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Guidance for the
Reregistration of
Pesticide Products
Containing METALDEHYDE
as the Active Ingredient
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OMB Control No. 2070-0057
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
METALDEHYDE
AS THE ACTIVE INGREDIENT
CAS REGISTRY NO. 9002-91-9 (HOMOPOLYMER)
108-62-3 (TETRAMER)
OPP Chemical Code 053001
EPA CASE NUMBER 0576
December 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, DC 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical Covered by this Standard . . 4
A. Description of Chemical
B. Use Profile
C. Background
III. Agency Assessment 7
A. Health Effects Assessment
B. Environmental Profile
C. Tolerance Reassessment
IV. Regulatory Position and Rationale 10
A. Regulatory Positions and Rationales
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 15
VI. Requirement for Submittal of Generic Data 17
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Registrant requests regarding data
requirements and Agency responses
F. Test protocols and standards
G. Procedures for requesting a change in protocol
H. Procedures for requesting extensions of time
I. Data Format and Reporting Requirements
J. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submittal of
Product-Specific Data 24
VIII. Requirement for Submittal of Revised Labeling ... 25
IX. Instructions for Submittal 26
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End use products (multiple active)
E. Intrastate Products
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APPENDICES
I. DATA APPENDICES 29
Guide to Tables
Table A
Table B
II. LABELING APPENDICES 58
Summary of label requirements and table
40 CFR 156.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. BIBLIOGRAPHY APPENDICES 83
Guide to Bibliography
Bibliography
IV. FORMS APPENDICES 88
EPA Form 8580-1 FIFRA 3(c)(2)(B) Summary Sheet
EPA Form 8580-3 Generic Data Exemption Statement
EPA Form 8580-4 Product Specific Data Report
EPA Form 8580-6 Certification of Attempt to Enter
Into an Agreement with Other
Registrants for Development of Data
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
a. i.
CAS
CSF
EEC
EP
EPA
FIFRA
FFDCA
LC50
LD50
LEL
MPI
MRID
MP
Acceptable Daily Intake. Also known as the
Reference Dose or RfD.
Active ingredient
Chemical Abstracts Service
Confidential Statement of Formula
Estimated Environmental Concentration. The
estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
End Use Product
U.S. Environmental Protection Agency
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Median lethal concentration - a statistically
derived concentration of a substance that can be
expected to cause death in 50% of test animals. It
is usually expressed as the weight of substance per
weight or volume of water or feed, e.g. , mg/1 or
ppm.
Median lethal dose - a statistically derived single
dose than can be expected to cause death in 50% of
the test animals, when administered by the route
indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight
of animal, e.g., mg/kg.
Lowest Effect Level
Maximum Permissible Intake
Master Record Identification (number). EPA's
system of recording and tracking studies submitted
to the Agency.
Manufacturing Use Product
111
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NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts per million
TMRC Theoretical Maximal Residue Contribution
IV
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be
reviewed and standards set for compliance with FIFRA. The
standards are applicable to reregistration and future
applications for registration of products containing the same
active ingredient. Each registrant of a product containing an
active ingredient subject to this Standard who wishes to
continue to sell or distribute that product must bring his
product and labeling into compliance with FIFRA, as
instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA
identifies:
l. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to
protect man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request,1 focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and
conclusions from available data in its files pertaining to
the pesticide active ingredient. However, during the review
of these data the Agency is also looking for potential
hazards that may be associated with the end use products that
contain the active ingredient. The Agency will apply the
provisions of this Registration Standard to end use products
if necessary to protect man and the environment.
The scientific reviews and Compendium of Acceptable _
Uses may be obtained from the OPP Public Docket. Write to
OPP Public Docket, Field Operations Division (H7506C),
Office of Pesticide Programs, EPA, Washington, D.C. 20460
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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their
registrations in compliance with FIFRA. These steps may
include:
1. Submittal of data in support of product
registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154 to
examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency may
propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI)
provisions of FIFRA sec. 3(c)(2)(B) to require that
registrants submit data to answer our questions regarding the
chemical, toxicological, and environmental characteristics
and fate of a pesticide. This Registration Standard lists the
data EPA believes are necessary to resolve our concerns about
this pesticide. These data are listed in the Tables A, B, and
C in Appendix I. Failure to comply with the DCI requirements
enumerated in this Registration Standard may result in
issuance by EPA of a Notice of Intent to Suspend the affected
product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2)
requires them to submit factual information concerning
possible unreasonable adverse effects of a pesticide at any
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time that they become aware of such information. Registrants
must notify the Agency of any information, including interim
or preliminary results of studies, if that information
suggests possible adverse effects on man or the environment.
This requirement is independent of the specific time
requirements imposed by EPA for submittal of completed
studies called in by the Agency and continues as long as the
products are registered under FIFRA.
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II. CHEMICAL COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICAL
Common Name: Metaldehyde
Chemical Name: 2,4,6,8-tetramethyl-l,3,5,7-tetraoxycyclo-octane
Chemical Family: Hydrocarbon
Trade Names: Meta, Metason, Halizan, Antimilace, Namekil,
Cekumeta
CAS Registry No.: 9002-91-9 (homopolymer)
108-62-3 (tetramer)
OPP Chemical Code: 053001
Empirical Formula: C8H16O4
Molecular Weight: 176.2
Chemical/Physical Characteristics:
Color: White
Physical State: Crystalline powder
Odor: Aldehyde odor
Melting Point: 246° C
Bulk Density: 65g/100cc
Solubility: at 20° C, 0.2 g/L in water and very
slightly soluble in alcohol
Vapor Pressure: 1mm Hg at 20° C
Flammability: 36-40° C
B. USE PROFILE
Type of Pesticide: Molluscicide
Year of Initial Registration: 1962
Registered Uses:
TERRESTRIAL FOOD CROP: alfalfa, almond, anise, apple,
apricot, artichoke, asparagus, avocado, banana, barley,
beans, beets, blackberry, blackeyed peas, blueberry,
boysenberry, broccoli, brussels sprouts, cabbage, caneberry,
cantaloupes, caraway, carrots, catnip, cauliflower, celery,
cereal crops, cherry, chicory, chive, citrus fruits, clover,
cole crops, collards, coriander, corn, cowpeas, cucumber,
currant, dewberry, dill, eggplant, endive, garlic, ginseng,
gooseberry, grapefruit, grapes, horseradish, kale, kohlrabi,
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leek, legume, lemon, lentils, lettuce, lime, loganberry,
melons, muskmelons, mustard, mustard greens, nectarine,
oats, okra, onion, orange, oregano, parsley, parsnip, peach,
pear, peas, pecan, peppermint, peppers, pimento, plum,
potato, pumpkin, radish, raspberry, rhubarb, rutabaga, sage,
salsify, savory, shallot, spearmint, spinach, squash, stone
fruits, strawberry, sugar beets, sweet potato, swiss chard,
thyme, tomato, turnips vegetable crops, walnut, watermelons,
wheat; seed crops; alfalfa, beans, clover, corn (sweet),
grasses, peas, potato.
TERRESTRIAL NONFOOD CROP: seed crops; beets, cabbage,
carrots, collards, kale, kohlrabi, lettuce, mustard, radish,
spinach, swiss chard, tobacco, turnips.
GREENHOUSE FOOD CROP; asparagus, beans, beets, cabbage,
carrots, celery, corn, cucumber, eggplant, endive, lettuce,
melons, onion, peas, peppers, potato, radish, spinach,
squash, tomato, turnips.
GREENHOUSE NONFOOD CROP: orchids, ornamental plants.
DOMESTIC AND NONDOMESTIC OUTDOOR: domestic dwellings,
greenhouses, lath houses, lawns (including dichondra),
ornamental grasses, ornamental plants (including nursery
stocks), turf.
INDOOR: farm buildings.
Pests Controlled: slugs and snails
Methods of Application: by hand, ground, or aerial equipment
Formulations: wettable powders, dusts, emulsifiable
concentrates, flowable concentrates, granules,
ready-to-use products (liquids) and
pelleted/tableted
Annual Usage: 400,000 - 600,000 Ibs ai (1986 estimate)
Predominate Usage: home orchards, gardens and ornamentals, and
commercial vegetables (artichokes, broccoli,
cauliflower, lettuce, cabbage, and tomatoes),
and fruits (citrus, stone, pome, and
strawberries)
U. S. Producer: Lonza, Incorporated
Number of Registrations: 77 end-use products (EPs), 4 technical
products/formulation intermediates, and
7 "special local need" registrations
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C. BACKGROUND
Historically, the Agency did not consider the use of baits
in-field to protect fruits and vegetables to be a food use and
tolerances were not required. However, Residue Chemistry
Guidelines, updated in October 1982, state that if residues could
occur in foods or feed, the use is considered to be a food use
and a petition for tolerance/exemption from tolerance is
required. The Agency has no basis for concluding that residues
will not occur in the food and feed crops treated with
metaldehyde. Therefore, EPA will require data on metaldehyde to
support food uses.
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III. AGENCY ASSESSMENT
The Agency has reviewed all data currently supporting the
registration of metaldehyde as of April 1988. Based on the
available data, EPA has reached the following conclusions.
A. HEALTH EFFECTS ASSESSMENT
Toxicology. Metaldehyde is of moderate to low acute
toxicity by the oral route and of low acute toxicity by dermal
and inhalation exposure. Metaldehyde was not found to be a
dermal irritant. However, all of the available acute studies must
have the purity of the test material established before they can
be fully accepted.
The only other available data are a partially acceptable
mutagenicity study and a nonrodent subchronic study which
provides supplementary information but is not acceptable for
fulfilling data requirements.
In the chromosome aberration assay, the portion performed in
the absence of metabolic activation system is acceptable;
metaldehyde was not found to be clastogenic under the conditions
of the assay.
In a 26-week dog feeding study with metaldehyde, the
possibility of- degenerative changes in the liver, prostate, and
male gonads was suggested. Because of certain deficiencies in
its conduct, this study is not acceptable for fulfilling
registration requirements.
The remainder of the toxicity data base is essentially
either inadequate or vacant because of past policy classifying
bait formulations as nonfood uses. Data are required as set
forth in Table A of this document.
Poisoning Incidents. Poisoning incident reports show that
the use of metaldehyde, especially homeowner use, has been
associated with dog poisonings. These reports indicate that dogs
have died as a result of metaldehyde poisonings. There are also
numerous reports of children ingesting metaldehyde baits, but no
adverse effects have been reported.
Worker Exposure/Reentry. Because of the low acute toxicity
of metaldehyde, mixer/loaders and applicators are not expected to
experience adverse effects as a result of their exposure to
metaldehyde. The Agency has determined that, because of the low
acute toxicity of metaldehyde and the use patterns of this
pesticide, reentry data are not required.
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B. ENVIRONMENTAL PROFILE
Ecological Effects. None of the available ecological
effects data meet Agency requirements. However, the available
data suggest that metaldehyde is of low toxicity to birds and is
practically nontoxic to aquatic organisms. Data are required as
set forth in Table A.
Based on the nature of registered metaldehyde formulations
and uses, significant bee exposure is not anticipated. Thus, bee
data are not required for metaldehyde.
Environmental Fate. Presently, the Agency does not have
adequate environmental fate data on which to base environmental
fate and groundwater leaching assessments for metaldehyde.
Metaldehyde is a polymer of acetaldehyde and its initial
breakdown product is expected to be acetaldehyde. Data are
required as set forth in Table A.
C. TOLERANCE REASSESSMENT
Tolerances Issued. Although tolerances had not been
generally required for food/feed uses of baits, there is a food
additive regulation of zero ppm for strawberries (40 CFR
185.4025). This is not supported by adequate data. A tolerance
assessment will be made when the essential toxicity and residue
data are available. The tolerance is expressed in terms of
metaldehyde per se.
EPA has evaluated the residue and toxicology data pertaining
to metaldehyde. The results of the Agency's evaluation are as
follows:
Residue Data. No acceptable data are available on the
nature of the residues in both plants and animals, including
identification of major metabolites and degradates of the
pesticide. Data are required as set forth in Table A.
No acceptable analytical methodology for determining the
levels of residues in plants and animals are available. Data are
required as set forth in Table A.
The submitted data do not establish appropriate storage
conditions. Data are required as set forth in Table A.
Data on the magnitude and levels of residues of metaldehyde
in individual raw agricultural commodities, animal products, and
processed food and feed items are either inadequate or completely
lacking. Data are required as set forth in Table A.
The Food and Drug Administration (FDA) Total Diet Studies,
as well as Surveillance and Compliance program for domestic and
imported commodities do not employ methodology capable of
determining residues of metaldehyde.
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No Codex MRLs or Canadian or Mexican tolerances have been
established in or on food or feed commodities or in animal
products.
Toxicology. The toxicological data are inadequate to allow
an assessment of any dietary exposure to metaldehyde.
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IV. REGULATORY POSITION AND RATIONALE
Based on review and evaluation of all available data and
other relevant information on metaldehyde, the Agency has made
the following determinations:
1. Metaldehyde is not being placed into Special Review at
this time.
Rationale: Since there are so few acceptable studies
available to support registration of products containing
metaldehyde, the Agency is not able to determine whether any of
the criteria of 40 CFR 154.7 have been met or exceeded.
2. The Agency is not restricting the use of metaldehyde at
this time.
Rationale: FIFRA section 3(d)(l)(C) provides that some or
all uses of a pesticide will be classified for restricted use if
the Administrator determines that without such restriction the
pesticide "may generally cause unreasonable adverse effects in
man or the environment." The Agency does not have sufficient
data at this time to determine if metaldehyde meets any of the
risk criteria of 40 CFR 152.170. Upon receipt of data required
under this Standard, the Agency will apply the criteria of 40 CFR
152.170 to determine if any uses of metaldehyde warrant
restricted use classification.
3. The Agency will continue to require precautionary
statements to protect dogs and other pets, but special
precautionary statements for children are not necessary.
Rationale; Poisoning incident reports continually indicate
fatalities to dogs associated with the use of metaldehyde baits
but there is no evidence that exposed children have been
adversely affected.
4. The Agency will assess metaldehyde's potential for
contaminating ground water upon receipt of the required
environmental fate data set forth in Table A of this Standard.
Rationale; The Agency is unable to assess the potential for
metaldehyde to contaminate ground water because the environmental
fate of this chemical is uncharacterized. When data required in
this Standard have been received and evaluated, the Agency will
assess metaldehyde's potential for ground water contamination.
5. The Agency is classifying in-field uses of metaldehyde
on food and feed crops as food uses and is requiring
tolerances/exemptions from tolerances. Tolerances supported by
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data must be proposed for residues of metaldehyde in or on any
agricultural commodities on which metaldehyde is used. When a
strawberry tolerance is established, the existing food additive
regulation for strawberries will be revoked. Additionally,
tolerances must be proposed, and supporting residue data
provided, for the forage and fodder of field corn, popcorn and
sweet corn, for the forage hay, and straw of wheat (which will be
translated to barley and oat straw) and for spent mint hay.
Alternatively for these latter commodities, the registrant may
propose a feeding restriction for such commodities as
appropriate.
Rationale; Historically, the use of baits in-field to
protect fruits and vegetables was not considered to be a food use
and tolerances were not required. Current Residue Chemistry
Guidelines (October 1982;34) state that "... if residues could
occur in foods or feed, then the use is a food use and a petition
for tolerance/exemption from tolerance is required." The Agency
has no basis for concluding that residues will not occur in the
food and feed crops listed. Therefore, these uses are now
considered to be food uses.
6. The Agency will not approve tolerances until the Agency
has received data sufficient to perform a tolerance reassessment.
Rationale; Plant and animal metabolism studies, analytical
methods, residue studies, storage stability studies, and
processing studies are needed before the Agency can determine
appropriate tolerance levels and perform a tolerance
reassessment. A full set of chronic toxicology data is also
required.
7. The Agency is not requiring a reentry interval for
metaldehyde products.
Rationale; Based on the toxicological data available to the
Agency, metaldehyde products are of low toxicity. Because of
these low toxicity levels, it is not considered necessary to
establish a reentry interval.
8. The Agency is not requiring protective clothing labeling
for end-use products.
Rationale: The available data base for metaldehyde shows
that metaldehyde has low acute toxicity. There are no other data
to indicate that protective clothing is needed. The Agency will
reassess this position when required toxicity studies have been
submitted and evaluated.
9. Current label warnings on some products indicating that
"Metaldehyde is toxic to fish and wildlife" and "Birds feeding on
treated areas may be killed" are not now required.
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Rationale: The Agency has no data to support the imposition
of such warnings. Available supplementary data indicate that the
magnitude of the risk is unlikely to require such warnings for
metaldehyde.
10. The Agency will assign priority review for metaldehyde
studies involving animal and plant metabolism, potential to
contaminate ground water, and exposure to fish and wildlife.
Rationale; The metabolism studies are needed prior to
commencement of residue studies and the other studies are needed
to determine whether additional studies are required.
11. While data gaps are being filled, currently registered
products containing metaldehyde may be sold, distributed,
formulated, and used, subject to the terms and conditions
specified in this Registration Standard. Registrants must
provide or agree to develop additional data, as specified in the
Data Tables, in order to maintain existing registrations.
Rationale; Even when authorized under FIFRA sections
3(c)(2)(B) and 3(c)(7), the Agency may elect not to cancel or
withhold registration even though data are missing or are
inadequate. Issuance of this Standard provides a mechanism for
identifying data needs. These data will be reviewed and
evaluated, after which the Agency will determine if additional
regulatory actions are necessary.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, products
must contain this pesticide, bear required labeling, and conform
to the product composition, acute toxicity limits, and use
pattern requirements listed in this document.
C. ACCEPTABLE RANGES AND LIMITS
Product Composition Standard. To be registered or
reregistered under this Standard, manufacturing-use products
(MPs) must contain this pesticide. Each MP formulation proposed
for registration must be fully described with an appropriate
certification of limits, stating maximum and minimum amounts of
the active ingredient and inert ingredients which are present in
products, as well as impurities found at greater than 0.1
percent.
Acute Toxicity Limits. The Agency will consider
registration of technical grade and manufacturing-use products
containing this pesticide provided that the product labeling
bears appropriate precautionary statements for the acute toxicity
category in which each product is placed.
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Use Patterns. To be registered under this Standard,
manufacturing-use products bearing federally registered uses.
The EPA Index to Pesticide Chemicals (for availability, see page
1) lists all federally registered uses of this pesticide
ingredient, as well as approved maximum application rates and
frequencies.
D. REQUIRED LABELING
All products must bear appropriate labeling as specified in
40 CFR 156.10, PR Notices 83-2, 83-3, and below. Appendix II
contains further information on label requirements.
Pesticide products containing this pesticide as an active
ingredient may not be released for shipment by the registrant
after December 23, 1989, unless the product bears amended
labeling that complies with the requirements of FIFRA, as set out
in this Registration Standard.
Pesticide products containing this pesticide as an active
ingredient may not be distributed or sold by any person after
December 23, 1990, unless that product bears amended labeling
that complies with the requirements of this Standard.
The labels of all products must bear the appropriate storage
and disposal statements (see Appendix II).
a. Manufacturing-Use Products (MPS)
1. The ingredient statement for MPS must declare the active
ingredient as:
Metaldehyde (2,4,6,8-tetramethyl-l,3,5,7-
tetraoxycyclo-octane) %
2. Labels for MPS must bear the following identifying
phrase directly beneath the product name:
"A molluscicide for formulating use only."
3. In the directions for use, the following statement must
appear:
"Formulators using this product are responsible for
obtaining EPA registration of their formulated
product."
4. In the directions for use, the following statement
regarding acceptable use patterns must appear; however, no
use may be included on the label where the registrant fails to
agree to comply with the data requirements for that use pattern:
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"For formulation into end-use insecticide products
intended only for (list acceptable sites)-11
5. If detailed instructions for formulating are not
provided on the label, the following statement must appear:
"Refer to attached Technical Bulletin for formulating
and other information."
6. The following statements are required to appear under
the "Environmental Hazards" heading:
"Do not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or public
waters unless this product is specifically identified
and addressed in an NPDES permit. Do not discharge
effluent containing this product to sewer systems
without previously notifying the sewage treatment plant
authority- For guidance, contact your State Water
Board or Regional Office of the EPA."
b. End-Use Products (EP)
1. The active ingredient for EPs must declare the active
ingredient as:
Metaldehyde (2,4,6,8-tetramethyl-l,3,5,7-
tetraoxycyclo-octane) %
2. All EPs allowing for outdoor uses must bear the
following environmental hazards statements:
"Do not apply directly to water or wetlands (swamps,
bogs, marshes, and potholes). Do not contaminate water
when disposing of equipment washwaters."
"This pesticide may be fatal to dogs or other pets if
eaten. Keep pets out of treated area."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain
requirements for data submittal or changes in composition,
labeling or packaging of the product. The applicable
requirements depend on whether the product is a manufacturing
or end use product and whether the pesticide is the sole
active ingredient or one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to
the manufacturing use product.
2. The data requirements listed in Tables A and B.2
3. The labeling requirements specified for
manufacturing use products in Section IV.
4. Administrative requirements (application forms.
Confidential Statement of Formula, data
compensation provisions) associated with
reregistration.
B. Manufacturing use products containing this pesticide as
one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to
all products containing the pesticide subject to this
Registration Standard. Table B lists product-specific data
applicable to manufacturing-use products. The data in Tables
A and B need not be submitted by an end-use producer who is
eligible for the generic data exemption for that active
ingredient.
Table C lists product-specific data applicable to end-
use products. The Agency has decided that, in most cases, it
will not require the submittal of product-specific data for
end-use products at this time. Therefore, most Registration
Standards do not contain a Table C.
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2. The labeling requirements specified for
manufacturing use products in Section IV.
C. End use products containing this pesticide as the sole
active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to
the end use product.
2. If eligible for the generic data exemption,3 the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data
requirements listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the generic data exemption, the
data requirements listed in Tables A and C.
2. If eligible for the generic data exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
3If you purchase from another producer and use as the
source of your active ingredient only EPA-registered
products, you are eligible for the generic data exemption for
generic data concerning that active ingredient (Table A) and
product-specific data for the registered manufacturing use
product you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption and
become subject to the data requirements in Table A.
2) If no producer subject to the generic data
requirements in Table A agrees to submit the required data,
all end-use producers lose the exemption, and become subject
to the data requirements in Table A.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the
registration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often
required for ecological effects studies and applies to all
products having that formulation type. These are classed as
generic data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is
complying with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer
in compliance with this data requirements notice, the Agency
will consider that both they and you are not in compliance
and will normally initiate proceedings to suspend the
registrations of both your product(s) and their product(s)
unless you commit to submit and submit the required data in
the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the
data.
Registrations granted after issuance of this Standard
will be conditioned upon submittal or citation of the data
listed in this Registration Standard.
- 17 -
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if you are not now eligible for a generic data
exemption, you may qualify for one if you change your source
of supply to a registered source that does not share
ownership in common with your firm. If you choose to change
sources of supply, the Confidential Statement of Formula must
identify the new source(s) and you must submit a Generic Data
Exemption Statement.
If you apply for a new registration for products
containing this active ingredient after the issuance of this
Registration Standard, you will be required to submit or cite
generic data relevant to the uses of your product if, at the
time the application is submitted, the data have been
submitted to the Agency by current registrants. If the
required data have not yet been submitted, any new
registration will be conditioned upon the new registrant's
submittal or citation of the required data not later than the
date upon which current registrants of similar products are
required to provide such data. See FIFRA sec. 3(c)(7)(A).
If you thereafter fail to comply with the condition of that
registration to provide data, the registration may be
cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency-
D. How to comply with DCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop
-------
who will be submitting the data that you may rely upon its
submittal. The Agency will also require adequate assurance
that the person whom you state will provide the data is
taking appropriate steps to secure it. The agreement to
produce the data need not specify all of the terms of the
final arrangement between the parties or a mechanism to
resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number, as part of your 90-day response. The
request must include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated
representative of the consortium, with whom EPA
will correspond concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the
consortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your
registration for non-compliance with the DCI. EPA has
determined that, as a general policy, it will not suspend the
registration of a product when the registrant has in good
faith sought and continues to seek to enter into a data
development/cost sharing program, but the other registrants
developing the data have refused to accept its offer. [If
your offer is accepted, you may qualify for Option 2 above by
entering into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for
Development of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of
your offer (such as a certified mail receipt). Your offer
must, at a minimum, contain the following language or its
equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
- 19 -
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3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement to be
bound by binding arbitration as provided by FIFRA section
The remainder of your offer may not in any way attempt
to limit this commitment. If the other registrant to whom
your offer is made does not accept your offer, and if the
other registrant informs us on a DCI Summary Sheet that he
will develop and submit the data required under the DCI,
then you may qualify for this option. In order for you to
avoid suspension under this method, you may not later
withdraw or limit your offer to share in the burden of
developing the data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit and
submit the required data in the specified timeframe. In such
cases, the Agency generally will not grant a time extension
for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses , you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use
factors that lead you to believe that a requirement does not
apply. Since the Agency has carefully considered the
composition and uses of pesticide products in determining
that a data requirement applies, EPA does not anticipate
that many waivers will be granted. A request for waiver does
not extend the timeframes for developing required data, and
if your waiver request is denied, your registration may be
suspended if you fail to submit the data. The Agency will
respond in writing to your request for a waiver.
5. You request that EPA amend your registration by
deleting the uses for which the data are needed. You are not
required to submit data for uses which are no longer on your
label.
6. You request voluntary cancellation of the regis-
tration of your product (s) for which the data are needed.
E. Registrant Requests Regarding Data Requirements and
Agency Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
- 20 -
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changes, or time extensions must be submitted in writing.
The original requirement remains in effect unless the Agency
has notified you in writing that it has agreed to a change in
the requirement. While being considered by the Agency, such
requests for changes in the requirements do not alter the
original requirements or extend the time allowed for meeting
the requirement.
F. Test Protocols and Standards
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing. All testing must
be conducted in accordance with applicable Good Laboratory
Practices regulations in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are
referenced in the Data Tables, are available from the
National Technical Information Service (NTIS), Attn: Order
Desk, 5285 Port Royal Road, Springfield, VA 22161 (tel:
703-487-4650) .
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD-recommended test standards conform to those specified in
the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
G. Procedures for requesting a change in test protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning
testing, because the Agency will not ordinarily accept as
sufficient studies using unapproved protocols. A request for
protocol approval will not extend the timeframe for submittal
of the data, nor will extensions generally be given to
- 21 -
-------
conduct studies due to submittal of inappropriate protocols.
The Agency will respond in writing to your request for
protocol approval or change.
H. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time.
EPA will view failure to request an extension before the
data submittal response deadline as a waiver of any future
claim that there was insufficient time to submit the data.
While EPA considers your request, you must strive to meet the
deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you have
taken to meet the testing deadline. Time extensions normally
will not be granted due to problems with laboratory capacity
or adequacy of funding, since the Agency believes that with
proper planning these can be overcome. The Agency will
respond in writing to any requests for extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must
comply with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of
results, and the adequacy of any required supporting (or raw)
data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR Notice 86-5
(issued July 29, 1986). All studies must be submitted in the
form of a final report; a preliminary report will not be
considered to fulfill the submittal requirement.
J. Existing stocks provision upon suspension or
cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under FIFRA
sec. 3(c)(2)(B), an existing stocks provision for the
registrant is not consistent with the Act. Accordingly, the
Agency does not anticipate granting permission to sell or
distribute existing stocks of suspended product except in
rare circumstances. If you believe that your product will be
suspended or cancelled and that an existing stocks provision
should be granted, you have the burden of clearly
demonstrating to EPA that granting such permission would be
consistent with the Act. The following information must be
included in any request for an existing stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of existing
- 22 -
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stocks and your estimate of the time required for their sale
or distribution; and
2. Demonstration that such a provision would be
consistent with the provisions of FIFRA.
- 23 -
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that
certain product-specific data are required to maintain your
registrations in effect. Product-specific data are derived
from testing using a specific formulated product, and, unlike
generic data, generally support only the registration of that
product. All such data must be submitted by the dates
specified in this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data
requirements, you must follow the same procedures as for
generic data. See Section VI.D through J. You should note,
however, that product chemistry data are required for every
product, and the only acceptable responses are options
VI.D.I. (submit data) or VI.D.6. (cancellation of
registration).
Failure to comply with the product-specific data
requirements for your products will result in suspension of
the product's registration.
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VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with
accurate, complete and sufficient instructions and
precautions, reflecting the Agency's assessment of the data
supporting the product and its uses. General labeling
requirements are set out in 40 CFR 156.10 (see Appendix II -
LABELING and SUMMARY). In addition, labeling language
specific to products containing this pesticide is specified
in Section IV.D of this Registration Standard. Responses to
this Registration Standard must include draft labeling for
Agency review.
Labeling must be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. Draft labeling must indicate the
intended colors of the final label, clear indication of the
front panel of the label, and the intended type sizes of the
text.
If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific
instructions in Section IV.D., EPA may seek to cancel the
registration of your product under FIFRA sec. 6.
- 25 -
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IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration
Standard must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, B.C. 20460
Attn: Metalhyde Registration Standard
All submittals in response to this Registration
Standard are non-fee items, including 90-day responses,
protocols and waiver requests, data, and revised labeling.
Submittals must be clearly identified as being in response to
the Registration Standard. Under no circumstances may
Registration Standard responses be combined with other types
of filings for which fees are required.
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit for each product subject to this Registration
Standard:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the "FIFRA Section 3(c)(2)(B)
Summary Sheet" (EPA Form 8580-1), with appropriate
attachments.
b. Confidential Statement of Formula (EPA Form
8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40
CFR 152.80-152.99.
2. Within 9 months from receipt of this document you
must submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
d. Product Specific Data Report (EPA Form 8580-4).
- 26 -
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3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject
pesticide in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA sec. 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form
8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
2. Within 9 months of receipt of this document, you
must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you
must submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
C. End Use Products containing the subject pesticide as
sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA
Form 8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from receipt of this document you
must submit:
a. Two copies of any product-specific data, if
required by Table C.
- 27 -
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t>. Product Specific Data Report (EPA Form 8580-4), if
Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
D. End Use Products containing the subject active
ingredient as one of multiple active ingredients
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA
Form 8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from the receipt of this document,
you must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application for registration was submitted
by that date, no product may be released for shipment by the
producer after July 31, 1988.
- 28 -
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I. DATA APPENDICES
- 29 -
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TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A 'contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test subst.ance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 153.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 153. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
3 = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I- = Indoor
Any other designations will b/a defined in a footnote to the table,
- 30 -
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TGUIDE-2
4- Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152. Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable da'ta in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted,this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
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TABLE A
GENERIC DATA REQUIREMENTS FOR THE METALDEHYDE TECHNICAL GRADE OF THE ACTIVE INGREDIENT
1
co
to
1
Data Requirement
Part 158 Suboart C -
Product Composition
61-2. Beginning Materials and Production Process
61-3. Formation of Impurities
Analysis and Certification of Product Ingredients
62-1 -Preliminary Analysis
Physical and Chemical Characteristics
63-2. Color
63-3. Physical State
63-4. Odor
63-5. Melting Point
63-6. Boiling Point
63-7. Density, Bulk Density or Specific Gravity
63-8. Solubility
63-9. Vapor Pressure
63-10. Dissociation Constant
63-11. Octanol/Uater Partitioning Coefficient
63-12. pH
63-13. Stability
Other Requirements;
64-1. Submittal of Samples
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
N/A
Does EPA have data
to satisfy this
requi rement?
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
N/A
Bibliographic
Citation
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must additional data be
submitted under FIFRA
Section 3
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TABLE A.
GENERIC DATA REQUIREMENTS FOR THE METALDEHYDE TECHNICAL GRADE OF THE ACTIVE INGREDIENT
and (9) a description of the procedures used to assure consistent composition of the substance produced (quality control methods).
3. A discussion regarding the origin of the following potential impurities must be provided: (1) each impurity associated with the active ingredient
which was found to be present if any analysis of the product conducted by or for the registrant, and (2) each impurity which the registrant has reason
to believe may be present at a level equal to or greater than 0.1% (w/w) based on the composition of each starting material, intended and side reactions
which may occur during production, the possible degradation of ingredients after production, post-production reactions between ingredients, possible
contamination from packaging materials or production equipment, and process control, purification and quality control measures.
A. Five or more representative samples must be analyzed for the amount of active ingredient and each impurity present at 0.1X or greater. If the product
is produced by a batch process, five separate batches should be represented in preliminary analyses. Complete and detailed descriptions of the methods
used for sample analysis must be submitted, including statements of their precision and accuracy. The preliminary analysis report should include the
identity and quantity of each ingredient for which analysis is conducted along with the mean and relative standard deviation of the analytical results.
Based on the preliminary analysis, a statement of the composition of the technical grade of active ingredient must be provided.
I 5. Data on melting point are required if the technical chemical is a solid at room temperature.
^ 6. Data on boiling point are required if the technical product is a liquid at room temperature.
I 7. Data on octanol/water partition coefficient are required if the technical chemical is organic and non polar.
8. Data on pH are required if the test substance is dispersible in water.
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TABLE A
GENERIC DATA REQUIREMENTS FOR METALDEHYDE
I
00
Data Requirement
158.240
171-4.
171-4.
171-4.
171-4.
171-4.
Residue Chemistry
Qualitative Nature of the
residue (Metabolism)
- Plants
Qualitative Nature of the
residue (Metabolism)
- Livestock
Residue analytical methods
Storage stabi I i ty
Magnitude of the residue
in plantsS
Root/Tuber Vegetables Group
Leaves of Root/Tuber
Vegetables Group
Turnip Tops
Bulb Vegetables Group
Leafy Vegetables Group
Brassica Leafy Vegetables
Group
Legume Vegetables Group
Foliage of Legume
Vegetables Group
Fruiting Vegetables Group
Test Does EPA
Substance Have Data?
PAIRA Partially
PAIRA and plant No
metabolites
TGAI and Partially
metabolites
TEP and Partially
metabolites
TEP No
TEP No
TEP No
TEP No
TEP No
TEP No
TEP No
TEP No
Bibliographic
Citation
00138262.
N/A
00138262.
00138262.
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must additional data
be submitted?
Yes1
Yes2'3
Yes4'5'6
Yes7
Yes12
Yes13
YesU
Yes15
Yes16
Yes17
Yes18
Yes19
Time Frame
for Data
Submission
18 Months
18 Months
15 Months
18 Months
18 Months
24 Months
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
24 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR HETALDEHYDE
Test Does EPA
Data Requirement Substance Have Data?
158.240 Residue Chemistry
Cucurbit Vegetables Group TEP No
Citrus Fruits Group TEP No
Pome Fruits Group TEP No
1 Stone Fruits Group TEP No
u>
en
Small Fruits and Berries TEP Partially
1 Group
Tree Nuts Group TEP No
Cereal Grains Group TEp No
Bibliographic Must additional data
Citation be submitted?
N/A Yes20
N/A Yes^1
N/A Yes23
N/A Yes2?
Yes26
00033213, 00138262 Ies27
N/A Yes29
N/A Yfl3°32
Time Frame
for Data
Submission
18 Months
18 Months
24 Months
18 Months
24 Months
18 Months
24 Months
18 Months
24 Months
18 Months
18 Months
24 Months
Grass Forage, Fodder, and TEP
Hay Group
Non-Grass Animal Feeds Group TEP
Herbs and Spices Group TEP
Miscellaneous Commodities
- Artichoke TEP
- Asparagus TEP
- Avocados TEP
No
Partially
No
No
No
No
N/A
00127145
N/A
N/A
N/A
N/A
Yes33
Yes34
Yes
37
Yes
38
Yes
39
18 Months
18 Months
18 Months
24 Months
18 Months
18 Months
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR HETALDEHYDE
Data Requirement
- Bananas
- Mint
- Okra
Test
Substance
TEP
TEP
TEP
Does EPA
Have Data?
Partially
No
No
Bibliographic
Citation
00127144
N/A
N/A
Must additional data
be submitted?
Yes40
Yesg
Yes
Yes43
Time Frame
for Data
Submission
18 Months
18 Months
24 Months
18 Months
- Tobacco PAIRA & TEP
171-4. Magnitude of residue in TGAI or plant
Meat/Milk/Poultry/Eggs metabolites
No
No
N/A
N/A
Yes
Reserved46
18 Months
18 Months
18 Months
1. Data depicting the distribution and metabolism of universally ring-labeled I Clmetaldehyde in or on three dissimilar food crops (e.g., a root crop,
a legume or cereal grain crop, and a leafy vegetable) are required. If metabolism is not similar in the three crops, additional studies using other crops
may be required. A completely characterized test substance representative of technical metaldehyde used in commercial formulations must be applied
foliarly and via the soil several times up to and including the day of harvest at rates sufficiently high to permit complete characterization of C-
residues. The identities and quantities of residues in or on mature plant parts must be determined in order to elucidate terminal residues.
Representative samples must also be analyzed by proposed enforcement methods to ascertain that all residues of concern are determined.
2.. Metabolism studies utilizing runinants and poultry are required. Animals must be dosed orally for a minimum of 3 days with universally ring-labeled
[Clmetaldehyde at a level sufficient to make residue identification and quantification possible. Milk and eggs must be collected twice a day during
the dosing period. Animals must be sacrificed within 24 hours of the final dose. The distribution and identity of residues must be determined in milk,
eggs, liver, kidney, muscle, and fat. Samples from these studies must also be analyzed using enforcement methods to ascertain that the methods are capable
of adequately recovering and identifying all residues of toxicological concern.
3. Data depicting the qualitative nature of metaldehyde residues in swine are also required if the required metabolism studies with ruminants and poultry
reveal that the metabolism of metaldehyde in these animals differs from that in rats.
4. The results of a successful confirmatory trial of the Selim and Seiber GLC method (or other proposed enforcement method) conducted by an independent
laboratory must be submitted for a representative fatty and nonfatty plant-derived food commodity. The rationale for selection of commodities must be
provided. If the method must be significantly modified to accommodate analysis of specific commodities, separate confirmatory trials for each specific
commodity are required. Results of at least one set of samples per commodity (a total of six samples, including two control samples, two control samples
fortified at the tolerance level, and two control samples fortified at 2-5 times the tolerance level) must be submitted. No more than three sets of
samples per commodity may be tested to achieve successful recovery rates of 70-120% with negligible interference compared tot he established tolerance(s).
For additional details of data requirements, refer to PR Notice 88-5, Tolerance Enforcement Methods - Independent Laboratory Confirmation by Petitioner.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METALDEHYDE
5. The nature of the residue in plants and animals has not been adequately described. If the metabolism studies requested in the section "Qualitative
Mature of the Residue in Plants" reveal the presence of additional metabolites of concern in or on plant commodities, additional validated methods for
data collection and tolerance enforcement will be required. Also, if the metabolism studies requested in the section "Qualitative Nature of Residue in
Animals" reveal the presence of residues of concern in meat, milk, or eggs, validated methods for data collection and tolerance enforcement will be
required.
6. Representative samples of fatty and nonfatty plant commodities bear-ing residues of metaldehyde must be subjected to multiresidue protocols I and III
which are available from the National Technical Information Service under Order No. PB203735/AS. If residues of concern are found in animal commodities,
these commodities must also be subjected to analysis using multiresidue protocols I and III.
7. All residue data requested in this Standard must accompanied by information specifying the storage intervals and conditions for samples analyzed.
Data must also be provided which depict the decline in metaldehyde residues of concern in commodities stored under the range of conditions and for the
range of intervals specified. One representative sample from each crop group bearing field-weathered residues or fortified samples must be analyzed
immediately after harvest or fortification and again after storage intervals that represent actual residue sample storage conditions and allow for
reasonable unforeseen delays in sample analysis. For additional guidance on conducting storage stability studies, the Registrant is referred to an August
1987 "Position Document on the Effects of Storage on Validity of Pesticide Residue Data" available from NTIS under order no. PB88112362/AS.
8. It should be noted that data gaps exist for plant and animal metabolism and storage stability. Since the data required for individual conmodities
are dependent on the metabolism data, that the required metabolism data must be obtained and submitted for review prior to initiation of residue trials.
9. Data are required depicting metaldehyde residue of concern in or on (1) carrots, radishes, and potatoes harvested after the last multiple soil
applications with a pelleted/tableted (p/t) formulation at 20 Ib ai/A as a broadcast soil treatment repeated at 14-day intervals and (2) sugar beets
harvested 6 days following the last of multiple broadcast soil applications (7-day intervals) with the 4X P/T formulation at 2.4 Ib ai/A. Radish, carrot,
and potato samples must be collected immediately after the last application and at several closely spaced intervals thereafter so that a residue uptake
and decline curve can be established. Tests for carrots, potatoes, and radishes must be conducted in states that represent the major growing regions
for each crop according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Department of Commerce). Sugar
beet tests must be conducted in OR.
10. Data depicting residues of concern in granules, chips, wet peel, and dry peel processed from potatoes bearing measurable weathered residue must be
submitted. If residues concentrate, appropriate food/feed additive regulations must be proposed.
11. Data depicting metaldehyde residues of concern in dehydrated pulp, molasses, and refined sugar processed from sugar beets bearing measurable weathered
residue must be submitted. If residues concentrate, appropriate food/feed additive regulations must be proposed.
12. Data are required depicting metaldehyde residues of concern in or on (i) turnip tops harvested following the last of multiple applications with a
P/T formulation at 20 Ib ai/A applied as a broadcast soil application at 14-day intervals and (ii) sugar beet tops harvested 6 days following the last
of multiple broadcast soil applications (7 day intervals) with the 4% P/T formulation at 2.4 Ib ai/A. Turnip top samples must be collected immediately
after the last application and at several closely spaced intervals thereafter such that a residue uptake and decline curve can be established. Tests
on turnips must be conducted in states that represent the major growing regions for each crop according to the latest edition of Agricultural statistics
(USDA) or the 1982 Census of Agriculture (U.S. Dept. of Commerce. Tests on sugar beets tops must be conducted in OR.
13. Data are required depicting metaldehyde residue of concern in or on onions (green and dry bulb) and garlic following the last of several soil
treatments with a P/T formulation at 20 Ib ai/A applied as a broadcast soil treatment using ground equipment repeated at 14-day intervals. Samples must
be collected immediately after the last application and at several closely spaced intervals thereafter such that a residue uptake and decline curve can
be established. Test must be conducted in states that represent the major growing regions for each crop according to the latest edition of Agricultural
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METALDEHYDE
Statistics. (USDA) or the 1982 Census of Agriculture (U.S. Dept. of Commerce).
14. Data are required depicting metaldehyde residue of concern in or on celery, lettuce (head and leaf) and spinach following the last of several
applications with a P/T formulation at 20 Ib ai/A made as a broadcast soil treatment using ground equipment and repeated at 14-day intervals. Samples
must be collected immediately after the last application and at several closely spaced intervals thereafter such that a residue uptake and decline curve
can be established. Tests must be conducted in states that represent the major growing regions for each crop according to the latest edition of
Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Dept. of Conmerce).
15. Data are required depicting metaldehyde residue of concern in or on broccoli, cabbage and mustard greens following the last of several broadcast
soil applications with a P/T formulation at 20 Ib ai/A repeated at 14-day intervals. Samples must be collected immediately after the last application
and at several closely spaced intervals thereafter such that a residue uptake and decline curve can be established. Tests must be conducted in states
that represent the major growing regions for each crop according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture
(U.S. Dept. of Commerce).
16. Data are required depicting metaldehyde residue of concern in or on beans and peas (a succulent and dry variety of each) following the last of several
soil applications made at 14-day intervals with a P/T formulation at 20 Ib ai/A. Samples must be collected immediately after the last application and
at several closely spaced intervals thereafter such that a residue uptake and decline curve can be established. Tests must be conducted in states that
represent the major growing regions for each crop according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture
I (U.S. Dept. of Commerce).
<-° 17. Data are required depicting metaldehyde residue of concern in or on bean vines and hay and pea vines and hay harvested following the last of multiple
00 soil treatments with a P/T formulation at 20 Ib ai/A applied as a broadcast soil treatment repeated at 14-day intervals. Samples must be collected
I immediately after the last application and at several closely spaced intervals thereafter such that a residue uptake and decline curve can be established.
Tests must be conducted in states that represent the major growing regions for each crop according to the latest edition of Agricultural Statistics (USDA)
or the 1982 Census of Agriculture (U.S. Dept. of Commerce)
18. Data are required depicting metaldehyde residue of concern in or on peppers and tomatoes harvested following the last of multiple broadcast soil
treatments with a P/T formulation at 20 Ib ai/A. Samples must be collected immediately after the last application and at several closely spaced intervals
thereafter such that a residue uptake and decline curve can be established. Tests must be conducted in states that represent the major growing regions
for each crop according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Dept. of Commerce).
19. Data are required depicting metaldehyde residues of concern in dry pomace, puree, catsup, and juice processed from tomatoes bearing measurable,
weathered residues. If residues concentrate in any product, an appropriate food/feed additive regulation must be proposed.
20. Data are required depicting metaldehyde residue of concern in or on cucumbers, melons (cantaloupe or muskmelon), and sunnier squash following the
last of several broadcast soil application with a P/T formulation at 20 Ib ai/A applied at 14-day intervals. Samples must be collected immediately after
the last application and at several closely spaced intervals thereafter such that a residue uptake and decline curve can be established. Tests must be
conducted in states that represent the major growing regions for each crop according to the latest edition of Agricultural Statistics (USDA) or the 1982
Census of Agriculture (U.S. Dept. of Commerce).
21. Data are required depicting metaldehyde residue of concern in or on grapefruits, lemons, and oranges following the last of several broadcast soil
applications with a P/T formulation at 1.5 Ib ai/A. Samples must be collected immediately after the last application and at several closely spaced
intervals thereafter such that a residue uptake and decline curve can be established. Tests must be conducted in states that represent the major growing
regions for each crop according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Dept. of Conmerce).
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METALDEHYDE
22. Data are required depicting metaldehyde residues of concern in wet and dried pulp, oil molasses, and juice processed from citrus bearing measurable,
weathered residues. If residue concentrate in any product, an appropriate food/feed additive regulation must be proposed.
23. Data are required depicting metaldehyde residue of concern in or on apples and pears following the last of several broadcast soil applications with
a P/T formulation at 1.5 Ib ai/A. Samples must be collected immediately after the last application and at several closely spaced intervals thereafter
such that a residue uptake and decline curve can be established. Tests must be conducted in states that represent the major growing regions for each
crop according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Dept. of Commerce).
24. Data depicting metaldehyde residues of concern in juice, and wet and dry pomace processed from apples bearing measurable, weathered residues are
required. If residue concentrate in any product, an appropriate food/feed additive regulation must be proposed.
25. Data are required depicting metaldehyde residue of concern in or on cherries (sweet and sour), plums, and peaches following the last of several
broadcast soil treatments with a P/t formulation at 1.5 Ib ai/A. Samples must be collected immediately after the last application and at several closely
spaced intervals thereafter such that a residue uptake and decline curve can be established. Tests must be conducted in states that represent the major
growing regions for each crop according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Dept. of Commerce).
I 26. Data are required depicting metaldehyde residues of concern in dried prunes processes from plums bearing measurable weathered residues. If residues
concentrate in dried prunes, an appropriated food additive regulation must be proposed.
OJ
vo
27. Data are required depicting metaldehyde residue of concern in or on (i) blackberries and grapes harvested after the last of multiple broadcast soil
I applications with the 2.75X P/T made at 7-day intervals at 1.5 Ib ai/A, (ii) blueberries harvested after the last or multiple broadcast soil application
with the 10% G made at 7-day intervals at 1.6 Ib ai/A , (iii) strawberries harvested 6 days after the last of multiple applications at 14-day intervals
with a G formulation at 5.23 Ib ai/A, and (iv) strawberries harvested after the last of multiple soil-directed applications at 21-day intervals with
the 3.25% EC formulation at 1.12 Ib ai/A (4 gal product/A). Samples of blackberries, grapes, blueberries, and strawberries (iv only) must be collected
immediately after the last application and at several closely spaced intervals thereafter such that a residue uptake and decline curve can be established.
Tests must be conducted in states that represent the major growing regions for each crop according to the latest edition of Agricultural Statistics (USDA)
or the 1982 Census of Agriculture (U.S. Dept. of Commerce).
28. A processing study depicting metaldehyde residues of concern in products (raisins, dry pomace, raisin waste, and juice) processed from grapes bearing
measurable, weathered residues is required. If residues concentrate in any product, appropriate food/feed additive regulations must be proposed.
29. Data depicting metaldehyde residue of concern in or on almonds, pecans and walnuts harvested following the last of multiple broadcast soil treatments
with the 2% G MAI formulation at 0.44 Ib ai/A applied at 14-day intervals using ground equipment. Samples must be collected immediately after the last
application and at several closely spaced intervals thereafter such that a residue uptake and decline curve can be established. Tests must be conducted
in states that represent the major growing regions for each crop according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census
of Agriculture (U.S. Dept. of Commerce).
30. Data depicting metaldehyde residues of concern in or on (i) wheat grain harvested 30 days after the last of several broadcast soil applications of
a G formulation at 2.4 Ib ai/A, (ii) wheat grain harvested after the last of several broadcast soil applications with a G formulation at 2.4 Ib ai/A,
(ii) wheat grain harvested after the last of several broadcast soil applications with a G formulation at 1.5 Ib ai/A [wheat grown for seed], and (iii)
corn grain (field corn) and sweet corn kernels plus cob with husks removed harvested after the last of several broadcast soil applications made at 14-
day intervals with a P/T formulation at 20 Ib ai/A. Samples of wheat grown for seed (ii) and corn must be collected immediately after the last application
and at several closely spaced intervals thereafter such that a residue uptake and decline curve can be established. Tests must be conducted in states
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR HETALDEHYDE
that represent the major growing regions for each crop according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture
U.S. Dept. of Commerce).
31. A processing study is required depicting metaldehyde residues of concern in wet milled products (starch, crude oil, and refined oil) and in dry milled
products (grits, meal, flour, crude and refined oils), and grain dust from the processing of field corn bearing measurable, weathered residues. If
residues concentrate in any product, appropriate food/feed additive regulations must be proposed.
32. A processing study depicting metaldehyde residues of concern in milled products (bran, flour, middling and shorts) and grain dust from the processing
of wheat bearing measurable, weathered residues is required. If residues concentrate in any product, appropriate food/feed additive regulations must
be proposed. [Wheat data will be translated to oats and barley].
33. Data are required depicting metaldehyde residues of concern in or on grass hay, forage and seed (Bermuda grass, bluegrass, and bromegrass or fescue)
harvested after the last of several broadcast soil application with a G formulation made at 7-day intervals at 1.5 Ib ai/A. Samples must be collected
immediately after the last application and at several closely spaced intervals thereafter such that a residue uptake and decline curve can be established.
Tests must be conducted in states that represent the major growing regions for each crop according to the latest edition of Agricultural Statistics (USDA)
or the 1982 Census of Agriculture (U.S. Dept. of Commerce).
34. Data are required depicting metaldehyde residue of concern in or on alfalfa and clover hay, forage, and seed harvested after the last of multiple
I soil applications with the 4X G formulation at 2.4 Ib ai/A applied as broadcast soil applications and repeated at 7-day intervals. Samples must be
collected immediately after the last application and at several closely spaced intervals thereafter such that a residue uptake and decline curve can be
** established. Test must be conducted in states that represent the major growing regions for each crop according to the latest edition of Agricultural
° Statistics (USDA) or the 1982 Census of Agriculture (U.S. Department of Commerce).
I
35. Data are required depicting metaldehyde residue of concern in or on coriander (seeds and foliage), chives, dill (seeds and foliage), oregano, and
sage harvested 6 days following the last of multiple soil treatments with the 4X G formulation at 2.4 Ib ai/A applied as a broadcast treatment prior to
the formation of edible parts, and as a band application following edible part formation, at 7-day intervals using ground equipment. Tests must be
conducted in states that represent the major growing regions for each crop according to the latest edition of Agricultural statistics (USDA) or the 1982
Census of Agriculture (U.S. Department of Commerce).
36. Data are required depicting metaldehyde residues of concern in or on dried herbs and spices. If residues concentrate in any herb or spice, an
appropriate food additive regulation must be proposed.
37. Data are required depicting metaldehyde residue of concern in or on artichokes harvested following the last of multiple broadcast soil treatments
with a P/T formulation at 20 Ib ai/A and repeated at 14-day intervals. Samples must be collected immediately after the last application and at several
closely spaced intervals thereafter so that a residue uptake and decline curve can be established. Tests must be conducted in states that represent the
major growing regions for artichokes according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Department
of Commerce).
38. Data are required depicting metaldehyde residue of concern in or on asparagus harvested following the last of multiple broadcast soil treatments
with a P/T formulation at 20 Ib ai/A and repeated at 14-day intervals. Samples must be collected immediately after the last application and at several
closely spaced intervals thereafter so that a residue uptake and decline curve can be established. Tests must be conducted in states that represent the
major growing regions for artichokes according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Department
of Commerce).
39. Data are required depicting metaldehyde residue of concern in or on avocados harvested following the last of multiple broadcast soil treatments with
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METALDEHYDE
a P/T formulation at 1.5 Ib ai/A using ground equipment. Samples must be collected immediately after the last application and at several closely spaced
intervals thereafter so that a residue uptake and decline curve can be established. Tests must be conducted in states that represent the major growing
regions for avocados according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Department of Commerce).
40. Data are required depicting metaldehyde residue of concern in or on bananas harvested following the last of multiple broadcast soil treatments with
the 10% G formulation at 4.8 Ib ai/A and repeated at 14-day intervals using ground equipment. Samples must be collected immediately after the last
application and at several closely spaced intervals thereafter so that a residue uptake and decline curve can be established. Tests must be conducted
in states that represent the major growing regions for bananas according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of
Agriculture (U.S. Department of Commerce).
41. Data are required depicting metaldehyde residue of concern in or on spearmint or peppermint harvested 30 days following the last of multiple broadcast
soil treatments with the 4X P/T formulation at 2.4 Ib ai/A, repeated at 7-day intervals. Tests must be conducted in OR.
42. Data are required depicting metaldehyde residues of concern in or on spend hay and oil processed from fresh mint bearing measurable weathered
residues. If residues concentrate in any product, an appropriate food/feed additive regulation must be proposed.
43. Data are required depicting metaldehyde residue of concern in or on okra harvested following the last of multiple broadcast soil treatments with
a P/T formulation at 20 Ib ai/A using ground equipment applied at 14-day intervals. Samples must be collected immediately after the last application
and at several closely spaced intervals thereafter so that a residue uptake and decline curve can be established. Tests must be conducted in states that
represent the major growing regions for okra according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S.
Department of Commerce).
44. Data are required depicting metaldehyde residue of concern in or on green and cured or dry tobacco harvested following the last of multiple broadcast
soil treatments with the 3.25X P/T formulation at 1.4 Ib ai/A using ground equipment. Samples must be collected immediately after the last application
and at several closely spaced intervals thereafter so that a residue uptake and decline curve can be established.
45. If metaldehyde residues of concern are > 0.1 ppm in or on dry or cured tobacco, pyrolysis products derived from the active ingredient must be
characterized and the level of the residue in'smoke must be quantified. Universally ring-labeled [ C] metaldehyde must be used for identification of
pyrolysis products.
46. Data requirements regarding the magnitude of the residue in animal products will not be determined until all requested data regarding metabolism
in animals and magnitude of residue in feed items have been received.
-------
I
to
Table A
Generic Data Requirements for Netaldehyde
Data Requirement Composition
Section 158.290 Environmental Fate
DEGRADATION STUDIES - LAB;
161-1 - Hydrolysis
PHOTOOEGRADATION
161-2 - In Water
161-3 - On Soil
161-4 - In Air
METABOLISM STUDIES - LAB;
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
Does EPA
Have Data to
Use Satisfy This Bibliographic
Patterns Requirement? Citation
A,B,E,F.H,I No
A,B No
A No
A No
A,B,E,F,H No
A No
No
No
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)7
Yes
Yes
Yes
Reserved
Yes
Yes
No2
No2
Timeframe
For
Submission
9 months
9 months
9 months
27 months
27 months
MOBILITY STUDIES:
163-1 - Leaching and
Adsorpt i on/Desorpt i on
163-2 - Volatility (Lab)
A,B,E,F,H
A.E.F
No
No
Yes
Yes
12 months
9 months
-------
Table A
Generic Data Requirements for Metaldehyde
Use
Data Requirement Composition Patterns
Section 158.290 Environmental Fate (cont'd)
163-3 - Volatility (Field) A,E,F
DISSIPATION STUDIES - FIELD;
164-1 - Soil A,B,H
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-Term A
ACCUMULATION STUDIES:
165-1 - Rotational Crops A
(Confined)
165-2 - Rotational Crops A
(Field)
Does EPA
Have Data to
Satisfy This
Requirement?
No
No
No
No
No
No
No
No
kl«
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)7
Reserved/ 1
Yes
No2
No3
No4
Reserved/5
Yes
Reserved/6
u.,2
Timeframe
For Data]/
Submission
27 Months
39 Months
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Nontarget
Organisms
A.B.D
A,B,D
NO
NO
Yes
Reserved/7
12 Months
-------
Table A
Generic Data Requirements for Netaldehyde
Data Requirement
Composition
Use
Patterns
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(cH2KB)?
Timeframe
for
Submission
40 CFR 158.390
Reentry Protection:
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
Section 158.440 Spray Drift
202-1 - Spray Field Evaluation
202-1 - Drift Size Spectrum
Ground-Water Monitoring
TEP A,B,E,F,H,I No
TEP A,B,E,F No
TEP A,B,C,DfE,F,G,HfI No
TEP A,B,C,D,E,F,G,HfI No
A,B No
A,B No
B,C,E,F,H No
Reserved
Reserved
Reserved
Reserved,
Reserved^/
Reserved^/
FOOTNOTES
1/ This data requirement is reserved pending evaluation of the laboratory volatility data.
2/ Data are not required because there are no aquatic or aquatic impact uses.
3/ Based on use pattern, study is not required.
l\l Currently not imposed.
5/ This data requirement is reserved pending evaluation of the aerobic soil metabolism, leaching, and dissipation data.
6/ Pending evaluation of the confined crop rotation data and/or toxicological data.
7/ This data requirement is deferred pending the evaluation of the fish accumulation study and ecological issues.
8/ Spray drift data requirements are deferred pending evaluation of ecological effect issues.
9/ There are no data at present time to trigger ground water monitoring studies.
-------
Table A
Generic Data Requirements for Metaldehyde
Data
Requirement Composition
Use
Patterns
Does EPA
Have Data to
Satisfy This
Reaui rement?
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?
Timeframe
For Data
Submission
Section 158.340 Toxicology
ACUTE TESTING;
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation- Rabbit
- Dermal Sensitization
Guinea Pig
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B,E,F,H,I
A,B,E,F,HfI
A,B,E,F,H,I
A.B,E,F,H,I
A,B,E,F,H,I
A,B,E,F,H,I
N/A
Partially
Partially
Partially
No
Partially
No
No
00131435, 00131969 Yesl/
00131434 Yesl/
00131429 Yesl/
Yes
00131971 Yesl/
Yes
No2/
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
SUBCHRONIC TESTING:
82-1
- 90-Day Feeding -
Rodent
Nonrodent
TGAI
TGAI
A,B,E,F,H,I
A,B,E,F,H,I
No
No
No3/
No3/
-------
Table A
Generic Data Requirements for Metaldehyde
Data Requirement
Section 158.340 Toxicology
SUBCHRONIC TESTING (cont'd);
82-2 - 21 -Day Dermal
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
82-5 - 90 -Day Neurotoxicity
CHRONIC TESTING:
83-1 - Chronic Testing
-Rodent
-Nonrodent
83-2 - Oncogenicity Study
-Rat
-Mouse
83-3 -Teratogenicity
-Rat
-Mouse
Composition
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA
Have Data to
Use Satisfy This
Patterns Requirement?
A,B,E,F,H,I No
A,B,E,F,H,I No
A,B,E,F,H,I No
N/A No
A,B,E,F,H,I No
A,B,E,F,H,I No
A,B,E,F,H,I No
A,B,E,F,H,I No
A,B,E,F,H,I No
A,B,E,F,H,1 No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?
Yes
No4
No5
No6
Yes
Yes
Yes
Yes
Yes
Yes
Timeframe
For Data
Submission
9 Months
50 Months
50 Months
50 Months
15 Months
15 Months
-------
Table A
Generic Data Requirements for Metaldehyde
Data Requirement
Section 158.340 Toxicology
CHRONIC TESTING (cont'd);
83-4 - Reproduction
MUTAGENICITY TESTING;
84-2 - Gene Mutation
84-2 - Chromosome Aberration
84-4 - Other Mechanisms of
Does EPA
Have Data to
Use Satisfy This
Composition Patterns Requirement?
TGAI A,B,E,F,H,I No
TGAI A,B,E,F,H,I Mo
TGAI A,B,E,F,H,I Partially
TGAI A,B.E,F,H,I No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?
Yes
Yes
00163832 Yes7
Yes
Timeframe
For Data
Submission
39 Months
9 Months
ii
u
Mutagenicity
SPECIAL TESTING;
85-1 - General Metabolism
PAI or PAIRA
No
Yes
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR HETALDEHYDE
FOOTNOTES (Cont.)
1/ This requirement may be satisfied if the purity of the test material used in the existing study is submitted.
2/ This test is required only for compounds which are organophosphate inhibitors of cholinesterase, or related to
such inhibitors or metabolites of such inhibitors. Metaldehyde is not an organophosphate; therefore, a study is
not required.
3/ Data requirement waived based on the requirement for a chronic oral toxicity study in rodent and nonrodent.
4/ This study is not required because existing acceptable use patterns should not result in repeated or extended
human skin contact.
5/ This study is not required because existing acceptable use patterns should not result in repeated or extended
human contact by the inhalation route.
6/ Since an acute neurotoxicity study is not required for this compound and there is no evidence of neurotoxicity
in mammalian species from the available data, this study is not required.
' 71 The portion of the study performed in the absence of a metabolic activation system is acceptable and need not
£* be repeated. However, the portion of the study performed in the presence of the metabolic activation system is
oo not acceptable because neither cytotoxicity not the limit of solubility was demonstrated.
I
-------
Table A
Generic Data Requirements for MetaVdehyde
Data Requirement
Composition
Use
Pattern
Does EPA Have
Data to Satisfy
This Require-
ment? (Yes,
No Partially)
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data
Citation 3(c)(2)(B)7 Submission
Section 158.490 - Wildlife and Aquatic Organisms
SPECIAL TESTING
70-1 - Residue Monitoring
AVIAN AND MAMMALIAN TESTING
71-1 -Avian Acute Oral Toxicity
71-2 - Avian Subacute Dietary
Toxicity
- Upland Game Bird
- Waterfowl
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
- Upland Game Bird
- Waterfowl
71-5 - Simulated Field Testing
- Mammals
- Birds
- Actual Field Testing
- Mammals
- Birds
TEP
TGA1
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
TEP
TEP
A.B.H
A,B,F,H
A.B.F.H
A.B,F,H
A,B,F,H
A.B.F.H
A.B.F.H
A.B.H
A.B.H
A,B,H
A.B.H
No
No
No
No
No
No
No
No
No
No
No
Reserved_
Yes 9 Months
Yes 9 Months
Yes 9 Months
No2
Yes 24 Months
Yes 24 Months
Reserved^
Reserved^
Reserved ,,
Reserved^'
-------
o
I
Table A
Generic Data Requirements for Metaldehyde
Use
Data Requirement Compos it ion Pattern
Section 158.490 - Wildlife and Aquatic Organisms
AQUATIC ORGANISM TESTING
72-1 - Acute Toxicity to
Freshwater Fish Species
- Coldwater TGAI A.B.F.H
- Warmwater TGAI A,B,F,H
Does EPA Have
Data to Satisfy
This Require-
ment? (Yes, Bibliographic
No, Partially) Citation
No
Yes 0090362
Must Additional
Data Be Submitted
Under FIFRA Section
3(cH2HB)?
Yes
No
Timeframe
For Data
Submission
9 Months
72-2 - Acute Toxicity to
Freshwater Invertebrates TGAI
72-3 - Acute Toxicity to
Estuarine and Marine
Organisms
- Fish
- Mollusk
- Shrimp
72-4 - Fish Early Life Stage
and Aquatic Invertebrate
Life Cycle
- Freshwater Species
- Estuarine/Marine
72-5 - Fish Life Cycle TGAI
A,B,F,H
No
Yes
TGAI
TGAI
TGAI
TGAI
TGAI
A,B.F,H
A,B,F,H
A,B,F,H
A.B.H
A,B,H
No
NO
No
No
No
Reserved
Reserved
Reserved
Reserved
Reserved
V
A,B,H
No
Reserved
V
9 Months
-------
I
ui
Table A
Generic Data Requirements for Metaldehyde
Data
Requirement
Section 158.490 - Wildlife and^
72-6
72-7
- Aquatic Organisms
- Simulated Field Testing
- Aquatic Organisms
- Actual Field Testing
- Aquatic Organisms
Does EPA Have
Data to Satisfy
This Requi re-
Use merit? (Yes, Bibliographic
Composition Pattern No. Partially) Citation
Aquat i c Organisms
TEP A,B,H . No
TEP A,B,H No
TEP A.B.H No
Must Additional
Data Be Submitted Timeframe
Under F1FRA Section For Data
3(c)(2)(B)7 Submission
No3
Reserved1 '
Reserved17
I/ Data requirement reserved pending results of avian/aquatic organism toxicity and environmental fate studies.
2/ Based on use patterns, this study is not required.
3/ See environmental fate data tables (Section 158.290, Guideline 165.50).
-------
Table A
Generic Data Requirements for Metaldehyde
Does EPA Have
Data to Satisfy Must Additional
This Require- Data Be Submitted Timeframe
Use ment? (Yes, Bibliographic Under FIFRA Section For Data
Data Requirement Composition Pattern No. Partially) Citation 3(c)(2)(B)7 Submission
Section 158.540 - Plant Protection
121-1
- Target Area Phytotoxicity EP A,B,F,H No
Tier 1
No1/
Nontarget Area Phytotoxicitv
1
(ji
to
1
121-1
122-1
122-2
123-1
123-1
123-2
124-1
124-2
- Seed Germination/ TGAI A.B.F.H No
Seedling Emergence
- Vegetative Vigor TGAI A.B.F.H No
- Aquatic Plant Growth TGAI A,B,F,H No
Tier II
- Seed Germination/ TGAI A.B.F.H No
Seedling Emergence
- Vegetative Vigor TGAI A,B,F,H No
- Aquatic Plant Growth TGAI A.B.F.H No
Tier III
Terrestrial Field TEP A.B.F.H No
- Aquatic Field TEP A.B.F.H No
No1/
No1/
No1/
No1/
No1/
No1/
No1/
No1/
I/ Based on available data, these studies are not required.
-------
ui
OJ
Table A
Generic Data Requirements for Metaldehyde
Data Requirement
Section 158.590 •
Nontarget Insect
141-1 - Honey Bee
141-2 - Honey Bee
Composition
Montarget Insects
Testing - Pol I inators
Acute Toxicity TGAI
- Toxicity TEP
Does EPA Have
Data to Satisfy
This Requi re-
Use ment? (Yes, Bibliographic
Pattern No. Partially) Citation
A,B,H No
A,B No
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
No1
No1
Timeframe
For Data
Submission
of residues on foliage
141-4 - Honey Bee Subacute Reserved2/
Feeding Study
141-5 - Field Testing for TEP A,B,H
Pollinators
Nontarget Insect Testing
142-1 - Acute Toxicity to Reserved2/
Aquatic Insects
142-2 - Aquatic Insect Life Reserved2/
Cycle Study
142-3 - Simulated or Actual Reserved2/
Field Testing for
Aquatic Insects
143-1 Nontarget Insect Reserved /
thru Test ing-Predators
143-3 and Parasites
No
No1
/ The nature of the registered metaldehyde formulations and uses precluded any significant bee exposure. Thus, bee data are not required for
metaldehyde.
/ This requirement is reserved pending development of test methodology and/or decisions as to whether data should be required.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING METALDEHYDE
Test
Data Requirement Substance
Does EPA
Have Data To
Satisfy This
Requi rement?
Bibliographic
Citation 1
Must Additional
Data be Submitted
Under FIFRA Section
3?
Time Frame
For Data
Submission
Part 158. Suboart C - Product Chemistrv
Product Composition
61-1. Product Composition
61-2. Beginning Materials and
Production or Formulation
Process
61-3. Formation of Impurities
Analysis and Certification of
Product Ingredients
62-1. Preliminary Analysis
62-2. Certified Limits
62-3. Enforcement Analytical
Methods
MP
MP
MP
MP
MP
MP
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
Physical and Chemical Characteristics
63-2. Color
63-3. Physical State
63-4. Odor
63-7. Density, Bulk Density,
Specific Gravity
63-12. pH
62-14. Oxidizing or Reducing Action
62-15. F I amiability
63-16. Explodability
63-17. Storage Stability
63-18. Viscosity
63-19. Miscibility
63-20. Corrosion Characteristics
Other Requirements:
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
No
No
No
No
No
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes'
Yes3
Yes4
Yes5
Yes6
Yes7
Yes*
Yes*
Yes«
Yes8
ft O
Ycs?o
Yes?
Yes!
Yes12
Yes
YCS4
Yes1*
Yes
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
N/A
N/A
N/A
No
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING METALDEHYDE
1. Not Applicable. Although product chemistry data may have been submitted in the past, the Agency has determined that these data must be resubmitted
for each pesticide. New requirements have been introduced and previously submitted data must be updated. Therefore, bibliographic citations for the
old data are not applicable.
2. For each manufacturing use product that consists of the technical grade of the active ingredient only or is produced by an integrated system, the
following information must be provided: (1) the CA-approved chemical name, CAS Registry Nunber, any common names, the nominal concentration, upper and
lower certified limits in accordance with 40 CFR Section 158.175, and the purpose of each active and inert ingredient in the product; (2) the molecular,
structural and empirical formulae, and the molecular weight or weight range of each active ingredient in the product; (3) the chemical name and nominal
concentration of each impurity of toxicological significance associated with the active ingredient or present in any sample at a level equal to or greater
than 0.1X by weight of the TGA1; and (4) sufficient information to enable the Agency to identify the source and qualitative composition of all ingredients
that are not characterized. Impurities must be identified as such. For each manufacturing-use product that is produced from an EPA_registered product,
the following information must be provided: (1) the chemical and common name of each active ingredient as listed on the source product, its nominal
concentration in the product based upon the nominal concentration in the source product, and upper and tower certified limits i accordance with 158.175;
(2) the CA-approved chemical name of each inert ingredient in the product, its CAS Registry Number, any common names, nominal concentration, purpose,
and upper and lower certified limits in accordance with 158.175; and (2) sufficient information to enable the Agency to identify the source and qualitative
composition of all ingredients that cannot be characterized.
3. For each manufacturing-end use product that is produced from an EPA-registered product, the following information must be provided: (1) the name
I and EPA-registered product; (2) the brand name, trade name, or other commercial designation and information concerning the composition of each inert
ingredient; (3) a general characterization of the formulation or production process (e.g., batch or continuous); (4) the identity of the materials used
01 to produce the product, their relative amounts, and the order in which they are added; (5) a description of the equipment used; (6) a description of the
conditions (e.g., temperature, pressure, pH, humidity) that are controlled during each step of the process; and (7) • description of the procedures used
I to assure consistent composition of the substance produced (quality control methods). For each manufacturing use product that consists of the technical
grade of the active ingredient only or is produced by an integrated system, the following Information must be provided in addition to that listed above:
(1) the name and address of the producer of each starting material, the name and address of its producer, and information concerning its composition;
(3) a flow chart of the chemical equations of each intended reaction occurring at each step of the process and of the entire process; and (4) • description
of any purification procedures (including procedures to recover or recycle starting materials, intermediates or the substance produced).
4. For each manufacturing use product that consists of the technical grade of the active ingredient only or is produced by an integrated system, a
discussion regarding the origin of the following potential impurities must be provided: (1) each impurity associated with the active ingredient which
was found to be present in any analysis of the product conducted by or for the registrant, and (2) each impurity which the registrant has reason to believe
may be present in the product at a level equal to or greater than 0.1X (w/w) based on the composition of each starting material, intended and side
reactions which may occur in the production of the product, the possible degradation of ingredients in the product after production, post-production
reactions between the ingredients in the product, possible contamination from packaging materials or production equipment, and process control,
purification and quality control measures. For each manufacturing use product that is produced from an EPA-registered product, a discussion must be
provided for each impurity associated with the active ingredient which the registrant has reason to believe may be present in the product at a level equal
to or greater than 0.1X (w.w) based on the possible carryover of impurities present in the registered product which serves as the source of the active
ingredient, the possible carryover of impurities present in the inert ingredients in the product, possible reactions occurring during the formulation
of the product, post-production reactions between any of the product's active ingredients and any other component of the product or its packaging, and
possible contamination from packaging materials or production equipment.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING METALDEHYOE
5. For each manufacturing use product produced by an integrated system, the registrant must provide preliminary analyses of five or more representative
samples of each technical grade of active ingredient contained in the product to identify all impurities present at 0.1% or greater of the TGAI. If the
product is produced by a batch process, at least five separate batches should be represented. The preliminary analysis should be conducted at the point
in the production process after which no further chemical reactions designed to produce or purify the substance are intended. Complete and detailed
descriptions of the methods used for sample analysis must be submitted, including statements of their precision and accuracy. The preliminary analysis
report should include the identity and quantity of each ingredient for which analysis is conducted, along with the mean and relative standard deviation
of the analytical results. Based on the preliminary analysis, a statement of the composition of the technical grade of active ingredient must be provided.
If the technical grade of active ingredient cannot be isolated, a statement of the composition of the practical equivalent of the technical grade of active
ingredient must be submitted.
6. The registrant must propose upper and lower limits for each active and inert ingredient, if such limits would differ from the standard certified limits
determined by the Agency according to 40 CFR Section158.175(b)(2). Also, if the manufacturing use product contains the technical grade of the active
ingredient only or is produced by an integrated system, upper limits must be proposed for each lexicologically significant impurity associated with the
active ingredients and found to be present in any sample of the product (standard certified limits cannot be used for impurities). Certified limits
should be based on the sources and magnitude of variability in the manufacturing process and the stability of the ingredients following production. The
registrant must certify the accuracy of the information presented, and that the certified limits will be maintained. An explanation of how each certified
limit was established (e.g., sample analysis using a validated analytical procedure, quantitative estimate based on the amounts of ingredients used, etc.)
must be provided, along with information on the accuracy and precision of any analytical procedures used. Certifications must be submitted on EPA Form
8570-4 (Rev. 2/85).
7. Analytical methods which are suitable for enforcement purposes must be provided for each active ingredient and each additional ingredient or impurity
that is determined to be lexicologically significant. Suitability for enforcement purposes shall be determined from validation studies of method accuracy
and precision submitted by the registrant.
8. As required in 40 CFR Section 158.190 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, Guidelines Reference Nos. 63-
2 through 63-20, data must be submitted on physicochemical characteristics of each manufacturing-use product (color, physical state, odor, specific
gravity, pH, oxidizing or reducing action, flammability explodability, storage stability, viscosity, misclbility, and corrosion characteristics).
9. Data on pH are required if the test substance is dispersable in water.
10. Data are required on oxidizing/reducing potential if product contains an oxidizing or reducing agent.
11. Data are required on flanmabiltty if the product contains combustible liquids.
12. Data are required if the product is potentially explosive.
13. Data on viscosity are required if the product is a liquid.
14. Data on miscibility are required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Metaldehyde
Data Requirement
Section 158.340 Toxicology
Acute Testing
81-1 - Acute Oral - Rat
81-2 - Acute Dermal
81-3 - Acute Inhalation - Rat
81-4 - Eye Irritation - Rabbit
81-5 -'Dermal Irritation
-Rabbit
81-6 - Dermal Sensitization
- Guinea Pig
Composition
HP
MP
HP
MP
MP
MP
Use
Patterns
All
All
All
All
All
All
Does EPA
Have Data to
Satisfy This
Requirement?
No
No
No
No
No
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)7
Yes
Yes
Yes
Yes
Yes
Yes
Timeframe
For Data
Submission
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-------
II. LABELING APPENDICES
- 58 -
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 156.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 156.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 156.10(g)]
- 59 -
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations . the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT-LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 156.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 156.10(h)(1)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 156.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II. and III. [40 CFR 156.10(h)(1)(ill)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.56(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 156.10(h)(2)].
- 60 -
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 156.10(h) (2) ( i) ]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 156.10(h) (2) (ii) ]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of Part 152, Subpart I. You will be notified
of the Agency's classification decision.
- 61 -
-------
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label, requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 156.10(h) (1)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so. you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. .You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
- 62 -
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SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29. 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 156.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
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SUMMARY-6
LABELING REQUIREMENT OF TOE FIFRA, AS AMENDED
ITEM
1
2
3
4
I
c* 5
*>.
I
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precaut ionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead ot"
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be gcouptid together, preferably
blocked.
Note type size requirements.
Note type siie requirements.
-------
StMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Scull & cross-
bones and word
POISON (in red)
Statement of1
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precaut ionary
statements
Hazards to
hunans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxic ity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II. and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
FKEKEKKEL)
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
Ol
I
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Limed iately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immed iately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Mist be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS. and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
CT>
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Chapter I—Environmental Protection Agency
§156.10 Labeling Requirements for Pesticides and Devices.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
(e) of this section;
(v) The producing establishment number as prescribed in para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section;
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this section.
(2) Prominence and legibility. (i) All words, statements,
graphic representations, designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be placed
with such conspicuousness (as compared with other words, state-
ments, designs, or graphic matter on the labeling) and expressed
in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear in the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
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pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk containers—(A) Transportation.
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to S 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticidal claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
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-------
. (ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisonous," "noninjurious,"
harmless" or "nontoxic to humans and pets" with or without such
a qualifying phrase as "when used as directed"; and
(x) Non-numerical- and/or comparative statements on the safety
of the product, including but not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals known"
(C) "Pollution approved"
(6) Final printed labeling. (i) Except as provided in
paragraph (a)(6)(ii) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to $ 162.6(b)(4).
(c) Name and address of producer,, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be'considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***," or "Sold by ***" to show that the name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°F (20°C) and shall be
expressed in conventional American units'of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds -and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces."
- 69 -
-------
(5) in addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(?) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement—(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement "Inert Ingredients,
none" is not required for pesticides which contain 100 percent
active ingredients. Unless the ingredient statement is a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the ingredient statement.
(2) Position of ingredient statement. (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
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(3) Names to be used in ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one, followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case
will the use of a trademark or proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients
shall be stated in terms of weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements:
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]."
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient statement
if he determines that such ingredient(s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. ' With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
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Hazard Indicators
Oral LD
50
Inhalation 1C
Dermal LD.
50
Eye effects
Skin effects
|-
Up to and
Including
50 *g/kg
Up to and
Including
.2 mg/ liter
Up to and
Including
200 mg/kg
Corrosive;
cornea! opacity
not reversible
•Ithln 7 days
Corrosive
Toxicity <
II
From 50 thru
500 wig/kg
From .2 thru
2 mg/l Iter
From 200
thru 2000
Cornea 1 opacity
reversible
•Ithln 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
:ategor1es
III
From 500 thru
5000 mg/kg
From 2 thru
20 mg/l Iter
From 2,000 thru
20,000
No cornea 1 opacity;
Irritation
reversible
•Ithln 7 days
Mode-ate Irritation
at 72 hours
IV
Greater than
5000 mg/kg
Greater than
20 «g/Mter
Greater than
20,000
No Irritation
Mild or slight
Irritation at
72 hours
(i) Human hazard signal word.--(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned
the basis of its oral/ inhalation or
from skin and eye local effects) the
in red on a background of distinctly
skull and crossbones shall appear in
word "poison."
(B) Toxicity Category II.
to Toxicity Category I on
dermal toxicity (as distinct
word "Poison" shall appear
contrasting color and the
immediate proximity to the
criteria of Toxicity Category
the signal word "Warning."
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
All pesticide
II shall bear
products meeting the
on the front panel
All pesticide products meeting the
III shall bear on the front panel
All pesticide
IV shall bear
products meeting the
on the front panel
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.(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(iii) Statement of practical treatment—(A) Toxicity
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Points
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children"
6
6
8
10
12
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( 2) Other required warnings and precautionary statements.
warnings and precautionary statements as required below shall
together on the label under the "^*"*1irman
The
appear
-amines ana precautionary statements as required below shall
together on the label under the general heading "Precautionary
Statements" and under aroria s of "Hazard to Hu
" and "Physical or
Where a hazard
rae sueang
and Domestic Animals," "Environmental Hazard
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a haz
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
Toxic 11>
category
Precautionary statements by toxlc'ty category
Oral, Inhalation, or dermal toxlcttv
SKln and eye local effects
III .
iv .
Fatal (poisonous) If swallowed (Inhaled or
absorbed through sklnl. Do not breathe
vapor Idustl or spray mist). Do not get
In eyes, on skin, or on clothing (Front
panel statement of practical treatment
requ'red.l.
Corrosive, causes eye and skin damage lor
skin Irritation]. Do not get In eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
(Appropriate first aid statement required.)
May be fatal If swallowed (Inhaled or Causes eye (and sklnj Irritation. Do not
absorbed through the sklnl. Do not breathe) get In eyes, on skin, or on clothing.
vapo's [dust or spray mlstj. Do not get 1n| Harmful If swallowed. (Appropriate first
eyes, on skin, or on clothing. (Appropriate) aid statement required.).
first aid statements required.I.
Harmful If swallowed I Inhaled or absorbed
through the skin). Avoid breathing vapors
Idust or spray Mist). Avoid contact with
sk'n (eyes or clothing). (Appropriate
first aid statement required.!.
(No precautionary statements required.).
Avoid contact with skin, eyes or clothing.
In case of contact Immediately flush
eyes or skin with plenty of water. Get
medical attention If Irritation persists.
[No precautionary statements required.!.
( i i ) ^_
target, organisms
statements
appropriate
Environmental hazards.
Where a hazard exists to non-
excluding humans and domestic animals, precautionary
are required stating the nature of the hazard and the
precautions to avoid potential accident, injury or
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damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD5Q of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC50 of 1 ppm or less, the statement
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD$Q of 100 mg/kg or less, or
a subacute dietary LC^Q of 500 ppm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on the
flammability or explosive characteristics of the pesticide are
required as follows:
Flash point
Required text
(A) PRESSURIZED CONTAINERS
I
Flash point at or below 20*F; If there Is a
flashback at any valve opening*
Flash point above 20*F and not over 80*F or If
the flame extension Is more than 16 In. long
at a distance of 6 In. fro* the flame.
All other pressurized containers
Extremely flammable. Contents under pressure. |
Keep away from fire, sparks, and heated |
surfaces. Do not puncture or Incinerate |
container. Exposure to temperatures above |
130*F may cause bursting. |
Flammable. Contents under pressure. Keep away |
from heat, sparks, and open flame. Do not |
puncture or Incinerate container. Exposure to|
temperatures above 130*F may cause bursting. (
Contents under pressure. Do not use or store j
near heat or open flame. Do not punctur* or |
Incinerate container. Exposure to tempera- |
tores above I30*F may cause bursting. |
(B) NONPRESSURIZED CONTAINERS
I
At or below 20*F
..............| Extremely flammable. Keep away from fire,
| sparks, and heated surfaces.
Above 20*F and not over 80*F ......,...| Flammable. Keep away from heat and open flame.
Above 80*F and not over 150*F ....... . .I Do not use or store near heat or open flame.
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(i> Directions for Use—(1) General requirements—(i) Adequacy
and clarity of directions. Directions for use must be stated in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular." and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(iii) Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
(_!) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
O) The product will not come into the hands of the general
public except after incorporation into finished products; and
(_4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(^) The label clearly states that the product is for use only
by physicians or veterinarians;
(2) The Administrator determines that' such directions are not
nece~ssary to prevent unreasonable adverse effects on man or the
environment; and
(3) The product is also a drug and regulated under the provisions
of "the Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
(1) There is information readily available to the formulators
on The composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes ;
- 76 -
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(2) The label clearly states that the product ** intended for
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
(_3) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
M) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the headings "Directions for
Use " :
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in $ 162.10(h)(1)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) [Reserved] (
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision of a certified
applicator who is physically present.
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(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(J) Statement ofuse Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers/ one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of S 162.10(j)(2 ).
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in § 162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators, the following statement is,required: "For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation,
(k) Advertising. [Reserved]
[40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR
38571, Aug. 21,.1975, as amended at 43 FR 5786, Feb. 9, 1978;
amended at 53 FR 15952, May 4, 1988;
- 78 -
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Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions.
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area.
proper opening and closing procedures (particularly for
opened containers) , and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for domestic
use, must bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that must appear on
the label of these products:
1. The labels of all products, except domestic use, must contain the
statement, "Do not contaminate water, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
- 81 -
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
!• Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type,listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused!, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording) \
J_/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
- 82 -
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III. BIBLIOGRAPHY APPENDICES
- 83 -
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BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID) , each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
- 84 -
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BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
°ne, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission,
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second. 123456-
B; the 26th. 123456-Z; and the 27th, 123456-AA.
- 85 -
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Metaldehyde Standard
MRID Citation
00033213 Leganer, R.R.; Getzin, L.W.; Kimura, Y.; et al.
(1962) Pesticide Residue Analysis. (Unpublished study
received Mar 9, 1964 under 271-12; prepared by
Washington State Univ., Dept. of Agricultural Chemistry,
submitted by International Minerals & Chemical Corp.,
Terre Haute, Ind.; CDL:001932-B)
00090362 McCann, J.A. (1972) [Metaldehyde 99%: Bluegill
(Lepomis macro chirus)]: Test No. 454. (U.S.
Agricultural Research Serv- ice, Pesticides Regulation
Div., Animal Biology Laboratory, Fish Toxicity
Laboratory; unpublished study; CDL:130286-A)
00127144 Morgareidge, K. (1964) Analysis of Bananas for
Residues of Metaldehyde: Laboratory No. 85214 a-g, 85352
a-f, 85385 a-f. (Unpublished study received May 9, 1964
under unknown admin, no.; prepared by Food and Drug
Research Laboratories, Inc., submitted by United Fruit
CO., Boston, MA; CDL:119840-A)
00127145 Jones, L. (1956) Determination of Metaldehyde Spray
Residue: R.D.M.-6804. (Unpublished study received Mar
19, 1957 under 271-12; submitted by International
Minerals & Chemical Corp., Terre Haute, IN;
CDL:119896-A)
00131429 Berczy, Z.; Cobb, L.; Cherry, C. (1973) Acute
Inhalation Toxicity to the Rat of Metaldehyde Dust:
LZA1/73891. (Unpublished study received Aug 19, 1983
under 6836-90; prepared by Huntingdon Research Centre,
Eng., submitted by Lonza, Inc., Fair Lawn, NJ;
CDL:251377-A)
00131434 Davies, R. ; Collins, C. (1974) Acute Percutaneous
Toxicity to Rats of Metaldehyde: Report No. 2330/D3/74.
(Unpublished study received Aug 19, 1983 under 6836-90;
prepared by Huntingdon Research Centre, Eng., submitted
by Lonza, Inc., Fair Lawn, NJ; CDL:251377-F)
00131435 Hackenberg, U. (1973) Acute Toxicity of Metaldehyde
after Administration of a Single Intragastric Dose to
Female Rats: A 0409/1061.2. (Unpublished study received
Aug 19, 1983 under 6836-90; prepared by Institute fur
Biologische Forschung GmbH, submitted by Lonza, Inc.,
Fair Lawn, NJ; CDL:251377-G)
- 86 -
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Metaldehyde Standard
MRID Citation
00131969 Hackenberg, U. (1973) Acute Toxicity of Metaldehyde
after a Single Intragastric Dose in the Male Rat: Report
A 0409/1061.1; Inbifo Code No. S 2221 A. (Unpublished
study received Sep 6, 1983 under 6836-90; prepared by
Inbifo Institut fur Biologische Forschung, W. Ger.,
submitted by Lonza, Inc., Fair Lawn, NJ; CDL:251378-A)
00131971 Jones, J.; Hoare, A. (1983) P0071: A Primary Skin
Irritation and Corrosivity Study in the Rabbit: Report
No. 3478-733/165. (Unpublished study received Sep 6,
1983 under 6836-90; prepared by Hazleton Laboratories
Europe, Ltd., Eng., submitted by Lonza, Inc., Fair Lawn,
NJ; CDL:251380-A)
00138262 Interregional Research Project No. 4 (1974) The
Results of Tests on the Amount of Metaldehyde Residue
Remaining in or on Strawberries Including a Description
of the Analytical Methods Used. (Compilation;
unpublished study received Jun 19, 1974 under 4E1519;
CDL:072538-A)
00163832 Debets, F. (1986) Evaluation of the Ability of P0071
To Induce Chromosome Aberrations in Cultured Chinese
Hamster Ovary (CHO) Cells: NOTOX 0227/EC 112.
Unpublished study prepared by NOTOX V.O.F. 23 p.
- 87 -
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IV. FORM APPENDICES
- 88 -
-------
EPA Form 8580-1
OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3ICH2H6) SUMMARY SHEET
NO
PRODUCT NAME
S NAME
DATE GUIDANCE DOCUMENT ISSUED
With rvptct to tttt rtouirtmtnt to Mbmit "|tntric" d«U impend by th« FIFRA action 3(C)(2KBI iwtict eenttintd m the rifcftneid
Guidmct Oocurntnt. I am responding m ttit following monnir:
G I. I will aibmit dm in i ttmiiy mitwitr to •tidy ttit following requirtmtnu. II thi mt proctdum I wiH vm dtmni (rom (or irt not
WKifwd in) th« fttfinmion Guidtiinm or ttw frotocoli contunod HI tftt M«p«ra •< Ciptn Groupt to tn« Ch»m««ti Group. OECO
Crtwniult Tonmf Progremmt. I melon tht pfoteceU thn I will UN: '
D i I h*vt «nttrtd into M oorotmmt with ont or mort othor rttotnntt undor FIFMA Hction 3(C)(2)(l)(u) to atufy tht following dtu
nquirtmtnn Th« ttm. ind my rtquirtd protocols, will bf wbmrntd to EPA by:
NAME Of OTHE* REGISTRANT
D 3. t incloa i comptittd "CtnHiution ol Animpt to Enttt Into in Ao/Mmtnt with Othir Rtt>nr*nu tor Dtvitopmint ot 0*ti" with
rttptct to tftt following dao nquiromtntt:
C 4. I nquon tnit you om«nd my ro|Hmtion by doiofiflf KM (ollowmi iu» (thu option • not •vtiltoii to icplicinu (or ntw produco):
C S. I rtquin voluntory cinetllttion of tht rt|imtion 0« thu product (Thu option it not miiibli to tpplcinu lor niw product!.)
MGirrRANT'I AUTHORIZED REPRESENTATIVE
SIGNATURE
- 89 -
DATE
-------
CMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
ERA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified above, I
certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the active
ingredient named under FIFRA Section 3(c) (2) (B).
(2) My firm requests that EPA not suspend the registration of our product, despite
our lack of intent to submit the generic data in question, on the grounds that the
product contains the active ingredient solely as the result of the incorporation into
the product of another product which contains that active ingredient, which is
registered under FIFRA Section 3, and which is purchased by us from another producer.
(3) An accurate Confidential Statement of Formula (CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by company
name, registration number, and product name, the source of the subject active
ingredient in my firm's product, or
The CSF dated on file with EFA is complete, current and accurate and
contains the information requested on the current CSF Form 8570-4. The registered
source(s) of the above named active ingredient in my product(s) is/are and
their registration number(s) is/are .
My firm will apply for an amendment to the registration prior to changing the source
of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any portion of
this Statement is no longer true, or if my firm fails to comply with the undertakings
made in this Statement, my firm's product's registration may be suspended under FIFRA
Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption for the
product, my firm relies on the efforts of other persons to provide the Agency with the
required generic data. If the registrant (s) who have committed to generate and submit
the required data fail to take appropriate steps to meet requirements or are no longer
in compliance with this Notice's data requirements, the Agency will consider that both
they and my firm are not in compliance and will normally initiate proceedings to
suspend the registrations of my firm's product (s) and their product (s), unless my firm
commits to submit and submits the required data in the specified time frame. I
understand that, in such cases, the Agency generally will not grant a time extension
for submitting the data.
Registrant's authorized representative;
(Signature)
Dated:
(Typed)
EPA Form 8570- 3
- 90 -
-------
OMB Approval No. 2070-0057
Expires 11/30/89
EPA Reg. No..
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
Subpart C
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
fi.V-12
,
Name of Test
Identity of
incrredients
Statement of
composition
Discussion of
formation of
incrredients
Preliminary
analysis
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data rpqni remPTYt-s hv
Citing MRID
Number or
EPA Accession
Number
Certification of
limits
Analytical methods
for enforcement
limits J
Submit-
ting
Data (For EPA Use Only)
(At- MRID Numbers
tached) Assioned
Color
Phvsical state
Odor
Meltina roint
Boilina coint
Density, buUc-
density, or
specific aravitv
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
TH
EPA Form 8580-4
- 91 -
-------
OMB Approval No. 2070-0057
Expires 11/30/89
EPA Reg. No..
PRODUCT SPECIFIC DATA REPORT (cont'd)
Date
Guidance Document for
Registration
Guideline No.
Subpart C
PRODUCT
CHEMISTRY
(cont'd)
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.340
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Name of Test
Stability
Oxidizing/reducing
reaction
Flammability
Fxplortahility
Storaae stability
Viscosity
Miscibilitv
Corrosion
characteristics
Dielectric break-
down voltaae
Acute oral
toxicity, rat
Acute dermal
toxic if y, rabbit
Acute inhalation,
toxic ity. rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion.
Acute Delayed
neurotoxicitv. hen
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements bv
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
EPA Form 8580-4 (cont'd)
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EPA Form 8580-6
OMB Approval NO. 2070-0057
Expires 11/30/89
(To tummy. cerr/n/4U four inrmt
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I em duly ouihorizod to represent the following firm(s) who ere subject to the require-
ments of e Notice under FIFRA Section 3(c)(2IIB) contained in e Guidance Document
to submit dau concerning the active ingfedient:
OUIOANCt OOCUMINT O*T|
ACTIVf
MA*M Of FIRM
CFA COMPANY NUMBCH
n nn tirm or group ot firms is referred to below as my firm".)
2. My firm is willing to develop and submit the data • required by thn Notice. if necessary. However. my firm would prefer to enter
into an agrMmcnt with one or more other registreim to develop jointly, or to share in the eon of developing, the following required
items or data:
3. My firm das offered m writing to enter fata such a* agreement Copies of the often an attached. That offer MS irrevocable and included an offer to be
bound by an arbitration decision vndor FIFHA Section XcMZHIHM)» fin* eajeiment en a« terns eowld not bs riser* otherwise This offer w^
to thi following firm(i) on the following datadt:
MAMIOf FIMM
OATI OF OFFIM
However, none of those firm (si accepted my offer.
4. My firm requests that 6PA not suspend the registrations) of my firm's produet(s). if any of the firms named in paragraph (3) above
heve egreed to submit the data lined in paragraph (2) above in accordance with the Notice. 1 understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its regmretiondl under FIFRA Section 3(c«2)(8l. (This statement
does not apply to applicants for new products.) 1 give EPA permission to disclose this statement upon request.
aiONATUMC
DAT!
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