United States Prevention, Pesticides EPA738-R-94-017
Environmental Protection And Toxic Substances September 1994
Agency (7508W)
4>EPA Reregistration
Eligibility Decision (RED)
Metalaxyl
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
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 metalaxyl. The
enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the
data base of this chemical, 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 on the active ingredient 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, Judy Loranger at (703)-308-8056.
Sincerely yours,
Louis P. True, Jr., Acting Director
Special Review and
Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only
with respect to actual data submissions. Requests for data waivers must be submitted as part
of the 90-day response. Requests for time extensions should be submitted in the 90-day
response, but certainly no later than the 8-month response date. All data waiver and time
extension requests must be accompanied by a full justification. All waivers and time
extensions must be granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this
letter (RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current
regulations and requirements. Only make labeling changes which are required by the RED
and current regulations (40 CFR 156.10) and policies. Submit any other amendments (such
as formulation changes, or labeling changes not related to reregistration) separately. You
may delete uses which the RED says are ineligible for reregistration. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on
Applying for Registration in the U.S., Second Edition, August 1992" (available from the
National Technical Information Service, publication #PB92-221811; telephone number 703-
487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
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comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard
certified limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by
the analysis of five batches. If you choose the second option, you must submit or cite the
data for the five batches along with a certification statement as described in 40 CFR
§158.175(e). A copy of the CSF is enclosed; follow the instructions on its back.
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 NOTICE-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. Mail:
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 Davis 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
METALAXYL
LIST A
CASE 0081
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
METALAXYL REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 4
D. Data Requirements 6
E. Regulatory History 6
III. SCIENCE ASSESSMENT 7
A. Physical Chemistry Assessment 7
B. Human Health Assessment 7
1. Toxicology Assessment 7
a. Acute Toxicity 8
b. Subchronic Toxicity 8
c. Chronic Toxicity 9
d. Carcinogenicity 9
e. Developmental Toxicity 10
f. Reproductive Toxicity 11
g. Mutagenicity 11
h. Metabolism 12
i. Other Toxic Endpoints 14
j. Reference Dose 14
2. Exposure Assessment 14
a. Dietary Exposure 14
b. Occupational and Residential 22
3. Risk Assessment 23
a. Dietary 23
b. Occupational and Residential 24
C. Environmental Assessment 24
1. Environmental Fate 24
a. Environmental Chemistry, Fate and Transport 25
b. Environmental Fate Assessment 29
2. Ecological Effects 30
a. Ecological Effects Data 31
(1) Terrestrial Data 31
(2) Aquatic Data 32
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(3) Non-Target Insect Data 35
(4) Non-Target Plants Data 35
b. Ecological Effects Risk Assessment 35
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 41
A. Determination of Eligibility 41
1. Eligibility Decision 41
2. Eligible and Ineligible Uses 42
B. Regulatory Position 42
1. Tolerance Reassessment 42
2. Reference Dose (RfD) 54
3. Risk Mitigation 55
4. Endangered Species 55
5. Labeling Requirements 55
V. ACTIONS REQUIRED BY REGISTRANTS 61
A. Manufacturing-Use Products 61
1. Additional Generic Data Requirements 61
B. End-Use Products 61
1. Additional Product-Specific Data Requirements 61
2. Labeling Requirements for End-Use Products 62
C. Existing Stocks 64
VI. APPENDICES 65
APPENDIX A. Table of Use Patterns Subject to Reregistration 67
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 167
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of 0081 183
APPENDIX D. List of Available Related Documents 213
APPENDIX E 217
PR Notice 86-5 219
PR Notice 91-2 237
APPENDIX F. Combined Generic and Product Specific Data Call-in 243
Attachment 1. Chemical Status Sheets 261
Attachment 2. Combined Generic and Product Specific Data Call-in
Response Forms (Form A inserts) Plus Instructions 265
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and Instructions
271
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 279
Attachment 5. EPA Acceptance Criteria 287
Attachment 6. List of All Registrants Sent This Data Call-in (insert)
Notice 301
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Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 303
APPENDIX G. FACT SHEET 313
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METALAXYL REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Eric Maurer
Richard Michell
Wilfred Burr
Stephen Jarboe
Environmental Fate and Effects Division
Betsy Grim
Richard Mahler
Estella Waldman
Joseph Sylvester
Health Effects Division
Flora Chow
Susan Hummel
Laura Morris
Roger Gardner
Jennifer Wintersteen
Registration Division
Kathryn Scanlon
Alfred Smith
Mark Perry
Special Review and Reregistration Division
Carol Stangel
Judy Loranger
Office of Compliance Monitoring
Rose Lew
Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Chemical Coordination Branch
Reregistration Support Chemistry Branch
Occupational and Residential Exposure Branch
Toxicology Branch II
Science Analysis Branch
Fungicide-Herbicide Branch
Registration Support Branch
Registration Support Branch
Policy, Planning and Operations Branch
Reregistration Branch
Agriculture and Ecosystems Division
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
DRES Dietary Risk Evaluation System
DWEL 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.
EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
GLC Gas Liquid Chromatography
GRAS Generally Recognized As Safe as designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to
municipalities and other organizations when emergency spills or contamination
situations occur.
HOT Highest Dose Tested
in
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GLOSSARY OF TERMS AND ABBREVIATIONS
LD
50
LDlo
LEL
LOG
LOEL
MCLG
MP
MPI
MOE
MRID
N/A
NPDES
NOEL
OPP
PADI
PAM
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.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Level of Concern
Lowest Observed Effect Level
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the
Agency to regulate contaminants in drinking water under the Safe Drinking
Water Act.
Manufacturing-Use Product
Maximum Permissible Intake
Margin Of Exposure
Master Record Identification (number). EPA's system of recording and
tracking studies submitted.
Not Applicable
National Pollutant Discharge Elimination System
No Observed Effect Level
Office of Pesticide Programs
Provisional Acceptable Daily Intake
Pesticide Analytical Method
IV
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GLOSSARY OF TERMS AND ABBREVIATIONS
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q\ The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer
Risk Model
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
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.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
TLC Thin Layer Chromatography
WPS Worker Protection Standard
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EXECUTIVE SUMMARY
This Reregistration Eligibility Decision document (RED) addresses the reregistration
eligibility of the pesticide metalaxyl.
Metalaxyl is a systemic fungicide used to control plant diseases caused by the
Oomycetes or water-mold fungi. There are currently 81 (35 Section 3 and 46 Section 24 (c))
products registered for use on a number of terrestrial food, feed, and nonfood crops,
greenhouse nonfood crops, and outdoor residential plants. Metalaxyl formulations include
granulars, wettable powders, dusts, emulsifiable concentrates, flowable concentrates,
crystalline and liquid ready-to-use products. Application may be foliar or soil incorporation,
surface spraying (broadcast or band), drenching, sprinkler or drip irrigation, soil mix or seed
treatment. Metalaxyl registered products either contain metalaxyl as the sole active
ingredient or may be combined with a variety of other active ingredients (captan,
pentachloronitro-benzene, carboxin, bacillus subtilis, mancozeb, chlorothalonil,
thiabendazole, triadimefon, chloroneb, and copper compounds).
Metalaxyl was initially registered as a pesticide in 1979 by the Ciba-Geigy
Corporation. Registration Standards for metalaxyl were issued in June 1981 (NTIS #PB82-
172297) and September 1988 (NTIS #PB89-128979). The Registration Standards
summarized available data supporting the registration of products containing metalaxyl. The
Registration Standards also required the submission of product chemistry, residue chemistry,
toxicology, ecological effects and environmental fate studies. A Data Call-In (DCI) was
issued in June 1991 for metalaxyl requiring additional aquatic plant growth and field
rotational crop data. This RED reflects a reassessment of all data which were submitted in
response to the Registration Standards.
The Agency has now completed its review of the metalaxyl target data base including
data submitted in response to both Registration Standards and the DCI and has determined
that the uses of metalaxyl as currently registered will not cause unreasonable risk to humans
or the environment. All currently registered uses of metalaxyl are eligible for reregistration.
The Agency is, however, requiring additional product chemistry data, animal metabolism
(Guideline 171-4b), analytical method validation for additional metabolites (Guideline 171-
4c/d), storage stability (Guideline 171-4e), magnitude of the residue in plants to support a
newly registered formulation and residue data for cotton gin byproducts (Guideline 171-4k)
and magnitude of the residue in processed tomato products (Guideline 171-41) to support the
reregistration eligibility of all uses of metalaxyl. These data are considered confirmatory
because health risks from dietary exposure to metalaxyl appear to be minimal. In addition,
the Agency has determined that avian reproduction studies are now required to assess the
chronic risks of metalaxyl to birds.
The Agency is concerned about the potential for groundwater contamination from
registered uses of metalaxyl. Available laboratory and field studies indicate that metalaxyl is
persistent and mobile and will leach in many soils. Metalaxyl has been detected in
VI
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groundwater at levels typically ranging up to 3 ppb. Concentrations have been reported as
high as 236 ppb, but the Agency believes that these higher levels were not likely to have
resulted from normal use. In order to reduce the possibility of groundwater contamination in
areas where soils are permeable and the water table is shallow, the Agency is requiring a
groundwater label advisory for metalaxyl end-use products. The registrant has agreed to
conduct a user education program if levels of metalaxyl are detected in groundwater at or
above 400 ppb.
Metalaxyl was classified as a Group E carcinogen (signifies evidence of non-
carcinogenicity for humans) based on available data. A Reference Dose (RfD) was
established as 0.08 mg/kg/day based on a NOEL of 7.8 mg/kg/day and an uncertainty factor
of 100. The NOEL was obtained from a 6-month dog study. The RfD was approved by the
Agency on 7/8/86 and reaffirmed by the OPP RfD Committee on 4/3/94. The Theoretical
Maximum Residue Contribution (TMRC) for the overall U.S. population from all tolerances
is 0.012 mg/kg/day, which represents 16% of the RfD. For the most highly exposed
subgroup, children ages 1 through 6, the TMRC is 0.025 mg/kg/day, which represents 31%
of the RfD. The Agency concludes that based on available data, the chronic dietary risk is
minimal from all metalaxyl uses.
The Agency has reassessed metalaxyl tolerances and has determined that numerous
tolerance revisions will be required. These tolerance revisions will be handled
administratively by the Agency. The adequacy of the established tolerances for meat, fat and
meat byproducts of cattle, goats, horses, sheep, poultry, milk and eggs will be determined
once questions pertaining to the required analytical method data are resolved and the
ruminant feeding studies can be reevaluated.
Because there are no toxicological endpoints of concern for workers, the Agency has
determined that mixer/loader/applicator and postapplication/reentry data are not required to
support the reregistration of metalaxyl. Based on eye irritation data (Toxicity Category II), a
24 hour restricted entry interval (REI) will be imposed.
Before reregistering the products containing metalaxyl, 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 for each registration and acute toxicity testing. 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.
vn
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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 registration" 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 metalaxyl. The document consists of six sections. Section I is the
introduction. Section II describes metalaxyl, 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 metalaxyl.
Section V discusses the reregistration requirements for metalaxyl. 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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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Document:
• Common Name: metalaxyl
Chemical Name: N- (2,6-dimethylphenyl) -N- (methyoxyacetyl) -alanine
methyl ester
• Chemical Family: Substituted dimethyl aniline
• CAS Registry Number: 57837-19-1
• OPP Chemical Code: 113501
• Empirical Formula: C15H21N04
• Trade and Other Names: Ridomil, Subdue, Apron
• Basic Manufacturer: Ciba-Geigy Corporation
B. Use Profile
The following is information on the current registered uses with an
overview of use sites. A detailed table of specific crops, methods of
application and rates can be found in Appendix A.
For metalaxyl:
Type of Pesticide: systemic fungicide
Use Sites: Terrestrial food crop - asparagus, avocado, beets, blueberry,
cole crops (broccoli, cabbage, cauliflower), cranberry, cucurbits
(cucumber, melons, pumpkin, squash, watermelon), dill,
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eggplant, garbanzos, ginseng, lettuce, okra, onion, papaya,
pepper, radish, raspberry, spinach, stone fruits, strawberry,
walnut
Terrestrial food and feed crop - almond, apple, barley, beans,
buckwheat, citrus, corn, cotton, grapes, hops, millet, peanuts,
peas, pineapple, potato, rice, root and tuber vegetables, rye,
seed and pod vegetables, small grains, sorghum, soybean, sugar
beet, sunflower, tomato, triticale, wheat
Terrestrial feed crop - alfalfa, beans, clover, corn, cowpeas,
grasses (forage, fodder, hay), lespedeza, lupine, millet, trefoil,
vetch
Terrestrial nonfood crop - fruit trees, golf course turf, nut
crops/trees, ornamental and/or shade trees, ornamental
herbaceous plants, ornamental lawns and turf, ornamental
woody shrubs and vines, tobacco
Terrestrial nonfood and outdoor residential - ornamental and/or
shade trees, ornamental herbaceous plants, ornamental lawn and
turf, ornamental woody shrubs and vines
Terrestrial and greenhouse nonfood crop - Epcot display crops
Greenhouse nonfood crop - ornamental and/or shade trees,
ornamental herbaceous plants, ornamental woody shrub and
vines
Target Pests: white rust caused by Albugo spp; blue mold (downy
mildew) caused by Peronospora spp; downy mildew
caused by Pseudoperonospora spp; basal stem rot, black
shank, collar rot, crown rot, foot rot, fruit rot, heart rot,
leather rot, red stele, root rot, stem rot and trunk canker
caused by Phytophthora spp; damping-off, fruit rot, leak,
root rot, seed rot, and seedling disease complex caused
by Pythium spp
Formulation Types Registered:
Dust - 3.12 to 12.5% _+_ one other active ingredient
Granular - 1 to 5% _+_ one other active ingredient
Wettable powder - 7 to 50% _+_ one other active ingredient
Emulsifiable concentrate - 11.5 to 45% _+_ one other active ingredient
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Flowable concentrate - 28.35 to 33.3%
Liquid ready to use - 0.1 to 3.5% _+_ one other active ingredient
Use Practice Limitations:
The following use practice limitation statements only pertain to seed
treatments:
"Do not use treated seed for feed, food, or oil purposes."
"Do not feed clippings, crop waste, or vines to livestock. Do not graze
treated areas."
Preharvest interval (PHI) restrictions for metalaxyl are outlined
in the Product and Residue Chemistry Chapter (6/16/94). This
document is part of the Administrative Record for metalaxyl and is
included in the EPA's Office of Pesticide Programs Public Docket.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
metalaxyl. These estimates are derived from a variety of published and proprietary
sources 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. The table below summarizes the pesticide's use by
site.
Percent of Various U.S. Crops Treated Annually with Metalaxyl, 1989 - 1992
Site
Alfalfa
Apples
Beans, dry
Beans, snap
Broccoli
Cabbage
Cantaloupe
Carrots
Acres Grown
(000)
25,048
480
1,918
266
111
88
131
103
Multiple Acres
Treated (000)
low - high
1 - 10
1 - 5
5 - 10
10- 35
20- 30
10- 20
25 - 30
5 - 10
Percent Crop
Treated (%)
low - high
<1 - <1
<1 - 1
<1 - 1
<5 - 13
18- 27
11 - 23
19 - 23
5 - 10
Pounds AI Applied
(000)
low - high
1 - 1
1 - 5
1 - 5
5 - 20
1 - 1
1 - 2
5 - 10
5 - 10
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Site
Cauliflower
Cotton
Cucumbers
Grapefruit
Honeydew
Lemons
Lettuce
Oats/rye
Onions
Oranges
Peanuts
Peas, green
Peppers
Potatoes
Raspberries
Soybeans
Spinach
Strawberries
Sugarbeets
Sunflower
Tangelos
Tobacco
Tomatoes
Turf and
Ornamentals
Watermelons
Other
TOTAL
Acres Grown
(000)
60
13,230
132
144
26
63
244
5,473
144
622
1,863
361
73
1,378
11
58,763
35
48
1,421
2,289
10
758
475
620
251
N/A
Multiple Acres
Treated (000)
5 - 10
225 - 400
10- 15
10- 25
2 - 5
10- 15
50 - 150
1 - 5
50- 75
40 - 120
5 - 50
1 - 2
2 - 10
150 - 250
2 - 3
150 - 450
10- 15
5 - 10
5 - 10
15 - 20
1 - 2
175 - 300
25 - 250
60- 70
40- 60
25 - 75
1,151 - 2,547
Percent Crop
Treated (%)
8- 17
2 - <5
8 - 11
7 - 17
8 - 19
16 - 24
20- 61
<1 - <1
35 - 52
6 - 19
<1 - <5
0- <1
<5 - 14
11 - 18
18- 27
<1 - 1
29 - 43
10- 21
<1 - 1
<1 - 1
10- 20
23 - 40
5 - 53
10- 11
16 - 24
N/A
Pounds AI Applied
(000)
1 - 2
190 - 225
10- 15
10- 20
5 - 10
5 - 10
15 - 45
1 - 5
20- 25
35 - 125
5 - 55
1 - 1
1 - 5
25 - 50
1 - 2
20- 70
2 - 5
5 - 10
1 - 1
5 - 10
1 - 1
125 - 275
10- 50
105 - 120
15 - 20
15 - 40
649 - 1,251
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There are no known usage data available for Christmas trees, apricot,
nectarine, millet, fruit trees, black salsify, loquat, papaya, pineapple, chicory, dill,
ginger, hops, turmeric, pumpkin, squash, pimento, collard, kale, kohlrabi, endive,
fennel, mustard, parsley, rhubarb, okra, radish, sweet potato, and turnip.
There is no known usage on almond, corn, grape, peach, rice, walnut, lime,
tangerine, avocado, cherry, plum, prune, blueberry, asparagus, celery, kumquat,
Brussels sprout, garlic, eggplant, wheat, and sorghum.
D. Data Requirements
Product chemistry, toxicology and ecological effects studies were required in
the December 1981 Registration Standard for metalaxyl. Data requested in the
September 1988 Guidance document for metalaxyl included studies on product
chemistry, ecological effects, environmental fate, toxicology and residue chemistry.
These data were required to support the uses listed in the Registration Standard. The
1991 DCI required the submission of ecological effects and environmental fate
studies. Appendix B includes all data requirements for technical metalaxyl, identified
by the Agency for currently registered uses needed to support reregistration.
E. Regulatory History
Metalaxyl is a systemic fungicide used to control plant diseases caused by the
Oomycetes or water-mold fungi. There are currently 81 (35 Section 3 and 46 Section
24 (c)) products registered for use on a number of terrestrial food, feed, and nonfood
crops, greenhouse nonfood crops, and outdoor residential plants. Metalaxyl
formulations include granulars, wettable powders, dusts, emulsifiable concentrates,
flowable concentrates, crystalline and liquid-ready to use products. Application may
be foliar or soil incorporation, surface spraying (broadcast or band), drenching,
sprinkler or drip irrigation, soil mix or seed treatment. Metalaxyl registered products
either contain metalaxyl as the sole active ingredient or may be combined with a
variety of other active ingredients (captan, pentachloronitrobenzene, carboxin, bacillus
subtilis, mancozeb, chlorothalonil, thiabendazole, triadimefon, chloroneb, and copper
compounds).
Metalaxyl was initially registered as a pesticide in 1979 by the Ciba-Geigy
Corporation. Registration Standards for metalaxyl were issued in June 1981 (NTIS
#PB82-172297) and September 1988 (NTIS #PB89-128979). The Registration
Standards summarized available data supporting the registration of products containing
metalaxyl. The Registration Standards also required the submission of product
chemistry, residue chemistry, toxicology, ecological effects and environmental fate
studies. A Data Call-In (DCI) was issued in June 1991 for metalaxyl requiring
additional aquatic plant growth and field rotational crop data.
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III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Metalaxyl [N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-alanine methyl ester] is
a systemic fungicide registered for use on a variety of crops/sites (primarily citrus,
cotton, cucurbits, onions, ornamentals, potatoes, soybeans [seed treatment], tobacco,
tomatoes, and turf).
\
CH3
Empirical Formula:
Molecular Weight:
CAS Registry No.:
Shaughnessy No.:
279.3
57837-19-1
113501
Technical metalaxyl is a white to beige crystalline solid with a melting point
of 71-72 C and a vapor pressure of 2.2 x 10 ~6 mm Hg at 20 C. The solubility of
metalaxyl in water at 20 C is 7.1 g/L. Metalaxyl is also readily soluble in most
organic solvents (i.e., 65% soluble in methanol and 55% soluble in benzene).
B. Human Health Assessment
1. Toxicology Assessment
The toxicological database on metalaxyl is essentially complete for
reregistration purposes.
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a. Acute Toxicity
The table below summarizes the acute toxicity results for technical
grade metalaxyl.
Test
Acute Oral LD50 (rat)1
Acute Oral LD50 (mouse)2
Acute Oral LD50 (hamster)3
Acute Dermal LD50 (rabbit)4
Acute Inhalation LC50
Eye Irritation (rabbit)6*
Dermal Irritation (rabbit)7*
Skin Sensitization (guinea pig)8*
Result
669 mg/kg
788 mg/kg
7120 mg/kg
> 6000 mg/kg
Requirement waived5
Moderate Irritant
Mild Irritant
Negative
Category
III
III
IV
III
N/A
II
IV
N/A
1 MRID 00063990
2 MRID 00063991
3 MRID 00154308
4 MRID 00063993
5 Because metalaxyl cannot be prepared and tested in a respirable form, the requirement for an acute
inhalation study was waived by the Agency on May 10, 1991.
6 MRID 00084108
7 MRID 00084107
8 MRID 00084109
*Note: Data pertaining to acute eye irritation, dermal irritation, and dermal sensitization are not required to
support the reregistration of the TGAI. These data are presented for informational purposes.
N/A = not applicable
b. Subchronic Toxicity
A 90-day study was conducted with male and female Sprague-Dawley
rats fed diets containing 0, 50, 250, or 1250 ppm of metalaxyl. The diet
concentrations were equivalent to chemical intakes of 3.4, 17, and 83
mg/kg/day, respectively. At the high dose, food consumption by males was
slightly reduced and minimal liver cell hypertrophy was increased in
females. Based on these findings, the LOEL was 83 mg/kg/day and the
NOEL was 17 mg/kg/day. (MRID 00084110)
A 21 -day dermal study was conducted with male and female New
Zealand white rabbits. Metalaxyl was applied to intact or abraded skin at
dose levels of 10, 100, or 1000 mg/kg/day for 6 hours/day, 5 days/week.
Endpoints evaluated included body weight, food consumption, hematology,
clinical chemistry, organ weights, and histopathology. No treatment-related
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dermal or systemic effects were observed at any dose level. Therefore, the
NOEL for dermal and systemic toxicity was the highest dose tested, 1000
mg/kg/day. (MRID 00072394)
c. Chronic Toxicity
A 6-month study was conducted with beagle dogs fed diets containing
0, 50, 250, or 1000 ppm of metalaxyl. The diet concentrations were
equivalent to chemical intakes of 0, 1.6, 7.8, and 30.6 mg/kg/day for
males, and 0, 1.7, 7.4 and 32.4 mg/kg/day for females, respectively.
Exposure to the high dose was associated with an elevation in serum
alkaline phosphatase and an increase in liver weight (absolute and relative to
brain weight). No clinical signs or findings in hematology, urinalysis, or
histopathology were related to treatment. The LOEL was 25 mg/kg/day
and the NOEL was 6.3 mg/kg/day. (MRID 00071598)
In a chronic toxicity/carcinogenicity study, male and female
Sprague-Dawley rats were fed diets containing 0, 50, 250, or 1250 ppm of
metalaxyl for 2 years. These levels were equivalent to 2.5, 13, and 63
mg/kg/day, respectively. The high dose produced an increase in liver
weight (relative to body weight) and an increased incidence of periacinar
vacuolation of hepatocytes. Based on the liver changes, the systemic LOEL
was 63 mg/kg/day and the NOEL was 13 mg/kg/day. (MRID 00098481,
00132009, 00150185)
d. Carcinogenicity
A 2-year chronic toxicity/carcinogenicity study was conducted with
male and female Sprague-Dawley rats. Metalaxyl was administered in the
diet at concentrations of 0, 50, 250, or 1250 ppm, which were equivalent to
intakes of 2.5, 13, and 63 mg/kg/day, respectively. (MRID 00098481,
00132009, 00150185)
A 2-year carcinogenicity study was conducted with male and female
Swiss mice. Metalaxyl was administered in the diet at concentrations of 0,
50, 250, or 1250 ppm, which were equivalent to intakes of 7.5, 38, and
190 mg/kg/day, respectively. (MRID 00103354, 00150094)
In 1985 the EPA reviewed four major issues concerning the rat and
mouse carcinogenicity studies: (1) parafollicular cell adenomas in the
thyroid of female rats, (2) adrenal medullary tumors (pheochromocytomas)
in male rats, (3) liver tumors in male mice, and (4) use of a maximum
tolerated dose. (50 FR 49690)
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Concerns about the incidence of thyroid tumors in female rats were
mitigated by the following evidence: (1) no progression of adenomas
(benign) to carcinomas (malignant), (2) no increase in hyperplastic changes,
(3) no dose-response relationship, and (4) two re-evaluations of microscopic
slides showing no treatment-related effect. Similar microscopic
reassessments of the adrenal gland of male rats and the liver of male mice
indicated no compound-related effect on tumor incidence in these organs.
Although the highest dose tested (1250 ppm) was not a maximum
tolerated dose (MTD) in either study, the EPA concluded that the rat and
mouse studies were sufficient to demonstrate that metalaxyl did not have
carcinogenic potential in laboratory animals and further testing was
unwarranted. The conclusion was supported by the following evidence: (1)
the doses in both studies were high enough to produce treatment-related
changes in liver weight and/or histology (i.e., increased liver weight and
hepatocellular vacuolation in rats; fatty infiltration in the liver of mice), (2)
no structural relationship to known carcinogens, (3) no genotoxic activity,
and (4) no effect on neoplasm incidence in mice or rats of either sex at any
dose level tested.
In December 31, 1985, the Agency classified metalaxyl as a Group E
carcinogen (evidence of non-carcinogenicity for humans) based on the
available data.
e. Developmental Toxicity
A developmental toxicity study was conducted with pregnant Charles
River COBS CD rats administered doses of 0, 50, 250, or 400 mg/kg/day
by gavage on days 6 through 15 of gestation. Dams were sacrificed on day
20 of gestation. Doses of 250 mg/kg/day and higher were maternally toxic
producing ataxia and convulsions. The 400 mg/kg/day dosage resulted in
mortality of one-third of the dams. Doses of 250 mg/kg/day and higher
produced fetotoxicity manifest as an increased incidence of unossified
sternebrae. The LOEL was 250 mg/kg/day and the NOEL was 50
mg/kg/day for both maternal and developmental toxicity. (MRID
00144423, 00148867)
A developmental toxicity study was conducted with Dutch belted
rabbits given doses of 0, 30, 150, or 300 mg/kg/day of metalaxyl on days 7
through 19 of gestation. Does were sacrificed on day 28 of gestation. The
high dose does showed a slight loss in body weight. In a range-finding
study, 500 mg/kg/day decreased maternal body weight and 1000 mg/kg/day
produced mortality. No treatment-related developmental toxicity was
observed at any dose level. The LOEL for maternal toxicity was 300
10
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mg/kg/day and the NOEL was 150 mg/kg/day. The highest dose tested,
300 mg/kg/day, was the NOEL for developmental toxicity. (MRID
00144371, 00144372, 00148866, 00154938)
f. Reproductive Toxicity
A 3-generation reproduction study was conducted with SPF Crl:COBS
CD (SD) rats. Metalaxyl was administered in the diet at concentrations of
0, 50, 250, or 1250 ppm. These levels were equivalent to 2.5, 13, and 63
mg/kg/day, respectively. There were no treatment-related effects on
parental body weight, food consumption, mating, fertility, gestation length,
or macroscopic observations. Pre- and post-implantation loss, litter size
and weight, and incidence of fetal malformations/variations were also
unaffected by treatment. The NOEL for reproductive toxicity was the
highest dose tested, 63 mg/kg/day (1250 ppm). (MRID 00071600)
g. Mutagenicity
Metalaxyl was negative in bacterial and mammalian gene mutation, in
vivo cytogenetics, and several other genotoxicity assays.
Three studies evaluated metalaxyl in the Salmonella typhimurium
reverse mutation assay (Ames assay) using tester strains TA 98, TA 100,
TA 1535, and TA 1537. Metalaxyl did not increase the frequency of
reverse mutations with or without metabolic activation (S9) at
concentrations ranging from 25-2025 pig/plate, 20-5000 pig/plate, and
10-5000 pg/plate in the three experiments. (MRID 00084113, 00154301,
00154302)
A gene mutation assay in mammalian cells was conducted using the
L5178Y (TK +/-) mouse lymphoma cell line. Concentrations of metalaxyl
ranged from 0.125 to 1 mg/ml without S9 and 0.0625 to 0.5 mg/ml with
S9. Metalaxyl did not increase forward mutations at the thymidine kinase
(TK) locus. (MRID 00103362, 00154309)
Metalaxyl did not increase the frequency of reverse mutations in yeast
cells (Saccharomyces cereviseae) at concentrations of 400 to 10,000 pig/ml
with or without metabolic activation. Concentrations of 8000 pig/ml and
greater were cytotoxic. Assays for recombination and gene conversion
were unreliable. (MRID 00103359)
In an in vivo cytogenetics study, male and female Chinese hamsters
were administered two consecutive daily oral doses of 0, 595, 1190, or
2380 mg/kg of metalaxyl. The highest dose was one-third the oral LD50 in
11
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hamsters (7120 mg/kg). Bone marrow cells were scored 24 hours later for
nuclear changes which included single Jolly bodies, fragments of nuclei in
erythrocytes, micronuclei in erythroblasts, micronuclei in leukopoietic cells,
and polyploid cells. Metalaxyl had no effect on the incidence of nuclear
anomalies. (MRID 00103361, 00154307)
A dominant lethal test was conducted with male NMRI mice given a
single oral dose of 0, 65, or 195 mg/kg of metalaxyl. The highest dose
was one-fourth the reported LD50 in mice (788 mg/kg). Each male was
cohabited with two untreated females each week for 8 consecutive weeks.
Metalaxyl had no effect on mating, pregnancy, number of implants, or
embryo viability. A positive control was not used in the study. (MRID
00084114, 00154310)
Metalaxyl was tested twice in the unscheduled DNA synthesis (UDS)
assay using primary cultured rat hepatocytes. Concentrations tested ranged
from 16-2000 pig/ml in both experiments. Another UDS assay was
conducted using human fibroblasts. Metalaxyl concentrations ranged from
4 to 500 pig/ml. Concentrations up to cytotoxic levels were tested in each
assay. Metalaxyl did not increase unscheduled DNA synthesis above
control levels in any of the three assays. (MRID 00103363, 00154306,
00160037, 00154663)
h. Metabolism
Four studies with rats evaluated the absorption, distribution,
excretion, and/or metabolism of orally administered metalaxyl. A dermal
absorption study with rats was also conducted.
In a single dose study, male and female rats were administered 0.5 or
25 mg/kg of metalaxyl by gavage. Over 60% of the low or high dose was
excreted within 24 hours in urine or feces. Negligible amounts were
eliminated in expired air. Low tissue residues six days after treatment
indicated no appreciable bioaccumulation. Female rats eliminated the
majority of the dose (55-65%) in urine, and males eliminated most
(60-70%) in feces. Although metabolites were not identified, the
chromatographic pattern was similar for both sexes and doses. (MRID
00071613)
A metabolism study was conducted with female rats administered a
single oral dose of 28 mg/kg. Within 48 hours 96% of the dose had been
excreted in urine or feces. Consistent with the previous study, females
excreted over 60% of the dose in urine and about 30% in feces.
Approximately 20% of the metabolites in urine were identified. Hydrolysis
12
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of the ether and ester bonds was shown to be a significant metabolic
pathway. Glucuronidase treatment of urine fractions indicated metabolites
were either unconjugated or glucuronide conjugates. Fecal metabolites
were not identified. (MRID 00071614)
A similar study (females rats given 28 mg/kg as single oral dose)
corroborated that ester and ether bond hydrolysis is a primary metabolic
pathway. Secondary pathways included oxidation of methyl groups of the
phenyl moiety and oxidation of the phenyl moiety itself. Some metabolites
in urine were present as glucuronic acid conjugates. A large portion of the
metabolites were unidentified. (MRID 00099084)
A recent comprehensive study evaluated metalaxyl pharmacokinetics
with male and female Sprague-Dawley rats following a single intravenous
dose (1 mg/kg), single oral low dose (1 mg/kg), single oral high dose (200
mg/kg), or repeated oral low doses (1 mg/kg/day for 14 days). The
absorption, distribution, and elimination patterns were consistent with
previous findings. No major dose or sex differences were observed except
that urine was the predominant elimination route for females whereas feces
was the major route for males. Metalaxyl was readily absorbed (similar
i.v. and oral elimination profiles), extensively metabolized (< 1% parent
compound in excreta), and rapidly eliminated (70-80% in 24 hours). Ten
metabolites were identified. The majority of urinary metabolites were
conjugated (glucuronide or sulfate) whereas fecal metabolites were mostly
unconjugated. The major metabolite in urine and feces was
N-(2,6-dimethylphenyl)-N-(hydroxyacetyl) alanine. Three major and one
minor metabolic pathways were proposed. One pathway involved
hydrolysis of the ether, followed by oxidation of the resulting alcohol, ester
hydrolysis, or N-dealkylation of the ester chain. A second pathway
involved oxidation of an aromatic methyl to the benzylic acid or ester
hydrolysis. The third major pathway was ester hydrolysis, sometimes
followed by benzylic acid formation. The minor pathway involved
hydroxylation at the meta position of the phenyl ring. Two major
metabolites in urine were not identified. Additional data on major
unidentified metabolites must be provided to upgrade this study to
acceptable. Information to upgrade this study is currently in review
(MRID 41664501, original study; MRID 43317301, information to upgrade
original study).
A dermal absorption study was conducted with male and female rats
treated with 1 or 10 mg/kg. Thirty percent of the dose was absorbed from
the skin within 8 hours. The absorption half-times were 12 and 20 hours
for males at the low dose and high dose, respectively, and 13 hours for
females at both dose levels. Within 72 hours 70-80% of the applied dose
13
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had been excreted. The elimination half-times were 36 and 49 hours for
males and 42 and 44 hours for females at the low and high doses,
respectively. Females eliminated the majority of the dose in urine whereas
males eliminated most in feces. (MRID 00161402)
i. Other Toxic Endpoints
Smoke Inhalation Study.
Because metalaxyl is used on tobacco, a 90-day smoke inhalation
study was conducted. Male and female Fischer 344 rats were exposed to
smoke from cigarettes containing 0, 130, 3900, or 13,000 ppm of metalaxyl
for 4 hours/day, 5 days/week. The maximum air concentration of
metalaxyl was 5 ug/L. The concentrations in test cigarettes were 100 to
10,000 times average residue levels and 30 to 100 times greater than the
expected maximum residue levels. Although the study was limited in its
ability to simulate human exposure, the results were adequate to
demonstrate toxicological effects from exposures are unlikely beyond that
from exposures associated with heavy smoking. The profile of residues in
inhalable smoke indicated 30% was metalaxyl, 4% was 2,6-dimethylaniline,
and 65% was unidentified material. (MRID 00103364, 00109471)
j. Reference Dose
The RfD was established as 0.08 mg/kg/day based on a NOEL of 7.8
mg/kg/day and an uncertainty factor of 100. The NOEL was obtained from
a 6-month dog study. The RfD was approved by the Agency on 7/8/86 and
reaffirmed by the OPP RfD Committee on 4/3/94.
In 1982 the FAO/WHO Joint Meeting on Pesticide Residues allocated
an Acceptable Daily Intake (ADI) of 0.03 mg/kg/day for metalaxyl.
2. Exposure Assessment
a. Dietary Exposure
Plant Metabolism
The qualitative nature of the residue in plants is adequately
understood. Studies with potatoes, lettuce, grapes, and tobacco indicate that
metalaxyl is taken up, translocated, and extensively metabolized by plants.
Metabolism involves oxidation of a ring-methyl group and hydrolysis of the
methyl ester and methyl ether bonds; metabolites can be conjugated to
glucose. Studies with [14C]metalaxyl-treated seed indicate that no
14
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appreciable residue was transferred from treated seed to edible mature plant
parts. The residues to be regulated in plant commodities are those in the
current tolerance expression, which include metalaxyl, metabolites that can
be converted to 2,6-dimethyl aniline (2,6-DMA), and one metabolite
containing the 2-hydroxymethyl-6-methyl aniline (HMMA) moiety, N-(2-
hydroxymethyl-6-methylphenyl)-N-(methoxyacetyl) alanine methyl ester.
The molecular structures of the metabolites of concern are presented in
Table A.
Animal Metabolism
The qualitative nature of the residue in animals is adequately
understood. Metabolism in ruminants is via hydrolysis to the ester alcohol
and acid alcohol, which may then be de-alkylated. In ruminants, metalaxyl
may also be oxidized to benzylic alcohol or phenolic compounds. Some
breakdown products may be conjugated with glucuronic acid. A major
residue in milk is a mixture of the N-octanoic- and N-decanoic acid ester of
metabolite CGA-67869 [(N-(2,6-dimethylphenyl)-N-(hydroxyacetyl)-aniline
methyl ester]. 2,6-DMA-based residues accounted for up to ~ 50% of the
residues in ruminant tissues. HMMA containing compounds comprised
34% of the residue in kidney and 12-14% in muscle and fat. The parent
compound is rapidly excreted.
In poultry, metalaxyl is hydrolyzed to either the benzyl alcohol or the
ester alcohol. The benzylic alcohol is converted to a sulfate and the ester
alcohol is conjugated with fatty acid or converted to the acid alcohol, which
is subsequently hydrolyzed to the benzylic alcohol. The predominant
residues in poultry are the disubstituted free acid forms of the hydroxy
metabolite CGA-94689 isomers (-47% in thigh muscle and 24% in egg),
the sulfuric acid conjugate of the hydroxy metabolite (30% in thigh
muscle), fatty acid conjugates of the disubstituted free acids of CGA-94689
(27% in fat), and CGA-107955, N-(2,6-dimethylphenyl)-N-
hydroxyacetyl)alanine (40% in fat).
The Agency has determined that the residues to be regulated are
metalaxyl, metabolites that can be converted to 2,6-dimethylaniline (2,6-
DMA), and those containing the 2-hydroxymethyl-6-methylaniline (HMMA)
moiety. Some metabolites containing the HMMA moiety may be
convertible to 2,6-DMA and thus measured by the current enforcement
methodology. Data showing percent conversion of HMMA metabolites to
DMA are outstanding (enforcement method recovery data for HMMA
metabolites). The wording of the tolerance expression for livestock
commodities will be determined after these data are submitted. Current
residue levels estimated for livestock commodities represent an upper bound
15
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for HMMA containing metabolites. The molecular structures of the
metabolites of concern are presented in Table A.
16
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Table A. The chemical structure of metalaxyl and its metabolites of concern.
Structure
Metabolite: Chemical name
Structure
Metabolite: Chemical name
H3C
HaC , /Tx /CH:
H3C N \/
H3Cx J /CH>
OH
metalaxyl: N-(2,6-dimethylphenyl)-N-(methoxyacetyl) alanine
methyl ester
N- (2,6-dimethylphenyl)-N-(hydroxyacetyl) alanine methyl ester
OH
HN
N- (oxalyl) -2,6-dimethylaniline
H,C"
: I,,AI,,
:x J\ /CH>
N-(oxalyl)-N-(2,6-dimethylphenyl)alanine methyl ester
I
HN
/CH,
N- (2,6-dimethylphenyl) -2-hydroxyacetamide
HO
N- (2,6-dimethylphenyl) -N- (methyloxyacetyl) alanine
x/°-CH.
HO
ff
H,Cx,/^x/-CH3
N- [2-hydroxymethyl) -6-methylphenyl] -N- (methoxy acetyl)alanine
methyl ester
N- (2,6-dimethylphenyl) -N- (hydroxyacetyl) alanine
17
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Structure
Metabolite: Chemical name
Structure
Metabolite: Chemical name
/
I
H3CT
H,C-
xOH
xCH,
/CH,
N- (oxalyl) -N- (2,6-dimethylphenyl) alanine
N-decanoic acid ester of N-(2,6-dimethylphenyl)-N-
(hydroxyacetyl) alanine methyl ester
-o\^o
HO
/CH,
Sulfuric acid ester of N-[2-hydroxymethyl)-6-methyl-phenyl]-N-
(methoxyacetyl) alanine methyl ester
N- [ 2- (hydroxymethyl) -6-methylphenyl] -N- (hydroxyacetyl) alanine
H0
HO"
x-CH,
N-Fatty acid amide conjugates of N-[2-hydroxymethyl)-6-
methylphenyl] alanine
/\ /°-
N- [ 2- (hydroxymethyl) -6-methylphenyl-N- (methoxyacetyl) alanine
18
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Residue Analytical Methods - Plants and Animals
Adequate enforcement methods are available for the determination of
residues of metalaxyl and regulated metabolites in plants. Methods I and II
in PAM, Vol. II, correspond to Methods AG-348 and AG-349. Method
AG-395, an improved modification of AG-348, has undergone successful
Agency validation with plant matrices.
Metabolites which may not be covered by the current tolerance
expression have been identified in livestock commodities. Additional
validation data are needed to demonstrate that Method AG-576 adequately
recovers metabolites containing the 2,6-DMA moiety and HMMA
containing metabolites as 2,6-dimethyl aniline. Method AG-576 is a
combination of Method II in PAM, Vol. II, and AG-395, both of which
have undergone successful Agency validation, and adequately recovers
metalaxyl, per se. Method AG-576 may be adequate for enforcement of
tolerances in animal commodities, if it is proven to adequately recover all
residues of concern. If significantly less than 100% of the total toxic
residue is recovered using Method AG-572, then residue levels used in
future risk assessments may need to be adjusted to account for this.
Metalaxyl, per se, is completely recovered (>80%) using FDA
Multiresidue Protocol D (PAM, Vol. I, Section 232.4), and is not
recovered by Protocol E (PAM, Vol. I, Sections 211.1/231.1 and
212.1/232.1) [Source: PESTDATA, PAM, Vol. I, Appendix, 8/93].
Multiresidue data for representative metalaxyl metabolites have been
forwarded to FDA.
Storage Stability
Adequate storage stability data are available to support residue studies
on raw agricultural commodities stored less than 24 months at temperatures
of -20 C or less, with the exception of oilseed and grain crops. An interim
storage stability study on cranberries, potatoes, peppers, and spinach
indicates that weathered residues determined as 2,6-DMA are stable in
samples stored at -20 C for 18 to 24 months. A final report reflecting 38
months storage of these matrices is needed for field trial studies in which
the samples were stored for more than 24 months. This information will be
confirmatory. Storage stability data for metalaxyl and representative
metabolites in a representative oilseed (e.g., soybean or nut) and grain
(e.g., wheat) are required.
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No storage stability data are available to support processing studies.
Storage stability data for metalaxyl and representative metabolites are
required from all processed commodities of an oilseed, a grain, and a fruit
or fruiting vegetable.
Storage stability data for metalaxyl and representative metabolites in
livestock commodities representing one year of frozen storage are required.
Considering the demonstrated storage stability on several crops, the
outstanding storage stability data are considered confirmatory.
Magnitude of the Residue in Plants
All data requirements for magnitude of the residue in plants have been
evaluated and deemed adequate, except for the 50% WP formulation and
cotton gin byproducts. For other formulations, field trials were performed
representing the various conditions under which the pesticide can be
applied. Geographical representation is adequate and a sufficient number of
trials reflecting representative formulations were conducted. Residue data
are needed for cotton gin byproducts.
To support multiple foliar and other late season applications of the
50% WP formulation to strawberries, fruiting vegetables, and asparagus,
the registrant must either (1) submit available bridging data for
representative commodities which show that residues are similar for late
season, foliar applications of WP and EC formulations of metalaxyl at rates
similar to those registered for these crops, or (2) perform 3 side by side
field trials each for asparagus, strawberries, and tomatoes (9 total trials) in
geographically representative growing areas using the 50% WP formulation
and a representative EC formulation. If residues resulting from application
of the 50% WP are substantially higher than those using the EC
formulation, then additional field trial data may be required. These data are
considered confirmatory. At the registrants request, the Agency has
reevaluated the need for these studies and concludes that these studies are
still required.
Tolerances have not been established for forage, fodder, and straw for
the cereal grains group (excluding wheat, barley, and oats). A petition has
been submitted to the Agency.
Magnitude of the Residue in Processed Food/Feed
Processing studies have been conducted on the following commodities:
apples, citrus, cereal grains, cottonseeds, grapes, hops, legume vegetables,
peanuts, pineapples, potatoes, prunes, sunflowers, soybeans, sugar beets,
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and tomatoes. All data requirements for magnitude of the residue data in
processed food/feed commodities have been deemed adequate to determine
the extent to which residues of metalaxyl concentrate upon processing of the
raw agricultural commodity.
Residues concentrate in the following food commodities: citrus oil;
potato granules/flakes, and chips; prunes; raisins; sugar beet molasses, and
tomato puree.
Residues concentrate in the following processed feed items: apple
pomace (wet); citrus, molasses and pulp; grape pomace (wet and dried),
grape raisin waste; legume vegetable cannery waste; peanut meal;
pineapple, process residue, potato peels (dried); soybean hulls and meal;
sugar beet molasses, sunflower meal; and tomato pomace (dried).
Food/feed additive tolerances for potato granule/flakes, potato chips,
and tomato pomace must be proposed.
Because tomato paste is considered a processed food/feed
commodities, residue data are required. The data are considered
confirmatory.
Magnitude of the Residue in Meat, Milk, Poultry, and Eggs
Tolerances for the combined residues of metalaxyl and its metabolites
convertible to 2,6-dimethyl aniline and N-(2-hydroxymethyl-6-
methylphenyl)-N-(methoxyacetyl) alanine methyl ester have been established
for meat, fat, kidney, liver, and meat byproducts of cattle, goats, horses,
sheep and poultry and for milk and eggs. The evaluation of the submitted
ruminant feeding studies is deferred until the adequacy of the analytical
method used is determined.
The results from the submitted poultry feeding study indicate that
residues of metalaxyl will not exceed the established tolerances in poultry
tissues and eggs. However, judgement of the adequacy of the available data
is reserved until the analytical method used is determined to be adequate
and adequate storage stability data are provided.
There are no established or proposed direct animal uses for metalaxyl.
The existing ruminant and poultry feeding studies are adequate for risk
assessment.
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Confined Rotational Crops
Four confined rotational crop studies (MRID Nos. 42196501 through
42196503 and 43317302) are currently in review.
Field Rotational Crops
A field rotational crop study (MRID 41870308) is currently in review.
b. Occupational and Residential
Mixer/Loader/Applicator (Handler) Exposure
Based on current use patterns, several exposure scenarios are plausible
as defined by the types of application equipment and procedures that might
be employed by metalaxyl handlers; for example, open mixing of liquids
for foliar application to onions using center pivot irrigation, or loading of
granular formulation for soil broadcast treatment to non-bearing nut trees
using groundboom equipment.
Exposure data requirements are triggered based on the potential for
exposure and the toxicological significance of the active ingredient.
Metalaxyl meets the exposure criteria, but not the toxicity criteria.
Therefore, exposure data for occupational and residential activity patterns
(M/L/A) associated with the use of metalaxyl are not required for
reregistration eligibility. Similarly, an exposure assessment is not required.
Post-Application Exposure
The potential for post-application exposure to workers entering treated
sites exists and may be significant (e.g., human exposure to ornamental
lawns or turf after pesticide treatment). However, metalaxyl does not meet
the toxicity criteria for requiring post-application exposure data. Therefore,
neither exposure data nor an exposure analysis are required for
reregistration eligibility.
22
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3. Risk Assessment
a. Dietary
Toxicological Endpoints
Based on a review of the toxicology database, the Agency concluded
that there are no endpoints of concern for acute dietary exposure. For
chronic dietary exposure, the Agency has established a Reference Dose
(RfD) of 0.08 mg/kg/day, based on a No Observed Effect Level (NOEL) of
7.8 mg/kg/day and an uncertainty factor of 100. The NOEL was derived
from a 6-month dog feeding study which demonstrated increased alkaline
phosphatase activity and an increase in relative liver weights at 31
mg/kg/day.
Residue Information
A chronic dietary analysis was completed using available percent
crop treated information and tolerance residue levels from crops listed in 40
CFR §180.408 and 185.4000. The tolerance levels used in this analysis,
with the exception of cabbage, cauliflower and leafy vegetables, reflect the
changes that are outlined in Section IV, B, 1, the tolerance reassessment
section. It should be noted that although the Agency recommends a
reduction in the tolerance for cabbage and cauliflower from 2 to 1 ppm, the
higher value of 2 ppm was used for this dietary analysis. For leafy
vegetables (excluding Brassica and spinach), an increase in the tolerance
from 0.1 ppm to 5 ppm is recommended. The tolerance increase has not
been published in the Federal Register yet, but has been included here as a
pending tolerance of 4.9 ppm; the published tolerance of 0.1 ppm added to
this pending tolerance results in the 5 ppm tolerance recommended for
reregistration.
Chronic Exposure Analysis and Dietary Risk
The Dietary Risk Evaluation System (ORES) chronic analysis used
tolerance level residues to calculate the Theoretical Maximum Residue
Contribution (TMRC) for the overall U.S. population and 22 population
subgroups. These exposure estimates were then compared to the RfD to
arrive at the potential chronic dietary risk. The TMRC for the overall
U.S. population from all tolerances is 0.012 mg/kg/day, which represents
16% of the RfD. For the most highly exposed subgroup, children ages 1
through 6, the TMRC is 0.025 mg/kg/day, which represents 31% of the
RfD.
23
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The Percent of crop treated information was used to calculate the
Anticipated Residue Contribution (ARC) for those same population groups.
The ARC is considered the more accurate estimate of dietary exposure.
The ARC for the U.S. population from the published uses of metalaxyl
being recommended through reregistration is 6.1 x 1CT3 mg/kg/day, which
represents 8% of the RfD.
The ARC from published uses for the most highly exposed DRES
subgroup, children (ages 1 through 6), is 1.2 x 1CT2 mg/kg/day, which
represents 15% of the RfD.
The U.S. population and all the DRES subgroups have TMRCs and
ARCs for chronic dietary risk below the RfD when published and proposed
tolerances are considered. It appears that chronic dietary risk is minimal
for this chemical for published and proposed tolerances. Although the ARC
estimate is a more accurate estimate of dietary risk, it still is likely to be an
overestimate because tolerance level residues or high end residues for meat,
milk and eggs were assumed on all commodities.
b. Occupational and Residential
Significant potential for exposure exists for both handlers of metalaxyl
and for those exposed after application of metalaxyl during reentry
operations (e.g., at planting treatment of lettuce). Potential post-application
exposure concerns relate to workers and to users in residential settings.
However, exposure studies (and exposure analysis) are not required to
assess the risk to humans exposed to metalaxyl during or after pesticide
application because there are no toxicologic endpoints of concern, except
for potential eye irritation (Toxicity Category II). Potential eye effects will
be addressed by appropriate labeling and personal protective equipment
requirements.
C. Environmental Assessment
1. Environmental Fate
The environmental fate database for metalaxyl is adequate for
reregistration purposes. Although the data requirements for aerobic aquatic
metabolism, field dissipation for terrestrial uses, and aquatic field dissipation have
not been completely fulfilled for metalaxyl, the Agency has determined that
sufficient information exists from acceptable and supplemental studies to make a
sound qualitative assessment of the fate of metalaxyl in the environment. No
additional studies are required at this time.
24
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a. Environmental Chemistry, Fate and Transport
Detailed information regarding the fate of metalaxyl in the environment is
provided below. Environmental fate studies used to support the reregistration of
metalaxyl are given in Appendix B.
1. Hydrolysis
Metalaxyl was found to be moderately stable to hydrolysis under normal
environmental conditions. At 20 C, the calculated half-life was 200 days at pH 5
and 7 and 115 days at pH 9. (MRID 00104493)
2. Photodegradation in water
14C-Metalaxyl was photolytically stable in water when exposed to natural
sunlight, with a half-life of 400 days. Less than 10 percent of the material
photolyzed during the 28 day test period. The major degradation product, N-
2,6-dimethylphenyl-N-methoxyacetyl-alanine (CGA-62826) was found to
comprise 5.7 percent of the applied product in the day 14 irradiated sample and
6.1 percent in the 28 day sample. Total radiocarbon remaining as metalaxyl was
88.5 percent for the irradiated samples and 89.9 percent for the dark controls.
(MRID 41156001)
3. Photodegradation in soil
Metalaxyl was stable to photodegradation in a silty loam soil exposed to a
xenon arc lamp. The results indicate no difference between the degradation of
the irradiated sample and the control sample. The study also demonstrated that
the residues degraded at a rate comparable to those found in the aerobic
metabolism study. (MRID 00100456)
4. Aerobic soil metabolism
The aerobic soil metabolism half-life of metalaxyl was determined to be
about 40 days. The major degradate, CGA-62826, was further broken down to
non-extractable material and C02. CGA-62826 accounted for up to 53.6 percent
of the applied material at 66 days and thereafter degraded to 23 percent at 360
days. At 12 months, metalaxyl parent accounted for less than 2 percent of the
applied material and nonextractable residues accounted for 38.3 percent. (MRID
00104494)
25
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5. Anaerobic soil metabolism
In aerobic soil, parent metalaxyl was degraded to 60 percent of the applied
material at 31 days after which anaerobic conditions were established. After 66
days, the parent declined to 49.4 percent and after 89 days it had declined to 32.5
percent. The major degradation product was CGA-62826 which accumulated to
54.4 percent of applied product after 89 days. C02 did not appear to be a major
degradate and non-extractable compounds did not exceed 10 percent of the
material applied. (MRID 00104494)
6. Anaerobic aquatic metabolism
Metalaxyl degraded in the anaerobic aquatic environment with a half-life of
26.9 days in soil with water, while the half-lives were 21.7 and 29.9 days,
respectively, in the sediment and water phases. Metalaxyl accounted for 96.4
percent (1.7 ppm) at the start of the study and decreased to 1.3 percent (0.02
ppm) after 100 days post-treatment and was not detected after that time. CGA-
62826 increased up to 85.5 percent at 265 days after treatment and then decreased
to 48.0 percent by study termination at day 385. The metabolite, N-3-hydroxy-
2,6-dimethylphenyl-N-methoxyactyl-L-alanine (CGA-119857) accounted for up to
16.3 percent at the end of the study, while C02 accounted for only 1.4 percent
(0.02) ppm) of the applied radioactivity. (MRID 42259801)
7. Aerobic aquatic metabolism
Metalaxyl degraded in the aerobic aquatic environment with a half-life of
55.11 days in soil with water. The reported half-lives were approximately 70 and
41 days, respectively, in the sediment and water phases. Parent metalaxyl
(65.36%) and CGA-62826 (20.56%) were the only major metalaxyl residues
found in soil and water extracts after 30 days of incubation. Unextractable
residues accounted for 3.47 percent, while C02 was less than 0.5 percent of the
applied radioactivity.
This study was found to be unacceptable because data related to the
concentration of metalaxyl in the sediment or water individually were not
provided. (MRID 422590802)
8. Leaching and adsorption/desorption
In unaged leaching studies, parent 14C-metalaxyl leached rapidly in sandy
soil with up to 92 percent of the radioactivity recovered in the leachate. In sandy
clay loam and silt loam soils, the majority of the radioactivity was recovered in
the 6 to 24 cm soil layers with less than 0.6 percent in the leachates.
26
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In aged leaching studies, 79.2 percent of the applied radioactivity was found
in the leachate and 16.1 percent remained in the soil in the sandy soil column. Of
the activity found in the leachate, 56 percent was parent, 31 percent was CGA-
62826, and 12 percent was unidentified. In the silt loam soil, 48.7 percent was
in the leachate and 34.9% remained in the column. Approximately 70 percent of
the radioactivity found in the leachate was parent, 18 percent was CGA-62826
and 11 percent was unidentified.
Adsorption/desorption studies using radiolabeled metalaxyl demonstrate
partition coefficient, Kd values of 0.43, 0.48, 0.87 and 1.40 for sandy, sandy
loam, silt loam and sandy clay loam soil. (MRIDs 00100464, 00100465,
00100466)
9. Volatility
Volatilization studies demonstrated that less than 5 percent of the applied
metalaxyl would be lost due to volatilization, and that volatilization is not a major
route of metalaxyl dissipation. (MRID 00100455)
10. Terrestrial Field Dissipation
At the present time, none of the submitted field dissipation studies
completely satisfy the data requirements for field dissipation for terrestrial uses.
However, the Agency believes that little will be gained from the submission of
additional field dissipation studies. Field studies demonstrate that metalaxyl and
its primary degradate CGA-62826, are capable of leaching to the 36 to 48 inch
soil depth. Groundwater and drinking water monitoring studies demonstrate that
metalaxyl and CGA-62826 have the potential to reach groundwater. Furthermore,
there are sufficient data to demonstrate that the primary routes of dissipation are
leaching, aerobic soil metabolism and plant uptake. The reported half-lives of
metalaxyl at the various field locations, where the studies were considered
supplemental, varied from 14 to 56 days.
The field dissipation half-lives determined from four previously reviewed
field dissipation studies were approximately 27, 36, 148 and 296 days (although
the data in the latter two studies were too variable to accurately assess the
dissipation).
Three other field dissipation studies produced the following results:
1. In one study, metalaxyl dissipated with a half-life of 56 days from
the upper 6 inches of bareground plots of loamy sand soil in California after
a broadcast application of metalaxyl (Ridomil 2E, 2 Ibs/gallon EC) at 8 Ibs
Al/acre. The degradate, CGA-62826, was detected in the 0 to 6 inch soil
27
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depth at all sampling intervals. Metalaxyl and CGA-62826 leached to the
36 to 48 inch soil depth; leaching correlated with significant amounts of
irrigation water applied to the plots. This study is scientifically sound, but
does not meet guideline requirements because adequate freezer storage
stability data were not provided. (MRID 41765001)
2. In the second study, metalaxyl dissipated with a half-life of 50
days from the upper 6 inches of plots of sandy loam soil in a California
citrus grove following the last of three applications (3-month intervals) of
metalaxyl (Ridomil 2E, 2 Ib/gallon EC) at 4.4 Ibs Al/acre (13.2 Ibs Al/acre
total). The degradate, CGA-62826, was detected in the 0 to 6 inch soil
depth at most sampling intervals. Metalaxyl leached to the 24 to 36 inch
soil depth and CGA-62826 leached to the 36 to 48 inch soil depth. This
study is scientifically sound, but does not meet guideline requirements
because adequate freezer storage stability data were not provided. (MRID
41765002)
3. In the last study, metalaxyl dissipated with half-lives of 38 to 39
days from the upper 6 inches of bareground and cropped tobacco plots of
loamy sand soil in North Carolina after a single broadcast application of
metalaxyl (Ridomil 2E, 2 Ib/gallon EC) at 4.3 Ibs Al/acre. The degradate,
CGA-62826, was detected in the 0 to 6 inch soil depth at most sampling
intervals. Metalaxyl and CGA-62826 leached to the 36 to 48 inch soil
depth; however, leaching patterns were confounded with apparent
contamination during sampling. This study is scientifically sound, but does
not meet guideline requirements because the patterns of leaching of
metalaxyl and CGA-62826 were confounded by an apparent problem with
contamination during sampling; and adequate freezer storage stability data
were not provided. (MRID 41809301)
11. Aquatic field dissipation
Metalaxyl dissipated from rice paddy water with calculated half-lives of 5
and 20 days and from soil with half-lives of 11 and 24 days. The studies were
not acceptable because soil samples containing metalaxyl and its major degradate,
CGA-62826, were stored frozen for up to 436 days before analysis and storage
stability experiments were performed for only up to 180 days. The study is
scientifically sound but does not meet guideline requirements because adequate
storage stability data were not provided. (MRIDs 42259803, 422590804)
12. Accumulation in fish
In a 2 9-day flow-through study in which bluegill sunfish were exposed to a
metalaxyl concentration of 1 ppm, bioaccumulation factors of less than or equal
28
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to 7 were reported in whole fish. Bioaccumulation in edible and non-edible
tissues ranged from 0.60 to 0.98 and 3.25 to 14.65, respectively. Residues
declined rapidly during depuration. In another accumulation study with catfish,
bioaccumulation factors were below Ix in the edible, non-edible and whole fish
portions at all exposure sampling times. Greater than 80 percent of the residues
were recovered after 14 days of depuration. (MRIDs 00100468, 00100470)
b. Environmental Fate Assessment
Based on a review of all studies submitted, metalaxyl was found to be
moderately stable under normal environmental conditions. At 20 C the
calculated hydrolytic half-life was 200 days at pH 5 and 7, and 115 days at
pH 9. Metalaxyl was photolytically stable in water when exposed to natural
sunlight, with a half-life of 400 days, and less than 10 percent of the
material photolyzed during the 28-day test period. Studies indicate that
metalaxyl is stable to photodegradation on soil, with test results
demonstrating no difference between the irradiated sample and the control
sample. The aerobic soil metabolism half-life is determined to be about 40
days. In aquatic systems, metalaxyl degrades moderately rapidly under both
aerobic and anaerobic conditions. Finally, studies indicate that less than 0.5
percent of the applied metalaxyl would be lost to volatilization.
Metalaxyl and its degradates readily leach in sandy to sandy clay
loam, soils low in organic matter. It is considered to be a strong leacher
because 57 and 92 percent of the applied material was detected as parent in
leachates from two unaged 30-cm soil columns. In an aged leaching study
conducted with sandy soil, approximately 44 percent of the material applied
was found to be parent metalaxyl and 34 percent was CGA-62826. In an
aged leaching study with silty loam soil, the percent of parent and CGA-
62826 identified were 57 and 92, respectively.
Under field and laboratory conditions, the soil half-life of metalaxyl
ranged from 14 to 56 days. In two aquatic field dissipation studies,
metalaxyl dissipated from rice paddy water with half-lives of 5 and 20 days,
and from soil with half-lives of 11 and 24 days. The major degradation
product formed in the field studies was CGA-62826.
The Agency concludes that the primary routes of dissipation of
metalaxyl in surface soil appear to be aerobic soil metabolism, leaching and
plant uptake. In aquatic systems, such as rice culture, the Agency can only
tentatively identify a route of dissipation because the compound is stable to
hydrolysis, photolysis in water and soil and does not volatilize appreciably.
However, metalaxyl degrades moderately rapidly under aerobic aquatic and
anaerobic aquatic conditions, which are probably the main routes of
29
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dissipation in aquatic systems together with leaching, surface mobility and
plant uptake. Sensitized aqueous photodegradation, where absorbed light
energy could accelerate aqueous photodegradation, may also be important in
dissipation of metalaxyl and residues from aquatic systems.
Both laboratory and field studies indicate that metalaxyl is persistent
and mobile and will leach in many soils. Although metalaxyl has been
found to be less stable in the field than in laboratory studies, available field
and aquatic studies demonstrate that metalaxyl is mobile under normal use
conditions. In light of these concerns, the December 1981 Registration
Standard required the completion of groundwater monitoring studies for
metalaxyl. In 1988, the Agency required that retrospective studies be
conducted for metalaxyl because of its wide use as a pesticide and also due
to the potential for metalaxyl and its major degradate, CGA-62826 to reach
groundwater. Because the Agency has determined that sufficient data are
available to regulate metalaxyl and that additional groundwater studies were
not necessary, the requirement for retrospective groundwater monitoring
studies was placed on reserve in 1993.
Monitoring data demonstrate that metalaxyl and its primary degradate,
CGA-62826 have the potential to reach groundwater. Metalaxyl has been
detected in ground water in five states at levels typically ranging up to 3
ppb. Concentrations have been reported as high as 236 ppb, but
concentrations this high are not likely to be the result of normal field use.
Although metalaxyl does not pose a threat to nontarget species, it does
exceed the Level of Concern (LOG) for groundwater quality based on the
Agency's groundwater criteria for mobility and persistence.
Fish accumulation studies indicate that parent metalaxyl
bioaccumulation factors (BCF) in whole fish of less than or equal to 7X
were found when bluegill sunfish were exposed to 1 ppm 14C-metalaxyl in a
continuous flow-through system for 29 days. Fish accumulation did not
exceed seven fold when fish were exposed to metalaxyl at 1 ppm in water,
and residues were found to accumulate in the nonedible portions over the
edible portions in a ratio of about 4:1 to 15:1. Residues declined rapidly
during depuration. In addition, a separate fish accumulation study using
catfish showed accumulation of one fold and rapid depuration.
2. Ecological Effects
The ecotoxicological data base is essentially complete for
reregistration purposes. Available studies are adequate to characterize the toxicity
of metalaxyl to most nontarget terrestrial organisms and to aquatic species when
30
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used on terrestrial food, feed and nonfood sites. However, the Agency has
determined that avian reproduction studies are now required to assess the chronic
risk of metalaxyl to birds.
a. Ecological Effects Data
(1) Terrestrial Data
Avian Acute Toxicity
Avian Acute Oral Toxicity Findings
Species
Mallard duck
%Test
Material
(TGAI)
96.9
LD50
1466 mg/kg
Conclusions
slightly toxic
These results show that metalaxyl is slightly toxic to birds on an acute
basis. (MRID 00077334)
Avian Subacute Dietary Toxicity
Avian Subacute Dietary Toxicity Findings
Species
Bobwhite Quail
Mallard Duck
Japanese Quail
% Test
Material
96.9
96.9
tech.
^^50
> 10,000 ppm
> 10,000 ppm
> 10, 000 ppm
Conclusions
practically nontoxic
practically nontoxic
practically nontoxic
On a subacute dietary basis, metalaxyl has been characterized as being
practically non-toxic to avian species. (MRIDs 00077335, 00063989, 00063988).
Avian Reproduction
Avian reproduction studies are required when birds may be exposed
repeatedly or continuously through persistence, bioaccumulation, or multiple
applications, or if mammalian reproduction tests indicate reproductive hazard.
-------
There are no avian reproduction studies in the current metalaxyl database.
These studies had not been previously required because of the low acute toxicity
of metalaxyl. Although the Agency has no evidence to indicate that metalaxyl
may cause reproductive effects in birds, these studies are now required because
(1) new scientific knowledge indicates that subtle effects, that may not be evident
from acute testing, may occur from chronic exposure to some chemicals and (2)
present product labeling of metalaxyl allows several applications of the end-use
product per growing season. These studies are now required to assess the chronic
risk of metalaxyl to birds.
Toxicity to Nontarget Mammals
As stated in Section III, B, 1, the acute oral LD50 value in rats was found to
be 669 mg/kg indicating that metalaxyl is slightly toxic to wild mammals.
(MRID 00063990)
(2) Aquatic Data
Acute Freshwater Fish Toxicity
Freshwater Fish Acute Oral Toxicity Findings
Species
Rainbow trout
(2 studies)
Bluegill sunfish
(2 studies)
% Test Material
(TGAI)
95.1
94.4
94.4
95.1
L-^50
132 mg/L
130 mg/L
150 mg/L
139 mg/L
Conclusions
practically non-
toxic
practically non-
toxic
The results of the 9 6-hour acute toxicity studies indicate that metalaxyl can
be characterized as being practically non-toxic to both cold and warm water fish.
(MRIDs 00071303, 00100447, 00100446, 00071302)
32
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Acute testing with the formulated product
Freshwater Fish Acute Testing with the Formulated Product
Species
Bluegill
Rainbow trout
% A.I.
27.9
27.9
Result EC50
27 mg/L
18.4 mg/L
Conclusion
slightly toxic
slightly toxic
The results of the 9 6-hour EC 50 studies indicate that metalaxyl can be
characterized as slightly toxic to freshwater fish. (MRIDs 00071301, 00072396).
Chronic Test-Early Life Stage
Chronic Test-Early Life Cycle
Species
Fathead minnow
% A.I.
90.1
NOEC
9.1 mg/L
The highest concentration tested was 9.1 mg/L. Due to 90-100%, survival
the NOEC was established at 9.1 mg/L. (MRID 00071308).
Freshwater Invertebrate Toxicity
Acute Freshwater Invertebrate Toxicity
Freshwater Invertebrate Toxicity Findings
Species
Daphnia magna
% Test
Material
(TGAI)
95.1
96.9
94.4
LC50
121 mg/L
29 mg/L
28 mg/L
Conclusions
slightly toxic
slightly toxic
slightly toxic
There is sufficient information to characterize metalaxyl as slightly toxic to
aquatic invertebrates. (MRID 00100448, 00071306, 00063986)
33
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Acute testing with the formulated product
Acute Toxicity Findings on the End-Use Formulation
Species
Daphnia magna
% A.I. formulated
27
LC50
12 mg/L
Conclusion
slightly toxic
There is sufficient information to characterize the formulated product of
metalaxyl as slightly toxic to freshwater aquatic invertebrates. (MRID 00071304)
Chronic Test-life cycle
Chronic Test-Life Cycle
Species
Daphnia magna
% A.I.
90.1
Results
NOEC 1.2 7 mg/L
LOEC 2.70 mg/L
MATC 1.85 mg/L
Based on the data submitted, the No Observable Effect Concentration
(NOEC) was established at 1.27 mg/L; the Lowest Observable Effect
Concentration (LOEC) at 2.70 mg/L; and the Maximum Allowable Tolerated
Concentration (MATC) at 1.85 mg/L. (MRID 0071307)
Estuarine/Marine Toxicity
Estuarine/Marine Acute Toxicity Findings
Species
Mysidopsis bahia
(shrimp)
Crassostrea virginica
(oyster)
Mysidopsis bahia
Crassostrea virginica
% Test
Material
96.1
96.1
25.0
25.0
LC50
25.7 ppm
4.6 ppm
5.98 ppm
4.4 ppm
Conclusions
slightly toxic
moderately toxic
moderately toxic
moderately toxic
34
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There is sufficient information to characterize technical metalaxyl as slightly
toxic to mysid shrimp and the 25 % formulated product as moderately toxic to
mysid shrimp. Both formulated and technical metalaxyl were found to be
moderately toxic to the Eastern oyster. (MRIDs 41288101, 41288102, 41288103,
41288104, 41855801, 42378101, 42337501)
(3) Non-Target Insect Data
Nontarget Insect Acute Contact Toxicity Findings
Species
Apis mellifera
(honeybee)
%Test
Material
27.0
LD50
> lOOug/bee
Conclusion
practically non-toxic
There is sufficient information to characterize metalaxyl as practically non-
toxic to bees. (MRID 40276701).
(4) Non-Target Plants Data
Aquatic Plant Toxicity Findings
Species
Selenastrum capricornutum
(algae)
Lemna gibba
(duckweed)
% A.I.
90
90
EC50
140 ppm
92 ppm
Metalaxyl with an EC50 of 140 ppm (cells/ml) is not expected to exert a
detrimental effect on the alga Selenastrum at application rates up to 3.0 Ibs
Al/acre. Metalaxyl with an EC50 of 92 ppm (frond counts) is not expected to
exert a detrimental effect on duckweed at application rates up to 3.0 Ibs Al/acre.
(MRID 00148448)
b. Ecological Effects Risk Assessment
Metalaxyl is registered for numerous use sites. Exposure to non-target
organisms may result from direct applications, spray drift and/or runoff
from treated areas.
35
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1. Risk to Terrestrial Animals
a. Nontarget insects
Nontarget insects will be exposed to metalaxyl based on the end-use
product's terrestrial food and nonfood use patterns. For nontarget insects,
the honeybee or Apis mellifera is the representative test species; with an
acute contact LD50 value of greater than 100 pig/bee, metalaxyl is practically
nontoxic to honeybees.
b. Avian and mammalian species
Avian and mammalian species will be exposed to metalaxyl through
the consumption of insect and plant food material containing metalaxyl
residues. The criterion for the presumption of high risk from exposure for
acute avian and mammalian species is a value greater than or equal to 0.5
for the quotient of the estimated environmental concentration (EEC) divided
by the lowest LD50 value for birds and mammals; this is known as the risk
quotient (RQ).
Acute RQ = EEC/LC50 _>_ 0.5 for birds and mammals
Avian Acute Oral and Subacute Dietary Effects
Metalaxyl has been characterized as being practically non-toxic to
avian species on a dietary basis and slightly toxic on an acute, single dose
basis. Metalaxyl may be used in granular form or as a liquid formulation.
As a liquid formulation, the risk quotient of metalaxyl is the expected
environmental concentration (EEC) divided by the dietary LC50. For a
granular formulation, the risk quotient is the LD50 per square foot.
Granular Formulation (LD50/sq ft)
To calculate maximum mg ai/ft2 for a granular formulation with a
maximum application rate of 6.0 Ibs Al/acre, where 454,598 is the number
of milligrams per pound, and 43,560 are the number of square feet per
acre:
6.0 Ib ai/A x 454,590 mg/lb x 1 A/43,560 ft2 = 62.62 mg/ft2
The LD50 for the mallard duck is 1466 mg/kg. The average weight of
a mallard duck is 1.082 kg. To calculate the LD50 per square foot:
36
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62.62kg mg/ft2 =0.039 LD50/ ft2
1466mg/kg(1.082)
The risks to birds from exposure to granular metalaxyl was analyzed
by the above method, LD50 per square foot, to characterize acute risk.
When the LD50 per square foot value equals or exceeds 0.5, then the
pesticide is said to pose a high acute risk to birds. As the calculated value
is only 0.039, the risk from granular metalaxyl to exposed birds is minimal.
Nongranular Formulations (EEC/LC50)
Metalaxyl is registered as nongranular formulations for numerous use
sites. Exposure to nontarget organisms may result from direct application
spray drift and/or runoff from treated areas. The maximum expected
terrestrial residues based on a single application at different application rates
and on different categories of avian food items are presented in the
following table.
Application Rate (Ibs
AI/A)
0.141
0.332
0.903
l.O4
1.355
1.56
2.07
3.08
4.09
6.010
7.211
8.012
Short Grass
(ppm)
34
79
216
240
324
360
480
720
960
1440
1728
1920
Long Grass
(ppm)
15
36
99
110
149
165
220
330
440
660
792
880
Leaves and
Leafy
Crops
(ppm)
18
42
113
125
169
188
250
375
500
750
900
1000
Forage and
Insects
(ppm)
8
19
52
58
78
87
116
174
232
348
418
464
Seeds (ppm)
2
4
11
12
16
18
24
36
48
72
86
96
Fruits
(ppm)
1
2
6
7
10
11
14
21
28
42
50
56
1. broccoli, cabbage, cauliflower, cotton, cucumbers, melons, squash, onions, alfalfa, buckwheat, dill, cucumber 2. beans, lentils,
potatoes, avocados, raspberries, cotton, onions, cucurbits, barley, cole crops 3. hops, peas, soybeans, melons, ornamental turf, cotton,
forage and hay, brassica, spinach, rice, blueberries, tobacco 4. lettuce, peanuts, squash, ornamental plants, hops, strawberries 5.
soybeans, tomatoes, ornamental plants, cotton, vegetable bedding plants, onions, legume vegetables, lawn and turf 6. apples, cucurbits,
grapes, avocado, asparagus 7. spinach, pineapple, citrus, tomatoes, lettuce, legume vegetables, peanuts 8. tobacco, citrus, grapes,
herbaceous plants 9. apples, citrus, grapes, herbaceous plants 10. stone fruit, conifer trees, shrubs and vines 11. pome fruit, citrus trees
12. apples, citrus, stone fruit
37
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Acute dietary risk to birds from nongranular metalaxyl were analyzed by
comparing EEC's to the LC50 values. When the risk quotient (EEC/LC50) is at
least equal to 0.2, the chemical is a candidate for Restricted Use classification.
When the quotient is at least 0.5, the chemical is said to be a high acute risk to
birds. The EEC value for short grass based on the maximum application rate is
1920 ppm. The LC50 from the avian dietary studies were shown to be in excess of
10,000 ppm. If the LC50 were estimated as 5 times the no mortality level (criteria
for no risk is based on an EEC less than the LC50/0.2), then the estimated LC50
would be 50,000 ppm. The quotient of the EEC/LC50 (1920 ppm/50,000 ppm) is
significantly less 0.2 and 0.5. Therefore, it can be concluded that there are
minimal risks to birds from dietary exposure to metalaxyl.
Avian Chronic Risk
Chronic risk cannot be determined as there are no avian reproduction
studies for metalaxyl. Due to its widespread use (registered on over 100
agricultural crops), multiple applications, and persistence in the field, these
studies are needed.
Mammalian Risk
This small mammal risk assessment is based on a sole toxicity test using
laboratory rats. The test resulted in a rat LD50 value of 669 mg/kg which
indicates that metalaxyl is slightly toxic to small mammals. Due to this low
toxicity metalaxyl is not expected to present a risk to small mammals.
38
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2. Risk to Aquatic Animals
Estimated aquatic environmental concentrations were calculated and are
presented in the following table.
Application Rate
(Ibs Al/acre)
0.14
0.33
0.90
1.0
1.4
1.5
2.0
3.0
4.0
6.0
7.2
8.0
EEC Ground1 Application
(ppb)
0.85
2.01
5.49
6.10
8.24
9.15
12.2
18.3
24.4
36.6
43.9
48.8
EEC Aerial2 Application
(ppb)
0.94
2.23
6.04
6.71
9.06
10.07
13.2
20.1
26.8
40.3
48.3
53.7
EEC Direct3 Application
(ppb)
8.54
20.13
54.90
61.00
82.35
91.50
122.0
183.0
244.0
366.0
439.2
488.0
1. The total aquatic EEC from a 10-acre field treated by unincorporated ground application and draining into a 6-foot deep one acre water body. 2.
The total loading from both runoff (1%) and drift (5%) of a 10-acre field treated by aerial application and draining into a 6 foot deep one acre
water body. Aerial application includes mist blowers. 3. A single inadvertent direct application to a 6 foot deep one acre water body.
Acute Aquatic Risk
The Risk Quotients (RQ) are calculated by comparing the EEC values
for ground and aerial applications to the lowest LC50 values for freshwater
and estuarine fish and invertebrates for technical and formulated metalaxyl.
When the RQ's equal or exceed the levels of concern (LOG) the associated
risk can be presumed:
LOG Risk Presumption
0.5 high acute risk
0.1 Restricted Use
0.05 risk to endangered species
The following RQ's were calculated for ground and aerial applications for
freshwater and estuarine fish and invertebrates.
39
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Organism
Freshwater fish
technical
formulate
Daphnia
technical
formulate
Mysid
technical
formulate
Oyster
formulate
Ground Application
0.0004
0.003
0.002
0.004
0.002
0.008
0.011
Aerial Application
0.0004
0.003
0.002
0.005
0.002
0.009
0.012
As the RQ's are below the levels of concern, there are minimal risks to non-
endangered and endangered freshwater and estuarine species.
Chronic Aquatic Risk
When the risk quotient of the EEC/NOEC is less than 1.0, it is
presumed that the chemical will not pose a high chronic risk. Metalaxyl
can be applied on many of the registered crops up to four times per season.
As it is persistent, the maximum residues from ground and aerial
application are 0.193 ppm ground application and 0.213 ppm aerial
application. As these residue levels are below the NOEC of 9.1 mg/L from
the fathead minnow chronic study, chronic risks to freshwater fish are
minimal.
Risk to Aquatic Plants
The risk to aquatic plants is determined by comparing the EEC's from
ground and aerial applications to the EC50 values for duckweed and algae. As the
highest EEC's, 48.8 ppb and 53.7 ppb, respectively, are less than the EC50 values
of 92 and 140 ppm, metalaxyl is not expected to adversely affect aquatic plants.
Risk to Endangered Species
The registered uses of metalaxyl do not present an acute hazard to
endangered terrestrial and aquatic animals or plant species. If the Agency
discovers a chronic problem after reviewing the required avian reproductive
studies, then this issue will be revisited.
40
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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 metalaxyl as the active ingredient. The
Agency has completed its review of these generic data, and has determined that with
the exception of avian reproduction studies, data are sufficient to support reregistration
of all products containing metalaxyl. Although the Agency was unable to conduct a
chronic avian risk assessment due to lack of avian reproduction studies, the Agency has
decided that metalaxyl can be reregistered. However, the Agency will require avian
reproduction studies and take appropriate action after reviewing the results.
Appendix B identifies the generic data requirements that the Agency reviewed as
part of its determination of reregistration eligibility of metalaxyl, 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 metalaxyl and to
determine that metalaxyl can be used without resulting in unreasonable adverse effects
to humans and the environment. The Agency therefore finds that all products
containing metalaxyl as the active ingredients are eligible for reregistration. The
reregistration of particular products is addressed in Section V of this document.
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 metalaxyl 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
metalaxyl, 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 ingredient metalaxyl, the
Agency has sufficient information on the health effects of metalaxyl and on its potential
for causing adverse effects in fish and wildlife and the environment. Based on this
information, the Agency concludes that products containing metalaxyl for all uses are
eligible for reregistration.
The Agency has determined that metalaxyl products, labeled and used as specified
in this Reregistration Eligibility Decision, will not pose unreasonable risks or adverse
41
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effects to humans or the environment. 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.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of metalaxyl are eligible for
reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for
metalaxyl. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1. Tolerance Reassessment
The Agency is requiring that the chemical name of the metalaxyl
metabolite, N-(2-hydroxymethyl-6-methyl) -N-(methoxyacetyl) alanine
methyl ester, currently included in the tolerance expression in 40 CFR
180.408 (a) and (c), 185.40000 (a), and 186.40000 (a) be replaced by N-(2-
hydroxymethyl-6-methylphenyl)-N-(methoxyacetyl) alanine methyl ester.
Tolerances Listed Under 40 CFR § 180.408 (a):
The tolerances listed in 40 CFR § 180.408(a) are for the combined
residues of metalaxyl and its metabolites containing the 2,6-dimethylaniline
moiety, and iV-(2-hydroxy methyl-6-methylphenyl) -N-(methoxyacetyl) -
alanine methylester, each expressed as metalaxyl.
Sufficient data are available to ascertain the adequacy of the
established tolerances listed in 40 CFR § 180.408(a) for the following
commodities: alfalfa, almonds, apples, asparagus, avocados, blueberries,
broccoli, cabbage, cauliflower, cereal grains (excluding wheat, barley, and
oats) group, citrus fruits group, cranberries, cucurbit vegetables group,
fruiting vegetables (except cucurbits) group, ginseng, grapes, leafy
vegetables (excluding brassica) group, leaves of root and tuber vegetables
group, legume vegetables (succulent or dried group, excluding soybeans),
foliage of legume vegetables group, onions (bulb and green), peanuts,
pineapples, potatoes, raspberries, root and tuber vegetables (excluding
ginseng) group, soybeans, spinach, stone fruits group, strawberries,
sunflowers, and walnuts.
42
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The established tolerances for green hops (0.2 ppm), peanut vines (20
ppm), and pineapple forage and fodder (0.1 ppm) should be revoked as
these are no longer regulated raw agricultural commodities (RAC).
The established tolerances for beets (0.1 ppm), potatoes (0.5 ppm),
and sugar beets (0.1 ppm and 0.5 ppm) should be revoked as these
commodities are covered by the established root and tuber vegetable group
tolerance (0.5 ppm). The established root and tuber group should exclude
ginseng which has an established 3.0 ppm tolerance. In addition, the
established tolerances for beet tops (0.1 ppm) and sugar beet tops (10.0
ppm) should be revoked as they are covered under the established crop
group tolerance for leaves of root and tuber vegetables (15.0 ppm).
The established tolerance of 0.1 ppm for the Brassica (cole) leafy
vegetable group (excluding broccoli, cabbage, and cauliflower) should be
revoked as this tolerance was established to cover residues resulting from
seed treatments which are no longer registered uses. Separate tolerances
will be required for each member of the Brassica leafy vegetable group,
because of the greater than five fold difference in residue levels. The
available residue data indicate that the established tolerances for cabbage
and cauliflower (2 ppm) should be lowered to 1 ppm.
A petition (PP#OF3893) proposing a crop group tolerance for leafy
vegetables (except Brassica, excluding spinach) has been submitted.
Sufficient data have been submitted to ascertain the adequacy of the pending
tolerances. The established tolerance for the leafy vegetables group
(excluding Brassica) should be increased from 0.1 ppm to 5 ppm and the
group should be renamed to also exclude spinach. Once the increased
tolerance is established, the established tolerance for head lettuce (5 ppm)
should be revoked.
A petition (PP#1F3993) for crop group tolerances for the cereal
grains group (excluding wheat, barley, and oat) and the forage, fodder, and
straw of cereal grain group (excluding wheat, barley, and oat) has been
submitted. Sufficient data have been submitted to ascertain the adequacy of
the pending tolerances. A 0.1 ppm tolerance must be established for the
cereal grains group (excluding wheat, barley, and oats), and a tolerance of
1.0 ppm must be established for the forage, fodder, and straw of cereal
grains group (excluding wheat, barley, and oats).
Additional data are required to support the 0.1 ppm tolerances for
cottonseed. Additional data and a tolerance proposal are required for cotton
gin byproducts.
43
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The adequacy of the established tolerances for meat, fat, and meat
byproducts of cattle, goats, horses, sheep and poultry and for milk and eggs
will be determined once questions pertaining to the analytical method are
resolved and the submitted ruminant feeding studies are re-evaluated.
Tolerances Listed Under 40 CFR § 180.408(b):
The tolerances listed in 40 CFR § 180.408(b) are for the indirect or
inadvertent residues of metalaxyl present as a result of the application of
metalaxyl to the growing of the primary crops listed in 40 CFR §
180.408(a) and tobacco.
Sufficient data are available to ascertain the adequacy of the
established indirect or inadvertent tolerances listed in 40 CFR § 180.408(b).
Additional field rotational crop studies have been submitted and are
currently under review.
Tolerances Listed Under 40 CFR § 180.408(c):
The tolerance listed in 40 CFR § 180.408(c) are with regional
registration for the combined residues of metalaxyl and its metabolites
containing the 2,6-dimethylaniline moiety, and iV-(2-hydroxy methyl-6-
methylphenyl)-iV-(methoxyacetyi)-alanine methylester, each expressed as
metalaxyl in/on papaya in HI.
Sufficient data are available to ascertain the adequacy of the
established tolerances listed in 40 CFR § 180.408(c) for papaya.
Tolerances Listed Under 40 CFR § 185.4000(a):
The food additive tolerances listed in 40 CFR § 185.4000(a) are for
the combined residues of metalaxyl and its metabolites containing the 2,6-
dimethylaniline moiety, and iV-(2-hydroxy methyl-6-methylphenyi)-iV-
(methoxyacetyl)-alanine methylester, each expressed as metalaxyl.
Sufficient data are available to ascertain the adequacy of the
established food additive tolerances listed in 40 CFR § 185.4000(a) for the
following food commodities: citrus oil, dried prunes, raisins, potatoes
processed (including potato chips), and tomato puree.
The established tolerance for dried apricots (4 ppm) should be
revoked as it is not a regulated commodity.
44
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A 2.0 ppm food additive tolerance for potato granules/flakes and
potato chips should be proposed. Once these tolerances are established, the
food additive tolerance of 4.0 ppm for potatoes, processed (including potato
chips) should be revoked. Additional data and a tolerance proposal (if
needed) are required for tomato paste.
Tolerances Listed Under 40 CFR § 185.4000(b):
The food additive tolerances listed in 40 CFR § 185.4000(b) are for
the indirect or inadvertent residues of metalaxyl present as a result of the
application of metalaxyl to the growing of the primary crops listed in 40
CFR § 180.408(a) and tobacco.
Sufficient data are available to ascertain the adequacy of the
established inadvertent or indirect tolerances listed in 40 CFR §
185.4000(b). Additional field rotational crop studies have been submitted
and are currently under review.
Tolerances Listed Under 40 CFR § 185.4000(d):
The food additive tolerance listed in 40 CFR § 185.4000(d) is for the
combined residues of metalaxyl and its metabolites containing the 2,6-
dimethylaniline moiety, and JV-(2-hydroxymethyl-6-methylphenyl)-iV-
(methoxyacetyl) alanine methylester, each expressed as metalaxyl.
Sufficient data are available to ascertain the adequacy of the
established food additive tolerance listed in 40 CFR § 185.4000(d) for dried
hops. However, as the regulated RAC for hops is now considered to be
dried hops [Source: PR Notice 93-12 (12/23/93)], the 20 ppm tolerance for
hops, dried should be moved to 40 CFR §180.408(a).
Tolerances Listed Under 40 CFR § 186.4000(a):
The feed additive tolerances listed in 40 CFR § 186.4000(a) are for
the combined residues of metalaxyl and its metabolites containing the 2,6-
dimethylaniline moiety, and iV-(2-hydroxy methyl-6-methylphenyi)-iV-
(methoxyacetyl)-alanine methylester, each expressed as metalaxyl.
Sufficient data are available to ascertain the adequacy of the
established feed additive tolerances listed in 40 CFR § 186.4000(a) for the
following feed commodities: apple pomace (wet), citrus molasses and dried
pulp, grape pomace (wet and dried), peanut meal, processed potato waste,
raisin waste, soybean hulls and meal, sugar beet molasses, and tomato
pomace (dried).
45
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The tolerance for potato waste, dried, processed should be increased
from 4.0 ppm to 10 ppm and renamed potatoes, waste from processing.
The tolerance for sugar beet molasses should be increased from 1.0 ppm to
5.0 ppm concomitant with the revocation of the 5.0 ppm for indirect or
inadvertent residues in sugar beet molasses listed under 40 CFR 186.4000
The established 2.0 ppm tolerances for apple pomace (dry), hops
(dry), peanut soapstock, and soybean soapstock and the 5.0 ppm tolerance
for legume vegetable cannery waste should be revoked as these commodities
are no longer being regulated because they are not considered major
livestock feed items.
Feed additive tolerances must be proposed and established for
pineapple process residue (0.5 ppm) and sunflower meal (0.2 ppm).
Tolerances Listed Under 40 CFR § 186.4000(b):
The feed additive tolerances listed in 40 CFR § 186.4000(b) are for
the indirect or inadvertent residues of metalaxyl present as a result of the
application of metalaxyl to the growing of the primary crops listed in 40
CFR § 180.408(a) and tobacco.
Sufficient data are available to ascertain the adequacy of the
established indirect or inadvertent tolerances listed in 40 CFR §
186.4000(b) for the following feed commodities: barley, oats, and wheat,
milling fractions.
The indirect or inadvertent tolerance for sugar beet molasses of 5 ppm
should be revoked as the need for this tolerance is superseded by the 5 ppm
tolerance for this commodity in 40 CFR §186.4000(a).
Tolerances Listed Under 40 CFR § 186.4000(d):
The tolerances listed in 40 CFR § 186.4000(d) are for the combined
residues of metalaxyl and its metabolites containing the 2,6-dimethylaniline
moiety, and A/'-(2-hydroxymethyl-6-methylphenyl)-A/'-(methoxyacetyl) alanine
methylester, each expressed as metalaxyl.
The 20 ppm tolerance for spent hops should be revoked as residues in
spent hops will be covered by the 20 ppm tolerance on the RAC (hops,
dried).
46
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The reassessment of the established tolerances is set forth in the
Tolerance Reassessment Table as follows.
Tolerance Reassessment Summary for Metalaxyl
Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/Correcf
Commodity Definition
Tolerances listed under 40 CFR §180.408(a)
Alfalfa, forage
Alfalfa, hay
Almonds
Almonds, hulls
Apples
Asparagus
Avocados
Beets
Beet, top
Blueberries
Brassica (cole) leafy
vegetables group
[excluding broccoli,
cabbage, and cauliflower]
Broccoli
Cabbage
Cauliflower
Cattle, fat
Cattle, kidney
Cattle, liver
Cattle, meat
Cattle, meat byproduct
(excluding kidney and
liver)
Citrus fruit
6.0
20.0
0.5
10.0
0.2
7.0
4.0
0.1
0.1
2.0
0.1
2.0
2.0
2.0
0.4
0.4
0.4
0.05
0.05
1.0
6.0
20.0
0.5
10.0
0.2
7.0
4.0
Revoke
Revoke
2.0
Revoke
2.0
1.0
1.0
To be determined
1.0
Established 0. 1 ppm tolerance
was based on seed use which has
been superseded by preplant and
foliar uses. In addition, use is
covered by 0.5 ppm crop group
tolerance for root and tuber
vegetables (exc. ginseng).
Tolerance covered by 15.0 ppm
crop group tolerance for leaves of
root and tuber vegetables.
Separate tolerances are required
for each member of the Brassica
vegetable crop group for which
metalaxyl use is registered.
Depending on the results of
required analytical method and
storage stability data, additional
data may be required.
Citrus fruits group
47
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Commodity
Cottonseed
Cranberry
Cucurbit vegetables group
Eggs
Fruiting vegetables
(excluding cucurbits)
group
Ginseng
Goats, fat
Goats, kidney
Goats, liver
Goats, meat
Goats, meat byproduct
(excluding kidney and
liver)
Grain, crops
Grapes
Grasses, forage
Hogs, fat
Hogs, kidney
Hogs, liver
Hogs, meat
Hogs, meat byproduct
(excluding kidney and
liver)
Hops, green
Horses, fat
Horses, kidney
Horses, liver
Horses, meat
Current Tolerance
(ppm)
0.1
4.0
1.0
0.05
1.0
3.0
0.4
0.4
0.4
0.05
0.05
0.1
2.0
0.1
0.4
0.4
0.4
0.05
0.05
2.0
0.4
0.4
0.4
0.05
Tolerance
Reassessment (ppm)
To be determined
4.0
1.0
To be determined
1.0
3.0
To be determined
To be determined
0.1
2.0
0.1
To be determined
Revoke
To be determined
Comment/Correcf
Commodity Definition
Cotton, undelinted seed
Additional residue data are
required.
Cranberries
Depending on the results of
required analytical method and
storage stability data, additional
data may be required.
Depending on the results of
required analytical method and
storage stability data, additional
data may be required.
Depending on the results of
required analytical method and
storage stability data, additional
data may be required.
Cereal grains (exc. wheat, barley,
and oats).
Depending on the results of
required analytical method and
storage stability data, additional
data may be required.
Hops, green is no longer a
regulated RAC.
Depending on the results of
required analytical method and
storage stability data, additional
data may be required.
48
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Commodity
Horses, meat byproduct
(excluding kidney and
liver)
Leafy vegetables
(excluding brassica)
group
Lettuce, head
Leaves of root and tuber
vegetables (human food
or animal feed) group
Legume vegetable foliage
Legume vegetable group
(dry or succulent)
Milk
Onions, dry bulb
Onions, green
Peanut, hay
Peanut, vines
Peanut, nuts
Peanut, shells
Pineapples
Pineapple fodder
Pineapple forage
Potatoes
Poultry, fat
Poultry, kidney
Poultry, liver
Current Tolerance
(ppm)
0.05
0.1
5.0
15.0
8.0
0.2
0.02
3.0
10.0
20.0
20.0
0.2
2.0
0.1
0.1
0.1
0.5
0.4
0.4
0.4
Tolerance
Reassessment (ppm)
5.0
Revoke
15.0
8.0
0.2
To be determined
3.0
10.0
20.0
Revoke
0.2
2.0
0.1
Revoke
Revoke
Revoke
To be determined
To be determined
To be determined
Comment/Correcf
Commodity Definition
Leafy vegetables (exc. Brassica,
exc. spinach)
Tolerance will be covered by 5.0
ppm crop group tolerance for
leafy vegetables (exc. Brassica,
exc. spinach).
Legume vegetables group,
Foliage of
Legume vegetables (succulent or
dried) group, exc. soybeans
Depending on the results of
required analytical method and
storage stability data, additional
data may be required.
Peanut vines are no longer a
regulated RAC.
Peanuts, nutmeat
Peanuts, hulls (shells)
Pineapple fodder and forage are
no longer regulated RACs.
Tolerance covered by 0.5 ppm
crop group tolerance for root and
tuber vegetables (exc. ginseng).
Depending on the results of
required analytical method and
storage stability data, additional
data may be required.
Additional data may be required.
(Refer to poultry fat above).
Additional data may be required.
(Refer to poultry fat above).
49
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Commodity
Poultry, meat
Poultry, meat byproduct
(excluding kidney and
liver)
Raspberries
Root and tuber vegetables
group
Soybean, grain
Spinach
Sugar beets
Sugar beet (tops)
Sugar beet (roots)
Sheep, fat
Sheep, kidney
Sheep, liver
Sheep, meat
Sheep, meat byproduct
(excluding kidney and
liver)
Stone fruit group
Strawberries
Sunflowers
Sunflower, forage
Walnuts
Current Tolerance
(ppm)
0.05
0.05
0.5
0.5
1.0
10.0
0.1
10.0
0.5
0.4
0.4
0.4
0.05
0.05
1.0
10.0
0.1
0.1
0.5
Tolerance
Reassessment (ppm)
To be determined
To be determined
0.5
0.5
1.0
10.0
Revoke
Revoke
Revoke
To be determined
To be determined
To be determined
To be determined
To be determined
1.0
10.0
0.1
0.1
0.5
Comment/Correcf
Commodity Definition
Additional data may be required.
(Refer to poultry fat above).
Additional data may be required.
(Refer to poultry fat above).
Root and tuber vegetables (exc.
ginseng).
Soybeans
Tolerance covered by 0.5 ppm
crop group tolerance for root and
tuber vegetables (exc. ginseng).
Depending on the results of
required analytical method and
storage stability data, additional
data may be required.
Additional data may be required.
(Refer to sheep fat above).
Additional data may be required.
(Refer to sheep fat
above).
Additional data may be required.
(Refer to sheep fat above).
Additional data may be required.
(Refer to sheep fat above).
Stone fruits group
Sunflower, seed
Tolerances listed under 40 CFR §180.408(b)
Barley, grain
Barley, fodder
Barley, forage
Barley, straw
Oat, fodder
0.2
2.0
2.0
2.0
2.0
0.2
Revoke
2.0
2.0
Revoke
No longer regulated
No longer regulated
50
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Commodity
Oat, forage
Oat, grain
Oat, straw
Wheat, fodder
Wheat, forage
Wheat, grain
Wheat, straw
Current Tolerance
(ppm)
2.0
0.2
2.0
2.0
2.0
0.2
2.0
Tolerance
Reassessment (ppm)
2.0
0.2
2.0
Revoke
2.0
0.2
2.0
Comment/Correcf
Commodity Definition
Oats, forage
Oats, grain
Oats, straw
No longer regulated
Tolerances listed under 40 CFR §180.408(c)
Papaya
0.1
0.1
Food Additive Tolerances listed under 40 CFR §185.4000(a)
Apricots (dried)
Citrus, oil
Potatoes, processed
(including potato chips)
Prunes (dried)
Raisins
Tomatoes, processed
4.0
7.0
4.0
4.0
6.0
3.0
Revoke
7.0
Revoke
4.0
6.0
3.0
Dried apricots are not a regulated
commodity.
See potato granules/flakes and
potato chips below.
Grapes, raisins
Tomato, puree
Food Additive Tolerances listed under 40 CFR §185.4000(b)
Barley, milling fractions
Oat milling fractions
Wheat, milling fractions
1.0
1.0
1.0
1.0
1.0
1.0
Oats, milling fractions
Food Additive Tolerances listed under 40 CFR §185.4000(d)
Hops, dried
20.0
Move to 40 CFR
§180.408(a)
Hops, dried are now regulated as
aRAC
Feed Additive Tolerances listed under 40 CFR §186.4000(a)
Apple, pomace (dry)
Apple, pomace (wet)
Citrus, molasses
Citrus, pulp
Grape pomace (dry)
Grape pomace (wet)
Hops, dry
Legume vegetable,
cannery waste
2.0
0.4
7.0
7.0
10.0
10.0
2.0
5.0
Revoke
0.4
7.0
7.0
10.0
Revoke
Revoke
Revoke
Apple, pomace (dry) is no longer
produced as a significant
livestock feed.
Apple, pomace
Citrus, pulp, dried
Grapes, pomace, dried
Covered by 10 ppm tolerance on
Grapes, pomace, dried
Hops, dry is no longer a regulated
commodity.
Legume vegetable cannery waste
is no longer regulated.
51
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Commodity
Peanut, meal
Peanut, soapstock
Potato waste, dried,
processed
Raisin waste
Soybean, hulls
Soybean, meal
Soybean, soapstock
Sugar beet molasses
Tomato pomace (dry and
wet)
Current Tolerance
(ppm)
1.0
2.0
4.0
10.0
2.0
2.0
2.0
1.0
20.0
Tolerance
Reassessment (ppm)
1.0
Revoke
10.0
10.0
2.0
2.0
Revoke
5.0
20.0
Comment/Correcf
Commodity Definition
Peanuts, meal
Peanut soapstock is no longer a
regulated commodity.
Potatoes, waste from processing
Grapes, raisin waste
Soybeans, hulls
Soybeans, meal
Soybean soapstock is no longer a
regulated commodity.
Sugar beets, molasses
Tomato, pomace, dried
Feed Additive Tolerances listed under 40 CFR §186.4000(b)
Barley, milling fractions
Oat milling fractions
Sugar beet molasses
Wheat, milling fractions
1.0
1.0
5.0
1.0
1.0
1.0
Revoke
1.0
Oats, milling fractions
Inadvertent tolerance covered by
primary use tolerance listed under
40CFR§186.4000(a).
Feed Additive Tolerances listed under 40 CFR §186.4000(d)
Hops, spent
20
Revoke
Tolerance will be covered by the
20.0 ppm tolerance on the RAC,
Hops, dried.
Tolerances required under 40 CFR §180.408(a)
Forage, fodder, and straw
of cereal grains group
(excluding wheat, barley,
and oats)
Cotton, gin byproducts
None
None
1.0
To be determined
Must be established.
Appropriate tolerance must be
proposed and established.
Food Additive Tolerances required under 40 CFR §185.4000(a)
Potatoes, granules/flakes
Potatoes, chips
Tomato paste
None
None
None
2.0
2.0
To be determined
Must be proposed and
established.
Must be proposed and
established.
Appropriate tolerance (if needed)
must be proposed and
established.
52
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Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/Correcf
Commodity Definition \\
Feed Additive Tolerances required under 40 CFR §186.4000(a)||
Pineapples, process
residue
Sunflower seeds, meal
None
None
0.5
0.2
Must be established.
Must be established.
The Agency has determined that numerous tolerance revisions are required.
These revisions will be handled administratively by the Agency.
Codex Harmonization
Numerous maximum residue limits (MRLs) for metalaxyl residues in
plant commodities have been established by the Codex Committee on Pesticide
Residues, a committee within the Codex Alimentarius Commission, an
international organization formed to promote the coordination of international
food standards. Codex currently regulates metalaxyl per se in plant
commodities; however, the Agency has concluded that the U.S tolerance
definition for plant commodities should include metalaxyl and its metabolites
that can be converted to 2,6-dimethylaniline and N-(2-hydroxymethyl-6-
methylphenyl)-N-(methoxyacetyl) alanine methyl ester. The Codex MRLs
and the applicable U.S. tolerances are presented below.
Commodity
Apple
Asparagus
Avocado
Broccoli
Brussels sprouts
Cabbages, head
Cacao beans
Carrot
Cauliflower
Cereal grains
Citrus fruits
Cotton seed
Cucumber
Gherkin
Grapes
MRL
(mg/kg) a
0.05 d
0.05 d
0.2
0.5
0.2
0.5
0.2
0.05 d
0.5
0.05 d
5
0.05 d
0.5
0.5
1
U.S. Tolerance
(ppm) b
0.2
7.0
4.0
2.0
0. 1 (Brassica leafy
vegetables)
2.0
None
0.5 (Root and tuber
vegetables)
2.0
0.1 (Grain, crops)
1
0.1
1.0 (Cucurbit
vegetables)
1.0 (Cucurbit
vegetables)
None
Recommendation/
Comments c
—
—
—
—
--
-_
-_
--
—
—
—
—
--
--
--
53
-------
Commodity
Hops, dry
Lettuce, head
Melons, except watermelon
Onion, bulb
Peanut
Peas, shelled
Peppers
Pome fruits
Potato
Raspberries, Red, Black
Soya bean (dry)
Spinach
Squash, Summer
Strawberry
Sugar beet
Sunflower seed
Tomato
Watermelon
Winter squash
MRL
(mg/kg) a
10
2e
0.2
0.2e
0.1
0.05 d
1
1
0.05 d
0.2
0.05 d
2e
0.2
0.2
0.05 d
0.05 d
0.5
0.2
0.2
U.S. Tolerance
(ppm) b
20.0 (Hops, dried)
5.0
1.0 (Cucurbit
vegetables)
0.5
0.01
0.1 (Legume
vegetables)
1.0 (Fruiting
vegetables)
None
0.5
0.5
1.0
10.0
1.0 (Cucurbit
vegetables)
10.0
0.5 (Sugar beet, roots)
0.1
1.0 (Fruiting
vegetables)
1.0 (Cucurbit
vegetables)
1.0 (Cucurbit
vegetables)
Recommendation/
Comments c
—
—
--
-_
-_
--
--
-_
-_
-_
-_
-_
--
—
—
—
--
--
--
a/ All metalaxyl MRLs are final (CXL), except MRLs for lettuce, onions, and spinach which are at step 8 and the MRL for strawberries
which is at step 7B.
b/ Based on the combined residues of metalaxyl and its metabolites that can be converted to 2,6-DMA and N-(2-hydroxymethyl-6-
methylphenyl)-N-(methoxyacetyl) alanine methyl ester.
c/ As the tolerance definitions for Codex MRLs and U.S. tolerances are different, harmonization of Codex MRLs and U.S. tolerances is not
currently possible.
d/ At or about the limit of detection.
el MRL is temporary.
The following conclusion can be made regarding efforts to harmonize the U.S.
tolerances with the Codex MRLs:
O Harmonization of Codex MRLs and U.S. tolerances for metalaxyl is not possible at
the present time as the Codex and U.S. tolerance definitions are incompatible.
2. Reference Dose (RfD)
54
-------
The RfD was established as 0.08 mg/kg/day based on a NOEL of 7.8
mg/kg/day and an uncertainty factor of 100. The NOEL was obtained from a
6-month dog study. The RfD was approved on 4/3/94. In 1982 the FAO/WHO
Joint Meeting on Pesticide Residues established an Acceptable Daily Intake (ADI)
of 0.03 mg/kg/day for metalaxyl.
3. Risk Mitigation
The Agency has determined that the current uses of metalaxyl do not pose an
unreasonable threat to the environment based upon available environmental fate and
ecotoxicity data. However, because metalaxyl has been detected in groundwater, the
Agency will take the following actions to reduce the possibility of groundwater
contamination in vulnerable areas.
1. All end-use products will be required to contain a groundwater advisory
statement. (Refer to Section V, B, 2).
2. The registrant, Ciba-Geigy Corporation, has agreed to conduct a user
education program if they become aware of groundwater levels of metalaxyl at
or above 400 ppb in samples from monitoring sites. The function of this
program will be to alert users to the risks to groundwater from metalaxyl use
and to discuss ways to mitigate these risks.
4. Endangered Species
Based on available ecotoxicity data, the Agency has determined that
endangered species precautionary labeling will not be required at this time.
5. Labeling Requirements
A. 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 EPA' s labeling 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.
55
-------
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.
Post-application Reentry
Under the Worker Protection Standard (WPS), interim restricted entry
intervals (REI) for all uses within the scope of the WPS are established based on the
acute toxicity of the active ingredient. The toxicity categories of the active
ingredient for acute dermal toxicity, eye irritation potential, and skin irritation
potential are used to determine the interim WPS REI. If one or more of the three
acute toxicity effects are in Toxicity Category I, the interim WPS REI is established
at 48 hours. If none of the acute toxicity effects are in Category I, but one or more
of the three is classified as Category II, the interim WPS REI is established at 24
hours. If none of the three acute toxicity effects are in Category I or II, the interim
WPS REI is established at 12 hours. A 48 hour REI is increased to 72 hours when
an organophosphate pesticide is applied outdoors in arid areas. In addition, the WPS
specifically retains two types of REI's established by the Agency prior to the
promulgation of the WPS: product-specific REI's established on the basis of
adequate data and interim REI's that are longer than those that would be established
under the WPS.
For end-use product containing metalaxyl as an active ingredient, the Agency
is requiring the establishment of a 24-hour restricted entry interval for uses of the
product that fall within the scope of the WPS for agricultural pesticides. This
requirement is based on categorizing the eye irritation potential of the active
ingredient as Toxicity Category II, moderate eye irritant. The Agency found no
extenuating circumstance for retaining the 12-hour interim restricted entry interval
placed on metalaxyl products by PR Notice 93-7. The 12-hour interim WPS
restricted entry interval was established because early data indicated that metalaxyl
was in Toxicity Category III for eye irritation potential.
Personal Protective Equipment (PPE^ Requirements
Mixer/loader/applicator PPE
For each end-use product, PPE requirements for pesticide handlers will
be set during reregi strati on in one of two ways:
1. If the Agency has no special concerns regarding other adverse effects of an
56
-------
active ingredient, the PPE for pesticide handlers will be established based on
the acute toxicity of the end-use product. For occupational-use products, PPE
will be established using the process described in PR Notice 93-7 or more
recent EPA guidelines.
2. If the Agency has special concerns about an active ingredient due to very
high acute toxicity or certain adverse effects, such as allergic effects or other
effects (cancer, developmental toxicity, reproductive effects, etc):
-the Agency may establish in the RED minimum or "baseline" handler
PPE requirements for that active ingredient that pertain to all or most
occupational end-use products containing that active ingredient.
-these minimum PPE requirements must be compared with the PPE that
would be designated on the basis of the acute toxicity of each end-use
product, and
-the more stringent choice for each type of PPE (i.e., bodywear, hand
protection, footwear, eyewear, etc.) must be placed on the label of the
end-use product.
There are no special toxicological concerns about metalaxyl that warrant
the establishment of active-ingredient-based PPE requirements.
Early Entry PPE
Personal protective equipment requirements for persons who must enter
areas that remain under a restricted entry interval are based on the toxicity
concerns about the active ingredient. The requirements are set in one of two
ways:
1. If the Agency has no additional concerns about an active ingredient, it
established the early entry PPE requirements based on acute dermal toxicity,
skin irritation potential, and eye irritation potential of the active ingredient.
2. If the Agency has special concerns about an active ingredient due to very
high acute toxicity or to other adverse effects, such as allergic effects or
cancer, developmental toxicity, reproductive effects, etc., it may establish
early entry PPE requirements that are more stringent than would be established
on the basis of acute toxicity concerns.
Since metalaxyl is classified as category III for acute dermal toxicity
and category IV for skin irritation potential, and EPA has no special concerns
about other adverse effects, the PPE required early entry is: coveralls,
chemical-resistant gloves, shoes and socks. Since metalaxyl is classified as
57
-------
toxicity category II for eye irritation potential, protective eyewear is also
required.
Personal Protective Equipment for Handlers
The PPE for pesticide handlers will be based on the acute toxicity of the
end-use product. For occupational-use products, PPE will be established using
the process described in PR Notice 93-7 or more recent EPA guidelines.
Entry Restrictions
Some registered uses of metalaxyl are within the scope of the Worker
Protection standard for Agricultural Pesticides (WPS) and some are outside the
scope of the WPS.
WPS Uses: For occupational end-use products containing metalaxyl as an
active ingredient, the Agency is establishing a 24-hour restricted-entry interval
for each use of the product that is within the scope of the Worker Protection
Standard for Agricultural Pesticides (WPS). The PPE required for early entry
allowed by the WPS as stated earlier is: Coveralls, chemical-resistant gloves,
shoes plus socks, and protective eyewear.
Non-WPS Uses: The Agency is establishing the following entry restrictions
for all non WPS occupational uses of metalaxyl end-use products:
For liquid applications:
Do not enter or allow others to enter the treated area until sprays have dried.
For dry applications:
Do not enter or allow others to enter the treated area until dusts have settled.
Homeowner Products: Some products containing metalaxyl are intended
primarily for homeowner use. The Agency is concerned about post-
application exposures to homeowners following application of metalaxyl;
therefore, the Agency is requiring that home-use products contain the
following requirement:
For liquid applications:
Do not allow people or pets to enter the treated area until the sprays have
dried.
58
-------
For dry applications:
Do not allow people or pets to enter the treated area until dusts have settled.
Other Occupational/Residential Requirements
The Agency is requiring the following labelling statements to be located
on all end-use products containing metalaxyl that are intended primarily for
occupational use:
Application Restrictions:
Do not apply this product in a way that will contact workers or other persons,
either directly or through drift. Only protected handlers may be in the area
during application.
Engineering Controls:
When handlers use closed systems, enclosed cabs, or aircraft in a manner that
meets the requirements listed in the Worker Protection Standard (WPS) for
agricultural pesticides (40 CFR 170.240 (d) (4-6), the handler PPE
requirements may be reduced or modified as specified in the WPS.
User Safety Requirements:
Follow manufacture's instructions for cleaning/maintaining PPE. If no such
instructions exist for washables, use detergent and hot water. Keep and wash
PPE separately from other laundry.
User Safety Recommendations:
-Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.
-Users should remove clothing immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing.
-Users should remove PPE immediately after handling this product. Wash the
outside of gloves before removing. As soon as possible, wash thoroughly and
change into clean clothing.
B. Groundwater
The Agency is concerned about the potential for groundwater contamination
59
-------
from registered uses of metalaxyl. Available laboratory and field studies indicate
that metalaxyl is persistent and mobile and may leach in many soils. Metalaxyl has
been detected in groundwater at levels typically ranging up to 3 ppb. Concentrations
have been reported as high as 236 ppb, but the Agency believes that these higher
levels were not likely to have resulted from normal use. In order to reduce the
possibility of groundwater contamination in areas where soils are permeable and the
water table is shallow, the Agency is requiring a groundwater label advisory for
metalaxyl end-use products. In addition, the registrant has agreed to conduct a user
education program if they become aware of groundwater levels of metalaxyl at or
above 400 ppb in samples from monitoring sites. (Refer to Section V for required
label statement and Section IV, B, 4, above for a discussion of risk mitigation
measures including the groundwater education program).
C. Environmental Hazard
The Agency is requiring labeling to ensure that metalaxyl use will not
endangered sensitive aquatic species. (Refer to Section V, B, 2).
D. Spray Drift Advisory
In order to inform the user of best management practices that would minimize
spray drift from the target site, the Agency is currently preparing spray drift labeling
statements. This future labeling may be required for all metalaxyl products that may
be applied aerially to agricultural crops.
60
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V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregi strati on
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of metalaxyl for the above
eligible uses has been reviewed and determined to be substantially complete.
However, additional confirmatory data are needed to fulfill requirements for the
studies listed below:
Product chemistry
Animal metabolism (data showing percent conversion of HMMA to DMA
in livestock)
Analytical method validation for additional metabolites
Storage stability
Magnitude of residue in plants to support the newly registered 50% WP
formulation and use on cotton
Magnitude of residue in processed tomato
Avian reproduction
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.
61
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2. Labeling Requirements for End-Use Products
A. Worker Protection Standard
Metalaxyl is in Toxicity Category III for acute dermal toxicity, and the REI
imposed by the Worker Protection Standard was 12 hours. The RED evaluation of
the REI established by the WPS concluded that changes were warranted based on the
classification of the eye irritation study as Toxicity Category II. The REI should be
increased to 24 hours to reflect this finding. In addition to the PPE previously
required in the WPS for early entry, protective eyewear requirement is now imposed
for early entry for uses within scope of the WPS due to the change in the Toxicity
Category for ocular irritation.
Non-WPS Uses: The Agency is establishing the following entry restrictions for all
non WPS occupational uses of metalaxyl end-use products:
For liquid applications:
"Do not enter or allow others to enter the treated area until sprays have dried."
For dry applications:
"Do not enter or allow others to enter the treated area until dusts have settled."
Homeowner Products: Some products containing metalaxyl are intended
primarily for homeowner use. The Agency is concerned about post-
application exposures to homeowners following application of metalaxyl;
therefore, the Agency is requiring that home-use products contain the
following requirement:
For liquid applications:
"Do not allow people or pets to enter the treated area until the sprays have
dried."
For dry applications:
"Do not allow people or pets to enter the treated area until dusts have settled."
Other Occupational/Residential Requirements
The Agency is requiring the following labelling statements to be located
on all end-use products containing metalaxyl that are intended primarily for
occupational use:
62
-------
Application Restrictions:
"Do not apply this product in a way that will contact workers or other persons,
either directly or through drift. Only protected handlers may be in the area
during application."
Engineering Controls:
"When handlers use closed systems, enclosed cabs, or aircraft in a manner that
meets the requirements listed in the Worker Protection Standard (WPS) for
agricultural pesticides (40 CFR 170.240 (d) (4-6), the handler PPE
requirements may be reduced or modified as specified in the WPS."
User Safety Requirements:
"Follow manufacture's instructions for cleaning/maintaining PPE. If no such
instructions exist for washables, use detergent and hot water. Keep and wash
PPE separately from other laundry."
User Safety Recommendations:
-"Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
-"Users should remove clothing immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing."
-"Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible, wash thoroughly
and change into clean clothing."
B. Environmental Hazard
End-use product must contain the following label language:
"For terrestrial uses, do not apply to water or to areas where surface water is
present, or to intertidal areas below the mean high water mark. Do not apply
when weather conditions favor drift from treated areas. Do not contaminate
water when disposing of equipment wash water or rinsate."
C. Groundwater Advisory
The following Groundwater Advisory is required on all end-use products:
63
-------
"This chemical is known to leach through soil into groundwater under certain
conditions as a result of agricultural use. Use of this chemical in areas where
soils are permeable, particularly where the water table is shallow, may result in
ground water contamination."
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 Reregi strati on 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; Statement of Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell products bearing
old labels/labeling, i.e., labels absent the modifications specified in this RED document,
except as noted below, 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. Registrants and persons other than registrants remain
obligated to meet pre-existing Agency imposed label changes and existing stocks
requirements applicable to products they sell or distribute.
64
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VI. APPENDICES
65
-------
66
-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
67
-------
68
-------
Date 08/03/94 ) Time 14:22
APPENDIX A ) CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 ) Page 1
SITE Application Type, Application Form(s)
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
ALFALFA
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
Soil broadcast treatment., At planting.,
Sprayer.
ALMOND
Soil band treatment., Foliar., Sprayer.
Soil band treatment., Postplant . , Sprayer.
Soil band treatment., Spring., Sprayer.
Soil broadcast treatment., Foliar., Sprayer.
-
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
EC
EC
EC
EC
EC
Min. Appl .
Rate (AI un-
less noted
otherwise)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Max.
Appl. Soil
Rate (AI Tex.
unless
noted Max.
otherwise) Dose
.031
.031
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
.031
.031
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
5 Ib A *
Use Group
4 Ib A *
4 Ib A *
4 Ib A *
4 Ib A *
Max . tt Apps
@ Max. Rate
/crop /year
cycle
: TERRESTRIAL
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
: TERRESTRIAL
NS 3/1 yr
NS 3/1 yr
NS 3/1 yr
NS 3/1 yr
Max. Dose [ (AI
unless noted
otherwise) /A]
/crop /year
cycle
FEED 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
FOOD+FEED CROP
NS NS
NS NS
NS NS
NS NS
Min.
Interv
(days)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
60
60
60
60
Restr. Geographic Limitations
Entry Allowed Disallowed
Interv
[day(s) ]
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
0.5
0.5
0.5
0.5
Use
Limitations
Codes
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
C92,
C92,
C92,
C92,
C92,
G66
G66
G66
G66
C93,
C92,
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
G66
H12(60)
G03,
G03,
G03,
G03,
GM1
GM1
GM1
GM1
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
ALMOND (con't)
Soil broadcast treatment., Postplant . ,
Sprayer.
Soil broadcast treatment., Spring., Sprayer.
APPLE
Drench., Delayed dormant., Not on label.
Drench., Nonbearing., Not on label.
Drench., Postharvest . , Not on label.
Soil band treatment., Delayed dormant.,
Sprayer.
Soil band treatment., Nonbearing., Sprayer.
Soil broadcast treatment., Delayed dormant.,
EC
EC
EC
EC
EC
EC
EC
EC
NA
NA
NA
NA
NA
NA
NA
NA
4
4
.005 Ib
.005 Ib
.005 Ib
4
4
4
Use Group
Ib A *
Ib A *
Use Group
tree *
tree *
tree *
Ib A *
Ib A *
Ib A *
: TERRESTRIAL
NS
NS
3/1 yr
3/1 yr
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
CROP (con't)
NS
NS
CROP
NS
NS
NS
NS
NS
NS
60
60
NS
NS
NS
NS
NS
NS
0
0
0
0
0
0
0
0
.5
.5
.5
.5
.5
.5
.5
.5
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
G03, GM1
G03, GM1
GM1
GM1
GM1
GM1
GM1
GM1
Sprayer.
Soil broadcast treatment., Nonbearing.,
Sprayer.
Soil broadcast treatment., Postharvest.,
Sprayer.
ASPARAGUS
Soil broadcast treatment., Postplant.,
Sprayer.
Soil broadcast treatment., Preharvest. ,
Sprayer.
4 Ib A * NS NS
4 Ib A
NS NS
NS
Use Group: TERRESTRIAL FOOD CROP
1 Ib A * NS NS NS
EC
1 Ib A
NS NS
NS
NS
AVOCADO
Chemigation., Foliar., Drip irrigation. EC
Chemigation., Foliar., Sprinkler irrigation. EC
Soil broadcast treatment., Foliar., Not on EC
label.
Soil broadcast treatment., Transplant., Not EC
on label.
NA
NA
NA
Use Group: TERRESTRIAL FOOD CROP
UC * NS NS NS 12 Ib
UC * NS NS NS 12 Ib
.091 Ib tree * NS NS NS 12 Ib
.091 Ib tree
NS NS
NS 12 Ib
NS 0.5
NS 0.5
NS 0.5
NS 0.5
90 0.5
90 0.5
90 0.5
90 0.5
C92, GM1
C92, GM1
C92, HOI(28)
C92, HOI(28)
C92, HOI(28)
C92, HOI(28)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 3
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
AVOCADO (con't)
Soil drench treatment., Transplant., Not on
label .
Soil treatment., At planting., Granule
applicator.
Soil treatment., Transplant., Granule
applicator.
BARLEY
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
EC
G
G
Min. Appl. Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
NA
NA
Use Group
2.170E-04 Ib tree *
5.203E-04
sq
5.203E
-04
sq
Ib *
.ft
Ib *
.ft
Use Group
D
D
D
D
D
D
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.022
.033
.031
.031
.016
.022
.033
.031
.031
.016
.031
.031
.031
.035
.031
.031
.031
.031
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Max. # Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS NS
NS
NS
3/1 yr
3/1 yr
: TERRESTRIAL
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
FOOD CROP
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
( con ' t )
12 Ib 90
12 Ib
12 Ib
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
90
90
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
0.5
NS
NS
0.5
1
2
NS
NS
0.5
1
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Limitations Use
Disallowed Limitations
Codes
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
H01(
28)
HOI (28)
H01(
G66
G66
G66
G66
G66,
G66
G66
G66
G66
G66,
C93,
C92,
G66
G66
C93,
C92,
28)
GN3
GN3
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 4
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
BARLEY (con't)
BEANS
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
Seed treatment., At planting., Planter/seed
F1C
F1C
WP
WP
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
D
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
.031
.035
.031
.031
.031
.031
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
.031
.031
.007969
Use Group:
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Use Group:
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Use Group
Ib bu *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
TERRESTRIAL
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
: TERRESTRIAL
NS
NS
FOOD+FEED
NS
NS
NS
NS
FEED CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
CROP (con't)
NS
NS
NS
NS
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
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
CAE,
G66
C92
C92,
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
C92,
G66
G66
G66
G66
G66
G66
C93,
C92,
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
G66
G66
box.
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 5
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
BEANS (con't)
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
Spray., Foliar., Sprayer.
BEANS, DRIED -TYPE
D
D
D
D
D
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
EC
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
Use Group
.007813 Ib bu *
.031 Ib cwt *
.031 Ib cwt *
.016 Ib cwt *
.007969 Ib bu *
.007813 Ib bu *
.031 Ib cwt *
.031 Ib cwt *
.016 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.035 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.035 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.125 gal A *
Use Group
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
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
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
7
1
2
NS
NS
0.5
1
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS VA
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
G66
G66
G66
G66, G73
G66
G66
G66
G66
G66, G73
C93, G66
C92, G66
G66
G66
C93, G66
C92, G66
G66
G66
H01(3)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
BEANS, DRIED -TYPE (con't)
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
Soil band treatment., At planting., Granule
applicator.
BEANS, SUCCULENT (LIMA)
Seed treatment., At planting., Planter/seed
D
D
RTU
D
D
EC
F1C
F1C
F1C
RTU
WP
WP
EC
F1C
F1C
F1C
RTU
WP
WP
G
D
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
.031
.031
.019
.031
.031
.031
.031
.031
.035
.019
.031
.031
.031
.031
.031
.035
.019
.031
.031
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
.0075 Ib IK *
linear ft
.031
Use Group
Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
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
: TERRESTRIAL
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
CROP (con't)
NS
NS
NS
NS
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
2
NS
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
2
C92,
C92,
C46,
C92,
C92,
C46,
C46,
CAE,
G66
C46,
C92
C92,
C46,
C46,
CAE,
G66
C46,
C92
C92,
C92,
C92,
G66
G66
C92,
G66
G66
C93,
C92,
G66
C92,
G66
C93,
C92,
G66
C92,
G66
GL7
G66
G66
G66
G66
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 7
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
BEANS, SUCCULENT (LIMA) (con't)
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
BEANS, SUCCULENT (SNAP)
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
D
RTU
D
D
EC
F1C
F1C
F1C
RTU
WP
WP
EC
F1C
F1C
F1C
RTU
WP
WP
D
D
RTU
D
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
.031
.019
.031
.031
.031
.031
.031
.035
.019
.031
.031
.031
.031
.031
.035
.019
.031
.031
.031
.031
.019
.031
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Use Group
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Use Group
cwt *
cwt *
cwt *
cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
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
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
CROP (con't)
NS
NS
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
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
NS
NS
2
C92,
C46,
C92,
C92,
C46,
C46,
CAE,
G66
C46,
C92
C92,
C46,
C46,
CAE,
G66
C46,
C92
C92,
C92,
C92,
C46,
C92,
G66
C92,
G66
G66
C93,
C92,
G66
C92,
G66
C93,
C92,
G66
C92,
G66
G66
G66
C92,
G66
G66
G66
G66
G66
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
BEANS, SUCCULENT (SNAP) (con't)
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
Soil band treatment., At planting., Granule
applicator.
BEETS
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group
D
EC
F1C
F1C
F1C
RTU
WP
WP
EC
F1C
F1C
F1C
RTU
WP
WP
G
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.031
.031
.031
.031
.035
.019
.031
.031
.031
.031
.031
.035
.019
.031
.031
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
.0075 Ib
linear
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
IK *
ft
Use Group
D
D
EC
F1C
F1C
F1C
NA
NA
NA
NA
NA
NA
.031
.031
.031
.031
.031
.035
Ib
Ib
Ib
Ib
Ib
Ib
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
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
: TERRESTRIAL
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
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
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
(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
NS
NS
NS
NS
NS
NS
NS
0.5
NS
NS
NS
NS
NS
NS
C92,
C46,
C46,
CAE,
G66
C46,
C92
C92,
C46,
C46,
CAE,
G66
C46,
C92
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
G66
C93,
C92,
G66
C92,
G66
C93,
C92,
G66
C92,
G66
GL7
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 9
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
BEETS (con't)
Slurry., Seed., Slurry-type seed treater.
BEETS (UNSPECIFIED)
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
BLUEBERRY
Soil band treatment., At planting., Sprayer.
Soil band treatment., Foliar., Sprayer.
Soil band treatment., Postplant . , Sprayer.
Soil broadcast treatment., At planting.,
WP
WP
EC
F1C
F1C
F1C
WP
WP
D
D
EC
EC
EC
EC
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
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Use Group
Ib cwt *
Ib cwt *
Use Group
4 Ib A *
3.625 Ib A *
4 Ib A *
4 Ib A *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
3/1 yr
2/1 yr
3/1 yr
3/1 yr
FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
FOOD CROP
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
( 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
60
NS
60
60
NS
NS
NS
NS
NS
NS
NS
NS
2
2
0.5
0.5
0.5
0.5
C92
C92, G66
C46, C93, G66
C46, C92, G66
CAE, G66
G66
C92
C92, G66
C92, G66
C92, G66
C92
C92
C92
C92
Sprayer.
Soil broadcast treatment., Postplant.,
Sprayer.
Broadcast., At planting., Granule
applicator.
Broadcast., Preplant. , Granule applicator.
Chemigation., Foliar., Center pivot
irrigation.
4 Ib A
NS 3/1 yr
Use Group: TERRESTRIAL FOOD CROP
1 Ib A * NS
NS NS
0.5
G
WP
NA
NA
1 Ib A
.18 Ib A
NS
4
NS
NS
NS
NS
NS NS 0.5
NS 14 2
CAE
CAE
C92, H01(7)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 10
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
BROCCOLI (con't)
Chemigation. , Foliar., Hand move irrigation.
Chemigation. , Foliar., Moving wheel
irrigation.
Chemigation., Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Aircraft.
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
Soil band treatment., At planting., Not on
label .
Soil band treatment., Preplant . , Not on
label .
Soil broadcast treatment., At planting.,
Drip irrigation.
Soil broadcast treatment., At planting., Not
on label .
Soil broadcast treatment., At planting.,
Overhead sprinkler irrigation.
Soil broadcast treatment., Preplant., Drip
irrigation.
Soil broadcast treatment., Preplant., Not on
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise) /A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Use Group: TERRESTRIAL
WP
WP
WP
EC
EC
WP
EC
EC
WP
EC
WP
EC
EC
WP
WP
WP
WP
WP
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.18
.18
.18
.125
.18
.125
.18
.18
2
2
.681
.681
.681
.681
.681
Ib A
Ib A
Ib A
gal A
UC
Ib A
gal A
UC
Ib A
UC
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
* 4
* 4
* 4
* 4
* NS
* 4
* 4
* NS
* 4
* NS
* 4
* 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
FOOD CROP
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
14 2
14 2
14 2
14 NS CA
14 NS AZ
14 2
14 NS CA
14 NS AZ
14 2
14 NS AZ
14 2
NS 0.5
NS 0.5
NS 0.5
NS 0.5
NS 0.5
NS 0.5
NS 0.5
C92,
C92,
C92,
H01(7)
H01(7)
H01(7)
H01(7)
C92,
H01(7)
H01(7)
C92,
C92,
C92
C92
C92
C92
C92
C92
C92
H01(7)
H01(7)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 11
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
BROCCOLI (con't)
Soil broadcast treatment., Preplant . ,
Overhead sprinkler irrigation.
Soil incorporated treatment., Preplant., Not
on label .
BROCCOLI, CHINESE
Chemigation. , Foliar., Center pivot
irrigation.
Chemigation., Foliar., Hand move irrigation.
Chemigation., Foliar., Moving wheel
irrigation.
Chemigation., Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Aircraft .
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
Soil band treatment., At planting., Not on
WP
EC
WP
WP
WP
WP
EC
EC
WP
EC
EC
WP
EC
WP
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
.681 Ib A *
2 Ib A *
Use Group
.18 Ib A *
.18 Ib A *
.18 Ib A *
.18 Ib A *
.125 gal A *
UC *
.18 Ib A *
.125 gal A *
UC *
.18 Ib A *
UC *
.18 Ib A *
2 Ib A *
: TERRESTRIAL
NS
NS
NS
NS
: TERRESTRIAL
4
4
4
4
4
NS
4
4
NS
4
NS
4
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
FOOD CROP
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 0.5
NS 0.5
14 2
14 2
14 2
14 2
14 NS CA
14 NS AZ
14 2
14 NS CA
14 NS AZ
14 2
14 NS AZ
14 2
NS 0.5
C92
C92
C92,
C92,
C92,
C92,
H01(7)
H01(7)
H01(7)
H01(7)
H01(7)
C92,
H01(7)
H01(7)
C92,
C92,
C92
H01(7)
H01(7)
label.
Soil band treatment., Preplant., Not on
label.
Ib A
Soil incorporated treatment., Preplant., Not
on label.
2 Ib A * NS
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 12
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
BUCKWHEAT
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
CABBAGE
Broadcast., At planting., Granule
applicator.
Broadcast., Preplant . , Granule applicator.
Chemigation. , Foliar., Center pivot
irrigation.
Chemigation., Foliar., Hand move irrigation.
Chemigation., Foliar., Moving wheel
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
G
G
WP
WP
WP
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
.031
.031
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
.031
.031
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Use Group
1 Ib A *
1 Ib A *
18 Ib A *
18 Ib A *
18 Ib A *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
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
: TERRESTRIAL
NS
NS
4
4
4
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
FOOD+FEED CROP
NS
NS
NS
NS
NS
NS
NS
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
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
14
14
14
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
0.5
2
2
2
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
CAE
CAE
C92,
C92,
C92,
G66
G66
G66
G66
C93, G66
C92, G66
G66
G66
C93, G66
C92, G66
G66
G66
H01(7)
H01(7)
H01(7)
irrigation.
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 13
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CABBAGE (con't)
Chemigation. , Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Aircraft .
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
Soil band treatment., At planting., Not on
label .
Soil band treatment., Preplant . , Not on
label .
Soil broadcast treatment., At planting.,
Drip irrigation.
Soil broadcast treatment., At planting., Not
on label .
Soil broadcast treatment., At planting.,
Overhead sprinkler irrigation.
Soil broadcast treatment., Preplant., Drip
irrigation.
Soil broadcast treatment., Preplant., Not on
label .
Soil broadcast treatment., Preplant.,
Overhead sprinkler irrigation.
Soil incorporated treatment., Preplant., Not
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise) /A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Use Group: TERRESTRIAL
WP
EC
EC
WP
EC
EC
WP
EC
WP
EC
EC
WP
WP
WP
WP
WP
WP
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.18
.125
.18
.125
.18
.18
2
2
.681
.681
.681
.681
.681
.681
2
Ib A
gal A
UC
Ib A
gal A
UC
Ib A
UC
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
* 4
* 4
* NS
* 4
* 4
* NS
* 4
* NS
* 4
* 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
FOOD CROP
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
14 2
14 NS CA
14 NS AZ
14 2
14 NS CA
14 NS AZ
14 2
14 NS AZ
14 2
NS 0.5
NS 0.5
NS 0.5
NS 0.5
NS 0.5
NS 0.5
NS 0.5
NS 0.5
NS 0.5
C92,
H01(7)
H01(7)
C92,
H01(7)
H01(7)
C92,
C92,
C92
C92
C92
C92
C92
C92
C92
C92
C92
H01(7)
H01(7)
on label.
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 14
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CABBAGE, CHINESE
Chemigation. , Foliar., Center pivot
irrigation.
Chemigation., Foliar., Hand move irrigation.
Chemigation., Foliar., Moving wheel
irrigation.
Chemigation., Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Aircraft .
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
Soil band treatment., At planting., Not on
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise) /A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Use Group: TERRESTRIAL
WP
WP
WP
WP
EC
EC
WP
EC
EC
WP
EC
WP
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.18 Ib
.18 Ib
.18 Ib
.18 Ib
.125 gal
.18 Ib
.125 gal
.18 Ib
.18 Ib
2 Ib
A
A
A
A
A
UC
A
A
UC
A
UC
A
A
* 4
* 4
* 4
* 4
* 4
* NS
* 4
* 4
* NS
* 4
* NS
* 4
* NS
NS
NS
NS
NS
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
NS
NS
14 2
14 2
14 2
14 2
14 NS CA
14 NS AZ
14 2
14 NS CA
14 NS AZ
14 2
14 NS AZ
14 2
NS 0.5
C92, H01(7)
C92, H01(7)
C92, H01(7)
C92, H01(7)
H01(7)
C92, H01(7)
H01(7)
C92, H01(7)
C92, H01(7)
C92
label.
Soil band treatment., Preplant., Not on EC
label.
Soil incorporated treatment., Preplant., Not EC
on label.
CAULIFLOWER
Broadcast., At planting., Granule G
applicator.
Broadcast., Preplant., Granule applicator. G
Chemigation., Foliar., Center pivot WP
irrigation.
Ib A
2 Ib A * NS
NS
NS
NS NS
0.5
Use Group: TERRESTRIAL FOOD CROP
1 Ib A * NS NS NS NS NS 0.5
NA
NA
1 Ib A * NS
.18 Ib A * 4
NS
NS
NS
NS
NS NS 0.5
NS 14 2
CAE
CAE
C92, H01(7)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 15
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CAULIFLOWER ( con ' t )
Chemigation. , Foliar., Hand move irrigation.
Chemigation. , Foliar., Moving wheel
irrigation.
Chemigation., Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Aircraft.
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
Soil band treatment., At planting., Not on
label .
Soil band treatment., Preplant . , Not on
label .
Soil broadcast treatment., At planting.,
Drip irrigation.
Soil broadcast treatment., At planting., Not
on label .
Soil broadcast treatment., At planting.,
Overhead sprinkler irrigation.
Soil broadcast treatment., Preplant., Drip
irrigation.
Soil broadcast treatment., Preplant., Not on
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise) /A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Use Group: TERRESTRIAL
WP
WP
WP
EC
EC
WP
EC
EC
WP
EC
WP
EC
EC
WP
WP
WP
WP
WP
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.18
.18
.18
.125
.18
.125
.18
.18
2
2
.681
.681
.681
.681
.681
Ib A
Ib A
Ib A
gal A
UC
Ib A
gal A
UC
Ib A
UC
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
* 4
* 4
* 4
* 4
* NS
* 4
* 4
* NS
* 4
* NS
* 4
* 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
FOOD CROP
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
14 2
14 2
14 2
14 NS CA
14 NS AZ
14 2
14 NS CA
14 NS AZ
14 2
14 NS AZ
14 2
NS 0.5
NS 0.5
NS 0.5
NS 0.5
NS 0.5
NS 0.5
NS 0.5
C92,
C92,
C92,
H01(7)
H01(7)
H01(7)
H01(7)
C92,
H01(7)
H01(7)
C92,
C92,
C92
C92
C92
C92
C92
C92
C92
H01(7)
H01(7)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 16
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CAULIFLOWER ( con ' t )
Soil broadcast treatment., Preplant . ,
Overhead sprinkler irrigation.
Soil incorporated treatment., Preplant., Not
on label .
CITRUS FRUITS
Bark treatment., Foliar., Sprayer.
Chemigation. , Foliar.,
Chemigation. , Foliar.,
Soil band treatment.,
nurserystock . , Granule
Soil band treatment.,
nurserystock., Not on
Soil band treatment.,
irrigation.
Soil band treatment.,
label .
Soil band treatment.,
sprinkler irrigation.
Soil band treatment.,
applicator.
Soil band treatment.,
Sprayer.
Soil band treatment.,
Drip irrigation.
Sprinkler irrigation.
Nonbearing
applicator.
Nonbearing
label .
Nonbearing., Drip
Nonbearing., Not on
Nonbearing., Overhead
Nurserystock., Granule
Nurserystock. ,
Transplant., Sprayer.
Soil broadcast treatment., Foliar., Granule
WP
EC
EC
EC
EC
EC
G
EC
WP
WP
WP
G
EC
EC
G
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL FOOD CROP (con't)
.681 Ib A * NS NS NS NS NS
2 Ib A * NS NS NS NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
UC
UC
.031 Ib tree
.031 Ib tree
4 Ib A
4 Ib A
4.084 Ib A
4.084 Ib A
4.084 Ib A
4 Ib A
4 Ib A
4 Ib A
4 Ib A
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* 3
* NS
* NS
* 3
3/1 yr
3/1 yr
3/1 yr
3/1 yr
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
12 Ib
NS
.938 Ib
.938 Ib
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
90
NS
90
90
90
90
90
90
90
0.5
0.5
0.5 AZ, CA, TX
NS FL
0.5
0.5
0.5
0.5
0.5
0.5
0.5
NS AZ, CA, FL, PR
0.5 AZ, CA, FL, PR
0.5 AZ, CA, FL, PR
NS AZ , CA
C92
C92
C92
C92
C92
CAE
C92
C92
C92
C92
C92, H01(0)
C92
C92
C92, H01(0)
applicator.
Soil broadcast treatment., Foliar., Sprayer. EC
Soil broadcast treatment., Nonbearing G
nurserystock., Granule applicator.
NA
NA
4 Ib A * NS 3/1 yr NS NS 90 0.5 AZ, CA
4 Ib A * NS NS NS NS 90 0.5
C92
CAE
-------
Date 08/03/94 _ Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 17
SITE Application Type, Application Form(s)
Timing, Application Equipment _
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CITRUS FRUITS (con't)
Soil broadcast treatment., Nonbearing EC NA
nurserystock . , Not on label.
Soil broadcast treatment., Nonbearing., Drip WP NA
irrigation.
Soil broadcast treatment., Nonbearing., Not WP NA
on label .
Soil broadcast treatment., Nonbearing., WP NA
Overhead sprinkler irrigation.
Soil broadcast treatment., Nurserystock., G NA
Granule applicator.
Soil broadcast treatment., Nurserystock., EC NA
Sprayer.
Soil broadcast treatment., Transplant., G NA
Granule applicator.
Soil broadcast treatment., Transplant., EC NA
Sprayer.
Soil drench treatment., Nonbearing EC NA
nurserystock., Not on label.
Soil drench treatment., Nonbearing., Drip WP NA
irrigation.
Soil drench treatment., Nonbearing., Not on WP NA
label .
Soil drench treatment., Nonbearing., WP NA
Overhead sprinkler irrigation.
Soil drench treatment., Nurserystock., Not EC NA
on label .
Soil drench treatment., Transplant., Not on EC NA
label .
Soil treatment., Foliar., Sprayer. EC NA
Use Group
4 Ib A *
4.084 Ib A *
4.084 Ib A *
4.084 Ib A *
4 Ib A *
4 Ib A *
4 Ib A *
4 Ib A *
.234 Ib IK linear *
ft
UC *
.234 Ib IK linear *
ft
UC *
.234 Ib IK linear *
ft
.004688 Ib tree *
2 Ib A *
: TERRESTRIAL
NS
NS
NS
NS
3
NS
4
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
3/1 yr
FOOD+FEED
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
(con't)
NS 0.5
90 0.5
90 0.5
90 0.5
90 NS AZ, CA, FL, PR
90 0.5 AZ, CA, FL
90 NS AZ, CA, FL, PR
90 0.5 AZ, CA, FL
90 0.5
90 0.5
90 0.5
90 0.5
NS 0.5 AZ, CA, FL, PR
NS 0.5 AZ, CA, FL, PR
90 0.5 FL, PR
C92
C92
C92
C92
C92, H01(0)
C92
C92, H01(0)
C92
C92
C92
C92
C92
C92
C92
C92
Use Group: TERRESTRIAL FEED CROP
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 18
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CLOVER ( con ' t )
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
COLE CROPS
Chemigation. , Foliar., Center pivot
irrigation.
Chemigation., Foliar., Hand move irrigation.
Chemigation., Foliar., Moving wheel
irrigation.
Chemigation., Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar., High
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
WP
WP
WP
WP
WP
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
Use Group
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.035 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.035 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
Use Group
.18 Ib A *
.18 Ib A *
.18 Ib A *
.18 Ib A *
.18 Ib A *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
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
: TERRESTRIAL
4
4
4
4
4
NS
NS
NS
NS
NS
FEED CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
( 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
NS
NS
NS
NS
NS
NS
NS
14
14
14
14
14
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
2
2
2
2
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
C92,
C92,
C92,
C92,
C92,
G66
G66
G66
G66
C93, G66
C92, G66
G66
G66
C93, G66
C92, G66
G66
G66
H01(7)
H01(7)
H01(7)
H01(7)
H01(7)
volume ground.
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 19
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
COLE CROPS (con't)
Low volume spray (concentrate) ., Foliar.,
Aircraft.
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
Soil band treatment., At planting., Not on
label .
Soil band treatment., Preplant . , Not on
label .
Soil incorporated treatment., Preplant., Not
on label .
Soil treatment., At planting., Not on label.
CORN
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
WP
WP
EC
EC
EC
EC
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
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
Use Group
.18 Ib A *
.18 Ib A *
.031
.031
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
2 Ib A *
2 Ib A *
2 Ib A *
2 Ib A *
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
4 NS
4
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
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
FOOD CROP
NS
NS
NS
NS
NS
NS
FEED CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
( con ' t )
NS 14
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
14
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
2
2
0.5
0.5
0.5
0.5
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Limitations Use
Disallowed Limitations
Codes
C92,
C92,
C92
C92
C92
C92
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
H01(7)
H01(7)
G66
G66
G66
G66
C93,
C92,
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 20
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CORN (con't)
CORN (UNSPECIFIED)
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
CORN, FIELD
Seed treatment., At planting., Planter/seed
WP
WP
D
D
D
D
D
D
EC
F1C
F1C
WP
WP
EC
F1C
F1C
WP
WP
D
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group
.031 Ib cwt *
.031 Ib cwt *
Use Group
.007969 Ib bu *
.007813 Ib bu *
.00585 Ib bu *
.007969 Ib bu *
.007813 Ib bu *
.00585 Ib bu *
.219 Ib cwt *
.207 Ib cwt *
.234 Ib cwt *
.219 Ib cwt *
.219 Ib cwt *
.219 Ib cwt *
.207 Ib cwt *
.234 Ib cwt *
.219 Ib cwt *
.219 Ib cwt *
Use Group
.031 Ib cwt *
: TERRESTRIAL
NS
NS
NS
NS
: TERRESTRIAL
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
: TERRESTRIAL
NS
NS
FEED CROP
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
( con ' t )
NS
NS
CROP
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
0.5
1
NS
0.5
1
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
C92
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C46,
C46,
G66
C92
C92,
C46,
C46,
G66
C92
C92,
C92,
G66
G66
G66
G66, GN3
G66
G66
G66, GN3
C93, G66
C92, G66
G66
C93, G66
C92, G66
G66
G66
box.
D NA
Seed treatment., At planting., Seed treater. D NA
.031 Ib cwt
.031 Ib cwt
NS
NS
NS
NS
NS
NS
NS NS NS
NS NS 2
C92, G66
C92, G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 21
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CORN, FIELD (con't)
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
CORN, POP
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
D
D
D
D
EC
F1C
F1C
WP
WP
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
.031
.031
.031
.207
.035
.031
.031
.031
.031
.207
.035
.031
.031
.031
.031
.031
.031
.031
.031
.207
.031
.031
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Use Group
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Use Group
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
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
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
CROP (con't)
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
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
NS
2
NS
NS
NS
NS
NS
NS
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
C92
C92,
G66
C93,
C92,
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 22
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CORN, POP (con't)
Slurry., Seed., Slurry-type seed treater.
CORN, SWEET
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
COTTON (UNSPECIFIED)
Seed treatment., At planting., Planter/seed
EC
F1C
F1C
WP
WP
D
D
D
D
EC
F1C
F1C
WP
WP
EC
F1C
F1C
WP
WP
D
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
.031
.031
.207
.031
.031
.031
.031
.031
.031
.063
.062
.207
.063
.063
.063
.062
.207
.063
.063
.032
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Use Group
Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
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
: TERRESTRIAL
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
CROP (con't)
NS
NS
NS
NS
NS
CROP
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
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
C46,
C46,
CAE,
C92
C92,
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
C92
C92,
C46,
C46,
CAE,
C92
C92,
C92,
C93,
C92,
G66
G66
G66
G66
G66
G66
C93,
C92,
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
G66
G66
G66
G66
box.
.031 Ib cwt
C92, G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 23
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
COTTON (UNSPECIFIED) (con't)
D
D
D
RTU
Seed treatment., At planting., Seed treater. D
D
D
D
D
Slurry., Seed., Mist-type seed treater. EC
F1C
F1C
F1C
RTU
WP
WP
Slurry., Seed., Slurry-type seed treater. EC
F1C
F1C
F1C
RTU
WP
WP
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: TERRESTRIAL
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.031
.031
.031
.031
.032
.031
.031
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.031
.035
.031
.031
.031
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
* 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
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
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
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
(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
2
NS
NS
NS
0.5
1
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92,
C92,
C92,
C46,
C92,
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C46,
C92
C92,
C46,
C46,
CAE,
G66
C46,
C92
C92,
G66
G66
G66,
C92,
G66
G66
G66
G66
G66,
C93,
C92,
G66
C92,
G66
C93,
C92,
G66
C92,
G66
G73
G66
G73
G66
G66
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 24
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
COTTON (UNSPECIFIED) (con't)
Soil band treatment., At planting., Granule
applicator.
Soil in-furrow treatment., At planting.,
Granule applicator.
Soil in-furrow treatment., At planting.,
Sprayer.
COWPEA/BLACKEYED PEA
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
G
G
EC
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
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
Use Group
.007688 Ib IK *
linear ft
.009375 Ib IK *
linear ft
.009375 Ib IK *
linear ft
Use Group
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.070 Ib cwt *
.088 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.070 Ib cwt *
.088 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
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
FOOD+FEED
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
CROP (con't)
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
NS
NS
NS
0.5
NS
0.5
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92,
C92,
C92
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
GL8
H01(0)
G66
G66
G66
G66
C93, G66
C92, G66
G66
G66
C93, G66
C92, G66
G66
G66
Use Group: TERRESTRIAL FEED CROP
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 25
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
COWPEAS (con't)
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
CRANBERRY
Chemigation. , Foliar., Center pivot
irrigation.
Chemigation., Foliar., Drip irrigation.
Chemigation., Foliar., Hand move irrigation.
Chemigation., Foliar., Moving wheel
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
EC
EC
EC
EC
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
Use Group
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.035 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.035 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
Use Group
1.75 Ib A *
1.75 Ib A *
1.75 Ib A *
1.75 Ib A *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
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
: TERRESTRIAL
3
3
3
3
NS 5
NS 5
NS 5
NS 5
FEED CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
.25 Ib
.25 Ib
.25 Ib
.25 Ib
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
( 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
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
0.5
0.5
0.5
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
C92,
C92,
C92,
C92,
G66
G66
G66
G66
C93, G66
C92, G66
G66
G66
C93, G66
C92, G66
G66
G66
HOI (45)
HOI (45)
HOI (45)
HOI (45)
irrigation.
Chemigation. , Foliar., Solid set irrigation. EC
1.75 Ib A
C92, H01(45)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 26
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CRANBERRY (con
Chemigation. ,
Chemigation. ,
irrigation.
Chemigation. ,
Chemigation. ,
irrigation.
Chemigation. ,
irrigation.
Chemigation. ,
irrigation.
Chemigation. ,
irrigation.
Chemigation. ,
irrigation.
Chemigation. ,
Chemigation. ,
Chemigation. ,
irrigation.
Chemigation. ,
Chemigation. ,
Soil broadcast
Soil broadcast
Ground .
Soil broadcast
CUCUMBER
Broadcast . , At
't)
Foliar., Sprinkler irrigation.
Postharvest . , Center pivot
Postharvest . , Drip irrigation.
Postharvest . , Hand move
Postharvest . , Moving wheel
Postharvest., Solid set
Postharvest . , Sprinkler
Spring., Center pivot
Spring., Drip irrigation.
Spring., Hand move irrigation.
Spring., Moving wheel
Spring., Solid set irrigation.
Spring., Sprinkler irrigation.
treatment., Foliar., Ground.
treatment . , Postharvest . ,
treatment., Spring., Ground.
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
1.
1.
1
1
1.
1
1.
1
1.
1.
1.
1
1
1
1
1.
.75
.75
.75
.75
.75
.75
.75
.75
.75
.75
.75
.75
.75
.75
.75
.75
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
Use Group
planting., Granule
G
NA
1
Ib
A *
Max . tt Apps
@ Max. Rate
/crop /year
cycle
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
: TERRESTRIAL
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
: TERRESTRIAL
NS
NS
FOOD CROP
.25
.25
.25
.25
.25
.25
.25
.25
.25
.25
.25
.25
.25
.25
.25
.25
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
( 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
NS
NS
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
.5
.5
.5
.5
.5
.5
.5
.5
.5
.5
.5
.5
.5
.5
.5
.5
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
HOI (45)
HOI (45)
HOI (45)
HOI (45)
HOI (45)
HOI (45)
HOI (45)
HOI (45)
HOI (45)
HOI (45)
HOI (45)
HOI (45)
HOI (45)
HOI (45)
HOI (45)
HOI (45)
FOOD CROP
NS
NS
NS
0
.5
CAE
applicator.
Broadcast., Preplant. , Granule applicator.
1 Ib A * NS NS
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 27
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CUCUMBER (con't)
Chemigation. , Foliar., Center pivot
irrigation.
Chemigation., Foliar., Hand move irrigation.
Chemigation., Foliar., Moving wheel
irrigation.
Chemigation., Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) . , Foliar. ,
Aircraft .
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
Soil broadcast treatment., At planting.,
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: TERRESTRIAL
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
F1C
F1C
WP
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.27
.2
.193
.27
.193
.27
.193
.27
2
.193
.27
.2
.193
.27
2
.193
.27
.031 Ib
.031 Ib
.681
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
cwt
cwt
Ib A
* 4
* 4
* 4
* 4
* 4
* 4
* 4
* 4
* 4
* 4
* 4
* 4
* 4
* 4
* 4
* 4
* 4
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
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
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
( con ' t )
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
10
14
7
10
7
10
7
10
14
7
10
14
7
10
14
7
10
NS
NS
NS
2
1
1
2
1
2
1
2
1
1
2
1
1
2
1
1
2
NS 018
NS 018
0.5
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
CAE,
CAE,
C92
H03
C94,
C94,
H03
C94,
H03
C94,
H03
C94,
C94,
H03
C94,
C94,
H03
C94,
C94,
H03
G66
G66
HOI (5)
HOI (5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
Drip irrigation.
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 28
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CUCUMBER (con't)
Soil broadcast treatment., At planting., Not WP
on label .
Soil broadcast treatment., At planting., WP
Overhead sprinkler irrigation.
Soil broadcast treatment., Preplant . , Drip WP
irrigation.
Soil broadcast treatment., Preplant., Not on WP
label .
Soil broadcast treatment., Preplant., WP
Overhead sprinkler irrigation.
CUCURBIT VEGETABLES
Chemigation. , Foliar., Center pivot WP
irrigation.
WP
Chemigation., Foliar., Hand move irrigation. WP
Chemigation., Foliar., Moving wheel WP
irrigation.
WP
Chemigation., Foliar., Solid set irrigation. WP
WP
High volume spray (dilute) ., Foliar., WP
Ground .
High volume spray (dilute) ., Foliar., High WP
volume ground.
Low volume spray (concentrate) ., Foliar., WP
Aircraft.
WP
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group
NA .681 Ib A *
NA .681 Ib A *
NA .681 Ib A *
NA .681 Ib A *
NA .681 Ib A *
Use Group
NA .27 Ib A *
NA .2 Ib A *
NA .27 Ib A *
NA .27 Ib A *
NA .2 Ib A *
NA .27 Ib A *
NA .2 Ib A *
NA .2 Ib A *
NA .27 Ib A *
NA .27 Ib A *
NA .2 Ib A *
Max. tt
@ Max.
/crop
cycle
Apps Max. Dose [ (AI Min. Restr. Geographic Limitations
Rate unless noted Interv Entry Allowed Disallowed
/year otherwise) /A] (days) Interv
/crop /year [day(s)]
cycle
Use
Limitations
Codes
: TERRESTRIAL FOOD CROP (con't)
NS
NS
NS
NS
NS
NS NS NS NS 0.5
NS NS NS NS 0.5
NS NS NS NS 0.5
NS NS NS NS 0.5
NS NS NS NS 0.5
C92
C92
C92
C92
C92
: TERRESTRIAL FOOD CROP
4
4
4
4
4
4
4
4
4
4
4
NS NS NS 10 2
NS NS NS 14 2
NS NS NS 10 2
NS NS NS 10 2
NS NS NS 14 2
NS NS NS 10 2
NS NS NS 14 2
NS NS NS 14 2
NS NS NS 10 2
NS NS NS 10 2
NS NS NS 14 2
C92, H03
C92, C94, CAG,
HOI (5)
C92, H03
C92, H03
C92, C94, CAG,
HOI (5)
C92, H03
C92, C94, CAG,
HOI (5)
C92, C94, CAG,
HOI (5)
C92, H03
C92, H03
C92, C94, CAG,
HOI (5)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 29
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
CUCURBIT VEGETABLES (con't)
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
Soil band treatment., At planting., Not on
label .
Soil band treatment., Preplant . , Not on
label .
Soil incorporated treatment., Preplant., Not
on label .
Soil treatment., At planting., Not on label.
DILL
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
Seed treatment., At planting., Planter/seed
WP
EC
EC
EC
EC
D
D
EC
F1C
F1C
F1C
EC
F1C
F1C
F1C
D
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
Use Group:
.27 Ib A *
2 Ib A *
2 Ib A *
2 Ib A *
2 Ib A *
Use Group:
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.035 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.035 Ib cwt *
Use Group
.031 Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
TERRESTRIAL
4
NS
NS
NS
NS
NS
NS
NS
NS
NS
TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD + FEED
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
( con ' t )
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
10
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
0.5
0.5
0.5
0.5
2
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92,
C92
C92
C92
C92
C92,
C92,
C46,
C46,
CAE,
G66
C46,
C46,
CAE,
G66
C92,
H03
G66
G66
C93, G66
C92, G66
G66
C93, G66
C92, G66
G66
G66
box.
Seed treatment., At planting., Seed treater. D NA
EGGPLANT
.031 Ib cwt * NS NS NS
Use Group: TERRESTRIAL FOOD CROP
C92, G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 30
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
EGGPLANT (con't)
Broadcast., At planting., Granule G
applicator.
Broadcast., Preplant., Granule applicator. G
Soil band treatment., At planting., Not on EC
label.
Soil broadcast treatment., At planting., WP
Drip irrigation.
Soil broadcast treatment., At planting., Not EC
on label.
Use Group: TERRESTRIAL FOOD CROP (con't)
Soil broadcast treatment., At planting.,
Overhead sprinkler irrigation.
Soil broadcast treatment., Preplant., Drip
irrigation.
Soil broadcast treatment., Preplant., Not on
label.
Soil broadcast treatment., Preplant.,
Overhead sprinkler irrigation.
GARBANZOS (INCLUDING CHICK PEAS)
Seed treatment., At planting., Planter/seed
box.
WP
WP
Seed treatment., At planting., Seed treater
Seed treatment., Seed., Not on label.
Slurry., Seed., Mist-type seed treater.
D
D
D
F1C
EC
F1C
F1C
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
1 Ib A
NS NS
1 Ib A * NS NS
2 Ib A * NS NS
.681 Ib A
NS NS
2 Ib A * NS NS
.681 Ib A
.681 Ib A
NS NS
NS NS
NS
NS
3 Ib
NS
NS
NS
.681 Ib A * NS NS
.681 Ib A
.681 Ib A * NS NS
NS
NS NS 0.5
NS NS 0.5
NS NS 0.5
NS NS 0.5
NS NS 0.5
NS NS 0.5
NS NS 0.5
NS NS 0.5
NS NS 0.5
NS NS 0.5
Use Group: TERRESTRIAL FOOD CROP
.031 Ib cwt * NS NS NS NS NS
.031 Ib cwt * NS
.031 Ib cwt * NS
.031 Ib cwt * NS
.012 gal cwt * NS
.031 Ib cwt * NS
.031 Ib cwt * NS
.070 Ib cwt * NS
CAE
CAE
C92, H01(7)
C92
C92, H01(7)
C92
C92
C92, G66
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
2
NS
NS ID
NS
NS
NS
C92,
C92,
C92,
G66
C46,
C46,
CAE,
G66
G66
G66
C93,
C92,
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 31
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
GAREANZOS (INCLUDING CHICK PEAS) (con't)
Slurry., Seed., Slurry-type seed treater.
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
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
Use Group
.088 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.070 Ib cwt *
.088 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: TERRESTRIAL
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
GINSENG (MEDICINAL)
Soil drench treatment., Spring., Not on
label .
GRAPES
Chemigation. , Bloom through foliar., Center
pivot irrigation.
Chemigation., Bloom through foliar., Moving
wheel irrigation.
Chemigation., Bloom through foliar., Solid
set irrigation.
Chemigation., Early bloom., Center pivot
irrigation.
Chemigation., Early bloom., Moving wheel
irrigation.
F1C
F1C
EC
WP
WP
WP
WP
WP
NA
NA
NA
NA
NA
NA
NA
NA
.031 Ib cwt *
.031 Ib cwt *
Use Group
.75 Ib A *
Use Group
.2 Ib A *
.2 Ib A *
.2 Ib A *
.2 Ib A *
.2 Ib A *
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD + FEED
NS
NS
FOOD CROP
NS
FOOD+FEED
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
CROP
NS NS
NS NS
NS NS
CROP
NS NS
NS NS
NS NS
NS NS
NS NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS ND
NS ND
0.5
2
2
2
2
2
G66
C92
C92, G66
C46, C93, G66
C46, C92, G66
CAE, G66
G66
C92
C92, G66
G66
G66
C92
C92, C94, CAG,
HOI (66)
C92, C94, CAG,
HOI (66)
C92, C94, CAG,
HOI (66)
C92, C94, CAG,
HOI (66)
C92, C94, CAG,
HOI (66)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 32
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
GRAPES (con't)
Chemigation. , Early bloom., Solid set
irrigation.
High volume spray (dilute) . , Bloom through
foliar., Ground.
High volume spray (dilute) ., Early bloom.,
Ground .
Low volume spray (concentrate) . , Bloom
through foliar., Aircraft.
Low volume spray (concentrate) . , Early
bloom., Aircraft.
GRASS FORAGE/FODDER/HAY
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
WP
WP
WP
WP
WP
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
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
.031
.031
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
.031
Use Group
.2 Ib A *
. 2 Ib A *
.2 Ib A *
. 2 Ib A *
.2 Ib A *
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
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
FOOD+FEED CROP
NS
NS
NS
NS
NS
FEED 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
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
2
2
2
2
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92, C94, CAG,
HOI (66)
C92, C94, CAG,
HOI (66)
C92, C94, CAG,
HOI (66)
C92, C94, CAG,
HOI (66)
C92, C94, CAG,
HOI (66)
C92, G66
C92, G66
C92, G66
C92, G66
C46, C93, G66
C46, C92, G66
CAE, G66
G66
C92
C92, G66
C46, C93, G66
C46, C92, G66
CAE, G66
G66
C92
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 33
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
GRASS FORAGE/FODDER/HAY (con't)
HOPS
Soil treatment., Foliar., Not on label.
Spray., Foliar., Ground.
LEGUME VEGETABLES
Soil band treatment., At planting., Not on
label .
Soil band treatment., Preplant . , Not on
label .
Soil broadcast treatment., At planting., Not
on label .
Soil incorporated treatment., Preplant., Not
on label .
LENTILS
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
WP
EC
EC
EC
EC
EC
EC
EC
EC
EC
D
D
D
D
EC
F1C
F1C
F1C
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
Use Group
.031 Ib cwt *
Use Group
.5 Ib A *
.25 gal A *
.25 gal A *
.25 gal A *
.5 Ib A *
Use Group
1 Ib A *
1 Ib A *
1 Ib A *
1 Ib A *
Use Group
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.035 Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
: TERRESTRIAL
NS
3
3
3
NS
3/1 yr
NS
NS
NS
3/1 yr
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FEED CROP
NS
FOOD+FEED
NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
( con ' t )
NS
CROP
NS
NS
NS
NS
NS
CROP
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
0.5
NS ID
NS OR
NS WA
0.5
0.5
0.5
0.5
0.5
2
NS
2
NS
NS
NS
NS
NS
C92, G66
C92, GB6,
HOI (45)
HOI (45)
HOI (45)
C92, GB6,
C92
C92
C92
C92
C92, G66
C92, G66
C92, G66
C92, G66
C46, C93,
C46, C92,
CAE, G66
G66
HOI (45)
HOI (45)
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 34
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
LENTILS (con't)
Slurry., Seed., Slurry-type seed treater.
LESPEDEZA
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
WP
WP
EC
F1C
F1C
F1C
WP
WP
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
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
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Use Group
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Use Group
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
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
FOOD+FEED CROP
NS
NS
NS
NS
NS
NS
NS
NS
FEED 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
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
(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
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
G66
C93,
C92,
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 35
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
LESPEDEZA (con't)
LETTUCE
Broadcast., At planting.,
applicator.
WP NA
WP NA
Granule G NA
Broadcast., Preplant . , Granule applicator. G NA
Soil broadcast treatment.
Drip irrigation.
Soil broadcast treatment.
on label .
, At planting., WP NA
, At planting., Not WP NA
Soil broadcast treatment., At planting., WP NA
Overhead sprinkler irrigation.
Soil broadcast treatment.
irrigation.
Soil broadcast treatment.
label .
, Preplant . , Drip WP NA
, Preplant . , Not on WP NA
Soil broadcast treatment., Preplant., WP NA
Overhead sprinkler irrigation.
LETTUCE, HEAD
Broadcast., At planting.,
Granule G NA
Use Group
.031 Ib cwt *
.031 Ib cwt *
Use Group
1 Ib A *
1 Ib A *
.681 Ib A *
.681 Ib A *
.681 Ib A *
.681 Ib A *
.681 Ib A *
.681 Ib A *
Use Group
2 Ib A *
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
@ Max. Rate unless noted Interv Entry Allowed
/crop /year otherwise) /A] (days) Interv
cycle /crop /year [day(s)]
cycle
: TERRESTRIAL
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
FEED CROP (con't)
NS NS NS NS
NS NS NS NS
FOOD CROP
NS NS NS 0.5
NS NS NS 0.5
NS NS NS 0.5
NS NS NS 0.5
NS NS NS 0.5
NS NS NS 0.5
NS NS NS 0.5
NS NS NS 0.5
FOOD CROP
NS NS NS NS
Limitations Use
Disallowed Limitations
Codes
C92
C92, G66
CAE
CAE
C92
C92
C92
C92
C92
C92
C92, H01(0)
applicator.
Chemigation., Foliar., Center pivot
irrigation.
Chemigation., Foliar., Drip irrigation.
EC
Chemigation., Foliar., Hand move irrigation. EC
Chemigation., Foliar., Moving wheel EC
irrigation.
Chemigation., Foliar., Solid set irrigation. EC
Chemigation., Foliar., Sprinkler irrigation. EC
NA
NA
NA
NA
NA
.25 Ib A *
.25 Ib A *
.25 Ib A *
.25 Ib A *
.25 Ib A *
.25 Ib A *
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
NS 14
NS 14
NS 14
NS 14
NS 14
NS 14
NS TX
NS TX
NS TX
NS TX
NS TX
NS TX
HOI(7)
HOI(7)
HOI(7)
HOI(7)
HOI(7)
HOI(7)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 36
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
LETTUCE, HEAD (con't)
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Aircraft .
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
Soil band treatment., At planting., Granule
applicator.
Soil band treatment., At planting., Not on
label .
Soil band treatment., Preplant . , Granule
applicator.
Soil band treatment., Preplant., Not on
label .
Soil broadcast treatment., At planting.,
Granule applicator.
Soil broadcast treatment., Preplant.,
Granule applicator.
Soil incorporated treatment., Preplant., Not
on label .
Soil treatment., At planting., Not on label.
Spray., Foliar., Ground.
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: TERRESTRIAL
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
G
EC
G
EC
G
G
EC
EC
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.125 gal A
.125 gal A
.125 gal A
.125 gal A
.125 gal A
.25 Ib A
.125 gal A
.25 Ib A
.25 Ib A
.125 gal A
2 Ib A
2 Ib A
2 Ib A
2 Ib A
2 Ib A
2 Ib A
2 Ib A
2 Ib A
.25 Ib A
* 2
* 2
* 2
* 2
* 2
* 2
* 2
* NS
* NS
* 2
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* 2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
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
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
( 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
14
14
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
NS
0.5
NS
NS
0.5
0.5
NS
AZ
CA
WA
AZ
CA
CO
WA
FL
TX
AZ
CO
HOI (10)
HOI (10)
HOl(lO)
HOl(lO)
HOl(lO)
H01(7)
C92, H01(0)
C92
C92, H01(0)
C92
C92, H01(0)
C92, H01(0)
C92
C92
HOl(lO)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 37
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
LETTUCE, HEAD (con't)
LUPINE
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
Seed treatment., At planting., Planter/seed
EC
EC
NA
NA
Use Group: TERRESTRIAL
.25 Ib A * NS NS
.25 Ib A * NS NS
Use Group: TERRESTRIAL
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
RTU
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.031
.031
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
.031
.031
.019
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
Use
cwt
* 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
Group: TERRESTRIAL
* NS
NS
FOOD CROP
NS
NS
FEED CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD + FEED
NS
( con ' t )
NS 14
NS 14
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 FL
NS TX
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
H01(7)
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
G66
G66
G66
G66
C93, G66
C92, G66
G66
G66
C93, G66
C92, G66
G66
G66
C92, G66
box.
Slurry., Seed., Mist-type seed treater. RTU NA
Slurry., Seed., Slurry-type seed treater. RTU NA
.019 Ib cwt
.019 Ib cwt
NS
NS
NS
NS
NS NS NS
NS NS NS
NS
NS
C46, C92, G66
C46, C92, G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 38
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
MELONS Use Group: TERRESTRIAL FOOD CROP
Broadcast., At planting., Granule G NA 1 Ib A * NS NS NS NS NS 0.5
applicator.
Broadcast., Preplant . , Granule applicator. G NA 1 Ib A * NS NS NS NS NS 0.5
Chemigation. , Foliar., Center pivot WP NA .193 Ib A * 4 NS NS NS 7 1
irrigation.
Chemigation., Foliar., Hand move irrigation. WP NA .193 Ib A * 4 NS NS NS 7 1
Chemigation., Foliar., Moving wheel WP NA .193 Ib A * 4 NS NS NS 7 1
irrigation.
Chemigation., Foliar., Solid set irrigation. WP NA .193 Ib A * 4 NS NS NS 7 1
High volume spray (dilute)., Foliar., High WP NA .193 Ib A * 4 NS NS NS 7 1
volume ground.
Low volume spray (concentrate) ., Foliar., WP NA .193 Ib A * 4 NS NS NS 7 1
Aircraft.
Soil broadcast treatment., At planting., WP NA .681 Ib A * NS NS NS NS NS 0.5
Drip irrigation.
Soil broadcast treatment., At planting., Not WP NA .681 Ib A * NS NS NS NS NS 0.5
on label .
Soil broadcast treatment., At planting., WP NA .681 Ib A * NS NS NS NS NS 0.5
Overhead sprinkler irrigation.
Soil broadcast treatment., Preplant., Drip WP NA .681 Ib A * NS NS NS NS NS 0.5
irrigation.
Soil broadcast treatment., Preplant., Not on WP NA .681 Ib A * NS NS NS NS NS 0.5
label .
Soil broadcast treatment., Preplant., WP NA .681 Ib A * NS NS NS NS NS 0.5
Overhead sprinkler irrigation.
MELONS, CANTALOUPE Use Group: TERRESTRIAL FOOD CROP
Chemigation., Foliar., Center pivot WP NA .27 Ib A * 4 NS NS NS 10 2
irrigation.
WP NA .2 Ib A * 4 NS NS NS 14 1
WP NA .193 Ib A * 4 NS NS NS 7 1
CAE
CAE
C92, C94, H01(5)
C92, C94, H01(5)
C92, C94, H01(5)
C92, C94, H01(5)
C92, C94, H01(5)
C92, C94, H01(5)
C92
C92
C92
C92
C92
C92
C92, H03
C92, C94, H01(5)
C92, C94, H01(5)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 39
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
MELONS, CANTALOUPE (con't)
Chemigation. , Foliar., Hand move irrigation.
Chemigation. , Foliar., Moving wheel
irrigation.
Chemigation., Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Aircraft.
Low volume spray (concentrate) . , Foliar. ,
Low volume ground.
MELONS, HONEYDEW
Chemigation., Foliar., Center pivot
irrigation.
Chemigation., Foliar., Hand move irrigation.
Chemigation., Foliar., Moving wheel
irrigation.
Chemigation., Foliar., Solid set irrigation.
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group:
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.27
.193
.27
.193
.27
.2
.193
.27
2
.193
.27
.2
.193
.27
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
Use Group:
WP
WP
WP
WP
WP
WP
NA
NA
NA
NA
NA
NA
2
.193
.193
.193
2
.193
Ib
Ib
Ib
Ib
Ib
Ib
A *
A *
A *
A *
A *
A *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
TERRESTRIAL
4
4
4
4
4
4
4
4
4
4
4
4
4
4
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
TERRESTRIAL
4
4
4
4
4
4
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
( con ' t )
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
10
7
10
7
10
14
7
10
14
7
10
14
7
10
14
7
7
7
14
7
2
1
2
1
2
1
1
2
1
1
2
1
1
2
1
1
1
1
1
1
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
H03
C94,
H03
C94,
H03
C94,
C94,
H03
C94,
C94,
H03
C94,
C94,
H03
C94,
C94,
C94,
C94,
C94,
C94,
HOI (5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 40
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
MELONS, HONEYDEW (con't)
High volume spray (dilute) ., Foliar., High WP NA
volume ground.
WP NA
Low volume spray (concentrate) ., Foliar., WP NA
Aircraft .
WP NA
MELONS, MUSK
Chemigation. , Foliar. , Center pivot WP NA
irrigation.
Chemigation. , Foliar. , Hand move irrigation. WP NA
Chemigation. , Foliar. , Moving wheel WP NA
irrigation.
Chemigation. , Foliar. , Solid set irrigation. WP NA
High volume spray (dilute) ., Foliar., High WP NA
volume ground.
Low volume spray (concentrate) ., Foliar., WP NA
Aircraft .
Low volume spray (concentrate) ., Foliar., WP NA
Low volume ground.
MELONS, WATER
Chemigation. , Foliar. , Center pivot WP NA
irrigation.
WP NA
WP NA
Chemigation. , Foliar. , Hand move irrigation. WP NA
WP NA
Chemigation. , Foliar. , Moving wheel WP NA
2
.193
.2
.193
.27
.27
.27
.27
.27
.27
.27
.27
2
.193
.27
.193
.27
Use Group:
Ib A *
Ib A *
Ib A *
Ib A *
Use Group:
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Use Group:
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
@ Max. Rate unless noted Interv Entry Allowed
/crop /year otherwise) /A] (days) Interv
cycle /crop /year [day(s)]
cycle
TERRESTRIAL
4
4
4
4
NS
NS
NS
NS
TERRESTRIAL
4
4
4
4
4
4
4
NS
NS
NS
NS
NS
NS
NS
TERRESTRIAL
4
4
4
4
4
4
NS
NS
NS
NS
NS
NS
FOOD CROP (con't)
NS NS 14 1
NS NS 7 1
NS NS 14 1
NS NS 7 1
POOD CROP
NS NS 10 2
NS NS 10 2
NS NS 10 2
NS NS 10 2
NS NS 10 2
NS NS 10 2
NS NS 10 2
POOD CROP
NS NS 10 2
NS NS 14 1
NS NS 7 1
NS NS 10 2
NS NS 7 1
NS NS 10 2
Limitations Use
Disallowed Limitations
Codes
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C94,
C94,
C94,
C94,
H03
H03
H03
H03
H03
H03
H03
H03
C94,
C94,
H03
C94,
H03
H01(5)
HOI (5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
irrigation.
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 41
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
MELONS, WATER (con't)
Chemigation. , Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Aircraft .
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
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
.193
.27
2
.193
.27
.2
.193
.27
2
.193
.27
MELONS, WINTER (CASABA/CRENSHAW/HONEYDEW/PERSIAN)
Chemigation., Foliar., Center pivot
irrigation.
Chemigation., Foliar., Hand move irrigation.
Chemigation., Foliar., Moving wheel
irrigation.
Chemigation., Foliar., Solid set irrigation.
WP
WP
WP
WP
WP
WP
WP
WP
WP
NA
NA
NA
NA
NA
NA
NA
NA
NA
.27
2
.193
.27
.193
.27
.193
.27
.2
Use Group:
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Use Group:
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
TERRESTRIAL
4
4
4
4
4
4
4
4
4
4
4
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
TERRESTRIAL
4
4
4
4
4
4
4
4
4
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
( con ' t )
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
7
10
14
7
10
14
7
10
14
7
10
10
14
7
10
7
10
7
10
14
1
2
1
1
2
1
1
2
1
1
2
2
1
1
2
1
2
1
2
1
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C94,
H03
C94,
C94,
H03
C94,
C94,
H03
C94,
C94,
H03
H03
C94,
C94,
H03
C94,
H03
C94,
H03
C94,
HOI (5)
HOI (5)
HOI (5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 42
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
MELONS, WINTER (CASABA/CRENSHAW/HONEYDEW/PERSIAN)
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Aircraft .
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
MILLET (FOXTAIL)
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
WP
WP
WP
WP
WP
WP
WP
WP
D
D
D
D
EC
F1C
F1C
WP
WP
EC
F1C
F1C
WP
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
(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
.193 Ib A *
.27 Ib A *
.2 Ib A *
.193 Ib A *
.27 Ib A *
.2 Ib A *
.193 Ib A *
.27 Ib A *
Use Group
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.219 Ib cwt *
.207 Ib cwt *
.031 Ib cwt *
.219 Ib cwt *
.219 Ib cwt *
.219 Ib cwt *
.207 Ib cwt *
.031 Ib cwt *
.219 Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
4
4
4
4
4
4
4
4
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
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
FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
FEED CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
( con ' t )
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
7
10
14
7
10
14
7
10
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
2
1
1
2
1
1
2
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
C92
C92,
C46,
C46,
CAE,
C92
C94,
H03
C94,
C94,
H03
C94,
C94,
H03
G66
G66
G66
G66
C93,
C92,
G66
G66
C93,
C92,
G66
HOI (5)
HOI (5)
HOI (5)
H01(5)
H01(5)
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 43
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
MILLET (FOXTAIL) (con't)
OATS
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
OKRA
Seed treatment., At planting., Planter/seed
WP
D
D
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
D
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.219
.031
.031
.013
.031
.031
.013
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
.031
.031
.031
Use Group
Ib cwt *
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Use Group
Ib cwt *
: TERRESTRIAL
NS
NS
: TERRESTRIAL
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
: TERRESTRIAL
NS
NS
FEED CROP
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
( con ' t )
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
NS
NS
NS
NS
NS
NS
NS
NS
2
NS
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
C92,
G66
G66
G66
G66,
G66
G66
G66,
C93,
C92,
G66
G66
C93,
C92,
G66
G66
G66
GN3
GN3
G66
G66
G66
G66
box.
.031 Ib cwt
C92, G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 44
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
OKRA (con't)
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
ONION
Chemigation. , Foliar., Center pivot
irrigation.
Chemigation., Foliar., Hand move irrigation.
Chemigation., Foliar., Moving wheel
irrigation.
Chemigation., Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar., High
D
D
F1C
F1C
WP
WP
F1C
F1C
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
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
Use Group
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
Use Group
.2 Ib A *
.18 Ib A *
.193 Ib A *
.18 Ib A *
.193 Ib A *
.18 Ib A *
.193 Ib A *
.2 Ib A *
.18 Ib A *
.193 Ib A *
.2 Ib A *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
4
4
4
4
4
4
4
4
4
4
4
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
( 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
NS
14
14
7
14
7
14
7
14
14
7
14
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
2
1
2
1
2
1
1
2
1
1
C92,
C92,
C46,
CAE,
C92
C92,
C46,
CAE,
C92
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
G66
G66
C92, G66
G66
G66
C92, G66
G66
G66
C94, H01(7)
H01(7)
C94, H01(7)
H01(7)
C94, H01(7)
H01(7)
C94, H01(7)
C94, H01(7)
H01(7)
C94, H01(7)
C94, H01(7)
volume ground.
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 45
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
ONION (con't)
WP NA
WP NA
Low volume spray (concentrate) ., Foliar., WP NA
Aircraft.
WP NA
WP NA
Low volume spray (concentrate) ., Foliar., WP NA
Low volume ground.
Soil band treatment . , At planting. , Not on EC NA
label .
Soil band treatment . , Preplant . , Not on EC NA
label .
Soil broadcast treatment. , At planting. , Not EC NA
on label .
Soil broadcast treatment . , Preplant . , Not on EC NA
label .
Soil incorporated treatment . , Preplant . , Not EC NA
on label .
ONIONS (GREEN)
Chemigation. , Foliar. , Center pivot WP NA
irrigation.
Chemigation. , Foliar. , Hand move irrigation. WP NA
Chemigation. , Foliar. , Moving wheel WP NA
irrigation.
Chemigation. , Foliar. , Solid set irrigation. WP NA
High volume spray (dilute) ., Foliar., High WP NA
.18
.193
2
.18
.193
.18
1
1
1
1
1
.18
.18
.18
.18
.18
Use Group
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Use Group
Ib A *
Ib A *
Ib A *
Ib A *
Ib A *
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
@ Max. Rate unless noted Interv Entry Allowed
/crop /year otherwise) /A] (days) Interv
cycle /crop /year [day(s)]
cycle
: TERRESTRIAL
4
4
4
4
4
4
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
3
3
3
3
3
NS
NS
NS
NS
NS
POOD CROP (con't)
NS NS 14 2
NS NS 7 1
NS NS 14 1
NS NS 14 2
NS NS 7 1
NS NS 14 2
NS NS NS 0.5
NS NS NS 0.5
NS NS NS 0.5
NS NS NS 0.5
NS NS NS 0.5
FOOD CROP
NS NS 14 2
NS NS 14 2
NS NS 14 2
NS NS 14 2
NS NS 14 2
Limitations Use
Disallowed Limitations
Codes
C92, H01(7)
C92, C94, H01(7)
C92, C94, H01(7)
C92, H01(7)
C92, C94, H01(7)
C92, H01(7)
C92
C92
C92
C92
C92
C92, HOI (21)
C92, HOI (21)
C92, H01(21)
C92, H01(21)
C92, H01(21)
volume ground.
Low volume spray (concentrate)., Foliar., WP
Aircraft.
.18 Ib A
C92, H01(21)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 46
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
ONIONS (GREEN) (con't)
Low volume spray (concentrate) ., Foliar., WP NA
Low volume ground.
Soil band treatment., At planting., Not on EC NA
label .
Soil band treatment., Preplant . , Not on EC NA
label .
Soil broadcast treatment., At planting., Not EC NA
on label .
Soil broadcast treatment., Preplant., Not on EC NA
label .
Soil incorporated treatment., Preplant., Not EC NA
Use Group
.18 Ib A *
1 Ib A *
1 Ib A *
1 Ib A *
1 Ib A *
1 Ib A *
: TERRESTRIAL
3
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
POOD CROP
NS
NS
NS
NS
NS
NS
( con ' t )
NS 14 2 C92, HOI (21)
NS NS 0.5 C92
NS NS 0.5 C92
NS NS 0.5 C92
NS NS 0.5 C92
NS NS 0.5 C92
on label.
PAPAYA
Soil broadcast treatment., Transplant., Not EC
on label.
Soil drench treatment., Nurserystock., Not EC
on label.
PEANUTS
Slurry., Seed., Mist-type seed treater. F1C
Slurry., Seed., Slurry-type seed treater. F1C
PEANUTS (UNSPECIFIED)
Broadcast., At pegging., Spreader.
Use Group: TERRESTRIAL FOOD CROP
3.5 Ib A * NS 2/1 yr NS NS 14 0.5 HI
3.403 Ib A * NS 2/1 yr
NS
NS 30 0.5 HI
Chemigation., At pegging., Overhead
sprinkler irrigation.
G
G
EC
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL FEED CROP
.031 Ib cwt * NS NS NS NS NS NS
.031 Ib cwt * NS NS NS NS NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
.5 Ib A * NS NS .75 Ib NS NS 0.5
1 Ib A * NS NS 1 Ib NS NS 0.5
1 Ib A * NS NS NS NS NS 0.5
Chemigation., Foliar., Overhead sprinkler EC
irrigation.
Seed treatment., At planting., Planter/seed D
box.
1 Ib A * NS NS
NS
.016 Ib cwt
NS NS 0.5
NS NS 0.5
C92, HOI(90)
CAE, G66
CAE, G66
C92, GL9, HOI(75)
C92, GL9
C92
C92
C92, G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 47
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
PEANUTS (UNSPECIFIED) (con't)
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
Soil band treatment., At pegging., Granule
applicator.
Soil band treatment., At planting., Granule
applicator.
Soil band treatment., At planting., Not on
label .
Soil in-furrow treatment., At planting.,
Granule applicator.
Soil in-furrow treatment., At planting., Not
on label .
Soil incorporated treatment., At planting.,
Granule applicator.
Min. Appl . Max. Appl . Soil Max. tt Apps
Rate (AI un- Rate (AI Tex. @ Max. Rate
less noted unless noted Max. /crop /year
otherwise) otherwise) Dose cycle
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
Use Group: TERRESTRIAL FOOD+FEED
D
D
D
D
D
F1C
F1C
G
G
G
G
EC
G
EC
G
G
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.031 Ib cwt
.016 Ib cwt
.016 Ib cwt
.031 Ib cwt
.016 Ib cwt
.031 Ib cwt
.031 Ib cwt
.5 Ib A
1 Ib A
.041 Ib IK linear
ft
.25 Ib A
.25 Ib A
.020 Ib IK linear
ft
.25 Ib A
.25 Ib A
.25 Ib A
* 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
.75 Ib
1 Ib
NS
NS
NS
NS
NS
.75 Ib
1 Ib
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
NS
0.5
1
NS
NS
NS
0.5
0.5
NS
NS
0.5
NS
0.5
0.5
0.5
C92, G66
C92, G66, G73, GI2
C92, G66
C92, G66
C92, G66, G73, GI2
CAE, G66
CAE, G66
C92, GL9, HOI (75)
C92, GL9
C92, H01(0)
C92, H01(0)
C92
C92, H01(0)
C92
C92, GL9, HOI (75)
C92, GL9
PEAS (INCLUDING VINES)
Seed treatment., At planting., Planter/seed D
box.
D
Seed treatment., At planting., Seed treater. D
Use Group: TERRESTRIAL FEED CROP
.031 Ib cwt * NS
NS
NA
NA
.031 Ib cwt
.031 Ib cwt
NS NS
NS NS
NS
NS
NS NS 2
NS NS NS
NS NS 2
C92, G66
C92, G66
C92, G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 48
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
PEAS (INCLUDING VINES) (con't)
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
PEAS (UNSPECIFIED)
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Seed treatment., Seed., Mist-type seed
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
D
D
D
D
D
D
D
D
EC
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
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
.031
.031
.027
.026
.031
.031
.027
.026
.031
.031
.156
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Use Group
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Use Group
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
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
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FEED CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
( con ' t )
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
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
1
2
NS
0.5
1
2
NS
NS WA
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
G66
G66
C93,
C92,
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
G66
G66
G66
G66
G66
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 49
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
PEAS (UNSPECIFIED) (con't)
WP
WP
Seed treatment., Seed., Slurry-type seed EC
treater .
WP
WP
WP
WP
Slurry., Seed., Mist-type seed treater. EC
F1C
F1C
F1C
WP
WP
WP
WP
Slurry., Seed., Slurry-type seed treater. EC
F1C
F1C
F1C
WP
WP
WP
WP
Use Group: TERRESTRIAL
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.070
.070
.156
.070
.07
.070
.07
.068
.078
.070
.088
.078
.078
.070
.071
.068
.078
.070
.088
.078
.078
.070
.071
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
* 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
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
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
(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 ID
NS WA
NS
NS CA
NS ID
NS WA
NS
NS
NS
NS
NS
NS
NS CA
NS WA
NS
NS
NS
NS
NS
NS
NS CA
NS WA
G66
G66
G66
G66
G66
G66
G66
C46, C93, G66
C46, C92, G66
CAE, G66
G66
C92
C92, G66
G66
G66
C46, C93, G66
C46, C92, G66
CAE, G66
G66
C92
C92, G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 50
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
PEAS, FIELD
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
PEAS, SUCCULENT
Seed treatment., At planting., Planter/seed
D
D
RTU
D
D
EC
F1C
F1C
F1C
RTU
WP
WP
EC
F1C
F1C
F1C
RTU
WP
WP
D
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
.031
.031
.019
.031
.031
.031
.031
.070
.088
.019
.078
.078
.031
.031
.070
.088
.019
.078
.078
.031
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Use Group
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Use Group
cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
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
: TERRESTRIAL
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
CROP
NS
NS
NS
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
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
2
NS
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
Limitations Use
Disallowed Limitations
Codes
C92,
C92,
C46,
C92,
C92,
C46,
C46,
CAE,
G66
C46,
C92
C92,
C46,
C46,
CAE,
G66
C46,
C92
C92,
C92,
G66
G66
C92,
G66
G66
C93,
C92,
G66
C92,
G66
C93,
C92,
G66
C92,
G66
G66
G66
G66
G66
G66
G66
G66
G66
box.
D NA
Seed treatment., At planting., Seed treater. D NA
.031 Ib cwt
.031 Ib cwt
NS
NS
NS
NS
NS NS NS
NS NS NS
NS
2
C92, G66
C92, G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 51
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
PEAS, SUCCULENT (con't)
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
PEPPER
Broadcast., At planting., Granule
applicator.
Broadcast., Preplant . , Granule applicator.
Chemigation. , Foliar., Center pivot
irrigation.
Chemigation., Foliar., Moving wheel
irrigation.
Chemigation., Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar.,
Ground .
Low volume spray (concentrate) ., Foliar.,
Aircraft .
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
G
G
WP
WP
WP
WP
WP
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
Use Group
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.070 Ib cwt *
.088 Ib cwt *
.078 Ib cwt *
.078 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.070 Ib cwt *
.088 Ib cwt *
.078 Ib cwt *
.078 Ib cwt *
Use Group
1 Ib A *
1 Ib A *
.25 Ib A *
.25 Ib A *
.25 Ib A *
.25 Ib A *
.25 Ib A *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
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
: TERRESTRIAL
NS
NS
4
4
4
4
4
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED CROP
NS
NS
NS
NS
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
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
10
10
10
10
10
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
0.5
2
2
2
2
2
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
CAE
CAE
G66
C93, G66
C92, G66
G66
G66
C93, G66
C92, G66
G66
G66
C92, C94, CAG,
H01(7)
C92, C94, CAG,
H01(7)
C92, C94, CAG,
H01(7)
C92, C94, CAG,
H01(7)
C92, C94, CAG,
H01(7)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 52
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
PEPPER (con't)
Soil band treatment., At planting., Not on
label.
Soil broadcast treatment., At planting.,
Drip irrigation.
Soil broadcast treatment., At planting., Not
on label.
Use Group: TERRESTRIAL FOOD CROP (con't)
Ib A * NS NS 3 Ib NS NS 0.5
Ib A * NS NS NS NS NS 0.5
Ib A * NS NS 3 Ib NS NS 0.5
C92, H01(7)
C92, H01(7)
Soil broadcast treatment., At planting.,
Overhead sprinkler irrigation.
Soil broadcast treatment., Preplant., Drip
irrigation.
Soil broadcast treatment., Preplant., Not on
label.
Soil broadcast treatment., Preplant.,
Overhead sprinkler irrigation.
PINEAPPLE
Dip., Preplant., Not on label.
POTATO, WHITE/IRISH
Chemigation., Foliar., Center pivot
irrigation.
WP
WP
Chemigation., Foliar., Hand move irrigation.
Chemigation., Foliar., Moving wheel
irrigation.
NA
NA
.681 Ib A *
.681 Ib A *
.681 Ib A *
NS NS
NS NS
NS NS
.681 Ib A * NS NS
.681 Ib A
NS NS NS 0.5
NS NS NS 0.5
NS
NS NS 0.5
NS NS 0.5
NS NS 0.5
Use Group
EC
NA
1
Ib
A *
Use Group
WP
WP
WP
WP
WP
WP
WP
NA
NA
NA
NA
NA
NA
NA
.2
.158
.18
.25
.158
.18
.158
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A *
A *
A *
A *
A *
A *
A *
: TERRESTRIAL
NS
NS
: TERRESTRIAL
4
4
4
NS
4
4
4
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
CROP
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
14
14
14
14
14
14
14
0.!
1
1
2
2
1
2
1
C92
C92
C92
C92, C94, H01(14),
H01(3)
C92, C94, H01(3)
C92, H01(7)
C92, C94, CAG,
HOI (21)
C92, C94, HOI(3)
C92, HOI(7)
C92, C94, HOI(3)
.18 Ib A
C92, HOI(7)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 53
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
POTATO, WHITE/IRISH (con't)
Chemigation. , Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar.,
Ground .
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Aircraft .
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
Spray., Foliar., Ground.
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: TERRESTRIAL
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.25
.2
.158
.18
.25
.25
2
.158
.18
.2
.158
.18
2
2
.25
.18
2
2
lb
Ib
lb
lb
lb
lb
lb
lb
lb
lb
lb
lb
lb
lb
lb
lb
lb
lb
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
* NS
* 4
* 4
* 4
* NS
* NS
* 4
* 4
* 4
* 4
* 4
* 4
* 4
* 4
* NS
* 4
* 4
* 4
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
CROP (con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
2
1
1
2
2
2
1
1
2
1
1
2
NS ME
NS ND
2
2
NS ME
NS ND
C92, C94, CAG,
HOI (21)
C92, C94, H01(14) ,
H01(3)
C92, C94, H01(3)
C92, H01(7)
C92, C94, CAG,
HOI (21)
C92, C94, CAG,
H01(21)
C92, C94, H01(14) ,
H01(3)
C92, C94, H01(3)
C92, H01(7)
C92, C94, H01(14) ,
H01(3)
C92, C94, H01(3)
C92, H01(7)
H01(7)
H01(7)
C92, C94, CAG,
H01(21)
C92, H01(7)
H01(7)
H01(7)
Use Group: TERRESTRIAL FOOD CROP
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 54
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil
Timing, Application Equipment Rate (AI un- Rate (AI Tex.
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max.
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
PUMPKIN (con't)
Chemigation. , Foliar., Center pivot WP NA
irrigation.
Chemigation., Foliar., Hand move irrigation. WP NA
Chemigation., Foliar., Moving wheel WP NA
irrigation.
Chemigation., Foliar., Solid set irrigation. WP NA
High volume spray (dilute) ., Foliar., High WP NA
volume ground.
Low volume spray (concentrate) ., Foliar., WP NA
Aircraft .
Low volume spray (concentrate) ., Foliar., WP NA
Low volume ground.
RADISH
Low volume spray (concentrate) ., Foliar., WP NA
Aircraft .
Spray., Foliar., Ground. WP NA
RASPBERRY (BLACK, RED)
Soil band treatment., Postharvest . , Granule G NA
applicator.
Soil band treatment., Postharvest., Not on EC NA
label .
Soil band treatment., Spring., Granule G NA
applicator.
Soil band treatment., Spring., Not on label. EC NA
RICE
Chemigation., Preplant . , Center pivot EC NA
Use Group
.27 Ib A *
.27 Ib A *
.27 Ib A *
.27 Ib A *
.27 Ib A *
.27 Ib A *
.27 Ib A *
Use Group
.2 Ib A *
.2 Ib A *
Use Group
.25 Ib IK linear *
ft
.25 Ib IK linear *
ft
.25 Ib IK linear *
ft
.25 Ib IK linear *
ft
Use Group
.5 Ib A *
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
@ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
/crop /year otherwise) /A] (days) Interv Codes
cycle /crop /year [day(s)]
cycle
: TERRESTRIAL
4
4
4
4
4
4
4
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
2/1 yr
2/1 yr
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
FOOD CROP (con't)
NS NS 10 2 C92, H03
NS NS 10 2 C92, H03
NS NS 10 2 C92, H03
NS NS 10 2 C92, H03
NS NS 10 2 C92, H03
NS NS 10 2 C92, H03
NS NS 10 2 C92, H03
FOOD CROP
NS NS 14 NS WA C14, GF9, GI9, GO3
NS NS 14 NS WA C14, GF9, GI9, GO3
FOOD CROP
NS NS NS NS C92, HOI (45)
NS NS NS 0.5 C92, HOI (45)
NS NS NS NS C92, HOI (45)
NS NS NS 0.5 C92, HOI (45)
FOOD+FEED CROP
NS NS NS NS LA
irrigation.
Chemigation., Preplant., Drip irrigation. EC
.5 Ib A * NS NS
NS NS NS LA
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 55
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
RICE (con't)
Chemigation. , Preplant . , Hand move
irrigation.
Chemigation., Preplant., Moving wheel
irrigation.
Chemigation., Preplant., Solid set
irrigation.
Chemigation., Preplant., Sprinkler
irrigation.
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
EC
EC
EC
EC
D
D
D
D
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL
.5 Ib A * NS NS
.5 Ib A * NS NS
.5 Ib A * NS NS
.5 Ib A
.024
.035
.031
.031
.024
.035
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
* 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
FOOD+FEED
NS
NS
NS
NS
NS
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
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
(con't)
NS NS LA
NS NS LA
NS NS LA
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS LA
0.5
1
2
NS
0.5
1
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
G66
G66
G66
G66
G66
G66
G66
C93,
C92,
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 56
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
RICE (con't)
F1C
WP
WP
Soil broadcast treatment., Preplant . , EC
Use Group: TERRESTRIAL
NA
NA
NA
NA
.035 Ib cwt
.031 Ib cwt
.031 Ib cwt
.5 Ib A
* NS
* NS
* NS
* NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
CROP
NS
NS
NS
NS
(con't)
NS
NS
NS
NS
NS G66
NS C92
NS C92, G66
NS LA
Aircraft.
Soil broadcast treatment., Preplant.,
Ground.
ROOT AND TUBER VEGETABLES
Soil band treatment., At planting., Sprayer.
Soil band treatment., Preplant., Soil
incorpation equipment.
Soil broadcast treatment., At planting.,
Sprayer.
Soil broadcast treatment., Preplant., Soil
incorpation equipment.
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
EC
EC
NA
NA
.5 Ib A * NS
NS
NS
NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
Ib A * NS NS NS NS NS 0.5
Ib A * NS NS NS NS NS 0.5
2 Ib A * NS
Ib A
NS
NS
NS
NS
NS
NS NS
NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
.031 Ib cwt * NS NS NS NS NS
0.5
D
D
D
EC
F1C
F1C
F1C
WP
WP
NA
NA
NA
NA
NA
NA
NA
NA
NA
.031
.031
.031
.031
.031
.031
.035
.031
.031
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
* 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
2
NS
NS
NS
NS
NS
NS
NS
C92
C92
C92, G66
C92, G66
C92, G66
C92, G66
C46, C93, G66
C46, C92, G66
CAE, G66
G66
C92
C92, G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 57
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
RYE (con't)
Slurry., Seed., Slurry-type seed treater.
SMALL GRAINS
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
EC
F1C
F1C
F1C
WP
WP
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
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
.031
.031
.031
.035
.031
.031
.031
.031
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
.031
.031
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Use Group
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Use Group
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
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
FOOD+FEED CROP
NS
NS
NS
NS
NS
NS
FEED 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
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
(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
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C46,
C46,
CAE,
G66
C92
C92,
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
C93,
C92,
G66
G66
G66
G66
G66
G66
C93,
C92,
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 58
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SORGHUM
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
SORGHUM (UNSPECIFIED)
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
F1C
F1C
EC
F1C
EC
F1C
D
D
D
D
D
EC
F1C
F1C
WP
WP
EC
F1C
F1C
WP
WP
Min. Appl . Max. Appl .
Rate (AI un- Rate (AI
less noted unless noted
otherwise) otherwise)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.031
.031
.031
.031
.031
.031
.063
.063
.063
.063
.063
.219
.062
.234
.219
.219
.219
.062
.234
.219
.219
Use
Ib cwt
Ib cwt
Use
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Use
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Soil Max. tt Apps Max. Dose [ (AI Min.
Tex. @ Max. Rate unless noted Interv
Max. /crop /year otherwise) /A] (days)
Dose cycle /crop /year
cycle
Group : TERRESTRIAL
* NS
* NS
NS
NS
Group : TERRESTRIAL
* NS
* NS
* NS
* NS
NS
NS
NS
NS
Group : TERRESTRIAL
* 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
FEED CROP
NS
NS
FOOD + FEED
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
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
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
NS
NS
NS
NS
NS
NS
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Limitations Use
Disallowed Limitations
Codes
CAE,
CAE,
G66
CAE,
G66
CAE,
C92,
C92,
C92,
C92,
G66
C46,
CAE,
G66
C92
C92,
C46,
CAE,
G66
C92
C92,
G66
G66
G66
G66
G66
G66
G66
G66
C93, G66
G66
G66
C93, G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 59
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SOYBEANS
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
SOYBEANS (UNSPECIFIED)
Seed treatment., At planting., Planter/seed
box.
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
D
D
D
D
RTU
RTU
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
.031
.031
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
.031
.031
.027
.026
.031
.013
.019
.002557
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Use Group
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Use Group
cwt *
cwt *
cwt *
cwt *
cwt *
cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
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
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FEED CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
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
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
1
NS
NS
NS
NS
Limitations Use
Disallowed Limitations
Codes
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
C92,
C92,
C92,
C92,
C46,
G79
G66
G66
G66
G66
C93,
C92,
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
G66,
C92,
G66
G66
G66
G66
G73
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 60
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SOYBEANS (UNSPECIFIED) (con't)
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
Soil band treatment., At planting., Granule
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: TERRESTRIAL
D
D
D
D
D
EC
EC
F1C
F1C
F1C
RTU
WP
WP
EC
EC
F1C
F1C
F1C
RTU
WP
WP
G
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.027
.026
.031
.013
.031
.031
.031
.031
.031
.035
.019
.031
.031
.031
.031
.031
.031
.035
.019
.031
.031
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
Ib cwt
49 Ib A
* 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
FOOD+FEED
NS
NS
NS
NS
NS
NS
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
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
1
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92,
C92,
C92,
C92,
G66
C46,
G66
C46,
CAE,
G66
C46,
C92
C92,
C46,
G66
C46,
CAE,
G66
C46,
C92
C92,
C92,
G66
G66
G66
G66,
C93,
C92,
G66
C92,
G66
C93,
C92,
G66
C92,
G66
G73
G66
G66
G66
G66
G66
G66
H01(0)
applicator.
Soil band treatment., At planting., Not on
label.
1.25 Ib A * NS
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 61
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SOYBEANS (UNSPECIFIED) (con't)
Soil broadcast treatment., At planting., Not
on label .
Soil in-furrow treatment., At planting.,
Granule applicator.
Soil in-furrow treatment., At planting.,
Sprayer.
SOYBEANS, EDIBLE
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
EC
G
EC
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
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
1.
Use Group
25 Ib A *
.245 Ib A *
.017 Ib IK
.031
.031
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
.031
.031
linear *
ft
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
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
FOOD+FEED
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
CROP (con't)
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
NS
NS
NS
0.5
NS
0.5
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92
C92,
C92
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
H01(0)
G66
G66
G66
G66
C93, G66
C92, G66
G66
G66
C93, G66
C92, G66
G66
G66
Use Group: TERRESTRIAL FOOD CROP
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 62
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SPINACH (con't)
Broadcast., At planting., Granule G NA
applicator.
Broadcast., Preplant . , Granule applicator. G NA
Soil band treatment., At planting., Granule G NA
applicator.
Soil band treatment., Preplant., Granule G NA
applicator.
Soil band treatment., Preplant., Not on EC NA
label .
Soil broadcast treatment., At planting., WP NA
Drip irrigation.
Soil broadcast treatment., At planting., G NA
Granule applicator.
Soil broadcast treatment., At planting., Not WP NA
on label .
Soil broadcast treatment., At planting., WP NA
Overhead sprinkler irrigation.
Soil broadcast treatment., Preplant., Drip WP NA
irrigation.
Soil broadcast treatment., Preplant., G NA
Granule applicator.
Soil broadcast treatment., Preplant., Not on WP NA
label .
Soil broadcast treatment., Preplant., WP NA
Overhead sprinkler irrigation.
Soil in-furrow treatment., At planting., G NA
Granule applicator.
Use Group: TERRESTRIAL FOOD CROP (con't)
1 Ib A * NS NS NS NS NS 0.5
1 Ib A * NS NS NS NS NS 0.5
2 Ib A * NS NS NS NS NS NS
2 Ib A * NS NS NS NS NS NS
2 Ib A * NS NS NS NS NS 0.5
.681 Ib A * NS NS NS NS NS 0.5
2 Ib A * NS NS NS NS NS NS
.681 Ib A * NS NS NS NS NS 0.5
.681 Ib A * NS NS NS NS NS 0.5
.681 Ib A * NS NS NS NS NS 0.5
2 Ib A * NS NS NS NS NS NS
.681 Ib A * NS NS NS NS NS 0.5
.681 Ib A * NS NS NS NS NS 0.5
.063 Ib IK linear * NS NS NS NS NS NS
ft
CAE
CAE
C92, H01(21)
C92, HOI (21)
C92, HOI (21)
C92
C92, H01(21)
C92
C92
C92
C92, H01(21)
C92
C92
C92, H01(21)
Soil incorporated treatment., Fall., Ground. G NA
Soil incorporated treatment., Preplant., Not EC NA
on label.
.5 Ib A * 2
2 Ib A * NS
NS
NS
NS NS NS NS OK
NS NS NS 0.5
H01(21)
C92, H01(21)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 63
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SPINACH (con't)
Soil shanking treatment., At planting., Not EC
on label.
Soil treatment., Late winter., Ground. G
Soil treatment., Postemergence., Granule G
applicator.
SQUASH (ALL OR UNSPECIFIED)
Broadcast., At planting., Granule G
applicator.
Broadcast., Preplant., Granule applicator. G
Soil broadcast treatment., At planting., WP
Drip irrigation.
Soil broadcast treatment., At planting., Not WP
on label.
Soil broadcast treatment., At planting., WP
Overhead sprinkler irrigation.
Soil broadcast treatment., Preplant., Drip WP
irrigation.
Soil broadcast treatment., Preplant., Not on WP
label.
Soil broadcast treatment., Preplant., WP
Overhead sprinkler irrigation.
SQUASH (SUMMER)
Chemigation., Foliar., Center pivot WP
irrigation.
Chemigation., Foliar., Hand move irrigation. WP
NA
NA
NA
NA
Use Group: TERRESTRIAL FOOD CROP (con't)
.25 Ib A * NS NS NS NS NS 0.5
.5 Ib A
.25 Ib A
NS
NS
NS
NS
Use Group: TERRESTRIAL FOOD CROP
1 Ib A * NS NS NS
1 Ib A * NS NS NS
.681 Ib A * NS NS NS
.681 Ib A * NS NS NS
.681 Ib A * NS NS NS
.681 Ib A * NS NS NS
.681 Ib A * NS NS NS
.681 Ib A * NS NS NS
Use Group: TERRESTRIAL FOOD CROP
NS NS NS OK
NS NS NS
NS NS
NS NS
0.5
NS NS 0.5
NS NS 0.5
0.5
NS NS 0.5
NS NS 0.5
WP
WP
WP
WP
NA
NA
NA
NA
.2 Ib A * 4
.193 Ib A * 4
.27 Ib A * 4
.193 Ib A * 4
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
14
7
10
7
1
1
2
1
C92, HOI(21)
HOI (21)
C92, H01(21)
CAE
CAE
C92
C92
C92, H03
C92, C94, HOI(5)
C92, C94, HOI(5)
C92, H03
C92, C94, HOI(5)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 64
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SQUASH (SUMMER) (con't)
Chemigation. , Foliar., Moving wheel
irrigation.
Chemigation., Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Aircraft.
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
SQUASH (WINTER)
Chemigation., Foliar., Center pivot
irrigation.
Chemigation., Foliar., Hand move irrigation.
Chemigation., Foliar., Moving wheel
irrigation.
Chemigation., Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar., High
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group:
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
WP
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.27
.193
.27
.2
.193
.27
2
.193
.27
.2
.193
.27
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
Use Group:
WP
WP
WP
WP
WP
NA
NA
NA
NA
NA
.27
.27
.27
.27
.27
Ib
Ib
Ib
Ib
Ib
A *
A *
A *
A *
A *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
TERRESTRIAL
4
4
4
4
4
4
4
4
4
4
4
4
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
TERRESTRIAL
4
4
4
4
4
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
( con ' t )
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
10
7
10
14
7
10
14
7
10
14
7
10
10
10
10
10
10
2
1
2
1
1
2
1
1
2
1
1
2
2
2
2
2
2
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
H03
C94,
H03
C94,
C94,
H03
C94,
C94,
H03
C94,
C94,
H03
H03
H03
H03
H03
H03
HOI (5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
H01(5)
volume ground.
Low volume spray (concentrate)., Foliar.,
Aircraft.
.27 Ib A * 4
C92, H03
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 65
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SQUASH (WINTER) (con't)
Low volume spray (concentrate) ., Foliar., WP
Low volume ground.
STONE FRUITS
Soil band treatment., Foliar., Sprayer. EC
Soil band treatment., Postplant . , Sprayer. EC
Soil band treatment., Spring., Sprayer. EC
Soil broadcast treatment., Foliar., Sprayer. EC
Soil broadcast treatment., Postplant., EC
Sprayer.
Soil broadcast treatment., Spring., Sprayer. EC
STRAWBERRY
Chemigation. , During harvest., Drip EC
irrigation.
Chemigation., Foliar., Drip irrigation. EC
Chemigation., Postharvest . , Drip irrigation. EC
Chemigation., Posttransplant . , Drip EC
irrigation.
Chemigation., Prebloom., Drip irrigation. EC
High volume spray (dilute) ., Nurserystock . , EC
High volume ground.
Soil band treatment., During harvest., EC
Ground .
EC
Soil band treatment., Foliar., Ground. EC
EC
Soil band treatment., Postharvest., Ground. EC
EC
Min. Appl .
Rate (AI un-
less noted
otherwise)
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Max. Appl. Soil
Rate (AI Tex.
unless noted Max.
otherwise) Dose
Use Group
.27 Ib A *
Use Group
4 Ib A *
4 Ib A *
4 Ib A *
4 Ib A *
4 Ib A *
4 Ib A *
Use Group
.5 gal A *
.5 gal A *
.5 gal A *
.5 gal A *
.5 gal A *
.5 gal A *
1 Ib A *
.5 gal A *
1 Ib A *
.5 gal A *
1 Ib A *
.5 gal A *
Max . tt Apps
@ Max. Rate
/crop /year
cycle
: TERRESTRIAL
4 NS
: TERRESTRIAL
NS 3/1 yr
NS 3/1 yr
NS 3/1 yr
NS 3/1 yr
NS 3/1 yr
NS 3/1 yr
: TERRESTRIAL
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
3 NS
NS NS
3 NS
NS NS
3 NS
NS NS
Max. Dose [ (AI
unless noted
otherwise) /A]
/crop /year
cycle
FOOD CROP (con1
NS NS
FOOD CROP
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
FOOD CROP
NS 1.5 gal
NS 1.5 gal
NS 1.5 gal
NS 1.5 gal
NS 1.5 gal
1 gal NS
NS 3 Ib
NS 1.5 gal
NS 3 Ib
NS 1.5 gal
NS 3 Ib
NS 1.5 gal
Min.
Interv
(days)
t)
10
60
60
60
60
60
60
NS
NS
NS
NS
NS
30
NS
NS
NS
NS
NS
NS
Restr. Geographic Limitations
Entry Allowed Disallowed
Interv
[day(s) ]
2
0.5
0.5
0.5
0.5
0.5
0.5
NS CA
NS CA
NS CA
NS CA
NS CA
NS CA
0.5
NS CA
0.5
NS CA
0.5
NS CA
Use
Limitations
Codes
C92, H03
C92, G03, GM1
C92, G03, GM1
C92, G03, GM1
C92, G03, GM1
C92, G03, GM1
C92, G03, GM1
C92
C92
C92
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 66
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
STRAWBERRY (con't)
Soil band treatment., Posttransplant., EC NA
Ground.
EC NA
Soil band treatment., Prebloom., Ground. EC NA
Soil band treatment., Preharvest., Ground. EC NA
Soil band treatment., Spring., Ground. EC NA
Soil broadcast treatment., During harvest., EC NA
Drip irrigation.
Soil broadcast treatment., During harvest., EC NA
Ground.
Soil broadcast treatment., Foliar., Drip EC NA
irrigation.
Soil broadcast treatment., Foliar., Ground. EC NA
EC NA
Soil broadcast treatment., Postharvest., EC NA
Drip irrigation.
Soil broadcast treatment., Postharvest., EC NA
Ground.
Soil broadcast treatment., Posttransplant., EC NA
Drip irrigation.
Soil broadcast treatment., Posttransplant., EC NA
Ground.
Soil broadcast treatment., Prebloom., EC NA
Ground.
Soil broadcast treatment., Preharvest., Drip EC NA
irrigation.
Use Group: TERRESTRIAL FOOD CROP (con't)
1 Ib A * 3 NS NS 3 Ib NS 0.5
.5 gal A * NS NS
.5 gal A * NS NS
1 Ib A * 3 NS
1 Ib A * 3 NS
1 Ib A * 3 NS
1 Ib A
3 NS
.5 gal A * NS NS
1 Ib A * 3 NS
1 Ib A * 3 NS
.5 gal A * NS NS
1 Ib A * 3 NS
1 Ib A * 3 NS
.5 gal A * NS NS
1 Ib A * 3 NS
1 Ib A * 3 NS
.5 gal A * NS NS
.5 gal A * NS NS
1 Ib A * 3 NS
NS 1.5 gal NS NS CA
NS 1.5 gal NS NS CA
NS 3 Ib NS 0.5
NS 3 Ib NS 0.5
NS 3 Ib NS 0.5
NS
3 Ib NS 0.5
NS 1.5 gal NS NS CA
NS 3 Ib NS 0.5
NS 3 Ib NS 0.5
NS 1.5 gal NS NS CA
NS 3 Ib NS 0.5
NS
3 Ib NS 0.5
NS 1.5 gal NS NS CA
NS 3 Ib NS 0.5
NS
3 Ib NS 0.5
NS 1.5 gal NS
NS 1.5 gal NS
NS CA
NS CA
C92
C92
C92
C92
NS
3 Ib NS 0.5
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 67
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
STRAWBERRY (con't)
Soil broadcast treatment., Preharvest . ,
Ground .
Soil broadcast treatment., Spring., Drip
irrigation.
Soil broadcast treatment., Spring., Ground.
SUGAR BEET
Chemigation. , Foliar., Center pivot
irrigation.
Chemigation., Foliar., Solid set irrigation.
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Aircraft .
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Seed treater.
EC
EC
EC
WP
WP
WP
WP
D
D
RTU
D
D
EC
F1C
F1C
RTU
WP
WP
F1C
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.031
.031
.029
.031
.031
.031
.031
.035
.029
.031
.031
.031
Use Group
1 Ib A *
1 Ib A *
1 Ib A *
Use Group
.2 Ib A *
. 2 Ib A *
.2 Ib A *
. 2 Ib A *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
: TERRESTRIAL
3
3
3
NS
NS
NS
: TERRESTRIAL
4
4
4
4
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
FOOD CROP
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
( con ' t )
3 Ib
3 Ib
3 Ib
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
14
14
14
14
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
0.5
0.5
1
1
1
1
2
NS
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
C92
C92
C92
C92, C94, GAS,
H01(14)
C92, C94, GAS,
H01(14)
C92, C94, GAS,
H01(14)
C92, C94, GAS,
H01(14)
C92, G66
C92, G66
C46, C92, G66
C92, G66
C92, G66
C46, C93, G66
CAE, G66
G66
C46, C92, G66
C92
C92, G66
C46, C92, G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 68
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SUGAR BEET (con't)
Slurry., Seed., Slurry-type seed treater.
Soil band treatment., At planting., Granule
applicator.
Soil band treatment., At planting., Sprayer.
Soil band treatment., Preplant . , Granule
applicator.
Soil band treatment., Preplant., Soil
incorpation equipment.
Soil broadcast treatment., At planting.,
Granule applicator.
Soil broadcast treatment., At planting.,
Sprayer.
Soil broadcast treatment., Preplant.,
Granule applicator.
Soil broadcast treatment., Preplant., Soil
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: TERRESTRIAL
EC
F1C
F1C
F1C
RTU
WP
WP
G
EC
G
EC
G
EC
G
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.031 Ib cwt
.031 Ib cwt
.031 Ib cwt
.035 Ib cwt
.029 Ib cwt
.031 Ib cwt
.031 Ib cwt
2 Ib A
2 Ib A
2 Ib A
2 Ib A
2 Ib A
2 Ib A
2 Ib A
2 Ib A
* 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
FOOD+FEED
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
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
(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
0.5
NS
0.5
NS
0.5
NS
0.5
C46, C93, G66
C46, C92, G66
CAE, G66
G66
C46, C92, G66
C92
C92, G66
C92
C92
C92
C92
C92
C92
C92
C92
incorpation equipment.
SUNFLOWER
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Use Group: TERRESTRIAL FOOD+FEED CROP
.063 Ib cwt * NS NS NS NS NS 2
D
D
D
NA
NA
NA
.063
.063
.063
Ib
Ib
Ib
cwt
cwt
cwt
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
2
NS
C92, G66
C92, G66
C92, G66
C92, G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 69
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
SUNFLOWER (con't)
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
TOMATO
Broadcast., At planting., Granule
applicator.
Broadcast., Preplant . , Granule applicator.
Chemigation. , Foliar., Center pivot
irrigation.
EC
F1C
F1C
WP
WP
EC
F1C
F1C
WP
WP
G
G
WP
WP
WP
WP
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
Use Group
.219 Ib cwt *
.207 Ib cwt *
.207 Ib cwt *
.219 Ib cwt *
.219 Ib cwt *
.219 Ib cwt *
.207 Ib cwt *
.207 Ib cwt *
.219 Ib cwt *
.219 Ib cwt *
Use Group
1 Ib A *
1 Ib A *
.27 Ib A *
.2 Ib A *
.193 Ib A *
.25 Ib A *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
4
4
4
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
CROP (con't)
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
10
14
7
5
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
0.5
2
1
1
2
C46,
C46,
CAE,
C92
C92,
C46,
C46,
CAE,
C92
C92,
CAE
CAE
C92,
C92,
C92,
C92,
C93, G66
C92, G66
G66
G66
C93, G66
C92, G66
G66
G66
H01(7)
C94, HOI (5)
C94, HOI (5)
C94, CAG,
H01(7)
Chemigation., Foliar., Hand move irrigation.
Chemigation., Foliar., Moving wheel
WP
WP
WP
NA
NA
NA
.27 Ib A *
.193 Ib A *
.27 Ib A *
4
4
4
NS
NS
NS
NS
NS
NS
NS
NS
NS
10
7
10
2
1
2
C92,
C92,
C92,
H01(7)
C94, HOI (5)
H01(7)
irrigation.
.193 Ib A
C92, C94, H01(5)
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 70
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
TOMATO (con't)
Min. Appl . Max. Appl . Soil Max. tt Apps
Rate (AI un- Rate (AI Tex. @ Max. Rate
less noted unless noted Max. /crop /year
otherwise) otherwise) Dose cycle
Max. Dose [ (AI Min. Restr. Geographic
unless noted Interv Entry Allowed
otherwise) /A] (days) Interv
/crop /year [day(s)]
cycle
Use Group: TERRESTRIAL FOOD+FEED
WP
NA
.25
Ib A
* NS
NS
NS
CROP
NS
(con't)
5 2
Limitations Use
Disallowed Limitations
Codes
C92,
C94, CAG,
H01(7)
Chemigation. , Foliar., Solid set irrigation.
WP
WP
WP
WP
NA
NA
NA
NA
.27
.2
.193
.25
Ib A
Ib A
Ib A
Ib A
* 4
* 4
* 4
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
10 2
14 1
7 1
5 2
C92,
C92,
C92,
C92,
H01(7)
C94, HOI (5)
C94, HOI (5)
C94, CAG,
H01(7)
High volume spray (dilute) ., Foliar.,
Ground .
High volume spray (dilute) ., Foliar., High
volume ground.
Low volume spray (concentrate) ., Foliar.,
Aircraft.
WP
WP
WP
WP
WP
WP
WP
WP
NA
NA
NA
NA
NA
NA
NA
NA
.25
.27
2
.193
.27
.2
.193
.25
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
* NS
* 4
* 4
* 4
* 4
* 4
* 4
* 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
5 2
10 2
14 1
7 1
10 2
14 1
7 1
5 2
C92, C94, CAG,
H01(7)
C92,
C92,
C92,
C92,
C92,
C92,
C92,
H01(7)
C94, HOI (5)
C94, HOI (5)
H01(7)
C94, H01(5)
C94, H01(5)
C94, CAG,
H01(7)
Low volume spray (concentrate) ., Foliar.,
Low volume ground.
Soil band treatment., At planting., Granule
applicator.
Soil band treatment., At planting., Not on
label .
Soil broadcast treatment., At planting.,
Drip irrigation.
Soil broadcast treatment., At planting.,
WP
G
EC
WP
G
NA
NA
NA
NA
NA
.27
1
2
.681
1
Ib A
Ib A
Ib A
Ib A
Ib A
* 4
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
2 Ib
3 Ib
NS
2 Ib
NS
NS
NS
NS
NS
10 2
NS NS
NS 0.5
NS 0.5
NS NS
C92,
C92,
C92
C92
C92,
H01(7)
H01(7)
H01(7)
Granule applicator.
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 71
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
TOMATO (con't)
Soil broadcast treatment., At planting., Not
on label .
Soil broadcast treatment., At planting.,
Overhead sprinkler irrigation.
Soil broadcast treatment., Plant bed.,
Sprayer.
Soil broadcast treatment., Preplant . , Drip
irrigation.
Soil broadcast treatment., Preplant., Not on
label .
Soil broadcast treatment., Preplant.,
Overhead sprinkler irrigation.
Soil incorporated treatment., Plant bed.,
Injection.
Soil treatment., At planting., Not on label.
Soil treatment., Foliar., Not on label.
TREFOIL
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
WP
WP
EC
WP
WP
WP
EC
EC
EC
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
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
Use Group
.681 Ib A *
.681 Ib A *
1 Ib A *
.681 Ib A *
.681 Ib A *
.681 Ib A *
1 Ib A *
2 Ib A *
1 Ib A *
Use Group
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.035 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
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
3 Ib
NS
NS
NS
3 Ib
3 Ib
3 Ib
FEED 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
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
0.5
0.5
0.5
0.5
0.5
0.5
0.5
0.5
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92, G66
C92, G66
C46, C93,
C46, C92,
CAE, G66
G66
C92
C92, G66
C46, C93,
C46, C92,
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 72
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
TREFOIL (con't)
TRITICALE
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
USE 22002
Slurry., Seed., Mist-type seed treater.
F1C
F1C
WP
WP
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
WP
F1C
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
.031
.035
.031
.031
.031
.031
.031
.031
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
.031
.031
.234
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Use Group
Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
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
: TERRESTRIAL
NS
NS
FEED CROP
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
( con ' t )
NS
NS
NS
NS
CROP
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
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CAE,
G66
C92
C92,
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
G66
G66
G66
G66
G66
G66
G66
C93,
C92,
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 73
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
USE 22002 (con'
Slurry. , Seed. ,
USE 26018
Slurry. , Seed. ,
Slurry. , Seed. ,
USE 26019
Slurry. , Seed. ,
Slurry. , Seed. ,
USE 26020
Slurry. , Seed. ,
Slurry. , Seed. ,
USE 26021
Slurry. , Seed. ,
Slurry. , Seed. ,
VETCH
Seed treatment.
box.
Seed treatment.
Slurry. , Seed. ,
t)
Slurry-type seed treater.
Mist-type seed treater.
Slurry-type seed treater.
Mist-type seed treater.
Slurry-type seed treater.
Mist-type seed treater.
Slurry-type seed treater.
Mist-type seed treater.
Slurry-type seed treater.
, At planting., Planter/seed
, At planting., Seed treater.
Mist-type seed treater.
F1C
F1C
F1C
F1C
F1C
F1C
F1C
EC
F1C
EC
F1C
D
D
EC
F1C
F1C
F1C
WP
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
.234
.035
.035
.070
.070
.035
.035
.031
.234
.031
.234
.031
.031
.031
.031
.031
.035
.031
Use Group
Ib cwt *
Use Group
Ib cwt *
Ib cwt *
Use Group
Ib cwt *
Ib cwt *
Use Group
Ib cwt *
Ib cwt *
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL FOOD+FEED
NS
NS NS
: TERRESTRIAL FOOD+FEED
NS
NS
NS NS
NS NS
: TERRESTRIAL FOOD+FEED
NS
NS
NS NS
NS NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
CROP (con't)
NS
CROP
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
G66
G66
G66
G66
G66
: TERRESTRIAL FOOD CROP
NS
NS
NS NS
NS NS
: TERRESTRIAL FOOD+FEED
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
G66
G66
G66
G66
G66
G66
: TERRESTRIAL FEED 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
C92, G66
C92, G66
C46, C93, G66
C46, C92, G66
CAE, G66
G66
C92
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 74
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
VETCH (con't)
Slurry., Seed., Slurry-type seed treater.
WALNUT (ENGLISH/BLACK)
Soil band treatment., Foliar., Sprayer.
Soil band treatment., Postplant . , Sprayer.
Soil band treatment., Spring., Sprayer.
Soil broadcast treatment., Foliar., Sprayer.
Soil broadcast treatment., Postplant.,
Sprayer.
Soil broadcast treatment., Spring., Sprayer.
WHEAT
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
WP
EC
F1C
F1C
F1C
WP
WP
EC
EC
EC
EC
EC
EC
D
D
D
D
D
D
D
D
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
Use Group
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
.035 Ib cwt *
.031 Ib cwt *
.031 Ib cwt *
Use Group
4 Ib A *
4 Ib A *
4 Ib A *
4 Ib A *
4 Ib A *
4 Ib A *
Use Group
.007969 Ib bu *
.007813 Ib bu *
.031 Ib cwt *
.031 Ib cwt *
.00585 Ib bu *
.007969 Ib bu *
.007813 Ib bu *
.031 Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
3/1 yr
3/1 yr
3/1 yr
3/1 yr
3/1 yr
3/1 yr
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
FEED CROP
NS
NS
NS
NS
NS
NS
NS
FOOD CROP
NS
NS
NS
NS
NS
NS
FOOD+FEED
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
( con ' t )
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
60
60
60
60
60
60
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
0.5
0.5
0.5
0.5
0.5
0.5
1
2
NS
NS
0.5
1
2
C92,
C46,
C46,
CAE,
G66
C92
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
C92,
G66
C93, G66
C92, G66
G66
G66
G03, GM1
G03, GM1
G03, GM1
G03, GM1
G03, GM1
G03, GM1
G66
G66
G66
G66
G66, GN3
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 75
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
WHEAT (con't)
D
D
Slurry., Seed., Mist-type seed treater. EC
F1C
F1C
F1C
WP
WP
Slurry., Seed., Slurry-type seed treater. EC
F1C
F1C
F1C
WP
WP
NON- FOOD/NON- FEED
Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv
less noted unless noted Max. /crop /year otherwise) /A] (days)
otherwise) otherwise) Dose cycle /crop /year
cycle
Use Group: TERRESTRIAL
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.031
.00585
.031
.031
.031
.035
.031
.031
.031
.031
.031
.035
.031
.031
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
Ib
cwt
bu
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
cwt
* 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
FOOD+FEED
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
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
(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
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
C92
C92,
G66
G66, GN3
C93, G66
C92, G66
G66
G66
C93, G66
C92, G66
G66
G66
COMMERCIAL/INDUSTRIAL LAWNS
Spray., Foliar., Not on label.
DECIDUOUS FRUIT TREES (UNSPECIFIED)
Soil band treatment., Nonbearing., Granule
applicator.
Soil band treatment., Nonbearing., Not on
label.
Soil broadcast treatment., Nonbearing
nurserystock., Granule applicator.
Use Group: TERRESTRIAL NON-FOOD CROP
2.800E-05 Ib * NS NS NS NS 7 1
sq.ft
Use Group: TERRESTRIAL NON-FOOD CROP
4 Ib A * 3 NS NS NS 60 NS
4 Ib A * NS NS
Ib A * NS NS
NS 12 Ib 90 0.5
NS NS 90 0.5
C46, C92, C94, GB9,
GC1
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 76
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
DECIDUOUS FRUIT TREES (UNSPECIFIED) (con't)
Soil broadcast treatment., Nonbearing
nurserystock . , Not on label.
Soil broadcast treatment., Nonbearing., Drip
irrigation.
Soil broadcast treatment., Nonbearing.,
Granule applicator.
Soil broadcast treatment., Nonbearing., Not
on label .
Soil broadcast treatment., Nonbearing.,
Overhead sprinkler irrigation.
GOLF COURSE TURF
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
EC
WP
G
EC
WP
WP
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
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
Use Group
9.375E-05 Ib *
sq.ft
1.875E-04 Ib *
sq.ft
4 Ib A *
4 Ib A *
1.875E-04 Ib *
sq.ft
1.875E-04 Ib *
sq.ft
Use Group
.063 Ib cwt *
.063 Ib cwt *
.063 Ib cwt *
.063 Ib cwt *
.063 Ib cwt *
.062 Ib cwt *
.031 Ib cwt *
.070 Ib cwt *
.063 Ib cwt *
.063 Ib cwt *
.063 Ib cwt *
.062 Ib cwt *
.031 Ib cwt *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
3
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
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
NS .
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
CROP (con't)
275 Ib
NS
NS
12 Ib
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
90
90
60
90
90
90
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
0.5
NS
0.5
0.5
0.5
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C92
C92
C92
C92
C92
C92
C92,
C92,
C92,
C92,
C46,
C46,
CAE,
G66
C92
C92,
C46,
C46,
CAE,
G66
G66
G66
G66
C93,
C92,
G66
G66
C93,
C92,
G66
G66
G66
G66
G66
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 77
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
GOLF COURSE TURF (con't)
F1C
WP
WP
Spray., Foliar., Not on label. WP
Min. Appl.
Rate (AI un-
less noted
otherwise)
NA
NA
NA
NA
Max. Appl.
Rate (AI
unless noted
otherwise)
.070
.063
.063
2.800E
Soil
Tex.
Max.
Dose
Use Group
Ib cwt *
Ib cwt *
Ib cwt *
-05 Ib *
sq.ft
Max. #
@ Max.
/crop
cycle
Apps
Rate
/year
: TERRESTRIAL
NS NS
NS NS
NS NS
NS NS
Max. Dose [ (AI
unless noted
otherwise) /A]
/crop /year
cycle
NON- FOOD
NS
NS
NS
NS
CROP
NS
NS
NS
NS
Min.
Interv
(days)
(con' t)
NS
NS
NS
7
Restr. Geographic Limitations
Entry Allowed Disallowed
Interv
[day(s) ]
NS
NS
NS
1
Use
Limitations
Codes
G66
C92
C92, G66
C46, C92, C94, GB9
GC1
ORNAMENTAL AND/OR SHADE TREES
Broadcast., Seed bed., Drip irrigation. WP
Broadcast., Seed bed., Not on label. WP
Broadcast., Seed bed., Overhead sprinkler WP
irrigation.
Broadcast., Transplant., Drip irrigation. WP
Broadcast., Transplant., Not on label. WP
Broadcast., Transplant., Overhead sprinkler WP
irrigation.
Soil drench treatment., At planting., Drip WP
irrigation.
Soil drench treatment., At planting., Not on EC
label.
Soil drench treatment., At planting., WP
Overhead sprinkler irrigation.
Soil drench treatment., Containerized., Drip WP
irrigation.
Soil drench treatment., Containerized., Not EC
on label.
NA
NA
NA
NA
Use Group: GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS NS
NS NS NS NS
1.563E-05 Ib * NS
sq.ft
UC
NS
NS
UC * NS NS
3.125E-05 Ib * NS NS
sq.ft
UC * NS NS
UC * NS NS
1.563E-04 Ib * NS NS
sq.ft
1.563E-04 Ib * NS NS
sq.ft
UC * NS NS
UC * NS NS
1.563E-04 Ib * NS NS
sq.ft
1.563E-04 Ib * NS NS
sq.ft
NS
NS
NS
NS NS
NS NS
NS NS
NS NS
0.5
0.5
0.5
0.5
0.5
0.5
C92
C92
C92
C92
C92
C92
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 78
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
Timing, Application Equipment Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL AND/OR SHADE
Soil drench treatment.,
TREES (con't)
Containerized., WP NA
Use Group: GREENHOUSE NON-FOOD CROP (con't)
UC * NS NS NS NS 70 0.5
Limitations Use
Disallowed Limitations
Codes
C92
Overhead sprinkler irrigation.
Soil drench treatment.,
irrigation.
Soil drench treatment.,
label .
Soil drench treatment.,
sprinkler irrigation.
Soil drench treatment.,
Drip irrigation.
Soil drench treatment.,
on label .
Foliar., Drip WP NA
Foliar., Not on EC NA
WP NA
Foliar., Overhead WP NA
Interiorscapes . , WP NA
Interiorscapes . , Not EC NA
WP NA
Soil drench treatment., Interiorscapes . , WP NA
Overhead sprinkler irrigation.
Soil drench treatment.,
irrigation.
Soil drench treatment.,
label .
Soil drench treatment.,
sprinkler irrigation.
Soil drench treatment.,
irrigation.
Soil drench treatment.,
label .
Plant bed., Drip WP NA
Plant bed., Not on EC NA
WP NA
Plant bed., Overhead WP NA
Transplant . , Drip WP NA
Transplant . , Not on EC NA
WP NA
UC * NS NS NS NS 70 0.5
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
UC * NS NS NS NS 70 0.5
UC * NS NS NS NS 70 0.5
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
UC * NS NS NS NS 70 0.5
UC * NS NS NS NS 70 0.5
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
UC * NS NS NS NS 70 0.5
UC * NS NS NS NS 70 0.5
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
sq.ft
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 79
SITE Application Type, Application Form(s) Min. Appl . Max. Appl .
Timing, Application Equipment Rate (AI un- Rate (AI
Surface Type (Antimicrobial only) & Effica- less noted unless noted
cy Influencing Factor (Antimicrobial only) otherwise) otherwise)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL AND /OR SHADE TREES (con't)
Soil drench treatment., Transplant., WP NA
Overhead sprinkler irrigation.
Soil mix., Transplant., Granule applicator. G NA
Soil treatment.,
applicator.
Soil treatment.,
applicator.
Soil treatment.,
applicator.
Soil treatment.,
applicator.
Soil treatment.,
applicator.
Soil treatment.,
applicator.
Band treatment . ,
label .
Band treatment . ,
At planting., Granule G NA
Containerized., Granule G NA
Interiorscapes . , Granule G NA
Nurserystock . , Granule G NA
Plant bed., Granule G NA
Transplant . , Granule G NA
Early spring., Not on G NA
Fall., Not on label. G NA
Broadcast., Early spring., Not on label. G NA
Broadcast., Fall.
Broadcast . , Seed
Broadcast . , Seed
Broadcast . , Seed
. , Not on label . G NA
bed., Drip irrigation. WP NA
bed., Granule applicator. G NA
bed., Not on label. WP NA
Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Max. /crop /year otherwise) /A] (days) Interv Codes
Dose cycle /crop /year [day(s)]
cycle
Use Group: GREENHOUSE NON-FOOD CROP (con't)
UC * NS NS NS NS 70 0.5
5.781E-04 Ib * NS NS
cu.ft
1.563E-04 Ib
sq.ft
1.563E-04 Ib
sq.ft
1.563E-04 Ib
sq.ft
1.563E-04 Ib
sq.ft
1.563E-04 Ib
sq.ft
1.563E-04 Ib
sq.ft
Use
5 Ib A
5 Ib A
5 Ib A
5 Ib A
UC
.625 Ib A
1.563E-05 Ib
* NS NS
* NS NS
* NS NS
* NS NS
* NS NS
* NS NS
Group : TERRESTRIAL
* NS NS
* NS NS
* NS NS
* NS NS
* NS NS
* NS NS
* NS NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS 60 0.5
NS 70 0.5
NS 70 0.5
NS 70 0.5
NS 70 0.5
NS 70 0.5
NS 70 0.5
CROP
NS NS NS NC
NS NS NS NC
NS NS NS NC
NS NS NS NC
NS NS 0.5
NS NS 0.5
NS NS 0.5
C92
CAE
CAE
CAE
CAE
CAE
CAE
CAE
C92
CAE
C92
sq.ft
Broadcast., Seed bed., Overhead sprinkler WP
irrigation.
Broadcast., Transplant., Drip irrigation.
UC * NS
-------
Date 08/03/94 _ Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL AND /OR SHADE TREES (con't)
Broadcast., Transplant., Granule applicator. G NA
Broadcast . , Transplant . , Not on label . WP NA
Broadcast . , Transplant . , Overhead sprinkler WP NA
irrigation.
Soil band treatment., Early spring., EC NA
Sprayer.
Soil band treatment., Fall
. , Sprayer. EC NA
Soil band treatment., Foliar., Sprayer. EC NA
Soil broadcast treatment.,
Spreader.
Soil broadcast treatment.,
Sprayer.
Soil broadcast treatment.,
Soil broadcast treatment.,
Soil broadcast treatment.,
label .
Soil broadcast treatment.,
on label .
Soil drench treatment., At
irrigation.
Soil drench treatment., At
label .
Soil drench treatment., At
Containerized., G NA
Early spring., EC NA
Fall., Sprayer. EC NA
Foliar., Sprayer. EC NA
Seed bed., Not on EC NA
Transplant . , Not EC NA
planting., Drip WP NA
planting., Not on EC NA
WP NA
planting., WP NA
Use Group: TERRESTRIAL NON- FOOD CROP (con't)
1.25 Ib A * NS NS NS NS NS 0.5 CAE
3.125E-05 Ib * NS NS NS NS NS 0.5 C92
sq.ft
UC * NS NS NS NS NS 0.5 C92
5 Ib A * NS NS NS NS NS NS NC
5 Ib A * NS NS NS NS NS NS NC
7.813E-05 Ib * NS NS NS NS NS 0.5 C92
sq.ft
3.025E-05 Ib * NS NS NS NS 60 0.5 CAE, GB9
sq.ft
5 Ib A * NS NS NS NS NS NS NC
5 Ib A * NS NS NS NS NS NS NC
7.813E-05 Ib * NS NS NS NS NS 0.5 C92
sq.ft
.625 Ib A * NS NS NS NS NS 0.5 C92
1.25 Ib A * NS NS NS NS NS 0.5 C92
UC * NS NS NS NS 70 0.5 C92
1.563E-04 Ib * NS NS NS NS 70 0.5 C92
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5 C92
sq.ft
UC * NS NS NS NS 70 0.5 C92
Overhead sprinkler irrigation.
Soil drench treatment., Containerized., Drip WP NA
UC * NS NS NS NS 70 0.5 C92
irrigation.
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 81
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
Timing, Application Equipment Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL AND /OR SHADE TREES (con't)
Soil drench treatment., Containerized., Not EC NA
on label .
WP NA
Soil drench treatment., Containerized., WP NA
Overhead sprinkler irrigation.
Soil drench treatment., Foliar., Drip WP NA
irrigation.
Soil drench treatment., Foliar., Not on EC NA
label .
WP NA
Soil drench treatment., Foliar., Overhead WP NA
sprinkler irrigation.
Soil drench treatment., Interiorscapes . , WP NA
Drip irrigation.
Soil drench treatment., Interiorscapes., Not EC NA
on label .
WP NA
Soil drench treatment., Interiorscapes., WP NA
Overhead sprinkler irrigation.
Soil drench treatment., Plant bed., Drip WP NA
irrigation.
Soil drench treatment., Plant bed., Not on EC NA
label .
WP NA
Soil drench treatment., Plant bed., Overhead WP NA
sprinkler irrigation.
Soil drench treatment., Transplant., Drip WP NA
Use Group: TERRESTRIAL NON- FOOD CROP (con't)
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
UC * NS NS NS NS 70 0.5
UC * NS NS NS NS 70 0.5
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
UC * NS NS NS NS 70 0.5
UC * NS NS NS NS 70 0.5
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
UC * NS NS NS NS 70 0.5
UC * NS NS NS NS 70 0.5
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
UC * NS NS NS NS 70 0.5
UC * NS NS NS NS 70 0.5
Limitations Use
Disallowed Limitations
Codes
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
irrigation.
-------
Date 08/03/94 _ Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL AND /OR SHADE TREES (con't)
Soil drench treatment., Transplant., Not on EC
label .
WP
Soil drench treatment., Transplant., WP
Overhead sprinkler irrigation.
Soil mix., Transplant., Granule applicator. G
Soil mix., Transplant., Not on label. G
Soil treatment., At planting., Granule G
applicator.
Soil treatment., Containerized., Granule G
applicator.
Soil treatment., Interiorscapes . , Granule G
applicator.
Soil treatment., Nurserystock . , Granule G
applicator.
Soil treatment., Plant bed., Granule G
applicator.
Soil treatment., Transplant., Granule G
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group
NA 1.563E-04 Ib *
sq.ft
NA 1.563E-04 Ib *
sq.ft
NA UC *
NA 5.781E-04 Ib *
cu.ft
NA 6.716E-04 Ib *
cu.ft
NA 1.563E-04 Ib *
sq.ft
NA 1.563E-04 Ib *
sq.ft
NA 1.563E-04 Ib *
sq.ft
NA 1.563E-04 Ib *
sq.ft
NA 1.563E-04 Ib *
sq.ft
NA 1.563E-04 Ib *
Max. tt
@ Max.
/crop
cycle
Apps
Rate
/year
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Max. Dose [ (AI
unless noted
otherwise) /A]
/crop /year
cycle
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Min.
Interv
(days)
(con' t)
70
70
70
60
60
70
70
70
70
70
70
Restr. Geographic Limitations
Entry Allowed Disallowed
Interv
[day(s) ]
0
0
0
0
0
0
0
0
0
0
0
.5
.5
.5
.5
.5
.5
.5
.5
.5
.5
.5
Use
Limitations
Codes
C92
C92
C92
CAE
CAE, GB9
CAE
CAE
CAE
CAE
CAE
CAE
applicator.
Soil drench treatment., Foliar., Product RTU
container.
Soil drench treatment., Foliar., Sprinkler RTU
can.
ORNAMENTAL HERBACEOUS PLANTS
Soil drench treatment., At planting., Drip WP
irrigation.
sq.ft
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
NS NS 90 NS
-04 Ib * NS 4/1 yr
sq.ft
-04 Ib * NS 4/1 yr
sq.ft
NS
NS 90
NS
Use Group: GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS 42
C46, CAC
C46, CAC
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 83
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
Timing, Application Equipment Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL HERBACEOUS PLANTS (con't)
Soil drench treatment., At planting., Not on EC NA
label .
WP NA
Soil drench treatment., At planting., WP NA
Overhead sprinkler irrigation.
Soil drench treatment., Containerized., Drip WP NA
irrigation.
Soil drench treatment., Containerized., Not EC NA
on label .
WP NA
Soil drench treatment., Containerized., WP NA
Overhead sprinkler irrigation.
Soil drench treatment., Foliar., Drip WP NA
irrigation.
Soil drench treatment., Foliar., Not on EC NA
label .
WP NA
Soil drench treatment., Foliar., Overhead WP NA
sprinkler irrigation.
Soil drench treatment., Interiorscapes . , WP NA
Drip irrigation.
Soil drench treatment., Interiorscapes., Not EC NA
on label .
WP NA
Soil drench treatment., Interiorscapes., WP NA
Overhead sprinkler irrigation.
Soil drench treatment., Plant bed., Drip WP NA
Use Group: GREENHOUSE NON-FOOD CROP (con't)
9.766E-06 Ib * NS NS NS NS 42 0.5
sq.ft
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
UC * NS NS NS NS 42 0.5
UC * NS NS NS NS 42 0.5
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
UC * NS NS NS NS 42 0.5
UC * NS NS NS NS 42 0.5
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
UC * NS NS NS NS 42 0.5
UC * NS NS NS NS 42 0.5
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
UC * NS NS NS NS 42 0.5
UC * NS NS NS NS 42 0.5
Limitations Use
Disallowed Limitations
Codes
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
irrigation.
-------
Date 08/03/94 _ Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 84
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL HERBACEOUS PLANTS (con't)
Soil drench treatment., Plant bed., Not on EC
label .
WP
Soil drench treatment., Plant bed., Overhead WP
sprinkler irrigation.
Soil drench treatment., Transplant., Drip WP
irrigation.
Soil drench treatment., Transplant., Not on EC
label .
WP
Soil drench treatment., Transplant., WP
Overhead sprinkler irrigation.
Soil mix., At planting., Not on label. EC
Soil mix., Containerized., Not on label. EC
Soil mix., Foliar., Not on label. EC
Soil mix., Interiorscapes . , Not on label. EC
Soil mix., Plant bed., Not on label. EC
Soil mix., Transplant., Granule applicator. G
Soil mix., Transplant., Not on label. EC
Soil treatment., At planting., Granule G
applicator.
Soil treatment., Containerized., Granule G
applicator.
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group
NA 7.813E-05 Ib *
sq.ft
NA 7.813E-05 Ib *
sq.ft
NA UC *
NA UC *
NA 7.813E-05 Ib *
sq.ft
NA 7.813E-05 Ib *
sq.ft
NA UC *
NA 2.891E-04 Ib *
cu.ft
NA 2.891E-04 Ib *
cu.ft
NA 2.891E-04 Ib *
cu.ft
NA 2.891E-04 Ib *
cu.ft
NA 2.891E-04 Ib *
cu.ft
NA 3.700E-04 Ib *
cu.ft
NA 2.891E-04 Ib *
cu.ft
NA 7.500E-05 Ib *
sq.ft
NA 7.500E-05 Ib *
sq.ft
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations
@ Max. Rate unless noted Interv Entry Allowed Disallowed
/crop /year otherwise) /A] (days) Interv
cycle /crop /year [day(s)]
cycle
: GREENHOUSE NON-FOOD CROP (con't)
NS NS NS NS 42 0.5
NS NS NS NS 42 0.5
NS NS NS NS 42 0.5
NS NS NS NS 42 0.5
NS NS NS NS 42 0.5
NS NS NS NS 42 0.5
NS NS NS NS 42 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 NS NS NS 0.5
NS NS NS NS NS 0.5
NS NS NS NS 42 0.5
NS NS NS NS NS 0.5
NS NS NS NS 42 0.5
NS NS NS NS 42 0.5
Use
Limitations
Codes
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
CAE
C92
CAE
CAE
-------
Date 08/03/94 _ Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 85
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
Timing, Application Equipment Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL HERBACEOUS PLANTS (con't)
Soil treatment., Interiorscapes . , Granule G NA
applicator.
Soil treatment., Nurserystock . , Granule G NA
applicator.
Soil treatment., Plant bed., Granule G NA
applicator.
Soil treatment., Transplant., Granule G NA
applicator.
Soil band treatment., Foliar., Sprayer. EC NA
Soil broadcast treatment., Containerized., G NA
Spreader.
Soil broadcast treatment., Foliar., Sprayer. EC NA
Soil drench treatment., At planting., Drip WP NA
irrigation.
Soil drench treatment., At planting., Not on EC NA
label .
WP NA
Soil drench treatment., At planting., WP NA
Overhead sprinkler irrigation.
Soil drench treatment., Containerized., Drip WP NA
irrigation.
Soil drench treatment., Containerized., Not EC NA
on label .
WP NA
Soil drench treatment., Containerized., WP NA
Use Group: GREENHOUSE NON-FOOD CROP (con't)
7.500E-05 Ib * NS NS NS NS 42 0.5
sq.ft
7.500E-05 Ib * NS NS NS NS 42 0.5
sq.ft
7.500E-05 Ib * NS NS NS NS 42 0.5
sq.ft
3.750E-05 Ib * NS NS NS NS 42 0.5
sq.ft
Use Group: TERRESTRIAL NON-FOOD CROP
3.125E-05 Ib * NS NS NS NS NS 0.5
sq.ft
3.025E-05 Ib * NS NS NS NS 60 0.5
sq.ft
3.125E-05 Ib * NS NS NS NS NS 0.5
sq.ft
UC * NS NS NS NS NS 0.5
9.766E-06 Ib * NS NS NS NS 42 0.5
sq.ft
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
UC * NS NS NS NS NS 0.5
UC * NS NS NS NS NS 0.5
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
UC * NS NS NS NS NS 0.5
Limitations Use
Disallowed Limitations
Codes
CAE
CAE
CAE
CAE
C92
CAE, GB9
C92
C92
C92
C92
C92
C92
C92
C92
C92
Overhead sprinkler irrigation.
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
Timing, Application Equipment Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL HERBACEOUS PLANTS (con't)
Soil drench treatment., Foliar., Drip WP NA
irrigation.
Soil drench treatment., Foliar., Not on EC NA
label .
WP NA
Soil drench treatment., Foliar., Overhead WP NA
sprinkler irrigation.
Soil drench treatment., Interiorscapes . , WP NA
Drip irrigation.
Soil drench treatment., Interiorscapes., Not EC NA
on label .
WP NA
Soil drench treatment., Interiorscapes., WP NA
Overhead sprinkler irrigation.
Soil drench treatment., Plant bed., Drip WP NA
irrigation.
Soil drench treatment., Plant bed., Not on EC NA
label .
WP NA
Soil drench treatment., Plant bed., Overhead WP NA
sprinkler irrigation.
Soil drench treatment., Transplant., Drip WP NA
irrigation.
Soil drench treatment., Transplant., Not on EC NA
label .
WP NA
Soil drench treatment., Transplant., WP NA
Use Group: TERRESTRIAL NON- FOOD CROP (con't)
UC * NS NS NS NS NS 0.5
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
UC * NS NS NS NS NS 0.5
UC * NS NS NS NS NS 0.5
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
UC * NS NS NS NS NS 0.5
UC * NS NS NS NS NS 0.5
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
UC * NS NS NS NS NS 0.5
UC * NS NS NS NS NS 0.5
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
7.813E-05 Ib * NS NS NS NS 42 0.5
sq.ft
UC * NS NS NS NS NS 0.5
Limitations Use
Disallowed Limitations
Codes
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
Overhead sprinkler irrigation.
-------
Date 08/03/94 _ Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 87
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL HERBACEOUS PLANTS (con't)
Soil mix., At planting., Not on label. EC
Soil mix., Containerized., Not on label. EC
Soil mix., Foliar., Not on label. EC
Soil mix., Interiorscapes . , Not on label. EC
Soil mix., Plant bed., Not on label. EC
Soil mix., Transplant., Granule applicator. G
Soil mix., Transplant., Not on label. EC
G
Soil treatment., At planting., Granule G
applicator.
Soil treatment., Containerized., Granule G
applicator.
Soil treatment., Interiorscapes., Granule G
applicator.
Soil treatment., Nurserystock . , Granule G
applicator.
Soil treatment., Plant bed., Granule G
applicator.
Soil treatment., Transplant., Granule G
applicator.
ORNAMENTAL LAWNS AND TURF
Broadcast., Foliar., Granule applicator. G
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group
NA 2.891E-04 Ib *
cu.ft
NA 2.891E-04 Ib *
cu.ft
NA 2.891E-04 Ib *
cu.ft
NA 2.891E-04 Ib *
cu.ft
NA 2.891E-04 Ib *
cu.ft
NA 3.700E-04 Ib *
cu.ft
NA 2.891E-04 Ib *
cu.ft
NA 6.716E-04 Ib *
cu.ft
NA 7.500E-05 Ib *
sq.ft
NA 7.500E-05 Ib *
sq.ft
NA 7.500E-05 Ib *
sq.ft
NA 7.500E-05 Ib *
sq.ft
NA 7.500E-05 Ib *
sq.ft
NA 3.750E-05 Ib *
sq.ft
Use Group
NA 3.125E-05 Ib *
sq.ft
Max. tt
@ Max.
/crop
cycle
Apps
Rate
/year
: TERRESTRIAL
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
: TERRESTRIAL
NS
NS
Max. Dose [ (AI Min. Restr. Geographic Limitations
unless noted Interv Entry Allowed Disallowed
otherwise) /A] (days) Interv
/crop /year [day(s)]
cycle
NON- FOOD CROP (con't)
NS NS NS 0.5
NS NS NS 0.5
NS NS NS 0.5
NS NS NS 0.5
NS NS NS 0.5
NS NS 42 0.5
NS NS NS 0.5
NS NS 60 0.5
NS NS 42 0.5
NS NS 42 0.5
NS NS 42 0.5
NS NS 42 0.5
NS NS 42 0.5
NS NS 42 0.5
NON- FOOD CROP
NS NS 7 0.5
Use
Limitations
Codes
C92
C92
C92
C92
C92
CAE
C92
CAE, GB9
CAE
CAE
CAE
CAE
CAE
CAE
CAE
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL LAWNS AND TURF (con't)
Spray., Foliar., Not on label.
Spray., Foliar., Sprayer.
Broadcast., Foliar., Spreader.
Chemigation. , Foliar., Overhead sprinkler
irrigation.
Chemigation., Postplant . , Overhead sprinkler
irrigation.
Seed treatment., At planting., Planter/seed
box.
Seed treatment., At planting., Seed treater.
Slurry., Seed., Mist-type seed treater.
Slurry., Seed., Slurry-type seed treater.
Use Group: TERRESTRIAL
WP
EC
G
WP
WP
D
D
D
D
EC
F1C
F1C
F1C
WP
WP
EC
F1C
F1C
F1C
WP
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
2.800E-05 Ib
sq.ft
3.125E-05 Ib
sq.ft
Use
3.108E-05 Ib
sq.ft
3.125E-05 Ib
sq.ft
3.125E-05 Ib
sq.ft
.063 Ib cwt
.063 Ib cwt
.063 Ib cwt
.063 Ib cwt
.063 Ib cwt
.062 Ib cwt
.031 Ib cwt
.070 Ib cwt
.063 Ib cwt
.063 Ib cwt
.063 Ib cwt
.062 Ib cwt
.031 Ib cwt
.070 Ib cwt
.063 Ib cwt
* NS
* 3
NS
NS
Group : TERRESTRIAL
* 3
* 3
* 3
* 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
NON -FOOD
NS
NS
NON -FOOD -
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP (con't)
NS
NS
nOUTDOOR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
7
10
1
0.5
C46, C92, C94, GB9
GC1
C92
RESIDENTIAL
7
14
7
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
0.5
0.5
2
NS
2
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CAE, GB9
C92
C92
C92, G66
C92, G66
C92, G66
C92, G66
C46, C93, G66
C46, C92, G66
CAE, G66
G66
C92
C92, G66
C46, C93, G66
C46, C92, G66
CAE, G66
G66
C92
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL LAWNS AND TURF (con't)
WP
Spray., Foliar., Not on label. WP
Spray., Foliar., Sprayer. EC
Spray., Postplant . , Not on label. WP
Min. Appl .
Rate (AI un-
less noted
otherwise)
NA
NA
NA
NA
Max. Appl. Soil
Rate (AI Tex.
unless noted Max.
otherwise) Dose
Use Group
.063 Ib cwt *
3.125E-05 Ib *
sq.ft
1.111E-05 gal *
sq.ft
3.125E-05 Ib *
sq.ft
Max. tt
@ Max.
/crop
cycle
Apps
Rate
/year
: TERRESTRIAL
NS
3
NS
3
NS
NS
NS
NS
Max. Dose [ (AI
unless noted
otherwise) /A]
/crop /year
cycle
Min.
Interv
(days)
Restr. Geographic Limitations
Entry Allowed Disallowed
Interv
[day(s) ]
Use
Limitations
Codes
NON-FOOD+OUTDOOR RESIDENTIAL (con't)
NS NS
NS NS
NS NS
NS NS
NS
14
NS
7
NS
0.5
NS
0.5
C92, G66
C92
GB9, GC1
C92
ORNAMENTAL WOODY SHRUBS AND VINES
Chemigation., Foliar., Drip irrigation. WP
Chemigation., Foliar., Overhead sprinkler WP
irrigation.
Soil drench treatment., At planting., Drip WP
irrigation.
Soil drench treatment., At planting., Not on EC
label.
Soil drench treatment., At planting., WP
Overhead sprinkler irrigation.
Soil drench treatment., Containerized., Drip WP
irrigation.
Soil drench treatment., Containerized., Not EC
on label.
Soil drench treatment., Containerized.,
Overhead sprinkler irrigation.
Soil drench treatment., Foliar., Drip
irrigation.
Soil drench treatment., Foliar., Not on
label.
NA
NA
Use Group: GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS 60 0.5
UC * NS NS NS NS 60 0.5
UC * NS NS
1.563E-04 Ib * NS NS
sq.ft
1.563E-04 Ib * NS NS
sq.ft
UC * NS NS
UC * NS NS
1.563E-04 Ib * NS NS
sq.ft
1.563E-04 Ib * NS NS
sq.ft
UC * NS NS
1.563E-04 Ib * NS NS
sq.ft
NS NS 70 0.5
NS NS 70 0.5
NS NS 70 0.5
NS NS 70 0.5
NS NS 70 0.5
NS NS 70 0.5
NS NS 70 0.5
NS NS 70 0.5
NS NS 70 0.5
NS NS 70 0.5
C92
C92
C92
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 90
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment _ Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL WOODY SHRUBS
Soil drench treatment.,
sprinkler irrigation.
Soil drench treatment.,
Drip irrigation.
Soil drench treatment.,
on label .
AND VINES (con't)
WP NA
Foliar., Overhead WP NA
Interiorscapes . , WP NA
Interiorscapes . , Not EC NA
WP NA
Soil drench treatment., Interiorscapes . , WP NA
Overhead sprinkler irrigation.
Soil drench treatment.,
irrigation.
Soil drench treatment.,
label .
Soil drench treatment.,
sprinkler irrigation.
Soil drench treatment.,
irrigation.
Soil drench treatment.,
label .
Plant bed., Drip WP NA
Plant bed., Not on EC NA
WP NA
Plant bed., Overhead WP NA
Transplant . , Drip WP NA
Transplant . , Not on EC NA
WP NA
Soil drench treatment., Transplant., WP NA
Overhead sprinkler irrigation.
Soil mix., Transplant.,
Granule applicator. G NA
Soil treatment., At planting., Granule G NA
Use Group
1.563E-04 Ib *
sq.ft
UC *
UC *
1.563E-04 Ib *
sq.ft
1.563E-04 Ib *
sq.ft
UC *
UC *
1.563E-04 Ib *
sq.ft
1.563E-04 Ib *
sq.ft
UC *
UC *
1.563E-04 Ib *
sq.ft
1.563E-04 Ib *
sq.ft
UC *
5.781E-04 Ib *
cu.ft
1.563E-04 Ib *
: GREENHOUSE
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
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP (con
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
't)
70 0.5
70 0.5
70 0.5
70 0.5
70 0.5
70 0.5
70 0.5
70 0.5
70 0.5
70 0.5
70 0.5
70 0.5
70 0.5
70 0.5
60 0.5
70 0.5
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
CAE
CAE
applicator.
sq.ft
-------
Date 08/03/94 _ Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 91
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL WOODY SHRUBS AND VINES (con't)
Soil treatment.
applicator.
Soil treatment.
applicator.
Soil treatment.
applicator.
Soil treatment.
applicator.
Soil treatment.
applicator.
Spray. , Foliar.
Spray. , Foliar.
. , Containerized., Granule G NA
. , Interiorscapes . , Granule G NA
. , Nurserystock . , Granule G NA
. , Plant bed., Granule G NA
. , Transplant . , Granule G NA
. , Not on label . WP NA
WP NA
. , Sprayer. EC NA
Chemigation. , Foliar., Drip irrigation. WP NA
Chemigation. , Foliar., Overhead sprinkler WP NA
irrigation.
Soil band treatment., Foliar., Sprayer. EC NA
Soil broadcast
Spreader.
Soil broadcast
treatment., Containerized., G NA
treatment., Foliar., Sprayer. EC NA
Soil drench treatment., At planting., Drip WP NA
irrigation.
Soil drench treatment., At planting., Not on EC NA
label .
WP NA
Use Group: GREENHOUSE NON-FOOD CROP (con't)
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
UC * NS NS NS NS 10 NS PA
UC * NS NS NS NS 60 0.5
UC * NS NS NS NS 60 0.5
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS 60 0.5
UC * NS NS NS NS 60 0.5
7.813E-05 Ib * NS NS NS NS NS 0.5
sq.ft
3.025E-05 Ib * NS NS NS NS 60 0.5
sq.ft
7.813E-05 Ib * NS NS NS NS NS 0.5
sq.ft
UC * NS NS NS NS 70 0.5
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
CAE
CAE
CAE
CAE
CAE
C46
C92
C92
C92
C92
C92
CAE, GB9
C92
C92
C92
C92
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 92
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
Timing, Application Equipment Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL WOODY SHRUBS
AND VINES (con't)
Soil drench treatment., At planting., WP NA
Overhead sprinkler irrigation.
Soil drench treatment.,
irrigation.
Soil drench treatment.,
on label .
Soil drench treatment.,
Containerized., Drip WP NA
Containerized., Not EC NA
WP NA
Containerized., WP NA
Use Group: TERRESTRIAL NON- FOOD CROP (con't)
UC * NS NS NS NS 70 0.5
UC * NS NS NS NS 70 0.5
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
UC * NS NS NS NS 70 0.5
Limitations Use
Disallowed Limitations
Codes
C92
C92
C92
C92
C92
Overhead sprinkler irrigation.
Soil drench treatment.,
irrigation.
Soil drench treatment.,
label .
Soil drench treatment.,
sprinkler irrigation.
Soil drench treatment.,
Drip irrigation.
Soil drench treatment.,
on label .
Foliar., Drip WP NA
Foliar., Not on EC NA
WP NA
Foliar., Overhead WP NA
Interiorscapes . , WP NA
Interiorscapes . , Not EC NA
WP NA
Soil drench treatment., Interiorscapes . , WP NA
Overhead sprinkler irrigation.
Soil drench treatment.,
irrigation.
Soil drench treatment.,
label .
Plant bed., Drip WP NA
Plant bed., Not on EC NA
WP NA
UC * NS NS NS NS 70 0.5
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
UC * NS NS NS NS 70 0.5
UC * NS NS NS NS 70 0.5
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
UC * NS NS NS NS 70 0.5
UC * NS NS NS NS 70 0.5
1.563E-04 Ib * NS NS NS NS 70 0.5
sq.ft
1.563E-04 Ib * NS NS NS NS 70 0.5
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
C92
sq.ft
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 93
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
Timing, Application Equipment Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL WOODY SHRUBS AND VINES (con't)
Soil drench treatment., Plant bed., Overhead WP NA
sprinkler irrigation.
Soil drench treatment., Transplant., Drip WP NA
irrigation.
Soil drench treatment., Transplant., Not on EC NA
label .
WP NA
Soil drench treatment., Transplant., WP NA
Overhead sprinkler irrigation.
Soil mix., Transplant., Granule applicator. G NA
Soil mix., Transplant., Not on label. G NA
Soil treatment., At planting., Granule G NA
applicator.
Soil treatment., Containerized., Granule G NA
applicator.
Soil treatment., Interiorscapes . , Granule G NA
applicator.
Soil treatment., Nurserystock . , Granule G NA
applicator.
Soil treatment., Plant bed., Granule G NA
applicator.
Soil treatment., Transplant., Granule G NA
Limitations Use
Disallowed Limitations
Codes
Use Group: TERRESTRIAL NON- FOOD CROP (con't)
1.563E-04
sq.
1.563E-04
sq
5.781E-04
cu
6.716E-04
cu
1.563E-04
sq.
1.563E-04
sq.
1.563E-04
sq.
1.563E-04
sq.
1.563E-04
sq.
1.563E-04
UC * NS NS NS NS 70 0.5
UC * NS NS NS NS 70 0.5
Ib * NS NS NS NS 70 0.5
ft
Ib * NS NS NS NS 70 0.5
.ft
UC * NS NS NS NS 70 0.5
Ib * NS NS NS NS 60 0.5
.ft
Ib * NS NS NS NS 60 0.5
.ft
Ib * NS NS NS NS 70 0.5
ft
Ib * NS NS NS NS 70 0.5
ft
Ib * NS NS NS NS 70 0.5
ft
Ib * NS NS NS NS 70 0.5
ft
Ib * NS NS NS NS 70 0.5
ft
Ib * NS NS NS NS 70 0.5
C92
C92
C92
C92
C92
CAE
CAE, GB9
CAE
CAE
CAE
CAE
CAE
CAE
applicator.
Spray., Foliar., Not on label.
Spray., Foliar., Sprayer.
Spray., Foliar., Not on label.
sq.ft
WP
EC
NA
NA
UC * NS
UC * NS
NS
NS
NS
NS
NS 60 0.5
NS 60 0.5
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
UC * NS NS NS NS 10 NS PA
C92
C92
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 94
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
ORNAMENTAL WOODY SHRUBS AND VINES (con't)
Spray., Foliar., Sprayer. WP
Min. Appl . Max. Appl . Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
NA
RESIDENTIAL LAWNS
Spray. , Foliar.
TOBACCO
Soil broadcast
Sprayer.
Soil broadcast
on label .
Soil broadcast
Ground .
Soil broadcast
label .
Soil broadcast
Sprayer.
Soil broadcast
Not on label .
Soil treatment.
Spray. , Foliar.
. , Not on label . WP
NA
Use Group
UC *
Use Group
2.800E-05
sq.
Ib *
ft
Use Group
treatment., At planting., EC
treatment., Plant bed., Not EC
treatment . , Posttransplant . , EC
treatment., Preplant . , Not on EC
EC
EC
EC
EC
EC
EC
EC
treatment . , Preplant . , EC
treatment . , Pretransplant . , EC
. , Layby . , Ground . EC
. , Sprayer. EC
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.5 Ib
1 Ib
3 Ib
.25 gal
.25 gal
.25 gal
.25 gal
.25 gal
.5 gal
.25 gal
.25 gal
.5 Ib
1 Ib
.5 Ib
.125 gal
.125 gal
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
Max . tt Apps
@ Max. Rate
/crop /year
cycle
: TERRESTRIAL
NS NS
Max. Dose [ (AI Min.
unless noted Interv
otherwise) /A] (days)
/crop /year
cycle
NON- FOOD -
NS
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
nOUTDOOR RESIDENTIAL (con't)
NS 10 NS TX C46
: OUTDOOR RESIDENTIAL
NS
NS
: TERRESTRIAL
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
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1 . 5 gal
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
7
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
7
1
NS
0.5
0.5
NS
NS
NS
NS
NS
NS
NS
NS
NS
0.5
0.5
NS
NS
C46, C92, C94, GB9
GC1
OH C46
PA C92
PA C92
FL
GA
KY
MD
NC
PA
TN
VA
OH C46
C92
C92
SC
FL
-------
Date 08/03/94
Time 14:22
APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl]
LUIS 1.5 _ Page 95
SITE Application Type, Application Form(s)
Timing, Application Equipment
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED (con't)
TOBACCO (con't)
TREE NUTS
Soil band treatment., Nonbearing., Granule
applicator.
Soil band treatment., Nonbearing., Not on
label .
Soil broadcast treatment., Nonbearing
nurserystock . , Granule applicator.
Soil broadcast treatment., Nonbearing
nurserystock., Not on label.
Soil broadcast treatment., Nonbearing., Drip
irrigation.
Soil broadcast treatment., Nonbearing.,
Granule applicator.
Soil broadcast treatment., Nonbearing., Not
on label .
Soil broadcast treatment., Nonbearing.,
EC
EC
EC
EC
EC
EC
EC
EC
G
EC
G
EC
WP
G
EC
WP
WP
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
Use Group
.125 gal A *
.125 gal A *
.125 gal A *
.125 gal A *
.25 Ib A *
.125 gal A *
.125 gal A *
.125 gal A *
Use Group
4 Ib A *
4 Ib A *
8 Ib A *
9.375E-05 Ib *
sq.ft
1.875E-04 Ib *
sq.ft
4 Ib A *
4 Ib A *
1.875E-04 Ib *
sq.ft
1.875E-04 Ib *
Max. tt Apps Max. Dose [ (AI Min.
@ Max. Rate unless noted Interv
/crop /year otherwise) /A] (days)
cycle /crop /year
cycle
: TERRESTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: TERRESTRIAL
3
NS
NS
NS
NS
3
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NON -FOOD
NS
NS
NS
NS .
NS
NS
NS
NS
NS
CROP (con't)
NS 7
NS 7
NS 7
NS 7
NS 7
NS 7
NS 7
NS 7
CROP
NS 60
12 Ib 90
NS 90
275 Ib 90
NS 90
NS 60
12 Ib 90
NS 90
NS 90
Restr. Geographic Limitations Use
Entry Allowed Disallowed Limitations
Interv Codes
[day(s) ]
NS GA
NS KY
NS MD
NS NC
NS OH
NS PA
NS TN
NS VA
NS
0.5
0.5
0.5
0.5
NS
0.5
0.5
0.5
C46
C92
C92
CAE
C92
C92
C92
C92
C92
C92
Overhead sprinkler irrigation.
sq.ft
-------
Date 08/03/94 _ Time 14:22 APPENDIX A _ CASE 0081, [Metalaxyl] Chemical 113501 [Metalaxyl] LUIS 1.5 _ Page 96
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps ® Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
D : DUST
EC : EMULSIFIABLE CONCENTRATE
F1C : FLOWABLE CONCENTRATE
G : GRANULAR
RTU : LIQUID-READY TO USE
WP : WETTABLE POWDER
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : 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 : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
C14 : Grown for seed only.
C46 : Do not apply through any type of irrigation system.
C92 : For terrestrial uses, do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high water mark.
C93 : Do not apply directly to water.
C94 : Runoff from treated areas may be hazardous to aquatic organisms in neighboring areas.
CAC : Keep out of lakes, streams, and ponds.
CAE : Do not apply directly to water or wetlands (swamps, bogs, marshes, and potholes).
CAG : Do not apply where runoff is likely to occur.
G03 : Do not graze livestock in treated areas.
G66 : Do not use treated seed for feed, food or oil purposes.
G73 : Do not graze or feed livestock on hay grown from treated seed.
G79 : Treated seed must not be used for or mixed with food or animal feed or processing oil.
GAS : Do not feed treated tops to livestock.
GB6 : Do not feed crop waste to livestock.
GB9 : Do not feed clippings to livestock.
GC1 : Do not graze treated areas.
GF9 : Do not graze treated crop or allow hay, seeds or seed screenings from treated crop to be used for food or feed.
GI2 : Do not hog down treated fields.
GI9 : Do not graze or feed fodder and forage to livestock.
GL7 : Do not allow the feeding of vines or grazing of foliage by livestock.
GL8 : Do not allow the feeding or grazing of foliage by livestock.
GL9 : Do not allow the feeding or grazing of foliage or harvest residues by livestock.
GM1 : Do not graze or feed cover crops in treated orchards.
GN3 : Do not graze or feed livestock on treated areas for 42 days after planting.
GO3 : Do not cut green crop for feed or forage purposes.
HOI : day(s) preharvest interval.
-------
H03 : Preharvest interval not located on the label.
H12 : day(s) preharvest interval (forage, fodder).
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES
018 : Pacific Northwest
AZ : Arizona
CA : California
CO : Colorado
FL : Florida
GA : Georgia
HI : Hawaii
ID : Idaho
KY : Kentucky
LA : Louisiana
MD : Maryland
ME : Maine
NC : North Carolina
ND : North Dakota
OH : Ohio
OK : Oklahoma
OR : Oregon
PA : Pennsylvania
PR : Puerto Rico
SC : South Carolina
TN : Tennessee
TX : Texas
VA : Virginia
WA : Washington
-------
166
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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
167
-------
168
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the case 0081 covered by this Reregi strati on Eligibility Decision Document. It
contains generic data requirements that apply to 0081 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 31 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.
169
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170
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APPENDIX B
Generic Data Supporting Guideline Requirements for the Reregistration of Metalaxyl
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
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
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
00104498, 41055201, 41912901, 42409201,
42762801, 42762802,
41055201, 41912901, DATA GAP
41055201, 41055202, 41912901
41055202, 42319901, 42762801, 42762802
41055201,41055202, 41912901, 42409202
41055202, 41912901
00104483
00104483
00104483
00104483
NOT REQUIRED
00104483
00104483
00104483
00104483
40435001
40435001
00104483
171
-------
Generic Data Supporting Guideline Requirements for the Reregistration of Metalaxyl
REQUIREMENT
USE PATTERN
CITATION(S)
63-14 OxidizingYReducing Action
63-15 Flammability
63-16 Explodability
63-17 Storage stability
63-18 Viscosity
63-19 Miscibility
63-20 Corrosion characteristics
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral - Quail/Duck
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
71-4A Avian Reproduction - Quail
71-4B Avian Reproduction - Duck
72-1A Fish Toxicity Bluegill
72-1B Fish Toxicity Bluegill - TEP
72-1C Fish Toxicity Rainbow Trout
72-1D Fish Toxicity Rainbow Trout- TEP
72-2A Invertebrate Toxicity
72-2B Invertebrate Toxicity - TEP
ALL
ALL
All
All
ALL
ALL
All
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
WAIVED
NOT REQUIRED
WAIVED
DATA GAP, MANUFACTURING USE
DATA REQUIREMENT, REFER TO
PRODUCT SPECIFIC DCI
NOT REQUIRED
NOT REQUIRED
DATA GAP, MANUFACTURING USE
DATA REQUIREMENT, REFER TO
PRODUCT SPECIFIC DCI
00077334
00077335, 00063988
00063989
DATA GAP
DATA GAP
00071302, 00100446
00071301
00071303, 00100447
00072396
00071306, 00100448, 00063986
00071304
172
-------
Generic Data Supporting Guideline Requirements for the Reregistration of Metalaxyl
REQUIREMENT USE PATTERN CITATION(S)
72-3B Estuarine/Marine Toxicity -
Mollusk
72-3C Estuarine/Marine Toxicity - Shrimp
72-3E Estuarine/Marine Toxicity Mollusk
-TEP
72-3F Estuarine/Marine Toxicity Shrimp -
TEP
72-4A Early Life Stage Fish
72-4B Life Cycle Invertebrate
123-2 Aquatic Plant Growth
141-1 Honey Bee Acute Contact
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
41288101, 41855801
41288103
41288102, 41855801, 42378101
41288104, 41855801, 42337501
00071308
00071307
00148448
40276701
TOXICOLOGY
81-1 Acute Oral Toxicity
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
82-1A 90-Day Feeding - Rodent
82-1B 90-Day Feeding - Non-rodent
82-2 21-Day Dermal - Rabbit/Rat
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
00063990, 00063991, 00154308
00063993, 00063994
WAIVED
00084108
00084107
00084109
00084110, 00148087
00084111
00072394
173
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Generic Data Supporting Guideline Requirements for the Reregistration of Metalaxyl
REQUIREMENT
USE PATTERN
CITATION(S)
82-4 90-Day Inhalation - Rat A,B
83-1A Chronic Feeding Toxicity - Rodent A,B
83-1B Chronic Feeding Toxicity - A,B
Non-Rodent
83-2A Oncogenicity - Rat A,B
83-2B Oncogenicity - Mouse A,B
83-3A Developmental Toxicity - Rat A,B
83-3B Developmental Toxicity - Rabbit A,B
83-4 2-Generation Reproduction - Rat A,B
84-2A Gene Mutation (Ames Test) A,B
84-2B Structural Chromosomal A,B
Aberration
84-4 Other Genotoxic Effects A,B
85-1 General Metabolism A,B
OCCUPATIONAL/RESIDENTIAL EXPOSURE
No studies required.
00109471
00098481, 00132009, 00150185
00071598
00098481, 00013209, 00150185
00103354, 00150094
00161405, 00144423, 00148867
00144371, 00144372, 00148866, 00154938,
00161404
00071600
00084113, 00154301, 00154302, 00103359,
00103362, 00154309
00084114, 00103361, 00154307,00154310
00154306, 00154663, 00103363, 00160037
00071613, 00071614, 00099084, 41664501,
00161402, 43317301, DATA IN REVIEW
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodegradation - Water
A,B
A,B
00104493
41156001
174
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Generic Data Supporting Guideline Requirements for the Reregistration of Metalaxyl
REQUIREMENT
161-3
162-1
162-2
162-3
162-4
163-1
163-2
164-1
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/Adsorption and
Desorption
Volatility - Lab
Terrestrial Field Dissipation
USE PATTERN
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
CITATION(S)
00100456
00104494
00104494
42259801
42259802, NOT ACCEPTABLE BUT NO
ADDITIONAL DATA REQUIRED
00100464, 00100465, 00100466
00100455
41765001, 41765002, 41809301, NOT
164-2 Aquatic Field Dissipation
165-4 Bioaccumulation in Fish
166-2 Ground Water - Small
Retrospective
RESIDUE CHEMISTRY
171-4A Nature of Residue - Plants
171-4B
Nature of Residue - Livestock
A,B
A,B
A,B
A,B,C
A,B,C
ACCEPTABLE BUT NO ADDITIONAL
DATA REQUIRED
42259803, 42259804, NOT ACCEPTABLE
BUT NO ADDITIONAL DATA REQUIRED
00100468, 00100470
RESERVED
00071601, 00071602, 00071603, 00071604,
00071605, 00071606, 00071607, 00071608,
00071609, 00071610, 00114379, 00128102
00071611, 00071612, 41664503, 41664504,
41664505, 41664506, 42115801, 42115802,
42115803, 42115804, 42115805, 42115806
DATA GAP
175
-------
Generic Data Supporting Guideline Requirements for the Reregistration of Metalaxyl
REQUIREMENT USE PATTERN CITATION(S)
171-4C/D Residue Analytical Method - Plants
and Animals
171-4E Storage Stability
171-4J
A,B
Magnitude of Residues -
A,B,C
A,B
00071622, 00071623, 00071676, 00104378,
00104656, 00148440, 00157480, 40503101,
41055203, 41689701, 41689702, 42115809,
42115810, 42115807, 42115808, DATA GAP
00148440, 40106601, 41449001, 42021101,
42115809, 42350101, 42919401, 41912902,
DATA GAP
-fat, kidney and liver
-meat & meat byproducts
-eggs
-milk
171-4K Crop Field Trials
00100753, 42115809, 00071673, 00071674,
RESERVED
00100753, 42115809, 00071673, 00071674,
RESERVED
00071673, 42115809, RESERVED
00071674, RESERVED
A,B,C
Root and Tuber Group
-beets
-ginseng
-potatoes
-sugarbeets
Leaves of Root and Tuber Group
40838301, 4083802
00128102
41688900, 41688901
00104654, 00071616, 00098428
00128102, 40569301
40838301, 40838302
176
-------
Generic Data Supporting Guideline Requirements for the Reregistration of Metalaxyl
REQUIREMENT
USE PATTERN
CITATION(S)
-beet, tops
-sugarbeet, tops
Bulb Vegetable Group
-onions, dry bulb
-onions, green
Leafy Vegetables Group (except
Brassica)
-lettuce, head
-spinach
Brassica Leafy Vegetable Group
-brassica leafy vegetable group
(except broccoli, cabbage, and
cauliflower)
-broccoli
-cabbage
-cauliflower
Legume Vegetables Group
-legume vegetables group
-soybean, grain
Foliage of Vegetables Group
00128102
40569301
00071615, 00098428, 00130694, 00148103
00071615, 00098428, 00130694
41587801, 42021101
00071615, 00097511, 00114377, 40775801
00071672, 00114378, 40790201, 41636201
00071615, 00130773
00071615, 00130773
00071615, 00130773
00129003, 40569303
00071672, 00104390, 00148440
00129003, 00071672, 00104390, 00148440,
40569303
177
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Generic Data Supporting Guideline Requirements for the Reregistration of Metalaxyl
REQUIREMENT
USE PATTERN
CITATION(S)
Fruiting Vegetables (Except
Cucurbits)
Group
Cucurbit Vegetables Group
Citrus Fruits Group
Pome Fruits Group
-apples
Stone Fruits Group
Small Fruits and Berries Group
-blueberries
-cranberries
-grapes
-raspberries
-strawberries
Tree Nuts Group
-almonds
-walnuts
Cereal Grains Group
-grain, crops
Forage. Fodder and Straw of
Cereal Grains Group (except
wheat, barley and oats)
00148103, 00148440, 00157480 DATA GAP
00071615, 00098428, 00130693, 00148103
00117969, 00133020, 00148440
00126315, 00141519
00164650
00164649
41996401
00138818, 00155845, 41150101
00127769
00155237, 40880401, DATA GAP
00164651
00164651
00071672, 00104387, 00128102, 41689701,
41689702, 41870301
00128102, 41689701, 41689702, 41870301,
41870305, 41912903
178
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Generic Data Supporting Guideline Requirements for the Reregistration of Metalaxyl
REQUIREMENT
USE PATTERN
CITATION(S)
171-4L
Grass Forage. Fodder, and Hay
Group
-grasses, forage
NON-GRASS ANIMAL FEEDS
GROUP
-alfalfa
Miscellaneous Commodities
-asparagus
-avocados
-cottonseed
-hops, green
-papaya
-peanut
-pineapples
-sunflower
-tobacco
Processed Food
-apples
-citrus
Cereal Grains Group (except
wheat, barley, and oats)
NO ADDITIONAL DATA NEEDED AT
THIS TIME
40832901
00154446, DATA GAP
00074488
00109402, 41870305, DATA GAP
00079433, 40746901, 40909401
40490501
00128738, 41870306, 42498701
00109472
00128102, 41912902
00100476, 00100477, 00100478, 00104485,
00140371, 00148440, 42196503
00126315
00117969
41870301, 41870302, 41870303, 42498701,
42259805
179
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Generic Data Supporting Guideline Requirements for the Reregistration of Metalaxyl
REQUIREMENT USE PATTERN CITATION(S)
165-1
165-2
-grapes
-hops
-peanut
-pineapples
-potatoes
-prunes
-soybean
-sugarbeet
-sunflower
-tomatoes
Confined Rotational Crop
Field Rotational Crop
00138818, 00155845, 41150101
00079433, 40746901, 40909401
00128738
42233501
41870307
00164650
00071672
40106601, 40569301
41870304, 42498701
00148440, 00157480, DATA GAP
42196501, 42196502, 42196503, 43317302,
DATA IN REVIEW
00114376, 00071672, 00104387,
41870308, DATA IN REVIEW
180
-------
181
-------
182
-------
APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of 0081
183
-------
184
-------
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 Reregi strati on 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 as
(19??), the Agency was unable to determine or estimate the date of the document.
185
-------
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for "Company
Data Library." This accession number is in turn followed by an alphabetic
suffix which shows the relative position of the study within the volume.
186
-------
BIBLIOGRAPHY
MRID
CITATION
00063986 LeBlanc, G. A. (1977) Acute Toxicity of CGA-48988 Technical to the Water Flea
(Daphnia magna). (Unpublished study received Jul 13, 1978 under 100-EX-62;
prepared by EG&G, Bionomics, submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:234439-C)
00063988 Sachsse, K.; Ullmann, L. (1976) 8-Day-Feeding Toxicity in the Japanese Quail of
Technical CGA 48988: Project No. Siss 5388. (Unpublished study received Jul
13, 1978 under 100-EX-62; prepared by Ciba-Geigy, Ltd., Switzerland, submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:234439-G)
00063989 Fink, R.; Beavers, J.B.; Brown, R. (1977) Final Report: Eight-Day Dietary
LC50-Mallard Duck: Project No. 108-148. (Unpublished study received Jul 13,
1978 under 100-EX-62; prepared by Wildlife International, Ltd. and Washington
College, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:234439-H)
00063990 Sachsse, K.; Bathe, R. (1976) Acute Oral LD50 in the Rat of Technical CGA
48988: Project No. Siss 5388. (Unpublished study received Jul 13, 1978 under
100-EX-62; prepared by Ciba-Geigy, Ltd., Switzerland, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:234439-I)
00063991 Sachsse, K.; Bathe, R. (1976) Acute Oral LD50 in the Mouse of Technical CGA
48988: Project No. Siss 5388. (Unpublished study received Jul 13, 1978 under
100-EX-62; prepared by Ciba-Geigy, Ltd., Switzerland, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:234439-J)
00063993 Sachsse, K.; Ullmann, L. (1978) Acute Dermal LD50 in the Rabbit of Technical
CGA 48988: Project No. 408378-Siss 6547. (Unpublished study received Jul 13,
1978 under 100-EX-62; prepared by Ciba-Geigy, Ltd., Switzerland, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:234439-L)
00063994 Sachsse, K.; Bathe, R. (1976) Acute Dermal LD50 in the Rat of Technical CGA
48988: Project No. Siss 5388. (Unpublished study received Jul 13, 1978 under
100-EX-62; prepared by Ciba-Geigy, Ltd., Switzerland, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:234439-M)
00071301 U.S. Environmental Protection Agency, Animal Biology Laboratory (1979)
Ridomil 2%: Bluegill (Lepomis macrochirus): Test # 2411. (Unpublished study;
CDL:244183-B)
187
-------
BIBLIOGRAPHY
MRID
CITATION
00071302 U.S. Environmental Protection Agency, Terrestrial & Aquatic Biology
Laboratory (1979) Ridomil Tech: Bluegill (Lepomis macrochirus): Test # 2413.
(Unpublished study; CDL:244183-E)
00071303 U.S. Environmental Protection Agency, Terrestrial & Aquatic Biology
Laboratory (1979) Ridomil Tech: Rainbow Trout (Salmo gairdneri): Test # 2414.
(Unpublished study; CDL:244183-F)
00071304 U.S. Environmental Protection Agency, Terrestrial & Aquatic Biology
Laboratory (1979) Ridomil 2%:Daphnia magna: Test # 2416. (Unpublished
study; CDL:244183-G)
00071306 U.S. Environmental Protection Agency, Terrestrial & Aquatic Biology
Laboratory (1979) Ridomil Tech: Daphnia magna: Test # 2415. (Unpublished
study; CDL:244183-1)
00071307 LeBlanc, G.A.; Mastone, J.; Altshul, L.; et al. (1980) The Chronic Toxicity of
CGA-48988 to the Water Flea (Daphnia magna): Report # BW-80-5-668.
(Unpublished study received Jan 23, 1981 under 100-607; prepared by EG & G,
Bionomics, submitted by CibaGeigy Corp., Greensboro, N.C.; CDL:244183-J;
244782)
00071308 LeBlanc, G.A.; Mastone, J.; Wilson, B.F.; et al. (1980) The Toxicity of
CGA-48988 to Fathead Minnow (Pimephales promelas) Eggs and Fry: Report #
BW-80-4-642. (Unpublished study received Jan 23, 1981 under 100-607;
prepared by EG & G, Bionomics, submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:244183-K; 244782)
00071598 Beck, L.S.; DeWard, J.; Kitchen, D.N.; et al. (1981) Six Month Chronic Oral
Toxicity Study with CGA-48988 Technical in Beagle Dogs: Project No. 1545.
(Unpublished study received Apr 15, 1981 under 100-607; prepared by Elars
Bioresearch Laboratories, Inc., submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL: 070016-A)
00071600 Cozens, D.D.; Allen, P.A.; Clark, R.; et al. (1980) Effect of CGA 48-988 on
Reproductive Function of Multiple Generations in the Rat: CBG 181/80254.
(Unpublished study received Apr 15, 1981 under 100-607; prepared by
Huntingdon Research Centre, England, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:070015-A)
188
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BIBLIOGRAPHY
MRID
CITATION
00071601 Fischer, W.C.; Cassidy, I.E. (1978) Balance and Metabolism of Phenyl
14C-CGA-48988 in Potatoes: M6-69-1P, IS: Report No. ABR-78001.
(Unpublished study received Apr 15, 1981 under 100-607; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 070018-A)
00071602 Foster, R.A.; Fischer, W.C.; Cassidy, I.E. (1978) Uptake of
Phenyl-14C-CGA-48988 in Potatoes Grown in a Field Plot-Preparation of
Rotational Plots: M6-69-2P, 2S; Report No. ABR-78013. (Unpublished study
received Apr 15, 1981 under 100-607; submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:070018-B)
00071603 Honeycutt, R.C.; Fischer, W.C.; Madrid, S.; et al. (1980) Uptake, Balance and
Metabolism of Phenyl-14C-CGA-48988 in Field Grown Potatoes: M11-69-14P,
14S; Report No. ABR-80042. (Unpublished study received Apr 15, 1981 under
100-607; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:070018-C)
00071604 Honeycutt, R.C.; Cassidy, I.E. (1980) Translocation of Phenyl 14C-CGA-48988
and Metabolites from Leaves into Potato Tubers: Ml 1-69-12P, 12S; Report No.
ABR-80048. (Unpublished study received Apr 15, 1981 under 100-607;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:070018-D)
00071605 Gross, D. (1977) Metabolism of CGA 48 988 in Field Grown Potato Plants:
Project Report 30/77. (Unpublished study received Apr 15, 1981 under 100-607;
prepared by Ciba-Geigy Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
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00071606 Gross, D. (1978) Metabolism of CGA 48 988 in Grapevine: Project Report 11/78.
(Unpublished study received Apr 15, 1981 under 100607; prepared by
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00071607 Gross, D. (1979) Identification of Metabolites of CGA 48 988 (Ridomil in
Grapevine: Project Report 06/79. (Unpublished study received Apr 15, 1981
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00071608 Gross, D. (1979) Fate of CGA 48 988 in Lettuce: Project Report 387 79.
(Unpublished study received Apr 15, 1981 under 100-607; prepared by
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1981 under 100-607; prepared by Ciba-Geigy Ltd., Switzerland, submitted by
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00071610 Gross, D. (1980) Identification of Degradation Products of CGA 48988 (Ridomil)
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00071611 Seim, V.W. (1978) Biological Report for the Metabolism of Phenyl
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00071612 Fischer, W.C.; Foster, R.A.; Cassidy, I.E. (1978) Balance and Metabolism of
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(Unpublished study received Apr 15, 1981 under 100-607; submitted by
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00071613 Hambock, H. (1977) Distribution, Degradation and Excretion of CGA 48 988 in
the Rat: Project Report 18/77. (Unpublished study received Apr 15, 1981 under
100-607; prepared by Ciba-Geigy Ltd., Switzerland, submitted by Ciba-Geigy
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00071614 Hambock, H. (1978) Metabolism of CGA 48 988 in the Rat: Project Report
26/78. (Unpublished study received Apr 15, 1981 under 100-607; prepared by
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CDL:070018-N)
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5457 I. (Compilation; unpublished study, including AG-A 5725, 5456 I, 5545 I,
II..., received Apr 15, 1981 under 100-607; CDL:070019-A)
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Method no. AG-349 dated Nov 25, 1980. (Unpublished study received Apr 15,
1981 under 100-607; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
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00071623 Balasubramanian, K. (1980) Analytical Method for the Determination of Total
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00071674 Seim, V.; Thomas, W.; Brown, G. (1980) Biological Report for CGA48988:
Residue Test in Lactating Cows: Report No. Biol-79009. (Unpublished study
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00071675 Balasubramanian, K.; Ross, J.A. (1979) Validation of Method AG-330 for the
Determination of CGA-48988 and Its Metabolites Containing the
2,6-Dimethylaniline Common Moiety in Tobacco: Report No. ABR-79016.
(Unpublished study received Apr 15, 1981 under 100-607; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 070021-D)
00071676 Balasubramanian, K.; Ross, J.A. (1981) Comparison of Analyses of Potato
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00072396 U.S. Environmental Protection Agency, Terrestrial & Aquatic Biology
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00074488 Ciba-Geigy Corporation (1981) Residues of Metalaxyl in Avocados Resulting
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00077334 Fink, R.; Beavers, J.B.; Brown, R. (1977) Final Report: Acute Oral
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00077335 Fink, R.; Beavers, J.B.; Brown, R. (1977) Final Report: Eight-Day Dietary
LC50--Bobwhite Quail: Project No. 108-147. (Unpublished study received Jul
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00079433 Kahrs, R.A. (1981) Residues of Metalaxyl in Hops Resulting from Soil Drench
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00084107 Sachsse, K.; Ullmann, L. (1976) Skin Irritation in the Rabbit after Single
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00084108 Sachsse, K.; Ullmann, L. (1975) Eye Irritation in the Rabbit of Technical CGA
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00084109 Sachsse, K.; Ullmann, L. (1976) Skin Sensitizing (Contact Allergenic) Effect in
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00084110 Drake, J.C. (1977) 3 Months Dietary Study in Rats in Compound CGA 48 988.
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00084111 Finn, J.P.; Rider, L.; Briggs, K.; et al. (1977) CGA 48.988: 91 Day Dietary
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00084113 Ami, P.; Muller, D. (1978) Salmonella/Mammalian-microsome Mutagenicity
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(Unpublished study received Jul 13, 1978 under 100-EX-62; prepared by
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00084114 Fritz, H. (1978) Dominant Lethal Study-CGA 48 988 Tech.: Mouse: (Test for
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00097511 Ciba-Geigy Corporation (1981) Residues of Ridomil(R) in Lettuce.
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00098428 Kahrs, R.A. (1982) Metalaxyl-Melons, Cucumbers, Squash, Green Onions, Bulb
Onions, Potatoes-Supportive Data Requested by EPA: Report No. ABR-82014.
(Unpublished study received Apr 7, 1982 under 1F2500; submitted by
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00098481 Ashby, R.; Whitney, J.C.; Bhatt, A.; et al. (1980) Cga 48 988: Toxicity and
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00099084 Hambock, H. (1981) Metabolic Pathways of CGA 48 988 in the Rat: Project
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00100446 Buccafusco, R.; Stiefel, C.; Fratus, G.; et al. (1978) Acute Toxicity of
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#BW-78-12-381. (Unpublished study received Feb 21, 1979 under 100-601;
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00100447 Buccafusco, R.; Stiefel, C.; Fratus, G.; et al. (1978) Acute Toxicity of
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00100448 Suprenant, D. (1978) Acute Toxicity of CGA-48988 to the Water Flea (Daphnia
magna): Report #BW-78-12-364. (Unpublished study received Jan 25, 1979
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00100455 Burkhard, N. (1977) Volatilization of CGA-48988 from Soil under Laboratory
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00100456 Burkhard, N. (1978) Photolysis of CGA-48988 (Ridomil) on Soil Surfaces under
Artificial Sunlight Conditions: Project Report 09/78. (Unpublished study
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00100464 Guth, J. (1976) Leaching Model Study with the Fungicide CGA-48988 in Four
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00100465 Guth, J. (1978) Leaching Characteristics of Aged 14C-CGA 48988 (Ridomil)
Residues in Two Standard Soils: Project Report 33/78. (Unpublished study
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00100466 Guth, J. (1978) Adsorption and Desorption of CGA 48988 (Ridomil) in Various
Soil Types: Project Report 35/78. (Unpublished study received Apr 26, 1979
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00100468 Ladd, S.; Wilson, W. (1979) Accumulation and Elimination of 14Cresidues by
Bluegill Sunfish ... Exposed to 0-14C-CGA-48988: Report #BW-78-10-328.
(Unpublished study received Apr 26, 1979 under 100-600; prepared by EG & G,
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00100470 Ladd, S.; Enos, J. (1979) Kinetics of Phenyl-14C-CGA in a Model Aquatic
Ecosystem: Report #BW-79-2-401. (Unpublished study received Apr 26, 1979
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00100476 Cassidy, J.; Ross, J. (1979) Metalaxyl (CGA-48988)-Tobacco: Results of Tests
on the Amounts and Nature of Metalaxyl Residues in Tobacco and Its Smoke:
Report No. ABR-79103. Summary of studies 241245-A, 241245-B, 241246-A.
(Unpublished study received Oct 31, 1979 under 100-607; submitted by
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00100477 Honeycutt, R.; Szolics, I; Simoneaux, B.; et al. (1979) Identification of the Major
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Greenhouse Grown Bright Tobacco, Ml 1-69-2Y: Report No. ABR-79008.
(Unpublished study received Oct 31, 1979 under 100-607; submitted by
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00100478 Honeycutt, R.; Fischer, W.; Cassidy, J. (1979) Uptake and Balance of
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Ml 1-69-HP, US: Report No. ABR-79100. (Unpublished study received Oct 31,
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00100753 Ciba-Geigy Corp. (1982) ^Residues of Metalaxyl in Cattle and Goats.
(Compilation; unpublished study received May 11, 1982 under 1F2500;
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00103354 McSheehy, T.; Macrae, S.; Whitney, J. (1981) CGA 48 988: Oncogenicity in
Dietary Administration to Mice for Two Years: LSR Report No.: 80/CIA008/442.
(Unpublished study received Jun 11, 1982 under 100-607; prepared by Life
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CDL:247660-B)
00103359 Ami, P. (1982) Saccharomyces Cerevisiae D7/Mammalian-microsome
Mutagenicity Test in vitro with CGA 48 988 (Test for Mutagenic Properties in
Yeast Cells): No. of Experiment 811561. (Unpublished study received Jun 11,
1982 under 100-607; prepared by Ciba-Geigy, Ltd., Switz., submitted by
Ciba-Geigy Corp., Greensboro, NC; CDL:247661-B)
00103361 Langauer, M.; Muller, D. (1979) Nucleus Anomaly Test in Somatic Interphase
Nuclei: CGA 48 988: Chinese Hampster (Test for Mutagenic Effects on Bone
Marrow Cells): No. of Experiment 783007. (Unpublished study received Jun 11,
1982 under 100-607; prepared by Ciba-Geigy, Ltd., Switz., submitted by
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00103362 Strasser, F. (1982) L5178Y/TK+/-Mouse Lymphoma Mutagenicity Test: CGA 48
988 (In vitro Test for Mutagenic Properties of Chemical Substances in
Mammalian Cells): No. of Experiment 811258. (Unpublished study received Jun
11, 1982 under 100-607; prepared by Ciba-Geigy, Ltd., Switz., submitted by
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00103363 Puri, E. (1982) Autoradiographic DNA Repair Test on Rat Hepatocytes: CGA 48
988 (In vitro Test for DNA-damaging Properties): No. of Experiment 811259.
(Unpublished study received Jun 11, 1982 under 100-607; prepared by
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CDL:247661-F)
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00104378 Balasubramanian, K.; Nixon, W. (1978) Gas Chromatographic Residue
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(Unpublished study received Oct 31, 1979 under 100-607; submitted by
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00104387 Ciba-Geigy Corp. (1979) Residues of CGA-48988 on Wheat, Rye, Forage and
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00104390 Ciba-Geigy Corp. (1979) Residue Studies of CGA-48988 on Soybeans and Other
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00104483 Ciba-Geigy Corp. (1978) Chemical Data on the Fungicide Ridomil.
(Compilation; unpublished study received Jul 13, 1978 under 100EX-63;
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00104485 Honeycutt, R.; Simoneaux, B.; Szolics, I; et al. (1978) Characterization of Polar
Metabolites of Phenyl-14C-CGA-48988 in Greenhouse Grown Bright Tobacco:
Report No. ABR-78044. (Unpublished study received Jul 13, 1978 under
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00104493 Burkhard, N. (1976) Hydrolysis of CGA-48988 under Laboratory Conditions:
Project Report 26/76. (Unpublished study received Jul 13, 1978 under
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00104494 Ellgehausen, H. (1977) Distribution of the Non-extractable Radioactivity between
Different Soil Organic Matter Fractions of a Field Soil Treated with 14C-labeled
CGA 48988 (Addendum to Project Report 55/77): Project Report 56/77.
(Unpublished study received Jul 13, 1978 under 100-EX-62; prepared by
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00104498 Ciba-Geigy Corp. (1978) Chemistry of CGA-48988 Technical. (Compilation;
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00104654 Ross, I; Marco, G. (1978) CGA-48988-Potatoes Residues Observed and
Metabolism Data Including the Analytical Methods Used: Report No.
ABR-78055. (Unpublished study received Sep 5, 1978 under 100-EX-l;
submitted by Ciba-Geigy Corp., Greensboro, NC; CDL:097387-A)
00104656 Ciba-Geigy Corp. (1978) Ridomil 2E Fungicide Residue Study-Potatoes.
(Compilation; unpublished study received Sep 5, 1978 under 100-EX-l;
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00109402 Ciba-Geigy Corp. (1981) Metalaxyl-Cotton In-furrow Applications of Ridomil
2E and 5G Including Mixtures with PCNB: Report No. ABR81046.
(Compilation; unpublished study received Jul 28, 1982 under 100-607;
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00109471 Coate, W. (1982) Correction Pages and Addendum: Subchronic Inhalation Study
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00109472 Ciba-Geigy Corp. (1982) Metalaxyl Residues in Pineapple Resulting from a
Preplant Dip Application of Ridomil 2E. (Compilation; unpublished study
received Aug 12, 1982 under 100-607; CDL: 071034-A)
00114376 Ciba-Geigy Corp. (1982) Metalaxyl-Rotational Wheat: Report # ABR82061.
(Compilation; unpublished study received Sep 23, 1982 under 100-607;
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00114377 Ciba-Geigy Corp. (1982) Metalaxyl-Lettuce: Report # ABR-82060.
(Compilation; unpublished study received Sep 23, 1982 under 100607;
CDL: 071106-A)
00114378 Ciba-Geigy Corp. (1982) Metalaxyl-Spinach: Report # ABR-82050.
(Compilation; unpublished study received Sep 23, 1982 under 100607;
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00114379 Collins, P.; Williams, S.; Cassidy, J. (1982) Metabolism of
Phenyl-14C-CGA-48988 in Greenhouse Head Lettuce: Report No. ABR82054.
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198
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00117969 Cheung, M.; Manuli, P. (1982) Metalaxyl-Citrus: Residues Resulting from Soil
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(Unpublished study received Nov 16, 1982 under 100-607; submitted by
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00126315 Ciba-Geigy Corp. (1983) Summary of Section D: Metalaxyl-Apples.
(Compilation; unpublished study received Mar 7, 1983 under 100-607;
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00127769 Ciba-Geigy Corp. (1983) Metalaxyl—Red Raspberries: Residues Resulting from
Soil Application of Ridomil 2E or 5G. (Compilation; unpublished study received
Mar 7, 1983 under 100-607; CDL:071478-A)
00128102 Ciba-Geigy Corp. (1982) Metalaxyl (Apron 2E) Seed Treatments. (Compilation;
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00128738 Ciba-Geigy Corp. (1983) Summary of Section D: Metalaxyl-Peanuts: Residue
Reports. (Compilation; unpublished study received Jun 29, 1983 under 100-607;
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00129003 Ciba-Geigy Corp. (1983) Summary of Section D: Metalaxyl-Pod Vegetables.
(Compilation; unpublished study received Jun 23, 1983 under 3F2918;
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00130693 Ciba-Geigy Corp. (1983) Residue Summary: Metalaxyl—Cucumbers, Melons, and
Squash. (Compilation; unpublished study received Aug 19, 1983 under 100-607;
CDL:251019-A)
00130694 Ciba-Geigy Corp. (1983) Residue Summary: Metalaxyl-Green and Dry Bulb
Onions. (Compilation; unpublished study received Aug 19, 1983 under 100-607;
CDL:251020-A)
00130695 Ciba-Geigy Corp. (1983) Residue Summary: Metalaxyl—Lettuce and Spinach.
(Compilation; unpublished study received Aug 19, 1983 under 100-607;
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00130773 Ciba-Geigy Corp. (1983) Residue Summary: Metalaxyl—Broccoli, Cabbage and
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1983 under 100-607; prepared by Experimental Pathology Laboratories, Inc.,
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00133020 Ciba-Geigy Corp. (1983) Metalaxyl-Citrus Residues Resulting from Soil
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1983 under 100-628; CDL:251988-A)
00138818 Ciba-Geigy Corp. (1984) Residue Summary: Metalaxyl-Field Grapes.
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00140371 Cassidy, I.E.; Ross, J.A. (1978) CGA-48988-Tobacco: Results of Tests on the
Amounts and Nature of Residues in Tobacco and Its Smoke: Report No.
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78 p.
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94 p.
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200
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41 150101
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205
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41664505 Ross, J. (1990) Preparation of Diazomethane: Lab Project Number: AG/345.
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Enzyme Collagenase: Lab Project Number: SOP/NUMBER/7/22. Unpublished
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41689702 Ross, J. (1990) Metalaxyl Magnitude of Residues in Field Corn Forage
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41765002 Braxton, S.; Bird, R. (1991) Ridomil 2E-Field Dissipation-Tobacco And Bare
Soil-North Carolina: Lab Project Number: 23TBBS. Unpublished study prepared
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41809301 Leroy, R. (1990) Metalaxyl: Terrestrial Field Dissipation of Ridomil 2E on
Citrus: Final Report: Lab Project Number: EF-88-04A: 80201. Unpublished
study prepared by Pan-Agricultural Labs, Inc. and ChemAlysis, Inc. 254 p.
41855801 Surprenant, D. (1991) Technical Metalaxyl: Response to EPA ECOTOX
Review...Regarding Four Marine Estuarine Studies Conducted with Technical
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41288104). Unpublished study prepared by Springborn Labs, Inc. 32 p.
41870301 Ross, J. (1990) Amendment 1 to ABR-90075: Metalaxyl Magnitude of the
Residues in Field Corn Forage, Silage-stage Forage, Fodder, and Grain Following
Seed Treatment with Apron 25W. (Related to MRIDs 41689701 and 41689702):
Lab Project Number: ABR-90075. Unpublished study prepared by Ciba-Geigy
Corp. 222 p.
41870302 Eudy, L. (1991) Metalaxyl: Magnitude of the Residues in Processed Food/Feed
Commodities of Grain Sorghum Following Seed Treatment with Apron 25W:
Lab Project Number: ABR-90103. Unpublished study prepared by Ciba-Geigy
Corp. 147 p.
41870303 Smith, J. (1991) Metalaxyl: Magnitude of the Residues in Processed Food/Feed
Commodities of Rice Following Seed Treatment with Apron 25W plus
Preemergence Application of Ridomil 2E: Lab Project Number: ABR-90102.
Unpublished study prepared by CibaGeigy Corp. 135 p.
207
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41870304 Smith, J. (1991) Metalaxyl: Magnitude of the Residues in Processed Food/Feed
Commod-ities of Sunflowers Following Seed Treatment with Apron 25W: Lab
Project Number: ABR-90105. Unpublished study prepared by Ciba-Geigy Corp.
138 p.
41870305 Smith, J. (1991) Metalaxyl: Magnitude of the Residues in Processed Food/Feed
Commodities of Cottonseed Following Seed Treatment with Apron 25W plus
In-Furrow Application of Ridomil 5G: Lab Project Number: ABR-90104.
Unpublished study prepared by CibaGeigy Corp. 120 p.
41870306 Eudy, L. (1991) Metalaxyl: Magnitude of the Residues in Peanut Vines, Hay,
Nutmeats and Shells Following In-Furrow plus Banded Applications of Ridomil
5G: Lab Project Number: ABR-90107. Unpublished study prepared by
Ciba-Geigy Corp. 172 p.
41870307 Eudy, L. (1991) Metalaxyl: Magnitude of the Residues in Processed Food/Feed
Commodities of Potatoes Following Application of Ridomil 2E plus Ridomil
MZ58: Lab Project Number: ABR-90106. Unpublished study prepared by
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41870308 Dickson, G. (1983) Metalaxyl: Rotational Crop Studies: Lab Project Number:
EIR-82011. Unpublished study prepared by Ciba-Geigy Corp. 491 p.
41912901 Lail, L. (1989) Technical Metalaxyl: A Supplement to the Product Chemistry.
Unpublished study prepared by Ciba-Geigy Corp. 31 p.
41912902 Ross, J. (1990) Metalaxyl: Sample Storage Interval Summary Amendment 1: Lab
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Corporation. 29 p.
41912903 Ross, J. (1991) Metalaxyl: Response to EPA Review of Metalaxyl on Corn: Lab
Project Number: ABR-91035. Unpublished study prepared by Ciba-Geigy
Corporation. 13 p.
41996401 Smith, J. (1991) Metalaxyl—Cranberries/Residue Summary: Lab Project Number:
ABR-90046. Unpublished study prepared by CibaGeigy Corp., Ag. Div. 161 p.
208
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42021101 Cheung, M. (1991) Metalaxyl: Response to EPA Review of Metalaxyl on Leafy
Vegetables Crop Grouping (Excluding Spinach): Lab Project Number:
ABR-91058. Unpublished study prepared by Ciba-Geigy Corp. 20 p.
42115801 Ermani, J. (1990) Amendment to: Metabolism of phi-carbon 14 Metalaxyl in
Goats. Unpublished study prepared by Ciba-Geigy Corp. 4 p.
42115802 Emrani, J. (1990) Supplemental to: Metabolism of phi-carbon 14 Metalaxyl in
Goats. Unpublished study prepared by Ciba-Geigy Corp. 74 p.
42115803 Kennedy, E. (1990) Amendment to Metabolism of phi-carbon 14 Metalaxyl in
Hens. Unpublished study prepared by Ciba-Geigy Corp. 4 p.
42115804 Kennedy, E. (1990) Supplemental to Metabolism of phi-carbon 14 Metalaxyl in
Hens. Unpublished study prepared by Ciba-Geigy Corp. 176 p.
42115805 Kim Ha, J.; Lindsay, R. (1990) Method for the quantitative analysis of volatile
free and total branched-chain fatty acids in cheese and milk fat. J. of Dairy Sci.
73(8): 1988-1999.
42115806 Massart-Leen, A.; De Footer, H.; DeCloedt, M.; et al. (1981) Composition and
variability of the branched-chain fatty acid fraction in the milk of goats and cows.
Lipids 16(5): 286-292.
42115807 Eudy, L. (1991) Improved Analytical Method for the Determination of Total
Terminal Residues of Metalaxyl in Poultry Tissues and Eggs as 2,6-Dimethyl
Aniline: Lab Project Number: AG-576. Unpub lished study prepared by
Ciba-Geigy Corp. 45 p.
42115808 Yokley, R. (1991) Validation of Analytical Method AG-576 for the
Determination of Total Residues of Metalaxyl in Goat Tissues, Milk, Poultry
Tissues and Eggs: Lab Project Number: ABR-91008. Unpublished study prepared
by Ciba-Geigy Corp. 125 p.
42115809 Eudy, L. (1991) Metalaxyl: Three Level/28-Day Poultry Study: Lab Project
Number: ABR-91047. Unpublished study prepared by CibaGeigy Corp. 23 p.
209
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42115810 Cheung, M. (1982) Metalaxyl: Gas Chromatographic Determination of Metalaxyl
(Apron) Coatings on Seed: Lab Project Number: AG-397. Unpublished study
prepared by Ciba-Geigy Corp. lip.
42196501 McFarland, J. (1992) Uptake and Metabolism of Metalaxyl in Greenhouse
Rotational Crops Following Target Tobacco Grown in Soil Treated with
Phenyl-carbon 14-Metalaxyl: Lab Project Number: ABR-91084. Unpublished
study prepared by Ciba-Geigy Corp. 272 p.
42196502 Madrid, S. (1981) Uptake, Balance and Metabolism of carbon 14-CGA-48988 in
Field Grown Potatoes: Lab Project Number: ABR-81037. Unpublished study
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42196503 Honey curt, R. (1980) Identification of Four Sugar Conjugate Metabolites of
carbon 14-CGA-48988 in Tobacco: Lab Project Number: ABR-80035.
Unpublished study prepared by Ciba-Geigy Corp. 25 p.
42233501 Eudy, L. (1992) Metalaxyl: Magnitude of the Residue in Processed Food/Feed
Commodities of Pineapples Following Seed Piece Dip with Ridomil 2E: Lab
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HOp.
42259801 Vithala, R. (1992) Anaerobic Aquatic Metabolism of carbon 14-Metalaxyl:
Amended Final Report: Lab Project Number: 005/001/007/89. Unpublished
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42259802 Vithala, R. (1991) Aerobic Aquatic Metabolism of carbon 14-Metalaxyl: Lab
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Hazardous Materials Research. 130 p.
42259803 Leech, G.; Wiepke, T. (1992) Aquatic Dissipation of Metalaxyl (Ridomil 2E) in a
California Rice Paddy: Lab Project Number: EF-90-326: 31/90-CGA.l.
Unpublished study prepared by Pan-Agricultural Laboratories, Inc. and Twin City
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42259804 Biever, R. (1992) Ridomil 2E (metalaxyl): An Aquatic Dissipation Study for
Water Seeded Rice in Memphis, Tennessee: Final Report: Lab Project Number:
91-11-4013: 1781-0490-6242-330. Unpublished study prepared by Springborn
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210
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81 p.
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211
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Metalaxyl in Rats: Identification of Major Metabolites: Report Amendment 1:
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43317302 McFarland, J. (1992) Final Report Amendment on the Uptake and Metabolism
of Metalaxyl in Greenhouse Rotational Crops Following Target Tobacco Grown
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212
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APPENDIX D. List of Available Related Documents
213
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214
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The following is a list of available documents related to 0081. It's purpose is to provide a
path to more detailed information if it is needed. These accompanying documents are part of the
Administrative Record for 0081 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. 0081 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
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APPENDIX E. PR Notices 86-5 and 91-2
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PR Notice 86-5
219
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220
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
tpno1 WASHINGTON, B.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
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entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.
V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be C9mpatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy (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 is to avoid the additional C9sts and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of applicati9n
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
deadlines for inserting int9 the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each application
for registration or other action include a list 9f all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support f9r the application.
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
foll9ws the index on the next page, and samples of some of the
requirements are attached. Except for the language 9f the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
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
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D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10 (d) (1)1 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(1) ) 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 f9r 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--!.e., a registration application,
petition, experimental use permit (EUPT, §3 (c) (2) (B) data
call-in, §6(a)(2) submittal, or a special review; the transmittal
date; and a list of all individual studies included in the
gackage in the order of their appearance, showing (usually by
uideline 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 petition for tolerance or an
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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.
When a submittal package supports a tolerance petiti9n 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 should be identifiable and distinguishable by a
C9nventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with 39016 exceptions dis-
cussed in section C.I. Each study included in a submittal
Eackage must be bound as a separate entity. (See comments on
inding 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 following:
- Include the total number of pages in the complete study 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.1 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 tolerance petition, or an end-use product
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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
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 crop 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 C9mmodities 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 Study 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 Iaborat9ry 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)
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D.I. Title Page
A title page is 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.
b. Data requirement addressed. Include on the title page the
Guideline number(s) of the specific requirement(s) addressed by
the study.
c. Author(s). Cite only individuals with primary intellectual
responsibility for the C9ntent 9f 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 IdentificatJ9n. 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 work. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
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).
g. Facts of Publication. If the study is a reprint of a pub-
lished d9cument, identity on the title page all relevant facts of
publication, such as the J9urnal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d) (1) .
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)(1)(A), (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
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claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions (see NOTE Pg 13).
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 t9 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
)ortion of a submitted study other than described by FIFRA £
[I)(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 9f 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 RESUBMIT 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 t9 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 smpuld 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 9n one side only in
black ink, with high contrast and good res9lution. Bindings for
individual studies must be secure, but easily removable to permit
227
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disassembly for microfilming. Check with EPA for special
instructions bef9re submitting data in any medium other than
paper, such as film or magnetic media.
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 regulati9ns specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Stan-
dard 9r Special Review must be provided in four C9pies, fr9m one
of which all material claimed as CBI has been excised. 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".
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V. For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
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 G9od Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
"Smith Chemical 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
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. 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 J9int 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
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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 Requirement
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 Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
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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:
Title Signature
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:
Title Signature
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
Meth9ds 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.
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1)(A), (B), or (C), but for which y9u claim
C9nfidential 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.
• Encl9se C9pies 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 th9se harmful effects and explain why
they should be viewed as substantial.
• If you assert that the informati9n 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.
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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
following paragraph(s) at the indicated volume and page
references.
DELETED WORDS OR PHRASE: Ethvlene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
100 19
Example 2. (Confidential paragraph^ 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 paragraph(s) at the indicated volume and page
references.
DELETED PARAGRAPH (S):
( )
( Reproduce the deleted paragraph (s) here )
( )
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process §10(d)(l)(C)
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 paragraph(s) at the indicated volume and page
references.
DELETED PAGES (S): are attached immediately behind this page
PAGES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process §10(d)(l)(A)
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
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
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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 submittal
(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
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PR Notice 91-2
237
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238
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
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 9f such ingredient(s), as that term
is defined in 40 CFR 158.153(1). 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)(1)(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
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product compositi9n because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is imp9rtant 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 C9ncentrati9n expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (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 pr9vide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i. e., upper limit(s) 9nly) 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.
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.
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(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) ab9ve will have until July 1, 1997, to
comply with this Notice. 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.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
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APPENDIX F. Combined Generic and Product Specific
Data Call-In
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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 (EPA, the
Agency). These data are necessary to maintain the continued registration ofyour product(s)
containing this active ingredient. Within 90 days after you receive this Notice you must respond
as set forth in Section III 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 III-B); or
3. Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section III-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 ofyour 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 6).
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 into 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 II - Data Required by this Notice
Section III - 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
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2 - Generic Data Call-In and 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 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregi strati on
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms
SECTIONI. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reeyaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional 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 II. DATA REQUIRED BY THIS NOTICE
II-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
You are required to submit the data or otherwise satisfy the data requirements specified
in the Requirements Status and Registrant's Response Forms (Attachment 3) within the
timeframes provided.
II-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.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (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 willnpt 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 Street, N.W.,
Washington, 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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II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED
BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change
the requirements of any previous Data Call-In(s). or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. 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).
III-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 will 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.
III-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 III-C. A discussion of options relating to requests for data waivers is
contained in Section III-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 qualify for a Generic 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 (if 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 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 Data
Call-In Response Forms (Attachment 2), indicating your election of this option. Voluntary
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cancellation is item number 5 on both Data Call-In Response Form(sy 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
application for amendment, a copy of 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 Form by signing the certification, item number 8.
Application forms for amending registrations may be obtained from the Registration 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 FTFRA, 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 the Requirements Status and Registrant's Response Form.
Generic Data Exemption cannot be selected as an option for 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 committed to 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 of both your
and their product(s), unless you commit to submit and do submit the required data within the
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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 III-C.l. 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. If you choose item 6b (agree to satisfy
the generic data requirements), you must submit the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form as well as any other information/data
pertaining to the option chosen to address the 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 III-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 of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C.2. A discussion of options relating
to requests for data waivers is contained in Section III-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 2 and 3, respectively). The Data Call-in
Response Form must be submitted as part of every response to this Notice. In addition, one
copy of the Requirements Status and Registrant's Response Form also must be submitted for
each product listed on the Data Call-In Response Form unless the voluntary cancellation option
is selected. Please note that the company's authorized representative is required to sign the first
page of the Data Call-In Response Form and Requirements Status and Registrant's Response
Form (if 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 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 a completed Data Call-In Response Form.
indicating your election of this option. Voluntary cancellation is item number 5 on both the
Generic and Product Specific Data Call-In Response Forms. If you choose this
option, you must complete both Data Call-In response forms. These are the only forms that you
are required to complete.
If you choose to voluntarily cancel your product, further sale and distribution of your
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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. Satisfying the Product Specific Data Requirements of this Notice.
There are various options available to satisfy the product specific data requirements of
this Notice. These options are discussed in Section III-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 specific
data requirements for an MUP or EUP as applicable) on the product specific Data Call-In
Response Form. Note that the options available for addressing product specific data
requirements differ slightly from those options for fulfilling generic data requirements. Deletion
of 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 Reregi strati on Eligibility Decision document.
c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section III-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 Response Form
and the Requirements Status and Registrant's Response Form as well as any other
information/data pertaining to the option chosen to address the data requirement. Your response
must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1. Generic Data
If you acknowledge on 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. Your 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 the 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:
I will generate and submit data within the specified timeframe (Developing Data)
I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
I have made offers to cost-share (Offers to Cost Share)
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 cqnformance 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
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
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protocol must be submitted have been identified in the Requirements Status and Registrant's
Response Form and/or footnotes to the form. If you wish to use a protocol which differs 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
protocol not specified in Section II-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 information
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 for the submission of 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 to 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 cost-
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 to anything else, offer to
share in the burden of producing the data upon terms to be agreed to or, failing agreement, to be
bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify
this offer. The other registrant must also inform EPA 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 the data
required by this 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 some 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 of 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 data' 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 transcribed verbatim, dated,
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and verified accurate by signature), the exact copy or exact transcript 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 FIFRA Accelerated Reregi strati on 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.
If EPA has previously reviewed a protocol for a study you are submitting, you must
identify 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.
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 the 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
the 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.
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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 for 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 the
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 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 the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide 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)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
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 those described for generic data (see Section III.C.I, 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 share,
the same requirements apply to product specific data as to generic data (see Section III.C.l,
Option 2). However, registrants may only choose this option for acute toxicity data and certain
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efficacy data and only if EPA has indicated in the attached data tables that your product and at
least one other 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 share by the registrant selecting this option.
Option 3. Offer to Share in the Cost of Data Development —The same requirements for generic
data (Section III.C.L, Option 3) apply to this 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 III.C.L, Option 4) apply to this option for product specific data.
Option 5. Upgrading a Study — The same requirements described for generic data (see Section
III.C.L, Option 5) apply to this option for product specific data.
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section III.C.L, Option 6) 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 and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (III.C.L), as appropriate.
III-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 requirement(s) 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 FIFRA requires EPA to consider the appropriateness of
requiring data for low volume, minor use pesticides. In implementing this 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 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 produces)
containing the active ingredient. If applicable to the active ingredient, include foreign
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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.
(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 opposed 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 should
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 product(s) and, if a current copy of your Confidential
Statement of Formula is not already on file you must submit a current copy.
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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 produces), you must choose a method
of meeting the requirements of this Notice within the time frame provided by this Notice.
Within 30 days of your receipt of the 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 for product chemistry, acute toxicity and
efficacy (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 submitted without adequate supporting rationale will be denied
and the original due date will remain in force.
SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the 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.
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.
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).
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6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-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 Registrant's
Response Form.
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.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE
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 the 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, and the adequacy of any required supporting (or
raw) data, including, but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted in 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. If you believe such disposition of existing stocks of your product(s) which may
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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 with 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 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 VI. 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 specific 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,
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Louis P. True, Jr., Acting Director
Special Review and
Reregi strati on Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Call-In and 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 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregi strati on
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Confidential Statement of Formula. Cost Share and Data Compensation Forms
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Attachment 1. Chemical Status Sheets
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Metalaxyl DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have products
containing metalaxyl.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregi strati on of metalaxyl.
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 2), (4) a list of registrants receiving this DCI (Attachment 4), (5)
the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and Data Compensation
Forms in replying to this Generic Data Callln (Attachment F). Instructions and guidance
accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for metalaxyl
are contained in the Requirements Status and Registrant's Response. Attachment C. The Agency
has concluded that additional product chemistry data on metalaxyl are needed. These data are
needed to fully complete the reregi strati on of all eligible metalaxyl 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 Judy Loranger at (703) 308-8056.
All responses to this Notice for the generic data requirements should be submitted to:
Judy Loranger, Chemical Review Manager
Reregi strati on Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Metalaxyl, Case 0081
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Metalaxyl DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have products
containing metalaxyl.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregi strati on of
metalaxyl. This attachment is to be used in conjunction with (1) the Product Specific Data Call-
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 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 metalaxyl are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional data on metalaxyl 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 metalaxyl products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of metalaxyl, please contact
Judy Loranger at (703) 308-8056.
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: Metlalaxyl, 0081
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Attachment 2. Combined Generic and Product Specific
Data Call-In Response Forms (Form A inserts) Plus
Instructions
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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 to 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 Reregi strati on 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 before
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
Generic and Product 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 stamped.
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
Generic and Product Specific Data Call-In
incorporate that product 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 satisfy those requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
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Item 7a ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing use
product (MUP) for which you wish to maintain registration, you must agree to satisfy the data
requirements by responding "yes."
Item 7b.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
Status 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
Generic and Product Specific Data Call-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 title. 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 1 l.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 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 that its records are correct.
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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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272
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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
specific Data Call-in's as part of EPA's reregi strati on 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
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
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.
ItemS. 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 this 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 noted in
Section III 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
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
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
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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
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:
EUP End-Use Product
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical Grade Active
Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Ingredient or Pute Active
Ingredient Radiolabelled
PAIR A Pure Active Ingredient Radiolabelled
PAIRA/M Pure Active Ingredient Radiolabelled and Metabolites
PAIRA/PM Pure Active Ingredient Radiolabelled and Plant Metabolites
TEP Typical End-Use Product
TEP % Typical End-Use Product, Percent Active Ingredient
Specified
TEP/MET Typical End-Use Product and Metabolites
TEP/PAI/M Typical End-Use Product or Pure Active Ingredient and
Metabolites
TGAI Technical Grade Active Ingredient
TGAI/PAI Technical Grade Active Ingredient or Pure Active
Ingredient
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active Ingredient
Radiolabelled
TGAI/TEP Technical Grade Active Ingredient or Typical End-Use
Product
MET Metabolites
IMP Impurities
DEGR 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 submission
of product specific studies begins from the date stamped on the letter transmitting
the Reregi strati on Eligibility Decision document, and not from the date of receipt.
However, your response to the Data Call-In itself is due 90 days from the date of
receipt.
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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 frames 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 conditions for submittal of this study as
outlined in the Data Call-In Notice and that I will provide the protocols
and progress reports required in item 5 above.
Option 2. ON BOTH FORMS: (Agreement to Cost Shared 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 snaring 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.
Option 3. ON BOTH FORMS: (Offer to Cost Shared I have made an offer to enter
into an agreement with 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 that has 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.
Option 5. 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 that 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
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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 Studv^ I am citing an existing study that
has been previously classified by EPA 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 that 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
(Numbers 7, 8, and 9) are responses that 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 than lowvolume 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
that applies to the "Requirements Status and Registrant's Response Form" for
product specific data.
Option 7. (Waiver Request) I request a waiver for this study because it is
inappropriate for 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
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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 the 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 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 the Agency can ensure that its records are correct.
278
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
279
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280
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EPA'S BATCHING OF METALAXYL PRODUCTS FOR MEETING ACUTE TOXICITY DATA
REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregi strati on of products containing metalaxyl as the active
ingredient, the Agency has batched products which can be considered similar for purposes of acute
toxicity. Factors considered in the sorting process include each product's active and inert ingredients
(identity, percent composition and biological activity), type of formulation (e.g., emulsifiable
concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use
classification, precautionary labeling, etc.). Note that the Agency is not describing batched products
as "substantially similar" since some products within a batch may not be considered chemically
similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwith-standing the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute 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
toxicological studies for each of their own products. If a registrant chooses to generate the data for
a batch, he/she must use one of the products within the batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base is complete and valid by today's standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute toxicity data. Regardless of
whether new data is generated or existing data is referenced, registrants must clearly identify the test
material by EPA Registration Number. If more than one confidential statement of formula (CSF)
exists for a product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet
the data requirements for each product. The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product, including the standard six acute
toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she will
provide the data or depend on someone else to do so. If a registrant supplies the data to support a
batch of products, he/she must select one of the following options: Developing Data (Option 1),
Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among: Cost
Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a
registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a
registrant should know that choosing not to participate in a batch does not preclude other registrants
in the batch from citing his/her studies and offering to cost share (Option 3) those studies.
Eighty one products were found which contain metalaxyl as the active ingredient. The
products have been placed into seven batches and a "no batch" category in accordance with the
active and inert ingredients, type of formulation and current labeling. Table 1 identifies the products
in each batch. Table 2 lists the products which have been placed in the "no batch" category.
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Table 1
Batch
1
2
3
4
5
EPA Reg. No.
100-664
100-713
100-742
100-749
PA93000600
100-670
100-140
100-639
100-717
100-718
100-735
100-738
% Active Ingredient
Metalaxyl 1 . 0
PNCB 10.0
Metalaxyl 1 . 0
PNCB 10.0
Metalaxyl 7 . 0
Zinc ion ana manganese
ethylene bisdi-
thiocarbamate 70.0
Metalaxyl 7 . 0
Zinc ion ana manganese
ethylene bisdi-
thiocarbamate 70.0
Metalaxyl 7 . 0
Zinc ion ana manganese
ethylene bisdi-
thiocarbamate 70.0
Metalaxyl 12.5
Captan 30.8
Related derivatives 0.7
Metalaxyl 12.5
Captan 30.8
Related derivatives 0.7
Metalaxyl 25.0
Metalaxyl 25.0
Metalaxyl 25.0
Metalaxyl 50.0
Metalaxyl 50.0
Formulation
Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Table 1
Batch
6
EPA Reg. No.
100-607
100-619
100-626
AZ85000800
% Active Ingredient
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Formulation
Type
Liquid
Liquid
Liquid
Liquid
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Batch
EPA Reg. No.
AZ86001500
CA82002400
CA85006800
CA86001800
CA90004700
C088000100
FL81001700
FL82008600
FL86000200
FL89002300
GA81000400
ID89000500
KY81000300
LA92000400
MD81001400
NC81001100
OH81001100
OK90000500
OR89000800
PA81001800
SC81000100
TN87001500
TX91001100
VA81000700
VA88000600
% Active Ingredient
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 25.1
Formulation
Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
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Table 1
Batch
6
7
EPA Reg. No.
WA87000200
WA89001500
ID83003300
WA83003500
% Active Ingredient
Metalaxyl 25.1
Metalaxyl 25.1
Metalaxyl 35.0
Captan 33.1
Related derivatives 1.9
Metalaxyl 35.0
Captan 34.2
Related derivatives 0.8
Formulation
Type
Liquid
Liquid
Solid
Solid
The following table lists products that were either considered
not to be similar or the Agency lacked sufficient information for
decision making and were not placed in any batch. Registrants of
these products are responsible for meeting the acute toxicity data
requirements separately for each product.
Table 2 (No Batch)
EPA Reg.
No.
100-601
100-628
100-629
100-646
100-658
100-672
100-676
100-683
100-684
100-720
138-185
% Active Ingredient
Metalaxyl 90.0
Metalaxyl 5 . 0
Metalaxyl 10.0
Zinc ion and manganese ethylene
bisdithiocarbamate 48.0
Metalaxyl 5 . 0
Metalaxyl 9 . 0
Chlorothalonil 72.0
Metalaxyl 45.0
Thiabendazole 24.0
Metalaxyl 2 . 0
Metalaxyl 2 . 8
Captan 13.7
Related derivatives 0.3
Metalaxyl 33.3
Metalaxyl 10.0
Copper hydroxide 60.0
Metalaxyl 1.21
Formulation
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Liquid
Liquid
Solid
Solid
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EPA Reg.
No.
538-203
2935-427
2935-428
2935-458
7501-42
7501-126
7501-132
% Active Ingredient
Metalaxyl 16.0
1- (4-chlorophenoxy) -3 , 3-dimethyl-
1- (lH-l,2,4-triazole-l-yl) -2-
butanone 16.0
Metalaxyl 28.35
Metalaxyl 3.5
Chloroneb 30.0
Metalaxyl 11.5
Metalaxyl 28.35
Metalaxyl 6.25
Pentachloronitro-benzene 25.0
Metalaxyl 12.5
Formulation
Liquid
Liquid
Liquid
Liquid
Liquid
Solid
Solid
Table 2 (No Batch)
EPA Reg.
No.
7501-145
7501-148
35512-30
AR90000501
AR90000502
CA87000700
CA85007300
ID86000900
ID86001900
ME92000200
NC90000400
ND87000600
ND92000200
% Active Ingredient
Metalaxyl 3.12
Pentachloronitro-benzene 15.0
Carboxin 15.0
Metalaxyl 4.25
Pentachloronitro-benzene 16.67
Bacillus subtilis 0.1
Metalaxyl 0 . 1
Metalaxyl 25.1
Metalaxyl 5 . 0
Metalaxyl 45.0
Metalaxyl 35.0
Metalaxyl 28.35
Metalaxyl 45.0
Metalaxyl 10.0
Metalaxyl 2 . 0
Metalaxyl 28.35
Metalaxyl 10.0
Formulation
Solid
Solid
Liquid
Liquid
Solid
Solid
Solid
Liquid
Solid
Solid
Solid
Liquid
Solid
285
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EPA Reg.
No.
TX92001500
WA83003500
WA86002800
WA90003300
WA92004200
% Active Ingredient
Metalaxyl 7 . 0
Metalaxyl 35.0
Metalaxyl 45.0
Metalaxyl 35.0
Metalaxyl 10.0
Formulation
Solid
Solid
Solid
Solid
Solid
286
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Attachment 5. EPA Acceptance Criteria
287
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288
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
289
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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. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at > 0.1 % by weight 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 (CAS)
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.
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.
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).
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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;
polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and
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 limit proposed for each impurity present at > 0. 1% and for certain lexicologically significant
impurities at <0. 1 % along with explanation of now limit determined.
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.
291
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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
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
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 in lbs/ft3 or Ibs/gallon.]
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 (torr) 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 77350)
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
292
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal 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
293
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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/grqup.
3.^ Dosing, single oral may be administered over 24 hrs.
4." Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
Lj \J T
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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.JL 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 hours before dosing.
9. _ Application site at least 10% of body surface area.
10. _ Application site covered with a porous nonirritating 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.
295
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81-3 Acute Inhalation Toxic ity 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 inhalable size for man (aerodynamic diameter 15 (jm 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).
1 1 . _ Individual observations at least once a day.
12. _ Observation period to last at least 14 days.
1 3 . _ Individual body weights.
14. _ Gross necropsy on all animals.
296
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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 > 1 1 . 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 particulate substance.
6. _ Solid or granular test material ground to a fine dust.
7. _ Eyes not washed for at least 24 hours.
8. _ Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, 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.
Lj \J I
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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.
8. Application site covered with a gauze patch held in place with nonirritating 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).
1 l.f. Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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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 of the 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.JL 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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300
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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
301
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302
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Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
303
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304
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306
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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.
307
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308
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r/EPA
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 Expires 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):
Name of Firm(s)
Date of Ofler
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 of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
309
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310
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SEPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
OMt N*. 2070-0107
2070-0037
Approval Expire* 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, includina
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
aspectI 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 Numb«r
EFA t+g. No.
I Certify that:
1.
For each study cited in support of registration or ^registration under the Federal Insecticide, 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.
That for each study cited in support of registration or ^registration under FIFRA that is NOT an exclusive use
study, I am the original data submitter, or I have obtained the written permission of the original data submitter or I
have notified in writing the company(ies) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(C)(1)(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due. if any. The companies I have notified are: (check one)
I ] The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form.'
3. That I have previously complied with section 3(0(1 )(D) of FIFRA for the studies I have cited in support of
registration or reregistratten under FIFRA.
Signature
Nam* mid Till* (Pica** Typ* or Print)
Date
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to me
registration or reregistration of my products, to the extent required by FIFRA sections 3(O(1)(D) and 3(c)(2)(D).
Signature
Nam* and Tltl* (Pl*aa* Typ* or Print)
EPA Form M70.J1 (4-90)
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312
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APPENDIX G. FACT SHEET
313
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314
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United States
Enviro
nvironmental Protection
Prevention, Pesticides
oxic Substan
And
bstances
EPA-738-F-94-013
September 1994
&ERA R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Regulatory
History
Metalaxyl
All pesticides sold or distributed in the United States must be registered
by 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 re registration, 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 re registration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED for reregistration Case
0081, metalaxyl.
Metalaxyl is a systemic fungicide used to control plant diseases caused
by the Oomycetes or water-mold fungi. It is used on many food and feed
crops, and on non-food, residential and greenhouse crops such as tobacco,
ornamental plants, trees, shrubs and vines, and lawns and turf.
Formulations include a dust, granular, wettable powder, emulsifiable
concentrate, flowable concentrate, crystalline and ready-to-use liquid.
Metalaxyl may be applied by foliar application, soil incorporation, surface
spraying, drenching, sprinkler or drip irrigation, soil mix or seed treatment.
Use practice limitations on current product labeling prohibit use of treated
seed for feed, food or oil; feeding clippings, crop waste or vines to livestock;
or grazing treated areas. Preharvest interval restrictions also apply.
Metalaxyl was first registered as a pesticide in the U.S. in 1979. EPA
issued Registration Standards for metalaxyl in June 1981 (NTIS #PB82-
172297) and September 1988 (NTIS #PB89-128979). A June 1991 Data Call-
in (DCI) required additional aquatic plant growth and field rotational crop
studies.
Currently, 81 metalaxyl products are registered; 35 of these are full
Federal registrations and 46 are State special local need registrations. These
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Human Health
Assessment
products contain metalaxyl as the sole active ingredient or in combination with
other active ingredients.
Toxicity
Metalaxyl generally is of low acute toxicity but is a moderate eye
irritant and has been placed in Toxicity Category II (indicating the second-
highest degree of acute toxicity) for eye irritation effects.
In a subchronic feeding study using rats, reduced food consumption and
liver cell effects were noted at the highest dose tested. In a dermal study
using rabbits, no treatment-related effects were observed.
In a chronic toxicity study using beagle dogs, blood serum enzyme
effects and increased liver weights were noted in the highest dose group. A
study using rats resulted in liver effects.
Cancer studies using rats and mice raised concerns about the incidence
of thyroid, adrenal and liver tumors. EPA reviewed this issue in 1985 and
concluded that the studies demonstrated that metalaxyl did not have
carcinogenic potential in laboratory animals. In December 1985, EPA
classified metalaxyl as a Group E carcinogen; that is, a chemical that does not
show evidence of carcinogenicity for humans.
A developmental toxicity study using rats resulted in maternal toxicity
and fetotoxicity at the higher dose levels. However, no treatment-related
developmental effects were noted in a study using rabbits. Metalaxyl does not
cause reproductive toxicity or mutagenicity. A tobacco smoke inhalation
study using rats indicates that toxicological effects beyond those associated
with heavy cigarette smoking are unlikely.
Dietary Exposure
People may be exposed to residues of metalaxyl through the diet.
Tolerances or maximum residue limits have been established for well over
100 raw agricultural commodities, processed foods and feed (please see 40
CFR 180.408(a), (b) and (c); 40 CFR 185.4000(a), (b) and (d); and 40 CFR
186.4000(a), (b) and (d)). EPA has reassessed the metalaxyl tolerances and
found that numerous revisions are necessary. These revisions will be handled
administratively.
Numerous international Codex maximum residue limits (MRLs) have
been established for metalaxyl. Harmonization of Codex MRLs and U.S.
tolerances for metalaxyl is not possible at this time as Codex and U.S.
tolerance definitions are incompatible.
EPA has assessed the dietary risk posed by metalaxyl. For the overall
U.S. population and 22 population subgroups, exposure from all current
metalaxyl tolerances represents 16% of the Reference Dose (RfD), or amount
believed not to cause adverse effects if consumed daily over a 70-year
lifetime. The exposure level of the most highly exposed subgroup, children
ages 1 through 6, represents 31% of the RfD.
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Information on the percent of crop actually treated with metalaxyl was
included to more accurately estimate the dietary exposure of the same
population groups. The resulting Anticipated Residue Contribution (ARC) for
the overall U.S. population represents 8% of the RfD, and the ARC for
children is 15% of the RfD. When proposed metalaxyl tolerance changes are
considered, the exposure estimates for the overall U.S. population and all
subgroups are below the RfD. Therefore, it appears that chronic dietary risk
is minimal.
Occupational and Residential Exposure
Based on current use patterns, workers may be exposed to metalaxyl
both during and after applications in agricultural and other settings.
However, neither an application nor a post-application exposure assessment
is required because metalaxyl does not pose sufficient toxicity concerns.
Based on a reevaluation of eye irritation data (Toxicity Category II), the
12-hour Restricted Entry Interval (REI) imposed by the Worker Protection
Standard (WPS) is being increased to 24 hours to better protect workers. A
protective eyewear requirement also is being added to the Personal Protective
Equipment (PPE) previously required for early entry.
Human Risk Assessment
Metalaxyl generally is of low acute toxicity but is an eye irritant. It has
been classified as a Group E carcinogen; that is, a chemical showing evidence
of non-carcinogenicity for humans.
Although people may be exposed to residues of metalaxyl in many food
commodities, the chronic dietary risk from all uses is minimal. Application
and post-application risks to workers and others also are minimal because
metalaxyl has no toxicological endpoints of concern. Since metalaxyl can
irritate the eyes, a 24-hour restricted entry interval (REI) is being imposed
and use of personal protective equipment (PPE) including protective eyewear
is required.
Environmental
Assessment
Environmental Fate
Metalaxyl is moderately stable under normal environmental conditions.
It is photolytically stable in water when exposed to sunlight, with a half-life
of 400 days, and is stable to photodegradation in soil. In aquatic systems,
metalaxyl degrades moderately rapidly. Very little of the chemical is lost to
volatilization.
Metalaxyl is persistent and mobile, and both metalaxyl and its major
degradate readily leach in many soils. Monitoring data demonstrate that
metalaxyl and its primary degradate have the potential to reach groundwater.
Metalaxyl has been detected in ground water in five states at levels typically
reaching up to 3 parts per billion (ppb). Concentrations as high as 236 ppb
have been found, but are not likely the result of normal field use.
In order to reduce the possibility of groundwater contamination, EPA
is requiring a groundwater label advisory for metalaxyl end use products.
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Additional Data
Required
Product Labeling
Changes Required
The registrant also has agreed to conduct a user education program if levels
of metalaxyl are detected in groundwater at or above 400 ppb.
Ecological Effects
Metalaxyl is used in numerous sites, and exposure to non-target
organisms may result from direct application, spray drift and/or runoff from
treated areas.
Metalaxyl is practically non-toxic to birds on a dietary basis, and
slightly toxic on an acute, single dose basis. The risk to birds from granular
metalaxyl is minimal. Avian reproduction studies still are needed. Metalaxyl
is practically non-toxic to honeybees, and is not expected to present a risk to
small mammals. Minimal risks are posed to freshwater and estuarine
organisms. Metalaxyl is not expected to adversely affect aquatic plants.
Ecological Effects Risk Assessment
Metalaxyl poses minimal if any risks to birds, small mammals, fish and
estuarine species, honey bees and aquatic plants. The registered uses of
metalaxyl do not present an acute hazard to endangered terrestrial and aquatic
animals or plant species.
EPA is requiring the following additional generic data for metalaxyl to
confirm its regulatory assessments and conclusions: product chemistry,
animal metabolism, analytical method validation for additional metabolites,
storage stability, magnitude of the residue in plants for a newly registered
formulation, residue data for cotton gin byproducts, magnitude of the residue
in processed tomato products, and avian reproduction studies.
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 re registration.
All metalaxyl end-use products must comply with EPA's current
pesticide product labeling requirements, and with the following:
Worker Protection Standard - The following entry restrictions are required:
Non-WPS Occupational Uses
For liquid applications: "Do not enter or allow others to enter the
treated area until sprays have dried."
For dry applications: "Do not enter or allow others to enter the treated
area until dusts have settled."
318
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Homeowner Products
For liquid applications: "Do not allow people or pets to enter the
treated area until the sprays have dried. "
For dry applications: " Do not allow people or pets to enter the treated
area until dusts have settled. "
Other Occupational/Residential Requirements
Application Restrictions: "Do not apply this product in a way that will
contact workers or other persons, either directly or through drift. Only
protected handlers may be in the area during application."
Engineering Controls: "When handlers use closed systems, enclosed
cabs, or aircraft in a manner that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides (40 CFR
170.240 (d) (4-6), the handler PPE requirements may be reduced or
modified as specified in the WPS."
User Safety Requirements: "Follow manufacturer's instructions for
cleaning/maintaining PPE. If no such instructions exist for washables,
use detergent and hot water. Keep and wash PPE separately from other
laundry. "
User Safety Recommendations: "Users should wash hands before
eating, drinking, chewing gum, using tobacco, or using the toilet."
"Users should remove clothing immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing. "
"Users should remove PPE immediately after handling this product.
Wash the outside of gloves before removing. As soon as possible, wash
thoroughly and change into clean clothing. "
Environmental Hazard Statement - The following language is required:
"For terrestrial uses, do not apply to water or to areas where surface
water is present, or to intertidal areas below the mean high water mark.
Do not apply when weather conditions favor drift from treated areas.
Do not contaminate water when disposing of equipment wash water or
rinsate."
Groundwater Advisory - The following language is required on all end-use
products:
"This chemical is known to leach through soil into groundwater under
certain conditions as a result of agricultural use. Use of this chemical
in areas where soils are permeable, particularly where the water table
is shallow, may result in ground water contamination."
Regulatory T^e use °f currently registered products containing metalaxyl in
accordance with approved labeling will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, all uses of all products
containing the active ingredient metalaxyl are eligible for re registration.
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Information
These metalaxyl products will be reregistered once the confirmatory
generic data, product specific data, revised Confidential Statements of
Formula and revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for metalaxyl 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 metalaxyl 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
metalaxyl RED, or reregistration of individual products containing metalaxyl,
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, between 8:00 am and 6:00 pm Central Time, Monday through
Friday.
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