KalProtMfa
oEPA
P««kfci«i and Toxic I
WMhlngtonOC 20460
540/RS-88-099
June 30. 1988
PwttcMM
Guidance for the
Reregistration of
Pesticide Products
Containing
MALEIC HYDRAZIDE
as the Active Ingredient
540/RS-88099
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
Maleic Hydrazide
OFF Shaughnessy Numbers: 051501, 051502, & 051503
AS THE ACTIVE INGREDIENT
OPP Number: 0381
CAS Number: 123-33-1 and 28382-15-2
June 30, 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction
II. Chanical(s) Covered by this Standard 4
A. Description of Chemical
B. Use Profile
C. History
III. Agency Assessment 7
A. Summary Science Statement
B. lexicological Characteristics
C. Physiological and Biochemical Behavior Characteristics
D. Environmental Chracteristics
E. Exposure
F. Ecological Characteristics
G. Product Chemistry
H. Tolerance Assessment
IV. Regulatory Position and Rationale 19
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 26
VI. Requirement for Submission of Generic Data 28
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . . 34
VIII. Requirement for Submission of Revised Labeling 35
IX. Instructions for Submission 35
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
TAble A-2
Table B
Table B-2
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 156.10 Labeling Requirements
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 $3(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
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12 I. GLOSSARY OF TERMS AND ABBREVIATIONS
ADI: Acceptable daily intakes
ae: Acid equivalent
ai: Active ingredient
CAS: Chemical Abstract* Service (Number)
CSF: Confidential Statement of Formula
DEA: Diethanolamine salt of maleic hydrazide
CMF: Dimethyl formamlde
EC: Emulsifiable concentrate
EECi Estimated Environmental Concentration
EP: thd-use product
EPA The Environmental Protection Agency, also "the
Agency"
FI , F2: Refers to the generation in a multigeneration reproduction
study
FIFRA: The Federal Insecticide, Fungicide, and
Rodenticide Act
g/kg: Crams per kilogram
HOT: Highest dose tested
TRDC: International Research and Development
Corporation
K: Potassium
Kdes: Freundlich desorptlon value
Kads: Freundlich adsorption value
1X50: (Median lethal concentration) - A statistically
derived concentration of a substance that can
be expected to cause death in 50 percent of test
animals, expressed as weight or volume of test
substance per volume of air or water per weight
of feed (e.g., rog/L or ppm).
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(Median lethal dose) - A statistically derived
•Ingle dose that can be expected to cause death
In 50 percent of test animals when administered
by the route indicated, expressed as weight of
substance per unit of weight of test animal
(e.g., rag/kg).
IDT: Lowest dose tested
LEL: Lowest-effect level
LOEL: > Lowest-observed-effect level
MATC: Maximum allowable toxic concentration
ng/kg/bwt/
day: Milligrams per kilogram of body weight per day
MH: Malelc hydrazide including potassium salt
MDS: Margin of Safety
MP: Manufacturing-use product
MPI: Maximum permissible intake
MRID: Master Record Identification (Number) - EPA's
system of tracking studies used in support of
registration
NOEL: No-observed-effect level
NPDESs National Pollution Discharge Elimination System
OES: Office of Endangered Species, U.S. Fish and
Wildlife Service
OPP: The Office of Pesticide Programs
PAD1: Provisional acceptable daily Intake
PD 1: Position Document 1
ppbi Parts per billion
ppmt Parts per million
RAC: Row agricultural Commodity
RPAR: Rebuttable Presumption Against Registration
SC/S: Soluble concentrate/solid
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SC/L: Soluble concentrate/liquid
Scapulae: Shoulder blade
TGAI or technical: Technical grade of the active ingredient
TMRC: Iheoretical Maximum Residue Contribution
>: Greater than
<: Less than
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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.
1The scientific reviews and use Index may be obtained from the
National Technical Information Service (NTIS), ATOI: Order Desk, 5285 Port
Royal Road, Springfield, VA 22161 or by phone (703) 487-4650.
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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 PIPRA. These steps may include:
1. Submission of data In support of product registration;
2. Modification of product labels;
3* Modifications to the manufacturing process of the
pesticide to reduce the levels of Impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the Issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, In cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CPR Part 151
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 PIPRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxlcologlcal,
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
them 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 or preliminary
results of studies, if that information suggest possible
adverse effects on man or the environment. This requirement
is Independent of the specific time requirements imposed by
EPA for submission of completed studies called in by the
Agency and continues as long as a product is registered
under PIPRA.
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II. CHEMICALS COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICALS
The following chemicals are covered by this Registration
Standard:
Gomroon Name: Maleic Hydrazide, Diethanolamine salt, or
Potassium salt
Chemical Names: 6-Hydro-3(2H)-pyridazinone or
1,2, -Dihydro-3 , 6-pyr idazinedione
CAS Number: 123-33-1
OPP Shaughnessy Numbers: 051501, 051502, and 051503
Empirical Formula:
Trade Names: Drexel Sucker-Stuff, Super Sucker Stuff,
Retard, Burtolin, Decut, Drexel Sprout
Stop, Fair 2, Fair Plus, KMH, Maintain 3,
Malazide, Mazide, Regulox W, Regulox SOW,
Stuntman, Super-De-Sprout , Vondalhyde,
Vondrax, Royal MH-30, Royal MH-30SG,
Royal Slo-Gro, Malazide Slo Gro.
Year of Initial Registration: 1952
B. USE PROFILE
Type of Pesticide: Herbicide and plant growth regulator.
Registered Uses: Terrestrial food crops, nonfood crops,
and terrestrial noncrop lands.
Predominant Use: Sucker control for tobacco, sprout
inhibition in stored onions and
potatoes, frost protection in citrus,
and growth retardent in turf and
roadside maintenance.
Herbicidal activity on quackgrass,
wild onions, and wild garlic
Mode of Activity: A Uracil antimetabolite
Formulation: 90, 95, 97. and 99 percent TGAI
0.66 and 2.25 Ib ae/gal EC
0.6, 1.5, 2.0, 2.25, and 2.5 Ib ae/gal SC/L
Method of Application: Primarily as a foliar spray, with
some use by tree injection.
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C. HISTORY
MH was synthesized and determined to have growth
inhibiting properties in 1947. The chemical was first
registered in 1952. In October 1976 it was referred to
the Agency for RPAR. The referral was based on laboratory
studies which indicated that MB induced oncogenic, mutagenic,
and reproductive effects. In October 1977, the Agency initi-
ated an RPAR review by publishing a PD 1 for MH. The PD 1
described studies which met or exceeded the RPAR criteria
for oncogenic, mutagenic, and reproductive effects.
The Agency did not issue the PD 2/3 for maleic hydrazide
because of the absence of adequate risk data for oncogenic,
mutagenic and reproductive effects. Agency scientists could
not adequately assess the risk potential of maleic hydrazide
because of the paucity of valid toxicological information and
conflicting results within each data base. To fill these
data gaps, the Agency required all MH registrants to submit
data regarding the reproductive -effects and mutagenic poten-
tial of DEA-MH and K-MH pursuant to the authority of section
3(c)(2)(B) of FIFRA. The Notice announcing these data require-
ments for MH was sent to all registrants on August 14, 1980.
The manufacturers agreed to .submit, the required data
on K-MH on February 26, 1981. Because manufacturers of the
DEA-MH decided not to submit the required additional data,
the Agency suspended all DEA-MH registrations in November
1981. The suspension may be lifted at such time that
there is compliance with the data request.
The information submitted in response to the Data Call In
Notice was evaluated. The Agency determined that two of three
RPAR triggers (oncogenicity and reproductive effects) were not
supported. Although mutagenicity was an initial RPAR trigger,
our criteria for special review in this area area has become
more rigorous and focused on confirmation of effects in mammalian
systems. The limited mutagenicity data available is generally
negative. Additional data are required by this document.
During the evaluation of the available oncogenic studies,
the agency determined that consideration of hydrazine con-
tamination might help determine the oncogenic potential of
maleic hydrazide. The Agency reached this hypothesis because
two similar studies showed different results: Epstein and
Mantel (1968) reported an increased incidence of hepatomas,
where as Cabral at al.(1981) reported no significant increase
in tumor incidence. A primary difference between the two
studies was the level of hydrazine contamination in the MH
they used: 4000 ppm in the Epst-ein study and less than 1 ppm
in the study by Cabral.
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Several studies show a definite relationship between
hydrazine and tumor induction. The Agency used a study
by Biancifiori in which a dose related induction of hepatomas
was observed and the one hit model was used to determine
the lifetime risks to humans. In calculating the risk from
maleic hydrazide it was assumed that the hydrazine contamination
is 15 ppm, the highest level reported in currently registered
technical MH products. The estimated oncogenic risks did not
cause concern and the Agency consequently decided to terminate
the RPAR review of MH at that time.
The Agency published a Position Document (PD-4) for
Maleic Hydrazide in June 1982. The final determinations were
to terminate the RPAR to allow the continued use of potassium MH,
and to establish an acceptable limit of hydrazine at 15 ppm in
technical grade products to avoid the potential for unreasonable
adverse effects.
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III. AGENCY ASSESSMENT
A. SUMMARY SCIENCE STATEMENT
MH has low acute toxicity (Toxicity Category III) for
primary eye irritation and is in Toxicity Category IV for
acute oral, acute dermal, and primary dermal irritation.
MH caused no adverse reproductive effects; was not oncogenic
to mice; and not mutagenic. The teratology study in rabbits
had a teratogenic NOEL of 100 mg/kg/day (malformed scapulae
occurred in the mid and high dose). An exposure assessment
was performed and it was determined that MOSs were < 100 for
mixer/loaders, therefore, of potential concern. The Agency
is requesting additional teratology data to fully define the
teratogenic effect. To reduce exposure to applicators this
standard requires that the label be amended to require
protective clothing while handling, applying, mixing or loading
the chemical.
MH was stable to hydrolysis and photodegradation in
soil. It photodegraded in buffered aqueous solutions at
pH 5, 7, and 9. MH was very mobile in five soils and has
a low potential to bioaccumulate in fish. Additional persis-
tance and leaching data are needed to evaluate MH's potential
to contaminate ground water.
MH is considered practically nontoxic to birds, aquatic
invertebrates, freshwater fish, or honey bees. Endangered
animal species are not expected to be adversely affected by
the use of MH. Since no endangered plant species are listed
for tobacco cropland, citrus, apples, potatoes and onions
or canberries, little risk is expected to endangered
plants from these uses. A hazard assessment for the right-of-way
use is deferred until the Agency develops the non-cropland
cluster.
B. TOXICOLOGICAL CHARACTERISTICS
There are three forms of maleic hydrazide registered, the
technical, the K salt, and the DEA salt. All DEA salt registra-
tion were suspended in 1981 for failure to submit data in re-
sponse to a data call in notice. Some of the data discussed
below are on the parent and some of it are on the K salt. For
this Standard, they will be considered equivalent.
Even though the DEA salt is suspended, the suspension may
be lifted at such time that manufacturers comply with the
data request.
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Because there nay be qualitative or quantitative differences
in the behavior of the DEA salt due to the DEA moiety, and
because the DEA moiety itself may be oncogenic or cause
other effects not seen with the other salts, a separate set
of toxicology studies are required for the DEA salt. Refer
to the discussion below, and Table A-2, for specific data
requirements.
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Acute Toxicity
Acute oral and acute dermal toxlcity studies place MH in
Toxicity Category IV with an acute oral toxicity > 5 g/kg and
an acute dermal toxicity > 20 g/kg. In the dermal toxicity
study, the test material caused only very slight erythema and
edema resulting in a Toxicity Category IV classification.
These requirements are fulfilled for MH but are required for
the MH-DEA salt.
The available acute inhalation study did not provide
enough detail for evaluation, therefore an acute inhalation
study is needed for both MH and MH-DEA.
There are no data available on primary dermal
sensitization properties. Therefore, dermal sensitization
studies for both MH and the MH-DEA salt are needed.
Subchronic Toxicity
There are no data available on subchronic oral, dermal,
or inhalation toxicity. The data requirement for subchronic
oral toxicity is waived for the parent^ the K salt, and the DEA
salt because chronic studies are required for a rodent and a
nonrodent.
A 21-day dermal toxicity study is required for both MH
and the DEA salt. Ninety-day dermal subchronic studies are
not required for either the DEA salt or MH because existing
use patterns do not involve purposeful or prolonged dermal
exposure.
Subchronic inhalation studies are not required at this
time, but may be required once the requested residue data on
tobacco are received and reviewed.
Neurotoxicity
There are no data available for acute delayed or subchronic
delayed neurotoxicity for either MH or the DEA salt. Acute
delayed neurotoxicity studies are not required .because MH and
its salts are not organophosphates. Subchronic neurotoxicity
studies are not required because acute neurotoxicity testing
is not required and there is no evidence of neurotoxicity in
mammalian species.
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Chronic Toxlcity
The available chronic feeding study in rats is inadequate
because a NOEL was not established for renal toxicity and the
raw data were not available for review. The available
data indicate that the NOEL is < 500 mg/kg (LOT). There are
no chronic feeding studies available for nonrodents. Chronic
feeding studies are required for both MH and the DEA salt on
both rodents and nonrodents.
Oncogenicity
The oncogenicity potential in rats could not be adequately
determined because raw data (especially histopathology) were
unavailable for review. Therefore, .oncogenic studies with
rats are required for both MH and the DEA salt of MH.
Two recent oral oncogenicity studies are available to
evaluate the oncogenic potential of MH. These studies
collectively indicate that MH is not oncogenic in mice.
These studies are discussed below.
In a mouse oncogenicity study with common control
performed by Cabral and Ponomarkov, group I mice were fed an
oral dosage of 510 mg/kg MH daily for 125 weeks; group II
mice were dosed as follows: one group of mice received several
subcutaneous dosages totaling 55 mg/kg MH in the vehicle
tricaprylin applied during the first three weeks after birth
and a second group of solvent control animals received the
same amount of pure tricaprylin over the same period. Both
subgroups were sacrificed after 125 weeks. Untreated concurrent
control animals were shared by both oral group I and subcutaneous
treatment groups. No compound-related effects were seen in
group I. In group II, male mice had a statistically significant
increase in liver tumors when compared with untreated control
males, but -the increase was not statistically different from
the solvent control males. No evidence of compound-related
oncogenic effects was seen in females. Because the group II
results could be caused by either the MH, a low level of hydrazine,
or an interaction between MH or hydrazine and the tricaprylin,
group II could not be definitely interpreted. Because group II
could not be interpreted correctly and group I used only one
dosage, this study was classified as Supplementary data.
In a second study performed by IRDC, mice were fed oral
dosages of 0, 150-200, 500-600, 1600-1800 mg/kg/day for
their lifetime. Hemangiomas and lung adenomas and carcinomas in
females were considered to be of potential concern. When the
hemangiomas from all sites were combined, as is appropriate for
this data set, their incidence was judged not to be significant.
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While there was a significant trend in lung adenomas and/or
carcinomas, there were no significant pair-wise comparisons
between exposed and control mice, and the incidence of these
tumors were within the historical control range. Therefore,
MH was not considered oncogenic in mice.
Both group I of the cabral study and IRDC study used mice,
dosed orally for their lifetime. In both experiments, detailed
gross and microscopic pathologic examinations were performed on
a standard set of tissues and organs and appropriate statistical
analysis were performed on the data. The two studies were con-
sidered to be "supplementary" on their own, but collectively
provide an adequate data base to determine that maleic hydrazide
is not oncogenic to mice. No additional data are needed on this
potential effect for maleic hydrazide technical or the K salt.
An oncogenic study with mice is required for the DEA salt
of MH.
Teratoqenicity
No data are available to determine teratogenic effects in
rats. Therefore teratology studies are required in rats for
MH and the DEA salt of MH.
A teratology study in rabbits fed K salt MH dosages of
0, 100, 300, and 1000 mg/kg/day is available. No signs of
maternal toxicity were seen; therefore, the maternal NOEL is
1000 mg/kg/day (HDT). Malformed scapulae were seen in 4 out
of 99 animals at the mid-dose and 2 out of 107 animals at the
high-dose. Therefore the teratogenic NOEL is 100 mg/kg. This
is a rare malformations seen in only 1 fetus out of 1586 fetuses
in the historical control. This effect was considered signifi-
cant. Therefore the Agency performed an applicator exposure
assessment. Based on the exposure estimate, the MOSs for
dermal exposure for open-pour mixer/loaders for most applications
would be < 100 and a potential concern. Based on this concern,
additional information on parentage of affected rabbits is •
requested. Additional information may be required once this
information and the rat teratology study are reviewed. Until
this is resolved a label statement requiring protective
clothing will be added. Refer to labeling section for the
wording of this label statement.
A teratology study with rabbits is required for the DEA
salt of MH.
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Reproduction
The available two-generation study fulfills this
requirement for MH. No adverse effects on reproduction were
noted in male or female rats fed dosages of 0, 75, 750, and
2250 mg/kg. The maternal toxic NOEL is 750 mg/kg with a LOEL
of 2250 mg/kg (decreased parental weights). The fetotoxic
NOEL is 750 mg/kg with a LOEL of 2250 mg/kg (decreased body-
weights) .
A two-generation reproduction study in rats is required
for the DBA salt of MH.
Mutagenicity
No mutagenicity data are available for the DEA salt of
MH; therefore, studies are required to satisfy gene mutation,
chromosomal aberrations, and other mechanisms of mutagenicity.
A mutagenicity study of sex-linked recessive lethal
gene mutations in Drosophila revealed no sex-linked recessive
lethal mutations at cytotoxic doses from 0.4 to 1.0 percent
of 26.7 percent K-MH in water. This fulfills the gene
mutation requirement for MH. No data are available on the
mutagenicity of MH for chromosomal aberrations or other
mutagenic mechanisms, therefore these data are required.
Metabolism
There are no metabolism studies available for MH or the
DEA salt; therefore, rat studies of the absorption, distri-
bution, metabolism, and excretion after acute and repeated
exposures are required for both MH and the DEA salt of MH.
C. PHYSIOLOGICAL AND BIOCHEMICAL BEHAVIOR CHARACTERISTICS
Absorption of MH by roots and leaves is a function of
cell turgidity with most effective absorption occurring when
soil moisture is at field capacity and relative humidity is
high. Once absorbed, MH is rapidly translocated to leaves and
growing shoots.
The mechanism of pesticide action for MH is believed
to be as a uracil antimetabolite which interferes with cell
division, plant growth, and maturation. It also affects
respiration through inhibition of one or more dehydrogenases.
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Available tobacco metabolism data on MH indicate that the
major residues of MH in plants are the parent and its beta D-
glucoside conjugate. Additional plant metabolism data are
required.
No data are available for metabolism of MH in animals.
Metabolism studies using ruminants and poultry are required.
D. ENVIRONMENTAL CHARACTERISTICS
MH was stable to hydrolysis in buffered solutions at
pH 3, 6, and 9 when maintained at 45 °C for 61 days and 80 °C
for 30 days, and was stable to phot©degradation in soil after
17-day irradiation by artificial light. MH photodegraded in
buffered aqueous solutions at pH 5, 7, and 9 with half-lives of
58 days at pH 5 and 7 and 34 days at pH 9 when irradiated by
artificial light. Unaged MH was very mobile in a silt loam
soil, a sandy clay loam soil, a sandy loam soil, and two sandy
soils with Kads values of 0.14 to 2.61 and Kdes values of 0.39
to 14.45. Unaged MH was very mobile in soil columns of clay
loam and sandy loam soils. Aged MH was very mobile in soil
columns of sandy loam and clay loam soils and very mobile in
sandy loam soil with Kads value of 2.37 and the Kdes value
was 2.74. MH dissipated in a field application with a half-
life of 3 to 7 days from the upper 6 inches of clay loam soil.
MH has a low potential to bioaccumulate in fish with
octanol/water partition coefficient values of < 0.6 at pH 6,
7, and 9.
The available data are inconclusive for potential to
leach into ground water because of lack of information on
persistence of degradates under aerobic/anaerobic soil con-
ditions. The chemical is persistent in water since it is
stable to hydrolysis. The chemical is very mobile in five
soils. Available field persistence data do not adequately
define the depth of leaching and are inconclusive. The full
leaching potential of MH cannot be determined until persistence
data are submitted and evaluated. Once the leaching potential
of MH is determined, a ground water monitoring study may be
required.
The data requirements for hydrolysis, photodegradation in
soil and fish accumulation are satisifed. The following data
are required to fully assess the environmental fate of MH:
photodegradation in water, aerobic and anaerobic soil metabo-
lism studies, terrestrial field dissipation study, a soil
column and adsorption/desorption studies with aged MH, and a
confined accumulation study on rotational crops with wheat or
another small grain. Additional data may be required if
requested studies indicate the need for additional data.
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E. EXPOSURE AND RISK
During review of data an applicator exposure assessment
was performed because of rare teratogenic effects (refer to
discussion of teratogenic effects) seen in rabbits. The
exposure estimates were based on data available from the public
literature for individuals wearing long sleeved shirts and long
pants at all times and chemical resistant gloves during mixing
loading. The estimates were not adjusted for dermal absorption
of MH and, therefore, assume 100% dermal absorption. The MOS
for open-pour mixers-loaders were less than 100. The MOS for
closed system mixer loaders were greater than 100. The MOS for
pilots were greater than 1000. Those MOS's of less than 100 are
of potential concern (Standard Evaluation Procedure for Teratology
Studies, June 1986). To evaluate these potential concerns, the
Agency is requiring that additional information on parentage of
affected animals be submitted and that the labeling be amended
to require protective clothing. Refer to labeling section for
wording required. The Agency is planning a high priority on the
review of the rat teratology study.
Reentry data are not required for MH because current use
patterns (7- to 70-day PHI application to plants at early
growth stage) indicate little likelihood of exposure or low
exposure at this time, and the placement of the chemical in
Toxicity Category IV for acute oral and acute dermal toxicity
indicate minimal risk to humans.
F. ECOLOGICAL CHARACTERISTICS
Terrestrial Organisms
Based on acute oral toxicities of > 4640 mg/kg/day
(technical) and > 2250 (K salt) to mallard ducks, MH tech-
nical and K salt present very low toxicity to avian species
on an acute oral basis. Available data indicate that the
8-day dietary toxicity of MH technical is > 10,000 ppm for
both mallard ducks and bobwhite quail and that the 8-day
dietary toxicity'for the MH K salt is > 5620 ppm for mallard
ducks. Based on these data, the technical and R salt of MH
present very low toxicity to avian species on a dietary
basis. The requirements for acute oral toxicity and dietary
toxicity tests with avian species have been satisfied. No
data are required for the DEA salt because of the low order
of toxicity to avian species of the technical and K salt.
Avian reproduction studies are not required because the only
repeated use pattern of MH is small (golf course fairways)
and the acute oral and dietary toxicity values for birds show
it to present very low toxicity.
Mammals are not expected to encounter risk from the use
of MH or the K salt based on low acute toxicity to rats.
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The timing of application of MH on tobacco, the major
agricultural use, is at the time of full flower presenting
exposure to honey bees in the area. However, with a toxicity
value of > 36.26 ug/bee, MH presents very low toxicity to
honey bees; therefore honeybees in the area are not at risk.
Aquatic Organisms
Based on 48-hour acute toxicities of 107.5 ppm (technical)
and 1000 ppm (K salt), MH is considered to present very low
toxicity to freshwater invertebrates. There are no data
requirements for the DEA salt based on the low order of
toxicity of MH (technical and K salt) to aquatic organisms.
The requirement for an acute toxicity study with freshwater
invertebrates has been satisfied.
Based on acute toxicities of 1435 ppm (technical) to rain-
bow trout, 1608 ppm (technical) to bluegill and > 1000 ppm (K
salt) to rainbow trout, MH (technical and K salt) are considered
practically nontoxic to both coldwater and warmwater fish. There
are no data requirements for the DEA salt based on the low order
of toxicity of MH and the R salt to fish. The requirements for
acute toxicity testing with freshwater fish are satisfied.
The use of MH as a foliar application on tobacco and
roadway rights-of-way will not cause hazard to aquatic spe-
cies from runoff. The EEC for foliar application of MH is
12 ppb. The risk of MH to aquatic species inhabiting those
waters is low with a safety factor of over 1000 for aquatic
invertebrates, the most sensitive species.
Plant Protection
There are no data available for MH concerning phytotoxicity.
Because MH is a plant growth retardant and there is no previous
plant data base, the Agency assumes possible hazard to endan-
gered plant species. Therefore, Tier I nontarget area
phytotoxicity testing is required.
Endangered Species
Because MH is a plant growth retardant, the Agency assumes
hazard to any endangered plants occurring in areas where MH
is used. There are no endangered plants listed as occurring
in tobacco cropland, in citrus, apples, potatoes, onions, or
cranberries, therefore there is no risk to endangered plants
from use of MH on these sites. Evaluation of hazard to en-
dangered plants from use on right-of-ways will await evaluation
of all pesticides in the noncrop cluster.
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Because of the low toxicity of MH to mammals, avian
species, aquatic species, and the low potential for exposure
to MH, endangered animal species are not expected to be
affected by use of MH.
G. PRODUCT CHEMISTRY
The Agency has determined that product chemistry data for
all technical and MPs must be submitted for each pesticide
because new requirements.have been introduced and previously
submitted data must be updated. Therefore, a complete set of
product chemistry data is required for the TGAI and MPs.
During the RPAR review the Agency determined that hydrazine,
a contaminant of raaleic hydrazide products, is itself an oncogen
and that the amount of hydrazine occurring in technical products
must be ^ 15 ppm. Refer to History Section for details.
Available data indicate that nitrosamines may occur in EPs con-
taining the DEA salt of MH. Because some nitrosamines are
known carcinogens, testing for nitrosamines will be required
for all end use products containing the DEA salt.
H. TOLERANCE REASSESSMENT
Tolerances Issued
Tolerances are established for residues of the herbicide and
plant regulator MH (1,2-dihydro-3,6-pyridazinedione)(40 CFR 180.
175) in or on the RACs cranberries at 15.0 ppm; onions, dry bulb
at 15.0 ppm; and potatoes at 50.0 ppm.
A food additive tolerance is established for residues of the
herbicide and plant regulator MH (1,2-dihydro-3,6-pyridazinedione)
(21 CFR 193.270) on potato chips at 160 ppm as a result of the
pesticide application to the growing potato plant.
Canadian tolerances and Codex MRL (CXL) of 50 ppm on potatoes
and 15 ppm for onions are established for MH.
No Canadian tolerances or Codex MRL are established in cran-
berries , citrus, or tobacco and no Codex MRL is established in
apples. Therefore, no compatibility questions exist with respect
to Codex MRL. A Canadian tolerance of 7 ppm is established for
residues of MH in apples.
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Residue Data
The residue data reviewed in support of these tolerances,
and the data gaps are discussed below are discussed below.
1. Available tobacco metabolism data on MH indicate that
MH is absorbed rapidly and translocated to leaves and growing
shoots. The major metabolite in tobacco is the glucose conju-
gate of the parent, l,2-dihydro-3,6-pyridazinedione glucoside.
Additional plant metabolism data in cranberries, onions, and
potatoes are required.
2. Data from a cattle feeding study indicate that residues
of MH transfer to animal tissue. Livestock metabolism data are
not available and are required.
3. The available data for potatoes and dry bulb onions
indicate that the residues will not exceed the established
tolerances following registered use of SC/L K salt formula-
tion. Additional data are required to evaluate the use
of the EC K salt formulation on potatoes and onions. A
processing study is required on potatoes.
4. Available residue data on cranberries support the tole-
rance for cranberries. No additional data are required.
5. No data are available for the preharvest use of the
DEA salt of MH on potatoes and onions. Residue data will be
required for the DEA salt for use on potatoes and onions
should any registrant comply with the data requirements which
resulted in the suspension.
6. NO data are available to support a nonfood classifca-
tion for the use of MH on nonbearing apples. Data are required
and if residues are detectable on the fruit, tolerances must be
proposed and a processing study conducted to assess potential
concentration of residues in food and feed products.
7. Available data are insufficient to support a nonfood
use classification for use of MH on nonbearing citrus.
Residue data are required and if residues are detectable on
the fruit, tolerances must be proposed and a processing study
conducted to assess potential concentration of residues in
food and feed products.
8. The available data on tobacco are not sufficient to
adequately assess the exposure of man to residues of MH.
1
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Available data do indicate that MH residues of > O.Vppm are
likely to be present in tobacco and indicate the potential
for residues of hydrazine, nitrogen gas, ammonia, amines,
hydrogen gas, nitriles, and nitrogen heterocyclic compounds
following pyrolysis of MH. Residue data are required,
pyrolysis products must be characterized, and the level of
residues occurring in smoke quantified.
9. Animal metabolism data are needed to show whether
tolerances for MH or its metabolites are required in animal
commodities. If there is a need for a tolerance EPA will
also require data depicting the stability of MH or its
metabolites in animal commodities during the storage of
animal commodities.
10. Adequacy of analytical methodology will be determined
once requested method validation data are submitted. If the
required animal metabolism data reveal metabolites of concern,
validated analytical methods for residue data collection and
enforcement will be required.
Toxicology Data
The toxicology data considered in support of the tolerances
include a chronic study in rats with a LOEL of 500 mg/kg for
renal effects, a teratology study in rabbits with a teratogenic
NOEL of 100 mg/kg, and a reproduction study in rats with a NOEL
of 750 mg/kg. Refer to the toxicology section above for detailed
information on these studies and additional requirements.
The data gaps in the current data base relevant to a
reference dose (PADI) are a chronic study in a nonrodent
species (dog) and a rat teratology study. The Toxicology
Branch RfD Committee derived the reference dose of 0.5 mg/kg/
day from the LOEL of 500 mg/kg for renal dysfunction in the
rat by applying a total uncertainty factor of 1000 (a factor
of 100 for inter- and intraspecies differences and a factor
of 10 because the LOEL was used). Existing tolerances produce
a TMRC of 0.085 mg/kg/day which occupies 17 percent of the
PADI.
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITION AND RATIONALE
1. None of the criteria listed in 40 CFR 154.7 have
been exceeded for MH. Therefore, no referral to Special
Review is being made at this time.
Rationale; Based on available information, MH does
not exceed the risk criteria for adverse effects in 40 CPR
154.7. Available data indicate that MH does not pose a risk
of serious injury to humans, avian species, or aquatic
organisms.
2. The Agency will not approve any significant* new
food uses of MH until additional residue chemistry data are
available to assess existing uses.
Rationale; It is Agency policy not to establish
significant new uses where major data gaps exist. When
additional data are evaluated the Agency will determine
whether significant new food uses may be established.
3. The Agency is requiring that labeling on all EPs
require protective clothing: long sleeve shirt, long pants
and chemical resistant gloves at all times while handling,
applying, mixing, or loading this chemical.
Rationale: Rare teratogenic effects were observed
in test animal. Exposure estimates for dermal exposure
were based on individuals wearing long sleeve shirts, long
pants, and chemical resistant gloves and resulted in some
margin of safety estimate of less than 100. Refer to teratology
and exposure sections in Part III.B. and E. for additional
information and Part IV.D. for specific wording.
4. The Agency is requiring that additional leaching,
aerobic/anaerobic soil metabolism, and dissipation data be
submitted to fully define the potential of MH to leach into
groundwater.
Rationale; The available data are insufficient to
define the potential of MH to leach and contaminate ground
water. Refer to Part III.D. for additional information.
5. The Agency is requiring that additional information
be submitted on the rabbit teratology study and that a rat
teratology study be completed within 12 months.
*"Signifleant new uses" is defined in 44 FR 27934, May 11,
1979. In the case of a new food or feed use, the Agency
will consider as significant an increase in the TMRC of > 1
percent.
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Rationale; A rare teratogenic effect was seen in
the rabbit teratology study; therefore, additional informa-
tion on parentage of affected animals is needed to fully
define this effect. This information, along with the rat
teratology study, will be used to determine if additional
data on teratogenicity are needed and additional regulatory
restrictions are warranted. Refer to teratology section of
Part III.B. for additional information.
6. The Agency has determined that a full battery of
toxicology studies will be necessary for the DEA salt of MH
should manufacturers comply with data requirements that re-
resulted in suspension. Refer to Part III.B. for a detailed
listing of requirements.
Rationale; The Agency believes that there may be
qualitative or quantitative differences in the behavior of
DEA salt due to the DEA moiety, which itself may cause
effects not seen with other salts.
7. The Agency will continue to require the acceptable
limit of hydrazine occuring in technical products be <^ 1 Sppm
as required by the PD-4.
Rationale; The RPAR review, now called special review,
indicated that hydrazine is oncogenic and determined that
the potential risk associated with this level is very low.
8. The Agency has determined that product chemistry
data for all technical and MPs of MH must be submitted and
updated. Refer to charts for details.
Rationale; It is Agency policy to require that all
product chemistry data for technical and MPs be updated for
each pesticide.
9. The Agency has determined that all end use products
containing the DEA salt of MH must be tested for nitrosamines
if and when the manufacturers comply with data requirements
that resulted in-suspension.
Rationale; Available data indicate that nitrosamines
may occur in products containing the DEA salt .of MH and that
some nitrosamines are known carcinogens.
20
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10. The Agency has determined that reentry data or
restrictions are not required for MH at this time.
Rationale; Current use patterns of MH (7- to 70-day
PHI) or application to plants at early growth stages indicate
little likelihood of exposure or low exposure to workers re-
entering the field. The placement of MH in Toxicity Category
IV for acute dermal and acute oral toxicity indicates minimal
risk to humans.
11. The Agency will not require labeling to protect
endangered species at this time for products containing MH.
Rationale; Acute toxicity data on mammals, avian
species, and aquatic species coupled with low potential for
exposure to MH indicate that endangered species are not
expected to be adversely affected by the use of MH. Since
MH is a plant growth retardant, it could affect any endan-
gered plant species occurring in areas where MH is applied
to tobacco cropland, citrus, apples, onions, and potatoes.
However, no endangered plant species are listed as occurring
at these sites. Refer to Part III.F- for detailed information,
12. The Agency has determined that Tier I nontarget area
phototoxicity testing will be required for MH.
Rationale; No data are available on phytotoxicity
of MH to plants. Because MH is a plant growth retardant,
there are possible effects to nontarget plants; therefore,
the data are required.
13. The Agency will not require additional residue data
on cranberries.
Rationale; The available residue data support the
established tolerances on cranberries.
14. The.Agency will require additional residue data on
potatoes, onions, tobacco, nonbearing citrus, and nonbearing
apples. Refer to charts for detailed information on required
testing.
Rationale; Available data are not sufficient to
support the established tolerances for potatoes and onions.
Available data are not sufficient to support the nonfood
classification of nonbearing citrus and nonbearing apples.
The available data on tobacco are not sufficient to adequately
assess the exposure of man to residues of MH occurring in
tobacco.
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15. The Agency is requiring additional livestock and
plant metabolism data, and storage stability data on all
residue data previously submitted and any new residue data
requested by this document.
Rationale: The available plant metabolism data are
not adequate to fulfill requirements. There are no livestock
metabolism or storage stability data available for MH.
16. 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, for the reasons stated.
Part 158
Subpart C- Product Chemistry; Concern about hazard
presented by impurities
61-2 - Description of beginning materials
and manufacturing process
61-3 - Preliminary analysis of product samples
(hydrazine and nitrosamine data)
§158.240 - Residue Chemistry
171-4 - Plant metabolism because data required for
individual commodities are dependent on this data.
171-4 - Animal metabolism to determine if tolerance
on minor commodities are needed.
171-4 - Pryolysis residue data for tobacco to
determine if subchronic inhalation studies are
needed.
S158.290 - Environmental Fate to fully define the
potential of MH to contaminate groundwater.
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161-3 - Photodegradation in soil
161-1 - Aerobic soil metabolism
161-2 - Anaerobic soil metabolism
8158.340 - Toxicology to fully determine toxicological
potential of MH.
81-6 - Dermal sensitization
81-3 - Chronic toxicity in rodents and
nonrodents
83-2 - Oncogenicity study in rats
83-3 - Teratology study in rats
84-2 - Mutagenicity testing
85-1 - General metabolism
S158.540 - Plant Protection - Tiered Studies
122-1 - Tier I - Seed Germination/seedling
emergence
122-1 - Tier I - Vegative vigor
17. While data gaps are being filled, currently registered
MPs and EPs containing MH must be formulated and used, subject
to the terms and conditions in the data appendices, in order to
maintain existing registrations.
Rationale; Under FIFRA, the Agency may choose not
to cancel or withhold registration if data are missing or are
inadequate. See FIFRA sections 3(c)(2)(B) and 3(c)(7).
Issuance of this Standard provides a mechanism for
identifying data needs. These data will be reviewed and
evaluated, after which the Agency will determine if additional
regulatory changes are necessary.
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain MH or its K or DEA salts, bear required
labeling, and conform to the product composition, acute
toxicity limits, 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,
NPs must contain MH, its K salt, or its DEA salt. Each HP
formulation proposed for registration must be fully described
with an appropriate certification of limits, stating maximum
and minimum amounts of the active ingredient and inert ingre-
dients which are present in products as well as impurities
found at > 0.1 percent. Technical MH used in formulating
products must not contain hydrazine greater than 15 ppm.
2. Acute Toxicity Limits
The Agency will consider registration of technical
grade and MPs containing MH and salt provided that the product
labeling bears appropriate precautionary statements for the
acute toxicity category in which each product is placed.
3. Use Patterns
To be registered under this Standard, MPs may be
labeled'for formulation into EPS registered for the uses
listed in Appendix B, EPA Index to Pesticide Chemicals —
Maleic Hydrazide. The EPA Index to Pesticide Chemicals lists
all registered uses, as well as approved maximum application
rates and frequencies.
D. Required Labeling
All products must bear appropriate labeling as speci-
fied in 40 CPR 162.10, PR Notices 83-2, 83-3, and below.
No pesticide product containing maleic Hydrazide or
its salts ingredient may be released for shipment by the
registrant after June 30, 1989, unless the product bears an
amended label which complies with the requirements of this
standard. Five (5) copies of the labeling, revised in accord-
ance with this Standard, must be submitted prior to release
for shipment.
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Pesticide products containing maleic hydrazide or its salts
ingredient may not be distributed, sold, offered for sale, (having
been so received) delivered or offered to be delivered by any person
after July 30, 1990 unless the product bears amended labeling,
five copies of which have been submitted to the Agency, that
complies with the requirements of this Standard.
In addition to the above, the following information
must appear on the labeling:
1. Ingredient Statement
The ingredient statement for MPs must list the
active ingredients:
Maleic hydrazide
1,2-dihydro-3,6-pyridazinedione
2. Precautionary Statements
Statements for MPs:
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 the NPDES
permit. Do not discharge effluent con-
taining this product into sewer systems
without previously notifying the sewer
treatment plant authority. For guid-
ance contact your State Water Board or
Regional Office of the EPA.
Statements for EPs:
Do not apply directly to water or
wetlands (swamps, bogs, marshes, and
potholes). Do not contaminate water
when disposing of equipment washwaters.
3. The following statements must appear on all EPs:
"Wear a long-sleeve shirt, long pants, and
chemical resistant gloves at all times when
mixing, loading, handling, or applying this
chemical."
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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 submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product Is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active Ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed In Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B^
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 rereglstration.
2 Data requirements are listed in the three Tables In
Appendix I af 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 a producer who is eligible for the
forraulator's 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 submission 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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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. End use products containing this pesticide as the
sole active Ingredient are subject to:
1. The restrictions (If any) upon use, composition, or
packaging listed In Section IV If they pertain to the
end use product.
2. If eligible for the formulator's exemptions, the
data requirements listed In Table C.
3. If not eligible for the formulator's 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 formulator's exemption,
the date requirements listed in Tables A and C.
3 If you purchase from another producer and use as the
source of your active Ingredient only EPA-reglstered products,
you are eligible for the formulator's 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 those
data requirements.
f" 27
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2. If eligible for the forraulator's exemption, the
data requirements listed in Table B-2
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 PIPRA 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.1*
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 PIPRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (PIPRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fall to take appropriate
steps to meet the requirements or are no longer In compliance
with this data requirements notice, the Agency will consider
** Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
In this Registration Standard.
28
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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 formulator's 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 Formulator's Exemption
Statement form.
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 submission 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 fall
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with 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
submit the data on which you will rely. You must also provide
29
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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 submission.
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 from the Registration Support and Emergency
Response Branch, Registration Division. 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 submissions 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 registratl
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. Pile 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).
2. Provide us with a copy of your offer to the other
30
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registrant and proof of the other registrant's receipt of your
offer (such as a certified mall 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 PIPRA sec.
3(c)(2)(B) In the [name of active Ingredient] Registration
Standard upon terms to be agreed or falling agreement
to be bound by binding arbitration as provided by PIPRA
section 3(c)(2)(B)(lll).
The remainder of your offer may not In any way attempt to
limit this commitment. If the other registrant to whom your
offer Is made does not accept your offer, and If the other
registrant Informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share In the burden of developing the
data.
In addition, the other registrant must fulfill Its
commitment to develop and submit the data as required by this
Notice In a timely manner. If the other registrant falls 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,
l». 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
fall to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed.You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product's) for which the data are needed^
31
-------
E. Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
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.
As noted herein, these EPA 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-W-M650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable If
the OECD-recommended test standards conform to those specified
In the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
Identification which are environmental fate requirements) are
less restrictive than those In the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
P. Procedures for requesting a change in testing 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 submission of the
data, nor will extensions generally be given to conduct
studies due to submlttal of Inappropriate protocols.
G. 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. Any request for a time
32
-------
extension which Is made as an Initial response to a section
3(c)(2)(B) request notice must be submitted In writing to
the Product Manager listed at the end of this section and
must be made by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a time extension
must be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX.E.
EPA will view failure to request an extension before
the data submission 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.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
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 submission requirement.
I. 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 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
33
-------
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 PIPRA.
VII. REQUIREMENT FOR SUBMISSION OP 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 B-2. 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, E, P, and Q. 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.
34
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VIII. REQUIREMENT FOR SUBMISSION OP REVISED LABELING
PIPRA 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
HO CPR 156.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified In Section IV.D of this Registra-
tion Standard. Applications submitted In response to this
notice must Include draft labeling for Agency review.
If you fall 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 or suspend the
registration of your product under PIPRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
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 to the Product Manager In the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(e)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-M).
c. Formulator's Exemption Statement (EPA Form 8570-27),
If applicable.
d. Evidence of compliance with data compensation
requirements of FIPRA sec. 3(c)(l)(D). Refer to MO CPR
152.80-152.99.
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement Is .not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting Information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated In response to this notice. This submission Is In
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. . (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
35
-------
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
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.
Labeling should 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. The draft label 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.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring 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 to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months of receipt of this document, you must
submit to the Product Manager:
Three copies of draft labeling, Including the container
label and any associated supplemental labeling. Labeling
should 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. The draft label 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.
36
-------
3. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the forraulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring 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 to the Product Manager in the Registration Division:
a. PIPRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments* (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-M),
if Table C lists required product-specific data.
c. Three copies of draft labeling, Including the
container label and any associated supplemental labeling.
Labeling should 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. The 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. End use product labeling
must comply specifically with the Instructions in Section IV
(Regulatory Position and Rationale).
D. End Use Products containing the subject active ingredient
as one of multiple active ingredients
Within 9 months from the receipt of this document, you
must submit to the Product Manager:
Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling
should 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. The draft labeling must indicate
the Intended colors of the final label, clear indication
1 37
-------
of the front panel of the label, and the Intended type
sizes of the text. End use product labeling must comply
specifically with the instructions in Section IV (Regulatory
Position and Rationale).
E. Intrastate Products containing the subject pesticide either
as sole active ingredient or in combination with other
active ingredients.
Applications for full Federal registration of intrastate
products are required to be submitted no later than July 31,
1988.
F. Addresses
The required Information must be submitted to the following
address:
Robert Taylor
Product Manager (PM) 25
Fungicide Herbicide Branch
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
38
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TGUIDE-1
GUIDE TO TABLES
Tables A, B, and B-2 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 B-2 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 CPR 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 CPR Part 158. The following
letter designations are used for the given use patterns:
A
B
C
D
E
P
G
Terrestrial, food
Terrestrial, non-food
Aquatic, food
Aquatic, non-food
Greenhouse, food
Greenhouse, non-food
Forestry
H « Domestic outdoor
I - Indoor
Any other designations will be defined in a footnote to the table,
39
-------
TGUIDE-2
*». 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. Tlmeframe 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 tlmefraraes are those established either
as a result of a previous Data Call-in letter, or standardized
tlmeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
40
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TABLE A
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE
Data Rex
Part 151
Subpart
Product
61-2 -
61-3 -
Test
Pirement Substance
C - Product Chemistry
Identity and Composition
Description of Beginning
Materials and Manufac-
turing Process
Discussion of Formation
of Impurities
TGAI
TGAI
Does EPA
Have Data To
Satisfy These
Requirements?
No
No
Must
Additional
Bibliographic Data be
9/ Citation 9/ Submitted?
N/A
N/A
Yea!/
Yes!/
Tiraeframe
For Data
Submission
6 months
6 months
Analysis and Certification of
Product
62-1 -
Ingredients
Preliminary Analysis of
Product Samples
TGAI
No
N/A
Yes!/
12 months
Physical and Chemical Characteristics
63-2 -
63-3 -
63-4 -
63-5 -
63-6 -
Color
Physical State
Odor
Melting Point
Boiling Point
TGAI
TGAI
TGAI
TGAI
TGAI
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
Yes!/
YesV
YesV
YesV,!/
NOV,6./
6 months
6 months
6 months
6 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR MALEIC HYDRAZIDE
Test
Data Requirement Substance
Part 15$
Subpart C - Product Chemistry (Continued)
Physical and Chemical Characteristics (cont'd)
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
63-1 1 - Octanol/Water Partition PAI
Coefficient
63-12 - pH TGAI
63-13 - Stability TGAI
Does EPA
Have Data To
Satisfy These
Requirements ?9/
No
No
No
No
No
No
No
Bibliographic
Citation!/
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must
Additional
Data be
Submitted?
YesV
YesV
YesV
YesV
YesV,Z/
YesV,t/
YesV
Timeframe
For Data
Submission
6 months
6 months
6 months
6 months
6 months
6 months
6 months
Other Requirement;
64-1 - Submittal of Samples
N/A
N/A
N/A
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR MALEIC HYDRAZIDE
Part 158
Subpart C - Product Chemistry (Continued)
]_/ 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 must be provided, along
with information regarding the properties of each beginning material used to manufacture each product.
2f A detailed discussion must; be submitted of all impurities that are or may be present at >^ 0.1%, based on knowledge
of the beginning materials, chemical reactions (intended and side) in the manufacturing process, and any
contamination during and after production.
3/ Five or mote representative samples must be analyzed for the amount of active ingredient and each impurity for
which a certified limit is required. Specific analyses for the potential impurity, hydrazine, must be included.
Complete validation data (accuracy, precision) must be submitted for each analytical method used.
4/ Fhysicochemical characteristics must be submitted (color, physical state, odor, melting point, boiling point,
~~ specific gravity, solubility, vapor pressure, dissociation constant, Kgw, pH, and stability) as required in 40
CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D.
5/ Data needed because technical chemical is a solid at room temperature.
6/ Data not required because technical chemical is not a liquid at room temperature.
7/ Required because the technical chemical is organic and nonpolar.
£/ Required if the test substance is dispersible with water.
9/ Not 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.
-------
TABLE A
GENERIC BVTA REQUIREMENTS FDR MALEIC HYDRAZIDE
Data Requirement
Test
Substance
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
Bibliographic
Citation
Mist
Additional
Data be
Submitted?
Timeframe
For Data
Submission!/.
SI 58. 240 Residue Chemistry
171-2
171-3
171-4
171-4
171-4
- Chemical Identity?./
- Directions for Use
- Nature of the Residue
(Metabolism)
- Plants
- Livestock
- Residue Analytical
Methods
- Storage Stability
PAIRA
PAIRA and
Plant Metab-
olites
TGAI and
Metabolites
TEP and
Metabolites
(See Index)
Partially
No
Partially
Partially
00106979,00121599
00122399,00125641
N/A
00058579,00087400
00100749,00101295
00106267,00106979
00106983,00112750
00122366,00125636
00058587
Yes!/
YesV,!/
Yesi / TJ
Yes!/
18 months
18 months
15 months
18 months
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TABLE A
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE
Test
Data Requirement : Substance
51 58. 240 Residue Chemistry
171-4 - Magnitude of the
Residue in Plants (cont'd)
- Root and Tuber Vegetables
o Potatoes TEP
- Bulb Vegetables
o Onions TEP
- Small Fruits and Berries
o Cranberries TEP
- Nonbearing Orchard Crops
o Apples TEP
o Citrus Fruits TEP
- Tobacco TEP
PAIRA
Does KBfi.
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
Partially
Partially
Yes
No
Partially
Partially
Bibliographic
Citation
00086764,00106979
00121603,00122361
00122364
00058587,00106979
00121605,00122363
00141353
00100749,00101298
N/A
001012%
00087392,00125636
00165460
Hist
Additional
Data be
Submitted?
YeaBy
Yesll/
No
Yes!!/
Yes!!/
YesW
Yes]!/
Timeframe
For Data
Submission!/
18 months
24 months
18 months
18 months
18 months
18 months
24 months
171-4 - Magnitude of Residue in
Meat/Milk/Poultry/Eggs
TGAI or Plant
Metabolites
Partially 00106979
Yes16/
18 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FUR MALEIC HYDRAZIDE
SI 58.240 Residue Chemistry Footnotes
\J Data must be submitted within the indicated timeframe, based on the issue date of this Guidance Document.
2/ The same chemical identity data are required as under Part 158 Subpart C- Product Chemistry, with emphasis on
impurities that could constitute residue problems. Refer to Product Chemistry Data Requirements tables.
3/ Studies must be submitted depicting the distribution and the metabolism of [ring-l^c]maleic hydrazide (acid) in
cranberries, onions, and potatoes and [ethyl-'^C]diethanolamine salt of maleic hydrazide in onions and potatoes
following foliar broadcast applications at rates sufficiently high to permit complete characterization of all
'^C-residues. These studies must include specific protocols to characterize and quantify the impurity hydrazine.
Analyses must include hydrolysis and reextraction of plant samples and aqueous fractions to determine conjugated
'^C-residues of maleic hydrazide. Representative samples from these studies must also be analyzed using all
current and proposed enforcement methods (including all FDA Miltiresidue Protocols [I-IV], Method I in PAM Vol.
II and the modification of Lane [MRID No. 00106983]) to ascertain that these methods are capable of adequately
recovering and quantifying all residues of concern.
4/ Metabolism studies using ruminants and poultry must be submitted. Animals must be dosed for at least 3 days
with [ring-14c]maleic hydrazide (acid) at a level high enough to permit identification and quantification
of the ^C-residues. These studies must also include specific protocols to characterize and quantify
the impurity hydrazine. If necessary, hydrolysis and reextraction of samples and aqueous fractions must be
used to release ^-conjugates. Milk and eggs must be collected within 24 hours of the final dose. The
distribution and characterization of residues must be determined in milk, eggs, liver, kidney, muscle, and
fat. Samples from these studies must also be analyzed using all current and proposed enforcement methods
(including all FDA Mult ires idue Protocols [I-IV], and Method I in PAM Vol. II) to ascertain that the methods
are capable of adequately recovering and quantifying all residues of concern. [If the required plant metabolism
studies using the [ethyl-'^Cjdiethanolamine salt of maleic hydrazide reveal that diethanolamine per se and/or
the diethanolamine salt will occur as a residue in or on potatoes, metabolism studies in ruminants and poultry are
also required using ['^C]diethanolamine and/or the [ethyl-'^C]diethanolamine salt.]
V Data depicting the nature of maleic hydrazide residues in swine are also required if the required metabolism
studies with ruminants and poultry reveal that the metabolism of maleic hydrazide in these animals differs
• from that in rats.
6/ We have required that Mil tires idue Methods I-IV, Method I in PAM Vol. II, and the modification of Lane
(MRID No. 00106983) be tested in conjunction with the required plant and animal metabolism studies. Protocols
for Methods I, II, III, and IV are available from the National Technical Information Service under Order
js* No. PB 203734/AS.
Ox
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TABLE A
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE
SI58.240 Residue Chemistry Footnotes (cont'd)
y If the required animal metabolism data reveal metabolites, analytical methods for data collection
and tolerance enforcement will be required.
8/ Samples bearing measurable field-weathered residues or fortified samples must be analyzed immediately after
harvest or fortification and stored under conditions and for intervals equivalent to those under and for
which samples in the following previously submitted studies were stored: potatoes (MRID Nos. 00086764 and
00121603), onions (00121605), and cranberries (00100749 and 00101298). Also, all residue data requested in
this Standard must be accompanied by sample storage data (storage conditions and time stored) and data
depicting the stability of residues under the conditions and for the time intervals specified.
9/ Data must be submitted depicting maleic hydrazide residues in or on potatoes following treatment
with EC and SC/L diethanolamine salt formulations and EC potassium salt formulations at 3 Ib ai/A. Each salt
and formulation class must be reflected in a separate test. Application must be made to uniformly flowering
potatoes 7 days following blossom drop and to irrigated potatoes 2 to 3 weeks following full bloom when tubers
are 1 inch in diameter. Tests must be conducted in CA (6%), ID (25%), ME (7%), MI (4%)/WI (6%), and OR (7%)/WA
(15%) since these States collectively produced ca. 70% of the 1985 U.S. potato crop (Agricultural Statistics
1986, p. 164). A PHI must be proposed and reflected in the submitted data. The registrant must also propose a
PHI for the potassium salt SC/L and SC/S labels and amend the labels to permit only a single application/year.
10/ Data must be submitted depicting maleic hydrazide residues in chips, granules, and wet and dry peel,
processed from potatoes bearing measurable weathered residues. If residues concentrate in peel or granules,
appropriate feed/food additive tolerances must be proposed. The established food additive tolerance for
chips will be reassessed following evaluation of these data.
11 / Data must be submitted depicting maleic hydrazide residue in or on dry bulb onions following application
of a diethanolamine salt of an EC and SC/L formulation and potassium salt of an EC formulation, in
separate tests, at 2 pounds acid equivalent per acre (Ib ae/A). Tests must be conducted in CA (27%), CO (12%),
ID (8%), MI (6%), NY (9%), OR (15%)/ WA (5%), and TX (9%) since these States collectively produced ca. 74% of
the 1985 U.S. storage onion crop (Agricultural Statistics 1986, p. 161). A PHI must be proposed and reflected
in the submitted data. The registrant must also propose a PHI for the potassium salt SC/S and SC/L labels and
amend the labels to permit a single application/year.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR MALEIC HYDRAZIDE
8158.240 Residue Chemistry Footnotes (cont'd)
12/ Data must be submitted depicting maleic hydrazlde residues in or on apples treated with the 3 Ib/gal
SC/L diethanolamine salt formulation at 6 Ib ae/A in a nonbearing year. Fruit must be harvested at the shortest
possible interval following registered use and should include tests using early maturing varieties. Tests
must be conducted in CA (8%), MI (14%), NY (14%)/PA (7%), and WA (26%) because these States produced ca. 70%
of the 1985 U.S. apple crop (Agricultural Statistics 1986, p. 186). Upon receipt of the requsted data, the
appropriateness of the nonfood use classical:ion will be assessed. If residues are detectable in or on fruit,
a tolerance must be proposed and a processing study conducted to assess potential concentration of residues
in food and feed products (wet and dry pomace and juice).
13/ Data must be submitted depicting maleic hydrazide residues in or on citrus fruits (oranges and
grapefruit) treated twice (November 15 and 8 weeks later) to runoff with the EC and SC/L potassium and
diethanolamin salt formulations, in separate tests, at 1.5 Ib ae/100 gal water in a nonbearing year. Fruit
must be harvested at the shortest possible interval following registered use and should include tests using
early maturing varieties. Tests must be conducted in Florida. The registrant must propose a maximum rate or
volume/A, which must be reflected in the submitted data. Upon receipt of the requested data, the appropriateness
of the nonfood use classification will be assessed. If residues are detectable in or on fruit, a tolerance
must be proposed and a processing study conducted to assess potential concentration of residues in food and
feed products (dried pulp, oil, molasses, juice).
14/ Data must be submitted depicting maleic hydrazide residues in or on green freshly harvested and
cured or dry tobacco leaves following foliar broadcast application (i) after topping to plants in full
flower with the EC and SC/L diethanolamine formulation (in separate tests) at 3 Ib ae/A; and (ii) 7
days prior to harvest using an SC/L potassium salt formulation at 4.5 Ib ae/A to dark-fired tobacco
varieties. The residues data must include decline decline studies at regular intervals following
application of diethanolamine salts to tobacco. Tests must be conducted in KY (28%), NC (37%), and TN
(8%), States which produced ca. 73% of the 1985 U.S. tobacco crop (Agricultural Statistics 1986, p. 93).
15/ Pyrolysis products derived from the active ingredient must be characterized and the level of the residue in
smoke must be quantified. ([^Jroaleic hydrazide must be used for identification of pyrolysis products.)
16/ Following receipt and evaluation of the required plant and animal metabolism data and residue data for
.. potatoes (feed items - cull potatoes and processed potato waste), specific data requirements for livestock
,- feeding studies will be determined.
oo
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE
Data Requirement
Data Requirement
S 158. 340 Toxicology
ACUTE TESTING:
81-1 - Acute Oral - Rat
81-2 - Acute Dermal - Rabbit
81-3 - Acute Inhalation - Rat
81-4 - Eye Irritation - Rabbit
81-5 - Dermal Irritation - Rabbit
81-6 - Dermal Sensitization -
Guinea Pig
81-7 - Acute Delayed
Neurotoxicity - Hen
i <•
SUBCHRONIC TESTING
82-1-90-Day Feeding-
Rodent
Non-Rodent
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
Yes
Yes
No
Yes
Yes
No
No
No
No
Hist
Additional
Bibliographic Data be
Citation Submitted?
00079657 No
00079658 No
Yes
00079661 No
00079660 No
Yes
NOT/
No 2/
No 2 /
Timefrane
For Data
Submission
9 months
9 months
NO
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE
Data Requirement
§158.340 Toxicology
SUBCHRONIC TESTING: (cont'd)
82-2 - 21 -Day Dermal
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
82-5 - 90-Day Neurotoxicity
CHRONIC TESTING:
83-1 - Chronic Toxicity
- Rodent
. - Nonrodent
83-2 - Oncogenicity Study
- Rat
- Mouse
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
No
No
No
No
No
No
No
Yes
Most
Additional
Bibliographic Data be
Citation Submitted?
Yes
No3/
Reserved4/
Nol/
Yes
Yes
Yes
01)098466 No
40663501
Timeframe
For Data
Submission
15 months
50 months
50 months
50 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR MALEIC HYDRAZIDE
Data Requirement
5158.340 Toxicology
CHRONIC TESTING: (cont'd)
83-3 - Teratogenicity
- Rat
- Rabbit
83-4 - Reproduction
MUTAGENICITY TESTING
84-2 - Gene Mutation
(fanes Test)
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mjtagenicity
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Domestic Animal Safety
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
PAI or PAIRA
Choice
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
No
Partially
Yes
Yes
No
No
No
No
Mist
Additional
Bibliographic Data be
Citation Submitted?
Yes
00128721 Yes5/
00128720 No
00124883 No
Yes
Yes
Yes
Yes
Timeframe
For Data
Submission
12 months
12 months
12 months
12 months
24 months
24 months
-------
TABLE A
GENERIC C¥VTA REQUIREMENTS FDR MALEIC HYDRAZIDE
S158.340 Toxicology Footnotes
]J Not required because raaleic hydrazide is not an organophosate.
2/ This data requirement is waived based on the requirement for chronic studies in rodent and nonrodent.
3/ Uses do not involve purposeful, prolonged, or comparable dermal exposure.
V Repeated inhalation exposures at toxic concentrations are not expected; however, because of tobacco use, an
inhalation study may be required for maleic hydrazide and pyrolysis products depending upon their presence
in and nature on tobacco.
5/ Addition data required on parentage of affected offspring.
Ln
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE
Data Requirement
SI 58. 290 Environmental Fate
Test
Substance
Use
Pattern
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
Mast
Additional Timeframe
Bibliographic Data be For Data I/
Citation Submitted? Submission
Product Identity and Composition
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
PAIRA
PAIRA
PAIRA
PAIRA
PAIRA
PAIRA
PAIRA
PAIRA
A,B
A.B
A,B
A,B
A,B
A,B
-
-
Yes
Partially
Yes
No
No
No
No
No
00143322 No
00151951 Yea?/
00151951 No
Reserved3/
Yes
Yes
NoV
No!/
9 months
27 months
27 months
en
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR MALEIC HYDRAZIDE
Test Use
Data Requirement ; Substance Pattern
5158.29C
i environmental rate (cout a)
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
Most
Additional Timeframe
Bibliographic Data be For Data
Citation Submitted? Submission
MOBILITY STUDIES:
163-1 -
163-2 -
163-3 -
Leaching and
Adsorption/Desorption PAIRA A,B
Volatility (Lab) TEP A,B
Volatility (Field) TEP A,B
Partially
No
No
00151952 Yes6/
Reserved y/
Reserved?/
12 months
DISSIPATION STUDIES-FIELD:
164-1 -
164-2 -
164-3 -
164-4 -
Soil TEP A,B
Aquatic (Sediment) TEP
Forestry TEP
Combination and
No
No
No
No
Yes
No!/
No*/
NolP./
27 months
Tank Mixes
164-5 - Soil, Long-Term
TEP
No
Reservedli/
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR MALEIC HYDRAZIDE
Test
Data Requirement : Substance
slDo./yo Environmental Fate (cont d)
ACCUMULATION STUDIES:
Does EPA
Have Data To
Satisfy These
Requirements?
Use (Yes, No, or
Pattern Partially)
Bibliographic
Citation
Hist
Additional
Data be
Submitted?
Timeframe
For Data
Submission
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
PAIRA
A,B
AfB
Partially
No
00122390
Reserved 13/
165-3 -
165-4 -
165-5 -
$158.142
202-1 -
202-1 -
Irrigated Crops
In Fish
In Aquatic Nontarget
Organisms
Spray Drift
Drift Field Evaluation
Droplet Size Spectrum
TEP
PAIRA/TGAI
TEP
TEP
A,B
A,B
A,B
No
Yes
No
No
No
No!/
00163301 No 14/
No*/
NoW
No J3/
39 months
cn
Ui
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE
SI58.290 Environmental Fate Footnotes
j_/ Data must be submitted within;the indicated tiraeframes, based on the issue date of this guidance document.
2/ An absorption spectrum of maleic hydrazide is required.
3/ The requirement for data is reserved pending the results of an acceptable acute inhalation study.
4/ This study is not required to support the current use pattern, which does not include aquatic, forestry,
or aquatic impact uses.
5/ This study is not required to support the current use pattern, which does not include aquatic or aquatic
impact uses.
6/ This study is partially acceptable: An imaged adsorption/desorption study using five soils was acceptable;
however, an aged soil column study using two soils (one sand plus one representative of intended use area)
is required.
7/ The requirement for the study is reserved pending results of an acceptable acute inhalation study.
8/ The requirement for the study is reserved pending the results of the laboratory volatility study.
9/ This study is not required because the current use pattern does not include forestry uses.
10/ There are no current registered combination or tank mixes for maleic hydrazide.
JM/ The requirement for this study is reserved pending the results of the field dissipation study (SI64-1).
en
-------
TABLJE A
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE
Test
Data Requirement ; Substance
SI 58. 240 Residue Chemistry
171-4 - Magnitude of the
Residue in Plants (cont'd)
- Root and Tuber Vegetables
o Potatoes TEP
- Bulb Vegetables
o Onions TEP
- Small Fruits and Berries
o Cranberries TEP
- Nonbearing Orchard Crops
o Apples TEP
o Citrus Fruits TEP
- Tobacco ' TEP
PAIRA
171-4 - Magnitude of Residue in TGAI or Plant
Does EH&
Have Data To
Satisfy These Hist
Requirements? Additional
(Yes, No, or Bibliographic Data be
Partially) Citation Submitted?
Partially 00086764,00106979
00121603,00122361
00122364
Partially 00058587,00106979
00121605,00122363
00141353
Yes 00100749,00101298
No N/A
Partially 00101296
Partially 00087392,00125636
00165460
Partially 00106979
Yes?/
Yes!!/
No
Yes!!/
Yes!!/
YelH/
Yesj6/
Timeframe
For Data
Submission!/.
18 months
24 months
18 months
18 months
18 months
18 months
24 months
18 months
Meat/Milk/Poultry/Eggs
Metabolites
LH
-------
TABLE A
GENERIC t¥VTA REQUIREMENTS FUR MALEIC HYDRAZIDE
SI 58.240 Residue Chemistry Footnotes
\J Data must be submitted within the indicated timefraroe, based on the issue date of this Guidance Document.
2/ The sane chemical identity data are required as under Part 158 Subpart C- Product Chemistry, with emphasis on
impurities that could constitute residue problems. Refer to Product Chemistry Data Requirements tables.
3/ Studies must be submitted depicting the distribution and the metabolism of [ring-14C]maleic hydrazide (acid) in
cranberries, onions, and potatoes and [ethyl-1^C]diethanolamine salt of maleic hydrazide in onions and potatoes
following foliar broadcast applications at rates sufficiently high to permit complete characterization of all
'^C-residues. These studies must include specific protocols to characterize and quantify the impurity hydrazine.
Analyses must include hydrolysis and reextraction of plant samples and aqueous fractions to determine conjugated
'^-residues of maleic hydrazide. Representative samples from these studies must also be analyzed using all
current and proposed enforcement methods (including all Fltt Multiresidue Protocols [I-IV], Method I in PAM Vol.
II and the modification of Lane [MRID No. 00106983]) to ascertain that these methods are capable of adequately
recovering and quantifying all residues of concern.
4/ Metabolism studies using ruminants and poultry must be submitted. Animals must be dosed for at least 3 days
with [ring-t^cjmaleic hydrazide (acid) at a level high enough to permit identification and quantification
of the ^C-residues. These studies must also include specific protocols to characterize and quantify
the Impurity hydrazine. If necessary, hydrolysis and reextraction of samples and aqueous fractions must be
used to release I^C-conjugates. Milk and eggs must be collected within 24 hours of the final dose. The
distribution and characterization of residues must be determined in milk, eggs, liver, kidney, muscle, and
fat. Samples from these studies must also be analyzed using all current and proposed enforcement methods
(including all FTtt Multiresidue Protocols [I-IV], and Method I in PAM Vol. II) to ascertain that the methods
are capable of adequately recovering and quantifying all residues of concern. [If the required plant metabolism
studies using the [ethyl-1 ^CJdiethanolanine salt of maleic hydrazide reveal that dtethanolanlne per se and/or
the diethanolamine salt will occur as a residue in or on potatoes, metabolism studies in ruminants and poultry are
also required using M^CJdiethanolamine and/or the [ethyl-I^C]diethanolamine salt.]
5/ Data depicting the nature of maleic hydrazide residues in swine are also required if the required metabolism
studies with ruminants and poultry reveal that the metabolism of maleic hydrazide in these animals differs
from that in rats.
~-6/ We have required that Multiresidue Methods I-IV, Method I in PAM Vol. II, and the modification of Lane
~~ (MRID No. 00106983) be tested in conjunction with the required plant and animal metabolism studies. Protocols
for Methods I, II. Ill, and IV are available from the National Technical Information Service under Order
s* No. PB 203734/AS.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE
SI 58.240 Residue Chemistry Footnotes (cont'd)
7/ If the required animal metabolism data reveal metabolites, analytical methods for data collection
and tolerance enforcement will be required.
8/ Samples bearing measurable field-weathered residues or fortified samples must be analyzed immediately after
harvest or fortification and stored under conditions and for intervals equivalent to those under and for
which samples in the following previously submitted studies were stored: potatoes (MRID Nos. 00086764 and
00121603), onions (00121605), and cranberries (00100749 and 00101298). Also, all residue data requested in
this Standard must be accompanied by sample storage data (storage conditions and time stored) and data
depicting the stability of residues under the conditions and for the time intervals specified.
9/ Data must be submitted depicting maleic hydrazide residues in or on potatoes following treatment
with EC and SC/L diethanolamine salt formulations and EC potassium salt formulations at 3 Ib ai/A. Each salt
and formulation class must be reflected in a separate test. Application must be made to uniformly flowering
potatoes 7 days following blossom drop and to irrigated potatoes 2 to 3 weeks following full bloom when tubers
are 1 inch in diameter. Tests must be conducted in CA (6%), ID (25%), ME (7%), MI (4%)/WI (6%), and OR (7%)/V*V
(15%) since these States collectively produced ca. 70% of the 1985 U.S. potato crop (Agricultural Statistics
1986, p. 164). A PHI must be proposed and reflected in the submitted data. The registrant must also propose a
PHI for the potassium salt SC/L and SC/S labels and amend the labels to permit only a single application/year.
10/ Data must be submitted depicting maleic hydrazide residues in chips, granules, and wet and dry peel,
processed from potatoes bearing measurable weathered residues. If residues concentrate in peel or granules,
appropriate feed/food additive tolerances must be proposed. The established food additive tolerance for
chips will be reassessed following evaluation of these data.
11 / Data must be submitted depicting maleic hydrazide residue in or on dry bulb onions following application
of a diethanolamine salt of an EC and SC/L formulation and potassium salt of an EC formulation, in
separate tests, at 2 pounds acid equivalent per acre (Ib ae/A). Tests must be conducted in CA (27%), CO (12%),
ID (8%), MI (6%), NY (9%), OR (15%)/ WA (5%), and TX (9%) since these States collectively produced ca. 74% of
the 1985 U.S. storage onion crop (Agricultural Statistics 1986, p. 161). A PHI must be proposed and reflected
in the submitted data. The registrant must also propose a PHI for the potassium salt SC/S and SC/L labels and
amend the labels to permit a single application/year.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR MALEIC HYDRAZIDE
SI58.240 Residue Chemistry Footnotes (cont'd)
12/ Data must be submitted depicting maleic hydrazide residues in or on apples treated with the 3 Ib/gal
SC/L diethanolamine salt formulation at 6 Ib ae/A in a nonbearing year. Fruit must be harvested at the shortest
possible interval following registered use and should include tests using early maturing varieties. Tests
must be conducted in GA (8%), MI (14%), NY (14%)/PA (7%), and WA (26%) because these States produced ca. 70%
of the 1985 U.S. apple crop (Agricultural Statistics 1986, p. 186). Upon receipt of the requated data, the
appropriateness of the nonfood use classication will be assessed. If residues are detectable in or on fruit,
a tolerance must be proposed and a processing study conducted to assess potential concentration of residues
ih food and feed products (wet and dry pomace and juice).
13/ Data must be submitted depicting maleic hydrazide residues in or on citrus fruits (oranges and
grapefruit) treated twice (November 15 and 8 weeks later) to runoff with the EC and SC/L potassium and
diethanolanin salt formulations, in separate tests, at 1.5 Ib ae/100 gal water in a nonbearing year. Fruit
must be harvested at the shortest possible interval following registered use and should include tests using
early maturing varieties. Tests must be conducted in Florida. The registrant must propose a maximum rate or
volume/A, which must be reflected in the submitted data. Upon receipt of the requested data, die appropriateness
of the nonfood use classification will be assessed. If residues are detectable in or on fruit, a tolerance
must be proposed and a processing study conducted to assess potential concentration of residues in food and
feed products (dried pulp, oil, molasses, juice).
14/ Data must be submitted depicting maleic hydrazide residues in or on green freshly harvested and
cured or dry tobacco leaves following foliar broadcast application (i) after topping to plants in full
flower with the EC and SC/L diethanolamine formulation (in separate tests) at 3 Ib ae/A; and (ii) 7
days prior to harvest using an SC/L potassium salt formulation at 4.5 Ib ae/A to dark-fired tobacco
varieties. The residues data must include decline decline studies at regular intervals following
application of diethanolamine salts to tobacco. Tests must be conducted in KY (28%), NC (37%), and TN
(8%), States which produced ca. 73% of the 1985 U.S. tobacco crop (Agricultural Statistics 1986, p. 93).
15/ Pyrolysis products derived from the active ingredient must be characterized and the level of die residue in
smoke must be quantified. ([1^C]maleic hydrazide must be used for identification of pyrolysis products.)
16/ Following receipt and evaluation of the required plant and animal metabolism data and residue data for
._ potatoes (feed items - cull potatoes and processed potato waste), specific data requirements for livestock
,, feeding studies will be determined.
CO
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE
Data Requirement
Data Requirement
S 158. 340 Toxicology
ACUTE TESTING:
81-1 - Acute Oral - Rat
81-2 - Acute Dermal - Rabbit
81-3 - Acute Inhalation - Rat
81-4 - Eye Irritation - Rabbit
81-5 - Dermal Irritation - Rabbit
81-6 - Dermal Sens itlzat ion -
Guinea Pig
81-7 - Acute Delayed
Neurotoxicity - Hen
SUBCHRONIC TESTING
82-1-90-Day Feeding-
Rodent
Non-Rodent
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
Yes
Yes
No
Yes
Yes
No
No
No
No
Hist
Additional
Bibliographic Data be
Citation Submitted?
00079657 No
00079658 No
Yes
00079661 No
00079660 No
Yes
No!/
No 2/
No 21
Timeframe
For Data
Submission
9 months
9 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE
Data
S158.
Requirement
340 Toxicology
Test
Substance
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
Mist
Additional
Bibliographic Data be
Citation Submitted?
Timeframe
For Data
Submission
SUBCHRDNIC TESTING: (cont'd)
82-2
82-3
82-4
82-5
- 21 -Day Dermal
- 90-Day Dermal
- 90-Day Inhalation
- 90-Day Neurotoxicity
TGAI
TGAI
TGAI
TGAI
No
No
No
No
Yes
No3/
Reserved^/
Nol/
15 months
CHRONIC TESTING:
83-1
83-2
- Chronic Toxicity
- Rodent
, - Nonrodent
- Oncogenicity Study
- Rat
- Mouse
TGAI
TGAI
TGAI
TGAI
No
No
No
Yes
Yes
Yes
Yes
00098466 No
40663501
50 months
50 months
50 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR MALEIC HYDRAZIDE
Data Requirement
$158.340 Toxicology
CHRONIC TESTING: (cont'd)
83-3 - Teratogeniclty
- Rat
- Rabbit
83-4 - Reproduction
MtfEAGENICITY TESTING
84-2 - Gene Mutation
(Ames Test)
84-2 - Chroroosoraal Aberration
84-2 - Other Mechanisms of
Mjtagenicity
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Domestic Animal Safety
Test
Substance
TCAI
TGAI
TGAI
TGAI
TGAI
TGAI
PAI or PAIRA
Choice
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
No
Partially
Yes
Yes
No
No
No
No
Mast
Additional
Bibliographic Data be
Citation Submitted?
Yes
00128721 Yes5/
00128720 No
00124883 No
Yes
Yes
Yes
Yes
Timeframe
For Data
Submission
12 months
12 months
12 months
12 months
24 months
24 months
-------
TABLE A
GENERIC QYTA REQUIREMENTS FOR MALEIC HYDRAZIDE
SI 58.340 Toxicology Footnotes
V Mot required because maleic hydrazide is not an organophosate.
2J Hits data requirement is waived based on the requirement for chronic studies in rodent and nonrodent.
y Uses do not involve purposeful, prolonged, or comparable dermal exposure.
4/ Repeated inhalation exposures at toxic concentrations are not expected; however, because of tobacco use, an
inhalation study nay be required for raaleic hydrazide and pyrolysis products depending upon their presence
in and nature on tobacco.
5/ Addition data required on parentage of affected offspring.
C/i
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR MALEIC HYDRAZIDE
Data Requirement
SI 58. 290 Environmental Fate
Test Use
Substance Pattern
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
Mist
Additional Timeframe
Bibliographic Data be For Data I/
Citation Submitted? Submission
Product Identity and Composition
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
PAIRA A,B
PAIRA A,B
PAIRA A,B
PAIRA A,B
PAIRA A,B
PAIRA A,B
PAIRA
PAIRA
Yes
Partially
Yes
No
No
No
No
No
00143322 No
00151951 Yes2,/
00151951 No
Reserved!/
Yes
Yes
NoV
No!/
9 months
27 months
27 months
cn
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE
Data Requirement
Test Use
Substance Pattern
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
Mist
Additional Time frame
Bibliographic Data be For Data
Citation Submitted? Submission
S 158. 290 Environmental Fate (cont'd)
MOBILITY STUDIES:
163-1
163-2
163-3
- Leaching and
Adsorption/Desorption
- Volatility (Lab)
- Volatility (Field)
PAIRA A,B
TEP A,B
TEP A,B
Partially
No
No
00151952 Yes*/
Reserved y/
Reserved]*/
i
12 months
DISSIPATION STUDIES-FIELD:
164-1
164-2
164-3
164-4
164-5
- Soil
- Aquatic (Sediment)
- Forestry
- Combination and
Tank Mixes
- Soil, Long-Term
TEP A,B
TEP
TEP
-
TEP
No
No
No
No
No
Yes
NoV
No2/
NcJO/
Reserved!!/
27 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE
Data Requirement •
SI 58. 290 Enviixxiiieiital rate (cent
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Nontarget
Organisms
§158.142 Spray Drift
202-1 - Drift Field Evaluation
202-1 - Droplet Size Spectrun
Test
Substance
d)
PAIRA
TEP
TEP
PAIRA/TGAI
TEP
TEP
TEP
Does EPA
Have Data To
Satisfy These
Requirements?
Use (Yes, No, or Bibliographic
Pattern Partially) Citation
A,B Partially 00122390
A,B No
No
A.B Yes 00163301
No
A,B No
A,B No
Hist
Additional
Data be
Submitted?
Yesli/
Reserved ^3/
No5/
No 14/
NoV
No Ji5/
No l5/
Timeframe
For Data
Submission
39 months
Ln
-------
TABLE A
GENERIC tttTA REQUIREMENTS FDR MALEIC HYDRAZIDE
I158.290 Environmental Fate Footnotes
1_/ Data must be submitted within.the indicated timeframes, based on the issue date of this guidance document.
2/ An absorption spectrum of maleic hydrazide is required.
3/ The requirement for data is reserved pending the results of an acceptable acute inhalation study.
A/ This study is not required to support the current use pattern, which does not include aquatic, forestry,
or aquatic impact uses.
5/ This study is not required to support the current use pattern, which does not include aquatic or aquatic
impact uses.
6/ This study is partially acceptable: An imaged adsorption/desorption study using five soils was acceptable;
however, an aged soil column study using two soils (one sand plus one representative of intended use area)
is required.
7/ The requirement for the study is reserved pending results of an acceptable acute inhalation study.
&/ The requirement for the study is reserved pending the results of the laboratory volatility study.
9/ This study is not required because the current use pattern does not include forestry uses.
JO/ There are no current registered combination or tank mixes for maleic hydrazide.
JJ/ The requirement for this study is reserved pending the results of the field dissipation study (§164-1).
en
ON
-------
TABLE A
GfcNERIC QftTA RB^UIREMENTS FOR MALEIC HYDRAZIDE
SI 58.290 Environmental Fate Footnotes (cont'd)
12/ The available study fulfills the requirement for leafy vegetables and root crops, a confined study is needed
for wheat or another small grain.
13/ The requirement is reserved pending results rotational interval of the confined study or wheat.
14/ This study is not required because the reviewed octanol/water partition coefficient study (Cable, 00163301)
gave a value of < 0.6, thereby indicating a very low potential for maleic hydrazide to bioaccumulate in fish.
15/ The requirement for this study is reserved pending results of an acceptable acute inhalation study.
en
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MALE 1C HYDRAZIDE
Data Requirement
SI 58. 390 Reentry Protection
1 32-1 - 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 fePA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
No
No
No
No
Hist
Additional
Bibliographic Data be
Citation Submitted?
*
Noi/
Nol/
Nol/
Nol/
Timeframe
For Data
Submission
jy Reentry data are not required because of little likelihood of exposure, or very low exposure, based on current
use pattern.
OO
-------
TABLE A
MALEIC HYDRAZIDE GENERIC DMA REQUIREMENTS
Data
$158
Requirement
.490 Wildlife and Aquatic
Test
: Substance
Organisms
Use
Pattern
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes. No, or Bibliographic
Partially) Citation
Hist
Additional Timeframe
Data be For Data
Submitted? Submission
AVIAN AND MAMttLIAN TESTING
71-1
71-2
71-2
71-5
- Avian Single-Dose
Oral LD3Q
- Avian Dietary l£y)
A. Upland Game Bird
B. Waterfowl
- Avian Reproduction
A. Upland Game Bird
B. Waterfowl
- Simulated and Actual
TGAI
PS
DS
TGAI
PS
DS
TGAI
PS
DS
TGAI.PS.DS
TGAI.PS.DS
TEP.PS.DS
AfB,H
A,B,H
A.B,H
A.B.H
A,B,H
A.B.H
A.B.H
A.B.H
A.B.H
A.B.H
A.B.H
A.B.H
Yes 000124742
Yes 000146141
No
Yes 000126033
No
No
Yes 000107417
Yes 000147000
No
No
No
No
No
No
No I/
N° o
No2/
Nol>
No
**> i
No I/
No
No
No
Field Testing for
Mammals and Birds
vD
-------
MALEIC HYDRAZIDE
TABLE A
GENERIC DATA REQUIREMENTS
Data Requirement
SI 38 .490 Wildlife and Aquatic
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish LC50
A. Wairawater
B. Goldwater
72-2 - Acute LCso Aquatic
Invertebrates
Test
Substance
Organisms (cont
TGAI
PS
DS
TGAI
PS
DS
TGAI
PS
DS
72-3 - Acute LC™ Estuarine and TGAI, PS, DS
Marine "wganisms
72-4 - Fish and Early Life StJ
age TGAI, PS, DS
Use
Pattern
'd)
A,B,H
A.B.H
A.B.H
A.B.H
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
A.B.H
A,B,H
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or Bibliographic
Partially) Citation
Yes 00124739
No
No
Yes 00124740
Yes 00146142
No
Yes 00124741
Yes
No
No
No
Must
Additional
Data be
Submitted?
No
No 2/
No I/
No
No ,
No!/
No
No
No I/
No I/
No 3/
Timeframe
For Data
Submission
and Aquatic Invertebrate
Life Cycle
-------
TABLE A
MALEIC HYDRAZIDE GENERIC DATA REQUIREMENTS
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No. or
Partially)
Bibliographic
Citation
Hist
Additional
Data be
Submitted?
Timeframe
For Data
Submission
S158.490 Wildlife and Aquatic Organisms
AQUATIC ORGANISM TESTING (cont'd)
72-5 - Fish Life Cycle
TGAI.PS.DS A,B,H
No
No
f mm w
72-7
Accumulation TGAI.PS.DS A.B.H No
- Simulated or Actual TGAI.PS.DS A.B.H No
Field Testing for
Aquatic Organisms
*
No3/
No 3/
]_/ No data requirements based on the low toxicity of maleic hydrazide and the potassium salt.
2/ No data requirements based on the low toxicity of maelic hydrazide and the present data base already
~~ accumulated for the potassium salt of maleic hydrazide.
3/ Does not require any aquatic testing.
cr\
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR MALEIC HYDRAZIDE
Data Requirement
Does EPA
Have Data To
Satisfy These Mist
Requirements? Additional
> Test Use (Yes, No, or Bibliographic Data be
Substance Pattern Partially) Citation Submitted?
Timeframe
For Data
Submission
SI 58. 540 Plant Protection
121-1
- TARGET AREA
PHYTtfroXICITY
TGAI,PS,DS A,B,H
No
Nol/
NONTARGET AREA PHYTOTOXICITY
122-1
122-1
122-2
123-1
123-1
123-2
TIER I
- Seed Germination/
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
TIER II
- Seed Germination/
Seedling Emergence
- Vegetatative Vigor
- Aquatic Plant Growth
TGAI,PS,DS A,B,H
TGAI.PS.DS A.B.H
A,B,H
TGAI.PS.DS A,B,H
A,B,H
TGAI.PS.DS A.B.H
TGAI.PS.DS A.B.H
TGAI, PS.DS A.B.H
No
No
No
No
No
No
No
No
No
Yes Zy
Nol/
Yes 2/
Nol/
Yes2/
No I/
No I/
No I/
No 3/
9 months
9 months
9 months
t>o
-------
TABLE A
GENERIC DMA REQUIREMENTS FDR MALEIC HYDRAZIDE
Test
Data Requirement Substance
SI 58. 540 Plant Protection (cont'd)
TIER III
124-1 - Terrestrial Field TGAI.PS.DS
124-2 - Aquatic Field TGAI.PS.DS
Does EPA
Have Data To
Satisfy These
Requirements?
Use (Yes, No, or Bibliographic
Pattern Partially) Citation
A.B.H No
A.B.H No
Mist
Additional Timeframe
Data be For Data
Submitted? Submission
No*/
No */
\l No data required for Diethanolamine salt based on the low toxicity of maleic hydrazide and the potassium salt.
2/ Required because the chemical is a growth retardant to plants and no phytotoxicity are available.
3/ Depending on results of Tier I testing.
4/ Tier III will depend on results of Tier II testing.
CN
OM
-------
TABLE A-2
GENERIC DATA REQUIREMENTS FDR MALEIC HYDRAZIDE DIETHANOLAMINE
Data Requirement
Data Requirement
SI 58. 340 Toxicology
ACUTE TESTING:
81-1 - Acute Oral - Rat
81-2 - Acute Dermal - Rabbit
81-3 - Acute Inhalation - Rat
81-4 - Eye Irritation - Rabbit
81-5 - Dermal Irritation - Rabbit
81-6 - Dermal Sensitization -
Guinea Pig
81-7 - Acute Delayed
Neurotoxicity - Hen
SUBCHRONIC TESTING
82-1-90-Day Feeding-
Rodent
Non-Rodent
Test
Substance J_/
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
No
No
No
No
No
No
No
No
No
Hist
Additional
Bibliographic Data be
Citation Submitted?
Yes
Yes
Yes
Yes
Yes
Yes
No 2J
No Z/
No I/
Time frame
For Data
Submission
9 months
9 months
9 months
9 months
9 months
9 months
ON
-------
TABLE A-2
GENERIC DATA REQUIREMENTS FDR MALEIC HYDRAZIDE DIETHANOIAMINE
Data
S158.
Does ERA
Have Data To
Satisfy These Mast
Requirements? Additional Timeframe
Test (Yes, No, or Bibliographic Data be For Data
Requirement Substance Partially) Citation Submitted? Submission
,340 Toxicology
SUBCHRONIC TESTING: (cont'd)
82-2
82-3
82-4
82-5
- 21 -Day Dermal TGAI No
- 90-Day Dermal TGAI No
- 90-Day Inhalation TGAI No
- 90-Day Neurotoxicity TGAI No
Yes
Nq3/
Reserved^/
No5/
15 months
CHRONIC TESTING:
83-1
83-2
•—
CN
LH
- Chronic Toxicity
TGAI
. - Rodent No
TGAI
- Nonrodent No
- Oncogenicity Study
- Rat TGAI No
- Mouse TGAI No
Yes
Yes
Yes
Yes
50 months
50 months
50 months
50 months
-------
TABLE A-2
GENERIC DATA REQUIREMENTS FOR MALEIC HYDRAZIDE DIETHANOLAMINE
Data Requirement
$158.340 Toxicology
CHRONIC TESTING: (cont'd)
83-3 - Teratogenicity
- Rat
- Rabbit
83-4 - Reproduction
MUEAGENICITY TESTING
84-2 - Gene Mutation
(Ames Test)
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Domestic Animal Safety
ON
ON
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA
Have Data To
Satisfy These
Requirements?
(Yes, No, or
Partially)
No
No
No
No
No
No
No
No
Must
Additional
Bibliographic Data be
Citation Submitted?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes 6/
Timeframe
For Data
Submission
12 months
12 months
39 months
9 months
12 months
12 months
24 months
24 months
-------
TABLE A-2
GENERIC CttTA REQUIREMENTS FDR MALE 1C HYDRAZIDE DIETHANOLAMINE
SI58.340 Toxicology Footnotes
\J This testing must be done on the malelc hydrazlde technical plus DEA(diethanolamine) salt.
2/ Not required because maleic hydrazide is not an organophosate.
3/ Uses do not involve purposeful, prolonged, or comparable dermal exposure.
4/ Repeated inhalation exposures at toxic concentrations are not expected; however, because of tobacco use,
an inhalation study may be required for maleic hydrazide and pyrolysis products depending upon their
presence in and nature on tobacco.
5/ Since an acute neurotoxicity study is not required for this compound and there is no evidence of
~~ neurotoxicity in mammalian species this study is not required.
6/ This study should place emphasis on the diethanolamine moiety.
7/ This data requirement is waived based oh the requirement for chronic studies in rodent and nonrodent.
0\
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS
Does EPA
Have Data To
Satisfy These Bibliographic
Data Requirement • Composition a/ Requirements?'/ Citation!/.
Part 158
Subpart C -Product Chemistry
Product Identity and Composition
61-1 - Product Identity and MP No N/A
Disclosure of Ingredients
61-2 - Description of Beginning MP No N/A
Materials and Manufacturing
Process
61-3 - Discussion of Formation MP No N/A
of Impurities
Analysis and Certification of
Product Ingredients
62-1 . - Preliminary Analysis of MP No N/A
Product Samples
62-2 - Certification of MP No N/A
Ingredient Limits
62-3 - Analytical Methods MP No N/A
to Verify Certified
Limits
0\
OO
Must
Additional
Data be
Submitted
Under FIFRA
Section
3(c)(2)(B)?
Yes!/
Yes!/
YesV
Yes!/
Yes*/
YesZ/
Timeframe
For Data
Submission
6 months
6 months
6 months
12 months
12 months
12 months
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS
*
Data Requirement :
Part 158
Subpart C - Product Chemistry(cont
Composition
'd)
Does EPA
Have Data To
Satisfy These
Requirements? ' /
Bibliographic
Citation!/
Must
Additional
Data be
Submitted
Under F1FRA
Section
3(c)(2)(B)?
Timeframe
For Data
Submission!
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-15 - Flamability
63-16 - Explodability
63-17 - Storage Stability
MP
MP
MP
MP
MP
MP
MP
MP
MP
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
Yesi/
Yes8/
Yes8_/
Yes8/
Yes8/.2/
Yesi/, JO/
Yesi/JLl/
Yesl/,12/
Yesl/
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
15 months
ON
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS
Data Requirement
Composition
Does EPA
Have Data To
Satisfy These
Requirements ?!/.
Bibliographic
Citation!/
Part 158
Subpart C - Product Chemistry
Physical and Chemical Characteristics (cont'd)
63-18 - Viscosity MP No
63-19 - Miscibility MP No
63-20 - Corrosion MP No
Other Requirements;
64-1 - Submittal of Samples N/A N/A
N/A
Must
Additional
Data be
Submitted
Under FIFRA
Section
3(c)(2)(B)?
No
Tlmeframe
For Data
Submission!
N/A
N/A
N/A
Yesi/Jl/
Yes!/ .IV
Yes!/
6 months
6 months
15 months
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIRfcMNTS FDR MANUFACTURING-USE PRODUCTS
Part 158
Subpart C - Product Chemistry footnotes
a/ Manufacturing -Use Product.
1_/ Not 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.
2f The chemical name, nominal concentration, Chemical Abstracts Service (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.
3/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
~~ amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name
and address of the manufacturer, producer, or supplier of each beginning material used in the manufacture of
each product must be provided, along with information regarding the properties of those materials.
4/ A detailed discussion roust be submitted on all impurities that are or may be present at )> 0.1%, based on knowledge
"" of the beginning materials, chemical reactions (intended and side) in the manufacturing process, and any
contamination during and after production.
5/ Five or more representative samples must be analyzed for the amount of active Ingredient and each impurity
~ for which a certified limit is required. Complete validation data (accuracy, precision) must be submitted
for each analytical method used. Specific analyses for the potential impurity, hydrazine, must be included.
6/ Upper and lower limits must be submitted for the active ingredient and each intentionally added inert, and upper
~ iSiits for each impurity present at 2 0.1% (w/w) and each "toxicologically significant" impurity present at < 0.
(w/w) must be provided and certified. An upper limit for the impurity hydrazine at < 15 ppm must be included.
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~sTgnificance, regardless of the concentration at which they are present. Certifications
j must be submitted on EPA Form 8570 (Rev. 2-85).
0.1%
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS
Part 158
Subpart C - Product Chemistry (cont'd)
7J Analytical methods must be provided to determine the active ingredient and each toxicologically significant
~~ impurity and intentionally added inert for which certified limits are required. Each method must be
accompanied by validation studies indicating its accuracy and precision. These methods must be suitable for
enforcement of certified limits*
87 fttysicochdnical characteristics must be submitted (color, physical state; odor, specific gravity, pH, oxidising
or reducing action, flanmability, explodability, storage stability, viscosity, miscibility. and corrosion
characteristics) as required in 40 CFR 158.120 and more fully described in the Pesticide Assessment (Sidelines,
Subdivision D.
9/ Required if the test substance is dispersible with water.
10/ Required if the product contains an oxidizing or reducing agent.
1_1_/ Required if the product contains combustible liquids.
12/ Required if the product is potentially explosive.
13/ Required if the product is a liquid.
JV Required if the product is a liquid and is to be diluted with petroleum solvents.
-------
TABLE B-2
PHDDUCT-SPECIFIC DMA REQUIRQfcNTS FDR PRODUCTS CONTAINING DBA SALTS OF MALKIC HYDRAZIDE
Data Requirement
Part
Subpart
Product
61-1 -
61-2 -
C - Product Chemistry
Identity and Composition
Product Identity and
Disclosure of Ingredients
Description of Beginning
Does EFA
Have Data To
Satisfy These
Composition a/ Requirements?!/
Any Product
Any Product
No
No
Bibliographic
Citation!/
N/A
N/A
Hist
Additional
Data be
Submitted
Under FIFRA
Section
3(c)(2)(B)?
Yes!/
Yes!/
Time frame
For Data
Submission)
6 months
6 months
Materials and Manufacturing
61-3 -
Process
Discussion of Formation
of Impurities
Any Product
No
N/A
YesV
6 months
Analysis and Certification of
Product
62-1 -
62-2 -
62-3 -
Ingredients
Preliminary Analysis of
Product Samples
Certification of
Ingredient Limits
Analytical Methods
Any Product
•
Any Product
Any Product
No
No
No
N/A
N/A
N/A
Yea!/
Yeai/
YesZ/
12 months
12 months
12 months
to Verify Certified
Limits
-------
PRODUCT-SPECIFIC DATA REQUIREMENTS FDR
TABUE B-2
PRODUCTS CONTAINING DEA SALTS OF MALEIC HYDRAZIDE
Does EPA
Have Data To
• Satisfy These
Data Requirement Composition Requirements?1/
Part 158
Subpart C - Product Chemistry
Bibliographic
Mist
Additional
Data be
Submitted
Under FIFRA
Section
3(c)(2)(B)?
Timeframe
For Data
Submission
Physical and Chemical Characteristics
63-2
63-3
63-4
63-7
63-12
63-14
63-15
63-16
63-17
- Color
- Physical State
- Odor
- Density, Bulk Density, or
Specific Gravity
-pH
- Oxidizing or Reducing
Action
- Flammability
- Explodability
- Storage Stability
Any Product
Any Product
Any Product
Any Product
Any Product
Any Product
Any Product
Any Product
Any Product
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
Yesi/
Yes!/
Yes!/
Yes!/
Yes!/^/
Yesi/,™/
Yesi/ Jl/
Yesi/fj2/
Yesi/
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
15 months
-------
TABLE B-2
PRODUCT-SPECIFIC DATA REQUIREMENTS FDR PRODUCTS CONTAINING DBA SALTS OF MALEIC HYDRAZIDE
Part 158
Subpart C - Product Chemistry Footnotes
a/ The requirements are required for any product containing the diethanolamtne salt(DEA) of roaleic hydrazide.
]_/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubtnitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
2/ The chemical name, nominal concentration, Chemical Abstracts Service (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.
3/ Complete information must be provided regarding the nature of the process (batch or continuous) , the relative
~~ amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name
and address of the manufacturer, producer, or supplier of each beginning material used in the manufacture of
each product must be provided, along with information regarding the properties of those materials.
4/ A detailed discussion must be submitted on all impurities that are or may be present at >_ 0.1%, based on knowledge
~ of the beginning materials, chemical reactions (intended and side) in the manufacturing process, and any
contamination during and after production. Specific discussion of nitrosomine formation must be encluded regardless
of quantity.
5/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity
~ for which a certified limit is required. Complete validation data (accuracy, precision) must be submitted
for each analytical method used. All nitrosamines must be identified and quantified by methods sensitive
to 1ppm N-Nitrose contaminants in six samples of each diethanolamine salt end-use product; two samples of
each must be analyzed shortly after production, two at 3 months after production , and two at 6 months after
production.
6/ Upper and lower limits must be submitted for the active ingredient and each intentionally added inert, and upper
~ limits for each impurity present at > 0.1% (w/w) and each "toxicologically significant" impurity present at < 0.1%
(w/w) must be provided and certified. An upper limit for the impurity hydrazine at < 15 ppm must be included.
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~sTgnificance, regardless of the concentration at which they are present. Certifications
M
-------
TABLE B-2
PRODUCT-SPECIFIC DATA REQUIREMENTS FDR PRODUCTS CONTAINING DEA SALT OF MALEIC HYDRAZIDE
Part 158
Subpart C - Product Chemistry (cont'd)
TJ Analytical methods must be provided to determine the active ingredient and each toxicologically significant
impurity intentionally added inert and nitrosamines which certified limits are required. Each method must be
accompanied by validation studies indicating its accuracy and precision. These methods must be suitable for
enforcement of certified limits.
ON
-------
PRODUCT SPECIFIC DATA REPORT
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-H
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
Vaporjressure
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
,
77
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EPA Fbrm 8580-4
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.3^0
TOXICOLOGY
81-1
81-2
81-3
81-1
81-5
81-6
Name of Test
Stability
Ox Id Iz Ing/reduc Ing
reaction
Planmablllty
Explodablllty
Storage stability
Viscosity
Mlsclblllty
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxiclty, rat
Acute deraal
toxlcity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tlon
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
~
78
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SUMMARY-1
LABEL CONTENTS
40 CPR 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
th<
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. [MO CPR 156.10(d)3
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*
[HO CPR 156.10(e)3
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 CPR 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 CPR 156.10(g)]
79
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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 nust 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)(11)]
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)(1)]
Item 7C. SKULL 4 CROSSBONES AND WORD "POISON" - On products
assigned a toxiclty 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)(1)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxiclty Categories I,
II, and in. [40 CFR 156.10(h) (1) (ill)]
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 I62.56(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)].
I 7'
80
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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. [MO CPR 156.10(h)(2)(1)]
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 CPR 156.10(h)(2)(11) ]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - PLAMMABILITY
Precautionary statements relating to flaramabllity of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word .Is
used in conjunction with the flammablllty statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIPRA 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 rereglstration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of Part 152, Subpart I. You will be notified
of the Agency's classification decision.
81
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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. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
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.
82
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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 CPR 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.
83
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00
SUMMARY-?
ITEM
7C
7D
7E
8
8A
BB
LABEL ELEMENT
Skull & cross-
bones and word
POISON (In red)
Statanent 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 toxlclty
All products
In Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
In Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
Is used.
Others:
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
FHEHEKKEU
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.
-------
SUMMARY-8
in
00
ITEM
8C
9A
9B
1QA
10B
1UC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Sane as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COWENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Mist be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR.
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
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Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
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.
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 flare. 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.
86
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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.
87
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BIBGUIDE-2
a. Author. Whenever Che 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 narks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced che
date from evidence in che 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.
88
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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.
89
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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, cans, 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:
Container Type
Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
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.
Glass containers
Fiber drums
with liners
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
reusedj.. dispose of in the same manner.
Paper and
plastic bags
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)
Compressed gas
cylinders
J_/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
90
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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 below contain the exact wording that must appear on
the label of these products:
1. The labels of all products, except domestic use, must contain the
statement, "Do not contaminate water, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"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.
91
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Maleic Hydrazide Standard
MRID CITATION
00058587 Uniroyal Chemical (1951) Maleic hydrazide Residue. (Unpublished
study received Dec 22, 1952 under 400-38; CDL:231l89-L)
00058579 Harris, W.D. (1951) Residue Determinations of Maleic hydrazide In
Milk and Grass. (Unpublished study received Apr 4, 1952 under
400-38; submitted by Uniroyal Chemical, Bethany, Conn.; CDL:
231189-D)
00079657 Shapiro, R. (1977) Acute Oral Toxlclty: Report No. T-235. (Unpub-
lished study received Jan 6, 1978 under 400-84; prepared by
Nutrition International, Inc., submitted by Uniroyal Chemical,
Bethany, Conn.; CDL:232654-G)
00079658 Shapiro, R. (1977) Acute Dermal Toxlclty: Report No. T-242. (Un-
published study recieved Jan 6, 1978 under 400-84; prepared by
Nutrition International, Inc., submitted by Uniroyal Chemical,
Bethany, Conn.; CDL:232654-H)
00079660 Shapiro, R. (1977) Primary Skin Irritation: Report No. T-212.
(Unpublished study received Jan 6, 1978 under 400-84; prepared
by Nutrition International, Inc., submitted by Uniroyal Chem-
ical, Bethany, Conn.; CDL:232654-J)
00079661 Shapiro, R. (1977) Eye Irritation: Report No. T-220. (Unpublished
study received Jan 6, 1978 under 400-84; prepared by Nutrition
International, Inc., submitted by Uniroyal Chemical, Bethany,
Conn.; CDL:232654-K)
00086764 Uniroyal Chemical (1981) Summary of MH Residue In Potatoes Treated
with Royal MH-30. (Compilation; unpublished study received
Npv 3, 1981 under 400-84; CDL:246227-A)
00087392 Outhrle, P.E.; Bowery, T.G. (1967) Pesticide residues on tobacco.
Residue Review 19:31-56. (Also in unpublished submission re-
ceived on unknovn date under unknown admin, no.; submitted by
?; CDL:120496-E)
00087400 Wood, P.R. (1951) Determination of Maleic Hydrazide in Plant and
Anlral Products. Method dated Feb 21, 1951. (Unpublished study
received on unknown date under unknown admin, no.; submitted by
?; CDL:120496-P)
92
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Maleic Hydrazide Standard
MRID CITATION
00098466 Jessup, D.C.; Trunbull, R.R.; Richter, W.R.; et al. (1981) Life-
time Oncogenlclty Study In Wee: 399-007. (Unpublished study
received Jan 1, 1981 under unknown admin, no.; prepared by
International Research and Development Corp., submitted by
Uniroyal Chemical, Bethany, Conn.; CDL:247226-A; 247227)
00100749 Interregional Research Project No. 4 (1980) The Results of Tests
on the Amount of Maleic Hydrazide Residues Remaining in or on
Cranberries Including a Description of the Analytical Method
Used. (Compilation; unpublished study received May 4, 1982
under 2E2676; CDL:070832-A)
00101295 United States Rubber Co. (19??) General Method 0-114-A: Maleic
Hydrazlne (MH) Residues. (Unpublished study received on unknown
date under PP0284; CDL:092562-A)
00101296 United States Rubber Co. (I960) MH Residue In Lemon Juice, in Lemon
Peel and in Whole Lemon. (Unpublished study received on unknown
date under PP0284; CDL:092562-B)
00101298 United States Rubber Co. (I960) [Residues of MH In Cranberries].
(Compilation; unpublished study received on unknown date under
PP0284; CDL:092562-D)
00106267 Lane, J.; Oullstrcm, D.; Newell, J. (1953?) Adaptation of Residue
Methods To Include New Vegetables or To Extend the Sensitivity
Range; Extension of the Residue Methods for Maleic Hydrazide
and Alanap. (Unpublished study received May 10, 1957 under
unknown admin, no.; submitted by Uniroyal Chemical, Bethany,
CT; CDL:121143-A)
00106979 Naugatuck Chemical (1954) [Maleic Hydrazide: Residues In Beans and
Other Crops]. (Compilation; unpublished study received on un-
known date under PP0027; CDL:092309-B)
00106983 Lane, J. (1959) Maleic Hydrazide (MH) Residues: General Method
Q-114-A. (Unpublished study received Feb 16, 1961 under PP0284;
submitted by U.S. Rubber Co., Naugatuck, CT; CDL:092563-A)
00107417 Pink, R. (1974) Final Report: Eight-day Dietary LC50—Mallard
Ducks: [Technical MH]: Project No. 117-106. (Unpublished study
received Aug 20, 1974 under 400-41; prepared by Truslow Farms,
Inc., submitted by Uniroyal Chemical, Bethany, CT; CDL:130997-A)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Maleic Hydrazide Standard
MRID CITATION
00112750 United States Rubber Co. (1957) The Results of Tests by Practicable
Methods to Determine the Amount of the Food Additive [Maleic
Hydrazide] in the Finished Food and of Any Substance Formed
in or on the Food Because of Its Use. (Compilation; unpublished
study received May 26, 1959 under unknown admin, no.; CDL:
221555-B)
00121599 Brown, M.; Hitz, C. (1957) An interpretation of the influence of
malelc hydrazide upon the growth of strawberry runners based
upon radlolsotope studies. Proceedings of the American Society
for Horticultural Science 70:131-143. (Also in unpublished
submission received May 12, 1958 under 400-41; submitted by
Uniroyal Chemical, Bethany, CT; CDL:009740-A)
00121603 Uniroyal Chemical (1978) [Royal MH-30 Residue in Potatoes and Po-
tato Chips]. (Compilation; unpublished study received Sep 7,
1978 under 400-84; CDL:235113-A)
00121605 Uniroyal Chemical (1979) Summary of Royal MH-30 Residue Data.
(Compilation; unpublished study received Jun 29, 1979 under
400-84; CDL:238717-A)
00122361 Uniroyal Chemical (1970) Summary of Residue Data: [Royal MH-30].
(Compilation; unpublished study received Jun 2, 1975 under
400-84; CDL:101097-B)
00122363 Uniroyal Chemical (1956) Onions: [Sprayed with MH-30]. (Unpub-
lished study received May 7, 1959 under 400-41; CDL:120013-A)
00122364 Uniroyal Chemical (1953) Analysis of Potatoes for Dlethanolsmine
Residues from MH-30. (Unpublished study received Feb 24, 1958
under 400-67; CDL.-120039-A)
00122366 Anglln, C.; Mahon, J. (1953?) A Modified Procedure for Detecting
Maleic Hydrazide Residues in Plant Material. (Unpublished study
received on unknown date under unknown admin, no.; prepared by
Canada, Dept. of National Health and Welfare, submitted by 7;
CDL:124447-A)
00122390 Meek, R.; Smyser, B.; Smith, A. (1978) The Bivlronnental Studies on
Maleic Hydrazide. (Unpublished study received Feb 9, 1978 under
400-41; submitted by Uniroyal Chemical, Bethany, CT; CDL:
232908-A)
94
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Malelc Hydrazide Standard
MRID CITATION
00122399 Nooden, L. (1975) The mode of action and metabolism of raalelc
hydrazlde. Environ. Qual. Saf. 3:473-476. (Also in unpublished
submission received Feb 9, 1978 under 400-41; submitted by Unl-
royal Chemical, Bethany, CT; CDL:232908-J)
00124739 Kuc, W. (1977) The Acute Toxiclty of MH Technical QMS 479 BL 8721
to the Blueglll Sunfish, Leponrls macrochirus (Raflnesque) UCES
ProJ. f 11506-29-10. (Unpublished study received Jan 6, 1978
under 400-84; prepared by Union Carbide Corp., submitted by
Uniroyal Chsnieal, Bethany, CT; CDL:232653-A)
00124740 CaLnbacher, C. (1977) The Acute Toxlcity of MH Technical CMS 479,
BL 8721 to the Rainbow Trout, Salrao gairdnerl (Richardson):
UCES ProJ. # 11506-29-10. (Unpublished study received Jan 6,
1978 under 400-84; prepared by Union Carbide Corp., submitted
by Uniroyal Chemical, Bethany, CT; CDL:232653-B)
00124741 Vllkas, A. (1977) The Acute Toxlcity of MH Technical to the Water
Plea, Daphnia magna Straus: UCES ProJ. * 11506-29-10. (Unpub-
lished study received Jan 6, 1978 under 400-84; prepared by
Union Carbide Corp., submitted by Uniroyal Chemical, Bethany,
CT; CDL:232653-C)
00124742 Fink, R.; Beavers, J.; Brown, R. (1977) Acute Oral LD50—Mallard
Duck: MH Technical: Proejct No. 117-130. Final rept. (Unpub-
lished study received Jan 6, 1978 under 400-84; prepared by
Wildlife Ihternatlonl Ltd., submitted by Uniroyal Chemical,
Bethany, CT; CDL:232653-D)
00124883 Jagarmath, D. (1978) Sex-linked Recessive Lethal Assay in Dro-
sophila: Evaluation of Malelc Hydrazlde ... Technical in Dis-
tilled Water 26.78% (W/V): LBI Project No. 20906. Final rept.
(Unpublished study received Feb 27, 1978 under unknown admin.
no.; prepared by Litton Bionetlcs, Inc., submitted by Uniroyal
Chemical, Bethany, CT; CDL:249368-A)
00125636 Uniroyal Chemical (1976?) [Residues of Malelc Hydrazlde]. (Com-
pilation; unpublished study received Feb 16, 1978 under unknown
admin, no.; CDL:249370-B)
95
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Malelc Hydrazlde Standard
MRID CITATION
00125641 Frear, D.; Swanson, H. (1976?) Behavior and Fate of [14C] Malelc
Hydrazlde In Tobacco Plants. (Unpublished study received
Feb 16, 1978 under unknown admin, no.; prepared by U.S. Agricul-
tural Research Service, Metabolism and Radiation Research Labo-
ratory, submitted by Unlroyal Chemical, Bethany, CT; CDL:
249370-L)
00126033 Fink, R.; Beavers, J.; Brown, R. (1977) Eight-day Dietary LC50—
Bobwhite Quail: MH Technical: Project No. 117-129. Final rept.
(Unpublished study received Jan 6, 1978 under 100-84; prepared
by Wildlife International Ltd., submitted by Uniroyal Chemical,
Bethany, CT; CDL:232653-E)
00128720 Mackenzie, K.; Dupre, M.; MacWllliams, P.; et al. (1983) Two-gener-
ation Reproduction Study with KMH In Rats: Study No. 81065.
Final rept. (Unpublished study received Jun 16, 1983 under
400-84; prepared by Hazleton Raltech, Inc., submitted by Unl-
royal Chemical, Bethany, CT; CDL:250522-A)
00128721 Schardeln, J.; Aldrldge, D.; Allen, S.; et al. (1983) Teratology
Study In Rabbits with Potassium Salt of Maleic Hydrazlde: 399-
051. (Unpublished study received Jun 16, 1983 under 400-84;
prepared by International Research and Development Corp., sub-
mitted by Unlroyal Chemical, Bethany, CT; CDL:250523-A)
00141353 Unlroyal, Inc. (1978) Rebuttal to Rebuttable Presumption against
Registration of Malelc Hydrazlde: Volume I. Unpublished compi-
lation, 523 P»
00143322 Unlroyal Chemical Co. (19??): Environmental Data on Malelc Hydrazlde
In Soil and Vfeter:. Unpublished study. 4 p.
00146141 Beavers, J. (1985) An Acute Oral Toxlclty Study In the Mallard with
Potassium Salt of Technical Malelc Hydrazlde: Final Report:
Project. Nb. 117-146. Unpublished study prepared by Wildlife
International, Ltd. 15 p.
00146142 McAllister, W.; Cohle, P. (1984) Acute Toxlclty of Potassium Salt
of Technical Malelc Hydrazlde to Rainbow Trout (Salmo gaird-
nert): 32250. Unpublished study prepared by Analytical Bio-
chemistry laboratories, Inc. 53 P-
96
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Maleic Hydrazide Standard
MRID CITATION
00147000 Beavers, J. (1985) A Dietary LC50 Study in the Mallard with Potas-
sium Salt of Technical Maleic Hydrazide: Final Report: Project
No. 117-145. Unpublished study prepared by Wildlife Interna-
tional, Ltd. 13 p.
00151951 Lengen, M.; Frederick, C. (1985) The Photolysis of (Potassium
Salt) - Maleic Hydrazide in Aqueous Solution and on Soil: Pro-
ject No. 8573. Unpublished study prepared by Uniroyal Chemical.
13 p.
00151952 Lengen, M. (1985) Mobility Studies of (Potassium Salt) - Maleic Hy-
drazide on Soils: Project No. 8574. Unpublished study prepared
by Uniroyal Chemical. 14 p.
00163301 Cable, R. (1986) Octanol/Water Partition Coefficient of Maleic Hy-
drazide. Unpublished study prepared by Drexel Chemical Company.
55 p.
00165460 Uniroyal Chemical Co., Inc. (1970) [Efficacy Data of M3-30 and Oth-
er Pesticides for Control of Suckers on Tobacco]. Unpublished
compilation. 26 p.
05006328 Cohen, S.Z.; Zweig, G.; Law, M.; Wright, D.; Bontoyan, W.R. (1978)
Analytical determination of N-nitroso compounds in pesticides
by the United States Environmental Protection Agency—a
preliminary study. Pages 333-342, In Environmental Aspects
of N-Nitroso Compounds. Washington, D.C.: Environmental
Protection Agency. (IARC scientific publications, vol. 19)
40034802 Lengen, M.; Batorewicz, W. (1986) Field Dissipation of Maleic
Hydrazide—Salt Formulation—Royal M3-30 SG: Project No. 8575.
Unpublished study prepared by Uniroyal Chemical Co., Inc. 75 p.
40149901 Lengen, M. (1986) Anaerobic Soil Metabolism of :Carbon 14: Maleic
Hydrazide—Potassium Salt: [Revised]: Project No. 8634. Unpub-
lished study prepared by Uniroyal Chemical Co., Inc. 25 p.
40663501 Cabral, J.; Ponomarkov, V. (1982) Carcinogenicity Study of the
Pesticide Maleic Hydrazine in mice. Toxicology 24 (2):169-173.
91
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Form Approved. OMB No. 2070-0057. Approval expires 11-30-89.
FIFHA SECTION 3(C>(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
O 1. I will submit data in a timely manner to atisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
D 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
D 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following deta requirements:
D 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
D S. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
£PA Form 8580-1 (10-82)
98
-------
OMB No. 8071X087. Ejq*»» 11-30-«».
.To qualify, etrtlfyALL. four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are tubject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to inter into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm (t) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 85804 (10*2)
99
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EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT
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 jpoint
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
#
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
100
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
6>2l
$158.340
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, 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
101
-------
OMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of generic data on the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer.
(3) An accurate 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 number(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)
EPA Form 8580-3 1 02
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