US Environmental Protection Agency
Office of Pesticide Programs
Reregistration Eligibility Decision
for Chlormequat Chloride
September 27, 2007
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United States Prevention, Pesticides EPA738-R-07-014
Environmental Protection and Toxic Substances 2007
Agency (7508P) OPP-2007-0968
Reregistration
Eligibility Decision for
Chlormequat Chloride
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Reregistration Eligibility Decision (RED) Document for
Chlormequat Chloride
Approved by:
Date:
ListC
Case Number 3003
Steven Bradbury, Ph. D. '
Director
Special Review and Reregistration Division
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TABLE OF CONTENTS
Glossary of Terms and Abbreviations v
Abstract 1
I. Introduction 2
II. Chemical Overview 2
A. Regulatory History 3
B. Chemical Identification of Chlormequat Chloride 3
C. Use Profile 5
III. Summary of Chlormequat Chloride Risk Assessment 5
IV. Risk Management, Reregi strati on, and Tolerance Reassessment Decision 5
A. Determination of Reregistration Eligibility 5
B. Public Comments and Responses 6
C. Regulatory Position 6
V. What Registrants Need to Do 11
A. Manufacturing Use Products 11
B. End-Use Products 12
VI. Appendices 17
Appendix A. Use Patterns Eligible for Reregi strati on for chlormequat chloride 18
Appendix B 21
Data Supporting Guideline Requirements for the Reregi strati on of chlormequat chloride 21
Appendix C. Technical Support Documents 23
Appendix D. Citations Considered to be Part of the Database Supporting the
Reregi strati on Decision (Bibliography) 24
Appendix E. Product Data Call-In (PDCI) 58
Appendix F. EPA's Batching of chlormequat chloride Products for Meeting Toxicity Data
Requirements for Reregi strati on 59
Appendix G. List of Available Related Documents and Electronically Available
Documents 61
Appendix H. Data Required to Support the Outdoor Uses of Chlormequat Chloride 65
in
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Chlormequat Chloride Reregistration Eligibility Decision Team
Biological and Economic Analysis Assessment
Jenna Carter
Health Effects Risk Assessment
Charles Smith
Donald Wilbur
Judy Facey
Elissa Reaves
Environmental Fate and Effects Risk Assessment
Marietta Echeverria
Brian Kiernan
Registration Support
Tony Kish
Robert Westin
Risk Management
Joy Schnackenbeck
Anne Overstreet
Office of General Counsel
Scott Garrison
IV
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Glossary of Terms and Abbreviations
AGDCI
ai
aPAD
AR
BCF
CFR
cPAD
CSF
CSFII
DCI
DEEM
DFR
DWLOC
EC
EEC
EPA
EUP
FDA
FIFRA
FFDCA
FQPA
FOB
G
GENEEC
GLN
HAFT
IR
LD,
'50
LOC
LOD
LOAEL
MATC
l-ig/g
mg/kg/day
mg/L
MOE
Agricultural Data Call-In
Active Ingredient
Acute Population Adjusted Dose
Anticipated Residue
Bioconcentration Factor
Code of Federal Regulations
Chronic Population Adjusted Dose
Confidential Statement of Formula
USDA Continuing Surveys for Food Intake by Individuals
Data Call-In
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Drinking Water Level of Comparison.
Emulsifiable Concentrate Formulation
Estimated Environmental Concentration
Environmental Protection Agency
End-Use Product
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Functional Observation Battery
Granular Formulation
Tier I Surface Water Computer Model
Guideline Number
Highest Average Field Trial
Index Reservoir
Median Lethal Concentration. A statistically derived concentration of a
substance that can be expected to cause death in 50% of test animals. It is
usually expressed as the weight of substance per weight or volume of
water, air or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be
expected to cause death in 50% of the test animals when administered by
the route indicated (oral, dermal, inhalation). It is expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
Maximum Acceptable Toxicant Concentration
Micrograms Per Gram
Micrograms Per Liter
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
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MRID
MUP
NA
NAWQA
NPDES
NR
NOAEL
OP
OPP
OPPTS
PAD
PCA
PDF
PHED
PHI
ppb
PPE
ppm
PRZM/EXAMS
Qi*
RAC
RED
REI
RfD
RQ
SCI-GROW
SAP
SF
SLC
SLN
TGAI
TRR
USDA
USGS
UF
UV
WPS
Master Record Identification (number)
Manufacturing-Use Product
Not Applicable
USGS National Water Quality Assessment
National Pollutant Discharge Elimination System
Not Required
No Observed Adverse Effect Level
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Population Adjusted Dose
Percent Crop Area
USDA Pesticide Data Program
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Tier II Surface Water Computer Model
The Carcinogenic Potential of a Compound, Quantified by the EPA's
Cancer Risk Model
Raw Agriculture Commodity
Reregi strati on Eligibility Decision
Restricted Entry Interval
Reference Dose
Risk Quotient
Tier I Ground Water Computer Model
Science Advisory Panel
Safety Factor
Single Layer Clothing
Special Local Need (Registrations Under Section 24(c) of FIFRA)
Technical Grade Active Ingredient
Total Radioactive Residue
United States Department of Agriculture
United States Geological Survey
Uncertainty Factor
Ultraviolet
Worker Protection Standard
VI
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Abstract
This document presents the Environmental Protection Agency's (EPA or the Agency)
decision regarding the reregi strati on eligibility of the registered uses of the active ingredient
chlormequat chloride. The Agency has conducted human health and environmental fate and
effects risk assessments and has determined that clormequat chloride-containing products are
eligible for reregi strati on provided that the risk mitigation measures outlined in this document
are adopted and label amendments are made to reflect these measures.
Chlormequat chloride is a plant growth regulator (PGR) registered for use on ornamental
plants grown in greenhouses, nurseries and shadehouses. As chlormequat chloride has no
food/feed uses and no U.S. tolerances associated with its use, it is not subject to the Food Quality
Protection Act of 1996.
The Agency concludes that there is no concern for potential acute or chronic dietary
exposure from drinking water associated with the registered non-food uses of chlormequat
chloride. All handler and postapplication occupational risks for chlormequat chloride are below
the Agency's level of concern as well.
The Agency, using a screening level assessment, has identified potential ecological risks
of concern associated with the current registered uses of chlormequat chloride for birds,
amphibians, reptiles, mammals, and fish. To reduce these potential exposures and to address
current risks of concern, the Agency has directed, and the registrant has agreed to prohibit the
use of mechanical (tractor-drawn) multi-nozzle sprayer applications (groundboom), the
application method of concern. The Agency is also requiring appropriate data to confirm the
decision presented in this Reregi strati on Eligibility Decision (RED). Please see Appendix H for
additional data required to support the outdoor uses of chlormequat chloride, including the
groundboom application method.
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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 data submitted to the
Environmental Protection Agency (hereafter 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 a pesticide, to determine the need for additional data on health and
environmental effects, and to determine whether or not the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. As chlormequat chloride has no food/feed uses and no U.S.
tolerances associated with its use, it is not subject to the Food Quality Protection Act of 1996.
This document, consisting of five sections, presents the EPA decision regarding the
reregistration eligibility of the registered uses of chlormequat chloride. 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 provides a reference to the human health and
environmental fate and ecological risk assessments; and Section IV presents the Agency's
decision on reregistration eligibility and risk management. Where labeling revisions are
warranted, specific language is set forth in the summary table in Section V of this document.
Finally, Section VI contains the appendices, which list related information, supporting
documents, and studies evaluated for the reregistration decision. The risk assessments for
chlormequat chloride and other supporting documents are available in the Office of Pesticide
Program (OPP) public docket (http://www.regulations.gov) under docket number EPA-HQ-OPP-
2007-0968
As a result of this review, the Agency has determined that all currently registered
products containing the active ingredient chlormequat chloride are eligible for reregistration
provided that the risk mitigation measures outlined in this document are adopted and label
amendments are made to reflect these measures.
II. Chemical Overview
Chlormequat chloride, [(2-chloroethyl) trimethylammonium chloride] is a plant growth
regulator (PGR) that belongs to the quaternary ammonium class of chemicals. Chlormequat
chloride works through inhibition of a plant hormone's biosynthesis, which is useful in
regulating the growth characteristics of many plants. This early blockage prevents the synthesis
of numerous plant hormones needed for normal plant growth and development. It is formulated
as a soluble concentrate/liquid (SC/L). The product is applied to ornamental plants grown in
greenhouses, nurseries and shadehouses. Outdoor use is restricted to containerized ornamentals.
Table 1 includes a description of application methods and rates that are currently registered for
chlormequat chloride.
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Table 1. Chlormequat Chloride Use Patterns and Formulations
Formulation
CYCOCEL® Plant
Growth Regulator -
liquid
(11.8%a.i.)
For Commercial Use
EPA Reg #24 1-74
Chlormequat E-Pro
Plant Growth
Regulator - liquid
For Commercial Use
EPA Reg #81959-12
Use Site
Shadehouses and
nurseries
Greenhouse
Greenhouse
Greenhouse
Greenhouse
Method of
Application
foliar spray by
low pressure
handwand,
backpack sprayer,
or groundboom
foliar spray by
low pressure
handwand,
backpack sprayer
drench by high
pressure
handwand
foliar spray by
low pressure
handwand,
backpack sprayer
drench by high
pressure
handwand
Application Rate
0.017 Ib ai/gal
(at 2,000 ppm)
3.7 Ib ai/A
(at 2,000 ppm and
1 gal/200 ft2) or
5.5 Ib ai/A (at 2,000 ppm
and 1.5 gal/200 ft2 -only
for larger plants with well
defined canopies)
0.013 Ib ai/gal (at 1,500
ppm)
0.025 Ib ai/gal (at 3,000
ppm)
0.034 Ib ai/gal
(at 4,000 ppm)
0.034 Ib ai/gal
(at 4,000 ppm)
Label Restrictions
Do not apply through
any type of irrigation
equipment. Apply only
to containerized plants.
Do not apply as a soil
drench.
Do not apply through
any type of irrigation
equipment.
Do not apply through
any type of irrigation
equipment.
A. Regulatory History
The first Chlormequat chloride registration was issued to BASF by the U.S. Department
of Agriculture in 1962. This initial use was restricted to greenhouses. In 2006, the Agency
assessed the human health and ecological effects of a proposed outdoor use and amended the
registration of chlormequat chloride to include bedding plants and ornamentals in shadehouses
and nurseries.
B. Chemical Identification of Chlormequat Chloride
Tables 2 and 3 provide an overview of chlormequat chloride's structure and properties.
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Table 2. Test Compound Nomenclature
Chemical Structure
Empirical Formula
Common Name
Company Experimental Name
IUPAC Name
CAS Name
CAS Registry Number
End-use Product/EP
Chemical Class
Use Type
Known Impurities of Concern
Cl /^ XCH3
\/ ^w Cl-
HgO L»Hg,
C5Hi3Cl2 N
Chlormequat chloride
N/A
2-chloroethyl trimethyl ammonium chloride
2-chloro-jV,jV,7V-trimethylethanaminium chloride
999-81-5
CYCOCEL® Plant Growth Regulator
quaternary ammonium compound
plant growth regulator
N/A
Table 3. The Physicochemical Properties of Chlormequat Chloride
Parameter
Molecular Weight
Melting Point
pH
Density
Water Solubility (20° C)
Surface Tension
Vapor Pressure ( 20°C)
Octanol/water partition coefficient,
logKow(250C)
Value
158.1
245°C
5.14
1.241 g/ml
74 g/100 ml
70.3 mN/m
<1.0xlO"8mbar
Not Applicable
Reference
MSDS CYCOCEL® Plant Growth Regulator by
BASF Canada, 08/15/2000
MSDS CYCOCEL® Plant Growth Regulator by
BASF Canada, 08/15/2000
MSDS CYCOCEL® Plant Growth Regulator by
BASF Canada, 08/15/2000
Study: Surface Tension, Density and Vapour
Pressure of Chlormequat-Chloride (PAI) by
BASF Germany, 03/27/2001
MSDS CYCOCEL® Plant Growth Regulator by
BASF Canada, 08/15/2000
Study: Surface Tension, Density and Vapour
Pressure of Chlormequat-Chloride (PAI) by
BASF Germany, 03/27/2001
Study: Surface Tension, Density and Vapour
Pressure of Chlormequat-Chloride (PAI) by
BASF Germany, 03/27/2001
MSDS CYCOCEL® Plant Growth Regulator by
BASF Canada, 08/15/2000
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C. Use Profile
Type of Pesticide:
Summary of Use:
Formulation Type:
Application Methods:
Common Trade Names:
Plant growth regulator
Chlormequat chloride is currently registered for use on a wide
variety of ornamentals grown in greenhouses, shadehouses, and
nurseries. Crops include herbaceous and woody annual and
perennial plants such as begonias, vincas, azaleas, and poinsettias.
Outdoor use is restricted to containerized ornamentals.
Chlormequat chloride has no residential or food uses; therefore,
there are no associated tolerances.
Soluble concentrate liquid
Chlormequat chloride applications are applied using several types
of application equipment — including groundbooms, low-pressure
handwands, backpack sprayers, and high-pressure handwands.
Cycocel Plant Growth Regulant, ET-012, Chlormequat E-Pro Plant
Growth Regulator
Basic Manufacturer(s): BASF Corporation, Etigra LLC
III. Summary of Chlormequat Chloride Risk Assessment
Human health effects and environmental fate and effects assessments have been
performed for chlormequat chloride. The Agency did not identify any human health risks of
concern based on current use patterns and label restrictions. The environmental fate and effects
assessment demonstrates potential environmental risks of concern resulting from the outdoor
nursery use of chlormequat chloride. The full risk assessments and related supporting documents
are not included in this document. For additional information, please refer to the revised human
health and environmental fate and effects risk assessments for chlormequat, dated June 12, 2007,
and April 11, 2007, respectively. These documents are also available in the public docket EPA-
HQ-OPP-2007-0968 located on-line at http://www.regulations.gov.
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregi strati on. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support the
reregi strati on of products containing chlormequat chloride as an active ingredient.
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The Agency has completed its review of submitted data and its assessment of the dietary
(drinking water only), occupational and ecological risks associated with the use of pesticide
products containing the active ingredient chlormequat chloride. Dietary (food) risks were not
assessed because there are no food/feed uses of chlormequat chloride. Based on a review of the
chlormequat chloride data, the Agency has sufficient information on the human health and
ecological effects of chlormequat chloride to make decisions as part of the reregi strati on process
under FIFRA. The Agency has determined that currently registered uses of chlormequat chloride
will not pose unreasonable risks or adverse effects to humans or the environment provided that
the risk mitigation measures and label changes outlined in this RED are implemented; therefore,
products containing chlormequat chloride are eligible for reregi strati on.
Products containing chlormequat chloride are eligible for reregi strati on provided that
the risk mitigation measures outlined in the document are adopted, and label amendments are
made to implement these measures. Additionally, outstanding data requirements, as identified as
part of the November 2006 conditional registration for the outdoor use, must be submitted by
June 2009. Label changes are described in Section V of this document. Appendix B identifies
the generic data that the Agency reviewed as part of its determination of the reregi strati on
eligibility of chlormequat chloride and lists the submitted studies that the Agency found
acceptable.
Based on its evaluation of chlormequat chloride, the Agency has determined that
chlormequat chloride products, unless labeled and used as specified in this document, would
present risks inconsistent with FIFRA. Accordingly, should a registrant fail to implement any of
the risk mitigation measures identified in this document, the Agency may take regulatory action
to address the risk concerns from the use of chlormequat chloride. If all changes outlined in this
document are incorporated into the product labels, then current risks for chlormequat chloride
will be adequately mitigated for the purposes of this determination under FIFRA. Once a
comprehensive endangered species assessment is completed, further changes to these
registrations may be necessary.
B. Public Comments and Responses
Because the risks associated with the use of chlormequat chloride were minimal, a public
comment period on the chlormequat chloride risk assessments was not conducted. A 60-day
public comment period will be conducted after the RED is issued, and will be announced in the
Federal Register. Comments may be submitted under Docket Number EPA-HQ-OPP-2007-0968
at http://www.regulations.gov. The Agency will review and consider these comments and
amend the RED if appropriate. In addition, the chlormequat chloride RED document may be
accessed through the Agency's website at
http://www.epa.gov/pesticides/reregistration/status.htm.
C. Regulatory Position
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1. Regulatory Rationale
The Agency has determined that chlormequat chloride is eligible for reregi strati on
provided the risk mitigation measures outlined in this document are adopted and label
amendments are made to reflect these measures.
The following is a summary of the rationale for managing risks associated with the use of
chlormequat chloride. Where labeling revisions are warranted, specific language is set forth in
the summary table in Section V of this document.
a. Human Health Risk Management and Mitigation
No risks associated with the use of chlormequat chloride exceed the Agency's level of
concern for human health effects. Therefore, no additional mitigation is required to address risks
of human health.
For additional details on the chlormequat chloride human health risk assessment, please
refer to the human health risk assessments for chlormequat chloride. This document is available
in the public docket EPA-HQ-OPP-2007-0968, located on-line in the Federal Docket
Management System (FDMS) at http://www.regulations.gov.
1. Drinking Water Risk Mitigation
There is no concern for potential acute and chronic dietary exposure from drinking water
associated with the registered non-food uses of chlormequat chloride.
2. Occupational Risk Mitigation
All handler and postapplication occupational risks for chlormequat chloride are below the
Agency's level of concern (LOG).
b. Ecological Risk Management and Mitigation
For additional details on the chlormequat chloride ecological fate and effects risk
assessment, please refer to the ecological risk assessment for chlormequat chloride. This
document is available in the public docket EPA-HQ-OPP-2007-0968, located on-line in the
Federal Docket Management System (FDMS) at http://www.regulations.gov.
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The Agency has conducted a screening-level ecological and environmental risk
assessment for the registered outdoor use of chlormequat chloride. Based on the available data
and using conservative assumptions, the outdoor use of chlormequat chloride may pose acute and
subchronic risks of concern to birds, reptiles, terrestrial-phase amphibians, mammals, and both
terrestrial and aquatic plants. Because chlormequat chloride is classified as practically nontoxic
to freshwater fish and estuarine marine fish, the acute risk for freshwater fish and estuarine
marine fish is presumed to be low. Chlormequat chloride is classified as practically nontoxic to
honey bees (Apis melliferd) on both an acute contact and acute oral basis.
The available data indicate that chlormequat chloride is slightly toxic to birds, reptiles and
terrestrial phase amphibians on an acute exposure basis. Due to an absence of data, avian
terrestrial risk quotients (RQs) were considered representative of potential exposure for
terrestrial-phase amphibians and reptiles. Dose-based RQs range from 6.9 for small birds (20g)
foraging on short grass to 0.06 for large (lOOOg) birds foraging on fruit/pods/large insects. The
acute avian LOG is exceeded for all size classes foraging on short grass, tall grass and broadleaf
plants/small insects. A "no observed adverse effect concentration" (NOAEC) could not be
determined in the avian reproduction study because effects were seen at the lowest dose tested;
therefore, definitive chronic RQ values could not be calculated. However, calculating with the
lowest dose tested provides an indication of the minimum extent to which LOCs are exceeded.
RQ values calculated using the lowest dose tested exceed the chronic risk LOG (RQ>1.0) for all
forage groups The chronic LOG is exceeded by a factor of greater than 15X for birds foraging
on short grass.
Chlormequat chloride is slightly toxic to mammals on an acute oral exposure basis.
Mamalian RQs range from 0.01 for large (lOOOg) granivorous mammals to 2.2 for small (15g)
mammals foraging on short grass, a 4-fold exceedance of the acute risk LOG (RQ >.5). There
are exceedences of the acute risk LOG for all size classes foraging on short grass and broadleaf
plant/small insects and for small- and medium-sized mammals foraging on tall grass. Dose-
based RQs exceed the Agency's chronic risk LOG (1.0) for all size classes of mammals foraging
on short grass, tall grass and broadleaf plants/small insects, by factors ranging from 3X to 12X.
For a single application of chlormequat chloride (3.7 Ibs ai/A) the terrestrial plant LOG
(1.0) is exceeded for dicotyledonous plants in wetlands adjacent to chlormequat use sites. There
are no exceedances for adjacent upland species or as a result of drift alone.
While there are estimated exceedances of the LOG for some terrestrial and aquatic
species, the ecological risks associated with the use of chlormequat chloride are expected to be
extremely limited based on its use pattern and toxicity profile. Chlormequat chloride is not a
widely used chemical. Due to the high cost of the treatment, the outdoor use is a niche use
applied only on high value outdoor ornamentals with very limited acreage. The indoor uses,
comprising approximately 97% of usage, such as use in greenhouses, interior landscapes and
others, do not result in environmental exposure.
In addition to chlormequat chloride's low outdoor usage, the Agency's ecological and
environmental risk assessment was conservative. This high-end, screening level assessment for
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the outdoor use assumed maximum application rates allowed by the label, and the minimum
application intervals for chlormequat chloride. Furthermore, the models and scenarios used in
this assessment were developed to simulate pesticide applications in open agricultural fields and
not specifically for containerized ornamentals and bedding plants in nurseries and shadehouses,
which generally are not present in large contiguous acreages.
Foliar application of chlormequat chloride to plants in containers is distinct from other
outdoor use applications in that residues on treated foliage, in general, are not likely to be
available to wildlife because of the high value and protected nature of the plants. The plants are
held close together, and they are typically placed on bare ground, gravel or landscape barrier
fabric where non-target plants cannot grow. Based on the typical density of the pots, 90% of the
material applied will be intercepted by the foliage of the potted plant. When the ornamentals are
initially placed outdoors they are free of insects and weeds. Each plant has a high value and will
receive treatment for insects, if necessary, and weeds will not be allowed to grow in the
containers.
Moreover, the use in nurseries is for containerized plants, which is expected to limit the
amount of potential exposure from runoff and drift. Runoff is reduced in nurseries by waste-
water containment programs currently in place, which further reduces risk to aquatic organisms.
While there are currently no studies that can be used to quantify the effects of nursery waste-
water containment practices, these practices are believed to be effective in reducing risk to non-
target species. The Agency is aware that most container nurseries use a variety of methods to
control water runoff from nursery operations including grassed waterways, sediment control
ponds, constructed wetlands, and irrigation runoff water recycling ponds. The practice of
retaining water onsite is being driven by two factors: 1) the Clean Water Act and states'
regulatory efforts regarding non-point pollution control and storm water management, and 2)
water shortages that are appearing in various sections of the US, such as Florida, where nurseries
need to insure a consistent supply of irrigation water. Furthermore, the Agency understands
through discussions with the American Nursery Landscape Association that all new container
nursery operations under development are being designed for zero or minimum offsite water
discharge.
Despite chlormequat chloride's limited use, in order to ensure that the outdoor use of
chlormequat chloride does not result in terrestrial and aquatic exposure, the Agency has directed,
and the registrant has agreed, to modify the chlormequat chloride label to prohibit the use of
mechanical (tractor-drawn) groundboom multi-nozzle sprayer applications. The technical
registrant, BASF, submitted an amended label on September 11, 2007 with the groundboom
application method removed. The Agency approved the amended label on September 19, 2007.
This change will limit the outdoor application of chlormequat chloride to hand wand use only. It
is recognized that hand wand application is more targeted, resulting in less of the pesticide being
available for potential runoff, and less drift with associated potential for off-target exposures.
Furthermore, applicators using hand wands do not treat large contiguous acreages in a short time
frame as is typical for tractor mounted groundbooms. Specific language prohibiting this
application method is set forth in the summary table in Section V of this document.
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Additionally, the technical registrant has agreed to submit a freshwater fish life-cycle
study and an avian reproduction study by June 1, 2009, as outlined in a November 2006 letter
from the Agency to the technical registrant. These studies will fill current data gaps and confirm
the Agency's belief that there is no unreasonable adverse effect to the environment from the use
of chlormequat chloride. Please see Appendix H for additional data required to support the
outdoor uses of chlormequat chloride, including the groundboom application method.
2. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other 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, chlormequat chloride may be subjected to additional screening and/or
testing to better characterize effects related to endocrine disruption.
3. Endangered Species Considerations
a. The Endangered Species Program
The Endangered Species Act requires federal agencies to ensure that their actions are not
likely to jeopardize listed species or adversely modify designated critical habitat. The Agency
has developed the Endangered Species Protection Program to identify pesticides whose use may
cause adverse impacts on threatened and endangered species, and to implement mitigation
measures that address these impacts. To analyze the potential of registered pesticide uses that
may affect any particular species, the Agency uses basic toxicity and exposure data developed
for the REDs and then 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, this species-specific analysis
will also consider the risk mitigation measures that are being implemented as a result of this
RED.
Following this future species-specific analysis, a determination that there is a likelihood
of potential effects to a listed species may result in limitations on use of the pesticide, other
measures to mitigate any potential effects, or consultations with the Fish and Wildlife Service
and/or the National Marine Fisheries as appropriate. If the Agency determines use of
chlormequat chloride "may affect" listed species or their designated critical habitat, the Agency
will employ the provisions in the Services' regulations (50 CFR Part 402). Until the species-
specific analysis is completed, the risk mitigation measures being implemented through this RED
will reduce the likelihood that endangered and threatened species may be exposed to
10
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chlormequat chloride at levels of concern. The Agency is not requiring specific chlormequat
chloride label language at the present time relative to threatened and endangered species. If, in
the future, specific measures are necessary for the protection of listed species, the Agency will
implement them through the Endangered Species Program.
At this time, the Agency is not requiring label changes specific to the protection of listed
species. While RQs exceeded the Agency's endangered species LOG for several taxa, including
birds, mammals and both aquatic and terrestrial plants, these results are likely to be conservative
due to the limited use of chlormequat chloride and the prohibition of ground boom application.
These results were also based on a screening-level assessment, and do not constitute "may
affect" findings under the Endangered Species Act. After a species-specific assessment is
conducted, a determination that there is a likelihood of potential effects to a listed species may
result in limitations on the use of the pesticide, other measures to mitigate any potential effects,
or consultations with the Fish and Wildlife Service or National Marine Fisheries Service as
appropriate.
4. Spray Drift Management
The Agency has been working closely with stakeholders to develop improved approaches
for mitigating risks to human health and the environment from pesticide spray and dust drift. As
part of the reregi strati on process, the EPA will continue to work with all interested parties on this
important issue.
Because the outdoor use of chlormequat chloride is limited to direct, low-pressure,
handwand application to containerized ornamentals, the Agency concludes that spray drift
mitigation is not warranted as part of the reregi strati on eligibility determination.
5. Other 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 chlormequat chloride. For the
specific labeling statements and a list of outstanding data, refer to Section V of this document
V. What Registrants Need to Do
The Agency has determined that chlormequat chloride is eligible for reregi strati on
provided that the risk mitigation measures identified in this document are adopted and label
amendments are made to reflect these measures; however, additional data are required to confirm
this decision. The submission of this data was a condition for a previous label amendment
granted by the Agency for the outdoor use of chlormequat chloride. The registrant has
committed to completing and submitting these studies by June 2009. For product specific data,
the registrant will have 8 months to submit data and amend labels.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
11
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The generic database supporting the reregi strati on of chlormequat chloride has been
reviewed and determined to be adequate for this reregi strati on assessment. In order to reduce the
uncertainty in the ecological risk assessment, BASF has already agreed to submit data
conditional on their recent ammendment to the chlormequat chloride registration, which adds
shadehouses and nurseries to the accepted use of chlormequat chloride labeled use sites.
2. Labeling for Manufacturing-Use Products
To ensure compliance with FIFRA, technical and manufacturing use products (MP)
labeling should be revised to comply with all current EPA regulations, PR Notices and
applicable policies. In order to be eligible for reregi strati on, the technical registrants should
amend all product labels to incorporate the risk mitigation measures outlined in Section IV. The
technical and MP labeling should also bear the labeling statements contained in Table 4, the
Label Changes Summary Table.
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 product-specific data call-in (PDCI), outlining specific
data requirements.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above.
Specific language to incorporate these changes is specified in the Label Changes Summary Table
below.
3. Labeling Changes Summary Table
The following table describes how language on the labels should be amended.
12
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Labeling Changes Summary Table
In order to be eligible for reregi strati on, amend all product labels to incorporate the risk mitigation measures outlined in Section IV.
The following table describes how language on the labels should be amended.
Table 4: Summary of Labeling Changes for Chlormequat Chloride
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
For all Manufacturing
Use Products
"Only for formulation into a plant growth regulator for the following
use(s) [fill blank only with those uses that are being supported by MP
registrant]."
"Not for formulation into end-use products that permit application with
motorized groundboom equipment at outdoor sites."
Directions for Use
One of these statements
may be added to a label
to allow reformulation
of the product for a
specific use or all
additional uses
supported by a
formulator or user
"This product may be used to formulate products for specific use(s) not
listed on the MP label if the formulator, user group, or grower has
complied with U.S. EPA submission requirements regarding support of
such use(s)."
"This product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator, user group, or grower
has complied with U.S. EPA submission requirements regarding support
of such use(s)."
Directions for Use
Environmental Hazards
Statements Required
by the RED and
"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
Precautionary Statements
13
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Agency Label Policies
prior to discharge. Do not apply directly to water, or 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
washwater or rinsate"
End Use Products Intended for Occupational Use
PPE Requirements
Established by the
RED1
For Liquid
Formulations
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are"
(registrant inserts correct chemical-resistant material). "If you want
more options, follow the instructions for category" [registrant inserts
A,B,C,D,E,F,G,or H\ "on an EPA chemical-resistance category selection
chart."
"All mixers, loaders, applicators and other handlers must wear:
o Long-sleeved shirts and long pants,
o Shoes plus socks."
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
User Safety
Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. 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 materials that have been drenched
or heavily contaminated with this product's concentrate. Do not reuse
them."
Precautionary Statements: Hazards to
Humans and Domestic Animals
immediately following the PPE
requirements
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.
Precautionary Statements under:
Hazards to Humans and Domestic
Animals immediately following
Engineering Controls
14
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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."
(Must be placed in a box.)
Environmental Hazards
"This product is toxic to wildlife."
"Do not apply directly to water, or 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 washwater or rinsate."
"Keep out of lakes, streams and ponds. Drift and runoff may be
hazardous to aquatic organisms in water adjacent to treated areas spray."
For products packaged in containers equal to or greater than 5 gallons or
50 Ibs, add the following statement:
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or other waters unless in accordance with the
requirements of a National Pollution Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge. Do not discharge effluent containing this product to
sewer systems without previously notifying the local sewage treatment
plant authority. For guidance contact your State Water Board or
Regional Office of the EPA."
Precautionary Statements immediately
following the User Safety
Recommendations
Restricted-Entry
Interval for products
with directions for use
within scope of the
Worker Protection
Standard for
Agricultural Pesticides
(WPS)
"Do not enter or allow worker entry into treated areas during the
restricted entry interval (REI) of 12 hours."
Directions for Use, Under Agricultural
Use Requirements Box
Early Entry Personal
"PPE required for early entry to treated areas that is permitted under the
15
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Protective Equipment
for products with
directions for use
within the scope of the
WPS
Worker Protection Standard and that involves contact with anything that
has been treated, such as plants, soil, or water, is:
* coveralls,
* shoes plus socks
* chemical-resistant gloves made of any waterproof material."
Direction for Use
Agricultural Use Requirements box
General Application
Restrictions
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may be
in the area during application. For any requirements specific to your state
or tribe, consult the agency responsible for pesticide regulation."
Place in the Direction for Use directly
above the Agricultural Use Box.
Other Application
Restrictions (Risk
Mitigation)
"Application with motorized groundboom equipment in outdoor sites is
prohibited."
Apply using handheld nozzles or hand-held equipment, such as low-
pressure handwand equipment.
Directions for Use
PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more protective PPE must be
placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
16
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VI. Appendices
17
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Appendix A. Use Patterns Eligible for Reregistration for chlormequat chloride
Application
Timing
Application
Equipment
Application
Type
Formulation
Maximum
Single
Application
Rate
Maximum
No. Of
Applications
per Year
Maximum
Seasonal
Rate
Pre-
harvest
Interval
(days)
Minimum
Retreatemen
t interval
(days)
Reentry
Interval
Limitations
Ornamental and/or Shade Trees
Containerized
Drench.
Drencher.
Foliar
Spray.
Sprayer.
Soluble
Concentrate/
liquid
0.0339 Ib gal
NS
NS
NS
12 hr
Do not apply through any type of irrigation system
Do not apply when drift is likely to occur.
Do not contaminate food or feed by storage or
disposal.
Do not contaminate water by cleaning of equipment
or disposal of equipment wash waters.
Keep out of lakes, streams, and ponds.
This pesticide is toxic to wildlife.
Ornamental and/or Shade Trees
Foliar
Spray.
Sprayer.
Soluble
Concentrate/
liquid
3.71bai/A
NS
NS
NS
12 hr
Do not apply through any type of irrigation
equipment. Apply only to containerized plants. Do
not apply as a soil drench
Ornamental and/ or Shade Trees
Potted
Drench /Spray.
Drencher
/Sprayer.
Soluble
Concentrate/
liquid
0.0625 Ib pot
NS
NS
NS
12 hr
Do not apply through any type of irrigation system
Do not apply when drift is likely to occur.
Do not contaminate food or feed by storage or
disposal.
Do not contaminate water by cleaning of equipment
or disposal of equipment wash waters.
Keep out of lakes, streams, and ponds.
This pesticide is toxic to wildlife.
Ornamental Herbaceous Plants
Foliar
Spray. Sprayer
Plant bed
Drench /Spray.
Drencher
/Sprayer.
Soluble
Concentrate/
liquid
0.0339 Ib gal
NS
NS
NS
12 hr
Do not apply through any type of irrigation system
Do not apply when drift is likely to occur.
Do not contaminate food or feed by storage or
disposal.
Do not contaminate water by cleaning of equipment
or disposal of equipment wash waters.
Keep out of lakes, streams, and ponds.
18
-------
This pesticide is toxic to wildlife.
Ornamental Herbaceous Plants
Foliar
Spray.
Sprayer.
Soluble
Concentrate/
liquid
3.7 Ib ai/A
NS
NS
NS
12 hr
Do not apply through any type of irrigation
equipment. Apply only to containerized plants. Do
not apply as a soil drench
Ornamental Herbaceous Plants
Potted
Drench /Spray.
Drencher
/Sprayer.
Soluble
OUILIL'1^
Concentrate/
liniiiH
11L[U1U.
0.0625 Ib pot
NS
NS
NS
12 hr
Do not apply through any type of irrigation system
Do not apply when drift is likely to occur.
Do not contaminate food or feed by storage or
disposal.
Do not contaminate water by cleaning of equipment
or disposal of equipment wash waters.
Keep out of lakes, streams, and ponds.
This pesticide is toxic to wildlife.
Ornamental Woody Shrubs and Vines
Containerized
Drench.
Drencher.
Cutting
Drench /Spray.
Drencher
/Sprayer.
Foliar
Spray
Sprayer
Nurserystock
Drench /Spray.
Drencher
/Sprayer
Potted
Drench
/Spray .Drencher
/Sprayer.
Soluble
Concentrate/
liquid
0.0339 Ib gal
NS
NS
NS
12 hr
Do not apply through any type of irrigation system
Do not apply when drift is likely to occur.
Do not contaminate food or feed by storage or
disposal.
Do not contaminate water by cleaning of equipment
or disposal of equipment wash waters.Keep out of
lakes, streams, and ponds.
This pesticide is toxic to wildlife.
Ornamental Woody Shrubs and Vines
19
-------
Potted
Drench
/Spray .Drencher
/Sprayer.
Soluble
Concentrate/
0.0625 Ib pot
NS
NS
NS
12 hr
Do not apply through any type of irrigation system
Do not apply when drift is likely to occur.
Do not contaminate food or feed by storage or
disposal.
Do not contaminate water by cleaning of equipment
or disposal of equipment wash waters.Keep out of
lakes, streams, and ponds.
This pesticide is toxic to wildlife.
Ornamental Woody Shrubs and Vines
Foliar
Spray.
Sprayer.
Soluble
Concentrate/
liquid
3.71bai/A
NS
NS
NS
12 hr
Do not apply through any type of irrigation
equipment. Apply only to containerized plants. Do
not apply as a soil drench
Ornamental Woody Shrubs and Vines
Early bloom
Spray.
Sprayer.
Soluble
Concentrate/
liquid
0.0 127 Ib gal
NS
NS
NS
12 hr
Do not apply through any type of irrigation system
Do not apply when drift is likely to occur.
Do not contaminate food or feed by storage or
disposal.
Do not contaminate water by cleaning of equipment
or disposal of equipment wash waters.Keep out of
lakes, streams, and ponds.
This pesticide is toxic to wildlife.
NS = Not Specified
20
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Appendix B
Data Supporting Guideline Requirements for the Reregistration of chlormequat chloride
REQUIREMENT
Use
Pattern
CITATION(S)
ECOLOGICAL EFFECTS
Non-guideline
850.2200
850.2300
7 1-2 A
71-4B
Non-guideline
850.1075
850.1075
72-1 A
72-1B
Non-guideline
850.1010
850.1075
850.1035
850.1300
850.1400
72-2A
72-3A
72-3C
72-4A
72-4C
Non-guideline
Non-guideline
850.4400
850.4500
850.4550
850.3020
122-2
123-2
123-2
141-1
Avian Acute Oral
Toxicity
Avian Dietary Toxicity -
Quail
Avian Dietary Toxicity -
Duck
Avian Reproduction -
Quail
Freshwater Fish Acute
Toxicity - Bluegill
Fish Acute Toxicity
Fathead Minnow
Fish Acute Toxicity
Rainbow Trout
Invertebrate Acute
Daphnid Toxicity
Estuarine/Marine Fish
Acute Toxicity
Estuarine/Marine Acute
Toxicity
Daphnid Chronic Toxicity
(life cycle)
Freshwater Fish Early
Life Stage
Terrestrial Plant Toxicity,
Seedling Emergence
Vascular Aquatic Plant
Toxicity - lemna gibba
(Tier 1)
Aquatic Plant Growth -
Algae
Aquatic Plant Growth -
Cyanobacteria
Honey Bee Acute Contact
C,H,J
C, H, J
C, H, J
C, H, J
C,H,J
C,H,J
C,H,J
C,H,J
C,H,J
C,H,J
C,H,J
C,H,J
C,H,J
C, H, J
C, H, J
C, H, J
C, H, J
C, H, J
467152-11 (supplemental)
467152-122
(supplemental)
467 152- 13 (data gap)
467152-14 (supplemental)
001232-61
000374-33
467152-17 (supplemental)
001387-19 (supplemental)
ECOTOX
ECOTOX
467152-16 (supplemental)
Data Gap
467152-19 (supplemental)
467152-20 (supplemental)
467152-21
467152-22
467152-23
467152-24
TOXICOLOGY
21
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Appendix B
Data Supporting Guideline Requirements for the Reregistration of chlormequat chloride
REQUIREMENT
870.3100
82-1
Non-guideline
870.3200
870.3700
82-2
83-3
Non-guideline
870.3800
830.4100
870.4200a
870.4200b
870.5100
83-4
83-1
83-2a
83 -2b
84-2
Oral subchronic Toxicity
study - Rat
90-Day Oral Toxicity -
Rodent
2 1/28-Day Dermal
Toxicity - Rabbit
Prenatal Developmental
Toxicity
Prenatal Developmental
Toxicity - Rabbit
Reproduction and
Fertility Effects - Rat
Chronic Toxicity - Dog
Carcinogenicity Study -
rat
Carcinogenicity Study -
Mice
Bacterial Reverse
Mutation
Use
Pattern
C,H,J
C, H, J
C, H, J
C, H, J
C, H, J
C, H, J
C, H, J
C,H,J
C,H,J
C,H,J
CITATION(S)
00163408
00163408
42246603
42246604
46715205
46712006
46715201
46715203
46715204
41721610
ENVIRONMENTAL FATE
835.2120
835.2240
835.4200
835.1230
161-1
161-2
162-2
163-1
Hydrolysis
Photodegradation - Water
Anaerobic Soil
Metabolism
Sediment and Soil
Adsorption/Desorption
C, H, J
C, H, J
C,H,J
C,H,J
Data Gap
Data Gap
Data Gap
46715228,46715229
22
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Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket,
located in Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. It is open Monday through Friday, excluding legal holidays,
from 8:30 am to 4 pm.
The docket contains the risk assessments and related documents as of September 30,
2007. The availability announcement will be published in the Federal Register. All documents,
in hard copy form, may be viewed in the OPP docket room or downloaded or viewed via the
Internet at the following site: www.epa.gov/pesticides/reregistration. The following list details
all documents related to the Chlormequat chloride RED.
Health Effects Documents
1. chlormequat chloride. HED Human Health Risk Assessment for the Reregistration
Eligibility Decision. D336712; D. Wilbur; June 12, 2007
2. chlormequat chloride: Occupational and Residential Exposure Assessment for the
Reregistration Eligibility Decision Document. D336714; C. Smith; June 12, 2007
4. chlormequat chloride. Screening-Level Acute and Chronic Dietary (Drinking Water
Only) Exposure and Risk Assessment for the Reregistration Eligibility Decision.
D336716; D. Wilbur; June 7, 2007
5. Review of chlormequat chloride Incident Reports. D342351; M. Hawkins; August 14,
2007
6. chlormequat chloride - Carcinogenicity Studies in Rats and Mice (MRID # 46715203 and
46715204). D336713; J. Facey; June 11, 2007
Ecological Fate and Effects Documents
1. Environmental Fate and Ecological Risk Assessment for the Reregistration of
chlormequat chloride. B. Kiernan and M. Echeverria; April 11, 2007
2. Tier I Drinking Water Assessment for chlormequat chloride in Support of Reregistration
Eligibility Decision D336717;. M. Echeverria; March 19, 2007
23
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Appendix D. Citations Considered to be Part of the Database Supporting the
Reregistration Decision (Bibliography)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in
the Reregistration Eligibility Document. Primary sources for studies in this bibliography
have been the body of data submitted to EPA and its predecessor agencies in support of past
regulatory decisions. Selections from other sources including the published literature, in
those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct title (or at least a single subject),
can stand alone for purposes of review and can be described with a conventional
bibliographic citation. The Agency has also attempted to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation, and
should be used whenever a specific reference is required. It is not related to the six-digit
"Accession Number" which has been used to identify volumes of submitted studies (see
paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier.
These entries are listed after all MRID entries. This temporary identifying number is also to
be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists
of a citation containing standard elements followed, in the case of material submitted to EPA,
by a description of the earliest known submission. Bibliographic conventions used reflect the
standard of the American National Standards Institute (ANSI), expanded to provide for
certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to
show a personal author. When no individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When no author or laboratory
could be identified, the Agency has shown the first submitter as the author.
24
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b. Document date. The date of the study is taken directly from the document. When the
date is followed by a question mark, the bibliographer has deduced the date from the
evidence contained in the document. When the date appears as (1999), the Agency was
unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears immediately
following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
number, or other administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to
the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the
original submission of the study appears. The six-digit accession number follows
the symbol "CDL," which stands for "Company Data Library." This accession
number is in turn followed by an alphabetic suffix which shows the relative
position of the study within the volume.
25
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Bibliography
MRID
Citation Reference
9446
Welch, N.C. (1969) Report of Planned Work Accomplished: Growth Control
Regulators in Brussels Sprouts: Proj. No. 75. (Unpublished study received Oct 3,
1972 under 2F1271; prepared by Univ. of California, Cooperative Extension Service,
submitted by Uniroyal Chemical, Bethany, Conn.; CDL:091801-W)
9447
Rubatzky, V.E.; Sciaroni, R.H. (1970) Chemical Topping of Brussels Sprouts.
(Papers for American Society for Horticultural Science—Western Region, Univ. of
California—Berkeley, June 21-24, 1970; unpublished study received Oct 3, 1971
under 2F1271; prepared by Univ. of California—Davis, Agricultural Extension Ser-
vice, Dept. of Vegetable Crops, submitted by Uniroyal Chemical, Bethany, Conn.;
CDL:091801-Y)
9454
Kim, S.H.; Fieldhouse, D.J.; Morton, DJ. (1966) Effects of Bactericides and Growth
Regulators on Bacterial Spot, Yield, and Fruit Weight of Pepper—1966.
(Unpublished study received Oct 3, 1972 under 2F1271; prepared by Univ. of
Delaware, submitted by Uniroyal Chemical, Bethany, Conn.; CDL:091801-AG)
9486
Read, P.E.; Fieldhouse, DJ. (1970) Use of Growth Retardants for increasing tomato
yields and adaptation for mechanical harvest. Journal of the American Society of
Horticultural Science 95(1): 73-78. (Also in unpublished submission received Nov 4,
1975 under 400-79; submitted by Uniroyal Chemical, Bethany, Conn.; CDL:094840-
C)
9487
Bryan, H.H. (1970) Concentrating tomato maturity with growth regulators. Pages
123-126, In Preceedings of the Florida State Horticultural Society; Oct 27-29, 1970,
Miami, Florida. N.P. (Also in unpublished submission received Nov 4, 1975 under
400-79; submitted by Uniroyal Chemical, Bethany, Conn.; CDL: 094848-H)
9534
Edgerton, L.J.; Powell, L.E. (1967) Effects of Some Growth Regulators on Bloom
Date and Cold Hardiness of Apple and Cherry. (Unpublished study received Apr 10,
1967 under 7F0552; prepared by Cornell Univ., Dept. of Pomology, submitted by
United States Rubber Co., Naugatuck, Conn.; CDL:094768-D)
9558
Bryan, H.H. (1967) Preliminary Non-Projected Studies: Tomato Yield Response to
Growth Regulators. (Unpublished study received May 29, 1970 under OF0923;
prepared by Univ. of Florida, Sub-Tropical Experiment Station, submitted by
Uniroyal Chemical, Bethany, Conn.; CDL:091577-I)
9569
Oyer, E. (1967) Effects of Growth Regulants on Flowering and Fruiting of
Tomatoes. (Unpublished study received May 29, 1970 under OF0923; prepared by
Cornell Univ., submitted by Uniroyal Chemical, Bethany, Conn.; CDL:091577-W)
26
-------
MRID
Citation Reference
9580
Chilcote, D.O.; Phillips, J.C.; Frakes, R.V. (1974) Growth Regulators and Seed Yield
in Alfalfa. (Unpublished study received Mar 4, 1976 under 6F1752; submitted
by Uniroyal Chemical, Bethany, Conn.; CDL:095528-C)
9581
Oregon State University, Crop Science Department (1972) Influence of Selected
Growth Regulators on Alfalfa Seed Yield and Yield Components. (Unpublished
study received Mar 4, 1976 under 6F1752; prepared in cooperation with Southern
Oregon Experiment Station, submitted by Uniroyal Chemical, Bethany, Conn.; CDL:
095528-E)
9674
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CDL: 093 893-I)
123251
Wheldon, G.; Hunter, B.; Hague, P.; et al. (1971) Long-term Feeding Study of
Cycocel in the Mouse: 4059/71/217. (Unpublished study received 1971 under
4G1461; prepared by Huntingdon Research Centre, Eng., submitted by American
Cyanamid Co., Princeton, NJ; CDL:093893-J)
123252
Oettel, H.; Frohberg, H. (1966) Final Report on the 2-year Rat Feeding Experiment
with Chlorcholine-chloride (CCC): XIV/145= xv/96. (Translation; unpublished study
received 1966 under 4G1461; prepared by BASF, W. Ger., submitted by American
Cyan- amid Co., Princeton, NJ; CDL:093893-K)
123253
Leuschner, F.; Leuschner, A.; Schwerdtfeger, W. (1967) The Chronic Toxicity of
CCC: Chronic Reproductive Study in Three Generations of Wistar-rats.
(Unpublished study received 1967 under 4G1461; prepared by BASF, submitted by
American Cyanamid Co., Princeton NJ; CDL:093893-L)
123254
Oettel, H.; Frohberg, H. (1964) Report on the Testing of the Teratogenetic Effect of
Chlorcholinechloride on Mice: XIII/485 and XIV/145. (Unpublished study received
1964 under 4G1461; prepared by BASF, submitted by American Cyanamid Co.,
Princeton, NJ; CDL:093893-M)
123255
Oettel, H.; Frohberg, H. (1965) Report on the Testing of the Teratogenic Effect of
Chlorocholine Chloride in Mice Feeding Trials: XIII/485 and XIV/145.
(Unpublished study received 1965 under 4G1461; prepared by BASF, submitted by
American Cyanamid Co., Princeton, NJ; CDL:093893-N)
123256
Oettel, H.; Frohberg, H. (1965) Report on the Testing of Chlorocholinechloride
(CCC) in Respect to Teratogenic Effects on Mice in Chronic Feeding Tests: XV/96.
(Translation; unpublished study received 1965 under 4G1461; prepared by BASF,
36
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W. Ger., submitted by American Cyanamid Co., Princeton, NJ; CDL:093893-O)
123257
Oettel, H.; Frohberg, H. (1965) Report on Testing Chlorocholine- chloride (CCC) in
Respect to Possible Teratogenic Effects in Feeding Tests on Rats: XV/96.
(Translation; unpublished study received 1965 under 4G1461; prepared by BASF,
W. Ger., submitted by American Cyanamid Co., Princeton, NJ; CDL:093893-P)
123258
Oettel, H.; Frohberg, H. (1965) Report on the Testing of Chlorocholinechoride
(CCC) in Respect to Possible Teratogenic Effects in Feeding Tests on Rabbits:
XV/96. (Translation; unpublished study received 1965 under 4G1461; prepared by
BASF, W. Ger., submitted by American Cyanamid Co., Princeton, NJ; CDL:093893-
Q)
123259
Fletcher, D. (1972) Report to: 8-day Dietary LC50 Study with Cycocel Technical,
98% Pure in Ringneck Pheasants: IBT No. J1780. (Unpublished study received 1972
under 4G1461; prepared by Industrial Bio-Test Laboratories, Inc., submitted by
American Cyanamid Co., Princeton, NJ; CDL:093893-R)
123260
Fletcher, D. (1972) Report to ...: 8-day Dietary LC50 Study with Cycocel Technical,
98% Pure in Mallard Ducks: IBT No. J1779. (Unpublished study received 1972
under 4G1461; prepared by Industrial Bio-Test Laboratories, Inc., submitted by
American Cyanamid Co., Princeton, NJ; CDL:093893-S)
123261
Sleight, B. (1972) The Acute Toxicity of Cycocel and Experimental Insecticide AC
92,100 to Bluegill (Lepomis macrochirus) and Rainbow Trout (Salmo gairdneri).
(Unpublished study received 1972 under 4G1461; prepared by Bionomics, Inc.,
submitted by American Cyanamid Co., Princeton, NJ; CDL:093893-T)
123262
American Cyanamid Co. (1973) Investigations Made with Respect to the Fate of
Chlorocholine Chloride in Sugar Cane Grown in Hawaii, in the Rat and in the Soil.
(Compilation; unpublished study received 1973 under 4G1461; CDL:093893-U)
124052
American Cyanamid Co. (1975) Residue of Cycocel in Sugarcane Grown in Hawaii.
(Compilation; unpublished study received Mar 15, 1976 under 6F1759;
CDL:095136-A)
124053
American Cyanamid Co. (1975) Metabolic Fate of Cycocel in Plants, Soil, Animals:
Residue Summary. (Unpublished study received Mar 15, 1976 under 6F1759;
CDL:095138-A)
124054
Marei, A.; Higham, J. (1973) Cycocel Plant Growth Regulant: Fate of Carbon-14
Chlorocholine Chloride in Sugarcane Grown in Hawaii: PDM 10:31-64.
(Unpublished study received Mar 15, 1976 under 6F1759; submitted by American
Cyanamid Co., Princeton, NJ; CDL:095138-B)
124055
Blinn, R.; Gatterdam, P.; Champagne, D. (1965) Cycocel Plant Growth Regulant: A
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Study of 2-Chloroethyl Trimethylammonium in a Rat: PDM 2:238-247.
(Unpublished study received Mar 15, 1976 under 6F1759; submitted by American
Cyanamid Co., Princeton, NJ; CDL:095138-C)
124056
Haugwitz, M.; Adams, C. (1975) Excretion, Residual Radioactivity and Biochemical
Behavior of 14C-Cycocel Plant Growth Regulant in Lactating Goats: PD-M 12:870-
949. (Unpublished study received Mar 15, 1976 under 6F1759; prepared in
cooperation with Bio/dynamics, Inc., submitted by American Cyanamid Co., Prince-
ton, NJ; CDL:095138-E)
124057
Wozniak, L.; Amber, P.; Colavita, 1; et al. (1975) Cycocel Plant Growth Regulant: A
Study of the Disposition of 14C-CL 38,555 ... in Laying Hens: AIR 3:233-290.
(Unpublished study received Mar 15, 1976 under 6F1759; submitted by American
Cyanamid Co., Princeton, NJ; CDL:095138-F)
124058
American Cyanamid Co. (1975) General Summary: Cycocel Plant Growth Regulant:
Residue Data|. (Unpublished study received Mar 15, 1976 under 6F1759;
CDL:095139-A)
124059
Marei, A. (1973) Cycocel Plant Growth Regulant: Fate of Carbon-14 Chlorocholine
Chloride in Soil: Project No. 2-524. Progress rept, 11-22-71 to 2-2-73. (Unpublished
study received Mar 15, 1976 under 6F1759; submitted by American Cyanamid Co.,
Prince- ton, NJ; CDL:095139-B)
124060
Dupre, G. (1975) Runoff Characteristics of 14C-Cycocel Applied to Clay Loam Soil
under Greenhouse Conditions: Report No. 75020. (Unpublished study received Mar
15, 1976 under 6F1759; prepared by Bio/dynamics, Inc., submitted by American
Cyanamid Co., Princeton, NJ; CDL:095139-C)
124061
O'Grodnick, J.; Dupre, G. (1975) Leaching Characteristics of 14C- Cycocel and Its
Degradation Products following Aging in Clay Loam Soil under Laboratory
Conditions: Report No. 75022. (Un- published study received Mar 15, 1976 under
6F1759; prepared by Bio/dynamics, Inc., submitted by American Cyanamid Co.,
Prince- ton, NJ; CDL:095139-D)
124062
Dupre, G. (1975) Leaching Characteristics of 14C-Cycocel in Various Soil Types
under Laboratory Conditions: Report No. 75021. (Unpublished study received Mar
15, 1976 under 6F1759; prepared by Bio/dynamics, Inc., submitted by American
Cyanamid Co., Princeton, NJ; CDL:095139-E)
124063
Haugwitz, M.; Eisner, S. (1975) Cycocel Plant Growth Regulant: A Study of Its
Behavior in an Hydrolytic and in a Photolytic Environment: Project No. 2-524.
Progress rept., 7-18-75 to 8- 30-75. (Unpublished study received Mar 15, 1976 under
6F1759; submitted by American Cyanamid Co., Princeton, NJ; CDL:095139-F)
124064
Heitmuller, T. (1975) Acute Toxicity of Cycocel to Eastern Oysters (Crassostrea
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virginica), Pink Shrimp (Penaeus duorarum) and Fiddler Crabs (Uca pugilator).
(Unpublished study received Mar 15, 1976 under 6F1759; prepared by Bionomics,
EG & G, Inc., submitted by American Cyanamid Co., Princeton, NJ; CDL:095139-1)
124065
Jung, J. (1964) Influence of Choline Dichlorine (CCC) on Biological Processes in the
Soil. A translation of: Uber den Einfluss von Chlorcholinchlorid (CCC) auf
Biologische Vorgange im Boden. (Unpublished study received Mar 15, 1976 under
6F1759; prepared by Badischen Anilin & Soda-Fabrik AG, W. Ger., submitted by
American Cyanamid Co., Princeton, NJ; CDL:095139-K)
125181
American Cyanamid Co. (1976) Chemistry Data: Cycocel|. (Com- pilation;
unpublished study received Mar 15, 1976 under 6F1759; CDL:095134-A)
125182
American Cyanamid Co. (1975) Summary of the Toxicity Data on 2-Chlorethyl
Trimethylammonium Chloride: CL 38,555. (Unpublished study received Mar 15,
1976 under 6F1759; CDL:095134-B)
125183
Levinskas, G.; Bushey, C.; Kunde, M.; et al. (1962) Report on 2- Chloroethyl
Trimethylammonium Chloride; CL 38,555: Limited Re- lease Toxicity Studies:
Report No. 62-14. (Unpublished study received Mar 15, 1976 under 6F1759;
submitted by American Cyanamid Co., Princeton, NJ; CDL:095134-C)
125184
Roche, W. (1974) Acute Oral Toxicity in Beagle Dogs with Cycocel 4L: Contract
No. 121-2322-54. Final rept. (Unpublished study received Mar 15, 1976 under
6F1759; prepared by Affiliated Medical Research, Inc., submitted by American
Cyanamid Co., Princeton, NJ; CDL:095134-E)
125185
Deprospo, J. (1974) Acute Inhalation Study of Cycocel 4L in Rats: Contract No. 122-
2321-54. Final rept. (Unpublished study received Mar 15, 1976 under 6F1759;
prepared by Affiliated Medical Research, Inc., submitted by American Cyanamid
Co., Princeton NJ; CDL:095134-F)
125186
Cox, G.; Bailey, D. (1975) Subacute (21-day) Dermal Toxicity Study in Rabbits with
Cycocel 4 L: Laboratory No. 2367. (Unpublished study received Mar 15, 1976 under
6F1759; prepared by Food and Drug Research Laboratories, Inc., submitted by
American Cyanamid Co., Princeton, NJ; CDL:095134-G)
125187
Oettel, H.; Frohberg, H. (1965) Report on Testing the Elimination of
Chlorcholinechloride (CCC) after One Oral Administration in Rats: XV/163.
(Unpublished study received Mar 15, 1976 under 6F1759; prepared by BASF,
submitted by American Cyanamid Co., Princeton, NJ; CDL:095134-H)
125188
Oettel, H.; Schilling, B. (1965) Report on the Detoxification Experiments of
Chlorocholine Chloride (CCC) with Atropine: XV/96. (Unpublished study received
Mar 15, 1976 under 6F1759; prepared by BASF, submitted by American Cyanamid
Co., Princeton, NJ; CDL:095134-1)
39
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125189
Oettel, H.; Frohberg, H. (1964) Report on the Three Months' Rat Feeding Test with
Chlorcholinechloride in Powdered Feed: IXX/ 467, XIV/68. (Unpublished study
received Mar 15, 1976 under 6F1759; prepared by BASF, submitted by American
Cyanamid Co., Princeton, NJ; CDL:095134-J)
125190
Oettel, H.; Hofmann, H. (1964) Report on the Examination of the Chronic Oral
Toxicity of Chlorcholinechloride in Cats. (Un- published study received Mar 15,
1976 under 6F1759; prepared by BASF, submitted by American Cyanamid Co.,
Princeton, NJ; CDL: 095134-K)
125191
BASF (1967) Final Report on Two Year Dog Feeding Experiment with Chlor-
choline-chloride (CCC): XIV/145, 156. (Unpublished study received Mar 15, 1976
under 6F1759; submitted by American Cyanamid Co., Princeton, NJ; CDL:095134-
L)
125192
Leuschner, F.; Leuschner, A.; Schwerdtfeger, W. (1967) The Chronic Toxicity of
CCC: Chronic Reproductive Study in Three Generations of Wistar-rats.
(Unpublished study received Mar 15, 1976 under 6F1759; submitted by American
Cyanamid Co., Princeton, NJ; CDL: 095135-B)
125193
Oettel, H.; Frohberg, H. (1964) Report on the Testing of the Teratogenetic Effect of
Chlorcholinechloride on Mice: XIII/485. (Unpublished study received Mar 15, 1976
under 6F1759; prepared by BASF, submitted by American Cyanamid Co., Princeton,
NJ;CDL: 095135-C)
125195
Oettel, H.; Frohberg, H. (1965) Report on the Testing of Chloro- cholinechloride
(CCC) in Respect to Teratogenic Effects on Mice in Chronic Feeding Tests: XV/96.
(Translation; unpublished study received Mar 15, 1976 under 6F1759; prepared by
BASF, submitted by American Cyanamid Co., Princeton, NJ; CDL:095135-E)
125196
Oettel, H.; Frohberg, H. (1965) Report on Testing Chlorocholine- chloride (CCC) in
Respect to Possible Teratogenic Effects in Feeding Tests on Rats: XV/96.
(Translation; unpublished study received Mar 15, 1976 under 6F1759; prepared by
BASF, submitted by American Cyanamid Co., Princeton, NJ; CDL:095135-F)
125197
Oettel, H.; Frohberg, H. (1965) Report on the Testing of Chloro-cholinechloride
(CCC) in Respect to Possible Teratogenic Effects in Feeding Tests on Rabbits:
XV/96. (Translation; unpublished study received Mar 15, 1976 under 6F1759;
prepared by BASF, submitted by American Cyanamid Co., Princeton, NJ;
CDL:095135-G)
125198
Bailey, D.; Morgareidge, K. (1975) Teratologic Evaluation of Cyco- eel in Rats:
Laboratory 2288. (Unpublished study received Mar 15, 1976 under 6F1759; prepared
by Food and Drug Research Laboratories, Inc., submitted by American Cyanamid
Co., Prince- ton, NJ; CDL:095135-H)
40
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125199
Fletcher, D. (1972) Report to: 8-day Dietary LC50 Study with Cycocel Technical,
98% Pure in Mallard Ducks: IBT No. J1779. (Unpublished study received Mar 15,
1976 under 6F1759; prepared by Industrial Bio-Test Laboratories, Inc., submitted by
American Cyanamid Co., Princeton, NJ; CDL:095135-J)
125211
Snyder, R. (1976) Letter sent to J. Cummings dated Dec 16, 1976: Cycocel residues
in sugar cane, liver and milk. (Unpublished study received 1976 under 6F1759;
prepared by U.S. Environ- mental Protection Agency, submitted by American
Cyanamid Co., Princeton, NJ; CDL:095133-A)
125212
American Cyanamid Co. (1976) Chemistry of Cycocel Plant Growth Regulant|.
(Compilation; unpublished study received Mar 15, 1976 under 6F1759;
CDL:095133-B)
125213
Fischer, J. (1979) Toxicity Data Report: Cycocel|: Report No. A79- 96. (Unpublished
study received 1979 under 6F1759; submitted by American Cyanamid Co.,
Princeton, NJ; CDL:095133-C)
125214
American Cyanamid Co. (1975) Toxicity of Cycocel Plant Growth Regulant to
Mammals, Fish and Wildlife. (Unpublished study received Mar 15, 1976 under
6F1759;CDL:095133-D)
126869
Owen, P.; Sheppard, D.; Glaister, J. (1983) PGR A7/16 Acute Inhalation Toxicity
Study~(LC50) in Rats-4 Hour Exposure: Report No. 3222-191/2. (Unpublished
study received Apr 11, 1983 under 47361-EX-1; prepared by Hazleton Laboratories
Europe, Ltd., Eng., submitted by Mandops, Inc., West Palm Beach, FL; CDL:
249993-A)
126870
Owen, P.; Sheppard, D.; Glaister, J. (1983) PGR S8/16 Acute Inhalation Toxicity
Study~(LC50) in Rats-4 Hour Exposure: Report No. 3221-191/3. (Unpublished
study received Apr 11, 1983 under 47361-EX-1; prepared by Hazleton Laboratories
Europe, Ltd., Eng., submitted by Mandops, Inc., West Palm Beach, FL; CDL:
249994-A)
126871
Gunn, J.; Goodwin, M.; Wood, C. (1982) Further Acute Oral Toxicity Study in the
Rat~PGR/4A: Ref. No. 148/8210. (Unpublished study received Apr 11, 1983 under
47361-EX-1; prepared by Toxicol Laboratories, Ltd., Eng., submitted by Mandops,
Inc., West Palm Beach, FL; CDL:249995-A)
126872
Gunn, J.; Goodwin, M. (1982) Acute Oral LD50 Study in the Rat- PGR/4A: Ref.
No. 246/8207. (Unpublished study received Apr 11, 1983 under 47361-EX-l;
prepared by Toxicol Laboratories, Ltd., Eng., submitted by Mandops, Inc., West
Palm Beach, FL; CDL: 249995-B)
126873
Gunn, J.; Goodwin, M.; Wood, C. (1982) Further Acute Oral Toxicity Study in the
Rat~PGR/6S: Ref. No. 146/8210. (Unpublished study received Apr 11, 1983 under
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47361-EX-1; prepared by Toxicol Laboratories, Ltd., Eng., submitted by Mandops,
Inc., West Palm Beach, FL; CDL:249996-A)
126874
Goodwin, M.; Gunn, J. (1982) Acute Oral LD50 Study in the Rat- PGR/6S: Ref. No.
245/8207. (Extract; unpublished study received Apr 11, 1983 under 47361-EX-1;
prepared by Toxicol Laboratories, Ltd., Eng., submitted by Mandops, Inc., West
Palm Beach, FL; CDL:249996-B)
127776
Deprospo, J. (1974) Acute Inhalation Study of Cycocel 4L in Rats: Contract No.:
122-2321-54. Final rept. (Unpublished study received Jun 26, 1974 under 241-EX-
66; prepared by Affiliated Medical Research, Inc., submitted by American Cyanamid
Co., Princeton, NJ; CDL:249758-A)
133656
American Cyanamid Co. (1965) Toxicity Data: Cycocel 11.8%|: Report 65-5.
(Unpublished study received Oct 23, 1970 under unknown admin, no.; CDL: 107910-
A)
137642
Haugwitz, M.; Eisner, S. (1975) Cycocel Plant Growth Regulant: A Study of Its
Behavior in an Hydrolytic and in a Photolytic Environment: PD-M 12:1270-1290.
Progress rept. Jul 18, 1975 to Aug 30, 1975. (Unpublished study received Feb 28,
1984 under 241- EX-103; submitted by American Cyanamid Co., Princeton, NJ;
CDL: 072397-A)
137643
BASF AG (1982) Behaviour of Pesticides in Water: Chloromequat- chloride, CCC|.
(Unpublished study received Feb 28, 1984 under 241-EX-103; submitted by
American Cyanamid Co., Princeton, NJ; CDL:072397-B)
137644
Marei, A. (1973) Cycocel Plant Growth Regulant: Fate of Carbon-14 Chlorocholine
Chloride in Soil: PD-M 10:65-112. Progress rept. Nov 22, 1971 to Jul 20, 1972 and
Feb 2, 1973 to Mar 22, 1973. (Unpublished study received Feb 28, 1984 under 241-
EX-103; sub- mitted by American Cyanamid Co., Princeton, NJ; CDL:072397-C)
137645
Jung, J. (1975) Degradation Studies on Cycocel (CCC + CC) in Various Soils.
(Translation; unpublished study received Feb 28, 1984 under 241-EX-103; prepared
by BASF AG, W. Ger., submitted by American Cyanamid Co., Princeton, NJ;
CDL:072397-D)
137646
American Cyanamid Co. (1975) Residue of Cycocel in Various Soils|. (Compilation;
unpublished study received Feb 28, 1984 under 241- EX-103; CDL:072397-E)
137647
American Cyanamid Co. (1974) Leaching Behaviour of Cycocel|. (Compilation;
unpublished study received Feb 28, 1984 under 241- EX-103; CDL:072397-H)
137648
Jung, J. (1974) Leaching Behaviour of Cycocel. (Translation; un-published study
received Feb 28, 1984 under 241-EX-103; prepared by BASF, W. Ger., submitted by
American Cyanamid Co., Princeton, NJ; CDL:072397-1)
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137649
Jung, J.; Hulsmann, J. (1974) Determination of the Growth Regulator Chlorocholine
Chloride (CCC) in Soil and Leaching Water: Report No. 1221. (Translation;
unpublished study received Feb 28, 1984 under 241-EX-103; prepared by BASF, W.
Ger., submitted by Ameri- can Cyanamid Co., Princeton, NJ; CDL:072397-J)
137650
Jung, J.; Otto, S. (1975) An Investigation into the Leaching of U 46 and Cycocel
from the Top Soil by Means of Lysimeters: Report No. 1294. (Unpublished study
received Feb 28, 1984 under 241- EX-103; prepared by BASF, W. Ger., submitted
by American Cyana-mid Co., Princeton, NJ; CDL:072397-K)
137651
Jung, J. (1964) Influence of Choline Bichloride (CCC) on Biological Processes in the
Soil. (Unpublished study received Feb 28, 1984 under 241-EX-103; submitted by
American Cyanamid Co., Princeton, NJ; CDL:072397-M)
138710
BASF (1979) Study of the Prenatal Toxicity of 2-chloroethyltri- methylammonium
chloride ... on Rabbits. (Unpublished study received Feb 28, 1984 under 241-EX-
103; CDL:072391-A)
138711
Leuschner, F. (1975) Study of the Effect of the Dietary Administration of CCC + CC
(Mixture of Chlorocholine Chloride and 41% of Choline Chloride) on the Prenatal,
Perinatal and Postnatal Development of Rats. (Unpublished study received Feb 28,
1984 under 241-EX-103; prepared by Laboratory of Pharmacology, and Toxicology,
submitted by American Cyanamid Co., Princeton NJ; CDL:072391-B)
138712
Leuschner, F.; Leucshner, A.; Schwerdtfeger, W. (1967) The Chronic Toxicity of
CCC: Chronic Reproductive Study in Three Generations of Wistar-Rats.
(Unpublished study received Feb 28, 1984 under 241-EX-103; prepared by
Laboratory of Pharmacology and Toxicology, submitted by American Cyanamid Co.,
Princeton, NJ; CDL: 072392-A)
138713
Leuschner, F.; Hubscher, F.; Dontenwill, W. (1975) Trail of the Long-term
Tolerance of a Mixture of Chloro-choline Chloride(CCC) and Choline Chloride (CC)
- Abbreviated to CCC + CC - in a Reproduction Experiment over Three Generations
on Sprague-Dawley Rats. (Unpublished study received Feb 28, 1984 under 241-EX-
103; prepared by Laboratory of Pharmacology and Toxicology, submitted by
American Cyanamid Co., Princeton, NJ; CDL:072392-B)
138714
Ulland, B.; Gordon, E.; Cardy, R.; et al. (1979) Bioassay of (2- Chloroethyl)
Trimethylammonium Chloride (CCC) for Possible Carcinogenicity. By National
Institutes of Health, National Center Institute, Div. of Cancer Cause and Prevention,
Carciogenesis Testing Program. Bethesda, MD: U.S. Dept. of Health, Education, and
Welfare. (National Cancer Institute, Carcinogenesis, Technical report series No. 158;
also In unpublished submission received Feb 28, 1984 under 241-EX-103; submitted
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138715
Ross, D.; Burroughs, S; Roberts, N. (1974) The Acute Toxicity (LD50) of Two
Formulations of Cycocel to the Pheasant: BSF55/ 74910. (Unpublished study
received Feb 28, 1984 under 241-EX- 103; prepared by Huntingdon Research
Centre, Eng., submitted by American Cyanamid Co., Princeton, NJ; CDL:072394-A)
138716
Ross, D.; Roberts, N. (1974) The Acute Toxicity (LD50) of Two Formulations of
Cycocel to the Japanese Quail: BSF55/74727. (Unpublished study received Feb 28,
1984 under 241-EX-103; pre- pared by Huntingdon Research Centre, Eng.,
submitted by American Cyanamid Co., Princeton, NJ;CDL:072394-B)
138717
Fletcher, D. (1972) Report to American Cyanamid Co. 8-Day Dietary LC50 Study
with Cycocel Technical, 98% Pure in Ringneck Pheasants: IBT No. J1780.
(Unpublished study received Feb 28, 1984 under 241-EX-103, submitted by
American Cyanamid Co., Princeton, NJ; CDL:072394-C)
138718
Fletcher, D. (1972) Report to American Cyanamid Co. 8-day Dietary LC50 Study
With Cycocel Technical, 98% Pure in Mallard Ducks: IBT No. J1779. (Unpublished
study received Feb 28, 1984 under 241-EX-103; submitted by American Cyanamid
Co., Princeton, NJ; CDL:072394-D)
138719
Mueller. (1981) Determination of the Acute Toxicity of Chlormequat chloride BAS
062-W to the Waterflea Daphnia magna Straus. (Un- published study received Feb
28, 1984 under 241-EX-103; prepared by BASF AG, submitted by American
Cyanamid Co., Princeton, NJ; CDL:072394-G)
139022
American Cyanamid Co. (1983) Residue: Cycocel on Cereals & Other Food
Commodities). (Compilation; unpublished study received Feb 28, 1984 under 241-
EX-103; CDL:072395-A; 072396)
140110
American Cyanamid Co. (1975) General Summary: Cycocel Plant Growth Regulant|.
(Unpublished study received Mar 15, 1976 under 6F1759; CDL:095941-A)
140111
Marei, A.; Higham, J. (1973) Cycocel Plant Growth Regulant: Fate of Carbon-14
Chlorocholine Chloride in Sugarcane Grown in Hawaii: Project No. 2-524. Progress
rept, Apr 6, 1973. (Unpublished study received Mar 15, 1976 under 6F1759;
submitted by American Cyanamid Co., Princeton, NJ; CDL:095941-B)
140112
Blinn, R.; Gatterdam, P.; Champagne, D. (1965) Cycocel Plant Growth Regulant: A
Study of 2-Chloroethyl Trimethylammonium Chloride in a Rat: Project No. 35-54-3-
15-25. Progress rept., Nov 5, 1965. (Unpublished study received Mar 15, 1976 under
6F1759; submitted by American Cyanamid Co., Princeton, NJ; CDL:095941-C)
140113
Marei, A. (1973) Cycocel Plant Growth Regulant: Fate of Carbon-14 Chlorocholine
Chloride in Soil: Project No. 2-524. Progress rept., Jul 25, 1973. (Unpublished study
received Mar 15, 1976 under 6F1759; submitted by American Cyanamid Co.,
Princeton, NJ; CDL:095941-D)
44
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140114
Haugwitz, M.; Adams, C. (1975) Excretion, Residual Radioactivity, and Biochemical
Behavior of 14C-Cycocel Plant Growth Regulator in Lactating Goats: Project No. 2-
524. Progress rept, Oct 1, 1975. (Unpublished study received Mar 15, 1976 under
6F1759; submitted by American Cyanamid Co., Princeton, NJ; CDL:095941-E)
163390
American Cyanamid Co. (1983) Name, Chemical and Physical Properties of Cycocel
Plant Growth Regulant. Unpublished compilation. 49 p.
163391
American Cyanamid Co. (1976) [Toxicology and Residue Studies of Chlormequat].
Unpublished compilation. 40 p.
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Registration of ET-013. Transmittal of 1 Study.
47030401
Wo, C. (2006) ET-013: Storage Stability and Corrosion Characteristics. Project
Number: 17926, P800, 050718/3H. Unpublished study prepared by Product Safety
Laboratories. 21 p.
47088300
Fine Agrochemicals Ltd. (2007) Submission of Product Chemistry Data in Support
of the Application for Registration of Chlomequat Chloride Technical. Transmittal of
1 Study.
47088301
Smith, F. (2007) Discussion of Formation of Impurities and Certified Limits:
(Chlomequat Chloride Technical). Unpublished study prepared by SciReg, Inc. 5 p.
47090200
Fine Agrochemicals Ltd. (2007) Submission of Product Chemistry and Toxicity Data
in Support of the Application for Registration of Citadel. Transmittal of 9 Studies.
47090201
Smith, F. (2007) Product Identity and Composition, Description of Beginning
Materials, Formulation Process, Discussion of Formation of Impurities, and Certified
Limits. Project Number: UC80C2076/63421. Unpublished study prepared by SciReg
Inc. 57 p.
47090202
Smith, F. (2007) Summary of the OPPTS 830 Series Physical-Chemical Properties
Test Guidelines. Unpublished study prepared by SciReg Inc. 7 p.
47090203
Parsons, H. (2006) Generation of Chemical and Physical Data for the Chlormequat
End-Use Product: Amended Interim Report. Project Number: J15671, FOR/05/032.
Unpublished study prepared by G C Laboratories Ltd. 18 p.
47090204
Dreher, D. (2006) chlormequat chloride 11.8 Percent SL Formulation: Acute Oral
Toxicity Study in the Female Rat (Acute Toxic Class): Final Report. Project
Number: 2242/031, 01462733898. Unpublished study prepared by Covance
Laboratories Ltd. 27 p.
47090205
Dreher, D. (2006) chlormequat chloride 11.8 Percent SL Formulation: Acute Dermal
Toxicity Study in the Rat: Final Report. Project Number: 2242/032, 01462733898.
Unpublished study prepared by Covance Laboratories Ltd. 26 p.
47090206
Janssen, P. (2006) Assessment of Acute Inhalation Toxicity with 11.8 Percent
chlormequat chloride Formulation in the Rat. Project Number: 465839, 166068/A.
Unpublished study prepared by Notox B.V. 35 p.
47090207
Dreher, D. (2006) chlormequat chloride 11.8 Percent SL Formulation: Eye Irritation
Study in the Rabbit: Final Report. Project Number: 2242/034, 01462733898.
Unpublished study prepared by Covance Laboratories Ltd. 24 p.
55
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MRID
Citation Reference
47090208
Dreher, D. (2006) chlormequat chloride 11.8 Percent SL Formulation: Dermal
Irritation Study in the Rabbit: Final Report. Project Number: 2242/033,
01452733898. Unpublished study prepared by Covance Laboratories Ltd. 24 p.
47090209
Dreher, D. (2006) chlormequat chloride 11.8 Percent SL Formulation: Local Nymph
Node Assay in the Mouse (Individual Method): Final Report. Project Number:
2242/036, 01462733898. Unpublished study prepared by Covance Laboratories Ltd.
27 p.
47100500
Taminco N.V Inc. (2007) Submission of Product Chemistry Data in Support of the
Application for Registration of chlormequat chloride Technical. Transmittal of 13
Studies.
47100501
Smith, F. (2007) Product Identity and Composition, Description of Beginning
Material, and Production Process: (Chlomequat Chloride Technical). Unpublished
study prepared by Taminco, n.v. 22 p.
47100502
Genari, G. (2003) Characterization of Five Batches of Technical chlormequat
chloride: Final Report. Project Number: PCP06880, M/91/48/E, M/91/29/E.
Unpublished study prepared by BASF Aktiengesellschaft, Labor fuer
Oekotoxicologie. 47 p.
47100503
Ziegler, H. (1999) Development and Validation of the Analytical Method CF-A 583:
Determination of Chlormequat-Chlorid in Soluble Concentrates (BAS 062 03 W):
Final Report. Project Number: PCF/02028, 08/06/1999. Unpublished study prepared
by BASF Aktiengesellschaft. 19 p.
47100504
Smith, F. (2007) Summary of the Physical-Chemical Properties Test Guidelines.
Unpublished study prepared by SciReg, Inc. 8 p.
47100505
Kastel, R. (1999) Physical And Chemical Properties of BAS 062 03 W: (Chlomequat
Chloride Technical): Final Report. Project Number: PCF02038, 99/11112,
CF/P/062/4. Unpublished study prepared by BASF Aktiengesellschaft. 23 p.
47100506
Pession, G. (1998) Boiling Point of Belcocel Technico. Project Number: C/0603/98.
Unpublished study prepared by Bioagril Laboratorios Ltda. lip.
47100508
Weissenfeld, M. (2006) Determination of the Water Solubility of chlormequat
chloride Pure. Project Number: A49566. Unpublished study prepared by RCC Ltd.
20 p.
47100510
Daum, A. (2000) Determination of the Partition Coefficient (N-octanol/water) of
chlormequat chloride (BAS 062W, Reg. No. 24605) at 2 Degree Celsius by Flask
Shaking Method: Final Report. Project Number: PCP05666, DOCID/2000/1013492.
Unpublished study prepared by BASF Aktiengesellschaft. 17 p.
56
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MRID
Citation Reference
47100511
Gilbert, E. (1999) Statement on the Oxidizing Properties of chlormequat chloride 750
g/L. Project Number: 263892. Unpublished study prepared by Notox B.V. 11 p.
47100512
Gilbert, E. (1999) Determination of the Auto-Ignition Temperature (Liquids) of
chlormequat chloride 750 g/L. Project Number: 263857. Unpublished study prepared
by Notox B.V. 16 p.
47100513
Gilbert, E. (1999) Statement on the Explosive Properties of chlormequat chloride 750
g/L. Project Number: 263879. Unpublished study prepared by Notox B.V. 11 p.
47100514
Kastel, R. (2001) Shelf Life in Original Container of the Formulation BAS 062 03
W: 24 Months Storage-Physical Properties: (Chlomequat Chloride Technical): Final
Report. Project Number: PCF02037, DOCID/2001/1014616, CF/P/038/5.
Unpublished study prepared by BASF Aktiengesellschaft. 19 p.
47100515
Daum, A. (2000) UV-, NMR-, IR-, MS-Spectra of chlormequat chloride (Reg. No.
24605, BAS 062W): Final Report. Project Number: PCP05668,
DOCID/2000/1013489, 2000/103/C13. Unpublished study prepared by BASF
Aktiengesellschaft. 19 p.
47115300
Taminco, N.V (2007) Submission of Product Chemistry Data in Support of the
Application for Registration of chlormequat chloride Technical. Transmittal of 2
Studies.
47115301
Kastel, R. (2007) Surface Tension, Density and Vapour Pressure of Chlormequat-
Chloride (PAI): Final Report. Project Number: PCF02277, CF/P/014/13, CF/P/065/6.
Unpublished study prepared by BASF Ag Research Station (Basf Aktieng). 16 p.
47115302
Ohnsorge, U. (2006) Dissociation Constant of chlormequat chloride . Project
Number: 2001/1006083. Unpublished study prepared by BASF Ag Research Station
(BASF Aktiengesellshaft). 6 p.
93001000
American Cyanamid Company (1990) Reregistration Phase 3 Response: Chloroethyl
trimethyl ammonium chloride.
93001999
American Cyanamid Company (1990) Reregistration Phase 3 Response: Chloroethyl
trimethyl ammonium chloride. Correspondence and Supporting Material.
57
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Appendix E. Product Data Call-In (PDCI)
58
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Appendix F. EPA's Batching of chlormequat chloride Products for Meeting Toxicity Data
Requirements for Reregistration
EPA'S BATCHING OF CHLORMEQUAT CHLORIDE 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 CHLORMEQUAT
CHLORIDE as the active ingredient, the Agency has batched products which can be considered
similar for purposes of acute toxicity. Factors considered in the sorting process include each
product's active and inert ingredients (identity, percent composition and biological activity), type
of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and
labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the Agency
is not describing batched products as "substantially similar" since some products within a batch
may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwith-standing the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute 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.
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In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the
choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to
participate in a batch does not preclude other registrants in the batch from citing his/her studies
and offering to cost share (Option 3) those studies.
Four products were found which contain Chlormequat chloride as the active ingredient. These
products have been placed into two batches in accordance with the active and inert ingredients
and type of formulation.
Batching Instructions:
NOTE: The technical acute toxicity values included in this document are for informational
purposes only. The data supporting these values may or may not meet the current acceptance
criteria.
Batch 1
EPA Reg. No.
241-256
81959-11
Percent Active Ingredient
63.0
63.0
Batch 2
EPA Reg. No.
241-74
81959-12
Percent Active Ingredient
11.8
11.8
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Appendix G. List of Available Related Documents and Electronically Available Documents
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/forms/
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out
on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing
policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing
Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail atwilliams.nicole@epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
Application for Pesticide
Registration/ Amendment
Confidential Statement of Formula
Notice of Supplemental Registration
of Distribution of a Registered
Pesticide Product
Application for an Experimental Use
Permit
Application for/Notification of State
Registration of a Pesticide To Meet a
Special Local Need
Formulator's Exemption Statement
Certification of Compliance with
Data Gap Procedures
Pesticide Registration Maintenance
Fee Filing
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.sov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.sov/opprd001/forms/8570-17.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www.epa.sov/opprd001/forms/8570-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
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8570-32
8570-34
8570-35
8570-36
8570-37
Certification of Attempt to Enter into
an Agreement with other Registrants
for Development of Data
Certification with Respect to
Citations of Data (PR Notice 98-5)
Data Matrix (PR Notice 98-5)
Summary of the Physical/Chemical
Properties (PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (PR
Notice 98-1)
http://www.epa.sov/opprd001/forms/8570-32.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
S.odf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
S.odf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.odf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
Pesticide Registration Kit
Dear Registrant:
www. epa. sov/pesticides/resistrationkit/
For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food,
Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act
(FQPA)of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.sov/opppmsdl/PR Notices
3. Pesticide Product Registration Application Forms (These forms are in PDF format and
will require the Acrobat reader).
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
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d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require
the Acrobat reader).
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
(PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional
sources of information. These include:
1. The Office of Pesticide Programs' website.
2. The booklet "General Information on Applying for Registration of Pesticides in the
United States", PB92-221811, available through the National Technical Information
Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service does charge
a fee for subscriptions and custom searches. You can contact NPIRS by telephone at
(765) 494-6614 or through their website.
4. The National Pesticide Telecommunications Network (NPTN) can provide information
on active ingredients, uses, toxicology, and chemistry of pesticides. You can contact
NPTN by telephone at (800) 858-7378 or through their website: ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or
petitioner encloses with his submission a stamped, self-addressed postcard. The postcard
must contain the following entries to be completed by OPP:
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• Date of receipt;
• EPA identifying number; and
• Product Manager assignment.
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date
of receipt and provide the EPA identifying file symbol or petition number for the new
submission. The identifying number should be used whenever you contact the Agency
concerning an application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly
coded and assigned to your company, please include a list of all synonyms, common and
trade names, company experimental codes, and other names which identify the chemical
(including "blind" codes used when a sample was submitted for testing by commercial or
academic facilities). Please provide a chemical abstract system (CAS) number if one has
been assigned.
Documents Associated with this RED
The documents listed in Appendix C are part of the Administrative Record for this RED
document and may be included in the EPA's Office of Pesticide Programs Public Docket. Copies
of these documents may also be obtained by contacting the person listed on the respective
Chemical Status Sheet.
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Appendix H. Data Required to Support the Outdoor Uses of Chlormequat Chloride
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
\> WASHINGTON, DC 20460
§
office c*
HKWMIlON.PKtWHBMID
TOMCSUBSTANCIS
Khalid H. Akkari
Regulatory Manager "OV I 5 2006
BASF Corporation
26 Davis Drive
Research Triangle Park, NC 27709
Subject: CYCOCEL Plant Growth Regulator
EPA Reg. No, 241-74
Amendment dated 6/16/04; resubmissions 12/15/05, 7/5/06 and 10/30/06
EPA Decision Number 345462
Dear Dr. Akkari:
The amended label referred to above that adds shadehouses and nurseries to the accepted uses,
submitted in connection with registration under the Federal Insecticide, Fungicide and
Rodenticide Act as amended, is acceptable provided the following change is made:
1, In the first paragraph of the section "Conditions of Sale and Warranty", change "All such
risks shall be assumed by the Buyer." to "To the extent consistent with applicable law, all
such risks shall be assumed by the Buyer."
In addition, you must submit the following conditional data to support the shadehouse and
nursery uses before the due date of June I, 2009:
1. Freshwater Fish Early Life Stage - Bluegill (72-4C, 850.1400)
2. Avian reproduction - Duck (71-4B, 850.2300)
3. Hydrolysis (161-1)
4. Photolysis in water (161 -2)
5. Soil Metabolism — anaerobic (162-2)
In addition, the Agency may require that you submit the following conditional data:
6. Bobwhite quail reproduction study (71-4A, 850.2300) may be required later depending
on the duck reproduction results.
7. Terrestrial field dissipation (164-1) may be required depending on results of the technical
review of MRIDs 124060 and 137650(DP333237).
One copy of the labei stamped "Accepted with comments" is enclosed for your records. This
label supersedes all labels previously accepted for this product. Please submit one copy of the
final printed label that incorporates the required changes before the product is released for
shipment.
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EPA Reg. No. 241-74
CYCOCEL Plant Growth Regulator
Page 2 of2
If you have any questions, please contact Robert Westin by phone at (703) 305-5721 or via email
at westin.robert@epa.gov.
Sincerely,
Tony Kish
Product Manager (22)
Fungicide Branch
Registration Division (7505P)
Enclosure
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