Reregistration Eligibility
Decision (RED) for
Dichlorprop-p (2,4-DP-p)
August 29, 2007
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?/EPA
United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508P)
EPA 738-R-07-008
Reregistration
Eligibility Decision
for Dichlorprop-p
(2,4-DP-p)
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Reregistration Eligibility Decision (RED) for
Dichlorprop-p (2,4-DP-p)
List A
Case No. 0294
Approved by: ^
Date:
Steven Bradbury, PhD., Director
Special Review and Reregistration Division
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Table of Contents
Glossary of Terms and Abbreviations 4
I. Introduction 5
II. Chemical Overview 6
A. Regulatory History 6
B. Chemical Identification 7
C. Use Profile 8
D. Estimated Usage of Pesticide 10
III. Summary of 2,4-DP-p Risk Assessments 11
A. Human Health Risk Assessment 11
1. Toxicity of Dichlorprop-p 11
2. Residential and Non-Occupational Exposure and Risk 15
3. Aggregate Exposure and Risk 17
4. Occupational Exposures Assessment 18
5. Incident Reports 20
B. Environmental Risk Assessment 20
1. Environmental Fate and Transport 21
2. Ecological Exposure and Risk 21
IV. Risk Management and Reregistration Decision 35
A. Determination of Reregistration Eligibility 35
B. Public Comments and Responses 35
C. Risk Mitigation and Regulatory Position 35
1. Human Health Risk Management 36
2. Ecological Risk Management 37
D. Labeling Requirements 40
E. Import Tolerance 40
F. Endocrine Disruption 40
V. What Registrants Need to Do 42
A. Manufacturing Use Products 43
1. Additional Generic Data Requirements 43
2. Labeling for Manufacturing-Use Products 43
B. End-Use Products 44
1. Additional Product-Specific Data Requirements 44
2. Labeling for End-Use Products 44
C. Labeling Changes Summary Table 44
APPENDIX A. Use Patterns Eligible for Reregistration 53
APPENDIX B. Data Supporting Guideline Requirements for 2,4-DP-p 54
APPENDIX C. Technical Support Documents 58
APPENDIX D. Bibliography 59
APPENDIX E. Generic Data Call-in (GDCI) 68
APPENDIX F. Product-specific Data Call-in (PDCI) 69
APPENDIX G. EPA's Batching of 2,4-DP-p Products for Meeting Acute Toxicity Data.. 70
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EPA 2,4-DP-p Team
Ecological Fate and Effects Division
Marie Janson
Thuy Nguyen
James Lin
Health Effects Division
Paul Chin
Toiya Goodlow
Matthew Lloyd
Elizabeth Mendez
Debbie Smegal
Registration Division
Joanne Miller
Eugene Wilson
Special Review and Reregistration Division
Kevin Costello
Rosanna Louie
Patricia Moe
Biological Economics and Analysis Division
Jenna Carter
Steve Jarboe
Andrew Lee
Bill Phillips
Sunil Ratnayake
Elisa Rim
U.S. Department of Agriculture
Harold Coble
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Glossary of Terms and Abbreviations
ae Acid Equivalent
ai Active Ingredient
CFR Code of Federal Regulations
CSF Confidential Statement of Formula
DCI Data Call-In
ED WC Estimated Drinking Water Concentration
EEC Estimated Environmental Concentration
EPA Environmental Protection Agency
EUP End-Use Product
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
GENEEC Tier I Surface Water Computer Model (Estimated Aquatic Environmental Concentrations)
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected
to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or
volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of
the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as
a weight of substance per unit weight of animal, e.g., mg/kg.
LOC Level of Concern
LOAEL Lowest Observed Adverse Effect Level
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
MUP Manufacturing-Use Product
N/A Not Applicable
NOAEL No Observed Adverse Effect Level
OPP EPA Office of Pesticide Programs
ppb Parts per Billion
PPE Personal Protective Equipment
ppm Parts per Million
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RQ Risk Quotient
TGAI Technical Grade Active Ingredient
UV Ultraviolet
WP S Worker Protection Standard
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act calls for the development and submission of data to support the
reregistration of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency (referred to as EPA or "the Agency"). Reregistration involves
a thorough review of the scientific database underlying a pesticide's registration. The purpose of
the Agency's review is to reassess the potential risks arising from the currently registered uses of
the pesticide, to determine the need for additional data on health and environmental effects, and
to determine whether or not the pesticide meets the "no unreasonable adverse effects" criterion
of FIFRA.
This document summarizes EPA's human health and ecological risk assessments and
reregistration eligibility decision (RED) for dichlorprop-p (2,4-DP-p), in the form of 2,4-DP-p
acid, 2,4-DP-p dimethylamine salt (2,4-DP-p DMAS), and 2,4-DP-p EHE. Because it is
expected for these forms of 2,4-DP-p to quickly dissociate to the 2,4-DP-p acid, 2,4-DP-p will
represent the acid form throughout this document. The document consists of six sections.
Section I contains the regulatory framework for reregistration; Section II provides an overview
of the chemical and a profile of its use and usage; Section III gives an overview of the human
health and environmental effects risk assessments; Section IV presents the Agency's decision on
reregistration eligibility and risk management; and Section V summarizes the label changes
necessary to implement the risk mitigation measures outlined in Section IV. Finally, the
Appendices list related information, supporting documents, and studies evaluated for the
reregistration decision. The risk assessments for 2,4-DP-p and all other supporting documents
are available in the Office of Pesticide Programs (OPP) public docket at www.regulations.gov
under docket number EPA-HQ-OPP-2006-0944.
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II. Chemical Overview
A. Regulatory History
A Registration Standard Guidance Document was issued in December 1988 on
dichlorprop acid, its salts, and ester forms, which summarized the regulatory conclusions based
on available data, and specified the additional data required for reregi strati on purposes. The
dichlorprop case (0294) includes several forms of 2,4-DP-p, of which only three forms are being
supported for reregi strati on. The technical registrants, A.H. Marks and Company Limited,
NuFarm UK Limited, and NuFarm Americas Incorporated, formed the 2,4-DP-p Task Force to
produce data needed for the reregi strati on review of 2,4-DP-p.
Originally registered as an herbicide in the 1960s, the composition was a 50:50 ratio
mixture of the dextro and levo (or R and S, respectively) isomers of 2,4-DP. Subsequently, the
dextro isomer was identified as the herbicidally active isomer, but no economic route was
available to produce only the dextro isomer. In the 1980s, technologies were developed to
produce the single enriched isomer form, 2,4-DP-p, on a commercial scale, which achieved
approximately 93-95% purity of 2,4-DP-p. Thus, the 2,4-DP-p Task Force agreed to develop
data to fulfill guideline requirements for reregi strati on based on the enriched isomer, 2,4-DP-p.
Subsequently, data submissions have been received and evaluated since the Registration
Standard Guidance Document was published.
In 1996, the technical manufacturers began to obtain EPA registrations for technical 2,4-
DP-p. Gradually, some end-use product (EUP) registrants began converting their formulations
from the older racemic form to the single enriched isomer compositions. In September 2006, the
Agency presented options to EUP registrants producing formulations that contained the racemic
dichlorprop: 1) convert their product formulations to contain the enriched isomer, 2,4-DP-p; 2)
produce data supporting the racemic dichlorprop; or 3) submit voluntary cancellations for
products they no longer wish to support. As of January 2007, EPA received voluntary
cancellations or commitments to convert product formulations to the enriched isomer, 2,4-DP-p,
for all products. Most products have been reformulated to the enriched isomer formulation and
all reformulations are anticipated to be completed by the Fall of 2007. Table 1 lists all forms of
2,4-DP-p included as part of the case and identifies active ingredients the 2,4-DP-p Task Force is
supporting.
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Table 1. Summary of Dichlorprop Active Ingredients, Case No. 0294
PC Code
031401
031402
031403
031416
031419
031453
031463
031465
CAS#
120-36-5
15165-67-0
104786-87-0
84731-66-8
53404-32-3
53404-31-2
28631-35-8
865363-39-9
Name
Dichlorprop, 2,4-DP
Propanoic acid, 2-(2,4-
dichlorophenoxy)-, (R)-
Propanoic acid, 2-(2,4-
dichlorophenoxy)-, (R)-, compd.
with N-methylmethanamine (1:1)
2,4-DP, Diethanolamine salt
Dimethylamine 2-(2,4-
dichlorophenoxy)propionate
Butoxyethyl 2-(2,4-
dichlorophenoxy)propionate
Isooctyl 2-(2,4-
dichlorophenoxy)propionate
2-Ethylhexyl (R)-2-(2,4-
dichlorophenoxy)propionate
Task Force
Supported
No
Yes
Yes
No
No
No
No
Yes
Active
Registrations
No
Yes
Yes
No
Yes*
No
No
Yes
*This indicates that product labels are currently transitioning from 2,4-DP to 2,4-DP-p as the active ingredient.
On December 3, 1986, EPA issued preliminary notification for Special Review of 2,4-DP
because of its similarity to 2,4-D. At that time, there were concerns for possible epidemiological
links of 2,4-D, 2,4-DB, and 2,4-DP to non-Hodgkin's lymphoma from both occupational and
residential exposure. A proposed decision Not to Initiate Special Review was published on
March 23, 1988 (53 FR 990; FRL-3353-3) based on the findings that such a link is not supported
by the existing data. In 1992, a Science Advisory Board/Scientific Advisory Panel Special Joint
Committee 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." Subsequently, 2,4-D
was classified as a Group D, "not classifiable as to human carcinogenicity." EPA then requested
further histopathological examinations of mouse and rat tissue from previously conducted studies
and reviewed epidemiological studies in January 2004 and December 2004, which further
supported this classification. Thus, the Agency made a final decision not to initiate a Special
Review of 2,4-DP (August 8, 2007 Federal Register Notice titled "2,4-D, 2,4-DP, and 2,4-DB;
Decision Not to Initiate Special Review" [72 FR 44510-44511]).
B.
Chemical Identification
2,4-DP-p compounds are plant growth regulators that are part of the chlorophenoxy
group of herbicides. Chemical information and structures for technical 2,4-DP-p and its salts
that are being supported are presented in Table 2. Table 3 presents the specific physical
properties of 2,4-DP-p acid.
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Table 2. 2,4-DP-p Chemical Information and Structures
Compound Name
PC Code
CAS Number
Molecular
Weight
Structure
2,4-DP-p
031402
15165-67-0
235.1g/mol
2,4-DP-p DMAS
031403
104786-87-0
280.2 g/mol
H-C
CH-
2,4-DP-p EHE
031465
865363-39-9
347.3 g/mol
Table 3. Physical and Chemical Properties of 2,4-DP-p acid.
Parameter
Chemical Name
CAS Number
Empirical Formula
Molecular Weight
Appearance
Melting Point
Vapor pressure (20 °C)
Water Solubility (20 °C)
Value and Unit
2-(2,4-dichlorophenoxy) propionic acid
15165-67-0
C9H8C12O3
235.1 g/mole
White solid with a strong, naphthalene-like
odor
116-120°C
4.65xlO-7mmHgat20°C; 1.35x10-6 at
25 °C
729 mg/L at 20 °C; 864.8 mg/L at 25 °C
c.
Use Profile
Dichlorprop-p (2,4-DP-p) is a member of the chlorophenoxy class of herbicides. It is the
enriched isomer form (R isomer) and all technical product registrations now contain 93-95%
purity 2,4-DP-p as the active ingredient. At the present, the 2,4-DP-p Task Force is supporting
2,4-DP-p acid, 2,4-DP-p dimethylamine salt (2,4-DP-p DMAS), and 2,4-DP-p ethylhexyl ester
-------
(2,4-DP-p EHE). Henceforth, 2,4-DP-p will be used to represent all three forms unless otherwise
stated in this document.
Type of Pesticide:
Target Pests:
Mode of Action:
Use Sites:
Use Classification:
Formulation Types:
Application Methods:
Application Rates:
Application Timing:
Registrants:
Herbicide
Annual and perennial broadleaf weeds, brush.
2,4-DP-p is thought to increase cell-wall plasticity, biosynthesis of
proteins, and the production of ethylene. The abnormal increase in
these processes result in abnormal and excessive cell division and
growth, damaging vascular tissue. The most susceptible tissues are
those that are undergoing active cell division and growth.
Ornamental lawns, recreational turf, sports fields, sod farms,
roadsides, industrial sites, rights-of-way, and forests.
General Use
Acid- granular, emulsifiable concentrate, water-soluble
concentrate dry, wettable powder.
DMAS - granular, water-soluble concentrate liquid, water-soluble
concentrate dry.
EHE - emulsifiable concentrate, soluble concentrate,
Ready-to-Use solution.
Aerial (no longer supported by the 2,4-DP-p Task Force), boom
sprayers, handheld nozzle or wand sprayers, knapsack
sprayers, and granular spreaders.
Maximum application rate was 6.0 Ibs acid equivalent of
2,4-DP-p per acre (ae 2,4-DP-p/A), with a maximum of two
applications per year. The Task Force indicated that the
majority of use rates range from 0.20 - 0.75 Ib ae 2,4-DP-p/A.
Post-emergence, when weeds are young and actively growing.
A.H. Marks and Company Limited, NuFarm UK Limited, and
NuFarm Americas Incorporated.
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D. Estimated Usage of Pesticide
The majority of 2,4-DP-p is co-formulated with other chlorophenoxy herbicides for use
on residential lawns, with smaller usage in other recreational turf and other non-agricultural
grassy areas. Based on usage information provided by the 2,4-DP-p Task Force, total annual
domestic usage of 2,4-DP-p is approximately 4 million pounds: 60% is applied to residential turf,
8% is applied to sports turf, 9% is applied to golf courses, 8% is applied to commercial turf, 10%
is applied to sod farms, and 5% is applied to uncultivated non-agricultural land. According to
the Task Force, geographical use areas for applications to turf are in roughly the following
descending order: Midwest, Northeast, South, Northwest, and West.
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III. Summary of 2,4-DP-p Risk Assessments
The purpose of this summary is to assist the reader by identifying the key features and
findings of these risk assessments, and to help the reader better understand the conclusions
reached in the RED. The human health and ecological risk assessments and supporting
documents found in Appendix C were used to formulate the safety finding and regulatory
decision for the pesticidal use of dichlorprop-p and its related salts.
While the risk assessments and related addenda are not included in this document, they
are available in the OPP Public Docket, docket number EPA-HQ-OPP-2006-0944, and may be
accessed through the Agency's website at http://www.regulations.gov/. Hard copies of these
documents may also be found in the OPP public docket under this same docket number.
• 2-(2,4-dichlorophenoxy) R-propionic acid (2,4-DP-p), its salts and esters. HED
Human Health Risk Assessment. August 13, 2007.
• 2,4-DP-p: Occupational and Residential Exposure Assessment for the Reregistration
Eligibility Decision. April 3, 2007
• 2,4-DP-p: Refined Occupational and Residential Exposure Assessment of Granular
Products for the Reregistration eligibility Decision. August 7, 2007.
• FQPA Drinking Water Assessment for Dichlorprop-p. April 12, 2007.
• Environmental Fate and Effects Science Chapter for 2,4-DP-p acid, 2,4-DP-p DMAS,
and 2,4-DP-p EHE. August 24, 2007.
A. Human Health Risk Assessment
The human health risk assessment addressed potential risks from all registered sources.
Because 2,4-DP-p is not registered on any food commodity in the U.S., the Agency assessed
potential exposures via residues in drinking water, residential uses, and occupational
applications. For the complete human health risk assessment, refer to 2-(2,4-dichlororphenoxy)
R-propionic acid (2,4-DP-p), its salts and esters. HED Preliminary Human Health Risk
Assessment, August 13, 2007, which is available in the public docket.
1. Toxicity of Dichlorprop-p
The toxicology database for dichlorprop contains studies conducted with both the older
racemic 2,4-DP and enriched isomer 2,4-DP-p. The older toxicity studies used 2,4-DP, while the
newer toxicity studies were conducted with 2,4-DP-p. Available toxicity profiles comparing 2,4-
DP-p and the older racemic 2,4-DP showed no significant differences in toxicity between the two
isomeric forms. Degradation products of 2,4-DP-p include 2,4-dichlorophenol, 2,4-
dichloroanisole, and carbon dioxide, which are all common degradates to 2,4-D. 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. The database to assess potential human exposures to 2,4-
DP-p is complete and deemed adequate for evaluating hazard.
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EPA relied on available 2,4-DP and 2,4-DP-p toxicity studies that assessed acute,
subchronic and chronic toxicity, mutagenicity, multi-generation reproduction effects, and
developmental toxicity. Both 2,4-DP and 2,4-DP-p were tested in rat subchronic and
developmental toxicity studies, which indicated that 2,4-DP and 2,4-DP-p generally produced
similar toxicity at comparable dose levels in subchronic and developmental toxicity studies in
rats. A chronic feeding toxicity study conducted with 2,4-DP-p in rats was not available; thus,
the chronic feeding study with 2,4-DP is used as a bridging study. Therefore, the 2,4-DP-p
database, with a bridging chronic toxicity study with 2,4-DP, is adequate for selecting toxicity
endpoints for risk assessment.
As for the different forms of 2,4-DP-p (2,4-DP-p acid, 2,4-DP-p EHE and 2,4-DP-p
DMAS), there were no data to compare the relative toxicities. However, the rat metabolism
studies on 2,4-DP-p, 2,4-DP-p EHE and 2,4-DP-p DMAS showed similar pharmacokinetic
parameters between all compounds. These studies showed that both 2,4-DP-p EHE and 2,4-DP -
p DMAS were quantitatively converted to the 2,4-DP-p free acid and absorbed, distributed and
metabolized. Furthermore, an in vitro dissociation/degradation study conducted with 2,4-DP-p
EHE showed that all of the administered 2,4-DP-p EHE was converted to 2,4-DP-p. It was
concluded that in the in vivo environment, the ester form of 2,4-DP-p EHE is expected to
hydrolyze to the free acid 2,4-DP-p and be absorbed, distributed, and metabolized. 2,4-DP-p
DMAS is also expected to hydrolyze to the 2,4-DP-p acid form under in vivo conditions.
a. Toxicity Profile and Endpoint Selection
The available acute toxicity studies indicate that 2,4-DP-p EHE and DMAS are of
relatively low oral, dermal, and inhalation toxicity (Toxicity Categories III and IV). 2,4-DP-p is
a corrosive ocular irritant and is a Toxicity Category I for primary eye irritation. Available
dermal studies indicate that 2,4-DP-p was not a dermal sensitizer; however, 2,4-DP-p EHE and
2,4-DP-p DMAS were dermal sensitizers. Table 4 shows the acute toxicity profile of 2,4-DP-p.
Table 4. Acute Toxicity Profile for 2,4-DP-p acid, DMAS, and EHE.
Study Type
Acute Oral - rat
Acute Dermal -
rat
Acute Inhalation
-Rat
Primary Eye
Irritation - Rabbit
Primary Skin
Irritation - Rabbit
Dermal
Sensitization -
Guinea pig
2,4-DP-p
Results
567 mg/kg
LD50 >2,000
mg/kg
>2.7 mg/kg
A severe
eye irritant
A slight or
mild irritant
Not a skin
sensitizer
Toxicity
Category
III
III
IV
I
IV
N/A
2,4-DP-p DMAS
Results
637 mg/kg
>2,000 mg/kg
>5. 28 mg/kg
NA
NA
A skin
sensitizer
Toxicity
Category
III
III
IV
—
—
N/A
2,4-DP-p EHE
Results
825 mg/kg
>2,000 mg/kg
>4. 1 mg/kg
NA
NA
A skin
sensitizer
Toxicity
Category
III
III
IV
—
—
N/A
mg/kg = milligrams per kilogram
n/a = not applicable
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The Agency has classified 2,4-DP-p for potential carcinogenicity as "not likely to be
carcinogenic to humans." A 100X uncertainty factor (UF) is used to account for interspecies
extrapolation and intraspecies variability (10X and 10X, respectively). The reference doses used
in the human health risk assessment for 2,4-DP-p are listed in Table 5.
Table 5. Summary of Toxicological Doses and Endpoints for 2,4-DP-p.
Exposure Scenario
Acute Dietary
(All populations)
Chronic Dietary
(All populations)
Incidental Oral
(Short-term
1-30 days)
Incidental Oral
(Intermediate -term
1-6 months)
Dermal
(Short- (1-30 days)
and Intermediate-
term (1-6 months))
Inhalation
(Short-term
1-30 days)
Inhalation
(Intermediate -term
1-6 months)
Cancer
Point of Departure
Uncertainty Factor
RfD/Level of Concern
NOAEL = 5.1mg/kg/day
UF = 100
Acute RfD = 0.05 mg/kg/day
NOAEL = 3.6 mg/kg/day
UF = 100
Chronic RfD = 0.036 mg/kg/day
NOAEL = 5.1 mg/kg/day
UF = 100
LOG = 100
NOAEL = 3.6 mg/kg/day
UF = 100
LOG = 100
Study and Toxicological Effects
90-day oral toxicity study in dogs.
(MRID 43462601)
LOAEL =15.7 mg/kg/day based on frequent
diarrhea in 4/5 males and 2/5 females during
weeks 1-10.
2-year chronic toxicity study in rats.
(MRID 00 1463 94)
LOAEL =11 mg/kg/day based on decreases in
specific gravity and protein in urine.
90-day oral toxicity study in dogs.
(MRID 43462601)
LOAEL =15.7 mg/kg/day based on frequent
diarrhea in 4/5 males and 2/5 females during
weeks 1-10.
2-year chronic toxicity study in rats.
(MRID 00 1463 94)
LOAEL =11 mg/kg/day based on decreases in
specific gravity and protein in urine.
No dermal exposure quantification is required because no hazard was identified.
NOAEL = 5.1 mg/kg/day
UF = 100
LOG = 100
NOAEL = 3.6 mg/kg/day
UF = 100
LOG = 100
90-day oral toxicity study in dogs.
(MRID 43462601)
LOAEL =15.7 mg/kg/day based on frequent
diarrhea in 4/5 males and 2/5 females during
weeks 1-10.
2-year chronic toxicity study in rats.
(MRID 00 1463 94)
LOAEL =11 mg/kg/day based on decreases in
specific gravity and protein in urine.
Classification: "Not Likely to be Carcinogenic to Humans."
NOAEL = No Observed Adverse Effects Level
LOAEL = Lowest Observed Adverse Effects Level
UF = Uncertainty Factor
mg/kg/day = milligram per kilogram per day
MOE = Margin of Exposure
RfD = Reference Dose
LOG = Level of Concern
b. Dietary Exposure (Drinking Water Only)
EPA assessed potential exposure to 2,4-DP-p resulting only from drinking water
exposure, based on the quick and complete dissociation of 2,4-DP-p DMAS and the rapid
13
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hydrolysis of 2,4-DP-p EHE into 2,4-DP-p acid, DMAS, and EHE ions. Therefore, the drinking
water assessment for 2,4-DP-p DMAS and 2,4-DP-p EHE is represented by the acid. For more
detail on the toxicological database and Agency's drinking water determination, refer to the 2-
(2,4-dichlorophenoxy) R-propionic acid (2,4-DP-p), its salts and esters. HED Human Health
Risk Assessment, dated August 13, 2007, and the FQPA Drinking Water Assessment for
Dichlorprop-p (2,4-DP-p), dated April 12, 2007, which are available in the public docket.
Exposure to pesticides from drinking water can occur through surface and groundwater
contamination. All forms of 2,4-DP-p are soluble in water and mobile in terrestrial and aquatic
environments, giving it the potential to move in water and be transported in runoff from the
application site. The Agency considers potential risks from both acute (one-day) and chronic
(long-term) drinking water exposures and uses either modeling or actual monitoring data, if
available. To model potential runoff concentrations from applications of 2,4-DP-p, EPA used
the Tier II Pesticide Root Zone Model (PRZM), and Exposure Analysis Modeling System
(EXAMS) models. EPA has assessed potential acute and chronic dietary risk from exposure to
2,4-DP-p in only surface water sources using screening-level model estimates. Because the
estimated surface water residues are higher than those of groundwater, exposures to surface
water residues are presented here and are considered to be protective of potential exposure to
groundwater drinking sources.
Acute Drinking Water Assessment
The acute estimated drinking water concentration (EDWC) used to estimate 2,4-DP-p
residues in surface water sources of drinking water were determined using the Tier II
PRZM/EXAMS model. Conservative screening-level drinking water estimates were used in this
assessment (i.e., the highest peak surface water level for a one-in-ten year concentration);
therefore, the risk estimates were reported at the 95th percentile of exposure. The acute analysis
was performed incorporating the EDWC value of 40.22 parts per billion (ppb) for ground spray
applications to Christmas trees, because this application yielded the highest EDWC values. For
the U.S. population, the exposure was 0.002101 milligram per kilogram per day (mg/kg/day),
which utilized 4.1% of the acute reference dose (aRfD). The exposure for all infants, which was
the most highly exposed population subgroup, was 0.00792 mg/kg/day, which utilized 16.0% of
the aRfD at the 95th percentile of exposure. Thus, all potential acute exposures to 2,4-DP-p
residues in drinking water are below the Agency's Level of Concern (LOG). Table 6 shows
acute drinking water exposures and risks for all populations.
Chronic Drinking Water Assessment
The chronic EDWC used to estimate 2,4-DP-p residues in surface water sources of
drinking water was determined using the Tier II PRZM/EXAMS model. A chronic drinking
water analysis was performed based on the chronic EDWC value for Christmas trees, resulting in
a concentration of 2.69 ppb. For the U.S. population, the exposure was 0.000057 mg/kg/day,
which utilized <1% of the chronic reference dose (cRfD). The exposure for all infants, which
was the most highly exposed population subgroup, was 0.000186 mg/kg/day, which utilized <1%
of the cRfD. Thus, all potential chronic exposures to 2,4-DP-p residues in drinking water are
14
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below the Agency's LOG. Table 6 shows the chronic drinking water exposures and risks for all
populations.
Table 6. Summary of Acute and Chronic Drinking Water Exposure and Risk for 2,4-DP-p
Population
Subgroup Age
General U.S. Population
All Infants (<1 year)
Children 1-2 years
Children 3-5 years
Females 13-49 years
Acute Drinking Water
95th Percentile
aRfD
(mg/kg/day)
0.051
Dietary
Exposure
(mg/kg/day)
0.002101
0.007922
0.003297
0.003012
0.001958
%
aRfD
4.1
16
6.5
5.9
3.8
Chronic Drinking Water
cRfD
(mg/kg/day)
0.036
Dietary
Exposure
(mg/kg/day)
0.000057
0.000186
0.000084
0.000079
0.000053
%
cRfD
<1
<1
<1
<1
<1
aRfD = Acute Reference Dose
mg/kg/day = milligram per kilogram per day
cRfD = Chronic Reference Dose
2. Residential and Non-Occupational Exposure and Risk
Residential exposure assessments consider all potential non-occupational pesticide
exposure, other than exposure due to residues in drinking water. To estimate potential
exposures, EPA calculates a margin of exposure (MOE), which is then compared to a LOG to
measure potential risk. The LOG is the same value as the Uncertainty Factors (UF), to account
for interspecies extrapolation (10X) and intraspecies variability (10X), applied to a particular
toxicity study. For 2,4-DP-p, the target MOE is 100. Any MOE greater than the target MOE
would not pose any risks of concern to the Agency.
Homeowner exposures to 2,4-DP-p may result from outdoor residential applications to
lawns and other turf areas. Residential products are typically co-formulated with other
chlorophenoxy herbicides as dry weed and feed products or as liquid concentrates or Ready-to-
Use (RTU) sprays. Both spot and broadcast treatments are currently permitted homeowner
applications. Exposures are expected to be short-term in duration, as broadcast treatments are
only permitted twice per year, and any repeat spot treatments would occur two to three weeks
after the initial application. The majority of products are formulated and typically used at rates
ranging from 0.25 - 0.75 Ib ae 2,4-DP-p/A. The higher rates ranging from 2.0 - 6.0 Ibs ae 2,4-
DP-p/A registered for spot treatments (less than 1,000 ft2/A). Because of the small amount of
area treated and due to the specific and limited use pattern (i.e., woody plants or brush on non-
agricultural, uncultivated land), the residential handler and applicator scenarios are considered to
be protective of any exposure from spot treatment uses in the risk assessment.
The Agency has determined that there is a potential for exposures in residential settings
for those who handle (mix, load, and apply) products containing 2,4-DP-p, and for potential oral
and incidental ingestion exposures for toddlers playing on treated turf areas. Based on available
dermal exposure studies, no systemic toxicity occurred at the limit dose of 1,000 mg/kg/day.
Additionally, there is no evidence of developmental toxicity by dermal routes of exposure. Thus,
a dermal exposure assessment was not conducted. For specific details, refer to the 2,4-DP-p:
Occupational and Residential Exposure Assessment for the Reregistration Eligibility Decision,
15
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dated April 3, 2007, and 2,4-DP-p: Refined Occupational and Residential Exposure Assessment
of Granular Products for the Reregistration eligibility Decision, dated August 7, 2007.
a. Residential Handler Exposure and Risk Assessment
The Agency has determined that there is a potential for short-term (up to 30 days)
inhalation exposure in residential settings for those who handle (mix, load, and apply) products
containing 2,4-DP-p. Because products containing 2,4-DP-p are only applied once or twice a
year, with at least two to three weeks between applications for spot treatments, neither
intermediate- or long-term exposure is expected. Thus, only short-term inhalation exposure was
assessed. The maximum application rate assessed for residential handlers is 0.75 Ib ae 2,4-DP-
p/A, the highest typical rate that is used by homeowners. The target MOE for residential
handlers is 100 for short-term inhalation exposures. The MOEs for short-term residential
handler exposure for all scenarios are greater than the target LOG of 100 and are not of concern
to the Agency. Table 7 shows the MOEs for all residential handler exposure scenarios.
Table 7. 2,4-DP-p Short-term MOEs for Homeowner Applications to Lawns
Exposure Scenario
1 . Hand Application of Granules (spot treatment)
2. Belly Grinder Application (spot treatment)
3. Broadcast Spreader; Load/Apply Granules
4. Hose end sprayer; MLAP liquids (mix your own)
5. Hose end sprayer; MLAP liquids (Ready-to-Use)
6. Hand Held Pump Sprayer; MLAP liquids
7. Ready to Use Sprayer; MLAP liquids
Treated Area (acre/day)*
1,000 ft2
(0.023 acre)
0.5
0.5
0.5
1,000 ft2
(0.023 acre)
Inhalation
MOE
44,000
330,000
1,000,000
56,000
87,000
7,700,000
1,100,000
MLAP = mix/load/apply
* = highest typical application rate of 0.75 Ib ae 2,4-DP-p/A
MOE > 100 = no risk of concern
b. Residential Post-application (Turf) Exposure Assessment
After application of products containing 2,4-DP-p to turf, there is a potential for exposure
to toddlers playing on treated lawns and other recreational areas. Because there are no exposure
risks of concern resulting from dermal exposure, only short-term incidental oral exposure and
incidental granule ingestion exposure were assessed. The target MOE for residential post-
application exposure is 100.
Short-term Incidental Oral Exposure Assessment
Children, namely toddlers, can be exposed to 2,4-DP-p while playing on treated lawns.
EPA assessed various oral ingestion exposure scenarios that would occur repeatedly over a short-
term (up to 30 days) duration. Because any one or all three of these exposures may occur within
a short-term duration, combined exposures were also assessed. Based on exposures from
transferable turf residues (TTR) applied at the maximum use rate, all MOEs are greater than the
target LOG of 100 and pose no risks of concern to the Agency. A summary of the MOEs for
each exposure scenario assessed is shown in Table 8.
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Table 8. 2,4-DP-p MOEs for Short-term Incidental Oral Exposures to Toddlers
Exposure Scenario
Hand-to-mouth Ingestion
Object-to-Mouth Ingestion
Soil Ingestion
Total of Above Exposures
Dose (mg/kg/day)*
0.0112
0.0028
0.000038
0.014
MOE
460
1820
136,000
360
MOE > 100 = no risk of concern
* = highest typical application rate of 0.75 Ib ae 2,4-DP-p/A
mg/kg/day = milligram per kilogram per day
Granule Ingestion Exposure Assessment
The Agency also considered incidental oral ingestion of granular 2,4-DP-p products for
toddlers playing on treated lawns or other turf areas. Granule ingestion was assessed separately
because this scenario is considered a one-time (single acute episodic) exposure event, rather than
a repeated exposures over a duration of up to 30 days. The incidental oral ingestion of granules
MOE is greater than the target LOG of 100 and poses no risk of concern to the Agency. The
summary of the MOE for the granular exposure scenario assessed is shown in Table 9.
Table 9. 2,4-DP-p MOEs for Incidental Oral Ingestion of Granules by Toddlers
Percent 2,4-DP-p in
Granular Product
0.35
Potential Dose Rate
(mg/day)
0.315
Potential Dose
(mg/kg/day)
0.021
Acute MOE
140
MOE > 100 = risk not of concern
mg/kg/day = milligram per kilogram per day
3. Aggregate Exposure and Risk
Because the majority of 2,4-DP-p usage is applied annually to residential lawns, the
Agency determined that aggregating the drinking water and residential exposures would be more
representative of actual exposure. When aggregating risk from various sources, both the route
and duration of exposure are considered. Because there are no registered food uses in the U.S.
and dermal exposures are not expected to be a significant exposure route of concern, only 2,4-
DP-p exposures via drinking water and residential post-application exposure routes are
considered in the aggregate assessment.
To estimate residential handler aggregate risk, a hand application of granules was used to
estimate the aggregate risk because this scenario results in the highest potential exposure among
all assessed scenarios. For residential exposure in children, three subpopulation groups were
examined: all infants (<1 year), the group which resulted in the highest potential exposure to
drinking water, and children 1-2 and 3-5 years old who might exhibit hand-to-mouth, object-to-
mouth, and soil ingestion behaviors. All aggregated exposure scenarios assessed result in MOEs
greater than 100 and do not pose any risks of concerns to the Agency. A summary of exposures
and the respective MOEs is shown in Table 10.
17
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Table 10. 2,4-DP-p MOEs for Aggregate Short-term Exposures (Drinking Water and Residential)
Exposure Scenario
Residential Handler, hand application of
granules
Incidental Oral Exposure, <1 Year Old
Incidental Oral Exposure, 1-2 Years Old
Incidental Oral Exposure, 3-5 Years Old
Drinking Water
Exposure
(mg/kg/day)
0.000056
0.000186
0.000084
0.000079
Residential
Exposure
(mg/kg/day)
0.000115
0.014
0.014
0.014
Aggregate
Exposure
(mg/kg/day)
0.000171
0.0142
0.0141
0.0141
MOE
29,800
360
360
360
MOE > 100 = no risk of concern
mg/kg/day = milligram per kilogram per day
4. Occupational Exposures Assessment
Workers can be exposed when mixing, loading, and applying 2,4-DP-p, and there is also
the potential for post-application exposure when re-entering a treated site. The Agency assessed
risk to occupational handlers and workers in the same manner as it used to assess risks to
residential users, using the MOE approach. The target MOE of 100 reflects the ratio of the
estimated exposure divided by the NOAEL. MOEs greater than 100 are not of concern to the
Agency.
To assess the handler risks, the Agency used surrogate unit exposure data from the
Pesticide Handler Exposure Database (PHED), the Outdoor Residential Exposure Task Force
(ORETF) studies, and the California Department of Pesticide Regulation (CA DPR). The PHED
data were used primarily for the large scale agricultural and forestry scenarios and the ORETF
data were used to assess exposures to professional lawn care operators. The CA DPR data were
used for the backpack applicator forest site preparation scenario where multiple applicators are
supplied by a nurse tank. Short- and intermediate-term handler risks were assessed, with
inhalation exposures being the exposure route of concern.
MOEs for both the maximum and typical application use rates for all short- (up to 30
days) and intermediate-term (1-6 months) agricultural handler scenarios are assessed at baseline
PPE except aerial applicators, which were assessed with closed cockpit (i.e., engineering
controls) built in. Based on these application scenarios, all assessed scenarios do not pose a risk
concern at baseline exposure except for the following two scenarios: (1) mixing and loading
liquids for aerial forestry applications for short- and intermediate-term durations, and (2) mixing
and loading wettable powder for turfgun for intermediate-term duration. Because aerial
applications are no longer supported, this use does not pose a risk of concern. For the
mixer/loader wettable powder for turfgun scenario, the addition of a filtering facepiece respirator
(i.e., PF5 respirator) in addition to baseline personal protective equipment (PPE) results in
acceptable MOEs. A summary of the MOEs is shown in Table 11.
18
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Table 1 1 . 2,4-DP-p MOEs for Occupational Handlers and Applicators Using Baseline PPE
Exposure Scenario
Crop or Site
Application
Rate
(Ib ae/acre)
Acres/
Day
Short- term/
Intermediate-
term Exposure
MOE
Level of PPE
Mixer/Loader (M/L)
M/L Liquids for Aerial
M/L Liquids for ROW
Sprayer
M/L Wettable Powder for
Turfgun Application
M/L Liquids for Turf Gun
M/L Liquids for
Groundboom
M/L Liquids for
Backpack Sprayer
M/L Liquids for
Groundboom
Load Granulars for
Broadcast Spreader
Conifer
Release
Forestry
ROW
Turf
Turf
Sod Farms
Forest Site
Prep
Golf Courses
Golf Courses
0.87
6
0.75
6
0.75
0.75
1200
50
100
80
40
40
280/200
200/150
990/700
110/390
4,000/2,800
5,000/3,500
1,200/880
9,900/7,000
7,000/4,900
Baseline
Respirator
with PF5
Baseline
Baseline/
Respirator
with PF5
Baseline
Baseline
Baseline
Baseline
Baseline
Applicator
Aerial* - closed cockpit
Groundboom
ROW
Turfgun
Broadcast Spreader
Backpack
Conifer
Release
Forestry
ROW
Sod Farms
Golf Courses
ROW
Turf
Golf Courses
Forest Site
Prep
0.87
6
0.75
6
0.75
6
1,200
350
80
40
50
5
40
4
9,900/7,000
729/520
20,000/1,800
8,000/5,700
16,000/11,000
310/220
68,000/1,700
9,900/67,000
280/190
Baseline
Baseline
Baseline
Baseline
Baseline
Baseline
Baseline
Baseline
Baseline
Mixer/Loader/Applicator (M/L/ A)
M/L/A Liquid Flowables
with Turfgun
M/L/A Liquids with
Backpack Sprayer
Load/Apply Granules
with a Push Cyclone
Turf
Forestry/
ROW
Turf
0.75
6
0.75
5
4
5
53,000/37,000
500/350
13,000/9,000
Baseline
Baseline
Baseline
Flagger
Flag Aerial Application*
ROW
6
350
490/340
Baseline
MOE < 100 = no risk of concern ROW = rights-of-way PPE = Personal Protective Equipment
Baseline = PPE including single-layer gloves, long-sleeved shirt, shoes and socks, and long pants.
* = aerial applications are not being supported by the registrants.
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b. Occupational Post-application Exposures
There is potential for dermal and inhalation exposures to post-application workers who
enter treated areas. However, the Agency determined that these exposures are minimal and are
unlikely to pose any risks of concern. Occupational post-application dermal risks were not
assessed because of the lack of any systemic toxicity via dermal exposures for all forms of 2,4-
DP-p. Occupational post-application inhalation exposures are not anticipated because 2,4-DP-p
has a low vapor pressure and, thus, will not readily volatilize, and because it is applied outdoors
as a coarse spray. Because it is a severe eye irritant, the default Restricted Entry Interval (REI)
for 2,4-DP-p is 48 hours for labels including uses where the Worker Protection Standard (WPS)
applies. Therefore, with the existing protective measures in place, the Agency has determined
that any potential post-application exposures do not pose any risks of concern to the Agency.
5. Incident Reports
The Agency reviews various databases to determine if any substantiated reported
incidents warrant further investigation for effects not considered. Databases searched include the
Office of Pesticides Program Incident Data System (IDS), Poison Control Center, California
Department of Pesticide Regulation (CDPR), the National Pesticide Telecommunications
Network (NPTN), and the National Institute of Occupational safety and Health's Sentinel Event
Notification system for Occupational Risks (NIOSH SENSOR). There were no human incident
reports identified for 2,4-DP-p.
B. Environmental Risk Assessment
The ecological risk assessment evaluated three active ingredients: 2,4-DP-p acid, 2,4-DP-
p DMAS, and 2,4-DP-p EHE. Because not all ecological studies conducted with each of the
three 2,4-DP-p forms were available, the Agency developed a strategy to bridge the majority of
fate and ecotoxicity data requirements for 2,4-DP-p acid, 2,4-DP-p DMAS, and 2,4-DP EHE.
Likewise, this bridging strategy was used to reflect the most sensitive endpoint assessed. Based
on available bridging data, which demonstrated that 2,4-DP-p DMAS rapidly dissociated to 2,4-
DP-p acid and the dimethylamine ion, the Agency determined that acceptable studies conducted
with the 2,4-DP-p acid, EHE, or DMAS form could be used as "surrogate" data, as appropriate,
for the respective unavailable or deficient 2,4-DP-p studies. The Agency expects that the
toxicities between 2,4-DP-p acid and 2,4-DP-p DMAS are similar, based on the assumption that
2,4-DP-p DMAS will completely and rapidly dissociate to 2,4-DP-p acid and the DMAS ion. In
most cases, the same is assumed for 2,4-DP-p EHE. The one exception is in considering
exposure to non-target organisms due to direct deposition from spray drift, as 2,4-DP-p EHE
may persist in waters with an acidic to neutral pH. However, 2,4-DP-p EHE is not expected to
persist in runoff waters due to degradation via microbial-mediated or surface catalyzed
hydrolysis processes. For consistency throughout this section, 2,4-DP-p will refer to the acid
equivalent of dichlorprop, where all appropriate conversions are made from the equivalent
DMAS and EHE forms. A summary of the EPA's ecological fate and effects assessment is
presented below. The full assessment, Environmental Fate and Effects Science Chapter for 2,4-
DP-p acid, 2,4-DP-p DMAS, and 2,4-DP-p EHE, dated August 24, 2007, and response to public
20
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comments are available on the internet and in the public docket at www.regulations.gov (EPA-
HQ-OPP-2006-0944).
1. Environmental Fate and Transport
Available environmental fate data indicates that 2,4-DP-p is non-persistent to moderately
persistent. The primary routes of dissipation appear to be photodegradation in water, microbial-
mediated degradation, and leaching. 2,4-DP-p does not adsorb strongly to soils and, thus, is
likely to be mobile in terrestrial and aquatic environments. 2,4-DP-p DMAS and 2,4-DP-p EHE
are expected to dissociate quickly, where the dimethylamine and the ethyl-hexyl alcohol ions
degrade by microbial-mediated processes. 2,4-DP-p rapidly photodegrades (ti/2 = 4 days) in
aqueous environments, and is non-persistent to moderately persistent (ti/2 = 14 days) in aerobic
terrestrial and aquatic environments. Conversely, 2,4-DP-p can be persistent in anaerobic
aquatic environments (ti/2 =159 days). 2,4-DP-p is stable to abiotic hydrolysis in pH 5, 7, and 9
buffer solutions. Degradation products of 2,4-DP-p include 2,4-dichlorophenol, 2,4-
dichloroanisole, and carbon dioxide, which are all common degradates to 2,4-D. The Agency
reviewed available data on 2,4-dichlorophenol, which indicated that the toxicity is slightly
greater (less than one order of magnitude than the parent, 2,4-DP-p) for aquatic organisms. The
Agency determined that these degradates would not pose any greater risk concerns than that of
the parent. Thus, the Agency is assuming that degradates are of equal or less toxicity than the
parent compound.
The potentially highest residue levels can occur in surface waters adjacent to treated areas
due to spray drift at the time of application and/or from runoff after a rain event. Because 2,4-
DP-p EHE may persist longer in acidic to neutral pH waters, the Agency considered potential
off-site movement from the direct deposition via spray drift from brush control uses. Current
labeling does not prohibit aerial applications; thus, direct deposition from this application
method was considered in the ecological assessment. However, the technical registrants have
confirmed that this application method will no longer be supported. Thus, aerial applications
will be prohibited for products containing 2,4-DP-p.
2. Ecological Exposure and Risk
The pesticide use profile, exposure data, and toxicity information are used to determine
risk estimates to non-target aquatic and terrestrial organisms. As applicable, acute and chronic
terrestrial toxicity studies are required to establish the potential toxicity (hazard) of 2,4-DP-p to
non-target species. Estimated Environmental Concentrations (EECs) are estimates of potential
residue concentrations from the maximum or typical application rate of 2,4-DP-p, to which an
organism may be exposed. A risk quotient (RQ) is the ratio of the EECs to the organism's
toxicity endpoint, which would yield the maximum exposure estimates. The RQ is then
compared to the level of concern (LOG) to determine if that particular exposure scenario would
pose a risk of concern to the non-target organism. Table 12 outlines the Agency's LOCs and the
corresponding risk presumptions.
21
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Table 12. Agency's LOCs and Risk Presumptions
Risk Presumption
Acute Risk - there is potential for acute risk; regulatory
action may be warranted.
Acute Endangered Species - there is potential for
endangered species risk; regulatory action may be
warranted.
Chronic Risk - there is potential for chronic risk; regulatory
action may be warranted.
LOG
Terrestrial
Animals
0.5
0.1
1
LOG
Aquatic
Animals
0.5
0.05
1
LOG
Plants
1
1
N/A
a. Terrestrial Organisms
Terrestrial animals (birds, mammals, reptiles, and terrestrial-phase amphibians) that are
nesting in or near the treated field may be exposed to 2,4-DP-p due to direct deposition from
labeled use of the pesticide, runoff, and from spray drift onto areas adjacent to treated sites. The
Agency estimates exposures and potential risk to birds and mammals, which also serve as
surrogates for exposures to terrestrial-phase amphibians and reptiles, and dryland and semi-
aquatic plants. For exposure to terrestrial animals and plants, pesticide residues on food items
are estimated based on the assumption that organisms are exposed to a single pesticide residue in
a given exposure scenario.
The greatest 2,4-DP-p residues and exposure levels are likely to occur in the surface soil
and on foliage (e.g., short and tall grasses, broadleaf plants), seeds, and insects on treated areas
immediately following ground spraying and/or granular treatments. In addition to exposure
through spray residues on and adjacent to the application area, direct terrestrial exposure is also
expected through granular applications, as animals may ingest the granules. Bioaccumulation of
2,4-DP-p in the food chain is not expected to be a significant exposure source to non-target
terrestrial organisms.
Residues of 2,4-DP-p from single and multiple applications are expected to occur on
avian and mammalian food items. The Agency used the RQ method to determine potential risks
of concern. Predicted maximum and mean concentrations of pesticide residues are based on the
Kenaga nomogram by Hoerger and Kenaga (1972) as modified by Fletcher et al. (1994). The
typical and maximum application rates are used to produce EECs and were used in the Agency's
screening-level analyses. The Agency reviewed available acute and chronic terrestrial organism
toxicity studies to establish the hazard of 2,4-DP-p to non-target species. With this information,
each EEC is then divided by the corresponding acute and/or chronic toxicity value, to produce
the RQ, and evaluated against the Agency's LOG to measure potential risk to that organism.
22
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In estimating foliar residues for this screening-level assessment, the Agency assessed a
maximum use scenario, based on the following assumptions:
- residues are based on maximum application rate of 6.0 Ibs ae 2,4-DP-p/A used or the
maximum typical rate of 0.75 Ib ae 2,4-DP-p/A, with 2 applications made per year;
an interval of 30 days, the shortest timeframe between repeat applications;
most, if not all, of the applied pesticide will settle in the use area; and
- a first-order residue default degradation half-life of 35 days.
Based on the above factors, EPA estimated several EECs for various food sources
(grasses, fruit, seed, and insects) associated with the registered uses of 2,4-DP-p. Consumption-
weighted EECs are determined for each food source to be more representative of actual
exposures based on the size of the animal and its typical eating habits. The EECs on food items
may be compared directly with dietary toxicity data or converted to a single oral dose. Single
oral dose estimates represent an exposure scenario where absorption of the pesticide is
maximized over a single ingestion event and represents a conservative estimate.
1.
Avian and Mammalian Assessment
Residues of 2,4-DP-p from single and multiple application scenarios are expected to
occur on avian and mammalian food items. Predicted maximum and typical EECs of pesticide
residues from single and multiple applications of 2,4-DP-p were used in the screening-level
ecological assessment. In estimating foliar residues from multiple applications, EPA used first
order dissipation values, maximum application rates, minimum application intervals, and
maximum number of applications.
The EECs were calculated using the T-REX (Version 1.2.3) model and corresponding
avian acute and chronic RQs are based on the most sensitive acute and chronic endpoints,
respectively, for birds. 2,4-DP-p appears to cause moderate acute oral toxicity to avian and
mammalian species. Table 13 shows the toxicity endpoints used in the avian and mammalian
assessments.
Table 13. Summary of Avian Acute and Chronic Toxicity Data Conducted with 2,4-DP-p
Species
LD50
Acute Oral
Toxicity, MRID
LCso
NOAEC/LOAEC
(mg/kg), MRID
Conducted with 2, 4-DP-p DMAS
Japanese quail
Northern Bobwhite
quail
—
242 mg/kg
—
Moderately toxic
42987901
—
>4,658 mg/kg
NOAEC - 244 mg /kg
LOAEC - not determined
46879201
NOAEC - not determined
Conducted with 2,4-DP-p acid
Laboratory rat
534 mg/kg
Category III
42614601
—
NOAEC - 40
LOAEC - 219.6
46721401
mg/kg = milligram per kilogram
23
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Birds
For birds, the acute risk LOG is 0.5. Based on estimated avian dose-based acute RQs for
spray applications to both turf and for brush control applications, the LOG for non-endangered
birds is exceeded for some scenarios. The acute endangered RQ exceeded the LOG of 0.1 for
acute risk to birds. Because the subacute dietary LCso was non-definitive (greater than the
highest test concentration 4,625 mg ae/kg), dietary based acute RQs would not exceed the LOG
and, thus, were not calculated in the assessment. The dietary-based chronic RQs for birds exceed
the Agency's LOG of 1 for most food items, which applies to both non-endangered and
endangered species. Calculations for dietary-based RQs are not adjusted for bodyweight. Tables
14 and 15 summarize the respective acute and chronic RQs for avian species, with LOG
exceedances identified in bold text.
Table 14. 2,4-DP-p Acute Dose-based RQs for Birds, Spray Applications
Use
Ornamental
Turf
Woody Plant
Control in Non-
crop Areas
Application
Rate
0.75 Ib ae/A
2 per season
30 days
6.0 Ibs ae/A
1 per season
Body
Weight
(grams)
20
100
1000
20
100
1000
Acute RQs
Short
Grass
1.82
0.82
0.26
9.41
4.21
1.34
Tall
Grass
0.84
0.37
0.12
4.31
1.93
0.61
Broadleaf
Plants/Small
Insects
1.03
0.46
0.15
5.29
2.37
0.75
Fruits/
Pods/Seeds/
Large Insects
0.11
0.05
0.02
0.59
0.26
0.08
Acute non-endangered LOG for terrestrial animals > 0.5, endangered LOG > 0.1.
Bold = LOG exceedance.
Table 15. 2,4-DP-p Chronic Dietary-based EECs and RQs for Birds, Spray Applications
Use Site
Ornamental
Turf
Woody Plant
Control in
Non-crop
Areas
Application
Rate
0.75 Ib ae/A
2 per season
30 day interval
6.0 Ibs ae/A
1 per season
Food Items
Short grass
EEC
279.37
1440
RQ
1.14
5.90
Tall Grass
EEC
128.04
660
RQ
0.52
2.70
Broadleaf plants/
small insects
EEC
157.14
810
RQ
0.64
3.32
Fruits/
pods/seed/
large insects
EEC
17.46
90
RQ
0.07
0.37
Chronic non-endangered and endangered LOG for terrestrial animals is > 1.0.
Bold = LOG exceedance.
Birds can also be exposed to 2,4-DP-p from granular applications. Acute exposures to
granular applications are measured based on the lethal doses available within one square foot
immediately after application. Based on the modeled turf and non-crop areas treated for woody
brush control, acute RQs exceeded the LOG for small and medium-sized birds. Table 16
summarizes the acute RQs, with non-endangered LOG exceedances identified in bold text, for
birds consuming foodstuff treated with granular applications of 2,4-DP-p.
24
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Table 16. 2,4-DP-p Acute Dose-based RQs for Birds, Granular Applications
Use Site
Ornamental Turf
Woody Plant Control
in Non-crop Areas
Application Rate
0.75
2 per season
6.0
1 per season
Body Weight,
grams
20
100
1000
20
100
1000
Acute RQ
2.24
0.35
0.02
17.92
2.81
0.20
Acute non-endangered LOG for terrestrial animals > 0.5, endangered LOG > 0.1.
Mammals
Bold = LOG exceedance.
As with birds, EPA assesses acute and chronic risk to mammals based on an acute LOG
of 0.5, acute endangered LOG of 0.1, and a chronic LOG of 1.0. Mammalian acute and chronic
RQs exceeded the LOCs for some food items based on both spray and granular applications at
the maximum application rate of 6.0 Ibs ae 2,4-DP-p/A. Although to a lesser degree, dietary-
based chronic RQs also exceed the Agency's LOG. As expected, chronic RQ exceedances are
greater with the higher application rate used for control of woody plants and brush. The acute
and chronic RQ summaries are presented in Tables 17, 18, 19, and 20, with non-endangered
LOG exceedances identified in bold text.
Table 17. 2,4-DP-p Acute Dose-based RQs for Mammals, Spray Applications
Use
Ornamental
Turf
Woody Plant
Control in
Non-crop
Areas
Application
Rate
0.75 Ib ae/A
2 per season
30 day interval
6.0 Ibs ae/A
1 per season
Body
Weight
(grams)
15
35
1000
15
35
1000
Acute RQs
Short
Grass
0.23
0.19
0.10
1.17
1.00
0.54
Tall
Grass
0.10
0.09
0.05
0.54
0.46
0.25
Broadleaf
Plants/Small
Insects
0.13
0.11
0.06
0.66
0.56
0.30
Fruits/pods/
large
insects
0.01
0.01
0.01
0.07
0.06
0.03
Seeds
0.00
0.00
0.00
0.02
0.01
0.01
Acute non-endangered LOG for terrestrial animals > 0.5, endangered LOG > 0.1.
Bold = LOG exceedance.
Table 18. 2,4-DP-p Acute Dose-based RQs for Mammals, Granular Applications
Use Site
Ornamental Turf
Woody Plant Control
in Non-crop Areas
Application Rate
0.75
2 per season
6.0
1 per season
Body Weight,
grams
20
100
1,000
20
100
1,000
Acute RQs
0.44
0.23
0.02
3.55
1.88
0.15
Chronic non-endangered and endangered LOG for terrestrial animals is > 1.0.
Bold = LOG exceedance.
25
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Table 19. 2,4-DP-p Dose-based Chronic RQs for Mammals, Spray Applications
Use
Ornamental Turf
Woody Plant
Control in Non-
crop Areas
Application
Rate
0.75 Ib ae/A
2 per season
30 day interval
6.0 Ibs ae/A
1 per season
Body
Weight,
grams
15
35
1000
15
35
1000
Chronic RQs
Short
Grass
3.03
2.59
1.39
15.62
13.34
7.15
Tall
Grass
1.39
1.19
0.64
7.16
6.11
3.28
Broadleaf
Plants/Small
Insects
1.70
1.46
0.78
8.78
7.50
4.02
Fruits/pods/
large
insects
0.19
0.16
0.09
0.98
0.83
0.45
Seeds
0.04
0.04
0.02
0.22
0.19
0.10
Chronic non-endangered and endangered LOG for terrestrial animals is > 1.0. Bold = LOG exceedance.
Table 20. 2,4-DP-p Dietary -based Chronic RQs for Mammals
Use
Application Method
Ornamental Turf
Woody Plant
Control in Non-crop
Areas
Application Rate
0.75 Ib ae/A
2 per season
30 day interval
6.0 Ibs ae/A
1 per season
Food Items
Short grass
Tall grass
Broadleaf plants/small insects
Fruits, pods, seeds, and large insects
Short grass
Tall grass
Broadleaf plants/small insects
Fruits, pods, seeds, and large insects
EEC
279.37
128.04
157.14
17.46
1440
660
810
90
Chronic
RQ
1.14
0.52
0.64
0.07
5.90
2.70
3.32
0.37
Chronic non-endangered and endangered LOG for terrestrial animals is > 1.0. Bold = LOG exceedance.
2. Terrestrial and Semi-aquatic Plant Assessment
Non-target terrestrial and semi-aquatic plants can be exposed to 2,4-DP-p from spray
drift and runoff moving to off-target field foliage and surface soil. Using TERRPLANT 1.2.1
modeling, EECs for terrestrial and semi-aquatic plants were derived for areas adjacent to the
treatment site. Acute RQs for terrestrial plants are calculated by dividing the EEC by the £€25
from available Tier II seedling emergence and vegetative vigor toxicity tests. To calculate acute
RQs for endangered species, EECs are divided by the NOAEC value. Table 21 shows the
toxicity data used to evaluate risks to terrestrial and semi-aquatic plants.
26
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Table 21. Summary of 2,4-DP-p Terrestrial Plant Toxicity Data
Species
Toxicity
Most Sensitive
Endpoint
MRID
2, 4-DP-p Acid and DMAS Terrestrial Plant Toxicity
Vegetative Vigor
Seedling Emergence
Most sensitive monocot: onion
NOAECO.OlOlbae/A
EC25 0.036 Ib ae/A
Most sensitive dicot: cabbage, lettuce
NOAEC 0.015 Ib ae/A
EC25 0.003 Ib ae/A
Most sensitive monocot: onion
NOAEC 0.005 Ib ae/A
EC25 0.29 Ib ae/A
Most sensitive dicot: lettuce
NOAEC 0.005 Ib ae/A
EC25 0.09 Ib ae/A
Dry Weight
43525801
43016702
2, 4-DP-p EHE Terrestrial Plant Toxicity
Vegetative Vigor
Seedling Emergence
Most sensitive monocot: corn
NOAEC 0.064 Ib ae/A
EC250.121bae/A
Most sensitive dicot: lettuce
NOAEC 0.0009 Ib ae/A
EC25 0.01 lib ae/A
Most sensitive monocot: oat
NOAEC 0.023 Ib ae/A
EC25 0.065 Ib ae/A
Most sensitive dicot: radish
NOAEC 0.008 Ib ae/A
EC25 0.038 Ib ae/A
Dry Weight
43279201
43279202
RQs are developed for terrestrial (dryland) plants are based on 2,4-DP-p runoff and drift
from one treated hectare moving to adjacent areas, whereas semi-aquatic areas (wetlands) are
based on movement from a ten-hectare site. As expected with an herbicide, the acute LOCs
(LOG of 1 for plants) were exceeded for endangered and non-endangered terrestrial and semi-
aquatic plants located adjacent to treated areas, both as a result of combined runoff and spray
drift, and from spray drift alone for 2,4-DP-p. This difference in the modeling values (1 versus
10 hectares) is reflected in the ten-fold difference in the resulting RQs, with non-endangered
LOG exceedances identified in bold text, are shown in Table 22.
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Table 22. 2,4-DP-p acid and DMAS Terrestrial Plant RQs (Acute only)
Plant
Non-endangered
Adjacent to
treated sites
EEC
RQ
Semi-aquatic
areas
EEC
RQ
Drift Alone
EEC
RQ
Endangered
Adjacent to
treated sites
EEC
RQ
Semi-aquatic
areas
EEC
RQ
Drift Alone
EEC
RQ
Aerial spray application (6.0 Ibs ae/A)*
M
D
0.60
20.69
6.67
3.30
113.79
36.67
0.300
8.33
30
0.60
120
120
3.30
660
660
0.300
30
100
Ground spray application (6. 0 Ibs ae/A)
M
D
0.36
12.414
4
3.06
105.52
34.00
0.06
1.67
6
0.36
72
72
3.06
612
612
0.06
6
20
Granular ground application (6. 0 Ibs ae/A)
M
D
0.30
10.34
3.33
3.00
103.45
33.33
n/a
0.30
60
60
3.00
600
600
n/a
Aerial spray application (0. 75 Ib ae/A) *
M
D
0.075
2.59
0.83
0.413
14.22
4.58
0.038
1.04
3.75
0.075
15
15
0.413
82.5
82.50
0.038
3.75
12.5
Ground spray application (0. 75 Ib ae/A)
M
D
0.045
1.55
0.50
0.383
13.19
4.25
0.008
0.21
0.75
0.045
9
9
0.383
76.5
76.50
0.008
0.75
2.5
Granular ground application (0. 75 Ib ae/A)
M
D
0.0375
1.29
0.42
0.375
12.93
4.17
n/a
0.0375
7.5
7.5
0.375
75
75
n/a
* Aerial applications are not being supported by the registrants, but are currently on existing labels.
Acute non-endangered and endangered LOG for terrestrial plants > 1.0. n/a = not applicable
Bold = LOG exceedance. M = monocot D = dicot
RQs were also calculated for terrestrial plants exposed to 2,4-DP-p EHE based on a
seedling emergence study, the most sensitive terrestrial plant study. Table 23 shows the EECs
and RQs, with LOG exceedances identified in bold text, for terrestrial and semi-aquatic plants,
reflecting estimates from runoff and drift exposures based on the various maximum single
application rates.
28
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Table 23. 2,4-DP-p EHE Terrestrial Plant RQs (Acute only)
Scenario
Acute Non-endangered RQs
Adjacent to
treated sites
EEC
RQ
Semi-aquatic
areas
EEC
RQ
Drift
EEC
RQ
Acute Endangered RQs
Adjacent to
treated sites
EEC
RQ
Semi-aquatic
areas
EEC
RQ
Drift
EEC
RQ
Aerial spray application (6.0 Ibs ae/A)*
Monocot
Dicot
0.60
9.23
15.79
3.30
50.77
86.84
0.30
25.00
27.27
0.60
26.09
75.00
3.30
143.48
412.50
0.30
4.69
333.33
Ground spray application (6. 0 Ibs ae/acre)
Monocot
Dicot
0.36
5.538
9.47
3.06
47.08
80.53
0.06
5.00
5.45
0.36
15.65
45.00
3.06
133.04
382.50
0.06
0.94
66.67
Granular ground application (6. 0 Ibs ae/A)
Monocot
Dicot
0.30
4.62
7.89
3.00
46.15
78.95
n/a
n/a
0.30
13.04
37.50
3.00
130.43
375.00
n/a
n/a
Aerial spray application (0. 75 Ib ae/A)
Monocot
Dicot
0.075
1.15
1.97
0.413
6.35
10.86
0.038
3.13
3.41
0.075
3.26
9.38
0.413
17.93
51.56
0.038
0.59
41.67
Ground spray application (0. 75 Ib ae/A)
Monocot
Dicot
0.045
0.692
1.18
0.38
5.88
10.07
0.0075
0.63
0.68
0.045
1.96
5.63
0.38
16.63
47.81
0.0075
0.12
8.33
Granular ground application (0. 75 Ib ae/A)
Monocot
Dicot
0.038
0.58
0.99
0.38
5.77
9.87
n/a
n/a
0.038
1.63
4.69
0.38
16.30
46.88
n/a
n/a
* Aerial applications are not being supported by the registrants, but are currently on existing labels.
Acute non-endangered and endangered LOG for terrestrial plants > 1.0. n/a = not applicable
Bold = LOG exceedance. M = monocot D = dicot
b. Aquatic Organisms
Fish, amphibians, and aquatic invertebrates that live in aquatic environments are
potentially exposed to 2,4-DP-p residues in surface water by direct contact of their integument,
and via uptake through their gills or integument. Immediately following applications of 2,4-DP-
p, the highest residue levels are expected to be located in surface waters adjacent to treated fields
due to spray drift at the time of application and/or from runoff after a rain event. 2,4-DP-p has
low persistence in some terrestrial environments; however, the likelihood of transport by runoff
and leaching still exists. Although the Task Force is no longer supporting this application
method, aerial applications and potential drift were assessed because they are still listed on some
current product labels. Routes of exposure evaluated in the aquatic assessment focused on aerial
applications, ground spray for ornamental turf, and granular applications for woody plant
control. Because 2,4-DP-p EHE can persist in waters with an acidic to neutral pH, EPA assessed
direct deposition of 2,4-DP-p EFIE from aerial drift, runoff, and spray drift applications. The
Agency predicted 2,4-DP-p EECs for aquatic ecosystems assessments using the Tier II
PRZM/EXAMS models. PRZM is used to simulate pesticide transport as a result of runoff and
erosion, and EXAMS considers the environmental date and transport of pesticides. The
exposure values used in the ecological risk assessment are based on the "standard pond"
scenario, intended to better represent the spatial and physical qualities of habitats relevant to risk
29
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assessment for aquatic non-target organisms in ponds or streams that may be in or adjacent to
treated areas. The resulting EECs predict high-end values of pesticide concentrations that may
be found in ecologically sensitive environments following pesticide applications and, thus,
represent conservative exposure estimates to which non-target organisms may be exposed. The
EECs values determined for impact to non-target aquatic organisms are specific to ecological
and fate properties in the respective scenarios assessed and, therefore, are different from those
used to assess human health exposure in the drinking water assessment. Peak (l-in-10 year)
surface water EECs were estimated based on applications made to Oregon Christmas trees and
Florida turf (e.g., sod farm) scenarios.
Currently, the Agency does not have a model with which to predict concentrations of 2,4-
DP-p in surface water from applications to home lawns, ornamental turf areas, or other grassy
areas. Runoff from applications to these areas is expected to move over lawns and impervious
surfaces to storm sewers and then to surface water. 2,4-DP-p applications predicted by
PRZM/EXAMS modeling are sufficiently conservative to be representative of applications to
turf, lawns, and other grass sites. Application rates, number of applications, and minimal
retreatment intervals were based on the maximum values identified by the technical registrants in
the 2,4-DP-p Task Force.
1. Fish and Invertebrates Assessment
A limited number of acute aquatic toxicity studies were submitted for both freshwater
and marine/estuarine fish and invertebrates. Due to the lack of aquatic toxicity data, acute and
chronic RQs were derived to estimate potential acute risk to the following: marine/estuarine fish
and invertebrates, and chronic risk to both freshwater and marine/estuarine animals. These
derived values are identified with an asterisk in Table 24. Derived toxicity endpoints are
calculated by taking the largest acute-to-chronic ratio from available studies conducted with a
similar chlorophenoxy herbicide, e.g., 2,4-D or MCPA, and dividing that ratio value by the
respective acute or chronic toxicity value. Data were also unavailable for 2,4-DP-p EHE toxicity
to fish and aquatic invertebrates. Compared to other chlorophenoxy herbicides, the general
relationship between the acid and amine salts to the EFIE suggests that the esters are more toxic
by approximately two orders of magnitude. Thus, the respective acute or chronic toxicity value
is divided by 100 to estimate to 2,4-DP-p EHE toxicity to the respective animal. Table 24 is a
summary of aquatic toxicity studies the Agency used to evaluate risks from 2,4-DP-p acid,
DMAS, and EHE.
30
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Table 24. Summary of 2,4-DP-p Fish and Aquatic Invertebrates Toxicity Values.
2, 4-DP-p acid and DMAS
Species
Freshwater fish
Rainbow trout
Freshwater invertebrates
Water flea
Estuarine/marine fish
Estuarine/marine invertebrates
Acute Toxicity LC50,
MRID, Toxicity Category
>214mgae/L
MRID 44580 101
Practically non-toxic
558 mg ae/L
MRID 43867603
Practically non-toxic
>142.7mgae/L*
1, 297 mg ae/L*
Chronic Toxicity
NOAEC
14.7 mg ae/L*
74.9 mg ae/L*
>9.8 mg ae/L*
74.9 mg ae/L*
2, 4-DP-p EHE
Freshwater fish
Bluegill sunfish
Freshwater invertebrates
Water flea
Estuarine/marine fish
Estuarine/marine invertebrates
5.21 mg ae/L (direct deposition only)
42767004
Moderately toxic
>214 mg ae/L (aerial, ground,
and granular applications)
MRID 44580 101
Practically non-toxic
5.58 mg ae/L (direct deposition only)*
558 mg ae/L (aerial, ground, and granular
applications)
MRID 43867603
Practically non-toxic
>1.43mgae/L
12.7 mg ae/L
0.147mgae/L*
(direct deposition
application only)
0.749 mg ae/L*
0.098mg ae/L*
0.749 mg ae/L*
*Because chemical-specific toxicity data were not available, the toxicity value was derived for this species.
mg ae/L = milligrams of acid equivalent per liter NOAEC = no observed adverse effects concentration
Freshwater Fish and Invertebrates
Similar to the way that RQs calculated for terrestrial organisms, aquatic acute RQs are
derived by dividing the peak EECs by the LC50 for acute hazard. Acute RQs were not calculated
for freshwater fish because no mortality occurred at the highest test levels, which are greater than
the EECs. Chronic RQs for freshwater invertebrates are derived by dividing the 21-day EECs by
the NOAEC values.
As no chronic data were available for freshwater fish, the Agency used derived toxicity
values to estimate potential risk. Based on predicted modeling assessing both ground spray and
granular applications, all acute RQs are <0.001 for freshwater fish and invertebrates, and chronic
exposures to freshwater invertebrates do not exceed the Agency's LOCs.
-------
Marine Fish and Invertebrates
Acute and chronic RQ values were derived from estimated values for marine/estuarine
animals, as chemical-specific data on acute and chronic toxicity are not available. Using derived
values, RQs for all modeled scenarios were <0.001 and did not exceed LOCs.
2. Aquatic Plants
Likewise for non-target fish and invertebrates, surface water concentrations were
predicted using PRZM/EXAMS modeling assessing 2,4-DP-p applications to turf scenarios,
considering aerial, ground spray, and granular applications. Aquatic plants toxicity data were
available to determine potential toxicity of 2,4-DP-p acid and DMAS to non-target aquatic
plants. Because there were no 2,4-DP-p EHE toxicity data conducted on aquatic plants, the
Agency derived the toxicity values based on the magnitude of toxicity seen in similar
chlorophenoxy herbicides. Table 25 summarizes the toxicity studies used to calculate RQs for
aquatic plants.
Table 25. Summary of 2,4-DP-p Aquatic Plant Toxicity Studies.
2, 4-DP-p acid and DMAS Toxicity Values
Species
Non-Vascular, Navicula pelliculosa
Vascular, Lemna gibba
EC50
0.077 mg ae/L
26.8 mg ae/L
NOAEC
0.013mgae/L
1.57 mg ae/L
2,4-DP-p EHE Toxicity Values
Vascular
Non-Vascular
2.68 mg ae/L*
0.007 mg ae/L*
n/a
n/a
* Because EHE-specific data were not available, the toxicity value was estimated for this species.
For vascular and nonvascular plants, peak EECs were compared to acute ECso toxicity
endpoints for the most sensitive plant species. RQs for endangered plants are calculated using
the ECos toxicity endpoint, as NOAECs could not be determined from available submitted data.
There were no LOG exceedances for non-endangered aquatic plants at the LOG of 1. The only
exceedance for endangered aquatic plants was for non-vascular plants, identified below in bold
text; however, no non-vascular plants are listed as endangered or threatened. Table 26
summarizes the RQs for aquatic plants.
32
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Table 26. Summary of Aquatic Plant RQs for Aerial*, Ground Spray, and Granular Applications of
2,4-DP-p
Application Scenario
Non-crop Areas
6 Ibs ae/A
1 application
Ornamental Turf
0.75 Ib ae/A
2 applications
Ornamental Turf
0.75 Ib ae/A
2 applications
A
G
GR
A
G
GR
A
G
GR
EECs
.017
.00967
.008
.00809
.00759
.00747
.00469
.00399
.00397
Vascular Plant RQs
Non-endangered
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
Endangered
0.01
0.006
0.005
0.005
0.005
0.005
0.003
0.003
0.003
Non-vascular Plant RQs
Non-
endangered
0.22
0.13
0.10
0.12
0.10
0.10
0.06
0.05
0.05
Endangered
1.31
0.74
0.62
0.62
0.58
0.58
0.36
0.31
0.31
* Aerial applications are not being supported by the registrants, but are currently on existing labels.
Acute non-endangered and endangered LOG for aquatic plants > 1.0. Bold = LOG exceedance.
A = aerial G = ground GR = granular
c. Spray Drift
Although it is expected that the highest concentrations of 2,4-DP-p would occur in
directly treated areas, spray drift adjacent to treated areas may still present the potential for
exposures to non-target organisms. Exposures to non-target organisms include potential
movement of 2,4-DP-p to off-target field surface soil, foliage, and insects. Spray drift into water
bodies adjacent to treated areas can move to surface water, potentially affecting aquatic
organisms.
Because 2,4-DP-p is an herbicide, a more in-depth spray drift exposure assessment
utilizing Tier I AgDRIFT (version 2.01) modeling is also provided to better characterize
potential exposure of terrestrial plants. The Agency used AgDRIFT to evaluate potential risk at
several distances from the field, simulating typical applications with a low-boom sprayer. Based
on the assessed turf scenario, predicted deposition away from the target area exceeded both non-
endangered and endangered LOCs at the edge of the treated field (at zero feet). However, the
amount of predicted deposition at 250 feet was less than the £€25 levels from plant toxicity
studies and is below the acute LOCs at that distance. Therefore, applications made at 0.75 Ib ae
2,4-DP-p/A on turf would result in deposition that would exceed the acute LOG only to a
distance less than 250 feet. The amount of deposition at 250 feet is less than most no-effect
levels, and therefore, below the endangered species LOG. However, a no-effect level for 2,4-
DP-p DMAS could not be determined in the available vegetative vigor test for the most sensitive
species (onion), so the distance to which endangered plants might be affected from this use
cannot be definitely quantified. Spray drift deposition from an application at the maximum use
rate (6.0 Ibs ae 2,4-DP-p/A) indicated that the potential exceedance of the acute LOG for plants
can occur at drift distances greater than 750 feet. However, the rate reduction and additional
mitigation measures specified herein would reduce the amount potential spray drift to non-target
areas.
33
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d. Ecological Incidents
Ecological incidents are voluntarily reported to the Agency by local, state, other federal
agencies, or at times, submitted under FIFRA section 6(a)2. The Ecological Incident
Information System (EIIS) database contains ecological incidents that have been voluntarily
submitted to EPA by state agencies. A review of the EIIS did not show any reported incidences
that were caused by 2,4-DP-p.
34
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IV. Risk Management and Reregi strati on Decision
A. Determination of Reregi strati on Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregi strati on. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support reregi strati on
of products containing 2,4-DP-p as an active ingredient. The Agency has completed its review
of these generic data, and has determined that the data are sufficient to support reregi strati on of
all products containing 2,4-DP-p.
The Agency has determined that 2,4-DP-p-containing products are eligible for
reregi strati on provided that the risk mitigation measures outlined in section C of this document
are adopted and label amendments are made to implement these mitigation measures, as outlined
in Chapter V. Appendix A summarizes the uses of 2,4-DP-p that are eligible for reregi strati on.
Appendix B identifies the generic data requirements that the Agency reviewed as part of its
determination of reregi strati on eligibility of 2,4-DP-p, and lists the submitted studies that the
Agency found acceptable. Data gaps are identified as generic data requirements that have not
been satisfied with acceptable data. Should a registrant fail to implement any of the
reregi strati on requirements identified in this document, the Agency may take regulatory action to
address these concerns.
B. Public Comments and Responses
When making its reregi strati on decision, the Agency considered all comments received in
the docket during the public participation phase. During the public comment period, which
closed on June 25, 2007, the Agency received comments from interested stakeholders. These
comments in their entirety are available in the public docket (EPA-HQ-OPP-2006-0944) at
www.regulations.gov. The RED document, supporting documents for 2,4-DP-p, and the
Agency's response to received comments are also available in the docket. In addition, the 2,4-
DP-p RED document may be downloaded or viewed through the Agency's website at
http://www.epa.gov/pesticides/reregistration/status.htm.
C. Risk Mitigation and Regulatory Position
Products containing 2,4-DP-p are eligible for reregi strati on provided that the following
risk mitigation measures and label amendments are adopted accordingly. Table 27 summarizes
the human and ecological risks of concern and the respective mitigation measure.
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Table 27. 2,4-DP-p Human and Ecological Risk Mitigation Measures
Risk of Concern
Acute eye irritation (Toxicity Category I).
Inhalation risk from occupational
exposure.
Occupational inhalation exposure risk.
Non-target terrestrial exposures to
animals and plants, including spray drift.
Mitigation Measures
For any use (e.g., sod farms) for which the WPS applies, a
48-hour REI is required after applications of 2,4-DP-p.
For early entry workers, protective eyewear must be worn
in addition to baseline PPE.
There are risk concerns for mixers/loaders of liquid
products containing 2,4-DP-p for aerial forestry
applications. Because aerial applications of products
containing 2,4-DP-p are prohibited, no further action is
needed.
For any use for which the WPS applies, mixers and
loaders using wettable powder formulations must wear
PF5 respirator (i.e., dustmask).
The maximum application rate for broadcast treatments is
0.75 Ib ae 2,4-DP-p/A.
For spot treatments only, the maximum use rate permitted
is the equivalent to 2.0 Ibs ae 2,4-DP-p/A, to be applied
areas to no larger than 100 ft2 per 5,000 ft2.
Aerial applications of products containing 2,4-DP-p are
prohibited.
Applications must be made using medium- to coarse-sized
droplets.
Ibs ae 2,4-DP-p/A = pounds of acid equivalent 2,4-DP-p per acre.
The following is a summary of the rationale for managing risks associated with the use of
2,4-DP-p.
1.
Human Health Risk Management
The Agency has determined that based on currently registered uses of 2,4-DP-p there are
no risks of concern for all residential (drinking water, handler, and post-application) exposures.
All occupational scenarios are below the Agency's LOG except for 1) exposure to mixers/loaders
of liquid products containing 2,4-DP-p for aerial forestry applications, and 2) occupational
inhalation risks to mixer/loaders of wettable powders products containing 2,4-DP-p for turfgun
applications. Because aerial applications are not supported, all aerial applications will be
prohibited; and thus, mitigates the Agency's concern for occupational exposure from aerial
forestry applications. For occupational inhalation risks to mixer/loaders of wettable powders
products containing 2,4-DP-p, the use of a PF5 respirator (i.e., dust mask) or water-soluble bag
packaging is required. As is expected of an acid, 2,4-DP-p acid is an acute Toxicity Category I
eye irritant. In the absence of available acute eye toxicity data conducted with the respective 2,4-
DP-p DMAS and 2,4-DP-p EHE, the Agency assumes a default Toxicity Category I. To address
this concern, uses of 2,4-DP-p where the Worker Protection Standard guidelines apply will
require a 48-hour REI after applications of 2,4-DP-p. Early entry workers must wear goggles in
addition to baseline PPE.
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2. Ecological Risk Management
Based on available toxicological data and refined use information, the ecological risk
assessment identified some exposure scenarios with 2,4-DP-p that may pose ecological risks of
concern to the Agency, including effects on endangered species. However, considering the
assumptions made in the ecological assessment and additional proposed labeling mitigation
measures refined conservative usage information, the Agency has determined that its current use
patterns are eligible for reregi strati on. The following section is a summary for each respective
affected organism identified earlier in Chapter III, as well as characterization of the actual usage
of 2,4-DP-p versus the screening-level modeling estimates.
a. Terrestrial Organisms
Birds and Mammals
The ecological assessment identified potential risk to some non-target terrestrial animals.
When considering the upper-bound residues on treated food items at the highest typical rate
(0.75 Ib ae 2,4-DP-p/A), EPA's avian assessment shows that there are some acute and chronic
LOG exceedances based on granular and spray application scenarios. Exceedances were also
identified for acute and chronic exposures based on the assessed food items for mammals. As
expected, estimates for both acute and chronic RQs are greater when assessing spot treatments at
the highest application rate of 6.0 Ibs ae 2,4-DP-p/A. There are some conservative assumptions
made in the acute and chronic risk assessments that may have overestimated potential terrestrial
risks. First, both the dose-based and dietary-based assessments presumed that the animal's diet
is comprised of 100% of treated foodstuff (i.e., plant foliage, insects, fruit, and seeds) with
upper-bound residues. Typically, wildlife organisms consume a variety of foodstuff from
various locations, rather than from a single location. Assuming mean residues, many of the acute
and chronic RQs no longer exceeded the LOCs, with the exception of some small-sized birds or
mammals. Also, due to the lack of a foliar dissipation study, the Agency used the default foliar
dissipation half-life of 35 days, resulting in the greatest 2,4-DP-p residues on food items.
To reduce the amount of 2,4-DP-p residues in a given area, application rates have been
reduced and the highest concentration rate has been further restricted to specific types of
applications (spot treatments). For broadcast treatments (primarily to lawns and other
ornamental turf), with the exception of spot treatment use, the maximum application rate
permitted is 0.75 Ib ae 2,4-DP-p/A (used during greater weed infestation). Typical application
rates range from 0.25 - 0.50 Ib ae 2,4-DP-p/A, which further reduces the amount of residues in a
treated area. The application rate for spot treatments has been reduced to 2.0 Ibs ae 2,4-DP-p/A
and is restricted to application areas no greater than 1,000 ft2 per acre. These reduced rates and
more restrictive use patterns effectively reduce the amount of residues available to birds and
mammals. Reducing the area treated in spot treatments also decreases the likelihood of animals
consuming 100% of foodstuff from a treated area, as the model assumes. Refer to Table 28 for
additional specific labeling language.
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Terrestrial Plants
There are some risks of concern to the Agency for effects to non-target terrestrial plants.
The highest RQ estimates for effects to terrestrial plants resulted from combined runoff and drift;
however, the majority of RQs exceeded the LOCs even for drift alone at the typical application
rate (0.75 Ib ae 2,4-DP-p/A). As conservative assumptions were made in the assessment, some
RQ estimates may be overestimating potential risks. The majority of 2,4-DP-p usage is applied
to residential lawns, which are typically adjacent to other lawns, rather than wetlands or other
habitats of non-target plants that are used in the models. Because the predominant use of 2,4-
DP-p products are on residential turf, 2,4-DP-p movement from a treated area is more likely to
move onto adjacent hard surfaces (i.e., sidewalks and streets) and into storm sewers or receiving
water bodies, rather than to an adjacent wetland or wild habitat as presumed in the model.
Additional assumptions that may overestimate the potential amount of 2,4-DP-p transported via
runoff and drift are as follows: a maximum use rate of 6.0 Ibs ae 2,4-DP-p/A and the highest
typical application rate of 0.75 ae 2,4-DP-p/A; a default half-life of 35 days in the modeling;
assuming exposure to terrestrial plants from an application applied to one hectare; and exposure
to semi-aquatic plants based on a 10 hectare application.
Specific to spray drift, risk is estimated in two ways: the amount of pesticide that could
be deposited onto non-target plant surfaces and the distance from the target application area
where pesticide drift could occur. Droplet size can influence the distance a pesticide drifts from
the target area. Spray drift was assessed based on fine to medium-coarse droplet sizes that can
occur from aerial applications and/or those made using a high ground boom (four feet above the
canopy). Most applications are made using handheld or broadcast sprayers, such as hand-wand
sprayers, Ready-to-Use, and hose-end liquid products. These application methods produce a
coarser droplet size and are applied closer (15-30 inches) to the ground, rather than applications
made with a high boom sprayer. Furthermore, the registrants are not supporting aerial
applications of 2,4-DP-p. Applications made to a residential lawn are more likely to drift to
adjacent lawns, rather than onto a wetland or wild habitat as presumed in the model. Because the
majority of 2,4-DP-p usage is applied to ornamental turf, the likelihood of the drift movement is
to similar turf areas. Likewise in the runoff assessment, the reduction in rates, restricting droplet
size to medium- to coarse-sized droplets, and prohibiting aerial application will reduce the
amount of 2,4-DP-p deposited via spray drift.
Even considering all these factors that could over-estimate movement of runoff and drift
onto non-target areas, there are still risks of concern for non-target plants, specifically in or next
to golf courses, adjacent to sod farms, and forests. To reduce the potential for non-target
exposures, the Agency is imposing rate reductions to 0.75 Ib ae 2,4-DP-p for broadcast
treatments. Spot treatments are restricted to applications no greater than 1,000 ft2/A at the
maximum rate of 2.0 Ibs ae 2,4-DP-p/A; thus, the 2.0 Ibs ae 2,4-DP-p/A rate would not be
applied to an entire acre. Because spot treatments are expected to be very small treatment areas
(no greater than 100 ft2 per 5,000 ft2), concentrated products (liquid and soluble) will have
dilution directions for the respective broadcast or spot treatments that specify the quantity
(volume) of diluted solution for the respective size of the treatment area. Applying liquid
products using medium-to-coarse droplets reduces the amount of spray drift from target areas.
Aerial applications would result in the greatest distance of spray drift away from the target area;
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however, registrants are no longer supporting this application. Thus, aerial applications will be
prohibited for products containing 2,4-DP-p. With the implementation of these mitigation
measures and labeling requirements, movement of 2,4-DP-p to non-target areas will be reduced.
The Agency has conducted this assessment with the available vegetative vigor and seedling
emergence studies that were conducted using the technical product. To confirm the Agency's
assumption that the toxicity of the end-use product is the same as the technical product, EPA is
requiring additional seedling emergence and vegetative vigor studies conducted with the end-use
product containing 2,4-DP-p. Refer to Table 28 for the mitigation measures required respective
to the risks of concern and Table 29 for specific labeling language.
b. Aquatic Organisms
Fish and Aquatic Invertebrates
Based on available acute toxicity data, there are no exceedances of the Agency's LOCs
for fish and aquatic and aquatic invertebrates. Although no chemical-specific data were
available to assess potential chronic risks to fish and aquatic invertebrates, the Agency compared
potential chronic effects to aquatic animals based on available data conducted with other
chlorophenoxy compounds. Based on available chronic data on fish and invertebrates in
freshwater and marine/estuarine environments, 2,4-D poses low potential for chronic toxicity.
Additionally, 2,4-DP-p exhibits low acute toxicity potential to fish and other aquatic animals.
Thus, no additional data is needed at this time.
Aquatic Plants
Based on available data for aquatic plants, there are no risks of concern to the Agency
with the exception of one exceedance identified for endangered non-vascular plants. The LOG
was exceeded for non-vascular plants based on an aerial application scenario applying 6.0 Ibs ae
2,4-DP-p/A. In addition to the reduction in the maximum application rate to 2.0 Ibs ae 2,4-DP-
p/A, aerial applications will be prohibited for products containing 2,4-DP-p. Thus, there are no
longer any exceedances of concern for non-vascular plants. Thus, no mitigation is needed at this
time.
c. Endangered Species
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on endangered and threatened species and to
implement mitigation measures that address these impacts. The Endangered Species Act (ESA)
requires federal agencies to ensure that their actions are not likely to jeopardize listed species or
adversely modify designated critical habitat. To analyze the potential of registered pesticide uses
that may affect any particular species, EPA uses basic toxicity and exposure data and considers
ecological parameters, pesticide use information, geographic relationship between specific
pesticide uses and species locations, and biological requirements and behavioral aspects of the
particular species. When conducted, these analyses take into consideration any regulatory
changes recommended in this RED being implemented at that time.
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The ecological assessment that EPA conducted for this RED does not, in itself, constitute
a determination as to whether specific species or critical habitat may be harmed by the pesticide.
Rather, this assessment serves as a screen to determine the need for any species-specific
assessment that will evaluate whether exposure may be at levels that could cause harm to
specific listed species and their critical habitat. The species-specific assessment refines the
screening-level assessment to take into account information such as the geographic area of
pesticide use in relation to the listed species and the habits and habitat requirements of the listed
species. If the Agency's specific assessments for 2,4-DP-p result in the need to modify use of
the pesticide, any geographically specific changes to the pesticide's registration will be
implemented through the process described in the Agency's Federal Register Notice (54 FR
27984) regarding implementation of the Endangered Species Protection Program.
Based on EPA's screening level assessment for 2,4-DP-p, RQs exceed the LOCs for
mammals, birds, and terrestrial plants. Additionally, chronic effects to fish and aquatic
invertebrates cannot be precluded from concern for potentially affected endangered species.
However, these findings are based solely on EPA's screening-level assessment and do not
constitute "may affect" findings under the ESA. A determination that there is a likelihood of
potential effects to a listed species may result in limitations on the use of the pesticide, other
measures to mitigate any potential effects, and/or consultations with the Fish and Wildlife
Service or National Marine Fisheries Service, as necessary. If the Agency determines use of 2,4-
DP-p "may affect" listed species or their designated critical habitat, EPA will employ the
provisions in the Services regulations (50 CFR Part 402). The Agency is requiring additional
data to further characterize and refines its ecological and endangered species risk assessments.
D. Labeling Requirements
In order to be eligible for reregi strati on, various use and safety information will be
included in the labeling of all end-use products containing 2,4-DP-p. For the specific labeling
statements, refer to Table 28 of this RED document.
E. Import Tolerance
2,4-DP-p is not registered for any food uses in the United States. The Agency is aware of
the use of 2,4-DP-p on food commodities, specifically on grains, in Europe and Canada. The
2,4-DP-p Task Force provided data to the Pest Management Regulatory Agency (PMRA) in
Canada that showed all grain samples collected at normal crop maturity showed no detectable
residues (<0.005 ppm) of 2,4-DP-p. Therefore, no import tolerance is required.
F. Endocrine Disruption
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other such endocrine effects as the Administrator may designate. "
Following the recommendations of its Endocrine Disrupter Screening and Testing Advisory
Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of
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the program, androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. When the appropriate screening and/or testing protocols being
considered under the Agency's Endocrine Disrupter Screening Program (EDSP) have been
developed and vetted, 2,4-DP-p may be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption.
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V. What Registrants Need to Do
For 2,4-DP-p technical-grade active ingredient products, registrants need to submit the
following items.
Within 90 days from receipt of the generic data call-in (GDCI):
(1) completed response forms to the GDCI (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 GDCI, cite any existing generic data which
addresses data requirements or submit new generic data responding to the GDCI. Please contact
Rosanna Louie at (703) 308-0037 with questions regarding generic reregi strati on and/or the DCI.
All materials submitted in response to the GDCI should be addressed:
By U.S. mail: By express or courier service:
Document Processing Desk (DCI/SRRD) Document Processing Desk (DCI/SRRD)
Rosanna Louie Rosanna Louie
U. S. EPA (7508P) U. S. EPA (7508P)
1200 Pennsylvania Ave., NW 2777 South Crystal Drive
Washington, D.C. 20460 Arlington, VA 22202
For end-use products containing the active ingredient 2,4-DP-p, registrants need to
submit the following items for each product.
Within 90 days from receipt of the product-specific data call-in (PDCI):
(1) completed response forms to the PDCI (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 eight months from receipt of the PDCI:
(1) submit two copies of the confidential statement of formula, EPA form 8570-4;
(2) a completed original application for reregi strati on (EPA form 8570-1). Indicate
on the form that it is an "application for reregi strati on";
(3) five copies of the draft label incorporating all label amendments outlined in Table
27 of this document;
(4) a completed form certifying compliance with data compensation requirements
(EPA Form 8570-34);
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(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 Bonnie Adler at 703-308-8523 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed:
By U.S. mail:
Document Processing Desk (DCI/SRRD)
Bonnie Adler
U.S. EPA(7508P)
1200 Pennsylvania Ave., NW
Washington, D.C. 20460
A. Manufacturing Use Products
By express or courier service:
Document Processing Desk (DCI/SRRD)
Bonnie Adler
U.S. EPA(7508P)
2777 South Crystal Drive
Arlington, VA 22202
1.
Additional Generic Data Requirements
The generic database supporting the reregi strati on of 2,4-DP-p for currently registered
uses has been reviewed and determined to be substantially complete. However, confirmatory
data is required in some instances. The Agency has conducted this assessment with the available
vegetative vigor and seedling emergence studies that were conducted using the technical product.
To confirm the Agency's assumption that the toxicity of the end-use product is the same as the
technical product, EPA is requiring additional seedling emergence and vegetative vigor studies
conducted with the end-use product containing 2,4-DP-p, and these are listed below.
OPPTS Guideline Number
(old) (new)
Not available 830.7050
123-l(a) 850.4225
123-l(b) 850.4250
Study, Test Species
UV/Visible Absorption
Seedling germination/seedling emergence (Tier II)
Vegetative Vigor (Tier II)
2. Labeling for Manufacturing-Use Products
To ensure compliance with FIFRA, manufacturing-use product (MUP) labeling should be
revised to comply with all current EPA regulations, PR Notices, and applicable policies. The
MUP labeling should bear the specific labeling language shown in Table 28.
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B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The Registrant
must review previous data submissions to ensure that they meet current EPA acceptance criteria
and if not, commit to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product. The Agency intends to issue a separate product-specific data call-in (PDCI), outlining
specific data requirements. For any questions regarding the PDCI, please contact Bonnie Adler
at 703-308-8523.
2. Labeling for End-Use Products
To be eligible for reregi strati on, labeling changes are necessary to implement measures
outlined in Section IV above. Specific language to incorporate these changes is specified in
Table 28. Generally, conditions for the distribution and sale of products bearing old
labels/labeling will be established when the label changes are approved. However, specific
existing stocks time frames will be established case-by-case, depending on the number of
products involved, the number of label changes, and other factors.
C. Labeling Changes Summary Table
In order to be eligible for reregi strati on, amend all product labels to comply with the
following table. Table 28 shows how language on the labels should be amended.
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Table 28. 2,4-DP-p Labeling Requirements Table
Description
Dichlorprop-p (2,4-DP-p): Required Labeling Language
Placement on Label
Manufacturing-Use Products
For all Manufacturing
Use Products
One of these
statements may be
added to a label to
allow reformulation of
the product for a
specific use or all
additional uses
supported by a
formulator or user
group.
Environmental
Hazards Statements
Required by the RED
and Agency Label
Policies
"Only for formulation as an herbicide for the following use(s) [fill blank only
with those uses that are being supported by MP registrant]."
"Only for formulation into end-products with directions for use that prohibit
aerial application."
"Only for formulation into end-products with directions for use that prohibit
broadcast applications greater than 0.75 Ib ae 2,4-DP-p/A."
"Only for formulation into end-use products with directions for use that
prohibit spot treatment applications greater than 2.0 Ibs ae 2,4-DP-p/A."
Must only be formulated into Ready-to-Use spray containers that produce
droplets that are medium or coarse in size according to the ASAE (S572)
definition for standard nozzles.
"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)."
"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."
Directions for Use
Directions for Use
Directions for Use
End-Use Products Intended for Occupational Use (WPS andNon-WPS)
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PPE Requirements
Established by the
RED for all
formulations except for
wettable powder,
granular, and Ready-
to-Use formulations
"Personal Protective Equipment (PPE)
All mixers, loaders, applicators, and other handlers must wear the following
PPE:
- long-sleeved shirt and long pants, and
- shoes plus socks."
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
PPE Requirements
Established by the
RED for wettable
powder formulations
"Personal Protective Equipment (PPE)
All mixers, loaders, applicators, and other handlers must wear the following
PPE:
- long-sleeved shirt and long pants, and
- shoes plus socks."
"In addition, mixers and loaders supporting handgun applications must wear
a NIOSH-approved dust/mist filtering respirator with NIOSH/MSHA
approval number prefix TC-21C or a NIOSH-approved respirator with any
N**,R,P or HE filter."
* Instruction to Registrant: Drop the "N" type prefilter from the respirator
statement, if the pesticide product contains, or is used with, oil.
See engineering controls statements for exceptions to these requirements.
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
PPE Requirements
Established by the
RED for granular
formulations
"Personal Protective Equipment (PPE)
All loaders, applicators, and other handlers must wear the following PPE:
- long-sleeved shirt and long pants, and
- shoes plus socks."
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
PPE Requirements
Established by the
RED for Ready-to-
Use formulations
"Personal Protective Equipment (PPE)
All applicators and other handlers must wear the following PPE:
- long-sleeved shirt and long pants, and
- shoes plus socks."
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
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Engineering Controls
for wettable powder
products
"Engineering Controls
Water-soluble packets when used correctly qualify as a closed
mixing/loading system under the Worker Protection Standard for Agricultural
Pesticides [40 CFR 170.240(d)(4)]. Mixers and loaders using water-soluble
packets must:
~ wear long-sleeved shirt, long pants, and shoe plus socks, and
~ if they are supporting handgun applications, be provided and must have
immediately available for use in an emergency, such as a broken package,
spill, or equipment breakdown: aNIOSH-approved dust/mist filtering
respirator with NIOSH/MSHA approval number prefix TC-21C or a NIOSH-
approved respirator with any N**, R, P or HE filter."
* Instruction to Registrant: Drop the "N" type prefilter from the respirator
statement, if the pesticide product contains, or is used with, oil.
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
Restricted Entry
Interval for products
with WPS uses
"Do not enter or allow worker entry into treated areas during the restricted
entry interval (REI) of 48 hours."
Directions for Use, Agricultural Use
Requirements Box
Early Entry Personal
Protective Equipment
for products 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 as follows:
- coveralls,
- shoes plus socks,
- chemical-resistant gloves made of any waterproof material, and
- protective eyewear."
Directions for Use, Agricultural Use
Requirements Box
General Application
Restrictions
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may be in
the area during application."
Place in the Direction for Use directly
above the Agricultural Use Box.
Entry Restrictions for
Non-WPS Uses for
Products Applied as a
Spray
"Do not enter or allow entry until sprays have dried."
Directions for Use Under General
Precautions and Restrictions. If the
product also contains WPS uses, then
create a Non-Agricultural 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
Non-WPS Uses for
Granular Products
If the product does not have instructions for watering in, include the
following statement:
"Do not enter or allow entry to the treated area until dusts have settled."
If the product has instructions for watering in, include the following
statement:
"Do not enter or allow entry to the treated areas (except those involved in the
watering) until the watering in is complete and the surface is dry."
Directions for Use Under General
Precautions and Restrictions. If the
product also contains WPS uses, then
create a Non-Agricultural Use
Requirements box as directed in PR
Notice 93-7 and place the appropriate
statement inside that box.
User Safety
Requirement
"Follow manufacturer's instructions for cleaning/maintaining PPE. jf no
such instructions for washables exist, use detergent and hot water. Keep and
wash PPE separately from other laundry."
"Discard clothing and other absorbent material that have been drenched or
heavily contaminated with the product's concentrate. Do not reuse them."
Precautionary Statements: Hazards to
Humans and Domestic Animals
Immediately following the PPE
requirements
User Safety
Recommendations
"USER SAFETY RECOMMENDATIONS"
"Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
"Users should remove clothing/PPE immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing."
"Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible, wash thoroughly
and change into clean clothing."
Precautionary Statements: Hazards to
Humans and Domestic Animals
immediately following Engineering
Controls
(Must be placed in a box.)
Environmental Hazard
Statement
"This pesticide may adversely affect non-target plants. Do not apply directly
to water, to areas where surface water is present, or to intertidal areas below
the mean high water mark. Do not 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
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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 or per 1,000
square feet, not just as
pounds acid equivalent
per acre.)
Other Application
Restrictions
General Application
Restrictions
For broadcast treatments:
Limited to 2 applications per year.
Maximum of 0.75 Ib ae 2,4-DP-p/A per application (or the respective Ib ae
2,4-DP-p/ 1,000 ft2).
Minimum of 30 days between applications."
For spot treatments for all use sites:
Limited to 2 applications per year.
Maximum of 2.0 Ibs ae 2,4-DP-p/A per application (or the respective Ib ae
2,4-DP-p/ 1,000 ft2).
Minimum of 30 days between applications.
Broadcast application is prohibited at this use rate."
Spot treatment is defined as a treatment area no greater than 1,000 ft2 per
acre.
"Aerial application of this product is prohibited."
"Do not use this product on or near desirable plants, including within the
dripline of the roots of desirable trees and shrubs, since injury may result."
Directions for
Use Associated with
the Specific Use Pattern
Directions for
Precautions
Directions for
Precautions
Use under Other Use
Use under Other Use
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Spray Drift
Management
"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.
groundboom, sprayer) can influence pesticide drift. The applicator must
evaluate all factors and make appropriate adjustments when applying this
product."
Droplet Size:
"Use only Medium or coarser spray nozzles according to ASAE (S572)
definition for standard nozzles."
Wind Speed
"Do not apply at wind speeds greater than 10 mph."
Temperature Inversions:
"If applying at wind speeds less than 3 mph, the applicator must determine if
1) conditions of temperature inversion exist, or 2) stable atmospheric
conditions exist at or below nozzle height. Do not make applications into
areas of temperature inversions or stable atmospheric conditions."
Additional Requirements for groundboom application:
"Do not apply with a nozzle height greater than four feet above the target
site."
Directions for Use under Use
Precautions
End-Use Products Intended for Residential Use
Application
Restrictions
Entry Restrictions for
products applied as a
spray
"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."
"Do not allow people or pets to enter the treated area until sprays have
dried."
Directions for use under General
Precautions and Restrictions
Directions for use under General
Precautions and Restrictions
50
-------
Entry Restrictions for
granular formulations
If the product does not have instructions for watering in:
"Do not allow people or pets to enter the treated area until dusts have
settled."
If the product has instructions for watering in:
"Do not enter or allow others (including children or pets) to enter the treated
areas (except those involved in the watering) until the watering-in is
complete and the surface is dry."
Directions for use under General
Precautions and Restrictions
Environmental Hazard
Statement for
Residential Use labels
"This pesticide may adversely affect non-target plants. Do not apply directly
to water. Do not contaminate water when disposing of equipment wash
waters or rinsate."
Precautionary Statements
immediately following the User
Safety Recommendations
Other Application
Restrictions
See the "General Application Restrictions" listed above for requirement for
all products.
In addition also add:
"Do not apply as a fine mist because of potential injury to desirable plants."
Directions for Use under Other Use
Precautions
51
-------
Other Application
Restrictions
Requirements for Granular Formulations:
"Do not apply directly to or near water, storm drains, gutters, sewers, or
drainage ditches. Do not apply within 25 feet of rivers, fish ponds, lakes,
streams, reservoirs, marshes, estuaries, bays, and oceans. Do not apply when
windy. Apply this product directly to your lawn or garden, and sweep any
product landing on the driveway, sidewalk, gutter, or street, back onto the
treated area. To prevent product run-off, do not over water the treated area to
the point of runoff or apply when raining or when rain is expected that day."
Requirements for Liquid and Dust products (excludes Ready to Use
Products):
"Do not apply directly to or near water, storm drains, gutters, sewers, or
drainage ditches. Do not apply within 25 feet of rivers, fish ponds, lakes,
streams, reservoirs, marshes, estuaries, bays, and oceans. Do not apply when
windy. To prevent product run-off, do not over water the treated area(s) to
the point of runoff or apply when raining or when rain is expected that day.
Rinse applicator over lawn or garden area only."
Requirements for Ready to Use Formulations labeled or intended for
outdoor use:
"Do not apply directly to or near water, storm drains, gutters, sewers, or
drainage ditches. Do not apply within 25 feet of rivers, fish ponds, lakes,
streams, reservoirs, marshes, estuaries, bays, and oceans. Do not apply when
windy. To prevent product run-off, do not over water to the point of runoff,
or apply when raining or when rain is expected that day."
Directions for Use under Other Use
Precautions
52
-------
APPENDIX A. Use Patterns Eligible for Reregistration
Table of 2,4-DP-p Use Patterns Eligible for Reregistration (Case #0249)
Use Site
Ground Broadcast
Treatments to:
residential turf,
ornamental turf (e.g.,
golf courses,
cemeteries, parks,
sports fields, and
turfgrass), sod farms,
and uncultivated non-
agricultural areas
(e.g., roadsides and
rights-of-ways)
Spot Treatments (for
woody plants and
brush management)
in uncultivated non-
agricultural areas
(e.g., utility power
lines, hedgerows,
industrial sites,
ditches, airports, and
fence rows)
Formulations
2,4-DP-p acid:
granular,
concentrate, water-
soluble dry
concentrate, and
wettable powder
2,4-DP-p DMAS:
granular, water-
soluble liquid
concentrate and
water-soluble
concentrate dry
2,4-DP-p EHE:
granular and
emulsifiable
concentrate
Typical
Application
Rate
0.20-0.50
Ib ae/A
Not
applicable
Maximum
Application
Rate
0.75 Ib ae/A
Concentration
equivalent up
to 2.0 Ibs
ae/A
Restrictions
Maximum of 2
applications per
year
- Treatment areas
no greater than
100 feet (linear
or square feet)/A
- Maximum of 2
applications per
year
Timing
Post-
emergence
Restricted
Entry
Interval
48 hours
Application
Equipment
Boom sprayer,
handheld nozzle
sprayer, wand
sprayer, knapsack
sprayer, and
granular spreader
Handheld nozzle
sprayer, wand
sprayer, knapsack
sprayer, and
granular spreader
Ib ae/A = pound of acid equivalent per acre
53
-------
APPENDIX B. Data Supporting Guideline Requirements for 2,4-DP-p
Data Supporting Guideline Requirements for the Reregistration of Dichlorprop-p (2,4-DP-p)
PRODUCT CHEMISTRY
New
Guideline
Number
830.1550
830.1600
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7050
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
830.7550
830.7000
830.6313
830.6314
830.6315
830.6316
830.6317
830.7100
830.6319
830.6320
Old
Guideline
Number
61-1
61-2a
61-2b
62-1
62-2
62-3
63-2
63-3
63-4
None
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Study Description
Product Identity and Composition
Starting Materials & Manufacturing
Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
UV/Visible Absorption
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition Coefficient
pH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion characteristics
Use
Pattern
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
Citation(s)
46591916
46591916
46591916
46591916
46591916
46591916
42845001
42916202
46591916
ECOLOGICAL EFFECTS
850.2100
850.2200
71-la
71-2a
Avian Acute Oral Toxicity - Quail
Avian Dietary Toxicity - Quail
All
All
42987901
43867601
44090001
43220201
43220202
43227401
43227402
43811401
54
-------
Data Supporting Guideline Requirements for the Reregistration of Dichlorprop-p (2,4-DP-p)
850.2200
850.2300
850.1075
850.1075
850.1010
850.5400
850.4225
850.4250
850.4400
71-2b
71-4a
72-la
72-lc
72-2a
122-2
123-la
123-lb
123-2
Avian Dietary Toxicity - Duck
Avian Reproduction - Quail
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity - Water flea
Aquatic Plant Growth
Seed Germ./ Seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
All
All
All
All
All
All
All
All
All
43227401
43220202
46879201 - supplemental
42767002
42767004
44580101
42767001
42767003
42971101
43867603
44030301
46613901 -supplemental
42665701
43016702 - supplemental
43279202 (oat) - supplemental
43525801
Note: additional data needed
conducted with end-use
product
43016701 -supplemental
43016702 - supplemental
43279201 (corn) - supplemental
42595901
42595902
42665701
42681001
46856701
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
81-1
81-2
81-3
81-4
81-5
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
All
All
All
All
All
40955602
42614601
42614602
42985308
40955603
42614603
42614604
42985309
41231201
42914501
42937001
42985310
40955605
42729101
42985311
40955604
42729102
42729103
42985312
55
-------
Data Supporting Guideline Requirements for the Reregistration of Dichlorprop-p (2,4-DP-p)
870.2600
870.6200
870.3100
870.3150
870.3200
870.6200
870.4100
870.4100
870.4200
870.4200
870.3700
870.3700
870.3800
870.4300
870.5140
870.5375
None
870.7485
81-6
81-8-SS
82-la
82-lb
82-2
82-7
83-la
83-lb
83-2a
83-2b
83-3a
83-3b
83-4
83-5
84-2a
84-2b
84-4
85-1
Dermal Sensitization
Acute Neurotoxicity Screen
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21 -Day Dermal - Rabbit/Rat
Neurotoxicity Screening Battery
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity -
Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Combined Chronic Toxicity/
Carcinogenicity
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
Metabolism and Pharmacokinetics
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
40982202
42955401
43749701
43749702
43749703
43770901
43915101
00116494
00250351
41653801
43103201
43915101
43462601
43103201
42914301
43706401
43634401
43915101
00146394
44638401
00146394
44888201
44900801
42845805
42845804
46721401 (racemic 2,4-DP)
46591904
00146394
42985313
42985315
42985316
42860301
42860303
44900802
40581901
41646803
42985314
43189401
42985314
44900802
43113301
42937005
00116493
44187601
44187602
OCCUPATIONAL/RESIDENTIAL EXPOSURE
56
-------
Data Supporting Guideline Requirements for the Reregistration of Dichlorprop-p (2,4-DP-p)
835.2110
835.2120
835.2240
835.2410
835.2370
835.4100
835.1240
835.6100
None
161-1
161-1
161-2
161-3
161-4
162-1
163-1
164-1
165-4
Hydrolysis as a function of pH
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Photodegradation - Air
Aerobic Soil Metabolism
Leaching/Adsorption/Desorption
Terrestrial Field Dissipation
Bioaccumulation in Fish
All
All
All
All
All
All
All
All
All
46591911
42683001
42917601
42937006
43101501
42899601
Not required
42935301
44028901
44130103
Not Required
OTHER
850.3020
141-1
Honey Bee Acute Contact
All
42204601
42621801
46591910
57
-------
APPENDIX C. Technical Support Documents
Additional documentation in support of the 2,4-DP-p RED is maintained in the OPP
Regulatory Public Docket, located in Room S-4400 One Potomac Yard (South Building), 2777
S. Crystal Drive, Arlington, VA. It is open Monday through Friday, excluding legal holidays,
from 8:30 a.m. to 4:00 p.m. All documents may be viewed in the OPP Docket room or viewed
and/or downloaded via the Internet at http://www.regulations.gov. The Agency's documents in
support of this RED include the following:
1. Smegal, D., et al. 2-(2,4-dichlorophenoxy) R-propionic acid (2,4-DP-p), its salts and
esters. HED Human Health Risk Assessment. August 13, 2007.
2. Lloyd, M. 2,4-DP-p: Occupational and Residential Exposure Assessment for the
Reregi strati on Eligibility Decision. April 3, 2007.
3. Lloyd, M. 2,4-DP-p: Refined Occupational and Residential Exposure Assessment of
Granular Products for the Reregi strati on eligibility Decision. August 7, 2007.
4. Hetrick, J. FQPA Drinking Water Assessment for Dichlorprop-p. April 12, 2007.
Environmental Fate and Effects Science Chapter for 2,4-DP-p acid, 2,4-DP-p DMAS,
and 2,4-DP-p EHE. August 24, 2007.
5. Janson, M., et al. Environmental Fate and Effects Science Chapter for 2,4-DP-p acid,
2,4-DP-p DMAS, and 2,4-DP-p EHE. August 24, 2007.
6. Phillips, W., Lee, A. A Preliminary evaluation of Mecoprop (MCPP-p) and Dichlorprop
(2,4-DP-p) Use and Potential Alternatives. August 21, 2007.
58
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APPENDIX D. Bibliography
In addition to the studies listed in Appendix B, this bibliography contains additional
citations considered to be part of the database supporting the reregi strati on decision for 2,4-DP-
P-
116493 Gilbert, C.; Hopkins, R.; Bibby, M.; et al. (1978) The Metabolic Fate of (14C)-Dichlorprop
(DL-2-(2,4-Dichloro (Ring-u-14C) Phenoxy) Propionic Acid) in the Rat: Report No. 1313R2-
277/1. (Unpublished study received Mar 28, 1979 under 264-222; prepared by Hazleton
Laboratories Europe Ltd., Eng., submitted by Union Carbide Agricultural Products Co., Inc.,
Research Triangle Park, NC; CDL:237982-A)
116494 Til, H.; Leegwater, D.; Kuper, F. (1977) Sub-chronic (90-day) Oral Toxicity Study with 2,4-
DP in Rats: Report No. R 5419/a. Final rept. (Unpublished study received March 28, 1979
under 264-222; prepared by Centraal Instituut Voor Voedingsonderzoek TNO, Neth.,
submitted by Union Carbide Agricultural Products Co., Inc., Research Triangle Park, NC;
CDL:237985-A; 237984)
146394 Mitsumori, K. (1984) 2,4-DP Acid (2-(2,4-dichlorophenoxy)propanoic Acid): 24-Month Oral
Chronic Dietary Study in Rats: Final Rept. Unpublished study prepared by The institute of
Environmental Toxicology. 1069 p.
40581901 Murli, H. (1988) Mutagenicity Test on 2,4-DP Tech in an in vitro Cytogenetic Assay
Measuring Chromosomal Aberration Frequencies in Chinese Hamster Ovary (CHO) Cells:
HLA Study No. 10158-0-437. Unpublished study prepared by Hazleton Laboratories America,
Inc. 28 p.
40955602 Kirsch, P. (1983) Report on the Study of the Acute Oral Toxicity in Rats of 2,4-DP
(Dichlorprop) (D-Form): Document No. BASF: 84/0032. Unpublished study prepared by
BASFAg. 13 p.
40955603 Kirsch, P. (1984) Report on the Study of the Acute Dermal Toxicity in Rats of 2,4-DP
Dichlorprop (D-Form): Document No. 84/0153. Unpublished study prepared by BASF Ag. 12
P-
40955604 Kirsch, P. (1983) Report on the Study of the Irritation to the Intact and Abraded Dorsal Skin of
the White Rabbit Based on Draize of 2,4-DP (Dichlorprop) (D-Form): Document No. 84-
0034. Unpublished study prepared by BASF Ag. 10 p.
40955605 Kirsch, P. (1983) Report on the Study of the Irritation to the Eye of the White Rabbit Based on
Draize of 2, 4-DP (Dichlorprop) (D-Form): Document No. BASF: 84/0035. Unpublished study
prepared by BASF Ag. 10 p.
40982202 Kirsch, M. (1984) Report on the Study on the Sensitizing Effect of 2,4-DP in the Guinea Pig
Maximization Test: Doc. No. BASF 84/0245. Unpublished study prepared by BASF
Aktiengesellschaft. 36 p
41231201 Klimisch, H. (1989) Report on the Acute Inhalation Toxicity LC50 4 Hours (Rat; Dust Aerosol
Study of 2,4-DP; D-Form): Doc. No. 87/0359. Unpublished study prepared by BASF
Aktiengesellschaft. 23 p.
41646803 Engelhardt, G. (1985) Mutagenicity Testing: Cytogenetic Investigations of 2,4-DP in Chinese
Hamsters - Sister Chromatid Exchange: Lab Project Number: 16M0048/8309: 85/0096.
Unpublished study prepared by BASF Aktiengesellschaft. 40 p.
59
-------
41653801 Kuhborth, B. (1987) Subchronic Testing-Oral Toxicity of the D-Form of 2,4-DP in Rats: Oral
Administration in the Diet over 3-Months: Lab Project Number: 31S0495/8594: 88/0537.
Unpublished study prepared by BASF Aktiengesellschaft. 357 p.
42204601 Hoxter, K.; Lynn, S. (1992) 2,4-DP-p 2-EHE: An Acute Contact Toxicity Study with the
Honey Bee: Lab Project Number: 147-145A. Unpublished study prepared by Wildlife
International Ltd. 31 p.
42595901 Hoberg, J. (1992) 2,4-DP-p DMAS-Toxicity to the Marine Diatom, Skeletonema Costatum:
Final Report: Lab Project Number: 92-4-4220: 10566.1191.6212.450. Unpublished study
prepared by Springborn Laboratories, Inc. 64 p.
42595902 Hoberg, J. (1992) 2,4-DP-p DMAS-Toxicity to the Freshwater Green Alga, Selenastrum
capricornutum: Final Report: Lab Project Number: 92-6-4290: 10566.1191.6212.430.
Unpublished study prepared by Springborn Laboratories, Inc. 65 p.
42614601 Allan, S. (1992) Acute Oral Toxicity to Rats of 2,4-DP-p-DMAS: Lab Project Number:
920501D/JEL 36/AC. Unpublished study prepared by Huntingdon Research Centre, Ltd. 25 p
42614602 Allan, S. (1992) Acute Oral Toxicity to Rats of 2,4-DP-p-2EHE: Lab Project Number:
920505D/JEL 37/AC. Unpublished study prepared by Huntingdon Research Centre, Ltd. 25 p.
42614603 Denton, S. (1992) Acute Dermal Toxicity to Rabbits of 2,4-DP-p-DMAS: Lab Project
Number: 920676D/JEL 38/AC. Unpublished study prepared by Huntingdon Research Centre,
Ltd. 20 p.
42614604 Denton, S. (1992) Acute Dermal Toxicity to the Rabbit of 2,4-DP-p-2EHE: Lab Project
Number: 920622D/JEL 39/AC. Unpublished study prepared by Huntingdon Research Centre,
Ltd. 20 p.
42621801 Hoxter, K.; Smith, G. (1992) 2,4-DP-p DMAS: An Acute Contact Toxicity Study with the
Honey Bee: Lab Project Number: 147-154. Unpublished study prepared by Wildlife
International Ltd. 29 p.
42665701 Hoberg, J. (1992) Toxicity to the Freshwater Diatom, Navicula pelliculosa: 2,4-DP-p DMAS:
Final Report: Lab Project Number: 92-10-4460: 10566.1191.6212.440. Unpublished study
prepared by Springborn Labs., Inc. 71 p.
42681001 Hoberg, J. (1992) 2,4-DP-p DMAS-Toxicity to the Freshwater Blue-Green Alga, Anabaena
flos-aquae: Lab Project Number: 92-7-4318: 10566.1191.6212.420. Unpublished study
prepared by Springborn Laboratories, Inc. 63 p.
42683001 Lai, I. (1993) Hydrolysis of (carbon 14)-2,4-DP-p Acid in Buffered Aqueous Solutions: Final
Report: Lab Project Number: SC910083. Unpublished study prepared by Battelle Memorial
Institute. 76 p.
42729101 Liggett, M. (1992) Eye Irritation to the Rabbit of 2,4-DP-p-2EHE: Lab Project Number:
920825D/JEL 74/SE. Unpublished study prepared by Huntingdon Research Centre Ltd. 14 p.
42729102 Liggett, M. (1992) Skin Irritation to the Rabbit of 2,4-DP-p-DMAS: Lab Project Number:
920814D/JEL 75/SE. Unpublished study prepared by Huntingdon Research Centre Ltd. 14 p.
42729103 Liggett, M. (1992) Skin Irritation to the Rabbit of 2,4-DP-p-2EHE: Lab Project Number:
920819D/JEL 76/SE. Unpublished study prepared by Huntingdon Research Centre Ltd. 14 p.
60
-------
42767001 Munk, R. (1992) Acute Toxicity Study on the Rainbow Trout (Oncorhynchus mykiss
WALBAUM 1792) of Dichlorprop-p DMA Salt in a Static System (96 Hours): Lab Project
Number: 12F0463/915077. Unpublished study prepared by BASF Aktiengesellschaft. 36 p.
42767003 Munk, R. (1992) Acute Toxicity Study on the Rainbow Trout (Oncorhynchus mykiss
WALBAUM 1792) of Dichlorprop-p 2EHE in a Static System (96 Hours): Lab Project
Number: 12F0384/915067. Unpublished study prepared by BASF Aktiengesellschaft. 42 p.
42767004 Munk, R. (1992) Acute Toxicity Study on the Bluegill (Lepomis macrochirus RAF.) of
Dichlorprop-p DMA Salt in a Static System (96 Hours): Lab Project Number:
14F0463/915078. Unpublished study prepared by BASF Aktiengesellschaft. 37 p.
42845001 Andrews, K. (1993) Special Study: Dissociation of 2,4-DP-p DMAS in Water: Final Report:
Lab Project Number: SC920206. Unpublished study prepared by Battelle Columbus
Operations. 38 p.
42845804 Hellwig, J.; Hildebrand, B. (1993) Prenatal Toxicity of Dichlorprop-p in Rabbits After Oral
Administration (gavage): Lab Project Number: 40RO187/91031: 93/10230. Unpublished study
prepared by BASF Aktiengesellschaft, Department of Toxicology. 326 p.
42845805 Hellwig, J.; Hildebrand, B. (1993) Prenatal Toxicity of Dichlorprop-p in Rats After Oral
Administration (gavage): Lab Project Number: 30R0187/91030: 93/10227. Unpublished study
prepared by BASF Aktiengesellschaft, Department of Toxicology. 388 p.
42860301 Jones, E.; Kitching, J.; Anderson, A.; et al. (1993) Ames Salmonella typhimurium Bacterial
Reverse Mutation Assay on 2,4-DP-p DMAS: Final Report: Lab Project Number: JEL
41/921055. Unpublished study prepared by Huntingdon Research Centre Ltd. 44 p.
42860303 Jones, E.; Kitching, J.; Anderson, A.; et al. (1993) Ames Salmonella typhimurium Bacterial
Reverse Mutation Assay on 2,4-DP-p Acid: Final Report: Lab Project Number: JEL
43/921057. Unpublished study prepared by Huntingdon Research Centre Ltd. 44 p.
42899601 Saxena, A.; Schweitzer, S.; Pena-Cordova, L.; et al. (1993) Photodegradation of (carbon 14)-
2,4-DP-p Acid on a Sandy Loam Soil Under Artificial Sunlight Irradiation: Final Report: Lab
Project Number: SC910085. Unpublished study prepared by Battelle Memori
42914301 Allan, S.; Crook, D.; Gibson, W.; et al. (1993) 21 Day Dermal Toxicity Study in the Rabbit
with 2,4-DP-p Acid: Final Report: Lab Project Number: JEL 40/921532. Unpublished study
prepared by Huntingdon Research Centre Ltd. 114 p.
42914501 Jackson, G.; Molloy, G.; Hardy, C. (1993) Acute Inhalation Toxicity to Rats of 2,4-DP-p
DMAS: Final Report: Lab Project Number: JEL 69/930599. Unpublished study prepared by
Huntingdon Research Centre Ltd. 53 p.
42916202 Cameron, B.; Dinwoodie, N.; MacLean, K. (1992) Establishment and Validation of Method
No. 5117 for the Analysis of 2,4-DP-p in Water and Octanol and Determination of the
Partition Coefficient: Lab Project Number: 7543: 351176. Unpublished study prepared b
42917601 Skinner, W. (1993) Hydrolysis of Optically Active (Carbon 14)-2-(2,4-Dichlorophenoxy)
Propionic Acid 2-Ethylhexyl Ester at pH 5, 7 and 9: Lab Project Number: 406W-1: 406W:
P406W. Unpublished study prepared by PTRL West, Inc. 74 p.
42935301 Blumhorst, M. (1993) Aerobic Soil Metabolism of 2-(2,4-Dichlorophenoxy)proprionic Acid:
Lab Project Number: 135-007: 169-001: EPLBAS-22. Unpublished study prepared by EPL-
Bio-Analytical Services, Inc. 143 p.
61
-------
42937001 Jackson, G.; Molloy, G.; Hardy, C. (1993) Acute Inhalation Toxicity to Rats of 2,4-DP-p
2EHE: Lab Project Number: JEL 70/930600. Unpublished study prepared by Huntingdon
Research Centre Ltd. 61 p.
42937005 Adams, K.; Ransome, S.; Anderson, A. et al. (1993) Chinese Hamster Ovary/HGPRT Locus
Assay: 2,4-DP-p DMAS: Lab Project Number: JEL 64/921618. Unpublished study prepared
by Huntingdon Research Centre Ltd. 42 p.
42937006 Skinner, W. (1993) Hydrolysis of Optically Active (Carbon 14)-2-(2,4-Dichlorophenoxy)
Propionic Acid 2-Ethylhexyl Ester in Soil/Water Systems: Lab Project Number: 407W-1:
407W. Unpublished study prepared by PTRL West, Inc. 85 p.
42955401 Parcell, B. (1993) Skin Sensitisation to the Guinea-Pig of 2,4-DP-p-DMAS: Final Report: Lab
Project Number: 920878D/JEL 79/SS. Unpublished study prepared by Huntingdon Research
Centre, Ltd. 26 p.
42971101 Elendt-Schneider, ?. (1991) Determination of the Acute Toxicity of Dichlorprop-p (Reg. No.
172 365) to the Water Flea Daphnia Magna: Lab Project Number: 1/89/0279/50/1: 91/10117.
Unpublished study prepared by BASF Aktiengesellschaft, Dept. of Toxicology.
42985308 Cummins, H. (1990) Dichlorprop-P: Acute Oral Toxicity Study in the Rat: Lab Project
Number: AMS/007: 90/AMS007/0530: 90/0530. Unpublished study prepared by Life Science
Research Ltd. 36 p.
42985309 Cummins, H. (1990) Dichlorprop-p: Acute Percutaneous Toxicity Study in the Rat: Lab
Project Number: AMS/008: 90/AMS008/0494: 90/0494. Unpublished study prepared by Life
Science Research Ltd. 19 p.
42985310 Cracknell, S. (1990) Dichlorprop-p: Acute Inhalation Toxicity Study in the Rat: Final Report:
Lab Project Number: AMS/014/DICHLORPROP-: 90/AMSO14/0275: 90/0275. Unpublished
study prepared by Life Science Research Ltd. 64 p.
42985311 Smith, K. (1990) Dichlorprop-p: Acute Eye Irritation/Corrosion Test in the Rabbit: Lab
Project Number: AMS/010: 90/AMSO 10/0496: 90/0496. Unpublished study prepared by Life
Science Research Ltd. 21 p.
42985312 Smith, K. (1990) Dichlorprop-p: Acute Dermal Irritation/Corrosion Test in the Rabbit: Lab
Project Number: 90/0495: AMS/009: 90/AMS009/0495. Unpublished study prepared by Life
Science Research Ltd. 20 p.
42985313 Smith, K. (1990) Dichlorprop-p: Assessment of Mutagenic Potential in Histidine Auxotrophs
of Salmonella typhimurium (The Ames Test): Lab Project Number: AMS/011:
90/AMSO 11/0255: 90/0255. Unpublished study prepared by Life Science Research Ltd. 29 p.
42985314 May, K. (1990) In Vitro Assessment of the Clastogenic Activity of Dichlorprop-p in Cultured
Human Lymphocytes: Lab Project Number: AMS/012: 90/AMSO 12/0404: 90/0404.
Unpublished study prepared by Life Science Research Ltd. 30 p.
42985315 Lloyd, J. (1990) Dichlorprop-p: Investigation of Mutagenic Activity at the HGPRT Locus in a
Chinese Hamster V79 Cell Mutation System: Final Report: Lab Project Number: AMS/023:
90/AMS023/0901: 90/0901. Unpublished study prepared by Life Science Research Ltd.
42985316 Edwards, C. (1991) Dichlorprop-p: Assessment of Clastogenic Action on Bone Marrow
Erythrocytes in the Micronucleus Test: Final Report: Lab Project Number: AMS/024:
90/AMS024/1080: 90/1080. Unpublished study prepared by Life Science Research Ltd. 46 p.
62
-------
42987901 Pedersen, C.; Solatycki, A. (1993) 2-(2,4-Dichlorophenoxy) Propionic Acid Dimethylamine
Salt (2,4-DP-P DMAS): 14-Day Acute Oral LD50 Study in Bobwhite Quail: Revised Report:
Lab Project Number: 119-005-03. Unpublished study prepared by Bio-Life Associates
43016701 Maggi, V. (1993) Tier II: The Effects of 2,4-DP-p DMAS on Nontarget Plants: Vegetative
Vigor: Final Report: Lab Project Number: CAR 146-91 A: 654. Unpublished study prepared by
California Agricultural Research, Inc. 171 p.
43016702 Maggi, V. (1993) Tier II: The Effects of 2,4-DP-p DMAS on Nontarget Plants: Seed
Germination/Seedling Emergence and Vegetative Vigor (Tier II): Final Report: Lab Project
Number: CAR 146-9ID: 652.0. Unpublished study prepared by California Agricultural Res
43101501 Saxena, A.; Marengo, J.; Schweitzer, S. et al. (1994) Photodegradation of (carbon 14)-2,4-DP-
p Acid in a Buffered Aqueous Solution Under Artificial Sunlight: Final Report: Lab Project
Number: SC910084. Unpublished study prepared by Battelle Memorial Insti
43103201 Mellert, W. (1993) Subchronic Oral Toxicity Study with Dichlorprop-p Acid in B6C3F1 Mice
Administered in the Diet for 3 Months: Lab Project Number: 35C0001/91001. Unpublished
study prepared by BASF Aktiengesellschaft. 284 p.
43113301 Adams, K.; Kirkpatrick, D.; Anderson, A. et al. (1993) Chinese Hamster Ovary/HGPRT Locus
Assay: 2,4-DP-p Acid: Final Report: Lab Project Number: JEL89/931161. Unpublished study
prepared by Huntingdon Research Centre Ltd. 42 p.
43189401 Heidemann, A. (1994) Chromosome Aberration Assay in Human Lymphocytes in vitro with
Dichlorprop-p Acid: Lab Project Number: 429300. Unpublished study prepared by Cytotest
Cell Research GmbH & Co. KG (CCR). 36 p.
43220201 Campbell, S.; Beavers, J. (1994) A Dietary LC50 Study with the Northern Bobwhite: 2,4-DP-p
2-EHE: Lab Project Number: 147-161. Unpublished study prepared by Wildlife International
Ltd. 42 p.
43220202 Campbell, S.; Beavers, J. (1994) A Dietary LC50 Study with the Mallard: 2,4-DP-p 2-EHE:
Lab Project Number: 147-162. Unpublished study prepared by Wildlife International Ltd. 42
P-
43227401 Pedersen, C. (1994) R(+)2-(2,4-dichlorophenoxy) propionic acid dimethylamine salt (2,4-DP-
p DMAS): 8 Day Acute Dietary LC50 Study in Mallard Ducks: Lab Project Number: 119-004-
02R. Unpublished study prepared by Bio-Life Associates, Ltd. 130 p.
43227402 Pedersen, C. (1994) R(+)2-(2,4-dichlorophenoxy) propionic acid dimethylamine salt (2,4-DP-
p DMAS): 10-Day Acute Dietary LC50 Study in Bobwhite Quail: Lab Project Number: 119-
003-01R. Unpublished study prepared by Bio-Life Associates, Ltd. 151 p.
43279201 Chetram, R. (1994) Tier 2 Vegetative Vigor Nontarget Phytotoxicity Study Using 2,4-DP-p 2-
EHE: Lab Project Number: 653.0: BL91-455: AL-91-144. Unpublished study prepared by
Pan-Agricultural Labs, Inc. 251 p.
43279202 Chetram, R. (1994) Tier 2 Seed Germination/Seedling Emergence Nontarget Phytotoxicity
Study Using 2,4-DP-p 2-EHE: Lab Project Number: 655.0: BL91-456: AL-91-144.
Unpublished study prepared by Pan-Agricultural Labs, Inc. 274 p.
43462601 Hellwig, J. (1994) Report on the Study of the Toxicity of Dichlorprop-p in Beagle Dogs
Administered via the Diet Over 3 Months: Lab Project Number: 31D0187/91091. Unpublished
study prepared by BASF Aktiengesellschaft. 486 p.
63
-------
43525801 Chetram, R.; Cone, C. (1995) Tier 2 Vegetative Vigor Nontarget Phytotoxicity Study Using
2,4-DP-p Acid: Lab Project Number: 94360. Unpublished study prepared by ABC Labs, Pan-
Ag Division. 220 p.
43634401 Kirsch, P.; Deckardt, K.; Gembardt, C. et al. (1995) Study of the Dermal Toxicity of
Dichlorprop-p-DMA Salt in Wistar Rats: Application to the Intact Skin (21 Applications): Lab
Project Number: 37H0463/91130. Unpublished study prepared by BASF Aktiengesel
43706401 Kirsch, P.; Deckardt, K.; Gembardt, C.; et al (1995) Study of the Dermal Toxicity of
Dichlorprop-p-2EH-Ester in Wistar Rats: Application to Intact Skin (21 Applications): Lab
Project Number: 37H0384/91129: 37H0384: 91129. Unpublished study prepared by BASF
Aktiengesellschaft. 195 p.
43749701 Rossbacher, R.; Hellwig, J. (1995) Report on the Maximization Test for the Sensitizing
Potential of Dichlorprop-p in Guinea Pigs: Lab Project Number: 30H0187/912277: PCP
01358: 0195. Unpublished study prepared by BASF Aktiengesellschaft. 46 p.
43749702 Rossbacher, R.; Hellwig, J. (1995) Report on the Maximization Test for the Sensitizing
Potential of 2,4-DP-p-2EH-Ester in Guinea Pigs: Lab Project Number: 3OH0384/912274: CP
2123: PCP02926. Unpublished study prepared by BASF Aktiengesellschaft. 47 p.
43749703 Rossbacher, R.; Hellwig, J. (1995) Report on the Maximization Test for the Sensitizing
Potential of Dichlorprop-p-DMA Salt in Guinea Pigs: Lab Project Number: 30H0463/912276:
0177: RR-DB; 0177. Unpublished study prepared by BASF Aktiengesellschaft. 39 p.
43770901 Mellert, W.; Kaufmann, W.; Hildebrand, B. (1995) Dichlorprop-p~Acute Oral Neurotoxicity
Study in Wistar Rats: Lab Project Number: 20S0187/91156. Unpublished study prepared by
BASF Aktiengesellschaft. 503 p.
43811401 Campbell, S.; Beavers, J. (1994) 2,4-DP-p 2-EHE: A Dietary LC50 Study with the Northern
Bobwhite: Lab Project Number: 94/5097: 147-161. Unpublished study prepared by Wildlife
International, Ltd. 45 p.
43867601 Munk, R. (1989) Avian Single-Dose Oral LD50 of Reg. No. 172 365 (2,4-DP-p) Acid to the
Bobwhite Quail (Colinus virginianus): Lab Project Number: 89/0552: 11W0068/89003.
Unpublished study prepared by BASF Aktiengesellschaft. 35 p.
43867603 Fritsch (1988) Determination of the Acute Toxicity of Duplosan DP (BAS 044 18H) to the
Waterflea, Daphnia magna Straus: Lab Project Number: 88/0625: 14F0068/895060.
Unpublished study prepared by BASF Aktiengesellschaft. 21 p.
43915101 Mellert, W.; Deckardt, K.; Kaufmann, W.; et al. (1995) Dichlorprop-p~Subchronic Oral
Dietary Toxicity and Neurotoxicity Study in Wistar Rats: Lab Project Number:
50C0187/91158: 92/32/EEC. Unpublished study prepared by BASF Aktiengesellschaft. 653 p.
44028901 Wells, D. (1996) 2,4-DP-p: Determination of Batch-Equilibrium Adsorption and Desorption
Coefficients Following FIFRA Guideline 163-1: Lab Project Number: 13021.0495.6105.710:
95-9-6099: 032295. Unpublished study prepared by Springborn Laboratories, Inc. 7
44030301 Andreae (1995) Determination of the Acute Toxicity of Dichlorprop-p-DMA Salt to the Water
Flea Daphnia magna STRAUS: Lab Project Number: 95/0382/50/1: 95/092: PCP03614.
Unpublished study prepared by BASF Aktiengesellschaft. 24 p.
44090001 Munk, R.; Kuettler, K. (1995) 2,4-DP-p-2EH-Ester (=CompoundNo. 91/384)-Avian Single-
Dose Oral LD50 on the Bobwhite Quail (Colinus Virginianus): Lab Project Number:
11W0384/91171: 95/10851. Unpublished study prepared by BASF Aktiengesellschaft. 40 p.
64
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44130103 Kludas, R. (1996) Terrestrial Field Dissipation of 2,4-DP-p DMA (Liquid Product) Applied to
Turf and Bare Ground in New York: Final Report: Lab Project Number: GR9443: AGR9443:
ADPEN-932-94-AGR9443-003. Unpublished study prepared by Grayson Research, Ltd.
44187601 Lappin, G. (1996) (Carbon 14)-Dichlorprop-p: Absorption, Distribution, Metabolism, and
Excretion in the Rat: Final Report: Lab Project Number: 1149/17/1011. Unpublished study
prepared by Corning Hazleton (Europe). 347 p.
44187602 Lappin, G. (1996) (Carbon 14)-DP-p-EHE and (Carbon 14)-2,4-DP-p-DMA: Absorption,
Distribution, Metabolism, and Excretion in the Rat: Final Report: Lab Project Number:
1149/15-1011. Unpublished study prepared by Corning Hazleton (Europe). 301 p.
44580101 Munk, R. (1998) Report: Dichlorprop-p: Acute Toxicity Study on the Rainbow Trout
(Oncorhynchus mykiss Walbaum 1792) in a Static System (96 hours): Lab Project Number:
12F0187/915150. Unpublished study prepared by BASF Aktiengesellschaft. 43 p. {OPPTS
850.
44638401 Bachmann, S.; Deckardt, K.; Gembardt, C. et al. (1997) Dichlorprop-p - Chronic Oral Toxicity
Study in Beagle Dogs Administration in the Diet for 12 Months: Lab Project Number:
33D0187/91167: 97/11116: 33D0002/91166. Unpublished study prepared by BASF Akti
44888201 Mellert, W.; Deckardt, K.; Kuettler, K.; et al. (1998) Report: Dichlorprop-p~Carcinogenicity
Study in Female B6C3Fl/CrlBR Mice Administration in the Diet for 18 Months:
(Supplementary Study): Lab Project Number: 76SO187/91143: 98/11378: MR0012. Unpublish
44900801 Mellert, W.; Deckardt, K.; Kuettler, K. et al. (1996) Dichlorprop-p-Carcinogenicity Study in
B6C3Fl/CrlBRMice: Administration in the Diet for 18 Months: Lab Project Number:
76S0187/91105: 96/10441. Unpublished study prepared by BASF Aktiengesellschaft. 8
44900802 Fautz, R. (1994) In vivo/in vitro Unscheduled DNA Synthesis in Rat Hepatocytes with
Dichlorprop-p acid: Lab Project Number: 429302. Unpublished study prepared by CCR-
Cytotest Cell Research Gmbh and Co. KG. 32 p.
46591904 Milburn, G. (2001) Dichloroprop-p: Preliminary Reproduction Toxicity Study in Rats. Project
Number: CTL/RR0888/TOX/REPT, RR0888. Unpublished study prepared by Central
Toxicology Lab. (Syngenta). 33 p.
46591910 Harwood, R.; Allan, J. (2001) Dichlorprop-p Acid: A Laboratory Evaluation of the Acute
Toxicity of Dichlorprop-p acid to the Honey Bee (Apis mellifera): 48 Hour Contact and Oral
LD50. Project Number: 19390B, 398979. Unpublished study prepared by Inveresk
46591911 Mullee, D. (2004) Dichlorprop-p: Determination of Abuitic Degradation, Hydrolysis as a
Function of pH. Project Number: 2029/001. Unpublished study prepared by Safepharm
Laboratories Ltd. 18 p.
46591916 Ohnsorge, U. (2000) Henry's Law Constant for Dichlorprop-p. Project Number:
2000/1010206. Unpublished study prepared by BASF Aktiengesellschaft. 4 p.
46613901 Knight, B.; Altan, J. (2002) Dichlorprop-p: Determination of Acute Toxicity (EC50) to
Daphnia (48 h, Semi-Static): Amended Report. Project Number: 398413, 19711. Unpublished
study prepared by Inveresk Research International. 25 p.
46721401 Hellwig, J. (1992) Reproduction Study with 2,4-DP in Rats: Continuous Dietary
Administration over 2 Generations. Project Number: 92/10868, 70R0820/89046,
DATATOX/RC/2. Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer
Oekotoxicologie and P.M. Millar. 1748 p.
65
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46856701 Firth, K. (2003) Dichlorprop-p DMA Salt Formulation Higher Plant (Lemna) Growth
Inhibition Test. Project Number: TDF002/032964. Unpublished study prepared by Huntingdon
Life Sciences, Ltd. 44 p.
46879201 Mitchell, L.; Martin, K.; Beavers, J.; et. al.; (2001) Dichlorprop-p DMA 600: A Reproduction
Study with the Japanese Quail: Final Report. Project Number: 510/101. Unpublished study
prepared by Wildlife International, Ltd. 264 p.
Human Health Risk Assessment
Desi and Sos, Acta Med Acad Sci Hung 18:429-433, 1962
Desi et al., Acta Physio Acad Sci Hung 22:73-80, 1962
De Duffard et al., NeuroToxicology 11: 563-572, 1990
EFSA 2006. EFSA Scientific Report (2005) 52, 1-67. Conclusion on the peer review of
dichlorprop-p. http://www.efsa.eu.int. Finalized January 13, 2006.
U.S. EPA, December 19, 1997 Draft Standard Operating Procedures for Residential Exposure
Assessments. U.S. Environmental Protection Agency, Office of Pesticide Programs.
U.S. EPA, 1998. PHED Surrogate Exposure Guide. VI. 1. U.S. Environmental Protection
Agency, Office of Pesticide Programs, August 1998.
U.S. EPA SAP, "Exposure Data Requirement for Assessing Risks from Pesticide Exposure of
Children", SAP Meeting of March 8, 1999, page 60.
U.S. EPA, 1999, "Use of Values from the PHED Surrogate Table and Chemical-Specific Data."
Science Advisory Council for Exposure, Policy.007, U.S. Environmental Protection Agency.
Office of Pesticide Programs.
U.S. EPA, August 7, 2000, "Agricultural Default Transfer Coefficients" Science Advisory
Council for Exposure, SOP 003.1, .U.S. Environmental Protection Agency, Office of Pesticide
Programs.
U.S. EPA, July 5, 2000, "Standard Values for Daily Acres Treated in Agriculture" HED Science
Advisory Council for Exposure, Policy.009, U.S. Environmental Protection Agency, Office of
Pesticide Programs.
U.S. EPA, 2006. Use Closure Memo Update; 2-(2,4-dichlorophenoxy)propionic acid (also
known as 2,4-DP or dichlorprop) its salts and esters. Case 0294: From M. Howard to 2,4-DP
RED Team. November 14, 2006.
U.S. EPA, 2007. FQPA Drinking Water Assessment for Dichlorprop (2,4-DP-p). From J.
Hetrick to M. Goodis. April 2007.
66
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U.S. EPA. April 3, 2007. 2,4-DP : Occupational and Residential Exposure Assessment for the
Reregi strati on Eligibility Decision. From M. Lloyd to D. Smegal/M. Howard. D3229695
Hervonen et al., Toxicology Appl Pharmacol 65: 23-31, 1982
67
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APPENDIX E. Generic Data Call-in (GDCI)
68
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DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0294 2,4-DP DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 031402 GENERIC
NO CITY, XX 00000 Propanoic acid, 2-(2,4-dichlorophenoxy)-, (R)- |Q# GDC|.031402.NNNNN
4. EPA Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and I
agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
7b. My product is an EUP and I
agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any know n^y Qate
false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company 11. Phone Number
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0294 2,4-DP
Chemical # and Name 031402
Propanoic acid, 2-(2,4-dichlorophenoxy)-, (R)-
3. Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID# GDCI-031402-NNNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
Nontarqet Plant Protection Data Requirements (Conventional
Chemical)
850.4225
850.4250
830.7050
Seedling emergence, Tier II (1 ,2 ,3 ,4)
Vegetative vigor, Tier II (5 ,6 ,7 ,8 ,9)
Product Chemistry Data Requirements (Conventional Chemical
UV/Visible absorption
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
TEP
TEP
TGAI/PAI
12
12
(N
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
11. Date
12. Name of Company
13. Phone Number
-------
DRAFT COPY Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0294 2,4-DP
DCI Number: GDCI-031402-NNNNN
Key: TEP = Typical End Use Product [TEP]; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
C - Terrestrial nonfood crop Q - Residential outdoor use U - Residential and public access pr
J- Forestry use R- Agricultural premises and equipr HH - Occupational Use Conventional
K- Residential T- Commercial, institutional and inc II- Residential Use Conventional C
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
1 Not required for contained pesticide treatments such as bait boxes and pheromone traps unless adverse effects reports are received by the Agency.
2 Reserved for aquatic residential uses.
3 Required if a terrestrial species exhibits a 25 percent or greater detrimental effect in Tier 1.
4 Required for known phytotoxicants such as herbicides, desiccants, defoliants, and plant growth regulators.
5 Not required for contained pesticide treatments such as bait boxes and pheromone traps unless adverse effects reports are received by the Agency.
6 Reserved for aquatic residential uses.
7 Generally not required for granular formulations. May be requested on a case-by-case basis.
8 Required if a terrestrial species exhibits a 25 percent or greater detrimental effect in Tier 1.
9 Required for known phytotoxicants such as herbicides, desiccants, defoliants, and plant growth regulators.
-------
United States Environmental Protection
Agency Washington, D.C. 20460
Co. Nr.
264
15440
70596
LIST OF ALL REGISTRANTS SENT THIS
Case # and Name: 0294,2,4-DP
Company Name Agent For
BAYER CROPSCIENCE LP
A H MARKS & CO LTD REGISTRATION AND REGULATORY
SERVICES
NUFARM BV NUFRAM BV
DATA CALL-IN NOTICE
Address
2 T.W. ALEXANDER DRIVE
PMB 239, 7474 CREEDMOOR ROAD
PO Box 13439
City & State
RESEARCH
TRIANGLE PARK
RALEIGH
RTP
Zip
NC 27709
NC 27613
NC 27709
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-010?
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0294 2,4-DP DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 031403 GENERIC
NO CITY, XX 00000 Propanoic acid, 2-(2,4-dichlorophenoxy)-, (R)-, compd. „„„ .,.,.,.,.,
with N-methylmethanamine (1:1) ID# GDCI-031403-NNNNN
4. EPA Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and I
agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
7b. My product is an EUP and I
agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any know n^y Qate
false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company 11. Phone Number
w
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
850.4225
850.4250
830.7050
5. Study Title
2. Case # and Name 3. Date and Type of DCI and Number
0294 2,4-DP DD-MMM-YYYY
Chemical* and Name 031403 GENERIC
Propanoicacid, 2-(2,4-dichlorophenoxy)-, (R)-, |D# QDCI-031403-NNNNN
compd. with N-methylmethanamine (1:1)
Nontarqet Plant Protection Data Requirements (Conventional
Chemical)
Seedling emergence, Tier II (1 ,2 ,3 ,4)
Vegetative vigor, Tier II (5 ,6 ,7 ,8 ,9)
Product Chemistrv Data Requirements (Conventional Chemical
UV/Visible absorption
p
R
o
T
O
C
o
L
Progress
Reports
1
2
3
6. Use
Pattern
C, HH, II, J, K, R, T, U
C, HH, II, J, K, R, T, U
C, HH, II, J, K, R, T, U
7. Test
Substance
TEP
TEP
TGAI/PAI
8. Time
Frame
(Months)
12
12
8
9. Registrant
Response
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any 11. Date
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
12. Name of Company
13. Phone Number
w
-------
DRAFT COPY Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0294 2,4-DP
DCI Number: GDCI-031403-NNNNN
Key: TEP = Typical End Use Product [TEP]; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
C- Terrestrial nonfood crop R- Agricultural premises and equipr HH - Occupational Use Conventional
J- Forestry use T- Commercial, institutional and inc II- Residential Use Conventional Cl
K- Residential U- Residential and public access pr
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
1 Not required for contained pesticide treatments such as bait boxes and pheromone traps unless adverse effects reports are received by the Agency.
2 Reserved for aquatic residential uses.
3 Required if a terrestrial species exhibits a 25 percent or greater detrimental effect in Tier 1.
4 Required for known phytotoxicants such as herbicides, desiccants, defoliants, and plant growth regulators.
5 Not required for contained pesticide treatments such as bait boxes and pheromone traps unless adverse effects reports are received by the Agency.
6 Reserved for aquatic residential uses.
7 Generally not required for granular formulations. May be requested on a case-by-case basis.
8 Required if a terrestrial species exhibits a 25 percent or greater detrimental effect in Tier 1.
9 Required for known phytotoxicants such as herbicides, desiccants, defoliants, and plant growth regulators.
-------
LIST OF
United States Environmental Protection
Agency Washington, D.C. 20460
ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0294,2,4-DP
Co. Nr.
228
15440
Company Name
NUFARM AMERICAS INC.
A H MARKS & CO LTD
Agent For Address
150 HARVESTER DRIVE, SUITE 200
REGISTRATION AND REGULATORY PMB 239, 7474 CREEDMOOR ROAD
City & State Zip
BURR RIDGE IL 60527
RALEIGH NC 27613
70596
NUFARM BV
SERVICES
NUFRAM BV
PO Box 13439
RTP
NC 27709
oo
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-010?
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0294 2,4-DP DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 031465 GENERIC
NO CITY, XX 00000 2-Ethylhexyl (R)-2-(2,4-dichlorophenoxy)propionate |Q# GDC|.031465.NNNNN
4. EPA Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and I
agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
7b. My product is an EUP and I
agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any know n^y Qate
false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company 11. Phone Number
w
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0294 2,4-DP
Chemical # and Name 031465
2-Ethylhexyl (R)-2-(2,4-dichlorophenoxy)propionate
3. Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID# GDCI-031465-NNNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
Nontarqet Plant Protection Data Requirements (Conventional
Chemical)
850.4225
850.4250
830.7050
Seedling emergence, Tier II (1 ,2 ,3 ,4)
Vegetative vigor, Tier II (5 ,6 ,7 ,8 ,9)
Product Chemistry Data Requirements (Conventional Chemical
UV/Visible absorption
A, C, HH, II, J, K, Q, R,
T, U
A, C, HH, II, J, K, Q, R,
T, U
A, C, HH, II, J, K, Q, R,
T, U
TEP
TEP
TGAI/PAI
12
12
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
11. Date
12. Name of Company
13. Phone Number
-------
DRAFT COPY Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0294 2,4-DP
DCI Number: GDCI-031465-NNNNN
Key: TEP = Typical End Use Product [TEP]; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A- Terrestrial food crop K- Residential T- Commercial, institutional and inc II- Residential Use Conventional C
C - Terrestrial nonfood crop Q - Residential outdoor use U - Residential and public access pr
J- Forestry use R- Agricultural premises and equipr HH - Occupational Use Conventional
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
1 Not required for contained pesticide treatments such as bait boxes and pheromone traps unless adverse effects reports are received by the Agency.
2 Reserved for aquatic residential uses.
3 Required if a terrestrial species exhibits a 25 percent or greater detrimental effect in Tier 1.
4 Required for known phytotoxicants such as herbicides, desiccants, defoliants, and plant growth regulators.
5 Not required for contained pesticide treatments such as bait boxes and pheromone traps unless adverse effects reports are received by the Agency.
6 Reserved for aquatic residential uses.
7 Generally not required for granular formulations. May be requested on a case-by-case basis.
8 Required if a terrestrial species exhibits a 25 percent or greater detrimental effect in Tier 1.
9 Required for known phytotoxicants such as herbicides, desiccants, defoliants, and plant growth regulators.
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0294,2,4-DP
Co. Nr.
15440
70596
Company Name Agent For Address
A H MARKS & CO LTD REGISTRATION AND REGULATORY PMB 239, 7474 CREEDMOOR ROAD
SERVICES
NUFARMBV NUFRAM BV PO Box 13439
City & State Zip
RALEIGH NC 27613
RTP NC 27709
(N
-------
APPENDIX F. Product-specific Data Call-in (PDCI)
69
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DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0294 2,4-DP DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 031465 PRODUCT SPECIFIC
NO CITY, XX 00000 2-Ethylhexyl (R)-2-(2,4-dichlorophenoxy)propionate |Q# pDC|.031465.NNNN
4. EPA Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is an MUP and I
agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and I
agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any know n^y Qate
false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company 11. Phone Number
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0294 2,4-DP DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 031402 PRODUCT SPECIFIC
NO CITY, XX 00000 Propanoic acid, 2-(2,4-dichlorophenoxy)-, (R)- |D# PDC|.031402.NNNN
4. EPA Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is an MUP and I
agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and I
agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any know n^y Qate
false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company 11. Phone Number
(N
PH
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0294 2,4-DP DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 031403 PRODUCT SPECIFIC
NO CITY, XX 00000 Propanoic acid, 2-(2,4-dichlorophenoxy)-, (R)-, compd. mi/im MMMM
with N-methylmethanamine (1:1) IU# ^LJOI-OJ140J-NNNN
4. EPA Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is an MUP and I
agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and I
agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any know n^y Qate
false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company 11. Phone Number
m
PH
-------
DRAFT COPY
Page 1 of 4
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
5. Study Title
2. Case # and Name 3. Date and Type of DCI and Number
0294 2,4-DP DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-031465-NNNN
EPA Reg. No.NNNNNN-NNNNN
Product Chemistry Data Requirements (Conventional Chemical
Product Identity and composition
(1)
Description of materials used to produce the product (2)
Description of production process
Description of formulation process
Discussion of formation of impurities
Preliminary analysis
Certified limits
Enforcement analytical method
Color
Physical state
Odor
(3)
(4)
(5)
(6 ,7 ,8)
(9,10)
(11)
(12)
(13)
(14)
P
R
O
T
O
c
O
L
Progress
Reports
1
2
3
6. Use
Pattern
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
7. Test
Substance
TGAI/MP/EP
TGAI/MP/EP
TGAI
MP/EP
TGAI/MP/EP
TGAI
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
8
8
9. Registrant
Response
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any 11. Date
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
12. Name of Company
13. Phone Number
-------
DRAFT COPY
Page 2 of 4
United States Environmental Protection OMB Approval 2070-010?
Agency Washington, D.C. 20460 OMB Approval 2070-0057
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0294 2,4-DP DD-MMM-YYYY
NO STREET ADDRESS PRODUCT SPECIFIC
NO CITY, XX 00000 ID# PDCI-031465-NNNN
EPA Reg. No.NNNNNN-NNNNN
4. Guideline
Requirement
Number
830.6313
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7050
830.7100
5. Study Title
Stability to sunlight, normal and elevated temperatures (15,16)
metals, and metal ions
Oxidizing or reducing action (1 7)
Flammability (18)
Explodability (19)
Storage stability of product (20)
Miscibility (21)
Corrosion characteristics (22)
Dielectric breakdown voltage (23)
pH of water solutions or suspensions (24 ,25)
UV/Visible absorption
Viscosity (26)
Initial to indicate certification as to information on this page (full
text of certification is on page one).
P
R
O
T
O
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
7. Test
Substance
TGAI
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
TGAI/MP/EP
TGAI/PAI
MP/EP
Date
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
8
8
9. Registrant
Response
PH
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DRAFT COPY
Page 3 of 4
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.7200
830.7220
830.7300
830.7370
830.7550
830.7570
830.7840
830.7860
830.7950
870.1100
870.1200
5. Study Title
Melting point/melting range
Boiling point/boiling range
Density/relative density
Dissociation constant in water
2. Case # and Name 3. Date and Type of DCI and Number
0294 2,4-DP DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-031465-NNNN
EPA Reg. No.NNNNNN-NNNNN
(27 ,28)
(29 ,30)
(31 ,32)
(33 ,34)
Partition coefficient (n-octanol/water), shake flask (35)
method
Partition coefficient (n-octanol/water), estimation by (36)
liquid chromatography
Water solubility: Column elution method, shake flask (37)
method
Water solubility, generator column method (38)
Vapor pressure
(39 ,40)
Toxicoloav Data Requirements (Conventional Chemical)
Acute Oral Toxicity
Acute dermal toxicity
(41)
(42 ,43)
Initial to indicate certification as to information on this page (full
text of certification is on page one).
P
R
O
T
O
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
7. Test
Substance
TGAI
TGAI
TGAI/MP/EP
TGAI or PAI
TGAI/PAI
TGAI/PAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
TGAI.EP.dilute EP?
TGAI.EP.dilute EP?
Date
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
8
8
9. Registrant
Response
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DRAFT COPY
Page 4 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use
additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
870.1300
870.2400
870.2500
870.2600
5. Study Title
Acute inhalation toxicity
Acute eye irritation
Acute dermal irritation
Skin sensitization
2. Case # and Name 3. Date and Type of DCI and Number
0294 2,4-DP DD-MMM-YYYY
PRODUCT SPECIFIC
EPA Reg. No.NNNNNN-NNNNN
(44)
(45)
(46 ,47)
(48 ,49)
Initial to indicate certification as to information on this page (full
text of certification is on page one).
P
R
O
T
O
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
C, HH, II, J, K, Q, R, T,
U
7. Test
Substance
TGAI & EP
TGAI & EP
TGAI & EP
TGAI & EP
Date
8. Time
Frame
(Months)
8
8
8
8
9. Registrant
Response
PH
-------
DRAFT COPY Page1of6
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0294 2,4-DP
DCI Number: PDCI-031465-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI & EP = Technical Grade of the Active Ingredient and End-Use Product; TGAI or P,
Technical Grade of the Active Ingredient or Pure Active Ingredient; TGAI,EP,dilute EP? = Technical Grade of the Active Ingredient, End Use Product, and possibly diluted End Use Product; TGAI/MP/E
Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
C - Terrestrial nonfood crop Q - Residential outdoor use U - Residential and public access pr
J- Forestry use R- Agricultural premises and equipr HH - Occupational Use Conventional
K- Residential T- Commercial, institutional and inc II- Residential Use Conventional C
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
1 Data must be provided in accordance with the "Product Composition" Section.(158.155)
2 Data must be provided in accordance with the "Description of Materials used to Produce the Product" Section.(158.160)
oo
i
PH
Data must be provided in accordance with the "Description of Production Process" Section.(158.162)
Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
Data must be provided in accordance with the "Description of Formation of Impurities" Section(158.167)
Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
Required for TGAIs and products produced by an integrated system.
If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
Data must be provided in accordance with the "Certified Limits" Section(158.175)
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DRAFT COPY Page2of6
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0294 2,4-DP
DCI Number: PDCI-031465-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI & EP = Technical Grade of the Active Ingredient and End-Use Product; TGAI or P,
Technical Grade of the Active Ingredient or Pure Active Ingredient; TGAI,EP,dilute EP? = Technical Grade of the Active Ingredient, End Use Product, and possibly diluted End Use Product; TGAI/MP/E
Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
10 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
11 Data must be provided in accordance with the "Enforcement Analytical Method" Section.(158.180)
12 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
13 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
14 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
15 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
16 Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
17 Required if the product contains an oxidizing or reducing agent
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DRAFT COPY Page3of6
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0294 2,4-DP
DCI Number: PDCI-031465-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI & EP = Technical Grade of the Active Ingredient and End-Use Product; TGAI or P,
Technical Grade of the Active Ingredient or Pure Active Ingredient; TGAI,EP,dilute EP? = Technical Grade of the Active Ingredient, End Use Product, and possibly diluted End Use Product; TGAI/MP/E
Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
18 Required when the product contains combustible liquids.
1 g Required when the product is potentially explosive.
20 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the Pro
Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
21 Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
22 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the Pro
Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
23 Required if the end-use product is a liquid and is to be used around electrical equipment.
24 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
25 Required if the product is dispersible with water.
26 Required if the product is a liquid.
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DRAFT COPY Page 4 of 6
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0294 2,4-DP
DCI Number: PDCI-031465-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI & EP = Technical Grade of the Active Ingredient and End-Use Product; TGAI or P,
Technical Grade of the Active Ingredient or Pure Active Ingredient; TGAI,EP,dilute EP? = Technical Grade of the Active Ingredient, End Use Product, and possibly diluted End Use Product; TGAI/MP/E
Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
27 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
28 Required when the TGAI is solid at room temperature.
29 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
30 Required if the TGAI is liquid at room temperature.
31 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
32 True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
33 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
34 Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).
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DRAFT COPY Page5of6
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0294 2,4-DP
DCI Number: PDCI-031465-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI & EP = Technical Grade of the Active Ingredient and End-Use Product; TGAI or P,
Technical Grade of the Active Ingredient or Pure Active Ingredient; TGAI,EP,dilute EP? = Technical Grade of the Active Ingredient, End Use Product, and possibly diluted End Use Product; TGAI/MP/E
Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
35 Required if the TGAI or PAI is organic and non-polar.
36 Required if the TGAI or PAI is organic and non-polar.
' (N
i
PH
37 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
38 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
39 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
40 Not required for salts.
41 Not required if test material is a gas or a highly volatile liquid.
42 Not required if test material is a gas or a highly volatile liquid.
43 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
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DRAFT COPY Page 6 of 6
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0294 2,4-DP
DCI Number: PDCI-031465-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI & EP = Technical Grade of the Active Ingredient and End-Use Product; TGAI or P,
Technical Grade of the Active Ingredient or Pure Active Ingredient; TGAI,EP,dilute EP? = Technical Grade of the Active Ingredient, End Use Product, and possibly diluted End Use Product; TGAI/MP/E
Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
44 Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).
45 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
PH
46 Not required if test material is a gas or a highly volatile liquid.
47 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
48 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
49 Required if repeated dermal exposure is likely to occur under conditions of use.
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United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0294,2,4-DP
Co. Nr.
228
2217
9688
15440
Company Name
NUFARM AMERICAS INC.
PBI/GORDON CORP
CHEMSICO
A H MARKS & CO LTD
Agent For Address
150 HARVESTER DRIVE, SUITE 200
PO Box 01 4090 1 21 7 WEST 1 2TH STREET
PO Box 142642
REGISTRATION AND REGULATORY PMB 239, 7474 CREEDMOOR ROAD
City & State
BURR RIDGE
KANSAS CITY
ST LOUIS
RALEIGH
Zip
IL 60527
MO 641 01 0090
MO 63 11 40642
NC 27613
70596
NUFARM BV
SERVICES
NUFRAM BV
PO Box 13439
RTP
NC 27709
PH
-------
United States Environmental Protection
Agency Washington, D.C. 20460
Co. Nr.
264
15440
70596
LIST OF ALL REGISTRANTS SENT THIS
Case # and Name: 0294,2,4-DP
Company Name Agent For
BAYER CROPSCIENCE LP
A H MARKS & CO LTD REGISTRATION AND REGULATORY
SERVICES
NUFARM BV NUFRAM BV
DATA CALL-IN NOTICE
Address
2 T.W. ALEXANDER DRIVE
PMB 239, 7474 CREEDMOOR ROAD
PO Box 13439
City & State
RESEARCH
TRIANGLE PARK
RALEIGH
RTP
Zip
NC 27709
NC 27613
NC 27709
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Co. Nr.
228
239
2217
8378
9688
10088
15440
32802
34704
70596
Case # and Name: 0294,2,4-DP
Company Name Agent For
NUFARM AMERICAS INC.
THE ORTHO BUSINESS GROUP
PBI/GORDON CORP
KNOX FERTILIZER CO INC TOTAL TURF CONSULTING LLC
CHEMSICO
ATHEA LABORATORIES INC
A H MARKS & CO LTD REGISTRATION AND REGULATORY
SERVICES
HOWARD JOHNSON'S
ENTERPRISES INC
LOVELAND PRODUCTS, INC.
NUFARM BV NUFRAM BV
Address
150 HARVESTER DRIVE, SUITE 200
PO Box 1 90
PO Box 01 4090 1 21 7 WEST 1 2TH STREET
300 W. FIFTH ST., #411
PO Box 142642
PO Box 24001 4
PMB 239, 7474 CREEDMOOR ROAD
700 W. VIRGINIA ST STE 222
PO Box 1 286
PO Box 13439
City & State
BURR RIDGE
MARYSVILLE
KANSAS CITY
CHARLOTTE
ST LOUIS
MILWAUKEE
RALEIGH
MILWAUKEE
GREELEY
RTP
Zip
IL 60527
OH 43040
MO 641 01 0090
NC 28202
MO 63 11 40642
Wl 53224
NC 27613
Wl 532041548
CO 806321 286
NC 27709
VO
i
PH
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APPENDIX G. EPA's Batching of 2,4-DP-p Products for Meeting Acute Toxicity Data
Requirements for Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregi strati on of products containing 2,4-DP-p as the active
ingredient, the Agency has batched products which can be considered similar for purposes of
acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see acceptance
criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity,
and the formulation has not been significantly altered since submission and acceptance of the
acute toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than one
confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
Because of the extensive number of products to consider in this batching process, the
batching report will be made available at a later date and posted on-line in the Public Docket.
70
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