>EPA
UnMrfi
EnviroAiMnul ProtMiwi
Agency
OfflM*
PMicidM and Toxic
WMhingtoitOC 2M60
Septenter 1988
540/RS-88-115
Guidance for the
Reregistration of
Pesticide Products
Containing 2,4-DICHLORO
PHENOXYACETIC ACID
as the Active Ingredient
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OMB Control No. 2070-0057
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
2,4-DICHLOROPHENOXYACETIC ACID
(2,4-D)
AND ITS SALTS, AMINES AND ESTERS
AS THE ACTIVE INGREDIENT
CAS REGISTRY NO. 94-75-7
OPP CHEMICAL CODE 030001 (ACID)
EPA CASE NUMBER — GS-0073
SEPTEMBER 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, B.C. 20460
U.S. Ivnvlrnr "-+--1 Pr-'-tnotlon Agency
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£!• ' ;... '\ . •••::• i i;v,.--^^c, JAOOIQ 1670
Chioa«o, 1L 60604
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TABLE OF CONTENTS
Page
I. INTRODUCTION 1
II. CHEMICAL COVERED BY THIS STANDARD 4
A. Description of Chemicals 4
B. Use Profile 8
C. Background 9
III. AGENCY ASSESSMENT 11
A. Summary 11
B. Toxicological Assessment 12
C. Other Science Findings 17
D. Tolerance Assessment 23
IV. REGULATORY POSITION AND RATIONALE 25
A. Regulatory Positions and Rationales 25
B. Criteria for Registration 30
C. Acceptable Ranges and Limits 30
D. Labeling 31
V. PRODUCTS SUBJECT TO THIS STANDARD 37
A. Manufacturing-Use Products (Sole Active) ... 37
B. Manufacturing-Use Products (Multiple Active) . 37
C. End-Use Products (Sole Active) 38
D. End-Use Products (Multiple Active) 38
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA .... 39
A. What are generic data? 39
B. Who must submit generic data? 39
C. What generic data must be submitted? 40
D. How to comply with DCI requirements 40
E. Registrant requests regarding data
requirements and Agency procedures 43
F. Test protocols and standards 43
G. Procedures for requesting a change in
testing protocols 43
H. Procedures for requesting extensions
of time 44
I. Data format and reporting requirements .... 44
J. Existing stocks provisions upon
suspension or cancellation 44
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT SPECIFIC
DATA 47
VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING . . 47
i
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IX. INSTRUCTIONS FOR SUBMISSION 48
A. Manufacturing-Use Products (Sole Active) ... 48
B. Manufacturing-Use Products (Multiple Active) . 49
C. End-Use Products (Sole Active) 49
D. End-Use Products (Multiple Active) 50
E. Intrastate Products 50
APPENDICES
I. DATA APPENDICES 51
Guide to Tables 52
Table A 55
Table B 102
II. LABELING APPENDICES 107
Laberl Contents 108
40 CFR 156.10 Labeling Requirements 118
Physical/Chemical Hazards Labeling Statements . . . 129
Storage Instructions 130
Pesticide Disposal Instructions 131
Container Disposal Instructions 133
III. BIBLIOGRAPHY APPENDICES 134
Guide to Bibliography 135
Bibliography 137
IV. FORMS APPENDICES 171
EPA Form 8580-1 - FIFRA 3(c)(2)(B) Summary Sheet . . 172
EPA Form 8580-6 - Certification of Attempt to Enter
Into an Agreement With Other Registrants for
Development of Data 173
EPA Form 8580-4 - Product-Specific Data Report . . . 174
EPA Form 8570-27- Generic Data Exemption Statement . 176
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI: Acceptable Daily Intake - an acceptable daily
intake of pesticide residue based on a complete
data base.
a.i.: Active ingredient
CAS: Chemical Abstract Services (number)
Core Classification: A general guide to the acceptability of
data for the purpose of supporting registration:
Guideline - studies which satisfy Agency data
requirements;
Minimum - studies which are acceptable to support
registration of pesticide products but were not
necessarily done according to Agency guidelines;
Supplementary - studies which are scientifically
sound, thus information may be useful; however, the
studies were performed under conditions that
deviated substantially from recommended protocols.
Studies do not meet guidelines requirements and
thus do not support registration of a product; and,
Invalid - studies which are deficient in some vital
parameter or which have been judged not to be
scientifically sound or whose reliability is
seriously questioned.
CSF: Confidential Statement of Formula
EEC: Estimated Environmental Concentration - estimated
pesticide concentration in the environment
(terrestrial or aquatic ecosystem).
EPA: The U.S. Environmental Protection Agency (Agency)
FIFRA: Federal Insecticide, Fungicide and Rodenticide Act
LC50: Median lethal concentration - a statistically
derived concentration of a substance that can be
expected to cause death in 50 percent of test
animals, expressed as weight or volume of test
substance per volume of air or water or per weight
of feed (e.g., mg/1 or ppm).
LD50: Median lethal dose - a statistically derived single
dose that can be expected to cause death in 50
percent of test animals when administered by the
iii
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LOEL:
MPI:
MRID:
MP:
NPDES:
NOEL:
OPP:
OES:
PHI:
PPM:
RfD:
Technical:
TMRC:
route indicated, expressed as weight of substance
per unit weight of test animal (e.g., mg/kg).
Lowest Observed Effect Level
Maximum Permissible Intake
Master Record Identification (number) - EPA's
system of tracking studies used in support of
registration.
Manufacturing-use product
National Pollution Discharge Elimination System
No Observed Effect Level - the maximum dose used
in a test which produces no observed adverse
effects.
The Office of Pesticide Programs of the U.S. EPA
The Office of Endangered Species, U.S. Fish and
Wildlife Service
Preharvest Interval
Parts per million
Reference Dose
: Active ingredient as manufactured
Theoretical Maximum Residue Contribution - an
estimate of dietary exposure obtained by
multiplying residue tolerance levels for a given
pesticide by the average daily per capita food
consumption figure then adding the exposure figures
for each crop. TMRC is usually expressed in terms
of mg ai/day, assuming a 60 kg person.
IV
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be
reviewed and standards set for compliance with FIFRA. The
standards are applicable to reregistration and future
applications for registration of products containing the same
active ingredient. Each registrant of a product containing
an active ingredient subject to this Standard who wishes to
continue to sell or distribute that product must bring his
product and labeling into compliance with FIFRA, as
instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA
identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to
protect man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request1, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and
•'-The scientific reviews and Compendium of Uses may be
obtained from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield,
VA 22161. Tel: (703) 487-4650.
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conclusions from available data in its files pertaining to
the pesticide active ingredient. However, during the review
of these data the Agency is also looking for potential
hazards that may be associated with the end use products that
contain the active ingredient. The Agency will apply the
provisions of this Registration Standard to end use products
if necessary to protect man and the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their
registrations in compliance with FIFRA. These steps may
include:
1. Submission of data in support of product
registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154 to
examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency may
propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI)
provisions of FIFRA sec. 3(c)(2)(B) to require that
registrants submit data to answer our questions regarding the
chemical, toxicological, and environmental characteristics
and fate of a pesticide. This Registration Standard lists
the data EPA believes are necessary to resolve our concerns
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about this pesticide. These data are listed in the Tables A,
B, and C. in Appendix I. Failure to comply with the DCI
requirements enumerated in this Registration Standard may
result in issuance by EPA of a Notice of Intent to Suspend
the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2)
requires them to submit factual information concerning
possible unreasonable adverse effects of a pesticide at any
time that they become aware of such information. Registrants
must notify the Agency of any information, including interim
or preliminary results of studies, if that information
suggests possible adverse effects on man or the environment.
This requirement is independent of the specific time
requirements imposed by EPA for submission of completed
studies called in by the Agency and continues as long as the
products are registered under FIFRA.
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II. CHEMICALS COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICALS
This Standard covers 2,4-dichlorophenoxyacetic acid
(2,4-D)f and its inorganic salts, amines and esters.
Most often, the acid is not formulated as an end-use
product; instead the typical end-use product, as applied, is
usually a formulation of an amine or ester of the parent
compound. With these formulations, the esters or amines may
greatly influence the physical characteristics, biological
activity and environmental fate of the chemical. The Agency
has little or no data to evaluate the behavior of these
compounds in the environment. Therefore, the data
requirements in this Standard address not only the acid and
its inorganic salts but also the amine salts and esters.
Identifying characteristics, codes and structures are
shown below:
Chemical Name: 2,4-D acid
Empirical Formula:
Molecular Weight: 221.0
CAS Registry Number: 94-75-7
OPP Chemical Code: 030001
Chemical Name: Lithium salt
Empirical Formula: C8H5Cl2Li03
Molecular Weight: 227 (estimate)
CAS Registry Number: 3766-27-6
OPP Chemical Code: 030002
Chemical Name: Sodium salt
Empirical Formula: Cgl^C^NaC^
Molecular Weight: 243.03 (anhydrous)
CAS Registry Number: 2702-72-9
OPP Chemical Code: 030004
Chemical Name: Ammonium salt
Empirical Formula:
Molecular Weight: 238.07
CAS Registry Number: 2707-55-3
OPP Chemical Code: 030005
Chemical Name: Alkanolamine salt (of the ethanol and iso-
propanol series - a mixture of compounds described
under OPP chemical code numbers 030021 and 030024)
Empirical Formula: Combination
Molecular Weight: Combination
CAS Registry Number: NA
OPP Chemical Code: 030010
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Chemical Name: Alkylamine (C^) salt (formulated only
as an end-use product in combination with 2,4-D,
alkylamine (014) salt)
Empirical Formula: C2oH33Cl2N03
Molecular Weight: 406 (estimate)
CAS Registry Number: 2212-54-6
OPP Chemical Code: 030011
Chemical Name: Alkylamine (C14 salt (formulated only
as an end-use product in combination with C12 salt)
Empirical Formula: C22H37C12N03
Molecular Weight: 434 (estimate)
CAS Registry Number: 25685-18-9
OPP Chemical Code: 030013
Chemical Name: Alkylamine (derived from tall oil) salt
(tall oil is a by-product of the wood pulp industry
containing a mixture of rosin acids, oleic acid,
linoleic acid, and other compounds)
Empirical Formula: Complex mixture
Molecular Weight: Complex mixture
CAS Registry Number: NA
OPP Chemical Code: 030014
Chemical Name: Diethanolamine Salt
Empirical Formula:
Molecular Weight: 326.18
CAS Registry Number: 5742-19-8
OPP Chemical Code: 030016
Chemical Name: Diethylamine salt
Empirical Formula: C12H17C12N03
Molecular Weight: 294.18
CAS Registry Number: 20940-37-8
OPP Chemical Code: 030017
Chemical Name: Dimethylamine salt
Empirical Formula:
Molecular Weight: 266.13
CAS Registry Number: 2008-39-1
OPP Chemical Code: 030019
Chemical Name: N,N-dimethyloleylamine salt (formulated
only as an end-use product in combination with
2,4-D acid)
Empirical Formula: C28H47C12NO3
Molecular Weight: 516 (estimate)
CAS Registry Number: 53535-36-7
OPP Chemical Code: 030020
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Chemical Name: Ethanolamine salt
Empirical Formula: CiQH13cl2N04
Molecular Weight: 282.13
CAS Registry Number: 3599-58-4
OPP Chemical Code: 030021
Chemical Name: Heptylamine salt
Empirical Formula: C15H23C12N03
Molecular Weight: 336 (estimate)
CAS Registry Number: 37102-63-9
OPP Chemical Code: 030023
Chemical Name: Isopropanolamine salt
Empirical Formula:
Molecular Weight: 296.15
CAS Registry Number: 6365-72-6
OPP Chemical Code: 030024
Chemical Name: Isopropylamine salt
Empirical Formula: C11H15C12N03
Molecular Weight: 280.04
CAS Registry Number: 5742-17-6
OPP Chemical Code: 030025
Chemical Name: Morpholine salt
Empirical Formula: C^2H15C12N04
Molecular Weight: 308.16
CAS Registry Number: 6365-73-7
OPP Chemical Code: 030028
Chemical Name: N-oleyl-1,3-propylenediamine salt
Empirical Formula:
Molecular Weight: 766.6
CAS Registry Number: 2212-59-1
OPP Chemical Code: 030029
Chemical Name: Octylamine salt
Empirical Formula: C^6H25Cl2N03
Molecular Weight: 350 (estimate)
CAS Registry Number: 2212-53-5
OPP Chemical Code: 030030
Chemical Name: Triethanolamine salt
Empirical Formula:
Molecular Weight: 3770.23
CAS Registry Number: 2569-01-9
OPP Chemical Code: 030033
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Chemical Name: Triethylamine salt
Empirical Formula:
Molecular Weight: 322.23
CAS Registry Number: 2646-78-8
OPP Chemical Code: 030034
Chemical Name: Triisopropanolamine salt
Empirical Formula: C17H27C12N06
Molecular Weight: 412.31
CAS Registry Number: 32341-80-3
OPP Chemical Code: 030035
Chemical Name: N,N-dimethyloleyl-linoleylamine salt
Empirical Formula: Not determined
Molecular Weight: Not determined
CAS Registry Number: 55256-32-1
OPP Chemical Code: 030039
Chemical Name: Butoxyethoxypropyl ester
Empirical Formula:
Molecular Weight: 379.28
CAS Registry Number: 1928-57-0
OPP Chemical Code: 030052
Chemical Name: 2-butoxyethyl ester
Empirical Formula:
Molecular Weight: 321.20
CAS Registry Number: 1929-73-3
OPP Chemical Code: 030053
Chemical Name: Butoxypropyl ester
Empirical Formula:
Molecular Weight: 335.24
CAS Registry Number: 1928-45-6
OPP Chemical Code: 030055
Chemical Name: Butyl ester
Empirical Formula: C12H14C12°3
Molecular Weight: 277.16
CAS Registry Number:94-80-4
OPP Chemical Code: 030056
Chemical Name: Isobutyl ester
Empirical Formula: C12H14C12°3
Molecular Weight: 277.15
CAS Registry Number: 1713-15-1
OPP Chemical Code: 030062
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Chemical Name: isooctyl (2-ethylhexyl) ester
Empirical Formula: Ci6H22cl2°3
Molecular Weight: 333.27
CAS Registry Number: 1928-43-4
OPP Chemical Code: 030063
Chemical Name: Isooctyl (2-ethyl-4-methylpentyl) ester
Empirical Formula:
Molecular Weight: 333.27
CAS Registry Number: 53404-37-8
OPP Chemical Code: 030064
Chemical Name: Isooctyl (2-octyl) ester
Empirical Formula: C16H22C12°3
Molecular Weight: 333.27
CAS Registry Number: 1917-97-1
OPP Chemical Code: 030065
Chemical Name: Isopropyl ester
Empirical Formula: cnHi2cl2(-)3
Molecular Weight: 263.12
CAS Registry Number: 94-11-1
OPP Chemical Code: 030066
Chemical Name: Propylene glycol butyl ether ester
Empirical Formula: C15H20C12°4
Molecular Weight: 335.24
CAS Registry Number: 1320-18-9
OPP Chemical Code: 030072
B. USE PROFILE
Type of Pesticide: Herbicide; Plant Growth Regulator.
Pests Controlled: Broadleaf weeds; grasses and other
monocots; woody plants; aquatic weeds; and nonflowering
plants.
Registered Uses: Terrestrial, food and nonfood; aquatic,
food and nonfood; domestic; and forestry.
Predominant Uses: Postemergent weed control in agricultural
crops (approximately 57 percent of total usage; over 45
percent of total usage is on wheat and corn; 20 percent
of total usage on pastures and rangelands; other major
crops are sorghum, other small grains, rice and
sugarcane); the remainder is used on noncrop areas, with
a small amount used as a plant growth regulator (in
filberts, citrus and potatoes).
Mode of Activity: 2,4-D acid stimulates nucleic acid and
protein synthesis affecting the activity of enzymes,
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respiration and cell division. Broadleaf plants exhibit
malformed leaves, stems and roots.
Formulation Types Registered: Granular; amine and ester
liquids; and aerosol spray (foam).
Methods of Application: Aerial and ground equipment,
knapsack sprayers, pressure and hose-end applicators,
and lawn spreaders.
C. BACKGROUND
In 1979 and 1980, the Agency conducted a review of the
toxicological studies supporting the registration of 2,4-D and
concluded from the studies that continued use of this product
would not pose a significant hazard to public health or the
environment. However, the Agency determined that additional
toxicological data were needed and, in a 1980 Data Call-in (DCI),
required the registrants to submit additional studies. Since
that time, these studies have been received and reviewed by EPA.
The Agency also reviewed a number of epidemiologic studies,
including a new study conducted by the National Cancer Institute
(NCI) and the University of Kansas published in 1986, in which
the researchers found a correlation between the use by farmers of
phenoxy herbicides, including 2,4-D, and an increased cancer risk
(non-Hodgkin's lymphoma) among farmers handling such herbicides.
Based on the epidemiologic evidence, in September 1986, the
Agency issued a preliminary notification of special review to the
registrants of 2,4-D, 2,4-DB and 2,4-DP. The special review
process is a mechanism for evaluating and weighing the risks and
benefits of a pesticide to determine whether the pesticide and
its uses pose unreasonable adverse risks to humans and the
environment.
Subsequent to the issuance of the preliminary notification,
the epidemiologic evidence underwent further review by the
Agency's Office of Pesticide Programs (OPP), by three epidemio-
logists, two of whom are national experts on epidemiology, and by
the FIFRA Scientific Advisory Panel (SAP) (a committee of
scientific experts from outside EPA). Based on these further
reviews, OPP concluded that, although the accumulated evidence in
humans implicated the phenoxy herbicides as potential risk
factors, the evidence for 2,4-D alone was inadequate.
Furthermore, OPP determined that the oncogenicity studies
submitted in response to the 1980 DCI did not achieve a maximum
tolerated dose. Therefore, the studies were considered
inadequate to assess the oncogenic potential of 2,4-D. The
Agency has, however, since requested that the pathology slides be
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submitted for an independent evaluation before reaching a final
conclusion regarding the acceptability of these studies.
Given that the available epidemiologic evidence and animal
toxicological data were judged as inadequate to classify 2,4-D
with respect to carcinogenicity, and in accordance with the
Agency's Guidelines for Assessing Carcinogenic Risk, OPP
classified 2,4-D as a Group D compound (not classifiable as to
human carcinogenicity). The Carcinogen Assessment Group (CAG),
of the Office of Research and Development (ORD), considered the
epidemiologic evidence as stronger (limited evidence of human
carcinogenicity) than did OPP but deferred its decision regarding
the classification of 2,4-D until additional epidemiologic data
are received and evaluated. The NCI has two other epidemiologic
studies underway that will assess herbicides, in general, and
2,4-D specifically as to potential cancer associations. These
studies are expected to be completed in the near future. CAG,
OPP and other interested program offices will review the upcoming
investigations to reach an Agency position on the carcinogenicity
of 2,4-D.
The Agency also proposed that special review for 2,4-D,
2,4-DB, and 2,4-DP is not appropriate at this time (53 FR 9590,
March 23, 1988). Final action will not be taken on this
proposal until the Agency Jias reviewed the additional
epidemiologic data and reached a conclusion regarding the
oncogenicity studies.
In addition, as part of the Agency's strategy on dioxins,
EPA issued a DCI Notice in June 1987 requiring registrants to
analyze their 2,4-D products for certain halogenated dibenzo-p-
dioxin or dibenzofuran (HDD and HDF) contaminants. This Notice
was issued based on the Agency's assumption that, because of the
chemical structure, class and certain manufacturing and process-
ing conditions, 2,4-D products could be contaminated with HDDs or
HDFs.
EPA has long recognized the potential public health and
environmental significance of 2,3,7,8-tetrachlorodibenzo-p-dioxin
(2,3,7,8-TCDD) which has lethal effects at exceptionally low
doses to aquatic organisms, birds, and some mammals. It has been
shown to be carcinogenic, teratogenic, and fetotoxic in experi-
mental animals and is acnegenic in humans. EPA also recognizes
the potential health significance of a variety of HDDs and HDFs
that are structurally related to 2,3,7,8-TCDD. While
2,3,7,8-TCDD has not been found in 2,4-D at levels analyzed to
date, structurally related HDD and HDF contaminants have been
reported.
Draft protocols for analyzing the pesticide have been
submitted. EPA is evaluating the proposed methods to determine
whether they meet the requir-ements specified in the DCI Notice.
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III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed available data submitted to
support registration of 2,4-D products. The reviewed data
are basically those studies available to the Agency as of
February 20, 1987; in the case of toxicology data, all
available data have been included. Based on the review of
these data, EPA has reached the conclusions set forth in this
Standard. A summary of those conclusions follows.
Additional discussion is contained in the remainder of this
Chapter.
1. When 2,4-D is formulated as an ester or amine, the
physical characteristics, biological activity and fate
in the environment may be affected. EPA has little or
no data to evaluate the effects of the ester or amine
forms of 2,4-D. Therefore, the data requirements
imposed by this Standard include testing for the 2,4-D
esters and amines as well as the acid.
2. OPP has classified 2,4-D as a Group D oncogen (not
classifiable as to human carcinogenicity) because the
existing data are not adequate to assess the
carcinogenic potential of 2,4-D. Additional information
and data are required before a final classification of
2,4-D can be determined.
3. While published data indicate that 2,4-D may be
teratogenic, an acceptable rat study is negative. An
additional study in rabbits is required.
4. Several instances of accidental human poisoning with
2,4-D through dermal exposure, which has resulted in
severe neurotoxicity, have been reported. Data are
required to assess the neurotoxicity of 2,4-D.
5. Residues of 2,4-D have been detected in groundwater,
mostly from point sources. Although laboratory data
demonstrate that 2,4-D is mobile in soils, its potential
to contaminate groundwater is limited by its rapid rate
of degradation and uptake by target plants. Additional
data and a label warning are required.
6. Certain formulations of 2,4-D are highly toxic to fish
and/or aquatic invertebrates. Other formulations, for
which the Agency has data, are in the range of
moderately toxic to practically nontoxic to nontarget
organisms.
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7. The Office of Endangered Species has determined that
certain uses of 2,4-D may jeopardize the continued
existence of endangered species or critical habitat of
certain endangered species.
As a result of this review, the Agency has identified
missing data necessary to further evaluate the environmental
and human risks associated with the use of 2,4-D. These data
must be submitted in order to maintain registration of
products or to register new products containing 2,4-D. These
data are listed in the Data Tables contained in Appendix I.
The Agency has also determined that certain label
restrictions or revisions are necessary, in order for 2,4-D
products to remain in compliance with FIFRA. The Labeling
section of this Standard contains the specific language
required for each of the statements.
B. TOXICOLOGICAL ASSESSMENT
This section discusses acceptable data available to the
Agency for 2,4-D. From a toxicological standpoint, the acid
and its inorganic salts can be considered essentially
identical. The amines and esters, however, are significantly
different and, lacking data to indicate otherwise, may be
expected to have different qualitative and/or quantitative
toxicological properties.
The major exposure to these compounds is during
application. Considering the common 2,4-D moiety in each
compound, it could be expected that the 2,4-D portion of each
molecule would be released during use. Thus, exposure would
be to 2,4-D regardless of which 2,4-D compound is used. This
expectation has particular validity if it serves to identify
a serious toxicological problem with 2,4-D. If, for example,
such a problem is identified, it is likely that all 2,4-D
compounds will share this toxicity. However, if such a
problem is not identified with 2,4-D, this does not preclude
the possibility that one or more of the organic amines and/or
esters does have such a problem.
Toxicological data for the acid, and for each amine and
ester, are considered necessary to determine if the toxicity
of these organic amines and esters differ significantly from
the acid and from each other, and whether these toxic effects
constitute an unacceptable risk to applicators.
Except as noted, the studies discussed below pertain to
the 2,4-D acid.
ACUTE TOXICITY STUDIES. 2,4-D acid is of low oral,
dermal and inhalation toxicity (Toxicity Category III). It
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is not a dermal sensitizer. No data are available on eye and
dermal irritation.
Acute studies are available on a manufacturing use
product of 2,4-D diethanolamine salt. These studies show low
toxicity (Toxicity Categories III and IV) for the oral,
dermal, and inhalation routes of exposure and for dermal
irritation. The compound is not a dermal sensitizer. Data
show, however, that this compound produced signs of severe
irritation and corneal ulcer which was not resolved 21 days
after treatment and is, therefore, considered a Toxicity
Category I compound for eye irritation.
Acute oral and dermal toxicity studies of the isooctyl
and isobutyl esters of 2,4-D show a low order of toxicity
(Toxicity Category III).
Acute oral data show the 2,4-D isopropyl ester to be a
Toxicity Category II compound while dermal, inhalation and
eye and dermal irritation studies show a low toxicity
(Toxicity Categories III and IV). Isopropyl ester is not a
dermal sensitizer.
Data on 2,4-D butoxyethyl ester show low toxicity
(Toxicity Category III) for oral, dermal, inhalation and
primary eye and dermal irritation. The compound was found to
be a dermal sensitizer in two studies while a third indicated
no dermal sensitization.
SUBCHRONIC TOXICITY STUDIES. Supplementary studies in
rats and mice indicate that the most sensitive effect was in
the kidneys. Effects consisted of increased homogeneity and
altered tinctorial properties of the cytoplasm and decreased
intracellular/intraluminal vacuolization in the cortex. The
lowest observed effect level (LOEL) for both species was l
mg/kg/day, the lowest dose tested.
CHRONIC TOXICITY/ONCOGENICITY STUDIES. In a two-year
oncogenicity study in mice, effects were seen in absolute
and relative kidney and adrenal weights at 15 mg/kg/day and
45 mg/kg/day, the highest dose tested. Histopathology
revealed an increase in the mid- and high-dose groups in
cytoplasmic homogeneity of the renal tubular epithelium due
to a reduction of cytoplasmic vacuoles. The no observed
effects level (NOEL) for systemic effects was 1 mg/kg/day and
the LOEL was 15 mg/kg/day.
In a two-year chronic/oncogenicity study in rats,
compound related effects (increased tubular brown pigment and
vacuolization of the cytoplasm of the cortex) were observed
in the kidneys of males and females. The LOEL for systemic
effects was 5 mg/kg/day and the NOEL was 1 mg/kg/day.
13
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A review of the one-year interim sacrifice data from the
rat and mouse studies indicated minimal toxicity at the
highest dose tested (45 mg/kg/day). Increased kidney weights
were observed in the high dose male rats and high dose female
mice but even fewer kidney effects were seen at the highest
dose after 52 weeks than had been evident at the same dose in
the subchronic studies.
Based on available information, the Agency believes that
neither the rat nor the mouse study reached a maximum
tolerated dose (MTD). However, the Agency believes an
independent evaluation of the kidney slides is appropriate
before reaching a conclusion regarding the acceptability of
these studies.
TERATOLOGY STUDIES. A teratogenicity study in rats was
negative for teratogenic effects at the highest dose tested,
75 mg/kg/day. In this study, the test compound was
administered by gavage to Fischer 344 female rats on days 6-
15 of gestation at doses of 0, 8, 25 or 75 mg/kg/day. Twenty
seven to thirty females per group were pregnant. Maternal
toxicity was not observed at the highest dose tested;
fetotoxicity, consisting of delayed ossification, was seen at
the highest dose tested. The NOEL was 25 mg/kg/day. An
additional study in the rabbit is required.
A teratology study of 2,4-dichlorophenol, a metabolite
of 2,4-D, showed no teratogenic effects at 750 mg/kg/day, the
highest dose tested. In this study, the test compound was
administered by gavage to Fischer 344 female rats on days 6-
15 of gestation at doses of 0, 200, 375, or 750 mg/kg/day.
Maternal toxicity, consisting of depressed weight gains, was
observed at 750 and 375 mg/kg/day; the NOEL was 200
mg/kg/day. Fetotoxicity, identified as delayed ossification,
was observed at 750 mg/kg/day; the NOEL was 350 mg/kg/day.
REPRODUCTION STUDIES. In a dietary two-generation
reproduction study in rats, toxicity consisted of reduced pup
weight at birth and during lactation at 20 mg/kg/day with a
NOEL of 5 mg/kg/day. Toxic effects to the adult females
consisted of statistically significant weight depression
during the four weeks prior to sacrifice but after weaning
the F2b pups, at 20 mg/kg/day with a NOEL of 5 mg/kg/day.
Histopathology identified kidney tubule degeneration in the
adult F0 males at 80 mg/kg/day and to a lesser degree in the
adult FQ and F^ adult males dosed at 20 mg/kg/day, with a
NOEL of 5 mg/kg/day. No effects were seen on fertility in
the FQ or F^ males or females.
MUTAGENICITY AND METABOLISM STUDIES. No data are
available on the mutagenic potential or metabolism of 2,4-D.
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NEUROTOXICITY STUDIES. The only available
neurotoxicity study, one performed with the dimethylamine
salt of 2,4-D, did not show neurotoxic effects. This study,
however, has significant deficiencies and cannot be used for
evaluation of the chemical's neurotoxicity. Additional data
are required.
HUMAN EXPOSURE
Epidemiology Studies. In a population-based case
control study conducted by the National Cancer Institute in
Kansas (NCI), a relationship was found between farm herbicide
use (phenoxyacetic acids) and non-Hodgkin's lymphoma but not
between herbicide use and soft tissue sarcoma or Hodgkin's
disease.
Although the Agency has concluded that this study was
well conducted and served as a good basis for a hypothesis of
a non-Hodgkin's lymphoma and phenoxy herbicide association,
the Agency has concerns about the study. Some of the key
areas of concern are lack of appropriate controls, exposure
to multiple chemicals and insufficient information on actual
exposure to 2,4-D. Because of these numerous areas of
uncertainty, the Agency has not finalized its position
regarding 2,4-D as the causative agent in the non-Hodgkin's
lymphoma cases. In addition, another NCI study, published in
1987, on 2,4-D use by farmers in Western Washington does not
confirm the Kansas study's conclusions.
A number of other epidemiologic studies pertaining to
2,4-D were found inappropriate for assessing cancer risk for
2,4-D users. However, NCI has two other epidemiology studies
underway which will assess herbicides in general and 2,4-D
specifically as to potential cancer associations. These
studies are expected to be completed in the near future.
Incident Reports. Accidental human poisoning with
2,4-D, which resulted in severe neurotoxicity, has been
reported. Reports available to the Agency involve three
individuals accidentally exposed to an unidentified 2,4-D
ester formulation, one individual exposed to 2,4-D
dimethylamine salt and another exposed to a formulation
containing 5.4 percent picloram and 20.9 percent 2,4-D
isopropanolamine. All reports involved dermal exposure; in
each case, neuropathy was reported following the accidental
exposure and most reported slow recovery with some
irreversible damage.
Statistical reports available to the Agency covering
mortalities, hospitalizations and physician-treated poisoning
provide the following information on 2,4-D:
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Mortalities - During the years all accidental
deaths due to pesticides were counted (1961, 1969,
1973, 1974), there were no deaths attributed to
2,4-D.
Hospitalizations - Based on a 12 percent sample of
the nation's hospitals, 2,4-D was estimated to have
caused an average of 12 hospitalizations each year
during 1971-76, or 0.4 percent of the total
pesticide poisoning hospitalizations. During 1974,
2,4-D was associated with 0.1 occupational
hospitalizations per 1 million pounds reported
used in agriculture. The average ratio of
poisonings for all pesticides was 0.9 cases per
million pounds reported in use.
Physician-Treated Poisonings - California, the only
state which enforces mandatory reporting of
occupational pesticide incidents, reported an
average of one physician-treated 2,4-D poisoning
each year from 1980 through 1986. An additional
3.1 cases per year were reported as either due to
skin or eye injury.
Worker Exposure. Studies from the published literature
were reviewed to define worker exposure to 2,4-D.
Several factors were identified as affecting the
exposure of workers handling 2,4-D. Work activities appeared
to affect worker exposure, with mixer/loaders in general
receiving higher exposures than workers performing
application tasks. In addition, the use of protective
clothing, particularly protective gloves, coupled with good
hygienic practices appears to reduce worker exposure to
2,4-D. The contribution of respiratory exposure to total
worker exposure was judged by all investigators who measured
air concentrations of 2,4-D to be negligible, indicating that
the dermal route accounts for the major portion of worker
exposure. Amounts of 2,4-D excreted were also noted to be a
function of the duration of exposure and the application
rate.
The dermal exposures reported in these studies are as
follows:
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Application
Site
Worker
Exposure
Applicator
Applicator
Applicator
Mixer/Loader
Applicator
Pilot
Mixer/Loader
1With ordinary precautions
2With special precautions, including
protective gloves
Aquatic
Pasture
Nonerop
Grassland
Forestry
12 ug/kg/lb ai applied
<. 18 mg (hands)
30-52 ug/ft treated
8-486 ug/operation
10-191 mg/hr
5 ug/kg1
<0.1 ug/kg2
448 ug/kg-1-
22.2 ug/kg2
C. OTHER SCIENCE FINDINGS
ENVIRONMENTAL FATE. Available data are insufficient to
fully assess the environmental fate of 2,4-D. An ester or
amine derivative of 2,4-D may behave differently in the
environment. Only after the ester or amine derivative of
2,4-D acid degrades into the acid moiety is general data on
2,4-D applicable. The Agency needs environmental fate data
on each ester and amine as well as the acid itself.
The rate and completeness of the dissociation or
degradation reaction are essential to the development of the
environmental fate profile of each registered chemical
covered under this Standard. The required data will enable
the Agency to evaluate the process or processes involved in
the degradation of the amine and ester derivatives of 2,4-D,
as well as the fate of the degradates.
The only acceptable data available to the Agency is for
the parent 2,4-D. Based on that data, the following
conclusions can be made:
Under aerobic conditions, 2,4-D degrades rapidly in most
soils and is mobile to highly mobile in sand, silt, loam,
clay loam and sandy loam. However, in an aged residue study,
2,4-D was only slightly mobile. It appears that the compound
has an affinity to bind with organic matter over time. The
2,4-D degradates of ester and amine forms of 2,4-D can also
be expected to be mobile. The leaching potential of these
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2,4-D degradates will be affected by the rate of its
degradation of the ester and amine compounds and the binding
capacity of the soil and rate of degradation of 2,4-D acid.
Supplemental data, which do not fulfill requirements for
registration, indicate that residues of 2,4-D, per se, in
water systems from aquatic application reach a maximum
concentration within 1 day of application. These data
indicate that residues dissipate rapidly in moving water; in
still waters, such as ponds, lakes, and reservoirs, residues
of 2,4-D, per se, were detected as much as 6 months after
application. Supplemental octanol/water partition
coefficient data indicate low potential for 2,4-D, per se, to
accumulate in fish.
The Agency has no acceptable data on the ester or amine
forms of 2,4-D. However, supplemental data indicate that the
rate of degradation/dissociation of 2,4-D compounds to the
parent acid is variable. Rapid rate of dissociation of
dimethylamine salts and triethanolamine are reported.
Additionally, in moving water, dissipation of all 2,4-D
residues from addition of dimethylamine salt occurred in less
than l day. Conversely, in ponds, lakes and reservoirs,
residues of 2,4-D, per se, were detected in water as much as
6 months after treatment. In all cases, maximum 2,4-D
concentrations in water were reached within 1 day and
dissipated rapidly thereafter.
Data sumiuarized from the Pesticide Incident Monitoring
System, as reported below, indicate that 2,4-D is volatile
and may adversely affect non-target crops.
Groundwater. Available laboratory data indicate that
the parent 2,4-D is mobile in soils ranging in texture from
sand to clay loam. 2,4-D has been detected in about 100 of
at least 1700 samples of groundwater taken in nine states.
Positive samples were found in six of these states. Most of
the positive findings of 2,4-D in groundwater have been
associated with point sources. The highest concentration
found, believed to be from a point source, is 36.5 ppb
(ug/LJl. The highest nonpoint source (i.e., normal use
patterns and subsequent leaching) finding was 4.2 ppb with
most findings being less than 1.0 ppb.
The potential of 2,4-D to contaminate groundwater under
normal use conditions is limited by the rapid rate of
degradation, by binding to organic material in the soil, and
by uptake in the target plants. Limited data are available
on the rates of degradation of the various 2,4-D compounds.
The mobility of parent materials as well as rates of
formation and decline of the resultant 2,4-D will affect the
potential to contaminate groundwater.
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Reentry. Based on available toxicological data, 2,4-D
products are of low acute toxicity, generally falling in
Toxicity Categories III and IV. Because of these levels of
toxicity, reentry is not a concern.
Pesticide Incident Monitoring System (PIMS). Based on
the PIMS files, covering the period 1966 to 1979, reports
were received concerning the off-target movement of 2,4-D in
unspecified formulations, esters and amines. The incidents
involved drift from aerial (173 reports) and ground (104
reports) applications as well as volatilization and drift (35
reports) and resulted in damage to off-target crops or other
desirable plants.
ECOLOGICAL EFFECTS. Available data are insufficient to
completely evaluate the ecological effects of 2,4-D acid.
Data, as set forth in the data tables, are either required or
reserved pending further evaluation. However, the following
conclusions can be made based on available data:
Effects on Birds. Of the data available to the Agency,
only studies with 2,4-D acid and 2,4-D butyl ester are
acceptable in support of registration. These data report
toxicity values (LD50s) of >2000 mg/kg (Mallards) and 472
mg/kg (Pheasant) for 2,4-D acid, which indicates moderately
to practically nontoxic on an acute basis. Toxicity values
(LC50s and LD50s) of 10000 ppm (Mallards), 12979 ppm
(Bobwhite) and 4640 mg/kg (Mallards) are reported for the
butyl ester, which may be characterized as practically
nontoxic to avian species on an acute and chronic basis.
Effects on Fish. Based on studies available to the
Agency, 2,4-D acid and certain of its salts, esters and
amines can be characterized in the range of moderately toxic
to practically nontoxic to fish. However, the compounds N-
oleyl-1,3- propylenediamine salt, N,N-dimethyloleyl-
linoleylamine, butyl ester, butoxyethanol ester and propylene
glycol butyl ether ester can be characterized as highly toxic
to fish. The toxicity values (LC50s) reflected below are
from acceptable studies performed with the technical grade of
the test compound:
2,4-D acid 110 ppm (Salmo gairdneri
[rainbow trout])
180 ppm (Lepomis machchirus
[bluegill sunfish])
24.5-172 ppm (Salmo clarki
[cutthroat trout])
44.5-120 ppm (Salvelinus
namaycush [lake trout])
Lithium salt >180 ppm (bluegill sunfish)
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Sodium salt
Alkanolamine salt
Butyl ester
Isooctyl ester
Propylene glycol butyl
ether ester
>100 ppm (rainbow trout)
>180 ppm (bluegill sunfish and
rainbow trout)
0.49-2.82 ppm (cutthroat trout)
0.5-2.8 ppm (lake trout)
0.4-0.96 ppm (rainbow trout)
0.29-0.3 ppm (bluegill sunfish)
19.5 ppm (bluegill sunfish)
96 ppm (rainbow trout)
0.33-2.8 ppm (cutthroat trout)
0.39-2.93 ppm (lake trout)
0.95-1.44 ppm (rainbow trout)
0.56-0.67 ppm (bluegill
sunfish)
The toxicity values (LC50s) reflected below are from
acceptable studies performed with a formulated product:
Alkylamine salt
Diethanolamine salt
Dimethylamine
Isopropylamine salt
N-oleyl-1,3-
propylenediamine salt
Octylamine salt
N,N-dimethyloleyl-
linoleylamine
Butoxyethanol ester
Butoxypropyl ester
Isooctyl ester
Propylene glycol butyl
ether ester
3.93-9.4 ppm (bluegill sunfish)
6.1-15.7 ppm (rainbow trout)
1030 ppm (rainbow trout)
>100-395 ppm (Ictalurus
punctatus [channel
catfish])
>100-420 ppm (rainbow trout)
266-800 ppm (Pimephales
promelus [fathead
minnow])
>100-335 ppm (bluegill sunfish)
1700 ppm (bluegill sunfish)
2840 ppm (rainbow trout)
2231 ppm (fathead minnow)
0.3 ppm (bluegill sunfish)
0.8 ppm (channel catfish)
28 ppm (bluegill sunfish)
0.64 ppm (rainbow trout)
0.65 ppm (rainbow trout)
0.76-1.2 ppm (bluegill sunfish)
3.3 ppm (fathead minnow)
0.78-1.35 ppm (channel catfish)
5.4 ppm (rainbow trout)
51-64 ppm (rainbow trout)
0.8 ppm (bluegill sunfish)
Partially acceptable studies for 2,4-D heptylamine salt
are available; these studies did not report percent of active
ingredient of the test material. Toxicity values (LC50s)
reported are 15 ppm (bluegill) and 4.7 ppm (rainbow trout).
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Effects on Freshwater Invertebrates. Based on data
available to the Agency, dimethylamine, isooctyl ester,
butoxyethanol ester and propylene glycol butyl ether ester
forms of 2,4-D can be characterized as highly toxic to
aquatic invertebrates. Data available on other 2,4-D
compounds indicate toxicity in the range of slightly toxic to
practically nontoxic.
Studies with the propylene glycol butyl ether ester were
performed with a technical grade of the compound. The
toxicity values (LC50S) from these studies are 0.1-14 ppm
(Daphnia magna); 4.9 ppm (Simocephalus serrulatus); and 0.42
ppm (Cypridopsis vidua).
The toxicity values (LC50S) reflected below are from
acceptable studies performed with a formulated product:
Alkylamine salt 3.26 ppm (Daphnia maana
[waterflea])
2.38 ppm (Hyalella [scud])
Dimethylamine 4.0->100 ppm (waterflea)
>100 ppm (Gammarus fasciatus
[side swimmer])
>100 ppm (Chironomus plumosus
[midge])
Isopropylamine salt 583 ppm (waterflea)
Butyl ester 2.8 ppm (waterflea)
Isooctyl ester 0.5 ppm (waterflea)
Butoxyethanol ester 1.7-6.4 ppm (waterflea)
2.2 ppm (Cypridopsis vidua
[seed shrimp])
2.6 ppm (Asellus brevicaudus
[sow bug])
0.44-6.1 ppm (side swimmer)
0.39-0.79 ppm (midge)
In addition, a study using a 2,4-D dimethylamine
formulated product on Paleamonetes kadiakensis (grass shrimp)
reported an LC50 of 0.15 ppm. This study does not satisfy
requirements for registration because the test species is not
a recommended species and mature individuals were used. The
study, however, is a valid study.
Effects on Estuarine and Marine Organisms. Acceptable
data are available only for a formulated product of 2,4-D
butoxyethanol ester. These data report toxicity values
(LC50S) of 5.0 mg/L (Fundulus similis [longnose killifish]),
2.6 mg/L (Crassostrea virginica [Eastern oyster]) and 5.6
mg/L (Penaeus aztecus [brown shrimp]), which indicate that
the material is moderately toxic to estuarine "and marine
organisms.
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Effects on Plants. Limited plant protection studies are
available.
In a spray drift study, two application methods were
compared as to quantity and pattern of deposition. No
difference was found between the amine derivatives
(diethanolamine and dimethylamine). With these amines, drift
was observed beyond 225 feet from the site of application.
No residues, attributable to drift, were found when applied
postemergent to wheat or corn.
The toxicity of butoxyethanol ester was tested on four
species of algae, using a formulated product. The toxicity
values (EC50s) were 75 mg/L (Isochrysis aalbana. Dunaliella
tertiolecta and Chlorococcum sp.) and 150 mg/L (Phaeodactylum
tricornutum).
Risks to Nontarget Organisms (Including Endangered
Species). Because of limited environmental fate and
ecological effects data, complete hazard assessments cannot
be conducted at this time.
Because of its demonstrated toxicity to nontarget
species and its intended use pattern, this pesticide has been
identified by the Office of Endangered Species (OES) , U.S.
Fish and Wildlife Service, as being likely to jeopardize the
continued existence of certain endangered species when used
on range, pastureland, corn, wheat, sorghum, oats, barley,
and/or rye. Based on this determination, OES specified
reasonable and prudent alternatives to avoid jeopardizing the
continued existence of the identified species by these uses.
EPA is working with the Fish and Wildlife Service and other
Federal and State agencies to implement the alternatives in a
technically sound manner.
Nontarget Insects. There is sufficient information to
characterize 2,4-D as relatively nontoxic to honey bees, when
bees are exposed to direct treatment.
PRODUCT CHEMISTRY. EPA has evaluated the available
data which identify the ingredients, materials, and
manufacturing process and provide information on the physical
and chemical properties of 2,4-D.
The Agency has noted that 2,4-D may be contaminated
with tetra- through heptahalogenated dibenzo-p-dioxins or
dibenzofurans or N-nitrosamines. Certain polyhalogenated
dibenzo-p-dioxin or dibenzofuran congeners have been found to
be mutagenic, oncogenic, teratogenic and to cause reproduc-
tive toxicity. Nitrosamines have been found to be oncogenic.
Analytic data to identify and quantify tetra- through hepta-
chlorinated dibenzo-p-dioxin or dibenzofuran contaminants
22
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were required in a Data Call-in Notice issued in June 1987.
Analytic data to identify and quantify N-nitrosamines are
being required, as specified in the data tables.
D. TOLERANCE ASSESSMENT
Tolerances and food and feed additive regulations have
been established for residues of 2,4-D in a variety of raw
agricultural commodities and meat byproducts (40 CFR
180.142), and in processed food (40 CFR 185.1450) and feed
(40 CFR 186.1450). EPA has evaluated the residue and
toxicology data supporting these tolerances. The following
were considered during this evaluation:
o Whether the current tolerances and food additive
regulations are sufficient to cover the actual residues
resulting from use (including FIFRA section 24(c) and
intrastate uses).
o Whether group tolerances can be established in
accordance with 40 CFR 180.34(f).
o Whether, in the absence of tolerances, restrictions on
use, grazing, or feeding of treated commodities are
necessary.
o Whether the tolerances are expressed accurately and in
current terminology.
The regulatory results of the Agency's review are set
out in the Regulatory Positions and Rationale section.
Residue Data. The residue data reviewed in support of
these tolerances include the following:
1. Data on the nature of the residues in both plants and
animals, including identification of major metabolites
and degradates of 2,4-D. The nature of the residue is
not adequately understood.
2. Analytical methodology for determining the levels of
residues of 2,4-D in plants and animals. Available
methods are adequate only for collection of data
pertaining to residues of 2,4-D, per se, on most plant
and animal commodities.
3. Storage stability data. These data demonstrate that
residues of 2,4-D, per se, in potatoes are stable for up
to 73 weeks when stored at -20°C. Additional data are
required.
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4. Data on the magnitude and levels of residues of 2,4-D,
per se, in individual raw agricultural commodities,
animal products, and processed food and feed items.
Data are not adequate to support all of the established
tolerances.
Toxicology Data. A provisional acceptable daily intake
(PADI) of 0.003 mg/kg/day for 2,4-D acid has been established
based on a two-year rat feeding study. Compound-related
effects were observed in the kidneys of both male and female
rats. The LOEL was 5 mg/kg/day and the NOEL was 1
mg/kg/day. An uncertainty factor of 100 was used to account
for the inter- and intraspecies differences. An additional
uncertainty factor of 3 was used since there is no dog study
available and no information available that indicates the dog
is less sensitive than the rat.
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
Based on the review and evaluation of available data on
2,4-D, the Agency has made the following determinations. Where
label revisions are imposed, specific language is set forth in
the Labeling section of this chapter.
1. The Agency will not place 2,4-D in special review at this
time.
Rationale. In September 1986, based on epidemiologic
evidence available at that time, the Agency issued a
preliminary notification of special review to the
registrants of 2,4-D. Based on additional evaluation of
this evidence and other toxicological data, the Agency
subsequently concluded that these data were inadequate to
assess the oncogenic potential of 2,4-D. Therefore, in
March 1988, EPA proposed not to initiate a special review of
the chemical at this time.
The Agency's concerns regarding the toxicological effects of
2,4-D have not been fully resolved. Additional
epidemiological studies are expected to be completed soon
and additional laboratory studies are required by this
Standard. As these data become available, the Agency will
further evaluate the potential risks of 2,4-D and could
initiate a special review at a later time and/or consider
additional regulatory action, if applicable.
2. The Agency will not restrict the use of 2,4-D products to
certified applicators.
Rationale. Based on available data, 2,4-D products have
not met or exceeded any of the criteria specified in 40 CFR
152.170 which would indicate a need to restrict its use.
3. The Agency will require data on the salts, amines and
esters of 2,4-D as well as the acid, as reflected in the
data tables.
Rationale. When 2,4-D is formulated as an ester or amine,
the physical characteristics, biological activity and fate
in the environment may be affected. The Agency has little
or no data to evaluate the effects of the ester or amine
derivative of 2,4-D. Data on each salt, ester and amine
derivative are needed to allow evaluation of these forms of
2,4-D.
4. The Agency will not consider establishment of significant
new food use tolerances for 2,4-D.
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Rationale. The current residue chemistry and toxicology
data are not sufficient to assess existing and pending
tolerances. In addition, the Agency has concerns about the
human carcinogenicity of this chemical. Therefore, the
Agency will not consider any significant new uses until data
are available to resolve these issues.
5. The Agency is requiring additional data, as set forth in
the data tables, to support established tolerances.
Rationale. Existing data are insufficient to support
established tolerances, as specified in the data tables.
6. The Agency will assess the adequacy of the tolerances for
residues of 2,4-D in meat, milk, poultry, eggs, fish and
shellfish, upon receipt and evaluation of required
metabolism data.
Rationale. Data are unavailable to ascertain the adequacy
of these tolerances.
7. The Agency will require that tolerances be proposed and
appropriate supporting data be submitted for oat hay,
flaxseed, flax straw, alfalfa, ladino clover, non-grass
animal feeds, and avocados. In lieu of proposing
tolerances and submitting supporting data, registrants may
delete these uses from the label or, for oat hay, add
feeding restrictions to the label. Registrants have 3
months to notify the Agency of which option they choose.
Rationale. Tolerances have not been proposed or
established for residues of 2,4-D that occur from its use on
these commodities.
8. The Agency is requiring registrants to amend label
directions for products registered for use on pastures and
rangeland grasses and to propose label amendments to
clarify the uses of 2,4-D on certain other raw agricultural
commodities.
Rationale. Directions on labels of products registered for
use on grass hay do not contain the appropriate pregrazing,
preharvest and preslaughter intervals supported by data
available to the Agency. Labels of products registered for
use on certain other raw agricultural commodities do not
provide sufficient information regarding preharvest
intervals, applications rates, allowable ranges of diluent
for treatment, etc.
9. Pending submission of analytical method validation data and
the results of water degradation/metabolism studies, the
Agency will delete obsolete crop groupings and establish a
26
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single tolerance of 1 ppm for 2,4-D residues resulting from
use of irrigation water containing up to 0.5 ppm in or on
members of crop groups listed in 40 CFR 180.34 and
individual miscellaneous commodities. If additional
degradates/metabolites of toxicological concern are observed
in the water degradation/metabolism studies, additional
residue data on irrigated crops will be required.
Rationale. Data submitted for various irrigated crops
indicate the level of 2,4-D per se residues expected in
irrigation water as a result of aquatic use on ponds, lakes
and reservoirs is 0.5 ppm.
10. The Agency will propose the following technical changes in
the listing of 2,4-D tolerances: (i) the commodity entry
"nuts" will be amended to "tree nuts;" (ii) the commodity
entry "millet forage and straw" will be deleted; and (iii)
the commodity entry "millet grain" will be amended to
"millet grain, proso."
Rationale. These technical changes are required because
(i) "tree nuts" is the appropriate commodity definition;
(ii) millet forage and straw are not considered raw
agricultural commodities of millet; and (iii) the addition
of "proso" clarifies the tolerance statement for millet
grain.
11. The Agency will:
(1) eliminate the following 2,4-D derivatives from the
tolerance expression: alkyl (C-13), alkyl (C-14),
amylamine, diisopropanolamine, ethylamine, linoleyl-
amine, methylamine, oleylamine, propylamine, tri-
methylamine, amyl (pentyl), butoxypolythylene glycol
butyl ether, dipropylene glycol isobutyl ether, eth-
oxyethoxyethyl, ethoxyethoxypropyl, ethyl, ethoxy-
propyl, methyl, polyethylene glycol 200, polyprop-
oxybutyl, polypropylene glycol, propylene glycol,
propylene glycol isobutyl ether, tetrahydrofurfuryl and
tripropylene glycol isobutyl ether;
(2) revoke the tolerance of 5 ppm for residues of 2,4-D in
or on quinces, and the tolerance for residues of 2,4-D
in or on apricots, resulting from the appli- cation of
dimethylamine salt; and
(3) revise the tolerance statement for use on citrus
fruits to include the 2,4-D triethanolamine salt.
Rationale. There are no registered uses for the above
listed derivatives of 2,4-D; for quinces; or for 2,4-D
dimethylamine salt in apricot orchards apart from the
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general use on stone fruits. Therefore, these tolerances
are unnecessary. There are registered uses for the 2,4-D
triethanolamine salt on citrus fruits and it should be a
part of the tolerance statement.
12. The Agency will revoke the food additive regulation of 0.1
ppm for residues of 2,4-D in potable water.
Rationale. The Agency no longer establishes tolerances for
pesticides in potable water but rather sets maximum
contaminant levels (MCLs) in drinking water. An MCL of 0.1
mg/L is currently established for 2,4-D in drinking water.
13. The Agency is requiring precautionary labeling to minimize
any potential hazard to nontarget organisms.
Rationale. Certain formulations of 2,4-D are highly toxic
to fish and/or aquatic invertebrates. Precautionary
labeling will reduce any potential risks to these organisms
from the use of 2,4-D.
14. The Office of Endangered Species (OES) in the U.S. Fish and
Wildlife Service has determined the use of 2,4-D may
jeopardize the continued existence of endangered species or
critical habitat of certain endangered species. EPA is
developing a program to reduce or eliminate exposure to
these species to a point where use does not result in
jeopardy, and will issue notice of any necessary labeling
revisions when the program is developed. No additional
labeling is being required at this time. As explained
below, labeling requirements issued in Pesticide Regulation
(PR) Notices 87-4 and 87-5 have been withdrawn.
Rationale. In May 1987, EPA issued PR Notices 87-4 and 87-5
in response to OES findings that certain pesticides,
including this chemical, jeopardized the continued existence
of endangered species. Those PR Notices directed
registrants to add labeling to their products which referred
users to additional information that, in turn, explained
limitations on use of the pesticide within the range of
jeopardized endangered species. Subsequent to issuance of
these PR Notices, EPA identified a number of significant
technical errors and inconsistences in the information to
which users would have been referred. Therefore, on January
26, 1988, the Agency issued PR Notice 88-1 which withdrew PR
Notices 87-4 and 87-5 pending development of a more focused
program to protect endangered species.
EPA is working to correct these errors prior to requiring
labeling to protect endangered species. When that program
is fully developed, notice of any labeling necessary to
protect endangered species will be issued.
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15. The Agency is requiring a groundwater warning statement on
the labels of 2,4-D products.
Rationale. Although laboratory data demonstrate that 2,4-D
is mobile in soils, its potential to contaminate
groundwater is limited by its rapid rate of degradation and
uptake by target plants. However, residues of 2,4-D have
been detected in groundwater, mostly from point sources,
such as mixing, loading and disposal. Since 2,4-D could be
a potential groundwater contaminant, a label statement will
advise users to exercise caution when handling 2,4-D
products to prevent such contamination.
The Agency is currently finalizing its Agricultural
Chemicals in Groundwater Strategy and its policy for
restricting the use of pesticide products which may reach
groundwater. When the policies are in place, the Agency
will consider what action is appropriate for 2,4-D products
and other products containing ingredients which may reach
groundwater.
16. The Agency is not requiring a reentry interval for 2,4-D
products.
Rationale. Based on the toxicological data available to
the Agency, 2,4-D products are of low toxicity (Toxicity
Categories III and IV). Because of these low toxicity
levels, it is not considered necessary to establish a
reentry interval.
17. The Agency is requiring protective clothing (gloves)
labelling for end-use products.
Rationale. Based on the available data, the major route of
exposure to workers handling 2,4-D is dermal and reported
incidents of accidental poisoning involve dermal exposure.
This exposure can be reduced through the use of protective
gloves. The use of gloves while handling 2,4-D products
will reduce lower exposure.
18. The Agency is requiring special neurotoxicity studies.
Rationale. Several instances of accidental human poisoning
from dermal exposure to 2,4-D formulations, which resulted
in neurotoxicity, have been reported. Data are required so
that the Agency can evaluate the chemical's neurotoxicity.
19. EPA is requiring analytical chemistry data for 2,4-D products
to evaluate contamination with tetra- through heptahalogenated
dibenzo-p-dioxins or dibenzofurans or N-nitrosamines.
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Rationale. Polyhalogenated dibenzo-p-dioxins or
dibenzofurans may be formed during manufacture of 2,4-D
and N-nitrosamines may be formed during manufacture or
storage of 2,4-D. The Agency has identified these
contaminants as being toxicologically significant. The
Agency does not have sufficient data to determine the
extent and significance of the contamination.
20. The Agency will immediately review certain data as they
are submitted.
Rationale. Because of concerns regarding potential
risks from 2,4-D use, the Agency believes it is
essential that the following data be reviewed as they
are received: all toxicological studies; spray drift
data; plant and animal metabolism studies and validation
methods; and dioxin, furan and nitrosamine analysis and
octanol/water partition coefficient data.
21. While data gaps are being filled, currently registered
manufacturing-use products (HP's) and end-use products
(EP's) containing 2,4-D may be sold, distributed,
formulated, and used, subject to the terms and conditions
specified in this Standard. However, significant new uses
will not be registered. Registrants must provide or agree
to develop additional data, as specified in the data tables,
in order to maintain existing registrations.
Rationale. Under FIFRA, the Agency may elect not to
cancel or withhold registration even though data are
missing or are inadequate (see FIFRA section 3(c)(2)(B)
and 3(c)(7)). Issuance of this Standard provides a
mechanism for identifying data needs. These data will
be reviewed and evaluated, after which the Agency will
determine if additional regulatory actions are
necessary. Because of the quantity of data required to
maintain existing registrations, the Agency has elected
not to consider registration of any significant new uses
while data gaps are being filled and data evaluated.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain this pesticide, bear required labeling,
and conform to the product composition, acute toxicity
limits, and use pattern requirements listed in this document.
C. ACCEPTABLE RANGES AND LIMITS
Product Composition Standard. To be registered or
reregistered under this Standard, manufacturing-use products
(MPs) must contain this pesticide. Each MP formulation
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proposed for registration must be fully described with an
appropriate certification of limits, stating maximum and
minimum amounts of the active ingredient and inert
ingredients which are present in products, as well as
impurities found at greater than 0.1 percent.
Acute Toxicity Limits. The Agency will consider registration
of technical grade and manufacturing-use products containing
this pesticide provided that the product labeling bears
appropriate precautionary statements for the acute toxicity
category in which each product is placed.
Use Patterns. To be registered under this Standard,
manufacturing-use products may be labeled for formulation
into end-use products bearing federally registered uses. The
EPA Index to Pesticide Chemicals (for availability, see page
1) lists all federally registered uses of this pesticide
ingredient, as well as approved maximum application rates and
frequencies.
The use patterns currently registered are terrestrial (food
and nonfood); aquatic (food and nonfood); domestic; and
forestry.
D. LABELING
All products must bear appropriate labeling as specified
in 40 CFR 156.10, PR Notices 83-2, 83-3, and below. Appendix
II contains further information on label requirements.
Time Frames for Compliance. Pesticide products
containing this pesticide as an active ingredient may not be
released for shipment by the registrant after October 1,
1989, unless the product bears amended labeling that complies
with the requirements of FIFRA, as set out in this
Registration Standard.
Pesticide products containing this pesticide as an
active ingredient may not be distributed or sold by any
person after October 1, 1990, unless the product bears
amended labeling that complies with the requirements of this
Standard.
In addition to the above labeling requirements, the
following information must appear on the labeling of all
manufacturing use and end use products.
Ingredient Statement. The ingredient statement for MP's
must list the active ingredient as:
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2,4-Dichlorophenoxyacetic Acid %
OR
(Applicable salt, amine or ester) %
2,4-Dichlorophenoxyacetic Acid Equivalent:
Use Pattern Statements. All manufacturing-use products
must state that they are intended for formulation into end-
use products for acceptable use patterns. However, no use
may be included on the label where the registrant fails to
agree to comply with the data requirements in Table A for
that use pattern.
Disposal Statements. Certain unused 2,4-D stocks are
listed as toxic hazardous waste under the Resource
Conservation and Recovery Act (RCRA); others may be
hazardous waste because of their chemical physical
characteristics. The following is the appropriate pesticide
disposal statement for all 2,4-D products, except those
labeled for household use only:
"Pesticide wastes are toxic. Improper disposal of
excess pesticide, spray mixture, or rinsate, is a
violation of Federal Law and may contaminate
groundwater. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA
Regional Office for guidance."
Products labeled for household use only must bear the
following disposal statement:
"Securely wrap original container in several layers of
newspaper and discard in trash."
The labels of all products must bear the appropriate
container disposal statement (see Appendix II).
Precautionary Statements
1. For all 2,4-D products, except those listed below in
items 2 and 3, the following precautionary statements
are required.
Manufacturing-Use Products
"Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or
public waters unless this product is specifically
identified and addressed in an NPDES permit. Do
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not discharge effluent containing this product to
sewer systems without previously notifying the
sewage treatment plant authority. For guidance,
contact your State Water Board or Regional Office
of the EPA."
End-Use Products
Aquatic Uses. "Drift or runoff may adversely
affect nontarget plants. Do not apply directly to
water except as specified on tJiis label. Do not
contaminate water when disposing of equipment
washwaters."
Nonaguatic Uses. "Drift or runoff may adversely
affect nontarget plants. Do not apply directly to
water or wetlands (swamps, bogs, marshes, and
potholes). Do mat contaminate water wiien disposing
of equipment washwaters. "
2. The following precautionary statement are required for
end-use products containing the following 2,4-D
derivatives:
N-oleyl-1,3-propylenediamine saJLt
N ,N-dimethyloleyl-li3BOleylamins!-
Butyl ester
Butoxyethanol ester
Propylene glycol butyl ether esteir
Manufacturing-Use Products
"This product is toxic to fish. Do not discharge
effluent containing this product into lakes,
streams, ponds, estuaries, oceans, or public waters
unless this product is specifically identified and
addressed in an NPDES permit. JDo not discharge
effluent containing this product to sewer systems
without previously notifying the sewage treatment
plant authority. For guidance,, contact your State
Water Board or Regional Office
-------
Nonaquatic Uses. "This product is toxic to fish.
Drift or runoff may adversely affect fish and
nontarget plants. Do not apply directly to water
or wetlands (swamps, bogs, marshes, and potholes).
Do not contaminate water when disposing of
equipment washwaters."
The following precautionary statements are required for
end-use products containing the following derivatives of
2,4-D.
Dimethylamine
Isooctyl ester
Manufacturing-Use Products
"This product is toxic to aquatic invertebrates.
Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or
public waters unless this product is specifically
identified and addressed in an NPDES permit. Do
not discharge effluent containing this product to
sewer systems without previously notifying the
sewage treatment plant authority. For guidance,
contact your state Water Board or Regional Office
of the EPA."
End-Use Products
Aquatic Uses. "This product is toxic to aquatic
invertebrates. Drift or runoff may adversely
affect aquatic invertebrates and nontarget plants.
Do not apply directly to water except as specified
on this label. Do not contaminate water when
disposing of equipment washwaters."
Nonaquatic Uses. "This product is toxic to aquatic
invertebrates. Drift or runoff may adversely
affect aquatic invertebrates and nontarget plants.
Do not apply directly to water or wetlands (swamps,
bogs, marshes, and potholes). Do not contaminate
water when disposing of equipment washwaters."
All End-Use Products. The following statements are
required in the use directions for all end-use products:
End-Use Products - Liquid
"This product can reach groundwater as a result of
mixing and loading. To minimize groundwater con-
tamination from spills during mixing, loading and
cleaning of equipment, take the following steps:
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"Mixing and Loading; When mixing, loading or
applying this product, wear chemical resistant
gloves. Wash nondisposable gloves thoroughly with
soap and water before removing.
"The mixing and loading of spray mixtures into the
spray equipment must be carried out on an
impervious pad (i.e., concrete slab, plastic
sheeting) large enough to catch any spilled
material. If spills occur, contain the spill by
using an absorbent material (e.g, sand, earth or
synthetic absorbent). Dispose of the contaminated
absorbent material by placing in a plastic bag and
following disposal instructions on this label.
"Triple rinse empty containers and add the rinsate
to the mixing tank.
"Cleaning of Equipment; When cleaning equipment,
do not pour the washwater on the ground; spray or
drain over a large area away from wells and other
water sources."
End-Use Products - Granular
"This product can reach groundwater from improper
handling. To minimize groundwater contamination
from spills during loading and cleaning of
equipment, take the following steps:
"Handling; When handling this product, wear
chemical resistant gloves. Wash nondisposable
gloves thoroughly with soap and water before
removing. If spills occur, collect the material
and dispose of by following disposal instructions
on this label.
"Cleaning of Equipment; When cleaning equipment,
do not pour the washwater on the ground; spray or
drain over a large area away from wells and other
water sources."
5. End-Use Products - Use on Pastures and Rangeland
Grasses. Labels for products registered for use on
pastures and rangeland grasses must be revised to
reflect the following intervals, if such intervals are
not currently on the label:
a. A 7-day pregrazing interval for dairy cattle;
b. A 30-day preharvest interval for grass cut for hay;
and
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c. A preslaughter interval for meat animals of 3 days.
6. End-Use Products - Certain Food/Feed Uses. Label use
directions for products registered for the following
uses must be revised: potatoes, apples, pears, grapes,
strawberries, barley and barley forage, corn and corn
forage and fodder, millet, oats, rice and rice straw,
rye, sorghum and sorghum forage and fodder, wheat,
rangeland and pasture grass, asparagus, and sugarcane.
The revisions pertain to preharvest intervals, ranges of
diluent, and maximum seasonal application rates and/or
number of applications. The data tables contain
specific requirements for each commodity. The
registrants must propose the specific language. Since
these revised use directions must be reflective of data
required by this Standard, time frames for these
requirements will coincide with the time frames for
submission of data.
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain
requirements for data submittal or changes in composition,
labeling or packaging of the product. The applicable
requirements depend on whether the product is a manufacturing
or end use product and whether the pesticide is the sole
active ingredient or one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to
the manufacturing use product.
2. The data requirements listed in Tables A and B.2
3. The labeling requirements specified for
manufacturing use products in Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensa-
tion provisions) associated with reregistration.
B. Manufacturing use products containing this pesticide as
one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to
all products containing the pesticide subject to this
Registration Standard. Table B lists product-specific data
applicable to manufacturing-use products. The data in Tables
A and B need not be submitted by an end-use producer who is
eligible for the generic data exemption for that active
ingredient.
Table C lists product-specific data applicable to end-
use products. The Agency has decided that, in most cases, it
will not require the submittal of product-specific data for
end-use products at this time. Therefore, most Registration
Standards do not contain a Table C.
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2. The labeling requirements specified for
manufacturing use products in Section IV.
C. End use products containing this pesticide as the sole
active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to
the end use product.
2. If eligible for the generic data exemption,3 the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data
requirements listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the generic data exemption, the
data requirements listed in Tables A and C.
2. If eligible for the generic data exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
3If you purchase from another producer and use as the
source of your active ingredient only EPA-registered
products, you are eligible for the generic data exemption for
generic data concerning that active ingredient (Table A) and
product-specific data for the registered manufacturing use
product you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption and
become subject to the data requirements in Table A.
2) If no producer subject to the generic data
requirements in Table A agrees to submit the required data,
all end-use producers lose the exemption, and become subject
to the data requirements in Table A.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the
registration of products containing this active ingredient.
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often
required for ecological effects studies and applies to all
products having that formulation type. These are classed as
generic data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is
complying with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer
in compliance with this data requirements notice, the Agency
will consider that both they and you are not in compliance
and will normally initiate proceedings to suspend the
registrations of both your product(s) and their product(s)
unless you commit to submit and submit the required data in
the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the
data.
^Registrations granted after issuance of this Standard
will be conditioned upon submittal or citation of the data
listed in this Registration Standard.
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If you are not now eligible for a generic data
exemption, you may qualify for one if you change your source
of supply to a registered source that does not share
ownership in common with your firm. If you choose to change
sources of supply, the Confidential Statement of Formula must
identify the new source(s) and you must submit a Generic Data
Exemption Statement.
If you apply for a new registration for products
containing this active ingredient after the issuance of this
Registration Standard, you will be required to submit or cite
generic data relevant to the uses of your product if, at the
time the application is submitted, the data have been
submitted to the Agency by current registrants. If the
required data have not yet been submitted, any new
registration will be conditioned upon the new registrant's
submittal or citation of the required data not later than the
date upon which current registrants of similar products are
required to provide such data. See FIFRA sec. 3(c)(7)(A).
If you thereafter fail to comply with the condition of that
registration to provide data, the registration may be
cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with DCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also
provide EPA with documentary evidence that an agreement has
been formed which allows you to rely upon the data to be
submitted. Such evidence may be: (1) your letter offering to
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join in an agreement and the other registrant's acceptance of
your offer, (2) a written statement by the parties that an
agreement exists, or (3) a written statement by the person
who will be submitting the data that you may rely upon its
submittal. The Agency will also require adequate assurance
that the person whom you state will provide the data is
taking appropriate steps to secure it. The agreement to
produce the data need not specify all of the terms of the
final arrangement between the parties or a mechanism to
resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number, as part of your 90-day response. The
request must include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated
representative of the consortium, with whom EPA
will correspond concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the
consortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your
registration for non-compliance with the DCI. EPA has
determined that, as a general policy, it will not suspend the
registration of a product when the registrant has in good
faith sought and continues to seek to enter into a data
development/cost sharing program, but the other registrants
developing the data have refused to accept its offer. [If
your offer is accepted, you may qualify for Option 2 above by
entering into an agreement to supply the data.]
In order to qualify for this method, you must:
l. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for
Development of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of
your offer (such as a certified mail receipt). Your offer
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must, at a minimum, contain the following language or its
equivalent :
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement to be
bound by binding arbitration as provided by FIFRA section
The remainder of your offer may not in any way attempt
to limit this commitment. If the other registrant to whom
your offer is made does not accept your offer, and if the
other registrant informs us on a DCI Summary Sheet that he
will develop and submit the data required under the DCI,
then you may qualify for this option. In order for you to
avoid suspension under this method, you may not later
withdraw or limit your offer to share in the burden of
developing the data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of
suspension proceedings , unless you commit to submit and
submit the required data in the specified timeframe. In such
cases, the Agency generally will not grant a time extension
for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use
factors that lead you to believe that a requirement does not
apply. Since the Agency has carefully considered the
composition and uses of pesticide products in determining
that a data requirement applies, EPA does not anticipate
that many waivers will be granted. A request for waiver does
not extend the time-frames for developing required data, and
if your waiver request is denied, your registration may be
suspended if you fail to submit the data. The Agency will
respond in writing to your request for a waiver.
5. You request that EPA amend your registration by
deleting the uses for which the data are needed. You are not
required to submit data for uses which are no longer on your
label.
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6. You request voluntary cancellation of the regis-
tration of your product(s) for which the data are needed.
E. Registrant Requests Regarding Data Requirements and
Agency Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing. The
original requirement remains in effect unless the Agency has
notified you in writing that it has agreed to a change in the
requirement. While being considered by the Agency, such
requests for changes in the requirements do not alter the
original requirements or extend the time allowed for meeting
the requirement.
F. Test Protocols and Standards
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing. All testing must
be conducted in accordance with applicable Good Laboratory
Practices regulations in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are
referenced in the Data Tables, are available from the
National Technical Information Service (NTIS), Attn: Order
Desk, 5285 Port Royal Road, Springfield, VA 22161 (tel:
703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD-recommended test standards conform to those specified in
the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
G. Procedures for requesting a change in test protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
43
-------
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning
testing, because the Agency will not ordinarily accept as
sufficient studies using unapproved protocols. A request for
protocol approval will not extend the timeframe for submittal
of the data, nor will extensions generally be given to
conduct studies due to submittal of inappropriate protocols.
The Agency will respond in writing to your request for
protocol approval or change.
H. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time.
EPA will view failure to request an extension before the
data submittal response deadline as a waiver of any future
claim that there was insufficient time to submit the data.
While EPA considers your request, you must strive to meet the
deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you have
taken to meet the testing deadline. Time extensions normally
will not be granted due to problems with laboratory capacity
or adequacy of funding, since the Agency believes that with
proper planning these can be overcome. The Agency will
respond in writing to any requests for extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must
comply with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of
results, and the adequacy of any required supporting (or raw)
data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR Notice 86-5
(issued July 29, 1986). All studies must be submitted in the
form of a final report; a preliminary report will not be
considered to fulfill the submittal requirement.
J. Existing stocks provision upon suspension or
cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under FIFRA
sec. 3(c)(2)(B), an existing stocks provision for the
44
-------
registrant is not consistent with the Act. Accordingly, the
Agency does not anticipate granting permission to sell or
distribute existing stocks of suspended product except in
rare circumstances. If you believe that your product will be
suspended or cancelled and that an existing stocks provision
should be granted, you have the burden of clearly
demonstrating to EPA that granting such permission would be
consistent with the Act. The following information must be
included in any request for an existing stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale
or distribution; and
2. Demonstration that such a provision would be
consistent with the provisions of FIFRA.
45
-------
-------
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that
certain product-specific data are required to maintain your
registrations in effect. Product-specific data are derived
from testing using a specific formulated product, and, unlike
generic data, generally support only the registration of that
product. All such data must be submitted by the dates
specified in this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data
requirements, you must follow the same procedures as for
generic data. See Section VI.D through J. You should note,
however, that product chemistry data are required for every
product, and the only acceptable responses are options
VI.D.I. (submit data) or VI.D.6. (cancellation of
registration).
Failure to comply with the product-specific data
requirements for your products will result in suspension of
the product's registration.
46
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELS
FIFRA requires each product to be labeled with
accurate, complete and sufficient instructions and
precautions, reflecting the Agency's assessment of the data
supporting the product and its uses. General labeling
requirements are set out in 40 CFR 156.10 (see Appendix II -
LABELING and SUMMARY). In addition, labeling language
specific to products containing this pesticide is specified
in Section IV.D of this Registration Standard. Responses to
this Registration Standard must include draft labeling for
Agency review.
Labeling must be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. Draft labeling must indicate the
intended colors of the final label, clear indication of the
front panel of the label, and the intended type sizes of the
text.
If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific
instructions in Section IV.D., EPA may seek to cancel the
registration of your product under FIFRA sec. 6.
47
-------
IX. INSTRUCTIONS FOR SUBMISSION
All submittals in response to this Registration
Standard must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, B.C. 20460
Attn: [Name of chemical] Registration Standard
All submittals in response to this Registration
Standard are non-fee items, including 90-day responses,
protocols and waiver requests, data, and revised labeling.
Submittals must be clearly identified as being in response to
the Registration Standard. Under no circumstances may
Registration Standard responses be combined with other types
of filings for which fees are required.
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit for each product subject to this Registration
Standard:
a. Generic Data Exemption Statement (EPA Form 8580-3) ,
if applicable, or the "FIFRA Section 3(c)(2)(B)
Summary Sheet" (EPA Form 8580-1), with appropriate
attachments.
b. Confidential Statement of Formula (EPA Form
8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40
CFR 152.80-152.99.
2. Within 9 months from receipt of this document you
must submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
48
-------
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject
pesticide in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA sec. 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form
8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
2. Within 9 months of receipt of this document, you
must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you
must submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
C. End Use Products containing the subject pesticide as
sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA
Form 8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from receipt of this document you
must submit:
49
-------
a. Two copies of any product-specific data, if
required by Table C.
b. Product Specific Data Report (EPA Form 8580-4), if
Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
D. End Use Products containing the subject active
ingredient as one of multiple active ingredients
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA
Form 8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from the receipt of this document,
you must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application for registration was submitted
by that date, no product may be released for shipment by the
producer after July 31, 1988.
50
-------
I. DATA APPENDICES
51
-------
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that
apply to the pesticide in all products, including
data requirements for which a "typical formulation"
is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment
Guidelines, which are available from the National Technical
Information Service, 5285 Prot Royal Road, Springfield, VA
22161.
2. Test Substance (Column 2). This column lists the
composition of the test substance required to be used for the
test, as follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure Active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The
following letter designations are used for the given use
patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
52
-------
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the
table.
4. Does EPA have data? (Column 4). This column indicates
one of three answers:
- EPA has data in its files that completely
satisfy this data requirement. These data may be
cited by other registrants in accordance with data
compensation requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but
such data do not fully satisfy the data
requirement. In some cases, the Agency may possess
data on one of two required species or may possess
data on one test substance but not all. The term
may also indicate that the data available to EPA
are incomplete. In this case, when the data are
clarified, or additional details of the testing
submitted by the original data submitter, the data
may be determined to be acceptable. If this is the
case, a footnote to the table will usually say so.
NO - EPA either possesses no data which are
sufficient to fulfill the data requirement, or the
data which EPA does possess are flawed
scientifically in a manner that cannot be remedied
by clarification or additional information.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the
identifying number of each study. This normally is the
Master Record Identification (MRID) number, but may be a GS
number if no MRID number has been assigned. Refer to the
Bibliography Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column e
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not
require its submission because of the unique characteristics
of the chemical; because data on another chemical can be used
to fulfill the data requirement; or because the data
53
-------
requirement has been waived or reserved. Any such unusual
situations will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 6
requires that data be submitted, this column indicates when
the data are to be submitted, based on the issuance date of
the Registration Standard. The timeframes are those
established either as a result of a previous Data Call-in
letter, or standardized timeframes established by PR Notice
85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
54
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Data Requirement
Test
Substance
Does EPA
Have Data To
Satisfy This
Requirement?
Bibliographic
Citation1
Must Additional
Data Be Submitted?
Timeframe for
Submission^
Ul
Ul
Part 158
Subpart C - Product Chemistry
61-2 - Description of Beginning
Materials and Manufac-
turing Process
61-3 - Discussion of Formation
of Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis
Physical and Chemical
Characteristics"
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
TGAI
TGAI
TGAI
No
No
No
N/A
N/A
N/A
Yes3
Yes4
Yes5
6 Months
6 Months
12 Months
TGAI
TGAI
TGAI
TGAI
TGAI
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes7
Yes 8
6 Months
6 Months
6 Months
6 Months
6 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHIDROPHENQKYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Data Requirement
Does EPA
Have Data To
Test Satisfy This
Substance Requirement?
Bibliographic
Citation1
Must Additional Timeframe for
Data Be Submitted? Submission^
Part 158
Subpart C - Product Chemistry
Physical and Chemical Characteristics
(Continued)
63-7
63-8
63-9
63-10
63-11
63-12
63-13
- Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/vrater partition
coefficient
- pH
- Stability
1GAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
Yes 9
Yes10
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
Other Requirements:
64-1 - Submittal of samples
N/A
N/A
N/A
N/A
N/A
-------
TA3LE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETl6jACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Part 158
Subpart C - Product Chemistry
1 Not applicable. Although product chemistry data may been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore bibliographic citations for the old data are not applicable.
2 Data must be submitted within the indicated timeframes, which begin on receipt of the Guidance Document.
3 Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name and
address of the manufacturer, producer, or supplier of each beginning material used in the manufacture of each
product must be provided, along with information regarding the properties of those materials.
VJl
4 A detailed discussion of all impurities that are or may be present at >^ 0.1 percent, based on knowledge of the
beginning materials, chemical reactions (intended and side) in the manufacturing process, and any contamination
during and after production must be submitted. This discussion must also address the possible formation of
N-nitrosamines (amine formulations) and dibenzo-p-dioxins and dibenzofurans occurring in 2,4-D acid, salts and
esters. Data submitted in response to the Data Call-in (DCI) Notice for analytical chemistry data on poly-
halogenated dibenzo-p-dioxins/dibenzofurans in 2,4-D acid and its salts and esters may also partially fulfill this
data requirement. These data are due as specified in the DCI Notice.
5 Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which certified limits are required. Complete validation data (accuracy and precision) must be submitted for
each analytical method used.
6 Physicochemical characteristics as required in 40 CFR 158.190 and more fully described in the Pesticide Assessment
Guidelines, Subdivision D, must be submitted.
7 Data needed if the technical product is a solid at room temperature.
8 Data required if the technical product is a liquid at room temperature.
9 Data required if the technical product is organic and nonpolar.
10 Data required if the test substance is dispersible in water.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHIDROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
VJl
OJ
Does EPA
Have Data To
Test Satisfy This Bibliographic Must Additional Timefratne for
Data Requirement Substance Requirement? Citation Data Be Submitted? Submission1
§158.240 Residue Chemistry
171-4 - Nature of the residue PAIRA Partially 00004666,
(Metabolism) 00004669,
- Plants 00004676,
00004680,
00004682,
00004689,
00004698,
00004715,
00004960,
00074214,
00074216,
00102675,
00102679,
00123973,
40600202,
00004667, Yes2 18 Months
00004675,
00004677 ,
00004681 ,
00004683,
00004693,
00004699,
00004723,
00004996,
00074215,
0007421 7 ,
00102676,
00102717,
40595701 ,
171-4 - Nature of the residue
(Metabolism)
- Livestock
PAIRA
and plant
metabolites
Partially 00004705, 00068891
Yes3.4
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
VJl
o
Does EPA
Have Data To
Test Satisfy This Bibliographic Must Additional
Data Requirement Substance Requirement? Citation Data Be Submitted?
§158.240 Residue Chemistry (continued)
171-4 - Residue analytical TGAI and Partially 00004701, 00004707, Yes5*6/7
methods metabolites 00004719, 00004720,
00033119, 00035913,
00036171, 00037169,
00042288, 00045364,
00045365, 00046125,
00046185, 00055485,
00059025, 00059026,
00059027, 00059033,
00060113, 00060120,
00060870, 00060872,
00060880, 00061012,
00061014, 00061016,
00061017, 00061018,
00061645, 00066156,
00067425, 00068011,
00068892, 00068893,
00071787, 00074219,
00075198, 00075715,
00075716, 00075719,
00088176, 00102605,
00102710, 00102713,
00102714, 00102717,
00102719, 00102760,
00102815, 00102816,
00102821, 00102862,
00102865, 00109535,
00115499, 00115509
Timeframe for
Submission1
15 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
o
Test
Data Requirement Substance
§158.240 Residue Chemistry (continued)
171-4 - Residue analytical
methods
Does EPA
Have Data To
Satisfy This Bibliographic Must Additional
Requirement? Citation Data Be Submitted?
00043278, 00115515,
00115741, 00115745,
00120057, 00121711,
00121733, 00123269,
00126684, 00127273,
00133938, 00136845,
00136848, 00139511,
00139951, 00140032,
00140092, 00156264,
40595702, 40595803,
40595804, 40600201,
Timeframe for
Submission^
171-4 - Storage stability
171-4 - Magnitude of the residue
in plants^
Root and Tuber Vegetables
GrouplO
- Potatoes
TEP and
metabolites
Partially
00035913, 00136845
00139511, 00140092
00145248
Yes{
15 Months
TEP
Partially 00060876, 00102814
00102862, 00136845
Yes12
18 Months
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Test
Data Requirement Substance
§158.240 Residue Chemistry (continued)
Citrus Fruits TEP
Pome Fruits GrouplS
- Apples TEP
- Pears TEP
Stone Fruits Group TEP
Small Fruits and Berries
Group21
- Blueberries TEP
- Cranberries TEP
- Grapes TEP
Does EPA
Have Data To
Satisfy This Bibliographic Must
Requirement? Citation Data
Partially 00042526, 00102605,
00102737, 00102879,
00115509, 00139059,
00163903
Partially 00102824
Partially 00102824
Partially 00088176
Partially 00061010, 00061012
Partially 00061010, 00061012
Partially 00061012, 00102833
Additional
Be Submitted?
Yesl3,14
Yes16
Yes17
Yes18
Yesl9
Yes20
Yes22
Yes23,24,25
Yes26
Yes27
Timeframe for
Submission^
18 Months
18 Months
24 Months
18 Months
18 Months
24 Months
18 Months
18 Months
18 Months
24 Months
- Strawberries
TEP
Partially 00102717, 00102812
Yes28
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETlC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
s>
Does EPA
Have Data To
Test Satisfy This Bibliographic
Data Requirement Substance Requirement? citation
§158.240 Residue Chemistry (continued)
Tree Nuts Group TEP Partially 00088176,
Cereal Grains Group3!
- Barley TEP Partially 00004610,
00036169,
00059025,
00059029,
00061010
- Corn (field & fresh) TEP Partially 00021755,
00025383,
00030697,
- Millet TEP Partially 00025330,
- Oats TEP Partially 00036169,
00102816
- Rice TEP Partially 00004594,
- Rye TEP No N/A
- Sorghum TEP Partially 00102719,
00120057
00115509
00036168
00036171
00059027
00060117
00022329
00030692
00102865
00161187
00059028
00120057
00102889
Must Additional Timeframe for
Data Be Submitted? Submissionl
Yes29*30 18 Months
Yes32/33 18 Months
Yes34'35,36,37,38 18 Months
Yes39 24 Months
Yes40^41 18 Months
Yes42 24 Months
Yes43'44 18 Months
Yes45 18 Months
Yes46 24 Months
Yes47/48 18 Months
Yes49/50'51 18 Months
Yes52 24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Data Requirement
Test
Substance
Does EPA
Have Data To
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted?
Tiraeframe for
Submission^-
§158.240 Residue Chemistry (continued)
- Wheat TEP
Forage, Fodder, and
Straw of Cereal Grains
Group58
- Barley forage, hay
and straw
TEP
- Corn forage and fodder TEP
Partially
Partially
Partially
00022622, 00036168, Yes53/54/55
00036170, 00036171, Yes56'57
00045369, 00046127,
00059029, 00060111,
00061010, 00078482,
00090361, 00127226,
00128778
18 Months
24 Months
00036168, 00036171, Yes59
00059025, 00059027
18 Months
Oat forage, hay
and straw
Rice straw
Rye forage
Sorghum forage,
TEP
TEP
TEP
TEP
Partially
Partially
NO
Partially
00139511
00059028
00120057
00102719
00021755, 00022622, yes60'61'62*63'64 18 Months
00025383, 00030692,
00030697, 00073273,
00075715, 00075724,
00102865, 00127273,
18 Months
18 Months
18 Months
18 Months
Yes
68
fodder and hay
00120057
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
-JN-
Test
Data Requirement Substance
§158.240 Residue Chemistry (continued)
- Wheat forage, hay and TEP
straw
Grass Forage, Fodder and
Hay Group
- Grass, pasture and TEP
rangeland
Miscellaneous
Commodities
- Asparagus TEP
- Pistachios TEP
- Sugarcane TEP
Does EPA
Have Data TO
Satisfy This Bibliographic Must Additional Timeframe for
Requirement? Citation Data Be Submitted? Submission1
Partially 00022622, 00036168, Yes72'73'74 18 Months
00078482, 00127273,
00128778
Partially 00004485, 00028173, Yes75r?6,77,78 is Months
00028200, 00042288,
00061010, 00063507,
00090360, 00102712,
00120057, 00138635,
00144791, 00147047
Partially 00025338, 00060870 Yes79 18 Months
No N/A Yes80 18 Months
Partially 00030701, 00068889, Yes81 18 Months
00079738, 00102640,
00102794, 00115793,
00127823
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Data Requirement
Test
Substance
Does EPA
Have Data To
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted?
Timeframe for
Submission1
ON
§158.
171-4
171-4
240 Residue Chemistry (continued)
- Magnitude of residue in
Meat/Mi Ik/Poult ry/Eggs
- Magnitude of residue
in potable water,
irrigated crops,
and fish
TGAI or
plant
metabolites
TGAI or
plant
metabolites
O 1
Partially 00004701, 00004707, Yes82
00004719, 00059034,
00068892, 00068893,
00102713, 00102714,
00102719
Partially 00028443, 00035913, Yes83
00038429, 00043280,
00043759, 00052597,
00055755, 00102760,
00102788, 00118549
00139511
18 M<
18 M
§158.240 Residue Chemistry Footnotes
1 Data must be submitted within the indicated timeframes, which begin on receipt of the Guidance Document,
except residue studies, which begin on receipt of the Agency's review of the metabolism studies.
2 Data depicting the total terminal residue of ring-labeled [14C]2,4-D in three representative, dissimilar
crops (potatoes, a grain crop, and an orchard fruit crop) are required. Residues must be characterized in
the raw agricultural commodities produced following application of formulated [14C]2,4-D to the crops under
conditions representing normal cropping practices. Exaggerated dosages may be necessary in order to have
sufficient 14C-residues present for characterization. i^C-Residues must also be analyzed by analytical
methods suitable for tolerance enforcement.
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLQROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
3 Metabolism studies characterizing the 2,4-D residues of concern in ruminants and poultry are required. Animals
must be dosed orally for a minimum of 3 days with ring-labeled [14C]2,4-D fed in the diet at a level sufficient
to make residue identification and quantification possible. Milk and eggs must be collected twice a day during
the dosing period. Animals must be slaughtered within 24 hours of the final dose. The distribution and
identity of residues must be determined in milk, eggs, liver, kidney, muscle, and fat. Samples from these
studies must also be analyzed using residue analytical methods for tolerance enforcement to ascertain that
the methods are capable of adequately recovering and identifying all residues of concern.
4 Data depicting the nature of 2,4-D residues in swine are also required if the required metabolism studies
with ruminants and poultry reveal that the metabolism of 2,4-D in these animals differs from that in rats.
5 Validation data must be submitted for all GLC analytical methods used to collect data in support of
tolerances for 2,4-D in plant and animal commodities.
6 The pesticide Analytical Manual (PAM) Vol. I, Sec. 221 rnultiresidue procedure for chlorophenoxy acids will suffice
for the testing of 2,4-D acid (and 2,4-D phenol) in or on raw agricultural commodities under the PAM Vol. I
Multiresidue Protocols I-IV.
7 The nature of the residue of 2,4-D in plants and in animals is not adequately understood. If the requested
plant and animal metabolism studies reveal the presence of additional residues of concern in plant and/or
animal commodities, additional validated methods for data collection and tolerance enforcement may be required.
8 The storage conditions and intervals must be submitted for all samples used to provide data previously
submitted and requested in this Standard to support the established tolerances for 2,4-D residues of concern
in or on raw agricultural commodities. This information must be accompanied by data depicting the percent
decline in 2,4-D residues under the storage conditions and for the intervals specified. Samples bearing
field-weathered residues or fortified samples must be analyzed immediately after harvest or fortification
and again after storage intervals that are equivalent to those reflected in all previously submitted and
currently requested residue data. Storage conditions for the samples must reflect data submitted previously
and in response to requirements of this Standard. The storage intervals selected must allow for reasonable
unforeseen delays in sample analysis. Upon receipt of these data, the adequacy of the established tolerances
for 2,4-D residues of concern in or on raw agricultural commodities will be reevaluated.
9 Residue data may be required after receipt and evaluation of the toxicology data required for each amine and ester.
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2r4-D acid); AMINES AND ESTERS
Footnotes (Continued)
10 If the registrant seeks a crop group tolerance the following additional data are required:
"Additional residue data and label amendments for uses on potatoes (see the requirements for potatoes for more
details).
°Use directions must be proposed and appropriate residue data must be submitted for the additional representative
group members carrots, radishes and sugarbeets.
11 Data depicting 2,4-D residues of concern in or on red potatoes harvested at regular intervals following the last of
two foliar applications of, in separate tests, representative 2,4-D low volatile ester EC formulations (butoxypropyl
or isooctyl) at 0.06 Ib ae/A/application in 5 gal of water/A at 7-day intervals, and the 2,4-D isopropyl ester 1
percent dust (D) formulation at 0.07 Ib ae/A/application at 10-day intervals must be submitted. The registrants must
propose label amendments establishing an appropriate PHI and specifying the allowable range of diluent/A for all
formulations applied as a liquid spray, conditions that must be reflected in the data requested above. Tests must
be conducted in CA (6%), ID (25%), ME (7%), MN (4%) or ND (6%) or WI (6%), and OR (7%) or WA (15%) representing ca.
80 percent of 1985 U.S. potato production.
12 Data depicting the potential for concentration of 2,4-D residues in potato chips, granules or flakes, and wet and
dry peel processed from potatoes bearing measurable weathered residues must be submitted. If residues concentrate
in any of these commodities, appropriate food/feed additive regulations must be proposed.
13 Data depicting 2,4-D residues of concern in or on grapefruit and oranges sampled the day of treatment and
at regular intervals following postharvest treatment with a water-wax emulsion containing 500 ppm ae of a
representative 2,4-D amine salt formulation and a 2,4-D isopropyl ester EC formulation. Tests must be
conducted in CA and FL representing 93 and 98 percent of 1984-85 U.S. grapefruit and orange production,
respectively.
14 Data depicting 2,4-D residues of concern in dried pulp, oil, molasses and juice processed from oranges bearing
measurable weathered residues must be submitted. If the data indicate a potential for residue concentration in any
of these commodities, the registrants must propose appropriate food/feed additive regulations.
15 If the registrant seeks a crop group tolerance the following additional data are required:
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2f4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid)? AMINES AND ESTERS
Footnotes (Continued)
"Additional residue data for apples and label amendments for uses on pears (see individual crops for more details).
°Data depicting 2,4-D residues of concern in or on pears harvested at regular intervals following the last of
multiple, broadcast, directed postemergence applications applied at regular intervals in the minimum amount of water
for good weed covergage of the following (in separate tests): a representative EC formulation containing 2,4-D
acid, at 1.8 lb ae/A/application; and a representative EC formulation of an oil-soluble 2,4-D alkylamine salt at 2
Ib ae/A. The registrants must propose label amendments establishing (i) appropriate PHls, (ii) maximum seasonal
application rates and/or number of applications, and (iii) allowable ranges of diluent for treatment, all of which
must be reflected in the requested data. Tests must be conducted in CA(39%), NY (2%), OR (26%), and WA (30%),
representing ca. 100% of the 1985 U.S. pear production.
16 Data depicting 2,4-D residues of concern in or on apples harvested at regular intervals following the last of
^ multiple, broadcast, directed postemergence applications applied at regular intervals in the minimum amount of
<» water for good weed coverage of the following (in separate tests): a representative emulsifiable concentrate
(EC) formulation containing 2,4-D acid, at 1.8 lb ae/A/application; and a representative EC formulation of an
oil-soluble 2,4-D alkylamine salt at 2 lb ae/A must be submitted. The registrants must propose label amendments
establishing (i) appropriate PHIs, (ii) maximum seasonal application rates and/or number of applications, and (iii)
allowable ranges of diluent for treatment, all of which must be reflected in the requested data. Tests must be
conducted in CA (8%), MI (14%), NY (14%) or PA (7%), and WA (26%), representing ca. 70 percent of 1985 U.S. apple
production.
I"7 Data depicting 2,4-D residues of concern in dry pomace and juice processed from apples bearing measurable
weathered residues must be submitted. If the data indicate a potential for concentration of residues in any of
these processed commodities, appropriate food/feed additive regulations must be proposed.
18 For residue data requirements for pears see Pome Fruits Group footnote. Also, the registrants must propose label
amendments establishing (i) appropriate PHIs, (ii) maximum seasonal, application rates and/or number of
applications, and (iii) allowable ranges of diluent for treatment.
19 Data depicting 2,4-D residues of concern in or on the representative crop group members cherries, peaches,
and plums (fresh prunes) harvested 40 days following the last of two postemergence directed spray applications
of, in separate tests, the 3.8 lb ae/gal Emulsifiable Concentrate Multiple Active Ingredient (EC MAI) formulation
(9.5% 2,4-D acid plus 33.36% 2,4-D triethylamine salt) and the 3.8 lb ae/gal Soluble Concentrate/Liquid (SC/L) MAI
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
formulation (16.3% 2,4-D diethanolamine salt plus 33.2% 2,4-D DMA salt) at 1.4 Ibs ae/A/application (in 20 gal
water/A must be submitted. Tests must be conducted in CA (9%), MI (51%) and OR (12%) or WA (14%) for cherries; in
CA (69%), GA (4%) or SC (11%), and NJ (5%) for peaches; and in ID (9%), MI (22%) and OR (49%) or WA (20%) for plums
(fresh prunes) representing ca. 90, 90, and 80 percent of 1985 U.S. production for the respective fruit crops.
20 Data depicting residues of 2,4-D in or on prunes processed from plums bearing measurable, weathered residues must
be submitted. If the data indicate a potential for residue concentration of residues during processing, an
appropriate food additive regulation must be proposed.
21 if the registrant seeks a crop group tolerance the following additional data are required:
Additional data for blueberries, cranberries, grapes, and strawberries (see individual crops for details).
°Use directions must be proposed and appropriate residue data must be submitted for the additional representative
group member blackberry or other Rubus spp.
22 Data depicting 2,4-D residues of concern in or on blueberries harvested two years following application of a
representative 2,4-D ester EC formulation in an aqueous solution containing 1 Ib ae/50 gal/A must be submitted.
Tests must be conducted in ME where this use is permitted.
23 Data depicting 2,4-D residues of concern in or on cranberries harvested at normal crop maturity following
a single broadcast application of a 2,4-D isooctyl (2-ethylhexyl) G formulation at 3.8 Ib ae/A must be submitted.
Application must be made in the spring after snow and ice have melted from dormant vines. Tests must be conducted
in MA (48%) and WI (36%) representing ca. 80 percent of 1985 U.S. cranberry production.
24 Data depicting 2,4-D residues of concern in or on cranberries harvested 30 days following a single
postemergence foliar application of the 2,4-D DMA salt 78.9 percent crystalline (Cr) formulation at 0.39 Ib ae/A in
130 gal of water/A must be submitted. Tests must be conducted in MA where this use is permitted under EPA SLN Reg.
No. MA830003. Alternatively, the registrant may elect to cancel this use.
25 Data depicting 2,4-D residues of concern in or on cranberries harvested following one postemergence directed
application of the 3.77 Ib/gal EC formulation of 2,4-D DMA salt diluted in water (1:2, 1.26 Ib ae/gal of water) must
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
submitted. Application must be made manually with a soaked towel wrapped on a hockey stick to weeds growing taller
than cranberry plants. Tests must be conducted in MA and wi. Alternatively, the registrant may elect to cancel
this use permitted under EPA SLN Reg. Nos. MA790001 and WI800081.
26 Data depicting 2,4-D residues of concern in or on grapes harvested at regular intervals following
postemergence directed spray application of the 3.8 Ib ae/gal EC MAI formulation (9.5% 2,4-D acid plus
33.36% ae 2,4-D triethylamine salt) in 60 gal of water/A must be submitted. The registrant must propose label
amendments establishing a PHI that is reflected in the data requested above. Tests must be conducted in CA (93%)
and NY (3%), representing ca. 100 percent of 1985 U.S. grape production.
27 Data depicting residues of 2,4-D in or on raisins, raisin waste, dry pomace and juice processed from grapes
bearing measurable weathered residues must be submitted, if the data indicate a potential for residue concentration
any of these commodities, the registrant must propose appropriate food/feed additive regulations.
0 28 Data depicting 2,4-D residues of concern in or on strawberries harvested at regular intervals following early
spring application of a representative 2,4-D amine salt EC formulation at 1.5 Ib ae/A in 20 gal of
water/A must be submitted. The registrant must propose label amendments to establish a PHI which is reflected in
the data requested above. Tests must be conducted in CA (77%) and PL (14%) representing ca. 91 percent of 1985
U.S. strawberry production.
29 Data depicting 2,4-D residues in or on almonds, almond hullsf fecans, and English walrilit§ harvested 60 days
after the last of two applications of representative registered 2f4-D formulations at 1.4 Ib ae/A in 20 gal/A
of water, directed at weeds on the orchard floor must be submitted. Tests must be conducted in CA for almonds and
walnuts and in GA (34%), NM (12%), and TX (32%) for pecans representing ca. 100, 100, and 80 percent of 1985 U.S.
commercial production for the respective nut crops.
30 Data depicting 2,4-D residues in or on filberts harvested 45 days following the last of four applications of
an EC MAI formulation containing 0.95 Ib ae/100 gal water with a spreader-sticker directed spray on suckers must be
submitted. Tests must be conducted in OR which accounted for ca. 100% of the 1985 U.S. filbert production.
31 if the registrant seeks a crop group tolerance, the following additional data are required:
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
"Additional residue data to support the existing tolerances for residues in or on corn (field and fresh), rice,
sorghum, and wheat.
32 The registrants must propose an amendment to all product labels that specifies an appropriate PHI (based on
residue data required for wheat) and maximum seasonal application rates and/or number of applications.
33 Data requested depicting 2,4-D residues in or on wheat grain and in milled products derived from wheat will
be translated to barley. Refer to wheat footnotes for details of data requirements.
34 Data depicting 2,4-D residues of concern in or on corn grain and fresh corn (K+CWHR) harvested at regular
intervals after postemergence treatments of each of the following must be submitted: (i) a representative EC
formulation of 2,4-D acid at 1.4 Ib ae/A applied with ground equipment; (ii) a representative Cr, EC, or SC/L
formulation of a dimethylamine salt at 1.5 Ib ae/A using ground and aerial equipment in separate tests; (iii) a
representative EC formulation of a low volatile ester at 2 Ib ae/A using ground and serial equipment in separate
tests; and (iv) a representative EC formulation of a high volatile ester at 0.6 Ib ae/A applied with ground equipment
and with aerial equipment in 1 gal of oil/A. The tests on corn grain must be conducted in IL (17%), IA (19%), NM
(8%), NE (11%), and OH(6%) which collectively produced ca. 60 percent of 1985 U.S. corn grain. Tests on fresh corn
must be conducted in ID (6%), OR (13%), or WA (12%) and MN (26%) or WI (25%), states that collectively produced ca.
80 percent of 1985 U.S. sweet corn.
35 Data depicting residues of 2,4-D in or on corn grain and fresh corn (K+CWHR) harvested at regular intervals
after layby treatments of each of the following must be submitted: (i) a representative EC or SC/L formulation of a
dimethylamine salt at 0.45 Ib ae/A using ground and aerial equipment in separate tests; (ii) a representative EC
formulation of a low volatile ester at 0.24 Ib ae/A using ground equipment; and (iii) a representative EC formulation
of a high volatile ester at 1.5 Ib ae/A applied with ground equipment. The tests on corn grain must be conducted in
IL (17%), IA (19%), MN (8%), NE (11%), and OH (6%) which collectively produced ca. 60 percent of 1985 U.S. corn
grain. Tests on fresh corn must be conducted in ID (6%), OR (13%), or WA (12%) and MN (26%) or WI (25%), states
that collectively produced ca. 80 percent of 1985 U.S. sweet corn.
36 Data depicting residues of 2,4-D in or on corn grain and fresh corn (K+CWHR) harvested at regular intervals
after postlayby treatments of each of the following must be submitted: (i) a representative EC or SC/L formulation
of a dimethylamine salt at 0.71 Ib ae/A using ground equipment; (ii) a representative EC formulation of a low
volatile ester at 0.48 Ib ae/A using ground equipment; and (iii) a representative EC formulation of a high volatile
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
ester at 0.5 Ib ae/A applied with ground equipment. The tests on corn grain must be conducted in IL (17%), IA
(19%), MN (8%), NE (11%), and OH (6%) which collectively produced ca. 60 percent of 1985 U.S. corn grain. Tests on
fresh corn must be conducted in ID (6%), OR (13%), or WA (12%) and MN (26%) or WI (25%), states that collectively
produced ca. 80 percent of 1985 U.S. sweet corn.
37 Data depicting residues of 2,4-D in or on corn grain harvested at regular intervals after preharvest treatments
(made after the hard dough or denting stage) of each of the following must be submitted: (i) a representative EC or
SC/L formulation of a dimethylamine salt at 1 Ib ae/A using ground and aerial equipment in separate tests; (ii) a
representative EC formulation of a low volatile ester at 1 Ib ae/A using ground and aerial equipment in separate
tests; and (iii) a representative EC formulation of a high volatile ester at 0.97 Ib ae/A applied with ground
equipment and with aerial equipment in 1 gal/water/A must be submitted. The tests on corn grain grain must be
conducted in IL (17%), IA (19%), MN (8%), NE (11%), and OH (6%) which collectively produced ca. 60 percent of 1985
U.S. corn grain.
38 The registrant must propose amendments to all pertinent product labels that specify an appropriate PHI (based
on the requested data) and a maximum seasonal application rate that is reflected in the requested data.
39 Data are required depicting the concentration of 2,4-D residues in starch, crude oil, and refined oil (from
wet milling); grits, meal, flour, crude oil, and refined oil (from dry milling) and grain dust processed from
corn grain bearing measurable weathered residues. If residues concentrate in any of these commodities,
appropriate food/feed additive regulations must be proposed.
40 Data depicting 2,4-D residues of concern in or on millet grain harvested at regular intervals after
postemergence broadcast application of the 3.8 Ib ae/gal EC formulation of 2,4-D alkanolamine salt (ethanol
and isopropanol series) at 1.43 Ib ae/A just before the boot stage, followed in same plot by a
preharvest broadcast application of the same formulation at the same rate when grain is in the dough stage must be
submitted. The postemergence treatments must be applied, in separate tests, in 5 gal of water/A using ground equipme
and 1 gal of water/A using aerial equipment. The registrants must propose label amendments establishing a PHI and
specifying a maximum seasonal use rate or maximum number of applications per season. These amendments must be
reflected in the data requested above. Tests must be conducted in CO (14%) or NE (11%) and SD (53%) or ND (18%)
representing ca. 100 percent of the 1982 U.S. proso millet production.
41 Data depicting 2,4-D residues of concern in or on millet grain harvested at normal crop maturity following
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
postemergence broadcast application of the 2,4-D DMA salt 4 Ib/gal EC formulation at 2 Ib ae/A in 5 gal of
water/A when the crop is 4 to 6 inches tall must be submitted. Tests must be conducted in ND where this use is
permitted by EPA SLN No. ND820015. Alternatively, the registrant may elect to cancel this special local needs use.
42 Data depicting the potential for concentration of 2,4-D residues of concern in the hulls, meal, and flour
processed from grain bearing measurable weathered residues must be submitted. If residues concentrate in any of
these milled products, the registrant must propose appropriate food/feed additive regulations.
43 The registrants must propose an amendment to all product labels that specifies an appropriate PHI (based on
residue data required for wheat) and maximum seasonal application rates and/or number of applications.
44 The required data depicting 2,4-D residues in or on wheat grain and in milled products derived from wheat
will be translated to oats. Refer to wheat footnotes for details of data requirements.
45 Data depicting 2,4-D residues of concern in or on rice grain harvested at regular intervals following the
last of multiple, broadcast, directed postemergence applications applied at regular intervals in the minimum
amount of water for good weed coverage of the following (in separate tests) must be submitted : (i) a representative
EC formulation containing 2,4-D as the acid and n-oleyl-l,3-propylenediamine salt at 0.9 Ib ae/A; (ii) the 2.87
Ib/gal invert-emulsifiable concentrate (InEC) formulation of the alkylamine (derived from tall oil) salt at 2.9 Ib
ae/A; (iii) a representative Soluble Concentrate/Solid (SC/S) formulation of the lithium salt at 1.5 Ib ae/A (using
ground and aerial equipment); and (iv) the 4 Ib/gal EC formulation of the propylene glycol butyl ether ester of
2,4-D at 1.25 Ib ae/A. The registrants must propose label amendments establishing: (i) appropriate PHIs; (ii)
maximum seasonal application rates and/or number of applications and (iii) volume of water to be used as diluent in
ground and aerial applications all of which must be reflected in the requested data. Tests must be conducted in AR
(40%), LA (15%), and TX (13%), representing ca. 70 percent of 1985 U.S. production of rice.
46 Data depicting 2,4-D residues of concern in the milled products of rice (bran, hulls, and polished
rice) processed from rice bearing measurable weathered residues must be submitted. If the data indicate a potential
for concentration of residues in any of these processed commodities, appropriate food/feed additive regulations
must be proposed.
47 The registrants must propose an amendment to all product labels that specifies an appropriate PHI (based
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
on residue data required for wheat) and maximum seasonal application rates and/or number of applications.
48 Data required depicting residues of 2,4-D in or on wheat grain and in milled fractions derived from wheat
will be translated to rye. Refer to wheat footnotes for details of data requirements.
49 Data depicting 2f4-D residues of concern in or on sorghum grain harvested at regular intervals following
the last of multiple, postemergence, directed spray applications applied at regular intervals in the minimum
amount of diluent for good weed coverage of the following must be submitted: the 79 percent EC acid formulation
at 1 Ib ae/A; the 2.87 Ib/gal InEC alkylamine (derived from tall oil) salt formulation at 2.9 Ib ae/A (using ground
and aerial equipment in separate tests); a representative EC or SC/L diethanolamine salt formulation at 1 Ib
ai/A; a representative EC butoxypropyl ester formulation at 0.6 Ib ae/A; and a representative EC butyl ester
formulation at 0.5 Ib ae/A. Applications must be made when sorghum is 8 to 10 inches high. The registrants must
propose label amendments establishing (i) appropriate PHIs, (ii) maximum seasonal application rates and/or number of
applications, and (ii) allowable ranges of diluent for treatment, all of which must be reflected in the requested
data. Tests must be conducted in KS (26%), MO (11%), NE (14%) and TX (22%) which accounted for ca. 70 percent of
the 1985 U.S. sorghum production.
50 Data depicting 2,4-D residues of concern in or on sorghum harvested at regular intervals after postemergence
broadcast application of a representative SC/S formulation of 2,4-D lithium salt at 0.75 Ib ae/A must be submitted.
Ground applications must be made in at least 5 gal/A and aerial applications must be made in at least 1 gal/A when
the crop is 4 inches high. The registrants must propose a label amendment establishing a PHI and specifying a
maximum seasonal use rate or maximum number of applications per season. These amendments must be reflected in the
data requested above.
51 Data depicting 2,4-D residues of concern in or on sorghum harvested at regular intervals following
application of the 5.64 Ib/gal EC formulation of 2,4-D butyl ester must be submitted. The registrant must
propose label amendments specifying the rates of application, a maximum seasonal use rate or maximum number of
applications per season, and establishing a PHI. These amendments must be reflected in the data
requested above. Tests must be conducted in KS. Alternatively, the registrant may elect to cancel
this use permitted under EPA SLN No. KS820008.
52 Data depicting the potential for concentration of 2,4-D residues of concern in flour and starch processed
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
from grain bearing measurable weathered residues must be submitted. If residues concentrate in any of these milled
products, the registrant must propose appropriate food additive regulations.
53 Data depicting 2,4-D residues of concern in or on wheat grain harvested at regular intervals after postemergence
broadcast application of the following must be submitted: (i) a representative EC MAI formulation containing 2,4-D
acid plus n-oleyl-l,3-propylenediamine salt at 1.42 Ib ae/A in 5 gal water/A using ground equipment, and in a
separate test, using aerial equipment in the minimum amount of diluent for adequate coverage; (ii) a representative
(SC/S) formulation of 2,4-D lithium salt at 0.5 Ib ae/A in 20 gal water/A using ground equipment only; (iii) the
2.87 Ib ae/gal InEC formulation of 2,4-D alkylamine salt (derived from tall oil) at 2.9 Ib ae/A using ground and
aerial equipment, in separate tests, in the minimum amount of diluent for adequate coverage; (iv) a representative
EC formulation of 2,4-D butoxyethyl ester at 0.95 Ib ae/A in 5 gal water/A and in 2 gal oil/A using ground and
aerial equipment respectively, in separate tests; (v) a representative EC formulation of 2,4-D butyl ester at 1.4
Ib ae/A in 5 gal water/A using ground equipment and in 1 gal water/A using aerial equipment in separate tests; and
(vi) a representative EC or SC/L formulation of 2,4-D dimethylamine salt at 1.44 Ib ae/A in 10 gal of water/A using
ground equipment and in a separate test in 3 gal water/A using aerial equipment. The registrant must amend all
2,4-D product labels specifying appropriate PHls, minimum amounts of diluent, and a maximum seasonal use rate or
maximum number of applications per season. These amendments must be reflected in the data requested above. Tests
must be conducted in KS (18%), or CO (6%), MN (6%), ND (13%), or SD (5%), TX (8%) or OK (7%), and WA (5%) or MT
(2%) since these states collectively accounted for ca. 70 percent of 1985 U.S. total wheat-growing regions in the
U.S.
54 Data depicting 2,4-D residues of concern in or on wheat grain harvested at regular intervals following
preharvest broadcast applications of the following must be submitted: (i) a representative EC MAI formulation
containing 2,4-D acid plus n-oleyl-l,3-propylenediamine salt at 1.42 Ib ae/A in 5 gal water/A using ground equipment,
in a separate test and using aerial equipment in the minimum amount of diluent for adequate coverage; (ii) the 3.8 Ib
ae/gal SC/L MAI formulation (16.3% diethanolamine salt plus 33.2% dimethylamine salt) at 1.5 Ib ae/A using ground
and aerial equipment in separate tests in the minimum amount of diluent for adequate coverage; (iii) a representative
EC formulation of 2,4-D propylene glycol butyl ether ester at 1 Ib ae/A using ground and aerial equipment, in
separate tests, in the minimum amount of diluent for adequate coverage; and (iv) the 6 Ib ae/gal EC MAI formulation
(38.8% butyl ester plus 36.8% isopropyl ester) at 1.12 Ib ae/A in 1 gal oil/A. The registrants must amend all 2,4-D
product labels specifying appropriate PHIs, minimum amount of diluent, and a maximum seasonal use rate or maximum
number of applications per season. These amendments must be reflected in the data requested above.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
55 Data depicting 2,4-D residues of concern in or on wheat grain harvested at regular intervals following
postemergence broadcast applications of the 3.8 Ib ae/gal SC/L MAI formulation containing 2,4-D acid plus
2,4-D DMA salt at 1 Ib ae/A must be submitted. Applications must be made in 1 and 0.5 gal water/A using ULV ground
and aerial equipment, respectively, in separate tests. Tests must be conducted in ID, KS, MT, NE, ND, OR, SD, UT,
and WA states in which this use is permitted. The registrant must amend all product labels specifying an
appropriate PHI and a maximum number of applications per season or a maximum seasonal application rate.
Alternatively, the registrants may cancel this use permitted under EPA SLN Nos. ID820032, KS830014, MT820011,
NE830006, ND820013, OR820056, SD830004, UT830002, and WA820057.
56 Data depicting 2,4-D residues of concern in bran, middlings, shorts, and grain dusts processed from wheat
grain bearing measurable weathered residues must be submitted. The established food/feed additive regulations for
residues of 2,4-D in milled products (excluding flour) will be reassessed following evaluation of these data.
57 The registrant must propose food additive regulations for residues of 2,4-D in flour. 2,4-D residues may
concentrate up to 2x in flour processed from treated wheat grain. The establishment of any regulation is dependent
upon toxicological considerations.
58 Available data are insufficient to determine the appropriateness of a crop group tolerance. Additional data are
required to support the established tolerances for residues in or on corn, wheat, and one additional member of the
cereal grains group.
59 Data required for wheat forage will be translated to barley forage. Refer to wheat forage footnote for details of
data requirements. The registrant must propose amendments to all product labels that specify an appropriate PHI
(based on residue data required for wheat) and maximum seasonal application rates and/or number of applications.
60 Data depicting 2,4-D residues of concern in or on corn forage and fodder harvested at regular intervals
after postemergence treatments of each of the following must be submitted: (i) a representative EC formulation of
2,4-D acid at 1.4 Ib ae/A applied with ground equipment; (ii) a representative Cr, EC, or SC/L formulation of a
dimethylamine salt at 1.5 Ib ae/A using ground and aerial equipment in separate tests; (iii) a representative EC
formulation of a low volatile ester at 2 Ib ae/A using ground and aerial equipment in separate tests; and (iv) a
representative EC formulation of a high volatile ester at 0.6 Ib ae/A applied with ground equipment and with aerial
equipment in 1 gal of oil/A. The tests on corn grain must be conducted in IL (17%), IA (19%), MN (8%), NE (11%),
and OH(6%) which collectively produced ca. 60 percent of 1985 U.S. corn grain. Tests on fresh corn must be
conducted in ID (6%), OR (13%), or WA (12%) and MN (26%) or WI (25%), states that collectively produced ca. 80
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
percent of 1985 U.S. sweet corn.
61 Data depicting 2,4-D residues of concern in or on corn forage and fodder harvested at regular intervals
after layby treatments of each of the following must be submitted: (i) a representative EC or SC/L formulation of
a dimethylamine salt at 0.45 Ib ae/A using ground and aerial equipment in separate tests; (ii) a representative EC
formulation of a low volatile ester at 0.24 Ib ae/A using ground equipment; and (iii) a representative EC formulation
of a high volatile ester at 1.5 Ib ae/A applied with ground equipment. The tests on corn grain must be conducted in
IL (17%), IA (19%), MN (8%), NE (11%), and OH (6%) which collectively produced ca. 60 percent of 1985 U.S. corn
grain. Tests on fresh corn must be conducted in ID (6%), OR (13%), or WA (12%) and MN (26%) or WI (25%), states that
collectively produced ca. 80 percent of 1985 U.S. sweet corn.
62 Data depicting 2,4-D residues of concern in or on corn forage and fodder harvested at regular intervals
after postlayby treatments of each of the following must be submitted: (i) a representative EC or SC/L formulation
of a dimethylamine salt at 0.71 Ib ae/A using ground equipment; (ii) a representative EC formulation of a low
volatile ester at 0.48 Ib ae/A using ground equipment; and (iii) a representative EC formulation of a high volatile
ester at 0.5 Ib ae/A applied with ground equipment. The tests on corn grain must be conducted in IL (17%), IA
(19%), MN (8%), NE (11%), and OH (6%) which collectively produced ca. 60 percent of 1985 U.S. corn grain. Tests on
fresh corn must be conducted in ID (6%), OR (13%), or WA (12%) and MN (26%) or WI (25%), states that collectively
produced ca. 80 percent of 1985 U.S. sweet corn.
63 Data depicting 2,4-D residues of concern in or on corn forage and fodder harvested at regular intervals
after preharvest treatments (made after the hard dough or denting stage) of each of the following must be
submitted: (i) a representative EC or SC/L formulation of a dimethylamine salt at 1 Ib ae/A using ground and aerial
equipment in separate tests; (ii) a representative EC formulation of a low volatile ester at 1 Ib ae/A using ground
and aerial equipment in separate tests; and (iii) a representative EC formulation of a high volatile ester at 0.97
Ib ae/A applied with ground equipment and with aerial equipment in 1 gal/water/A. The tests on grain must be
conducted (17%), IA (19%), MM (8%), NE (11%), and OH (6%) which collectively produced ca. 60 percent of 1985 U.S.
corn grain.
64 The registrant must propose label amendments to all products that specify an appropriate PHI (based on the required
data) and a maximum seasonal application rate.
65 since oat hay is a raw agricultural commodity, the registrant must propose tolerances and submit appropriate
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
supporting residue data. Alternatively, the registrant may amend all pertinent labels to prohibit the feeding
of oat hay to livestock.
66 Data required for wheat forage will be translated to oat forage. Refer to wheat forage footnotes for details
of data requirements.
67 Data depicting 2,4-D residues of concern in or on rice straw harvested at regular intervals following the
last of multiple, broadcast, directed, postemergence applications applied at regular intervals in the minimum
amount of water for good weed coverage of the following (in separate tests) must be submitted: (i) a representative
EC formulation containing 2,4-D as the acid and n-oleyl-l,3-propylenediamine salt at 0.9 Ib ae/A; (ii) the 2.87
Ib/gal inEC formulation of the alkylamine (derived from tall oil) salt at 2.9 Ib ae/A; (iii) a representative SC/S
formulation of the lithium salt at 1.5 Ib ae/A (using ground aerial equipment); and (iv) the 4 Ib/gal EC formulation
of the propylene glycol butyl ether ester at 1.25 Ib ae/A. The registrants must propose label amendments
establishing (i) appropriate PHls; (ii) maximum seasonal application rates and/or number of applications; and (iii)
volume of water to be used as diluent in ground and aerial applications, all of which must be reflected in the
requested data. Tests must be conducted in AR (40%), LA (15%), and TX (13%), representing ca. 70 percent of 1985
U.S. production of rice.
68 Data required for wheat forage will be translated to rye forage. Refer to wheat forage footnotes for details of da
requirements.
69 Data depicting 2,4-D residues of concern in or on sorghum forage and sorghum fodder harvested at regular
intervals following the last of multiple postemergence directed spray applications applied at regular
intervals in the minimum amount of diluent for good weed coverage of the following must be submitted: the 79 percent
EC formulation containing 2,4-D as the acid at 1 Ib ae/A; the 2.87 Ib/gal InEC formulation of 2,4-D alkylamine
(derived from tall oil) salt at 2.9 Ib ae/A; a representative EC or SC/L formulation of 2,4-D diethanolamine
salt at 1 Ib ae/A (using ground and aerial equipment in separate tests); a representative EC formulation of
2,4-D butoxypropyl ester at 0.6 Ib ae/A; and a representative EC formulation of 2,4-D butyl ester at 0.5 Ib
ae/A (in 10 gal/A using ground equipment and 3 gal/water/A using aerial equipment, in separate tests). Applications
must be made when sorghum is 8 to 10 inches high. The registrants must propose label amendments establishing:
(i) appropriate PHIs, (ii) maximum seasonal application rates and/or number of applications, and (iii) allowable
ranges of diluent for treatment, all of which must be reflected in the requested data. Tests must be conducted
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2f4-D acid); AMINES AND ESTERS
Footnotes (Continued)
in KS (26%), MO (11%), NE (14%) and TX (22%) which accounted for ca. 70 percent of the 1985 U.S. sorghum
production.
70 Data depicting 2,4-D residues of concern in or on sorghum forage and fodder harvested at regular intervals
after postemergence broadcast application of a representative SC/S formulation of 2,4-D lithium salt at
0.75 Ib ae/A must be submitted. Ground applications must be made in at least 5 gal/water/A and aerial applications
must be made in at least 1 gal/water/A when the crop is 4 inches high. The registrants must propose a label
amendment establishing a PHI and specifying a maximum seasonal use rate or maximum number of applications per
season. These
amendments must be reflected in the data requested above.
71 Data depicting 2,4-D residues of concern in or on sorghum forage and fodder harvested at regular intervals
following application of the 5.64 Ib/gal EC formulation of 2,4-D butyl ester must be submitted. The registrant must
propose label amendments specifying the rates of application, a maximum seasonal use rate or maximum number of
applications per season, and establishing a PHI. These amendments must be reflected in the data requested above.
Tests must be conducted in KS. Alternatively, the registrant may elect to cancel this use permitted under EPA SLN
No. KS820008.
72 Data depicting 2,4-D residues of concern in or on wheat forage harvested 14 days after postemergence
broadcast application of the following must be submitted, (i) a representative EC MAI formulation containing 2,4-D
acid plus n-oleyl-l,3-propylenediamine salt at 1.42 Ib ae/A in 5 gal water/A using ground equipment, and in a
separate test, using aerial equipment in the minimum amount of diluent for adequate coverage; (ii) a representative
SC/S formulation of 2,4-D lithium salt at 0.5 Ib ae/A in 20 gal water/A using ground equipment only; (ii) the 2.87
Ib ae/gal InEC formulation of 2,4-D alkylamine salt (derived from tall oil) at 2.9 Ib ae/A using ground and aerial
equipment, in separate tests, in the minimum amount of diluent for adequate coverage; (iv) a representative EC
formulation of 2,4-D butoxyethyl ester at 0.95 Ib ae/A in 5 gal water/A and in 2 gal oil/A using ground and aerial
equipment respectively, in separate tests; (v) a representative EC formulation of 2,4-D butyl ester at 1.4 Ib ae/A
in 5 gal water/A using ground equipment and in 1 gal water/A using aerial equipment in separate tests; and (vi) a
representative EC or SC/L formulation of 2,4-D dimethylamine salt at 1.44 Ib ae/A in 10 gal of water/A using ground
equipment and in a separate test in 3 gal water/A using aerial equipment. The registrants must amend all 2,4-D
product labels specifying appropriate PHls, minimum amount of diluent, and a maximum seasonal use rate or maximum
number of applications per season. These amendments must be reflected in the data requested above. Tests must be
conducted in KS (18%), or CO (6%), MN (6%), ND (13%), or SD (5%), TX (8%) or OK (7%), and WA (5%) or MT (2%) since
these states collectively accounted for ca. 70 percent of 1985 U.S. total wheat-growing regions in the U.S.
-------
00
o
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
73 Data depicting 2,4-D residues of concern in or on wheat forage harvested 14 days following preharvest
broadcast applications of the following must be submitted: (i) a representative EC MAI formulation containing 2,4-D
acid plus n-oleyl-l,3-propylenediamine salt at 1.42 Ib ae/A in 5 gal water/A using ground equipment, and in a
separate test, using aerial equipment in the minimum amount of diluent for adequate coverage; (ii) the 3.8 Ib ae/gal
SC/L MAI formulation (16.3% diethanolamine salt plus 33.2% dimethylamine salt) at 1.5 Ib ae/A using ground and
aerial equipment in separate tests in the minimum amount of diluent for adequate coverage; (iii) a representative EC
formulation of 2,4-D propylene glycol butyl ether ester at 1 Ib ae/A using ground and aerial equipment, in separate
tests, in the minimum amount of diluent for adequate coverage; and (iv) the 6 Ib ai/gal EC MAI formulation (38.8%
butyl ester plus 36.8% isopropyl ester) at 1.12 Ib ae/A in 1 gal oil/A. The registrants must amend all 2,4-D product
labels specifying appropriate PHIs, minimum amount of diluent, and a maximum seasonal use rate or maximum number of
applications per season. These amendments must be reflected in the data requested above.
74 Data depicting 2,4-D residues of concern in or on wheat forage harvested at regular intervals following
postemergence broadcast applications of the 3.8 Ib ae/gal SC/L MAI formulation containing 2,4-D acid plus
2,4-D DMA salt at 1 Ib ae/A must be submitted. Applications must be made in 1 and 0.5 gal water/A using ULV ground
and aerial equipment respectively, in separate tests. Tests must be conducted in ID, KS, MT, NE, ND, OR, SD, UT, and
WA, states in which this use is permitted. The registrant must amend all product labels specifying an appropriate
PHI and a maximum number of applications per season or a maximum seasonal application rate. Alternatively, the
registrants may cancel this use permitted under EPA SLN Nos. ID820032, KS830014, MT820011, NE830006, ND820013,
OR820056, SD830004, UT830002, and WA820057.
75 Data depicting 2,4-D residues of concern in or on rangeland and pasture grasses (7 day PGI), and grass
hay harvested 30 days following application in the minimum amount of water for good weed coverage of the
following (in separate tests) must be submitted, (i) a representative EC formulation containing 2,4-D acid at 2.8
Ib ae/A by ground equipment; (ii) a representative SC/S formulation containing an inorganic salt at 3.0 Ib ae/A by
ground equipment; (iii) a representative EC formulation containing an amine salt and 2,4-D acid at 5.7 Ib ae/A by
ground or aerial equipment; (v) a representative EC or SC/L formulation containing a low volatile ester at 3.87 Ib
ae/A in oil by aerial equipment; (vii) a representative EC formulation containing a high volatile ester at 13.1 Ib
ae/A by dilute (up to 400 gal/A) ground equipment; and, (viii) a representative EC formulation containing a high
volatile ester at 3.0 Ib ae/A in oil by ground or aerial equipment. The registrant must include the 7-day PGI and
the 30-day PHI for grass hay on all labeling, in addition, the registrant must lower the existing 7-day PSI to 3
days on all labeling. Tests must be conducted in AR (3%), KS (4%), KY (6%), MO (11%), NY (5%), OK (4%), PA (4%), TN
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2f4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
(4%), TX (13%), and VA (3%) which produced ca. 60 percent of the total 1982 domestic hay crop (other than alfalfa
and small grains) and which may represent pasture grasses as well. For rangeland grasses, tests must be conducted
in KS (8%), MT (6%), NE (17%)f ND (10%), OK (5%), SD (12%), and WY (5%) which produced ca. 63 percent of the total
wild hay.
76 Data depicting 2,4-D residues of concern in or on rangeland or pastureland grass 7 days (30 days for grass
hay) following application of a RTU formulation containing a water-soluble amine salt at 3.0 Ib ae/A applied
undiluted by aerial equipment must be submitted. Tests must be conducted in WA. Alternatively, the registrant may
elect to cancel this use permitted under EPA SLN WA790065.
77 Data depicting 2,4-D residues of concern in or on rangeland or pastureland grass 7 days (30 days for grass
hay) following application of an 18.8% G formulation containing an isooctyl ester at 1.88 Ib ae/A by spreader
must be submitted. Tests must be conducted in MT. Alternatively, the registrant may elect to cancel this use
permitted under EPA SLN MT850005.
78 The registrant must propose a maximum seasonal use rate or number of treatments per season and the allowable
ranges of diluent for treatment all of which must be reflected in the requested data.
79 Data depicting 2,4-D residues of concern in or on asparagus following two 2 Ib ae/A applications at 30-day
intervals of the 79 percent EC acid, the 80.5 percent SC/L sodium salt, and the 3.8 Ib ae/gal EC alkanolamine
salt (ethanol and isopropanol series) formulations (each formulation must be applied in a separate test using
both ground and aerial equipment with 60 and 12 gal/A of water, respectively) must be submitted. Applications must
be made in April and May and if asparagus spears are visible must be delayed until after cutting. The registrant
must propose a minimum postharvest interval. Tests must be conducted in CA (39%) or WA (31%) and MI (20%) which
collectively accounted for ca. 90 percent of the U.S. asparagus acreage.
80 Data depicting 2,4-D residues of concern in or on pistachios harvested 60 days following the last of two
postemergence directed spray applications of the 3.8 Ib ae/gal EC MAI formulation (16.3% 2,4-D diethanolamine
salt plus 33.2% 2,4-D DMA salt) at 1.4 Ibs ae/A/application (in 20 gal water/A) must be submitted. Tests must be
conducted in CA which accounted for ca. 100 percent of the 1982 U.S. pistachio production.
81 Data depicting residues of 2,4-D in or on sugarcane and sugarcane forage harvested at regular intervals
following each of these treatment schedules must be submitted: (i) broadcast applications of a representative MAI
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2r4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Footnotes (Continued)
formulation containing 2,4-D acid and the N-oleyl-l,3-propylenediamine salt of 2,4-D at 1.8 Ib ae/A made
postemergence at layby; (ii) preemergence and postemergence broadcast or band applications of a representative
EC or SC/L formulation of the dimethylamine salt of 2,4-D at 2 Ib ae/A; and (iii) broadcast applications of a
representative EC formulation of the 2-butoxyethyl ester or the isooctyl ester form of 2f4-D at 1.9 Ib/A made
postemergence through layby. The required data must reflect the use of ground and aerial equipment in separate
tests. The registrant must amend all pertinent labels to specify a PHI and a maximum number of applications per
season. Tests must be conducted in PL (47%), HI (29%), and LA (20%), states that collectively accounted for 96
percent of 1985 U.S. production of sugarcane. The established food/feed additive regulations for residues in
sugarcane molasses and bagasse will be reassessed following evaluation of these data.
82 upon receipt of the required plant metabolism, residue data for feed items, and validation of analytical
methods, the need for and nature of tolerances for 2,4-D residues of concern in livestock and poultry will be
assessed.
83 A metabolism study must be submitted in which fish are exposed (for at least 3 days) to water containing
[14c]2,4-D at a concentration sufficiently high to permit complete quantification and characterization
of l^C-residues in edible tissues (flesh and skin).
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
oa
Data
$158
Requirement
.340 - Toxicology
Does EPA
Have Data To
Test Satisfy This
Substance Requirement
Bibliographic Must Additional.
Citation Data Be
Submitted?
Timeframe
for
Submission!
ACUTE TESTING:
81-1
- Acute Oral Toxicity
- Rat
ACID -
TGAI
AMINE - TGAI
ESTER - TGAI
81-2
- Acute Dermal Toxicity
- Rabbit
ACID -
TGAI
AMINE - TGAI
ESTER - TGAI
81-3
Yes
NO
Partially
Yes
NO
Partially
00101605,
00101595,
00138284,
00101596
00101592,
00138284,
00101591
00101601
40629801
00101600
40629802
NO
Yes 2
Yes 3
NO
Yes2
Yes3
9
9
9
9
Months
Months
Months
Months
- Acute Inhalation Toxicity
- Rat
ACID -
AMINE -
TGAI
TGAI
ESTER - TGAI
81-4
81-5
81-6
- Eye irritation
- Rabbit
- Dermal irritation
- Rabbit
Dermal Sensitization
-Guinea Pig
ACID -
AMINE -
ESTER -
ACID -
AMINE -
ESTER -
ACID -
AMINE -
ESTER -
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Yes
NO
partially
NO
NO
Partially
NO
NO
Partially
Yes
NO
Partially
00161660
40352701,
40352702,
40352703,
00161659
00156564,
40629803
40629804
40629805
00156637
NO
Yes2
Yes4
Yes
Yes2
Yes4
Yes
Yes2
Yes4
NO
Yes2
Yes4
9
9
9
9
9
9
9
9
9
9
Months
Months
Months
Months
Months
Months
Months
Months
Months
Months
40352704. 40629806
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TABLE A
GENERIC DATA REQUIREMENTS FDR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2f4-D acid); AMINES AND ESTERS
Data Requirement
Test
Substance
Does EPA
Have Data To
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data be Submitted?
Timeframe
for
Submission^
00
§158.340 - Toxicology - Continued
81-7 - Acute Delayed
Neurotoxicity
- Hen
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding:
- Rodent, and
- Non-rodent (Dog)
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation:
82-5 - 90-Day Neurotoxicity:
ACID - TGAI NO
AMINE - TGAI No
ESTER - TGAI No
ACID - TGAI
AMINE - TGAI
ESTER - TGAI
ACID - TGAI
AMINE - TGAI
ESTER - TGAI
ACID - TGAI
AMINE - TGAI
ESTER - TGAI
ACID - TGAI
AMINE - TGAI
ESTER - TGAI
ACID - TGAI
AMINE - TGAI
ESTER - TGAI
ACID - TGAI
AMINE - TGAI
ESTER - TGAI
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
MO5
NO5
NO5
NO6
Yes
Yes
NO7
Yes
Yes
Yes
Yes
Yes
No8
No8
No8
NO8
NO8
NO8
15 Months
15 Months
18 Months
18 Months
12 Months
12 Months
12 Months
NO
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TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
OJ
VJI
Data Requirement
CHRONIC TESTING
83-1 - Chronic Toxicity -
2 species:
- Rodent, and
- Non-rodent (Dog)
83-2 - Oncogenicity -
2 species:
- Rat
- Mouse
83-3 - Teratogenicity -
2 species:
- Rat
- Rabbit
Does EPA
Have Data To
Test Satisfy This
Substance Requirement?
ACID -
AMINE -
ESTER -
ACID -
AMINE -
ESTER -
ACID -
AMINE -
ESTER -
ACID -
AMINE -
ESTER -
ACID -
AMINE -
ESTER -
ACID -
AMINE -
ESTER -
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Yes
No
NO
NO
NO
NO
Partially
No
No
Partially
NO
No
Yes
NO
No
No
No
NO
Bibliographic Must Additional
Citation Data be
Submitted?
00160876 No
Reserved1^11
Reserved1**,11
Yes11
Reserved1*}/11
00160876 Reserved12
Reserved1*^
Reserved1*}
40061801 Reserved12
Reserved1*}
Reserved ifl
00130407, 00130707 No
Yes
Yes
Yes
Yes
Yes
Timeframe
for
Submission*
50 Months
15 Months
15 Months
15 Months
15 Months
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
0}
Data Requirement
Test
Substance
Does EPA
Have Data To Bibliographic Must Additional
Satisfy This Citation Data be
Requirement? Submitted? .
Timeframe
for
Submission1
§158.340 - Toxicoloqy - Continued
83-4
- Reproduction - Rat
2-generation
ACID -
AMINE
ESTER
TGAI
- TGAI
- TGAI
Yes
No
No
00150557 Reserved13
Reserved13
Reserved13
MUTAGENICITY TESTING
84-2
84-2
84-2
- Gene Mutation
- Structural Chromosomal
Aberration
- Other Mechanisms of
Mutagenicity
ACID -
AMINE -
ESTER -
ACID -
AMINE -
ESTER -
ACID -
AMINE -
ESTER -
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
No
No
No
NO
NO
NO
NO
NO
NO
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
SPECIAL TESTING
85-1
81-X
- General Metabolism
- Neurotoxicity (dermal)
ACID -
AMINE -
ESTER -
ACID -
AMINE -
ESTER -
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
NO
NO
NO
NO
NO
NO
Yes
Yes
Yes
Yes14
Yes14
Yes14
24 Months
24 Months
24 Months
12 Months
12 Months
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
§158.340 Toxicology Footnotes
1 Data must be submitted within the indicated timeframes, which begin on receipt of the Guidance Document.
2 Data must be submitted for each amine derivative of 2,4-D. The data submitted on 2,4-D Triethanolamine Salt
could not be reviewed as the compound tested was not sufficiently identified (MRIDs 40515701, 40515702, 40515703,
40515704, 40515705, 40515706).
3 The Agency has acceptable data on 2,4~D butoxyethyl ester, 2,4-D isooctyl ester, 2,4-D idobutyl ester and 2,4-D
isopropyl ester. Data must be submitted for each remaining ester derivative of 2,4-D.
4 The Agency has acceptable data on 2,4-D butoxyethyl ester and 2,4-D isopropyl ester. Data must be submitted for
each remaining ester derivative of 2,4-D.
5 This test is required only for compounds which are organophosphate inhibitors of cholinesterase, or related to
such inhibitors or metabolites of such inhibitors. 2,4-D acid and its salts, amines and esters are not
organophosphates, therefore, a study is not required.
6 This requirement is waived for 2,4-D acid based on the submission of an acceptable chronic feeding study in the rat.
7 This requirement is waived for 2,4-D acid based on the requirement of a chronic feeding study in the nonrodent.
8 This study is not required for the registered use patterns.
9 since an acute neurotoxicity study is not required for these compounds, this study is not required. If evidence of
neurotoxicity in a mammalian species is observed a study will be required in that species.
10 upon receipt and evaluation of the data required for each amine and ester, additional chronic toxicology and
residue data may be required. Upon determination by the Agency that these studies are required, registrants will
be notified and data will be due 50 months from date of notification.
-------
OJ
0}
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2f4-D acid); AMINES AND ESTERS
§158.340 Toxicology Footnotes (Continued)
H Registrants who conduct chronic feeding studies must inform the Agency in writing of the dosage levels planned
and their reasons for believing that the highest dose approaches or equals the Maximum Tolerated Dose observed in
subchronic or range finding studies, and must also consult with the Agency to determine that the appropriate
dosage levels are being used in the chronic feeding and/or oncogenicity studies. If registrants do not consult with
the Agency and EPA determines that the dosages used were too low to assess long term toxic effects, the Agency will
determine that the submitted studies do not satisfy applicable requirements and may issue a Notice of Intent to
Suspend the product(s).
12 Reserved pending independent evaluation of all kidney slides from the relevant chronic and subchronic studies.
13 Upon receipt and evaluation of the data required for each amine and ester, additional chronic toxicology and
residue data may be required. Upon determination by the Agency that these studies are required, registrants will be
notified and data will be due 39 months from date of notification.
14 A protocol must be submitted and approved by the Agency prior to submission of this study. For such studies the
following must be addressed.
°An experimental animal species must be chosen that has been shown to respond to a "chemical known
to produce sensory paresthesiaes like those seen most often in the case reports".
"Parameters observed must have been shown to detect the effects, in experimental animals, of a known
neurotoxin having this type of effect in man.
°The dose tested must be a single large dermal dose, in the order of an LD^' which produces obvious
signs of toxicity. The dose may be applied to the skin of the back and the test animals observed for
at least 30 days after dosing.
°The compound tested should be 2,4-D acid or Na salt and each of the organic amine salts and organic
esters.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS1
oj
Test
Data Requirement Substance
Does EPA
Have Data To
Use Satisfy This Bibliographic Must Additional Timeframe for
Patterns Requirement? Citation Data Be Submitted? Submission^
§158.290 Environmental Fate
DEGRADATION STUDIES-IAB:
161-1
- Hydrolysis TGAI or
PAIRA
A,B,C,D,G
No
Yes
9 Months
Photodegradat ion
161-2
161-3
161-4
- In water TGAI or
- On soil TGAI or
- In Air TGAI or
PAIRA
PAIRA
PAIRA
A,B,C,D,G
A,G
A
No
No
No
Yes
Yes
Yes
9 Months
9 Months
9 Months
METABOLISM STUDIES-LAB:
162-1
162-2
162-3
162-4
- Aerobic Soil TGAI or
- Anaerobic Soil TGAI or
- Anaerobic Aquatic TGAI or
- Aerobic Aquatic TGAI or
PAIRA
PAIRA
PAIRA
PAIRA
A,B,G
A
C,D,G
C,D
Partially 00116625
No
No
No
Yes3
Yes
Yes
Yes
27 Months
27 Months
27 Months
27 Months
MDBILITY STUDIES:
163-1
163-2
163-3
- Leaching and TGAI or
Adsorption/ Desorpt ion
- Volatility (Lab) TEP
- Volatility (Field) . TEP
PAIRA
A,B,C,D,G
A
A
Partially 00057313
00112937
No
No
Yes^
Yes
Yes
12 Months
12 Months
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS1
Data Requirement
§158.290 Environmental Fate -
Test
Substance
• Continued
Use
Patterns
Does EPA
Have Data To
Satisfy This Bibliographic
Requirement? Citation
Must Additional Timeframe for
Data Be Submitted? Submission2
DISSIPATION STUDIES-FIELD
164-1
164-2
164-3
164-4
164-5
- Soil
- Aquatic (Sediment)
- Forestry
- Combination and
Tank Mixes
- Soil, Long-term
TEP
TEP
TEP
TEP
TEP
A,B
C,D,G
G
_
A,C
No
No
No
No
No
Yes
Yes
Yes
No5
Reserved^
27 Months
27 Months
27 Months
ACCUMULATION STUDIES
165-1
165-2
165-3
165-4
165-5
- Rotational Crops
(Confined)
- Rotational Crops
(Field)
- Irrigated Crops
- In Fish
- In Aquatic Non-Target
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
A,C
A,C
C,D
A,B,C,D,G
D,G
No
No
No
Partially 00110675
Partially 00110675
Yes
Reserved?
Yes
Yes 8
Yes 8
39 Months
39 Months
12 Months
12 Months
Organisms
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS*
§158.290 Environmental Fate Footnotes
1 Requirements of this data table apply to all products (as prescribed by registered use) containing the
2,4-Dichlorophenoxyacetic acid or inorganic cations and each ester and amine derivative of 2,4-D. Special
emphasis on the ester and amine derivatives should be given to the fate of the ester or amine moieties in the
environment.
2 Data must be submitted within the indicated timeframes, which begin upon receipt of the Guidance Document.
3 The Agency has acceptable data for 2,4-D acid and its inorganic salts. Data are required for each ester and
amine derivative of 2,4-D.
4 This data requirement is partially fulfilled for 2,4-D acid and inorganic salts. Addditional mobility data
is required on unaged 2,4-D in a sediment and on aged 2,4-D in soil. This data requirement must be fulfilled
for each ester and amine derivative of 2,4-D.
5 Tank mix data requirements are not being imposed by this standard.
6 Soil long term study with 2,4-D acid and 2,4-D ester and amine derivatives is reserved pending results of acceptable
field dissipation studies with 2,4-D and with each ester and amine derivative of 2,4-D.
7 The rotational crop field study is reserved pending the results of an acceptable confined rotational crop
study on 2,4-D or its inorganic salts and on each ester and amine derivative of 2,4-D.
8 Data will not be required if acceptable octanol/water partition coefficient data indicating low potential
for bioaccumulation are submitted. Octanol/water partition coefficient data are required for 2,4-D acids
or its inorganic salts and for each ester and amine derivative.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLQROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS1
Data Requirement
§158.390 Reentry Protection
1 32-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
§158.440 Spray Drift
201-1 - Droplet Size
201-1 - Drift Field
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
Use
Patterns
A,B
A
A,B
A,B
A,B,C,D,G
A,B,C,D,G
Does EPA
Have Data To
Satisfy This
Requirement?
No
No
No
No
No
No
Bibliographic Must Additional
Citation Data Be Submitted?
No3
No3
No3
No3
Yes4
Yes4
Timeframe for
Submission^
12 Months
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHDOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS1
§158.390 Reentry Protection Footnotes
1 Requirements of this data table apply to all products (as prescribed by registered use) containing the
2,4-D acid and each amine and ester derivative of 2,4-D.
2 Data must be submitted within the indicated timeframes, which begin upon receipt of the Guidance Document.
3 Reentry data requirements are not being imposed under this standard.
^ The droplet spectrum study is to be performed to reflect the nozzle and other equipment types to be used in the
application of 2,4-D and each amine and ester derivative of 2,4-D to crops, non-crops and forestry products. The
spray drift field evaluation is to be performed to reflect the application, equipment, use pattern, and typical
locations of use, which includes different weather factors, in the application of 2,4-D for these uses.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
JN-
Test
Data Requirement Substance
§158.490 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Acute Avian Oral Toxicity
71-2 - Avian Subacute Dietary
Toxicity
- Upland Game Bird, and
- Waterfowl
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing
- Mammals, and
- Birds
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
Does EPA
Have Data To
Use Satisfy This
Patterns Requirement?
A,B,C,D,G Partially
A,B,C,D,G No
A,B,C,D,G NO
A,B,G No
A,B,G NO
A,B,G NO
A,B,G NO
Bibliographic Must Additional
Citation Data Be Submitted?
00160000 Yes2
Yes
Yes
No3
Reserved4
Reserved^
Reserved^
Timeframe for
Submission^
9 Months
9 Months
9 Months
-------
vn
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Test Use
Data Requirement Substance Patterns
§158.490 Wildlife and
Does EPA
Have Data To
Satisfy This Bibliographic Must Additional Timeframe for
Requirement? Citation Data Be Submitted? Submission1
Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish Toxicity
Warmwater
Coldwater
Warmwater
Coldwater
72-2 - Acute Toxicity to
Freshwater Invertebrates
72-3 - Acute Toxicity to
TGAI
TGAI
TEP
TEP
TGAI
TEP
TGAI
A,B,
A,
A,
A,
A,
A,
A,
B,
B,
B,
B,
B,
B,
c,
c,
c,
c,
c,
c,
c,
D,G
D,G
D
D
D,G
D
D,G
Partially
Partially
Partially
Partially
Partially
Partially
Partially
40098001
40098001
00050678,
00050715,
00054045,
40600203
00050669,
00050713,
00050674,
00102908,
00054025,
40228401
00050681
00054025
40098001,
00050712
00053986
00053996
40098001
40098001
Yes6
Yes6'7
Yes8
Yes9
YesiO
Yes11
Yes12
9
9
9
9
9
9
12
Months
Months
Months
Months
Months
Months
Months
Estuarine and Marine
Organisms
72-4 - Fish Early Life Stage, TGAI
and Aquatic Invertebrate
Life-Cycle
A,B,C,D
No
Yes
13
12 Months
72-5 - Fish - Life-Cycle
TGAI A,B,C,D
No
Reservedl4
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS {2,4-D acid); AMINES AND ESTERS
Data Requirement
Test Use
Substance Patterns
Does EPA
Have Data To
Satisfy This Bibliographic Must Additional
Requirement? Citation Data Be Submitted?
Timeframe for
Submission1
§158.490 Wildlife and
Aquatic Organisms - Continued
TGAI
72-6 - Aquatic Organism
Accumulation
72-7 - Simulated and Actual
Field Testing
- Aquatic Organisms
TEP
A,B,C,D No
A,B,C,D No
Yes15
Reserved^
12 Months
1 Data must be submitted within the indicated timeframes, which begin on receipt of the Guidance Document.
2 The Agency has acceptable data on 2,4-D acid. Data must be submitted on salts, amines and esters.
3 Not currently a requirement.
4 Reserved pending receipt and review of all environmental fate data.
5 Reserved pending receipt and review of all environmental fate data. This study is not required for 2,4-D acid,
2,4-D Lithium Salt, 2,4-D Sodium Salt, and 2,4-D Alkanolamine Salt because of the use.
6 The Agency has acceptable data on 2,4-D Propylene Glycol Butyl Ether Ester, and 2,4-D acid. Data must be submitted
on all other salts, amines and esters.
7 The Agency has acceptable data on 2,4-D Propylene Glycol Butyl Ether Ester and 2,4-D acid. Data must be submitted
on all other salts, amines and esters. Testing is required for 2,4-D Butoxypropyl Ester products having 67.2 percent
acid equivalent.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
§158.490 Footnotes (Continued)
8 The Agency has acceptable data on 2,4-D Butoxyethanol ester, 2,4-D Propylene Glycol Butyl Ether Ester, 2,4-D Lithium
Salt, 2,4-D Alkanolamine Salt, and 2,4-D Alkyl Amine (C12/C14) Salt. Data must be submitted for all other salts
amines, and esters. Testing is required for 2,4-D acid products having the following percent acid equivalent: 79.0,
and MAI 8.5; 2,4-D Sodium Salt products having 17.5 and MAI 0.36 acid equivalent; and other 2,4-D derivatives
having aquatic uses.
9 The Agency has acceptable data on 2,4-D Butoxyethanol Ester, 2,4-D Butoxypropyl Ester, 2,4-D Sodium Salt, 2,4-D
alkanolamine Salt, and 2,4-D Alkyl Amine (C12/C14) Salt. Testing is required for products having the following
percent acid equivalent: 2,4-D Propylene Glycol Butyl Ether Ester products 72.8, 41.0, 68.6; 2,4-D Acid 9.5, 10.3,
13.8, 15.9, 21.6, and 22.8; and 2,4-D Lithium Salt 85.0 and 95.0. Data must be submitted on all other 2,4-D
derivatives with aquatic uses.
10 The Agency has acceptable data on 2,4-D Propylene Glycol Butyl Ether Ester. Data must be submitted on 2,4-D acid
and all other salts, amines and esters.
11 The Agency has acceptable data on 2,4-D Butoxyethanol Ester. Testing is required for products having the following
percent acid equivalent: 2,4-D acid products having 79.0, MAls 8.5, 9.5, 10.3, 13.8, 15.9, 21.6 and 22.8; 2,4-D
Lithium Salt products having 85.0 and 95.0; 2,4-D Sodium Salt products having 17.5, and MAI 0.36; 2,4-D Alkanolamine
Salt products having 59.7, 56.5, and 31.1; 2,4-D Butoxypropyl ester products having 67.2; 2,4-D Propylene Glycol
Butyl Ether Ester products having 72.8, 41.0 and 68.6; and all other 2,4-D acid derivatives with aquatic uses.
12 The Agency has acceptable data on 2,4-D Butoxyethanol Ester. Data are required for 2,4-D Butoxypropyl Ester
products with uses on corn, turf, forestry, pasture/rangeland, sorghum and ditchbanks; and 2,4-D Propylene
Glycol Butyl Ether Ester products with uses on aquatic sites, corn, turf, pasture/rangeland and sorghum. Data
are required for 2,4-D acid and all other salts, amines and esters with aquatic uses.
13 Data are required for 2,4-D Butoxyethanol Ester products with uses on corn, turf, forestry, rice, pasture/range-
land, sorghum, ditchbanks and aquatic uses; and 2,4-D Propylene Glycol Butyl Ether Ester products with uses on
aquatic uses on aquatic sites, corn, turf, pasture/rangeland and sorghum. Data are also required for 2,4-D
acid and all other salts, amines and esters with aquatic uses.
14 Data are required for 2,4-D Butoxyethanol Ester products with uses on corn, turf, forestry, rice, pasture/range-
land, sorghum, ditchbanks and aquatic uses. This data requirement is reserved for all other salts, amines and esters
pending receipt and review of environmental fate data.
15 See Environmental Fate Data Table (§158.290, Guideline 165-5).
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Data Requirement
Test Use
Substance Patterns
Does EPA
Have Data To
Satisfy This Bibliographic Must Additional Timeframe for
Requirement? Citation Data Be Submitted? Submission1
•o
0}
§158.540 Plant Protection
121-1 - TARGET AREA TEP
PHYTOTOXICITY
NONTARGET AREA PHYTOTOXICITY
TIER I
122-1 - Seed Germination/
Seedling Emergence
122-1 - Vegetative Vigor
122-2 - Aquatic Plant Growth
TIER II
123-1 - Seed Germination/
Seedling Emergence
123-1 - Vegetative Vigor
123-2 - Aquatic Plant Growth
TIER III
124-1 - Terrestrial Field TEP
124-2 - Aquatic Field TEP
A,B,C,D,F,G No
TGAI A,B,C,D,G
TGAI A,B,C,D,G
No
TGAI A,B,C,D,G No
TGAI A,B,C,D,G No
No
TGAI A,B,CfD,G No
TGAI A,B,C,D,G No
A,B,C,DfG No
A,B,C,D NO
NO2
NO3
NO3
NO3
Yes
Yes
Reserved^
Reserved 5
9 Months
9 Months
9 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
§158.540 Plant Protection Footnotes
' Data must be submitted within the indicated timeframes, which begin on receipt of the Guidance Document.
2 Not currently a requirement.
3 Data are available in the open literature on the phytotoxicity of 2,4-D to broadleaf plants, therefore
testing should be conducted at the Tier II level to establish EC5Q values.
4- Application to aquatic sites will require submission of data for five species of aquatic plants. Vvhere
the herbicide is applied to terrestrial sites, only the algae Selenastrum capricornutum is required.
5 Reserved pending results of Tier II.
\o
•£>
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHLOROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
o
o
§158.590 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute
contact toxicity
141-2 - Honey bee - toxicity
of residues on
foliage
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to
aquatic insects
142-1 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
TGAI
TEP
A.B.G
A.B.G
Yes
No
00036935
TEP
A,B,G
No
No
No2
Reserved-*
No2
Reserved^
Reserved^
Reserved^
-------
h-1
o
TABLE A
GENERIC DATA REQUIREMENTS FOR 2,4-DICHIDROPHENOXYACETIC ACID AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Does EPA
Have Data To
Test Use Satisfy This Bibliographic Mast Additional Timeframe for
Data Requirement Substance Patterns Requirement? Citation Data Be Submitted? Submission1
143-1 - NONTARGET INSECT Reserved^
thru TESTING - PREDATORS
143-3 AND PARASITES
1 Data must be submitted within the indicated timeframes, which begin on receipt of the Guidance Document.
2 As data from the acute contact test indicate low toxicity, no further testing is required.
3 Reserved pending development of test methodology.
4 Reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING 2,4-DICHLOROPHENOXYACETIC ACID
AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Data Requirement
Test
Substance
Does EPA
Have Data To
Satisfy This
Requirement?
Bibliographic
Citation2
Must Additional
Data Be Submitted?
Timeframe for
Submission^
o
Part 158
Subpart C- Product Chemistry
Product Identity
61-1 - Product Identity and MP
Disclosure of
Ingredients
61-2 - Description of Beginning MP
Materials and
Manufacturing Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to Verify MP
Certified Limit
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
No
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes3
Yes4
Yes6
Yes?
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
Yes9
6 Months
6 Months
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING 2,4-DICHLOROPHENOXYACETIC ACID
AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
o
Does EPA
Have Data To
Test Satisfy This Bibliographic
Data Requirement Substance Requirement? Citation2
Must Additional Timefratne for
Data Be Submitted? Submission1
Part 158
Subpart C - Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-4 - Odor
63-7
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Other
64-1
- Density, Bulk Density, or
Specific Gravity
- PH
- Oxidizing or Reducing Action
- Flammability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion Characteristics
Requirements
- Submittal of samples
MP .
MP
MP
MP
MP
MP
MP
MP
MP
MP
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes9
Yes9
Yes9,10
Yes9J1
Yes9J2
Yes9,13
Yes9
Yes9,14
Yes9,15
Yes9
N/A
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
N/A
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING 2,4-DICHLOROPHENOXYACETIC ACID
AND INORGANIC SALTS (2r4-D acid); AMINES AND ESTERS
Part 158
Subpart C - Product Chemistry
1 Data must be submitted within the indicated timeframes, which begin on receipt of the Guidance Document.
2 Not applicable. Although product chemistry data may been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore bibliographic citations for the old data are not applicable.
3 The chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and purpose of the active
ingredient and each intentionally added inert must be provided. For the active ingredients, the following must
also be provided: the product, common, and trade names; the molecular, structural, and empirical formulas; the
molecular weight or weight range; and any experimental or internally assigned company code numbers.
M
4N- 4 Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name and
address of the manufacturer, producer, or supplier of each beginning material used in the manufacture of each
product must be provided, along with information regarding the properties of those materials. In order to
assess the potential for contamination with halogenated dibenzo-p-dioxins and dibenzofurans, the description
of the manufacturing process must also include the range of temperature conditions, pressure, and pH at each
reaction step.
5 A detailed discussion of all impurities that are or may be present at 0.1 percent or greater, based on knowledge
of the beginning materials, chemical reactions (intended and side) in the manufacturing process, and any
contamination during and after production must be submitted. This discussion must also address the possible
formation N-nitrosamines (amine formulations) and dibenzo-p-dioxins and dibenzofurans occurring in 2,4-D acid
salts, and esters. Data submitted in response to the Data Call-in (DCI) Notices for analytical chemistry data
on polyhalogenated dibenzo-p-dioxins/dibenzofurans in 2,4-D acid and its salts and esters may also partially
fulfill this data requirement. These data are due as specified in the DCI Notice.
6 Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which certified limits are required. Complete validation data (accuracy and precision) must be submitted for
each analytical method used. All nitrosamines must be identified and quantified in six samples of each product
containing the dimethylamine salt; two samples must be analyzed shortly after production, 3 months after
production, and 6 months after production. A method sensitive to at least 1 ppm of N-nitroso contaminants must
be used. An upper limit must be provided (and certified) for all nitrosamines, dibenzo-p-dioxins and dibenzofurans
found. Certifications should be submitted on EPA Form 8570 Rev. 2-85.
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING 2,4-DICHLOROPHENOXYACETIC ACID
AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Part 158 ~~
Subpart C - Product Chemistry
1 Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for each
impurity present at >^ 0.1 percent (w/w) and each "toxicologically significant" impurity present at < 0.1 percent
(w/w) must be provided and certified. Also, an explanation of how each certified limit was established must be
provided (e.g., sample analysis using validated analytical procedures, quantitative estimate based on amounts
of ingredients used, etc.). Limits for impurities not associated with the active ingredient need be provided
only if they are considered to be of toxicological significance, regardless of the concentration at which they
are present these include N-nitrosoamines (amine formulations), dibenzo-p-dioxins and dibenzofurans.
Certifications must be submitted on EPA Form 8570 Rev. 2-85.
Data submitted in response to the Data Call-in (DCI) Notices for analytical chemistry data on polyhalogenated
dibenzo-p-dioxins/dibenzofurans in 2,4-D acid and its salts and esters may also partially fulfill this data
requirement. These data are due as specified in the DCI Notice.
8 Analytical methods must be provided to determine the active ingredient, and each toxicologically significant
impurity and intentionally added inert for which certified limits are required. Each method must be accompanied
by validation studies indicating its accuracy and precision. These methods must be suitable for enforcement of
certified limits.
Data submitted in response to the Data Call-in (DCI) Notices for analytical chemistry data on polyhalogenated
dibenzo-p-dioxins/dibenzofurans in 2,4-D acid and its salts and esters may also partially fulfill this data
requirement. These data are due as specified in the DCI Notice.
9 Physicochemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
solubility vapor pressure, dissociation constant, partition coefficient, pH, and stability) as required in
40 CFR 158.190 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
10 Data required if the test substance is dispersible in water.
11 Data required if the product contains oxidizing or reducing agents.
12 Data required if the product contains combustible liquids.
13 Data required if the product is potentially explosive.
14 Data required if the product is a liquid.
15 Data required if the product is a liquid and is to be diluted with petroleum solvents.
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o
ON
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING 2,4-DICHLOROPHENOXYACETIC ACID
AND INORGANIC SALTS (2,4-D acid); AMINES AND ESTERS
Data
§158
Test
Requirement Substance
.340 Toxicology
Does EPA
Have Data To
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted?
Timeframe for
Submission^
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
- Acute oral Toxicity - Rat MP
- Acute Dermal Toxicity MP
- Acute Inhalation Toxicity MP
- Rat
- Primary Eye MP
Irritation - Rabbit
- Primary Dermal MP
Irritation - Rabbit
- Dermal Sensitization MP
- Guinea Pig
Yes
Yes
Yes
Yes
Yes
Yes
40448801
40448802
40448803
40448804
40448805
40448806
Yes2
Yes2
Yes2
Yes2
Yes2
Yes2
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
1 Data must be submitted within the indicated timeframes, which begin on receipt of the Guidance Document.
2 The Agency has acceptable data on 2,4-D Diethanolamine Salt.
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II. LABELING APPENDICES
107
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LABEL CONTENTS
40 CFR 156.10 requires that certain specific labeling
statements appear at certain locations on the label. This is
referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably
centered in the upper part of the panel. The name of a
product will not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and
address of the registrant or distributor is required on the
label. The name and address should preferably be located at
the bottom of the front panel or at the end of the label
text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the
end of the label test. The net contents must be expressed in
the largest suitable unit, e.g., "1 pound 10 ounces" rather
than "26 ounces." In addition to English units, net contents
may be expressed in metric units. [40 CFR 156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
[40 CFR 156.10(6)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA
establishment number, preceded by the phrase "EPA Est." is
the final establishment at which the product was produced,
and may appear in any suitable location on the label or
immediate container. It must also appear on the wrapper or
outside container of the package if the EPA establishment
number on the immediate container cannot be clearly read
through such wrapper or container. [40 CFR 156.10(f>]
Item 6A. INGREDIENTS STATEMENT - An ingredients
statement is required on the front panel. The ingredients
statement must contain the name and percentage by weight of
108
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each active ingredient and the total percentage by weight of
all inert ingredients. The preferred location is immediately
below the product name. The ingredients statement must run
parallel with, and be clearly distinguished from, other text
on the panel. It must not be placed in the body of other
text. [40 CFR 156.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid
agricul- tural formulations, the pounds per gallon of active
ingredient must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front
panel precautionary statements must be grouped together,
preferably within a block outline. The table below shows the
minimum type size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The
statement "Keep Out of Reach of Children" must be located on
the front panel above the signal word except where contact
with children during distribution or use is unlikely. [40
CFR I56.l0(h) (l) (ii) ]
Item 7B. SIGNAL WORD - The signal word (DANGER,
WARNING, or CAUTION) is required on the front panel
immediately below the child hazard warning statement. [ 40CFR
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On
products assigned a toxicity Category I on the basis of
oral, dermal, or inhalation toxicity, the word "Poison" shall
appear on the label in red on a background of distinctly
contrasting color and the skull and crossbones shall appear
in immediate proximity to the word POISON. [40 CFR
156.10(h) (1) (i)
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A
statement of practical treatment (first aid or other) shall
appear on the label of pesticide products in toxicity
Categories I, II, and III. [40 CFR 156. 10(h) (1) (iii ) ]
Item 7E. REFERRAL STATEMENT - The statement "see Side
(or Back) Panel for Additional Precautionary Statements" is
109
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required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 156.10(h)(1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on
the label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that
these statements be surrounded by a block outline. Each of
the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 156.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where
a hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 156.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists
to non-target organisms excluding humans and domestic
animals, precautionary statements are required stating the
nature of the hazard and the appropriate precautions to avoid
potential accident, injury, or damage. [40 CFR
156.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY -
Precautionary statements relating to flammability of a
product are required to appear on the label if it meets the
criteria in the PHYS/CHEM Labeling Appendix. The requirement
is based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all
products. These statements are to be located in the
side/back panel precautionary statements section, preceded by
the heading "Physical/Chemical Hazards." Note that no signal
word is used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec.
3(d) requires that all pesticide formulations/uses be
classified for either general or restricted use. Products
classified for restricted use may be limited to use by
certified applicators or persons under their direct
supervision (or may be subject to other restrictions that may
be imposed by regulation).
In the Registration Standard, the Agency has (1)
indicated certain formulations/uses are to be restricted
(Section IV indicates why the product has been classified for
restricted use); or (2) reserved any classification decision
until appropriate data are submitted.
110
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The Regulatory Position and Rationale states whether
products containing this active ingredient are classified for
restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be
classified for restricted use, you must submit any
information and rationale with your application for
reregistration. During the Agency's review of your
application, your proposed classification determination will
be evaluated in accordance with the provisions of 40 CFR
162.11(c). You will be notified of the Agency's
classification decision.
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
l. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the
label. The statement must be set in type of
the same minimum size as required for human
hazard signal word (see table in 40 CFR
156.10(h)(1)(iv).
b. Directly below this statement on the front
panel, a summary statement of the terms of
restriction must appear (including the reasons
for restriction if specified in Section I).
If use is restricted to certified applicators,
the following statement is required: "For
retail sale to and use only by Certified
Applicators or persons under their direct
supervision and only for those uses covered by
the certified Applicator's Certification."
2. Some but not all uses restricted. If the
Regulatory Position and Rationale states that some uses are
classified for restricted use, and some are unclassified,
several courses of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label
uses that are unrestricted, but you may not
distinguish them on the label as being
unrestricted.
ill
-------
b. You may delete all restricted uses from your
label and submit draft labeling bearing only
unrestricted uses.
c. You may "split" your registration, i.e.,
register two separate products with identical
formulations, one bearing only unrestricted
uses, and the other bearing restricted uses.
To do so, submit two applications for
reregistration, each containing all forms and
necessary labels. Both applications should be
submitted simultaneously. Note that the
products will be assigned separate
registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions for
use, directly beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the
directions for use. This heading must be set in the same
type sizes as required for the child hazard warning. Refer
to Appendix II, STOR, PEST/DIS, and CONT/DIS to determine the
storage and disposal instructions appropriate for your
products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to sue or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. [40
CFR 156.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
112
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accepted in connection with registration of the product. It
should be made part of the response to this notice and
submitted for review.
113
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LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
1
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precaut lonary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREPEKKEU
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . < .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Pract ical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domest ic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of* the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable fron from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS. and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
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Chapter I—Environmental Protection Agency
§156.10 Labeling Requirements for Pesticides and Devices.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
(e) of this section;
(v) The producing establishment number as prescribed in para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section;
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this section.
(2) Prominence and legibility. (i) All words, statements,
graphic representations, designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be placed
with such conspicuousness (as compared with other words, state-
ments, designs, or graphic matter on the labeling) and expressed
in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear in the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public, when
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
117
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pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk containers—(A) Transportation.
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to § 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticidal claims. -Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
lift
-------
(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisonous," "noninjurious,"
"harmless" or "nontoxic to humans and pets" with or without such
a qualifying phrase as "when used as directed"; and
(x) Non-numerical and/or comparative statements on the safety
of the product, including but not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals known*
(C) "Pollution approved"
(6) Final printed labeling. (i) Except as provided in
paragraph (a)(6)(ii) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to § 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***," or "Sold by ***" to show that the name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°F (20°C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces* rather than
"26 ounces."
119
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(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement—(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement "Inert Ingredients,
none" is not required for pesticides which contain 100 percent
active ingredients. Unless the ingredient statement is a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the ingredient statement.
(2) Position of ingredient statement. (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
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(3) Names to be used in ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one, followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case
will the use of a trademark or proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients
shall be stated in terms of weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements :
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]."
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredie'nt statement
if he determines that such ingredient(s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
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Hazard Indicators
Oral LD5Q
Inhalation LC
Dermal LD
50
Eye effects
Skin effects
1
Up to and
Including
50 mg/Kg
Up to and
Including
.2 mg/l Iter
Up to and
Including
200 mg/kg
Corrosive;
cornea 1 opacity
not reversible
within 7 days
Corros 1 ve
Toxic Itt <
II
From 50 thru
500 mg/kg
From .2 thru
2 mg/l Iter
From 200
thru 2000
Cornea 1 opacity
reversible
within 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
:ategor!es
1 1 1
From 500 thru
5000 mg/kg
From 2 thru
20 mg/l Iter
From 2,000 thru
20,000
No cornea I opacity;
Irritation
reversible
within 7 days
Moderate Irritation
at 72 hours
IV
Greater than
5000 mg/kg
Greater than
20 mg/l Iter
Greater than
20,000
No Irritation
Mild or slight
Irritation at
72 hours
(i) Human hazard
signal word.--(A) Toxicity
criteria of ToxicTty
Category I.
All
I
pesticide products meeting the criteria of Toxicity Category
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison."
All pesticide products meeting the
front panel*
(B) Toxicity Category II
criteria of Toxicity Category
the signal word "Warning."
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
II shall bear on the
All pesticide
III shall bear
All pesticide
IV shall bear
products meeting the
on the front panel
products meeting the
on the front panel
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(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(iii) Statement of practical treatment—(A) Toxicity
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Above 10 to 15
Above 15 to 30
Over 30
Poir
Required
signal word,
all capitals
6
10
12
14
18
its
"Keep out
of reach of
Children"
6
6
8
10
12
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(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall appear
together on the label under the general heading "Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental Hazard" and "Physical or
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a hazard
exists to humans or domestic animals/ precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
Toxlclty
category
Precautionary statements by toxlclty category
Oral, Inhalation, or dermal toxlclty
Skin and eye local effects
I
II
111
IV
Fata! (poisonous) If swallowed I Inhaled or
abso-bed through skin]. Do not breathe
vapor IdustJ or spray mist]. Do not get
In eyes, on skin, or on clothing [Front
panel statement of practical treatment
required.].
May be fatal If swallowed [Inhaled or
Corrosive, causes eye and skin damage [or
skin Irritation]. Do not get In eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
[Appropriate first aid statement required.)
Causes eye [and skin] Irritation. Do not
get In eyes, on skin, or on clothing.
absorbed through the skin]. Do not breathe
vapors [dust or spray mist). Do not get 1n| Harmful If swallowed. [Appropriate first
eyes, on skin, or on clothing. [Appropriate] aid statement required.].
first aid statements required.].
Harmful If swallowed (Inhaled or absorbed
through the skin). Avoid breathing vapors
[dust or spray mist]. Avoid contact with
skin [eyes or clothing]. [Appropriate
first aid statement required.].
[No precautionary statements required.].
Avoid contact with skin, eyes or clothing.
In case of contact Immediately flush
eyes or skin with plenty of water. Get
medical attention If Irritation persists.
JNo precautionary statements required.],
(ii) Environmental hazards. Where a hazard exists to non-
target organisms excluding humans and domestic animals, precautionary
statements are required stating the nature of the hazard and the
appropriate precautions to avoid potential accident, injury or
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damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD5Q of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC50 of 1 ppm or less, the statement
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD5Q of 100 mg/kg or less, or
a subacute dietary LCso of 500 ppm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on the
flammability or explosive characteristics of the pesticide are
required as follows:
Flash point
Required text
(A) PRESSURIZED CONTAINERS
Flash point at or below 20*F; If there Is a
flashback at any valve opening.
Flash point above 20*F and not over 80*F or If
the flame extension Is more than 16 In. long
at a distance of 6 1 n. from the flame.
Extremely flammable. Contents under pressure.
Keep away from fire, sparks, and heated
surfaces. Do not puncture or Incinerate
container. Exposure to temperatures above
130*F may cause bursting.
Flammable. Contents under pressure. Keep away
from heat, sparks, and open flame. Do not
puncture or Incinerate container. Exposure to
temperatures above 130*F may cause bursting.
Contents under pressure. Do not use or store
near heat or open flame. Do not punctur% or
Incinerate container. Exposure to tempera-
tures above 130*F may cause bursting.
(B) NONPRESSURIZED CONTAINERS
Extremely flammable. Keep away from fire,
sparks, and heated surfaces.
Flammable. Keep away from heat and open flame.
Do not use or store near heat or open flame.
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(i) Directions for Use—(1) General requirements—(i) Adequacy
and clarity of directions. Directions for use must be stated in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular." and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(iii) Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
(^) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(^) The product will not come into the hands of the general
public except after incorporation into finished products; and
(£) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(_!) The label clearly states that the product is for use only
by physicians or veterinarians;
(2) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(_3) The product is also a drug and regulated under the provisions
of the Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
(_1) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
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(2^) The label clearly states that the product is intended for
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
(^) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(_4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the headings "Directions for
Use":
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in § 162.10(h)(1)(iv ).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision of a certified
applicator who is physically present.
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(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of § 162.10(j)(2 ).
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in § 162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted use
Pesticide" shall appear.
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators, the following statement is required: "For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation,
(k) Advertising. [Reserved]
[40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, 1978;
amended at 53 FR 15952, May 4, 1988]
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PHYSICAL-CHEMICAL HAZARDS
Criteria Required Label Statement
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate container. Exposure
to temperatures above
130°F may cause bursting.
Extremely flammable.
Keep away from fire,
sparks, and heated
surfaces.
Flammable. keep away
from heat and open flame,
Do not use or store near
heat and open flame.
None required.
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STORAGE INSTRUCTIONS FOR PESTICIDES
HEADING; All products are required to bear specific label
instructions about storage and disposal. Storage and
disposal instructions must be grouped together in the
directions for use portion of the label under the heading
STORAGE AND DISPOSAL. Products intended solely for domestic
use need not include the heading "STORAGE AND DISPOSAL."
STORAGE INSTRUCTIONS; All product labels are required to
have appropriate storage instructions. Specific storage
instructions are not prescribed. Each registrant must
develop his own storage instructions, considering, when
applicable, the following factors:
1. Conditions of storage that might alter the composition
or usefulness of the pesticide. Examples could be
temperature extremes, excessive moisture or humidity,
heat, sunlight, friction, or contaminating substances or
media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might
include positioning of the container in storage, storage
or damage due to stacking, penetration of moisture, and
ability to withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged
in any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage
occurs.
5. General precautions concerning locked storage, storage
in original container only, and separation of
pesticides during storage to prevent cross-
contamination of other pesticides, fertilizer, food, and
feed.
6. General storage instructions for household products
should emphasize storage in original container and
placement in locked storage areas.
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PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact
wording that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement:
"Do not contaminate water, food, or feed by storage
or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active
ingredients that are Acute Hazardous Wastes or are
assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the
basis of acute inhalation toxicity must bear the
following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper
disposal of excess pesticide, spray mixture, or
rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or
Environmental Control Agency or the Hazardous Waste
representative at the nearest EPA Regional Office
for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that are Toxic Hazardous Wastes or meet any of the
criteria in 40 CFR 261, Subpart C for a hazardous waste
must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of
excess pesticide, spray mixture, or rinsate is a
violation of Federal Law. If these wastes cannot
be disposed of by use according to label
instructions, contact your State Pesticide or
Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional
Office for guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
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"Wastes resulting from the use of this product may
be disposed of on site or at an approved waste
disposal facility."
5. Products intended for domestic use only must bear the
following disposal statement:
"Securely wrap original container in several layers
of newspaper and discard in trash."
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CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following container
disposal statements:
Container Type
Statement
|Non- aerosol products
((bottles, cans, iars)
| Non-aerosol products
| (baas)
| Aerosol products
1
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type, listed below:
Container Type
Statement
Metal
containers
(non- aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures .
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^/ . dispose of in the same manner.
Completely empty bag into application equip-
ment. Then dispose of empty bag in a sani-
tary landfill or by incineration, or, if
allowed by State and local authorities, by
burning. If burned, stay out of smoke.
Return empty cylinder for reuse (or
similar wording).
V Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
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III. BIBLIOGRAPHY APPENDICES
134
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Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. 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, will be 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 attempted also 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 at any time 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 a 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 identifier 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
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the Agency could confidently
identify one, 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 author. As a last resort, the Agency has
shown the first submitter as author.
135
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b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the date
from evidence in the document. When the date appears
as (19??), the Agency was unable to determine or
estimate the date of the document.
c. Title. In some cases, it has been necessary for
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,
following the phrase "submitted by." 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," standing 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.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
136
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID
Citation
00004485 Leng, M.L.; Gentry, W.M. (1970) Residue Data for 2,4-D,
2,4,5-T and Silvex in Grass from Treatments with Various
Formulations of the Herbicides. (Unpublished study
received Jan 11, 1971 under 9F0761; prepared by Dow
Chemical Co., submitted by National Agricultural
Chemicals Association, Industry Task Force on Phenoxy
Herbicide Tolerances, Washington, D.C.; CDL:091313-B)
00004594 Rhodia, Incorporated (1971) Phenoxy Herbicides on
Stubble Crop Rice. (Unpublished study received Nov 21,
1973 under 359-170; submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, N.J.; CDL:230485-B)
00004610 Feeny, R.W.; Higham, J.W.; Snyder, E.H.; Colbert, D.R. ;
Agamalian, H. (1975) Avenge: (CL 84,777): Determination
of CL 84,777(1,2-Dimethyl pyrazolium methyl sulfate) and
Bromoxynil (3,5-Dibromo-4-hydroxylbenzonitrile) Residues
in Barley Straw and Grain Following Ground Application
(California): Report No. C-592. (Unpublished study
received Jan 8, 1975 under 241-EX-64; prepared in
cooperation with Lake Ontario Environmental Laboratory,
submitted by American Cyanamid Co., Princeton, N.J. ;
CDL:224170-R)
00004666 Andreae, W.A.; Good, N.E. (1957) Studies on
3-Indoleacetic acid metabolism: IV. Conjugation with
Aspartic acid and Ammonia as processes in the
metabolism of Carboxylic acids. Plant Physiology
32(?):566-572. (Also in unpublished submission
received Sep 16, 1968 under 8F0676 ; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:092090-F)
00004667 Bach, M.K. (1961) Metabolites of 2,4-Dichlorophenoxy-
acetic acid from bean stems. Plant Physiology
36(?):558-565. (Also in unpublished submission received
Sep 16, 1968 under 8F0676; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:092090-G
00004669 Easier, E. (1964) The decarboxylation of Phenoxyacetic
acid herbicides by excised leaves of woody plants.
Weeds 12(? ):14-16. Also in unpublished submission
received Sep 16, 1968 under 8F0676; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:092090-K)
137
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID
Citation
00004675 Fang, S.C. (1958) Absorption, translocation and
metabolism of 2,4-D-l-C14: in pea and tomato plants.
Weeds 6(? ):179-186. (Also in unpublished submission
received Sep 16, 1968 under 8F0676; submitted by Dow
Chemical U.S.A.; Midland, Mich.; CDL:092090-S)
00004676 Fang, S.C.; Butts, J.S. (1954) Studies in plant
metabolism: III. Absorption, translocation and
metabolism of radioactive 2,4-D in corn and wheat
plants. Plant Physiology 29(? ):56-60. (Also in
unpublished submission received Sep 16, 1968 under
8F0676; submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:092090-T)
00004677 Fites, R.C.; Slife, F.W.; Hanson, J.B. (1964)
Translocation and metabolism of radioactive 2,4-D in
jimsonweed. Weeds 12(? ):180-183. (Also in unpublished
submission received Sep 16, 1968 under 8F0676; submitted
by Dow Chemical U.S.A., Midland, Mich.; CDL:092090-U)
00004680 Holley, R.W. (1952) Studies of the fate of radioactive
2,4-Dichlorophenoxyacetic acid in bean plants: II. A
water-soluble transformation product of 2,4-D. Archives
of Biochemistry and Biophysics 35(? ):171-175. (Also in
unpublished submission received Sep 16, 1968 under
8F0676; submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL.-092090-X)
00004681 Holley, R.W.; Boyle, F.P.; Hand, D.B. (1950) Studies of
the fate of radioactive 2,4-Dichlorophenoxyacetic acid
in bean plants. Archives of Biochemistry and Biophysics
27(?):143-151. (Also unpublished submission received
Sep 16, 1968 under 8F0676;submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:092090-Y)
00004682 Jaworski, E.G.; Butts, J.S. (1952) Studies in plant
metabolism: II. The metabolism of C14:-Labeled
2,4-Dichlorophenoxyacetic acid in bean plants. Archives
of Biochemistry and Biophysics 38(? ):207-218. (Also in
unpublished submission received Sep 16,1968 under
8F0676; submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:092090-Z)
138
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00004683 Jaworski, E.G.; Fang, S.C.; Freed, V.H. (1955) Studies
in plant metabolism: V. The metabolism of radioactive
2,4-D in etiolated bean plants. Plant Physiology
30(?):272-275. (Also in unpublished submission received
Sep 16, 1968 under 8F0676; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:092090-AA)
00004689 Morgan, P.W.; Hall, W.C. (1963) Metabolism of 2,4-D by
cotton and grain sorghum. Weeds 11(? ):130-135. (Also
in unpublished submission received Sep 12, 1968 under
8F0676; submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:092980-C)
00004693 Slife, F.W.; Key, J.L.; Yamaguchi, S.; Crafts, A.S.
(1962) Penetration, translocation, and metabolism of
2,4-D and 2,4,5-T in wild and cultivated cucumber
plants. Weeds 10(? ):29-35. (Also in unpublished
submission received Sep 12, 1968 under 8F0676; submitted
by Dow Chemical U.S.A., Midland, Mich.; CDL:092980-G)
00004698 Weintraub, R.L.; Yeatman, J.N.; Lockhart, J.A.;
Reinhart, J.H. ,-Fields, M. (1952) Metabolism of
2,4-Dichlorophenoxyacetic acid: II. Metabolism of the
side chain by bean plants. Archives of Biochemistry and
Biophysics 40(? ):277-285. (Also in unpublished
submission received Sep 12, 1968 under 8F0676; submitted
by Dow Chemical U.S.A., Midland, Mich.; CDL:092980-L)
00004699 Weintraub, R.L.; Reinhart, J.H.; Scherff, R.A. ;
Schisler, L.C. (1954) Metabolism of 2,4-Dichloro-
phenoxyacetic acid: III. Metabolism and persistence in
dormant plant tissue. Plant Physiology 29(? ):303-304.
(Also in unpublished submission received Sep 12, 1968
under 8F0676, submitted by Dow Chemical U.S.A.,Midland,
Mich.; CDL:092980-M)
00004701 Bache, C.A.; Hardee, D.D.; Holland, R.F.; Lisk, D.J.
(1964) Absence of Phenoxyacid herbicide residues in the
milk of dairy cows at high feeding levels. Journal of
Dairy Science XLVII(3):298-299. (Also in unpublished
submission received Sep 12, 1968 under 8F0676; submitted
by Dow Chemical U.S.A., Midland, Mich.; CDL:092980-0)
139
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D standard
MRID Citation
00004705 Clark, D.E.; Young, J.E.; Younger, R.L.; Hunt, L.M. ;
McLaran, J.K. (1964) The fate of 2,4-Dichlorophenoxy-
acetic acid in sheep. Journal of Agricultural and Food
Chemistry 12(1):43-45. (Also in unpublished submission
received Sep 12, 1968 under 8F0676; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:092980-S)
00004707 Gutenmann, W.H.; Hardee, D.D.; Holland, R.F.; Lisk, D.J.
(1963) Residue studies with 2,4-Dichlorophenoxyacetic
acid herbicide in the dairy cow and in a natural and
artificial rumen. Journal of Dairy Science
XLVI(11):1287-1288. (Also in unpublished submission
received Sep 12, 1968 under 8F0676; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:092980-V)
00004715 Erickson, L.C.; Brannaman, B.L.; Coggins, C.W., Jr.
(1963) Residues in stored lemons treated with various
formulations of 2,4-D.Journal of Agricultural and Food
Chemistry 11(5):437-440. (Also unpublished submission
received Sep 12, 1968 under 8F0676; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:092980-AG)
00004719 Klingman, D.L.; Gordon, C.H.; Yip, G.; Burchfield, H.P.
(1966) Residues in the forage and in milk from cows
grazing forage treated with esters of 2,4-D. Weeds
14(? ):164-167. (Also in unpublished submission received
Sep 12, 1968 under 8F0676; submitted by Dow Chemical
U.S.A., Midland, Mich.;CDL:092980-AK)
00004720 Lee, Y.N.; Luh, B.S. (1968) Effect of Chlorophenoxy-
acetic acid growth-regulator sprays on residues in
canned apricots and grapes. Journal of Food Science
33(? ):104-108. (Also in unpublished submission
received Sep 12, 1968 under 8F0676; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:092980-AL)
00004723 Morton, H.L. ; Robison, E.D. ; Meyer, R.E. (1967)
Persistence of 2,4-D, 2,4,5-T, and Dicamba in range
forage grasses. Weeds 15 (?):268-271. (Also in
unpublished submission received Sep 12, 1968 under
8F0676; submitted by Dow Chemical U.S.A., Midland,
Mich.;CDL:092980-AO)
140
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D standard
MRID Citation
00004960 Primer, P.E. (1965) Investigations into the Fate of
Some 14C Labeled Growth Regulators of the Phenoxy and
Naphthalenic Type in Apple Tissue. Doctoral
dissertation, Cornell Univ., Dept. of Pomology.
(Unpublished study received Dec 4, 1970 under 1E1094;
submitted by Interregional Research Project No. 4, New
Brunswick, N.J.; CDL:090854-I)
00004996 Corbett, J.R.; Miller, C.S. (1966) The persistence of
2,4-D in cotton when applied with desiccants. Weeds
14(? ):34-37. (Also in unpublished submission received
Sep 16, 1968 under 8F0676; submitted by Dow Chemical
U.S.A., Midland, Mich.;CDL:092090-0)
00021755 Burnside, I. (1975) Crop Residue Report: FSDS No.
A-8647. (Unpublished study received May 2, 1975 under
476-2156; prepared by Univ. of Nebraska, submitted by
Stauffer Chemical Co., Richmond, Calif.;CDL:009609-K)
00022329 Grage, D.; Dietz, B.; Dietze, R.; et al. (1976)
Sequential Applications of Eradicane 6.7-E (PPI) and
2,4-D (POES): Summary of Crop Residue Data on Corn.
(Unpublished study received Apr 20, 1976 under 476-2157;
prepared in cooperation with Morse Laboratories, Inc.,
submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:224614-E)
00022622 Woofter, D.; Appleby, A.P.; Watson, V.H.; et al. (1972)
[Chemical Sprays on Corn, Sorghum and Wheat].
Unpublished study received Jan 3, 1973 under 876-25;
prepared in cooperation with Oregon State Univ. and
others, submitted by Velsicol Chemical Corp., Chicago,
111. ; CDL:005052-C)
00025330 Suzuki, H.K.; Fenster, C.R. (1976) Dicamba: Residue
Tolerance Petition—Proso Millet. (Unpublished study
received Jan 24, 1979 under 9E2166; prepared in
cooperation with Univ. of Nebraska,submitted by Velsicol
Chemical Corp., Chicago, 111.; CDL:097773-A)
00025338 Klausen-Rogers, G.; Renfrew, J.; Slater, L.; et al.
(1970) Residue Results: [Dicamba]. (Unpublished study
received Jun 15, 1973 under 1F1131; prepared in
cooperation with Del Monte Corp. and others, submitted
by Velsicol Chemical Corp., Chicago, 111.;CDL:090907-F)
141
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00025383 Suzuki, H.K.; Behrens, R.; Kilmer, D. (1975) Residue
Chemistry: [Dicamba]. (Unpublished study including
report no. 404000, nos. 174, 176 and 179, received
Nov 18, 1976 under 876-255; prepared in cooperation with
International Research and Development Corp. and Univ.
of Wisconsin, submitted by Velsicol Chemical Corp.,
Chicago, 111.; CDL:226930-A)
00028173 Hoffman, C.; Haas, R.; Criswell, T.; et al. (1970)
Grass: Project No. 404000. (Unpublished study received
Jun 15, 1970 under 876-25; submitted by Velsicol
Chemical Corp., Chicago, 111.; CDL:004524-D)
00028200 Tullos, B.; Martin, L. ; Morse, R.; et al. (1975)
Weedmaster Herbicide Residue Data. (Unpublished study
received Oct 2, 1975 under 876-203; prepared in
cooperation with Kerr Foundation and others, submitted
by Velsicol Chemical Corp., Chicago, 111.;CDL:195015-A)
00028443 Duke, T. (1971) Technical Report on the Effect of 2,4-D
Formulations on Estuarine Organisms. (Unpublished study
received Jul 13, 1971 under 1E1046; prepared by U.S.
Environmental Protection Agency, Gulf Breeze Laboratory,
submitted by U.S. Dept. of the Army, Office of the Chief
of Engineers, Washington, D.C.; CDL:091865-H)
00030692 Suzuki, H.K. ; Whitacre, D.M. ; Wellman, J. ; et al. (1978)
Residue Data: [Banvel]. (Unpublished study received
Sep 14, 1979 under SD79-13; prepared in cooperation with
Craven Laboratories and others, submitted by state of
South Dakota for Velsicol Chemical Corp., Chicago, 111.;
CDL:241007-E)
00030697 Suzuki, H.K.; Whitacre, D.M.; Anderson, R.F.; et al.
(1976) Residue Project 75-1-D, Banvel: Corn-Harvest Aid.
(Unpublished study received Aug 30, 1979 under 876-25;
prepared in cooperation with International Research and
Development Corp. and ABC Laboratories, submitted by
Velsicol Chemical Corp., Chicago, 111.; CDL:240896-A)
142
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID
Citation
00030701 Suzuki, H.K.; Whitacre, D.M.; Boudreaux, H.; et al.
(1980) Weedmaster: Herbicide on Sugarcane: Residue Data
and Processing Studies. (Unpublished study received
Apr 12, 1980 under 876-203; prepared in cooperation with
International Research & Development Corp. and T. Lanaux
& Sons, submitted by Velsicol Chemical Corp., Chicago,
111.; CDL:242414-B)
00033119 Washington State University (1963) [Residues of 2,4-D in
Apples and Pears]. (Unpublished study received Dec 24,
1963 under 264-37; submitted by Union Carbide
Agricultural Products Co., Ambler, Pa.; CDL:001835-B)
00035913 Gangstad, E.G.; Zimmerman, P.W.; Hitchcock, A.E.; et al.
(1974) Aquatic-Use Patterns for 2,4-D Dimethylamine and
Integrated Control. By U.S. Dept. of the Army, Office
of the Chief of Engineers, Aquatic Plant Control
Program. Vicksburg, Miss.: U.S. Army Engineer,
Waterways Experiment Station. (APCP technical report 7;
published study; CDL:096474-C)
00036168 Bjerke, E.L.; Ervick, D.K.; Stymiest, C.; et al. (1973)
A Residue Study of the Disappearance of Picloram and
2,4-Dichlorophenoxyacetic acid in Small Grain following
Application of Tordon Herbicide: GH-C 683. (Unpublished
study received Jul 3, 1975 under 6F1653; prepared in
cooperation with South Dakota State Univ. and others,
submitted by Dow Chemical Co., Indianapolis, Ind.;
CDL:094498-C)
00036169 Southwick, L.; Hartman, G.P.; Stritzke, J.; et al.
(1975) A Residue Study of Picloram and 2,4-D in Oats and
Barley following Postemergence Application of Tordon:
202 Herbicide: GHP-912. (Unpublished study received
Jul 3, 1975 under 6F1653; prepared in cooperation with
Univ. of Montana and others, submitted by Dow Chemical
Co., Indianapolis, Ind.; CDL:094498-D)
143
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00036170 Southwick, L.; Behrens, R.; Hartman, G.P. (1975) A
Residue Study of Picloram and 2,4-Dichlorophenoxyacetic
acid in Wheat following One, Two and Three Years Use of
Picloram and 2,4-D (Tordon: 202 Mixture): GHP-913.
(Unpublished study received Jul 3, 1975 under 6F1653;
prepared in cooperation with Univ. of Minnesota and
Univ. of Montana, submitted by Dow Chemical Co.,
Indianapolis, Ind.; CDL:094498-E)
00036171 Bjerke, E.L.; Dietrich, I.; Baker, L.O.; et al. (1975) A
Residue Study of Picloram and 2,4-D in Wheat and Barley
following Postemergence Application of Tordon 22K Weed
Killer plus Formula 40 Herbicide: GH-C 821. (Unpublished
study received Jul 3, 1975 under 6F1653; prepared in
cooperation with Univ. of Montana and Montana State
Univ., submitted by Dow Chemical Co., Indianapolis,
Ind.; CDL:094498-F)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975)
Toxicity of Pesticides and Other Agricultural Chemicals
to Honey Bees: Laboratory studies. By University of
California, Dept. of Entomology. ?: UC, Cooperative
Extension. (Leaflet 2287; published study.)
00037169 Marquardt, R.P.; Luce, E.N. (1961) A new basic procedure
for determining Phenoxy acid herbicides in agricultural
products. Journal of Agricultural and Food Chemistry
9(4):266-270. (Also in unpublished submission received
Dec 6, 1972 under 3G1339; submitted by Interregional
Research Project No. 4, New Brunswick, N.J.;
CDL:093578-A)
00038429 Smith, G.E.; Isom, B.C. (1967) Investigation of effects
of large scale applications of 2,4-D on aquatic fauna
and water quality. Pesticides Monitoring Journal
1(3):16-21. (Also in unpublished submission received
Jul 11, 1971 under 1E1046; submitted by U.S. Dept. of
the Army, Washington, D.C.; CDL:093359-Y)
144
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00042288 Grigsby, B.H.; Farwell, E.D. (1950) Some Effects of
Herbicides on Pasture and on Grazing Livestock.
Michigan Agricultural Experiment Station Quarterly
Bulletin 32(3): 378-385. (Submitter ACD file no. HF-19;
also in unpublished submission received Oct 3, 1966
under unknown admin, no.; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:106349-A)
00042526 Meagher, W.G.; Phillips, R.L. (1966) Physiological
Effects and Chemical Residues Resulting from 2,4-TP and
2,4,5-TP Sprays used for Control of Preharvest Fruit
Drop in Pineapple Oranges. Progress rept., Jun 30,
1966. (Unpublished study received Mar 4, 1974 under
4E1476; prepared by Univ. of Florida, Citrus Experiment
Station, submitted by Interregional Research Project No.
4, New Brunswick, N.J.; CDL:093925-D)
00043278 Wojtalik, T.A.; Hall, T.F.; Hill, L.O. (1971) Monitoring
ecological conditions associated with wide-scale
applications of DMA 2,4-D to aquatic environments.
Pesticides Monitoring Journal 4(4):184-203. (Available
from: Superintendent of Documents, U.S. Government
Printing Office, published study; CDL:242936-B)
00043280 Whitney, E.W.; Montgomery, A.B.; Martin, E.G.; et al.
(1968) The effects of a 2,4-D application on the biota
and water quality in Currituck Sound, North Carolina.
[Without title]? (? ):13-17. (Also in unpublished
submission received Aug 4, 1976 under 876-222; submitted
by Velsicol Chemical Corp., Chicago, 111.;
CDL:242936-D)
00043759 Sikka, H.C. (1976) Fate of 2,4-D in Fish and Blue Crabs:
Contract No. DACW39-74-C-0068. (Syracuse Research Corp.
for U.S. Army, Office of the Chief of Engineers,
Environmental Characterization Branch, MESL, Waterways
Experiment Station, unpublished study; CDL:099544-D)
145
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID
Citation
00045364 Swann, R.L.; Pettyjohn, M.A.; Bjerke, E.L. (1972)
Determination of Residues of 2,4-D in Wheat, Barley and
Oat Green Forage, Grain and Straw by Gas Chromatography.
Method ACR 72.8 dated May 12, 1972. (Unpublished study
received Jul 3, 1975 under 6F1653; prepared in
cooperation with International Research and Development
Corp., submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL:094500-B)
00045365 Bjerke, E.L. (1973) A Study of Extraction of Picloram
and 2,4-D from Small Cereal Grains: GH-C 680.
(Unpublished study received Jul 3, 1975 under 6F1653;
submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL:094500-C)
00045369 Bjerke, E.L. ; Ervick, O.K. (1975) A Residue study of
Picloram and 2,4-D in Milled Wheat Fractions: GH-C 798.
(Unpublished study received Jul 3, 1975 under 6F1653;
submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL:094501-B)
00046125 Yip, G. (1964) Herbicides and plant growth regulators:
Determination of herbicides in oils. Journal of the
Association of Official Analytical Chemists
47(6):1116-1119. (Also in unpublished submission
received on unknown date under 6F0459; submitted by U.S.
Dept. of Agriculture, Agricultural Research Service,
unknown location; CDL:098165-1)
00046127 Phillips, W.M.; Yip, G.; Finney, K.F.; et al. (1964) The
Effects and Residue Status of Applications of Amine and
Ester; Applications of 2,4-D at Three Preharvest Growth
Stages on Hard Red Winter Wheat. (Unpublished study
received on unknown date under 6F0459; prepared in
cooperation with Kansas State Univ., Agricultural
Experiment Station, Dept. of Flour and Feed Milling
Industries and others, submitted by U.S. Dept. of
Agriculture, Agricultural Research Service, unknown
location; CDL:098165-L)
00046185 U.S. Office of Science and Technology, Panel on
Herbicides (1970) Report on 2,4-D. (Unpublished study;
CDL:119429-A)
146
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00050669 Pitcher, F.G.; McCann, J.A. (1974) Amine-Four Herbicide:
R. Trout (S. gairdneri): Test No. 756. (U.S.
Environmental Protection Agency, Chemical & Biological
Investigations Branch, Technical Services Div.,
unpublished study; CDL:127915-A)
00050674 Pitcher, F.G. (1974) Weed-Rhap LV OXY 6D: Rainbow Trout
(Salmo gairdneri): Test No. 683. (U.S. Environmental
Protection Agency, Pesticides Regulation Div., Animal
Biology Laboratory, unpublished study; CDL:128512-A)
00050678 McCann, J.A. (1970) Combination of Component A & B of
Emulsamine E-3: Bluegill (Lepomis macrochirus): Test No.
243. (U.S. Agricultural Research Service, Pesticides
Regulation Div., Animal Biology Laboratory, unpublished
study; CDL:130743-A)
00050681 Pitcher, F.G.; McCann, J.A. (1974) Pop-In Weed Control
Spray: Bluegill (L. macrochirus). (U. S. Environmental
Protection Agency, Technical Services Div., Chemical &
Biological Investigations Branch, unpublished study;
CDL:131067-A)
00050712 McCann, J.A. (1970) Compound A of Emulsamine E-3:
Toxicity to Rainbow Trout (Salmo gairdneri): Test No.
236. (U.S. Agricultural Research Service, Pesticides
Regulation Div., Agricultural Research Center, Animal
Biology Laboratory, unpublished study; CDL:121592-A)
00050713 McCann, J.A. (1970) Emulsamine E-3: Toxicity to Rainbow
Trout (Salmo gairdneri): Test No. 238. (U.S.
Agricultural Research Service, Pesticides Regulation
Div., Agricultural Research Center, Animal Biology
Laboratory, unpublished study; CDL:121592-B)
00050715 McCann, J.A. (1970) Emulsamine E-3: Toxicity to Bluegill
(Lepomis macrochirus): Test No. 245. (U.S. Agricultural
Research Service, Pesticides Regulation Div.,
Agricultural Research Center, Animal Biology Laboratory,
unpublished study; CDL:121592-D)
00052597 Frank, P.A. (1969) Residues of 2,4-D in Irrigation Water
and Irrigated Crops. (U.S. Dept. of Agriculture, Crops
Protection Branch, unpublished study; CDL:091863-D)
147
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00053986 McCann, J.A.; Pitcher, F. (1973) Aquacide: Rainbow Trout
(Salmo gairdneri): Test No. 546. (U.S. Environmental
Protection Agency, Pesticides Regulation Div., Animal
Biology Laboratory, unpublished study; CDL:128584-A)
00053996 Pitcher, F.G. (1974) LV 2,4-D Ester Four BP: Rainbow
Trout (Salmo gairdneri): Test No. 684; Report No.
040209. (U.S. Environmental Protection Agency,
Pesticides Regulation Div., Animal Biology Laboratory,
unpublished study; CDL:128511-A)
00054025 Bentley, R.E. (1973) Acute Toxicity of Emulsamine E-3 to
Bluegill (Lepomis macrochirus), Channel Catfish
(Ictalurus punctatus), iargemouth Bass (Micropterus
salmoides), and Water Flea (Daphnia magna), Midge Larvae
(Chironomus tentans), and Scud (Hyalella azteca).
(Unpublished study received Sep 27, 1974 under 264-179;
prepared by Bionomics, Inc., submitted by Union Carbide
Agricultural Products Co., Inc., Ambler, Pa.;
CDL:132104-A)
00054045 McCann, J.A. (1968) Dow Estron 99: Bluegill (Lepomis
macrochirus): Test No. «4. (U.S. Agricultural Research
Service, Pesticides Regulation Div., Animal Biology
Section (Fish), unpublished study; CDL:121599-A)
00055485 Khajeh-Noori, K. (19??) IMethod for Analysis of Residues
of N,N-Dimethyl-2,4-dicaaiorophenoxyacetamide on Whole
Fish. Undated method. (Unpublished study received
Nov 22, 1971 under 16133-1; prepared by Thornton
Laboratories, Inc., submitted by Clearwater Chemical
Corp., Ft. Myers, Fla.; CDL:015056-K)
00055755 Whitney, E.W.; Montgomery, A.B.; Martin, E.G.; et al.
(19??) The effects of a .2,4-D application on the biota
and water quality in Currituck Sound, North Carolina.
[Without Title]? (? ):13-17. (Also in unpublished
submission received May 19, 1975 under 2E1221; submitted
by U.S. Dept. of the Army, Washington, D.C.;
CDL:094080-J)
148
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00057313 Brandau, E.G. (1975) Letter sent to Route List dated
Mar 13, 1975 [Mobility of FMC 25213, Carbofuran, DDT,
and 2,4-D in soil] M-3644. (Unpublished study received
Aug 26, 1975 under unknown admin, no.; submitted by FMC
Corp., Philadelphia, Pa.; CDL:226068-N)
00059025 Glas, R.D. (1975) Residues of Dowco 290 and 2,4-D in
Wheat and Barley following Postemergence Application of
Lontrel 205 Herbicide: GH-C 836. (Unpublished study
received Nov 12, 1980 under 464-563; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:099735-D)
00059026 Gardner, R.C.; Bjerke, E.L. (1975) Residues of Dowco
290, 2,4-D and MCPA in Green Forage, Straw and Grain of
Wheat and Barley after Postemergence Treatment with
Lontrel Herbicides: GH-C 850. (Unpublished study
received Nov 12, 1980 under 464-563; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:099735-E)
00059027 Kutschinski, A.H. (1979) Residues of Dowco 290 and 2,4-D
in Barley and Wheat following Postemergence Application
of Lontrel 205 Herbicide by Ground vs Aerial Sprayer:
GH-C 1208. (Unpublished study received Nov 12, 1980
under 464-563; submitted by Dow Chemical U.S.A.,
Midland, Mich.; CDL:099735-F)
00059028 Kutschinski, A.H. (1979) Residues of Dowco 290 and 2,4-D
in Oats following Postemergence Application of Lontrel
205 Herbicide: GH-C 1217. (Unpublished study received
Nov 12, 1980 under 464-563; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL: 099735-G)
00059029 Glas, R.D. (1978) Residues of 3,6-Dichloropicolinic acid
and 2,4-D in Milling and Malting Fractions following
Postemergence Application of Lontrel 205 Herbicide to
Wheat and Barley: GH-C 977. (Unpublished study received
Nov 12, 1980 under 464-563; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:099735-H)
00059033 Kutschinski, A.H. (1979) Determination of Residues of
3,6-Dichloropicolinic acid and 2,4-D in Barley and Wheat
by Gas Chromatography. Method ACR 79.5 dated Apr 18,
1979. (Unpublished study received Nov 12, 1980 under
464-563; submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:099735-L)
149
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00059034 Miller, P.W. (1975) Residues of 2,4-D and
2,4-Dichlorophenol in Milk from Cows Fed 2,4-D in
Conjunction with Dowco 290: GH-C804. (Unpublished study
received Nov 12, 1980 under 464-563; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:099736-A)
00060111 American Cyanamid Company (1977) General Summary:
[Avenge in Wheat Grain and Straw]. (Compilation;
unpublished study received Apr 26, 1977 under 241-250;
CDL:229617-A)
00060113 Peterson, R.P. (1976) CL 84,777 Combination: Gas
Chromatographic Procedure for the Determination of 2,4-D
Residues in Wheat. Method M-733 dated Oct 8, 1976.
(Unpublished study received Apr 26, 1977 under 241-250;
submitted by American Cyanamid Co., Princeton, N.J.;
CDL:229617-D)
00060117 American Cyanamid Company (1975) General Summary:
[Studies to Determine Avenge and 2,4-D Residues in
Barley Grain and Straw]. (Compilation; unpublished study
received Apr 26, 1977 under 241-250; CDL:229616-A)
00060120 Peterson, R.P. (1976) CL 84,777 Combination: Gas
Chromatographic Procedure for the Determination of 2,4-D
Residues in Barley. Method M-738 dated Oct 8, 1976.
(Unpublished study received Apr 26, 1977 under 241-250;
submitted by American Cyanamid Co., Princeton, N. J. ;
CDL:229616-D)
00060870 Dow Chemical U.S.A. (1956) Residue Study on Samples from
Washington and California Trials: 2,4-D for Weed Control
in Asparagus Culture. (Unpublished study received
Jan 2, 1958 under PP0162; CDL:090188-K)
00060872 Dow Chemical U.S.A. (1955?) Method of Analysis for 2,4-D
on Treated Asparagus. (Unpublished study received
Jan 2, 1958 under PP0162; CDL:092439-C)
00060876 Florida Fruit & Vegetable Association (1960) The Results
of Tests on the Amount of Residue Remaining, Including a
Description of the Analytical Method Used: [2,4-D].
(Unpublished study received Oct 12, 1963 under PP0272;
CDL:090295-B)
150
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D standard
MRID Citation
00060880 University of California—Davis (19??) Analysis for
Combined 2,4-D esters in Potatoes. Undated method.
(Unpublished study received Oct 12, 1963 under PP0272;
prepared by Agricultural Extension Service, Dept. of
Agronomy, submitted by Florida Fruit & Vegetable
Association, Orlando, Fla.; CDL:090295-G)
00061010 National Agricultural Chemical Association (1965?) The
Results of Tests on the Amount of Residue Remaining,
Including a Description of the Analytical Method Used:
[2,4-Dichlorophenoxyacetic acid]. (Compilation;
unpublished study received May 15, 1967 under 8F0670;
CDL:091172-AL)
00061012 National Agricultural Chemical Association (1967?)
Summary of Residues. (Compilation; unpublished study
received May 15, 1967 under 8F0670; CDL:091172-AN)
00061014 Dow Chemical Company (1959) Analytical Method:
Determination of Trace Amounts of
2,4-Dichlorophenoxyacetic acid in Sugar Cane Juice.
Method no. MLE.59.4 dated Apr 23, 1959. (Unpublished
study received May 15, 1967 under 8F0670; submitted by
National Agricultural Chemical Association, unknown
location; CDL: 091172-AR)
00061016 Dow Chemical Company (1964) Determination of
2,4-Dichlorophenoxyxyacetic acid in Peanut Hay and
Immature Peanut Vines. Method no. MLE.64.16 dated
Aug 20, 1964. (Unpublished study received May 15, 1967
under 8F0670; submitted by National Agricultural
Chemical Association, unknown location; CDL:091172-AT)
00061017 Dow Chemical Company (1964) Analytical Method:
Determination of 2,4-Dichlorophenoxyacetic acid in
Peanuts. Method no. MLE.64.21 dated Apr 17, 1964.
(Unpublished study received May 15, 1967 under 8F0670;
submitted by National Agricultural Chemical
Association, unknown location; CDL:091172-AU)
151
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00061018 Marquardt, R.P.; Luce, E.N. (1955) Determination of
2,4-Dichlorophenoxyacetic acid (2,4-D) in grain and
seed. Agricultural and Food Chemistry 3(1):51-53.
(Also in unpublished submission received May 15, 1967
under 8F0670; submitted by National Agricultural
Chemical Association, unknown location; CDL:091172-AV)
00061645 Munro, H.E. (1972) Determination of 2,4-Dichlorophen-
oxyacetic acid and 2,4,5-Trichlorophenoxyacetic acid in
tomato plants and other commercial crops by
microcoulometric gas chromatography. Pesticide Science
3(4):371-377; taken from Weed Abstracts, 1973 22(2):38.
(Abstract no. 376). (Also in unpublished submission
received Dec 9, 1974 under 33652-1; submitted by Chemie
Linz AG, Chemie, Austria; CDL:230516-U)
00063507 Colorado. Department of Agriculture (1979) Residue Test
No. 1734: Range Grass from York, Nebraska. (Unpublished
Study; CDL: 244533-J)
00066156 Duffy, J.R.; Shelfoon, P. (1967) Determination of 2,4-D
and its butoxyethanol ester in oysters by gas
chromatography. Journal of the Association of Official
Analytical Chemists 50(5):1098-1102. (Also in
unpublished submission received Aug 4, 1976 under
876-222; submitted by Velsicol Chemical Corp., Chicago,
111.; CDL:229171-E)
00067425 Monsanto Company (1980) Residues of Glyphosate and Other
Herbicides in Wheat following Chemical Fallow
Applications of Roundup: Tank Mix Combinations. Includes
method dated Jul 1, 1979 and undated methods entitled:
2,4-D in wheat forage, straw and grain; Dicamba in wheat
forage, straw and grain; Residues of alachlor in wheat
grain, forage and straw; Atrazine in wheat forage, straw
and grain; Cyanazine in wheat forage, straw and grain;
Metribuzin and metabolites in wheat forage, straw and
grain. (Unpublished study, including published data,
received Dec 29, 1980 under 524-308; CDL:243990-A;
243991)
00068011 Diamond Shamrock Agricultural Chemicals (1975) Residue
Studies in Grass and Hay. (Compilation; unpublished
study, including published data, received Nov 19, 1980
under unknown admin, no.; CDL:244821-A)
152
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00068889 Kutschinski, A.H.; Bates, T.W.; Swann, R.L. (1971)
Residues of 2,4-D in Sugarcane and Its Factory Products
Resulting from Applications of Amine or Ester
Formulations of the Herbicides. Final rept. (Unpublished
study received Oct 9, 1971 under 8F0670; prepared by Dow
Chemical Co. in cooperation with International Research
and Development Corp., submitted by National
Agricultural Chemicals Association, Industry Task Force
on Phenoxy Herbicide Tolerances, Washington, D.C. ;
CDL:091173-D)
00068891 Miller, P.W.; Jensen, D.J. (1971) Identification of
2,4,6-Trichlorophenol and 2,6-Dichlorophenol Residues in
Milk from Cows Fed 2,4-Dichlorophenoxyacetic acid.
(Unpublished study received Oct 9, 1971 under 8F0670;
prepared by Dow Chemical Co., submitted by National
Agricultural Chemicals Association, Industry Task Force
on Phenoxy Herbicide Tolerances, Washington, B.C.;
CDL:091173-G)
00068892 Miller, P.W.; Jensen, D.J.; Gentry, W.M. (1971) Residues
of 2,4-Dichlorophenoxyacetic acid and 2,4-Dichlorophenol
in Tissues of Beef Calves Fed 2,4-D. Final rept.
(Unpublished study received Oct 9, 1971 under 8F0670;
prepared by Dow Chemical Co., submitted by National
Agricultural Chemicals Association, industry Task Force
on Phenoxy Herbicide Tolerances, Washington, D.C. ;
CDL:091173-H)
00068893 Jensen, D.J.; Miller, P.W.; Palmer, J.S. (1971) Residues
of 2,4-Dichlorophenoxyacetic acid and 2,4-Dichlorophenol
in Tissues of Sheep Fed 2,4-D. (Unpublished study
received Oct 9, 1971 under 8F0670; prepared by Dow
Chemical Co. in cooperation with U.S. Agricultural
Research Service, Animal Disease and Parasite Research
Div., submitted by National Agricultural Chemicals
Association, Industry Task Force on Phenoxy Herbicide
Tolerances, Washington, D.C.; CDL:091173-1)
00071787 Toetz, D. (1976) Residues of 2,4-D in Flesh of Selected
Fish Species in Lake Fort Cobb as a Result of Herbicide
Use on Eurasian Watermilfoil Myriophyllum spicatum.
(Oklahoma State Univ., School of Biological Sciences,
Research Foundation for U.S. Dept. of the Interior,
Bureau of Reclamation; unpublished study; CDL:099179-D)
153
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID
Citation
00073273 Anon. (1979) A Comparison of Dicamba dimethylamine salt
Emulsifiable Concentrate with Dicamba acid Granules in
Terms of Stand Reduction and Residues. (Reports by
various sources; unpublished study received Nov 3, 1980
under OK 80/13; submitted by Oklahoma, Dept. of
Agriculture, Oklahoma City, Okla.; CDL: 243740-A)
00074214 Feung, C.; Hamilton, R.H.; Mumma, R.O. (1975) Metabolism
of 2,4-dichlorophenoxyacetic acid. VII. Comparison of
metabolites from five species of plant callus tissue
cultures. Journal of Agricultural and Food Chemistry
23(3):373-376. (Also in unpublished submission received
Apr 14, 1981 under OF2404; submitted by Dow Chemical
Co., Indianapolis, Ind.; CDL:070006-D)
00074215 Feung, C.; Hamilton, R.H.; Mumma, R.O. (1973) Metabolism
of 2,4-dichlorophenoxyacetic acid. V. Identification of
metabolites in soybean callus tissue cultures. Journal
of Agricultural and Food Chemistry 21(4):637-640. (Also
in unpublished submission received Apr 14, 1981 under
OF2404; submitted by Dow Chemical Co., Indianapolis,
Ind.; CDL:070006-E)
00074216 Feung, C.; Hamilton, R.H.; Witham, F.H. (1971)
Metabolism of 2,4-dichlorophenoxyacetic acid by soybean
cotyledon callus tissue cultures. Journal of
Agricultural and Food Chemistry 19(3):475, 479. (Also
in unpublished submission received Apr 14, 1981 under
OF2404; submitted by Dow Chemical Co., Indianapolis,
Ind.; CDL:070006-F)
00074217 Hamilton, R.H.; Hurter, J.; Hall, J.K.; et al. (1971)
Metabolism of 2,4-dichlorophenoxyacetic acid and
2,4,5-trichlorophenoxyacetic acid by bean plants.
Journal of Agricultural and Food Chemistry
19(3):480-483. (Also in unpublished submission received
Apr 14, 1981 under OF2404; submitted by Dow Chemical
Co., Indianapolis, Ind.; CDL:070006-G)
00074219 Lokke, H. (1975) Analysis of free and bound
chlorophenoxy acids in cereals. Bulletin of
Environmental Contamination & Toxicology 13(6):730-736.
(Also in unpublished submission received Apr 14, 1981
under OF2404; submitted by Dow Chemical Co.,
Indianapolis, Ind.; CDL:070006-J)
154
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00075198 Carlile, B.L. (1968) Degradation and Depletion of
Herbicides in Drainage Waters and Accumulation of
Residues in Crops Irrigated with Treated Water: Annual
Report—2,4-D and Silvex. (Battelle Memorial Institute
for U.S. Dept. of Agriculture; unpublished study;
CDL:090913-D)
00075715 Velsicol Chemical Corporation (1981) [Residues in Corn].
Includes undated method AM-0691. (Compilation,
unpublished study received Jun 12, 1981 under 876-25;
CDL:245471-B)
00075716 Velsicol Chemical Corporation (1981) [Residues in
Wheat]. Includes undated method AM-0691.
(Compilation; unpublished study received Jun 12, 1981
under 876-25; CDL:245471-C)
00075719 Velsicol Chemical Corporation (1981) [Determination of
Banvel and Dicamba in Sorghum]. (Compilation;
unpublished study received Jun 12, 1981 under 876-25;
CDL:245471-F)
00075724 Colorado (1981) [Determination of Banvel and Dicamba in
Various Crops]. Includes method AM-0691 dated Jul 25,
1979. (Compilation; unpublished study received Jun 22,
1981 under CO 81/11; CDL:245581-A)
00078482 Montana, Department of Agriculture (1974) [Residue Tests
for Picloram in Grains]. (Compilation; unpublished
study received on unknown date under 4E1489;
CDL:093948-F)
00079738 Velsicol Chemical Corporation (1981) Sugarcane Residue
Studies. (Compilation; unpublished study received
Sep 11, 1981 under 876-25; CDL:070319-D)
00088176 Interregional Research Project Number 4 (1978) [Residues
Study of Envy 2,4-D on Stone Fruit]. (Compilation;
unpublished study received Nov 18, 1981 under 2E2606;
CDL:070506-A)
155
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Bas<> Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00090360 Klingman, D.L.; Gordon, C.H.; Yip, G.; et al. (1966)
Residues in the forage and in milk from cows grazing
forage treated with esters of 2,4-D. Weeds
14(2):164-167. (Also in unpublished submission received
May 31, 1966 under 6F0459; submitted by U.S. Dept. of
Agriculture, Agricultural Research Service, unknown
address; CDL:090505-A)
00090361 Hilton, J.L.; Phillips, W.M.; Shaw, W.C. (1960) A
Summary of the Effects of Amine and Ester Formulations
of 2,4-Dichlorophenoxyacetic Acid [2,4-D] on Small
Grains, Including the Status of Residues When 2,4-D is
Applied to the Crop at Various Stage of Growth: Line
Project No. CR FL-16. (U.S. Agricultural Research
Service, Crops Research Div.; unpublished study;
CDL:090505-C)
00101591 Mayhew, D.; Johnson, Y.; Kingery, A. (1981) Acute Oral
Toxicity Study in Albino Rats with ITF-5;
2,4-Dichlorophenoxyacetic Acid, Sodium Salt: Project No.
WIL-81233. (Unpublished study received Jul 23, 1981
under unknown admin, no.; prepared by WIL Research
Laboratories, Inc., submitted by Dow Chemical U.S.A.,
Midland, MI; CDL:247496-A)
00101592 Mayhew, D.; Johnson, Y.; Kingery, A. (1981) Acute Dermal
Toxicity Study in Albino Rabbits with ITF-4;
2,4-Dichlorophenoxyacetic Acid, Isobutyl Ester: Project
No. WIL-81232. (Unpublished study received Jul 23, 1981
under unknown admin, no.; prepared by WIL Research
Laboratories, Inc., submitted by Dow Chemical U.S.A.,
Midland, MI; CDL:247496-B)
00101595 Mayhew, D.; Johnson, Y.; Kingery, A. (1981) Acute Oral
Toxicity Study in Albino Rats with ITF-4;
2,4-Dichlorophenoxyacetic Acid, Isobutyl Ester: Project
No. WIL-81232. (Unpublished study received Jul 23, 1981
under unknown admin, no.; prepared by WIL Research
Laboratories, Inc., submitted by Dow Chemical U.S.A.,
Midland, MI; CDL:247496-E)
156
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID
Citation
00101596 Mayhew, D.; Johnson, Y.; Kingery, A. (1981) Acute Dermal
Toxicity Study in Albino Rabbits with ITF-5;
2,4-Dichlorophenoxyacetic Acid, Sodium Salt: Project No.
WIL-81233. (Unpublished study received Jul 23, 1981
under unknown admin, no.; prepared by WIL Research
Laboratories, Inc., submitted by Dow Chemical U.S.A.,
Midland, MI; CDL:247496-F)
00101600 Johnson, D.; Myer, J.; Marroquin, F.; et al. (1981)
Determination of Acute Dermal LD50 in Rabbits: Study No.
490-005. (Unpublished study received Dec 21, 1981 under
unknown admin, no.; prepared by International Research
and Development Corp., submitted by Dow Chemical U.S.A.,
Midland, MI; CDL:247498-A)
00101601 Johnson, D.; Myer, J.; Uraih, L.; et al. (1981)
Determination of Acute Oral LD50 in Fischer 344 Rats:
IRDC Study No. 490-002. (Unpublished study received
Dec 21, 1981 under unknown admin, no.; prepared by
International Research and Development Corp., submitted
by Dow Chemical U.S.A., Midland, MI; CDL:247498-B)
00101605 Johnson, D.; Myer, J.; Moxon, P.; et al. (1981)
Determination of Acute Oral LD50 in Fischer 344 Rats:
490-001. Rev. (Unpublished study received Dec 21, 1981
under unknown admin, no.; prepared by International
Research and Development Corp., submitted by Dow
Chemical U.S.A., Midland, MI; CDL:247499-C)
00102605 Phillips, R. (1970) 2,4-D—Oranges and Grapefruit—CES
(Lake Alfred) 1969. (Unpublished study received Sep 28,
1970 under 359-177; prepared by Univ. of Florida, Dept.
of Food Science, Pesticide Research Laboratory,
submitted by Rhone-Poulenc, Inc., Monmouth Junction, NJ;
CDL-.026724-A)
00102640 National Agricultural Chemicals Assoc. (1970) [2,4-D:
Residues in Sugarcane]. (Compilation; unpublished study
received Jan 18, 1971 under 8F0670; CDL:091176-A)
157
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID
Citation
00102675 Canny, M.; Markus, K. (1960) The breakdown of
2,4-dichlorophenoxyacetic acid in shoots and roots.
Australian J. Biol. Sci. 13(4):486-502. (Also in
unpublished submission received Sep 12, 1968 under
8F0670; submitted by National Agricultural Chemicals
Assoc., Industry Task Force on Phenoxy Herbicide
Tolerances, Washington, DC; CDL:092089-L)
00102676 National Agricultural Chemicals Assoc. (1968) [Phenoxy
Herbicides: Residues in Various Crops]. (Compilation;
unpublished study received Sep 12, 1968 under 8F0670;
CDL:092089-O)
00102679 Luckwill, L.; Lloyd-Jones, C. (1960) Metabolism of plant
growth regulators I. 2,4-dichlorophenoxyacetic acid in
leaves of red and of black currant. II. Decarboxylation
of 2,4-dichlorophenoxyacetic acid in leaves of apple and
strawberry. Ann. Appl. Biol. 48(3):613-636. (Also in
unpublished submission received Sep 12, 1968 under
8F0670; submitted by National Agricultural Chemicals
Assoc., Industry Task Force on Phenoxy Herbicide
Tolerances, Washington, DC; CDL:092089-AC)
00102710 Florida Fruit & Vegetable Assoc. (1960) [Analyses for
2,4-D Residue in Potatoes]. (Compilation; unpublished
study received Sep 26, 1960 under PP0272; CDL:092551-D)
00102712 Gentry, W. (1971) Residues of 2,4-Dichlorophenoxyacetic
Acid, 2,4,5-Trichlorophenoxyacetic Acid, and 2-(2,4,5-
Trichlorophenoxy) Propionic Acid in Grass Treated with
Phenoxy Herbicides. (Unpublished study received Sep 7,
1973 under 8F0670; prepared by Dow Chemical Co.,
submitted by National Agricultural Chemicals Assoc.,
Industry Task Force on Phenoxy Herbicide Tolerances,
Washington, DC; CDL:092965-C)
00102713 National Agricultural Chemicals Assoc. (1973) Discussion
of Analyses for Residues of 2,4-D and 2,4-Dichlorophenol
in Animal Tissues, July 1973. Summary of study
092142-AD. (Compilation; unpublished study received
Sep 7, 1973 under 8F0670; CDL: 092965-D)
158
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00102714 National Agricultural Chemicals Assoc. (1973) Discussion
of Analyses for Residues of 2,4-D and 2,4-Dichlorophenol
in Milk, July 1973. (Compilation; unpublished study
received Sep 7, 1973 under 8F0670; CDL:092965-F)
00102717 Crabtree, G.; Sheets, W.; Montgomery, M.; et al. (1974)
Residue Study: 2,4-D for Control of Broadleaf Weeds in
Strawberries. (Unpublished study received on unknown
date under 5E1544; prepared by Oregon State Univ.,
submitted by Interregional Research Project No. 4, New
Brunswick, NJ; CDL:094206-A)
00102719 National Agricultural Chemicals Assoc. (1975) Summary of
Additional Residue Data for 2,4-D in Sorghum, Poultry
and Eggs, and Discussion on Residues in/on Forage
Grasses. (Compilation; unpublished study received
Jul 16, 1975 under 8F0670; CDL: 094530-A)
00102737 Honse, C.; Yoh, J.; Moye, H.; et al. (1973)
[Alkanolamine Salt of 2,4-D: Residues in Oranges].
(Unpublished study received Sep 25, 1975 under 6E1678;
prepared by Univ. of Florida, Pesticide Research
Laboratory, submitted by Interregional Research Project
NO. 4, New Brunswick, NJ; CDL:097352-B)
00102760 Rawls, C. (1968) The Accumulation and Loss of
Field-applied Butoxyethanol Ester of
2,4-dichlorophenoxyacetic Acid in Eastern Oysters, ...
and Soft-shelled Clams, Mya arenaria. (Unpublished
study received Jan 5, 1972 under 2E1221; prepared by
Univ. of Maryland, Natural Resources Institute,
Chesapeake Biological Laboratory, submitted by U.S.
Dept. of the Army, Washington, DC; CDL:097882-Z)
00102788 Bartley, T.; Gangstad, E. (1975) Dissipation of Residues
of 2,4-D in Irrigation Canals. (U.S. Dept. of the
Interior, Bureau of Reclamation, Office of the Chief
Engineer, Division of Research and U.S. Dept. of the
Army, Office of the Chief of Engineers, Directorate of
Civil Works, Planning Div.; unpublished study;
CDL:097921-A)
159
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00102794 Kutschinski, A. (1972) Residues of 2,4-D in Louisiana
Sugarcane Resulting from Multiple Applications of Amine
Formulations Including a Late Summer Treatment: GH-C
512. (Unpublished study received Dec 6, 1973 under
464-1; submitted by Dow Chemical U.S.A., Midland, MI;
CDL:101303-A)
00102812 Reasor Hill Corp. (1960) [Residues of 2,4-D in
Strawberries and Cranberries]. (Compilation;
unpublished study received Feb 27, 1961 under 347-136;
CDL:120079-A)
00102814 Zweig, G. (1962) Letter sent to J. McLean dated Nov 27,
1962 [Report of analysis for 2,4-D in potatoes].
(Unpublished study received Dec 17, 1962 under unknown
admin, no.; prepared by Univ. of California—Davis,
Pesticide Residue Research, submitted by Chemical
Machines, Winnipeg, Canada; CDL:120204-A)
00102815 Brannock, D.; Freed, V. (1965) Analysis of Pears and
Apples for Residues of 2,4-D from Dacamine-D.
(Unpublished study received May 18, 1965 under 677-200;
prepared by Oregon State Univ., Dept. of Agricultural
Chemistry, submitted by Diamond Shamrock Agricultural
Chemicals, Cleveland, OH; CDL:120205-A)
00102816 Dow Chemical Co. (1955?) Studies on Raw Agricultural
Commodities for Residues of 2,4-Dichlorophenoxyacetic
Acid (2,4-D). (Unpublished study received on unknown
date under unknown admin, no.; CDL:120208-A)
00102821 Boyce Thompson Institute for Plant Research, Inc. (1962)
Residues of 2,4-D in Milk from Cows Grazing on Sprague
Pastures. (Unpublished study received Mar 22, 1962
under unknown admin, no.; submitted by Rhone-Poulenc,
Inc., Monmouth Junction, NJ; CDL: 122170-A)
00102824 Legault, R.; Benson, N.; Reynolds, D.; et al. (1963)
Pesticide Residue Analysis. (Unpublished study received
1964 under 264-37; prepared by Washington State Univ.,
Dept. of Agricultural Chemistry, submitted by Union
Carbide Agricultural Products Co., Inc., Research
Triangle Park, NC; CDL:122187-A)
160
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00102833 Rhone-Poulenc, Inc. (1964) Use of Weedez Bar (2,4-D) in
Grape Vineyards—Application to USDA for Registration on
no Residue Basis. (Unpublished study received Mar 23,
1964 under 359-EX-42; CDL:125194-B)
00102862 Chemical Machines (1964) [2,4-D: Residues in Potatoes].
(Compilation; unpublished study received Mar 24, 1964
under 3462-8; CDL:221908-B)
00102865 Leng, M.; Jensen, D.; Miller, P. (1973) Residues of
2,4-D in Field Corn and Sweet Corn from Preemergence or
Postemergence Treatments with the Herbicide.
(Unpublished study received Mar 4, 1976 under 464-201;
submitted by Dow Chemical U.S.A., Midland, MI;
CDL:223616-A)
00102879 Bice, J. (1961) Physiological Effect of 2,4-D on Lemons.
(Unpublished study received Jun 15, 1967 under 5202-18;
submitted by Brogdex Co., Pomona, CA; CDL:230582-A)
00102889 Wisconsin Alumni Research Foundation (1969) Assay
Report: W.A.R.F. No. 8110601-630. (Unpublished study
received Oct 5, 1976 under 11275-2; submitted by Guth
Corp., Naperville, IL; CDL:235811-A)
00102908 McCarty, W. (1977) Toxicity of 2,4-Dichlorophenoxyacetic
Acid Propylene Glycol Butyl Ether Esters to Daphnids.
(Unpublished study received Sep 12, 1979 under 464-187;
submitted by Dow Chemical U.S.A., Midland, MI;
CDL:240966-A)
00109535 Velsicol Chemical Corp. (1982) [Dicamba: Residues in
Cows & Other Subjects]. (Compilation; unpublished study
received Aug 6, 1982 under 876-168; CDL:248024-A)
00110675 Brandau, E.; Goertler, M.; Robinson, R. (1975)
Determination of Partition Coefficients for Carbofuran,
FMC 33297, FMC 25213, certain Potential Metabolites and
Two Benchmark Chemicals: Analytical Report M-3779.
(Unpublished study received Jan 3, 1978 under 279-3013;
submitted by FMC Corp., Philadelphia, PA; CDL:
096697-N)
161
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00112937 Brandau, E.; Goertler, M.; Otsa, H.; et al. (1975)
Carbofuran, FMC 33297, FMC 25213 and Endosulfan Soil
Adsorption/Desorption Studies: Analytical Report M-3785.
(Unpublished study received Jan 3, 1978 under 279-3013;
submitted by FMC Corp., Philadelphia, PA; CDL:096699-T)
00115499 Dow Chemical Co. (1972) Amendment to PP 1F1102
Requesting Tolerances for Residues of ... (2,4,5-T).
(Compilation; unpublished study received Jul 21, 1972
under 1F1102; CDL:090864-A)
00115509 National Agricultural Chemicals Assoc. (1967) [Study:
2,4-D Residue in Crops, Animal Tissue of Animal
Products!. (Compilation; unpublished study received
Sep 16, 1968 under 8F0669; CDL: 092964-Q)
00115515 Dow Chemical Co. (1971) [Study: 2,4,5-T Residues in
Animals and Selected Crops]. (Compilation; unpublished
study received Sep 29, 1971 under 1F1102; CDL:093415-A)
00115741 Otto, N. (1982) Letter sent to Chief, Applied Sciences
Branch dated Sep 8, 1982: Herbicidal residues and
environmental effects resulting from the experimental
application of two 2,4-D formulations to control
eurasian watermilfoil. (U.S. Bureau of Reclamation,
Engineering and Research Center; unpublished study;
CDL: 248613-B)
00115745 Hoeppel, R.; Westerdahl, H. (1982) Dissipation of 2,4-D
DMA and BEE from Water, Mud, and Fish at Lake Seminole,
Georgia. (U.S. Dept. of the Army, Army Engineer
Waterways Experiment Station, Environmental Laboratory;
unpublished study; CDL:248614-A)
00115793 Ciba-Geigy Corp. (1977) Residues of Ametryn and 2,4-D
Amine in or on Sugarcane from Single and Multiple
Applications—Louisiana. (Compilation; unpublished study
received Jan 16, 1978 under 100-473; CDL:232676-A)
162
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00116625 McCall, P.; Vrona, S.; Kelley, S. (1981) Fate of
uniformly carbon-14 ring labeled 2,4,5-trichlorophen-
oxyacetic acid and 2,4-Dichlorophenoxyacetic acid.
[Source unknown]. (Also in unpublished submission
received Oct 21, 1982 under 11683-EX-2; submitted by
U.S. Dept. of the Interior, Washington, DC; CDL:
248614-U)
00118549 Amchem Products, Inc. (1971) Fenac Residue Data—Total
Water Treatment. (Compilation; unpublished study
received Jul 7, 1972 under 2F1213; CDL:091039-T)
00120057 National Agricultural Chemicals Assoc. (1970) The
Results of Tests on the Amount of Residue Remaining,
Including a Description of the Analytical Method Used:
[2,4-Dichlorophenoxyacetic Acid]. (Compilation;
unpublished study received Jan 18, 1971 under 8F0670;
CDL:091174-A)
00121711 Washington, Dept. of Game (1967) [DDT: Residues in
Seafood]. (Compilation; unpublished study received 1967
under 4F0419; CDL:092706-A)
00121733 Thompson Chemicals Corp. (19??) Method: [Residues of
Phenoxyacids and Their Amine Salts in Apples and Other
Crops]. (Unpublished study received Apr 3, 1967 under
7F0589; CDL:092877-A)
00123269 Interregional Research Project No. 4 (1973) [2,4-D
Residues in Asparagus and Other Subjects].
(Compilation; unpublished study received Mar 1, 1974
under 4E1475; CDL:093923-A)
00123973 U.S. Fish and Wildlife Service (1972) Metabolism of
Pesticides: [2,4-D]. (Unpublished study received 1972
under 4G1487; CDL: 093950-A)
00126684 PBI-Gordon Corp. (1982) [Ultra-Sulv (2,4-D) Residues in
Wheat and Corn and Rate of Decline in Soil].
(Compilation; unpublished study received Apr 1, 1983
under 2217-703; CDL:249863-G)
00127226 U.S. Agricultural Research Service (1961) [Residues:
2,4-D]. (Compilation; unpublished study received
Mar 16, 1964 under 6F0459; CDL:092748-A)
163
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID
Citation
00127273 PBI-Gordon Corp. (1982) Residues: [MCPP—Soil and Other
Subjects]. (Compilation; unpublished study received
Apr 1, 1983 under 2271-EX-3; CDL:071501-Z)
00127823 Velsicol Chemical Co. (1981) Hawaiian Sugarcane Residue
Data: [Banvel]. (Compilation; unpublished study
received Apr 15, 1983 under 876-25; CDL:249983-A)
00128778 Uniroyal Chemical (1981) Residue: [2,4-D Amine].
(Compilation; unpublished study received Jun 27, 1983
under 400-390; CDL: 250616-A)
00130407 Rodwell, D. ; Werchowski, K.; Mercieca, M.; et al. (1983)
A Teratology Study in Fischer 344 Rats with
2,4-Dichlorophenoxyacetic Acid: Project No. WIL-81135.
Final rept. (Unpublished study received Jun 1, 1983
under unknown admin, no.; prepared by WIL Research
Laboratories, Inc., submitted by 2-4 D Task Force,
Washington, DC; CDL:251031-A)
00130707 Rodwell, D. ; Winbigler, J.; Mercieca, M.; et al. (1983)
A Teratoloy Study in Fischer 344 Rats with
2,4-Dichlorophenol: Project No. WIL-81134. Final rept.
(Unpublished study received Jun 1,1983 under unknown
admin, no.; prepared by WIL Research Laboratories, Inc.,
submitted by 2,4-D Task Force, Washington, DC;
CDL:251030-A)
00133938 Stauffer Chemical Co. (1976) Residue Chemistry Data:
[Eradicane 6.7-E and Other Chemicals in Corn].
(Compilation; unpublished study received Apr 20, 1976
under 476-2157; CDL:224095-A)
00136845 Interregional Research Project No. 4 (1974) [Residue
Levels of 2,4-Dichlorophenoxyacetic Acid and
2,4-Dichlorophenol in Red Potato Tubers]. (Compilation;
unpublished study received 1974 under 1E1122;
CDL:093432-A)
00136848 U.S. Dept. of the Interior (1962?) Residues: Method of
Analysis of 2,4-D in Water and Crop Plants.
(Compilation; unpublished study received Jan 22, 1971
under 1E1136; CDL:093444-A)
164
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00138284 Diemham, H.; Spalding, T. (1983) Acute Oral Toxicity
Limit Test/LD50: [Technical Isopropyl Ester of 2,4-D]:
NVP No. X2J033. (Unpublished study received Feb 23, 1983
under 5481-144; prepared by Northview Pacific
Laboratories, Inc., submitted by Amvac Chemical Corp.,
Los Angeles, CA; CDL:253099-A)
00138635 Velsicol Chemical Corp. (1983) The Results of Tests on
the Amount of Residue Remaining, Including a Description
of the Analytical Method Used: [Dicamba and 5-Hydroxy
Dicamba Residue in Vegetables, Forage Crops, Legumes,
Cottonseed and Cottonseed Fractions and Grains].
(Compilation; unpublished study received Feb 2, 1984
under 876-449; CDL:072332-A)
00139059 California. (1975) [Residue of 2,4-Dichlorophenoxyacetic
Acid Isopropyl Ester in Oranges]. (Compilation;
unpublished study received Feb 29, 1984 under CA 83/69;
CDL:252533-A)
00139511 U.S. Dept. of the Interior (1973) [Residue Studies:
2,4-D: Crops]. (Compilation; unpublished study received
Apr 21, 1983 under 3E2876; CDL:071564-F)
00139951 International Research and Development Corporation
(19??) Determination of Residues of
2,4-Dichlorophenoxyacetic Acid (2,4-D) in Asparagus-gas
Chromatography. Undated method IRDC 6. (Unpublished
study received Jan 11, 1971 under 1F1131; submitted by
Velsicol Chemical Corp., Chicago, 111.; CDL:091953-P)
00140032 Union Carbide Agricultural Products Company,
Incorporated (1965?) Analytical Methods. (Unpublished
study received Apr 19, 1968 under 264-EX-303;
CDL:123220-E)
00140092 National Agricultural Chemicals Assoc. (1970) Residue
Studies on Sugarcane. (Compilation; unpublished study
received Jul 19, 1973 under 8F0670; CDL:092966-A)
00144791 Uniroyal Chemical (1985) DED-WEED SULV Residues in
Pasture Grass and Wheat Forage. Unpublished study.14p.
165
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D standard
MRID Citation
00145248 Velsicol Chemical Corp. (1984) Foliar Absorption,
Metabolism and Translocation of Dicamba; Residue of
Banvel Herbicide in Cotton and Grain Crops; Toxicology
of Contaminants. Unpublished compilation. 367 p.
00147047 PBI Gordon Corp. (1984) Residue Analysis. Unpublished
study. 25 p.
00150557 Tasker, E. (1985) A Dietary Two-Generation Reproduction
Study in Fischer 344 Rats with 2,4-Dichlorophenoxyacetic
Acid: Final Report: Project No. WIL-81137. Unpublished
study prepared by Wil Research Laboratories, Inc. 1402
P-
00156264 Interregional Research Project No. 4 (1985) The Results
of Tests on the Amount of 2,4-D Residues Remaining in or
on Soybeans Including a Description of the Analytical
Method Used. Unpublished compilation. 62 p.
00156564 Buehler, E.V. (1985) Delayed Contact Hypersensitivity
Study in Guinea Pigs of AGR 218503 2,4-D Butoxyethyl
Ester for Dow Chemical USA. Hill Top Research, No.
85-1197-21; Nov 21, 1985.
00156637 Carreon, R.E. (1985) 2,4-D Butoxyethyl Ester; Dermal
Sensitization Potential in the Guinea Pig. Mammalian
and Environmental Toxicology Research Laboratory, Dow
Chemical Co.; July 22, 1985.
00160000 Hudson, R.; Tucker, R.; Haegele, M. (1984) Handbook of
toxicity of pesticides to wildlife: Second edition. US
Fish and Wildlife Service: Resource Publication 153.
91 p.
00160876 Serota, D. (1986) Combined Toxicity and Oncogenicity
Study in Rats: 2,4-Dichlorophenoxyacetic Acid: Final
Report: Project No. 2184-103. Unpublished study
prepared by Hazleton Laboratories America, Inc. 2049 p.
00161187 Interregional Research Project No. 4 (1977) The Results
of Tests on the Amount of Residues 2,4-D and its
Metabolite Remaining in or on Millet Including a
Description of the Analytical Method Used. Unpublished
compilation. 10 p.
166
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID Citation
00161659 Gargus, J. (1986) Dermal Sensitization Study in Guinea
Pigs: 2,4-Dichlorophenoxyacetic Acid: Final Report:
Project No. 2184-105. Unpublished study prepared by
Hazleton Laboratories, Inc. 10 p.
00161660 Auletta, C.; Daly, I. (1986) An Acute Inhalation
Toxicity Study of 2,4-Dichlorophenoxyacetic Acid in the
Rat: Final Report: Project No.86-7893. Unpublished study
prepared by Bio/dynamics Inc. 39 p.
00163903 FMC Corp. (1986) Freshgard 26 Product Data: Residue
Chemistry Data. Unpublished compilation. 17 p.
40061801 Serota, D. (1986) Oncogenicity Study in Mice with
2,4-Dichlorophenoxyacetic Acid (2,4-D): Final Report:
HLA Project No. 2184-101. Unpublished study prepared by
Hazleton Laboratories America, Inc. 1797 p.
40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute
Toxicity: Interpretation and Data Base 410 Chemicals and
66 Species of Fresh Water Animals. US Fish & Wildlife
Service; Resource Publication (160):1-36.
40228401 Mayer, F. (1986) Acute toxicity handbook of chemicals to
estuarine organisms: EPA/600/X-86/231. Prepared by US
EPA Environmental Research Laboratory, Gulf Breeze, FL.
275 p.
40352701 Maedgen, J. (1986) Rat Acute Inhalation Toxicity: Tech.
Isopropyl Ester of 2,4-D: Proj. No. 4377-86.
Unpublished study prepared by Stillmeadow, Inc. 15 p.
40352702 Maedgen, J. (1986) Rabbit Eye Irritation: Tech.
Isopropyl Ester of 2,4-D: Proj. No. 4374-86.
Unpublished study prepared by Stillmeadow, Inc. 16 p.
40352703 Maedgen, J. (1986) Rabbit Skin Irritation: Tech.
Isopropyl Ester of 2,4-D: Proj. No. 4375-86.
Unpublished study prepared by Stillmeadow, Inc. 11 p.
40352704 Maedgen, J. (1986) Guinea Pig Skin Sensitization: Tech.
Isopropyl Ester of 2,4-D: Proj. No. 4376-86.
Unpublished study prepared by Stillmeadow, Inc. 15 p.
167
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID
Citation
40448801 Jeffrey, M.M.; Battles, J.E.; and Johnson, K.A. (1986)
XRM-3925 Herbicide Formulation: Acute Oral Toxicity
Study in Fischer 344 Rats. Mammalian and Environmental
Toxicology Research Laboratory, Dow Chemical Co.
Laboratory ID HET M-003925-003A; Dec 12, 1986.
40448802 Jeffrey, M.M.; Battles, J.E.; and zimmer, M.A. (1986)
XRM-3925 Herbicide Formulation: Acute Dermal Toxicity
Study in New Zealand White Rabbits. Mammalian and
Environmental Toxicology Research Laboratory, Dow
Chemical Co. Laboratory ID HET M-003925-003D; Dec 9,
1986.
40448803 Streeter, C.M.; Battles, J.E.; and Lomax, L.G. (1987)
XRM 3925 Herbicide Formulation: Acute Aerosol
Inhalation Study in Fischer 344 Rats. Mammalian and
Environmental Toxicology Research Laboratory, Dow
Chemical Co. Laboratory ID M-003925-002; March 1987.
40448804 Jeffrey, M.M. (1986) XRM-3925 Herbicide Formulation:
Primary Eye Irritation Study in New Zealand White
Rabbits. Mammalian and Environmental Toxicology
Research Laboratory, Dow Chemical Co. Laboratory ID HET
M-003925-003C; Nov 19, 1986.
40448805 Jeffrey, M.M. (1986) XRM-3925 Herbicide Formulation:
Primary Dermal Irritation Study in New Zealand White
Rabbits. Mammalian and Environmental Toxicology
Research Laboratory, Dow Chemical Co. Laboratory ID HET
M-003925-003B; Oct 28, 1986.
40448806 Jeffrey, M.M. (1986) XRM-3925 Herbicide Formulation:
Dermal Sensitization Potential in Hartly Albino Guinea
Pigs. Mammalian and Environmental Toxicology Research
Laboratory, Dow Chemical Co. Laboratory ID HET M-003925-
003E; Jan 7, 1987.
40595701 Blacklow, W.; Linscott, D. (1968) The fate Of 2,4-D
applied to viking birdsfoot trefoil and resistant
intercross. Weed Science 16:515-519.
40595702 Freed, V. (1948) Qualitative reaction for 2,4-
Dichlorophenoxyacetic Acid. Science 107:98-99.
168
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D Standard
MRID
Citation
40595803 Aly, O. ; Faust, S (1964) Determination of Phenoxyacetic
Acids with J and Phenyl J Acids. Analytical Chemistry
36(11): 2200-2201.
40595804 Lagerstedt, H. (1979) 2,4-D/Filberts/Sucker Control.
Unpublished report prepared by Oregon State University.
Corvallis Or. 9 p.
40600201 Jensen, D.; Glas, R. (1981) Analysis for Residues of
Acidic Herbicides. Pages 223-320, In Chemical Analysis,
Vol 58. Edited by John Wiley & Sons, New York.
40600202 Feung, C.; Hamilton, R.; Witham, F.; et al. (1972) The
Relative Amounts and Identification of
2,4-Dichlorophenoxyacetic Acid Metabolites Isolated from
Soybean Cotyledon Callus Cultures. Plant Physiol. Vol
50:80-86.
40600203 McCann, J.; Pitcher, F. (1974) Amine-Four Herbicide:
Bluegill Sunfish (Lepomis macrochirus): Test No. 778.
(U.S. Environmental Protection Agency, Chemical and
Biological Investigations Branch, Technical Services
Div., unpublished study.
40629801 Jeffrey, M.M.; Battles, J.E.; and Lomax, L.J. (1987)
2,4-D Butoxyethyl Ester Technical: Acute Oral Toxicity
Study in Fischer 344 Rats. Mammalian and Environmental
Toxicology Research Laboratory, Dow Chemical Co.
Laboratory Project Study ID K-007722-006A; Apr 22, 1987.
40629802 Jeffrey, M.M.; Battles, J.E.; and Zimmer, M.A. (1987)
2,4-D Butoxyethyl Ester Technical: Acute Dermal
Toxicity Study in New Zealand White Rabbits. Mammalian
and Environmental Toxicology Research Laboratory, Dow
Chemical Co. Laboratory Project Study ID K-007722-006D;
Jul 8, 1987.
40629803 Jeffrey, M.M.; Battles, J.E.; and Yano, B.L. (1987)
2,4-D Butoxyethyl Ester Technical: Acute Aerosol
Inhalation Study in Fischer 344 Rats. Mammalian and
Environmental Toxicology Research Laboratory, Dow
Chemical Co. Laboratory Project Study ID K-007722-007;
Sept 16, 1987.
169
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-D standard
MRID
Citation
40629804 Jeffrey, M.M. (1987) 2,4-D Butoxyethyl Ester Technical:
Primary Eye Irritation Study in New Zealand White
Rabbits. Mammalian and Environmental Toxicology
Research Laboratory, Dow Chemical Co. Laboratory Project
Study ID K-007722-006C; July 8, 1987.
40629805 Jeffrey, M.M. (1987) 2,4-D Butoxyethyl Ester Technical:
Primary Dermal Irritation study in New Zealand White
Rabbits. Mammalian and Environmental Toxicology
Research Laboratory, Dow Chemical Co. Laboratory Project
Study ID K-007722-006B; July 8, 1987.
40629806 Jeffrey, M.M. (1987) Butoxyethyl
2,4-Dichlorophenoxyacetate, Dermal Sensitization
Potential in Hartly Strain Guinea Pigs. Mammalian and
Environmental Toxicology Research Laboratory, Dow
Chemical Co. Laboratory Project Study ID K-007722-005 ;
July 8, 1987.
170
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IV. FORMS APPENDICES
171
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EPA Form 8580-1
OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3
-------
EPA Form 8580-6
OMB Approval NO. 2070-0057
Expires 11/30/89
(To qutlify, certify ALL four ittmtl
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(e)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm hai offered in writing to entar into such an agreement Copies of th» offers an attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not bt reached otherwise. This offer was made
to tht following firm(s) on tht following datt(s):
NAMff Of PIMM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration^) of my firm's product!*), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of in registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
173
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OMB Approval No. 2070-0057
Expires 11/30/89
EPA Reg. No..
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
Subpart C
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
inoredients
Statement of
composition
Discussion of
formation of
inoredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Meltina point
Test not
required
for my
product
listed
above
(check
below)
Boilina point
Density, bulk-
density, or
specific aravitv
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
I am complying with
data requirements bv
Citing MRID
Number or
EPA Accession
Number
I Submit-
ting
[Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
'
EPA Form 8580-4
174
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OMB Approval No. 2070-0057
Expires 11/30/89
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT (cont'd)
Date
Guidance Document for
Registration
Guideline No.
Subpart C
PRODUCT
CHEMISTRY
(cont'd)
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.340
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Name of Test
Test not
required
for my
product
listed
above
(check
below)
Stability
Oxidizing/reducing
reaction
Flamnability
TibrplnrlaMlitV
Storaae stability
Viscositv
Miscibility
Corrosion
characteristics
Dielectric break-
down voltaae
Acute oral
toxicity. rat
Acute dermal
toxicitv. rabbit
Acute inhalation,
toxicitv. rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion,
Acute Delayed
neurotoxicity, hen
I am complying with
data requirements bv
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assioned
EPA Form 8580-4 (cont'd)
175
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CMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DMA EXEMPTION STATEMENT
EPA Product Registration Number:.
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified above, I
certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the active
ingredient named under FIFRA Section 3(c) (2) (B).
(2) My firm requests that EPA not suspend the registration of our product, despite
our lack of intent to submit the generic data in question, on the grounds that the
product contains the active ingredient solely as the result of the incorporation into
the product of another product which contains that active ingredient, which is
registered under FIFRA Section 3, and which is purchased by us from another producer.
(3) An accurate Confidential Statement of Formula (CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by company
name, registration number, and product name, the source of the subject active
ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form 8570-4. The registered
source(s) of the above named active ingredient in my product(s) is/are and
their registration number (s) is/are .
My firm will apply for an amendment to the registration prior to changing the source
of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any portion of
this Statement is no longer true, or if my firm fails to comply with the undertakings
made in this Statement, my firm's product's registration may be suspended under FIFRA
Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption for the
product, my firm relies on the efforts of other persons to provide the Agency with the
required generic data. If the registrant (s) who have committed to generate and submit
the required data fail to take appropriate steps to meet requirements or are no longer
in compliance with this Notice's data requirements, the Agency will consider that both
they and my firm are not in compliance and will normally initiate proceedings to
suspend the registrations of my firm's product(s) and their product(s), unless my firm
commits to submit and submits the required data in the specified time frame. I
understand that, in such cases, the Agency generally will not grant a time extension
for submitting the data.
Registrant's authorized representative: (Signature)
Dated: (Typed)
EPA Form 8570-27
176
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