United States Prevention, Pesticides EPA 738-R-94-010
Environmental Protection And Toxic Substances June 1994
Agency (7508W)
Reregistration
Eligibility Decision (RED)
MALEIC HYDRAZIDE
738R94010
SM-X)
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
8 SEP 1994
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case 0381 which
includes the active ingredients maleic hydrazide, and maleic hydrazide potassium salt. The
enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the
data base of these chemicals, its conclusions of the potential human health and environmental
risks of the current product uses, and its decisions and conditions under which these uses and
products will be eligible for reregistration. The RED includes the data and labeling
requirements for products for reregistration. It may also include requirements for additional
data (generic) on the active ingredients to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Franklin Gee at (703) 308-8008. Address any questions on required generic data to the
Special Review and Reregistration Division representative Susanne Cerrelli at (703)-308-
8077.
Sincerely yours,
r **+L
Daniel M. Barolo, Director
Special Review and /
Reregistration Division
Enclosures
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e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOHCE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Matt;
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C) -
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Divis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS-EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
MALEIC HYDRAZIDE
LIST A
CASE 0381
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
MALEIC HYDRAZIDE REREGISTRAT1ON ELIGmiLITY DECISION TEAM . . . . i
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 3
C. Estimated Usage of Pesticide 4
D. Data Requirements 6
E. Regulatory History 7
HI. SCIENCE ASSESSMENT 8
A. Physical Chemistry Assessment 8
B. Human Health Assessment 9
1. Toxicology Assessment 9
a. Acute Toxicity 10
b. Subchronic Toxicity 10
c. Chronic toxicity 11
d. Carcinogenicity 11
e. Developmental Toxicity 12
f. Reproductive Toxicity 13
g. Mutagenicity 14
h. Metabolism 16
i. Neurotoxicity 16
j. Other Toxicological Considerations 16
k. Reference Dose 17
2. Exposure Assessment 18
a. Dietary Exposure 18
b. Occupational and Residential 19
3. Risk Assessment 20
a. Dietary ; 20
b. Occupational and Residential 22
C. Environmental Assessment 23
1. Environmental Fate 23
a. Environmental Chemistry, Fate and Transport 23
b. Environmental Fate Assessment 24
2. Ecological Effects 26
a. Ecological Effects Data 26
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(1) Terrestrial Data 26
(2) Aquatic Data 27
(3) Non-Target Insects Data 28
(4) Non-Target Plants Data 28
b. Ecological Effects Risk Assessment 32
(1) Terrestrial Organisms 32
(2) Aquatic Organisms 36
(3) Non-Target Insects 37
(4) Non-Target Plants 37
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 42
A. Determination of Eligibility 42
1. Eligibility Decision 43
2. Eligible and Ineligible Uses 43
B. Regulatory Position 43
1. Tolerance Reassessment 44
2. Endangered Species Statement 46
3. Labeling Rationale 47
V. ACTIONS REQUIRED BY REGISTRANTS 48
A. Manufacturing-Use Products 48
1. Additional Generic Data Requirements 48
B. End-Use Products 43
1. Additional Product-Specific Data Requirements 48
2. Labeling Requirements for End-Use Products 49
C. Existing Stocks 50
VL APPENDICES 51
APPENDIX A. Table of Use Patterns Subject to Reregistration 53
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 71
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Maleic Hydrazide 85
APPENDIX D. List of Available Related Documents 105
APPENDIX E 109
PR Notice 86-5 Ill
PR Notice 91-2 131
APPENDIX F. Combined Generic and Product Specific Data Call-In 137
Attachment 1. Chemical Status Sheets 155
Attachment 2. Combined Generic and Product Specific Data Call-In
Response Forms (Form A inserts) Plus Instructions 159
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and Instructions
165
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Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 173
Attachment 5. EPA Acceptance Criteria 179
Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
193
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 195
APPENDIX G. FACT SHEET 205
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MALEIC HYDRAZIDE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Kitty Keough
Phyllis Johnson
Sandy Zavolta
Environmental Fate and Effects Division
Stephanie Syslo
William Erickson
Sharlene Matten
Health • Effects • Division
Edwin Budd
Jane Smith
Jeff Evans
William Smith
Registration Division
Dolphine Wilson
Ian Blackwell
Special Review and Reregistration Division
Susanne Cerrelli
Linda Propst
Carol Stangel
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Toxicology Branch I
Chemical Coordination Branch
Occupational and Residential Exposure Branch
Reregistration Support Chemistry Branch
Fungicide-Herbicide Branch
Registration Support Branch
Reregistration Branch
Reregistration Branch
Planning and Reregistration Branch
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i
CAS
CSF
DWEL
EEC
EP
EPA
FDA
FIFRA
FFDCA
GRAS
HA
HOT
LC50
LD
'50
Active Ingredient
Chemical Abstracts Service
Confidential Statement of Formula
Drinking Water Equivalent Level (DWEL) The DWEL represents a medium
specific (i.e. drinking water) lifetime exposure at which adverse, non
carcinogenic health effects are not anticipated to occur.
Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Generally Recognized As Safe as designated by FDA
Health Advisory (HA) The HA values are used as informal guidance to
municipalities and other organizations when emergency spills or contamination
situations occur.
Highest Dose Tested
Median Lethal Concentration. A statistically derived concentration of a
substance that can be expected to cause death in 50% of test animals. It is
usually expressed as the weight of substance per weight or volume of water, air
or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.
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GLOSSARY OF TERMS AND ABBREVIATIONS
Ldlo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOG Level of Concern
LOEL Lowest Observed Effect Level
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the
Agency to regulate contaminants in drinking water under the Safe Drinking
Water Act.
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MOE Margin Of Exposure
MRID Master Record Identification (number). EPA's system of recording and
tracking studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer
Risk Model
RED Reregistration Eligibility Decision
RiD Reference Dose
RS Registration Standard
IV
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GLOSSARY OF TERMS AND ABBREVIATIONS
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The concentration at which a substance produces a toxic
effect.
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
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EXECUTIVE SUMMARY
Reregistration Decision
The Agency has determined that all uses of currently registered products containing
maleic hydrazide and maleic hydrazide potassium salt are eligible for reregistration. The
maleic hydrazide diethanolamine salt is not addressed in this document because all maleic
hydrazide diethanolamine salt products are cancelled. Except where otherwise noted, the term
"maleic hydrazide," in this document refers to the technical acid and the potassium salt of
maleic hydrazide. The Agency has determined that the uses of maleic hydrazide and maleic
hydrazide potassium salt as currently registered will not cause unreasonable risk to humans.
The use of maleic hydrazide and maleic hydrazide potassium salt may adversely effect non-
target plants. The scientific data base is adequate to support the reregistration eligibility of all
registered uses of maleic hydrazide. The Agency is, however, requiring the following
additional data to confirm the risk assessments: animal metabolism [Guideline 171-4(b)];
residue analytical method for animal commodities [Guideline 171-4(d)]; magnitude of the
residue in animal commodities [Guideline 171-4(j)]; confined rotational crops [Guideline 165-
1]; droplet size spectrum [Guideline 201-1]; and drift field evaluation [Guideline 202-1] data
requirements. All of these data requirements except for Guidelines 171-4(b), 171-4(d) and 17-
4(j) were included in a Data Call-In (DCI) issued November 16, 1992 and are currently being
generated. The Data Call-In Notice in Appendix F addresses the remaining generic data
requirements (Guidelines 171-4(b), 171-4(d) and 171-4(j)). The rationale for these
requirements is presented below.
Background
Maleic hydrazide is a plant growth regulator (sprout inhibitor) and herbicide whose
mode of activity is as a uracil antimetabolite. It is registered for use on tobacco, potatoes,
onions, non-bearing citrus, turf, utility and highway rights-of-way, airports, industrial land,
lawns, recreational areas, ornamental/shade trees and ornamental plants. Use on cranberries
is neither registered nor supported. The existing tolerance for residues of maleic hydrazide on
cranberries will be revoked.
In 1982 the Agency established an upper limit for hydrazine, a contaminant, at <_15
ppm in technical grade products containing maleic hydrazide. Hydrazine has been associated
with tumor induction in animals. This level alleviates any concern based on estimates of
excess lifetime carcinogenic risks to humans considering both dietary and worker exposure.
The Agency continues to require that the hydrazine content of the technical chemical be
limited to ^15 ppm.
VI
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In June 1988, the Registration Standard on Maleic Hydrazide (NTIS #PB88-236849)
was issued. This document identified additional generic data required to support the continued
registration of maleic hydrazide as an herbicide and plant growth regulator. A Data Call-In
was issued November 15, 1992 for additional ecological effects and environmental fate data
requirements. The Agency has now completed its evaluation of the data base for maleic
hydrazide.
Supporting Rationales for Reregistration Decision
Maleic hydrazide and the potassium salt of maleic hydrazide are considered to be
equivalent with respect to fulfillment of applicable toxicity study requirements.
Acute toxicity studies indicate that maleic hydrazide is practically non-toxic by the oral
route (Toxicity Category IV in rat), practically non-toxic by the dermal route (Toxicity
Category IV in rabbit), and practically non-toxic by the inhalation route (Toxicity Category IV
in rat). Maleic hydrazide is a slight dermal irritant (Category IV in rabbit), causes only a
slight irritation to the eyes (Toxicity Category HI in rabbit), and is not a dermal sensitizer.
Maleic hydrazide does not appear to cause any adverse developmental or reproductive
effects of concern. The potassium salt of maleic hydrazide was not found to be carcinogenic
and the chemical was classified as a "Group E" carcinogen by OPP's Health Effects Division
RfD Peer Review Committee.
Maleic hydrazide appears to be genotoxic at high doses in some of the mutagenicity
tests. Since maleic hydrazide is an uracil antimetabolite and this is presumably its mechanism
of action with respect to its plant growth regulator/herbicidal properties, it might be expected
that equivocal or positive results would be observed in some genotoxicity tests. When the
totality of genotoxicity studies is considered together with the results of all the other
lexicological studies on maleic hydrazide and its potassium salt, including, negative
carcinogenicity studies in rats and mice, it was concluded that the potential human genotoxic
hazard is negligible.
The RfD was established at 0.25 mg/kg/day based on chronic feeding studies in rats
and dogs and an uncertainty factor of 100. The estimated TMRC for the overall U.S.
population from food uses of maleic hydrazide is 0.074 mg/kg bodyweight per day, which
represents 29.5% of the reference dose. The vast majority of the estimate (27.5% of the RfD)
was from potatoes. For the most highly exposed subgroup, children (one to six years old), the
estimated TMRC is 0.151 mg/kg bodyweight per day, which represents 60.3% of the RfD.
There is a potential for mixer/loader/applicator (handlers) exposure via the inhalation
and dermal routes. However, the risk posed by this chemical is considered minimal for all
workers based on the lack of lexicological concerns. A mixer/loader/ applicator risk
assessmenl based on potential development toxicity was discussed in ihe Regislration
Vll
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Standard Guidance document issued in June 1988. Since then, additional information and
studies have been submitted which demonstrate developmental effects are no longer a concern.
There are currently no maleic hydrazide tolerances for animal commodities. The
appropriate information concerning animal metabolism, analytical methodology and magnitude
of the residue in meat, milk, poultry and eggs to establish tolerances at this time has not been
submitted to the Agency, but are currently being generated and are due December 20, 1995.
However, suitable data have been submitted to enable a reasonable worst case dietary risk
assessment to be conducted. These data are derived from analysis of the total radioactivity in
milk and tissues found in animals that were fed [14C]maleic hydrazide. The additional data
required on animal metabolism, analytical methodology and magnitude of the residue in meat,
milk, poultry and eggs data will be used to confirm this assessment and to establish tolerances'.
Preliminary studies have indicated that detectable residues could occur on winter wheat
planted as a rotational crop in fields that have been treated with maleic hydrazide. Further
data have been required to determine if there is a need for establishment of rotational
tolerances or suitable plant-back intervals to avoid these residues. However, these data are
considered to be confirmatory. The available data base is adequate to make a reasonable
upper bound dietary risk assessment and conclude that the risk is not significant.
The major route of dissipation of maleic hydrazide in the environment is by biotic
processes. Hydrolysis, photodegradation, and volatilization do not appear to play a significant
role in the dissipation process. Based on available data, maleic hydrazide does not appear to
be persistent in the soil under aerobic conditions but is somewhat more persistent under
anaerobic conditions. However, because of its high solubility and mobility, there is potential
for surface water runoff. The potential for maleic hydrazide to bioaccumulate in fish is very
low.
Based on available information, maleic hydrazide is not likely to impact ground-water
quality. However, maleic hydrazide has the potential to move off site and thus exceeds the
level of concern for surface water contamination. In addition, maleic hydrazide is aerially or
air-blast applied, so there is the potential for drift from approved use sites which could affect
non-target crops or areas containing endangered plant species. Therefore, in order to assess
the extent of this exposure, the spray drift data requirements (Guidelines 201-1 and 202-1)
were imposed in the November 1992 DCI. The Agency is requiring that a surface water
advisory statement and spray drift management information be added to the maleic hydrazide
end-use product labels.
From the ecological effects data analyzed, the following conclusions were reached:
there are minimal acute risks to avian, mammalian, and aquatic species from acute and dietary
exposure to maleic hydrazide; no chronic data were required; and there is minimal risk to
non-target insects and non-target aquatic plants from the use of maleic hydrazide.
vui
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The levels of concern (LOCs) for semi-aquatic plants were exceeded from runoff onto
wet areas for all use sites and the LOCs for terrestrial plants were exceeded by direct
application to rights-of-way. To mitigate the exposure of non-target plants at the sites where
the highest application rates are used, the Agency is requiring that the number of applications
to fallow land, rights-of way, turf, and lawns be limited to 1 per year. When the Agency
completes its Endangered Species program, additional precautionary labeling may be required
to mitigate the risk to endangered plant species.
Before reregistering the products containing maleic hydrazide, the Agency is
requiring that product specific data, revised Confidential Statements of Formula (CSF) and
revised labeling be submitted within eight months of the issuance of this document. These data
include product chemistry and acute toxicity testing for each registration. After reviewing
these data and any revised labels and finding them acceptable in accordance with Section
3(c)(5) of FIFRA, the Agency will reregister a product. Those products which contain other
active ingredients will be eligible for reregistration only when the other active ingredients are
determined to be eligible for reregistration.
IX
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
of an active ingredient and the generation and submission of data to fulfill the requirements.
The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for reregistration" before calling in
data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration 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" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of maleic hydrazide. The document consists of six sections. Section I is the
introduction. Section n describes maleic hydrazide, its uses, data requirements and regulatory
history. Section III discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregistration decision for maleic hydrazide
Section V discusses the reregistration requirements for maleic hydrazide. Finally, Section VI
is the Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredients are covered by this Reregistration Eligibility
Decision:
• Common Name: Maleic Hydrazide
• Chemical Name: l,2-dihydro-3,6-pyridazinedione
• CAS Registry Number: 123-33-1
• OPP Chemical Code: 051501
• Empirical Formula: C4H4N2O2
• Trade and Other Names: MH
• Basic Manufacturers: Uniroyal Chemical Company, Inc., Drexel
Chemical Company, and Fair Products Inc.
• Common Name: Maleic Hydrazide, potassium salt
• Chemical Name: l,2-dihydro-3,6-pyridazinedione, potassium salt
• CAS Registry Number: 28382-15-2
• • OPP Chemical Code: 051503
• Empirical Formula: KC4H3N2O2
• Trade and Other Names: KMH, Sucker-Stuff, Super Sprout Stop, Super
Sucker-Stuff, Retard
• Basic Manufacturers: Uniroyal Chemical Company, Inc., Drexel
Chemical Company, and Fair Products Inc.
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B. Use Profile
Information on the currently registered uses of maleic hydrazide use sites and
application methods is presented below. A detailed table of the uses of maleic
hydrazide (051501) and the potassium salt of maleic hydrazide (051503) is presented in
Appendix A.
For l,2-dihydro-3.6-pyridinedione, potassium salt (maleic hydrazide, potassium salt):
Type of Pesticide: Plant growth regulator, Herbicide
Mechanism of Action: A growth retardant which inhibits miotic division in plants.
This mode of action has been utilized to control suckers in tobacco, sprouting of
potatoes, the growth of grasses (a substitute for mechanical mowing), and the growth
of certain ornamental trees and shrubs (to reduce the frequency of manual pruning).
Weeds are indirectly killed by the inhibition of growth, which prevents flowering and
seed production or weakens perennial weeds to the point of not being able to survive a
winter.
Use Groups and Sites:
TERRESTRIAL FOOD CROP
Onion
TERRESTRIAL FOOD + FEED CROP
Potato
TERRESTRIAL NONFOOD CROP
Agricultural fallow/idleland, airports/landing fields, non-bearing orchard crops (citrus
fruits), commercial/industrial lawns, golf course turf, industrial areas, rights-of-way,
nonagricultural uncultivated areas, ornamental and/or shade trees, ornamental lawns
and turf, ornamental woody shrubs and vines, recreational areas, tobacco
OUTDOOR RESIDENTIAL
Residential lawns
Target Pests:
bigleaf maple, silver maple, quackgrass, bentgrass, bromegrass, bermudagrass,
orchardgrass, fescue, perennial rye, red rice, bluegrass, wild onion, wild garlic,
eucalyptus, sycamore, London planetree, cottonwood, silverleaf nightshade
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Formulation Types Registered:
Single Active Ingredient Products
Emulsifiable concentrate-8%
Soluble concentrate/liquid-21.6 to 33.3%
Soluble concentrate/solid~80%
Multiple Active Ingredient (AI) Product
Emulsifiable concentrate—11.1% + 1 other AI
Method and Rates of Application:
Emulsifiable concentrate
In spring or fall, at dormant or foliar stage, spray by backpack or compressed-air
sprayer at 2.1 to 6.6 Ib acid equivalent (AE)/ acre or 0.08 to 0.12 Ib AE/667 plants.
In spring or fall, apply edging treatment by hose-end sprayer at 4.4 Ib AE/acre.
Soluble concentrate/liquid
At pre-or postharvest, foliar, nonbearing, or dormant stage, or in spring, summer or
fall, spray by aircraft, ground, airblast, boom, compressed-air, tractor-mounted, or
hose-end sprayer at 1.2 to 9 Ib AE/acre or 0.03 to 0.05 Ib AE/gal or 0.3 to 0.6 Ib
AE/1,000 plants. When needed, treat trees by injection with suitable equipment at 0.9
Ib AE/gal. In fall or spring, apply edging treatment by boom, compressed-air, or
hose-end sprayer at 0.7 to 6 Ib AE/acre or 0.035 Ib AE/gal.
Soluble concentrate/solid
At pre- or postharvest or foliar stage, in spring, summer, or fall, spray by aircraft,
ground, airblast, boom, tractor-mounted, or compressed-air sprayer at 2 to 9 Ib
AE/acre or 1.8 tbsp AE/gal or 0.03 to 0.2 Ib AE/gal. In spring or fall, apply edging
treatment by compressed-air or hose-end sprayer at 0.75 Ib AE/acre or 1.8 Tbsp
AE/gal or 0.2 Ib AE/gal.
Use Practices Limitations:
Do not treat within 7 days of harvest. Do not graze or feed forage or hay from treated
areas to livestock.
C. Estimated Usage of Pesticide
This section summarizes the best usage estimates available for maleic hydrazide.
These estimates are derived from a variety of published and proprietary sources
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available to the Agency. The data, reported on an aggregate and site (crop) basis,
reflect annual fluctuations in use patterns as well as the variability in using data from
various information sources.
Approximately 2.9 to 3.1 million pounds of maleic hydrazide active ingredient
(a.i.) was applied on 722 to 1,045 thousand acres annually between 1990 and 1991 (see
Table 1). Growers applied maleic hydrazide to tobacco, Irish potatoes, onions, and
garlic. An overwhelming majority of the pounds (86%) was applied to tobacco. Only
3% of the total use on tobacco is applied to dark tobacco. Many of these acres appear
to be treated more than once. If all of these applications were double treatments, an
average of 78% of the total tobacco acres were treated annually. However, this
estimate of a.i. and acres treated includes multiple treatments for a given year and;
thus, would decrease depending on the number of multiple treatments.
Maleic hydrazide constitutes a small part of the non-agricultural plant growth
regulator market. Information on the use of maleic hydrazide on rights-of-ways or
roadways to slow the growth of weeds, hedges, and trees is limited. Maleic hydrazide
comprises about 50% of the total pounds a.i. of plant growth regulators applied for
electric utility uses in the United States. Electric utility companies may apply maleic
hydrazide when utilizing mechanical tree trimming. Trees, mostly near residential
areas and commercial developments, may be injected with maleic hydrazide to slow the
growth. Maleic hydrazide is also applied on roadways to control the plant growth.
State agencies may purchase large quantities of maleic hydrazide and apply it over
more than one growing season. Documentation of the specific numerical statistics of
these uses was not found.
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The table below summarizes the usage by site.
ESTIMATED CURRENT U.S ANNUAL MALEIC HYDRAZIDE USAGE BY SITE, 1990-1991
APPROXIMATE QUANTITY A.I.
Site
Garlic
Irish Potatoes
Onions
Tobacco
dark
Trees,
Shrubs, Ivy
Other
TOTAL
Pounds
(000)
low high
6- 10
300- 350
40- 55
2,500 - 2,700
75- 80
3- 4
7- 8
2,856- 3127
Percentage of
Total Usage"
0.2- 0.3
10- 11
1 - 2
88- 86
n/a
.1- .1
.2- .3
100 - 100.0
ESTIMATED
ACREAGE TREATED
Multiple Acre U.S. Acres
Treatments1* Harvested
(000) (000)
low high
2- 5
100- 115
20- 25
600- 900
10- 18
n/a n/a
n/a n/a
722- 1,045
23
1,343
138
724
n/a
n/a
n/a
Percentage of
Acreage Planted
low high
9- 22
10- 20
15 18
65- 91
n/a n/a
n/a n/a
n/a n/a
n/a n/a
n/a not available
" Percentages are based on the average values.
b The number of acres treated per year including repeat treatments
D. Data Requirements
Data requested in the June 1988 Registration Standard for Maleic Hydrazide
include studies on product chemistry, ecological effects, environmental fate, toxicology
and residue chemistry. On November 16,1992 a Data Call In was issued for MH and K-
MH which required additional data to address ecological effects, environmental fate and
residue chemistry data gaps. Appendix B includes all data requirements identified by the
Agency for currently registered uses needed to support reregistration.
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E. Regulatory History
Maleic hydrazide (MH) was first synthesized in 1895 but its ability to regulate
plant growth was not discovered until 1949. The chemical was registered by USDA in
1952 for use as a plant growth regulator. In October 1976, it was referred to the Agency
for a Rebuttable Presumption Against Registration (RPAR) (now known as Special
Review) based on laboratory studies which indicated that MH induced carcinogenic,
mutagenic, and reproductive effects. In October 1977, the Agency initiated the RPAR
review by publishing a Position Document 1 (PD 1) for MH. The PD 1 described studies
which met or exceeded the RPAR criteria for carcinogenic, 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 carcinogenic, mutagenic, and reproductive effects. The potential
risk of maleic hydrazide could not be adequately assessed because of the paucity of valid
toxicological information and conflicting results of studies. In an attempt to resolve these
issues, the Agency issued a Data Call In Notice (DCI) August 14, 1980 requiring all MH
registrants to submit data regarding the reproductive effects and mutagenic potential of the
diethanolamine salt of maleic hydrazide (DEA-MH) and the potassium salt of maleic
hydrazide (K-MH).
On February 26, 1981, the manufacturers agreed to submit the required data on
K-MH. The manufacturers of the DEA-MH did not commit to submit the additional data.
Consequently, the Agency suspended all DEA-MH registrations in November 1981. At
the present time, all DEA-MH registrations are cancelled.
The Agency evaluated the information submitted in response to the August 1980
DCI and determined that two of the three RPAR triggers (carcinogenicity and reproductive
effects) were not supported. It was also determined that only extremely weak suggestive
evidence supported the contention that MH is mutagenic in mammalian systems, and that
additional mutagenicity studies were needed.
During this evaluation the Agency considered the possibility that hydrazine
contamination might help determine the carcinogenic potential of maleic hydrazide. The
Agency reached this conclusion because two similar studies showed different results:
Epstein and Mantel (1968) reported an increased incidence in hepatomas, at the same time
Cabral et. 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 Epstein study and less than 1 ppm in the study by Cabral.
Several animal studies have associated hydrazine with tumor induction.
In June 1982, the PD-4 was published. The final decision was to allow the
continued use of potassium salt of MH and to establish an upper limit of 15 ppm hydrazine
(a contaminant) in technical grade products containing maleic hydrazide. The Agency
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determined that this level would not cause concern based on estimates of excess lifetime
carcinogenic risks to humans for both worker and dietary exposure.
The Registration Standard on Maleic Hydrazide (NTIS #PB88-236849) was issued
in June 1988. In the Standard the Agency continued to require that the hydrazine content
of the technical chemical be limited to <_15 ppm. On November 16, 1992 a Data Call In
was issued for MH and K-MH which required additional data to address ecological effects,
environmental fate and residue chemistry data gaps. This Reregistration Eligibility
Decision reflects a reassessment of all data submitted to date in response to the
Registration Standard and the November 1992 DCI.
m. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
DESCRIPTION OF CHEMICAL
Maleic hydrazide (l,2-dihydro-3,6-pyridazinedione) is a plant growth regulator and
herbicide. The molecular structure of maleic hydrazide is illustrated below:
OH
Maleic Hydrazide
Other identifying characteristics and codes are:
Empirical Formula: C4H4N202
Molecular Weight: 112.1
CAS Registry No.: 123-33-1
OPP Chemical Code: 051501
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IDENTIFICATION OF ACTIVE INGREDIENT
Technical maleic hydrazide is a white crystalline powder with a melting point of
292°C and decomposes at above 300°C. It is stable to hydrolysis but is decomposed by
strong oxidizing agents with release of nitrogen. Maleic hydrazide behaves as a mono-
basic acid and forms salts; its alkali metal (potassium) salt is water soluble (50% at 25°C).
The Agency published a Position Document (PD-4) for maleic hydrazide in June, 1982
and established an acceptable limit of hydrazine (a contaminant) at 15 ppm in technical
grade products to avoid the potential for unreasonable adverse effects.
Other Product Chemistry Issues
All pertinent data requirements for Uniroyal's maleic hydrazide 97% T (EPA Reg.
No. 400-97) have been satisfied. All pertinent data requirements for Drexel's maleic
hydrazide 95% T and 97% T (EPA Reg. Nos. 19713-25 and 19713-26, respectively) have
been satisfied. In addition, Fair Products Inc. has satisfied all pertinent data requirements
for the maleic hydrazide 96% T (EPA Reg. No. 51873-10) with the exception of the
required information regarding oxidizing/reducing action, and storage stability (Guideline
Ref. Nos. 63-14 and 63-17). These data are considered confirmatory.
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base in support of the food uses for maleic hydrazide
is adequate and will support reregistration.
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a. Acute Toxicity
Acute toxicity data for maleic hydrazide are listed in the table
below.
Acute Toxicity
Test Result Category
Acute Oral LD50 > 5000 mg/kg IV
(rat)1-'
Acute Dermal LD50 (rabbit)2' "
Acute Inhalation LC50 (rat)3- b
Eye Irritation (rabbit)4- a
Dermal Irritation (rabbit)5- a
Skin Sensitization (guinea pig)6-
b
> 20,000 mg/kg
> 4.0 mg/L
slight irritation
slight irritation
Negative
IV
IV
m
IV
N/A
M MRIDs 00079657, 00079658, 41185401, 00079661, 00079660, and 41289101
a Test material was technical grade maleic hydrazide.
b Test material was 97.8% potassium salt of maleic hydrazide.
N/A = not applicable
b. Subchronic Toxicity
In a 21-day dermal toxicity study, male and female Sprague-Dawley
rats were treated for 6 hours per day for 3 weeks with a solution of the
potassium salt of maleic hydrazide in distilled water. Dosage levels were
0, 100, 500 or 1000 mg/kg/day. Parameters examined included clinical
signs of toxicity, mortality, body weights, food and water consumption,
hematology, clinical chemistry, necropsy, organ weights and
histopathological examination of selected tissues/organs. The test material
was essentially non-irritating to the skin and there were no treatment-
related effects observed at any dosage level. The NOEL for dermal
toxicity and the NOEL for systemic toxicity are both > 1000 mg/kg/day
(MRID 41289102) ~~
10
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c. Chronic toxicity
A chronic feeding/carcinogenicity study was conducted using male
and female Sprague-Dawley rats (50/sex/group) which were fed diets
containing the potassium salt of maleic hydrazide at dosage levels
equivalent to 0, 25, 500 or 1000 mg/kg/day of maleic hydrazide for 104
weeks. Additional animals (20/sex/group) were fed identical diets but were
sacrificed and examined at 52 weeks. Treatment-related decreases in
absolute body weights were consistently observed after 72 weeks for males
at 500 and 1000 mg/kg/day and after 4 weeks for females at 1000
mg/kg/day. Body weight gains for weeks 0 -104 were decreased 13% for
males at both 500 and 1000 mg/kg/day and 20% for females at 1000
mg/kg/day. There were no other effects observed during the study that
were clearly attributed to treatment with the test material. Parameters
examined included clinical signs of toxicity, mortality, food consumption,
ophthalmoscopy, hematology, clinical chemistry, urinalyses, organ
weights, necropsy and histopathologic examination of tissues/organs.
Therefore, the NOEL for systemic toxicity is 25 mg/kg/day and the LOEL
is 500 mg/kg/day. (MRID 42570101, 42770401)
The potassium salt of maleic hydrazide was incorporated in the feed
of male and female beagle dogs (6/sex/group) at dietary levels of 0, 750,
2500 or 25000 ppm of maleic hydrazide for 52 weeks. These levels were
equivalent to 0, 29, 87 and 974 mg/kg/day of maleic hydrazide for males
and 0, 29, 105 and 974 mg/kg/day for females. No effects attributed to the
test material were observed at 750 ppm. At 2500 ppm, decreased body
weight gains of 32% were observed in males and 22% in females for
weeks 0-52. Reduced heart weight was also observed in males at 2500
ppm. At 25000 ppm, additional treatment-related effects included reduced
heart weight in females, increased thyroid weight in females and thyroid
focal follicular epithelial hypertrophy in males and females, and increased
hepatic lobulation and inflammation in males and females. The NOEL is
750 ppm (29 mg/kg/day) of maleic hydrazide. The LOEL is 2500 ppm (87
mg/kg/day and 105 mg/kg/day for males and females respectively) of
maleic hydrazide. (MRID 42214101, 42248101)
d. Carcinogenicity
A chronic feeding/carcinogenicity study was conducted using male
and female Sprague-Dawley rats (50/sex/group) which were fed diets
containing the potassium salt of maleic hydrazide at dosage levels
equivalent to 0, 25, 500 or 1000 mg/kg/day of maleic hydrazide for 104
weeks. Additional animals (20/sex/group) were fed identical diets but were
sacrificed and examined at 52 weeks. There were no neoplastic findings
11
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observed in this study in either males or females that were considered
related to the test material. The potassium salt of maleic hydrazide was not
carcinogenic under the conditions of this study. (MRID 42570101
42770401)
The potassium salt of maleic hydrazide was incorporated in the feed
of male and female CD-I mice (50/sex/group) at dietary levels of 0, 1000,
3200 or 10000 ppm of maleic hydrazide for 23 months. These levels were
equivalent to 0, 157, 509 and 1545 mg/kg/day of maleic hydrazide for
males and 0, 189, 598 and 1811 mg/kg/day for females. There were no
treatment-related effects observed during the study. Parameters examined
included clinical signs of toxicity, mortality, body weights, food
consumption, hematology, necropsy and histopathologic examination of
tissues/organs. At 10000 ppm, slightly increased incidence in female mice
of uterine hemangiomas (0, 0, 0 and 2 in the control, low, mid and high
dose groups, respectively) and of lung adenomas (3, 3, 0 and 7 in the
control, low, mid and high dose groups, respectively) were not considered
to be related to treatment with the test material. The potassium salt of
maleic hydrazide was not carcinogenic under the conditions of this study
(MRID 00097886, 00098466)
e. Developmental Toxicity
A developmental toxicity study was conducted with pregnant
Sprague-Dawley rats (23-25/group) which were given daily doses of the
potassium salt of maleic hydrazide by oral gavage on days 6 through 16 of
gestation. Doses were selected to be equivalent to 0, 30, 300 or 1000
mg/kg/day of maleic hydrazide. The dams were sacrificed on day 20 and
the fetuses examined. No treatment-related maternal effects or effects on
reproductive performance of dams were observed. Slightly increased
incidence of numbers of fetuses with testicular displacements or with
supernumerary 14th ribs were noted in the maleic hydrazide treated
animals, but were determined to be within the range of recent historical
control incidence and were not considered to be related to treatment with
the test material. The NOELs for maternal toxicity and for developmental
toxicity are both *1000 mg/kg/day of maleic hydrazide. (MRID 41458201
41702901)
In a second developmental toxicity study on rats, pregnant Wistar
rats (20/group) were given daily doses of 0, 400, 800, 1200 or 1600
mg/kg/day of maleic hydrazide dissolved in corn oil by oral gavage on days
6 through 15 of gestation. The dams were sacrificed on day 22 and the
fetuses examined. No adverse maternal effects or effects on reproductive
12
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performance were observed. At 1600 mg/kg/day, a slightly increased
incidence of numbers of fetuses with minor skeletal variations was
observed. The NOEL for maternal toxicity is 1600 mg/kg/day of maleic
hydrazide. The NOEL and LOEL for developmental toxicity are 1200
mg/kg/day and 1600 mg/kg/day, respectively, of maleic hydrazide.
(MRID 40874202, 41055903)
Pregnant Dutch Belted rabbits (16/group) were given daily doses of
the potassium salt of maleic hydrazide by oral gavage on days 7 through 27
of gestation. The doses were equivalent to 0, 100, 300 or 1000 mg/kg/day
of maleic hydrazide. The does were sacrificed on day 28 and the fetuses
examined for external, visceral and skeletal abnormalities. No treatment-
related adverse maternal effects or effects on reproductive indices were
observed. At 300 mg/kg/day and 1000 mg/kg/day, increased incidence of
fetuses with malformations of the scapula were noted (0, 0, 4 and 2 for the
control, low, mid and high dose groups, respectively). To more fully
assess this potential effect, additional information was requested in the 1988
Registration Standard. Following receipt and evaluation of the requested
information, the malformed scapulae observed in this study were
determined to not be treatment-related. Therefore, the NOELs for
maternal toxicity and for developmental toxicity in this study are both
>1000 mg/kg/day of maleic hydrazide, the highest dose tested. (MRID
00128721, 40985311)
When the negative developmental toxicity study in rabbits was
considered together with the two developmental toxicity studies in rats that
were also negative (except for some minor skeletal variations noted in one
study at the very high dose of 1600 mg/kg/day), the RfD Committee
(8/5/93) dismissed developmental toxicity as an issue of concern for maleic
hydrazide.
f. Reproductive Toxicity
In a standard 2-generation reproduction study with 2 litters per
generation, the potassium salt of maleic hydrazide was incorporated
continuously in the feed of male and female Sprague-Dawley rats at dietary
levels of 0, 1000, 10000 or 30000 ppm of maleic hydrazide for 2
successive generations. These levels were equivalent to 0, 81, 791 and
2405 mg/kg/day of maleic hydrazide for males and 0, 97, 932 and 2874
mg/kg/day for females. Parental animal groups (F0 and Flb) consisted of
15 males and 30 females per group. An additional dietary level of 50000
ppm was discontinued during the study because of reduced body weights
of F0 adults and Flb pups. The reproductive indices of male and female
13
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parents were not adversely affected by the test material at any treatment
level or at any time during the study. At 30000 ppm, however, reduced
body weight gains were observed for F0 female parental animals during
growth and reproduction phases and increased mortality was noted for Plb
parental animals. Therefore, the parental NOEL is 10000 ppm (791
mg/kg/day and 932 mg/kg/day for males and females respectively) of
maleic hydrazide and the LOEL is 30000 ppm (2405 mg/kg/day and 2874
mg/kg/day for males and females, respectively). At 30000 ppm, decreased
body weight gains were also observed for Fjb, F^ and F2b pups during
lactation. Based on these decreased body weight gains for pups, the
developmental NOEL is 10000 ppm (791 mg/kg/day and 932 mg/kg/day
for males and females, respectively) of maleic hydrazide and the LOEL is
30000 ppm (2405 mg/kg/day and 2874 mg/kg/day for males and females
respectively). (MRID 00128720)
g. Mutagenicity
A Salmonella typhimurium reverse mutation assay (Ames assay)
was conducted using the potassium salt of maleic hydrazide as the test
material. Strains TA98, TA100, TA1535, TA1537 and TA1538 were
tested without and with S9 metabolic activation. No increases in reverse
mutations were observed at concentrations up to 10000 ug/plate (MRID
41149001)
The potassium salt of maleic hydrazide was tested in a chromosomal
aberration assay using Chinese Hamster Ovary (CHO) cells in vitro. Based
on the results of cytotoxicity testing, the test material was assayed at 1000,
2150 or 4640 /stg/ml in the absence of S9 metabolic activation and at 2150,
4640 or 10000 (maximal limit concentration) /tg/ml in the presence of S9!
There was a marked increase in osmotic pressure (osmolality) at 10000
Aig/ml. Results were considered to be negative in the absence of S9. In the
presence of S9, a statistically significant (p < 0.01) increase in aberration-
bearing cells was found in 10000 /Kg/ml cultures at the 12-hour sampling,
but not at the 24-hour sampling. The apparent positive results in this assay
are considered to be equivocal because of the possible confounding effect
of the increased osmotic pressure. (MRID 41147302)
Male and female B6C3F1 mice were given a single intraperitoneal
injection of the potassium salt of maleic hydrazide at dose levels up to 1100
mg/kg, the level causing death. Bone marrow cells were subsequently
examined for sister-chromatid exchanges. No significant increases in
exchanges over control levels were found in any treated male or female
dose group. (MRID 41660001)
14
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Male and female CD-I mice were dosed once by oral gavage with
the potassium salt of maleic hydrazide at doses equivalent to 2500 or 5000
(limit dose) mg/kg of maleic hydrazide. Bone marrow cells were scored
72 hours later for polychromatic erythrocytes with micronuclei (m-PCE).
No significant increases in the incidence of m-PCE over control levels were
observed in the treated male or female mice at either dose level. (MRID
41719101)
Cultures of strain M45 (rec-) and strain H17 (rec*) of Bacillus
subtilis were treated with the potassium salt of maleic hydrazide or with
technical grade maleic hydrazide at doses up to 10000 /ig/plate, both in the
absence and presence of S9 metabolic activation. Surviving colonies of
each strain were counted after 1-2 days and the survival index (SI), i.e.,
the ratio of the relative survival of M45 to H17 strains, was determined for
each treatment. For the potassium salt of maleic hydrazide, no differences
in SI were observed for the various treatments in trials without S9. In
trials with S9, however, differential toxicities, indicated by a decreased SI,
were observed at the highest dose of 10000 jig/plate. For the technical
grade maleic hydrazide, decreased Sis were observed at doses of 5000 and
10000 jig/plate in trials without and with S9. It was concluded that both
the potassium salt of maleic hydrazide and technical grade maleic hydrazide
appear to be genotoxic, i.e. have the potential to affect DNA repair
processes, at the extremely high dose levels of 5000 to 10000 /tg/plate.
(MRID 41176601 and 41176602)
The potassium salt of maleic hydrazide was tested in a sister-
chromatid exchange assay using Chinese Hamster Ovary (CHO) cells in
vitro at doses up to 10000 ftg/ml. Preliminary dose-selection testing, based
on delays in cell cycling, indicated delays at 10000 jig/ml in the absence of
S9 metabolic activation and at 3200 and 10000 pg/ml in the presence of S9.
Significant increases in sister-chromatid exchanges were observed in
cultures without S9 at 10000 jig/ml and in cultures with S9 at 3200 and
10000 fj.g/ml. Hence, the potassium salt of maleic hydrazide appears to be
genotoxic in this assay, but only at cytotoxic doses, as measured by delays
in cell cycling. (MRID 41147303)
Since maleic hydrazide is a uracil antimetabolite and this is
presumably its mechanism of action with respect to its plant growth
regulator/herbicidal properties, it might be expected that equivocal or
positive results would be observed in some genotoxicity tests. When all of
the genotoxicity studies are considered together with the results of all the
other lexicological studies on maleic hydrazide and its potassium salt,
including, especially the negative carcinogenicity studies in rats and mice,
15
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it was concluded that the potential genotoxic hazard is negligible and does
not warrant continued concern.
h. Metabolism
Male and female Sprague-Dawley rats were given 14C-maleic
hydrazide as a single intravenous dose of 2 mg/kg or as single oral doses
of 2 or 100 mg/kg. Additional rats were given repeated oral doses of 2
mg/kg of maleic hydrazide for 14 days followed by a single oral dose of 2
mg/kg of 14C-maleic hydrazide. Total recovery of radioactivity at 7 days
post-dosing ranged from 92-98% in the various groups. Most of the
administered radioactivity, regardless of dosing regimen, was recovered in
the urine (76 - 87% at 7 days) with lesser amounts appearing in the feces
(5 - 15%). Less than 1% of the administered radioactivity appeared in
expired air. Absorption and elimination were rapid. Within 4 hours after
intravenous dosing, about 63% of the administered radioactivity was
excreted in the urine and after oral dosing at 2 or 100 mg/kg (single or
repeated dosing groups), 43-55% was excreted in the urine. Excretion
was nearly complete within 24 hours. There were no differences between
sexes in the excretory rates. There was no evidence of bioaccumulation of
radioactivity in any tissue or organ. Four-hour urine contained mostly
unchanged maleic hydrazide (>60% of urinary radioactivity in males and
> 80% in females) with a lesser amount of the sulfate conjugate of maleic
hydrazide. No other significant metabolite was present in the urine. Fecal
metabolites were not identified. (MRID 41571701, 41679701 and
42432301)
i. Neurotoxicity
No neurotoxicity potential has been observed in any of the animal
laboratory studies. Neither acute delayed neurotoxicity study or a 28-day
delayed neurotoxicity study in hens is required.
j. Other lexicological Considerations
Technical Impurity: Hydrazine - Technical grade maleic hydrazide
contains hydrazine as a contaminant. Hydrazine has been associated with
tumor induction in animals. In 1982, the Agency established (in the PD-4)
an upper limit for hydrazine at 15 ppm in technical grade products
containing maleic hydrazide. In the 1988 Registration Standard on Maleic
Hydrazide, the Agency continued to require that the hydrazine content of
the technical chemical be limited to j£l5 ppm. This was a level
determined to not cause concern based on estimates of excess lifetime
16
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carcinogenic risks to humans for both worker and dietary exposure. This
limit is still in effect.
Potassium Salt - Toxicological studies on maleic hydrazide and on
the potassium salt of maleic hydrazide are considered to be equivalent with
respect to fulfillment of applicable toxicity study requirements. This was
also the case in the 1988 Registration Standard for Maleic Hydrazide.
This decision was confirmed by the HED RfD/Peer Review Committee in
August, 1993. It should also be noted that in nearly all studies described
in which the potassium salt of maleic hydrazide was the test material,
dosage levels were expressed in units of maleic hydrazide, rather than in
units of the potassium salt.
Pyrolysis and Inhalation Studies: Tobacco - Regarding the use of
maleic hydrazide and its potassium salt on tobacco, the 1988 Registration
Standard stated that a 90-day inhalation study "may be required for maleic
hydrazide and pyrolysis products depending upon their presence in and
nature on tobacco" (paragraph 158.340, Table A, footnote 4). The
Standard also required submission of residue and degradation
information/data on tobacco. The degradation data on tobacco were
submitted and reviewed. The major pyrolysis products from maleic
hydrazide were determined to be essentially similar to those of untreated
tobacco. They included carbon dioxide, carbon monoxide, hydrogen
cyanide, ammonia, and a complex mixture of over 1200 organic
compounds. Furthermore, the level of hydrazine was also essentially the
same in treated and untreated tobacco. The Agency concluded that residues
of maleic hydrazide in/on tobacco would not be expected to result in
increased hydrazine levels in tobacco smoke. Based on the residue and
pyrolysis information described above and on the lack of significant
lexicological concerns, additional inhalation studies on maleic hydrazide or
on its pyrolysis products are not required to support the uses of maleic
hydrazide on tobacco.
k. Reference Dose
On August 5, 1993, the Health Effects Division Reference Dose
(RfD) Peer Review Committee recommended that the RfD for maleic
hydrazide be established at 0.25 mg/kg/day. This value was based on a
NOEL of 25 mg/kg/day observed in the 104-week chronic feeding study
in rats. At the LOEL of 500 mg/kg/day, decreased body weight gains
were observed in male rats. In addition, a NOEL of 29 mg/kg/day was
observed in the co-critical 52-week chronic feeding study in dogs. At the
17
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LOEL of 87 mg/kg/day (males) and 105 mg/kg/day (females), decreased
body weight gains were observed in both males and females along with
reduced heart weight in males. An uncertainty factor (UF) of 100 was used
to account for inter-species extrapolation and intra-species variance.
2. Exposure Assessment
a. Dietary Exposure
Tolerances for residues of maleic hydrazide in or on food items
have been established in terms of the parent only (Source: 40 CFR
§180.175 and §185.3900). An adequate enforcement method is available
for determination of maleic hydrazide per se in plant commodities.
The qualitative nature of the residue in plants is adequately
understood. Studies conducted on potatoes and onions indicate that maleic
hydrazide is translocated but not metabolized extensively in plants. The
residue of concern is maleic hydrazide ger se.
The qualitative nature of the residue in animals is not adequately
understood. Supplementary data are required to upgrade the existing
poultry (MRID 42641501) and ruminant (MRE> 42567801) studies. Three
major components were identified in extracts from milk, eggs, and tissues:
maleic hydrazide, a sulfate conjugate of maleic hydrazide, and metabolite
1, proposed to be an acid stable conjugate of either the N- or O-methyl
derivative of maleic hydrazide. Further attempts to identify metabolite 1 in
eggs, milk, and tissues are required.
An adequate method for purposes of data collection and
enforcement of tolerances for maleic hydrazide per se in or on potatoes and
potato processed commodities, onions, peaches, and cranberries is listed in
PAM, Vol. n as Method I. There are no existing enforcement methods
available for animal commodities in PAM, Vol. II.
The available storage stability data indicate that maleic hydrazide is
stable under frozen storage conditions in animal commodities up to 20
months, potato and onion raw agricultural commodities stored up to 6
months and processed potato commodities stored up to 10 months.
Tobacco field data indicated that residues of maleic hydrazide
ranged from 27 to 327 ppm in or on flue-cured tobacco treated with maleic
hydrazide at 0.7X the maximum registered rate. The major pyrolysis
products of maleic hydrazide are similar to those of untreated tobacco.
18
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Residues of maleic hydrazide in or on tobacco will not result in an increase
in the levels of hydrazine in tobacco smoke.
All data requirements for magnitude of the residue in plants have
been satisfied.
Data are still required for magnitude of the residue in animals.
Simulated feeding studies using [14C] maleic hydrazide indicate that
detectable residues may occur in livestock. When the nature of the residue
in animals is adequately understood, feeding studies for ruminants and
poultry must be conducted using analytical methodology specific for
residues of concern.
A confined rotational crop study using winter wheat is required.
The requirement for field studies will be determined when the data on
confined rotational crop studies are evaluated. Preliminary studies have
indicated that detectable residues could occur on winter wheat planted as
a rotational crop in fields that have been treated with maleic hydrazide.
Further data have been required to determine if there is a need for
establishment of rotational tolerances or suitable plantback intervals to
avoid these residues. However, these data are considered to be either
confirmatory or supplemental to our recommendation that maleic hydrazide
is eligible for reregistration because the available data base is adequate to
make a reasonable upper bound dietary risk assessment and conclude that
the risk is not significant. The outstanding rotational crop data are not
expected to change our conclusions concerning dietary risk.
b. Occupational and Residential
Mixer/Loader/Applicator Exposure
There is a potential for mixer/loader/applicator (handlers) exposure
via the inhalation and dermal routes. Maleic hydrazide is applied to foliar
growth by ground boom equipment, backpack sprayers, and aircraft. A
mixer/loader/applicator risk assessment was discussed in the Registration
Standard based on potential developmental toxicity. In the assessment, it
was determined that Margins of Exposure (MOE) were less than 100 for
many of me scenarios (MOE's equal to or greater than 100 are considered
acceptable to the Agency). As a result, the Agency required that handlers
wear a long-sleeve shirt, long pants, and chemical resistant gloves at all
times when mixing/loading and applying maleic hydrazide. Although there
are several scenarios in which there is a potential for
mixer/loader/applicator exposure, there are no longer any developmental
19
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lexicological concerns; therefore, mixer/loader/applicator data are not
required to support the reregistration of maleic hydrazide.
Post-Application Worker Exposure
Worker and residential post-application and reentry exposure data
were not required in the 1988 Registration Standard based on the likelihood
of low exposure due to 7 to 70 day preharvest intervals or because
applications are made at the early stages of plant development. Since there
are no longer any lexicological concerns, post-application/reentry dala are
not required to support ihe reregisiralion of maleic hydrazide.
Worker Protection
The Agency's Worker Protection Standard (WPS) for Agricultural
Pesticides - 40 CFR Parts 156 and 170 - establishes a minimum reslricled
interval (REI) of 12 hours for maleic hydrazide based on its acute dermal
toxicity, skin irritation potential, eye irritation potential Toxicity Category
III or IV. The Agency considers Ihe 12-hour REI for ihis chemical a
prudent risk mitigation measure to protect workers. Therefore, the Agency
retains the 12-hour REI for uses within the scope of the WPS and will
allow workers to enter areas ireated wilh maleic hydrazide during ihe REI
only in the few narrow exceptions allowed in the WPS.
The WPS also requires personal protective equipmenl (PPE) for all
handling activities in ihe form of a long-sleeved shirt, long panls, socks,
and shoes.
3. Risk Assessment
a. Dietary
The appropriate data set(s) to assess dietary risk is the rat chronic
feeding sludy (MRID 42570101, 42770401) and/or Ihe dog chronic feeding
siudy (MRID 42214101, 42248101). If any effecls were observed in short
term sludies, they were minimal and occurred only al exlremely high
doses. For the purposes of evaluating acute worker exposure, ihere are no
lexicological concerns associated wilh maleic hydrazide.
The chronic dielary risk analysis used reassessed tolerance levels for
residues on cranberries, onions (dry bulb), potatoes, potato chips, potato
granules and potato waste (from processing); upper bound residue levels
for meat, milk, poultry and eggs; and assumed all of the crops were
treated with maleic hydrazide to estimate the Theoretical Maximum
20
-------
Residue Contribution (TMRC) for the overall U.S. population and 22
population subgroups. These exposures (TMRCs) were then compared to
the Reference Dose (RfD) of 0.25 mg/kg/day for maleic hydrazide to
estimate chronic dietary risk. The analysis does not include a food form
designated as potato chips and the entire RAC/food form potatoes (white),
peeled/cooked, not junker specified was substituted. The upper bound
residue levels for meat, milk, poultry, and eggs were determined from data
submitted to Agency for this dietary analysis since residues are possible,
but tolerances have not yet been established. (See the Tolerance
Reassessment Section of this document)
The estimated TMRC for the overall U.S. population from food
uses of maleic hydrazide is 0.074 mg/kg bodyweight per day, which
represents 29.5% of the reference dose. The vast majority of the estimate
(27.5% of the RfD) was contributed by potato consumption. For the most
highly exposed subgroup, Children (One to Six Years Old), the estimated
TMRC is 0.151 mg/kg bodyweight per day, which represents 60.3% of the
RfD. The next most highly exposed subgroup, Non-nursing Infants (Less
Than One Year Old), the TMRC is 0.148 mg/kg bodyweight per day,
which represents 59.1 % of the RfD. All other subgroups had TMRCs of
less than 44% of the RfD.
The TMRCs or exposure/risk estimates are considered
overestimates because it is assumed that 100% of the commodities used in
the analysis contain this herbicide either at the maximum legal level or the
upper bound residue level. About 90% of the exposure is contributed by
potatoes. The use of the entire RAC/food form potatoes (white),
peeled/cooked, not further specified to represent potato chips is also a
source of overestimation. Therefore, given the risk values arrived at by
this analysis, it appears that the chronic dietary risk posed by this pesticide
on these food uses is minimal.
In 1982 the Agency established an upper limit for hydrazine, a
contaminant, at <15 ppm in technical grade products containing maleic
hydrazide. This level alleviates any concern based on calculations of
lifetime carcinogenic risks to humans considering both dietary and worker
exposure. The Agency continues to require that the hydrazine content of
the technical chemical be limited to ^15 ppm because no changes in the
use have occurred that would increase the risk since it was originally
determined in 1982.
21
-------
b. Occupational and Residential
There is a potential for mixer/loader/applicator (handlers) exposure
via the inhalation and dermal route. A mixer/loader/ applicator risk
assessment was discussed in the Registration Standard based on potential
developmental toxicity. Since then, additional information and studies have
been submitted which demonstrate developmental effects are no longer a
concern. Based on the lack of acute lexicological concerns and exposure,
the risk posed by this chemical is considered minimal for all workers.
Increased hydrazine levels from the use of maleic hydrazide have
been a concern as a pyrolysis product from tobacco. Increased levels of
hydrazine are NOT expected; therefore, the risk is no greater than that
risk already associated with the use of tobacco.
Data Requirements
There are currently no maleic hydrazide tolerances for animal commodities
and the appropriate information concerning animal metabolism, analytical
methodology and magnitude of the residue in meat, milk, poultry and eggs
for the establishment of tolerances has not been submitted to the Agency at
this time. Suitable data have been submitted to enable a reasonable worst
case dietary risk assessment to be conducted. These data are derived from
feeding studies in which the animals were fed [14C-]maleic hydrazide
followed by analysis of meat, milk and tissues for total radioactivity.
The following data requirements remain unfulfilled:
-animal metabolism (Guideline 171-4(b))
-residue analytical method for animal commodities (Guideline 171-4(d))
-magnitude of the residue in animal commodities (Guideline 171-4(j))
-confined rotational crops (Guideline 165-1)
-product chemistry (Guidelines 63-14, and 63-17)
These data are considered confirmatory since the data base is sufficient at
this time to make a reasonable upper bound dietary risk assessment.
22
-------
C. Environmental Assessment
1. Environmental Fate
a. Environmental Chemistry, Fate and Transport
Maleic hydrazide is soluble in water (water solubility of 5,000
ppm). The active ingredient in the end-use products is maleic hydrazide -
potassium salt which has a high water solubility (550,000 ppm).
Maleic hydrazide was stable to hydrolysis in aqueous buffered
solutions atpH 3, 6, and 9 at elevated temperatures of 45°C (61 days) and
80°C (30 days) (MRID 00143322). Maleic hydrazide degraded slowly
(< 10% at 28 days) at pH 5, was stable at pH 7, and degraded with an
observed half-life of > 30 days at pH 9 in sterile aqueous buffer solutions
that were irradiated under artificial light (xenon lamp) (MRIDs 42872301,
42692101, 43141001, 43177301). At 30 days' post-treatment, [14C]maleic
hydrazide was the only [14C] compound isolated from the pH 5 and 7
solutions; in the irradiated pH 9 solution, two photodegradates were
isolated, maleic acid and succinic acid. Maleic acid and succinic acid were
present at concentrations (as maleic hydrazide equivalents) of 0.032 and
0.037 mg/L, respectively, after 30 days irradiation. Photodegradation on
sandy soil did not occur. Maleic hydrazide was stable to photolysis after
17 days irradiation (UV lamp, equivalent to 34 days sunlight) (MRID
00141951).
Aerobic soil metabolism data indicate that maleic hydrazide is
metabolized rapidly in aerobic sandy loam soil (observed half-life of < 24
hours), with the ultimate degradate being CO2 (MRID 41896201). Other
nonvolatile degradates, maleic acid and maleimide, were identified in small
amounts (<5% of the applied) early in the aerobic soil metabolism of the
compound, but did not persist. Maleic hydrazide is moderately persistent
under anaerobic soil conditions (half-life 30-60 days; flooding plus nitrogen
atmosphere) in loamy sand soil, with mineralization to CO2 essentially
complete after 60 days of anaerobic soil metabolism (MRID 41918201).
Two nonvolatile degradates identified in the soil plus floodwater, maleic
acid and maleimide, did not persist under anaerobic conditions.
Maleic hydrazide is expected to be mobile, due to its low adsorption
to soils. K^. values for parent maleic hydrazide were 0.14 to 2.61 in five
unaged soils (silt loam, sandy loam, sandy clay loam, and 2 sandy soils)
(MRID 00151952). Column leaching of unaged sandy and clay loam soils
yielded all of the radioactivity in the leachate (MRID 00151952).
23
-------
Based on column leaching studies, aged maleic hydrazide and
maleic hydrazide residues were found to be mobile (39.76% of the applied
radioactivity was in the leachate) in columns of loamy sand soil, and very
mobile (100.79% of the applied radioactivity in the leachate) in columns of
sandy soil (MRID 41896202). The degradates maleic acid and maleimide
were detected in the leachate from the loamy sand soil column; only maleic
hydrazide was detected in the leachate from the sandy soil.
Maleic hydrazide did not persist in the available field dissipation
studies. In two acceptable field studies, maleic hydrazide dissipated with
observed half-lives of 3 days on bare ground and 5 days in turf plots of
sandy loam soil located in California (MRIDs 42790901 and 42744801) and
with observed half-lives of <14 and <27 days on bare ground and
vegetated (mature tobacco) plots, respectively, of loam soil located in
North Carolina (MRID 42693301); in general, maleic hydrazide was not
detected below the 30-cm soil depth at either location. In an unacceptable
field dissipation study that provided supplemental information, maleic
hydrazide dissipated with a half-life of 3-7 days in clay loam son in New
Mexico; in the 6- to 12-inch soil depth, maleic hydrazide concentrations
were <0.1 ppm at all sampling intervals, and in the 12- to 18-inch soil
depth, maleic hydrazide was not detected (<0.05 ppm) at any sampling
interval (MRID 40034802).
The potential for maleic hydrazide to bioaccumulate in fish is very
low, as indicated by the octanol/water partition coefficient of < 0.6 CMRID
00163301).
When maleic hydrazide is aerially or air-blast sprayed, drift from
approved use sites could affect non-target crops or areas containing
endangered plant species. Therefore, in order to assess the extent of this
exposure, the Spray Drift data requirements were imposed in the
November 1992 Data Call-In.
b. Environmental Fate Assessment
Available field dissipation and laboratory data indicate that maleic
hydrazide is not persistent in the environment. The submitted
environmental fate data indicate that mineralization to CO2 is the major
route of dissipation. Small amounts of nonvolatile degradates are produced
early in the aerobic soil metabolism of the compound. Maleic hydrazide
is moderately persistent under anaerobic soil conditions, but mineralization
to C02 is essentially complete after 60 days of anaerobic soil metabolism.
Hydrolysis, photodegradation, and volatilization do not appear to play a
24
-------
significant role in the dissipation process. Both parent maleic hydrazide
and its minor degradates, maleic acid and maleimide, are mobile, with the
highest mobility in sandy soils. Available field data indicate that maleic
hydrazide has a half-life of less than two weeks, with little or no leaching
observed. The potential for maleic hydrazide to bioaccumulate in fish is
very low.
Groundwater Impact
An evaluation of maleic hydrazide using the OPP "New Paradigm"
for ground water shows that the Level of Concern (LOG) for mobility is
exceeded by this pesticide. However, the LOG for persistence is not
exceeded, and for this reason, maleic hydrazide is unlikely to impact
groundwater quality.
No further regulation with respect to ground water is needed at this
time.
Surface Water Impact
Although available data indicate that maleic hydrazide degrades
rapidly under aerobic conditions (observed half-life of < 24 hours) and has
a half-life of less than two weeks in the field, maleic hydrazide residues
were mobile to very mobile (up to 100% of the applied radioactivity was
present in the leachate from sandy soil columns). Its persistence under
anaerobic conditions could pose a risk of contamination of surface waters
if maleic hydrazide were washed into anaerobic zones by rainfall events
that occur soon after application.
Because there is a potential for surface water runoff, the following
label advisory is required:
Surface water advisory:
"Under some conditions, maleic hydrazide may have a significant potential
for runoff into surface water (primarily via dissolution in runoff water), for
several days post-application. Conditions favoring runoff include poorly
draining soils or wet soils with readily visible slopes, frequently flooded
areas, areas where an intense or sustained rainfall is forecast to occur
within 48 hours, areas overlying extremely shallow ground water, and
areas overlying tile drainage systems that flow to surface water."
25
-------
2. Ecological Effects
a. Ecological Effects Data
(1) Terrestrial Data
Effects to Non-Target Birds
Acute Avian Oral Toxicity:
The data indicate that technical maleic hydrazide and the
potassium salt of maleic hydrazide are "practically nontoxic" to
avian species on an acute oral basis. The guideline requirement
(71-1) for an acute oral toxicity study with avian species is satisfied.
Species
Mallard
%ai
901
34.52
LDso
(mg/kg)
>4640
>2250
MRID
No.
00124742
00146141
Study
Classification
Core
Core
'technical maleic hydrazide
potassium salt of maleic hydrazide
Acute Avian Dietary Toxicity:
The data indicate that the technical and the potassium salt of
maleic hydrazide are "practically nontoxic" to avian species on a
dietary basis. The guideline requirement (71-2) for a dietary
toxicity test with avian species is satisfied.
Species
Mallard
Bobwhite
quail
%ai
901
34.52
901
LCso
(ppm)
> 10,000
>5620
> 10,000
MRID
No.
00107417
00147000
00126033
Study
Classification
Core
Core
Core
'technical maleic hydrazide
potassium salt of maleic hydrazide
26
-------
Avian reproduction
Avian reproduction studies are not required for maleic
hydrazide because it is not applied more than once prior to or
during the breeding season, and it is practically nontoxic to birds.
(2) Aquatic Data
(a) Effects on Freshwater Fish
The data indicate that the technical and the potassium salt of
maleic hydrazide are "practically nontoxic" to coldwater and
warmwater fish. The guideline requirement (72-1) for acute
toxicity testing with freshwater fish is fulfilled.
Species
Rainbow
trout
Bluegill
%ai
901
34.52
901
LCjo
(ppm)
1435
>1000
1608
MRID
No.
00124740
00146142
00124739
Study
Classification
Core
Core
Core
'technical maleic hydrazide
2potassium salt of maleic hydrazide
(b) Effects on Freshwater Invertebrates
These data indicate that technical maleic hydrazide and the
potassium salt are "practically nontoxic" to freshwater
invertebrates. The guideline requirement (72-2) for an acute
toxicity study with freshwater invertebrates is satisfied.
Species
Daphnia
magna
%ai
901
34.52
lAo
(ppm)
107.5
>1000
MRID
No.
00124741
00146143
Study
Classification
Core
Core
technical maleic hydrazide
2potassium salt of maleic hydrazide
27
-------
(3) Non-Target Insects Data
The data indicate that maleic hydrazide is practically
nontoxic to the honey bee. The guideline requirement (141-1) for
an acute-contact toxicity study with the honey bee is satisfied.
Species
Honey bee
%ai
N/A
LDso
Otg/bee)
> 36.26
MRID/
Fiche No.
00018842
Study
Classification
Scientifically
sound
(4) Non-Target Plants Data
Tier I and E plant testing is complete. The guideline
requirement (122-1) for seed germination/seedling
emergence/vegetative vigor is satisfied. The guideline requirement
(123-2) for aquatic plant growth also is satisfied.
The acceptable Tier I and n phytotoxicity data on maleic
hydrazide are indicated below.
28
-------
Species
Selenastrum
capricornutum
Seed
germination
Seed
emergence
Vegetative
vigor
Anabaena
flos-aquae
Nitzschia
palea
Skeletonema
costatum
Lemna
gibba
%ai
72.51
30.22
98.9
Results
(mg/1)
NOEC >9.84 (the
highest level tested)
(see next page)3
(see next page)4
(see next page)5
EC50 >95
NOEC = 95
LOEC = 60
EC50 >97.8
NOEC = 97.8
LOEC = 60.4
EC50 > 102
NOEC >102
LOEC = 102
EC50 = 114
NOEC = 38.6
LOEC = 23.7
MRID
No.
41318001
41289301
41289301
41289302
43006901
43006902
43006903
43006904
Study
Classification
Core
Core
Core
Core
Core
Core
Core
Core
technical maleic hydrazide
2potassium salt of maleic hydrazide
29
-------
3Tier n seed germination test results (lowest observed EC values, Ibs ai/acre; rl=radicle
length, pg= percent germination): ~
Plant
Soybean
Lettuce
Carrot
Tomato
Cucumber
Cabbage
Oat
Ryegrass
Corn
Onion
ECM
>6.00(rl,pg)
2.01 (rl)
0.62 (rl)
1.23 (rl)
>6.00(rl)
>6.00(rl,pg)
0.79 (rl)
0.97 (rl)
1.06(rl)
0.68 (rl)
EC*,
>6.00(rl,pg)
>6.00 (rl)
>6.00(rl)
>6.00(rl)
>6.00(rl)
>6.00(rl,pg)
4.59 (rl)
>6.00(rl)
>6.00(rl)
>6.00(rl)
NOEC
>6.00
1.50
3.00
1.50
3.00
6.00
0.75
3.00
0.60
3.00
30
-------
4Tier n vegetative vigor test results (lowest observed EC values, Ibs
ai/acre; pr=% plant phytotoxicity, ph=plant height, dw=dry weight):
Plant
Soybean
Lettuce
Carrot
Tomato
Cucumber
Cabbage
Oat
Ryegrass
Corn
Onion
ECy
2.31 (pr)
2.22 (ph.dw)
4.73 (pr)
4.71 (pr.ph)
4.63 (pr,ph)
1.10(pr,dw)
1.95(ph,dw)
4.87 (ph)
4.01 (ph)
1.44(ph)
. ECso
>6.00(ph)
4.47 (dw)
>6.00(ph)
>6.00(ph)
>6.00(ph)
3.48 (dw)
3.97 (dw)
7.61 (ph)
>6.00(ph)
4.45 (ph)
NOEC
0.38
0.75
0.75
1.50
1.50
0.75
1.50
3.00
1.50
0.38
31
-------
5Tier n seedling emergence test results (lowest observed EC values. Ibs
ai/acre; ph=plant height, dw=dry weight):
Plant
Soybean
Lettuce
Carrot
Tomato
Cucumber
Cabbage
Oat
Ryegrass
Corn
Onion
ECM
1.09(ph)
2.77 (ph)
>6.00(ph)
1.03 (dw)
>6.00(ph)
1.07 (dw)
1.35(ph)
2.52 (ph)
3.02 (ph)
0.53 (ph)
EC*,
2.72
>6.00
>6.00
2.28
>6.00
4.40
4.70
>6.00
5.40
4.60
NOEC
0.75
1.50
6.00
0.75
6.00
0.75
<0.38
1.50
1.50
0.38
b. Ecological Effects Risk Assessment
(1) Terrestrial Organisms
Risks to Birds:
Wildlife may be exposed to maleic hydrazide when consuming
contaminated food items, such as grasses, seeds, fruits, and insects. Actual
residue data on potential food items are not available, but estimates of
maximum expected terrestrial residues, based on maximum application
rates can be calculated according to Hoerger and Kenaga (1972). Based on
these estimates, use patterns with application rates less than or equal to 9
Ibs ai/acre are not considered to present a potential risk to birds.
The following maximum residues are expected from maximum
applications of maleic hydrazide on fallow lands (9 Ibs ai/acre) and turf and
rights-of-way (6 Ibs ai/acre):
32
-------
Site
Short grass
Tall grass
Leaves,
Leafy crops
Forage,
Small insects
Seed pods,
Large insects
Fruits
Estimated Residue (ppm)
9 Ibs ai/acre1
Max.
2050
980
1060
510
105
63
Typical
1068
819
297
290
26
13
6 Ibs ai/acre2
Max.
1425
650
750
345
71
42
Typical
742
543
210
196
18
9
applies to a single application for control of
nightshade on fallow lands
2applies to rights-of-way, turf, and lawns
Risk to birds is assessed by comparing these estimated
residues with multiples of the dietary LC50 value. If residues are ^
0.5 LC50, a "high risk" to avian species is presumed. If residues
are £ 0.2 LC^, a "restricted use" trigger is exceeded; this is a level
at which risk can be reduced by restricted-use labeling. Lastly an
"endangered species" concern is triggered if residues are £ 0.1
LC50. However, when the estimated residue levels are relatively
low and the LC50 exceeds 5000 ppm ("practically nontoxic") with
no dose-related mortality, the Agency presumes no undue risk to
either endangered or nonendangered birds. Therefore because the
avian LCX values for maleic hydrazide and its salt are > 5620 and
> 10,000 ppm, respectively, no risk to birds is anticipated from
the present uses of maleic hydrazide (See following table).
33
-------
Use site
Fallow land
Rights-of-way,
Commercial turf,
Lawns
Tobacco, Trees,
Shrubs, Ivy
Onions,
Potatoes
Broadleaf trees
Ornamentals, Citrus,
Ivy,
Iceplant
Max. appl.
rate (Ibs
ai/ acre)
9
6
4.5
2-3
unknown
(injected)
unknown
(apply to
drip pt.)
Level of
concern1
(ppm)
HR= >5000
RU = >2000
ES = > 1000
HR = >5000
RU= >2000
ES = > 1000
HR = >5000
RU = >2000
ES = > 1000
SR= >5000
RU= >2000
ES = > 1000
as above
as above
Relevant
EEC2
(ppm)
819
819
819
742
742
742
154
154
154
105
105
105
unknown
unknown
(ES) = 0.1 LC50
2where EEC = typical expected residues on potential food items, based on the
maximum application rate for that use site
The Agency cannot fully evaluate the risk to birds from
applying maleic hydrazide to ornamental trees and shrubs, ivy,
iceplant, and young citrus trees when the application rate is not
specified. Spraying to the drip point may contaminate insects and
expose birds feeding on insects. However, risk is probably minimal
because maleic hydrazide is practically nontoxic to birds.
Applications to broadleaf trees by injection are not likely to pose a
risk.
34
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Risks to Mammals:
Risk to small mammals is assessed by estimating dietary
value from acute oral toxicity testing with the laboratory rat.
The LD50 values to male and female rats are greater than 5000
mg/kg for both technical maleic hydrazide and the potassium salt.
These values are assumed to be applicable to other small mammals,
including a representative herbivore (meadow vole), granivore
(deer mouse), and insectivore (Least shrew). Body weights and
daily food consumption for these species were obtained from Davis
and Golly (1963).
The following LC50 values were estimated:
'Wh<
Species
Meadow vole
Deer
mouse
Least
shrew
Body wt.
(g)
46
13
5
Food eaten/
day (g)
28.1
2.1
5.5
Expected
foods
grasses
seeds,
insects
insects
Ley
(ppm)
>8185
> 30,952
>4545
jre LC50 = LD50 x body weight 4- daily food consumption
The LOCs for assessing risk to nonendangered and
endangered mammals are the same as those indicated for birds (0.5,
0.2, and 0.1 x LC50). Applying the same approach as for birds of
presuming that a trigger is not exceeded when residues are
relatively low and an LC^, value exceeds 5000 ppm or thereabouts,
minimal risk is anticipated to nonendangered or endangered
mammals (see following table).
35
-------
Use site
Fallow land
Rights-of-way,
Turf,
Lawns
Tobacco, Trees,
Shrubs, Ivy
Onions,
Potatoes
Broadleaf trees
Ornamental,
Citrus, Ivy,
Iceplant
Max. appl.
rate (Ibs
ai/ acre)
9
6
4.5
2-3
unknown
(injected)
unknown
(apply to
drip pt.)
Level of
concern1
(ppm)
HR = >5000
RU = >2000
ES = > 1000
HR = >5000
RU = >2000
ES = > 1000
HR = >5000
RU = >2000
ES = > 1000
HR = >5000
RU = >2000
ES = > 1000
as above
as above
Relevant EEC2 (ppm)
MV3 DM LS
819 290 290
819 290 290
819 290 290
742 196 196
742 196 196
742 196 196
154 147 147
154 147 147
154 147 147
121 99 99
121 99 99
121 99 99
unknown
unknown
High Risk (HR) = 0.5 LC50; Restricted Use (RU) = 0.2 LC50; Endangered Species
(ES) = 0.1 LC50
2EEC = typical expected residues on potential food items
3MV = meadow vole; DM = deer mouse; LS = Least shrew
(2) Aquatic Organisms
Foliar applications of maleic hydrazide by ground or air
could result in a potential risk to aquatic organisms from runoff and
drift into water bodies. The maximum aquatic concentrations of
maleic hydrazide are estimated below. They are based on runoff
from ground applications and both runoff and drift from aerial and
air-blast applications.
36
-------
Application
method
Ground
Air blast
Aerial
Max. appl. rate
(Ibs ai/acre)
9
6
3
Expected aquatic concentrations (ppm)
at water depths of 0.5- 6 feet
0.5'
3.303
1.541
0.770
1'
1.653
0.771
0.385
3'
0.549
0.256
0.128
6'
0.274
0.128
0.064
Risk to nonendangered or endangered aquatic organisms is
expected to be minimal because anticipated aquatic concentrations
of maleic hydrazide are much lower than lethal concentrations to
fish or aquatic invertebrates (LC50 values ranging from 107.5 ppm
to > 1000 ppm), Since the potential for risk to aquatic organisms
from ground applications at 6-9 Ibs ai/acre or from aerial
applications at 3 Ibs ai/acre is minimal, risk at lower application
rates is also expected to be minimal.
(3) Non-Target Insects
Maleic hydrazide applications to tobacco are made during
flowering, at which time honey bees might be exposed to the
pesticide. However, with an LD^ value greater than 36.26 jig/bee,
maleic hydrazide is considered "practically nontoxic" to honey
bees. Therefore, minimal risk to honey bees is anticipated.
(4) Non-Target Plants
LOCs have been exceeded for terrestrial and semi-aquatic
plants; however, the LOG has not been exceeded for aquatic plants.
Exposure of terrestrial and semi-aquatic plants to maleic hydrazide
is based on expected runoff from an application by ground and from
runoff and drift for aerial and air-blast applications. Direct
applications by ground on rights-of-way also are a concern, because
endangered and other nontarget plants growing in rights-of-way will
be directly exposed to the pesticide spray. No refined modeling
was done.
It should be noted that maleic hydrazide is a growth
inhibitor, and thus it would not be expected to kill many nontarget
37
-------
plants. However, inhibiting growth might affect reproduction
(e.g., inhibit flowering or seed production) which would adversely
impact nontarget plant populations.
38
-------
Summary of risk to terrestrial, semi-aquatic, and aquatic plants
Use site
Fallow land
Rights-of-way,
Commercial turf,
Lawns
Tobacco, Ivy, Trees,
Shrubs
Onions,
Potatoes
Max. appl.
rate (Ibs
ai/acre)
9
6
4.5
2-3
Toxicity results1
ECa = 0.53
ECso = >9.84
ECa = 0.53
ECa = 1.10
EC50 = >9.84
ECa = 0.53
EC50= >9.84
ECa = 0.53
ECa = 0.53
ECa = 1-10
EC50 = >9.84
Relevant EEC2
Direct
appl.
(Ibs ai/
acre)
_
6*
_
.
Adjacent
to site
(Ibs ai/
acre)
0.45
0.3-0.48
0.3
0.23
0.15
0.243
0.154
Wet area
away
(Ibs ai/
acre)
4.5*
2.1-3.0*
0.3
2.3*
1.5*
1.053-*
0.154
Aquatic
site
(ppm)
3.3
2.2
1.6
1.1
a) terrestrial plants - lowest ECM value (onion seedling emergence (se) [plant height] = 0.53 Ibs ai/acre) from seed germination (sg)
and seedling emergence (se) tests for runoff and runoff + drift; lowest ECM value (cabbage [dry weight] = 1.10 Ibs ai/acre) for
vegetative vigor tests for drift only; b) aquatic plants - lowest EC*, value from aquatic plant studies (Selonostrum EC50 = > 9.84 mg/1,
the highest level tested).
2EEC values are based on runoff from ground applications, except where noted for aerial application to onions and potatoes; the aquatic
site EEC is for a 0.5-ft deep water body.
'Exceeds the New Ecorisk Paradigm level of concern for risk to non-target plants (i.e., EEC > LOG)
3EEC value for aerial application (runoff + drift)
4EEC value for aerial application (drift only)
39
-------
Terrestrial and Semi-Aquatic Plants
The following use sites were used in the evaluation of risk:
(1) Fallow land; Maximum application rate = 9 lb
a.i./A
(2) Rights-of-way, commercial turf, lawn; Maximum
application rate = 6 lb a.i./A
(3) Tobacco, Ivy, Trees, Shrubs; Maximum application
rate = 4.5 lb a.i./A
(4) Onions, Potatoes; Maximum application rate = 2-3
lb a.i./A
Semi-aquatic plant LOCs were exceeded from runoff
onto wet areas (i.e., moist, saturated, or flooded soils) for
all use sites noted above and terrestrial plant LOCs were
exceeded by direct application to rights-of-way (see Tables
below). Risk exists for both nonendangered and endangered
terrestrial plants if runoff exceeds the nontarget-plant EC^
values for seed germination and seedling emergence test
results. EEC values are based on runoff from ground
applications, except where noted for aerial application to
onions and potatoes.
40
-------
Risk to semi-aquatic plants (plants growing in wet, off-site areas away from treated sites)
is shown below.
Use Site
Fallow land
Rights-of-
way,Commercial
turf, Lawns
Tobacco, Ivy,
Trees, Shrubs
Onions, Potatoes
Toxicity results1
ECtf = 0.53
ECjj = 0.53
EC25 = 0.53
ECjj = 0.53
ECzs = 0.53
Relevant EEC
Semi- Aquatic
Plants (Ibs a.i./A)
4.5
3.0
2.3
1.52
1.053
Risk Quotient
(EEC/EC2S)
8.5
5.7
4.3
2.8
2.0
lowest ECzs value (onion seedling emergence, plant height)
2EEC value from runoff (ground application).
3EEC value from runoff and drift (aerial application)
A risk exists for semi-aquatic plants, i.e., plants
growing in wet, off-site areas away from treated sites. A
risk exists to plants in such wet areas from applications as
low as 2 Ibs ai/acre. Therefore, almost all registered uses
of maleic hydrazide are likely to pose a risk to semi-aquatic
plants growing on off-site wet areas.
Risk to terrestrial non-target plants inhabiting rights-
of-way is expected from direct applications of 6 Ibs ai/acre.
Use Site
Rights-of-way
Toxicity Results1
EC2, = 0.53
Relevant EEC
for Direct
application (Ibs
6.0
Risk Quotient
(EEC/ECjj)
11.3
lowest ECjs value (onion seedling emergence, plant height)
41
-------
A high risk to plants inhabiting rights-of-way also is
expected from direct applications of 6 Ibs ai/acre. No risk
to terrestrial plants is expected in areas adjacent to treated
sites. In the seed germination/seedling emergence studies,
the lowest EC^ value was 0.53 Ibs ai/acre for onions. EC^
values for carrots, oats, and ryegrass also were less than 1
Ib ai/acre.
Aquatic plants
The lowest EC^ value for aquatic plants is presumed
to be 9.84 mg/1 (the highest level tested) for Selanastrum
capricomutum. Because the estimated aquatic
concentrations for even a 0.5-ft. deep water body (0.7-3.3
ppm) are less than the LOG for aquatic plants (>9.84
ppm), no risk to nonendangered or endangered aquatic
plants is expected.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing maleic hydrazide and the potassium salt of
maleic hydrazide active ingredients. The Agency has completed its review of these
generic data, and has determined that the data are sufficient to support reregistration of
all products containing maleic hydrazide and the potassium salt of maleic hydrazide.
Appendix B identifies the generic data requirements that the Agency reviewed as part of
its determination of reregistration eligibility of maleic hydrazide and the potassium salt of
maleic hydrazide, and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of maleic hydrazide and the potassium salt of maleic hydrazide and to
determine that maleic hydrazide and the potassium salt of maleic hydrazide can be used
without resulting in unreasonable adverse effects to humans and the environment. The
Agency therefore finds that all products containing maleic hydrazide and the potassium salt
of maleic hydrazide as the active ingredients are eligible for reregistration. The
reregistration of particular products is addressed in Section V of this document.
42
-------
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data and the data identified in Appendix B. Although the Agency
has found that all uses of maleic hydrazide and the potassium salt of maleic hydrazide are
eligible for reregistration, it should be understood that the Agency may take appropriate
regulatory action, and/or require the submission of additional data to support the
registration of products containing maleic hydrazide and the potassium salt of maleic
hydrazide, if new information comes to the Agency's attention or if the data requirements
for registration (or the guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients maleic hydrazide
and the potassium salt of maleic hydrazide, the Agency has sufficient information on the
health effects of maleic hydrazide and the potassium salt of maleic hydrazide and on its
potential for causing adverse effects in fish and wildlife and the environment. Therefore,
the Agency concludes that products containing maleic hydrazide and the potassium salt of
maleic hydrazide for all uses are eligible for reregistration.
The Agency has determined that maleic hydrazide and the potassium salt of maleic
hydrazide products, labeled and used as specified in this Reregistration Eligibility
Decision, will not pose unreasonable risks or adverse effects to humans or the
environment.
2. Eligible and Ineligible Uses
The Agency has determined that the current uses of maleic hydrazide and
the potassium salt of maleic hydrazide are eligible for reregistration. These uses
are listed in Appendix A. Uses eligible for reregistration do not include
cranberries. Use on cranberries is neither registered nor supported; although a
tolerance exists for residues of maleic hydrazide on cranberries, that tolerance will
be revoked. (See Tolerance Reassessment below.)
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for maleic
hydrazide and the potassium salt of maleic hydrazide. Where labeling revisions are
imposed, specific language is set forth in Section V of this document.
43
-------
1. Tolerance Reassessment
There are no current tolerances for maleic hydrazide in animal commodities. On
receipt of the required data from animal feeding studies, tolerances for maleic
hydrazide in animal commodities will be determined.
Sufficient data for determining an upper bound estimate of human dietary exposure
from consumption of animal commodities has been provided. Simulated cattle and
poultry feeding studies, in which [14C]maleic hydrazide is fed and total 14C
determined, indicate that in cattle appropriate levels of maleic hydrazide for upper
bound dietary risk assessment purposes would be 0.2 ppm in milk; 0.8 ppm in
liver; 4 ppm in kidney; and 0.4 ppm in muscle and fat. In poultry, appropriate
levels of maleic hydrazide for upper bound dietary risk assessment purposes would
be 0.3 ppm in meat and meat by-products; 0.07 ppm in skin, fat and eggs.
Tolerances Listed Under 40 CFR §180.175(a):
The tolerances listed in 40 CFR §180.175(a) are for residues of maleic hydrazide
per se in or on onions (dry bulb) and potatoes. Sufficient data are available to
ascertain the adequacy of the established tolerances listed in the 40 CFR for these
plant commodities (Table A).
The commodity definition of the tolerance for dry bulb onions is not in accordance
with the definition listed in the Commodity Index Report dated 10/28/92; see Table
A for the modification.
Tolerances Listed Under 40 CFR §180.175(b):
The tolerance [with regional registration as defined in §180.1(n)] listed in 40 CFR
§180.175(b) is for residues of maleic hydrazide (l,2-dihydro-3,6-pyridazinedione)
per se in or on cranberries.
Sufficient magnitude of the residue, but not nature of the residue, data are
available to ascertain the adequacy of the established tolerance listed in 40 CFR
§180.175(b) for cranberries. However, the registrant is not supporting uses of
maleic hydrazide on this commodity, and cranberries are not currently registered
on end-use product labels. If no other party intends to support uses on cranberries,
the established tolerance with regional registration of 15 ppm for residues of
maleic hydrazide in or on cranberries will be revoked (Table A).
Tolerances Listed Under 40 CFR §185.3900:
The food additive tolerance listed in 40 CFR §185.3900 is for residues of maleic
hydrazide (l,2-dihydro-3,6-pyridazinedione) per se present as a result of the
44
-------
application of a pesticide formulation containing maleic hydrazide to the growing
potato plant.
Sufficient data are available to ascertain the adequacy of the established tolerance
listed in 40 CFR §185.3900 for potato chips. The Agency has required that the
established food additive tolerance for potato chips be increased from 160 to 200
ppm (Table A).
New Tolerances Needed:
The Agency has required that food/feed additive tolerances be established for the
following processed commodities: "potatoes, granules" (200 ppm); and "potatoes,
waste from processing" (200 ppm) (Table A). In response, The Maleic Hydrazide
Task Force II has submitted petitions for the tolerance changes requested above.
TABLE A. TOLERANCE REASSESSMENT SUMMARY
' C^nfljo^iy
Cujrejtf Tol«raaee
.. . CSPPJ**) ;
- Tolerance
Reassessment (ppm)
CtmatGatfGDrrect
CommtxBty&e&Mm
Tolerances listed under 180.175(a)
Onions, dry bulb 15.0 Same Onions, dry bulb (only)
Potatoes 50.0 Same
Tolerance listed under 180.175(b)
Cranberries
15.0
Revoke
Cranberry uses are not
registered
Tolerance listed under 185.3900
Potato chips
Potatoes, granules
160
N/A
200
200
Increased tolerance needed
New tolerance needed
Tolerance listed under 186.3900
Potatoes, waste from
processing
N/A
200
New tolerance needed
CODEX HARMONIZATION
Codex Maximum Residue Limits (MRLs) for the sum of free and conjugated
maleic hydrazide expressed as maleic hydrazide are established at 15 mg/kg in or
on bulb onions and 50 mg/kg in or on potatoes. These limits are numerically
equivalent to established U.S. tolerances but the U.S. tolerances are established for
maleic hydrazide (without specifying the free or conjugated form). Although the
U.S tolerances and Codex MRLs are expressed differently, they are compatible
45
-------
because the tolerance enforcement analytical method includes a destructive
distillation step that ensures the quantification of maleic hydrazide, whether it is
conjugated or free.
TABLE B. CODEX MRLS AND APPLICABLE U.S. TOLERANCES.
Commodity
MRL
-------
3. Labeling Rationale
End Use Product
The environmental fate and ecological risk assessment identified a potential
risk to non-target terrestrial and semi-aquatic plants from exposure to runoff from
sites treated with maleic hydrazide. Based on this assessment, the Agency is
requiring a surface water advisory. In addition, to mitigate the exposure of non-
target plants at the sites where the highest application rates are used, the Agency
is requiring that the number of applications to fallow land, rights-of way, turf, and
lawns be limited to 1 per year.
Currently, there are some maleic hydrazide end-use products which fail to
provide guidance about the rate of application per a given area, only instructing the
user to spray to drip-point. To reduce possible misuse of this product, the Agency
is requiring that these labels clearly indicate the maximum application rates per
acre.
Spray drift management labeling statements may be required in a future
notice that is currently being prepared by the Agency. This future labeling may
be required for all maleic hydrazide products with aerial application, in order to
inform the user of recommended practices to minimize spray drift from the target
site.
47
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V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of maleic hydrazide for
the above eligible uses has been reviewed and determined to be substantially
complete. The data for the following guidelines are outstanding but are considered
confirmatory data: Guidelines 171-4(b), Nature of residue in animals; 171-4(d),
Residue analytical method in animals; 171-4(j), Magnitude of the residue in
animal; 165-1, Confined rotational crop; 201-1, Droplet size spectrum; and 202-
1, Drift field evaluation. These additional generic data requirements are not part
of the target database for maleic hydrazide and do not affect the reregistration
eligibility of maleic hydrazide.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. The product specific data requirements are listed in Appendix G, the
Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to
the instructions in the Requirement Status and Registrants Response Form provided
for each product.
Worker Protection Standard
Any product whose labeling reasonably permits use in the production of an
agricultural plant on any farm, forest, nursery, or greenhouse must comply with
the labeling requirements of PR Notice 93-7, "Labeling Revisions Required by the
Worker Protection Standard (WPS), and PR Notice 93-11, "Supplemental
Guidance for PR Notice 93-7, which reflect the requirements of EPA1 s labeling
48
-------
regulations for worker protection statements (40 CFR part 156, subpart K). These
labeling revisions are necessary to implement the Worker Protection Standard for
Agricultural Pesticides (40 CFR part 170) and must be completed in accordance
with, and within the deadlines specified in, PR Notices 93-7 and 93-11. Unless
otherwise specifically directed in this RED, all statements required by PR Notices
93-7 and 93-11 are to be on the product label exactly as instructed in those notices.
After April 21, 1994, except as otherwise provided in PR Notices 93-7 and
93-11, all products within the scope of those notices must bear WPS PR Notice
complying labeling when they are distributed or sold by the primary registrant or
any supplementally registered distributor.
After October 23, 1995, except as otherwise provided in PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS PR Notice
complying labeling when they are distributed or sold by any person.
2. Labeling Requirements for End-Use Products
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10 and other applicable
notices.
The labels of all maleic hydrazide end-use products must be revised to bear
the following statement:
Surface Water Advisory
"Under some conditions, maleic hydrazide may have a significant potential
for runoff into surface water (primarily via dissolution in runoff water), for several
days post-application. Conditions favoring runoff include poorly draining soils or
wet soils with readily visible slopes, frequently flooded areas, areas where an
intense or sustained rainfall is forecast to occur within 48 hours, areas overlying
extremely shallow ground water, and areas overlying tile drainage systems that
flow to surface water."
49
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Application Rates
Application rates must be provided for all uses. In instances where labels indicates
to spray to "drip-point," labels must clearly state the maximum application rate per
an acre.
For fallow land, lawns, turf and rights of way uses, labels must indicate that the
number of applications are limited to one per year.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products for
50 months from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; State of Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell maleic
hydrazide and maleic hydrazide, potassium salt products bearing old labels/labeling for
26 months from the date of issuance of this RED. Persons other than the registrant may
distribute or sell such products for 50 months from the date of the issuance of this RED.
50
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VI. APPENDICES
51
-------
(-ft
N>
-------
Data Supporting Guideline Requirements for the Registration of Maleic Hvdrazide
REQUIREMENT
82-2
83-1A
83-1B
83-2A
83-2B
83-3A
83-3B
83-4
84-2A
84-2B
84-4
85-1
21-Day Dermal - Rabbit/Rat
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity -
Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Structural Chromosomal
Aberration
Other Genotoxic Effects
General Metabolism
USE PATTERN
ABCK
AB
AB
AB
AB
AB
AB
AB
ABCK
ABCK
ABCK
AB
CITATION(S)
41289102
42570101, 42770401
42214101, 42248101
42570101, 42770401
00097886, 00098466
41458201, 41702901, 40874202, 41055903
00128721, 40985311
00128720
41149001
41147302, 41660001, 41719101
41176601, 41176602, 41147303
41571701, 41679701, 42432301
ENVIRONMENTAL FATE
161-1
161-2
161-3
162-1
162-2
163-1
164-1
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Leaching/Adsorption/Desorption
Terrestrial Field Dissipation
ABCK
ABC
ABC
ABCK
ABC
ABCK
ABCK
00143322
42692101, 42872301
00151951
41896201
41918201
00151952, 41896202
42693301, 42736901, 42744801, 42790901
80
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Data Supporting Guideline Requirements for the Reregistration of Maleic Hvdrazide
REQUIREMENT
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral - Quail/Duck
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
72-1A Fish Toxicity Bluegill
72-1C Fish Toxicity Rainbow Trout
72-2A Invertebrate Toxicity
72-2B Invertebrate Toxicity - TEP
123-1A Seed Germination/Seedling
Emergence
123-1B Vegetative Vigor
123-2 Aquatic Plant Growth
141-1 Honey Bee Acute Contact
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity -
Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation - Rabbit
81-6 Dermal Sensitization - Guinea Pig
USE PATTERN
ACKO
ACKO
ACKO
ACKO
ACKO
ACKO
ACKO
ACKO
ACKO
ACKO
ACKO
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
CITATION(S)
00124742, 00146141
00126033
00107417, 00147000
00124739
00124740, 00146142
00124741
00146143
41289301
41289302
41318001, 43006901, 43006902, 43006903,
43006904
00018842
00079657
00079658
41185401
00079661
00079660
41289101
79
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Data Supporting Guideline Requirements for the Reregistration of Maleic Hydrazide
REQUIREMENT USE PATTERN ^ CITATION(S)
Registrant: Fair Products, Inc.
Product(s); 96% (EPA Reg. No. 51873-10)
61-1 Chemical Identity A B C K
61-2A Start. Mat. & Mnfg. Process A B C K
61-2B Formation of Impurities A B C K
62-1 Preliminary Analysis A B C K
62-2 Certification of limits A B C K
62-3 Analytical Method A B C K
63-2 Color A B C K
63-3 Physical State A B C K
63-4 Odor A B C K
63-5 Melting Point A B C K
63-7 Density A B C K
63-8 Solubility A B C K
63-10 Dissociation Constant A B C K
63-11 Octanol/Water Partition A B C K
63-12 pH ABCK
63-13 Stability ABCK
63-17 Storage stability ABCK
63-20 Corrosion characteristics ABCK
40975901, 41229602
40975901, 41229602, 41233201
40975901, 41229602, 41233201
40975901, 41280701
40975901, 41229602
41185402, 41185403
41233201
41233201
41233201
41233201
41233201
41233201
41165401
41165401
41165401
41267701, 42005601
42005601
42005601
78
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Data Supporting Guideline Requirements for the Reregistration of Maleic Hydrazide
REQUIREMENT USE PATTERN CITATION(S)
Registrant: Drexel Chemical Company
Product(s): 95% T and 97% T (EPA Reg. Nos. 19713-25 and 19713-26)
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-7 Density
63-8 Solubility
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
63-14 Oxidizing/Reducing Action
63-17 Storage stability
63-20 Corrosion characteristics
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
41132901, 41132903
41132901, 41132903
41132901, 41132903, 41336902, 41336904
41336901, 41667801
41132901, 41132903, 41336901
41185402, 41185403
41132902, 41132904
41132902, 41132904
41132902, 41132904
41132902, 41132904
41132902, 41132904
41132902, 41132904, 41336903, 41336905,
42308501
41165401
41132902, 41132904
41132902, 41132904
41132902, 41132904, 42240101, 42413701
41132902, 41132904
41667801
41667801
77
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Data Supporting Guideline Requirements for the Reregistration of Maleic Hydrazide
'UIREMENT USE PATTERN CITATION(S)
Octanol/Water Partition
pH
Stability
Oxidizing/Reducing Action
Explodability
Storage stability
Corrosion characteristics
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
40985307
40985308
40993001
41484401
40985309, 40985310
41278001, 41471501
41222101, 41278002, 41471502
76
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Maleic Hydrazide
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY1
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-7
63-8
63-9
63-10
Registrant: Uniroyal Chemical Co.
Product(s): 97% T (EPA Reg. No. 400-97)
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Density
Solubility
Vapor Pressure
Dissociation Constant
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
41186001
40985301
41186002
41186003
41186004
41186003, 41186005
40985302
40985302
40985302
40985302
40985303
40985304
40985305
40985306
1 The product chemistry submissions are presented in this table separately for each of the 3 technical producers: Uniroyal
Chemical Co., Fair Products, Inc. and Drexel Chemical Co.
75
-------
74
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Maleic Hydrazide covered by this Reregistration Eligibility
Decision Document. It contains generic data requirements that apply to Maleic Hydrazide in
all products, including data requirements for which a "typical formulation" is the test
substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). 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 appendix for a complete citation of the study.
73
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72
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
71
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Date 06/29/94 - Time 13:24 APPENDIX A - CASE 0381, [Maleic Hydrazide] Chemical 051503 [l,2-Dihydro-3,6-pyridazinedione, potassiu LUIS 1.4 - Page 15
LEGEND
HEADER ABBREVIATIONS
Max. Apps 9 Max Rate : Maximum number of Applications at Maximum Dosage Rate
Mln. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C
M
F
O
ABBREVIATIONS
AN
NA
NS
UC
Coarse
Medium
Fine
Others
FORMULAT ON CODES
EC EMULSIFIABLE CONCENTRATE
SC/L SOLUBLE CONCENTRATE/LIQUID
SC/S SOLUBLE CONCENTRATE/SOLID
As Needed
Not Applicable
Not Specified (on label)
Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, —
APPLICATION RATE
DCNC
No Calc
W
V
cwt
nnE-xx
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Hundred Weight
nn times (10 power -xx); for instance,
"1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
C46
C93
G74
GI6
GM3
HOI
Do not apply through any type of irrigation system.
Do not apply directly to water.
Do not feed treated foliage to livestock or graze treated areas.
Do not graze or feed forage or hay from treated areas to livestock.
Do not pasture or use treated crop for feed, food, forage or bedding purposes.
day{s) preharvest interval.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES
AZ : Arizona
CA : California
FL : Florida
-------
Date 06/29/94 - Time 13:24
APPENDIX A - CASE 0381, [Malelc Hydrazlde] Chemical 051503 [l,2-Dlhydro-3,6-pyridazinedione, potasslu
LUIS 1.4 - Page 13
SITE Application Type, Application Form(s)
Timing, Application Equipment -
Surface Type (Antimicrobial only) c Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
SMALL FRUITS
Spray., Early summer.. Sprayer.
Spray., Spring., Sprayer.
SUBTROPICAL/TROPICAL FRUIT
Spray., Early summer.. Sprayer.
Spray., Spring., Sprayer.
TOBACCO
Low volume spray (concentrate).. Foliar.,
Aircraft.
Spray., Foliar., Animal-drawn sprayer.
Spray., Foliar., Compressed air sprayer.
Spray., Foliar., Sprayer.
Min. Appl. Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group:
SC/L
SC/S
SC/L
SC/S
NA
NA
NA
NA
UC *
UC *
UC *
UC *
Use Group:
SC/L
SC/S
SC/L
SC/S
NA
NA
NA
NA
UC *
UC *
UC *
UC *
Use Group:
SC/L
SC/L
SC/L
EC
SC/L
SC/L
SC/L
SC/L
SC/S
SC/S
EC
SC/L
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
4.5 Ib (AE)
4.5 Ib (AE)
4.5 Ib (AE)
A *
A *
A *
.1186 Ib (AE) 667 *
plants
4.5 Ib (AE)
4.5 Ib (AE)
4.5 Ib (AE)
4.5 Ib (AE)
4.5 Ib (AE)
4.5 Ib (AE)
2.106 Ib (AE)
4.5 Ib (AE)
A *
A *
A *
A *
A *
A *
A *
A *
Max. Maximum Dose
Apps /crop cycle
9 Max or /year
Rate
TERRESTRIAL
1/Y
1/Y
1/Y
1/Y
TERRESTRIAL
1/Y
1/Y
1/Y
1/Y
TERRESTRIAL
1/C
1/C
1/C
1/C
1/C
1/C
1/C
1/C
1/C
1/C
1/C
1/C
Min. Restr. Geographic Limitations Use
Interv Entry Allowed Disallowed Limitations
(days) Interv Codes
[day(s»
NON- FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46,
C46
C46,
C46
GM3
GM3
NON- FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46,
C46
C46,
C46
GM3
GM3
NON- FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46,
C46,
HOI (7)
HOI (7)
HOI (7)
C46,
C46,
G74,
GM3,
HOI (7)
HOI (7)
GM3, HOI (7)
HOI (7)
H01(7)
C46, G74, GM3,
HOI (7)
C46,
C46,
C46,
HOI (7)
HOI (7)
HOI (7)
-------
Date 06/29/94 - Time 13:24 APPENDIX A - CASE 0381, [Maleic Hydrazlde] chemical 051503 [l,2-Dlhydro-3,6-pyridazinedione, potasslu LUIS 1.4 - Page 14
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max.
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. Apps
Surface Type (Antimicrobial only) t Effica- less noted unless noted Max. 9 Max
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose Rate
Maximum Dose Min. Restr. Geographic Limitations Use
/crop cycle Interv Entry Allowed Disallowed Limitations
or /year (days) Interv Codes
Iday(s))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
TOBACCO (con't)
Spray., Foliar,, Tractor-mounted sprayer.
WALNUT (ENGLISH/BLACK)
Spray., Early summer., Sprayer.
Spray., Spring., Compressed air sprayer.
Spray., Spring., Hose-end sprayer.
Spray., Spring., Sprayer.
Spray., Summer., Compressed air sprayer.
Spray., Summer., Hose-end sprayer.
Spray., Summer., Sprayer.
SC/S
SC/L
SC/L
SC/L
SC/L
SC/S
SC/S
SC/L
SC/S
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
SC/L
SC/L
SC/L
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group;
4.5 Ib (AE) A *
4.5 Ib (AE) A *
4.5 Ib (AE) A *
4.5 Ib (AE) A *
4.5 Ib (AE) A *
4.5 Ib (AE) A *
4.5 Ib (AE) A *
Use Group:
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
TERRESTRIAL
1/C
1/C
1/C
1/C
1/C
1/C
1/C
TERRESTRIAL
1/Y
1/Y
NS
NS
NS
1/Y
NS
1/Y
NS
NS
NS
NS
NON- FOOD CROP (con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46,
C46,
G74,
GM3,
HOI (7)
HOI (7)
GM3, HOI (7)
HOI (7)
H01(7)
C46, G74, GM3,
HOI (7)
C46,
HOI (7)
NON- FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46,
C46
G74,
G74,
GM3
C46,
G74,
C46
G74,
G74,
GM3
G74,
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
-------
Date 06/29/94 - Time 13:24
APPENDIX A - CASE 0381, [Maleic Hydrazide) Chemical 051503 [l,2-Dihydro-3,6-pyridazinedione, potasslu
LUIS 1.4 - Page 12
SITE Application Type, Application Form(s)
Timing, Application Equipment -
Surface Type (Antimicrobial only) i Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED ( con ' t )
ORNAMENTAL WOODY SHRUBS AND VINES (con't)
Spray., Summer., Sprayer.
RECREATIONAL AREAS
Tree injection treatment., When needed.,
Tree injection equipment.
RESIDENTIAL LAWNS
Edging treatment., Dormant., Sprayer.
Edging treatment., Fall., Boom sprayer.
Edging treatment., Fall., Sprayer.
Edging treatment.. Spring., Boom sprayer.
Edging treatment.. Spring., Compressed air
sprayer .
Edging treatment.. Spring., Hose-end
sprayer.
Edging treatment., Spring., Sprayer.
Min. Appl. Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group:
SC/L
SC/S
NA
NA
UC *
UC *
Use Group:
SC/L
NA
UC *
Use Group:
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
SC/L
SC/S
SC/L
SC/L
SC/S
SC/L
SC/L
SC/S
SC/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
6.008 Ib (AE)
6 Ib (AE)
5.063 Ib (AE)
.1172 Ib (AE)
sq.
6 Ib (AE)
.08789 Ib (AE)
sq.
4.5 tbsp (AE)
sq.
4.402 Ib (AE)
4.002 Ib (AE)
3.938 Ib (AE)
.09375 Ib (AE)
sq.
.75 Ib (AE)
A *
A *
A *
IK *
ft
UC *
A *
IK *
ft
IK *
ft
A *
A *
UC *
A *
IK *
ft
UC *
A *
Max, Maximum Dose
Apps /crop cycle
8 Max or /year
Rate
TERRESTRIAL
NS
NS
TERRESTRIAL
NS
Min. Restr. Geographic Limitations Use
Interv Entry Allowed Disallowed Limitations
(days) Interv Codes
Iday(s)]
NON- FOOD CROP (con't)
NS
NS
NS
NS
NS
NS
G74,
C46,
GM3
G74,
GM3
NON- FOOD CROP
NS
NS
NS
C46
OUTDOOR RESIDENTIAL
1/Y
1/Y
1/Y
NS
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
NS
1/Y
1/Y
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
GM3
C46,
GM3
G74,
C46
C46,
G74,
C46,
C46,
G74,
C46,
GM3
G74,
C46
C46,
GM3
GM3
GM3
GM3
G74,
G74,
GM3
G74,
GM3
G74,
GM3
GM3
GM3
GM3
-------
Date 06/29/94 - Time 13:24 APPENDIX A - CASE 0381, [Maleic Hydrazide] Chemical 051503 [l,2-Dihydro-3,6-pyridazinedione, potassiu LUIS 1.4 - Page 11
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max.
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. Apps
Surface Type (Antimicrobial only) < Effica- less noted unless noted Max. 9 Max
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose Rate
Maximum Dose Min. Restr. Geographic Limitations Use
/crop cycle Interv Entry Allowed Disallowed Limitations
or /year (days) Interv Codes
(day(s)]
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL LAWNS AND TURF (con't)
Spray., Spring., Sprayer.
Spray., Spring., Tractor-mounted sprayer.
ORNAMENTAL WOODY SHRUBS AND VINES
Spray., Early summer., Sprayer.
Spray., Spring., Compressed air sprayer.
Spray., Spring., Hose-end sprayer.
Spray., Spring., Sprayer.
Spray., Summer., Compressed air sprayer.
Spray., Summer., Hose-end sprayer.
SC/S
sc/s
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
SC/S
SC/L
SC/S
SC/L
SC/S
SC/L
SC/L
SC/L
SC/L
SC/S
SC/S
SC/L
SC/S
SC/L
SC/L
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group:
UC *
3 Ib (AE) A *
3.3 Ib (AE) A *
3 Ib (AE) A *
3.938 Ib (AE) A *
4.005 Ib (AE) A *
3 Ib (AE) A *
3 Ib (AE) A *
3 Ib (AE) A *
Use Group:
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
TERRESTRIAL
1/Y
1/Y
1/Y
1/Y
1/Y
NS
1/Y
1/Y
1/Y
TERRESTRIAL
1/Y
1/Y
NS
NS
NS
NS
1/Y
NS
1/Y
NS
NS
NS
NS
NS
NON- FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46
C46,
C46,
G74,
GM3
G74,
C46,
G74,
C46,
G74,
G74,
GM3
GM3
G74,
GM3
G74,
GM3
GM3
GM3
GM3
NON- FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46,
C46
G74,
C46,
G74,
GM3
C46,
G74,
C46
C46,
G74,
C46,
G74,
GM3
GM3
GM3
G74,
GM3
GM3
GM3
G74,
GM3
G74,
GM3
GM3
GM3
GM3
-------
Date 06/29/94 - Time 13i24
~ CASE °381' [Maleic Hyd«3idel Chemical 051503 [l,2-Dihydro-3,6-pyridazinedione, potassiu LUIS 1.4 - Page
SITE Application Type, Application Form(s)
Timing, Application Equipment -
Surface Type (Antimicrobial only) c Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED (con't)
ORNAMENTAL LAWNS AND TURF (con't)
Spray., Dormant., Tractor-mounted sprayer.
Spray., Fall., Air carrier sprayer.
Spray., Fall., Airblast.
Spray., Fall., Boom sprayer.
Spray., Fall., Sprayer.
Spray., Fall., Tractor-mounted sprayer.
Spray., Spring., Air carrier sprayer.
Spray., Spring., Airblast.
Spray., Spring., Boom sprayer.
Min. Appl. Max. Appl.
Rate (AI un- Rate (AI
less noted unless noted
otherwise) otherwise)
Soil Max. Maximum Dose Min. Restr. Geographic Limitations Use
Tex. Apps /crop cycle Interv Entry Allowed Disallowed Limitations
Max. 9 Max or /year (days) Interv Codes
Dose Rate [day(s|]
Use Group: TERRESTRIAL NON- FOOD CROP
SC/S
SC/L
SC/S
SC/L
SC/L
SC/S
SC/L
SC/L
SC/h
SC/S
SC/S
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
SC/S
SC/L
SC/L
SC/S
SC/L
SC/L
SC/L
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
4.5
1.2
4.5
4.995
4.05
3.75
6
4.05
4.995
3.75
4.455
4.05
5.063
4.995
3.75
4.05
3.75
4.005
3
3
6
3
4.005
Ib (AE)
Ib (AE)
Ib (AE)
ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
Ib (AE)
A
A
A
A
A
A
A
A
A
UC
A
A
A
A
A
A
A
A
A
A
A
A
A
A
* 1/Y
* 1/Y
* 1/Y
* NS
* 1/Y
* 1/Y
* 1/Y
* 1/Y
* NS
* 1/Y
* 1/Y
* 1/Y
* 1/Y
* 1/Y
* NS
* 1/Y
* 1/Y
* 1/Y
* NS
* 1/Y
* 1/Y
* 1/Y
* 1/Y
* NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46,
G74,
C46,
G74,
G74,
C46,
C46,
G74,
G74,
C46
C46,
C46,
G74,
GM3
G74,
C46,
G74,
C46,
G74,
G74,
C46,
C46,
G74,
G74,
G74,
GM3
G74,
GM3
GM3
G74,
GM3
GM3
GM3
G74,
G74,
GM3
GM3
G74,
GM3
G74,
GM3
GM3
G74,
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
10
-------
Date 06/29/94 - Time 13:24 APPENDIX A - CASE 0381, [Malelc Hydrazide] chemical 051503 [1,2-Dihydro-3,6-pyridazlnedlone, potassiu LUIS 1.4 - Page 9
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max.
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. Apps
Surface Type (Antimicrobial only) i Effica- less noted unless noted Max. 0 Max
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose Rate
Maximum Dose Min. Restr. Geographic Limitations Use
/crop cycle Interv Entry Allowed Disallowed Limitations
or /year (days) Interv Codes
(day(s)]
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL AND/OR SHADE TREES
Spray., Early summer., Sprayer.
Spray., Spring., Compressed air sprayer.
Spray., Spring., Hose-end sprayer.
Spray., Spring., Sprayer.
Spray., Summer., Compressed air sprayer.
Spray., Summer., Hose-end sprayer.
Spray., Summer., Sprayer.
ORNAMENTAL LAWNS AND TURF
Spray., Dormant., Airblast.
Spray., Dormant., Boom sprayer.
Spray., Dormant., Sprayer.
SC/L
SC/S
SC/L
SC/S
SC/L
SC/L
SC/L
SC/L
SC/S
SC/S
SC/L
SC/S
SC/L
SC/L
SC/L
SC/S
SC/L
SC/S
SC/L
SC/S
SC/L
SC/L
SC/L
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA •
NA
NA
NA
Use Group:
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
Use Group:
1.2 Ib (AE) A *
4.5 Ib (AE) A *
1.2 Ib (AE) A *
4.5 Ib (AE) A *
6.6 Ib (AE) A *
1.2 Ib (AE) A *
6.008 Ib (AE) A *
TERRESTRIAL NON- FOOD
1/Y
1/Y
NS
NS
NS
NS
1/Y
NS
1/Y
NS
NS
NS
NS
NS
NS
NS
TERRESTRIAL
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46,
C46
G74,
C46,
G74,
GM3
C46,
G74,
C46
C46,
G74,
C46,
G74,
GM3
G74,
C46,
GM3
GM3
G74,
GM3
GM3
GM3
G74,
GM3
G74,
GM3
GM3
G74,
GM3
GM3
GM3
GM3
NON- FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
G74,
C46,
G74,
C46,
C46,
G74,
GM3
GM3
G74,
GM3
G74,
G74,
GM3
GM3
GM3
GM3
-------
Date 06/29/94 - Time 13:24
°381' fMale*c
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. Apps
Surface Type (Antimicrobial only) « Effica- less noted unless noted Max. 8 Max
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose Rate
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Chemical 051503 [l,2-Dihydro-3, 6-pyridazinedlone, potassiu
LUIS 1.4 - Page
Maximum Dose Min. Restr. Geographic Limitations Use
/crop cycle Interv Entry Allowed Disallowed Limitations
or /year (days) Interv Codes
[day(s))
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS (con't)
Spray., Fall., Boom sprayer.
Spray., Fall., Sprayer.
Spray., Fall., Tractor-mounted sprayer.
Spray., Spring., Airblast.
Spray., Spring., Boom sprayer.
Spray., Spring., Sprayer.
Spray., Spring., Tractor-mounted sprayer.
SC/S
SC/L
SC/L
SC/S
SC/S
SC/L
SC/L
SC/L
SC/S
SC/L
SC/S
SC/L
SC/S
SC/L
SC/L
SC/S
SC/S
SC/L
SC/L
SC/L
SC/S
SC/L
SC/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
3.75 Ib
6 Ib
4.05 Ib
3.15 Ib
4.455 Ib
4.05 Ib
4.5 Ib
3.75 Ib
4.05 Ib
3.75 Ib
3 Ib
3 Ib
6 Ib
3 Ib
Use Group
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
A *
A *
A *
UC *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
UC *
3 Ib
3.3 Ib
3 Ib
3 Ib
3 Ib
3 Ib
3 Ib
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
A *
A *
A *
A *
A *
A *
A *
: TERRESTRIAL NON-FOOD CROP
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
1/Y
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46,
C46,
G74,
C46
C46,
C46,
G74,
GM3
C46,
G74,
C46,
G74,
C46,
C46,
G74,
C46
C46,
C46,
G74,
GM3
C46,
G74,
C46,
G74,
GM3
GM3
G74,
G74,
GM3
G74,
GM3
G74,
GM3
G74,
GM3
GM3
G74,
G74,
GM3
G74,
GM3
G74,
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
-------
Date 06/29/94 - Time 13:24
APPENDIX A - CASE 0381, (Maleic Hydrazide] Chemical 051503 (l,2-Dihydro-3,6-pyridazinedione, potassiu
LUIS 1.4 - Page 7
SITE Application Type, Application Form(s)
Timing, Application Equipment -
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED ( con ' t )
NONAGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS
Spray., Fall., Tractor-mounted sprayer.
Spray., Spring., Air carrier sprayer.
Spray., Spring., Airblast.
Spray., Spring., Boom sprayer.
Spray., Spring., Sprayer.
Spray., Spring., Tractor-mounted sprayer.
Tree injection treatment.. When needed.,
SC/L
SC/L
SC/S
SC/L
SC/S
SC/L
SC/L
SC/S
SC/L
SC/L
SC/L
SC/S
SC/S
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
SC/S
SC/L
Mln. Appl. Max. Appl. Soil Max. Maximum Dose Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. Apps /crop cycle Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. 9 Max or /year (days) Interv Codes
otherwise) otherwise) Dose Rate [day(s) ]
(con't)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL NON-FOOD CROP
5.063
4.995
4.5
3.758
4.5
4.005
2.993
4.5
6
2.993
4.005
4.5
6.6
1.2
4.5
4.005
4.5
2.993
4.5
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
A
A
A
A
A
A
A
A
A
A
A
UC
A
A
A
A
A
A
A
A
UC
* 1/Y
* NS
* 1/Y
* 1/Y
* 1/Y
* NS
* 1/Y
* 1/Y
* 1/Y
* 1/Y
* NS
* 1/Y
* 1/Y
* 1/Y
* 1/Y
* 1/Y
* NS
* 1/Y
* 1/Y
* 1/Y
* NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
GM3
G74,
C46,
G74,
C46,
G74,
G74,
C46,
C46,
G74,
G74,
C46
C46,
C46,
G74,
GM3
G74,
C46,
G74,
C46,
C46
GM3
G74,
GM3
G74,
GM3
GM3
G74,
GM3
GM3
GM3
G74,
G74,
GM3
GM3
G74,
GM3
G74,
GM3
GM3
GM3
GM3
GM3
GM3
GM3
Tree injection equipment.
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS
Spray., Fall., Airblast.
SC/L NA
Use Group: TERRESTRIAL NON-FOOD CROP
4.05 Ib (AE) A * 1/Y NS NS
NS
G74, GM3
-------
chemical °51503
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max
Timing, Application Equipment - Rate (AI un- Rate (AI Tex ADDS
Surface Type (Antimicrobial only) « Efflca- less noted unless noted Max! 9 Max
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose Rate
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
. potasslu
LUIS
Maximum Dose Min. Restr. Geographic Limitations Use ""
/crop cycle Interv Entry Allowed Disallowed Limitations
or /year (days) Interv Codes
(day(s))
MULBERRY
Spray. ,
Spray.,
Spray.,
Spray.,
Spray.,
Spray. ,
Spray. ,
Early summer., Sprayer. sc/L
SC/S
Spring., Compressed air sprayer. SC/L
Spring., Hose-end sprayer. SC/L
SC/L
Spring., Sprayer. SC/L
SC/L
SC/S
Summer., Compressed air sprayer. SC/L
Summer., Hose-end sprayer. SC/L
SC/L
Summer., Sprayer. SC/L
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NONAGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS
Spray. ,
Spray.,
Spray.,
Spray.,
Spray.,
Dormant., Sprayer. SC/L
Fall., Air carrier sprayer. SC/L
Fall., Airblast. SC/L
SC/S
Fall., Boom sprayer. SC/L
SC/L
SC/L
SC/S
SC/S
Fall., Sprayer. SC/L
SC/L
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
UC *
Use Group:
6.008 Ib (AE) A *
4.995 Ib
-------
Date 06/29/94 - Time 13:24
APPENDIX A - CASE 0381, (Halelc Hydrazide) Chemical 051503 (l,2-Dihydro-3,6-pyridazlnedlone, potasslu
LUIS 1.4 - Page 5
SITE Application Type, Application Form(s)
Timing, Application Equipment -
Surface Type (Antimicrobial only) C Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED (con't)
GOLF COURSE TURF (con't)
Spray., Spring., Boom sprayer.
Spray., Spring., Sprayer.
Spray., Spring., Tractor-mounted sprayer.
INDUSTRIAL AREAS (OUTDOOR)
Spray., Fall., Air carrier sprayer.
Spray., Fall., Boom sprayer.
Spray., Fall., Sprayer.
Spray., Spring., Air carrier sprayer.
Spray., Spring., Boom sprayer.
Spray., Spring., Sprayer.
SC/S
SC/L
SC/L
SC/L
SC/S
SC/S
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
SC/S
SC/L
SC/L
SC/L
SC/S
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
Min. Appl. Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
3
6
3
4.005
3
3.3
3
3
4.005
3
3
3
4.995
6
4.995
4.995
4.005
6
4.005
4.005
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Use Group:
(AE) A *
(AE) A *
(AE) A *
(AE) A *
UC *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
Use Group:
(AE) A *
(AE) A *
(AE) A *
UC *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
UC *
(AE) A *
Max. Maximum Dose Min. Restr. Geographic Limitations Use
Apps /crop cycle Interv Entry Allowed Disallowed Limitations
8 Max or /year (days) Interv Codes
Rate [day(s))
TERRESTRIAL
1/Y
1/Y
1/Y
NS
1/Y
1/Y
1/Y
1/Y
1/Y
NS
1/Y
1/Y
1/Y
TERRESTRIAL
NS
1/Y
NS
1/Y
NS
NS
1/Y
NS
1/Y
NS
NON- FOOD CROP (con't)
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NON- FOOD CROP
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46,
C46,
G74,
G74,
C46
C46,
C46,
674,
GM3
G74,
C46,
G74,
C46,
G74,
C46,
G74,
C46
G74,
G74,
C46,
G74,
C46
G74,
G74,
GM3
GM3
GM3
G74,
G74,
GM3
GM3
G74,
GM3
G74,
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
-------
™!.!!™^._:..!™."I". "rfl??"™.:..^!."!!!:.^™!.1!.!^!!!1?"1 Chemlcal °51503 U.2-Dihydro-3.6-pyrld«ln.dionef potassiu LUIS 1.4 - Page A
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. soil Max
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. Apps
Surface Type (Antimicrobial only) < Effica- less noted unless noted Max 9 Max
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose Rate
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Maximum Dose Min. Restr. Geographic Limitations Use
/crop cycle Interv Entry Allowed Disallowed Limitations
or /year (days) Interv Codes
tday(s)]
COMMERCIAL/INDUSTRIAL LAWNS (con't)
Spray., Spring., Sprayer.
ELDERBERRY
Spray., Early summer. , Sprayer.
Spray., Spring., Sprayer.
GOLF COURSE TURF
Spray., Fall., Air carrier sprayer.
Spray., Fall., Airblast.
Spray., Fall., Boom sprayer.
Spray., Fall., Sprayer.
Spray., Fall., Tractor-mounted sprayer.
Spray., Spring., Air carrier sprayer.
Spray., Spring., Airblast.
SC/L
SC/L
SC/S
SC/L
SC/S
SC/L
SC/L
SC/S
SC/L
SC/L
SC/L
SC/S
SC/S
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
SC/S
SC/L
SC/L
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
4.005
4.995
4.05
3.75
6
4.05
4.995
3.75
4.455
4.05
4.5
4.9»5
3.75
4.05
3.75
4.005
3
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Use Group:
(AE) A *
Use Group:
UC *
UC *
UC *
UC *
Use Group:
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
UC *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
TERRESTRIAL
NS
TERRESTRIAL
1/Y
1/Y
1/Y
1/Y
TERRESTRIAL
NS
1/Y
1/Y
1/Y
1/Y
NS
1/Y
1/Y
1/Y
1/Y
1/Y
NS
1/Y
1/Y
1/Y
NS
1/Y
NON-FOOD CROP (con't)
NS NS
NON-FOOD CROP
NS NS
NS NS
NS NS
NS NS
NON-FOOD CROP
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
G74,
C46,
C46
C46,
C46
G74,
G74,
C46,
C46,
G74,
G74,
C46
C46,
C46,
G74,
GM3
G74,
C46,
G74,
C46,
674,
G74,
GM3
GM3
GM3
GM3
GM3
G74,
GM3
GM3
GM3
G74,
G74,
GM3
GM3
G74,
•GM3
G74,
GM3
GM3
GM3
GM3
GM3
GM3
GM3
-------
Date 06/29/94 - Time 13:24
APPENDIX A - CASE 0381, [Maleic Hydrazide] Chemical 051503 [l,2-Dihydro-3,6-pyridazinedione, potassiu
LUIS 1.4 - Page 3
SITE Application Type, Application Form(s)
Timing, Application Equipment -
Surface Type (Antimicrobial only) i Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED ( con ' t )
Min. Appl. Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
AIRPORTS/LANDING FIELDS (con't)
Spray. ,
Spray.,
Spray.,
Spray.,
Spray.,
CITRUS
Spray. ,
Spring., Air carrier sprayer.
Spring., Airblast.
Spring., Boom sprayer.
Spring., Sprayer.
Spring., Tractor-mounted sprayer.
FRUITS
Nonbearing., Sprayer.
SC/L
SC/L
SC/S
SC/L
SC/L
SC/L
SC/S
SC/S
SC/L
.SC/L
SC/L
SC/L
SC/S
SC/L
SC/S
SC/L
SC/L
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
4.005 Ib
3 Ib
3 Ib
6 Ib
3 Ib
4.005 Ib
3 Ib
3.3 Ib
3 Ib
3 Ib
4.005 Ib
3 Ib
3 Ib
3 Ib
COMMERCIAL/ INDUSTRIAL LAWNS
Spray.,
Spray. ,
Spray. ,
Spray. ,
Spray. ,
Fall., Air carrier sprayer.
Fall., Boom sprayer.
Fall., Sprayer.
Spring., Air carrier sprayer.
Spring., Boom sprayer.
SC/L
SC/L
SC/L
SC/L
SC/L
NA
NA
NA
NA
NA
4.995 Ib
4.995 Ib
4.995 Ib
4.005 Ib
4.005 Ib
Use Group:
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
UC *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
Use Group:
UC *
UC *
Use Group:
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
Max. Maximum Dose Min. Restr. Geographic Limitations Use
Apps /crop cycle Interv Entry Allowed Disallowed Limitations
@ Max or /year (days) Interv Codes
Rate (day(s)J
TERRESTRIAL
NS
1/Y
1/Y
1/Y
1/Y
NS
1/Y
1/Y
1/Y
1/Y
1/Y
NS
1/Y
1/Y
1/Y
TERRESTRIAL
NS
NS
TERRESTRIAL
NS
NS
NS
NS
NS
NON- FOOD CROP (con't)
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NON- FOOD CROP
NS 42
NS 42
NON- FOOD CROP
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS FL
NS FL
NS
NS
NS
NS
NS
G74,
G74,
C46,
C46,
G74,
G74,
C46
C46,
C46,
G74,
GM3
G74,
C46,
G74,
C46,
G74,
GM3
G74,
G74,
G74,
G74,
G74,
GM3
GM3
G74,
GM3
GM3
GM3
G74,
G74,
GM3
GM3
G74,
GM3
674,
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
GM3
-------
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max.
Timing, Application Equipment - Rate (AI un- Rate (AI Tex. Apps
Surface Type (Antimicrobial only) 4 Efflca- less noted unless noted Max. 9 Max
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose Rate
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
Chemlcal °51503 U.Z-Mhydro-a.e-pyrldazinedlon.. PotaSsiU
LUIS 1.4 - Page 2
ose Min. Restr. Geographic Limitations Use
/crop cycle Interv Entry Allowed Disallowed Limitations
or /year (days) Interv codes
(day(s)]
POTATO, WHITE/IRISH (con't)
NON- FOOD/NON- FEED
AGRICULTURAL FALLOW/ I DLELAND
Spray., Postharvest., Boom sprayer.
Spray., Postharvest., Sprayer.
AIRPORTS/LANDING FIELDS
Spray., Fall., Air carrier sprayer.
Spray., Fall., Airblast.
Spray., Fall., Boom sprayer.
Spray., Fall., Sprayer.
Spray., Fall., Tractor-mounted sprayer.
SC/L
SC/S
SC/S
NA
NA
NA
Use Groups
2.993 Ib (AE) A *
9 Ib (AE) 3 A *
3 Ib (AE) A *
3 Ib (AE) A *
Use Group:
SC/L
SC/S
NA
NA
9
9
Ib
Ib
(AE)
(AE)
A *
A *
Use Group:
SC/L
SC/L
SC/S
SC/L
SC/L
SC/L
SC/S
SC/S
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
SC/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
4.995
4.05
3.75
6
4.05
4.995
3.75
4.455
4.05
4.5
4.995
3.75
4.05
3.75
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
(AE)
A *
A *
A *
A *
A *
A *
UC *
A *
A *
A *
A *
A *
A *
A *
A *
TERRESTRIAL
NS
NS
NS
TERRESTRIAL
NS
NS
TERRESTRIAL
NS
1/Y
1/Y
1/Y
1/Y
NS
1/Y
1/Y
1/Y
1/Y
1/Y
NS
1/Y
1/Y
1/Y
FOOD+FEED CROP
NS NS
NS NS
NS NS
NON- FOOD CROP
NS NS
NS NS
NON- FOOD CROP
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
GM3
C46
C46, G74,
AZ, CA C46, GI6,
AZ, CA C46, GI6
G74, GM3
G74, GM3
C46, G74,
C46, GM3
G74, GM3
G74, GM3
C46
C46, G74,
C46, G74,
G74, GM3
GM3
G74, GM3
C46, G74,
G74, GM3
C46, G74,
GM3
GM3
GM3
GM3
GM3
GM3
GM3
-------
Date 06/29/94 - Time 13:24
APPENDIX A - CASE 0381, [Malelc Hydrazlde) chemical 051503 [l,2-Dlhydro-3,6-pyridazinedlone, potassiu
LUIS 1.4 - Page 1
SITE Application Type, Application Form(s)
Timing, Application Equipment -
Surface Type (Antimicrobial only) c Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
ONION
Low volume spray (concentrate)., Foliar.,
Aircraft.
Low volume spray (concentrate).,
Preharvest., Aircraft.
Spray., Foliar., Ground.
Spray., Preharvest., Ground.
POTATO, WHITE/ IRISH
Low volume spray (concentrate)., Foliar.,
Aircraft.
Spray., Foliar., Ground.
SC/L
SC/L
SC/L
SC/L
SC/S
SC/S
SC/L
SC/L
SC/L
SC/L
SC/S
SC/S
SC/L
SC/L
SC/L
SC/L
SC/S
SC/S
SC/L
SC/L
SC/L
Min. Appl. Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
1.995
1.547
1.969
1.998
1.998
1.995
1.547
1.969
1.998
1.998
3
2.25
2.993
9 Ib
3
3
3
2.25
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Use Group:
UC *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
UC *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
(AE) A *
Use Group:
UC *
(AE) A *
(AE) A *
(AE) A *
(AE) 3 A *
Ib (AE) A V *
Ib
Ib
Ib
(AE) A *
UC *
(AE) A *
(AE) A *
Max. Maximum Dose Min. Restr. Geographic Limitations Use
Apps /crop cycle Interv Entry Allowed Disallowed Limitations
8 Max or /year (days) Interv Codes
Rate [day(s) )
TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
FOOD* FEED CROP
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
0.5
NS
NS
NS
NS
NS
0.5
NS
NS
NS
NS
NS
0.5
NS
NS
NS
NS
NS
0.5
NS
NS
C46,
C46
G74,
GM3
C46
C46,
C46,
C46
G74,
GM3
C46
C46,
C46,
C46
' G74,
GM3
C46
C46,
C46,
C46
G74,
C93
GM3
G74,
C93
GM3
G74,
C93
GM3
G74,
C93
GM3
GM3
GM3
GM3
-------
-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
53
-------
Data Supporting Guideline Requirements for the Registration of Maleic Hvdrazide
REQUIREMENT
165-1
165-4
165-5
Confined Rotational Crop
Bioaccumulation in Fish
Bioaccumulation - Aquatic
USE PATTERN
ABC
ABC
ABC
CITATION(S)
00122390, 41937801
00163301
00163301
NonTarget
RESIDUE CHEMISTRY
171-4A Nature of Residue - Plants
171-4B Nature of Residue - Livestock
171-4C & Residue Analytical Method - Plants
171-4D & - Animals
171-4E Storage Stability
171-4J Magnitude of Residues -
Meat/Milk/Poultry/Egg
171-4K Crop Field Trials
Root and Tuber Vegetable Group
- Potatoes
Bulb Vegetable Group
- Onions (dry bulb)
Small Fruits and Berries Group
AB
B
AB
AB
B
AB
00106979, 00121599, 00122399, 00125641,
41488201, 41488202, 42654901
42567801, 42641501
00058579,
00106267,
00122366,
42654901
00058587,
42641501,
00087400, 00100749, 00101295,
00106979, 00106983, 00112750,
00125636, 42125301, 42382101,
42567804, 42567805, 42567806,
42905801
00106979, 42567802, 42567803
00086764, 00106979, 00121603, 00122361,
00122364, 42567804
00058587, 00106979, 00121605, 00122363,
00141353, 42567805
81
-------
Data Supporting Guideline Requirements for the Reregistration of Maleic Hydrazide
REQUIREMENT . USE PATTERN CITATIONSS*
- Cranberries
Nonbearing Orchard Crops
• Citrus Fruits
Miscellaneous Commodities
- Tobacco
171-4L Processed Food
-Processed Potatoes
AB
00100749, 00101298
00101296
00087392, 00125636, 00165460, 41055901,
41055902, 41294301
42567806
82
-------
oo
-------
84
-------
APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Maleic Hydrazide
85
-------
86
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
87
-------
as (19??), the Agency was unable to determine or estimate the date of the
document
document.
c.
Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative position of the study within
the vn1nm*»
-------
BIBLIOGRAPHY
MRID
CITATION
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)
00058587 Uniroyal Chemical (1951) Maleic hydrazide Residue. (Unpublished study
received Dec 22, 1952 under 400-38; CDL:231189-L)
00079657 Shapiro, R. (1977) Acute Oral Toxicity: Report No. T-235. (Unpublished
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 Toxicity: Report No. T-242. (Unpublished
study received 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 Chemical, 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 Nov 3, 1981 under
400-84; CDL:246227-A)
00087392 Guthrie, F.E.; Bowery, T.G. (1967) Pesticide residues on tobacco. Residue
Review 19:31-56. (Also in unpublished submission received on unknown date
under unknown admin, no.; submitted by ?; CDL:120496-E)
00087400 Wood, P.R. (1951) Determination of Maleic Hydrazide in Plant and Animal
Products. Method dated Feb 21, 1951. (Unpublished study received on
unknown date under unknown admin, no.; submitted by ?; CDL:120496-P)
00097886 International Research and Development Corporation (1981) Lifetime
Oncogenicity Study in Mice: Study No. 399-007. (Unpublished study received
Nov 20, 1981 under 400-84; submitted by Uniroyal Chemical, Bethany, Conn.;
CDL:246286-A)
89
-------
BIBLIOGRAPHY
MRID
CITATION
00098466
00100749
00101295
00101296
00101298
00106267
00106979
00106983
00107417
Jessup, D.C.; Trumbull, R.R.; Richter, W.R.; et al. (1981) Lifetime
Oncogenicity Study in Mice: 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)
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)
United States Rubber Co. (19??) General Method G-114-A: Maleic Hydrazine
(MH) Residues. (Unpublished study received on unknown date under PP0284-
CDL:092562-A)
United States Rubber Co. (1960) MH Residue in Lemon Juice, in Lemon Peel
and in Whole Lemon. (Unpublished study received on unknown date under
PP0284; CDL:092562-B)
United States Rubber Co. (1960) Residues of MH in Cranberries. (Compilation;
unpublished study received on unknown date under PP0284; CDL:092562-D)
Lane, J.; Gullstrom, 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)
Naugatuck Chemical (1954) Maleic Hydrazide: Residues in Beans and Other
Crops. (Compilation; unpublished study received on unknown date under
PP0027; CDL:092309-B)
Lane, J. (1959) Maleic Hydrazide (MH) Residues: General Method G-114-A
(Unpublished study received Feb 16, 1961 under PP0284; submitted by U S
Rubber Co., Naugatuck, CT; CDL:092563-A)
Fink, R. (1974) Final Report: Eight-day Dietary LC50~Mallard Ducks:
Technical MH: Project No. 117-106. (Unpublished study received Aug 20,
90
-------
BIBLIOGRAPHY
MRID
CITATION
1974 under 400-41; prepared by Truslow Farms, Inc., submitted by Uniroyal
Chemical, Bethany, CT; CDL:130997-A)
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 maleic
hydrazide upon the growth of strawberry runners based upon radioisotope
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 Potato 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. (Unpublished study
received May 7, 1959 under 400-41; CDL:120013-A)
00122364 Uniroyal Chemical (1953) Analysis of Potatoes for Diethanolamine Residues
from MH-30. (Unpublished study received Feb 24, 1958 under 400-67;
CDL:120039-A)
00122366 Anglin, 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 ?; CDL: 124447-A)
91
-------
MRID
BIBLIOGRAPHY
CITATION
00122390
00122399
00124739
00124740
00124741
00124742
00125636
00126033
Meek, R.; Smyser, B.; Smith, A. (1978) The Environmental Studies on Maleic
Hydrazide. (Unpublished study received Feb 9, 1978 under 400-41; submitted
by Uniroyal Chemical, Bethany, CT; CDL: 232908-A)
Nooden, L. (1975) The mode of action and metabolism of maleic hydrazide.
Environ. Qual. Saf. 3:473-476. (Also In unpublished submission received Feb
9, 1978 under 400-41; submitted by Uniroyal Chemical, Bethany, CT-
CDL:232908-J)
Kuc, W. (1977) The Acute Toxicity of MH Technical GMS 479 BL 8721 to the
Bluegill Sunfish, Lepomis macrochirus (Rafmesque) 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-A)
Calmbacher, C. (1977) The Acute Toxicity of MH Technical GMS 479, BL
8721 to the Rainbow Trout, Salmo gairdneri (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)
Vilkas, A. (1977) The Acute Toxicity of MH Technical to the Water Flea,
Daphnia magna Straus: 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-C)
Fink, R.; Beavers, J.; Brown, R. (1977) Acute Oral LD50-MaUard Duck: MH
Technical: Project No. 117-130. Final report. (Unpublished study received
Jan 6, 1978 under 400-84; prepared by Wildlife International Ltd., submitted
by Uniroyal Chemical, Bethany, CT; CDL:232653-D)
Uniroyal Chemical (1976?) Residues of Maleic Hydrazide. (Compilation;
unpublished study received Feb 16, 1978 under unknown admin, no.;
CDL:249370-B)
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 400-84; prepared by Wildlife International Ltd.,
submitted by Uniroyal Chemical, Bethany, CT; CDL:232653-E)
92
-------
BIBLIOGRAPHY
MRID
CITATION
00141353 Uniroyal, Inc. (1978) Rebuttal to Returnable Presumption against Registration
of Maleic Hydrazide: Volume I. Unpublished compilation. 523 p.
00143322 Uniroyal Chemical Co. (19??) Environmental Data on Maleic Hydrazide in Soil
and Water. Unpublished study. 4 p.
00146141 Beavers, J. (1985) An Acute Oral Toxicity Study in the Mallard with Potassium
Salt of Technical Maleic Hydrazide: Final Report: Project. No. 117-146.
Unpublished study prepared by Wildlife International, Ltd. 15 p.
00146142 McAllister, W.; Cohle, P. (1984) Acute Toxicity of Potassium Salt of
Technical Maleic Hydrazide to Rainbow Trout (Salmo gairdneri): 32250.
Unpublished study prepared by Analytical Biochemistry Laboratories, Inc. 53
P-
00146143 Forbis, A.; Burgess, D.; Georgie, L. (1984) Acute Toxicity of Potassium Salt
of Technical Maleic Hydrazide to Daphnia magna; 32251. Unpublished study
prepared by Analytical Bio-Chemistry Laboratories, Inc. 40 p.
00151951 Lengen, M.; Frederick, C. (1985) The Photolysis of (Potassium Salt) Maleic
Hydrazide in Aqueous Solution and on Soil: Project No. 8573. Unpublished
study prepared by Uniroyal Chemical. 13 p.
00151952 Lengen, M. (1985) Mobility Studies of (Potassium Salt) Maleic Hydrazide on
Soils: Project No. 8574. Unpublished study prepared by Uniroyal Chemical.
14 p.
00163301 Cable, R. (1986) Octanol/Water Partition Coefficient of Maleic Hydrazide.
Unpublished study prepared by Drexel Chemical Company. 55 p.
00165460 Uniroyal Chemical Co., Inc. (1970) Efficacy Data of MH-30 and Other
Pesticides for Control of Suckers on Tobacco. Unpublished compilation. 26 p.
40874202 Khera, K.; Whalen, C.; Trivett, G.; et al. (1988) Teratology assessment of
maleic hydrazide and daminozide, and formulations of ethoxyquin,
thiabendazole and naled rats. J. Environ. Sci. Health B14(16):563-577.
93
-------
BIBLIOGRAPHY
MRID
CITATION
40975901
40985301
40985302
40985303
40985304
40985305
40985306
40985307
40985308
40985309
Fair Products, Inc. (1989) Fair Products Application for Registration of Maleic
Hydrazide 95% Technical Grade to Comply with S.O.P. Notice 3068.2.
Unpublished study. 28 p.
Pierce, J. (1988) Discussion of Beginning Materials and Manufacturing Process
for Maleic Hydrazide Technical. Unpublished study prepared by Uniroyal
Chemical Co., Inc. 64 p.
Pierce, J. (1989) Product Chemistry for Maleic Hydrazide Color, Odor,
Physical State and Melting Point: EPA29/1/31/89/7. Unpublished study
prepared by Uniroyal Chemical Co., Inc. 3 p.
Sweetapple, G. (1988) Maleic Hydrazide-Determination of Absolute Density:
Document No. 1961-88-0201-AS-001: Lab ID: 1961-88-0201-AS.
Unpublished study prepared by Ricerca, Inc. 22 p.
Jewell, G. (1989) Solubility of Maleic Hydrazide in Water, Organic Solvents
and Buffer Solutions: Project No. GRL-FR-10006 89/01/30. Unpublished
study prepared by Uniroyal Chemical Ltd. 52 p.
Kauppila, K.; Lorence, P.; Walls, G. (1989) Maleic Hydrazide-Determination
of Vapor Pressure: Document No. 1961-88-0146-AS-001:1AB id;
1961-88-0146-AS. Unpublished study prepared by Ricerca, Inc. 52 p.
Book, D.; Thomas, E. (1988) Maleic Hydrazide-Determination of Dissociation
Constant: Document No. 1961-88-0200-AS-001: Lab ID: 1961-88-0200-AS.
Unpublished study prepared by Ricerca, Inc. 36 p.
Kerish, M.; Parkins, M. (1985) Octanol/Water Partition Coefficient of MH:
Project No. 8587. Unpublished study prepared by Uniroyal Chemical Co., Inc
12 p.
Mattschei, P. (1989) PH Measurement of Maleic Hydrazide (MH): Project No.
8902. Unpublished study prepared by Uniroyal Chemical Co., Inc. 9 p.
Sanders, J. (1988) Maleic Hydrazide-Determination of Thermal Explodability:
Document No. 1961-88-014-AS-001: Lab ID: 1 1961-88/0148-AS.
Unpublished study prepared by Ricerca, Inc. 35 p.
94
-------
BIBLIOGRAPHY
MRID
CITATION
40985310 Sweetapple, G. (1988) Maleic Hydrazide-Determination of Impact
Explodability: Document No. 1961-88-0149-AS-001: Lab ID:
1961-88-0149-AS. Unpublished study prepared by Ricerca, Inc. 23 p.
40985311 Schardein, J. (1988) Additional Data and Information on Study of Teratological
Effects of Maleic Hydrazide in the Rabbit. Unpublished study prepared by
International Research & Development Corp. 6 p.
40993001 Drozdick, M. (1989) Stability of Maleic Hydrazide Technical: Project No.
958-PR-8905. Unpublished study prepared by Uniroyal Chemical Co., Inc. 15
P-
41055901 Sheets, T. (1989) A Compilation of Published and Unpublished Information
Concerning Maleic Hydrazide in Residues in Tobacco. Unpublished
compilation prepared by Pesticide Residue Research Laboratory. 47 p.
41055902 Uniroyal Chemical Co. (1989) A Compilation of Published and Unpublished
Information Concerning the Products of Controlled combustion of Tobacco.
Unpublished compilation. 171 p.
41055903 Khera, K.; Whalen, C.; Trivett, G.; et al. (1989) Teratologic Assessment of
Maleic Hydrazide and Daminozide, and Formulations of Ethoxyquin,
Thiabendazole and Naled in Rats: Version with Raw Data Sheets Appended.
Unpublished study prepared by Bureau of Chemical Safety. 93 p.
41132901 Drexel Chemical Co. (1989) Product Identity and Composition: Drexel Maleic
Hydrazide 95% Technical Grade. Unpublished compilation. 73 p.
41132902 Drexel Chemical Co. (1989) Physical and Chemical Characteristics: Drexel
Maleic Hydrazide-95% Technical Grade. Unpublished compilation. 102 p.
41132903 Drexel Chemical Co. (1989) Product Identity and Composition: Drexel Maleic
Hydrazide 99% Technical Grade. Unpublished compilation. 73 p.
41132904 Drexel Chemical Co. (1989) Physical and Chemical Characteristics: Drexel
Maleic Hydrazide 99% Technical Grade. Unpublished compilation. 102 p.
95
-------
BIBLIOGRAPHY
MRID
CITATION
41147302
41147303
41149001
41165401
41176600
41176601
41176602
41185401
41185402
Mosesso, P. (1989) Chromosome Aberrations in Chinese Hamster Cells in
vitro: Test Substance: Maleic Hydrazide. Potassium Salt: Project No.
131008-M-03088. Unpublished study prepared by Life Science Research 58
P-
Mosesso, P. (1989) Sister Chromatid Exchange in Chinese Hamster Cells in
vitro: Test Substance: Maleic Hydrazide, Potassium Salt: Project ID
131006-M-03188. Unpublished study prepared by Life Science Research 49
P-
Forster, R.; Meli, C. (1989) Reverse Mutation in Salmonella typhimurium:
Test Substance: Maleic Hydrazide, Potassium Salt: Project ID
131004-M-02988. Unpublished study prepared by Life Science Research. 54
P-
Fair Products, Inc. (1989) Fair Product's Submission of Data on Physical and
Chemical Properties Subpart F...of Products Containing Maleic Hydrazide as
an Active Ingredient, Guidance Document #51501 issued June 38, 1988,
Registration Case #0381. Unpublished study, lip.
MH Task Force II (1989) Submission of Toxicity Data in Support of Maleic
Hydrazide Reregistration Standard. Transmittal of 2 studies.
Hoorn, A. (1988) Mutagenicity Test on Maleic Hydrazide Potassium Salt
(KMH) in the Rec-Assay with Bacillus Subtilis (Preincubation Method): Final
Report: HBC Study No: E-9836-0-404-P. Unpublished study prepared by
Hazleton Biotechnologies. 21 p.
Hoorn, A. (1988) Mutagenicity Test on MH Technical in the Rec-Assay with
Bacillus Subtilis (Suspension Method): Final Report: HBC Study No.:
E-9784-0-404-S. Unpublished study prepared by Hazleton Biotechnologies. 19
P-
McDonald, P. (1989) Maleic Hydrazide: acute Inhalation Toxicity Study in
Rats: Project ID 641624. Unpublished study prepared by Inveresk Research
International Ltd. 35 p.
Gaydosh, K. (1989) Analysis of Technical MH for Toxicity Study: Project ID
88147. Unpublished study prepared by Uniroyal Chemical Co., Inc. 52 p.
96
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BIBLIOGRAPHY
MRID
CITATION
41185403 Gaydosh, K. (1989) Analysis of Technical KMH for Toxicity Study: Project ID
8917. Unpublished Study Prepared by Uniroyal Chemical Co., Inc. 50 p.
41186001 Blem, A.; Pierce, B. (1989) Product Identity and Composition: RS0381.
Unpublished study prepared by Uniroyal Chemical Co. 7 p.
41186002 Pierce, J. (1989) Product Identity and Composition: Theoretical Discussion of
Possible Impurities in Maleic Hydrazide: Archive No. 8997. Unpublished
study prepared by Uniroyal Chemical Co. 8 p.
41186003 Batorewicz, W.; Bakker, R. (1989) Compositional Analysis for Maleic
Hydrazide: Project No. 8963. Unpublished study prepared by Uniroyal
Chemical Co. 46 p.
41186004 Cardona, R. (1989) Certification of Ingredient Limits (EPA Form 8570-4) for
Maleic Hydrazide Technical. Unpublished study prepared by Uniroyal
Chemical Co. 7 p.
41186005 Uniroyal Chemical Co. (1989) Determination of MH Technical Material,
MH30 and Royal MH30 Formulations by High Performance Liquid
Chromatography (Internal Standard Method): Control Test No. AC1087B.
Unpublished study. 8 p.
41222101 Sweetapple, G. (1989) Maleic Hydrazide Determination of Corrosion
Characteristics: Report Amendment: Proj. NO. 8895. Unpublished study
prepared by Ricerca, Inc., Dept. of Analytical Services. 63 p.
41229602 Fair Products, Inc. (1989) Fair Products Response to the Scientific Review of
the Application for Registration of Maleic Hydrazide 95% Technical Grade ....
Unpublished compilation. 16 p.
41233201 Fair Products, Inc. (1989) Fair Products' Submission of Data on the Beginning
Materials and Manufacturing Process (Section 61-2), Formation of Impurities
... of Product Containing Maleic Hydrazide as an Active Ingredient, Guidance
Document #51501, Registration Case #0381. Unpublished study. 20 p.
41267701 Fair Products, Inc. (1989) Fair Product's Submission ...Analysis and
Certification of Product Ingredients ... Stability. Unpublished study. 4 p.
97
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BIBLIOGRAPHY
MRID
CITATION
41278001
41278002
41280701
41289101
41289102
41289301
41289302
41294301
41318001
41336901
Thomson, P. (1989) Storage Stability of Maleic Hydrazide at 25 Degree C:
Interim Report: Lab Project Number: GRL-IR-10013. Unpublished study
prepared by Uniroyal Chemical Co., Inc. 13 p.
Thomson, P. (1989) Corrosion Characteristics of Maleic Hydrazide at 25
Degree C: Interim Report: Lab Project Number: GRL/IR/10012.
Unpublished study prepared by Uniroyal Chemical Co., Inc. 12 p.
Fair Products, Inc. (1989) Fair Products Submission of Data on Subpart C,
Product Chemistry, Sec. 61-3 to Comply with Guidance Document
#51501, Registration Case #0381. Unpublished study. 24 p.
Cuthbert, J.; Jackson, D. (1989) Maleic Hydrazide: Buehler Sensitization Test
in Guinea Pigs: Lab Project Number: 243032 : 5807. Unpublished study
prepared by Inveresk Research International. 31 p.
Perry, C.; Smith, A.; Finch, J.; (1989) Maleic Hydrazide: 3 Week Dermal
Toxicity Study in Rats: Lab Project Number: 437923; 5924. Unpublished
study prepared by Inveresk Research International. 97 p.
Chetram, R. (1989) Tier 2 Seed Germination/Seedling Emergence Nontarget
Phytoxicity Test: Maleic Hydrazide/Potassium Salt: Lab Project Number:
LR89/09A. Unpublished study prepared by Pan-Agricultural Laboratories,
Inc. 225 p.
Chetram, R. (1989) Tier 2 Vegetative Vigor: Nontarget Phytotoxicity Test:
Maleic Hydrazide/Potassium Salt: Lab Project Number: LR89/09B.
Unpublished study prepared by Pan-Agricultural Laboratories, Inc. 161 p.
Sheets, T. (1989) MH Residues on Flue-Cured and Burley Tobacco From 1972
Through 1986. Unpublished study prepared by Pesticide Residue Research
Laboratory. 29 p.
Hughes, J. (1989) The Toxicity of LX1182-02 (Maleic Hydrazide Technical) to
Selenastrum capricornutum: Lab Project Number: 1479-01-1100-01.
Unpublished study prepared by Malcolm Pirnie, Inc. 42 p.
Drexel Chemical Co. (1989) Drexel Maleic Hydrazide 95% Technical Grade:
Analysis and Certification of Ingredients. Unpublished study. 53 p.
98
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BIBLIOGRAPHY
MRID
CITATION
41336902 Drexel Chemical Co. (1989) Drexel Maleic Hydrazide 95% Technical Grade:
Discussion of the Formation of Impurities Supplemental Information.
Unpublished study. 5 p.
41336903 Drexel Chemical Co. (1989) Drexel Maleic Hydrazide 95% Technical:
Solubility Supplemental Information. Unpublished study. 3 p.
41336904 Drexel Chemical Co. (1989) Drexel Maleic Hydrazide 99% Technical Grade:
Discussion of the Formation of Impurities Supplemental Information.
Unpublished study. 5 p.
41336905 Drexel Chemical Co. (1989) Drexel Maleic Hydrazide 99% Technical:
Solubility Supplemental Information. Unpublished study. 3 p.
41458201 Wilson, J.; Hazelden, K. (1990) Maleic Hydrazide: Teratogenicity Study in
Rats: Lab Project Number: IRI437970: IRI7150. Unpublished study prepared
by Inveresk Research International. 124 p.
41471501 Thomson, P. (1990) Storage Stability of Maleic Hydrazide at 25 Degrees
Centigrade: Final Report: Lab Project No. GRL-FR-10013. Unpublished study
prepared by Uniroyal Chemical Ltd. 14 p.
41471502 Thomson, P. (1990) Corrosion Characteristics of Maleic Hydrazide at 25
Degrees Centigrade: Final Report: Lab Project Number: GRLFR-10012.
Unpublished study prepared by Uniroyal Chemical Ltd. 14 p.
41484401 Sanders, J. (1990) Maleic Hydrazide-determination of Oxidation reduction: Lab
Project I.D.: 4091-90-0103-AS. Unpublished study prepared by Ricerca, Inc.
32 p.
41488201 Caley, C.; Cameron, B.; Chapleo, S.; et al. (1990) The Uptake, Translocation
and Metabolism of Carbon 14-Maleic Hydrazide in Potatoes-Field Study: Lab
Project Number: 140396: 6281. Unpublished study prepared by Inveresk
Research International. 56 p.
41488202 Caley, C.; Cameron, B.; Chapleo, S.; et al. (1990) The Uptake, Translocation
and Metabolism of carbon 14 -Maleic Hydrazide in Onions-A Field Study: Lab
99
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BIBLIOGRAPHY
MRID
CITATION
Project Number: 140380: 6280. Unpublished study prepared by Inveresk
Research International. 52 p.
41571701
41598501
41660001
41667801
41679701
41702901
41719101
41896201
41896202
Caley, C.; Cameron, B. (1990) The Metabolism of carbon 14 -Maleic
Hydrazide in the Rat: Lab Project Number: 140024. Unpublished study
prepared by Inveresk Research International. 86 p.
Drozdick, M. (1989) Maleic Hydrazide, Potassium Salt: Converting MH
Technical to Potassium Salt: Lab Project Number: METHOD BTM-018.
Unpublished study prepared by Uniroyal Chemical Co. 8 p.
Putman, D. (1990) In vivo Sister Chromatid Exchange Assay: Maleic
Hydrazine: Final Report: Lab Project Number: T9183.130. Unpublished study
prepared by Microbiological Associates, Inc. 30 p.
Drexel Chemical Co. (1990) Drexel Maleic Hydrazide-95% Technical Grade;
99% Technical Grade: Supplement to MRIDs 41336901 through 41336905.
Unpublished study prepared by Drexel Chemical Co. 4 p.
Caley, C.; Cameron, B.; Martin, W. (1990) The Identification of Metabolites
of carbon 14 -Maleic hydrazide in Rat Urine: Lab Project Number: 7436.
Unpublished study prepared by Inveresk Research International. 36 p.
Hazelden, K. (1990) Maleic Hydrazide, Potassium Salt: Maleic
Hydrazide/Teratogenicity Study in Rats: Lab Project Number: IRI437970: IRI
7150. Unpublished study prepared by Inveresk Research International. 7 p.
Putman, D.; Morris, M. (1990) KMH-Micronucleus Cytogenetie Assay in
Mice: Final Report (Supplement to MRID 41147301): Lab Project Number:
T9183. 122018. Unpublished study prepared by Microbiological Associates,
Inc. 22 p.
Mackie, J.; Hall, B.; Cameron, B. (1991) Carbon 14-Maleic Hydrazide
Metabolism in Soil Under Aerobic Conditions: Lab Project Number: 7630:
380427. Unpublished study prepared by Inveresk Research International. 74 p.
Haig, E.; Mackie, J.; Hall, B.; et al. (1991) Carbon 14-Maleic Hydrazide:
Aged Soil Leaching: Lab Project Number: 7638: 140050. Unpublished study
prepared by Inveresk Research International. 82 p.
100
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BIBLIOGRAPHY
MRID
CITATION
41918201 Mackie, J.; Hall, B.; Cameron, B. (1991) Carbon 14-Maleic Hydrazide
Metabolism in Soil Under Anaerobic Conditions: Lab Project No: 140066:
Report No. 7643. Unpublished study prepared by Inveresk Research
International. 69 p.
41937801 Caley, C.; Cameron, B.; Chapleo, S.; et al. (1990) The Uptake, Translocation,
and Metabolism of Carbon 14 Maleic Hydrazide in a Rotated Crop of Winter
Wheat-A Field Study. (Supplement to MRID 00122390): Lab Project
Number: 140307: 7531. Unpublished study prepared by Inveresk Research Int.
69 p.
42005601 Fair Products, Inc. (1991) Fair Products Inc. Submission of Data on Physical
and Chemical Properties, Subpart F of Products Containing Maleic Hydrazide
as an Active Ingredient. Unpublished study. 7 p.
42125301 Ver Hey, M. (1991) Maleic Hydrazide Multiresidue Method Testing: Final
Report: Lab Project Number: RP-91042: UNIROYAL-1160. Unpublished
study prepared by Colorado Analytical Research & Development Corp. 59 p.
42214101 Anderson, B.; McDonald, P. (1991) Maleic Hydrazide: 52 Week Dietary
Toxicity Study in Dogs: Lab Project Number: 7709. Unpublished study
prepared by Inveresk Research International. 247 p.
42248101 Anderson, B.; McDonald, P. (1991) Maleic Hydrazide 52 Week Dietary
Toxicity Study in Dogs: Supplemental Information: Lab Project Number: 7709:
641540. Unpublished study prepared by Inveresk Research International. 247
P-
42308501 Cummings, M. (1992) Determination of the Solubility of Maleic Hydrazide in
Two Solvents: Lab Project Number: DREX-9201. Unpublished study prepared
by Compliance Services International 40 p.
42382101 Shaw, I.; McGuire, G. (1992) Analysis of Maleic Hydrazide in Potatoes and
Onions from Metabolism Studies with carbon 14 -Labelled Maleic Hydrazide:
Lab Project Number: 8798: 354418. Unpublished study prepared by Inveresk
Research International. 23 p.
101
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MRID
BIBLIOGRAPHY
CITATION
42432301
42567801
42567802
42567803
42567804
42567805
42567806
42570101
Caley, C.; Cameron, B.; Martin, W. (1990) The Identification of Metabolites
of carbon 14 Maleic Hydrazide in Rat Urine: Lab Project Number: 7436:
380060. Unpublished study prepared by Inveresk Research Intl. 36 p.
Cameron, S.; Haycox, G.; Johnston, A. (1992) Absorption, Distribution,
Metabolism and Excretion in the Lactating Goat: carbon 14 -Maleic Hydrazide:
Lab Project Number: 151921. Unpublished study prepared by Inveresk
Research Intl. 94 p.
Jackson, R.; Hall, B. (1992) Determination of the carbon 14 Residues in Milk
and Edible Tissues from Lactating Cows following Simulated Dietary Intake of
carbon 14 -Maleic Hydrazide: Lab Project Number: 381719. Unpublished
study prepared by Inveresk Research Int'l. 72 p.
Jackson, R.; Hall, B. (1992) Determination of the carbon 14 Residues in Eggs
and Edible Tissues from Laying Hens following Simulated Dietary Intake of
carbon 14 -Maleic Hydrazide: Lab Project Number: 381745. Unpublished
study prepared by Inveresk Research Int'l. 87 p.
Jacobson, S.; Wight, R. (1992) Determination of the Magnitude of Residues of
Maleic Hydrazide in Potatoes Treated with Super Sprout Stop: Lab Project
Number: 351988. Unpublished study prepared by Inveresk Research Int'l 296
P-
Jacobson, S.; Wight, R. (1992) Determination of the Magnitude of Residues of
Maleic Hydrazide in Onions Treated with Super Sprout Stop: Lab Project
Number: 351988. Unpublished study prepared by Inveresk Research Int'l 306
P-
Jacobson, S.; Wight, R. (1992) Determination of the Magnitude of Residues of
Maleic Hydrazide in Processed Fractions from Potatoes Treated with Super
Sprout Stop: Lab Project Number: 351988. Unpublished study prepared by
Inveresk Research Int'l. 201 p.
Perry, C.; Strutt, A.; Finn, J.; et al. (1991) Maleic Hydrazide: 104 Week
Dietary Combined Chronic Toxicity/Oncogenicity Study in Rats with 52 Week
Interim Kill: Lab Project Number: 7823: 437944. Unpublished study prepared
by Inveresk Research International. 1381 p.
102
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BIBLIOGRAPHY
MRID
CITATION
42641501 Johnston, A.; Jackson, R.; Hall, B.; et al. (1993) Chromatographic Analysis of
Samples from Hens following Administration of (carbon 14)-Maleic Hydrazide:
Lab Project Number: 8492: 381635. Unpublished study prepared by Inveresk
Research International. 156 p.
42654901 McGuire, G. (1993) Response to EPA Requests as Detailed in U.S. EPA
Memorandum on Radiovalidation Study (Maleic Hydrazide), Supplemental: Lab
Project Number: 354418: 3798. Unpublished study prepared by Inveresk
Research International, Ltd. 13 p.
42692101 Schocken, M. (1993) Response to EPA's Comments Regarding the Maleic
Hydrazide Aqueous Photolysis Study Conducted by Springborn Labs., Inc.:
Supplemental Information: Lab Project Number: 41-0890-6119-720: 91-5-3766.
Unpublished study prepared by Springborn Labs., Inc. 7 p.
42693301 Dykeman, R. (1993) Determination of the Dissipation of Residues of Maleic
Hydrazide in a North Carolina Tobacco Field: Lab Project Number:
MHTF-9005: 44-875-614-545. Unpublished study prepared by Inveresk
Research International, Ltd. in assistance with American Agricultural Services,
Inc. and Compliance Services International. 679 p.
42736901 Dykeman, R. (1993) Determination of the Dissipation of Residues of Maleic
Hydrazide in a Washington State Potato Field Treated with Super Sprout Stop:
A Supplemental: Lab Project Number: MHTF-9004. Unpublished study
prepared by Inveresk Research International, Ltd. 674 p.
42744801 Dykeman, R. (1993) Determination of the Dissipation of Residues of Maleic
Hydrazide in a California Turf Soil Treated with Royal SLO-GRO: Lab Project
Number: MHTF-9006. Unpublished study prepared by Inveresk Research
International, Ltd. in assistance with Research for Hire and Compliance
Services International. 731 p.
42770401 Perry, C. (1993) Maleic Hydrazide: 104 Week Dietary Combined Chronic
Toxicity/Oncogenicity Study in Rats with 52 Week Interim Kill: Addendum:
Lab Project Number: 437944: IRI437944. Unpublished study prepared by
Inveresk Research International Lab. 973 p.
42790901 Dykeman, R. (1993) Determination of the Dissipation of Residues of Maleic
Hydrazide in a California Turf Soil Treated with Royal Slo-Gro: Amendment 1
103
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BIBLIOGRAPHY
MRID
CITATION
to Study Report: Lab Project Number: MHTF-9006. Unpublished study
prepared by Inveresk Research Intl., Research for Hire and Compliance
Services Intl. 24 p.
42872301
42905801
43006901
43006902
43006903
43006904
43177301
Fackler, P. (1993) Maleic Hydrazide-Determination of Aqueous Photolysis
Rate Constant and Half-Life: Amended Final Report: Lab Project Number
91-5-3766: 41.0890.6119.720. Unpublished study prepared by Springborn
Labs, Inc. 55 p.
Jacobson, S. (1993) Determination of the Magnitude of Residues of Maleic
Hydrazide in Processed Fractions of Potatoes Treated with Super Sprout Stop:
Amendment 1 to: Lab Project Number: MHTF-9002: MHTF-9002-M01: 8983.
Unpublished study prepared by Inveresk Research International, Ltd. 24 p.
Davis, J. (1993) Maleic Hydrazide (Potassium Salt): Acute Toxicity to the
Freshwater Blue-Green Alga, Anabaena flos-aquae, Under Static Test
Conditions: Lab Project Number: J9306001G. Unpublished study prepared by
Toxikon Environmental Sciences. 55 p.
Davis, J. (1993) Maleic Hydrazide (Potassium Salt): Acute Toxicity to the
Freshwater Diatom, Nitzschia palea, Under Static Test Conditions: Lab Project
Number: J9306001F. Unpublished study prepared by Toxikon Environmental
Sciences. 53 p.
Davis, J. (1993) Maleic Hydrazide (Potassium Salt): Acute Toxicity to the
Saltwater Diatom, Skeletonema costatum, Under Static Test Conditions: Lab
Project Number: J9306001E. Unpublished study prepared by Toxikon
Environmental Sciences. 53 p.
Davis, J. (1993) Maleic Hydrazide (Potassium Salt): Toxicity to Duckweed,
Lemna gibba G3, Under Static Test Conditions: Lab Project Number:
J9306001D. Unpublished study prepared by Toxikon Environmental Sciences
54 p.
Shocken, M.J. (1994) Maleic Hydrazide-Identification of Photolytic
Degradation Products: Supplemental Information: Lab Project I.D.: 94-2-5161;
Sponsor Project No. 9364. Supplemental letter reports prepared by Springborn
Laboratories, Inc. 5 p.
104
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APPENDIX D. List of Available Related Documents
105
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106
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. The following is a list of available documents related to Maleic Hydrazide. Its purpose
is to provide a path to more detailed information if needed. These accompanying documents
are part of the Administrative Record for Maleic Hydrazide and are included in the EPA's
Office of Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Maleic Hydrazide RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
107
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108
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APPENDIX E. PR Notices 86-5 and 91-2
109
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110
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PR Notice 86-5
111
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112
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29,1986
OFFICE OF
PR NOTICE 86-5 PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Pers9ns responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and certain provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining
pesticide registrations, experimental use permits, tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA. These data are defined in FIFRA §10(d)(1). This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the
submitter for necessary revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in
the Federal Register (49 FR 37956) which include Requirements for
Data Submission (40 CFR §158.32), and Procedures for Claims of
Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
_ OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
entire proposed regulation becomes final. Adequate lead time is
113
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being provided for submitters to comply with the new
requirements. *
V- Relationship of this Notice to Other OPP Policy and Guida
this Notice contains requirements for organizing and
submit tals of supporting data, it does not addriss the
f £esti reP°rts . themselves . "Data reporting" guidance
n-ir development in OPP, and will specify how the study
SSfSJiSI8' irotoco1' observations, findings, and conclusions Ire
organized and presented within the study report. The data
£f£ * s £uldance will.be C9mpatible with submittal format
requirements described in this Notice.
Am-ii0?? hafeafS?v,P?°mulg^ed f P°licy (pR Notice 86-4 dated
April 15, 1986) that. provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen 1? to avoid the . additional costs and prolonged delays
Sf?£S~«6d alth*ha£dling: significantly incomplete application
£??£ geoi,^As-°f -vhe effective date of this Notice, the screen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
i??^ fo:? inserting int9 the docket documents submitted in
requiring an Additional copy ot any data submitted to the docket.
requirement. iOn a OU tnis
for o-?ao^e?PL??onr!£i$S ?&,?% SS^f^Sble
•8*^&*?J&Fo¥%SSg?i£ SS S|$ijit!o-nisfied-the
Typically, many requirements are satisfied by reference to data
previously submitted—either by the applicant or by another
party. That requirement is not altered by this notice, which
applies only to data submitted with an application?
VI. Format Requirements
A more detailed discussion of these format requirements
toiiows the index on the next page, and samples of some of the
requirements are attached. Except for the language of the two
ao^rna^lv?4-£orms °£ £he Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are11ilustrltlYe- As.l°n9.a? the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference. »euVJ.es may oe
- INDEX-
Text Example
A. Organization of the Submittal Package Pagf Pagi7
B. Transmittal Document 4 ^
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies . . 5
D. Organization of each Study Volume 6 17
D. 1 study Title Page 7 12
D. 2 Statement of Data Confidentiality Claims
114
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(based on FIFRA §10(d)(l)) 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(l)) 8 14
D. 5 Good Laboratory Practice Compliance Statement . . 9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies .... 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at
the same time for review in support of a single regulatory
action, along with a transmittal document and other related
administrative material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this Notice. The transmittal and any other admin-
istrative material must be gr9uped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims).
B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted—i.e., a registration application,
petition, experimental use permit (EUP), §3(c)(2)(B) data
call-in, §6(a)(2) submittal,. 9r a special review; the transmittal
date; and a list of all individual studies included in the
package in the order of their appearance, showing (usually by
Guideline reference number) the data requirement(s) addressed by
each one. The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petiti9n for tolerance or an
application for an EUP should be subdivided into sections A, B,
C, . . . . of the petition or application, as defined in 40 CFR 180.7
and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
115
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When a_submittal package supports a tolerance petition and
an application for a registration or an EUP, list the petition"
studies first, _then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
. A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study slKmld be identifiable and distinguishable by a
conventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with some exceptions dis-
cussed in section C.I. Each study included in a submittal
package must_be bound as a separate entity. (See comments on
binding studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must,be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
.with the proper study during handling or review) use either of
the foilowing:
- Include the total number of pages in the complete studv on
each page (i.e., 1 of 250, 2 of 250, ...250 of 250) .
- Include a company name or mark and study number on each
page of the study, e g , Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies
. When a single study is extremely long, binding it in mul-
tiple V9lumes_is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.I Special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical C9ntrol data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import t9lerance petition, or an end-use product
produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61, 62, and 63) for
C9nventional pesticides, or for the equivalent subject range for
biorational pesticides. The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
116
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would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
second W9uld cover Guidelines 151-23 and 151-25; the third would
cover Guideline 151-26.
Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
§10(d)(1)(A), (B), or (C), and if so must be handled as described
in section D.3. of this notice.
c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
h9wever, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single cr9p or from processing a
single crop. When more than one commodity is derived from a
single crop (such as beet tops and beet roots) residue data on
all such commodities should be reported as a single study. When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D.
Organization of Each Studv Volume
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports laboratory Page 16
work subject to GLP require-
ments
For certain t9xicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10(d) (1) (A), (B), or (C)
CBI Attachment If CBI is claimed under FIFRA
§10 (d) (1) (A), (B), or (C) Page 15
Supplemental Statement Only if confidentiality is Page 14
of Data Confidentiality claimed on a basis other than
Claims FIFRA §10 (d) (1) (A) , (B) , or (C)
117
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D.I. Title Page
^n •\title pag€v j? always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study title. The study title should be as descriptive as
possible It must clearly identify the substance (s) tested and
correspond to the name of the data requirement as it appears in
the Guidelines .
k. Data requirement addressed . Include on the title page the
Guideline number (s) of the specific requirement { s ) addressed by
the study. *
c. Auttuprfs) . Cite only individuals with primary intellectual
responsibility for the content of the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e- , Performing Laboratory Identification. if the study reports
work done by one or more laboratories, include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number (s) for
the W9rk. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the studv
sponsor or submitter. *
f- Supplemental Submissions . If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include 9n the title page elements a. through d. for the
previ9usly submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers. (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary study. Do not include supplements to more than one
study under a single title page) .
?: Facts of Publication. if the study is a reprint of a pub-
lished documentTiaentity on the title page all relevant facts of
publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA
Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 (b) and (c) (See
Attachment 3) . These statements apply only to claims of data
confidentiality based on FIFRA §10 (d) (iTTA), (B) , or (C) . Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(l) data confidentiality (§158. 33 (b)) or
to waive such a claim (§158.33 (c) ). In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. Do not make CBI
claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions (see NOTE Pg 13).
118
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D.3. Confidential Attachment
If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
§10(D)(1) (A) , (B), or (C) (as described in D.2. above) all such
information must be excised from the body of the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5).
The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment." An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet. Paginate the Confidential Attachment
separately from the body of the study, beginning with page 1 of X
on the title page. Each passage confined to the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
§10(d)(1) on which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
- Attachment 4)
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §10(d)
(1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims
must be submitted^ identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RESDBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us to retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies snpuld not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed on one side only in
black ink, with high contrast and good resplution. Bindings for
individual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
instructions before submitting data in any medium other than
paper, such as film or magnetic media.
119
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Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than
black ink.
• Make sure that photocopies are clear, complete, and
fully readable.
• Do not include oversize computer printouts or fold-out
pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence.
... Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The prop9sed regulations specified two copies; three
are now.being required to expedite and reduce the cost of
processing data.into the OPP Pesticide Document Management System
ana getting it into review.)
G- Special Requirements for Submitting Data to the Docket-.
j j Dat« submittal.packages associated with a Registration Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been~¥xcised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data
Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d) (1) (A) , (B) , or (C). Do not
close up or paraphrase text remaining after this
excision.
• Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential".
V. For Further Information
Fortfurther information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Divison
120
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Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality
Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample Good Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
121
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
!• Name and address of submitter (or all joint submitters**)
+S^thOiemical Corporation Jones Chemical Company
1234.West.Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
*Smith Chemical Corp will act as sole agent for all submitters.
2- Regulatory action in support of which this package is
submitted —~"
U?e ^e EPA.identification number (e.g. 359-EUP-67) if you know
™ Otherwise describe the type of request (e.g. experimental
use permit, data call-in - of xx-xx-xx date).
-3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline
No. )
Vol n Title of nth study in the submittal (Guideline
No. )
* Applicants commonly provide this information in a tran-
smittal letter. This remains an acceptable practice so
long as all four elements are included.
* Indicate which of the jpint submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data.
Company Official:
Name Signature
Company Name
Company Contact:_
Name Phone
122
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Recruirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Pronect ID
ABC 47-79
Page 1 of X
number
(X is the total number of pages in the study)
123
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124
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10 (d) (1) (A) , (B) , or (C)
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information
contained in this study on the basis of its falling within
the scope of FIFRA 6§10 (d) (1) (A) , (B) , or (C) .
Company
Company Agent: Typed Name Date :
2. Claim of confidentiality under FIFRA §10(d) (1)(A), (B), or (C).
Information claimed confidential on the basis of Its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent: Typed Name Date:
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method. These
analytical methods are published in the FDA Pesticide Analytical
Methods Manual, and therefore cannot be claimed: as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
125
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
* pipl Sf<5?!f >S)?f (Sir^lT? g^o^ijg Tou f!H£ibed
confidential treatment 9n another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
Identify specifically by page and line number (s) each
portion of the study for which you claim
confidentiality.
Cite _ the reasons why the cited passage qualifies for
confidential treatment.
Indicate the length of time — until a specific date or
event, or permanently — for which the information should
be treated as confidential.
Identify the measures taken to guard against undesired
disclosure of this information.
Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
Enclose copies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
If y9u assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe those harmful effects and explain why
they should be viewed as substantial.
If you assert that the information in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
126
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the
fallowing paragraph^) at the indicated volume and page
references.
DELETED WORDS OR PHRASE:_ Ethvlene Glvcol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study in place of the
following paragraphs) at the indicated volume and page
references.
DELETED PARAGRAPH®):
( >
( Reproduce the deleted paragraphs) here )
( )
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the
following paragraphs) at the indicated volume and page
references.
DELETED PAGESfS): are attached immediately behind this page
PAGES LINES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process §10(d)(l)(A)
127
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1..
2..
3.
Submitter.
Sponsor
Study Director.
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
128
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submhtal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
•Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims
• *****
: * when flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
LEGEND
129
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130
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PR Notice 91-2
131
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132
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide P^gram's P9licy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CFR 158.153(i). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
9f identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting go9d manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175(c)(3).
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(l)(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
133
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product composition because the nominal concentration would be
the amount of active ingredient typically found in the product.
n. . It is important for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently,registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal cpncentration expressed as a percentage by weight as the
label claim_in the ingredient(s) statement and equivalence
statements inapplicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. C9pies of the raw analytical data must be submitted
with the nominal_ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to provide certified limits
f?r ef9h active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) only) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
134
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to C9ntrol pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3{c)(3)(B). Therefore,_
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
(3) All other products/applications that are not subject to
(1) and (2) above will have until July 1, 1997, to
comply with this N9tice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
Ann* fi. tindaay, Director
Registration Division (H-75O5
135
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136
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APPENDIX F. Combined Generic and Product Specific
Data Call-In
137
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138
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GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status
Sheet, to submit certain data as noted herein to the U.S. Environmental Protection Agency
(EPS, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you
must respond as set forth in Section m below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 7; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3 (for both generic and product specific data), the Requirements
Status and Registrant's Response Form, (see section m-B); or
3. Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section Hl-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-In Response Forms. Also included is a list of all
registrants who were sent this Notice (Attachment b).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No.
2070-0107 and 2070-0057 (expiration date 3-31-96).
This Notice is divided int9 six sections and seven Attachments. The Notice itself
contains information and instructions applicable to all Data Call-In Notices. The Attachments
contain specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You are Receiving this Notice
Section n - Data Required by this Notice
Section HI - Compliance with Requirements of this Notice
Section IV - Consequences of Failure to Comply with this Notice
Section V - Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Section VI - Inquiries and Responses to this Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
139
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2 ' Generic Data Call-In and Product Specific Data Call-In Response Forms with
instructions c
3 - Generic Data Call-In and Product Specific Data Call-in Requirements Status
ana Registrant s Response forms with Instructions
4 ' *^A grouping or End-use "Products for Meeting Acute Toxicology Data
Requirements tor Reregistration— —~ —
5 - EfA Acceptance Criteria
6 - List or Registrants Receiving This Notice
7 - L.ost snare and uata CompensatioiTForms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
A » The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s) This
reevaluation identified additonal data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because
you have product(s) containing the subject active ingredients.
SECTION H. DATA REQUIRED BY THIS NOTICE
n-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and
Registrant s Response Forms: Attachment 3 (for both generic and product specific data
requirements;, Depending on the results of the studies required in this Notice, additional
studies/testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
• *v T1You.are required to submit the data or otherwise satisfy the data requirements specified
m "» Requirements Status and Registrant's Response Forms (Attachment 3) within the
timeframes provided. — ~~ -
n-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
Guidelines are available from the National Technical Information Service
0rder Desk' 5285 Port Roval Road> Springfield, Va 22161 (Telephone number:
/-4o D(J) .
me/-™ rotoc?ls 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 Date Requirements regulation (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD 2001 L
Strel1' y^S-lS^^S*0** D'C- 20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160].
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H-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED
BY THE A(JbIS(JY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or
change the requirements of any previous JJata uall-ln(sj, or any otiier agreements entered into
with the Agency pertaining to sucn prior Notice. Registrants must comply with the
requirements of all Notices to avoia issuance of a Notice of Intent to Suspend their affected
products.
SECTION m. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to this
Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is
specified in item number 3 on the four Data Call-In forms (Attachments 2 and 3).
HI-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for generic and product
specific data must be submitted to the Agency within 90 days after your receipt of this Notice.
Failure to adequately respond to this Notice within 90 days of your receipt wfll be a basis for
issuing a Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for
issuance of NOIS due to failure to comply with this Notice are presented in Section IV-A and
IV-B.
m-B. OPTIONS FOR RESPONDING TO THE AGENCY
1. Generic Data Requirements
The options for responding to this Notice for generic data requirements are: (a)
voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy
the generic data requirements imposed by this Notice or (e) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option, the
Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion
of the various options available for satisfying the generic data requirements of this Notice is
contained in Section ffl-C. A discussion of options relating to requests for data waivers is
contained in Section ffl-D.
Two forms apply to generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response. These two forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form,
(contained in Attachments 2. and 3, respectively).
The Data Call-In Response Forms must be submitted as part of every response to this
Notice. The Requirements status and Registrant's Response Forms also must be submitted if
you do not quality tor a uenenc Data Exemption or are not requesting voluntary cancellation
of your registration(s). Please note that the company's authorized representative is required to
sign the first page of both Data Call-In Response Forms and the Requirements Status and
Registrant's Response Forms (it this torm is required) and initial any subsequent pages. The
forms contain separate detailed instructions on the response options. Do not alter the printed
material. If you nave questi9ns or need assistance in preparing your response, call or write the
contact person(s) identified in Attachment 1.
a. Voluntary Cancellation -
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit completed Generic and Product Specific
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Data Call-In Response Forms (Attachment 2), indicating your election of this option
Voluntary cancellation is item number 5 on both Data Call-in Response Form(s) If you
choose this option, these are the only forms that you are required to <
complete.
• If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C
b. Use Deletion -
You may avoid the requirements of this Notice by eliminating the uses of your product
to which the requirements apply. If you wish to amend your registration to delete uses you
must submit the Requirements Status and Registrant's Response Form (Attachment 3) a
completed applicauon ior amendment, a copy ot your proposed amended labeling and all
other information required for processing the application. Use deletion is option number 7
under item 9 in the instructions for the Requirements Status and Registrant's Response Forms
You must also complete a Data Call-In Response horrn by signing the certification, item
number 8. Application forms ror amending registrations may be obtained from the
Registranon Support Branch, Registration Division, Office of Pesticide Programs, EPA, by
calling (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due
date of your 90 day response, is allowed only if the product bears an amended label.
c. Generic Data Exemption -
Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is
exempt from the requirement to submit or cite generic data concerning an active ingredient if
the active ingredient in the product is derived exclusively from purchased, registered pesticide
products containing the active ingredient. EPA has concluded, as an exercise of its discretion
that it normally will not suspend the registration of a product which would qualify and
continue to qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA To qualify
all of the following requirements must be met:
(i). The active ingredient in your registered product must be present solely because of
incorporation of another registered product which contains the subject active ingredient
and is purchased from a source not connected with you;
(ii). Every registrant who is the ultimate source of the active ingredient in your
product subject to this DCI must be in compliance with the requirements of this Notice
and must remain in compliance; and
(iii). You must have provided to EPA an accurate and current "Confidential Statement
of Formula" for each of your products to which this Notice applies.
To apply for the Generic Data Exemption you must submit a completed Data Call-In
Response Form, Attachment 2 and all supporting documentation. The Generic Data Exemption
is item number 6a on the Data Call-in Response Form. If you claim a generic data exemption
you are not required to complete tne Kequirements status and Registrant's Response Form.
Generic Data Exemption cannot be selected as an option ror responding to product specific
data requirements.
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 registrant(s) who have committedto
generate and submit the required data fail to take appropriate steps to meet requirements or are
no longer in compliance with this Data Call-In Notice, the Agency will consider that both they
and you are not compliance and will normally initiate proceedings to suspend the registrations
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of both your and their product(s), unless you commit to submit and do submit the required
data within the specified time. In such cases the Agency generally will not grant a time
extension for submitting the data.
d. Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this
Notice. These options are discussed in Section ffl-C.1. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
Form and item 6b on the Data Call-In Response Form, it you choose item ob (agree to satisfy
tne generic data requirements;, you must supmit tne Data Call-In Response Form and the
Requirements Status and Registrant's Response Form as wen as any otner information/data
pertaining to tfte option cnosen to address tne data requirement. Your response must be on the
forms marked "GENERIC" in item number 3.
e. Request for Generic Data Waivers.
Waivers for generic data are discussed in Section IH-D.l. of this Notice and are
covered by options 8 and 9 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.
2. Product Specific Data Requirements
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this Notice
or (c) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below. A discussion or the various options available for satisfying the product
specific data requirements of this Notice is cpntained in Section DI-C.2. A discussion of
options relating to requests for data waivers is contained in Section ffl-D.2.
Two forms apply to the product specific data requirements one or both of which must
be used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form,
for product specific data (contained in Attachments I ana 3, respectively), me L?ata uaii-ln
Response Form must be submitted as part of every response to mis Notice. In addition, one
copy ot tne Requirements Status and Registrant's Response Form also must be submitted for
each product listed on tfte uata uau-in Response Form unless the voluntary cancellation option
is selected. Please note that tne company's authorized representative is required to sign the
first page of the Data Call-In Response Form and Requirements Status an(f Registrant s
Response Form (it this form is required; and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or wnte the contact
person(s) identified in Attachment 1.
a. Voluntary Cancellation
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit a completed Data Call-In Response Form,
indicating your election ofthis option. Voluntary cancellation is item numoer 3 on ootn tfte—
Generic and Product Specific Data Call-In Response Forms. If you choose this
option, you must complete ootn uata call-in response forms. These are the only forms that
you are required to complete.
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n^Jil™^0!? ¥ voiuntariJv can(5?l vour Product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
D- Satisfying the Product Specific Data Requirements of this Notice.
*u- XT Jhertare vari9us options available to satisfy the product specific data requirements of
this Notice. These optwns are discussed in Section IE-C.2. of this Notice and comprise
options 1 through 6 of item 9 in the instructions for the product specific Requirements Status
and Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product —
slightly uremens.
Deletion ot a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements. It is important to ensure that you are using the correct
-. forms and [instructions when completing your response to the Reregistration Eligibility
Decision document. * y
c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section IE-D.2. of this Notice and
are covered by option 7 of item 9 in the instructions for the Requirements Status and
Registrant s Response Form. If you choose this option, you must submit the Data Call-In
Kesponse form ana tne Kequirements Status and Registrant's Response Form as well as any
otner mrormation/data pertaining to tne option chosen to address the data requirement Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3
m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1. Generic Data
• f. ? you acknowledie ?n the Generic Data Call-In Response Form that you agree to
satisfy the generic data requirements (i.e. you select item number 6b), then you must select
one of the six options on the Generic Requirements Status and Registrant's Response Form
related to data production for each data requirement. Vour option selection should be entered
under item number 9, "Registrant Response." The six options related to data production are
the first six options discussed under item 9 in the instructions for completing toe Requirements
Status and Registrant s Response Form. These six options are listed ^
immediately below with information in parentheses to guide you to additional instructions
provided in this Section. The options are:
(1) r will generate and submit data within the specified timeframe (Developing
Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing) *
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an
Existing Study)
Option 1. Developing Data
If you choose to develop the required data it must be in conformance with Agency
deadlines and with other Agency requirements as referenced herein and in the attachments All
data generated and submitted must comply with the Good Laboratory Practice (GLP) rule (40
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CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and be
in conformance with the requirements of PR Notice 86-5. In addition, certain studies require
Agency approval of test protocols in advance of study initiation. Those studies for which a
protocol must be submitted have been identified in the Requirements Status and Registrant's
Response Form and/or footnotes to the form. If you wisn to use a protocol whicn diners from
the options discussed in Section II-C of this Notice, you must submit a detailed description of
the proposed protocol and your reason for wishing to use it. The Agency may choose to reject
a protocpl not specified in Section H-C. If the Agency rejects your protocol you will be
notified in writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from the date you
are required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost share or agreeing to share in the cost of
developing that study. This 90-day progress report must include the date the study was or will
be initiated and, for studies to be started within 12 months of commitment, the name and
address of the laboratory(ies) or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year,
interim reports must be submitted at 12 month intervals from the date you are required to
commit to generate or otherwise address the requirement for the study. In addition to the other
infprmation specified in the preceding paragraph, at a minimum, a brief description of current
activity on and the status of the study must be included as well as a full
description of any problems encountered since the last progress report.
The time frames in the Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing tor tne suomission or completed study reports or
protocols. The noted deadlines run from the date of the receipt of this Notice by the registrant.
If the data are not submitted by the deadline, each registrant is subject to receipt of a Notice of
Intent to Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to
the Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your request, the
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the cost of producing the required
data but will not be submitting the data yourself, you must provide the name of the registrant
who will be submitting the data. You must also provide EPA with documentary evidence that
an agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
may resolve their differences through binding arbitration.
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Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt 19 enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful, you
may request EPA (by selecting this option) to exercise its discretion not to suspend your
registration(s), although you do not comply with the data submission requirements of this
Notice. EPA has determined that as a general policy, absent other relevant considerations, it
will not suspend the registration of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but the other
registrant(s) developing the data has refused to accept the offer. To qualify for this option, you
must submit documentation to the Agency proving that you have made an offer to another
registrant (who has an obligation to submit data) to share in the burden of developing that
data. You must also submit to the Agency a completed EPA Form 8570-32, Certification of
Offer to Cost Share in the Development of Data, Attachment 7. In addition, you must
demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a C9st-sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition
ed to
of its
election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit tne data required by tnis Notice.
In order for you to avoid suspension under this option, you may not withdraw 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. If the other
registrant fails to develop the data or for 59106 other reason is subject to suspension, your
registration as well as that of the other registrant normally will be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit, the required data in the
specified time frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.
Option 4. Submitting an Existing Study
If you choose to submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this Notice. You may only
submit a study that has not been previously submitted to the Agency or previously cited by
anyone. Existing studies are studies which predate issuance of this Notice. Do not use this
option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date or submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly Met:
a. You must certify at the time that the existing study is submitted that the raw
data and specimens from the study are available for audit and review and you
must identify where they are available. This must be done in accordance with
the requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR
Part 160. As stated in 40 CFR 160.3 'Raw data1 means any laboratory
worksheets, records, memoranda, notes, or exact copies thereof, that are the
result of original observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
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transcribed verbatim, dated, and verified accurate by signature), the exact copy
or exact transcrrot may be substituted for the original source as raw data. 'Raw
data' may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded data
from automated instruments." The term "specimens", according to 40 CFR
160.3, means "any material derived from a test system for examination or
analysis."
b. Health and safety studies completed after May 1984 also must also contain all
GLP-required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants also must certify at the time of
submitting the existing study that such GLP information is available for post
May 1984 studies by including an appropriate statement on or attached to the
study signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FBFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the
study clearly meets the purpose of the PAG. The registrant is referred to 40
CFR 158.70 which states the Agency's policy regarding acceptable protocols. If
you wish to submit the study, you must, in addition to certifying that the
purposes of the PAG are met by the study, clearly articulate the rationale why
you believe the study meets the purpose of the PAG, including copies of any
supporting information or data. It has been the Agency's experience that studies
completed prior to January 1970 rarely satisfied the purpose of the PAG and
that necessary raw data usually are not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements
of the criteria outlined above.
-j •*.If EPA has Previously reviewed a protocol for a study you are submitting, you must
identity any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed
in the final protocol and study.
If you know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
files, you need only cite it along with the notification. If not in the Agency's files you must
submit a summary and copies as required by PR Notice 86-5.
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Option 5. Upgrading a Study
If a study has been classified as partially acceptable and upgradeable, you may submit
data to upgrade that study. The Agency will review toe data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
be required to submit new data normally without any time extension. Deficient, but
upgradeable studies will normally be classified as supplemental. However, it is important to
note that not all studies classified as supplemental are upgradeable. If you have questions
regarding the classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of how the deficiencies have been remedied or
corrected and why toe study should be rated as acceptable to EPA. Your submission must also
specify the MRID number(s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option also should be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.
The criteria fpr submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally, your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with each
of those criteria, as well as a certification regarding protocol compliance with Agency
requirements.
Option 6. Citing Existing Studies
If you choose to cite a study that has been previously submitted to EPA, that study
must have been previously classified by EPA as acceptable, or it must be a study which has
not yet been reviewed by the Agency. Acceptable toxicology studies generally will have been
classified as "core-guideline" or "core-minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all other disciplines the classification
would be "acceptable." With respect to any studies for which you wish to select this option,
you must provide the MRID number of the study you are citing and, if the study has been
reviewed by toe Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements.
2. Product Specific Data
If you acknowledge on the product specific Data Call-In Response Form that you agree
to satisfy the product specific data requirements (i.e. you select option 7a or 7b), then you
must select one of the six options on the Requirements Status and Registrant's Response Form
related to data production for each data requirement. Your option selection snouid De entered
under item number 9, "Registrant Response." The six options related to data production are
the first six options discussed under item 9 in the instructions for completing toe Requirements
Status and Registrant's Response Form. These six options are listed immediately below with
miormation in parentneses to guiae registrants to additional instructions provided in this
Section. The options are:
(1) I will generate and submit data within the specified time-frame (Developing
Data)
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(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been
submitted but not reviewed by the Agency (Citing an Existing Study)
Option 1. Developing Data — The requirements for developing product specific data are the
same as tnose aescnoea tor generic data (see Section HI.C.l, Option 1) except that normally
no protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data ~ If you enter into an agreement to cost
snare, tne same requirements apply to product specific data as to generic data (see Section
IH.C.l, Option 2). However, registrants may only choose this option for acute toxicity data
and certain efficacy data and only if EPA has mcncated in the attached data tables that your
product and at least one offier product are similar for purposes of depending on
the same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which data will be submitted must be noted
in the agreement to cost snare by the registrant selecting this option.
Option 3. Offer to Share in the Cost of Data Development -The same requirements for
generic data (.section ui.u.i., uption 6) apply to tms option. This option only applies to acute
toxicity and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study - The same requirements described for generic data
(see Section um.u.i", uption 4) apply to this option for product specific data.
ion 5. Upgrading a Study — The same requirements described for generic data (see Section
.u.i., uption D; apply to tnis option for product specific data.
Option 6. Citing Existing Studies - The same requirements described for generic data (see
Section lii.u.i" uption o) apply to this option for product specific data.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form ana the
Requirements Status and Registrant's Response Form, ana in tne generic data requirements
section (.111.u.i.), as appropriate.
m-D REQUESTS FOR DATA WAIVERS
1. Generic Data
There are two types of data waiver responses to this Notice. The first is a request for a
low volume/minor use waiver and the second is a waiver request based on your belief that the
data requirements) are not appropriate for your product.
a. Low Volume/Minor Use Waiver
Option 8 under item 9 on the Requirements Status and Registrant's Response
Form. Section 3(c)(2)(A) of FIFR^ requires EPA to consider the appropriateness ot
requiring data for low volume, minor use pesticides. In implementing mis provision,
EPA considers low volume pesticides to be only those active ingredients whose total
production volume for all pesticide registrants is small. In determining whether to grant
a low volume, minor use waiver, the Agency will consider the extent, pattern and
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volume of use, the economic incentive to conduct the testing, the importance of the
pesticide, and the exposure and risk from use of the pesticide. If an active ingredient is
used for both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient are low volume and the combined volumes
for all uses are also low, then an exemption may be granted, depending on review of
other information outlined below. An exemption will not be granted if any registrant of
the active ingredient elects to conduct the testing. Any registrant receiving a low
volume minor use waiver must remain within the sales figures in their forecast
supporting the waiver request in order to remain qualified for such waiver. If granted a
waiver, a registrant will be required, as a condition of the waiver, to submit annual
sales reports. The Agency will respond to requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the following
information, as applicable to your product(s), as part of your 90-day response to this
Notice:
(i). Total company sales (pounds and dollars) of all registered product(s)
containing the active ingredient. If applicable to the active ingredient, include foreign
sales for those products that are not registered in this country but are applied to sugar
(cane or beet), coffee, bananas, cocoa, and other such crops. Present the above
information by year for each of the past five years.
(ii) Provide an estimate of the sales (pounds and dollars) of the active
ingredient for each major use site. Present the above information by year for each of
the past five years.
(iii) Total direct production cost of product(s) containing the active ingredient
by year for the past five years. Include information on raw material cost, direct labor
cost, advertising, sales and marketing, and any other significant costs listed separately.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product(s) containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were directly related to the active
ingredient, such as costs of initial registration and any data development.
(v) A list of each data requirement for which you seek a waiver. Indicate the
type of waiver sought and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill each of these
• data requirements.
(vi) A list of each data requirement for which you are not seeking any waiver
and the estimated cost to you (listed separately for each data requirement and associated
test) of conducting the testing needed to fulfill each of these data requirements.
(vii) For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient, direct production costs of product(s)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of product(s) containing the active ingredient (following the
parameters in item 3 above), and costs of data development pertaining to the active
ingredient.
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(viii) A description of the importance and unique benefits of the active
ingredient to users. Discuss the use patterns and the effectiveness of the active
ingredient relative to registered alternative chemicals and non-chemical control
strategies. Focus on benefits unique to the active ingredient, providing information that
is as quantitative as possible. If you do not have quantitative data upon which to base
your estimates, then present the reasoning used to derive your estimates. To assist the
Agency in determining the degree of importance of the active ingredient in terms of its
benefits, you should provide information on any of the following factors, as applicable
to your product(s): (a) documentation of the usefulness of the active ingredient in
Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient, as 9pposed to its registered alternatives,
(c) information on the breakdown of the active ingredient after use and on its
persistence in the environment, and (d) description of its usefulness against a pest(s) of
public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the
request for a waiver.
b. Request for Waiver of Data
Option 9, under Item 9, on the Requirements Status and Registrant's Response
Form. This option may be used if you believe that a particular data requirement snould
not apply because the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You also must
submit the current label(s) of your produces) and, if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice are not appropriate to your
product(s), you will not be required to supply the data pursuant to section 3(c)(2)(B). If
EPA determines that the data are required for your product(s), you must choose a
metnod ot meeting tne requirements ot uus JNotice witnm tne time trame provided" by
this Notice. Within 3u days ot your receipt ot tne Agency's written decision, you must
submit a revised Requirements Status and Registrant s Response Form indicating the
option chosen.
2. Product Specific Data
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. (Note: any supplemental data must be submitted in the format required by PR
Notice 86-5). This will be the only opportunity to state the reasons or provide
information in support of your request. If the Agency approves your waiver request,
you will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA. If
the Agency denies your waiver request, you must choose an option for meeting the data
requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the product specific Requirements
Status and Registrant's Response Form. Product specific data requirements lor product
cnemistry, acute toxicity and erticacy (.where appropriate) are required for all products
and the Agency would grant a waiver only under extraordinary circumstances. You
should also be aware that submitting a waiver request will not automatically extend the
due date for the study in question. Waiver requests submitte3"without adequate
supporting rationale will be denied and the original due date will remain in force.
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SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
INUTHJH; ~~
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to 8SK by a.re8ls,tr^t£xComPlv with me requirements of this Data Call-In Notice, pursuant
to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent
to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of
this Notice. F
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a
study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice. J
5. Failure to take a required action or submit adequate information pertaining to
any option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration
concerning joint data development or failure to comply with any terms of a data
waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section m-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer
or failure of a registrant on whom you rely for a generic data exemption either
to:
i. Inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-In Response Form and a Requirements Status and Reqistrant's
Response Form. " — - : - 3 -
ii. Fulfill the commitment to develop and submit the data as required by this
Notice; or
iii. Otherwise take appropriate steps to meet the requirements stated in this
Notice,
unless you commit to submit and do submit the required data in the specified
time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any
time following the issuance of this Notice.
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IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1) EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding die design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection
of species, number of animals, sex and distribution of animals, dose and effect levels to
be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2) EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3) EPA requirements regarding the reporting of data, including the manner of
reporting, the completeness of results, ana the adequacy of any required supporting (or
raw) data, including, but not limited to, requirements referenced or includea in this
Notice or contained in PR 86-5. All studies must be submitted hi the form of a final
report; a preliminary report will not be considered to fulfill the submission
requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding generally would
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances. Ifypu believe such disposition of existing stocks of your product(s)
which may be suspended for failure to comply with this Notice should be permitted, you have
the burden of clearly demonstrating to EPA that granting such permission would be consistent
with the Act. You also must explain 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, distribution, and use. Unless you meet this burden, the Agency will not consider any
request pertaining to the continued sale, distribution, or use of your existing stocks after
suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required
by this Notice will not result in the agency granting any additional time to sell, distribute, or
use existing stocks beyond a year from the date the 90 day response was due, unless you
demonstrate to the Agency that you are in full compliance witn all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3-year study is scheduled to be submitted, all progress
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reports and other information necessary to establish that you have been conducting the study in
an acceptable and good faith manner must have been submitted to the Agency, before EPA
will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies,
regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.
SECTION VL INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status
Sheet. —
All responses to this Notice must include completed Data Call-In Response Forms
(Attachment 2)and completed Requirements Status and Registrant s Response Forms
(Attachment 3), for both (generic and product specitic data) and any other documents required
by this Notice, and should be submitted to the contact person(s) identified in Attachment 1. If
the voluntary cancellation or generic data exemption option is chosen, only the Generic and
Product Specific Data Call-in Response Forms need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance
Assurance (OECA), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Louis P. True, Jr., Acting Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - uenenc Data uaii-in ana product specific Data Call-In Response Forms with
Instructions
3 - Generic Data Call-In and Product Specific Data Call-in Requirements Status
and Registrant's Response forms with instructions
4- UFA uroupmg ot EDO-use products for Meeting Acute Toxicology Data
Requirements tor Keregistration
5 - EFA Acceptance Cnferia
6- List ot Registrants Receiving This Notice
7 - Confidential statement ot Formula, uost Share and Data Compensation Forms
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Attachment 1. Chemical Status Sheets
155
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156
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MALEIC HYDRAZIDE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing maleic hydrazide.
This Generic Data Call-in Chemical Status Sheet, contains an overview of data
required by this notice, and point ot contact lor inquiries pertaining to the reregistration of
maleic hydrazide. This attachment is to be used in conjunction with (1) the Generic Data Call-
in Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the Requirements
Status and Registrant's Form (Attachment 3), (4) the EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration (Attachment 4), (5) the EPA Acceptance
Criteria (Attachment 5), and (6) a list of registrants receiving this DCI (Attachment 6), (7) the
Cost Share and Data Compensation Forms in replying to this Maleic Hydrazide Generic Data
Call-in (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
ine additional data requirements needed to complete the generic database for maleic
hydrazide are contained in the Requirements Status and Registrant's Response, Attachment 3.
The Agency has concluded that additional product cnemistry data on maleic hydrazide are
needed. These data are needed to fully complete the reregistration of all eligible maleic
hydrazide products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact at (703) 308-8077.
All responses to this Notice for the generic data requirements should be submitted to:
Susanne Cerrelli, Chemical Review Manager
Reregistrati9n Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Maleic Hydrazide
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MALEIC HYDRAZIDE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
produces) containing maleic hydrazide.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point ol contact for inquiries pertaining to the reregistration of
maleic hydrazide. This attachment is to be used in conjunction with (1) the Product Specific
Data Cafl-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3)
the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-
Use Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Maleic Hydrazide
Product Specific Data Call-In (Attachment 7). Instructions and guidance accompany each
form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for maleic hydrazide
are contained in the Requirements Status and Registrant's Response, Attachment 3. The
Agency has concluded that additional data on maleic nydrazide are needed for specific
products. These data are required to be submitted to the Agency within the time frame listed.
These data are needed to fully complete the reregistration of all eligible maleic hydrazide
products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of maleic hydrazide, please
contact at (703) 308-8077.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Franklin Gee at (703) 308-8008. or
Veronica Dutch at (703) 308-8585.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Veronica Dutch
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Maleic Hydrazide
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Attachment 2. Combined Generic and Product Specific
Data Call-In Response Forms (Form A inserts) Plus
Instructions
159
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160
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Instructions For Completing The "Data Call-In Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
These instructions apply 19 the Generic and Product Specific "Data Call-in Response Forms"
and are to be used by registrants to respond to generic and product specific Data Call-Ins as
part of EPA's Reregistration Program under the Federal Insecticide, Fungicide, and
Rodenticide Act. The type of data call-in (generic or product specific) is indicated in
item number 3 ("Date and Type of DCI") on each form. BOTH "Data Call-In Response"
forms must be completed.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling
out the forms.
EPA has developed these forms individually for each registrant, and has preprinted these
forms with a number of items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed
by the registrant as appropriate. Items 8 through 11 must be completed by the registrant
oefore submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect
of this collection of information, including suggestions for reducing this burden, to Chief
Information Policy Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M
St., S.W., Washington, D.C. 20460; and to the Office of Management and Budget
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
uenenc ana rroduct specific Data Call-In
Item l.ON BOTH FORMS: This item identifies your company name, number and address.
Item 2.ON BOTH FORMS: This item identifies the case number, case name, EPA chemical
number and chemical name.
Item 3.ON BOTH FORMS: This item identifies the type of Data Call-In. The date of
issuance is date stamr
Item 4.ON BOTH FORMS: This item identifies the EPA product registrations relevant to
the data call-in. Please note that you are also responsible for informing the Agency of your
response regarding any product that you believe may be covered by this Data Call-in but that
is not listed by the Agency in Item 4. You must bring any such apparent omission to the
Agency's attention within the period required for submission of this response form.
Item 5.ON BOTH FORMS: Check this item for each product registration you wish to
cancel voluntarily. If a registration number is listed for a product for which you previously
requested voluntary cancellation, indicate in Item 5 the date of that request. Since this Data
Call-In requires both generic and product specific data, you must complete item 5 on both
Data Call-In response forms. You do not need to complete any item on the Requirements
Status and Registrant's Response Forms.
Item 6a.ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
generic data as indicated in Item 3 and you are eligible for a Generic Data Exemption for the
chemical listed in Item 2 and used in the subject product. By electing this exemption, you
agree to the terms and conditions of a Generic Data Exemption as explained in the Data
Call-in Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA registration Number
of each registered source of that active ingredient that you use in your product.
Typically, if you purchase an EPA-registered product from one or more other producers
(who, with respect to the incorporated product, are in compliance with this and any other
outstanding Data Call-In Notice), and
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
uenenc ana product specific Data Call-In
incorporate thatproduct into all your products, you may complete this item for all products
listed on this form. If, however, you produce the active ingredient yourself, or use any
unregistered product (regardless of the fact that some of your sources are registered), you
may not claim a Generic Data Exemption and you may not select this item.
Item 6b.ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
generic data as indicated in Item 3 and if you are agreeing to satisfy the generic data
requirements of this Data Call-in. Attach the Requirements Status and Registrant's Response
Form that indicates how you will sansry tnose requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
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2?m. ™Prm ^ PRUODUCT SPECIFIC DATA FORM: For each manufacturing use
product (MUP) for which you wish to maintain registration, you must agree to satisfy die data
requirements by responding "yes."
Item Tb.For each end use product (EUP) for which you wish to maintain registration you
must agree to satisfy the data requirements by responding "yes.
FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if your product
is identical to another product and you qualify for a data exemption. You must provide the
EPA registration numbers of your source(s); do not complete the Requirements Status and
Registrant s Response form. Examples of such products include repackaged products and
Special Local Needs (Section 24c) products which are identical to federally registered
products.
If you are requesting a data waiver, answer "yes" here; in addition, on the "Requirements
btatus and Registrant s Response" form under Item 9, you must respond with option 7
(Waiver Request) for each study for which you are requesting a waiver.
NOTE: Item 7a and 7b are not applicable for Generic Data.
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Lrenenc ana rroauct Specific Data L'all-In
Item 8.ON BOTH FORMS: This certification statement must be signed by an authorized
representative of your company and the person signing must include his/her tide. Additional
pages used in your response must be initialled and dated in the space provided for the
certification.
Item 9.ON BOTH FORMS: Enter the date of signature.
Item 10. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11 .ON BOTH FORMS: Enter the phone number of your company contact.
Note: You may provide additional information mat does not fit on this form in a signed letter that accompanies your response. For example, you
may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant details so that EPA can ensure mat its records are correct
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DRAFT COPY
Page 1 of 1
United States Environmental Protection Agency Form Approved
Washington, D. C. 20460 OMB NO. 2070-0107
DATA CALL-IN RESPONSE 2070-0057
Approval Expires 03-31-96
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company name and Address 2. Case it and Name 3. Date and Type of DC I
SAMPLE COMPANY 0381 Maleic Hydrazide PRODUCT SPECIFIC
NO STREET ADDRESS
NO CITY, XX 00000
4. EPA Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. 1 agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is a MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification 9. Date
1 certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact 11. Phone Number
-------
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Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms (Form B inserts)
and Instructions
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Instructions For Completing
The
"Requirements Status and Registrant's Response Forms"
For The Generic and Product Specific Data Call-in
INTRODUCTION
These instructions apply to the Generic and Product Specific "Requirements Status and
Registrant's Response Forms" and are to be used by registrants to respond to generic and
product specificX)ata Call-in's as part of EPA's reregistration program under the Federal
Insecticide, Fungicide, and Rodenticide Act. The type of Data Call-In (generic or product
specific) is indicated in item number 3 ("Date and Type of DCI") on each form. Both
"Requirements Status and Registrant's Response" forms must be completed.
Although the form is the same for both product specific and generic data, instructions
for completing the forms differ slightly. Specifically, options for satisfying product specific
data requirements do not include (1) deletion of uses or (2) request for a low volume/minor
use waiver. Please read these instructions carefully before filling out the forms.
EPA has developed these forms individually for each registrant, and has preprinted
these forms to include certain information unique to this chemical. DO NOT use these forms
for any other active ingredient.
Items 1 through 8 have been preprinted on the form. Item 9 must be completed by the
registrant as appropriate. Items 10 through 13 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average
30 minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this burden, to Chief,
Information Policy Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M
St., S.W., Washington, D.C. 20460; and to the Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
RhUlSTRANl 'S RbSPUNSb FORMSIr"
Generic ana nroduct specinc Data uaii-fn
Item 1. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2. ON THE GENERIC DATA FORM: This item identifies the case number,
case name, EPA chemical number and chemical name.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
case number, case name, and the EPA Registration Number of the product for
which the Agency is requesting product specific data.
Item 3. ON THE GENERIC DATA FORM: This item identifies the type of Data
Call-in. The date of issuance is date stamped.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the type
of Data Call-in. The date of issuance is also date stamped. Note the unique
identifier number (ID#) assigned by the Agency. This ID number must be used
in the transmittal document for any data submissions in response to mis Data
Call-In Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline reference number of
studies required. These guidelines, in addition to the requirements specified in
the Data Call-In Notice, govern the conduct of the required studies. Note that
series 61 and 62 in product chemistry are now listed under 40 CFR 158.155
through 158.180, Subpart c.
Item 5. ON BOTH FORMS: This item identifies the study title associated with the
guideline reference number and whether protocols and 1, 2, or 3-year progress
reports are required to be submitted in connection with the study. As notea in
Section HI of the Data Call-In Notice, 90-day progress reports are required for
all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's
Response Form.
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
RblJISTRAN'l 'S RbSPONSb FORMS" *
Generic ana product specific uata uaii-ih
Item 6. ON BOTH FORMS: This item identifies the code associated with the use
pattern of the pesticide. In the case of efficacy data (product specific
requirement), the required study only pertains to products which have the use
sites and/or pests indicated. A brief description of each code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
168
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D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
EUP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
Item 7. ON BOTH FORMS: This item identifies the code assigned to the substance
that must be used for testing. A brief description of each code follows:
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade Active
Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active Ingredient and
Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient or Typical End-Use
Product
Metabolites
Impurities
Degradates
* See: guideline comment
Item 8. This item completed by the Agency identifies the time frame allowed for
submission of the study or protocol identified in item 5.
ON THE GENERIC DATA FORM: The time frame runs from the date of
your receipt of the Data Call-In notice.
ON THE PRODUCT SPECIFIC DATA FORM: The due date for
submissi9n of product specific studies begins from the date stamped on the letter
transmitting the Reregistration Eligibility Decision document, and not from the
TEP/MET
TEP/PAI/M
TGAI
TGAI/PAI
TGAI/PAIRA
TGAI/TEP
MET
IMP
DEGR
169
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date of receipt. However, your response to the Data Call-In itself is due 90
days from the date of receipt.
Item 9. ON BOTH FORMS: Enter the appropriate Response Code or Codes to show
how you intend to comply with each data requirement. Brief descriptions of
each code follow. The Data Call-In Notice contains a fuller description of each
of these options.
Option 1. ON BOTH FORMS: (Developing Data) I will conduct a new study and
submit it within the time rrames specified in item 8 above. By indicating
that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the cpnditions for submittal of this study as
outlined in the Data Call-In N9tice and that I will provide the protocols
and progress reports required in item 5 above.
Option 2. ON BOTH FORMS: (Agreement to Cost Share) I have entered into an
agreement with one or more registrants to develop data jointly. By
indicating that I have chosen this option, I certify that I will comply with
all the requirements pertaining to sharing in the cost of developing data
as outlined in the Data Call-In Notice.
However, for Product Specific Data, I understand that this
option is available for acute toxicity or certain efficacy data ONLY if
the Agency indicates in an attachment to this notice that my product is
similar enough to another product to qualify for this option. I certify that
another party in the agreement is committing to submit or provide the
required data; if the required study is not submitted on time, my product
may be subject to suspension.
Options. ON BOTH FORMS: (Offer to Cost Share) I have made an offer to
enter into an agreement witn one or more registrants to develop data
jointly. I am also submitting a completed "Certification of offer to Cost
Share in the Development of Data" form. I am submitting evidence that
I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am including a copy of
my offer and proof of the other registrant's receipt of that offer. I am
identifying the party which is committing to submit or provide the
required data; if the required study is not submitted on time, my product
may be subject to suspension. I understand that other terms under Option
3 in the Data Call-In Notice apply as well.
However, for Product Specific Data, I understand that this
option is available only for acute toxicity or certain efficacy data and
only if the Agency indicates in an attachment to this Data Call-in Notice
that my product is similar enough to another product to qualify for this
option.
Option 4. ON BOTH FORMS: (Submitting Existing Data) I will submit an
existing study by the specified due date tnat nas never before been
submitted to EPA. By indicating that I have chosen this option, I certify
that this study meets all the requirements pertaining to the conditions for
submittal of existing data outlined in the Data Call-In Notice and I have
attached the needed supporting information along with this response.
170
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Options. ON BOTH FORMS: (Upgrading a Study) I will submit by the
specified due date, or will cite data to upgrade a study that EPA has
classified as partially acceptable and potentially upgradeable. By
indicating that I have chosen this option, I certify mat I have met all the
requirements pertaining to the conditions for submitting or citing
existing data to upgrade a study described in the Data Call-in Notice. I
am indicating on attached correspondence the Master Record
Identification Number (MRID) that EPA has assigned to the data that I
am citing as well as the MRID of the study I am attempting to upgrade.
Option 6. ON BOTH FORMS; (Citing a Study) I am citing an existing study
that has been previously ciassmea oy fcPA as acceptable, core, core
minimum, or a study that has not yet been reviewed by the Agency. If
reviewed, I am providing the Agency's classification of the study.
However, for Product Specific Data, I am citing another
registrant's study. I understand mat this option is available ONLY for
acute toxicity or certain efficacy data and ONLY if the cited study was
conducted on my product, an identical product or a product which the
Agency has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing
my own data. In either case, I will provide the MRID or Accession
number (s). If I cite another registrant's data, I will submit a completed
Certification With Respect To Data Compensation Requirements'^
form.
FOR THE GENERIC DATA FORM ONLY: The following three options
pumpers 7, 8, ana y) are responses mat apply only to the ^Requirements Status
and Registrant's Response Form" for generic data.
Option 7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
Option 8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In
Notice and I request a low-volume minor use waiver of the data
requirement. I am attaching a detailed justification to support this waiver
request including, among other things, all information required to
support the request. I understand that, unless modified by the Agency in
writing, the data requirement as stated in the Notice governs.
Option 9. (Request for Waiver of Data) I have read the statements concerning data
waivers other tnan lowvoiume minor-use data waivers in the Data
Call-In Notice and I request a waiver of the data requirement. I am
attaching a rationale explaining why I believe the data requirements do
not apply. I am also submitting a copy of my current labels. (You must
also submit a copy of your Confidential Statement of Formula if not
already on file with EPA). I understand that, unless modified by the
Agency in writing, the data requirement as stated in the Notice governs.
FOR PRODUCT SPECIFIC DATA; The following option (number 7) is a
response mat applies to uie Requirements Status and Registrant's Response
Form" for product specific data.
171
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Option 7. (Waiver Request) I request a waiver for this study because it is
inappropriate tor my product. I am attaching a complete justification for
this request, including technical reasons, data and references to relevant
EPA regulations, guidelines or policies. [Note: any supplemental data
must be submitted in the format required by P.R. Notice 86-5]. I
understand that this is my only opportunity to state the reasons or
provide information in support of my request. If the Agency approves
my waiver request, I will not be required to supply the data pursuant to
Section 3(c) (2) (B) of FIFRA. If the Agency denies my waiver request,
I must choose a method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I must, within 30
days-of my receipt of the Agency's written decision, submit a revised
"Requirements Status" form specifying die option chosen. I also
understand that the deadline for submission of data as specified by the
original Data Call-In notice will not change.
Item 10. ON BOTH FORMS: This item must be signed by an authorized representative
of your company. The person signing must include his/her title, and must initial
and date all other pages of this form.
Item 11. ON BOTH FORMS: Enter the date of signature.
Item 12. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 13. ON BOTH FORMS: Enter the phone number of your company contact.
NOTE: You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example,
you may wish to report that your product bas already been transferred to anotber company or that you have already voluntarily cancelled
172
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DRAFT COPY
Page 1 of 1
United States Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary
1. Co^Mny iNMt and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
171-4 (b) *
I71-4(d) *
171-4(j) *
5. Study Title
Nature of residue - livestock
Res. analyt. method - animal
Nag. meat/milk/poultry/egg
|
2. Case # and Name
0381 Maleic Hydrazide
Chemical # and Name 051501
Dihydro-3,6-pyridazinedione
Progress
Reports
1
Y
Y
Y
2
3
6. Use
Pattern
AB
AB
AB
7. Test
Substance
PAIRA/PM
TGAI/METABO
* See gdln comment
10. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. bate and Type of DCI
GENERIC
8. Time
Frame
17
17
17
mos.
mbs* ;::
mos.
9. Registrant
Response
11. Date
13. Phone Number
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DRAFT COPY
Page 1 of 1
United states Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
171-4 (b) *
171^4 (d) *
171-4 (j) *
5. Study Title
Nature of residue - livestock
Res. ahalyt. method - animal
Mag. meat/milk/poultry/egg
f
2. Case # and Name
0381 Maleic Hydrazide
Chemical # and Name 051503
Potassium 1 ,2-dihydro-3,6-pyridazinedione
Progress
Reports
1
Y
Y
Y
2
3
6. Use
Pattern
AB
AB
AB
7. Test
Substance
PAIRA/PM
TCAlpjfiWO H:?!!
* See gdln comment
10. Certification
1 certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
3. Date and Type of DC1
GENERIC
8. Time
Frame
17
17
17
mos .
mos.
mos.
9. Registrant
Response
11. Date
13. Phone Number
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D.C. 20460
* COMMENTS FOR GUIDELINE REQUIREMENTS
Case # and Name
0381 Maleic Hydrazide
Chemical # and Name
051501 Dihydro-3,6-pyridazinedione and 051503 Potassium l,2-dihydro-3,6-pyridazinedlone
GUIDELINE COMMENT
171-4 (b) The unidentified metabolite 1, comprising as much as 60% of the TRR in some tissues,
must be identified. Representative samples from metabolism studies must be analyzed by a
suitable enforcement method to ascertain if the method adequately recovers all residues
of concern.
171-4(d) A method for enforcement of tolerances in animal commodities must be described and
validated.
171-4(j) Test substance for this guideline is TGAI or plant metabolites. New feeding studies
must be conducted to determine appropriate tolerance levels in animal commodities. You
must provide further characterization of unidentified metabolite 1 before the residue of
concern in animal commodities can be determined.
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DRAFT COPY
Page 1 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requi rement
U, , i
Number
61-1
61-2 (a)
61-2 (b)
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
the attached instructions and supply the information requested
2. Case # and Name
0381 Maleic Hydrazide
EPA Reg. No. NNNNNN-NNNNN
5. Study Title
Prod Che* - Regular Chemical
Product identity & composition (1)
Oescriptn starting materials, (1,2)
productn & formulatn
process
Discussion of formation of (1,3)
impurities
Preliminary analysis (1,4)
Certification of limits (1,5)
Analytical method (1)
Color (SO)
Physical state
Odoi- (50)
Melting point (6)
Boiling point (7)
Density
10. Certification
5
?
Progress
Reports
1
2
3
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DC I
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
7. Test
Substance
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
and TGAI
and TGAI
and TGAI
and TGAI
and TGAI
and TGAI
and TGAI
and TGAI
and TdAl
TGAI
TGAI
MP/EP and TGAI
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may
or both under applicable law.
Signature and Title of Company's Authorized Representative
be punishable by fine, imprisonment
12. Name of Company Contact
8. Time
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos *
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response
11. Date
13. Phone Number
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DRAFT COPY
Page 2 of
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
«. Guideline
Requirement
Number
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
81-1
81-2
81-3
the attached instructions and supply the information requested
2. Case # and Name
0381 Maleic Hydrazide
EPA Reg. No. NNNNNN-NNNNN
5. Study Title
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition (8)
coefficient
pH <9>
Stability
Oxidizing or reducing action (10)
Ftanroabiltty (11)
Explodability (12)
Storage stability (50)
Viscosity (13)
MiscibUity (14)
Corrosion characteristics
Dielectric breakdown voltage <1S)
Acute Jox^ic^Requiar, Chemical
Acute ora 1 toxi ci ty- rat < 1 ,36, 3?)
Acute dermal (1,2,37)
tox<yrabbit/rat
Acute inhalation toxicity-rat (3)
Initial to indicate certification as to information on this page
(full text of certification is on page one).
§
o
c
f
Progress
Reports
1
2
3
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
7. Test
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
Substance
TGAI/PAI
TGAI/PAI
TGAI/PAI
PAI
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
and TGAI
and TGAI
and TGAI
and TGAI
and TGAI
8. Time
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos*
8 mos.
8 rood*
8 mos*
8 mos.
8 mos.
9. Registrant
Response
,
Date
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DRAFT COPY
Page 3 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
81-4
81-5
81-6
the attached instructions and supply the information requested
2. Case # and Name
0381 Maleic Hydrazide
EPA Reg. No. NNNNNN-NNNNN
5. Study Title
Primary eye irritation-rabbit (2)
Primary dermal irritation (1,2)
Dermal sensitization (4)
{I
?
I
Progress
Reports
1
2
3
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKlMNO
Initial to indicate certification as to information on this page
(full text of certification is on page one).
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
7. Test
Substance
MP/EP
MP/EP
MP/EP
8. Time
Frame
8 mos.
8 mos.
8 mos.
9. Registrant
Response
Date
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DRAFT COPY Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0381 Maleic Hydrazide
Key: HP = manufacturing-use product; EP = end-use product; provided formulators purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product.[NOTE: If a product is a 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.]; TEP = typical end-use product;
TGA1 = technical grade of the active ingredient; PAI = "pure" active ingredient; PAIRA = "pure" active ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop 0 - Aquatic food crop E - Aquatic nonfood outdoor
F - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food M - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in column two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Prod Chew - Regular Chemical
1 Requirements pertaining to product identity, composition, analysis, and certification of ingredients are detailed further in the following sections: *158.155 for
product identity and composition (61-1); *158.160, 158.162, and 158.165 for description of starting materials and manufacturing process (61-2); *158.167 for
discussion of formation of impurities (61-3); *158.170 for preliminary analysis (62-1); *158.175 for certification of limits (62-2); and *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice if the pesticide is not already under full scale production and an experimental
use permit is being sought.
3 If the pesticide is not already under full scale production and an experimental use permit is sought, a discussion of unintentional ingredients shall be submitted to
the extent this information is available.
4 To support registration of an MP or EP, whether produced by an integrated system or not, the technical grade of Active Ingredient must be analyzed. If the technical
grade of Active Ingredient cannot be isolated, a statement of composition of the practical equivalent of the technical grade of Active Ingredient must be submitted.
Data on EPs or MPs will be required on a case-by-case basis.
5 Certified limits are not required for inert ingredients in products proposed for experimental use.
6 Required if technical chemical is solid at room temperature.
7 Required if technical chemical is liquid at room temperature.
8 Required if technical chemical is organic and non-polar.
9 Required if test substances are dispersible with water.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive.
13 Required if product is a liquid.
14 Required if product is an emulsifiable liquid and is to be diluted with petroleum solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
50 Data are not required unless product falls under criteria outlined in PR Notice 92-5.
Acute Toxic - Regular Chemical
1 Not required if test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as Toxicity Category I on the basis
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DRAFT COPY
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0381 Maleic Hydrazide
Footnotes (cont.):
of potential eye and dermal irritation effects.
3 Required if the product consists of, or under conditions of use will result in, an inhalable material (e. g., gas, volatile substances, or aerosol/particulate).
4 Required unless repeated dermal exposure does not occur under conditions of use.
36 Special testing (acute, subchronic, and/or chronic) is required for organophospates, and may be required for other cholinesterase inhibitors and other pesticides
which have demonstrated a potential to adversely affect the visual system. Registrants should consult with the agency for development of protocols and methodology
prior to initiation of studies.
37 Testing of the EP dilution is required if it can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
applicators specified in 40 CFR 152.170.
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
173
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174
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EPA'S BATCHING OF PRODUCTS CONTAINING MALEIC HYDRAZIDE AS THE
ACTIVE INGREDIENT FOR MEETING ACUTE TOX1C1TV DATA REQUIREMENTS
FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing the active ingredient maleic
hydrazide (l,2-E5ihydro-3,6-pyridazinedione and i,2-Dihydro-3,6-pyridazinedione, potassium salt)
the Agency has batched products which can be considered similar in terms of acute toxicity.
Factors considered in the sorting process include each product's active and inert ingredients
(identity, percent composition and oiological activity), type of formulation (e.g., emulsifiable
concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use
classification, precautionary labeling, etc.). Note that the Agency is not describing batched
products as "substantially similar" since some products within a batch may not be considered
chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves die right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute lexicological studies to represent all the products within that batch.
It is the registrants' option to participate in the process with all other registrants, only some of the
other registrants, or only their own products within a batch, or to generate all the required acute
lexicological studies for each of their own products. If a registrani chooses to generate the data
for a batch, he/she must use one of the producls wilhin ihe balch as ihe lesl material. If a
registrant chooses to rely upon previously submitted acute toxicity dala, he/she may do so
provided lhal Ihe dala base is complete and valid by today's slandards (see acceptance criteria
attached), ihe formulation tested is considered by EPA to be similar for acute toxicity, and ihe
formulation has nol been significantly altered since submission and acceptance of the acute toxicity
data. Regardless of whether new data is generated or existing data is referenced, registrants must
clearly identify Ihe tesl material by EPA Regislration Number. If more than one confidential
slatement of formula (CSF) exisls for a producl, the registrani musl indicate Ihe formulation
actually tested by identifying the corresponding CSF.
In deciding how to meel the producl specific data requiremenls, registranls musl follow ihe
directions given in ihe Dala Call-In Notice and ils atlachmenls appended to Ihe RED. The DCI
Notice conlains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet
the dala requirements for each producl. The second form, "Requiremenls Status and Registrani's
Response, lisls Ihe producl specific data required for each producl, including Ihe standard six
acute toxicity tesis. A regislranl who wishes to participate hi a bateh musl decide whelher he/she
will provide Ihe data or depend on someone else to do so. If a regislranl supplies ihe data to
support a bateh of producls, he/she musl selecl one of ihe following options: Developing Date
(Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or
Citing an Existing Study (Option 6). If a registrani depends on anolher's date, he/she musl
choose among: Cosl Sharing (Option 2), Offers to Cosl Share (Option 3) or Citing an Existing
Sludy (Option 6). If a registrant does not want to participate in a balch, ihe choices are Options
1, 4, 5 or 6. However, a regislranl should know lhal choosing nol to participate hi a baton does
nol preclude oiher registrants in the bateh from citing his/her studies and offering to cosl share
(Option 3) Ihose studies.
Table 1 displays ihe balch for ihe active ingredient maleic hydrazide.
175
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Table 1.
Batch
1
2
3
4
5
6
Registration Number
400-97
19713-25
19713-26
51873-10
400-84
400-94
51873-2
51873-8
% Active Ingredient
l,2-dihydro-3,6-pyridazinedione ... 97.0%
l,2-dihydro-3,6-pyridazinedione ... 97.0%
l,2-dihydro-3,6-pyridazinedione ... 97.0%
l,2-dihydro-3,6-pyridazinedione ... 96.0%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 21.7%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 21.7%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 21.7%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 21.7%
Form
powder
powder
powder
powder
liquid
liquid
liquid
liquid
19713-20
19713-294
2155-105
19713-1
19713-2
19713-17
19713-293
51873-9
19713-361
19713-371
19713-372
19713-105
51873-6
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 21.6%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 21.6%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 30.2%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 30.2%
l,2-dihydro3,6-pyridazinedione, potassium salt ... 30.2%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 27.8%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 30.2%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 30.2%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 80.0%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 80.0%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 80.0%
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
powder
powder
powder
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 11.1%
N-decanol ... 38.3%
l,2-dihydro-3,6-pyridazinedione, potassium salt ... 11.1%
N-decanol ... 38.3%
liquid
liquid
176
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Table 2 lists those products the Agency was unable to batch. These products were either
considered not to be similar to other products for purposes of acute toxicity or the Agency lacked
sufficient information for decision making. Registrants of these products are responsible for
meeting the acute toxicity data requirements for each product.
Table 2.
Unbatched Products
Reg. No.
400-165
400-424
2155-104
48211-76
% Active Ingredient
l,2-dihydro-3,6-pyridazinedione, potassium salt
l,2-dihydro-3,6-pyridazinedione, potassium salt
l,2-dihydro-3,6-pyridazinedione, potassium salt
l,2-dihydro-3,6-pyridazinedione, potassium salt
...80.0%
... 33.3%
... 21.7%
... 8.0%
Form
powder
liquid
liquid
liquid
177
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178
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Attachment 5. EPA Acceptance Criteria
179
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180
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and C9mposition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
181
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1 • Name of technical material tested (include product name and trade name, if appropriate).
2' S^a^add^m^rfufc^t "^ ^ ^ "^1OWer) ** "* active kgredient tnd
3 • N*™6 and "PPW certified jimit for each impurity or each group of impurities present at > 0.1 % by weieht
and for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present at <0.1 %.
4. Purpose of each active ingredient and each intentionally-added inert.
5 • Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (C AS)
Registry Number for each active ingredient and, if available, for each intentionally-added inert.
6- Molecular, structural, and empirical formulas, molecular weight or weight range, and any company
assigned experimental or internal code numbers for each active ingredient. wmpany
7- Description of each beginning material in the manufacturing process
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition
properties or toxicity. r
8 Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and the
parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9- Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
which may be present at > 0.1% or was found at > 0.1% by product analyses and (2) certain
lexicologically significant impurities (see #3). —
182
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present
the information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
and all impurities present at > 0.1%.
2. Degree of accountability or closure >^ ca 98 %>.
3. Analyses conducted for certain trace toxic impurities at lower than 0.1 % (examples, nitrosamines in the case
of products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites;
' "'" " "' ''' J' i dibenzofurans). [Note that in the case of nitrosamines both fresh and
1 dibenzodioxins and i
stored samples must be analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with
explanation of how the limits were determined.
8. Upper certified limitproposed for each impurity present at > 0.1 % and for certain lexicologically significant
impurities at <0.1 % along with explanation of how limlrdetermined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if
exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy.
183
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
_ Verbal description of coloration (or lack of it)
_ Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
_ if6*?! description of physical state provided using terms such as "solid, granular, volatile liauid"
_ Based on visual inspection at about 20-25 ° C 4
63-4 Odor
- Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds
_ Observed at room temperature
63-5 Melting Point
_ Reported in °C
_ Any observed decomposition reported
63-6 Boiling Point
_ Reported in °C
_ _ Pressure under which B.P. measured reported
_ Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
_ Measured at about 20-25 ° C
_ Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of registered products may be reported ui Ibs/ft3 or
IDs/gallon.] - r
63-8 Solubility
_ Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
_ Measured at about 20-25 ° C
_ Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
_ Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if
pressure too low to measure at 25° C)
_ Experimental procedure described
_ •_ Reported in mm Hg (ton) or other conventional units
63-10 Dissociation Constant
_ Experimental method described
_ Temperature of measurement specified (preferably about
20-25 °C)
63-11 Octanol/water Partition Coefficient
_ Measured at about 20-25 ° C
_ Experimentally determined and description of procedure provided (preferred method-45 Fed. Register
_ Data supporting reported value provided
63-12 pH
_ Measured at about 20-25 ° C
_ Measured following dilution or dispersion in distilled water
63-13 Stability
_ Sensitivity to metal ions and metal determined
_ Stability at normal and elevated temperatures
_ Sensitivity to sunlight determined
184
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dennal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
185
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1 • Identify material tested (technical, end-use product, etc).
2.At least 5 young adult rats/sex/group.
3-., Dosing, single oral may be administered over 24 hrs
4. Vehicle control if other than water.
•!• POSCS tested, sufficient to determine a toxicity category or a limit dose (5000 me/kg)
o. Individual observations at least once a day. ° v ««6"»6/.
7.
'• Uoservanon period to last at least 14 days, or until all test animals aonear normal whirh^wr
8. Individual daily observations. «uu««» appwu uuruuu wmcncver
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are siq>plemental and may not be required for every study.
186
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.^ Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.* Vehicle control, only if toxicity of vehicle is unknown.
7.~ Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 nours oerore dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous noninitating cover to retain test material and to prevent
mgestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. ^. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
187
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2- Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use
or contains particles of mhalable size for man (aerodynamic diameter 15 tan or less)
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5- Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (+2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10- Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
respirable substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on aU animals.
188
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of <2 or > 11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or paniculate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 fir, then daily until eyes are normal
or 21 days (whichever is shorter).
9.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
189
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1 • Identify material tested (technical, end-use product, etc)
2- Study not required if material is corrosive or has a pH of <2 or > 11.5.
3. 6 adult animals. — —
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
£• Application site covered with a gauze patch held in place with noninitating tape.
9. Material removed, washed with water, without trauma to application site.
10- Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11. * Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
-------
81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof <2or >11.5.
3. One offfie following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.* Reference for test.
6. Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
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192
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Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice
193
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194
-------
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
195
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196
-------
Confidential Business Information: Doos Not Conttin National Security Information (E.O. 12065)
United SUMa Environmental Protection Agency A. _.
Q.CDA ^lOSff&SSSr"* D B.,ic Formulation
\PC n/A Confidential Statement of Formula LJ Alternate Formulation
Form Approved. OMB No. 2070-0060. Approval Expires 2/28/941
P.,.
ol
Saa Instruction* on Back
1 . Name and Address of Applicant/Registrant (Include ZIP Codt) 2. Name and Address of Producer (Include ZIP Code)
3. Product Name
EPA USE ONLY
10. Component* in Formulation ILitt it tctutlly introduced
into Iht lormulttion. Givf commonly tcctpted chimictl
nimt. tttdfntmf. indCAS numbtr.l
4. Rtgittrition No./File Symbol
7. Poundi/Gil or Bulk ftamity
11. Supplier Nami & Address
5. EPA Product Mgr/Taam No.
8 pH
12. EPA Reg. No.
1 6. Typed Name of Approving Official
1 8. Signature of Approving Official
13. Each Component
in Formulation
•.Amount OAbyW.nh
17. Total
19. Title
EPA Form 8570-4 (Rev. 12-90) Previous editions are obsolete. If you can photocopy this, please submit an additional copy
White - EPA
Weight
100%
6. Country Where Formulated
9. Flash Point/Flame Extension
14. C«nifi«4 luniu
X by Weight
i.UppwluM b lowtrlnil
IS PurpoMin
Formulation
20. Phona No. tlntkideArtt Codtl
21. Date
File Copy (original) Yellow- Applicant copy
-------
198
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product specific data submission must
also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
"f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source product's
label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric system
units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow
the 40 CFR 158.175 instructions. An explanation must be provided if the proposed
limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
199
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200
-------
SEPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expire* 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223. U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA 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):
Nun* ol Flrm(»)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature
Name and
at Company's Authorized Representative
Title (Please Type
Date
or Print)
EPA Form 8570-32 (591) Kepbco EPA Form »5SO, which b obsolete
201
-------
202
-------
?/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
3070*0107
2070-0017
3-31-M
!«*,,*•_ _^. - is estimated to average 15 minutes per response, including
instructions, searching existing data sources, gathering and maintaining the data needed, and
*?£*%?* TIT1*18.1!* co"«cllon of information. Send comments regarding the burden estimate or any other
aspea of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Prelection Agency, 401M St, S.W.. Washington, DC 20460: and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington. DC 20503.
Please nil In blanks btlow.
Company
DA Mg
Number
. MO.
I Certify that
1. Fweachstuoycitedinsupp^ofregistraionorreregisirationur^ermeFec^rallnstxt^ Fungicide and
Rodenticide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
2. That tor each study cted in supped of registration or reregistration under RFRA that is NOT an exclusive use
study. I am the original data submitter, or I have obtained the written perrrtobn of the original dtta submitter, or I
have notified in wrting the companyf.es) that submitted data I have cited and have oNeredio: (a) Pay
compensation tor those data to accordance with sections 3(C)(1)(D) and 3(c)(2)(D) of FIFRA: and (b) Commence
negotiation to determine which data art subject to the compensation requirement of FIFRA and the amount ol
compensation due, if any. The companies I have notified are: (check one)
I) Thtcornpa^wrvhmsubminad the studies listed on the back of Ms torm or attached
sheets, or indicated on the attached •Requirements Status and Registrants' Response Form,"
&jsr/cwnplfdw^
registration or ^registration under FIFRA.
Due
GENERAL OFFER TO PAY: I hereby offer and agrtt to pay compensation to olhtr parsons, wkhragard to the
njg*nton or restoration of my producu, to the txtent required by FIFRA sections 3(C«1)(D) and 3(c)(2)(D).
Stgtture
Tt*u
Nam an* Tttto
MTO.J1
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204
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APPENDIX G. FACT SHEET
205
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206
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United States. _ . Prevention, Pesticides EPA-73S-F-94-009
Environmental Protection And Toxic Substances June 1994
Agency
R.E.D. FACTS
Maleic Hydrazide
Pesticide AH pesticides sold or distributed in the United States must be
Reregistration rc§istered ty EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
feet sheet summarizes the information in the RED for Case 0381, technical
maleic hydrazide and maleic hydrazide potassium salt, referred to as maleic
hydrazide.
Use Profile Maleic hydrazide is a plant growth regulator (sprout inhibitor) and
herbicide, that acts by inhibiting cell division in plants. It is used to control
sprouting of potatoes and onions, suckers in tobacco, and growth of weeds,
grasses and trees in/along lawns, turf, ornamental plants, non-bearing citrus,
utility and highway rights-of-way, airports and industrial land. Most of the
maleic hydrazide used in the U.S. is applied to tobacco (86-88%), followed
by potatoes (11-12%).
Formulations include an emulsifiable concentrate and soluble
concentrate/liquid and solid. Maleic hydrazide is applied by aircraft or
ground spray equipment. Current use practice limitations prohibit treating
crops within 7 days of harvest, and grazing or feeding forage or hay from
treated areas to livestock.
-------
Regulatory Maleic hydrazide was first synthesized in 1895 but its ability to
History regulate plant growth was not discovered until 1949. It was first registered
as a plant growth regulator in 1952. In October 1976, maleic hydrazide
went into Special Review (then called Rebuttable Presumption Against
Registration or RPAR) because it met the risk criteria for oncogenic,
mutagenic and reproductive effects.
A Data Call-In notice issued in August 1980 resulted in suspension of
the diethanolamine salt of maleic hydrazide (DEA-MH) when its
manufacturers did not submit the required data. All DEA-MH registrations
now are cancelled.
Based on other data submitted, EPA determined that the oncogenicity
and reproductive effects triggers were not supported, and that only weak
evidence supported the mutagenicity trigger. In concluding the RPAR in
June 1982, EPA allowed continued use of maleic hydrazide and its
potassium salt (K-MH), but established an upper limit of 15 ppm for the
contaminant hydrazine (associated with tumor induction) in technical grade
maleic hydrazide. At this level, lifetime cancer risks for both dietary and
worker exposure are not of concern.
The Registration Standard issued in June 1988 (NTIS #PB88-236849)
continued to limit hydrazine in the technical product to 15 ppm. A Data
Call-In issued in November 1992 required additional ecological effects and
environmental fate data. Currently, 26 maleic hydrazide products remain
registered including 4 technical grade/manufacturing-use product(s).
Human Health
Assessment
Toxicity
In acute toxicity studies using laboratory animals, maleic hydrazide is
practically non-toxic by the oral, dermal and inhalation routes and has been
placed in Toxicity Category IV (the lowest of four levels) for these effects.
It causes slight irritation to the eyes (Toxicity Category HI) and skin
(Toxicity Category IV), and is not a skin sensitizer.
Maleic hydrazide does not appear to cause any adverse developmental
or reproductive effects of concern. The potassium salt (K-MH) was not
found to be carcinogenic and has been classified as a "Group E" carcinogen-
-a chemical that is not considered to be a human carcinogen.
Maleic hydrazide and its potassium salt appear to be genotoxic (that is,
they have the potential to affect DNA repair processes) at high doses in
some mutagenicity tests. However, when all the available mutagenicity
studies are considered together with the results of all the other lexicological
studies on maleic hydrazide and its potassium salt, especially the negative
cancer studies, the potential genotoxic hazard is considered negligible.
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Dietary Exposure
People may be exposed to residues of maleic hydrazide in the diet
when consuming potatoes, potato chips and other potato products made from
potato granules; onions; and meat, milk, poultry and eggs.
Tolerances or maximum residue limits are established, and have been
reassessed, for residues of maleic hydrazide in or on potatoes, potato chips,
potato granules, potato waste (from processing), onions and cranberries
(please see 40 CFR 180.175, 185.3900, and 186.3900). The potato and
onion tolerances are acceptable, but an increased tolerance is needed for
potato chips and new, food/feed additive tolerances are needed for potato
granules and potato waste. The cranberry use is not on any currently
registered product labels and is not supported for reregistration by its
manufacturer. Unless another party decides to support this use, the
tolerance should be revoked.
Tolerances are needed but have not yet been established for meat,
milk, poultry or eggs. Animal feeding studies are being required in order to
set these tolerances. Also, a confined rotational crop study is required to
determine whether tolerances are needed for winter wheat planted as a
rotational crop in fields treated with maleic hydrazide.
Compatible international Codex Maximum Residue Levels (MRLs) are
established for potatoes and onions.
Based on reassessed tolerance levels for cranberries, onions, potatoes,
potato chips, potato granules and potato waste, and based on upper bound
residue levels for meat, milk, poultry and eggs, EPA estimates that the
overall U.S. population is exposed to about 29.5% of the Reference Dose
(RfD), or amount believed not to cause adverse effects if consumed daily
over a 70-year lifetime. Most of this exposure (27.5% of the RfD) is
contributed by potatoes. For children age 1-6 and non-nursing infants, the
two most highly exposed subgroups, the TMRC represents about 60% of the
RfD. These TMRCs are overestimates, however; and actual chronic dietary
risk (of decreased body weight gain) posed by maleic hydrazide is minimal.
Occupational and Residential Exposure
Pesticide handlers (mixers, loaders and applicators) may be exposed to
maleic hydrazide via the inhalation and dermal route. However, based on
the lack of lexicological concerns with maleic hydrazide, the risk is
considered minimal for all workers.
Smokers and others near them may be exposed to maleic hydrazide
and the contaminant hydrazine as pyrolysis products from tobacco.
However, increased levels of hydrazine are not expected, so the risk is no
greater than that already associated with the use of tobacco.
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Human Risk Assessment
Maleic hydrazide is of low acute toxicity. It has been shown to cause
genotoxic effects in some mutagenicity studies. However, in view of
several negative cancer studies, its genotoxic hazard is considered
negligible. The contaminant hydrazine has been shown to induce tumors.
However, EPA has set an upper limit of ^15 ppm hydrazine in technical
grade maleic hydrazide products. This level alleviates any concern of
lifetime cancer risk to humans considering both dietary and worker
exposure.
Environmental Environmental Fate
Assessment Maleic hydrazide is mobile, especially in sandy soils, but not
persistent in the environment. It therefore is not likely to impact
groundwater quality. It could contaminate surface waters, however, if it is
washed into anaerobic soil zones by rainfall soon after application. EPA is
requiring a surface water label advisory to address this concern.
When maleic hydrazide is aerially or air-blast sprayed, drift from use
sites could affect non-target crops or endangered plant species.
Ecological Effects
In acute toxicity studies, maleic hydrazide is "practically nontoxic" to
birds, fish, invertebrates and honey bees. It is considered to pose minimal
risks to birds, mammals, aquatic organisms, non-target insects and aquatic
plants.
Maleic hydrazide may pose risks of concern to non-target terrestrial
and semi-aquatic plants as a result of runoff from ground application, and
runoff and drift from aerial and air-blast applications.
Ecological Effects Risk Assessment
Maleic hydrazide does not pose risks to ground water but it has the
potential to contaminate surface water. It also may drift from target use
sites when it is aerially or air-blast applied. EPA is requiring that a surface
water advisory statement and spray drift management information be added
to maleic hydrazide end-use product labels to address these concerns.
Maleic hydrazide poses minimal acute risks to birds, mammals,
aquatic species, insects and non-target aquatic plants, but exceeds levels of
concern for non-target semi-aquatic and terrestrial plants. To mitigate
exposure to non-target plants, EPA is requiring that the number of
applications to fallow land, rights-of-way, turf and lawns be limited to one
per year.
EPA has concerns about the exposure of endangered plant species to
maleic hydrazide. These concerns will be addressed through
implementation of the Endangered Species Protection Program.
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Additional Data EPA is requiring the following additional generic data for maleic
Required hydrazide to confirm its regulatory assessments and conclusions:
Nature of the residue in animals;
Analytical method for residue in animals;
Magnitude of the residue in animal commodities;
Confined rotational crop;
Droplet size spectrum; and
Drift field evaluation.
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSF) and revised labeling for reregistration.
Product Labeling All maleic hydrazide end-use products must comply with EPA's
Changes Required current pesticide product labeling requirements, and with the following:
Worker Protection Standard (WPS) - All maleic hydrazide products
within the scope of the Worker Protection Standard (WPS) for Agricultural
Pesticides (see PR Notice 93-7) must, within the timeframes listed in PR
Notices 93-7 and 93-11, revise their labeling to be consistent with the WPS,
as directed in those notices and the requirements of the RED.
Surface Water Advisory - All end-use labels must be revised to bear the
following statement:
"Under some conditions, maleic hydrazide may have a significant
potential for runoff into surface water (primarily via dissolution in
runoff water), for several days post-application. Conditions favoring
runoff include poorly draining soils or wet soils with readily visible
slopes, frequently flooded areas, areas where an intense or sustained
rainfall is forecast to occur within 48 hours, areas overlying extremely
shallow ground water, and areas overlying tile drainage systems that
flow to surface water."
Application Rates - Application rates must be provided for all uses. In
instances where labels indicate to spray to "drip-point," labels must clearly
state the maximum application rate per acre. For fallow land, lawns, turf
and rights of way uses, labels must indicate that the number of applications
is limited to one per year.
Regulatory The use of currently registered pesticide products containing maleic
Conclusion hydrazide and the potassium salt of maleic hydrazide in accordance with
approved labeling will not pose unreasonable risks or adverse effects to
humans or the environment. Therefore, all uses of these currently
registered products are eligible for reregistration. (The cranberry use of
maleic hydrazide, which is not on any currently registered product labels, is
not among the uses eligible for reregistration.)
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Eligible maleic hydrazide products will be reregistered once the
required confirmatory generic data, product specific data, Confidential
Statements of Formula and revised labeling are received and accepted by
EPA.
Products which contain active ingredients in addition to maleic
hydrazide will be reregistered when all of their other active ingredients also
are eligible for reregistration.
For More EPA is requesting public comments on the Reregistration Eligibility
Information Decision (RED) document for maleic hydrazide during a 60-day time
period, as announced in a Notice of Availability published in the Federal
Register. To obtain a copy of the RED document or to submit written
comments, please contact the Pesticide Docket, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Following the comment period, the maleic hydrazide RED document
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the maleic hydrazide RED, or reregistration of individual products
containing maleic hydrazide, please contact the Special Review and
Reregistration Division (7508W), OPP, US EPA, Washington, DC 20460,
telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, from 8:00 am to 6:00 pm Central Time, Monday
through Friday.
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vvEPA
United States
Environmental Protection Agency
(7508 W)
Washington, DC 20460
Official Business
Penalty for Private Use
$300
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