1 .08 ppm in/on wheat grain (14-day PHI) and a
3.6x concentration factor for bran.
Tolerance Listed Under 40 CFR §180.142 (b) 5
Wild rice
0.1
0.05
Tolerance expires 12/31/05. Adequate data are
available to establish a permanent tolerance with a
regional registration to be recodified as § 180. 142(c)
for Rice, wild, grain at 0.05 ppm.
Tolerance Needed Under 40 CFR §180.142 (c) 6
Rice, wild, grain
None
0.05
regional tolerance with use restricted to MN
Tolerances Needed Under 40 CFR §180.142 (d) 7
Commodities and
crop groups currently
listed under paragraph
(a)(3)
0.1 (N)
NA
See comments listed under § 1 80. 142(a)(3)
Maximum residue of treated RAC sample(s) following application of 2,4-D formulations according to use patterns
the Task Force II registrants intend to support for reregistration.
This subparagraph will be deleted and tolerances recodified under revised paragraph (a).
TBD = To be determined. Reassessment of tolerances(s) cannot be made at this time because additional data are
required.
Tolerances listed under § 180.142 (a)(3) for inadvertent residues will be recodified as either § 180.142(a) or
§180.142(d).
This paragraph will be reserved for future time-limited tolerances under Section 18 Emergency Exemptions.
Tolerances with regional use registration.
Page 96 of 304
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7 Paragraph (d) will contain tolerances for inadvertent residues (e.g., residues in irrigated crops) only, i.e., there is no
registration for direct use in the U.S. If residues may result inadvertently as well as intentionally (direct, labeled
treatment), the tolerance is codified at §180.142(a)
3. Codex Harmonization
The Codex Alimentarius Commission has established several maximum residue limits (MRLs)
for residues of 2,4-D in/on various plant and animal commodities. The Codex MRLs are expressed in
terms of 2,4-D per se. The expression of residues for Codex MRLs and U. S. tolerances is
harmonized. A numerical comparison of the Codex MRLs and the corresponding reassessed U.S.
tolerances is presented in Table 39.
Table 39. Codex MRLs and applicable U.S. tolerances for 2,4-D. Recommendations for
compatibility are based on conclusions following reassessment of U.S. tolerances
Codex
Commodity, As Defined
Barley
Blackberries
Citrus fruits
Eggs
Maize
Meat (from mammals other
than marine mammals)
Milk products
Milks
Oats
Potato
Raspberries, Red, Black
Rice
Rye
Sorghum
Vaccinium berries, including
Bearberry
Wheat
MRL
(mg/kg)
0.5
0.1
2.0
0.05 (*)
0.05 (*)
0.05 (*)
0.05 (*)
0.05 (*)
0.5
0.2
0.1
0.05 (*)
0.5
0.05 (*)
0.1
0.5
Reassessed U.S. Tolerance,
ppm
2.0
0.20
3.0
Revoked
0.05
0.30
4.0
0.05
0.05
2.0
0.40
0.20
0.50
2.0
0.20
0.20
2.0
Recommendation And Comments
U.S. tolerance for Berries group 13
Meat, fat, and mbyp except kidney
Kidney
U.S. tolerance for Berries group 13
Forage, grain, and stover=0.2
U.S. tolerance for Berries group 13
(*) = At or about the limit of detection.
4. Residue Analytical Methods - Plants and Livestock (GLN 860.1340)
For the purpose of reregistration, adequate methods are available for data collection and the
enforcement of plant commodity tolerances. The Pesticide Analytical Manual (PAM) Vol. II lists
three GC methods (designated as Methods A, B, and C) with microcoulometric detection and one GC
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method (designated as Method D) with electron capture detection (BCD). In a letter dated September
3, 1993 (CBRS No. 12270, DP Barcode D193335, 9/3/93, W. Smith), Task Force H indicated that the
enforcement methods currently listed in PAM Vol. n are unsuitable for determining residues of 2,4-D
in wheat and poultry commodities.
Plant Commodities: Task Force II submitted an adequate proposed GC/ECD enforcement method for
plants (designated as EN-CAS Method No. ENC-2/93) which has been independently validated.
Adequate radiovalidation data have been submitted and evaluated for the proposed enforcement
method using samples from the wheat metabolism study. The proposed enforcement method or
modifications of the enforcement method were used for data collection purposes.
Livestock Commodities: Task Force II submitted two separate (but essentially comparable) proposed
enforcement methods (GC/ECD) for determination of 2,4-D in livestock commodities. Adequate
radiovalidation data have been submitted for the method using samples of fat, kidney, and milk from
the goat metabolism study and samples of eggs from the poultry metabolism study. The Agency
concluded that the methods are adequate provided the registrants satisfy the following requests: (i)
submit a revised method which combines the two methods into a single method; (ii) delete from the
method all references to the use of diazomethane as a derivatizing agent; and (iii) provide complete
raw data and sample calculations (including chromatograms showing peak areas, external standard
linearity curves and associated data, standard calculations, etc.). Once an adequate revised method is
submitted, the Agency will evaluate the tolerance method validation. Recently, it has been
determined that the technology to generate diazomethane has advanced such that it is no longer
considered to be a dangerous procedure; as a result, the use of diazomethane as a derivatizing agent is
now considered acceptable.
E. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the use of 2,4-
D. Where labeling revisions are warranted, specific language is set forth in the summary tables of
Section V of this document.
1. Human Health Risk Management
a. Residential Risk
1) Residential risk summary
A Margin of Exposure (MOE) of 1000 (1 Ox for interspecies extrapolation, lOx for intraspecies
variation, and lOx database uncertainty factor) is considered adequately protective for this assessment
of residential risks. Residential handler risks are not of concern. All MOEs for post-application, oral
exposure to children from playing on treated lawns meet or exceed 1000; therefore, post-application
exposure to children is not of concern. Likewise, all adult acute/short term MOEs meet or exceed
1000, so post-application exposure is not of concern for adults.
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As discussed below, potential risks were identified to individuals who swim in water treated
with 2,4-D. Although the risk assessment is likely to be conservative, mitigation measures will be
required.
2) Residential Post-application Mitigation
For residential, post-application exposures, when the calculated MOE of 1000 based on
modeling is considered in conjunction with biomonitoring results, it is clear that the modeled short-
term risks from post-application exposure are upper bound estimates. At one day post-treatment, the
MOEs for the volunteers who wore shorts and no shoes ranged from 1400 to 35000 with the lowest
MOE corresponding to the volunteer who removed his shirt during the exposure period. The MOEs
for the remaining volunteers ranged from 24000 to 37000. The Agency has concluded that no
further mitigation is needed for residential post-application exposures.
3) Residential Swimmer Mitigation
The acute MSWC of 9.8 ppm for exposures to 2,4-D acid or amine is greater than the proposed
maximum application rate of 4.0 ppm, therefore, acute exposures to acid or amine are not of concern.
The MSWC of 3.6 ppm for short-term exposures to acid or amine is also not of concern because
some dissipation or dispersion is likely to occur which would cause the 7-day average of 2,4-D
concentrations to be less than 3.6 ppm. Dissipation studies submitted to the Agency indicated that
the half lives following pond and lake liquid treatments ranged from 3.2 days to 27.8 days which
yield 7 day average concentrations of 1.9 ppm when the half life equals 3.2 days, to 3.6 ppm when the
half life equals 27.8 days.
The MSWCs for 2,4-D BEE are less than the master label application rate of 4 ppm, but they
are unlikely to be of concern for the following reasons:
• 2,4-D BEE degrades rapidly by abiotic hydrolysis in sterile water to form 2,4-D acid
particularly when the pH is 7.5 or above.
• 2,4-D BEE degrades to 2,4-D acid by microbial hydrolysis with an average half life of 2.6 +
1.8 hours at a bacterial concentration of 5 x 10"8 organisms per liter. Therefore, degradation of 2,4-D
BEE to 2,4-D under typical environmental conditions will be rapid leading to significantly lower risk
estimates because the 2,4-D acid has a lower rate of dermal absorption.
• Modeling predicts direct water application of 2,4-D BEE will yield surface water concentrations
of 2,4-D BEE concentrations in the Agency standard pond of 624 ug/L for peak (24 hour average), 30
ug/L for the 21-day average, and 10 ug/L for the 60-day average.
• The existing label rates for 2,4-D BEE products are also lower than the master label rate.
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Although the risk characterization above suggests that the risk estimates are conservative, a 24
hour post-application restriction on swimming is necessary to ensure the safety of children swimming
in water treated with 2,4-D BEE.
b. Aggregate Risk
The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic Act
(FFDCA, Section 408(b)(2)(A)(ii)) require "that there is a reasonable certainty that no harm will
result from aggregate exposure to pesticide chemical residue, including all anticipated dietary
exposures and other exposures for which there is reliable information." Aggregate exposure will
typically include exposures from food, drinking water, residential uses of a pesticide, and other non-
occupational sources of exposure.
1) Aggregate Risk Summary
For 2,4-D, EPA conducted acute, short-term, and chronic aggregate risk assessments using the
reduced maximum application rate for residential turf (1.5 Ibs ae/A). The aggregate risk assessment
compares the Drinking Water Level of Comparison (DWLOC) for each scenario with the appropriate
Estimated Drinking Water Concentration (EDWC) for the pesticide. The DWLOC is the maximum
concentration in drinking water which, when considered together with food, and, if appropriate,
residential exposure, does not exceed EPA's level of concern. Generally, EDWCs that are less than
the corresponding DWLOC are not of concern to the Agency.
It is important to note that the MCL for 2,4-D, established by EPA's Office of Water under the
Safe Drinking Water Act (SDWA), is 70 ug/L. To minimize the possibility that direct aquatic
applications will result in drinking water concentrations in excess of the MCL, the Agency has
worked with the 2,4-D Task Force and water quality specialists to develop appropriate label
requirements for 2,4-D products registered for use to control aquatic weeds.
2) Acute Aggregate Risk
DWLOC Approach
Acute DWLOCs were calculated based upon acute dietary exposures. Acute residential
exposures from swimming in treated water bodies or playing on treated turf were not included
because exposures are unlikely to co-occur with acute dietary exposures. The acute DWLOCs are
range from 432 to 1932 with the most sensitive population being females 13 to 49 years old. The
EDWCs of 118 ug/liter for surface water and 15 ug/liter for groundwater are substantially less than
the DWLOCs which means that the risks are not of concern.
Forward Calculation Approach
Acute aggregate risks were assessed by directly combining acute food exposures and estimates
of acute water exposures. The acute aggregate risks and are not of concern because they are less than
100 percent of the aPAD. The highest risks (58 percent of the aPAD) are for females 13-49 years old
because these risks are based upon the lower NOAEL of 25 mg/kg/day from a developmental study in
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rats. Whereas, estimates of other population groups are based on a NOAEL of 67 mg/kg/day from an
acute neurotoxicity study in rats.
3) Short-term Aggregate Risk
DWLOC Approach
Short-term aggregate risks assessments were conducted by calculating DWLOCs based upon
short-term turf exposures, chronic food exposures and short-term endpoints. Short-term exposures
from swimming in treated water bodies were not included because these exposures represent high-end
unlikely scenarios. The short-term DWLOCs were calculated only for females 13-49 and children 1-
6 because these population subgroups have the highest exposure and estimates calculated for these
groups are protective of the other subgroups. The DWLOCs range from 24 to 36 ug/liter. The
EDWCs range from 15 to 23 ug/liter. Since the DWLOCs are all greater than the EDWCs, the short
term risks are not of concern.
Forward Calculation Approach
Short-term aggregate risks were assessed by aggregating short-term turf exposures, chronic
food exposures and chronic water exposures. Short-term aggregate risk were calculated only for
females 13-49 and children 1-6 because these population subgroups have the highest exposure and
estimates calculated for these groups are protective of the other subgroups. The short-term aggregate
MOEs indicate that the short term risks are not of concern because the MOEs equal or exceed the
target MOE of 1000.
4) Chronic (Non-Cancer) Aggregate Risk
DWLOC Approach
Chronic DWLOCs were calculated based upon chronic dietary exposures. As there are no
chronic residential exposures, residential exposures were not included in the chronic DWLOC
calculations. The chronic DWLOCs are 46 ug/L or greater with the most sensitive populations being
infants and children. The EDWCs, which range from 1.5 to 23 ug/L, are less than the DWLOCs
which means that the risks are not of concern. It should be noted that the master label indicates that
potable water consumption from a treated water body cannot begin until the 2,4-D concentration is 70
ug/L or below, therefore an annual average exposure at the MCL of 70 ug/L would not occur because
dissipation would reduce the initial concentration of 70 ug/L to an annual average concentration of 11
ug/L.
Forward Calculation Approach
Chronic aggregate risks were assessed by aggregating chronic food exposures and chronic
water exposures. The chronic aggregate risks are not of concern because they are less than 100
percent of the cPAD. The highest risks (38 percent of the cPAD) are for children 1-2 years old.
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5) Aggregate Risk Mitigation
Given the reduced maximum application rate to residential lawns (1.5 Ibs ae/A), the highest
aggregate risks are the risks from short-term exposures, which include the turf exposure scenarios.
For the most sensitive subpopulation (females 13-49) these risks meet the target MOE of 1000 and
the turf exposure is the risk driver as it contributes 96 percent of the risk.
Whereas calculated risks just meet the Agency's target MOE, it is important to note that the turf
exposure estimate is based upon modeling and is greater than exposure measurements obtained from
biomonitoring. As described in the human health assessment, the results of a biomonitoring study
were used to calculated MOEs by assuming that all of the urinary 2,4-D measured in the 96 hours
after the exposure period was the result of the turf exposure. This assumption is protective because
2,4-D exposures due to inhalation and due to food and water ingestion would be counted as dermal
exposure. The biomonitoring results were adjusted by a factor of two to account for the SOP
assumption of two hours of daily exposure vs one hour of exposure during the study, and a factor of
1.7 to account for an application rate of 1.5 Ibs ae/acre vs 0.88 Ib ae/acre applied during the study. At
one day post-treatment, the MOEs for the volunteers who wore shorts and no shoes ranged from 1400
to 35000 with the lowest MOE corresponding to the volunteer who removed his shirt during the
exposure period. The MOEs for the remaining volunteers ranged from 24000 to 37000. If the
calculated MOE of 1000 based on modeling is considered in conjunction with the MOE calculated
based on biomonitoring results, it is clear that the modeled short-term risks are upper bound
estimates. The Agency has concluded that aggregate risks from acute, short-term and chronic
exposures are not of concern. No further mitigation beyond reducing the maximum application rate
from 2.0 to 1.5 Ibs/ae per acre is needed.
c. Occupational Risk Mitigation
1) Handler Risk Mitigation
With the exception of mixing/loading wettable powder, the short-term and intermediate-term
Margin of Exposure estimates (MOEs) exceed 100 with baseline attire (i.e., long-sleeved shirt, long
pants, shoes plus socks) or single layer attire (i.e., long-sleeved shirt, long pants, shoes plus socks,
gloves) and are not of concern. The MOEs for handling wettable powder are acceptable with
engineering controls (i.e. water soluble bags). Water soluble bags will be required for wettable
powder formulations.
2) Post-application Risk Mitigation
All short- and intermediate-term MOEs are above 100 on day zero. All occupational
postapplication risk scenarios are below EPA's level of concern. Products containing 2,4-D salt and
ester forms as active ingredient with Worker Protection Standard (WPS) uses will require a re-entry
interval (REI) of 12 hours. Because of acute eye irritation concerns, products containing 2,4-D acid
and amine forms with WPS uses will require a REI of 48 hours and protective eyewear. The
requirements for individual products will be finalized based on product-specific chemistry and acute
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toxicity review. The exposure reduction program implemented in 1992 will be replaced with the
personal protective equipment described in section V.D. of this document.
2. Environmental Risk Mitigation
The Agency has considered available information on 2,4-D's toxicity, use areas, usage, fate
properties, application methods, and formulations in calculating ecological risks. The resulting
assessment suggests that the use of 2,4-D for aquatic weed control presents risk to aquatic organisms,
while 2,4-D use on terrestrial sites presents greater potential risks to small mammals, birds, and non-
target terrestrial plants, than to other plants and animals.
a. Birds
Acute Risk
Whereas the assessment of risk to birds from the terrestrial use of 2,4-D suggests risks of
concern, the assessed exposures to 2,4-D are likely conservative in the following ways. Currently,
Agency models do not account for the uptake of 2,4-D by plants and therefore assume that all non-
dissipated pesticide applied to the field is present for exposure to organisms. In fact, many pesticides,
including 2,4-D, are systemic and are absorbed by plants in the field and therefore, the current
approach may overestimate the amount of 2,4-D available for exposure in terrestrial and aquatic
systems.
For non-granular spray application, the highest acute avian RQ (3.5) was from the cranberry
use-site scenario, for birds feeding on short grass. That assessment was based on a maximum
application rate of 4 Ibs ae/acre; however, the average application rate is 1.83 Ibs ae/acre (see the
Agency's quantitative use assessment). If the modeled application rate was reduced to 1.83 Ibs
ae/acre for cranberries, and an assumption made that the resulting EEC will be reduced linearly, the
RQ would be 1.6.
To determine the hazard associated with acute exposures to birds, the assessment has relied on
two types of data, a suite of dietary studies and a suite of gavage studies. For avian acute exposures,
the dietary studies result in non-definitive endpoints which are not appropriate for estimating risk.
Therefore, the assessment has relied on the gavage studies to estimate avian acute risks. The Agency
recognizes that this approach may overestimate risk to birds due to the fact that birds would not
typically be expected to consume 2,4-D in this manner.
Chronic Risk
Potential chronic risks to birds is limited to the following use sites: non-cropland, forest,
asparagus, and cranberry. The RQs for these sites range from one to slightly above one. Further
characterization of these use sites by evaluating average application rates versus maximum
application rates lower these RQs to below the LOCs.
Given the conservative assumptions in both exposure scenarios and hazard determinations, the
Agency finds that the acute and chronic risks to birds from 2,4-D exposure are not of concern.
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b. Mammals
Acute risk
All of the calculated RQs for mammalian acute risk for the non-granular use of 2,4-D were
based on maximum labeled application rates. The EPA's quantitative use assessment (EPA QUA)
suggests that the average application rates for many crops are considerably less than the modeled
maximum application rates. For non-granular spray application mammalian acute concerns, the
highest RQ was 1.72 for use on asparagus for small mammals feeding on short grass based on a
maximum application rate of 2 Ibs ae/A applied two times a year; however, the average application
rate was only 1.10 Ibs ae/A (EPA QUA). If the modeled application rate was reduced to the reported
average application rate of 1.10 Ibs ae/A for asparagus, the RQ would be 1.08 which is still above the
acute LOG of 0.5. However, asparagus is representative of a minor 2,4-D use, and risk to mammals
from use of 2,4-D on asparagus would be minimal, given that fact.
To add context to the acute mammalian assessment, the effect of assuming an average
application rate was determined. Major 2,4-D crops include pasture/rangeland, turf, wheat, corn, and
soybeans. For pasture/rangeland, the highest acute RQ was 0.86 for small mammals feeding on short
grass based on a maximum application rate of 4 Ibs ae/A. However, the average application rate was
only 0.62 Ibs ae/A (BEAD QUA). If the modeled application rate was reduced to 0.62 Ibs ae/A for
pasture/rangeland, the resulting RQ is 0.31 which is below the acute LOG, but above the restricted
use LOG of 0.2. Similar trends are noted for other major use sites.
Although the calculated RQ values still exceed the Agency's level of concern when average
applications rates are considered, the Agency has concluded that the benefits from 2,4-D use
(including control of invasive and noxious weed species), taken together with the low toxicity of 2,4-
D to humans, outweigh the concerns of toxicity to small mammals. No additional mitigation steps
will be taken.
Chronic risk
Calculated chronic risks to mammals were greatest for small herbivores/insectivores. For 15 g
mammalian herbivores/insectivores, chronic RQs based on maximum residues and mean residues
ranged from <1 to 200 and <1 to 70, respectively. For major use sites, including rangeland/pasture,
RQs were approximately 100. These chronic risk estimates are likely conservative as described
below.
The chronic RQs calculated for mammalian herbivores/insectivores are based on conservative
estimates of exposure that are not likely to occur in nature. In the example of pasture/rangeland, the
chronic RQ of approximately 100 for maximum residues (35 for mean residues) was calculated based
on an application rate of 2 Ibs ae/A applied twice per year, at a 30 day interval. However, the EPA
has determined that the average application rate on pasture/rangeland is only 0.62 Ibs ae/A (EPA
QUA). Moreover, information from several of the Agency's state contacts indicate that a once per
year application of less than 1 Ib ae/A is typical (personal communications). As the typical rate is
approximately 25% of the assessed rate, use of the typical rate would be expected to decrease the RQ
for the pasture/rangeland scenario approximately four-fold, to approximately 25 for maximum
residues and 9 for mean residues.
A second example of the conservative assumptions included in the assessment of exposure to
mammalian herbivores/insectivores is the assumption that 100% of the long term diet is relegated to
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single food types foraged only from treated fields. The assumption of 100% diet from a single food
type may be realistic for acute exposures, but diets are likely to be more variable over longer periods
of time. The risk assessment assumed that 100% of the small mammals' diet consists of short
grasses. Several published reports suggest that actual diets of small mammals are more varied, and
would likely include invertebrates, worms, fungi, and seeds, in addition to plant matter.
Given the conservative assumptions in the exposure scenarios, the Agency finds that the risks
identified in the risk assessment are likely to overestimate actual risks to mammals from 2,4-D
applications. Based on information about average application rates and dietary patterns as described
above, the Agency has concluded that actual 2,4-D exposures to mammals are likely to be
significantly lower than those assessed but may still be above the chronic LOG for this screening
level assessment. However, the Agency has concluded that the benefits from 2,4-D use (including
control of invasive and noxious weed species), taken together with the low toxicity of 2,4-D to
humans, outweigh the concerns of toxicity to small mammals. No additional mitigation is being
required at this time.
c. Aquatic Organisms
Whereas the assessment of risk to aquatic organisms suggests risks of concern, the assessed
exposures to 2,4-D are likely conservative as follows. Whereas the maximum labeled target
concentration for control of aquatic weeds is 4 ppm, the typical target concentration is 2 ppm. A rate
of 4 ppm is reserved for spot-treating new aquatic weed stands and hybrid weed species that tend to
be less susceptible to 2,4-D. Per the product label, re-application of 2,4-D can occur after 21 days.
In the current assessment, the risks to aquatic organisms were estimated based on a 2,4-D
application that resulted in a whole-reservoir concentration of 4 ppm. Treating 100% of the water
body would likely result in a large amount of decaying plant life, thereby creating an oxygen-depleted
environment that would most likely result in fish kills. To avoid that scenario, the current 2,4-D label
advises that the applicator avoid treating more than 50% of a water body in a 21-day period. In actual
practice, aquatic weeds that 2,4-D controls tend to grow near the shore of lakes, ponds, and
reservoirs. As a result, generally a maximum of 20-30% of a water body is treated in a single
application. Applying the typical rate of 2 ppm, and taking into account a typical maximum treated
area of 30%, would decrease calculated RQs by approximately 6-fold.
While noting the potential risks to aquatic organisms from the direct application of 2,4-D for the
control of aquatic weeds identified above, it is important to note the benefits gained through the direct
application of 2,4-D to aquatic bodies, for the control of invasive species. The U.S Army Corps of
Engineers (USAGE) and state agencies have identified 2,4-D as an important tool for protecting water
bodies from the invasion and establishment of some species of exotic nuisance vegetation. 2,4-D has
a reputation as a selective and economical means to remove invasive plants, enhance the growth and
recovery of desirable native vegetation, restore water quality, reduce sedimentation rates in reservoirs,
and improve fish and wildlife habitat. 2,4-D products are used to control invasive weeds, such as
Eurasian water milfoil (Myriophyllum spicatuni) in the northern tier states and water hyacinth
(Eichhornia crassipes) in the Gulf Coast states. Effective control of these plants can benefit public
health with respect to reducing levels of mosquito habitat. In addition, according to USAGE, no other
product (or alternative technique) can control these plants in a more cost-effective manner (K.
Getsmger, USAGE, Public Comment; Docket ID# OPP-2004-0167-0053).
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Given the typical application rates and treatment areas, and considering the beneficial aspects of
using 2,4-D to control invasive plant species, the Agency concludes that the benefits from direct
aquatic use of 2,4-D outweigh the risk concerns for aquatic organisms. No additional mitigation
measures will be required at this time to address risk to aquatic organisms.
d. Non-target Insects
Risk to non-target insects do not exceed the Agency's level of concern. Available data from a
honey bee acute toxicity study indicated that technical 2,4-D is practically non-toxic to the honey bee.
The potential for 2,4-D and its salts and esters to pose risk to pollinators and other beneficial insects is
expected to be minimal.
e. Non-target Terrestrial Plants
Estimated RQs exceeded acute LOCs for both non-endangered and endangered terrestrial plants
for non-granular and granular uses at many use sites. Consideration of average application rates did
not result in exposure below LOCs. However, the exposure estimates used to develop the RQs were
likely conservative, as follows.
In the exposure calculation for non-target aquatic plants and terrestrial plants in intermittently
flooded areas, the major contributor is run-off from the application site. The run-off and leaching
vulnerability schemes used in this assessment incorporate several conservative assumptions which are
fully discussed in the ecological risk assessment. Also, it is likely that farm management practices
would be in place to limit run-off, as run-off events are detrimental to the farm as a whole for reasons
other than pesticide damage.
Whereas the risk assessments are likely conservative as described above, the Agency is
concerned about the risk to non-target terrestrial plants from drift of 2,4-D during application. To
address that concern, the Agency is implementing spray drift controls that will decrease the risk that
2,4-D will drift onto non-target plants.
f. Summary of Environmental Risk Mitigation
Characterization of the risks identified in the Agency's screening level risk assessment suggests
that risks from drift onto non-target plants exceeds the Agency's level of concern. The Agency is
implementing spray drift controls that will decrease the risk that 2,4-D will drift onto non-target
plants.
F. Other Labeling Requirements
In order to be eligible for reregistration, various use and safety information will be included in
the labeling of all end-use products containing 2,4-D. For the specific labeling statements and a list of
outstanding data, refer to Section V of this RED document.
1. Endangered Species Considerations
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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 federal
agencies to ensure that their actions are not likely to jeopardize listed species or adversely modify
designated critical habitat. To analyze the potential of registered pesticide uses that may affect any
particular species, EPA uses basic toxicity and exposure data and considers ecological parameters,
pesticide use information, geographic relationship between specific pesticide uses and species
locations, and biological requirements and behavioral aspects of the particular species. Based on
EPA's screening level assessment for 2,4-D, RQs exceed levels of concern for mammals, birds,
aquatic plants, and terrestrial plants. However, these findings are based solely on EPA's screening
level assessment and do not constitute "may affect" findings under the ESA. The Agency is requiring
additional data to further characterize and refine its ecological and endangered species risk
assessments. The 2,4-D Task Force has submitted a limited endangered species assessment on
several crops for the Agency's consideration. This assessment was generated using the FIFRA
Endangered Species Task Force (FESTF) integrated management system (IMS).
2. Spray Drift Management
The Agency has been working closely with stakeholders to develop improved approaches for
mitigating risks to human health and the environment from pesticide spray and dust drift. As part of
the reregistration process, we will continue to work with all interested parties on this important issue.
From its assessment of 2,4-D, as summarized in this document, the Agency concludes that
certain drift mitigation measures are needed to address the risks from off-target drift for 2,4-D. Label
statements implementing these measures are listed in the "spray drift management" section of the
Labeling Changes Summary Table in section V.D. of this RED document. In the future, 2,4-D
product labels may need to be revised to include additional or different drift label statements.
3. Consumer Labeling Initiative
The Consumer Labeling Initiative (CLI) is an effort among federal, state, and local government
agencies, industry, environmental groups, and other interested parties working to improve product
labels on residential pesticides in order to improve consumer understanding and compliance of
consumer labels. The CLI Work Group of the Pesticide Program Dialogue Committee (PPDC) is
working to revise consumer labels. In addition to the labeling changes presented in this RED, the
Agency will leave open the possibility that changes to residential product labeling may occur as the
result of the PPDC CLI.
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V. What Registrants Need To Do
For 2,4-D technical grade active ingredient products, registrants need
to submit the following items.
Within 90 days from receipt of the generic data call-in (DCI):
(1) completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
(2) submit any time extension and/or waiver requests with a full written
justification.
Within the time limit specified in the generic DCI:
(1) cite any existing generic data which address data requirements or submit new
generic data responding to the DCI.
Please contact Katie Hall at (703) 308-0166 with questions regarding generic reregistration
and/or the DCI. All materials submitted in response to the generic DCI should be addressed:
By US mail: By express or courier service:
Document Processing Desk (DCI/SRRD) Document Processing Desk (DCI/SRRD)
Katie Hall Katie Hall
US EPA (7508C) Office of Pesticide Programs (7508C)
1200 Pennsylvania Ave., NW Room 604, Crystal Mall 2
Washington, DC 20460 1801 S. Bell Street
Arlington, VA 22202 -4501
For products containing the active ingredient 2,4-D registrants need to
submit the following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
(1) completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
(2) submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
(1) two copies of the confidential statement of formula (EPA Form 8570-4);
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(2) a completed original application for reregistration (EPA Form 8570-1).
Indicate on the form that it is an "application for reregistration";
(3) five copies of the draft label incorporating all label amendments outlined in
Table 40 of this document;
(4) a completed form certifying compliance with data compensation requirements
(EPA Form 8570-34);
(5) if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
(6) the product-specific data responding to the PDCI.
Please contact Moana Appleyard at (703) 308-8175 with questions regarding product
reregistration and/or the PDCI. All materials submitted in response to the PDCI should be addressed:
By US mail:
Document Processing Desk (PDCI/PRB)
Moana Appleyard
US EPA (7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service only:
Document Processing Desk (PDCI/PRB)
Moana Appleyard
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1801 Bell Street
Arlington, VA 22202
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of 2,4-D for eligible uses has been
reviewed and determined to be substantially complete. However the following data requirements are
necessary to confirm the reregistration eligibility decision documented in this RED.
Table 40. Data Requirements for the Reregistration Eligibility Decision for 2,4-D
Guideline Study Name
New OPPTS
Guideline No.
Old
Guideline
No.
Environmental Fate and Effects Data Requirements
Aquatic field dissipation studies (Behavior of 2,4-D BEE under acidic to neutral
aquatic conditions in a water/sediment system)
Laboratory volatility study (2,4-D IPE)
Terrestrial field dissipation studies (2,4-D IPA, 2,4-D TIPA, 2,4-D DBA, 2,4-D
BEE)
835.6200
835.1410
835.6100
164-2
163-2
164-1
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Guideline Study Name
Aquatic field dissipation studies in a rice use scenario (2,4-D IP A, 2,4-D TIP A, 2-
4-D DBA)
Aquatic field dissipation studies in an aquatic weed control scenario (2,4-D IP A,
2,4-D TIPA, 2-4-D DBA)
Forest field dissipation studies (2,4-D IPA, 2,4-D Iff A, 2,4-D BEE, and 2,4-D
DBA)
Fish acute toxicity test, freshwater and marine with typical end-use product (TEP)
(2,4-D BEE)
Oyster acute toxicity test with TEP (2,4-D BEE)
Mysid acute toxicity test with TEP (2,4-D BEE)
Penaid acute toxicity test with TEP (2,4-D BEE)
Sediment and soil adsorption/desorption (2,4-D BEE granular formulation)
Seedling Germination/Seedling Emergence
Vegetative Vigor
Non-target terrestrial plants - TEP representative testing from the acid and amine
salts group, and representative testing from the ester group. The test products
should include the most common and most active surfactants and adjuvants which
affect the toxicity of the product. The registrants should consult with the Agency
before finalizing which products to test.
The registrant must provide information on the proximity of Federally listed
freshwater vascular plants, birds, mammals, and non-target terrestrial plants (there
are no listed estuarine/marine invertebrates) to the 2,4-D use sites. This
requirement may be satisfied in one of three ways: 1) having membership in the
FIFRA Endangered Species Task Force (Pesticide Registration [PR] Notice 2000-
2); 2) citing FIFRA Endangered Species Task Force data; or 3) independently
producing these data, provided the information is of sufficient quality to meet
FIFRA requirements. Registrants should consult with the Agency prior to
fulfilling this data requirement.
New OPPTS
Guideline No.
835.6200
835.6200
835.6300
850.1075
850,1025
850.1035
850.1045
835.1230
850.4225
850.4250
Old
Guideline
No.
164-2
164-2
164-3
72-1
72-3
72-3
72-3
163-1
123-l(a)
123-l(b)
Human Health Effects Data Requirements
Developmental neurotoxicity study
Subchronic inhalation toxicity study (28-day)
Repeat two-generation reproduction study (using the most recent Agency
protocol) addressing concerns for endocrine disruption (thyroid and
immunotoxicity measures)
870.6300
870.3465
870.3800
83-6
82-4
83-4
Product and Residue Chemistry Data Requirements
Crop field trials - wheat hay
860.1500
171-4k
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Guideline Study Name
Water, fish, and irrigated crops - irrigated crop studies in strawberries and sugar
beet roots and tops
Residue analytical method - revised enforcement method for determination of 2,4-
D in livestock commodities
Directions for Use
New OPPTS
Guideline No.
860.1400
860.1340
860.1200
Old
Guideline
No.
171 -4f
171-4c
171-3
Other Data Requirements
UV/Visible Absorption
Droplet Size Spectrum
Drift Field Evaluation
The Agency is requiring that five recent batches of all technical products be
analyzed for 2,3,7,8-TCDD, 2,3,7,8-TCDF and their respective higher substituted
chlorinated congeners using validated analytical methods. The Agency specifies
that the manufacturers use the most current state-of-the art laboratory methods for
measuring 2,3,7,8-TCDD and TCDF at levels less than 1 part per trillion (EPA
Method 1613, Tetra- through Octa-Chlorinated Dioxins and Furans by Isotope
Dilution HRGC/HRMS). Because 1,2,3,7,8-PeCDD is eqm-potent to 2,3,7,8-
TCDD in the TEF scheme, the Agency is adding this compound to our testing
requirements.
830.7050
840.1100
840.1200
None
201-1
202-1
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 MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each product.
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 Table 40.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 12
months from the date of the issuance of this Reregistration Eligibility Decision document. Persons
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other than the registrant may generally distribute or sell such products for 24 months from the date of
the issuance of this RED. However, existing stocks time frames will be established case-by-case,
depending on the number of products involved, the number of label changes, and other factors. Refer
to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register, Volume 56, No.
123, June 26, 1991.
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D. Required Labeling Changes Summary Table
In order to be eligible for reregistration, all product labels must be amended to incorporate the risk mitigation measures outlined in Section
IV. The following table describes how language on the labels should be amended.
Table 41: Summary of Labeling Changes for 2,4-D
Description •
Language'
Macement 0n Label
For all Manufacturing Use
Products
"Only for formulation into an herbicide or plant growth regulator for the following use(s)
[fill blank only with those uses that are being supported by MP registrant]."
"Wettable powder formulations must be packaged in water-soluble packages."
Directions for Use
One of these statements may
be added to a label to allow
reformulation of the product
for a specific use or all
additional uses supported by a
formulator or user group
"This product may be used to formulate products for specific use(s) not listed on the MP
label if the formulator, user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on the
MP label if the formulator, user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s)."
Directions for Use
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
"This chemical is toxic to fish and aquatic invertebrates. Do not discharge effluent
containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless
in accordance with the requirements of a National Pollution Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing prior to
discharge. Do not discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
Precautionary
Statements
fO^
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PPE Requirements
Established by the RED1
for liquids, wettable powders
formulated in water-soluble
packages, and water-
dispersible granules
"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,orH\ "on an EPA chemical-resistance
category selection chart."
"All mixers, loaders, applicators, flaggers, and other handlers must wear:
- long-sleeved shirt and long pants,
- shoes and socks, plus
- chemical resistant gloves, when applying postharvest dips or sprays to citrus, applying
with any handheld nozzle or equipment, mixing or loading, cleaning up spills or
equipment, or otherwise exposed to the concentrate.
- chemical resistant apron when applying postharvest dips or sprays to citrus, mixing or
loading, cleaning up spills or equipment, or otherwise exposed to the concentrate.
See engineering controls for additional requirements."
Immediately
following/below
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
PPE Requirements
Established by the RED1
for granular
formulations
"Personal Protective Equipment (PPE)
All loaders, applicators, and other handlers must wear:
- long-sleeved shirt and long pants,
- shoes plus socks."
Immediately
following/below
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions
for washables exist, use detergent and hot water. Keep and wash PPE separately from other
laundry."
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
immediately
following the PPE
requirements
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Engineering Controls
for aerial applications
Enclosed Cockpits
"Engineering Controls:
Pilots must use an enclosed cockpit that meets the requirements listed in the WPS for
agricultural pesticides [40 CFR 170.240(d)(6)]"
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
(Immediately
following PPE and
User Safety
Requirements.)
Engineering Controls
for wettable powder
formulations packaged in
water-soluble packages
"Engineering Controls"
"Water-soluble packets when used correctly qualify as a closed loading system under the
WPS. Mixers and loaders using water-soluble packets (1) must wear the PPE specified
above for mixers and loaders and (2) must be provided, have immediately available for use
in an emergency, such as a broken package, spill, or equipment breakdown a NIOSH-
approved dust mist filtering respirator with MSHA/NIOSH approval number prefix TC-
21C or a NIOSH-approved respirator with any N 2, R, P, or HE filter."
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
(Immediately
following PPE and
User Safety
Requirements.)
User Safety
Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the
toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then wash
thoroughly and put on clean clothing. If pesticide gets on skin, wash immediately with
soap and water.
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.)
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Environmental Hazard
Statement for Terrestrial Uses
"This pesticide may be toxic to fish and 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 except as noted on appropriate labels. Drift and runoff may be hazardous to
aquatic organisms in water adjacent to treated areas. Do not contaminate water when
disposing of equipment wash waters or rinsate.
This chemical has properties and characteristics associated with chemicals detected in
groundwater. The use of this chemical in areas where soils are permeable, particularly
where the water table is shallow, may result in groundwater contamination. Application
around a cistern or well may result in contamination of drinking water or groundwater."
Precautionary
Statements
immediately
following the User
Safety
Recommendations
Environmental Hazard
Statement for products used
for aquatic weed control
"Fish breathe dissolved oxygen in the water and decaying weeds also use oxygen. When
treating continuous, dense weed masses, it may be appropriate to treat only part of the
infestation at a time. For example, apply the product in lanes separated by untreated strips
that can be treated after vegetation in treated lanes has disintegrated. During the growing
season, weeds decompose in a 2 to 3 week period following treatment. Begin treatment
along the shore and proceed outwards in bands to allow fish to move into untreated areas.
Waters having limited and less dense weed infestations may not require partial treatments."
Precautionary
Statements
immediately
following the User
Safety
Recommendations
Restricted-Entry Interval for
products containing with
directions for use within the
scope of the WPS and
containing 2,4-D acid or amine
forms
"Do not enter or allow worker entry into treated areas during the restricted entry interval
(REI) of 48 hours."
Directions for Use,
Under Agricultural
Use Requirements
Box
Restricted-Entry Interval for
products containing with
directions for use within the
scope of the WPS and
containing 2,4-D salt or ester
forms
"Do not enter or allow worker entry into treated areas during the restricted entry interval
(REI) of 12 hours."
Directions for Use,
Under Agricultural
Use Requirements
Box
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Early Entry Personal
Protective Equipment
established by the RED for
products containing 2,4-D acid
or amine forms and 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,
- chemical-resistant gloves made of any water-proof material,
- shoes plus socks,
- protective eyewear."
Directions for Use,
Agricultural Use
Requirements Box
Early Entry Personal
Protective Equipment
established by the RED for
products containing 2,4-D salt
or ester forms and 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,
- chemical-resistant gloves made of any water-proof material,
- shoes plus socks."
Directions for Use,
Agricultural Use
Requirements Box
Entry Restrictions for Granular
Formulations with directions
for use outside the scope of the
WPS
"Do not enter or allow people (or pets) to enter the treated area until dusts have settled."
If no WPS uses on the
product, place the
appropriate statement
in the Directions for
Use Under General
Precautions and
Restrictions. If the
product also contains
WPS uses, then create
a NonAgricultural Use
Requirements box as
directed in PR Notice
93-7 and place the
appropriate statement
inside that box.
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Entry Restrictions for liquids,
water-dispersible granules, and
wettable powders formulated
in water-soluble packages with
directions for use outside the
scope of the WPS
"Do not enter or allow people (or pets) to enter the treated area until sprays have dried."
If no WPS uses on the
product, place the
appropriate statement
in the Directions for
Use Under General
Precautions and
Restrictions. If the
product also contains
WPS uses, then create
a NonAgricultural Use
Requirements box as
directed in PR Notice
93-7 and place the
appropriate statement
inside that box.
General Application
Restrictions for products
primarily intended for
occupational (professional) use
"Do not apply this product in a way that will contact workers or other persons, either
directly or through drift. Only protected handlers may be in the area during application.'
Directions for Use
under General
Precautions and
Restrictions
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Use-Specific Application
Restrictions
(Note: The maximum
allowable application rate must
be listed as pounds or gallons
of formulated product per
surface acre, not just as pounds
acid equivalent per surface
acre.)
"Aquatic weed control"
For all acids, salts, amines, and butoxyethanol ester forms used for aquatic weed control,
the following statements must appear on the product label:
> "Ditchbank application
Postemergence:
Limited to 2 applications per season.
Maximum of 2.0 Ibs ae/acre per application.
Minimum of 30 days between applications.
Spot treatment permitted.
Do not use on small canals with a flow rate less than 10 cubic feet per second (CFS) where
water will be used for drinking purposes. CFS may be estimated by using the formula
below. The approximate velocity needed for the calculation can be determined by
observing the length of time that it takes a floating object to travel a defined distance.
Divide the distance (ft.) by the time (sec.) to estimate velocity (ft. per sec.). Repeat 3 times
and use the average to calculate CFS.
Average Width (ft.) x Average Depth (ft.) x Average Velocity (ft. per sec.) = CFS
For ditchbank weeds:
Do not allow boom spray to be directed onto water surface.
Do not spray across stream to opposite bank.
Directions for Use
Associated with the
Specific Use Pattern
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Use-Specific Application
Restrictions
(Note: The maximum
allowable application rate must
be listed as pounds or gallons
of formulated product per
surface acre, not just as pounds
acid equivalent per surface
acre.)
For shoreline weeds:
Allow no more than 2 foot overspray onto water."
> "Floating and Emergent Weeds
Maximum of 4.0 Ibs ae/surface acre per application.
Limited to 2 applications per season.
Minimum of 21 days between applications.
Spot treatments are permitted.
Apply to emergent aquatic weeds in ponds, lakes, reservoirs, marshes, bayous, drainage
ditches, non-irrigation canals, rivers, and streams that are quiescent or slow moving.
Coordination and approval of local and state authorities may be required, either by letter of
agreement or issuance of special permits for aquatic applications.
Water Use
1. Water for irrigation or sprays:
A. If treated water is intended to be used only for crops or non-crop areas that are labled for
direct treatment with 2,4-D such as pastures, turf, or cereal grains, the treated water may be
used to irrigate and/or mix sprays for these sites at anytime after the 2,4-D aquatic
application.
Directions for Use
Associated with the
Specific Use Pattern
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Use-Specific Application
Restrictions
B. Due to potential phytotoxicity considerations, the following restrictions are applicable:
If treated water is intended to be used to irrigate or mix sprays for plants grown in
commercial nurseries and greenhouses; and other plants or crops that are not labeled for
direct treatment with 2,4-D, the water must not be used unless one of the following
restrictions has been observed:
i. A setback distance from functional water intake(s) of greater than or equal to 600 ft. was
used for the application, or,
ii. A waiting period of 7 days from the time of application has elapsed, or,
iii. An approved assay indicates that the 2,4-D concentration is 100 ppb (0.1 ppm) or less at
the water intake. Wait at least 3 days after application before initial sampling at water
intake.
2. Drinking water (potable water):
A. Consult with appropriate state or local water authorities before applying this product
to public waters. State or local agencies may require permits. The potable water use
restrictions on this label are to ensure that consumption of water by the public is allowed
only when the concentration of 2,4-D in the water is less than the MCL (Maximum
Contaminant Level) of 70 ppb. Applicators should consider the unique characteristics of the
treated waters to assure that 2,4-D concentrations in potable water do not exceed 70 ppb at
the time of consumption.
Directions for Use
Associated with the
Specific Use Pattern
Page 121 of 304
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Use-Specific Application
Restrictions
B. For floating and emergent weed applications, the drinking water setback
distance from functioning potable water intakes is greater than or equal to 600 ft.
C. If no setback distance of greater than or equal to 600 ft. is used for application,
applicators or the authorizing organization must provide a drinking water notification prior
to a 2,4-D application to the party responsible for public water supply or to individual
private water uses. Notification to the party responsible for a public water supply or to
individual private water users must be done in a manner to assure that the party is aware of
the water use restrictions when this product is applied to potable water.
The following is an example of a notification via posting, but other methods of notification
which convey the above restrictions may be used and may be required in some cases under
state or local law or as a condition of a permit.
Example:
Posting notification should be located every 250 feet including the shoreline of the treated
area and up to 250 feet of shoreline past the application site to include immediate public
access points. Posting must include the day and time of application. Posting may be
removed if analysis of a sample collected at the intake 3 or more days following application
shows that the concentration in the water is less than 70 ppb (100 ppb for irrigation or
sprays), or after 7 days following application, whichever occurs first.
Directions for Use
Associated with the
Specific Use Pattern
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Use-Specific Application
Restrictions
Text of notification: Wait 7 days before diverting functioning surface water intakes
from the treated aquatic site to use as drinking water, irrigation, or sprays, unless water at
functioning drinking water intakes is tested at least 3 days after application and is
demonstrated by assay to contain not more than 70 ppb 2,4-D (100 ppb for irrigation or
sprays). Application Date: Time:
D. Following each application of this product, treated water must not be used for
drinking water unless one of the following restrictions has been observed:
i. A setback distance from functional water intake(s) of greater than or equal to 600 ft. was
used for the application, or,
ii. A waiting period of at least 7 days from the time of application has elapsed, or,
iii. An approved assay indicates that the 2,4-D concentration is 70 ppb (0.07 ppm) or less at
the water intake. Sampling for drinking water analysis should occur no sooner than 3 days
after 2,4-D application. Analysis of samples must be completed by a laboratory that is
certified under the Safe Drinking Water Act to perform drinking water analysis using a
currently approved version of analytical Method Number 515, 555, other methods for 2,4-
D as may be listed in Title 40 CFR, Part 141.24, or Method Number 4015 (immunoassay
of 2,4-D) from U.S. EPA Test Methods for Evaluating Solid Waste SW-846.
E. Note: Existing potable water intakes that are no longer in use, such as those replaced
by a connection to a municipal water system or a potable water well, are not
considered to be functioning potable water intakes.
Directions for Use
Associated with the
Specific Use Pattern
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Use-Specific Application
Restrictions
F. Drinking water setback distances do not apply to terrestrial applications of 2,4-D
adjacent to water bodies with potable water intakes.
3. Swimming (2,4-D butoxyethanol ester only):
A. Do not swim in treated water for a minimum of 24 hours after application.
B. Users must provide notification prior to performing a 2,4-D BEE application.
Notification to the party responsible for the public swimming area or to individual private
users must be done in a manner to assure that the party is aware of the water use swimming
restrictions when this product is applied to water. The following is an example of a
notification via posting, but other methods of notification which convey the above
restrictions may be used and may be required in some cases under state or local law or as a
condition of a permit.
Example:
Posting notification should be located every 250 feet including the shoreline of the treated
area and up to 250 feet of shoreline past the application site to include immediate public
access points.
Text of Notification: Do not swim in treated water for a minimum of 24 hours after
application. Application Date: Time: .
4. Except as stated above, there are no restrictions on using water from treated areas for
swimming, fishing, watering livestock or domestic purposes."
Directions for Use
Associated with the
Specific Use Pattern
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Use-Specific Application
Restrictions
(Note: The maximum
allowable application rate must
be listed as pounds or gallons
of formulated product per acre-
foot, not just as pounds acid
equivalent per acre-foot.)
> "Submersed Weeds
Maximum of 10.8 Ibs ae/per acre-foot per application.
Limited to 2 applications per season.
Apply to aquatic weeds in ponds, lakes, reservoirs, marshes, bayous, drainage ditches, non-
irrigation canals, rivers, and streams that are quiescent or slow moving.
Do not apply within 21 days of previous application.
When treating moving bodies of water, applications must be made while traveling
upstream to prevent concentration of 2,4-D downstream from the application.
Coordination and approval of local and state authorities may be required, either by letter of
agreement or issuance of special permits for such use.
Table 1. Amount of 2,4-D to Apply for a Target Subsurface Concentration
Surface Area
Average Depth
1ft.
2ft.
3ft.
4ft.
5ft.
For typical
conditions - 2 ppm
2,4-D ae/acre-foot
5.4 Ibs
10.8 Ibs
16.2 Ibs
21.6 Ibs
27.0 Ibs
For difficult
conditions* - 4
ppm 2,4-D ae/acre-
foot
10.8 Ibs
21.6 Ibs
32.4 Ibs
43.2 Ibs
54.0 Ibs
* Examples include spot treatment of pioneer colonies of Eurasian Water Milfoil and
certain difficult to control aquatic species.
Directions for Use
Associated with the
Specific Use Pattern
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Use-Specific Application
Restrictions
Water Use:
1. Water for irrigation or sprays:
A. If treated water is intended to be used only for crops or non-crop areas that are labeled
for direct treatment with 2,4-D such as pastures, turf, or cereal grains, the treated water may
be used to irrigate and/or mix sprays for these sites at anytime after the 2,4-D aquatic
application.
B. Due to potential phytotoxicity and/or residue considerations, the following restrictions
are applicable:
If treated water is intended to be used to irrigate or mix sprays for unlabeled crops, non-
crop areas or other plants not labeled for direct treatment with 2,4-D, the water must not be
used unless one of the following restrictions has been observed:
i. A setback distance described in the Drinking Water Setback Table was used for the
application, or,
ii. A waiting period of 21 days from the time of application has elapsed, or,
iii. An approved assay indicates that the 2,4-D concentration is 100 ppb (0.1 ppm) or less at
the water intake. See Table 3 for the waiting period after application but before taking the
initial sampling at water intake.
2. Drinking water (potable water):
A. Consult with appropriate state or local water authorities before applying this product to
public waters. State or local agencies may require permits.
Directions for Use
Associated with the
Specific Use Pattern
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Use-Specific Application
Restrictions
The potable water use restrictions on this label are to ensure that consumption of water by
the public is allowed only when the concentration of 2,4-D in the water is less than the
MCL (Maximum Contaminant Level) of 70 ppb. Applicators should consider the unique
characteristics of the treated waters to assure that 2,4-D concentrations in potable water do
not exceed 70 ppb at the time of consumption.
B. For submersed weed applications, the drinking water setback distances from
functioning potable water intakes are provided in Table 2. Drinking Water Setback
Distance (below).
C. If no setback distance from the Drinking Water Setback Table (Table 2) is to be used for
the application, applicators or the authorizing organization must provide a drinking water
notification and an advisory to shut off all potable water intakes prior to a 2,4-D
application. Notification to the party responsible for a public water supply or to individual
private water users must be done in a manner to assure that the party is aware of the water
use restrictions when this product is applied to potable water. The following is an example
of a notification via posting, but other methods of notification which convey the above
restrictions may be used and may be required in some cases under state or local law or as a
condition of a permit.
Directions for Use
Associated with the
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Use-Specific Application
Restrictions
Example:
Posting notification should be located every 250 feet including the shoreline of the treated
area and up to 250 feet of shoreline past the application site to include immediate public
access points. Posting should include the day and time of application. Posting may be
removed if analysis of a sample collected at the intake no sooner than stated in Table 3
(below) shows that the concentration in the water is less than 70 ppb (100 ppb for irrigation
or sprays), or after 21 days following application, whichever occurs first.
Text of notification: Wait 21 days before diverting functioning surface water intakes from
the treated aquatic site to use as drinking water, irrigation, or sprays, unless water at
functioning drinking water intakes is tested no sooner than (insert days from Table 3) and is
demonstrated by assay to contain not more than 70 ppb 2,4-D (100 ppb for irrigation or
sprays).
Application Date: Time: .
D. Following each application of this product, treated water must not be used for drinking
water unless one of the following restrictions has been observed:
i. A setback distance described in the Drinking Water Setback Distance Table was used for
the application, or,
ii. A waiting period of at least 21 days from the time of application has elapsed, or,
Directions for Use
Associated with the
Specific Use Pattern
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Use-Specific Application
Restrictions
iii. An approved assay indicates that the 2,4-D concentration is 70 ppb (0.07 ppm) or less at
the water intake. Sampling for drinking water analysis should occur no sooner than stated
in Table 3. Analysis of samples must be completed by a laboratory that is certified under
the Safe Drinking Water Act to perform drinking water analysis using a currently approved
version of analytical Method Number 515, 555, other methods for 2,4-D as may be listed in
Title 40 CFR, Part 141.24, or Method Number 4015 (immunoassay of 2,4-D) from U.S.
EPA Test Methods for Evaluating Solid Waste SW-846.
E. Note: Existing potable water intakes that are no longer in use, such as those replaced by
a connection to a municipal water system or a potable water well, are not considered to be
functioning potable water intakes.
F. Drinking water setback distances do not apply to terrestrial applications of 2,4-D
adjacent to water bodies with potable water intakes.
Directions for Use
Associated with the
Specific Use Pattern
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Use-Specific Application
Restrictions
Use-Specific Application
Restrictions
3. Swimming (2,4-D butoxyethanol ester only):
A. Do not swim in treated water for a minimum of 24 hours after application.
B. Users must provide the following notification prior to performing a 2,4-D BEE
application. Notification to the party responsible for the public swimming area or to
individual private users must be done in a manner to assure that the party is aware of the
water use swimming restrictions when this product is applied to water. The following is an
example of a notification via posting, but other methods of notification which convey the
above restrictions may be used and may be required in some cases under state or local law
or as a condition of a permit.
Example:
Posting notification should be located every 250 feet including the shoreline of the treated
area and up to 250 feet of shoreline past the application site to include immediate public
access points.
Text of Notification: Do not swim in treated water for a minimum of 24 hours after
application. Application Date: Time:
4. Except as stated above, there are no restrictions on using water from treated areas for
swimming, fishing, watering livestock or domestic purposes."
Table 2. Drinking Water Setback Distance
for Submersed Weed Applications
Application Rate and Minimum Setback Distance (feet) From Functioning Potable Water
Intake
Directions for Use
Associated with the
Specific Use Pattern
Directions for Use
Associated with the
Specific Use Pattern
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1 ppm*
600
2 ppm*
1200
3 ppm*
1800
4 ppm*
2400
* ppm acid equivalent target water concentration
Table 3. Sampling for Drinking Water Analysis After 2,4-D Application for
Submersed Weed Applications
Minimum Days After Application Before Initial Water Sampling at the Functioning
Potable Water Intake
1 ppm*
5
2 ppm*
10
3 ppm*
10
4 ppm*
14
* ppm acid equivalent target water concentration"
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Use-Specific Application
Restrictions
(Note: The maximum
allowable application rate must
be listed as pounds or gallons
of formulated product per acre,
not just as pounds acid
equivalent per acre.
"Asparagus"
Permitted forms of 2,4-D include acid, salts, and amines.
"The preharvest interval (PHI) is 3 days.
Limited to 2 applications per crop cycle.
Maximum of 2.0 Ib ae/acre per application
Minimum of 30 days between applications."
"Blueberry, low bush"
Permitted forms of 2,4-D include acid, salts, and amines.
"Postemergence:
Limited to one postemergence application per year.
Maximum of 0.0375 Ibs ae/gallons of spray solution per application.
Postharvest:
Limited to one postharvest application per year.
Maximum of 1.0 Ibs ae/gallon spray solution per application.
For spot or directed wipe treatment only.
Apply only in non-bearing years."
Directions for Use
Associated with the
Specific Use Pattern
Page 132 of 304
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Use-Specific Application
Restrictions
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Blueberry, high bush"
Permitted forms of 2,4-D include acid, salts, and amines.
"The preharvest interval (PHI) is 30 days.
Postemergence and postharvest:
Limited to 2 applications per year.
Maximum of 1.4 Ibs ae/acre per application."
"Cereal Grains (wheat, barley, millet, oats, and rye)"
Permitted forms of 2,4-D include acid, salts, amines, and esters.
"The preharvest interval (PHI) is 14 days.
Postemergence:
Limited to one postemergence application per crop cycle.
Maximum of 1.25 Ibs ae/acre per application.
Preharvest:
Limited to one preharvest application per crop cycle.
Maximum of 0.5 Ibs ae/acre per application.
Limited to 1.75 Ibs ae/acre per crop cycle."
Directions for Use
Associated with the
Specific Use Pattern
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Citrus (growing fruit)
Permitted form of 2,4-D is isopropyl ester.
"The preharvest interval (PHI) is 7 days.
-To increase fruit size on growing Navel oranges, Valencia oranges, and grapefruit:
Limited to one application per crop cycle.
Maximum of 45 grams ae per acre (0.1 Ibs ae/acre).
-To reduce pre-harvest fruit drop on growing Navel oranges, Valencia oranges, and
grapefruit:
Limited to one application per crop cycle.
Maximum rate of 200 ppm per application.
-To prevent pre-harvest drop of mature fruit and leaves on lemons. Navel oranges. Valencia
oranges, and Tangelos:
Limited to one application per crop cycle.
Maximum rate of 24 ppm per application."
Directions for Use
Associated with the
Specific Use Pattern
Page 134 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
Postharvest Citrus Treatment
Permitted form of 2,4-D is isopropyl ester.
"Permitted application methods include dip or spray.
Postharvest packing house application to lemons:
Limited to one application per crop.
Maximum rate of 500 ppm per application."
Directions for Use
Associated with the
Specific Use Pattern
Page 135 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Corn, field and pop"
Permitted forms of 2,4-D include acid, salts, amines, and esters.
"Do not use treated crop as fodder for 7 days following application.
The preharvest interval (PHI) is 7 days.
Maximum of 3 Ibs ae/acre per crop cycle.
Preplant or preemergence:
Limited to one preplant or preemergence application per crop cycle.
Maximum of 1.0 Ib ae/acre per application.
Postemergence:
Limited to one postemergence application per crop cycle.
Maximum of 0.5 Ib ae/acre per application.
Preharvest:
Limited to one preharvest application per crop cycle.
Maximum of 1.5 Ibs ae/acre per application."
Directions for Use
Associated with the
Specific Use Pattern
Page 136 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Corn, sweet"
Permitted forms of 2,4-D include acid, salts, amines, and esters.
"Do not use treated crop as fodder for 7 days following application.
The preharvest interval (PHI) is 45 days.
Minimum of 21 days between applications.
Maximum of 1.5 Ibs ae/acre per crop cycle.
Preplant or preemergence:
Limited to one preplant or preemergence application per crop cycle.
Maximim of 1.0 Ib ae/acre per application.
Postemergence:
Limited to one postemergence application per crop cycle.
Maximum of to 0.5 Ib ae/acre per application."
Directions for Use
Associated with the
Specific Use Pattern
Page 137 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Cranberries"
Permitted forms of 2,4-D include acid, salts, amines, and esters.
"The preharvest interval (PHI) is 30 days.
Dormant Season:
Limited to one application per crop cycle.
Maximum of 4.0 Ibs ae/acre per dormant season
Postemergence:
Limited to 2 applications per crop cycle.
Maximum of 1.2 Ibs ae/acre per postemergence application."
"Filberts"
Permitted forms of 2,4-D include acid, salts, and amines.
"The preharvest interval (PHI) is 45 days.
Minimum of 30 days between applications.
Limited to 4 applications per year.
Maximum of 1.0 Ibs ae per 100 gallons of spray solution per application.
"Fallowland (crop stubble on idle land, or postharvest to crops, or between crops)"
Permitted forms of 2,4-D include acid, salts, amines, and esters.
"Plant only labeled crops within 29 days following application.
Limited to 2 applications per year.
Maximum of 2.0 Ibs ae/acre per application.
Minimum of 30 days between applications."
Directions for Use
Associated with the
Specific Use Pattern
Page 138 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Forestry (forest site preparation, forest roadsides, brush control, established conifer
release, Chrismas trees, reforestation areas)"
Permitted forms of 2,4-D include acid, salts, amines, and esters.
Broadcast application:
Limited to 1 broadcast application per year.
Maximum of 4.0 Ibs ae/acre per broadcast application.
Basal spray, Cut Surface - Stumps, and Frill:
Limit of one basal spray or cut surface application per year.
Maximum of 8.0 Ibs ae per 100 gallons of spray solution.
Injection:
Limit to one injection application per year.
Maximum of 2 ml of 4.0 Ibs ae formulation per injection site."
"Grapes"
Permitted forms of 2,4-D include acid, salts, and amines.
"For use only in California.
The preharvest interval (PHI) is 100 days.
Limited to 1 application per crop cycle.
Maximum of 1.36 Ibs ae/acre per application."
Directions for Use
Associated with the
Specific Use Pattern
Page 139 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Grasses (pastures and rangeland not in agricultural production)"
Permitted forms of 2.4-D include acid, salts, amines, and esters.
"The preharvest interval (PHI) is 7 days (cut forage for hay).
Postemergence:
Limited to 2 applications per year.
Maximum of 2.0 Ibs ae/acre per application.
Minimum of 30 days between applications.
If grass is to be cut for hay, Agricultural Use Requirements for the Worker Protection
Standard are applicable.
For program lands, such as Conservation Reserve Program, consult program rules to
determine whether grass or hay may be used. The more restrictive requirements of the
program rules or this label must be followed."
"Hops"
Permitted forms of 2,4-D include acid and amines.
"The preharvest interval (PHI) is 28 days.
Postemergence:
Limited to 3 applications per crop cycle.
Maximum of 0.5 Ib ae/acre per application.
Maximum of 1.5 Ibs ae/acre per crop cycle.
Minimum of 30 days between applications."
Directions for Use
Associated with the
Specific Use Pattern
Page 140 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Non-Cropland (fencerows, hedgerows, roadsides, ditches, rights-of-way, utility
power lines, railroads, airports, and industrial sites)"
Permitted forms of 2,4-D include acid, salts, amines, and esters.
"Postemergence (annual and perennial weeds):
Limited to 2 applications per year.
Maximum of 2.0 Ibs ae/acre per application.
Minimum of 30 days between applications.
Postemergence (woody plants):
Limited to 1 application per year.
Maximum of 4.0 Ibs ae/acre per year.
Applications to non-cropland areas are not applicable to treatment of commercial timber or
other plants being grown for sale or other commercial use, or for commercial seed
production, or for research purposes."
Directions for Use
Associated with the
Specific Use Pattern
Page 141 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Pasture and Rangeland (established grass pastures, rangeland, and perennial
grasslands not in agricultural production)"
Permitted forms of 2,4-D include acid, salt, amines, and esters.
"Do not cut forage for hay within 7 days of application.
Postemergence:
For susceptible annual and biennial broadleaf weeds: Use 1.0 Ibs ae/acre per application.
For moderately susceptible biennial and perennial broadleaf weeds: Use 1.0 to 2.0 Ibs
ae/acre per application.
For difficult to control weeds and woody plants: Use 2.0 Ibs ae/acre per application.
Spot treatment: Use 2.0 Ibs ae/acre.
Maximum of two applications per year.
Maximum of 4.0 Ibs ae/acre per year.
Minimum of 30 days between applications.
If grass is to be cut for hay, Agricultural Use Requirements for the Worker Protection
Standard are applicable."
"Pistachios"
Permitted forms of 2,4-D include acid, salts, and amines.
"Do not cut orchard floor forage for hay within 7 days of application.
The preharvest interval (PHI) is 60 days.
Postemergence:
Limited to 2 applications per year.
Maximum of 2.0 Ibs ae/acre per application.
Minimum of 30 days between applications."
Directions for Use
Associated with the
Specific Use Pattern
Page 142 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Pome Fruits"
Permitted forms of 2,4-D include acid, salts, and amines.
"The preharvest interval (PHI) is 14 days.
Do not cut orchard floor forage for hay within 7 days of application.
Postemergence:
Limited to 2 applications per crop cycle.
Maximum of 2.0 Ibs ae/acre per application.
Minimum of 75 days between applications."
"Potatoes"
Permitted forms of 2,4-D include acid, salts, amines, and esters.
"Only for use on potatoes intended for fresh market.
The preharvest interval (PHI) is 45 days.
Postemergence:
Limited to 2 applications per crop cycle.
Maximum of 0.07 Ib ae/acre per application.
Minimum of 10 days between applications."
Directions for Use
Associated with the
Specific Use Pattern
Page 143 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Rice"
Permitted forms of 2,4-D include acid, salts, and amines.
"The preharvest interval (PHI) is 60 days.
Maximum of 1.5 Ibs ae/acre per crop cycle."
Preplant:
Limited to one preplant application per crop cycle.
Maximum of 1.0 Ibs ae/acre per preplant application..
Postemergence:
Limited to one postemergence application per crop cycle.
Maximum of 1.5 Ibs ae/acre per postemergence application.
"Rice, wild"
Permitted forms of 2,4-D include acid, salts, and amines.
"For use in Minnesota only.
The preharvest interval (PHI) is 60 days.
Postemergence:
Limited to 1 application per crop cycle .
Maximum of 0.25 Ib ae/acre per application."
Directions for Use
Associated with the
Specific Use Pattern
Page 144 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Sorghum"
Permitted forms of 2,4-D include acid, salts, amines, and esters.
"The preharvest interval (PHI) is 30 days.
Do not permit meat or dairy animals to consume treated crop as fodder or forage for 30
days following application.
Postemergence (acid, salts, and amines):
Limited to 1 application per crop cycle.
Maximum of 1.0 Ib ae/acre per application.
Postemergence (esters):
Limited to 1 application per crop cycle.
Maximum of 0.5 Ib ae/acre per application."
Directions for Use
Associated with the
Specific Use Pattern
Page 145 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Soybeans"
Permitted forms of 2,4-D include acid, salts, amines, and esters.
"The maximum rate per crop cycle is 1.0 Ib ae/acre.
Preplant:
Limited to 2 preplant applications per crop cycle.
Maximum of 0.5 Ib ae/acre per preplant application.
> Esters: Apply not less than 7 days prior to planting soybeans.
>Amines, acid, salts: Apply not less than 15 days prior to planting soybeans.'
or
"Preplant:
Limited to 1 application per crop cycle.
Maximum of 1.0 ae/acre per preplant application.
>Esters: Apply not less than 15 days prior to planting soybeans.
>Amines, acid, salts: Apply not less than 30 days prior to planting soybeans.'
"Stone Fruits"
Permitted forms of 2,4-D include acid, salts, and amines.
"The preharvest interval (PHI) is 40 days.
Do not cut orchard floor forage for hay within 7 days of application.
Postemergence:
Limited to 2 applications per crop cycle.
Maximum of 2.0 Ib ae/acre per application.
Minimum of 75 days between applications."
Directions for Use
Associated with the
Specific Use Pattern
Page 146 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Strawberry"
Permitted forms of 2,4-D include acid, salts, and amines.
"Do not apply in California or Florida.
Dormant or after last picking:
Limited to 1 application per crop cycle.
Maximum of 1.5 Ibs ae/acre per application."
"Sugarcane"
Permitted forms of 2,4-D include acid, salts, and amines.
"Do not harvest cane prior to crop maturity.
Do not apply more than 4 Ibs ae/acre per crop cycle.
Preemergence:
Limited to one application per crop cycle.
Maximum of 2.0 Ibs ae/acre per application.
Postemergence:
Limited to one application per crop cycle.
Maximum of 2.0 Ibs ae/acre per application.."
Directions for Use
Associated with the
Specific Use Pattern
Page 147 of 304
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Other Application Restrictions
(Risk Mitigation)
(Note: The maximum
allowable application rate and
maximum allowable rate per
year must be listed as pounds
or gallons of formulated
product per acre, not just as
pounds acid equivalent per
acre.)
"Tree Nuts"
Permitted forms of 2,4-D include acid, salts, and amines.
"The preharvest interval (PHI) is 60 days.
Do not cut orchard floor forage for harvest within 7 days of application.
Postemergence:
Limited to 2 applications per crop cycle
Maximum of 2.0 Ibs ae/acre per application.
Minimum of 30 days between applications."
"Turf, ornamental (golf courses, cemetaries, parks, sports fields, turfgrass, lawns and
other grass areas)"
Permitted forms of 2,4-D include acid, salts, amines, and esters.
"Postemergence:
Limited to 2 applications per year.
Maximum of 1.5 Ibs ae/acre per application.
The maximum seasonal rate is 3.0 Ibs ae/acre, excluding spot treatments."
"Turf, grown for seed or sod"
Permitted forms of 2,4-d include acid, salts, amines, and esters.
"Limited to 2 applications per year.
Maximum of 2.0 Ibs ae/acre per application.
Minimum of 21 days between applications."
Directions for Use
Associated with the
Specific Use Pattern
Page 148 of 304
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Spray Drift
"SPRAY DRIFT MANAGEMENT"
"A variety of factors including weather conditions (e.g., wind direction, wind speed,
temperature, relative humidity) and method of application (e.g., ground, aerial, airblast,
chemigation) can influence pesticide drift. The applicator must evaluate all factors and
make appropriate adjustments when applying this product."
Droplet Size
"When applying sprays that contain 2,4-D as the sole active ingredient, or when applying
sprays that contain 2,4-D mixed with active ingredients that require a Coarse or coarser
spray, apply only as a Coarse or coarser spray (ASAE standard 572) or a volume mean
diameter of 385 microns or greater for spinning atomizer nozzles."
"When applying sprays that contain 2,4-D mixed with other active ingredients that require
a Medium or more fine spray, apply only as a Medium or coarser spray (ASAE standard
572) or a volume mean diameter of 300 microns or greater for spinning atomizer nozzles."
Wind Speed
"Do not apply at wind speeds greater than 15 mph. Only apply this product if the wind
direction favors on-target deposition and there are not sensitive areas (including, but not
limited to, residential areas, bodies of water, known habitat for nontarget species, nontarget
crops) within 250 feet downwind. If applying a Medium spray, leave one swath unsprayed
at the downwind edge of the treated field."
Directions for Use
Page 149 of 304
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Temperature Inversions
"If applying at wind speeds less than 3 mph, the applicator must determine if: a)
conditions of temperature inversion exist, or b) stable atmospheric conditions exist at or
below nozzle height. Do not make applications into areas of temperature inversions or
stable atmospheric conditions."
Susceptible Plants
"Do not apply under circumstances where spray drift may occur to food, forage, or other
plantings that might be damaged or crops thereof rendered unfit for sale, use or
consumption. Susceptible crops include, but are not limited to, cotton, okra, flowers,
grapes (in growing stage), fruit trees (foliage), soybeans (vegetative stage), ornamentals,
sunflowers, tomatoes, beans, and other vegetables, or tobacco. Small amounts of spray
drift that might not be visible may injure susceptible broadleaf plants."
Other State and Local Requirements
"Applicators must follow all state and local pesticide drift requirements regarding
application of 2,4-D herbicides. Where states have more stringent regulations, they must be
observed."
Equipment
"All aerial and ground application equipment must be properly maintained and calibrated
using appropriate carriers or surrogates."
Additional requirements for aerial applications:
"The boom length must not exceed 75% of the wingspan or 90% of the rotor blade
diameter."
Page 150 of 304
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"Release spray at the lowest height consistent with efficacy and flight safety. Do not
release spray at a height greater than 10 feet above the crop canopy unless a greater height
is required for aircraft safety. This requirement does not apply to forestry or rights-of-way
applications."
"When applications are made with a crosswind, the swath will be displaced downwind.
The applicator must compensate for this by adjusting the path of the aircraft upwind."
Additional requirements for ground boom application:
"Do not apply with a nozzle height greater than 4 feet above the crop canopy."
Additional requirements for liquid products applied as a spray and containing an ester
form of2,4-D (e.g. 2,4-D butoxyethyl ester, 2,4-D ethylhexyl ester, 2,4-D isopropyl ester):
"2,4-D esters may volatilize during conditions of low humidity and high temperatures.
Do not apply during conditions of low humidity and high temperatures."
Application Restrictions
"Do not apply this product in a way that will contact any person or pet, either directly or
through drift. Keep people and pets out of the area during application."
Directions for Use
under General
Precautions and
Restrictions
Entry Restrictions for liquids,
water-dispersible granules, and
wettable powders formulated
in water-soluble packages
"Do not allow people or pets to enter the treated area until sprays have dried."
Directions for use
under General
Precautions and
Restrictions
Page 151 of 304
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Entry Restrictions for granular
formulations
"Do not allow people or pets to enter the treated area until dusts have settled."
Directions for use
under General
Precautions and
Restrictions
Environmental Hazard
Statement for Residential Use
labels
"This pesticide is toxic to fish and 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
except as noted on appropriate labels. Drift and runoff may be hazardous to aquatic
organisms in water adjacent to treated areas. Do not contaminate water when disposing of
equipment wash waters or rinsate.2
This chemical has properties and characteristics associated with chemicals detected in
groundwater. The use of this chemical in areas where soils are permeable, particularly
where the water table is shallow, may result in groundwater contamination. Application
around a cistern or well may result in contamination of drinking water or groundwater."
Precautionary
Statements
immediately
following the User
Safety
Recommendations
1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more
protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
2 May be deleted for ready-to-use products.
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VL Appendicies
Page 153 of 304
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Appendix A. Table of 2,4-D Use Patterns Eligible for Reregistration (Case 0073)
Page 154 of 304
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Appendix A. Use Patterns Subject to Reregistration for 2,4-D (Case 0073)
Use Site
Aquatic
weed control
- Ditchbank
application
Aquatic
weed control
- floating
and
emergent
weeds
Formulation
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid,
Soluble
concentrate -
solid,
Granular
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid,
Soluble
concentrate -
solid,
Granular
Max.
Single
App.
Rate
2.0
4.0
Unit
Lbs ae/acre
Lbs
ae/surface
acre
Max. #
App. Per
Crop
Cycle/Yea
2 per season
2 per season
Max. App.
Rate Per
Crop
Cycle/Year
4.0 Ibs
ae/acre
8.0 Ibs
ae/surface
acre
Min.
Retreatm
ent
Interval
(days)
30
21
Reentry
Interval (REI)
NA
NA
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
NA
NA
Restrictions/Comments
See Label Changes Summary Table
in 2,4-D RED.
Apply to aquatic weeds in ponds,
lakes, reservoirs, marshes, bayous,
drainage ditches, non-irrigation
canals, rivers, and streams that are
quiescent or slow moving.
Coordination and approval of local
and state authorities may be required,
either by letter of agreement or
issuance of special permits for such
use.
See Label Changes Summary Table
in 2,4-D RED.
Page 155 of 304
-------
Use Site
Aquatic
weed control
- submersed
weeds
Asparagus
Formulation
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid,
Soluble
concentrate -
solid,
Granular
Wettable powder,
Emulsifiable
concentrate,
soluble
concentrate -
liquid, soluble
concentrate - solid
Max.
Single
App,
Rate
10.8
2.0
Unit
Lbs ae per
acre-foot
Lbs ae/acre
Max. #
App. Per
Crop
Cycle/Yea
r
2 per season
2 per crop
cycle
Max. App.
Rate Per
Crop
Cycle/Year
21.61bsae
per acre-foot
per season
4.0 Ibs
ae/acre
Min.
Retreatm
ent
Interval
(days)
21
30
Reentry
Interval (REI)
24 hour
swimming
restriction for
2,4-D BEE form
2,4-D acid and
amines -48
hours;
2,4-D salt and
esters - 12 hours
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
NA
NA
Restrictions/Comments
Apply to aquatic weeds in ponds,
lakes, reservoirs, marshes, bayous,
drainage ditches, non-irrigation
canals, rivers, and streams that are
quiescent or slow moving.
When treating moving bodies of
water, applications must be made
while traveling upstream to prevent
concentration of 2,4-D downstream
of the application.
Coordination and approval of local
and state authorities may be required,
either by letter of agreement or
issuance of special permits for such
use.
See Label Changes Summary Table
in 2,4-D RED.
See Label Changes Summary Table
in 2,4-D RED.
Page 156 of 304
-------
Use Site
Blueberry,
low bush
Blueberry,
high bush
Formulation
Wettable powder,
Emulsifiable
concentrate,
soluble
concentrate -
liquid, soluble
concentrate - solid
Wettable powder,
Emulsifiable
concentrate,
soluble
concentrate -
liquid, soluble
concentrate - solid
Max.
Single
App,
Rate
Postemerg
ence:
0.0375
Postharves
t:
1.0
1.4
Unit
Ibs ae per
gallon spray
solution per
application
Lbs ae/acre
Max. #
App. Per
Crop
Cycle/Yea
r
Postemergen
ce: 1
Postharvest:
1
2 per year
Max. App.
Rate Per
Crop
Cycle/Year
0.0375 Ibs ae
per gallon
spray
solution
2.8 Ibs
ae/acre
Min.
Retreatm
ent
Interval
(days)
NA
NS
Reentry
Interval (REI)
2,4-D acid and
amines -48
hours;
2,4-D salt and
esters - 12 hours
2,4-D acid and
amines -48
hours;
2,4-D salt and
esters - 12 hours
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
NA
PHI - 30 days
Restrictions/Comments
Postharvest: For spot or directed wipe
treatment only.
Apply only in non-bearing years.
See Label Changes Summary Table
in 2,4-D RED.
See Label Changes Summary Table
in 2,4-D RED
Page 157 of 304
-------
Use Site
Citrus,
growing fruit
Formulation
Emulsifiable
concentrate
Max.
Single
App,
Rate
To
increase
fruit size
on
growing
Navel
oranges,
Valencia
oranges,
and
grapefruit:
0,1
To reduce
pre-
harvest
fruit drop
on
growing
Navel
oranges,
Valencia
oranges,
and
grapefruit:
200
Unit
To increase
fruit size on
growing
Navel
oranges,
Valencia
oranges, and
grapefruit:
Ibs ae/acre
To reduce
pre-harvest
fruit drop on
growing
Navel
oranges,
Valencia
oranges, and
grapefruit:
ppm
Max. #
App. Per
Crop
Cycle/Yea
r
1 per crop
cycle
Max. App.
Rate Per
Crop
Cycle/Year
same as
max. single
app. rate
Min.
Retreatm
ent
Interval
(days)
NA
Reentry
Interval (REI)
12 hours
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
PHI - 7 days
Restrictions/Comments
See Label Changes Summary Table
in 2,4-D RED
Page 158 of 304
-------
Use Site
Citrus,
postharvest
treatement
Corn, field
and pop
Formulation
Emulsifiable
concentrate
Wettable powder,
Emulsifiable
concentrate,
Granular, Soluble
concentrate -
liquid, Soluble
concentrate - solid
Max.
Single
App.
Rate
To
prevent
pre-
harvest
drop of
mature
fruit and
leaves on
lemons,
Navel
oranges,
Valencia
oranges,
and
Tangelos:
24
500
Preplant
or
preemerge
nee: 1.0
Postemerg
ence: 0.5
Preharvest
: 1.5
Unit
To prevent
pre-harvest
drop of
mature fruit
and leaves
on lemons,
Navel
oranges,
Valencia
oranges, and
Tangelos:
ppm
ppm
Lbs ae/acre
Max. #
App. Per
Crop
Cycle/Yea
r
1
l
Preplant or
preemergenc
e: 1
Postemergen
ce: 1
Preharvest: 1
Max. App.
Rate Per
Crop
Cycle/Year
same as
max. single
app. rate
500 ppm
3.0 Ibs
ae/acre
Min.
Retreatm
ent
Interval
(days)
NA
NA
Reentry
Interval (REI)
NA
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
NA
PHI - 7 days
PGI - 7 days
Restrictions/Comments
Application methods include dip or
spray
See Label Changes Summary Table
in 2,4-D RED
See Label Changes Summary Table
in 2,4-D RED
Page 159 of 304
-------
Use Site
Corn, sweet
Cranberries
Filberts
Formulation
Wettable powder,
Emulsifiable
concentrate,
Granular, Soluble
concentrate -
liquid, Soluble
concentrate - solid
Wettable powder,
Emulsifiable
concentrate,
Granular, Soluble
concentrate -
liquid, Soluble
concentrate - solid
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Max.
Single
App.
Rate
Preplant
or
preemerge
nee: 1.0
Postemerg
ence: 0.5
Dormant
season:
4.0
Postemerg
ence: 1.2
1.0
Unit
Lbs ae/acre
Dormant
season: Ibs
ae/acre per
dormant
season
Postemergen
ce: Ibs
ae/acre per
postemergen
ce
application
Ibs ae per
100 gallons
of spray
solution
Max. #
App. Per
Crop
Cycle/Yea
r
Preplant or
preemergenc
e: 1
Postemergen
ce: 1
Dormant
season: 1
Postemergen
ce:2
4
Max. App.
Rate Per
Crop
Cycle/Year
1.5 Ibs
ae/acre per
crop cycle
Dormant
season: 4 Ibs
ae/acre per
dormant
season
Postemergen
ce: 2.4 Ibs
ae/acre per
postemergen
ce
application
4.0 Ibs ae per
100 gallons
of spray
solution per
year
Min.
Retreatm
ent
Interval
(days)
21
NS
30
Reentry
Interval (REI)
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
PHI - 45 days
PGI - 7 days
PHI - 30 days
PHI - 45 days
Restrictions/Comments
See Label Changes Summary Table
in 2,4-D RED
See Label Changes Summary Table
in 2,4-D RED
See Label Changes Summary Table
in 2,4-D RED
Page 160 of 304
-------
Use Site
Fallowland
(crop stubble
on idle land,
or
postharvest
to crops, or
between
crops)
Forestry
(forest site
preparation,
forest
roadsides,
brush
control,
established
conifer
release,
Christmas
trees,
reforestation
areas)
Grapes
Formulation
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Max.
Single
App,
Rate
2.0
Broadcast:
4.0
Basal
spray, cut
surface -
stumps,
frill: 8.0
Injection:
2
1.36
Unit
Lbs ae/acre
Broadcast:
Ibs ae/acre
Basal spray,
cut surface -
stumps, frill:
Ibs ae per
100 gallons
of spray
solution
Injection: ml
of 4.0 Ibs ae
formulation
per injection
site
Ibs ae/acre
Max. #
App. Per
Crop
Cycle/Yea
r
2 per year
1 per year
1 per crop
cycle
Max. App.
Rate Per
Crop
Cycle/Year
4.0 Ibs
ae/acre per
year
Broadcast:
4.0 Ibs
ae/acre per
year
Basal spray,
cut surface -
stumps, frill:
Ibs ae per
100 gallons
of spray
solution
Injection: ml
of 4.0 Ibs ae
formulation
per injection
site
1.36 Ibs
ae/acre per
year
Min.
Retreatm
ent
Interval
(days)
30
NA
NA
Reentry
Interval (REI)
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
NS
NA
PHI - 100 days
Restrictions/Comments
Plant only label crops within 29 days
following application.
See Label Changes Summary Table
in 2,4-D RED
See Label Changes Summary Table
in 2,4-D RED
For use in California only.
Do not apply to grape foliage, shoots,
or stems.
See Label Changes Summary Table
in 2,4-D RED
Page 161 of 304
-------
Use Site
Grasses
(pastures and
rangeland
not in
agricultural
production)
Hops
Formulation
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Max.
Single
App,
Rate
2.0
0.5
Unit
Lbs ae/acre
Lbs ae/acre
Max. #
App. Per
Crop
Cycle/Yea
r
2 per year
3 per crop
cycle
Max. App.
Rate Per
Crop
Cycle/Year
4.0 Ibs
ae/acre per
year
1.5 Ibs
ae/acre per
crop cycle
Min.
Retreatm
ent
Interval
(days)
30
NS
Reentry
Interval (REI)
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
2,4-D acid and
amines - 48
hours
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
PHI - 7 days
PHI - 28 days
Restrictions/Comments
Do not cut forage for hay within 7
days of application.
If grass is to be cut for hay,
Agricultural Use Requirements for
the Worker Protection Standard are
applicable.
For program lands, such as
Conservation Reserve Program,
consult program rules to determine
whether grass or hay may be used.
The more restrictive requirements of
the program rules or this label must
be followed.
See Label Changes Summary Table
in 2,4-D RED
See Label Changes Summary Table
in 2,4-D RED
Page 162 of 304
-------
Use Site
Non-
Cropland
(fenecrows,
hedgerows,
roadsides,
ditches,
rights-of-
way, utility
power lines,
Fell ironic! s ;
airports, and
industrial
sites)
Nut
Orchards
Formulation
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate -
solid, Granular
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Max.
Single
App,
Rate
Postemerg
ence
(annual
and
perennial
plants): 2
Postemerg
ence
(woody
plants): 4
2.0
Unit
Ibs ae/acre
Lbs ae/acre
Max. #
App. Per
Crop
Cycle/Yea
r
Postemergen
ce (annual
and
perennial
plants): 2
Postemergen
ce (woody
plants): 1
2 per year
Max. App.
Rate Per
Crop
Cycle/Year
4.0 Ibs
ae/acre
4.0 Ibs
ae/acre per
year
Min.
Retreatm
ent
Interval
(days)
Postemerg
ence
(annual
and
perennial
plants): 30
days
Postemerg
ence
(woody
plants):
NA
30
Reentry
Interval (REI)
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
2,4-D acid and
amines - 48
hours;
2,4-D salt - 12
hours
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
NA
NS
Restrictions/Comments
Applications to non-cropland areas
are not applicable to treatment of
commercial timber or other plants
being grown for sale or other
commercial use, or for commercial
seed production, or for research
purposes.
See Label Changes Summary Table
in 2,4-D RED.
Do not cut forage for hay within 7
days of application.
See Label Changes Summary Table
in 2,4-D RED.
Page 163 of 304
-------
Use Site
Pasture and
Rangeland
(established
grass
pastures,
rangeland,
and
perennial
grasslands
not in
agricultural
production)
Pome fruits
Formulation
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Max.
Single
App,
Rate
Susceptibl
e annual
and
biennial
broadleaf
weeds: 1.0
Moderate!
y
susceptibi
e biennial
and
perennial
broadleaf
weeus. i .u
to 2.0
Difficult
to control
weeds and
woody
plants: 2.0
Spot
treatment:
2.0
2.0
Unit
Lbs ae/acre
Lbs ae/acre
Max. #
App. Per
Crop
Cycle/Yea
r
2 per year
2 per crop
cycle
Max. App.
Rate Per
Crop
Cycle/Year
4.0 Ibs
ae/acre
4.0 Ibs
ae/acre
Min.
Retreatm
ent
Interval
(days)
30
75
Reentry
Interval (REI)
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
2,4-D acid and
amines - 48
hours;
2,4-D salt - 12
hours
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
PHI - 14 days
Restrictions/Comments
Do not forage for hay within 7 days
of application.
For program lands, such as
Conservation Reserve Program,
consult program rules to determine
whether grass or hay may be used.
The more restrictive requirements of
the program rules or this label must
be followed.
If grass is to be cut for hay,
Agricultural Use Requirements for
the Worker Protection Standard are
applicable.
See Label Changes Summary Table
in 2,4-D RED.
Do not cut orchard floor forage for
hay within 7 days of application.
See Label Changes Summary Table
in 2,4-D RED.
Page 164 of 304
-------
Use Site
Potatoes
Rice
Rice, wild
Formulation
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Max.
Single
App,
Rate
0.07
Preplant:
1.0
Postemerg
ence:
1.5
0.25
Unit
Lbs ae/acre
Lbs ae/acre
Lbs ae/acre
Max. #
App. Per
Crop
Cycle/Yea
r
2 per crop
cycle
Preplant: 1
per crop
cycle
Postemergen
ce: 1 per
crop cycle
1 per crop
cycle
Max. App.
Rate Per
Crop
Cycle/Year
0.14 per crop
cycle
1.5 Ibs
ae/acre per
crop cycle
0.25 Ibs
ae/acre per
crop cycle
Min.
Retreatm
ent
Interval
(days)
10
NA
NA
Reentry
Interval (REI)
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
2,4-D acid and
amines - 48
hours;
2,4-D salt - 12
hours
2,4-D acid and
amines - 48
hours;
2,4-D salt - 12
hours
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
PHI - 45 days
PHI - 60 days
PHI - 60 days
Restrictions/Comments
Only for use on potatoes intended for
fresh market.
See Label Changes Summary Table
in 2,4-D RED.
See Label Changes Summary Table
in 2,4-D RED.
For use in Minnesota only.
See Label Changes Summary Table
in 2,4-D RED.
Page 165 of 304
-------
Use Site
Sorghum
Soybean
Formulation
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Max.
Single
App,
Rate
Postemerg
ence
(acid,
salts, and
amines):
1.0
Postemerg
ence
(esters):
0.5
1.0
Unit
Lbs ae/acre
Lbs ae/acre
Max. #
App. Per
Crop
Cycle/Yea
r
1 per crop
cycle
1 app. of 1.0
Ibs ae/acre
per crop
cycle
OR
2 apps. Of
0.5 Ibs
ae/acre per
crop cycle
Max. App.
Rate Per
Crop
Cycle/Year
Postemergen
ce (acid,
salts, and
amines): 1.0
Ibs ae/acre
per crop
cycle
Postemergen
ce (esters):
0.5 Ibs
ae/acre per
crop cycle
1.0 Ibs
ae/acre per
crop cycle
Min.
Retreatm
ent
Interval
(days)
NA
NS
Reentry
Interval (REI)
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
PHI - 30 days
_
Restrictions/Comments
Do not permit meat or dairy animals
to consume treated crop as fodder or
forage for 30 days following
application.
See Label Changes Summary Table
in 2,4-D RED.
0.5 Ibs ae/acre rate:
>Esters: Apply not less than 7 days
prior to planting soybeans.
>Amines, acid, salts: Apply not less
than 15 days prior to planting
soybeans.
1.0 Ib ae/acre rate:
>Esters: Apply not less than 15 days
prior to planting soybeans.
>Amines, acid, salts: Apply not less
than 30 days prior to planting
soybeans.
See Label Changes Summary Table
in 2,4-D RED.
Page 166 of 304
-------
Use Site
Stone fruits
Strawberry
Sugarcane
Formulation
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate - solid
Max.
Single
App,
Rate
2.0
1.5
Preemerge
nee: 2.0
Postemerg
ence: 2.0
Unit
Lbs ae/acre
Lbs ae/acre
Lbs ae/acre
Max. #
App. Per
Crop
Cycle/Yea
r
2
1
Preemergenc
e: 1
Postemergen
ce: 1
Max. App.
Rate Per
Crop
Cycle/Year
4.0 Ibs
ae/acre per
crop cycle
1.5 Ibs
ae/acre per
cop cycle
4 Ibs ae/acre
per crop
cycle
Min.
Retreatm
ent
Interval
(days)
75
NA
NS
Reentry
Interval (REI)
2,4-D acid and
amines - 48
hours;
2,4-D salt - 12
hours
2,4-D acid and
amines - 48
hours;
2,4-D salt - 12
hours
2,4-D acid and
amines - 48
hours;
2,4-D salt - 12
hours
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
PHI - 40 days
-
_
Restrictions/Comments
Do not cut orchard floor forage for
hay within 7 days of application.
See Label Changes Summary Table
in 2,4-D RED.
Do not apply in California or Florida.
Apply in dormant stage or after last
picking.
See Label Changes Summary Table
in 2,4-D RED.
Do not harvest cane prior to crop
maturity.
See Label Changes Summary Table
in 2,4-D RED.
Page 167 of 304
-------
Use Site
Turf,
ornamental
(golf
courses,
cemetaries,
parks, sports
fields,
turfgrass,
lawns, and
other grass
areas)
Turf, grown
for seed or
sod
Formulation
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate -
solid, Granular
Wettable powder,
Emulsifiable
concentrate,
Soluble
concentrate -
liquid, Soluble
concentrate -
solid, Granular
Max.
Single
App,
Rate
1.5
2.0
Unit
Lbs ae/acre
Lbs ae/acre
Max. #
App. Per
Crop
Cycle/Yea
r
2
2
Max. App.
Rate Per
Crop
Cycle/Year
3.0 Ibs
ae/acre per
year,
excluding
spot
treatments
4.0 Ibs
ae/acre per
crop cycle
Min.
Retreatm
ent
Interval
(days)
NS
21
Reentry
Interval (REI)
NS
2,4-D acid and
amines - 48
hours;
2,4-D salt and
esters - 12 hours
Preharvest
Interval (PHI)
Pre grazing
Interval (PGI)
Preslaughtering
Interval (PSI)
_
_
Restrictions/Comments
See Label Changes Summary Table
in 2,4-D RED.
See Label Changes Summary Table
in 2,4-D RED.
Page 168 of 304
-------
Appendix B. Data Supporting Guideline Requirements for the Reregistration of 2,4-D
Page 169 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
Use Patterns
crrATioN(S)
PRODUCT CHEMISTRY
New
Guideline
Number
830.1550
830.1600
830.1620
Old
Guideline
Number
61-1
61-2A
61-2B
Product Identity and Composition
Description of materials used to
produce the product
Description of production process
All
All
41219701, 41223801, 41926201, 43516401, 43516402,
43981801, 40808301, 41219601, 41055804, 41055805,
41220101, 41973501, 41055801, 41055802, 41220101,
41973501, 41067001, 41203301, 41123601, 41055809,
41055810, 41964401, 41055815, 41055816, 41978001,
44807001, 41055818, 41055819, 41055812, 41055813,
41961301, 41055806, 41055807, 41968301, 41015001,
42188601, 42786501, 40443301, 41224201
41223801, 41637501, 41790601, 44149301, 44547901,
43516401, 40808301, 41246701, 41681901, 41796201,
41055804, 41496701, 41055801, 41496701, 41973501,
41067001, 41599401, 42537501, 44184201, 41055809,
41055815, 41055818, 41055812, 44584501, 44963803,
41055806, 44982101, 41015001, 42188601, 41376701,
40443301, 41224201
41223801, 41790601, 44149301, 44547901, 43516401,
40808301, 41246701, 41796201, 41496701, 41055801,
41973501, 41067001, 41599401, 41789901, 42537501,
44184201, 41055809, 41055815, 44727101, 44807001,
41055818, 44228301, 41055812, 44584501, 44963803,
41055806, 44982101, 41015001, 42188601, 41376701,
40443301, 41224201
Page 170 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
830.1670
830.1700
830.1750
61-2B
62-1
62-2
Formation of Impurities
Preliminary Analysis
Certification of limits
Use Patterns
All
All
All
crrATioN(S)
41223801, 41790601, 44149301, 44547901, 43516401,
40808301, 41246701, 41496701, 41055801, 41973501,
41067001, 41599401, 41789901, 41789902, 41 123601,
42537501, 44184201, 41055809, 41964401, 42798101,
41055815, 41978001, 42798301, 44727101, 44807001,
41055818, 42798201, 44228301, 41055812, 41961301,
44584501, 44963803, 41055806, 41968301, 44982101,
41015001, 42188601, 42786501, 40443301
41219701, 41926201, 41790602, 44149302, 44543502,
44543503, 44932701, 43516401, 43516402, 43981801,
40808301, 41724201, 41724202, 41349001, 41796201,
41796202, 41219601, 41796202, 41055805, 41220101,
41496701, 41973501, 43777501, 44287101, 41055802,
41220101, 41496701, 41973501, 43777502, 44228601,
41067001, 41203301, 41735701, 41123601, 41055810,
41964401, 43314701, 41055816, 41055819, 44620501,
41055813, 44963801, 41349002, 41724201, 41724203,
41055807, 45014801, 41015002, 42188601, 40443301,
41206901
41219701, 41223801, 41926201, 43516401, 43516402,
43981801, 40808301, 41219601, 41055804, 41055805,
41220101, 41496701, 41973501, 41055801, 41055802,
41220101, 41496701, 41973501, 41067001, 41203301,
41599401, 41123601, 41055809, 41055810, 41964401,
41055815, 41055816, 41978001, 44807001, 41055818,
41055819, 41055812, 41055813, 41961301, 44963804,
41055806, 41055807, 41968301, 41015001, 42188601,
40443301, 41206901
Page 171 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
830.1800
830.6302
830.6303
830.6304
830.6313
830.6314
62-3
63-2
63-3
63-4
63-13
Analytical Method
Color
Physical State
Odor
Stability to normal and elevated
temperatures, metals, and metal ions
Oxidation/Reduction: Chemical
Incompatibility
Use Patterns
All
All
All
All
All
All
crrATioN(S)
41219701, 41223801, 41637501, 41926201, 44543502,
44543503, 43516401, 43516402, 43981801, 40808301,
41219601, 41796202, 41055802, 41220101, 41496701,
41055802, 41220101, 41496701, 41067001, 41203301,
41599401, 41789902, 41 123601, 41055810, 41055816,
41055819, 41055813, 449638034, 44963804, 41055807,
44982102, 41015002, 42188601, 42786501, 40443301,
41206901
41223801, 44543504, 43516403, 43516404, 40808301,
41055803, 41067001, 41123601, 42857203, 41055811,
41055817, 41055820, 41055814, 44963802, 41055808,
41015003, 40443301, 41224201
41223801, 44543504, 43516403, 43516404, 40808301,
41055803, 41067001, 41123601, 42857203, 41055811,
41055817, 41055820, 41055814, 44963802, 41055808,
41015003, 40443301, 41224201
41223801, 44543504, 43516403, 43516404, 40808301,
41055803, 41067001, 41123601, 42857203, 41055811,
41055817, 41055820, 41055814, 44963802, 41055808,
41015003, 40443301, 41224201
41223801, 41745301, 42023601, 44543504, 41055803,
41855701, 42023601, 42795401, 43516403, 43516404,
40808301, 41055803, 41855701, 42023601, 42795401,
41055803, 42795401, 41973502, 41067001, 41855701,
42857209, 41978002, 42487901, 41968303, 44963802,
41015003, 42116702, 42786501, 40443301, 41224201
42023601, 43516403, 43516404, 40808301, 41973501,
41067001, 4105581 1, 41055817, 41055820, 41055814,
41968303, 44963802, 41055808, 40443301, 41224201
Page 172 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
830.6315
830.6316
830.6317
830.6319
830.6320
830.7000
830.7050
830.7100
830.7200
830.7220
63-12
None
63-5
63-6
Flammability
Explodability
Storage stability
Miscibility
Corrosion characteristics
PH
TJV/Visable Absorption
Viscosity
Melting Point
Boiling Point
Use Patterns
All
All
All
All
All
All
All
All
All
crrATioN(S)
4105581 1, 41055817, 41055820, 41055814, 41055808,
41015003, 40443301, 41224201
41745302, 43516403, 43516404, 40808301, 41973501,
41067001, 42537501, 4105581 1, 41055817, 41055820,
41055814, 41055808, 41015003, 40443301, 41224201
41745301, 41926203, 43516403, 43516404, 40808301,
43260501, 41067001, 41123601, 42227501, 41055811,
45642701, 41055817, 43874601, 41055820, 41055814,
41055808, 41015003, 42786501, 40443301, 41224201
40443301, 41224201
42023601, 43516403, 43516404, 40808301, 43260501,
41973501, 41067001, 41123601, 42227501, 41055811,
45642701, 41055817, 41055820, 41055814, 41055808,
41015003, 40443301, 41224201
41926202, 44543504, 43516403, 43516404, 40808301,
41 123601, 42857208, 4105581 1, 41055817, 41055820,
41015003, 40443301, 41224201
44543504, Datagap
4105581 1, 41055817, 41055820, 41055814, 41055808,
41015003, 40443301, 41224201
41223801, 44543504, 41055803, 41067001, 41223801,
43516403, 43516404, 40808301, 41055803, 41067001,
42537501, 42857209, 42829901, 42831001, 43325003,
43325001, 42830901, 43325001, 44963802, 43325002,
44963802, 42831 101, 41015003, 40443301, 41224201
Page 173 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
830.7300
830.7370
830 7550
830.7840
830.7950
63-7
63-10
63-11
63-8
63-9
Density
Dissociation constants in water
Partition coefficient, shake flask
method
Solubility
Vapor Pressure
Use Patterns
All
All
All
All
All
crrATioN(S)
41223801, 44543504, 43516403, 43516404, 40808301,
41055803, 41973501, 41067001, 41855701, 41 123601,
42857204, 41055811, 41055817, 41055820, 41055814,
44963802, 41055808, 41015003, 40443301, 41224201
41223801, 41308901, 44543504, 41055803, 41067001,
41972501, 44543504, 43516403, 43516404, 40808301,
41055803, 41067001, 41332009, 41015003, 41224201
41332004, 44543504, 41332004, 43516403, 43516404,
40808301, 41055803, 41067001, 42537501, 42857207,
41647001, 44963802, 41055808, 44963802, 41055808,
41015003, 42116702, 40443301, 41224201
41223801, 42023601, 41332002, 44543504, 45692501,
41055803, 45692501, 43516403, 43516404, 40808301,
45692501, 41055803, 41067001, 41332002, 41880601,
42537501, 42857205, 43358801, 41055811, 42021002,
41978001, 43358802, 41669501, 42830901, 42831101,
44963802, 41055808, 41968302, 41015003, 42116702 3,
42786501, 43302001, 40443301, 41224201
41223801, 44543504, 41055803, 41067001, 44543504,
43516403, 43516404, 40808301, 41055803, 41067001,
42537501, 42857206, 42021001, 41431 101, 41431301,
44963802, 41055808, 44963802, 41055808, 41015003,
40443301, 41224201
ECOLOGICAL FATE AND EFFECTS
835.2120
835.2240
835.2410
161-1
161-2
161-3
Hydrolysis
Photodegradation in Water
Photodegradation on Soil
A,B
A,B
A,B
410073-01,413537-01,414831-01,413496-01
427354-01, 427705-02, 427705-01
434412-01,
41 1253-06, 414831-02, 427497-02
411253-05,427497-02
Page 174 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
835.2370
835.4100
835.4200
835.4400
835.4300
835.1230
835.1410
835.8100
835.6100
835.6200
835.6300
840.1100
840.1200
850.2100
161-4
162-1
162-2
162-3
162-4
163-1
163-2
163-3
164-1
164-2
164-3
201-1
202-1
71-1A
Photodegradation in Air
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching-Adsorption/Desorption
Laboratory Volatility
Field Volatility
Terrestrial Field Dissipation
Aquatic Field Dissipation
Forestry Dissipation
Droplet Size Spectrum
Drift Field Evaluation
Avian Acute Oral Toxicity
Use Patterns
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
CITATION(S)
414831-03
431675-01, 437991-01, 431496-01, 434159-01, 436859-01,
437991-02,438215-01
433560-01,434159-01,
415579-01,433560-01,425747-01,437991-03,436063-01,
438829-01, 439083-01, 437991-05, 437991-04
420453-01, 429792-01, 441886-01, 437991-06, 431496-01,
436910-01, 436859-02, 444394-01, 437796-01, 437991-08,
437991-07
420253-02, 441179-01, 441585-01, 441052-01, Datgap
417180-01, 420596-01, Datagap
435146-01, 435334-01, 435428-01, 436406-01, 437052-02,
437624-04, 437624-03, 437624-01, 438317-02, 438317-01,
438491-02, 438640-01, 439147-01, 438727-03, 437634-02
446031-01, 434704-01, 436697-02, 435003-01, 436697-01,
435928-02, 436121-01, 436768-03, 437052-01, 437979-02,
438107-01, 438317-03, 438343-01, 438491-01, 438640-02,
438727-02, 438727-01, 438724-01, 446031-02, Datagap
445250-01,439083-02,439547-01,434916-01,458971-01,
439083-02, 439547-01, Datagap
439083-03,439271-01, 439547-02, Datagap
Datagap
Datagap
415462-02, 419751-01, 415462-01, 233351, 00138871, 416444-01,
414541-01, 41 1583-03, 72472, 226397, 439350-01
Page 175 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
850.2200
850.2300
850.1075
850.1010
850.1075
850.1025
850.1035
850.1045
850.1300
850.1350
850.1400
850.1500
850.4100
71-2A
71-2B
71-4A
71-4B
72-1
72-2A
72-3A
72-3B
72-3C
72-3
72-4A
72-4B
72-4C
72-5
122-1A
Avian Dietary Toxicity
Avian Reproduction
Fish Toxicity Bluegill
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity - Mollusk
Estuarine/Marine Toxicity - Shrimp
Estuarine/Marine Toxicity - Penaid
Fish Early Life Stage - Daphnid
Estuarine/Marine Invertebrate Life
Cycle
Freshwater Fish- Acute Toxicity
Life Cycle Fish
Terrestrial Plant Toxicity, Seedling
Emergence
Use Patterns
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
CITATION(S)
415861-01, 415462-02, 419751-02, 419751-03, 417495-01,
233351, 417495-02, 00138870, 00138872, 416444-02, 416444-03,
414484-01, 414290-07, 41 1583-05, 45070, 41 1583-04, 226397,
439349-01,439352-01
453364-01
411583-01, 53986, 419751-05, 419751-04, 0073-091-01, 233350,
411583-11,419751-04,234027,419751-04,01338869,413538-03,
413538-04, 413538-01, 00050674, 00053988, 417373-03, 45068,
45069, 439331-01, 439332-01, 439307-01
439103-01, Datagap
41 1583-01, 419751-06, 232630, 413538-03, 413538-01, 67328
429797-01, 417373-06, 420183-02, 419751-07, 411583-10,
419734-01, 41 1583-1 1, 418252-08, 232630, 414290-03, 414290-02,
414290-06,411583-10,418352-04,418352-01,411583-11,
418352-06,418352-03
429797-01, 420183-02, 41 1583-1 1, 419734-01, 414290-03,
414290-06,411583-10,418352-04, 418352-01, Datagap
417373-06, 419751-07, 41 1583-1 1, 419252-08, 232630, 414290-02,
414290-05, 418352-06, 418352-03, Datagap
Datagap
417373-04, 420183-04, 417677-01
418352-11,420183-03,418352-10,413583-02
413457-01,417373-05
Page 176 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
850.5400
850.4225
850.4250
850.4400
850.3020
122-2
123-1A
123-1B
123-2
141-1
Aquatic Plant Growth
Seedling Germination and Seedling
Emergence
Vegetative Vigor
Aquatic Plant Growth
Honey Bee Acute Contact
Use Patterns
A,B
A,B
A,B
A,B
A,B
crrATioN(S)
424168-02, 426091-1, 442756-01, 430167-02, 423895-01, 431970-
03, 431970-02, 431970-01, 424492-01, 439821-01, Datagap
424168-01, 426091-02, 423439-02, 437882-01, 426693-04,
43982 1-01, Datagap
442951-01, 427122-04, 427122-05, 427122-01, 427122-02,
427122-03, 415059-04, 414200-02, 415059-01, 415059-03,
415059-02, 417321-02, 434886-02, 417321-01, 434886-03,
434886-04, 434886-01, 420684-04, 417321-02, 420684-04,
420684-03, 417352-03, 417352-06, 417352-04, 417352-05,
417352-02
445173-04,445173-01
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit/Rat
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
Subchronic Oral Toxicity: 90-Day
Study Rodent
A,B
A,B
A,B
A,B
A,B
A,B
A,B
00101605, 41920901, 00157512, 00252291, 41709901, 41413501,
40629801,41209001
00101596, 4192091 1, 00157513, 00252291, 41709902, 41413502,
40629802,41209002
00161660, 41986601, 00157514, 40085501, 40352701, 41957601,
40629803, 42605202
41 125302, 41920902, 00157515, 00252291, 40352702, 41413504,
40629804, 44725303
42232701, 41920903, 00157516, 00252291, 40352703, 41413505,
40629805,41413505
00161659, 41920904, 41642805, 41233701, 40352704, 41413506,
40629806,41209006
41991501, 41928101, 41994001, 41896701, 41896702, 42021401,
43515901,42021402
Page 177 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
870.3150
870.3200
870.3465
870.4100
870.3700
870.3700
870.3800
870.4300
870.4200
870.5265
870.5300
870.5375
870.5385
870.5395
82-1B
82-2
82-4
83-1B
83-3A
83-3B
83-4
83-5
83-2B
84-2
84-2
84-2
84-2B
84-2
Subchronic Oral Toxicity: 90-Day
Study Non-rodent
21-Day Dermal - Rabbit/Rat
90-Day Inhalation-Rat
Chronic Feeding Toxicity
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Combined Chronic Toxicity/
Carcinogenicity: Rats
Carcinogenicity Mice
Gene Mutation
In vitro Mammalian Cell Gene
Mutation Test
In vitro Chromosome Aberration
In vivo chromosome aberration
Micronucleus Assay
Use Patterns
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
CITATION(S)
41737301, 42780001, 42780003, 43515501, 42780002
41735304, 41735301, 41407901, 41920905, 41735303,41735306,
41735302, 41735305, 41407903, 41407902
Datagap
43612001,430490001
00130407, 00130408, 41527101, 41527104, 41920906, 41986602,
41735201, 42304601, 42304602, 43523101, 43523001, 41527103;
41527106, 41527102; 41527105
41747601, 42158703, 42158706, 42055501, 42013501, 42224001,
42304603, 42304604, 42158702; 42158704, 42158701, 42158705
00150557, 00163996, Repeat Study Required
43879801,43597201
43612001
41409801, 41388204, 41797903, 41409802, 41409803,
41388203, 41797902, 42015701, 43935101, 41388202,
41797901
43394201, 43327304, 43327302
43327305, 43327303, 43327301
Mustonen, etal, 41478301, 42015704, 42015701, 42015707,
41409805, 41870102, 41409806, 41870103, 41478303,
42015701, 42015703, 42015706, 43930801, 41478302,
42015701, 42015702, 42015705
41409804, 41870101
Page 178 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
870.5450
870.6200
870.6300
870.7485
870.7600
84-2
81-8, 82-7,
83-1
83-6
85-1
85-3
Rodent Dominant Lethal Assay
Neurotoxicity Screening Battery
Developmental Neurotoxicity
General Metabolism
Dermal Penetration and Absorption
Use Patterns
A,B
A,B
A,B
A,B
A,B
crrATioN(S)
41409807, 41498101, 41409808, 41409809, 41498103,
43930501, 41498102
43115201,43293901
Datagap
41737302
Feldman. R. I And Maibach, H. I. (1974)
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.1100
875.1300
875.2200
231
232
132-lb
Estimation of Dermal Exposure at
Outdoor Sites
Estimation of Inhalation Exposure at
Outdoor Sites
Soil Residue Dissipation
A,B
A,B
A,B
449722-01, 444598-01
449722-01,444598-01
446557-01,446557-04,
446557-03,450331-01
RESIDUE CHEMISTRY
860.1200
860.1300
860.1300
171-4A
171-4B
Directions for Use
Plant Metabolism
Livestock Metabolism
A,B
A,B
A,B
Datagap
00004666, 00004667, 00004669, 00004675, 00004676,
00004677, 00004680, 00004681, 00004682, 00004683,
00004689, 00004693, 00004698, 00004699, 00004715,
00004723, 00004960, 00004996, 00074214, 00074215,
00074216, 00074217, 00102675, 00102676, 00102679
00102717, 00123973, Blacktop and Linscott. (1968),
Feung, etal. (1972), 41991503, 42423101, 42439701
42615601, 43290501, 43496101
00004705, 00068891, 42605201, 42749701, 43160201
Page 179 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
860.1340
860.1340
860.1340
860.1380
860.1380
860.1380
860.1400
171-4C
171-4C
171-4C
17ME
171-4E
17ME
171-4F
Residue Analytical Method - Plant
commodities
Residue Analytical Method - Livestock
commodities
Residue Analytical Method - Water
Storage Stability - Plant commodities
Storage Stability - Livestock
commodities
Storage Stability - Water
Water, Fish, and Irrigated Crops -
Irrigated Crops
Use Patterns
A,B
A,B
A,B
A,B
A,B
A,B
A,B
crrATioN(S)
00004720, 00033119, 00036171, 00037169, 00042288,
00045364, 00045365, 00046125, 00059025, 00059026,
00059027, 00059033, 000601 13, 00060120, 00060870,
00060872, 00060880, 00061012, 00061014, 00061016,
00061017, 00061018, 00061645, 00074219, 00075198,
00075715, 00075716, 00075719, 00088176, 00102605,
00102710, 00102717, 00102719, 00102737, 00102815,
00102862, 00102865, 00109535, 00115499, 00115509,
00120057, 00121733, 00123269, 00126684, 00127273,
00133938, 00136845, 00138635, 0013951 1, 00139951,
00140092, 00156264, PP#6E2606 (1979), Aly and Faust
(1964), Bontoyan (1985), Freed (1948), 43289301,
43691101,43893701
00004701, 00004707, 00004719, 00037169, 00043759,
00055485, 00066156, 00068011, 00068892, 00068893,
00071787, 00078237, 00102713, 00102714, 00102760,
00102816, 00102821, 00115509, 00115515, 00120057
Otto et al (1982), 44016501, 44016502, Datagap
00035913, 001 15509, 0012171 1, 00136848, 00140032, Otto
et aid 982)
00136845, 00140092, 00145248, 43809901, 43870301,
43879901, 43879902, 43879903, 43879904, 43879905,
43886401, 43886402, 43886403, 43886404, 43886405,
43886406, 43943101, 43963801, 43963802, 44211901,
45245601
44024801,44967401
00035913,00139511
00052597, 00139511, Datagap
Page 180 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
860.1400
860.1400
860.1480
860.1480
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
171-4F
171-4F
171-4J
171-4J
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
Water, Fish, and Irrigated Crops -
Fish and Shellfish
Water, Fish, and Irrigated Crops -
Water
Meat, Milk, Poultry, Eggs - Milk and
the Fat, Meat, and Meat Byproducts of
Cattle, Goats, Hogs, Horses, and Sheep
Meat, Milk, Poultry, Eggs - Eggs and
the Fat, Meat, and Meat Byproducts of
Poultry
Crop Field Trials (Root and Tuber
Vegetables Group - Potatoes)
Crop Field Trials (Legume Vegetables
(Succulent or Dried) Group - Soybean
seed)
Crop Field Trials (Foliage of Legume
Vegetables Group - Soybean forage
and hay)
Crop Field Trials (Citrus -
Grapefruits, Lemons, Oranges)
Crop Field Trials (Pome Fruits Group
- Apples, Pears, Quinces)
Crop Field Trials (Stone Fruits Group
- Cherry, Peach, Plum/Fresh Prune)
Crop Field Trials (Berries Group -
Blueberries, Raspberries)
Use Patterns
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
CLTATION(S)
00028443, 00035913, 00043759, 00052597, 00102760,
00115741, 43378801, 44135201, 44577801
00035913, 00038429, 00052597, 00102788, 00115741,
00118549, 42968501, 42968502
00004701, 00004707, 00004719, 00059034, 00068892,
00068893, 00102714, 44024801
00102719
00060876, 00102814, 00102862, 00136845, 43886401
43356301, 43356302, 43356303, 43669801
43356301, 43356302, 43356303, 43669801
00102605, 43870303, 00102879, 00115509, 43870303,
45462201, 00042526, 00102605, 00102737, 00139059,
00163903, 43870303, 45462201, 45672201
00102824, 43943101, 00102824, 43886405
00088176, 43879902, 43879901, 43879903
00061010, 00061012, 43886403, 44268501, 40881401
Page 181 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
860.1500
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
171-4K
Crop Field Trials (Tree Nut Group -
Almond, Filbert, Pecan, Walnut)
Crop Field Trials (Cereal Grains
Group - Barley, grain; Corn, Held,
grain; Corn, sweet (K+CWHR);
Millet, grain; Oats, grain; Rice, grain;
Rice, wild, grain; Rye, grain;
Sorghum, grain; Wheat, grain)
Crop Field Trials (Forage, Fodder, and
Straw of Cereal Grains Group -
Barley, haw and straw; Corn, field,
forage, and stover; Corn, sweet, forage
and stover; Millet, forage, hay, and
straw; Oat, forage, hay, and straw;
Rice, straw; Rye, forage and straw;
Sorghum, forage and stover; Wheat,
forage, hay, and straw)
Crop Field Trials (Grass Forage,
Fodder, and Hay Group - Grass
(pastures and rangeland) forage and
hay)
Use Patterns
A,B
A,B
A,B
A,B
CITATION(S)
00088176, 44211901, 43963801, 43963802, 00115509
00004610, 00036168, 00036169, 00036171, 00036169,
00059025, 00059027, 00059029, 00060117, 00061010,
00021755, 00022329, 00025383, 00028385, 00030697,
43676801, 43686001, 43693702, 00102865, 43886406,
00025330, 00161 187, 00036169, 00059028, 00102816,
00004594, 00120057, 43747901, 43785901, 43853601,
00102719, 00102889, 00120057, 43697801, 43718001,
43718002, 00022622, 00036168, 00036170, 00036171,
00045369, 00046127, 00059029, 00060111, 00061010,
00078482, 00090361, 00127226, 00128778, 43665201,
43665202, 43676802, 43797901, 43797903, 44190301,
44190302, Datagap
00036168, 00036171, 00059025, 00059027, 00021755,
00022622, 00025383, 00028385, 00030697, 00073273,
00075715, 00075724, 00102865, 00127273, 00139511,
43676801, 43686001, 43693702, 00059028, 00120057,
43747901, 43785901, 00102719, 00102889, 00120057,
43697801, 43718001, 43718002, 00004485, 00028173,
00028200, 00042288, 00061010, 00063507, 00090360,
00102712, 00120057, 00138635, 00144791, 00147047,
43665201, 43665202, 43676802, 43797901, 43797903,
44190301, 44190302, Datagap
00004485, 00028173, 00028200, 00042288, 00061010,
00063507, 00090360, 00102712, 00120057, 00138635,
00144791, 00147047, 43592101, 43610801, 43610802,
43665203, 43665204, 43665205, 43779501, 43779502,
43779503, 43779504
Page 182 of 304
-------
Appendix B
Data Supporting Guideline Requirements for the Reregistration of 2,4-D
REQUIREMENT
860.1500
860.1520
860.1850
171-4K
171-4L
165-1
Crop Field Trials (Miscellaneous
Commodities - Asparagus; Aspirated
Grain Fractions; Cranberries; Grapes;
Hops; Pistachios; Strawberries;
Sugarcane)
Processed Food/Feed (Apples; Barley;
Citrus; Corn, Held; Grape; Oats;
Potato; Prunes; Rice; Rye; Sorghum;
Soybean; Sugarcane; Wheat)
Confined Rotational Crops
Use Patterns
A,B
A,B
A,B
CITATION(S)
00025338, 00060870, 43879905, 43693701, 43709701,
00061010, 00061012, 43886402, 00061012, 00102833,
43947901, 45245601, 45647101, 45665801, 45512701,
43879904, 00102717, 00102812, 43886404, 00030701,
00079738, 00102640, 00102794, 001 15793, 00127823,
43736101,43736102
43943101, 43870302, 43709701, 45245601, 45647101,
43879903, 43755402, 43709702, 00030701, 00068889,
43755401, 43693701
43356002
OTHER
840.1100
840.1200
201-1
202-1
Droplet Size Spectrum
Drift Field Deposition Evaluation
A,B
A,B
Reserved
Reserved
Page 183 of 304
-------
Appendix C. Technical Support Documents
Page 184 of 304
-------
Appendix C. TECHNICAL SUPPORT DOCUMENTS
Additional documentation in support of this RED is maintained in the OPP docket, located
in Room 119, Crystal Mall #2, 1801 South Bell Street, Arlington, VA. It is open Monday through
Friday, excluding legal holidays, from 8:30 am to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of
June 23, 2004. Sixty days later the first public comment period closed. The EPA then considered
comments, revised the risk assessment, and added the response to comments documents,
preliminary mitigation strategies, and the revised risk assessments to the docket on January 12,
2005. The second sixty day public comment period closed on March 14, 2005. The 2,4-D
Reregistration Eligibility Decision (RED), revised risk assessments, and response to comments
documents were made available in the summer of 2005.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded
or viewed via the Internet at the following site:
www. epa. gov/pesticides/reregistration
These documents include:
HED Documents:
1. 2,4-D. HED's Revised Human Health Risk Assessment for the Reregistration Eligibility
Decision (RED) Revised to Reflect Public Comments. PC Code 030001; DP Barcode D316597.
May 12, 2005.
2. 2,4-D. Revised Acute and Chronic Dietary Exposure Assessments Including Proposed
New Uses Hops and Potatoes for the Reregistration Eligibility Decision. April 18, 2005.
3. 2,4-D: 3rd Revised Occupational and Residential Exposure and Risk Assessment and
Response to Public Comments for the Registration Eligibility Decision (RED) Document (PC Code
030001, DP Barcode D316596). May 4, 2005.
4. 2,4-D: Response to Phase 5 Public Comments (PC Code 030001, DP Barcode D315562).
June 7, 2005.
5. 2,4-D. Revised Acute and Chronic Dietary Exposure Assessments for the Reregisration
Eligibility Decision. October 13, 2004.
6. 2,4-D: Health Effects Division (HED) Metabolism Assessment Review Committee
(MARC) Decision Document-Revised. DP Barcodes D309452 Chemical ID. No. 030001. Case No.
0073. Meeting date 9/3/03. October 13. 2004.
7. 2,4-D. Revisions to the Product and Residue Chemistry Chatpers of the Reregistration
Eligibility Decision; Reregistration Case no. 0073. Chemical I. D. No. 030001; DP Barcode No.
D309450 and D309451. October 12, 2004.
8. 2,4-D PC Code 030001, Case No. 0073 DP Barcode D309450 Reregistration Eligibility
Decision Revised Chemistry Considerations. October 12, 2004.
Page 185 of 304
-------
9. 2,4-D Case 0073 Reregistration Eligibility Decision: Revised Product Chemistry
Considerations (DP Barcode D309451). October 12, 2004.
10. 2,4-D - Phase 3 Toxicology Chapter Revision. December 9, 2004.
11. 2,4-D: Response to Public Comments [PC Code 030001, DP Barcode D307717].
December 16, 2004.
EFED Documents:
1. Revised Environmental Fate and Effects Division Revised Preliminary Risk Assessment
for the 2,4-Dichlorophenoxyacetic acid (2,4-D) Reregistration Eligibility Decision Document.
October 28, 2004.
2. Revised EFED Revised Preliminary Risk Assesssment for the 2,4-D Reregistration
Eligibility Document. October 28, 2004.
3. 2,4-D - Response to Public Comments on the Revised EFED Science Chapter for the
Reregistration Eligibility Decision Document. October 28, 2004.
4. 2,4-D - Response to Public Comments from the San Francisco Department of the
Environment on the EFED Science Chapter for the Reregistration Eligibility Decision Document.
November 1, 2004.
Page 186 of 304
-------
Appendix D. Citations Considered to be Part of the Data Base Supporting the Reregistration
Eligibility Decision (Bibliography) for 2,4-D
Page 187 of 304
-------
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prepared by Ricerca, Inc. 124 p.
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2,4-D Bibliography
42609101 Backus, P. (1992) Effect of 2,4-D DEAS on Seed Germination/Seedling
Emergence (Tier II): Lab Project Number: 5283-92-0155-BE-001: 92-0155.
Unpublished study prepared by Ricerca, Inc. 210 p.
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Appendix E. Generic Data Call-In
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Appendk E.
The generic data call-in will be posted at a later date.
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Appendix F. Product Specific Data Call-In
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Appendk F.
The product specific data call-in will be posted at a later date.
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Appendix G. EPA's Batching of 2,4-D Products for Meeting Acute Toxicity Data
Requirements for Reregistration
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Appendk G.
The batching of 2,4-D products for meeting acute toxicity data requirements for reregistration will be
posted at a later date.
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Appendix H. List of Registrants Sent This Data Call-In
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Appendk H.
A list of registrants sent this data call-in will be posted at a later date.
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Appendix I. List Of Available Related Documents And Electronically Available Forms
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Appendix I. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS
Pesticide Registration Forms are available at the following EPA internet site;
http: //www. epa. gov/opprdOO 1 /forms/
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled
out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing
policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing
Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551 or
by e-mail atwilliams.nicole@epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
Application for Pesticide
Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide
Product.
Application for an Experimental Use
Permit
Application for/Notification of State
Registration of a Pesticide To Meet a
Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data
Gap Procedures
Pesticide Registration Maintenance Fee
Filing_
Certification of Attempt to Enter into
an Agreement with other Registrants
for Development of Data
Certification with Respect to Citations
of Data (PR Notice 98-5)
http: //www. epa. aov/opprdOO 1 /forms/85 70- 1 . pdf
http://www.epa.ROv/opprd001/forms/8570-4.pdf
http://www.epa.gov/opprd001/forms/8570-5.pdf
http://www.epa.aov/opprd001/forms/8570-17.pdf
http://www.epa.gov/opprd001/forms/8570-25.pdf
http://www.epa.aov/opprd001/forms/8570-27.pdf
http://www.epa.aov/opprd001/forms/8570-28.pdf
http://www.epa.aov/opprd001/forms/8570-30.pdf
http://www.epa.aov/opprd001/forms/8570-32.pdf
http://www. epa. aov/opppmsd 1 /PR Notices/pr98-
5.pdf
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8570-35
8570-36
8570-37
Data Matrix (PR Notice 98-5)
Summary of the Physical/Chemical
Properties (PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (PR
Notice 98-1)
http://www. epa. gov/opppmsd 1 /PR Notices/pr98-
5.pdf
http://www. epa. gov/opppmsd 1 /PR Notices/pr98-
l.pdf
http://www. epa. gov/opppmsd 1 /PR Notices/pr98-
l.pdf
Pesticide Registration Kit
Dear Registrant:
www. epa. gov/pesticides/registrationkit/
For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection
Act(FQPA)of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
§95-2 Notifications, Non-notifications, and Minor Formulation Amendments
98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR Notices
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader).
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader).
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 1 $6, 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)
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Before submitting your application for registration, you may wish to consult some additional
sources of information. These include:
1. The Office of Pesticide Programs' website.
2. The booklet "General Information on Applying for Registration of Pesticides in the
United States", PB92-221811, available through the National Technical Information
Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service does
charge a fee for subscriptions and custom searches. You can contact NPIRS by
telephone at (765) 494-6614 or through their website.
4. The National Pesticide 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 website:
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; and
• Product Manager assignment.
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the
date of receipt and provide the EPA identifying file symbol or petition number for the
new submission. The identifying number should be used whenever you contact the
Agency concerning an application for registration, experimental use permit, or
tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly
coded and assigned to your company, please include a list of all synonyms, common
and trade names, company experimental codes, and other names which identify the
chemical (including "blind" codes used when a sample was submitted for testing by
commercial or academic facilities). Please provide a chemical abstract system (CAS)
number if one has been assigned.
Documents Associated with this RED
The following documents are part of the Administrative Record for this RED document and
may be included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person listed on the
respective Chemical Status Sheet.
1. Detailed Label Usage Information System (LUIS) Report.
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