oEPA
United SUM*
Environments! Protection
Agtncy
Off to of
Ptrtteidw and TwcJc SubctanoM
Washington DC 20460
September 1988
540/RS-88-128
P«ticidw
Guidance for the
Reregistration of
Pesticide Products
Containing ETHEPHON
as the Active Ingredient
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TABLE OF CONTENTS
•\
I. Introduction 1
II. Chemical(s) Covered by this Standard 4
A. Description of Chemical
B. Use Profile
III. Agency Assessment 5
A. Summary
B. Preliminary Risk Assessment
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale 21
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 30
VI. Requirement for Submittal of Generic Data 32
A. What are generic data? 32
B. Who must submit generic data? 32
C. What generic data must be submitted? 33
D. How to comply with DCI requirements 33
E. Registrant Requests Regarding Data
Requirements and Agency Responses 36
F. Test Protocols and Standards 36
G. Procedures for requesting a change in protocol. . 37
H. Procedures for requesting extensions of time. . . 37
I. Data Format and Reporting Requirements 37
J. Existing stocks provisions upon suspension or
cancellation 38
VII. Requirement for Submittal of Product-Specific Data . . 38
VIII. Requirement for Submittal of Revised Labeling 39
IX. Instructions for Submittal 39
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End use products (multiple active)
E. Intrastate products
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SEP 29
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
ETHEPHON
AS THE ACTIVE INGREDIENT
CASE NUMBER 0382
CAS NUMBER 16672-87-0
Chemical Code 099801
September 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
a.i. active ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated
pesticide concentration system in an environment,
such as a terrestrial ecosystem.
EP End Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FR Federal Register
HOT Highest Dose Tested
LC50 Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
LD50 Median lethal dose - a statistically derived single dose
than can be expected to cause death in 50% of the test
animals, when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g.,
mg/kg.
LOT Lowest Dose Tested
LEL Lowest Effect Level
MP Manufacturing Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
ill
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 156.10 Labeling Requirements (162.10)
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
IV. FORMS APPENDICES
EPA Form 8580-1 FIFRA 53(c)(2)(B) Summary Sheet
EPA Form 8580-3 Generic Data Exemption Statement
EPA Form 8580~-4 Product Specific Data Report
EPA Form 8580-6
Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
11
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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 request^, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and 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.
scientific reviews and Compendium of Uses may be obtained
from the National Technical Information Service (NTIS),
Attr.: Order Desk, 5285 Port Royal Road, Springfield, VA
22161. Tel: (703) 487-4650.
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MTD Maximum Tolerated Dose
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
OES Office of Endangered Species, U.S. Fish and Wildlife
Service
PADI Provisional Acceptable Daily Intake
ppm parts per million
RBC Red Blood Cell (s)
RfD Reference Dose
TAS Tolerance Assessment System
TMRC Theoretical Maximal Residue Contribution
IV
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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. Submittal 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 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
therr to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants must notify
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the Agency of any information, including interim
results of studies/ if that information suggests
adverse effects on man or the environment. This
is independent of the specific time requirements
EPA for submittal of completed studies called in
Agency and continues as long as the products are
under FIFRA.
or preliminary
possible
requirement
imposed by
by the
registered
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II.
CHEMICAL COVERED BY THIS STANDARD
A. Description of Chemical
: Ethephon
Common Name
(ANSI)
Chemical Name
Empirical Formula
Molecular Weight
Physical State
Color
Melting Point
Solubility
Trade Name
OPP/Shaugnessy No.
CAS Registry No.
(2-Chloroethyl)
Phosphonic acid
C2H6CL03P
144.5
Waxy, solid
White
74 to 75C
Very soluble in water, alcohol,
propylene glycol; slightly
soluble in aromatic solvents
Bromeflor, Cerone, Chlorethephon
(N. Zealand), Ethrel, Florel, Prep,
and Flordimex
099801
16672-87-0
Wiswesser Line-Formula Notation: QPQ02G
Date of Initial Registration: 1973
Ethephon was discovered in 1965 and introduced
commercially in 1973 by the AmChem/Union Carbide Company for
inducing flowers on pineapples in Hawaii. At the present time,
Rhone-Poulenc is the only registrant of ethephon, having purchased
Union Carbide's registrations.
The following data have been required under Section
3(c)(2)(B) Of FIFRA:
STUDY
Oncogenicity Study
species other than rat
Teratogenic ity Study
species other than rat
DUE DATE
March 1989
May 1987
(submitted)
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The regulatory conclusions regarding the teratogenicity
study are discussed in part III (Agency Assessment).
B. Use Profile
Ethephon, a plant growth regulator that generates
ethylene gasf is used on many crops to promote fruit ripening,
abscission, flower induction, breaking of apical dominance,
and many other plant responses. Ethephon is applied broadcast
to plant foliage by ground or aerial equipment when the plant is
reaching maturity, usually the pre-flower stage. Ethephon releases
the natural plant hormone ethylene after application and the
ethylene produces the growth effects in the plants.
Cotton, tomatoes, grapes, and tobacco account for 98%
of the current use of ethephon in agriculture (approximately
1,135,000 acres). Other sites include apples, barley, wheat,
blackberries, boysenberry, blueberry, cantaloupe, cherry (tart
and sweet), cucumber, squash and pumpkin (hybrid seed production),
figs, cucumber (pickling), filberts, lemon, tangerine, tangelo,
pepper, pimento, walnut, ornamentals, guava, grapes for table
and raisin production, pineapples, sugarcane, coffee beans,
cottonseed, macadamia nuts, trees (forest and shelterbelt) and
cranberries.
Application rates vary from 0.08 to 2.0 pounds of active
ingredient per acre depending upon the use site and desired
effects.
There are two emulsifiable concentrates, seven soluble
concentrates/liquids, and two ready-to-use liquids available
for crop use. There is one 98% active ingredient technical
product.
Rhone-Poulenc is currently the sole manufacturer of
the technical product and formulator of the end-use products in
the U.S.A.
III. AGENCY ASSESSMENT
The Agency has conducted a thorough review of the scientific
data base available for ethephon. This part of the standard sets
forth the results of that review.
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A. Toxicoloqical Assessmerrt
1. Acute Oral, Dermal and inhalation Toxicity
Acute toxicity studies show that via the oral and
dermal routes, ethephon is relatively non-toxic except in hens
(see oral neurotoxicity study). An acute study with rats showed
an oral LDsg of 1.6 g/kg (Toxicity Category III). An acute
dermal study using rabbits showed a dermal LDso of > 5 g/kg
(Toxicity Category III). No adequate data are available on the
acute inhalation properties of ethephon. Acute inhalation data
is required (refer to Table A of this document).
2. Irritation and Sensitization (dermal and eye)
Sufficient data are available to show that the
technical grade of ethephon is extremely irritating to the
skin. Based upon an acceptable primary dermal irritation
study in rabbits, ethephon has been placed in Toxicity Category
I for this effect.
There are no acceptable data on the primary
eye irritation effects of ethephon. However, ethephon is presumed
to be extremely irritating; (corrosive) to the eyes (Toxicity
Category I irritant), based OK the primary skin irritation
study described above which indicates that ethephon is corrosive.
An eye irritation study is not teqired.
No data are available on the dermal sensitization
properties of ethephon.
3. Acute Delay>ed Oral Neurotoxicity
Ethephon was found to be acutely toxic in the hen
with an LD$Q of 3.8 g/kg. No dose related neuro-histopathology
was detected in the hens after 42 days at acute dose levels.
4. Subchronic Toxicity
NO adequate data are available on subchronic oral
toxicity in rats or dogs. However, the requirement for subchronic
studies in the rodent and non-rodent will be waived if the required
chronic studies are acceptable. There are two supplementary
studies, one for the rat and one for dogs, neither of which
demonstrated a NOEL.
Rat:
In the rat study, ethephon was administered by
gavage for 13 weeks to 20 rats per sex per dose level at 0, 50,
100, and 200 mg/kg/day. Plasma cholinesterase and brain cholines-
terase activity were found to be statistically significantly
different from the controls at all dose levels. Red blood cell
cholinesterase activity did not differ from the controls in any
dose group of males or females.
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Dog;
In the dog study, ethephon was administered in the
food to 4 dogs per sex per dose level at 0, 5.0, 25.0 and 187.5
mg/kg/day for 13 weeks. Plasma cholinesterase activity was
statistically significantly depressed in both males and females
at all dosage levels. Red blood cell cholinesterase activity
was statistically significantly depressed in the males (at all
dose levels except 5.0 mg/kg/day at 8 weeks) and at the 25.0 and
187.j mg/kg/day dose levels in the females. Brain cholinesterase
activity was statistically significant only in females dosed at
187.5 mg/kg/day.
A subchronic dermal test is also required (21-days)
because no data are available. A special smoke inhalation
study (21-day) is required because the existing study is supplemen-
tary and ethephon is registered for use on tobacco.
5. Chronic Toxicity and Oncoqenicity
Chronic Toxicity
are not
rodent.
The
adequate.
Rat:
available chronic toxicity data for ethephon
Studies are required for the rodent and non-
An available rat study is supplementary because
data were not submitted on the stability of ethephon in the feed,
and historical control data were not submitted on the incidence
of pancreatic islet cell adenomas and carcinomas. Dose related
non-oncogenic effects were limited to plasma and red blood cell
cholinesterase inhibition in the highest dose tested (HOT). This
inhibition was statistically significant in males and females for
red blood cells only. The NOEL for cholinesterase activity
effects in this study is 15 mg/kg/day. This study may be upgraded
if the data on the stability of ethephon in the feed and the
historical control data are submitted and found to be acceptable.
Dog:
An available dog study is supplementary because
no NOEL was demonstrated and data were not submitted on the
stability of ethephon in the feed. Red blood cell cholinesterase
activity was depressed only at the two highest dose levels 50 and
75 mg/kg/day. 75 mg/kg/day was given to the dogs only from weeks
0 to 3 then the dosage was reduced to 50 mg/kg/day to these animals
for weeks 4 and 5, and further reduced to 25 mg/kg/day for the
remainder of the study. In the study there were two, apparently
different, sources of the chemical tested and reported as source
A a nd so u re e B.
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For Source A ethephon, reduced body weights were
observed with a NOEL of 7.5 mg/kg/day. A NOEL for this effect
was not demonstrated for source B ethephon. This study may be
upgraded if the data on the stability of ethephon in the feed is
submitted and found to be acceptable.
Mouse:
In a supplementary chronic toxicity/oncogenicity study,
Swiss Albino mice, 85 per sex per group were fed diets containing
0, 4.5, 45, and 150 mg/kg/day of ethephon for 78 weeks. No
stability data on ethephon in the feed were submitted, if collected.
The oncogenic effects observed in this study are reported in the
oncogenicity data discussion. The following chronic effects were
observed in this study:
Inhibition of plasma cholinesterase activity was
significant at the 45 and 150 mg/kg/day dose levels in males and
females. The NOEL for plasma cholinesterase activity is 4.5 mg/
kg/day for both sexes and the LEL for this effect was 45 mg/kg/
day for both sexes.
There appeared to be a dose related decrease in
red blood cell (RBC) cholinesterase activity in females. There
was significant depression in RBC cholinesterase activity at the
45 and 150 mg/kg/day dose levels. Females in the 4.5 mg/kg/day
dose group exhibited depression in RBC cholinesterase activity
at 52 weeks (83% of control values) and 78 weeks (70% of control
values), which was not statistically significant. Because of
the apparent dose related decrease in RBC cholinesterase activity
in females in the 4.5 mg/kg/day dose group, the NOEL for this
effect in females is considered to be below 4.5 mg/kg/day, the
lowest dose tested.
RBC cholinesterase activity was nominally decreased
in males at the mid and high dose groups. These effects were
not statistically significant.
Brain cholinesterase activity was no different from
control values at any dose level in males or females.
Oncogenicity Data
The available data are not adequate to assess the
oncogenic potential of ethephon.
Rat:
Oncogenic effects were equivocal in this part of
the combined chronic/onco study. Feed containing ethephon at
levels of 0, 1.5, 15, and 150 mg/kg/day was administered to 55
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Sprague Dawley rats per sex per group. Slight increases which
were not statistically significant, occurred in pancreatic islet
cell adenomas and carcinomas in the 150 mg/kg/day dose group. No
statistically significant oncogenic effect was demonstrated during
the study or at termination. Depression of plasma and red blood
cell cholinesterase activity were the only observed effects.
Adequate historical control data must be submitted on pancreatic
islet cell adenomas and carcinomas.
The study is supplementary because data were not
submitted on the stability of ethephon in the feed, and historical
control data were not submitted on the incidence of pancreatic
islet cell adenomas and carcinomas. This study may be upgraded
if these data are submitted and found to be acceptable. The
highest dose tested (HDT) of 150mg/kg/day is considered to be
the maximum tolerated dose (MTD) based on decreased red blood
cell and plasma cholinesterase activity in males and females.
Mouse:
In a supplementary oncogenicity study, Swiss Albino
mice, 85 per sex per group were fed diets containing 0, 4.5, 45,
and 150 mg/kg/day of ethephon for 78 weeks. No stability data on
ethephon in the feed were submitted. There was a statistically
significant increased trend in fibrosarcomas in the females, but
none of the values were statistically significantly different
from controls. The incidence of hemopoietic carcinogenicity
(leukemia, lymphocytic leukemia, thymic and nonthymic lymphoma,
and reticulum cell sarcoma) was statistically significantly
elevated only for females in the mid dose group. Historical
control data were not submitted with this study and are needed
to evaluate the potential oncogenicity of this compound. No
consistent dose related changes occurred in body weight, food
consumption, hematology, or organ weights.
Using inhibition of plasma and RBC cholinesterase
as the criteria for determining whether an MTD was reached in
this study, the MTD was reached for females because statisically
significant inhibition of plasma and RBC cholinesterase was
observed. In males, however, the finding of statisically significant
inhibition of plasma cholinesterase and 21% inhibition of RBC
cholinesterase indicated that probably 1/2 MTD was reached.
The study is supplementary because data were not
submitted on the stability of ethephon in the feed and historical
control data on fibrosarcomas were not submitted. This study
may be upgraded if acceptable data are submitted.
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6. Teratology and Reproductive Effects
Teratpqenic and Fetotoxic Effects
Sufficient data are available on the teratogenic
potential of ethephon in the rat and the rabbit to meet these
data requirements.
Rat:
Ethephon was administered to rats by gavage at
doses of 0, 200, 600, and 1800 mg/kg/day from day 6 through day
19 of gestation. Maternal toxicity occurred in the form of
maternal death at the 1800 mg/kg/day dose level.
Fetal resorption was observed at the 1800 mg/kg/day
dose level. However, this apparent effect (resorption) is equivocal,
because of the small number of litters remaining for examination
(9 of a possible 25 litters). The NOEL for maternal and embryo/fetal
toxicity is 600 mg/kg/day. The NOEL for teratogenic effects is
600 mg/kg/day based on the dose related effects that were observed
at the HOT. Because of maternal mortality at the HOT, there were
not enough litters remaining to be statistically significant,
however three of the remaining fetuses were deformed. Therefore
the NOEL has been established at the level tested where no effects
were demonstrated.
Rabbit;
Ethephon was administered to rabbits at doses of 0,
50, 100, 250 mg/kg/day by gavage from day 6 through 19 of gestation.
Fetal resorptions were increased only in the 100 and 250 mg/kg/day
dose groups, but they were statistically significant only at the
250 mg/kg/day dose level. Doses of 250 mg/kg/day resulted in
depression of maternal cholinesterase levels, atoxia and an
increased incidence of various clinical findings, and gross
pathology in the gut. No effects were demonstrated in the 50
mg/kg/day dose group, which is designated as the NOEL.
Reproductive Effects:
Available data on the reproductive effects testing
of the technical grade of ethephon are not acceptable. Another
study is required.
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The available study is classified as core sup-
plementary because of the following deficiencies: 1) Data on
individual animals were not reported. 2) Data from necropsies
and histological examination were not reported. 3) Animal weights
and food consumption were not reported with sufficient frequency
to determine what if any effects occurred. 4) Clinical observations
were not reported. 5) No measures of data variability were
reported. 6) Biased methods may have been used in selecting
pups for further study. 7) The method used in breeding and
calculating indexes were ambiguous. 8) The test substance
appears to be a formulated product of unspecified composition.
9) Dxets were prepared weekly, but no data were submitted on
the stability of ethephon in the feed.
7. Mutaqenicity Data
a. Gene Mutation -
Sufficient data are available on the gene
mutation potential of the technical grade of ethephon to
demonstrate that the test substance is not mutagenic in the
Ames Test.
Five strains of Salmonella typhimurium were
tested up to the toxic concentration/limit dose of 100 ug/100
uL(10,000 ug/mL) with and without activation. No evidence of
mutagenicity occurred.
b. Structural Chromosomal Aberrations -
Insufficient data are available from structural
chromosomal aberration tests, because the identity of the test
material was insufficiently characterized. Unless the identity,
purity, and composition of the test material is submitted, another
test is required.
Ethephon of unspecified purity was tested in
the micronucleus test (indirect test for chromosomal aberrations)
at toxic dose levels (200 mg/kg) in the mouse system. NO evidence
of mutagenicity occurred. In order for the study to be acceptable,
the test material must be adequately identified.
c. Other Genotoxic Effects -
No acceptable data are available on other
genotoxic effects. A gene mutation study in mammalian cells
is required.
8. Metabolism
There are no available metabolism data. A rat
metabolism study is required.
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9. Information on Human Effects
Two studies were conducted on ethephon in humans.
The Agency does not condone nor require human testing. These
studies were available however, and the Agency considered all
available data in its assessment of the effects of this pesticide.
In the first study, humans demonstrated some symptoms
characteristic of anticholinesterase activity in a study of five
humans per sex dosed with ethephon at an average dose level of
1.8 mg/kg/day. Subjects receiving the test compound reported the
following symptoms and/or signs; the sudden onset of diarrhea or
an urgency of bowel movements, stomach cramps or gas, an increased
urgency and frequency of urination, and either a decrease or an
increase in appetite. None of the control subjects had complaints
similar to the test group. Plasma CHE and RBC CHE activities
were similar to or higher than initial values in test subjects.
In the second human study, 10 humans per sex were
dosed with ethephon at 0.5 mg/kg/day for 16 days, followed by a
recovery period of 2 weeks. Dose related effects occurred in
plasma cholinesterase activity, but not in red blood cell
cholinesterase activity. The effect was reversible within
15 days. When the control group and test groups were compared,
the decreased plasma cholinesterase activity was statistically
significant. No dose related effects were seen in hematology,
blood chemistry, or urine analyses.
It is not clear whether or not any of the symptoms
in the first human study described, such as diarrhea, urgency of
bowel movements, urinary urgency, or any other effects occurred
in the humans during the dosing period of the second study, since
symptoms and signs were not reported. Based on this study the
NOEL for plasma cholinesterase inhibition in humans is <.5 mg/
kg/day.
B. Human Exposure Hazard
1. Pesticide Incident Monitoring System (PIMS):
Ethephon usage has resulted in four cases of skin
injury (irritation) reported from 1980 through 1986 in California,
due to exposure to field residue. There were no physician-treated
poisonings from 1980 through 1986 in California. There were no
deaths reported in the U.S. (1961, 1969, 1973, 1974) and no
deaths reported in California from 1965 to 1977 or from 1982 to
1986.
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2. Protective Clothing
Technical grade ethephon is corrosive to the skin.
A few cases of skin injury to field workers in California have
been reported (see above PIMS information). Since ethephon has
been found to be corrosive to the eyes and skin, protective
clothing for mixers, loaders and applicators is required. Mixers,
loaders and applicators must wear a full face shield, long trousers,
long sleeved shirt, gloves, and boots to avoid as much skin and
eye contact as possible.
3. Reentry
Reentry data are required by S 158.390 if the pesticic
and its use patterns meet certain toxicity and exposure criteria.
Ethephon meets the toxicity criteria of 40 CFR S 158.390 because
it is classified as being extremely irritating to the skin
(toxicity category I) and the Agency has received epidemiological
evidence that residues of this pesticide can cause dermal irritation
to persons entering treated sites. Ethephon also meets the
exposure criteria of 40 CFR S 158.390 in that it is registered
for use on grapes and other crops which have human tasks that
could involve substantial exposure to the pesticide treated
surfaces. Foliar and soil dislogeable residue data are required
to estimate human exposure resulting from contact with treated
foliage or soil.
Human exposure monitoring data may be submitted, but
the data submitted should be limited to (1) foliar dislogeable
residues where exposure to treated leaves would be likely and
(2) edaphic dislogeable residues where there could be exposure
to treated soils.
These data will be used to establish reentry
intervals. Until these data are available, the the Agency is
imposing interim reentry intervals of 24 hours for ethephon
treated crops.
4. Possible Presence of Impurities
Available data indicate that technical ethephon
products may contain 2-chloroethanol as an impurity. 2-Chloroethano
is extremely toxic via the inhalation route and has caused human
deaths. Because of its volatility, 2-choroethanol is unlikely
to be present in ethephon end use products in amounts high enough
to pose an inhalation hazard. However, the impurity could pose
a hazard when technical or manufacuring use products are stored
or used in poorly ventilated spaces. Under these conditions,
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2-chloroethanol vapors could accumulate to levels which may be
hazardous to workers in the area. The Agency is requiring submissio
of product chemistry data to assess the extent of hazard posed
by 2-choroethanol.
The Agency has also determined that another impurity,
the mono-chloroethyl ester of (2-chloroethyl)-phosphonic acid,
may be present in technical ethephon products. This substance
degrades to form 2-choroacetic acid which is a metabolic inhibitor.
Because of the toxicological significance of 2-chloroacetic
acid, the Agency is requiring the submission of residue chemistry
data to determine whether ethephon-treated commodities contain
2-chloroacetic acid residues.
C. Tolerance Reassessment
1. Tolerances issued
Tolerances have been established for the residues of
ethephon on various crops under 40 CFR 180.300, 40 CFR 185.2700 and
and 40 CFR 186.2700. The following is a list of the established
tolerances for ethephon. There are no CODEX maximum residue
levels (MRL) for ethephon.
Commodity Tolerance (ppm)
Grapes 2.0
Hogs, fat 0.1
Hogs, mbyp 0.1
Hogs, meat 0.1
Horses, fat 0.1
Horses, mbyp 0.1
Horses, meat 0.1
Lemons 2
Macadamia nuts 0.5
Milk 0.1
Peppers 30
Pineapples 2
Pineapple fodder 3
Pineapple forage 3
Pumpkins 0.1
Sheep, fat 0.1
Sheep, mbyp 0.1
Sheep, meat 0.1
Tangerines 0.5
Tangerine hybrids 0.5
Tomatoes 2
Walnuts 0.5
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Commodity
Wheat, grain
Wheat, straw
Guavas
Sugarcane Hawaii only
Tolerance (ppm)
2.0
10.0
0.1
0.1
40 CFR 185.2700 and 185.2700 (food and feed additive)
Barley milling fractions
except flour 5.0
Wheat milling fractions
except flour 5.0
Raisins 12.0
Raisin waste 65.0
Sugarcane molasses 1.5
Barley milling fractions
except flour 5.0
Wheat milling fractions
except flour 5.0
2. Residue Data
a. Metabolism
The nature of residues in plants is adequately
understood. Ethephon degrades to ethylene, phosphate, and chloride.
The parent compound, ethephon and the ethylene gas it produces
are the major metabolites in plants. Plant metabolism data are
not required. Acceptable metabolism data are also available for
ruminants. The residue of concern in plant commodities, ruminant
tissues and milk is ethephon per se. Additional data are required
regarding metabolism in poultry tissues and eggs.
Upon receipt of the requested data on poultry
metabolism, storage stability data, and data regarding the
magnitude of the crop residues, the adequacy of the established
tolerances for residues of ethephon in animal feed commodities
will be assessed.
b. Possible Presence of Contaminant of Toxicoloqical
Concern
The Agency finds that residues of monochloroacetic
acid may be found in ethephon-treated commodities. Monochloro-
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acetic acid is a potential degradation product of an impurity in
ethephon, monochloroethyl ester of (2-chloroethyl )-phosphonic
acid. Monochloroacetic acid is an extremely toxic metabolic
inhibitor and has been prohibited from addition to food under 21
CFR 189.155. Analysis of certain food and feed crops for residues
of this contaminant are reguiTed as specified in Appendix I. A.
If residues of monochloroacetic acid are detected, data may be
required for all eth-ephon-treated commodities.
c. Analytical Methodology
Adequate gas-liquid chromatographic (GLC) methods
are available for collection of data pertaining to residues of
ethephon in or on plant and animal commodities. The Amchem-plant
method is the recommended method for enforcement purposes for
plant commodities other than wheat and barley straw. This
method has been subjected to a successful method trial for
pineapples and appears as Method I in PAM, Vol. II. The Amchem
-cereal method is recommended for enforcement purposes for
wheat and barley straw. This method has undergone a successful
method trial for wheat and barley and has been forwarded to FDA
for inclusion in the PAM, Vol. II as Method II. The Amchem
-tobacco method, the Amchem-sugarcane method, the AMchem-cotton
method, and the Amchem-citrus oil method are adequate for data
collection.
The nature of the residue in poultry has not
been adequately described. Therefore, the adequacy of available
analytical methods for poultry products cannot be ascertained.
The Union Carbide-animal GLC method employing a
flame-photometric detector, is the recommended method for enforcement
purposes for milk and animal tissue. This method has undergone
a successful method trial on milk and liver and has been forwarded
to FDA for inclusion in the "PAM, Vol. II as Method III. The
Amch^m-tissue GLC method using a phosphorous-specific alkali
thermionic detector (ATD) is adequate for collection of data
pertaining to residues in cattle and poultry tissues. The Union
Carbide method is adequate for collection of data pertaining to
residues in milk, meat and meat by-products but not in fat and
liver. The Amchem-milk and tissue GLC/ATD method is inadequate
for collection of data pertaining to animal tissues and milk
because recovery is unacceptably low.
Ethephon has not been analyzed by multiresidue
methods published in PAM Vol. I, Appendix II-Multiresidue Method
Testing as required in 40 CFR 15fi.125(b)(15). In addition,
representative plant samples, ruminant tissues and milk bearing
residues of ethephon must be subjected to analysis by PAM Vol. I
methods 211.1, 212.1, 231.1, 232.1 and 252. Protocols for
multiresidue mehtods are available from the National Technical
Information Service under Order No. PB 203734/AS.
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The usefulness of existing residue data for
poultry will be reassessed when the required poultry metabolism
data have been evaluated. Also methods to be used for future
data collection and enforcement will be determined after evalua-
tion of the required analytical method validation data.
d. Residue Storage Stability
Residue storage stability data are available
for sugarcane but not for other plant and animal commodities.
e- Field Residue Data
The available data support the established
tolerances for residues of ethephon in or on pumpkins, sugarcane
and sugarcane molasses, provided satisfactory storage stability
are submitted. In addition, a PHI of 2 2 months must be implemented
for sugarcane.
Additional residue data are required to support
the established tolerances for residues in or on "blackberries,
coffee beans, cottonseed, cranberries, grapes, guavas, lemons,
melons, pineapples, pineapple forage, tangerines, tomatoes,
wheat grain and wheat straw.
The residue data requested on wheat grain, wheat
straw, and the processed fractions of wheat will be used to
asse&s the established tolerances for residues in or on barley
grain, barley straw, and the processed fractions of barley.
These wheat data can be used to support the tolerances for barley
because of the similarity of the crops.
A tolerance must be proposed for residues of
ethephon in or on the agricultural commodity sugarcane forage.
Alternatively, a grazing restriction may be proposed.
f. Processing Data
Processing studies are needed on apples, citrus
fruits, coffee beans, figs, pineapples, sugarcane, tomatoes and
wheat grain.
Food/feed additive tolerances and supporting
data are needed for residues in cottonseed meal, cottonseed
refined oil, cottonseed soapstock, grape juice, dried grape
pomace and raisins.
Pyrolysis products derived from ethephon must
be characterized and the level if residue in tobacco smoke must
be quantified.
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g. Pre-ha^vest Intervals
Pre-harvest intervals (PHI) that are based upon
actual field residue data reflecting the maximum proposed use
rates are needed for applications of ethepon to apples, barley,
blackberries, blueberries, cherries, coffee beans, cotton, cranber-
ries, cucumbers, figs, filberts, grapes, guavas, melons, peppers,
pineapples, tangerines, tomatoes, walnuts and wheat. In the
interim, the PHI's listed in section D of this document must be
placed on end-use product labeling for each crop.
h. Other findings
An English translation of product labels showing
the use directions for the use of ethephon on coffee beans for
importation to the U.S. are required.
The entry "pineapple fodder" must be deleted
from 40 CFR 180.300 because pineapple fodder is considered a
processed feed not a raw agricultural commodity.
The tolerance for residues in or on guava
published in FR 45 (136):47147, must be added to the entries
under 40 CFR 180.300 in order to provide a complete listing of
residue tolerances under the appropriate CFR heading. Similarly,
a food additive regulation for ethephon residues in raisins must
be added to 21 CFR 193.186 in order to provide a complete
listing of food additive tolerances under the appropriate CFR
heading. CFR 180.300 currently designates "N" (negligible)
for certain crop tolerance entries. The concept of negligible
residues is no longer accepted by the Agency.
3. Dietary Assessment
The toxicology data considered to establish a
provisional acceptable daily intake (PADI) include the following:
a. A 16-day study in humans where a decrease in plasma chollnesterase
activity was observed at 0.5 mg/kg/day.
b. A 2-year feeding study in dogs (supplementary) that demonstrated
a NOEL for reduced body weight of 7.5 mg/kg/
day.
c. A 2-year feeding study in rats (supplementary) that demonstrated
an NOEL for cholinesterase activity at 300 mg/kg/day.
d. Two teratogenicity studies, one in rats and one in rabbits.
The rat NOEL was established at 600 mg/kg/day and the rabbit
NOEL at 50 mg/kg/day.
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The PADI for ethephon has recently been revised by
the Agency ADI Committee and is now established at 0.005 mg/kg/day
(0.5 mg/kg/day for a LEL, and an uncertainty factor of 100).
This value is based on an LEL of 0.5 mg/kg/day for a decrease in
plasma cholinesterase activity in a 16-day study in humans. An
uncertainty factor of 100 is derived from a factor of 10 for the
variation in the susceptibility of humans, and a factor of 10
for the use of an LEL instead of a NOEL. The PADI will be reevaluated
when the toxicity and residue chemistry data required by this
document, as listed in table A, are received and evaluated.
Utilizing the published tolerances, the Tolerance
Assessment System (TAS) routine analysis yielded a theoretical
maximum residue contribution (TMRC) value for the U.S. population
that was 284 percent of the PADI when calculated using 100 percent
of registered crops treated. After adjustment for percent of
crop treated and an anticipated residue value of 0.01 ppm for
milk, the calculated dietary exposure to ethephon for the U.S.
population dropped to 40 percent of the PADI. For nonnursing
infants and for children 1-6 years of age, the adjusted values
were 122 and 95 percent of the PADI, respectively.
D• Environmental Fate
Available data are insufficient to fully assess the
environmental fate of ethephon.
The only partially acceptable data available were two
leaching studies which provided conflicting results regarding
the leaching rates (in one study ethephon is a leacher and the
other study demonstrates that ethephon is not a leacher). In
one of these studies, ethephon was found to be of low to moderate
mobility in soils ranging in texture from loamy sand, peat and
silt loam based on soil thin layer chroma tog raphy (TLC) tests.
Therefore, the potential for contamination of ground water appears
to be low to moderate. Data are required on leaching, volatility,
and hydrolysis of ethephon to characterize the potential to reach
ground water.
E. Hazard Assessment For Terrestrial and Aquatic Organisms
1. Aquatic Organisms
Available acute toxicity data indicate that ethephon
is slightly toxic to all fish species tested. The Guidelines
requirements for freshwater fish acute LC$Q data with technical
ethephon have been met. The LC$Q for freshwater fish results
from two 96-hour studies using the technical grade material and
the LC values follow:
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Species !_§_i LC^n mq/L
Bluegill 21.6 67
Bluegill 21.5 > 180
Bluegill 71.3 221.7
Bluegill 92 106
Rainbow Trout 21.6 77
Rainbow Trout 71.3 254.5
Rainbow Trout 92 > 110
Ethephon is practically non-toxic to aquatic inver-
tebrates (daphnids) with an LC$Q value of > 180 mg/L. Technical
ethephon is slightly toxic on an acute basis to grass shrimp
with an LCsg of 160 to >370 mg/L and mud crabs with an LCso
of 167 to >370 mg/L. There are no data available to characterize
the toxicity of ethephon to either estuarine/ marine fish or
mollusks. Because the LC$Q values of freshwater (93 to 165
mg/L) and saltwater (160 to >370) invertebrates indicate similar
toxicities for fresh and saltwater classes of animals, and because
of low toxicity to freshwater fish, the Agency will waive the
requirement for estuarine/marine fish testing. However/ the
Guidelines requirements for testing mollusks are not satisfied,
and are required.
2. Terrestrial Organisms
There is no evidence to suggest that the use of
ethephon has resulted in avian or mammalian mortality or has
affected their population levels.
The data indicate that technical ethephon is slightly
toxic on an acute oral basis to bobwhite quail, and on a subacute
dietary basis is sightly toxic to bobwhite quail and mallard
ducks. The acute oral LCsg in bobwhite quail is from 596 to
804 mg/kg. The acute oral LCso is 3750 ppm for mallard duck
and >2160 ppm in bobwhite quail. The average acute oral toxicity
for formulated products is >10,000 ppm in bobwhite quail, or
practically non-toxic.
No avian reproduction study was available for
evaluation; the study is not being required at this time because
the use patterns are not anticipated to subject birds to repeated
exposure during the breeding season.
There is sufficient information to characterize
ethephon as relatively nontoxic to honeybees.
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3. Plant Protection
No plant protection studies were available for
evaluation: All Tier I data on Non-Target Area Phytotoxicity are
required for pesticides used in forests and natural grasslands.
In addition, Aquatic Plant Growth data are required as special
testing (Section 70-1) for the cranberry use because that use
involves application of ethephon in close proximity to aquatic
habitats. Thus, Tier I testing is required to assess the potential
hazard to both terrestrial and aquatic nontarget plants.
F. Endangered Species
No precautionary labeling is required at this time.
However, the Agency does not have adequate environmental fate
data to judge the potential risk to nontarget plant species.
The Agency will reassess the risk to nontarget plant species
when the environmental fate data required by this document
(listed in table A) are submitted and have been evaluated.
G. Product Chemistry Evaluation
Although product chemistry data may have 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. As
discussed above, the Agency has identified impurities which may
be present in in ethephon and is requiring data to ascertain the
extent of contamination.
IV. REGULATORY POSITION
A. Regulatory Positions and Rationales
Based on review and evaluation of all available data
and other relevant information on ethephon, the Agency has made
the following determinations:
1. A Special Review is not being initiated at this
time.
Rationale;
If a pesticide meets or exceeds any of the criteria
specified in 40 CFR 154.7, a Special Review of the chemical may
be conducted. Agency review and evaluation of the available data
indicate that none of the criteria specified have been met or
exceeded by the currently registered use patterns for ethephon.
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2. The Agency will not require restricted use
classification for ethephon end-use products.
Rationale;
Although ethephon meets one of the criteria for
restricted use classification because of its corrosivity to the
eyes and skin, label restrictions requiring protective clothing
will be adequate to address the hazard without imposition of
the restricted use classification. See section IV B of this
document for the required label statements.
3. The Agency is deferring decisions concerning ethephon1s
potential for contaminating ground water until information on
its environmental characteristics and fate have been submitted
a nd r ev i ew ed.
Rationale;
The Agency is unable to assess the potential for
ethephon to contaminate ground water because the environmental
fate of this chemical is largely unknown. Preliminary data
indicate that unaged ethephon may be mobile in loamy sand, silt
loam and peat soils, and immobile in sandy clay loam soils.
Additional data are needed in order to assess the environmental
fate of ethephon. When these data have been received and evaluated,
the Agency will assess ethephon1 s potential for ground water
contamination and will determine whether any regulatory action is
necessary.
4. The Agency has identified certain data that will
receive immediate review when submitted.
Rationale;
Certain data are essential to the Agency's
assessment of this pesticide and its uses and/or may trigger
the need for further studies which should be initiated as
soon as possible. The following studies have been identified
to receive priority review as soon as they are received by the
Agency:
Residue Chemistry: 158.240
Metabolism (animal) 171-4
Toxicology: 158.340
21-day Dermal 82-2
21-day Smoke Inhalation 82-X
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General Metabolism 85-1
Chronic Toxicity Rodent 83-1*
Oncogenicity data 83-2*
Environmental Fate 158.290
Leaching Adsorption/Desorption 163-1
Vegetative Vigor 122-1
Seedling Germination and
Seedling Emergence 122-1
Aquatic Plant Growth 122-1
*These studies may be upgraded or they will have to be repeated
5. The Agency has determined that foliar and soil
dislogeable residue data are required to establish reentry
intervals for all crops. An interim reentry interval of 24
hours is being imposed for all crops until final reentry
reentry intervals are established.
Rationale:
An interim 24-hour reentry interval is being imposed
for the agricultural uses of ethephon until adequate data have
been submitted and evaluated. Interim reentry intervals are
being imposed to provide worker protection while data needed to
establish reentry intervals are being generated.
6. Pre-harvest intervals are required on product
labeling for a variety of currently registered use sites.
Rationale:
The ethephon product labels do not specify pre-
harvest intervals (PHIs) for many crops, but include recommended
treatment-to-harvest intervals based on efficacy rather than
on residue data. In addition, data indicate that residues in or
on some of the commodities increase over time then decline.
Therefore, a PHI must be proposed based on the residue data for
the following crops:
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Peppers, cucumbers, melons, tangerines, apples, cherries, Black-
berries/boysenberries, cranberries, grapes, filberts, walnuts,
barley, wheat, wheat forage, hay and straw, coffee beans,
Cottonseed, figs, guavas, pineapples, and sugarcane.
Interim PHI's based on the existing data are
required on end-use product labels (refer to section D of this
document).
7. The Agency is requiring data on animal metabolism
as well as storage stability studies and residue studies for
poultry and eggs. In order to remain in compliance with FIFRA,
registrants must do one of the following:
a. Submit data which demonstrate that no residues
remain in eggs and poultry as a result of feeding treated
commodities;
b. Propose tolerances and provide appropriate
supporting data for residues in poultry tissues and eggs.
Rationale;
Ethephon residues may be found in agricultural
commodities used for poultry feed. If residue-bearing com-
modities are fed to poultry, residues may be present in poultry
and eggs (which may be used for human food). However, no tolerance
exist for these foods. In order to avoid unauthorized levels of
ethephon residues, it must be demonstrated that residues will
not be found in poultry and eggs, or tolerances must be established.
8. Additional residue data, including processing data,
must be submitted for the following raw agricultural commodities:
peppers, tomatoes, cucumbers, melons, lemons, tangerines, apples,
cherries, blackberries, boysenberries, blueberries, cranberries,
grapes, filberts, walnuts, barley (wheat data may substitute),
wheat, (and wheat straw), coffee beans, cotton seed, figs, guavas,
pineapples, sugarcane, and tobacco. For tobacco, pyrolysis data
must be submitted. If residues concentrate in any of the processed
products, the appropriate food additive tolerance(s) must be
proposed. Specific data requirements may be found in the data
tables.
Rationale:
The available data are inadequate to support
existing tolerances for these commodities.
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9. The Agency is requiring the proposal of either a
tolerance for sugarcane forage or a grazing prohbition for sugarcane
forage.
Rationale;
Since forage is a raw agricultural commodity of
sugarcane, a tolerance must be establish for it. However, no
tolerance exists. Residue data are needed to establish a tolerance
and a pregrazing interval.
10. The Agency has determined that the following revisions
in the tolerances listed in 40 CFR 180.300 and 21 CFR 193.186 are
necessary.
o The designation "N" (negligible) must be deleted
from all tolerances entries.
o The commodity "pineapple fodder" must be deleted
from 40 CFR 180.300.
o The tolerance for guava must be added to 40 CFR
180.300.
o The tolerance for raisins must be added to 21
CFR 193.186.
Rationale:
0 The Agency no longer accepts the concept of
"negligible" residues, therefore the designation
will no longer be used.
0 The tolerance for residues in or on pineapple
fodder is inappropriate because this commodity
is not a raw agricultural commodity but a proces-
sed animal feed item.
0 The tolerance for guava should be published
under 40 CFR 180.300. Although a tolerance was
published in the 1980 (45 FR 47147), the listing
of this tolerance does not appear in the Code of
Federal Regulations. Correction of this omission
will make the CFR current for ethephon.
0 A food additive tolerance for raisins was estab-
lished in 21 CFR 193.186 but does not appear in
current issues of the Code of Federal Regulations.
A correction would make the CFR current for
ethephon.
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11. Product chemistry and residue data are required
depicting residues of monochloroac etic acid in or on food and
feed commidities following registered applications of ethephon.
Rationale:
Monochloroac etic acid is a potential degradate
of certain impurities in the ethephon technical product. Because
of its extreme toxicity, it is currently regulated under 21 CFR
189.155 ("Food containing any added or detectable level of
monochloroac tic acid is deemed to be adulterated..."). Therefore,
the Agency deems it necessary to determine whether monochloroac etic
acid is likely to occur in food as a result of direct treatment
with ethephon.
12. The Agency has identified 2-chloroethanol as a
contaminant of toxiclogical concern. The Agency is requiring
data to assess the extent of contamination with this substance.
Additionally, the Agency is requiring that manufacturing use
products bear a label statement advising users to store and use
the product in well-ventilated areas. The label statement appears
in Section D. 3. of this document.
Rationale:
2-Chloroethanol has been found in technical ethephon
products. This substance is extremely toxic through the inhalation
route. More data are required to assess the extent of contamination
with 2-chloroethanol. The impurity could pose a hazard when
technical or manufacturing use products are stored or used
under conditions that permit 2-chloroethanol vapors to accumulate
to hazardous levels. Storage or use of technical or manufacturing
use ethephon products in wellventilated areas would reduce
the risk of posed by 2-choroethanol. Accordingly, the Agency
is that the labels of manufacturing use products be revised to
state that the product should be stored and used in well-ventilated
a r ea s.
13. While the data gaps are being filled, currently
registered manufacturing-use products and end-use products
containing ethephon as the sole active ingredient may be sold,
distributed, formulated, and used in the United States, subject
to the terms and conditions specified in this Standard.
Registrants must provide or agree to develop additional data,
as specified in Appendix I to maintain existing registrations.
The Agency will issue registrations for
substantially similar products and new uses will be issued
after considering the effects on the theoretical maximum residue
contribution (TMRC) and the maximum permissable intake (MPI).
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Rationale:
Section 6 of FIFRA authorizes the Administrator
to cancel a pesticide registration if he determines that the
pesticide will cause unreasonable adverse effects on the
environment. Based on available data, the Administrator has not
made such a determination as to ethephon. The Administrator has
authority under FIFRA sections 3(c)(2)(B) and 3(c)(7) to require
registrants and applicants for registration to provide data
needed to support new or continuing registrations.
Issuance of this Standard provides a mechanism for
identifying data needs. These data will be reviewed and evaluated
and the Agency will determine if the data will affect the registra-
tion of ethephon.
B. Criteria For Registration
To be registered or reregistered under this Standard,
products must contain ethephon as the sole active ingredient;
bear required labeling; and conform to the product composition,
and use pattern requirements listed in this section.
C. Acceptable Ranges and Limits
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain ethephon as the
sole active ingredient. Each MP formulation proposed for registratior
or reregistration 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.
2. Acute Toxicity
The Agency will consider registration of technical
grade and manufacturing-use products containing ethephon provided
that the product labeling bears appropriate precautionary state-
ments for the acute toxicity category in which each product is
placed.
3. Use Patterns
To be registered under this Standard, technical
grade or manufacturing-use products containing ethephon may be
labeled for formulation into end-use products registered only
for the uses listed in the EPA compendium of acceptable uses.
This compendium lists all registered uses, as well as approved
maximum application rates and frequencies and is available through
the preedom of Information Office.
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D. Required Labeling
In order to remain in compliance with FIFRA, products
must bear appropriate labeling as specified in 40 CFR 156.10
and in this Standard, or must be revised to conform to those
specifications. Appendix II contains information on labeling
requirements.
No pesticide product containing ethephon may be released
for shipment by the registrant or producer after September 30/ 1989
unless the product bears an amended label which complies with the
requirements of this standard.
No pesticide product containing ethephon may be
distributed or sold after September 30, 1990 unless the product
bears an amended label which complies with the requirements of
this Standard.
The following specific information must appear on
the labeling in order for porducts to remain in compliance
with FIFRA:
1. Ingredients Statement
The ingredient statement shall list the active
ingredient as:
ACTIVE INGREDIENT:
Ethephon [(2-chloroethyl) phosphonic acid]: %
2. Use Pattern Statement
All manufacturing-use products must state that
they are intended for formulation into end-use products for
acceptable use patterns. Labeling must specify sites, which are
listed in Use Patterns, section C.3. However, no use may be
included on the label where the registrant fails to agree to comply
with data requirements in Table A for that use pattern.
3. The Following Must Appear on MUP Labels
"Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public water
unless this product is specifically identified and addressed in a
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."
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"Technical grade ethephon must be stored and used
in ventilated areas only."
4. The Following Must Appear on EP Labels
"Do not apply directly to water or wetlands (swamps,
bogs, marshes, and potholes). Do not contaminate water when
disposing of equipment washwaters."
"Mixers, loaders and applicators must wear a full
face shield, long trousers, long sleeved shirt, gloves, and boots
to avoid as much skin and eye contact as possible."
"Do not enter treated fields within 24 hours
after application unless protective clothing is worn."
The following interim pre-harvest intervals (PHI)
must be included on end use product labels for the raw agricultural
commodities listed. These interim PHI's may be revised after the
required field residue data have been submitted and evaluated.
Apples, minimum 7 days; barley, 40 days;
blackberries and blueberries, 42 days; cherries, minimum 7 days';
coffee beans, 14 days; cotton, 14-21 days; cranberries, 17-21
days; cucumbers, 17-21 days; figs, 14 days; filberts, 7 days;
grapes, 14 days; guavas, 7 months; melons, 2 days; peppers, 14
days; pineapples, 2 days; tangerines, 5-10 days; tomatoes, 14-20
days for processing and 3-6 days for fresh market in California
only; walnuts, 5-10 days; wheat, 40 days.
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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 uf 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 fi2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data 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 Registra-
tion 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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31
B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
C. ^nd 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 exemption3, 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 require-
ments 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 reauirements listed in Tables A and C.
3 if 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
reauirements in Table A.
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32
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.
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 regis-
tration of products containing this active ingredient.4
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 S 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
4 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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33
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.
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. *That 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 PCI 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
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34
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 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 con-
sortium 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 PCI. 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:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
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35
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 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 3(c) (2)(B) (iii).
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
limih 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 require-
ment 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 ar-e not required
to submit data for uses which are no longer on your label.
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36
6. You request voluntary cancellation of the registration
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
list<=d 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.
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37
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
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.
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38
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
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 consis-
tent with the provisions of FIFRA.
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 require-
ments, 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 require-
ments for your products will result in suspension of the
product's registration.
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39
VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
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 Registra-
tion 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.
IX. INSTRUCTIONS FOR SUBMITTAL
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, D.C. 20460
Attn: ETHEPHON 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:
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40
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.
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
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41
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, o_r 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:
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.
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42
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.
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TGUIDE-1
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 Port 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
E = Greenhouse, food
F = Greenhouse, ndn-food
G = Forestry
H = Domestic outdoor
I - Indoor
Any other designations will be defined in a footnote to the table.
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44
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that 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 infor-
mation.
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 3
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 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 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration 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.
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TABLE A, GENERIC DATA REQUIREMENTS FOR THE TECHNICAL GRADE OF THE ACTIVE INGREDIENT
ETHEPHON
Test
Data Requirement Substance1
158 subpart c Product Chemistry
Product Identity^ and Composition
61-2 - Description of Beginning Mater- TGAI
ials and Manufacturing Process
61-3 - Discussion of Formation of TGAI
impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product TGAI
Samples
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point TGAI
63-7 - Density, Bulk Density or TGAI
Specific Gravity
63-8 - Solubility TGAI or PAI
63-9 - Vapor Pressure TGAI or PAI
63-10 - Dissociation Constant TGAI or PAI
63-11 - Octanol/Water Partitioning PAI
Coefficient
63-12 - pH TGAI
63-13 - Stability TGAI
Other Requirements;
Does EPA
Have Data2
NO
NO
No
No
NO
NO
NO
NO
NO
NO
NO
NO
NO
No
NO
n /»
Bibliographic
Citations
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Kl/»i
Must Addi-
tional Data
Be Submitted?
Yes4
r-
Yes5
*^
Yes7
*v~
Yes7
Yes7*8
Yes7*?
Yes7
Yes7
Yes7
Yes7
Yes7,10
Yes7,ll
Yes7
M/1
Timeframe
For
Submission
6 months
6 months
12 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
64-1 - Submittal of Samples
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TABLE A. GENERIC DATA RhJQUIKtMKNTS bUk THE TECHNICAL GRADE OF THE ACTIVE INGREDIENT E1HEPHCJN
= technical grade of the active ingredient. FAI = purified active ingredient.
2Not applicable. Although product chemistry data may have 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.
^Data must be submitted within the timeframe, based on the date of this Guidance Document.
^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.
^A detailed discussion of all impurities that are or may be present aO 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.
*>Five or more representative samples must be analyzed for the amount of active ingredient and each
impurity tor which certified limits are required. Complete validation data (accuracy and precision)
must be submitted for each analytical method used.
7physicochemical 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 158.120 and more fully described in the Pesticide Assessment Guidelines,
Subdivision D, must be submitted.
needed if the technical chemical is a solid at room temperature.
required if the technical product is a liquid at room temperature.
required if the technical product is organic and nonpolar. ^
11 Data required if the test substance is dispersible in water.
-------
TABLE A. GtNbKIC DATA RHOJJIRtMKNTS W)R KTHEPHON
Must Addi- Timeframe
Test Does RPA Bibliographic tional Data For
Data Requirement Substance^ Have Data? Citation Be Submitted? Submission^
158.240 Residue Chemistry
171-2
171-3
171-4
- Chemical Identity3 TGAi
- Directions for use TEP Yes
- Nature of the residue PAIRA Yes
(Metabolism)
- Plants
00038793,
00054018,
00067489,
00088983,
00108993,
00117893,
00122410
00038796,
0001)4021 ,
00081783,
00097422,
00116123,
00121613,
No
No
171-4 - Nature of the residue
(Metabolism)
- Livestock
PAIRA and Partially
plant metabo-
lites
00118508, 00141506,
00165339
Yes 4,5 18 months
-------
TABLE A.
DATA KhX^UlKEMKNTS K)K ETliEPHON (Continued)
Mist Addi- Timeframe
Test Does EPA Bibliographic tional Data For
Data Requirement Substance1 Have Data? Citation Be Submitted? Submission2
171-4 - Residue analytical TGAI and Partially 00030190,
methods metabolites 00038795,
00038880,
00042977,
0004791 1 ,
00053149,
00108992,
00117893,
00122410,
00122433,
00123237,
00142265,
00036500 Yes& 1 5 months
00038797,
00038881 ,
00041465,
00047913,
00103287,
00116123,
00121613,
00122421,
00122435,
00128726,
00145613,
171-4 - Storage stability
171-4 - Magnitude of the residue
in plants
Fruiting Vegetables
- Peppers
- Tomatoes
TEP and
metabolites
Partially 00151127
TtP
TEP
Partially
Partially
00061719, 00121613
00121613
Yes 7
18 months
Yes'"
Yes 11
6 months
18 months
24 months
CD
-------
TABLE A. GENERIC DATA REQUIREMENTS FDR ETHEPHON (Continued)
Test Does EPA
Data Requirement Substance1 Have Data?
Cucurbit Vegetables
- Cucumbers
- Melons TEP
- Pumpkins TEP
Citrus Fruits
- Lemons TEP
- Tangerines TEP
Pome Fruits
- Apples TEP
Stone Fruits TEP
- Cherries (sweet and
sour)
Small Fruits and Berries
- Blackberries and TEP
Boysenberries
- Blueberries TEP
- Cranberries TEP
Partially
Partially
Yes
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Must Addi-
Bibliographic tional Data
Citation Be Submitted?
PP//9E2225(098344)
001 1 7893
00122717
00121613
00121613
00061717, 00108992,
00123222
00081782, 00136287
00121613
00121613
00121613
Yes' 2> 9
Yes13,9
Reserved 9
Yes'4,9
Yes1 5
Yes16
Yes18'
Yes19,9
Yes20
Yes21 ,9
Yes22
Timeframe
For
Submission2
b months
18 months
18 months
24 months
18 months
6 months
24 months
6 months
18 months
6 months
18 months
-------
TABU-: Ak GENERIC DATA REQUI REMITS bOR LTHEPHON (Continued)
Data Requiranent
- Grapes
Tree Nuts
- Filberts
- Macadamia nuts
- Walnuts
Cereal Grains
- Barley
- Wheat
Forage, Fodder, and
Straw of Cereal Grains
- Barley straw
- Wheat straw
Miscellaneous
Commodities
- Coffee beans
Test
Substance^
TCP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA
Have Data?
Partially
Partially
Yes
Partially
Partially
Partially
Partially
Partially
Partially
Bibliographic
Citation
00053150, 00080482,
00121613
00038797
00128726
00038795, 00117752
00103287
00103287
00103287
00103287
00041465
Mjst Addi-
tional Data
Be Submitted?
Yes23
Yes24
YeS25.9
Reserved^
Yes26,9
Yes27,9
YeS28,9
y r\^*£- "
YoG-JVJ
V^o J • • J
Yes33
Yes34
Time frame
For
Submission2
18 months
18 months
6 months
6 months
18 month « —
O
18 month
24 month
18 months
18 months
18 months
24 months
6 months
-------
TAhLE A. GENERIC DATA REQUIREMENTS K)R ETHEPHON (Continued)
Data Requirement
- Cottonseed
- Figs
- Uuavas
- Pineapples
- Sugarcane
- Tobacco
171-4 - Magnitude of residue in
Test
Substance^
TEP
TEP
TEP
TEP
TEP
PAIRA
TGAI
Does EPA
Have Data?
Partially
Partially
Yes
Partially
Partially
Partially
Partially
Mist Addi-
Bibliographic tional Data
Citation Be Submitted?
00030190, 00122423
00036500
PP#9E2262
00040268, 00040269,
00054022, 00116123,
00122452, 00123222
00032573, 00145613
00122410
00083773, 00100517,
Yes35
Yes36
Yes37,9
Yes38
Yes3y,9
Yel4'
Yes42
Yes43
Yes44
Yes4^
Timeframe
For
Submission2
18 months
6 months
6 months
24 months
18 months
18 months
24 months
6 months
24 months
18 months
18 months
Meat/Milk/Poultry/Eggs
00121613
-------
TABLE A. GENERIC DATA REQUIREMENTS FOR ETHEPHON (Continued)
J-Test substance: TGAI = technical grade of the active ingredient; PAI = purified active ingredient;
PAIRA = purified active ingredient, radiolabeled; TEP = typical end-use product; EP = end-use product.
2]3ata must be submitted within the indicated timeframe, based on the date of this Guidance Document.
same chemical identity data are required as under 158. 120, with emphasis on impurities of toxicological
concern that constitute residue problems. Refer to Product Chemistry Data Requirement tables.
4A poultry metabolism study must be submitted. Animals must be dosed orally for a minimum of 3 days with [UL-14C
at a level sufficient to make residue identification and quantification possible. Eggs must be collected
twice a day during the dosing period. Animals must be sacrificed within 24 hours of the final dose. The
distribution and identity of l^C-residues (including l^c-residues incorporated into natural products)
must be determined in eggs, liver, kidney, muscle, and fat. Samples from these studies must also be
analyzed using the Union Carbide-animal method [MRID # 00142265] to ascertain that this method is capable
of adequately recovering and identifying all residues of toxicological concern.
5oata depicting the nature of ethephon residues in swine are also required unless the metabolism in
-------
TABLE A. GENERIC DATA RW^UlKtMENTS tt)k hTHEPHON (Continued)
8The registrant must amend all pertinent product labels to specity a PHI. The available data indicate
that a PHI of 5 days or longer would be appropriate.
^Additional residue data may be required on receipt of the storage stability data required in footnote
w I •
must be submitted depicting residues of ethephon and monochloroacetic acid in or on tomatoes
resulting from a single foliar application of the 2 Ib/gal SC/L formulation at 1.6 Ib ai/A, in 20 gal/A
using ground equipment and, in seperate tests, in 10 gal/A using aerial equipment. The data must depict
the increase and decline of residues over a suitable range of posttreatment intervals. The registrant
must propose a PHI based on these data. The tests must be conducted in CA (75%) and FL (8%), states
that represented ca. 80 percent of 1985 total U.S. tomato production.
must be submitted depicting the potential for concentration of residues in juice, dried pomace,
puree, and catsup processed from tomatoes bearing measurable weathered residues. If residues concentrate
in any processed fraction, an appropriate food/feed additive tolerance must be proposed.
registrant must propose a PHI based on the minimum interval expected between the second application
(5 days after the plants are at the four-leaf stage) and harvest. The available data indicate that a
PHI of 17 days or longer would be appropriate.
must be submitted depicting ethephon and monochloroacetic acid residues in or on cantaloupes
harvested 2 days (or a PHI proposed by the registrant) following aerial application of the 2 Ib/gal
SC/L formulation at 0.75 Ib ai/A. Tests must be conducted in TX. The registrant must propose a PHI
for application of ethephon to cantaloupes; the available data indicate that, following application
using ground equipment, a PHI of 2 days would be appropriate.
registrant must either (i) provide documentation that lemons will not be shipped or sold for >^ 2
weeks after treatment, or (ii) submit data depicting ethephon and monochloroacetic acid residues in or
on lemons immediately after a single postharvest application of the 2 Ib/gal SC/L formulation at 0.83
Ib ai/100 gal of water/ 1 00-1 30 tons of fruit.
-------
TABLE A. GENERIC DATA RHQUIREMENTS FOR ETHEPHON (Continued)
'-'Data must be submitted depicting the potential for concentration of ethephon residues in dried pulp, oil, and
molasses during the processing of treated lemons bearing measurable residues. If the data indicate a potential
for residue concentration In any of these commodities, the registrant must propose an appropriate food/feed
additive tolerance.
'&Data must be submitted depicting ethephon and monochloroacetic acid residues in or on whole tangerines harvested
at regular Intervals following a single foliar application of t he 2 Ib/gal SC/L formulation at 1 425 Ib ai/A in
400 gallons of water/A. The data must depict levels of ethephon residues and a PHI must be proposed based on
the requested data. Tests must be conducted in FL.
1?The registrant must propose a PHI. The available data indicate that a PHI of 7 days would be appropriate.
be Submitted depicting the potential for concentration of residues in dried pomace from treated
apples bearing measurable weathered residues. If the data indicate a potential for residue Concentration in
this commodity, the registrant must propose an appropriate feed additive tolerances
registrant must amend all pertinent labels to include a PHl based «H the Mtiittiutfi itifcervii expected
betveeh application and harvest. The available data indicate thafe a PHI of 7 days or l8HgeT Vtould be (jn
appropriate* -^*
20nata must be submitted depicting residues 8f ethephon and monpdhlotOacetie aeid itt or OH blackberries or
bovsenberries resultihfe from a single MU? §^PHeati»n of the ^ lb/gal SC/U foriffillatioh at 2.18 Ib at/A, ih
175 Si/AuX« RroUHd %utpmeht. Ihe data mtisfe dfetiict the levels of tesiduea over a suitable rame of p»t-
trfeatJeht intervals The registrant must propose a PM1 based on these dafeis The tests tttust be eendufetetJ in OK
which accounted for ca. 80 percent ef \Wt u,8» blaefeberry produefetem A tol§Mhd§ for *-e§idue§ in or on
boysenberrtes must be proposed.
2lThe registrant must propose a PHI for application of ethephon to blueberries. The available data
indicate that a 7-day PHI would be appropriate.
a PHI based on these data. Tests must be conducted in MA, NJ, and WI.
-------
TABLE A. GENbKLC IWi'A KtJQUIRHMENTS R)R hTHKPHON (Continued)
23Uata must be submitted depicting residues of ethephon and monochloroacetic acid in or on grapes and raisin
waste harvested at regular intervals following a single foliar application of the 2 Ib/gal SC'/L formulation at
0.5 Ib ai/A. Data must depict the level of residues over a suitable range of posttreatment intervals. Tests
must be conducted in CA where this use is registered. The registrant must propose adequate tolerance revisions
(if necessary) for residues of ethephon in or on grapes and raisin waste based on appropriate supporting residue
data. In addition, the registrant must propose a PHI based on the requested residue data.
an appropriate tolerance for residues in or on grapes is determined, food/feed additive tolerance at 4x
must be established for grape juice and dried grape pomace, and a food additive tolerance at 7x must be established
for raisins.
xhe registrant must amend all pertinent labels to include a PHI based on the minimum interval expected
between application and harvest. The available data indicate that a PHI of 7 days or longer would be
appropriate.
26ihe registrant must amend all pertinent labels to include a PHI based on the minimum interval expected
between application and harvest. The available data indicate that a PHI of 5 days or longer would be U
appropriate.
27xhe registrant must amend all pertinent product labels to include a PHI. The available data
(reflecting ground application) indicate that a PHI of 40 days would be appropriate.
28Residue data must be submitted of ethephon and monochloroacetic acid in or on wheat grain harvested following
one aerial application of a representative SC/L formulation at 0.5 Ib ai/A in 3 gal/A. Tests must be conducted
in KS H8%) or 00 (6%) ND (13%) or NM (6%), and in WA (5%) which collectively represent the tna.ior wheat growing
areas in the United States and ca. 50 percent of the 1985 U.S. wheat production The registrant must amend all
pertinent product labels to specify a PHI based on the residue data. The available data (from tests using
ground application indicate that a PHI of 40 days would be appropriate.
29nora must be submitted depicting concentration of residues in middlings and wheat grain dust resulting from
?he p^cessing^ wheat grain blaring measurable weathered residues. If the data indicate a potential for
concen^ation^of residue! in grain dust, an appropriate feed additive tolerance must be proposed.
-------
TABLE A. GENERIC DMA RE^U 1 KKMENTS FUR ETHEPHON (Continued)
30Data required to support the tolerance for residues in or on wheat straw will be translated to
barley straw.
3'Data must be submitted depicting residue ot ethephon and monochloroacet ic acid in or on wheat straw harvested
following one aerial application of a representative SC/L formulation at 0.5 Ib ai/A in 3 gal/A. Tests must be
conducted in KS (18%) or CO (6%), ND (13%) or MN (6%), and in WA (5%) which collectively represent the major
wheat growing areas in the United States and ca. 50 percent of the 1985 U.S. wheat production The registrant
must amend all pertinent product labels to specify a PHI based on the residue data. The available data (from
tests using ground application) indicate that a PHI of 40 days would be appropriate.
32Qata must be submitted depicting ethephon and monochloroacet ic acid in or on green coffee beans harvested at
regular intervals following a single foliar application of the 4 Ib/gal SC/L formulation at 600 rag/plant to a 4
meter coffee plant. Tests must be conducted in Guatemala, Costa Rica, and Brazil which accounted for the majority
of the 1985 coffee bean importation to the U.S. from North and South America. The registrant must amend all
pertinent product labels to specify a PHI. —
33oata must be submitted depicting the potential for concentration of residues in roasted beans and instant
coffee processed from beans bearing measurable weathered residues. If residues concentrate in any of these
processed commodities, an appropriate food additive tolerance must be proposed. CD
ON
34The registrant must submit an English translation of all labels bearing directions for use of
ethephon on coffee grown for importation into the U.S.
35[j&ta must be submitted depicting residues of ethephon and monochloroacet ic acid in or on cottonseed harvested
14 days after the last of two applications (one application made at 2 Ib ai/A when 50 percent of the bolls are
open and the second treatment made at 1 Ib ai/A 4 days later) of the 2 Ib/gal FLC and a representative EC
formulation (each in separate tests) applied with aerial equipment in 2 gal. water/A and, in separate tests,
usine eround equipment in 5 gal. water/A. The data must depict the posttreatment interval at which residues
decline. Tests must be conducted in AZ (7%), AR (5%), CA (23%), GA (3%), MS (12%), MM « 1%), OK (2%), and TX
(29%) which collectively accounted for ca. 80 percent of 1985 U.S. cotton production. The registrant must
propose an appropriate PHI based on the requested residue data.
-------
TABLE A. GENERIC [ATA REQUIREMENTS K)R ETHEPHON (Continued)
36WTien an appropriate tolerance for residues in or on cottonseed is determined, food/feed additive
tolerances at 6x in meal, 2x in refined oil, and 4x in soapstock must be proposed.
37The registrant must amend all pertinent product labels to specify a PHI. Available data indicate
that a PHI of 14 days or longer would be appropriate.
38Qata must be submitted depicting the potential for concentration of residues in dried figs processed from
fresh figs bearing measurable weathered residues. If residues concentrate in dried figs, an appropriate food
additive tolerance must be proposed.
registrant must submit data regarding the gal. water/A rate used in previously submitted field trials
(PP09E2262) and a PHI of _> 7 months must be proposed. If the gal. water/A data are not available or at least
250 gal/A were not applied, data depicting residues of ethephon and monochloroacetic acid in or on guavas harvested
following a postharvest application made at 3.13 Ib ai/25U gal. water/A must be submitted. The finished spray
must contain a nonionic surfactant. A PHI must be proposed based on the residue data. The tests must be conducted
in HI where this use is registered. Alternatively, the registrant may elect to cancel this use permitted under -^
EPA SLN No. HI800012.
must be submitted depicting residues of ethephon and monochloroacetic acid in or on pineapple fruit and
forage harvested at regular intervals following the last of two foliar applications of a representative SC/L
formulation at 1.5 Ib ai/A, one application made to foliage 6 to 8 months prior to harvest and one late-season
application to plants bearing immature fruit. The data must depict the posttreadnent interval at which residues
begin to decline. The registran must amend the pertinent labels to specify a PHI and a pregrazing interval;
these intervals must be reflected in the requested data. Tests must be conducted in HI, which accounts for ca.
100 percent of the U.S. total pineapple production.
41 A processing study must be submitted depicting residues in products (bran and juice) processed from pineapples
bearing measurable, weathered residues. If residues concentrate in any product, appropriate food/ feed additive
tolerances must be proposed.
PHI of > 2 months must be proposed.
-------
TABLE A. GENERIC tATA KE^ULHfcMENTS R>R hTHEPHON (Continued)
must be submitted depicting the potential for concentration of residues in refined «ugar processed from
sugarcane bearing measurable weathered residues. If the data indicate a potential for concentration of residues,
an appropriate food additive tolerance must be proposed.
^Pyrolysis products derived from ethephon must be characterized and the level of residue in tobacco
smoke must be quantified* Weathered residues of [^C]ethephon must be used for identification of
pyrolysis products*
45Kollowing receipt and evaluation of the required poultry metabolism data, storage stability data,
and residue data for feed items, specific data requirements for livestock feeding studies will be
determined.
Ul
GO
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR ETHEPHON
Data
Test use
Requirement Substance^ pattern
Does EPA Bibliographic
Have Data2 Citation
Must Addi- Timeframe
tional Data For
Be Submitted? Submission
158.340 Toxicology
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation - Rabbit
- Dermal Sensitization -
Guinea Pig
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
Yes 00029509
Yes 00029510
No
No
Yes 00029513
NO
Yes 00144559
No
No
Yes 9 months
No4
' *•**
NO
Yes 9 months c/i
^
NO
SUBCHRONIC TESTING:
82-1
- 90-Day Feeding -
Rodent
Non- rodent
TGAI
TGAI
A,B,G
A,B,G
No
NO
NO5
NO6
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR ETHEPHON
Data Requirement
158.340 Toxicology (Cont.)
82-2 - 21-Day Dermal-
82-3 - 90-Day Dermal-
82-4 - 90-Day Inhalation-
82-5 - 90-Day Neurotoxicity-
82-X - 21-Day Smoke Inhalation-
CHRONIC TESTING:
83-1 - Chronic Toxicity -
Rodent
Non- rodent
83-2 - Oncogenicity Study -
Rat
Mouse
83-3 - Teratogenicity -
Rat
Test
Substance^
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
•TGAI
TGAI
TGAI
TGAI
use
pattern
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
AfB,G
A,B,G
A,B,G
A,B,G
A,B,G
Does EPA
Have Data2
NO
No
NO
NO
NO
Partially
Partially
Partially
Partially
Yes
Must Addi- Timeframe
Bibliographic tional Data For
Citation Be Submitted? Submission
Yes 12 months
NO?
No8
No9
Yes10 12 months
O
00060358 Yes11 3 Months
00144558
Yes12 3 Months
00060358 Yes13 3 Months
00144558
00165591 Yes14 3 Months
00063745 No
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR ETHEPHON
Data Requirement
158.135 Toxicoloqy (Oont.)
83-3 - Rabbit
83-4 - Reproduction -
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Domestic Animal Safety
Test
Substance^
TGAI
TGAI
TGAI
TGAI
TGAI
PA I or PAIRA
Choice
use
pattern
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
ArB,G
Does EPA
Have Data2
Yes
No
Yes
Yes
No
NO
NO
Must Addi-
Bibliographic tional Data
Citation Be Submitted?
00085755 No
Yes
00029515 No
00077061 No
Yes15
Yes
NO16
Timeframe
For
Submission
39 months
12 months
24 months
-------
TABLE A
GRNERIC DATA REQUIREMENTS FOR ETHEPHON
^Composition: TGAI Technical Grade Active Ingredient; PAI = Pure Active Ingredient; PAIRA = Pure Active
Ingredient, Radiolabelled; Choice = Choice of several test substances determined on a case-by-case basis.
2The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic,
Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor; I = Indoor;
IP = Industrial Preservative.
^Unless otherwise specified, data must be submitted no later than six months after publication of this
standard.
^Primary Eye Irritation Studies are not required for substances which are corrosive in Primary Dermal
Irritation Studies. Since ethephon is corrosive, an Primary Eye Irritation Study is not required.
^This requirement is waived based on the submission of an acceptable chronic feeding study in the rat.
6This requirement is waived based on the submission of an acceptable chronic feeding study in the dog.
^This study is not required because existing acceptable end-uses should not result in repeated human ON
skin contact. rxj
8This study is not required because existing acceptable end-uses should not result in repeated
inhalation exposure.
9Since the Acute Delayed Neurotoxicity study in hens showed no dose related neuro-histopathology, a
study is not required.
study is required only if residues of degradation products of ethephon or ethephon residues on flue
cured tobacco are greater than 0.1 ppm. However, since formal guidelines for such a study have not been
developed, the registrant should consult with the Agency before performing the study.
11This study cannot be fully evaluated from the data available. Data on the stability of ethephon in
the feed must be submitted. In addition, historical control data must be submitted on pancreatic islet
cell carcinomas and adenomas in Sprague Dawley rats, preferably conducted in the testing facility
conducting the original study or the study must be repeated.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ETHEPHON
is study cannot be fully evaluated from the data available. Data on the stability of ethephon in the
feed must be submitted or the study must be repeated.
footnote 11.
is study cannot be fully evaluated from the data available. Data on the stability of ethephon in the
feed must be submitted. In addition, historical control data must be submitted on f ibrosarcomas in the
Swiss Albino mouse, preferably conducted in the testing facility conducting the original study.
study is required for gene mutation in mammalian cells.
!6This study is not required under the current use patterns.
ON
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR ETHEPHON
Data Requirement
158.290 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
PHOTODEGRADATION :
161-2 - In Water
161-3 - On Soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
163-1 - Leaching and
Adsorption/Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
Test
Substance^
PAIRA
PAIRA
PAIRA or TGAI
PAIRA or TGAI
PAIRA
PAIRA or TGAI
PAIRA or TGAI
PAIRA or TGAI
PAIRA
TEP
TEP
use Does EPA
pattern Have Data2
No
NO
NO
NO
A,B,F, NO
G,H
A,B NO
G NO
NO
AfB,F, NO
G,H
A,B,F NO
A,B,F NO
Must Addi- Timeframe
Bibliographic tional Data For
Citation Be Submitted? Submission
Yes 9 months
Yes 9 months
Yes 9 months
Reserved4
Yes 27 months
Yes5 27 months
Yes 27 months
NO6
Yes^ 12 months
Reserved4
Reserved4
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ETHEPHON
Data Requirement
158.290 Environmental Fate
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-Term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - irrigated Crops
165-4 - in Fish
Test use
Substancel pattern
(Cont.)
TEP A,B
TEP —
TEP G
TEP
TEP A,B
PAIRA A,B
TEP A,B
TEP —
PAIRA/TGAI A,B,G
Does EPA
Have Data2
No
NO
NO
NO
NO
NO
NO
NO
NO
Must Addi-
Bibliographic tional Data
Citation Be Submitted?
Yes
NO6
Yes
NO8
Reserved^
Yes
Reserved1^
Noll
Yesl2
Timeframe
For
Submission
27 months
27 months
39 months
12 months
165-5 - in Aquatic Non-
Target Organism
TEP
No
Reservedl3
-------
TABLE A
GENERIC Q(VTA REQUIREMENTS FDR ETHEPHON
1 Composition: TGAI - Technical Grade of the Active Ingredient; PAIRA = Pure Active Ingredient Radiolabelled-
TEP = Typical End Use Product.
2The use patterns are coded as follows: A = Terrestrial Food Crop; B = Terrestrial, Non-Food; C =• Aquatic,
Food Crop; D = Aquatic Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry;
H = Domestic Outdoor; I - Indoor.
^Data must be submitted within the indicated timetrame, based on the date of this Guidance Document.
*»This study is reserved, pending receipt and evaluation of other environmental fate data. '
^lf an anaerobic aquatic study is submitted, then the anaerobic soil §tudy need not be done.
&Not required because ethephon has no aquatic or aqua tie impact uses. o\
ON
^This data requirement remains unsatisfied because of discrepancies between Studies (ethephon was mobile
in three soils, including a peat in one study, and immobile in sandy clay loam soils in the other).
The registrant must either give an adequate explanation for the discrepancies or submit a new study on
the mobility of imaged ethephon. In addition, a study on the mobility of aged ethephon is required.
data requirement is not being imposed at this time.
^These data may be required, depending on the results of the field dissipation studies.
lOThese data may be required, depending on the results of the confined rotational crop study.
H Not required because ethephon has no aquatic uses.
^Registrant should submit an octanol-water partition coefficient. On the basis of this and other data,
the agency will then determine if a study is needed.
13rhis data requirement is reserved, pending results of data required under 165-4.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ETHEPHON
Data Requirement
158.390 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
Test
Substance*
TEP
TEP
TEP
TEP
use
pattern
A,B
A,B
A,B
A,B
Does EPA
Have Data2
No
NO
NO
NO
Must Addi- Timeframe
Bibliographic tional Data For
Citation Be Submitted? Submission
Yes3/4
Yes3/5
Conditional^
Conditional^
ON
1 TEP = Typical End Use Product.
2 A = Terrestrial Food Crop Uses; B = Terrestrial Non-Food Uses.
3 Data must be submitted no later than 18 months after issuance of this document.
4 For each end use, you must propose an acceptable reentry interval based upon dissipation of residues (decline
curve), considering human exposure and toxicity of the residues or on the time when there are no detectable
dislogeable or inhalable residues in the field.
5 soil dissipation data are required only for uses where workers will be exposed directly to the soil during
their work.
6 Human exposure monitoring data are not required at this time. If dermal exposure data are submitted, then
the inhalation exposure data must also be submitted.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ETHEPHON
Test use Does EPA
Data Requirement Substance1 pattern Have Data2
158.440 Spray Drift
202-1 - Drift Field Evaluation TEP A,B No
202-1 - Drift Size Spectrum TEP A,B No
Must Addi- Timeframe
Bibliographic tional Data For
Citation Be Submitted? Submission
Reserved3
Reserved3
ITEP = Typical End Use Product.
2A = Terrestrial Food Crop; B = Terrestrial Non-Food.
3This data requirement is being reserved, pending receipt and evaluation of phytotoxicity data required
by the Ecological Effects Branch.
00
-------
GENERIC DATA TABLE FOR ETHEPHON
Data Requirement
158.490 WILDLIFE AND AQUATIC
Avian and Mammalian Testing
71-1 - Avian Oral LDso
71-2 - Avian Dietary LCso
Upland game
Waterfowl
71-3 - Wild Mammal
71-4 - Avian Reproduction
Test
Substance^
ORGANISMS
TGAI
TGAI
TEP
TGAI
TGAI
TGAI
use
pattern
A,B,G
A,B,G
A,B,G
A,B,G
Does EPA
Have Data2
Yes
Yes
Yes
Yes
NO
NO
Bibliographic
Citation
00027493
00085446
00107428
00005684
Must Addi- Timeframe
tional Data For
Be Submitted? Submission
No
No
NO
NO
NO3
No6 ^
71-5 - Simulated and Actual
Field testing -
Mammals and Birds
Aquatic Testing
72-1 - Freshwater Fish
Warm water
Cold water
72-2 - Acute LCso Freshwater
Invertebrates
TEP
No
TGAI
TGAI
TGAI
TEP
A,B,G
A,B,G
A,B,G
A,B,G
Yes
Yes
Yes
Yes
00027495
00122412
00027495
00122412
00054013
00122448
No6
NO
NO
No
NO
NO
-------
GENERIC DATA TABLE FOR ETHEPHON
Data
luatic
1-3 -
!— 4 —
>_5 _
Requirement
: Testinq (Cont.)
Acute LC5Q Estuarine and
Marine Organisms
Fish Early Life Stage and
Aquatic Invertebrate
Life Cycle
Fish Life Cycle
Test
Substance^
TGAI
TGAI
TGAI
use
pattern
A,B,G
A,B,G
A,B,G
Does EPA
Have Data2
Partially
No
NO
Bibliographic
Citation
00054013
Must Addi-
tional Data
Be Submitted?
Yes4
NO6
NO6
Timeframe
For
Submission
12 months
72-6 - Aquatic Organism
Accumulation TGAI
72-7 - Simulated or actual
Field Testing -
Aquatic Organisms TEP
158.150 PLANT PROTECTION
121-1 - Target Area
Phvtotoxicity TEP
A,B,G
A,B,G
AfB,G
NO
NO
NO6
NO6
Reserved^
No
-------
GENERIC DATA TABLE FOR ETHEPHON
Data
Requirement
Test
Substance^-
use
pattern
Does EPA
Have Data2
Must Addi- Timef rame
Bibliographic tional Data For
Citation Be Submitted? Submission
Non-Tarqet Area Phytotoxicity
122-1
122-1
122-2
123-1
123-1
123-2
124-1
124-2
Tier I
- Seedling Germination/
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
Tier II
- Seed Germination/
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
Tier III
- Terrestrial Field
- Aquatic Field
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
A,B,G
A,BfG
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G
No
NO
NO
No
No
NO
NO
No
Yes 12 months
Yes 12 months
Yes 12 months
Reserved? ^j
Reserved?
Reserved?
Reserved**
Reserved**
-------
GENERIC IWPA TABLE R)K fcTittKPHON (continued)
1 Compos it ion: TGA1 « Technical Grade of the Active Ingredient, PAI = Pure Active Ingredient, TfcP = Typical
Knd-Use Product.
patterns are coded as follows: A = Terrestrial, food crop; B = Terrestrial, non-food; C = Aquatic,
food crop; D = Aquatic, non-food; E = Greenhouse, food crop; F = Greenhouse, non-food; G = Forestry;
H » Dontestic, outdoor; I ** Indoor.
3 Additional data not required because of existing rodent studies.
requirement for an estuarine/tnarine shrimp test is fulfilled. Submit either a 96-hour shell deposition study,
or a mollusc 48-hour embryo- larvae study. Because the LC5Q values of freshwater and saltwater crustaceans
indicate similar toxicities between fresh and saltwater taxa, and because the toxicity to freshwater fish is low,
the requirement is waived for the estuarine/marine fish component of the testing.
^Reserved pending the results of outstanding studies.
&Not currently a requirement. _ ^
^Reserved pending results of Tier I studies.
^Reserved pending the results of the Tier II studies.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ETHEPHON
Must Addi- Timeframe
Test use Does EPA Bibliographic tional Data For
Data Requirement Substance1 pattern Have Data2 Citation Be Submitted? Submissions
158.590 Nontarget Insect
NONTARGET INSECT TESTING - POLLINATORS;
141-1 - Honey bee acute TGAI A,B Yes 00018842 No
contact LD5Q
141-2 - Honey bee - Toxicity TEP A,B No No3 ^
of residues on foliage
-i
141-4 - Honey bee subacute [Reserved]4
feeding study ^.
141-5 - Field testing for TEP A,B No No3
pollinators
NONTARGET INSECT TESTING - AQUATIC INSECTS
142-1 - Acute toxicity to [Reserved]5
aquatic insects
142-2 - Aquatic insect life- [Reserved]5
cycle study
142-3 - Simulated or actual [Reserved]5
field testing for
aquatic insects
143-1 - NONTARGET INSECT [Reserved]5
thru TESTING-PREDATORS
143-3 AND PARASITES
-------
TABLE A
GENERIC CftTA REQUIREMENTS FOR ETHEPHON
^Composition: TGA1 = Technical grade of the active ingredient; TEP = Typical end-use product.
use patterns are coded as follows: A * Terrestrial, Food Crop; B = Terrestrial, Non-Food;
C = Aquatic, Food Crop; D - Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food;
G « Forestry; H « Domestic Outdoor; I = Indoor.
3As data from the acute contact test indicate low toxicity, no further testing is required.
^Reserved pending development of test methodology.
^Reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE B. PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
CONTAINING ETHEPHON
Test
Data Requirement Substancel
Does EPA
Have Data2
Must Addi- Timeframe
Bibliographic tional Data For
Citation Be Submitted? Submissions
158 Subpjrt c Product Chemistry
Product
61-1 -
61-2 -
61-3 -
Identity^ and Composition
Product Identity and Disclosure
of Ingredients
Description of Beginning Mater-
ials and Manufacturing Process
Discussion of Formation of
Impurities
MP
MP
MP
No
No
No
N/A
N/A
N/A
Yes4
Yes5
Yes6
6 months
6 months
6 months
Analysis and Certification of Product
Ingredients
62-1 -
62-2 -
62-3 -
Physical
63-2 -
63-3 -
63-4 -
63-7 -
63-12 -
63-14 -
63-15 -
63-16 -
63-17 -
63-18 -
Preliminary Analysis of Product
Sampl es
Certification of Ingredient
Limits
Analytical Methods to Verify
Certified Limits
and Chemical Characteristics
Color
Physical State
Odor
Density, Bulk Density or
Specific Gravity
pH
Oxidizing or Reducing Action
Flamability
Explodability
Storage Stability
Viscosity
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
NO
No
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes7
Yes8
Yes9
YeslO
YeslO
VooXv/
VooJ. \J
YeslO/ 11
YeslO/ 12
YeslO* 13
YeslO / 14
Yesin
Yes10/ 15
12 months
12 months
12 months
6 months
6 months
6 months
6 months
6 month
6 month
6 month
6 month
15 months
6 month
en
-------
TABLE B. PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
CONTAINING ETHEPHON
Must Addi- Timeframe
__.,_. .. Test . Does EPA Bibliographic tional Data For
Data Requirement Substance! Have Data2 Citation Be Submitted? Submission
158 Subpart C Product Chemistry (Cont.)
63-19 - Miscibility MP NO N/A yes10/16 6 months
63-20 - Corrosion Characteristics MP NO N/A v^dO ic ^n^l
N° N/A Yes10 15 nonths
Other Requirements:
64-1 - Submittal of Samples N/A N/A N/A NO
^Composition: MP = Manufacturing-Use Product.
2Not applicable. Although product chemistry data may have 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.
3Data must be submitted within the indicated timeframe, based on the date of this Guidance Document.
4The 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.
5Complete 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.
ON
-------
TABLE B. PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
CONTAINING ETHEPHON
*>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.
?Five Ot 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.
Cupper 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 (2-chloroethanol). Certifications must be submitted on EPA Form
8570 Rev. 2-85.
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. Bach
method must be accompanied by validation studies indicating its accuracy and precision. These methods
must be suitable for enforcement of certified limits.
lOphysiccchemical 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 158.120 and more fully described in the pesticide Assessment Guidelines,
Subdivision D, must be submitted.
Hoata required if the test substance is dispersible in water.
12oata required if the product contains oxidizing or reducing agents.
-------
TABLE B. PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
CONTAINING ETHEPHON
required if the product contains combustible liquids.
14Data required if the product is potentially explosive.
l^oata required if the product is a liquid.
16Data required if the product is a liquid and is to be diluted with petroleum solvents.
CP
-------
-------
TABLE B. PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ETHEPHON
Data Requirement
158.340 Toxicology
ACUTE TESTING:
81-1 - Acute Oral - Rat
81-2 - Acute Dermal
81-3 - Acute Inhalation - Rat
81-4 - Eye Irritation - Rabbit
81-5 - Dermal Irritation - Rabbit
81-6 - Dermal Sensitization -
Guinea Pig
Test
Substance1-
MP
MP
MP
MP
MP
MP
Does EPA
Have Data2
Yes
Yes
NO
No
Yes
NO
Must Addi- Timef rame
Bibliographic tional Data For
Citation Be Submitted? Submissions
00029509 No
00029510 No
Yes
NO3
00029513 No
Yes \O
^Composition: MP = Manufacturing-use product.
2unless otherwise specified data
must be submitted no later than
six months after publication of this
standard.
3primary Eye Irritation Studies are not required for substances which are corrosive in Primary Dermal
Irritation Studies. Since ethephon is corrosive, an Primary Eye Irritation Study is not required.
-------
' F'! 80
SUMMARY-1
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 text. 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(e)J
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment 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 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)]
-------
81
SUMMARY-2
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 156.10(h)(1)(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. [40 CFR 156.10(h)(1)(i)]
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
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 156.10(h)(l)(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)].
-------
82
SUMMARY-3
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 sect'ion, 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.
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 classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR Part 152, Subpart I. You will be
notified of the Agency's classification decision.
-------
83
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. 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. borne 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.
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 simul-
taneously. 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.
-------
84
SUMMARY-5
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 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.
[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
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
CD
en
ITEM
3
4
5
6A
6B
1
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Keg. No.
EPA Est. No.
Ingredients
statement
Pounds /gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
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
PREFERRED
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.
-------
SIM1ARY-7
00
ON
ITEM
7C
7D
7E
6
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
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
If 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
precaut ionary
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.
-------
SU*IARY-8
CD
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
DPTU IT DTTlS
KJy^UlKlMJ
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
* MT^T i*m\i
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Chapter 1—Environmental Protection Agency
$162.10 Labeling requirements.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and t;he 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) o£ 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.
Hi) MI required label text m»>s«-»
(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 nay 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
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89
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, th"e 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
pro^uc* fo»- 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;
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90
(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
onco 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 S 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."
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r 91
(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 o'n the wrapper or outside container o£
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. (inia«« «-he 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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i92
(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 naraa .by the Administrator
under the authority of Section 25t«MB) .
(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 b« listed in the ingredient 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 haxard to children, environmental
hazard, and physical or chcxiczl 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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93
Hazard Indicators
Oral UD
Inhalation 1C
50
Dermal LO
Eye effects
Sktn effects
I
Up to and
1 nc 1 ud 1 ng
50 «g/kg
Up to and
Including
.2 *g/l Iter
Up to and
Including
200 «gAg
Corrosive;
corneal opacity
not reversible
•Ithln 7 days
Corrosive
TO..CI* <
II
F-cm 50 thru
500 ng/kg
Fro* .2 thru
2 mo/liter
FroM 200
thru 2000
Corneal opacity
reversible
• within 7 days;
Irritation
persisting for
7 days
Seve-e Irritation
at 72 hours
:ategor1es
1 1 1
F-am 500 thru
5000 mg/kg
F-om 2 thru
20 Mg/Mter
From 2,000 thru
20.000
No corneal opacity;
Irritation
reversible
within 7 days
Mode-ata Irritation
at 72 hou-s
IV
Greater than
5000 «gAg
Greater than
20 «ig/Mter
Greater than
20,000
No Irritation
Mild or slight
Irritation at
72 hours
(i) Human hazard signal word.--(A) Toxicity Category I.
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
All
siieij.z uvai on tiiw iturit. yaiivt. uue aiyiiao. wutu uanyet. j
addition if the product was assigned to Toxicity Category I
».w« K,^;_ ~f «fc. ^_.i 4MK»im«.<^.. «» dermal toxicity (as distinct
on
the basis of its oral, ir.helaticr. or
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."
v Category II. All pesticide products meet
II shall bear on 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."
All pesticide products meeting the
III shall bear on the front panel
All pesticide products meeting the
IV shall bear on the front panel
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94
(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
Points
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children"
6
6
8
10
12
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-• ' 95
(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.
ToxicIty
category
Precautionary statements by toxictty category
Oral, Inhalation, or dermal toxlctty
Skin and eye local effect*
1
II
III .
Fatal (poisonous) If swallowed (Inhaled or
absorbed through skin). Oo not breath*
vapor (dust! or spray Mist). Do not get
In eyes, on skin, or on clothing (Front
panel statement of practical t-eatment
May b« fatal If swallowed (Inhaled or
« b so -bed through the skin!. Oo not breathe
va?s-$ (dust or spray mist). Oo not get In)
eyes, on skin, or on clothing. (Appropriate)
first aid statements required.!. j
I
Harmful If swallowed (Inhaled or absorbed |
through the sktnl. Avoid breathing vapors |
(dust or spray •1st). Avoid contact with |
sk'n (eyes or clothing). (Appropriate
first aid statement required.).
Corrosive, causes eye and skin damage tor
skin Irritation). Oo 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 *y* (and sktnl Irritation. Do not
get In eyes, on skin, or on clothing.
Harmful If swallowed. (Appropriate first
aid statement required.I.
Avoid contact with skin, eyes or clothing.
In case of contact Immediately flush
•yes or skin with plenty of water. G«t
medical attention If Irritation persists.
I
I
(No precautionary statements required.). | (No precautionary statements required.!.
I
(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
-------
P* 96
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 activ
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 activ
ingredient with a fish acute LC$Q of 1 ppm or less, the statemen
"This Pesticide is Toxic to Fish" is reauired.
(C) If a pesticide intended for outdoor use contains an activ
ingredient with an avian acute oral LD$Q of 100 mg/kg or less, o
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 th<
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 20V and net ever SO'F or If
tne flam* extension Is more than 18 In. long
at a d I stance of 6 1 n. fro* the f 1 a**.
Extremely flammable. Contents under pressure.
Keep a«ay from fire, sparks, and heated
surfaces. Do not puncture or Incinerate
container. Exposure to temperatures above
I30*F P-y c-"*" K--«»lng.
Flammable. Contents under pressure. Keep away
fro* neat, sparks, and open flame. Do not
puncture or Incinerate container. Exposure to|
temperatures above 130*F may cause bursting.
Contents under pressure. Ob net use or store
near heat or open flame. Do not punctur* or
Incinerate container. Exposure to tempera-
tures above tJO'F may cause bursting.
(B) HONPRESSURI ZED CONTAINERS
1
Extremely flammable. Keep a«ay from fire,
sparks, and heated surfaces*
Flammable. Keep away from heat and open flame.
Do not use or store near heat or open flame.
-------
-. ! 97
(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.
( i i i ) 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:
(JL) 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;
H) The product will not come into the hands of the general
public except after incorporation into finished products; and
M) 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 Cor which sale is limited to ohysicians,
veterinarians/ or druggists/ provided that:
U) 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
H) 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 t"he composition/ toxicity, methods of use/ applicable restrictions
or limitations/ and effectiveness of the product for pesticide
purposes;
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98
(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;
(2.) 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":
(1) 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 (Sec Table in S 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!
(C) 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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99
(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 S 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 S 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 PR 28268, July 3, 1975; 40 PR 32329, Aug. 1, 1975; 40 PR
38571, Aug. 21, 1975, as amended at 43 PR 5786, Peb. 9, 1978]
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100
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 208F
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.
C. 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.
Required Label Statement
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 incinerate
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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, -•' 1 01
STOR-1
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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102
PEST/DIS-1
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 beltw contain the exact wording that must appear on
the label of these products:
1. 3he 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:
"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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103
CONT/DIS-1
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, canSj jars)
Non-aerosol products
(bags)
Aerosol products
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:
ContainerType
Statement
Metal
containers
(non-aerosol)
Plastic containers
<5lass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse Cor 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
equipment. Then dispose of empty bag in
a sanitary 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)
J./ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
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104
BIBGUIDE-1
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 explana-
tion. 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.
-------
1 105
BIBGUIDE-2
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.
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 fol-
lowing 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.
-------
OFFICE OF PESTICIDE PROGRAMS ^
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Ethephon Standard
MRID CITATION
00009181 Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of
Pesticides on Apiculture: Project No. 1499. (Unpublished study
received Jul 29, 1976 under 352-342; prepared by Univ. of Cali-
fornia—Riverside, Dept. of Entomology, submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:224800-C)
00027493 Beavers, J.B.; Fink, R.; Brown, R. (1978) Final Report: Acute Oral
LD50--Bobwhite Quail: Project No. 164-104. (Unpublished study
received Apr 3, 1980 under 1529-EX-2; prepared by Wildlife In-
ternational, Ltd. in cooperation with Washington College, sub-
mitted by GAF Corp., Chemical Div., New York, N.Y.; CDL:
099355-A)
00027495 Bentley, R.E. (1974) Acute Toxicity of CPGR Formulation and CPGR
100% to Bluegill (Lepomis macrochirus) and Rainbow Trout
(Salmo gairdneri). (Unpublished study received Apr 3, 1980
under 1529-EX-2; prepared by Bionomics, EG&G Environmental Con-
sultants, submitted by GAF Corp., Chemical Div., New York, N.Y.;
CDL:099355-D)
00029509 Griffiths, J.T.; Parent, R.A. (1979) The Approximate Acute Oral
Toxicity (LD:50) of GAF CPD 71921/L9 in Male Sprague-Dawley
Rats: Laboratory No. 2-6153. (Unpublished study received Apr 3,
1980 under 1529-EX-2; prepared by Food and Drug Research Labora-
tories, Inc., submitted by GAF Corp., Chemical Div., New York,
N.Y.; CDL:099356-A)
00029510 Deprospo, J.R. (1975) Acute Dermal ID:50 Test in Rabbits: Contract
No. 120-2544-35. (Unpublished study received Apr 3, 1980 under
1529-EX-2; prepared by Affiliated Medical Research, Inc., sub-
mitted by GAF Corp., Chemical Div., New York, N.Y.; CDL:
099356-B)
00029513 Stevens, K.R. (1979) Primary Skin Irritation Study with Rabbits:
Laboratory No. 6153. (Unpublished study received Apr 3, 1980
under 1529-EX-2; prepared by Food and Drug Research Laborato-
ries, Inc., submitted by GAF Corp., Chemical Div., New York,
N.Y.; CDL:099356-E)
00029515 Pope, P.K.; McCuen, P.J. (1978) Evaluation of Three Compounds for
Their Mutagenic Potential Utilizing the Ames Methodology: HRC
Study No. 805875. (Unpublished study received Apr 3, 1980 under
1529-EX-2; prepared by Huntingdon Research Center, submitted by
GAF Corp., Chemical Div., New York, N.Y.; CDL:099356-G)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting 107
Registrations Under the Ethephon Standard
MRID CITATION
00030190 Hegidio. J.; Dyson, D.; Thomas, N.B.; et al. (1979) Residues. In-
cludes method dated Oct 1979. (Unpublished study received Dec
19, 1979 under 264-267; prepared in cooperation with Salyer Land
Co. and others, submitted by Union Carbide Agricultural Products
Co., Ambler, Pa.; CDL:099158-C)
00032573 Harrison, S.L.; Nygren, R.E.; Gross, S.M.; et al. (1980) Residues:
Ethrel/Sugarcane: Project No. 10223. (Unpublished study
received May 15, 1980 under 264-EX-59; prepared in cooperation
with Hawaiian Sugar Planters' Association, submitted by Union
Carbide Agricultural Products Co., Ambler, Pa.; CDL:099427-A)
00036500 Obenauf, G.L. (1973) Residues: [Ethephon]. (Unpublished study re-
ceived Mar 19, 1974 under 4F1490; prepared in cooperation with
Greenwood Laboratories, Inc., submitted by Union Carbide Agri-
cultural Products Co., Ambler, Pa.; CDL:093944-B)
00038793 Union Carbide Agricultural Products Company (1972) Metabolism: The
Nature and Quantities of Residues and Metabolic Degredation
Products Resulting from the Treatment of Walnuts with Ethephon.
(Unpublished study received Dec 20, 1972 under 3F1344; CDL:
093599-C)
00038795 Sibbett, S.; Hendricks, L.; Schraeder, W. (1972) Residues:
[Ethephon]. (Unpublished study received Dec 20, 1972 under
3F1344; prepared in cooperation with Morse Laboratories, Inc.,
submitted by Union Carbide Agricultural Products Co., Ambler,
Pa.; CDL.-093599-E)
00038796 Union Carbide Agricultural Products Company (1970) Metabolism: The
Nature and Quantities of Residues and Metabolic Degredation
Products Resulting from the Treatment of Filberts with Ethephon.
(Unpublished study received Dec 20, 1972 under 3F1344; CDL:
093599-F)
00038880 Amchem Products, Incorporated (1972) Detailed Method of Analysis
for Residues of (2-Chloroethyl)phosphonic acid (Ethephon) in
Walnuts. Method dated Nov 1972. (Unpublished study received
Dec 20, 1972 under 3F1344; submitted by Union Carbide Agri-
cultural Products Co., Ambler, Pa.; CDL:093596-A)
00038881 Amchem Products, Incorporated (1972) Detailed Method of Analysis
for Residues of (2-Chlorethyl)phosphonic acid (Ethephon) in
Filberts. Method dated Nov 1972. (Unpublished study received
Dec 20, 1972 under 3F1344; submitted by Union Carbide Agricul-
tural Products Co., Ambler, Pa.; CDL:093596-B)
-------
OFFICE OF PESTICIDE PROGRAMS I •"
REGISTRATION STANDARD BIBLIOGRAPHY \
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Ethephon Standard
MRID CITATION
00040268 Union Carbide Agricultural Products Company (19??) Effect of Tem-
perature on the Level of Ethephon Residue in Pineapple Shell.
(Unpublished study received Aug 27, 1971 under 2G1195; CDL:
095928-A)
00040269 Union Carbide Agricultural Products Company (1970) Relevance of
Laboratory Brarming Study to a Commercial Branning Operation.
(Unpublished study received Aug 27, 1971 under 2G1195; CDL:
095928-B)
00041465 Valenzuela, C.; Sarin, G.; Uribe, ?; et al. (1973) Residue: [Ethe-
phon]. Includes method dated Oct 1973. (Unpublished study re-
ceived on unknown date under 4E1440; prepared in cooperation
with Centre Agricola Valenzuela and Rorer—Hormoquimica, Ltda.,
submitted by Union Carbide Agricultural Products Co., Ambler,
Pa.; CDL:093839-A)
00042977 Union Carbide Agricultural Products Company (19??) Analysis of
Pineapple Tissue for Residues of 2-Chloroethylphosphonic acid.
Undated method. (Unpublished study received Dec 23, 1969 under
264-257; CDL:100700-D)
00047911 Westwood, M.; Anderson, J.L.; Edgerton, L.; et al. (1971) Valida-
tion of Analytical Method. (Unpublished study including letter
dated Aug 4, 1971 from S.L. Harrison to Richard J. Otten, re-
ceived Jun 16, 1971 under 1G1172; prepared in cooperation with
Oregon State Univ. and others, submitted by Union Carbide Agri-
cultural Products Co., Ambler, Pa.; CDL:093494-A)
00047913 Amchem Products, Incorporated (1971) Detailed Method of Analysis
for Residues of 2-Chloroethylphosphonic acid (Ethephon) in
Cherries. Method dated May 1971. (Unpublished study received
Jun 16, 1971 under 1G1172; submitted by Union Carbide Agricul-
tural Products Co., Ambler, Pa.; CDL:093494-C)
00053149 Amchem Products, Incorporated (1976) Detailed Method of Analysis
for Residues of (2-Chloroethyl) phosphonic acid (Ethephon) in
Grapes, Grape Juice, Grape Wine and Dried Grape Pomace. Method
dated Jul 1976. (Unpublished study received Sep 21, 1976 under
264-267; submitted by Union Carbide Agricultural Products Co.,
Inc., Ambler, Pa.; CDL:095290-E)
00053150 Amchem Products, Incorporated (1976) Results of Analyses of Grapes
for Ethephon Residues. (Reports by various sources; unpublished
study received Sep 21, 1976 under 264-267; submitted by Union
Carbide Agricultural Products Co., Inc., Ambler, Pa.; CDL:
095290-F)
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OFFICE OF PESTICIDt PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Ethephon Standard j
MRID CITATION
OOU54013 Bentley, R.E. (1974) Acute Toxicity of Technical Ethrel to Grass
Shrimp (Palaemonetes vulgaris), Mud Crab (Neopanope tex-
ana) Water Flea (Daphnia magna), Midge Larvae (Chironomus
tentans), and Scud (Garanarus fasciatus). (Unpublished study
received Dec 5, 1974 under 264-292; prepared by Bionomics,
EG&G, Inc., submitted by Union Carbide Agricultural Products
Co., Inc., Ambler, Pa.; CDL:230425-R)
00054018 Yamaguchi, M.; Chu, C.W.; Yang, S.F. (1971) Metabolism of Ethephon
in Tomatoes. (Unpublished study received Jun 7, 1972 under
2G1195; prepared by Univ. of California—Davis, Dept. of Vege-
table Crops, submitted by Union Carbide Agricultural Products
Co., Inc., Ambler, Pa.; CDL:091010-B)
00054021 Union Carbide Agricultural Products Company, Incorporated (1969)
2-Chloroethylphosphonic acid (Ethephon),1, 2-C14: Metabolism
Study. (Unpublished study received Jun 7, 1972 under 2G1195;
CDL:091010-E)
00054022 Union Carbide Agricultural Products Company, Incorporated (1970)
Residues: [Ethrel in Pineapples]. (Reports by various sources; •
unpublished study received Jun 7, 1972 under 2G1195; CDL:
091010-F)
00061717 Union Carbide Agricultural Products Company, Incorporated (1976)
Ethephon Analyses: Ethrel: Treated Apples. (Reports by
various sources; unpublished study, including letter dated Aug
11, 1976 from S.L. Harrison to W.A. Davis, received Sep 21, 1976
under 264-267; CDL:228350-B)
00067489 Abdel-Gawad, H.A.; Martin, G.C. (1973) The fate of 1,2-14:C-(2-
Chloroethyl)phosphonic acid (Ethephon) in peach. Hortscience
8(2): 125-126. (Also in unpublished submission received Jan 5,
1981 under 1529-EX-2; submitted by GAF Corp., Chemical Div.,
New York, N.Y.; CDL:099880-E)
00077061 Sorg, R.M.; Matthews, R.J.; Naismith, R.W. (1981) Genetic Toxicolo-
gy: Micronucleus Test (MNT): Ethephon: Study No. PH-309A-UC-001-
81. (Unpublished study received Jun 24, 1981 under 264-257;
prepared by Pharmakon Laboratories, submitted by Union Carbide
Agricultural Products Co., Inc., Ambler, Pa.; CDL:070173-A)
00080482 Harrison, S.L. (1979) Letter sent to Warren A. Davis dated Feb 9,
1979: Residues of Ethephon in Grapes and Related Foods and
Feeds. (Unpublished study received Mar 2, 1979 under 264-267;
submitted by Union Carbide Agricultural Products Co., Inc.,
Ambler, Pa.; CDL:097830-G)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY f
Citations Considered to be Part of the Data Base Supporting A \ 0
Registrations Under the Ethephon Standard
MRID CITATION
00081782 Union Carbide Agricultural Products Company', Incorporated (1971)
Residues: [Ethephon]. (Unpublished study received May 7, 1971
under 1G1172; CDL:090971-D)
00083773 Huhtanen, K.; Parkins, M.D.; Heintzelman, R.W. (1981) Analysis of
Cow Tissues for Possible Residues of Monochloroacetic Acid.
(Unpublished study received May 28, 1981 under 264-267; submit-
ted by Union Carbide Agricultural Products Co., Inc., Ambler,
Pa.; CDL:070122-A)
00085446 Fink, R.; Beavers, J.B.; Brown, R. (1977) Final Report: Eight-day
Dietary LC:50—Bobwhite Quail: Project No. 113-139. (Unpub-
lished study received Mar 2, 1979 under 264-267; prepared by
Wildlife International, Ltd. and Washington College, submitted
by Union Carbide Agricultural Products Co., Inc., Ambler, Pa.;
CDL:097830-F)
00088983 Heintzelman, R.W.; Madgwick, G.G. (1981) A Review of the Metabolism. "
of 2-Chloroethylphosphonic Acid (Ethephon): Project No. 866C51.
(Unpublished study received Dec 22, 1981 under 264-EX-62; sub-
mitted by Union Carbide Agricultural Products Co., Inc., Ambler,
Pa.; CDL:070579-C)
00097422 Harrison, S.L. (1974) Letter sent to R.J. Otten dated Mar 19, 1974:
Metabolism of ethephon in figs. (Unpublished study received Mar
19, 1974 under 4F1490; submitted by Union Carbide Agricultural
Products Co., Inc., Ambler, Pa.; CDL:093944-A)
00100515 Kelsey, W.H. (1982) Primary Eye Irritation: [Fruit Fix Super Con-
centrate 800]: N.V.P. Report No. X2B008. (Unpublished study
received Apr 19, 1982 under 5481-66; prepared by Northview
Pacific Laboratories, Inc., submitted by Amvac Chemical Corp.,
Los Angeles, Calif.; CDL:247314-B)
00103287 Harrison, S.; Madgwick, G. (1982) Residues of Ethephon in Vheat,
Barley and Oats Resulting from Application of Ethrel as an
Anti-lodging Agent: File No. 30263. (Unpublished study received
Jun 17, 1982 under 264-376; submitted by Union Carbide Agricul-
tural Products Co., Inc., Research Triangle Park, NC; CDL:
070929-D)
00107428 Fink, R.; Reno, F. (1974) Final Report: Eight-day Dietary LC50--
Mallard Ducks: [CPGR1: Project No. 257-102. (Unpublished study
received Mar 15, 1974 under 1529-20; prepared by Truslow Farms,
Inc., and Environmental Sciences Corp., submitted by GAF Corp.,
Chemical Div., New York, NY; CDL:132053-A)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY ''til
Citations Considered to be Part of the Data Base Supporting - 1 ' '
Registrations Under the Ethephon Standard
MRID CITATION
00108992 Fritz, D.; Barden, J.; Edgerton, L. (1971) Residues: [Ethepon in
Apples]. (Unpublished study received Jul 15, 1972 under 2G1217;
prepared in cooperation with Virginia Polytechnic Institute and
Cornell Univ., submitted by Amchem Products, Inc., Ambler, PA;
CDL:091045-A)
00108993 Edgerton, L.; Hatch, A. (1969) Metabolism of 14C-2-Chloroethyl-
phosphonic Acid in Apples. (Unpublished study received Jul 15,
1972 under 2G1217; prepared by Cornell Univ., submitted by Am-
chem Products, Inc., Ambler, PA; CDL.-091045-B)
00116123 Amchem Products, Inc. (1970) Residue and Metabolism: Ethephon in
Pineapples. (Compilation; unpublished study received Jul 30,
1970 under 1F1016; CDL: 091065-A)
00117752 Amchem Products, Inc. (1971) [Ethephon: Residues in Walnuts,
Grapes, and Rats]. (Compilation; unpublished study received May
5, 1971 under 1G1167; CDL:090965-B)
00117893 Amchem Products, Inc. (1972) Metabolism and Residue Data: Ethephon
in Cantaloupes, Grapes, Raisins. (Compilation; unpublished
study received Oct 7, 1972 under 2F1275; CDL:091811-A)
00118508 Chib, J.; Heintzelman, R. (1982) Ethephon, 2-Chloroethylphosphonic
Acid, Metabolism in Lactating Goat: File No. 30388. (Unpub-
lished study received Dec 17, 1982 under 2F2711; submitted by
Union Carbide Agricultural Products Co., Inc., Research Tri-
angle Park, NC; CDL:071263-A)
00121613 Union Carbide Agricultural Products Co., Inc. (1974) [Ethephon
Residue in Cranberries & Tomatoes]. (Compilation; unpublished
study received Jul 2, 1974 under 5F1524; CDL:094038-A; 094039)
00122410 Union Carbide Agricultural Prodcts Co., Inc. (1974) Residue and
Metabolism Data: Ethephon in Tobacco. (Compilation; unpublished
study received Dec 5, 1974 under 264-292; CDL:028295-A)
00122412 Sleight, B. (1971) The Acute Toxicity of Ethrel to Bluegill ... and
... Salmo gairdneri. (Unpublished study received Dec 5, 1974
under 264-292; prepared by Bionomics, Inc., submitted by Union
Carbide Agricultural Products Co., Inc., Research Triangle Park,
NC; CDL:028299-B)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY | ' -
Citations Considered to be Part of the Data Base Supporting i <
Registrations Under the Ethephon Standard ' » *
MRID CITATION
00122423 Gross, S.; Scott, A.; Smith, T.; et al. (1978) Residues of Ethrel
in Cotton Seed, Oil and Meal: Document No. 378A3. (Unpublished
study received Mar 16, 1978 under 264-EX-55; prepared in cooper-
ation with Rio Farms and others, submitted by Union Carbide
Agricultural Products Co., Inc., Research Triangle Park, NC;
CDL.-096972-B)
00122429 Interregional Research Project No. 4 (1976) The Results of Tests
on the Amount of Ethephon Residues Remaining in or on Cucum-
bers Including a Description of the Analytical Method Used.
(Compilation; unpublished study received Jun 20, 1979 under
9E2225; CDL: 098344-A)
00122433 Amchan Products, Inc. (1970) Detailed Method of Analysis for Resi-
dues of 2-Chloroethylphosphonic Acid (Ethephon) in Pineapples.
(Unpublished study received 1970 under 1F1016; submitted by
Union Carbide Agricultural Products Co., Inc., Research Triangle
Park, NC; CDL:098469-A)
00122435 Union Carbide Agricultural Products Co., Inc. (1974) [Ethephon Res-
idue in Grapes and Related Items]. (Compilation; unpublished
study received 1974 under 5F1524; CDL-.098573-B)
00122448 Pitcher, F. (1974) [Cepha—Daphnia magna]: Test No. 672. (Unpub-
lished study received Mar 13, 1974 under 1529-20; prepared by
Pesticides Regulation Div., Animal Biology Laboratory, submitted
by U.S. Environmental Protection Agency, Beltsville, MD; CDL:
132055-A)
00122452 Union Carbide Agricultural Products Co., Inc. (1975) [Residues:
Ethrel-treated Pineapples]. (Compilation; unpublished study
received Sep 4, 1975 under 264-257; CDL-.221823-B)
00122717 Union Carbide Agricultural Products Co., Inc. (1981) The Results
of Tests on the Amount of Ethephon Residues Remaining in or on
Pumpkins. (Compilation; unpublished study received Dec 21, 1982
under 264-263; CDL:071299-A)
00123222 Union Carbide Agricultural Products Co., Inc. (1972) [Ethephon:
Residues in Apples and Other Subjects]. (Compilation; unpub-
lished study received Oct 24, 1972 under 3F1325; CDL:093555-B)
00123237 Union Carbide Agricultural Products Co., Inc. (1973) Detailed
Method of Analysis for Residues of ... Ethephon in Cranberries.
(Compilation; unpublished study received Feb 5, 1973 under
3F1353; CDL.-093617-A)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Ethephon Standard f ;
U3
MRID CITATION
00128726 Interregional Research Project No. 4 (1975) The Results of Tests
on the Amount of Ethephon Residues Remaining in or on Macadamia
Nuts, Including a Description of the Analytical Method Used.
(Unpublished study received Jun 10, 1983 under 3E2909; CDL:
071698-A)
00136287 Amchem Products, Inc. (1972) [Residues: Ethephon]. (Compilation;
unpublished study received Oct 3, 1972 under 3F1321 ; CDL:
092129-B)
00141506 Heintzelman, R. (1984) Ethephon Goat Metabolism: V5007. Unpub-
lished study prepared by Union Carbide Agricultural Products
Co., Inc. 11 p.
00142265 Huhtanen, K. (1984) Cerone: Detailed Methods of Analysis for Resi-
due of (2-Chloroethyl) Phosphonic Acid (Ethephon) in Milk and
Cow Liver, Muscle, Kidney and Fat Tissues: Project Number:
866R10. Unpublished study prepared by Union Carbide Agricultur-
al Products Co., Inc.* 20 p.
00144559 Fletcher, D. (1983) 42-Day Neurotoxitlty Study with Ethephon:Base
250 in Mature White Leghorn Chickens: BLAL No. 83 DN 102. Un-
published study prepared by Bio-life Assoc., Ltd. 52 p.
00145613 Union Carbide Agricultural Products Co. (1984?) Residue Summary:
Ethephon Residue Data-, Unpublished compilation. 59 p.
00165339 Huhtanen, K.; Storm, J.; Heintzelman, R. (1984) Ethrel: Metabolism
of Carbon 14:-ethephon in Lactating Goats: Project No. 866R10:
File No. 32452. Unpublished study prepared by Union Carbide
Agricultural Products Co., Inc. 39 p.
40632101 Interregional Research Project No. 4 (1979) The Amount of Ethephon
Residues Remaining in or on Guava Fruit. Prepard by Agricultural
Biochemistry Department, University of Hawaii. 40 p.
-------
114
OMt Aporwtl No 20000*5
FIFHA SECTION 3(CJ(2I(8I SUMMARY SHEET
MOOUCT NAME
OAT€ GUIDANCE DOCUMENT ISSUED
With rop«i to tti« naunmtni to *rtxnit -g*>wic" di« impoird by lh« FIFflA action KCK2K8I neiKt :anumcd w m; <*»i«*c,.t,;
Cuidtoc* document. I «m rowondmf « lfc« (allowing m«uxr
Q I. .1 «nll •itxntl tttt m t timflT m«HMr to •taty tlM l»n««nnf rtqiufwnmti If MM MM proetdura I «M «t dcvuit !>om ia< oc not
9«ci><*d in) ItM H*finntian Guitfdmn or itic Protocol! cont*m*4 HI RM Mopom •< £i»«fi Grouot to l*w C-Vmcjii Ctouo. OECO
Cntmicah Ton«if Ptoonmnw. I ondooi tlM erotocolt tlt«t I will «•:
Di. I how «i«m4 imi w
•Mfc OM or ntcra otttor r*oi«
•oor FIFKA
WtoV Mv »Wty fV«|iNo'|9d •WOtocWoV vwM M oVOMMflM !• fePA vyi
MAMC Of OTHCP) ACCISTMAMT
D 2. I mdooi i coniflrM "ConKiemieii •( Antmpt to £mtr Ima tn A«r«om«nt witti Otftor M*fittriMn for OfvotoarMiii •( C«n" ».ir>
r«p«ct to in« fofltMAi 4tti nqniromoMi:
C 4. I notion mn von omm4 mv r»»«i«io« »t ««««tin| «M «o«ow»» MM (tlw totion • wi twiioii to iw»*»
-------
CMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC MTA EXEMPTION STATEMENT '
9 I *J
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, vrfiich is registered under FIFRA Section 3, and vfaich is purchased by
us from another producer.
r •
(3) An accurate Confidental 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 No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
and their registration nunber(s) is/are .
(4) My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product to one that is not registered
and purchased.
(5) 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).
(6) 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)
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PRODUCT SPECIFIC DATA REPORT
116
EPA Reg. No.
Date
Registration Standard for
Registration
Guideline No.
Part 158
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
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol /water
partition
coefficient
pH
Test not
required
for my
product
listed
above
(check
below)
»
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
EPA Form 8580-4
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117
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.340
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidiz ing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric "break-
down voltage
Acute oral
toxic ity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
»
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
- •
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118
CERTIFICATION Of ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT Of DATA
I. I *m duly «w8lonf«d to r«ormnt tfM (oUomnaq firm(t| «wt«o «r« lubjxn to lti« r«ou«»-
nMntt of • Netiet undtr Flf RA Section 3(c)(2l(8) conuwMd in iGu«J*nct Oocvmtnt
IO tutxnu
OUIOAMCC OOCUM«MT O«T«
ACTIVf IMC«(O«M1
MAMC Ot
(Tttn 1trn\ or youo ol 1«m% n fe«fff«^ to txlow tt "my
2. My firm it «*iMwi| to dfv*«OO «nd (u«m «grt«< «o"o— "9
3. My firn hit o>ttr(4 MI «ritiA| tt tmt« Mt« aicli »n tfrttmtni CofM t< tfM tM«n «rt Mtaetxtf. TMt tftif MM mrrociWt •«< iAtlu4«4 «n «tf«« to B«
»*IMI« »y tn arftitriMA ««ci»«n «n4« f If MA Stniwi 3(t)(2HI)(M> if IMM! l|r*toitm •• HI ttrmt ct«M Ml M rncfMtf tt»»«t*n« Thq tHef «M m*d«
Id Wt lallowMf («HI(I) «n IM
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