Reregistration Eligibility
Decision (RED) for
Mecoprop-p (mcpp)
August 29, 2007
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?/EPA
United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508P)
EPA 738-R-07-009
Reregistration
Eligibility Decision
for Mecoprop-p
(MCPP-p)
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Reregistration Eligibility Decision (RED) for
Mecoprop-p (MCPP-p)
List A
Case No. 0377
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 9
III. Summary of Mecoprop-p Risk Assessments 10
A. Human Health Risk Assessment 10
1. Toxicity of Mecoprop-p 10
2. Residential and Non-Occupational Exposure and Risk 14
3. Aggregate Exposure and Risk 16
4. Occupational Exposures Assessment 17
5. Incident Reports 19
B. Environmental Risk Assessment 19
1. Environmental Fate and Transport 19
2. Ecological Exposure and Risk 20
IV. Risk Management and Reregistration Decision 30
A. Determination of Reregistration Eligibility 30
B. Public Comments and Responses 30
C. Risk Mitigation and Regulatory Position 30
1. Human Health Risk Management 31
2. Ecological Risk Management 31
D. Labeling Requirements 35
E. Import Tolerance 35
V. What Registrants Need to Do 36
A. Manufacturing Use Products 37
1. Additional Generic Data Requirements 37
2. Labeling for Manufacturing-Use Products 37
B. End-Use Products 38
1. Additional Product-Specific Data Requirements 38
2. Labeling for End-Use Products 38
C. Labeling Changes Summary Table 38
APPENDIX A. Use Patterns Eligible for Reregistration 46
APPENDIX B. Data Supporting Guideline Requirements for MCPP-p 47
APPENDIX C. Technical Support Documents 50
APPENDIX D. Bibliography 51
APPENDIX E. Generic Data Call-in (GDCI) 61
APPENDIX F. Product-specific Data Call-in (PDCI) 62
APPENDIX G. EPA's Batching of MCPP-p Products for Meeting Acute Toxicity Data.. 63
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EPA MCPP-p Team
Ecological Fate and Effects Division
Christine Hartless
Holly Galavotti
Thuy Nguyen
James Lin
Health Effects Division
Timothy Dole
Kit Farwell
Whang Phang
Registration Division
Joanne Miller
Eugene Wilson
Special Review and Reregistration Division
Kevin Costello
Rosanna Louie
Patricia Moe
Biological Economics and Analysis Division
Jenna Carter
Bill Chism
Steve Jarboe
Andrew Lee
Bill Phillips
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 mecoprop-p (MCPP-p), in the form of MCPP-p acid,
MCPP-p dimethylamine salt (MCPP-p DMAS), and MCPP-p potassium salt. Because it is
expected for these forms of MCPP-p to quickly dissociate to the MCPP-p acid, MCPP-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 MCPP-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-2006-0943.
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II. Chemical Overview
A. Regulatory History
A Registration Standard Guidance Document was issued in December 1988 on mecoprop
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 mecoprop case
(0377) includes several forms of MCPP-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 MCPP-p Task Force to produce data
needed for the reregi strati on review of MCPP-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 MCPP. 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, MCPP-p, on a commercial scale, achieving
approximately 93-95% purity of MCPP-p. Thus, the MCPP-p Task Force agreed to develop new
data to fulfill guideline requirements for reregi strati on based on the enriched isomer, MCPP-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
MCPP-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 mecoprop: 1) convert their product formulations to contain the enriched
isomer, MCPP-p; 2) produce data supporting the racemic mecoprop; 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 all product formulations to the enriched
isomer, MCPP-p. 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
MCPP-p included as part of the case and identifies active ingredients the MCPP-p Task Force is
supporting.
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Table 1. Summary of Mecoprop and Mecoprop-p Active Ingredients, Case No. 0377
PC Code
031501
031503
031516
031519
031520
031563
031564
129046
119046
CAS#
7085-19-0
1929-86-8
1432-14-0
32351-70-5
66423-09-4
28473-03-2
861229-15-4
16484-77-8
66423-05-0
Name
Mecoprop (and salts and esters)
Mecoprop, potassium salt
Diethanolamine 2-(2-methyl-4-
chlorophenoxy)propionate
Mecoprop, dimethylamine salt
Propanoic acid, 2-(4-chloro-2-
methylphenoxy)-, (R)-, compd.
with N-methylmethanamine
(MCPP-p DMAS)
Mecoprop, isooctyl ester
2-Ethylhexyl (R)-2-(2-methyl-4-
chlorophenoxy)propionate
Mecoprop-p acid
(+)-(R)-2-(4-chloro-2-
methylphenoxy) propanoic acid,
potassium salt
Task Force
Supported
No
No
No
No
Yes
No
No
Yes
Yes
Active
Registrations
Yes*
No
No
Yes*
Yes
No
No
Yes
Yes
*This indicates that products labels are currently transitioning from MCPP to MCPP-p as the active ingredient.
B. Chemical Identification
MCPP-p compounds are plant growth regulators that are part of the chlorophenoxys
group of herbicides. Chemical information and structures for technical MCPP-p and its salts that
are being supported are presented in Table 2. Table 3 presents the physical and chemical
properties of MCPP-p acid.
Table 2. MCPP-p Chemical Information and Structures
Compound Name
MCPP-p; (+)-R-
2-(4-chloro-2-
methylphenoxy)
propanoic acid
(MCPP-p acid)
MCPP-p
Dimethylamine
Salt (DMAS)
MCPP-p
potassium salt
PC Code
129046
031520
119046
CAS Number
16484-77-8
66423-09-4
66423-05-0
Molecular
Weight
2 14.6 g/mol
259.7 g/mol
252.7 g/mol
Structure
ck_XN^
IT 1 o**
N»^\ 1 y°
\ ° 9 \
CH, H <"
CHj
H,C NHj' 0
0 /
\
el \_/ °
CHs
"Xl r- o
^V^X)— CH— C
CHa X0- K*
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Table 3. Physical and Chemical Properties of MCPP-p acid
Parameter
Chemical Name
CAS Number
Empirical Formula
Molecular Weight
Appearance
Odor
Density
Melting Point
Organic Solvents Solubility
Vapor pressure (20 °C)
Water Solubility (20 °C)
Value and Unit
2-(4-chloro-2-methylphenoxy) propanoic acid
16484-77-8
CioHnClOs
214.6g/mole
Colorless crystal
Odorless
0.6 g/ml, dry uncompacted
94 - 95 °C
Readily soluble in benzene, acetone, chlorinated hydrocarbons
1.4xlO"5torr
620 mg/L
C. Use Profile
Mecoprop-p (MCPP-p) is a member of the chlorophenoxy class of herbicides. All
technical product registrations now contain the MCPP-p (R) isomer as the active ingredient. At
the present, the MCPP-p Task Force is supporting MCPP-p acid, MCPP-p DMAS, and MCPP-p
potassium salt. Henceforth, the MCPP-p acid equivalent will be referred to as MCPP-p.
Type of Pesticide:
Target Pests:
Mode of Action:
Use Sites:
Use Classification:
Formulation Types:
Application Methods:
Application Rates:
Herbicide
Annual and perennial broadleaf weeds.
MCPP-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, and rights-of-ways.
General Use
Acid- granular, emulsifiable concentrate, water-soluble
concentrate dry, wettable powder.
DMAS - granular, water-soluble concentrate liquid, water soluble
concentrate dry.
Potassium Salt - emulsifiable concentrate, soluble concentrate,
Ready-to-Use solution.
Boom sprayers, handheld nozzle or wand sprayers, knapsack
sprayers, granular spreaders.
Maximum application rate is 1.2 Ibs acid equivalent of
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MCPP-p per acre (ae MCPP-p/A), with a maximum of two
applications per year. The Task Force indicated that the majority
of typical use rates range from 0.20 to 0.78 Ib ae MCPP-p/A.
Application Timing: Post-emergence, when weeds are young and actively growing.
Registrants: A.H. Marks and Company Limited, NuFarm UK Limited, and
NuFarm Americas Incorporated.
D. Estimated Usage of Pesticide
The majority of MCPP-p use is associated with residential lawns, with smaller usage on
other recreational turf and non-agricultural grassy areas. Based on usage information provided
by the MCPP-p Task Force (also referred to as the Task Force), total annual domestic usage of
MCPP-p is approximately 5 million pounds: >97% are applied to residential lawns, 2% is
applied to golf courses, and <1% is applied to turf farms and other uncultivated non-agricultural
land. According to the Task Force, geographical use areas for applications to turf in roughly
descending order: Midwest, Northeast, South, Northwest, and West. MCPP-p is often co-
formulated with other chlorophenoxy herbicides, including 2,4-D and dicamba.
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III. Summary of Mecoprop-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 mecoprop-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-2006-0943, 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.
• MCPP-p acid, MCPP-p DMAS, & MCPP-p potassium salt: RED Human Health Risk
Assessment. July 30, 2007.
• FQPA Drinking Water Assessment for Mecoprop-p. June 26, 2006.
• Environmental Fate and Effects Science Chapter for MCPP-p acid, MCPP-p DMAS,
and MCPP-p potassium salt. August 28, 2007.
A. Human Health Risk Assessment
The human health risk assessment addressed potential risks from all registered sources.
Because MCPP-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 MCPP-p acid, MCPP-p
DMAS, & MCPP-p potassium salt: HED Human Health Risk Assessment, July 30, 2007, which
is available in the public docket.
1. Toxicity of Mecoprop-p
The available toxicological data are sufficient for selecting toxicity endpoints for the risk
assessment. A comparison of more recent conducted studies using the isomeric MCPP-p, with
older studies conducted with the racemic MCPP, indicate that MCPP and MCPP-p produce
similar toxicities. As available, the Agency relied on the newer MCPP-p studies. Because the
racemic MCPP and MCPP-p are structurally similar and have comparable toxicities, the Agency
is assuming equal toxicities from MCPP, MCPP-p, its salts, and any of its metabolites.
To date, there are no studies available to compare the relative toxicities between the
DMA salt and the potassium salt forms of MCPP-p to the acid form. However, metabolism
studies conducted with MCPP-p acid and MCPP-p DMAS showed similar pharmacokinetic
parameters between both compounds. Furthermore, based on an in vitro
dissociation/degradation study conducted with MCPP-p DMAS, the Agency concluded that in
the in vivo environment, the DMAS form will completely dissociate to the MCPP-p acid.
MCPP-p potassium salt is also expected to dissociate similarly to MCPP-p in vivo. Thus, the
available toxicological studies are sufficient to select toxicity endpoints for the hazard
assessment.
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a. Toxicity Profile and Endpoint Selection
The available acute toxicity studies indicate that MCPP-p is of relatively low oral and
dermal toxicity (Toxicity Category III). An available 21-day dermal toxicity study conducted on
rabbits did not indicate any systemic toxicity at the highest tested dose level. As expected with
acids, MCPP-p caused severe eye irritation (Toxicity Category I). Table 4 lists the acute toxicity
profile of MCPP-p.
Table 4. Acute Toxicity Profile of MCPP-p
Guideline
Study Type
MRID
Results
Toxicity
Category
MCPP-p Acid
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Acute oral (rat)
Acute dermal (rat)
Acute inhalation (rat)
Acute eye irritation (rabbit)
Acute dermal irritation
(rabbit)
Skin sensitization
42947801
42947802
42947803
42947804
42947805
43749601
LD50 = 775 mg/kg
LD50 >2,000 mg/kg
The study is unacceptable.
Opacity, redness, discharge for
72 hours.
Redness and sloughing at 10
days.
Non-sensitizer
III
III
Unclassified
I
III
N/A
MCPP-p DMAS
870.1100
870.1200
Acute oral (rat)
Acute dermal (rabbit)
42614701
42614703
LD50 = 414mg/kg
LD50 >2,000 mg/kg
II
III
LD50 = 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) expressed in milligram per kilogram (mg/kg).
The Cancer Assessment Review Committee classified MCPP-p as "suggestive evidence
of carcinogenicity, but not sufficient to assess human carcinogenic potential." The No Observed
Adverse Effects Level (NOAEL) of 24 milligram per kilogram per day (mg/kg/day) was used to
measure dietary (drinking water only) risk. To account for any uncertainties in interspecies
extrapolation (10X) and intraspecies variability (10X), a 100X uncertainty factor (UF) is applied
in calculating the reference dose. The toxicological doses and endpoints used in the human
health risk assessment for MCPP-p are listed in Table 5.
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Table 5 . Summary of Toxicological Doses and Endpoints for MCPP-p
Exposure Scenario
Acute Dietary
(females age 13-49)
Acute Dietary
(general population)
Chronic Dietary
(all populations)
Incidental oral
(short- and
intermediate-term)
Dermal
(short- and
intermediate-term)
Inhalation
(short- and
intermediate-term)
Cancer
Point of Departure
Uncertainty Factor
RfD/Level of Concern
NOAEL = 50 mg/kg/day
UF = 100
Acute RfD = 0.5 mg/kg/day
NOAEL = 175 mg/kg/day
UF = 100
Acute RfD = 1.75 mg/kg/day
NOAEL = 4 mg/kg/day
UF = 100
Chronic RfD = 0.04 mg/kg/day
NOAEL = 35 mg/kg/day
UF = 100
LOG = 100
Not applicable
NOAEL = 35 mg/kg/day
UF = 100
LOG = 100
Study and Toxicological Effects
MCPP-p developmental toxicity in rats.
LOAEL =100 mg/kg/day based on increased
incidence of rudimentary cervical rib.
MCPP-p acute neurotoxicity in rats.
LOAEL = 350 mg/kg/day based on FOB
changes (closed eyelids, prone body position,
hypoactivity, ataxia, decreased number of
rearings in females, increased landing foot
splay in males, and decreased motor activity).
MCPP-p carcinogenicity study in mice.
LOAEL = 46 mg/kg/day based on increased
incidence of chronic nephropathy and
increased absolute/relative kidney weights in
females.
MCPP-p subchronic feeding/ subchronic
neurotoxicity in rats.
LOAEL =189 mg/kg/day based on decreased
body weight, increased water consumption,
decreased hematological parameters,
decreased adrenal weight, microscopic
changes in adrenal gland, increased liver
enzymes, increased liver weight and
microscopic changes, and kidney transitional
epithelial cells in urine of high-dose males.
No toxicity observed at 1,000 mg/kg/day and
no developmental toxicity concerns by
dermal route.
Subchronic feeding/subchronic neurotoxicity
study in rats.
LOAEL =189 mg/kg/day based on decreased
body weight, increased water consumption;
decreased hematological parameters,
decreased abs adrenal weight and lipid
storage in adrenals, increased liver enzymes
(females), increased absolute/relative liver
weight and microscopic changes; kidney
cells in urine of high-dose males.
Classification: Suggestive Evidence of Carcinogenicity, but Not Sufficient to
Assess Human Carcinogenic Potential.
NOAEL = No Observed Adverse Effects Level
LOAEL = Lowest Observed Adverse Effects Level
LOG = Level of Concern
mg/kg/day = milligram per kilogram per day
cPAD = chronic Population Adjusted Dose
RfD = Reference Dose
UF = Uncertainty Factor
FOB = functional observation battery
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b. Dietary Exposure (Drinking Water Only)
EPA assessed potential dietary exposure to MCPP-p resulting only from drinking water
exposure, based on the quick and complete dissociation of MCPP-p DMAS and MCPP-p
potassium salt into MCPP-p acid, DMAS, and potassium ions. Therefore, the drinking water
assessment for MCPP-p DMAS and MCPP-p potassium salt is represented by the acid.
Degradation products of MCPP-p (4-chloro-2-methylphenol and CC^) are presumed to be of
equal or lesser toxicity than that of the parent. For more detail on the toxicological database and
Agency's drinking water determination, refer to the MCPP-p acid, MCPP-p DMAS, & MCPP-p
potassium salt: HED Human Health Risk Assessment, dated July 30, 2007, and the FQPA
Drinking Water Assessment for Mecoprop-p (MCPP-p), dated June 26, 2006.
Exposure to pesticides from drinking water can occur through surface and groundwater
contamination. All forms of MCPP-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 MCPP-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 MCPP-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 MCPP-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 highest
estimate resulted from the modeled Florida turf scenario, producing a concentration of 45 parts
per billion (ppb). For the U.S. population, the exposure is 0.00236 mg/kg/day, which utilized
<1% of the acute reference dose (aRfD). The exposure to infants, the most highly exposed
population subgroup, is 0.00889 mg/kg/day, which occupies <1% of the aRfD at the 95th
percentile. Thus, all potential acute exposures to MCPP-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 MCPP-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 based on the Pennsylvania turf
scenario, resulting in a concentration of 18.41 ppb. For the U.S. population, the exposure was
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0.00039 mg/kg/day, which utilized 1.0% of the chronic reference dose (cRfD). The exposure for
all infants, which was the most highly exposed population subgroup, was 0.00127 mg/kg/day,
which used 3.2% of the cRfD. Thus, all potential chronic exposures to MCPP-p residues in
drinking water are 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 MCPP-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)
1.75
0.5
Dietary
Exposure
(mg/kg/day)
0.00236
0.00889
0.00370
0.00338
0.00220
%
aRfD
<1
<1
<1
<1
<1
Chronic Drinking Water
cRfD
(mg/kg/day)
0.04
Dietary
Exposure
(mg/kg/day)
0.00039
0.00127
0.00058
0.00054
0.00036
%
cRfD
1.0
3.2
1.4
1.3
<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. For non-occupational exposure,
EPA calculates a margin of exposure (MOE), which is then compared to a LOG to measure
potential risk. The UF of 100X is applied to a particular toxicity study to account for
interspecies extrapolation (10X) and intraspecies variability (10X). For MCPP-p, any MOE
greater than the target MOE of 100 would not pose any risks of concern to the Agency.
Homeowner exposures to MCPP-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 - 0.78 Ib ae MCPP-p/A. There is a higher rate of 1.2 Ibs ae MCPP-p/A
registered for spot treatments (less than 1,000 ft2/A). Because of the small amount of area
treated and the specific and limited use pattern (i.e., weeds on non-agricultural, uncultivated
land), the residential handler and applicator scenarios are considered to be protective for
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 MCPP-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 MCPP-p:
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Occupational and Residential Exposure Assessment for the Reregistration Eligibility Decision.,
dated August 13,2007.
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 MCPP-p. Because products containing MCPP-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 0.27 Ib ae MCPP-
p/A, the highest typical rate that is used by homeowners. 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. MCPP-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 . Load/Apply Granules with a Broadcast Spreader
4. Mix/Load/Apply with a Hose-end Sprayer (Mix your own)
5 . Mix/Load/Apply with a Hose-end Sprayer (RTU)
6. Mix/Load/Apply with Hand Held Pump Sprayer
7. Mix/Load/Apply with RTU Sprayer
Treated Area*
(acre/day)
1,000 ft2
(0.023 acre)
0.5
0.5
0.5
1,000 ft2
(0.023 acre)
Inhalation MOE
190,000
1,400,000
4,500,000
260,000
370,000
9,900,000
1,300,000
MOE > 100 = no risk of concern
*Area treated at the maximum application rate of 1.2 Ibs ae MCPP-p/A.
b. Residential Post-application (Turf) Exposure Assessment
After application of products containing MCPP-p to turf, there is a potential for exposure
to toddlers playing on treated lawns and other recreational areas. Because there are no 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 MCPP-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. MCPP-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)*
0.018
0.0048
0.00006
0.023
MOE
1,900
7,800
580,000
1,600
*Based on the maximum application rate of 1.2 Ibs ae MCPP-p/A.
Granule Ingestion Exposure Assessment
MOE > 100 = no risk of concern
The Agency also considered incidental oral ingestion of granular MCPP-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. MCPP-p
MOEs for Incidental
Oral Ingestion of Granules
Scenario
Granule Ingestion
Dose
by Toddlers
(mg/kg/day)*
0.14
MOE
1,400
*Based on each granule containing 0.69% MCPP-p (based on EPA Reg. #538-175).
3. Aggregate Exposure and Risk
Because the majority of MCPP-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
MCPP-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 their respective MOEs is shown in Table 10.
16
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Table 10. MCPP-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)
0.00036
0.0013
0.00058
0.00054
Residential
Exposure
(mg/kg/day)
0.00018
0.023
0.023
0.023
Aggregate
Exposure
(mg/kg/day)
0.00054
0.024
0.024
0.024
MOE
66,000
1,400
1,500
1,500
mg/kg/day = milligram per kilogram per day
4. Occupational Exposures Assessment
Workers can be exposed when mixing, loading, and applying MCPP-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) and the Outdoor Residential Exposure Task Force
(ORETF) studies. The PHED data were used to assess applications to residential and
commercial turf and non-turf areas (i.e., roadsides and rights-of-way) and the ORETF data were
used to assess exposures to professional lawn care operators. Short- and intermediate-term
handler risks were assessed, with inhalation exposures being the exposure route of concern.
Because of low toxicity concerns with dermal exposures, only inhalation exposures were
assessed. Only short- (up to 30 days) and intermediate-term (1-6 months) inhalation exposures
were assessed, as long-term (>6 months) exposures are not expected based on the use pattern.
Based on the assessed occupational exposure scenarios, all of the MOEs are greater than the
LOG of 100 with baseline personal protective equipment (PPE). Thus, these exposures do not
pose any risks of concern to the Agency. A summary of the MOEs is shown in Table 11.
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Table 1 1 . MCPP-p MOEs for Occupational Handlers and Applicators Using Baseline PPE
Scenario
Use Site
Application Rate
(Ib ae MCPP-p)
Daily Amount
Treated or
Applied
MOE
Mixer/Loader
M/L WP for Turfgun Application
(20 PCOs)
M/L WP for Groundboom
M/L DF for Turfgun (20 PCOs)
M/L DF for Groundboom
M/L Liquids for Turfgun (20 PCOs)
M/L Liquids for Groundboom
M/L Liquids for Groundboom
M/L Liquids for ROW Sprayer
Load Granulars for Broadcast
Spreader
PCO Turf
Golf Courses
PCO Turf
Golf Courses
PCO Turf
Sod Farms
Golf Courses
Non-turf
Areas*
Golf Courses
1.21bsae/A
.2 Ibs ae/A
.2 Ibs ae/A
.2 Ibs ae/A
.2 Ibs ae/A
.2 Ibs ae/A
.2 Ibs ae/A
0.01841bae/gallon
1.2 Ibs ae/A
100 acres
40 acres
100 acres
40 acres
100 acres
80 acres
40 acres
1000 gallons
40 acres
475
1,200
27,000
66,000
17,000
21,000
43,000
110,000
30,000
Applicator
Groundboom Application
Groundboom Application
ROW Sprayer Application
Turfgun Application
Broadcast Spreader Application
Sod Farms
Golf Courses
Non-turf
Areas*
PCO Turf
Golf Courses
1.2 Ibs ae/A
1.2 Ibs ae/A
0.01841bae/gallon
1.2 Ibs ae/A
1.2 Ibs ae/A
80 acres
40 acres
1000 gallons
5 acres
40 acres
35,000
69,000
34,000
410,000
43,000
Mixer/Loader/Applicator
M/L/A Wettable Powder with
Turfgun
M/L/A DF with Turfgun
M/L/A Liquid Flowables with
Turfgun
M/L/A Liquids with Backpack
Sprayer
M/L/A Granules with Push Cyclone
PCO Turf
PCO Turf
PCO Turf
Non-turf
Areas*
PCO Turf
1.2 Ibs ae/A
1.2 Ibs ae/A
1.2 Ibs ae/A
0.038 Ib ae/gallon
1.2 Ibs ae/A
5 acres
5 acres
5 acres
40 gallons
5 acres
6,600
190,000
210,000
54,000
54,000
M = mixer, L = loader, A = applicator
ae = acid equivalent
ROW = right-of-way PCO = Pest Control Operator
* use rate based on EPA Reg. #228-410
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
MCPP-p. Occupational post-application inhalation exposures are not anticipated because
MCPP-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 MCPP-p is 48 hours where the Worker Protection Standard applies.
18
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Therefore, with the existing protective measures in place, the Agency has determined that any
potential post-application exposures do not pose 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), and the National Institute of Occupational safety
and Health's Sentinel Event Notification system for Occupational Risks (NIOSH SENSOR). In
the case of MCPP-p, there were no human incident reports identified.
B. Environmental Risk Assessment
The ecological risk assessment evaluated three active ingredients: MCPP-p acid, MCPP-p
DMAS, and MCPP-p potassium salt. Because not all ecological studies conducted with each of
the three MCPP-p forms were available, the Agency developed a strategy to bridge the majority
of fate and ecotoxicity data requirements for MCPP-p acid, MCPP-p DMAS, and MCPP
potassium salt. Likewise, this bridging strategy was used to reflect the most sensitive endpoint
assessed. Based on available bridging data, which demonstrated that MCPP-p DMAS rapidly
dissociated to MCPP-p acid and the dimethylamine ion, the Agency determined that acceptable
studies conducted with the MCPP-p acid, DMAS, or potassium salt form could be used as
"surrogate" data, as appropriate, for the respective unavailable or deficient MCPP-p studies.
Assuming that MCPP-p potassium salt will likewise completely and rapidly dissociate to MCPP-
p acid and the potassium ion, the Agency expects that the toxicity is similar to the MCPP-p acid
and MCPP-p DMAS. A summary of the EPA's ecological fate and effects assessment is
presented below. The full assessment, Environmental Fate and Effects Science Chapter for
MCPP-p acid, MCPP-p DMAS, and MCPP-p potassium salt, dated August 28, 2007, and
response to public comments are available on the internet and in the public docket at
www.regulations.gov (EPA-HQ-OPP-2006-0943).
1. Environmental Fate and Transport
Available environmental fate data indicates that MCPP-p is generally non-persistent, but
may be persistent in certain (acidic) terrestrial environments. The primary routes of dissipation
appear to be photodegradation in water, microbial-mediated degradation, and leaching. MCPP-p
does not adsorb strongly to soils and, thus, is likely to be mobile in terrestrial and aquatic
environments. MCPP-p DMAS is expected to dissociate quickly, where the dimethylamine ion
degrades by microbial-mediated processes. Aqueous photolysis data indicates that MCPP-p
photodegrades in aqueous environments, with reported half-lives ranging from 4.9 to 7.2 days.
MCPP-p acid is stable to abiotic hydrolysis in pH 5, 7, and 9 buffer solutions. Primary
degradation products of MCPP-p include 4-chloro-2-methylphenol, o-cresol, and carbon dioxide,
depending on the type of degradation process. Although information on the toxicity of these
degradates are not available, the Agency is assuming that degradates are of equal or less toxicity
than the parent compound.
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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 MCPP-p to
non-target species. Estimated Environmental Concentrations (EECs) are estimates of potential
residue concentrations from the maximum or typical application rate of MCPP-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 to the non-target organism. Table 12 outlines the Agency's LOCs and the
corresponding risk presumptions.
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 MCPP-p due to direct deposition from
labeled uses 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 MCPP-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
MCPP-p in the food chain is not expected to be a significant exposure source to non-target
terrestrial organisms.
Residues of MCPP-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
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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 MCPP-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,
which is measured against the Agency's LOG to determine potential risk to that organism.
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 a maximum application rate of 1.2 Ibs ae MCPP-p/A or the
maximum typical rate assessed of 0.78 Ib ae MCPP-p/A, with 2 applications per year;
- a default residue degradation half-life of 35 days; and
an interval of 30 days, the shortest timeframe between repeat applications.
Based on the above factors, EPA estimated several EECs for various food sources
(grasses, fruit, seed, and insects) associated with the registered uses of MCPP-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 MCPP-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 MCPP-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 model (Version 1.2.3) and corresponding
avian acute and chronic RQs are based on the most sensitive acute and chronic endpoints,
respectively, for birds. MCPP-p appears to cause moderate acute oral toxicity to avian and
mammalian species. Table 13 lists the toxicity endpoints used in the avian and mammalian
assessments.
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Table 13. Summary of Avian and Mammalian Toxicity Data Conducted with MCPP-p
Species
Northern
Bobwhite quail
Mallard duck
Japanese quail
Laboratory rat
LD50
(mg ae/kg bwt)
491
—
—
414
Acute Oral
Toxicity, MRID
Moderately toxic,
42436701 (DMAS)
—
—
Moderately toxic
42614701 (DMAS)
LCso
(mg ae/kg)
—
>4,130
—
—
NOAEC/
LOAEC
(mg/kg/day)
—
—
NOAEC -5 1.6
LOAEC - 174
NOAEC - 54
LOAEC - 83
MRID
—
—
44925501
(DMAS)
46591804
(acid)
mg ae/kg bwt = milligrams of acid equivalent per kilogram body weight
Birds
For birds, the acute risk LOG is 0.5. Based on estimated avian acute dose-based RQs for
both spray and granular applications, the LOG for non-endangered birds is exceeded for some
scenarios. The acute endangered RQs exceeded the LOG (0.1) for birds. However, based on
dietary-based acute RQs, the all scenarios are below the LOG. Tables 14 and 15 summarize the
acute and chronic RQs for avian species, with acute non-endangered LOG exceedances identified
in bold text.
Table 14. MCPP-p Acute Dose-based RQs for Birds at 1.2 Ibs ae MCPP-p/A
Body
Weight
20 g
100 g
1,000 g
Spray Application
Short grass
EEC
509
290
130
RQ
1.44
0.64
0.20
Tall Grass
EEC
233
133
60
RQ
0.66
0.30
0.09
Broadleaf plants/
small insects
EEC
286
163
73
RQ
0.81
0.36
0.11
Fruits/pods/seed/
large insects
EEC
31
18
8
RQ
0.09
0.04
0.01
Granular
Application
LD50/ft2
RQ
1.77
0.28
0.02
Acute non-endangered LOG for terrestrial animals > 0.5, endangered LOG > 0.1.
Bold = LOG exceedance.
The Agency also assessed potential acute and chronic risk to birds using dietary-based
endpoints. The chronic risk LOG for birds is 1.0. Calculations for dietary-based RQs are not
adjusted for bodyweight variations. Based on estimated avian acute dietary-based RQs for spray
applications, the acute LOG is not exceeded. However, based on estimated chronic RQs, the
LOG for non-endangered birds is exceeded for most food items. Table 15 summarizes the acute
and chronic RQs for avian species.
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Table 15. MCPP-p Acute and Chronic Dietary-based RQs for Birds, Spray Application at 1.2 Ibs ae/A
Short grass
EEC
446.99
aRQ
0.11
cRQ
8.66
Tall grass
EEC
204.87
aRQ
0.05
cRQ
3.97
Broadleaf plants/small
insects
EEC
251.43
aRQ
0.06
cRQ
4.87
Fruits/pods/seed/large
insects
EEC
27.94
aRQ
0.01
cRQ
0.54
Acute non-endangered LOG for terrestrial animals > 0.5, endangered LOG > 0.1.
Chronic non-endangered and endangered LOG for terrestrial animals is > 1.0
Bold = LOG exceedance.
aRQ = acute RQ
cRQ = chronic RQ
According to the MCPP-p Task Force, more than 95% of products containing MCPP-p
are applied to residential lawns. The Agency assessed the maximum typical rate of 0.78 Ib ae
MCPP-p/A used by homeowners. Based on this typical use rate, some acute RQs and
endangered species RQs still exceeded the acute LOC. The non-endangered LOC exceedances
are identified in bold text. Acute RQs are shown in Table 16.
Table 16. MCPP-p Acute Dose-based RQs for Avian Species, 0.78 Ib ae MCPP-p/A
Body
Weight
20 g
100 g
1,000 g
Spray Applications
Short grass
EEC
330.90
188.69
84.48
RQ
0.94
0.42
0.13
Tall Grass
EEC
151.66
86.48
38.72
RQ
0.43
0.19
0.06
Broadleaf plants/
small insects
EEC
186.13
106.14
47.52
RQ
0.53
0.24
0.07
Fruits/pods/seed/
large insects
EEC
20.68
11.79
5.28
RQ
0.06
0.03
0.01
Granular
Application
LD50/ft2
RQ
1.15
0.18
0.01
Acute non-endangered LOC for terrestrial animals > 0.5, endangered LOC > 0.1.
Bold = LOC exceedance.
The Agency also assessed potential acute and chronic risk to birds using dietary-based
endpoints. Calculations for dietary-based RQs are not adjusted for bodyweight variations.
Based on estimated avian acute dietary-based RQs for spray applications, the acute LOC is not
exceeded. However, based on estimated chronic RQs, the LOC for non-endangered birds is
exceeded for most food items. Table 17 summarizes the acute and chronic RQs for avian
species.
Table 17. MCPP-p Acute and Chronic Dietary-based RQs for Birds, Spray Application at 0.78 Ib ae/A
Short grass
EEC
290.54
aRQ
0.07
cRQ
5.63
Tall grass
EEC
133.17
aRQ
0.03
cRQ
2.58
Broadleaf plants/small
insects
EEC
163.43
aRQ
0.04
cRQ
3.17
Fruits/pods/seed/large
insects
EEC
18.16
aRQ
<0.01
cRQ
0.35
Acute non-endangered LOC for terrestrial animals > 0.5, endangered LOC > 0.1.
Chronic non-endangered and endangered LOC for terrestrial animals is > 1.0
Bold = LOC exceedance.
aRQ = acute RQ
cRQ = chronic RQ
Mammals
As with birds, EPA assesses acute and chronic risk to mammals based on an acute LOC
of 0.5, acute endangered LOC of 0.1, and a chronic LOC of 1.0. Dose-based acute RQs for
mammals exceed the acute LOC based on MCPP-p spray applications, but acute RQs exceed the
23
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LOG of 0.1 for endangered mammals in both MCPP-p spray and granular applications. Based
on the MCPP-p spray application, mammalian chronic dose-based RQs exceeds the LOG;
however, dietary-based chronic RQs are below the Agency's LOG. The ranges of acute and
chronic RQs are presented in Table 18 with LOG exceedances identified in bold text.
Table 18. MCPP-p Acute and Chronic RQs for Mammals, 1.2 Ibs ae MCPP-p/A
Body
Weight
Spray Applications
Short grass
EEC
RQ
Tall grass
EEC
RQ
Broadleaf
plants/small
insects
EEC
RQ
Fruits/pods/
large insects
EEC
RQ
Seeds
(granivores)
EEC
RQ
Granular
Application
LD50/ft2
RQ
Acute, dose-based
15 g
35 g
1,000 g
426
295
68
0.35
0.30
0.16
195
135
31
0.16
0.14
0.07
240
166
38
0.20
0.17
0.09
27
31
4
0.02
0.02
0.01
6
4
1
<0.01
<0.01
<0.01
0.69
0.37
0.03
Chronic, dose-based
15 g
35 g
1,000 g
426
295
68
3.59
3.07
1.64
195
135
31
1.65
1.41
0.75
240
166
38
2.02
1.73
0.92
27
31
4
0.22
0.19
0.10
6
4
1
0.05
0.04
0.02
n/a
n/a
n/a
Chronic, dietary-based
n/a
447
0.41
205
0.19
251
0.23
28
0.03
28
0.03
n/a
Acute LOCs for terrestrial animals for non-endangered > 0.5, endangered > 0.1.
Chronic non-endangered and endangered LOG for terrestrial animals is > 1.0.
n/a = not assessed
Bold = LOG exceedance.
As discussed above, according to the MCPP-p Task Force, more than 95% of products
containing MCPP-p are applied to residential lawns by homeowners. The Agency assessed the
maximum typical rate of 0.78 Ib ae MCPP-p/A used by homeowners. Based on these typical use
rates, RQs for chronic risk to mammals are lower and are presented in Table 19.
Table 19. MCPP-p Chronic Dose-based RQs for Mammals, 0.78 Ib ae MCPP-p/A, Spray Applications
Body
Weight
15 g
35 g
1,000 g
Short grass
EEC
277.01
191.45
44.39
RQ
2.33
1.99
1.07
Tall grass
EEC
126.96
87.75
107.69
RQ
1.07
0.91
0.49
Broadleaf
plants/small
insects
EEC
155.82
107.69
24.97
RQ
1.31
1.12
0.60
Fruits/pods/
large insects
EEC
17.31
11.97
2.77
RQ
0.15
0.12
0.07
Seeds
(granivores)
EEC
3.85
2.66
0.62
RQ
0.03
0.03
0.01
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 MCPP-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 EC25
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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 20 shows the
toxicity data used to evaluate risks to terrestrial and semi-aquatic plants.
Table 20. Summary of Terrestrial Plant Toxicity Data Conducted with MCPP-p Acid.
Species
Seedling Emergence
Vegetative Vigor
Toxicity
Most sensitive monocot: Onion
EC25= 0.005 llbae/A
NOAEC = 0.00 14 Ibae/A
Most sensitive dicot: Cabbage
EC25= 0.0019 Ibae/A
NOAEC = 0.0005 Ib ae/A
Most sensitive monocot: Corn
EC25= 0.006 Ib ae/A
NOAEC = 0.00 lib ae/A
Most sensitive dicot: Cabbage
EC25= 0.01 lib ae/A
NOAEC = 0.00 lib ae/A
Most Sensitive
Endpoint
Dry Shoot Weight
MRID
43016601
43059301
Ib ae/A = pound of acid equivalent per acre
RQs are developed for terrestrial (dryland) plants are based on MCPP-p runoff and drift
from one treated hectare moving to adjacent areas, whereas semi-aquatic areas (wetlands) are
based on movement from a treated ten-hectare site. The difference in the model values (1 versus
10 hectares) are reflected in the ten-fold difference in resulting RQs, shown in Tables 20 and 21.
Using EECs based on the maximum single application rate of 1.2 Ibs ae MCPP-p/A, all RQs
exceed the Agency's LOG of 1 for non-endangered and endangered plant species. Even based
on the maximum typical rate of 0.78 Ib ae MCPP-p/A, all RQs exceeded the LOC; LOC
exceedances identified in bold text. Tables 21 and 22 summarize the EECs and RQs for
terrestrial and semi-aquatic plants exposed to MCPP-p.
Table 2 1 . Terrestrial Plant RQs for Ground Spray and Granular Applications, 1 .2 Ibs ae MCPP-p/A
Application
Non-Endangered,
ground spray
Non-Endangered,
granular
Endangered,
ground spray
Endangered,
granular
Adjacent Areas
EEC
(Ib)
0.072
0.060
0.072
0.060
RQs
M
14.12
11.76
51.43
42.86
D
37.89
31.58
144.00
120.00
Semi-aquatic Areas
EEC
(Ib)
0.612
0.600
0.612
0.600
RQs
M
120.00
117.65
437.14
428.57
D
322.11
315.79
1224.00
1200.00
Drift Only
EEC
(Ib)
0.12
RQs
M
2.35
D
6.32
n/a
0.12
8.57
24.00
n/a
n/a = not applicable
M = monocot D = dicot EEC unit is ae MCPP-p/A. Bold = LOC exceedance.
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Table 22. Terrestrial Plant RQs for Ground Spray and Granular Applications, 0.78 Ib ae MCPP-p/A
Application
Non-Endangered,
ground spray
Non-Endangered,
granular
Endangered,
ground spray
Endangered,
granular
Adjacent Areas
EEC
(Ib)
0.047
0.039
0.047
0.039
RQs
M
9.18
7.65
33.43
27.86
D
24.63
20.53
93.60
78.00
Semi-aquatic Areas
EEC
(Ib)
0.398
0.390
0.398
0.390
RQs
M
78.00
76.47
284.14
278.57
D
209.37
205.26
795.60
780.00
Drift Only
EEC
(Ib)
0.008
RQs
M
1.53
D
4.11
n/a
0.008
5.57
15.60
n/a
n/a = not applicable
M = monocot D = dicot EEC unit = ae MCPP-p/A. Bold = LOG exceedance.
b. Aquatic Organisms
Fish, amphibians, and aquatic invertebrates that live in aquatic environments are
potentially exposed to MCPP-p residues in surface water by direct contact of their integument
and via uptake through their gills or integument. Immediately following applications of MCPP-
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. MCPP-p has
low persistence in some terrestrial environments; however, the likelihood of transport by runoff
and leaching still exists. MCPP-p EECs for aquatic ecosystems were predicted 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
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
EEC values determined for impact to non-target aquatic organisms are specific to ecological and
fate properties in the respective turf scenarios assessed and, therefore, are different from those
used to assess human health exposure in the drinking water assessment. The modeling scenarios
for turf (i.e., sod farms) in Pennsylvania and Florida were selected for the assessment to
represent applications to turf, lawns, and grass areas.
Currently, the Agency does not have a model with which to predict concentrations of
MCPP-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. MCPP-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 MCPP-p Task Force. Estimated water concentrations of MCPP-p for representative turf
scenarios are listed in Table 23.
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Table 23. PRZM/EXAMS EECs of MCPP-p Acid in Water for Aquatic Exposure
Crop
Scenario
Application Rate
1 -in- 10 Year
Peak Acute
(ng/L)
1 -in- 10 Year
2 1 Day Chronic
(W?/L)
1 -in- 10 Year
60 Day Chronic
(ng/L)
Florida Turf
Ground
Granular
-1.21bsaeMCPP-p/A
- 2 applications
- 30 days apart
11.69
11.56
4.78
4.75
2.42
2.32
Pennsylvania Turf
Ground
Granular
- 1.21bsaeMCPP-p/A
- 2 applications
- 30 days apart
6.66
6.66
3.19
2.97
1.99
1.84
Ibs ae MCPP-p/A = pounds of acid equivalent of MCPP-p per acre.
1.
Fish and Invertebrates
A limited number of acute aquatic toxicity studies were submitted for both freshwater
and marine/estuarine fish and invertebrates. However, the registrant did not submit acute or
chronic toxicity data for any marine/estuarine species. Table 24 is a summary of aquatic toxicity
studies the Agency used in the ecological assessment.
Table 24. Summary of Fish and Invertebrate Toxicity Data for MCPP-p
Species
Freshwater Fish:
Bluegill sunfish
Freshwater Fish:
Rainbow trout
Freshwater
Invertebrate:
Water flea
Acute Toxicity
96-hour LC50
(mg ae/L)
>93
>93
—
48-hour
EC50
(mg ae/L)
—
—
>91
MRID,
Toxicity Category
42766901 (DMAS)
Slightly toxic
42844801 (DMAS)
Slightly toxic
45606104 (Acid)
Slightly toxic
Chronic Toxicity
NOAEC/LOAEC
(mg ae/L)
—
—
50.8/102.7
MRID
—
—
45606102
(Acid)
mg ae/L - milligrams of acid equivalent per liter
Freshwater Fish and Invertebrates
Similar to the way that RQs are calculated for terrestrial organisms, aquatic acute RQs
are derived by dividing the peak EECs by the LCso to estimate acute hazard. Chronic RQs for
freshwater invertebrates are derived by dividing the 21-day EECs by the NOAEC values. No
data were available to assess chronic risks to freshwater fish. Based on predicted modeling
assessing both ground spray and granular applications, all acute RQs are <0.01 for freshwater
fish and invertebrates, and chronic exposures to freshwater invertebrates are less than 1 and do
not exceed the Agency's LOCs.
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Marine Fish and Invertebrates
Because there is insufficient chronic data to estimate potential hazard to marine/estuarine
organisms, potential indirect acute and chronic effects to estuarine/marine fish and invertebrates
cannot be precluded based on the available data. However, based on available chronic toxicity
data conducted with 2,4-D, another chlorophenoxy herbicide, it is less likely that MCPP-p will
pose chronic effects to non-target marine animals.
2. Aquatic Plants
Likewise for non-target fish and invertebrates, surface water concentrations were
predicted using PRZM/EXAMS modeling for MCPP-p applications to turf scenarios,
considering both ground spray and granular applications. Aquatic plants toxicity data were
available to determine potential toxicity of MCPP-p to non-target aquatic plants. Table 25
summarizes the toxicity studies used to calculate RQs for aquatic plants.
Table 25. Summary of Aquatic Plant Toxicity Data for MCPP-p
Species
Vascular plant,
Lemna gibba
Nonvascular plant,
Skeletonema costatum
Toxicity
EC50 = 1.3 mg ae/L
NOAEC <0.44 mg ae/L
EC05 = 0.23 mg ae/L
EC50 = 0.014mgae/L
NOAEC <0.009 mg ae/L
EC05 = 0.0008 mg ae/L
Endpoint
Frond number
Cell count density
MRID
42486201
42633902
43657303
mg ae/L - milligrams of acid equivalent per liter
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 exceedances at the non-endangered aquatic plant LOG of 1 for non-endangered
plants. The only exceedance for endangered aquatic plants was for non-vascular plants;
however, no non-vascular plants are listed threatened as or endangered. Table 26 summarizes
the RQs for aquatic plants, with LOG exceedances identified in bold text.
Table 26. Aquatic Plant RQs for MCPP-p
Site
Florida Turf
Pennsylvania
Turf
Application
Method
Ground Spray
Granular
Ground Spray
Granular
Vascular
Non-endangered
0.01
0.01
<0.01
<0.01
Endangered
0.05
0.05
0.03
0.03
Non-vascular
Non-endangered
0.83
0.83
0.48
0.48
Endangered
14.61
14.45
8.32
8.32
Acute non-endangered and endangered LOG for aquatic plants > 1.0. Bold = LOG exceedance.
c. Spray Drift
Although it is expected that the highest concentrations of MCPP-p would occur in
directly treated areas, spray drift adjacent to treated areas may still present the potential for
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exposures to non-target organisms. Potential exposures to non-target organisms include
movement of MCPP-p to off-target field surface soil, foliage, and insects. Spray drift into water
bodies adjacent to treated areas can move to surface water, affecting sensitive aquatic organisms.
Because MCPP-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). Based on
available data, droplets were presumed to be fine to medium-coarse sizes. Table 27 shows the
RQS for terrestrial and semi-aquatic plants, with non-endangered LOG exceedances identified in
bold text.
Table 27. MCPP-p Spray Drift EECs and RQs for Terrestrial and Semi-aquatic Plant RQs
Exposure (EECs)
Distance from
edge of field (feet)
Deposition
(Ibs/acre)
Toxicity endpoints (Ib ae/acre)
Non-Endangered,
ground spray RQs
Monocot
0.0051
Dicot
0.0019
Endan
ground si
Monocot
0.0014
gered,
sray RQs
Dicot
0.0005
Maximum application rate of 1.2 Ibs ae/A
0
250
500
750
1.21
0.0026
0.0015
0.0010
237.25
0.51
0.29
0.20
636.84
1.37
0.79
0.53
864.29
1.86
1.07
0.71
2420.00
5.20
3.00
2.00
Typical application rate ofO. 78 Ibs ae/A
0
250
500
750
0.786
0.0017
0.0009
0.0006
154.12
0.33
0.18
0.12
413.68
0.89
0.47
0.32
561.43
1.21
0.64
0.43
1572.00
3.40
1.80
1.20
Acute non-endangered and endangered LOG for aquatic plants > 1.0. Bold = LOG exceedance.
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. A review of the EIIS database for
ecological incidents involving MCPP-p showed a reporting of six incidents. Five involved
damage to grass on homeowner lawns and one involved a fish kill in a nearby pond. For all
incidents, multiple active ingredients were used; therefore, it cannot be determined conclusively
if MCPP-p was responsible for these incidents. Results from these incidents do not necessarily
determine direct effects from MCPP-p only, as it is frequently co-formulated with other
chlorophenoxy herbicides.
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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 MCPP-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 MCPP-p.
The Agency has determined that MCPP-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 MCPP-p that are eligible for reregistration.
Appendix B identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of mecoprop-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
reregistration requirements identified in this document, the Agency may take regulatory action to
address these concerns.
B. Public Comments and Responses
When making its reregistration decision, the Agency considered all comments received in
the docket during the public participation phase, EPA worked with stakeholders and the public to
reach the regulatory decisions for MCPP-p. 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-2006-0943) at
www.regulations.gov. The RED document, supporting documents for MCPP-p, and the
Agency's response to received comments are also available in the docket. In addition, the
MCPP-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 MCPP-p are eligible for reregistration provided that the following
risk mitigation measures and label amendments are adopted accordingly. Table 28 summarizes
the human and ecological risks of concern and the respective mitigation measure.
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Table 28. MCPP-p Human and Ecological Risk Mitigation Measures
Risk of Concern
Acute eye irritation
(Toxicity Category I).
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 MCPP-p.
For early entry workers, protective eyewear must be worn in addition to
baseline PPE.
The maximum application rate for broadcast treatments is 0.75 Ib ae
MCPP-p/A.
For spot treatments only, the maximum use rate permitted is the
equivalent to 1 .2 Ibs ae MCPP-p/A, to be applied to areas no larger than
1,000 ft2 per acre.
Applications must be made using medium- to coarse-sized droplets.
Ibs ae MCPP-p/A = pounds of acid equivalent MCPP-p per acre. REI = restricted entry interval
The following is a summary of the rationale for managing risks associated with the use of
MCPP-p.
1. Human Health Risk Management
The Agency has determined that based on the currently registered residential uses of
MCPP-p, there are no risks of concern (drinking water, handler, and post-application exposures).
As is expected of an acid, MCPP-p acid is an acute severe eye irritant (Toxicity Category I). In
the absence of available acute eye toxicity data conducted with MCPP-p DMAS, the Agency
assumes a default Toxicity Category I. To address this concern, uses of MCPP-p where the
Worker Protection Standard applies, will require a 48-hour REI after applications of MCPP-p.
Early entry workers must wear goggles in addition to the baseline PPE.
2. Ecological Risk Management
Based on available toxicological data and refined use information, the ecological risk
assessment identified some exposure scenarios with MCPP-p that may pose ecological risks of
concern to the Agency, including effects on endangered species. However, considering the
conservative assumptions made in the ecological assessment and the refined usage information
provided by the Task Force, the risks can be sufficiently mitigated with the adoption of the
proposed labeling mitigation measures. Therefore, the Agency has determined that the current
use patterns, as specified in Appendix A, 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 MCPP-p versus the screening-level modeling estimates.
a. Terrestrial Organisms
Avian and Mammalian Species
The ecological assessment identified potential risk to some non-target terrestrial animals.
When considering the upper-bound residues on treated food items, even at the highest assessed
typical rate (0.78 Ib ae MCPP-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
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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 1.2 Ibs ae MCPP-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 MCPP-p residues
on food items.
To reduce the amount of MCPP-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 residential lawns and other
ornamental turf), with the exception of spot treatment use, the maximum supported application
rate permitted is 0.75 Ib ae MCPP-p/A (used during greater weed infestation). Typical
application rates range from 0.25 - 0.50 Ib ae MCPP-p/A, which further reduces the amount of
residues in a treated area. The application rate for spot treatments has been reduced to 1.2 Ibs ae
MCPP-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 29 for additional specific labeling language.
Terrestrial Plants
Typically with a terrestrial herbicide, 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 LOG even
for drift alone at the highest typical rate (0.78 Ib ae MCPP-p/A) assessed. As conservative
assumptions were made in the assessment, some RQ estimates may be overestimating potential
risks. The majority of MCPP-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 MCPP-p products are on residential turf, MCPP-
p 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 MCPP-p transported via runoff and drift are as follows: a maximum use rate
of 1.2 Ibs ae MCPP-p/A and the highest typical application rate assessed of 0.78 ae MCPP-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.
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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 applications 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. 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
MCPP-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 and restricting droplet size to
medium- to coarse-sized droplets will reduce the amount of MCPP-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 a maximum of 0.75 Ib ae MCPP-p for
broadcast treatments. Spot treatments will be restricted to applications no greater than 1,000
ft2/A at the maximum rate of 1.2 Ibs ae MCPP-p/A. Thus, the 1.2 Ibs ae MCPP-p/A rate would
not be applied to an entire acre. Because spot treatments are expected to be 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.
With the implementation of these mitigation measures and labeling requirements, movement of
MCPP-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 MCPP-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 risks of concern to the Agency, as
MCPP-p exhibits low acute toxicity potential of MCPP-p to fish and other aquatic animals.
Although no 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 chronic toxicity data
conducted with another chlorophenoxy, 2,4-D, on fish and invertebrates in freshwater and
marine/estuarine environments, 2,4-D poses low potential for chronic toxicity. The Agency
believes that it is unlikely that MCPP-p would pose risks to fish and aquatic invertebrates,
33
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considering its low acute toxicity and low chronic toxicity posed by other chlorophenoxy
compounds. Based on the current use patterns, no additional data is needed at this time to assess
potential chronic toxicity.
Aquatic Plants
Based on available data for aquatic plants, there are no risks of concern to the Agency,
with the exception of exceedances identified for endangered non-vascular plants. Although there
was indication for potential effects to non-target endangered non-vascular plants, there are no
non-vascular plants listed as endangered species. Thus, no mitigation for aquatic plants 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.
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 MCPP-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 MCPP-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
MCPP-p "may affect" listed species or their designated critical habitat, EPA will employ the
34
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provisions in the Services regulations (50 CFR Part 402). To reduce potential effects to non-
target endangered species, EPA is requiring various mitigation measures, including rate
reductions as well as additional labeling language to reduce the movement of pesticide away
from target application areas. Additionally, the Agency is requiring additional data to further
characterize and refine 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 MCPP-p. For the specific labeling
statements, refer to Table 29 of this RED document.
E. Import Tolerance
MCPP-p is not registered for any food uses in the United States. The Agency is aware of
the use of MCPP-p on food commodities, specifically on grains, in Europe and Canada. The
MCPP-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 MCPP-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
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, MCPP-p may be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption.
35
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V. What Registrants Need to Do
For MCPP-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 MCPP-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);
36
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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 Julia Stokes at 703-347-8966 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)
Julia Stokes
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)
Julia Stokes
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 MCPP-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 MCPP-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 labeling contained in Table 29.
37
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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 Julia Stokes at
703-347-8966.
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 29 describes how language on the labels should be amended.
38
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Table 29. MCPP-p Labeling Requirements Table
Description
Mecoprop-p (MCPP-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 MCPP-p/A."
"Only for formulation into end-use products with directions for use that
prohibit spot treatment applications greater than 1.2 Ibs ae MCPP-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
Precautionary Statements
End-Use Products Intended for Occupational Use (WPS andNon-WPS)
39
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PPE Requirements
Established by the
RED for all
formulations except for
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 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
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.
40
-------
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
41
-------
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.)
General Application
Restrictions
For broadcast treatments, include the following:
"Limited to 2 applications per year.
Maximum of 0.75 Ib ae MCPP-p/A per application (or the respective Ib ae
MCPP-p/1,000 ft2).
Minimum of 30 days between applications."
For spot treatments for all use sites, include the following statements:
"Limited to 2 applications per year.
Maximum of 1 .2 Ibs ae MCPP-p/A per application (or the respective Ib ae
MCPP-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.
"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 Use under Other Use
Precautions
42
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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
43
-------
Entry Restrictions for
granular formulations
If the product does not have instructions for watering in, include the
following statement:
"Do not allow people or pets to enter the treated area until dusts have
settled."
If the product has instructions for watering in, include the following
statement:
"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 the following statement:
"Do not apply as a fine mist because of potential injury to desirable plants."
Directions for Use under Other Use
Precautions
44
-------
Other Application
Restrictions
Requirements for Granular Formulations, include the following
statement:
"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), include the following statement:
"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, include the following statement:
"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
45
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APPENDIX A. Use Patterns Eligible for Reregistration
Table of MCPP-p Use Patterns Eligible for Reregistration (Case #0377)
Use Site
Ground Broadcast
Treatments in:
residential turf,
ornamental turf
(e.g., golf courses,
cemeteries, parks, sports
fields, and turfgrass),
cnrl farms nnH
uncultivated non-
agricultural areas (e.g.,
roadsides, fencerows,
and rights-of-ways)
Spot Treatments (for
woody plants
management) in
uncultivated non-
agricultural areas
(e.g., utility power lines,
hedgerows, industrial
sites, ditches, airports,
and fence rows)
Formulation
MCPP-p acid:
granular,
emulsifiable
concentrate,
water-soluble dry
concentrate, and
wettable powder
MCPP-p DMAS:
granular, water-
soluble liquid
concentrate, and
water-soluble
concentrate dry
Typical
Application
Rate
0.20-0.75
Ib ae/A
Not
applicable
Maximum
Application
Rate
0.75 Ib ae/A
Concentration
equivalent up
tol.21bs
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
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
46
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APPENDIX B. Data Supporting Guideline Requirements for MCPP-p
Data Supporting Guideline Requirements for the Reregistration of Mecoprop-p (MCPP-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)
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2300
850.1075
850.1075
71-la
71-2a
71-2b
71-4a
72-la
72-lc
Avian Acute Oral Toxicity - Quail
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Avian Reproduction - Quail
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
All
All
All
All
All
All
41013912
42436701
43810201
42435601
44030401
44925501 - supplemental
42766901
43810202
42844801
47
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Data Supporting Guideline Requirements for the Reregistration of Mecoprop-p (MCPP-p)
850.1010
850.1300
850.4400
850.4225
850.4250
850.4400
850.5400
72-2a
72-4
122-2
123-la
123-lb
123-2
123-2
Invertebrate Toxicity - Water flea
Daphnid Chronic Toxicity
Aquatic Plant Toxicity
Seed Germ./ Seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
Algal Toxicity
All
All
All
All
All
All
All
42971301
43372301
45606102 - supplemental
45606104 - supplemental
45606102 - supplemental
42486201
46591807
42845501 -supplemental
43016601 -supplemental
43385901
42775401 -supplemental
43059301 -supplemental
42486201
42633902
43657303
42633901
42666201
42698601 -supplemental
43048901
43657301
43657302
44294401
46591808 - supplemental
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.6200
870.3100
870.3200
870.3550
870.6200
870.4100
870.4100
870.4200
81-1
81-2
81-3
81-4
81-5
81-6
81-8-SS
82-la
82-2
None
82-7
83-la
83-lb
83-2a
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
Acute Neurotoxicity Screen
Repeated dose 28-day/
90-Day Feeding - Rodent
21 -Day Dermal - Rabbit/Rat
Reproduction/development Toxicity
Screening Test
Neurotoxicity Screening Battery
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-Rodent
Oncogenicity - Rat
All
All
All
All
All
All
All
All
All
All
All
All
All
All
42614701
42947801
42916401
42947804
42947805
43749601
43770801
00158359
41013910
43059201
43908201
42916401
43638101
43638102
46591804
43908201
40937501
44895501
44953601
44642401
40937501
46591801
48
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Data Supporting Guideline Requirements for the Reregistration of Mecoprop-p (MCPP-p)
870.4200
870.3700
870.3700
870.5140
870.5375
None
870.7485
875.2100
875.2400
875.2500
83-2b
83-3a
83-3b
84-2a
84-2b
84-4
85-1
132-1
132-3
132-4
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
Metabolism and Pharmacokinetics
Foliar Dislodgeable Residue Dissipation
Dermal Exposure
Inhalation Exposure
All
All
All
All
All
All
All
All
All
All
44895501
44953601
46591802
00164569
42815302
42815301
00158361
41013909
42860801
42936802
42947807
42980101
43113401
46614001
00158362
00158363
41013908
42860804
42936803
42947808
43189501
46614001
44895502
43717201
44362701
44362702
44655702
44655703
45033101
44459801
44459801
ENVIRONMENTAL FATE
835.2110
835.2240
835.2410
835.4100
835.1240
835.6100
161-1
161-2
161-3
162-1
162-4
163-1
164-1
Hydrolysis as a function of pH
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Aerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
Terrestrial Field Dissipation
All
All
All
All
All
All
All
44110901
44110901
44147001
44281301
42845301
42845302
44205701
43909701
43909702
43909703
43909704
43909705
43943201
OTHER
850.3020
141-1
Honey Bee Acute Contact
42159701
46591810
49
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APPENDIX C. Technical Support Documents
Additional documentation in support of the MCPP-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. Phang, W., et al. MCPP-p acid, MCPP-p DMAS, & MCPP-p potassium salt: HED
Human Health Risk Assessment. July 30, 2007.
2. Dole, T. MCPP-p: 2nd Revised Occupational and Residential Exposure and Risk
Assessment for the Reregi strati on Eligibility Decision (RED). July 27, 2007.
3. Hetrick, J. FQPA Drinking Water Assessment for Mecoprop-p. June 26, 2007.
4. Hartless, C., et al. Environmental Fate and Effects Science Chapter for MCPP-p acid,
MCPP-p DMAS, and MCPP-p potassium salt. August 28, 2007.
5. Phillips, W., Lee, A. A Preliminary evaluation of Mecoprop (MCPP-p) and Dichlorprop
(2,4-DP-p) Use and Potential Alternatives. August 21, 2007.
50
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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 MCPP-p.
44282 Irvine, L.F.H. (1980). Mecoprop oral teratogenicity study in the Dutch belted rabbit.
Hazleton Laboratories Europe Ltd., Otley Road, Harrogate, HG3 1PY, England. Report No.
1738R-277/5. lanuary 1980. Unpublished.
44294 Gilbert, C.M. and R Hopkins. (1978). The metabolic fate of [14C]-Mecoprop(DL-2-(4-
Chloro-2-methylphenoxy)propionic acid) in the rat Report No. 1333R3-177/1, Hazleton
Laboratories Europe Ltd., Otley Road, Harrogate, HG3 1PY, England. November 1978.
Unpublished.
158359 Kirsch, P., Deckardt, K., Gembardt, C., Aicher, B., and Hildebrand, B. (1985).
Report on the study of the toxicity of MCPP in rats after 3 months administration in
the diet. Department of Toxicology, BASF, Ludwigshafen, FRG. Study No.
31S0047/8303. April 1, 1985. Unpublished.
158361 Engelhardt, G.; Zeller, H. (1981) Report on the Study of 2-(4- Chloro-2-
methylphenoxy)propionic Acid (MCPP) in the Ames Test: 80/538. Unpublished translation
prepared by BASF Gewerbehygiene und Toxikologie, translated by M. Ruff. 16 p.
158362 Engelhardt, G.; Gelbke, H. (1985) Cytogenetic Investigations in Chinese Hamsters after a
Single Oral Administration of MCPP: Bone Marrow Chromosome Analysis: Project No.
10M0047/8306. Unpublished study prepared by BASF AG. 54 p.
158363 Engelhardt, G.; Gelbke, H. (1985) Cytogenetic Investigations in Chinese Hamsters after a
Single Oral Administration of MCPP: Bone Marrow Chromosome Analysis: Project No.
16M0047/8307. Unpublished study prepared by BASF AG. 35 p.
164659 Irvine, L.F.H. (1980). Mecoprop oral teratogenicity study in the rat. Hazelton
Laboratories Europe, Ltd. Study No. 1995-277/7b. June 1980. Unpublished.
40937501 Kuhborth, B., et al. (1988). Study on the chronic toxicity and oncogenic potential of
MCPP in rats. BASF AG, Department of Toxicology, 6700 Ludwigshafen/Rhein,
Germany. Laboratory report number 71S0047/8352, August 23, 1988. Unpublished.
41013908 Englehardt, G. (1985) Report on the Cytogenic Investigations in Chinese Hamsters after a
Single Oral Administration of MCPP; D-Form Bone Marrow Chromosome Analysis:
Registration Document No. BASF: 85/0225. Unpublished study prepared by BASF
Aktiengesellschaft. 50 p.
41013909 Engelhardt, G. (1984) Report on the Study MCPP (D-Form) Ames-Test: Registration
Document No. BASF: 84/0199. Unpublished study pre- pared by BASF Aktiengesellschaft.
20 p.
41013910 Kirsch, P. (1986) Report on the Comparative Study of the Toxicity of the Racemate and D-
Form of Mecoprop in Rats after 7-week Administration in the Diet: Registration Document
No. BASF: 86/0087. Unpublished study prepared by BASF Aktiengesellschaft. 339 p.
41013912 Munk, R. (1987) Avian Single-dose Oral LD50 of MCPP; D-Form to the Bobwhite Quail:
Registration Document No. BASF: 87/0517. Unpublished study prepared by BASF
Aktiengellschaft. 36 p.
51
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42159701 Hoxter, K.; Lynn, S. (1991) MCPP-p DMAS: An Acute Toxicity Study with the Honey Bee:
Lab Project Number: 147-142. Unpublished study prepared by Wildlife International Ltd. 30
P-
42435601 Pedersen, C.; Helsten, B. (1992) R(+)2-(2-Methyl-4-chlorophenoxy) propionic acid
dimethylamine salt (MCPP-p DMAS): 8-Day Acute Dietary LC50 Study in Bobwhite Quail:
Lab Project Number: 119-001-01. Unpublished study prepared by MCPP Task Force II. 91 p.
42436701 Pedersen, C.; Helsten, B. (1992) R+2-2-methyl-4-chlorophenoxy propionic acid
dimethylamine salt (MCPP-p DMAS): 14-day Acute Oral LD50 Study in Bobwhite Quail:
Lab Project Number: 119-002-03: 119-001-01. Unpublished study prepared by Bio-Life
Associates, Ltd. 91 p.
42486201 Hoberg, J. (1992) MCPP-p DMAS-Toxicity to the Duckweed Lemna gibba: Final Report:
Lab Project Number: 92-3-4174: 10566. 1191.6211.410: 574.1. Unpublished study prepared
by Springborn Labs, Inc. 62 p.
42614701 Allan, S. (1992) Acute Oral Toxicity to Rats of MCPP-p DMAS: Lab Proj ect Number:
920504D/JEL 46/AC. Unpublished study prepared by Huntingdon Research Centre Ltd. 25
P-
42633901 Hoberg, J. (1992) MCPP-p DMAS-Toxicity to the Freshwater Blue-Green Alga, Anabaena
flosaquae: Final Report: Lab Proj ect Number: 92-5-4261: 10566.1191.6211.420: 574.0.
Unpublished study prepared by Springborn Labs., Inc. 69 p.
42633902 Hoberg, J. (1992) MCPP-p DMAS-Toxicity to the Marine Diatom, Skeletonema costatum:
Final Report: Lab Proj ect Number: 92-3-4170: 10566.1191.6211.450: 574.0. Unpublished
study prepared by Springborn Labs., Inc. 73 p.
42666201 Hoberg, J. (1992) MCPP-p DMAS-Toxicity to the Freshwater Diatom, Navicula pelliculosa:
Final Report: Lab Project Number: 92-10-4463: 10566.1191.6211.440. Unpublished study
prepared by Springborn Labs, Inc. 70 p.
42698601 Hoberg, J. (1992) MCPP-p DMAS-Toxicity to the Freshwater Green Alga, Selenastrum
capricornutum: Final Report: Lab Project Number: 92-2-4113: 10566.1191.6211.430: 574.0.
Unpublished study prepared by Springborn Labs., Inc. 110 p.
42766901 Munk, R. (1992) Acute Toxicity Study on the Bluegill (Lepomis macrochirus RAF.) of
Mecoprop-p DMA Salt in a Static System (96 Hours): Lab Proj ect Number:
14F0210/915057. Unpublished study prepared by BASF Aktiengesellschaft. 36 p.
42775401 Maggi, V. (1993) The Effects of MCPP-p DMAS on Nontarget Plants: Vegetative Vigor:
Final Report: Lab Proj ect Number: CAR 146-9 IB: 571. Unpublished study prepared by
California Agricultural Research, Inc. 208 p.
42815301 Hellwig, J.; Hildebrand, B. (1993) Prenatal Toxicity of Mecoprop-p in Rabbits After Oral
Administration (Gavage): Lab Proj ect Number: 40R0002/91014. Unpublished study prepared
by BASF Aktiengesellschaft. 324 p.
42815302 Hellwig, J.; Hildebrand, B. (1993) Prenatal Toxicity of Mecoprop-p in Rats After Oral
Administration (Gavage): Lab Proj ect Number: 30R0002/91013. Unpublished study prepared
by BASF Aktiengesellschaft. 372 p.
42844801 Kirsch, P.; Munk, R. (1992) Acute Toxicity of Mecoprop-p DMA Salt in Rainbow Trout:
Lab Project Number: 12F0210/915056. Unpublished study prepared by BASF
Aktiengesellschaft. 29 p.
52
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42845301 Bieber, W.; Kroehn, R. (1991) Degradation of Mecoprop-p in Aerobic Aquatic Environment:
Lab Project Number: 90 9688/2: 91/10994. Unpublished study prepared by Natec Institute.
50 p.
42845302 Matla, Y.; Vonk, J. (1993) Adsorption of Mecoprop-p to Soil Particles in Three Soil Types:
Lab Project Number: IMW-92-0085-01: 93/10223. Unpublished study prepared by TNO
Environmental and Energy Research. 24 p.
42845501 Maggi, V. (1993) The Effects of MCPP-p DMAS on Nontarget Plants: Seed
Germination/Seedling Emergence: Final Report: Lab Project Number: CAR 146-91E: 568.
Unpublished study prepared by California Agricultural Research, Inc. and EPL Bio-
Analytical Services, Inc. 258 p.
42860801 Jones, E.; Kitching, J.; Anderson, A.; et al. (1993) Ames Salmonella typhimurium Bacterial
Reverse Mutation Assay on MCPP-p DMAS: Final Report: Lab Project Number: JEL
51/921058. Unpublished study prepared by Huntingdon Research Centre Ltd. 44 p.
42860804 Proudlock, R; Taylor, K.; Anderson, A.; et al. (1993) MCPP-p DMAS: Micronucleus Test:
Final Report: Lab Project Number: JEL 54/921201. Unpublished study prepared by
Huntingdon Research Centre Ltd. 43 p.
42916401 Allan, S.; Crook, D.; Gibson, W.; et al. (1993) Twenty-one Day Dermal Toxicity Study in the
Rabbit with MCPP-p Acid: Final Report: Lab Project Number: JEL 50/921436. Unpublished
study prepared by Huntingdon Research Centre Ltd. 121 p.
42936802 Adams, K.; Ransome, S.; Anderson, A.; et al. (1993) Chinese Hamster Ovary/HGPRT Locus
Assay MCPP-p DMAS: Final Report: Lab Project Number: JEL 60/921617. Unpublished
study prepared by Huntingdon Research Centre Ltd. 42 p.
42936803 Akhurst, L.; King, J.; Anderson, A.; et al. (1993) MCPP-p DMAS Metaphase Chromosome
Analysis of Human Lymphocytes Cultured In vitro: Final Report: Lab Project Number: JEL
62/921576. Unpublished study prepared by Huntingdon Research Centre Ltd. 44 p.
42947801 Cummins, H. (1990) Mecoprop-p: Acute Oral Toxicity Study in the Rat: Final Draft: Lab
Project Number: AMS/015: 90/AMSO15/0531: 90/0531. Unpublished study prepared by Life
Science Research Ltd. 39 p.
42947804 Smith, K. (1990) Mecoprop-p: Acute Eye Irritation/Corrosion Test in the Rabbit: Final Draft:
Lab Proj ect Number: AMS/018: 90/AMSO 18/0500: 90/0500. Unpublished study prepared by
Life Science Research Limited. 15 p.
42947805 Smith, K. (1990) Mecoprop-p: Acute Dermal Irritation/Corrosion Test in the Rabbit: Lab
Project Number: AMS/017: 90/AMSO 17/0499: 90/0499. Unpublished study prepared by Life
Science Research Limited. 16 p.
42947807 Lloyd, J. (1990) Mecoprop-p: Investigation of Mutagenic Activity at the HGPRT Locus in a
Chinese Hamster V79 Cell Mutation System: Final Report: Lab Proj ect Number: AMS/025:
90/AMS025/0968: 90/0968. Unpublished study prepared by Life Science Research. 44 p.
42947808 Edwards, C. (1991) Mecoprop-p: Assessment of Clastogenic Action on Bone Marrow
Erythrocytes in the Micronucleus Test: Final Report: Lab Project Number: AMS/026:
90/AMS026/1269: 90/1269. Unpublished study prepared by Life Science Research Limited.
46 p.
53
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42971301 Elendt-Schneider, ?. (1991) Determination of the Acute Toxicity of Mecoprop-p (Reg. No.
154 241) to the Water Flea Daphnia Magna: Lab Project Number: 1/89/0280/50/1: 91/10114.
Unpublished study prepared by BASF Aktiengesellschaft, Dept. of Toxicology. 25 p.
42980101 May, K. (1990) Mecoprop-p: Assessment of Mutagenic Potential in Histidine Auxotrophs of
Salmonella Typhimurium (The Ames Test): Lab Project Number: AMS/019:
90/AMSO19/0256: 90/0256. Unpublished study prepared by Life Science Research Limited.
29 p.
43016601 Chetram, R. (1993) Tier 2 Seed Germination/Seedling Emergence Nontarget Phytotoxicity
Study Using MCPP-p acid: Lab Project Number: 1981.0: BL91-485. Unpublished study
prepared by Pan-Agricultural Labs., Inc. 338 p.
43048901 Memmert, U.; Knoch, E. (1993) Toxicity of Mecoprop-p-DMA to Pseudokirchneriella
subcapitata, Synonym Selenastrum capricornutum: Test Report: Lab Project Number: RCC
421018: 421020. Unpublished study prepared by RCC Umweltchemie GmbH & Co. KG. 44
P-
43059201 MCPP Task Force II (1993) Report on the Oral Toxicity of Mecoprop-p Acid in B6C3F1
Mice Administered in the Diet for 3 Months: Lab Project Number: 35C0002/91002.
Unpublished study prepared by BASF Aktiengesellschaft, Dept. of Toxicology. 285 p.
43059301 Chetram, R. (1993) Tier 2 Vegetative Vigor Nontarget Phytotoxicity Study Using MCPP-p
acid: Lab Project Number: BL91-484: 1985.0: PAL-BL91-484. Unpublished study prepared
by Pan-Agricultural Labs., Inc. 253 p.
43113401 Adams, K.; Ransome, S.; Anderson, A. et al. (1993) Chinese Hamster Ovary/HGPRT Locus
Assay: MCPP-p Acid: Final Report: Lab Project Number: JEL 87/931132. Unpublished
study prepared by Huntingdon Research Centre Ltd. 42 p.
43189501 Heidemann, A. (1994) Chromosome Aberration Assay in Human Lymphocytes in vitro with
Mecoprop-p Acid: Lab Project Number: 429401. Unpublished study prepared by Cytotest
Cell Research GmbH & Co. KG (CCR). 35 p.
43372301 Memmert, U.; Knoch, E. (1993) Acute Toxicity of Marks Optica MP n to Daphnia magna
(48-Hour Immobilization Test): Lab Project Number: 409138. Unpublished study prepared
by RCC Umweltchemie GmbH & Co. KG. 37 p.
43385901 Maggi, V. (1994) Tier II: The Effects of MCPP-p DMAS on Nontarget Plants: Seedling
Emergence: Continuation of Study MRID No. 428455-01: Supplemental Report to the Final
Report # CAR 146-91E: Lab Project Number: CAR/122-94: 179S01: CAR/146/91E.
Unpublished study prepared by California Agricultural Research, Inc. and EPL Bio-
Analytical Services, Inc. 98 p.
43638101 Kirsch, P. et al. (1995). Study of the Dermal Toxicity of MCPP-p-2EHE in Wistar
Rats; Application to the Intact Skin (21 applications). Dept. of Toxicology of BASF
Aktiengesellschaft, D-67056 Ludwigshafen/Rhein, FRG. January 10, 1995. Project
No. 37H0383/91128. Unpublished.
43638102 Kirsch, P.; Deckardt, K.; Gembardt, C. et al. (1995) Study of the Dermal Toxicity of MCPP-
p-DMA Salt in Wistar Rats: Application to the Intact Skin (21 Applications): Lab Project
Number: 37H0210/91126. Unpublished study prepared by BASF Aktiengesellschaft. 188 p.
54
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43657301 Hoberg, J. (1995) MCPP-p DMAS--Toxicity to the Freshwater Diatom, Navicula pelliculosa:
Amended Final Report: Lab Project Number: 92/10/4463: 10566/1191/6211/440.
Unpublished study prepared by Springborn Labs, Inc. 70 p.
43657302 Hoberg, J. (1995) MCPP-p DMAS-Toxicity to the Freshwater Blue-Green Alga, Anabaena
flosaquae: Amended Final Report: Lab Project Number: 92/5/4261: 10566/1191/6211/420:
574/0. Unpublished study prepared by Springborn Labs, Inc. 69 p.
43657303 Hoberg, J. (1995) MCPP-p DMAS-Toxicity to the Marine Diatom, Skeletonema costatum:
Amended Final Report: Lab Project Number: 92/3/4170: 10566/1191/6211/450: 574/0.
Unpublished study prepared by Springborn Labs, Inc. 73 p.
43717201 John, S. (1995) (Carbon 14)-Mecoprop-p-DMA Salt ((Carbon 14)-Mecoprop-p-
dimethylammonium): Metabolism/Degradation in Plasma, Gastro-intestinal Tract,
Gastrointestinal Tract Contents and Post-Mitochondrial Liver Fraction (S9): Final Report:
Lab Project Numbers: 1149/11-1011:1149/11: P8994D. Unpublished study prepared by
Corning Hazleton (Europe). 78 p.
43749601 Rossbacher, R.; Hellwig, J. (1995) Report on the Maximization Test for the Sensitizing
Potential of Mecoprop-p in Guinea Pigs: Lab Project Number: 30H0002/912278.
Unpublished study prepared by BASF Aktiengesellschaft. 49 p.
43770801 Mellert, W.; Kaufmann, W.; Hildebrand, B. (1995) Mecoprop-p~Acute Oral Neurotoxicity
Study in Wistar Rats: Lab Project Number: 20S0002/91155. Unpublished study prepared by
BASF Aktiengesellschaft. 399 p.
43810201 Munk, R. (1994) Amendment 1 to the Report of February 5, 1987: Avian Single-Dose Oral
LD50 of MCPP, D-Form to the Bobwhite Quail (Colinus virginianus): Lab Project Number:
94/10444: 11W0494/85109: 87/0517. Unpublished study prepared by BASF
Aktiengesellschaft. 7 p.
43810202 Munk, R. (1989) Study of the Acute Toxicity of Mecoprop-p to Bluegill (Lepomis
macrochirus RAF.) plus Amendment: Lab Project Number: 89/10127: 94/10442:
14F0099/895061. Unpublished study prepared by BASF Aktiengesellschaft. 25 p.
43908201 Mellert, W.; Deckardt, K.; Kaufmann, W.; et al. (1995) Mecoprop-p~Subchronic Oral
Dietary Toxicity and Neurotoxicity Study in Wistar Rats: Lab Project Number:
50C0002/91157: 92/32/EEC. Unpublished study prepared by BASF Aktiengesellschaft. 655
P-
43909701 Kludas, R. (1995) Terrestrial Field Dissipation of MCPP-p DMA (Liquid Product) Applied
to Turf and Bare Ground in California: (Final Report): Lab Project Number: GR9446.
Unpublished study prepared by Grayson Research, Ltd. 840 p. Relates to letter L0000154.
43909702 Kludas, R. (1995) Terrestrial Field Dissipation of MCPP-p DMA (Liquid Product) Applied
to Turf and Bare Ground in New York: (Final Report): Lab Project Number: GR9447.
Unpublished study prepared by Grayson Research, Ltd. 802 p.
43909703 Kludas, R. (1995) Terrestrial Field Dissipation of MCPP-p DMA (Liquid Product) Applied
to Turf and Bare Ground in Georgia: (Final Report): Lab Project Number: GR9448.
Unpublished study prepared by Grayson Research, Ltd. 760 p.
43909704 Kludas, R. (1995) Terrestrial Field Dissipation of MCPP-p DMA (Granular Product) Applied
to Turf and Bare Ground in California: (Final Report): Lab Project Number: GR9475.
Unpublished study prepared by Grayson Research, Ltd. 813 p. Relates to letter L0000154.
55
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43909705
43943201
44030401
44110901
44147001
44205701
44281301
44294401
44362701
44362702
44459801
44642401
44655702
Kludas, R. (1995) Terrestrial Field Dissipation of MCPP-p DMA (Granular Product) Applied
to Turf and Bare Ground in Georgia: (Final Report): Lab Project Number: GR9477.
Unpublished study prepared by Grayson Research, Ltd. 857 p.
Kludas, R. (1995) Terrestrial Field Dissipation of MCPP-p DMA (Granular Product) Applied
to Turf and Bare Ground in New York: (Final Report): Lab Project Number: GR9476:
GRY06.REP. Unpublished study prepared by Grayson Research, Ltd. 816 p.
Munk, R. (1996) MCPP-p-DMA Salt-Avian Dietary LC50 Test in Chicks of the Mallard
Duck (Anas platyrhynchos L.): Lab Project Number: 32W0210/91172: 08B0210/916020.
Unpublished study prepared by BASF Aktiengesellschaft. 43 p.
Connor, S. (1996) MCPP-p~Aqueous Photolysis Study: Lab Project Number:
13565.0495.6100.720: 96-1-6341: 111594. Unpublished study prepared by Springborn
Laboratories, Inc. 209 p.
Connor, S. (1996) MCPP-p~Soil Photolysis Study: Lab Project Number:
13565.0495.6101.720: 96-1-6346. Unpublished study prepared by Springborn Labs, Inc.
P-
120
Hartley, D. (1996) MCPP-p-Aged-Soil Column Leaching Study: Final Report: Lab Project
Number: 13565.0495.6103.780: 96-7-6561: 031095/MCPP-P AGED-S. Unpublished study
prepared by Springborn Labs., Inc. 159 p.
Schocken, M. (1997) MCPP-p Aerobic Soil Metabolism: Lab Project Number: 96-4-6482:
13565.0495.6102.760. Unpublished study prepared by Springborn Laboratories, Inc. 146 p.
Hoberg, J. (1996) MCPP-p DMAS-Toxicity to the Freshwater Green Alga, Selenastrum
capricornutum: Amended Final Report: Lab Project Number: 92-2-4113:
10566.1191.6211.430: 574.0. Unpublished study prepared by Springborn Laboratories, Inc.
159 p.
Lappin, G. (1997) (Carbon-14)-Mecoprop-P: Absorption, Distribution, Metabolism and
Excretion in the Rat: Final Report: Lab Project Number: 1149/3-1007: 1149/3: 1149 3C.
Unpublished study prepared by Covance Labs., Ltd. 420 p.
Lappin, G. (1997) (Carbon-14)-Mecoprop-P-EHE and (carbon-14)-Mecoprop-p-DMA:
Absorption, Distribution, Metabolism and Excretion in the Rat: Final Report: Lab Project
Number: 1149/14-1007: 1149/14. Unpublished study prepared by Covance Labs., Ltd. 193 p.
Merricks, D. (1997) Carbaryl Mixer/Loader/Applicator Exposure Study During Application
of RP-2 Liquid (21%), Sevin Ready to Use Insect Spray or Sevin 10 Dust to Home Garden
Vegetables: Lab Project Number: 1519: 10564: ML97-0676-RHP. Unpublished study
prepared by Agrisearch Inc., Rhone-Poulenc Ag Co. and Morse Labs., Inc. 358 p.
Bahmann, S.; Deckardt, C.; Gembardt, C. et al. (1997)Mecoprop-p - Chronic Oral Toxicity
Study in Beagle Dogs Administration in the Diet for 12 Months: Lab Project Number:
33D0002/91166: 97/11083. Unpublished study prepared by BASF Aktiengellschaft 742 p.
{OPPTS 870.4100}
Barney, W. (1998) Determination of Transferable Turf Residues on Turf Treated with 2,4-D,
2,4-DP, MCPA, MCPP-p and Dicamba: Lab Project Number: BTHTFRTF 001: 98-313:
6926-103. Unpublished study prepared by Grayson Research, LCC. and Covance
Laboratories Inc. 521 p. {OPPTS 875.2100}
56
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44655703 Barney, W. (1998) Determination of Transferable Turf Residues on Turf Treated with 2,4-D
DMA + MCPP-p DMA + Dicamba DMA in Various Spray Volumes: Lab Project Number:
98-314: 6956-104: BTH TFR TF 002. Unpublished study prepared by Grayson Research,
LCC. and Covance Laboratories Inc. 235 p. {OPPTS 875.2100}
44895501 Mellert, W.; Deckardt, K.; Kuttler, K. et al. (1999) Report: Mecoprop-p-Carcinogenicity
Study in B6C3Fl/CrlBR Mice: Administration in the Diet for 18 Months (Supplementary
Study): Lab Project Number: 76S0002/91142: KR0022: 99/10101. Unpublished study
prepared by BASF Aktiengesellschaft. 515 p.
44895502 Fautz, R. (1994) In Vivo/In Vitro Unscheduled DNA Synthesis in Rat Hepatocytes with
Mecoprop-p acid: Lab Project Number: 94/11670: 429402. Unpublished study prepared by
Cytotest Cell Research GmbH and Co. KG 31 p.
44925501 Rodgers, M. (1999) Technical Mecoprop-p DMA: Effects on Reproduction in Japanese Quail
After Dietary Administration: Lab Project Number: RNP 594/985229: 1999/10910.
Unpublished study prepared by Huntingdon Life Sciences Ltd. 250 p. {OPPTS 850.2300}
44953601 Mellert, W.; Deckardt, K.; Hildebrand, B. et al. (1996) Report: Mecoprop-p~Carcinogenicity
Study in B6C3Fl/CrlBR Mice: Administration in the Diet for 18 Months: Lab Project
Number: 76S0002: 91102: 96/10432. Unpublished study prepared by BASF
Aktiengesellschaft. 702 p. {OPPTS 870.4200}
45022701 Mahlburg, W. (1999) Mecoprop-p Product Identity and Composition: Lab Project Number:
NUF/RPAG001. Unpublished study prepared by Nufarm B.V. 83 p. {OPPTS 830.1550,
830.1600, 830.1650, 830.1670, 830.1750, 830.1800}
45022702 Grienberger, G. (1999) Tetra-to-Hepta-Chlorinated Dioxins and Furanes in Seven Batches of
Technical R-2-(4-Chloro-2-methylphenoxy)propionic Acid (Mecoprop-p): Lab Project
Number: NUFARM-0599A. Unpublished study prepared by VA TECH Chemserv Industrie
Service GmbH. 207 p. {OPPTS 830.1700}
45022703 Comb, A. (1999) Mecoprop-p (Technical Grade) Five-Batch Analysis: Lab Project Number:
NUF/003. Unpublished study prepared by Huntingdon Life Sciences Ltd. 69 p. {OPPTS
830.1700}
45022704 Comb, A. (1999) Mecoprop-p (Pure Grade) Physico-Chemical Properties: Lab Project
Number: NUF/004. Unpublished study prepared by Huntingdon Life Sciences Ltd. 74 p.
{OPPTS 830.6302, 830.6303, 830.6304, 830.7200, 830.7220, 830.7300, 830.7950, 830.7840,
830.7550, 830.7370}
45022705 Comb, A. (1999) Mecoprop-p (Technical Grade) Physico-Chemical Properties: Lab Project
Number: NUF/002: 993274. Unpublished study prepared by Huntingdon Life Sciences Ltd.
27 p. {OPPTS 830.6302, 830.6303, 830.6304, 830.7840, 830.6315, 830.6316}
45022706 Comb, A. (1999) Mecoprop-p (Technical Grade) Physico-Chemical Properties (EPA
Additional Tests): Lab Project Number: NUF/001: NUFOO1/992960. Unpublished study
prepared by Huntingdon Life Sciences Ltd. 20 p. {OPPTS 830.6313, 830.7000, 830.7300}
45033101 Hughes, D.; Bomkamp, D. (2000) Determination of Transferable Turf Residues on Turf
Treated with 2,4-D, MCPA DMA, 2,4-D DMA + MCPP-p DMA + Dicamba DMA and
MCPA DMA + MCPP-p DMA + 2,4-DP-p DMA: Lab Project Number: BTH TFR TF 003:
6926-105. Unpublished study prepared by Covance Laboratories. 394 p. {OPPTS 875.2100}
57
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45606102 Dohmen, G. (1993) Effect of Mecoprop-p on the Reproduction of Daphnia magna STRAUS
in a Chronic Toxicity Test: Lab Project Number: P92-E117: 3728: 93/10844. Unpublished
study prepared by BASF Aktiengesellschaft. 41 p.
45606104 Bell, G. (1994) Mecoprop-p: Acute Toxicity to Daphnia Magna: Lab Project Number:
94/11735: RNP 447/941082. Unpublished study prepared by Huntingdon Research Centre
Ltd. 29 p.
46591801 Mellert, W.; Deckardt, K.; Kaufmann, W.; et. al. (2003) Mecoprop-p: Peroxisome
Proliferation Study in Wistar Rats Administration in the Diet Over 4 Weeks. Project Number:
48C0002/91188, NE0117. Unpublished study prepared by BASF Aktiengesellschaft. 96 p.
46591802 Mellert, W.; Deckardt, K.; Kaufmann, W.; et. al. (2003) Mecoprop-p Peroxisome
Proliferation Study in B6C3F1 Mice Administration in the Diet Over 4 Weeks. Project
Number: 49C0002/91189, NE0116. Unpublished study prepared by BASF
Aktiengesellschaft. 101 p.
46591803 Beimborn, B.; Leibold, E. (2003) (Carbon 14)-Mecoprop-p: Study of Plasmakinetics in Rats
After Repeated Oral Administration. Project Number: 02B0553/026015, BB0029/026015.
Unpublished study prepared by BASF Aktiengesellschaft. 50 p.
46591804 Clode, S. (2003) Mecoprop-p: Oral (Dietary Administration) Preliminary Reproduction
Toxicity Study in the Rat: Final Report. Project Number: 2252/1/D6154. Unpublished study
prepared by Covance Laboratories, Ltd. 222 p.
46591806 Beimborn, D.; Leibold, E. (2004) (Carbon 14)-Mecoprop-p: Study of the Plasmakinetics in
Rats After Repeated Oral Administration (60 Days Pretreatment). Project Number: 50390,
02B0553/026025. Unpublished study prepared by BASF Aktiengesellschaft. 51 p.
46591807 Caley, C.; Kelly, C. (2005) Mecoprop-p Dimethylamine Salt Lemna spp., Growth Inhibition
Test. Project Number: 395826, 17861, 9/8/5/S0285/TIF/H19. Unpublished study prepared by
Inveresk Research International. 37 p.
46591808 Armstrong, K. (2005) Mecoprop-p Dimethylamine Salt Alga, Growth Inhibition Test (72 h,
EC50). Project Number: S0033/TIF, 395831, 17864. Unpublished study prepared by
Inveresk Research International. 35 p.
46591810 Weyman, G. (1999) MCPP-P DMA: Acute Contact and Oral Toxicity to Honeybees. Project
Number: SO384/H16, 1149/24/D2145. Unpublished study prepared by Covance
Laboratories, Ltd. 26 p.
46614001 Engelhardt, G. (1985) Report on the Cytogenetic Investigations in Chinese Hamsters After a
Single Oral Administration of MCPP; D-Form Bone Marrow Chromosome Analysis. Project
Number: 85/0225, 85/0225/0001, S0254/TIF. Unpublished study prepared by BASF
Aktiengesellschaft. 50 p.
Human Health Risk Assessment
U.S. EPA, Product Chemistry Review of a Technical Grade Active Ingredient, Mecoprop-p
Technical Acid. 92% Mecoprop-p: (+)-R-2-(2-methyl-4-chlorophenoxy) propionic acid.
Data submitted by Rhone-Poulenc AG Co. D263488; March 15, 2000. MRID 42522701 to
45022706.
58
-------
Environmental Fate and Effects Chapter (Reregi strati on Eligibility Document). December 7,
2006.
FQPA Drinking Water Assessment for Mecoprop-p (MCPP-p). Memorandum from J. Hetrick to
M. Goodis. June 26, 2006 (DP Barcode 322772)
Mecoprop-p: Report of the Cancer Assessment Review Committee. March 13, 2003.
TXR No. 0051628
U.S. EPA, February 10, 1998, 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 Scientific Advisory Panel (SAP), "Exposure Data Requirement for Assessing Risks
from Pesticide Exposure of Children," Scientific Advisory Panel 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" FffiD Science
Advisory Council for Exposure, Policy.009, U.S. Environmental Protection Agency, Office
of Pesticide Programs.
U.S. EPA, Nov 3, 2006, Updated Use Closure Memorandum for Mecoprop (MCPP-p) and its
Related Salts, Case 0377. R. Louie to MCPP-p Team members.
Ecological Fate and Effects Chapter
Anderson, P., R. Jack, C. Burke, J. Cowles, B. Moran. 2004. Surface water monitoring data for
pesticides in salmonid-bearing streams, April to December 2003. Washington State Departments
of Ecology and Agriculture. Ecology Publication Number 04-03-048.
Beyer, W.N. 1994. Estimates of soil ingestion by wildlife. Journal of Wildlife Management
58(2):375-382.
Crum, J. R., F. W. Thomas, and J. N. Rogers III. 2003. Agronomic and engineering properties of
USGA putting greens. USGA Turfgrass and Environmental Research Online 2(15): 1-9.
59
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ECOFRAM. 1999. ECOFRAM Terrestrial Draft Report. Ecological Committee on FIFRA Risk
Assessment Methods. U.S. EPA, Washington, DC.
Fletcher, J.S., I.E. Nellessen, and T.G. Pfleeger. 1994. Literature review and evaluation of the
EPA food-chain (Kenaga) nomogram, an instrument for estimating pesticide residues on plants.
Environ. Tox. Chem. 13:1383-1391.
Hoerger, F., and E.E. Kenaga. 1972. Pesticide residues on plants: Correlation of representative
data as a basis for estimation of their magnitude in the environment. In F. Coulston and F. Korte,
eds., Environmental Quality and Safety: Chemistry, Toxicology, and Technology, Georg Thieme
Publ, Stuttgart, West Germany, pp. 9-28.
Gibson, L. R. and M. Liebman. 2002. Course Material for Principles of Weed Science,
Agronomy 317, Iowa State University. Website accessed 17 July 2006,
http: //www. agron. i astate. edu/cour ses/Agron317/Herbi ci de_mode_of_acti on. htm.
Kirkwood J.K. 1983. Minireview. A limit to metabolisable energy intake in mammals and birds.
Comp Biochem Physiol A 75(1): 1-3.
Merola-Zwartjes, M., and J. P. DeLong. 2005. Southwestern golf courses provide needed
riparian habitat for birds. USGA Turfgrass and Environmental Research Online 4(14): 1-18
Mineau, P., B. T. Collins, and A. Baril. 1996. On the use of scaling factors to improve
interspecies extrapolation of acute toxicity in birds. Regulatory Toxicology and Pharmacology.
24:24-29.
Seiders, K. and M. Roose. 2003. Padden Creek Pesticide Study: Final Report. Washington State
Department of Ecology, Environmental Assessment Program. Publication No. 03-03-048.
Stangel, P., and K. Distler. 2002. Golf courses for wildlife: Looking beyond the turf. USGA
Turfgrass and Environmental Research Online 1(2): 1-6.
U.S. EPA. 1992. Comparative Analysis of Acute Avian Risk from Granular Pesticides. U.S.
Environmental Protection Agency, Office of Pesticide Programs. March 1992.
U.S. EPA. 1993. Wildlife Exposure Factors Handbook. Volume I of II. Office of Research and
Development, Washington, D. C. 20460. EPA/600/R-93/187a.
USGS. 1999. Pesticides detected in urban streams during rainstorms and relations to retail sales
of pesticides in King County, Washington. USGS Fact Sheet 097-99.
Urban DJ. and N. J. Cook. 1986. Hazard Evaluation Division Standard Evaluation Procedure:
Ecological risk assessment. EPA 540/9-85-001. Office of Pesticide Programs, United States
Environmental Protection Agency, Washington, D.C.
60
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APPENDIX E. Generic Data Call-in (GDCI)
61
-------
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 0377 MCPP DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 129046 GENERIC
NO CITY, XX 00000 Mecoprop-P |D# GDCM29046_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
0377 MCPP
Chemical* and Name
Mecoprop-P
129046
3. Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID# GDCI-129046-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, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, 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: 0377 MCPP
PCI Number: GDCI-129046-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
K- Residential T- Commercial, institutional and inc II- Residential Use Conventional Cl
Q - Residential outdoor use 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.
-------
United States Environmental Protection
Agency Washington, D.C. 20460
Co. Nr.
264
2217
15440
70596
LIST OF ALL REGISTRANTS SENT THIS
Case # and Name: 0377, MCPP
Company Name Agent For
BAYER CROPSCIENCE LP
PBI/GORDON CORP
A H MARKS & CO LTD REGISTRATION AND REGULATORY
SERVICES
NUFARM BV NUFRAM BV
DATA CALL-IN NOTICE
Address
2 T.W. ALEXANDER DRIVE
PO Box 01 4090 1 21 7 WEST 1 2TH STREET
PMB 239, 7474 CREEDMOOR ROAD
PO Box 1 3439
City & State
RESEARCH
TRIANGLE PARK
KANSAS CITY
RALEIGH
RTP
Zip
NC 27709
MO 641 01 0090
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 0377 MCPP DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 031520 GENERIC
NO CITY, XX 00000 Propanoic acid, 2-(4-chloro-2-methylphenoxy)-, (R)-, MMMMM
compd. with N-methylmethanamine (1:1) ID# GDCI-031520-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
0377 MCPP
Chemical* and Name 031520
Propanoic acid, 2-(4-chloro-2-methylphenoxy)-, (R)-,
compd. with N-methylmethanamine (1:1)
3. Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID# GDCI-031520-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, K, Q, R, T,
U
A, C, HH, II, K, Q, R, T,
U
A, C, HH, II, 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: 0377 MCPP
DCI Number: GDCI-031520-NNNNN
Key: TEP = Typical End Use Product [TEP]; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop Q - Residential outdoor use U - Residential and public access pr
C- Terrestrial nonfood crop R- Agricultural premises and equipr HH - Occupational Use Conventional
K- Residential T- Commercial, institutional and inc II- Residential Use Conventional Cl
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: 0377, MCPP
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
oo
-------
APPENDIX F. Product-specific Data Call-in (PDCI)
As previously stated in Section II of this RED, most products have been reformulated
from the racemic mixture (MCPP) to the enriched isomer formulation (MCPP-p) and all
reformulations are anticipated to be completed by the Fall of 2007. Although the technical
registrants are supporting only the enriched isomeric forms of MCPP-p, the remaining
reformulations and respective labeling updates were still being processed at the time this RED
was issued. To ensure that all companies affected by this data call-in receive the PDCI, PDCIs
were generated for all current registrations that reflect either MCPP (racemic) or MCPP-p
(enriched isomer) forms as an active ingredient.
62
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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 DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 119046 PRODUCT SPECIFIC
NO CITY, XX 00000 MCPP-P-potassium |D# pDC|_119(M6_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 0377 MCPP DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 129046 PRODUCT SPECIFIC
NO CITY, XX 00000 Mecoprop-P |D# pDC|_129(M6_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 0377 MCPP DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 031501 PRODUCT SPECIFIC
NO CITY, XX 00000 Mecoprop (and salts and esters) |D# PDC|.031501.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 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 0377 MCPP DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 031519 PRODUCT SPECIFIC
NO CITY, XX 00000 Mecoprop, dimethylamine salt |D# PDC|.031519.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
PH
-------
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 0377 MCPP DD-MMM-YYYY
NO STREET ADDRESS Chemical* and Name 031520 PRODUCT SPECIFIC
NO CITY, XX 00000 Propanoic acid, 2-(4-chloro-2-methylphenoxy)-, (R)-,
compd. with N-methylmethanamine (1:1) ID# PDCI-031520-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
PH
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DRAFT COPY
Page 1 of 3
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
830.6313
5. Study Title
2. Case # and Name 3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
EPAReg. 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)
Stability to sunlight, normal and elevated temperature; (15,16)
metals, and metal ions
P
R
O
T
O
c
O
L
Progress
Reports
1
2
3
6. Use
Pattern
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, 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
TGAI
8. Time
Frame
(Months)
8
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
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DRAFT COPY
Page 2 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
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.
OMB Approval 2070-0107
OMB Approval 2070-0057
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY DD-MMM-YYYY
NO STREET ADDRESS PRODUCT SPECIFIC
NOCITY.XX 00000 ID# PDCI-119046-NNNN
EPA Reg. No.NNNNNN-NNNNN
4. Guideline
Requirement
Number
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7050
830.7100
830.7200
830.7220
830.7300
5. Study Title
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)
Melting point/melting range (27 ,28)
Boiling point/boiling range (29 ,30)
Density/relative density (31 ,32)
P
R
O
T
O
c
O
L
Progress
Reports
1
2
3
6. Use
Pattern
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
Initial to indicate certification as to information on this page (full
text of certification is on page one).
7. Test
Substance
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
TGAI/MP/EP
TGAI/PAI
MP/EP
TGAI
TGAI
TGAI/MP/EP
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
8
8
8
8
9. Registrant
Response
Date
PH
-------
DRAFT COPY
Page 3 of 3
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
830.7370
830.7550
830.7570
830.7840
830.7860
830.7950
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
5. Study Title
Dissociation constant in water
2. Case # and Name 3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-119046-NNNN
EPA Reg. No.NNNNNN-NNNNN
(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
Acute inhalation toxicity
Acute eye irritation
Acute dermal irritation
Skin sensitization
(41)
(42 ,43)
(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, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
C, HH, II, K, Q, R, T, U
7. Test
Substance
TGAI or PAI
TGAI/PAI
TGAI/PAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
TGAI.EP.dilute EP?
TGAI.EP.dilute EP?
TGAI & EP
TGAI & EP
TGAI & EP
TGAI & EP
Date
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
8
8
8
9. Registrant
Response
oo
I
PH
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DRAFT COPY Page1of6
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name:
DCI Number: PDCI-119046-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 R- Agricultural premises and equipr HH - Occupational Use Conventional
K- Residential T- Commercial, institutional and inc II- Residential Use Conventional Cl
Q - Residential outdoor use 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 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)
3 Data must be provided in accordance with the "Description of Production Process" Section.(158.162)
4 Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
5 Data must be provided in accordance with the "Description of Formation of Impurities" Section(158.167)
6 Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
7 Required for TGAIs and products produced by an integrated system.
8 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters, the
concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
g Data must be provided in accordance with the "Certified Limits" Section(158.175)
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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:
DCI Number: PDCI-119046-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:
DCI Number: PDCI-119046-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:
DCI Number: PDCI-119046-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:
DCI Number: PDCI-119046-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.
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:
DCI Number: PDCI-119046-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.
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Co. Nr.
4
228
239
478
802
869
2217
3862
8378
9198
9688
10088
10404
14774
15440
32802
34704
35512
70596
72155
Case # and Name: 0377, MCPP
Company Name Agent For
BONIDE PRODUCTS, INC.
NUFARM AMERICAS INC.
THE ORTHO BUSINESS GROUP
REALEX
CENTRAL GARDEN & PET D/B/A REGISTRATIONS BY DESIGN, INC.
LILLY MILLER BRANDS/EXCEL
GARDEN
GREEN LIGHT COMPANY
PBI/GORDON CORP
ABC COMPOUNDING CO, INC
KNOX FERTILIZER CO INC TOTAL TURF CONSULTING LLC
THE ANDERSONS LAWN
FERTILIZER DIVISION, INC.
CHEMSICO
ATHEA LABORATORIES INC
LESCO INC
WINFIELD SOLUTIONS, LLC
A H MARKS & CO LTD REGISTRATION AND REGULATORY
SERVICES
HOWARD JOHNSON'S
ENTERPRISES INC
LOVELAND PRODUCTS, INC.
HOWARD FERTILIZER & REGISTRATIONS BY DESIGN, INC.
CHEMICAL CO., INC
NUFARM BV NUFRAM BV
BAYER ADVANCED
Address
6301 SUTLIFF ROAD
150 HARVESTER DRIVE, SUITE 200
PO Box 1 90
PO Box 142642
1 181/2 EAST MAIN ST., SUITE 1
PO Box 1 7985
PO Box 01 4090 1 21 7 WEST 1 2TH STREET
PO Box 1 6247
300 W. FIFTH ST., #411
PO Box 119
PO Box 142642
PO Box 24001 4
1301 EAST9TH STREET, SUITE 1300
PO Box 64589
PMB 239, 7474 CREEDMOOR ROAD
700 W. VIRGINIA ST STE 222
PO Box 1 286
1 18 1/2 E MAIN ST, SUITE 1
PO Box 1 3439
PO Box 1 2014 2 T.W. ALEXANDER DRIVE
City & State
ORISKANY
BURR RIDGE
MARYSVILLE
ST LOUIS
SALEM
SAN ANTONIO
KANSAS CITY
ATLANTA
CHARLOTTE
MAUMEE
ST LOUIS
MILWAUKEE
CLEVELAND
ST. PAUL
RALEIGH
MILWAUKEE
GREELEY
SALEM
RTP
RESEARCH
TRIANGLE PARK
Zip
NY 13424
IL 60527
OH 43040
MO 631 140642
VA 241533805
TX 78217
MO 641 01 0090
GA 303210247
NC 28202
OH 43537
MO 631 140642
Wl 53224
OH 441141849
MN 55 1640589
NC 27613
Wl 532041548
CO 806321 286
VA 24153
NC 27709
NC 27709
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Co. Nr.
192
228
239
769
802
9688
10807
59144
72155
Case # and Name: 0377, MCPP
Company Name Agent For
VALUE GARDENS SUPPLY, LLC
NUFARM AMERICAS INC.
THE ORTHO BUSINESS GROUP
VALUE GARDENS SUPPLY, LLC
CENTRAL GARDEN & PET D/B/A REGISTRATIONS BY DESIGN, INC.
LILLY MILLER BRANDS/EXCEL
GARDEN
CHEMSICO
AMREP, INC
GRO TEC INC REGWEST COMPANY
BAYER ADVANCED
Address
PO Box 585
150 HARVESTER DRIVE, SUITE 200
PO Box 1 90
PO Box 585
1 181/2 EAST MAIN ST., SUITE 1
PO Box 142642
990 INDUSTRIAL DR
30856 ROCKY ROAD
PO Box 1 2014 2 T.W. ALEXANDER DRIVE
City & State
SAINT JOSEPH
BURR RIDGE
MARYSVILLE
SAINT JOSEPH
SALEM
ST LOUIS
MARIETTA
GREELEY
RESEARCH
TRIANGLE PARK
Zip
MO 64502
IL 60527
OH 43040
MO 64502
VA 241533805
MO 631 140642
GA 30062
CO 806319375
NC 27709
VO
i
PH
-------
LIST OF
United States Environmental Protection
Agency Washington, D.C. 20460
ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0377, MCPP
Co. Nr.
538
2217
Company Name
SCOTTS COMPANY, THE
PBI/GORDON CORP
Agent For Address
14111 SCOTTSLAWNRD
PO Box 01 4090 1 21 7 WEST 1 2TH STREET
City & State Zip
MARYSVILLE OH 43041
KANSAS CITY MO 641 01 0090
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Co. Nr.
228
239
264
538
802
2217
15440
32802
70596
71995
72155
Case # and Name: 0377, MCPP
Company Name Agent For
NUFARM AMERICAS INC.
THE ORTHO BUSINESS GROUP
BAYER CROPSCIENCE LP
SCOTTS COMPANY, THE
CENTRAL GARDEN & PET D/B/A REGISTRATIONS BY DESIGN, INC.
LILLY MILLER BRANDS/EXCEL
GARDEN
PBI/GORDON CORP
A H MARKS & CO LTD REGISTRATION AND REGULATORY
SERVICES
HOWARD JOHNSON'S
ENTERPRISES INC
NUFARM BV NUFRAM BV
MONSANTO MONSANTO
BAYER ADVANCED
Address
150 HARVESTER DRIVE, SUITE 200
PO Box 1 90
2 T.W. ALEXANDER DRIVE
14111 SCOTTSLAWNRD
1 181/2 EAST MAIN ST., SUITE 1
PO Box 01 4090 1 21 7 WEST 1 2TH STREET
PMB 239, 7474 CREEDMOOR ROAD
700 W. VIRGINIA ST STE 222
PO Box 1 3439
1300 I STREET, NW.SUITE 450 EAST
PO Box 1 2014 2 T.W. ALEXANDER DRIVE
City & State
BURR RIDGE
MARYSVILLE
RESEARCH
TRIANGLE PARK
MARYSVILLE
SALEM
KANSAS CITY
RALEIGH
MILWAUKEE
RTP
WASHINGTON
RESEARCH
TRIANGLE PARK
Zip
IL 60527
OH 43040
NC 27709
OH 43041
VA 241533805
MO 641 01 0090
NC 27613
Wl 532041548
NC 27709
DC 20005
NC 27709
oo
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United States
Environmental Protection
Agency Washington, D.C. 20460
Co. Nr.
1769
2217
11474
33955
34704
62719
72155
LIST OF ALL REGISTRANTS
Case # and Name:
Company Name Agent For
NCHCORP
PBI/GORDON CORP
SUNGRO CHEMICALS, INC.
PBI/GORDON CORP
LOVELAND PRODUCTS, INC.
DOWAGROSCIENCES LLC
BAYER ADVANCED
SENT THIS DATA CALL-IN NOTICE
Address
2727 CHEMSEARCH BLVD.
PO Box 01 4090 1 21 7 WEST 1 2TH STREET
PO Box 24632
PO Box 01 4090 1 21 7 WEST 1 2TH STREET
PO Box 1 286
9330 ZIONSVILLE RD 308/2E
PO Box 1 2014 2 T.W. ALEXANDER DRIVE
City & State
IRVING
KANSAS CITY
LOS ANGELES
KANSAS CITY
GREELEY
INDIANAPOLIS
RESEARCH
TRIANGLE PARK
Zip
TX 75062
MO 641 01 0090
CA 90024
MO 641 01 0090
CO 806321 286
IN 462681054
NC 27709
PH
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APPENDIX G. EPA's Batching of MCPP-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 MCPP-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.
63
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