540/RS-88-119
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
PHENMEDIPHAM
AS THE ACTIVE INGREDIENT
CHEMICAL CODE: 098701
CAS NUMBER: 13684-63-4
CASE NUMBER: 0277
March 30, 1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
540/RS-88-119
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by this Standard .4
A. Description of Chemical
B. Use Profile
III. Agency Assessment 5
A. Summary
B. Preliminary Risk Assessment
C. Other Science Findings
D. Tolerance Reassessment
E. Summary of Label Changes and Data Gaps
IV. Regulatory Position and Rationale. . . 10
A. Regulatory Positions 10
B. Criteria for Registration 13
C. Acceptable Ranges and Limits 13
D. Required Labeling 14
V. Products Subject to this Standard 16
VI. Requirement for Submission of Generic Data 18
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product Specific Data. .23
VIII. Requirement for Submission of Revised Labeling . . . .23
IX. Instructions for Submission 24
A. Manufacturing use products (Sole Active) ... .24
B. Manufacturing use products (Multiple Active) . .25
C. End use products 25
D. Intrastate products 26
E. Addresses 26
Glossary/Acronyms iii
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
EPA Form 8580-4 Formulator's Exemption Statement
EPA Form 8570-27 Certification with Respect to Citation of Data
ii
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GLOSSARY
1. The Agency: U.S Environmental Protection Agency/EPA
2. ADI: Acceptable daily intake (rag/kg/day) of a pesticide by an
individual weighing 60 kilograms
3. A.I.: Active ingredient
4. DCI: Data Call-in Notice
5. EPs: End-Use pesticide products
6. EUP: Experimental Use Permit
7. FIFRA: Federal Insecticide, Fungicide, Rodenticide Act (As amended)
8. MPs: Manufacturing-Use pesticide products
9. MPI: Maximum permitted intake of a pesticide in XX mg/day for a
60 kg individual.
10. NOEL: No Observed Effect Level
11. NPDES Permit: National Pollutant Discharge Elimination System
12. OES: Office of Endangered Species, U.S. Dept. of the Interior
13. PADI: a provisional/temporary ADI
14. RAC's: Raw agricultural commodities
15. 40 CFR: Title 40, Code of Federal Regulations
16. TMRC: Theoretical Maximum Residue Contribution for a pesticide in
the daily diet is based on the total tolerances in addition
to a daily food intake of X.X kg = X.X mg/kg.
iii
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I. INTRODUCTION
The Registration Standards Program
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.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme giving higher
priority to (1) pesticides in clusters used on food and feed
crops; and (2) pesticides produced in large volumes.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide. v
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request^, focuses on
scientific reviews may be requested from: Information Services
Section (TS-768C), Office of Pesticide Programs, U.S. Environmental
Protection Agency, Room 236, Crystal Mall #2, 1921 Jefferson Davis
Highway, Arlington, Virginia 22202 (telephone (703) 557-4453).
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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.
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. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 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.
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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 Table A in Appendix I. Failure to comply
with the DCI requirements enumerated in this Registration Standard
may result in issuance by EPA of a Notice of Intent to Suspend the
affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. You should notify the
Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. This requirement continues
as long as your products are registered by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD
A. Description of chemical
The following chemical is covered by this Registration
Standard:
Common name:
Chemical name:
CAS Number:
OPP (Shaughnessy) Number;
Empirical Formula:
Trade Names:
Chemical Family:
Pesticide Type:
Year of Initial
Registration:
Registrants of Technical
Products:
Phenmedipham
3-methoxycarbonylaminophenyl
-3-methylcarbanilate
13684-63-4
098701
C16H16N204
Betanal, GBP-1-127050, Kemipham,
Morton EP-452, Phenmediphame,
Schering 4072, Schering 4075,
Schering 38584, SN 38584, Spinaid,
Carbanilate
Herbicide
1970
Schering AG, Nor-Am Chemical Co.
Description of physical characteristics of chemical:
Phenmedipham is an odorless white to slightly colored powder
at room temperature, its melting point is 140-144° C, and its
molecular weight is 300.3. Its water solubility is 3.1 rag/
liter in pH 4 water at 25°C.
B. Use Profile
Type of pesticide:
Pests controlled:
Registered Uses:
Predominant uses:
Mode of activity:
Single active ingredient
Formulations:
Methods of application:
Application Rates:
Postemergence herbicide
Annual weeds
Field crops and vegetables
Sugar beets, table beets and spinach
Inhibition of photosynthesis
97% technical
Emulsifiable concentrates (15.9% &
8.0% a.i.)
Primarily applied as broadcast or
banded spray by ground or aerial
equipment.
Table beets, spinach: 0.5 to 1 Ib,
sugar beets: 0.17 to 0.61 Ib
(Ib ai/Acre).
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III. AGENCY ASSESSMENT
A. SUMMARY
Phenmedipham is a posteraergence carbanilate herbicide registered
for use on annual weeds on the following sites: spinach, table
beets and sugar beets. Most of this pesticide is applied on
sugar beets. About 18 to 45% of the U.S. sugar beet crop is
treated with phenmedipham. Application rates for all uses
range from 0.17 to 1.00 Ib. a. i. /acre per season.
Application techniques vary from aerial application to various
types of ground applications.
The Agency has reviewed all of the data submitted to support the
registration of phenmedipham, as well as open literature infor-
mation relevant to this compound. Based on the review of these
data, the Agency has reached the following conclusions:
1. The rat chronic feeding study with phenmedipham showed a
NOEL for oncogenicity greater than 500 ppm (25 mg/kg) ,
highest dose tested (HDT) . This study was classified as
core-supplementary data for oncogenic effects and core-
minimum data for chronic feeding. Although an increase in
neoplastic findings was not observed in this study up to
and including a dosage level of 500 ppm (HDT) , the oncogenic
potential of phenmedipham cannot be ascertained in the
absence of a maximum tolerated dose. The body weight gain
changes noted in the high dose females during the second
year are minimal evidence of systemic toxicity (less than
10%). Therefore, the NOEL for systemic effects is 100 ppm
with a lowest observed effect level (LOEL) for systemic
effects at 500 ppm (HDT).
In a dog chronic feeding study, phenmedipham showed a NOEL
of 1000 ppm (25 mg/kg, HDT). Neoplastic findings were not
observed in this study up to and including a dosage level
of 1 ,000 ppm (HDT).
This chemical is not structurally similar to known carcinogens,
2. For the reproduction/ teratology study in rats with Phenmedi-
dipham, the NOEL for reproductive effects is greater than
500 ppm (HDT). The NOEL for systemic toxicity is 100 ppm,
with a LOEL for systemic effects of 500 ppm (HDT) based on
the reduced body weights in the parental generations
and and P£ males) and lower body weights in the F^a
male pups, ?2a female pups and F3a male pups on day 21
For the teratology segment, dosing was in the feed rather
than by gavage as is presently recommended, and the highest
dose used (500 ppm) in the study did not show significant
maternal toxicity (not a limit dose) as is presently required.
The teratology study in the rat must be repeated.
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4. Phenmedipham exhibits low acute oral (Category IV) and dermal
(Category III) toxicity to mammals.
B. RISK CONCERNS
Available data indicate that there are minimal effects to the
environment when phenmedipham is applied in accordance with
current practices in agriculture.
C. OTHER SCIENCE FINDINGS
1. Ecological Effects
There is sufficient information to characterize phenmedipham
as having very low toxicity on an avian dietary basis (>
10,000 ppm) for Bobwhite quail and Mallard duck. However, an
avian single-dose oral toxicity study is lacking, therefore
this test is required. There is sufficient acute toxicity
data to characterize technical phenmedipham as moderately toxic
to fish and aquatic invertebrates. The 96-hour toxicity test
values were 1.41 ppm for Rainbow trout and 3.98 ppm for blue-
gill. The 48-hour toxicity test value for Daphnia magna was
3.2 ppm. In a laboratory acute contact study, phenmedipham
was shown to be very low in toxicity to honey bees.
Available toxicity data indicate that uses of Phenmedipham
are unlikely to pose a hazard to endangered aquatic or avian
species.
Phytotoxicity is not a concern because phenmedipham has low
volatility and it has limited terrestrial use on minor crops.
2. Environmental Fate
a. Ground Water
A ground water DCI was issued for phenmedipham. The data
received were insufficient to fully assess the leaching
potential of parent compound and metabolites in a variety
of soils. However, available studies indicate that phenme-
dipham has low mobility in loamy sand soils.
b. Degradation
In acid solution, phenmedipham is relatively stable, but at
neutral and basic conditions, it readily hydrolyzes. Under
aerobic conditions in loamy sand soil, phenmedipham degraded
with half-lives of 120 days at pH 5.0 and 20 days at pH 6.8.
A major degradation product was
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D. TOLERANCE REASSESSMENT
Sufficient data are available to ascertain the adequacy of the
established tolerances for residues of phenmedipham in or on
table beet roots and tops, sugar beet roots and tops, and spinach
(40 CFR 180.278).
Tolerances for phenmedipham have been approved for the raw agri-
cultural commodities (RAC's) listed below.
Tolerance(ppm) Food Factor a/ tag/day(1 .5kg)
Beets
Sugar, beet roots
Sugar, beet tops
Spinach
0.20
0.10
0.10
0.50
0.17
3.64
3.64
0.05
0.00052
0.00546
0.00546
0.00038
The provisional acceptable daily intake (PADI) for phenmedipham
is based on a 104 week rat feeding study. The systemic NOEL for
for this study is 100 ppm (5 mg/kg). The systemic lowest observed
effect level (LOEL) is 500 ppm (25 rag/kg/day, HOT). There is
also a 104 week dog feeding study with a NOEL of greater than
1000 ppm (25 mg/kg, HDT). Utilizing a safety factor of 100, the
PADI was set at 0.05 mg/kg/day. This is equivilant to a maximum
permitted intake (MPI) of 3.00 mg/day for a 60 kg individual.
The theoretical maximum residue contribution (TMRC) for phenme-
dipham in the daily diet based on the total tolerances above and
a daily food intake of 1.5 kg is 0.0064 mg/day. Under these
conditions, 0.21% of the PADI has been utilized.
Data gaps exist for plant and animal metabolism, analytical
methods, and storage stability. Processing studies are required
for sugar beets. Since the data required for individual commo-
dities are dependent on metabolism data, the Agency recommends
that metabolism data be obtained and submitted prior to any
required residue data.
The Agency will propose the following revisions:
1. The negligible residue designation (N) for beets and sugar
beet roots and tops be deleted from the 40 CFR;
2. The tolerance definition be amended to specify
"S-methoxycarbonylaminophenyl-S-methylcarbanilate" as the
residue of concern instead of "methyl m-hydroxycarbanilate
m-methylcarbanilate"; and
3. The tolerance definition for "beets" be amended to "beets,
table".
The Agency conludes that the above revisions are necessary to
clarify current residue chemistry terminology.
ja/ Food factor: Percentage (of the particular crop) in an average
daily diet of 1.5 kilograms consumed by a 60 kg individual.
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There are Canadian tolerances of 0.1 ppm for phenmedipham residues
in or on sugar beets and tops but no tolerances on spinach and
table beets. There are no Mexican tolerances, Codex Maximum
Residue Levels, or exemptions for phenmedipham on sugar beets,
spinach and table beets.
SUMMARY OF LABEL CHANGES AND DATA GAPS
The Agency has determined that label revisions must be made
in the following areas (See Section D, Part IV).
0 Environmental Precautions
The Agency has identified data necessary to evaluate the
environmental and human risks associated with the use of
phenmedipham. These data must be developed in order to maintain
registrations of products or register new products containing
phenmedipham. The following table summarizes the data gaps,
including product chemistry information. Please note that this
is only a summary and details can be obtained by referring to
Table A.
Summary of Data Gaps - Phenmedipham
158.120 Product Chemistry
All of the Product Chemistry data are required.
158.125 Residue Chemistry:
171-4 Nature of Residue (Plant & Animal Metabolism)
171-4 Residue Analytical Methods
171-4 Storage Stability
171-4 Residue Studies on Crops, Processed Food/Feed
Commodities
158.135 Toxicology:
81-3 Acute Inhalation Toxicity (Rat)
81-4 Primary Eye Irritation Toxicity (Rabbit)
81-5 Primary Dermal Irritation (Rabbit)
81-6 Dermal Sensitization (Guinea pig)
82-2 Subchronic Dermal (21-day)
83-2 Oncogencity (Two species)
83-3 Teratogenicity (Two species)
84-2 Mutagenicity
85-1 Metabolism
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158.130 Environmental Fate
161-1 Hydrolysis
161-2 Photodegradation in Water
162-2 Anaerobic Soil Metabolism
163-1 Mobility Studies (Leaching & Adsorption/
Desorption)
164-1 Soil Dissipation
165-1 Rotational Crops (Confined)
165-4 Accumulation in Fish
158.145 Wildlife and Aquatic Organisms
71-1 Avian Oral Toxicity
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IV. REGULATORY POSITION AND RATIONALE
A. Regulatory Positions
Based on a review and evaluation of all available data and other
relevant information on the herbicide, phenroedipham, the Agency
has reached the determinations listed below.
1. The Agency has determined that phenraedipham does not exceed any
of the risk criteria for adverse effects in 40 CFR, Section
154.7 at the present time.
Rationale: Available data indicate the following:
a. Phenmediphara does not promote neoplastic findings in chronic
toxicity studies of rats, (However, its oncogenic potential
cannot be ascertained without a maximum tolerated dose.),
b. Except for weight changes in a 3 generation rat study,
this compound does not induce reproductive effects in rats,
c. It does not pose a risk of serious acute injury to humans,
domestic animals or non-target organisms and,
d. It does not cause the destruction of habitat of non-target
organisms.
2. The Agency has determined that certain toxicological studies
are required to support the reregistration of phenmedipham
products.
Rationale: The Agency does not have the following data on
phenmedipham which meet Agency guidelines for toxicological
testing required to support its registration: acute inhalation
toxicity, primary eye irritation, primary dermal'irritation,
dermal sensitization, subchronic dermal (21-day), oncogenicity
in two species, teratology in two species, mutagenicity and
and metabolism studies.
3. The Agency has determined that present precautionary statements
for persons handling or applying phenmedipham products are
sufficient for the labels of manufacturing-use and end-use
products.
Rationale: Available data indicate that phenmedipham causes
low oral (Category IV) and dermal (Category III) toxicities
in test animals. Therefore, the labeling of these products
contains statements that caution persons applying or handling
this compound, give first aid instructions, and require the
use of precautionary measures to ensure safe handling of the
pesticide products.
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4. The Agency has determined that reentry intervals for workers
are not required for phenroedipham products.
Rationale: The low acute toxicity of this chemical does not war-
rant significant concern about exposure of workers reentering
treated areas, according to the criteria in 40 CFR Part 158.140.
Phenmedipharo products have been determined to be low in acute
oral, and dermal toxicity, and no chronic health concerns have
been identified.
5. At this time, the Agency will defer action on ground water
issues until receipt and evaluation of environmental fate
data.
Rationale: The Agency evaluated the data submitted in response
to the May 1984, Ground Water Data Call-in for Phenraedipham,
and found them to be inadequate. Subsequently, the Agency
required the registrant to resubmit ground water data. The
data were submitted to the Agency and again were found to be
inadequate.
Available data indicate that phenmedipham has low mobility in
loamy sand soils. These data are inadequate to fully assess
the potential of phenmedipham to reach ground water supplies.
The necessary environmental fate studies are being repeated at
the present time. Until these data are received and found
acceptable by the Agency, data gaps in environmental fate exist.
Therefore, these data are required under the Phenmedipham
Registration Standard. (See Data Appendices, Table A).
6. The Agency is requiring labeling which warns of potential
hazards to aquatic organisms. (See Part IV, Section D. Required
Labeling).
Rationale: Available acute toxicity data indicate that phenme-
diphara is moderately toxic to fish and aquatic invertebrates.
7. The available data indicate that this pesticide, when applied
at recommended rates, does not present unreasonable hazards to
birds.
Rationale: Existing studies on this compound indicate that its
dietary toxicity to birds is very low.
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8. The Agency has determined that specific labeling to mitigate
potential hazards to endangered species is not necessary be-
cause available data indicate that phenmedipham does not
promote unreasonable adverse effects in the environment.
Rationale: Phenmedipham exhibits low toxicity to avian species,
and moderate toxicity to fish and aquatic invertebrates. Crops
treated with this pesticide are not planted in the habitat of
endangered plants. In addition, this chemical has low volati-
lity and will not readily drift from its application sites to
endangered plants.
9. The Agency will not require phytotoxicity data.
Rationale: Phenmedipham has low volatility and will not readily
drift from its application sites to non-target plants and it
has limited terrestrial use on minor crops.
10. While the data gaps are being filled, currently registered MPs
and EPs containing phenmedipham as the sole active ingredient
may be sold, distributed, formulated and used in the United
States, subject to the terms and conditions specified in this
Standard. Registrants must provide and agree to develop
additional data, as specified in the Data Appendices of this
guidance document, in order to maintain existing registrations.
Rationale: Under FIFRA, the Agency does not normally cancel
or withhold registration simply because data are missing
or inadequate (see FIFRA sec. 3(c)(2)(B) and 3(c)(7)).
Issuance of this Standard provides a mechanism for identifying
data needs. These data will be evaluated, after which the
Agency will determine if additional regulatory changes are
necessary.
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B. Criteria for Registration
To be registered or reregistered under this Standard, raanufacturing-
use products must contain phenraedipham as the sole active ingredient,
bear required labeling, and conform to the product composition,
acute toxicity limits, and use pattern requirements listed in this
Section.
C. Acceptable Ranges and Limits
1. Product Composition Standard
To be covered under this Standard, manufacturing-use products (MPs)
must contain phenmedipham as the sole active ingredient. 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 which may be present in products.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade and MP
products containing phenmedipham, provided that the product labeling
bears appropriate precautionary statements for the acute toxicity
category in which each product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing use products con-
taining Phenmedipham must be labeled for formulation into end-use
products only for the commodities listed below. The EPA Index to
Pesticide Chemicals for Phenmedipham lists all registered uses, as
well as approved maximum application rates and frequencies.
0 Terrestrial food uses on field and vegetable crops: table beets,
spinach and sugar beets.
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D. Required Labeling
To be registered under this standard, all manufacturing-use and
end-use phenraedipham products must bear appropriate labeling as
specified in 40 CFR 162.10, and below. Appendix II contains
information on label requirements.
Pesticide products containing phenmedipham released for shipment
by a registrant or producer of that product after April 30, 1988,
are required to bear an amended label which complies with the
requirements of this Standard.
Pesticide products containing phenmedipham which are distributed,
sold, offered for sale, held for sale, shipped, delivered for
shipment, or received and (having been so received) delivered or
offered to be delivered by any person after April 30, 1989, are
required to bear an amended label which complies with the require
ments of this Standard.
The following information must appear on the labeling
within the time limits specified above:
1 . Ingredient Statement
The ingredient statement for all manufacturing-use products con-
taining phenraedipham products must list the active ingredient in
the following manner (example):
"3-methoxycarbonylaminophenyl-3-methylcarbanilate . ....... %";
2. Use Pattern Statements
All manufacturing-use products containing phenmedipham must state
that they are intended for formulation into end-use products for
only the aforementioned use patterns. Labeling must specify sites
for each approved use pattern. However, no use may be included on
the label if the registrant fails to comply with the data require-
ments for that use pattern, as listed in Table A of the Data
Appendices of this document.
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3. Precautionary Statements
a. Manufacturing-Use Product Statements
All phenmedipharo products intended for formulation Into
end-use products must bear the following statements:
"This pesticide Is toxic to fish and aquatic organisms.
Do not discharge effluent containing this product Into
lakes, streams, ponds, estuaries, oceans, or public
water unless this product Is specifically Identified and
addressed In an NPDES permit. Do not discharge effluent
containing this product into 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 Product Statements
The following precautionary statements must appear on all
phenmedipham EP labels:
"This pesticide is toxic to fish and aquatic organisms.
Do not apply directly to water or wetlands (swamps, bogs,
marshes, and potholes). Drift and runoff from treated
areas may be hazardous to fish and aquatic organisms in
adjacent aquatic sites. Do not contaminate water by
cleaning of equipment or disposal of wastes."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and fi2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
*
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption^, the
data requirements listed in Table C.
3. If not eligible for the forraulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
b. If eligible for the forraulator's exemption, the
data requirements listed in Table C.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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18
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.^
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients.
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and S 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
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19
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter 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 PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terras of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
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20
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant Has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the Dichlobenil 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 tha^t 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.
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21
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or Its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed.You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from (or are not specified in)
either 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
and await EPA approval, because the Agency will not ordinarily
accept as sufficient studies using unapproved protocols.
A request for protocol approval will not extend the timeframe
for submission of the data, nor will extensions generally be
given to conduct studies due to submittal of inappropriate
protocols.
F. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made before the deadline for response. Once dates
have been committed to and EPA has accepted these commitments,
any subsequent requests for a time extension must be submitted
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22
in writing to the Office of Compliance Monitoring at the
address given in Section IX.E.
EPA will view failure to request an extension before
the 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. Time extensions
may be considered when joint data development is planned,
or when the Agency must approve a new or modified protocol
before the study can be begun.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
G. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
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23
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section IV.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options IV.D.1. (submit data)
or IV.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
VIII. REQUIREMENT FOR SUBMISSION 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 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
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24
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing Phenmedipharo
as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Forraulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(1)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors .of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
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25
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing Phenmedipham
in combination with other active ingredients.
1. VJithin 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachraentsS (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the forraulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing Phenmedipham as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments* (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
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26
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling should
be either typewritten text on 8-1/2 x 11 inch paper or a mockup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. Intrastate Products containing Phenmedipham either
as sole active ingredient or in combination with~other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
E. Addresses
The required information must be submitted to the following
address:
Robert J. Taylor, PM-25
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
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27
TGUIDE-1
GUIDE TO TABLES
Table A contain listings of data requirements for the
pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the tes-t-, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP « Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I =» Indoor
Any other designations will be defined in a footnote to the table,
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28
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (HRID) 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 FDR PHENMEDIPHAM 97% TECHNICAL3 (EPA REG. NO. 45639-84)
DRAFT
Data Requirement Test
Substance
S 158. 120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples
62-2 - Certification of Ingredient
Limits
62-3 - Analytical Methods to Verify
Certified Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
TCAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use Does EPA Bibliographic Must Addtl Time Frame
Patterns Have Data? Citation1 Data be for
Submitted? Submission
All
All
All
All
All
All
All
All
All
All
All
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
Yes
Yes 2/
Yes J}/
Yes 4/
Yes V
Yes 6/
Yes
Yes
Yes
Yes
No 11
6 Months
6 Months
6 Months
12 Months <*
(\l
12 Months
12 Months
6 Months
6 Months
6 Months
6 Months
63-7 - Density, Bulk Density, or
Specific Gravity
TGAI
All
No
N/A
Yes
6 Months
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GENERIC DATA REQUIREMENTS TOR
Data Requirement
§158.120 Product Chemistry (Continued)
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-1 1 - Octanol/Water Partition
Coefficient
63-12 - pH
63-13 - Stability
TABLE A
PHENMEDIPHAM, 97% TECHNICAL3 (EPA REG. NO. 45639-84)
Test Use
Substance Patterns
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
DDBS EPA
Have Data?
No
No
No
No
No
No
Bibliographic
Citation1
N/A
N/A
N/A
N/A
N/A
N/A
Must Addtl
Data be
Submitted?
Yes 8/ 6
Yes 6
Yes 6
Yes 6
Yes 6
Yes 6
Time Frame
for
Submission
Months
Months
Months
Months
Months
Months
Other Requirement;
64-1- Submittal of samples
N/A
No
No 9/
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TABLE A
GENERIC DATA REQUIREMENTS FOR PHENMEDIPHAM, 97% TECHNICALa (EPA REG. NO. 1*5639-84)
§158.120 Product Chemistry (Continued)
a The 97% Technical serves as a manufacturing-use product.
I/ Not applicable. Although product chemistry data may have been submitted In the past, the Agency has determined that
certain data must be resubmltted for each pesticide. New requirements have been Introduced and previously
submitted data must be updated.
2/ The following additional data are required for the 97% Technical: a. Details of the manufacturing process,
Including the relative amounts of beginning materials, a description of the equipment used to produce the product,
reaction conditions, the duration of each step of the process, purification procedures, and quality control
measures, b. The name and address of the manufacturer, producer, and supplier of each beginning material used to
manufacture the product. Also, a copy of all technical specifications, data sheets, and other documents In which
the manufacturing producer, or supplier of the beginning material describes its composition and properties must
be submitted.
3/ The following additional information is required: A discussion of each Impurity believed to be present at
X).l%, based on knowledge of the beginning materials, all possible chemical reactions, and any contamination.
V In order to satisfy this data requirement, five or more representative samples must be analyzed for the amount *~~
of active Ingredient and each impurity present at X).l% (w/w) using valid analytical methods. '*'
5_/ The following data must be submitted on EPA Form 8570-4 (Rev 2/85): a. Upper limits must be provided,
validate and certified for each impurity present at X).l% (w/w). b. Upper and lower limits must be provided,
validated, and certified for Phenmedipham.
6/ None of the submitted methods was adequately validated. The following data are required: Quantitative
methods to determine phenmedipham and all impurities for which a certified limit is required. Each method must be
accompanied by validation studies of the precision and accuracy of the method.
7/ Data not required since the melting point of the active Ingredient is greater than MO°C.
8/ Additional data are required: Solubility must be reported at g/100 ml and various temperatures recorded in the tests.
9/ The compound does not require submittal of samples at this time.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PHENMEDIPHAM
Data Requirement
Test
Substance
Does EPA Bibliographic
Have Data? Citation
Must Addtl Time Frame
Data be for
Submitted? Submission
§158.125 Residue Chemistry
171-4 - Nature of Residue
(Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical
Method
- Plant residues
- Animal Residues
PAIRA
PAIRA & Plant
Meatbolites
THAI &
Metabolites
TGAI
Partially 00044726 00076662 Yes I/ 18 Months
00067281 00114931
No
Partially
No
00081757 00115847
00081759 00116709
00114936
Yes 2/ 18 Months
Yes 4/ 15 Months ™
Yes 3/ 15 Months
171-4 - Storage Stability Data PAI
171-4 - Magnitude of the Residue -
Residue Studies
a. Root & Tuber Vegetables 6/
0 Table Beets, roots
~ Crop Field Trials TEP
Partially 00081239 00114931 Yes 5/ 15 months
Yes
00114930,
No
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TABLE A
GENERIC DATA REQUIREMENTS FOR PHENMEDIPHAM
Data Requirement
•test
Substance
Does EPA Bibliographic
Have Data? Citation
Must Addtl
Data be
Submitted?
Time frame
for
Submission
§158.125 Residue Chemistry - Continued
171-4 - Magnitude of the Residue -
Residue Studies
0 Sugar Beets, Roots
— Crop Field Trials
TEP
Yes
— Processed Food/Feed EP
b. Leaves of Root & Tuber Vegetables 8/
0 Table Beets, Greens
— Crop Field Trials TEP
No
Yes
00047866 00081753
00049752 00081760
00066111 00113841
00070104 00115847
00070106
00114930
No
Yes 7/
24 Months
No
0 Sugar Beet Tops
— Crop Field Trials TEP
c. Leafy Vegetables £/
0 Spinach
— Crop Field Trials TEP
Yes
Yes
00049752 00113841
00066111 00114931
00070104 00115847
00070106
00071436 00081240
No
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHENMEDIPHAM
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Addtl
Data be
Submitted?
Time Frame
for
Submission
§138.125 Residue Chemistry - Continued
171-4 - Magnitude of the Residue -
Residue Studies
d. Meat/Milk/
Poultry/Eggs
- Potable Water
- Pish
- Irrigated Crops
- Pood Handling
TCAI or Plant
Metabolites
No
TEP
TEP
TEP
TEP
No
No
No
No
Reserved 10/
No IV
No ll/
No ll/
No ll/
ro
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHENMEDIPHAM
§158.123 Residue Chemistry - Continued
i
I/ The metabolism of phermedipham [3-methoxycarbonylamino 3-methylcarbanllate] Is not adequately understood due to
incomplete identification of metabolites. The following data are required: Data depicting the uptake, distribution,
and metabolism of chain-labeled and phenyl-labeled [l^Cjphenmedipham in either sugar beets or table beets and
spinach; the identities and quantities of residues in or on mature plant parts must be determined in order to
clarify the terminal residues; residue identities must be confirmed by a method such as GC, HPLC, and/or mass
spectrometry.
t
2/ Metabolism studies utilizing ruminants and poultry are required. Animals must be dosed for at least 3 days with
!^C labeled phermedlpham at a concentration In the total diet that will result in sufficient residues in the
tissues, milk, and eggs to permit characterization. Animals must be sacrificed within 2k hours of the final
dosing. Milk and eggs must be collected twice daily. ^C-Residues In muscle, fat, kidney, liver, milk, and eggs
must be characterized. Should the metabolism of phermedipham In ruminants and poultry be found to be significantly
different, studies of swine metabolism may be required.
[Note: Representative samples from the metabolism studies requested above must also be analyzed using accepted
enforcement methods to ascertain their validity.]
3/ No methods were submitted for collection of data reflecting residues of phenmedlpham in animal commodities. There-
fore, the following data must be submitted: Complete descriptions of analytical methods, Including residue and
validation data, for detection and quantitatlon of phenmedlpham In animal commodities, including meat, milk, LT>
poultry and eggs. <*"*
V Regulated pesticide residues are subjected to the multiresldue procedures published in an Addendum to Pesticide
Assessment Guidelines Subdivision 0 - Residue Chemistry Data Requirements for Analytical Methods in 40 CPR Part
158.125 Multiresldue Protocols. Such testing has not been conducted on pheimedipham. Therefore, the following data
are required: Residues of phenmedlpham in or on crop samples subjected to analysis by the multiresldue method
protocols. Protocols for methods I, II, III, and IV are available from National Technical Information Service
under Order No. PB 86 20373VAS.
5_/ Additional storage stability data are required.
a. The storage intervals and conditions of samples used to support all established tolerances for residues must be
submitted. These data must be accompanied by data depicting the percent decline in residues at the times and
under the conditions specified. (No additional stability studies are required for plant commodities stored
frozen for up to 3 months.) On receipt of these data, the adequacy of the aforementioned tolerances will be
reevaluated.
b. All residue data requested in this standard must be accompanied by data depicting the duration and conditions
of storage of samples analyzed. These data must be accompanied by data depicting the stability of residues
under the conditions and for the time intervals specified, with the exception of those In or on plant commodities
stored frozen for <3 months.
-------
§158.125 Residue Chemistry - Continued
c. Data delineating the stability of phenmedlpham analog in animal products (tissues, milk, and eggs). Spiked samples
should be stored at subfreezing temperatures for Intervals approximating the storage intervals associated with
treated samples used to determine the magnitude of the residue. [If the requested metabolism data indicate the
presence of additional residues of toxlcological concern in plant and animal commodities, data depicting the
stability of such residues in storage will be required].
6/ If a registrant seeks a crop group tolerance for root and tuber vegetables, then he must submit the following in-
formation: Propose use directions, and appropriate supporting residue data for the additional representative
group member, turnips.
7/ No data were submitted reflecting residues in or on products processed from sugar beet roots bearing measurable
weathered residues. Therefore, the following are required: Data reflecting phenmedipham residues of concern in or
on dehydrated pulp, molasses, and refined sugar processed from sugar beets bearing measurable weathered residues.
It may be necessary to use exaggerated rates to obtain such residues. If residues are found to concentrate upon
processing, then appropriate food/feed additive tolerances must be proposed.
8/ If a registrant seeks a crop group tolerance for the leaves of root and tuber vegetables, then he must submit the
following information: Proposed use directions, and appropriate supporting residue data for the additional _
representative group member, turnips. ^
9/ If a registrant seeks a crop group tolerance for leafy vegetables, then he must submit the following information:
Proposed use directions, and appropriate supporting residue data for the additional representative group
members (head lettuce, leaf lettuce and celery).
10/ Presently, the nature of the residue in animals is not adequately understood. Upon review of the data requested in
the section entitled "Nature of Residue in Animals," the appropriateness of tolerances for residues In animal products
will be determined. Data requirements regarding the magnitude of residues In animal products will not be determined
until all requested data regarding metabolism in animals and magnitude of residues in feed Items have been received.
ll/ The Guidelines and use patterns indicate that these data are not required.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHENMEDIPHAM
Data Requirement
SI 58. 130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradat ion
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
163-1 - Leaching &
Adsorption/
Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
Test
Substance
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TEP
TEP
Use
Patterns
A
A
A
A
A
A
N/A
N/A
A
A
A
Does EPA
Have Data?
No
Partially
Yes
No
Yes
Partially
to
No
Partially
No
No
Bibliographic
Citation
00142741
00142742
00142744
00142746
00142749.
00142747
Must Addtl Time Frame
Data be for
Submitted? Submission
Yes 9 Months
Yes jy 9 Months
No r^>.
fO
No y
No
Yes JV 27 Months
No 4/
No 4/
Yes V 12 Months
No 2/
No 21
-------
Data Requirement
GENERIC
Test
Subs tance
TABLE A
DATA REQUIREMENTS FDR PHENMEDIPHAM
Use
Patterns
Does EPA Bibliographic
Have Data? Citation
Must Addtl Time Frame
Data be for
Submitted? Submission
5158.130 Environmental Fate - Continued
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
A
N/A
N/A
N/A
A
A
A
N/A
A
N/A
Partially 00114931.
00142751
No
No
No
No
No
No
No
ND
No
Yes 6/ 27 Months
No 4/
No 4/
ffo 8/
CO
Reserved Tj ^
Yes £/ 39 Months
Reserved 10/
ND 4/
Yes 12 Months
No 4/
Organisms
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR PHENMEOIPHAM
Data Requirement
§158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
§158.142 Spray Drift
201-1 - Droplet Size Spectrum
201-1 - Drift Field Evaluation
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
Use
Pattern
A
A
A
A
A
A
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
Must Addtl Time Frame
Data be for
Submitted? Submission
No V
No 4/
No 4/
No 4/
No 4/ ON
No 4/
-------
TABLE A
GENERIC EATA REQUIREMENTS FOR PHENMEDIFHAM
SI 58.130 Environmental Fate - Continued
_1/ Additional data are required: nature of the light source; intensity, wavelength distribution and relationship
of light intensity to that of natural sunlight, and dociroentation for a material balance study.
21 Test is not required because Fhenraedipham has low vapor pressure.
3J Identity of the degradate, raethyl-N(3-hydroxyphenyl)-carbonate, must be verified.
4/ The Guidelines and use patterns indicate that these data are not required.
V Data are required from two other soil samples for column leaching or three other soil samples for adsorption/
desorption studies.
6/ Additional data are required: composition of formulations used in the tests, chronological records, and names of
the key scientests involved in the studies. Also, tests for soil residues at greater depths are reserved pending
results of crop rotation soil data and additionallaboartory leaching data.
TJ Tests are reserved pending results of the soil dissipation studies.
8/ The data requirements for combination and tank mixes are not addressed in this Standard.
9/ Studies must be conducted using U.S. soil plots and soil residues must be measured to a minimum depth of 15 cm
and the identity of leached residues must be confirmed.
10/ Tests are reserved pending results of the confined rotational crop studies.
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR PHENMEDIPHAM
Date Requirement
§158.135 Toxicology
ACUTE TESTING:
81-1 - Acute Oral Toxicity
81-2 - Acute Dermal Toxicity
8l-3 - Acute Inhalation
Toxicity
81-4 - Primary Eye Irritation
8l-5 - Primary Dermal
8l-6 - Dermal Sensitization
81-7 - Acute Delayed
Neurotoxicity - Hen
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding -
Rodent
Nonrodent (dog)
82-2 - 21-Day Dermal
Test Use Does EPA Bibliographic Must Addtl Time Frame
Substance Patterns Have Data? Citation Data be for
Submitted Submission
TGAI A, Yes 00067579,00076497, No
TGAI A, Yes 00155585, No
TGAI A, No - Yes 9 Months
TGAI A, No - Yes 9 Months
TGAI A, No - Yes 9 Months
TGAI A, No - Yes 9 Months ^
TGAI A, No No I/
TGAI A, No No 2/
TGAI A, No Yes 12 Months
-------
.TABLE A
GENERIC DATA REQUIREMENTS FOR PHENMEDIPHAM
Data Requirement
§158.135 Toxicology - Continued
SUBCHRONIC TESTING:
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
82-5 - 90-Day Neurotoxicity-
Hen
CHRONIC TESTING:
83-1 - Chronic Toxicity -
Rodent (rat)
Nonrodent (dog)
83-2 - Oncogenicity -
Rat
Mouse
83-3 - Teratogenicity -
Rat
Rabbit
83-4 - Reproduction -
Test
Substance
TCAI
TCAI
TCAI
TGAI
TGAI
TCAI
TCAI
TCAI
TGAI
TGAI
Use
Patterns
A,
A,
A,
A.
A,
A,
A,
A,
A,
A,
Does EPA Bibliographic
Have Data? Citation
No
No
No
Yes 00028651
Yes 00028650
No
No
No
No
Yes 00027482
Must Addtl Time Frame
Data be for
Submitted? Submission
No V
No 3/
No V
No
CXI
No **"
Yes 4/ 50 Months
Yes May 1988 5/
Yes 15 Months
Yes 15 Months
No
2-generation
-------
TABLE A
GENERIC DVTA REQUIREMENTS FOR PHENMEDIPHAM
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Addtl Time Frame
Data be for
Submitted? Submission
§158.135 Toxicology - Continued
MUTAGENICITY TESTING
84-2 - Gene Mutation
(Ames Test)
84-2 - Structural Chromosomal
Aberration
84-2 - Other Genotoxic
Effects
TGAI
TGAI
TGAI
A,
A,
A,
No
No
No
Yes
Yes
Yes
9 Months
12 Months
12 Months
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Domestic Animal
Safety
PAI or
PAIRA
Choice
A,
A,
Partially 00067595 00076653 Yes
No No 3/
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHENMEDIPHAM
§158.135 Toxicology - Continued
I/ Phenmedlpham Is not an organophosphate and available data do not Indicate a neurotoxlcological problem.
2/ There Is an adequate chronic study to meet this requirement.
3/ Use patterns In conjunction with the Guidelines Indicate that these data are not required.
V To fulfill this requirement, a carclnogenlclty study In rats Is currently In progress.
5/ To fulfill the September 12, 1983 Data Call-in requirement, a two year oncogenlclty study In mice will be completed
by the registrant In May 1988.
-------
Data Requirement
§158.115 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LD^o
71-2 - Avian Dietary LC^
a. Waterfowl
b. Upland game bird
71-3 - Wild Mammal
Toxlclty
71-1 - Avian Reproduction
a. Waterfowl
b. Upland game bird
71-5 - Simulated Field Testing
- Mammals, and
- Birds
Actual Field Testing
- Mammals, and
- Birds
AQUATIC ORGANISM TESTING
72-1 - Acute Toxlclty,
Freshwater Fish
a. Warmwater
b. Ooldwater
GENERIC DATA
TABLE A
REQUIREMENTS FOR PHENMEDIPHAM
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
TGAI
TOAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
TGAI
TGAI
A
A
A
A
A
A
A
A
A
A
i
No
Yes 00115850
Yes 00115819
No
No
No
No
No
Yes 00116336
Yes 00116337
Must Addtl Time Frame
Data be for
Submitted? Submission
Yes 9 Months
No
No in
•sr
No I/
No 2/
No 2/
No 2/
No 2/
No
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHENMEDIPHAM
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Addtl
Data be
Submitted?
Time Frame
for
Submission
§158.1*15 Wildlife and
Aquatic Organisms
AQUATIC ORGANISM TESTING
72-2 - Acute LC^o Freshwater
Invertebrates
72-3 - Acute L&JO Estuarine
and Marine Organisms
72-H - Fish Early Life
Stage and Aquatic
Invertebrate Life-
Cycle
72-5 - Fish full llfe-cyle
72-6 - Aquatic Organism
Accumulation
TGAI
THAI
72-7 - Simulated Field
Testing
- Aquatic Organisms
- Actual Field Testing
- Aquatic Organisms
TGAI
TGAI
TGAI, PAI,
Degradation
Product
TEP
A
A
Yes
No
00115851
No
No
No
No
No
No V
No 3/
No 3/
No V
No 3/
§158.150 Plant Protection 5/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHENMEDIPHAM
§158.145 Wildlife and Aquatic Organisms - Continued
I/ Phenmedlpham Is considered to be low In toxlclty to mammals, therefore the study Is not required.
2/ Phenmedlpham Is considered to be very low In toxlclty to waterfowl and upland gameblrds, therefore,
the study Is not required.
3/ Phenmedlpham Is considered to be moderately toxic to both warmwater and coldwater species of fish, therefore,
the study is not required.
V Phenmedlpham Is considered to be moderately toxic to freshwater Invertebrates, and the use patterns
(I.e. terrestrial food crops: sugar beets, table beets and spinach) Indicate that these studies are not required.
5/ Because of the low volatility and terrestrial uses on certain crops (spinach, sugar beets & table beets), no
phytotoxlcity data for phenmedlpham will be required at this time. Note that phytotoxlclty testing can be
required on a case-by-case basis to support, among others, products that may pose hazard to endangered ^
or threatened plant species. ^"
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHENMEDIPHAM
Data Requirement
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS:
141-1 - Honey bee acute
contact toxic ity
141-2 - Honey bee - toxiclty
Test
Substance
TGAI
TEP
Use Does EPA Bibliographic
Pattern Have Data? Citation
A Yes 00036935
A No
Must Addtl Time Frame
Data be for
Submitted? Submission
No
No I/ °°
of residues on
foliage
Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxlcity to
aquatic Insects
142-1 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic Insects
143-1 - NONTARGET INSECT
thru TESTING - PREDATORS
143-3 AND PARASITES
(Reserved) 2/
TEP
No
No I/
(Reserved) 3/
(Reserved) 3_/
(Reserved) 3_/
(Reserved) 3/
-------
. TABLE A
GENERIC DATA REQUIREMENTS FOR PHENMEDIPHAM
I/ Data from the acute contact study show low toxicity to honey bees. Therefore, no further testing is required.
-------
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 162.10(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 162.10 (h)(l)(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 162.10(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 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements roust be headed by the
appropriate hazard title. [40 CFR'162.1$00 (2) ]. ' ,-«
-------
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 162.10(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 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flaramability 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 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
51
-------
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 roust be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(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.
52
-------
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 terras 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 162.10]
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.
53
-------
LO
SUMMARY-6
LABELING REQUIREMENTS OF THE FTFRA, AS AMENDED
ITEM
1
2
3
4
5
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
precautionary
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 f or . . . ,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion 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
PREFERRED
Both in* close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
•
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SUMMARY-8
in
ITEM
8C
9A
9B
1QA
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
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
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 "RlESTRICTED 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."
Must 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
-------
Chapter 1—Environmental Protection Agency
$162.10 Labeling requirements.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label roust 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 sectipn.
(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
57
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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, th"e appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use/ shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to $ 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticidal claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
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;
58
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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 S 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***," or "Sold by ***" to show that the name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°F (20°C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces."
:V! •• F
59
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(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear 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.
"'•' 60
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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 sura 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:
61
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Hazard Indicators
Oral LD
50
Inhalation LC
50
Dermal LD,
SO
Eye effects
Skin effects
1
Up to and
Including
50 «g/kg
Up to and
Including
.2 ng/llter
Up to and
Including
200 mg/kg
Corrosive;
cornea) opacity
not reversible
within 7 days
Corros 1 ve
^
Toxicity «
II
From 50 thru
500 ng/kg
From .2 thru
2 »g/l Iter
'
From 200
thru 2000
Cornea! opacity
reversible
within 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
categories
III
From 500 thru
5000 mg/kg
From 2 thru
20 eg/liter
From 2,000 thru
20,000
No cornea) opacity;
Irritation
reversible
within 7 days
Moderate Irritation
at 72 hours
IV
Greater than
5000 «g/kg
Greater than
20 *g/l Iter
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 to Toxicity Category I on
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."
All pesticide
dermal toxicity (as distinct
word "Poison" shall appear
contrasting color and the
immediate proximity to the
(B) Toxicity Category II.
no.j. pcoui^iuc products meeting the
criteria of Toxicity Category II shall bear on the front panel*
the signal word "Warning."
(C) Toxicity Category III. All pesticide
III shall bear
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
products meeting the
on the front panel
All pesticide
IV shall bear
products meeting the
on "the front panel
62
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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
63
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(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall appear
together on the label under the general heading "Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental Hazard" and "Physical or
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
Toxictty
category
Precautionary statements by toxicIty category
Oral, Inhalation, or dermal toxlclty
Skin and eye local affects
II
III
IV
Fatal (poisonous) If swallowed (Inhaled or
absorbed through skin]. Do not breathe
vapor Idust) or spray mist]. Do not get
In eyes, on skin, or on clothing (Front
panel statement of practical treatment
required.).
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 skin] Irritation. Do not
absorbed through the skin]. Do not breathe] get In eyes, on skin, or on clothing.
vapors Idust or spray mist). Do not get 1n| Harmful If swallowed. (Appropriate first
eyes, on skin, or on clothing. (Appropriate
first aid statements required.!.
Harmful If swallowed (Inhaled or absorbed
through the skin]. Avoid breathing vapors
Idust or spray mist). Avoid contact with
skin (eyes or clothing). (Appropriate
first aid statement required.!.
(No precautionary statements required.).
aid statement 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.].
(ii) Environmental hazards. Where a hazard exists to non-
target organisms excluding humans and domestic animals, precautionary
statements are required stating the nature of the hazard and the
appropriate precautions to avoid potential accident, injury or
64
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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 1*059 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 LCso 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 LDso 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
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 flam* extension Is More than 18 In. long
at a distance of 6 In. from the flame.
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
near heat or open flame. Do not puncturfc or
Incinerate container. Exposure to tempera-
tures above 130*F may cause bursting.
(B) NONPRESSURI2ED CONTAINERS
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 or open flame.
65
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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.
{i i i) Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
(^) 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;
(^) The product will not come into the hands of the general
public except after incorporation into finished products; and
(£) 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
necessary 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:
(\) 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;
66
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(2) The label clearly states that the product is intended for
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
(^) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(4_) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the headings "Directions for
Use " :
(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 S 162.10(h)(1)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) [Reserved]
(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.
67
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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 of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of § 162.10(j)(2).
(1) General Use Classification. Pesticide products bearing
directions for use(s)classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in S 162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators, the following statement is required: "For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation,
(k) Advertising. [Reserved]
140 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]
68
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PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
69
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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.
70
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans , J^ars)
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.
71
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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 Hazar-
dous 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 accor-
ding to label instructions, contact your State Pesticide or En-
vironmental 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 pesti-
cide 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."
72
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EPA Index to Pesticide Chemicals
198701 PHENMEDIPHAM*
TYPE PESTICIDE; Herbicide
FORMULATIONS;
Tech (97!)
EC (0.66 Ib/gal or 81 a.l., 1.3 Ib/gal or 15.91 a.i.)
GENERAL WARNINGS AND LIMITATIONS; A postemergence herbicide applied as a
broadcast or band spray to control broadleaf .weeds and grasses. This
product is toxic to fish; do not apply to bodies of water, wetlands, or
where runoff is likely to occur. If application must be made on days with
extreme temperatures and/or brightness, delay spraying until evening.
Rainfall within 6 hours of application may reduce weed control. Do not
apply when wind velocity is over 10 miles per hour. Dp not allow spray
drift to contact adjacent crops. Do not spray while dew is present.
Crops may be severely injured if treated before the 2-leaf stage in sugar
beets and the 4- to 6-leaf stage in table beets and spinach. Do not add
additional wetting agents or adjuvants. For band treatment, reduce dos-
ages proportionally.
TIME REQUIRED FOR CONTROL; Not located.
PHYTOTOXICITY TO TARGET WEEDS; Not located.
PHYTOTOXICITY TO CROPS; May cause temporary growth retardation and/or
chlorosis or tip-burn.
MODE OF ACTION; Strong inhibitor of the Hill reaction.
BROADLEAF WEEDS CONTROLLED;
*
(PBFDCBC Annual sowthlstle
PARABBB Coast fiddleneck
PAZAOBB Common chlckweed
PBDAEBA Common lambsquarter
PEDADBA Common purslane
PBFAEBA Common ragweed
PEWAHBM Lanceleaf groundcherry
PBKBDBB London rocket
PBDAEBI Nettleleaf goosefoot
PBKAHBA Shepherdspurse
PBKBKBB Wild mustard
*Spln-aid (betanal)
methyl m-hydroxycarbanllate m-methyl carbanilate
Issuedi 2-19-86
1-098701-1
-------
Site, Dosage
and Formulation
(Ib a.i./A)
EPA Index to Pesticide Chemicals
PHENMEDIPHAM
Tolerance, Use, Limitations
TERRESTRIAL FOOD CROP
(Agricultural Crops)
14001AA Beets. Table
0.49-0.98
(1.3 Ib/gal EC)
045639-00076
0.2 (N) ppm
60 day preharvest interval.
Postemergence. Broadcast or band. Apply after
the 4 to 6-true leaf stage of the crop, in 11 to
22 gallons of water per acre by ground, or 5 to
20 gallons of water per acre by air. Use the
higher dosage on a well established crop which is
not under stress.
13024AA
13024BA
28020AA
Spinach (for proces-
sing)
0.49-0.98
(1.3 Ib/gal EC)
045639-00076
Sugar Beets
[MAI]
0.37-0.62
(0.66 Ib/gal EC)
[MAI]
0.17-0.25
(0.66 Ib/gal EC)
Issued: 2-19-86
0.5 ppm
40 day preharvest interval.
Postemergence. Broadcast or band. Apply after
the 4-6 true leaf stage of the crop, in 11 to 22
gallons of water per acre by ground or 5 to 20
gallons of water per acre by air. Use the higher
dosage on well established spinach plants which
are not under stress.
0.1 (N) ppm (roots, tops)
90 day preharvest interval.
General Information; Do not exceed a total of
0.99 pound active ingredient per acre per season.
Postemergence. Broadcast or band. Apply after
the 2-true leaf stage of the crop, in 20 to 50
gallons of water per acre by ground or 5 to 15
gallons of water per acre by air. A second appli-
cation to control late germinating weeds may be
made at least 7 days later, or after the beets
have at least 4 true leaves. The dosage for the
second application should not exceed 0.5 pound
active ingredient per acre of phenmedipham. Use
the higher dosage on a.well established crop which
is not under stress.
Formulated with desmedipham.
Use limited to all sugar beet growing areas except
CA. Broadcast or band. Apply at any stage of
crop growth to control early germinating, diffi-
cult to control weeds. Apply in 5 to 10 gallons
of water per acre when the earliest emerging weeds
have reached cotyledon size. A second application
l
1-098701-2
-------
13024BA
001500
AAAAAA
Site, Dosage '
and Formulation
(Ib a.i./A)
Sugar Beets (continued)
EPA Index to Pesticide Chemicals
PHENMEDIPHAM
Tolerance, Use, Limitations
should be made 5 to 7 days after the first, or
when another flush of weeds germinates.
Formulated with desmedipham.
TERRESTRIAL NONFOOD CROP
(Agricultural Crops)
Spinach (seed crop) N.F.
Refer to TERRESTRIAL FOOD CROP, (Agricultural
Crops), Spinach (for processing) for use and dose
information.
AERIAL AND TANK MIX APPLICATIONS
Aerial Application
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Beets, Table; Spinach; Sugar Beets
TERRESTRIAL NONFOOD CROP
(Agricultural Crops)
Spinach (seed crop)
Issued: 2-19-86
1-098701-3
75
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EPA Index to Pesticide Chemicals
PHENMEDIPHAM
Listing of Registered Pesticide Products by Formulation
97.0001 971 technical chemical
phenmedipham (098701)
045639-00084
:08.0012 81 a.l. (0.66 Ib/gal) emulslflable concentrate
phenmedipham (098701) plus desmedipham (104T01)
045639-00087
115.9012 15.91 a.l. (1.3 Ib/gal) eaulslflable concentrate
phenmedipham (098701)
045639-00076
999999 State Label Registrations
CA Reg No.
002139-04339
Issued: 2-19-86
1-098701-4
76
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EPA Index to Pesticide Chemicals
PHENMEDIPHAM
1 Appendix A-l
Listing of Active Ingredient(s) Found in Combination With the Report Chemical
Chemical Common Name EPA Acceptable
Code (source) Common/Chemical "Name
104801 — desmedipham
— Use EPA Acceptable Common/Chemical Name
Issued: 2-19-86 1-098701-5
77
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EPA Index to Pesticide Chemicals
PHENMEDIPHAM
Auxiliary Documentation
Registration Number 000491-00210 does not contain phenaedipham (as an ac-
tive ingredient) and therefore was not extracted for this report.
:d- 2-19-86 I-098701-a
-------
PR06I TIROli
PROGI TI«»1B
CHEMICAL N*ME| Ph«n«tdlph** (
) i
«.«. ENVIRONMENTAL PROTECTION AGENCY
• •orF,cE OF PESTICIDE PROGRAMS
TOLEHANCC INDEX BY SHAU6HNE38Y CODEl 098701
w-hydro«re«rb«f»fUt« »-«itthv1 e»rb«nH
CFR
160. ITS
PPM
0.5
O.ZM
O.tN
O.IN
COMHODITV
CUPE
I30Z4AA
taovUA
Z3009AA
Z50UZAA
COMMODITY
8EUUENCE
1112
I3Z
153
150
COMMODITY
NAME
SPINACH
BEETS
BEETSi 8UGAR,
BEETS* SUGAR*
TOPS
ROOTS
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY FOR PHENMEDIPHAM
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.
A. 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.
80
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OMB Approval No. 200O0468 (Expires: 12-31-83)
(To qualify, certify A L,h four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. 1 understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration^) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 85804 (10-62)
81
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BIRGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
82
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANIARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phenmedipharn Standard
MRID CITATION
00027482 Kapp, R.W., Jr.; Dawkins, K.K.; Mossburg, P.A. (1979) Final Report:
A Three-Generation Reproduction and Teratology Study in Rats:
Project No. 947-105. (Unpublished study received Apr 1, 1980
under 2139-101; prepared by Hazleton Laboratories America, Inc.,
submitted by Nor-Am Agricultural Products, Inc., Naperville,
111.; CDL:099352-A)
00028650 Reno, F.E.; Weatherholtz, W.W.; Kundzins, W.; et al. (1980) Final
Report: 104-Week Toxicity Study in Dogs: Project No. 947-104.
(Unpublished study received Apr 1, 1980 under 2139-101; prepared
by Hazleton Laboratories America, Inc., submitted by Nor-Ara
Agricultural Products, Inc., Naperville, 111.; CDL:099353-A)
00028651 Reno, F.E.; Scrota, D.G.; Alsaker, R.D.; et al. (1980) Final Re-
port: 104-Week Chronic Toxicity Study in Male and Female Rats:
Project No. 947-103. (Unpublished study received Apr 1, 1980
under 2139-101; prepared by Hazleton Laboratories America, Inc.,
submitted by Nor-Ara Agricultural Products, Inc., Naperville,
111.; CDL:099354-A)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
00044726 Kassebeer, H. (1971) Rate of Uptake, Metabolism and Storage of
Phenmedipham in Various Plants. (Translation; unpublished study
received Apr 14, 1971 under 1F1160; prepared by Christian-
Albrechts-Univ., Institute of Phytopathology, Germany, submitted
by Nor-Am Agricultural Products, Inc., Naperville, 111.; CDL:
093480-B)
00047866 Morton Chemical Company (19??) Phernediphara Residues in Sugar Beet
Roots Using Different Methods and Recovery Data. (Unpublished
study received Nov 4, 1968 under 9G0767; CDL:093078-A)
00049752 Pennvalt Corporation (1976) Residue Results. (Unpublished study
received Feb 14, 1977 under 4581-223; CDL:228035-A)
83
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phenmedipham Standard
MRID CITATION
00066111 Nor-Am Agricultural Products, Incorporated (1976) Residues of Phen-
medipham in Sugar Beets after Repeat Applications of Betanal.
(Compilation; unpublished study received Jan 4, 1977 under 2139-
101; CDL:228694-A)
00067281 Celorio, J.; Bruhl, ? (1980) Determination of Methyl N-(3-hydroxy-
phenyl) Carbamate Residues in Sugar Beets. (Unpublished study
received Aug 20, 1980 under 9E2202; prepared by Schering, AG, W.
Germany, submitted by Interregional Research Project No. 4, New
Brunswick, N.J.; CDL-.099549-A)
00067579 Schering, AG (1965) Acute Oral Toxicity: Rats, Single Administra-
tion. (Translation; unpublished study received May 3, 1970 un-
der OF0889; submitted by Nor-Am Agricultural Products, Inc.,
Naperville, 111.; CDL-.091532-C)
00067595 Janicke, ? (1969) Phenmedipham Metabolism in Animals. (Transla-
tion; unpublished study received May 3, 1970 under OF0889; pre-
pared by Schering, AG, submitted by Nor-Am Agricultural Prod-
ucts, Inc., Naperville, 111.; CDL-.091532-U)
00070104 Nor-Am Agricultural Products, Incorporated (1978) Residues of
Phenmedipham in Sugar Beets after Aerial Application of Betanal.
(Compilation; unpublished study received Mar 29, 1978 under
2139-101; CDL:233362-A)
00070106 Nor-Am Agricultural Products, Incorporated (1978) Residues of
Phenmedipham and Desmedipham 1n Sugar Beets after Aerial Appli-
cation of a Betanal/Betanex Tank Mix. (Compilation; unpub-
lished study received Mar 29, 1978 under 2139-101; CDL-.233364-A)
00071436 Jenny, N.A.; Schubel, J.; Niketos, P.; et al. (1981) Residues of
Phenmedipham in Spinach: Absence of 3-Aminophenol and Methyl-N-
{3-hydroxyphenol)-carbamate as Metabolites in Spinach Leaves
and Stems: Report No. 452/214. (Unpublished study received Feb
10, 1981 under 9E2202; prepared by Nor-Am Agricultural Products,
Inc. in cooperation with Univ. of Maryland, Vegetable Research
Farm, submitted by Interregional Research Project No. 4, New
. Brunswick, N.J.; CDL:099950-A)
00076497 Morton Chemical Company (1967) Acute Oral Toxicity—Rats, Single
Administration. (Compilation; unpublished study received Jan
12, 1969 under 9G0767; CDL:091321-D)
84
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phenmedipham Standard
MRID CITATION
00076653 Nor-Am Agricultural Products, Incorporated (1969) Letter sent to
unknown recipient dated Oct 16, 1969: Pharmacokinetics of
Betanol (phenmedipham) on rats. (Translation from Schering AG,
second rept.; unpublished study received May 18, 1981 under
1G2522; CDL:070102-B)
00076662 Borner, H. (1969) Decomposition and Translocation of Phenmedi-
pham in Beets. (Unpublished study received May 18, 1981 under
1G2522; prepared by Univ. of Kiel, Institute for Phytopathol-
ogy, submitted by Nor-Am Agricultural Products, Inc., Naper-
ville, 111.; CDL:070104-G)
00081239 Schering AG (1969) Storage Stability of Phenmedipham 1n Spiked
Samples of Mashed Red Beets. 21st rept. (Unpublished study
received Apr 24, 1979 under 9E2202; submitted by Interregional
Research Project No. 4, New Brunswick, N.J.; CDL:098222-K)
00081240 Lambert, M. (1979) Letter sent to George Markle dated Mar 27, 1979
Two residue reports on spinach treated with Betanal. (Unpub-
lished study received Apr 24, 1979 under 9E2202; prepared by
Nor-Am Agricultural Products, Inc., submitted by Interregional
Research Project No. 4, New Brunswick, N.J.; CDL-.098222-L)
00081753 Morton Chemical Company (1969) Residues of Phenmedipham in Sugar
Beets: Analysis Method Comparison: 452/25. (Unpublished study
received Feb 25, 1969 under 9G0767; CDL:091322-F)
00081757 Schering AG (1968) Method for Determination of Residues from
Schering 38584 (Phenmedipham) in Sugar Beets (Tentative Method
of Analysis). Method 38 584/1 dated Oct 21, 1966. (Transla-
tion; unpublished study received Feb 25, 1969 under 9G0767;
submitted by Morton Chemical Co., Woodstock, 111.; CDL:091322-J)
00081759 Morton Chemical Company (1968) Residue Determination of Morton EP-
452 (Phenmedipham) in Sugar Beets and Red Beets: 452/15. Method
dated Jul 19, 1968. (Unpublished study received Feb 25, 1969
under 9G0767; CDL:091322-L)
00081760 Morton Chemical Company (1968) Phenmedipham Residues in Sugar
Beets. (Compilation; unpublished study received Feb 25, 1969
under 9G0767; CDL:091322-M)
00113841 BASF Wyandotte Chemical Corp. (1972) Determination of Residues 1n
Sugarbeet Tops and Roots from Tank Mix Applications of Pyramln W
+ Betanal. (Compilation; unpublished study received Nov 3, 1972
under 7969-7; CDL:008109-B)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phenmedipham Standard
MRID CITATION
00114930 Nor-Am Agricultural Products, Inc. (1971) The Results of Tests
on the Amount of Phenmedipham Residue Remaining, Including
a Description of the Analytical Method Used. (Compilation;
unpublished study received on unknown date under 1F1160; COL:
090953-A)
00114931 Nor-Am Agricultural Products, Inc. (1969) The Results of Tests on
the Amount of Residue Remaining, Including a Description of
the Analytical Method Used: Phenmedipham. (Compilation; un-
published study received May 4, 1970 under OF0889; CDL-.091533-A)
00114936 Nor-Am Agricultural Products, Inc. (1977) Study: Phenmedipham Res-
idue in Sugar Beets. (Compilation; unpublished study received
on unknown date under OF0889; CDL:098506-A)
00115847 Nor-Am Agricultural Products, Inc. (1976) Residue Data: Betanal
Aerial Application: Betanal Sequential Application. (Compila-
tion; unpublished study received on unknown date under unknown
admin, no.; CDL:225900-A)
00115849 Roberts, S. (1977) Avian Dietary LC50 (5-day Dietary Exposure) of
Phenmedipham Technical to Bobwhite Quail: Laboratory No. 7E-
7072. (Unpublished study received Dec 29, 1977 under 2139-101;
prepared by Cannon Laboratories, Inc., submitted by Nor-Am
Agricultural Products, Inc., Naperville, IL; CDL:232544-A)
00115850 Roberts, S. (1977) Avian Dietary LC50 (5-day Dietary Exposure) of
Phenmedipham Technical to Mallard Duck: Laboratory No. 7E-7071.
(Unpublished study received Dec 29, 1977 under 2139-101; pre-
pared by Cannon Laboratories, Inc., submitted by Nor-Am Agri-
cultural Products, Inc., Naperville, IL; CDL:232544-B)
00115851 Johnson, H. (1977) The Acute Toxicity of Phenmedipham to Daphnia
magna. (Unpublished study received Dec 29, 1977 under 2139-
101; prepared by Michigan State Univ., Dept. of Fisheries and
Wildlife and Pesticide Research Center, submitted by Nor-Am
Agricultural Products, Inc., Naperville, IL; CDL:232544-C)
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 Phenmedipham Standard
MRID CITATION
00116336 Schneider, C. (1979) The Acute Toxicity of Phenmedipham Technical
to the Bluegill Sunfish Lepomis macrochirus Rafinesque: UCES
Proj. No. 11506-74-05. (Unpublished study received Mar 27, 1979
under 2139-101; prepared by Union Carbide Corp., submitted by
Nor-Am Agricultural Products, Inc., Naperville, IL; CDL:
237907-A)
00116337 Schneider, C. (1979) The Acute Toxicity of Phenmedipham Technical
to the Rainbow Trout Salmo gairdnerl Richardson: UCES
Proj. No. 11506-74-04. (Unpublished study received Mar 27, 1979
under 2139-101; prepared by Union Carbide Corp., submitted by
Nor-Am Agricultural Products, Inc., Napervllle, IL; CDL:
237907-B)
00116709 Nor-Am Agricultural Products, Inc. (1969) Phenmedipham: Proposed
Tolerance. (Compilation; unpublished study received Feb 27,
1969 under 2139-EX-14; CDL:126777-C)
00142741 Klehr, M. (1982) Photolysis of Phenmedipham (...) in Aqueous Solu-
tion: Report No. APC 04/82. Unpublished study prepared by Sche-
ring AG, Berlin, Germany. 28 p.
00142742 Brehm, M. (1983) Photodegradation of Phenmedipham (...) on Soil
Surfaces: Report No. APC 10/83. Unpublished study prepared by
Schering AG, Berlin, Germany. 28 p.
00142744 Bruehl, R. (1976) Degradation of Phenmediphan in Soil: First Comm-
unication: Aerobic Degradation: Report No. Pa. 38 584.72/6. Un-
published translation of study prepared by Schering AG. 21 p.
00142746 Bruehl, R. (1976) Degradation of Phenmedipham in Soil: Second Comm-
unication: Anaerobic Degradation: Report No: PA 38 582.72/6.
Unpublished study prepared by Schering AG. 8 p.
00142747 Bruehl, R. (1979) Determination of the Adsorption Behavior of Aged
Betanal in Soil. Unpublished study prepared by Schering AG.
7 p.
00142749 Bruehl, R.; CeloHo, J. (1980) Mobility of [UL-carbon-14]-Toly1-
Phenmedipham Residues after Aging 1n Two Soils: Report No. R+S-
64/80-PA 38 584.72/6. Unpublished study prepared by Schering
AG. 14 p. .
87
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phemedipham Standard
MRID CITATION
00142751 Jenny, N. (1971) Persistence of Fhenmedipham in United States
Soils: 452/85. Unpublished study prepared by Nor-Am Agricul-
tural Products, Inc. 11 p.
00155585 Guenzel, P.; Richter, K. (1971) Phermedipham: Systemic Tolerance
Test in Rats after Single Dermal Application (ID 50): Schering
Report No. 323. Unpublished translation of study prepared by
Schering AG. 9 p.
88
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OMB Approval No. 2000-0468 (Expires 12-31-83)
EPA REGISTRATION NO.
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by tha FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner
D1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
D 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(CM2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
D 4. I request that you amend my registration by delating the following uses (this option is not available to applicants for new products):
D 5. I request voluntary cancellation of tha registration of this product (This option is not available to applicants for new products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8680-1 (10-82)
89
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EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for ray
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
90
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Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/ reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corros ion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
(KB Approval No. 2000-0468
Expiration Date 5/31/86
ATTACHMENT D
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Nunber:
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 en familiar with the terms of the Notice from EPA
dated concerning a requirement for submission of generic data
on the active Ingredient naned under PIPRA sec. 3(c)(2)(B).
(2) Ky flra 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 vfoich
contains that active Ingredient, vdiich is registered under F3FRA sec. 3»
and which is purchased by us fron another producer.
(3) An accurate Confidential Statement of Formula (CSP) 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 CSP dated ___^ on file with EPA Is complete, current and
accurate and contains the Information requested on the current CSP Fora
No. 8570-4. The registered source(s) of the above naned active Ingredient
in my product(s) Is/are
and their registration number(s) is/are
VSy firm will apply for an amendment to the registration prior to
changing the source of the active Ingredient In our product.
I understand, and agree on behalf of my finn, that if at any
time any portion of this Statement is no longer true, or if my firm falls
to comply with the undertakings made in this Statement, my firm's product's
registration may be suspended under FIPRA sec. 3(c)(2)(B).
Registrant's authorized representative: _
Signature
Dated: -
(Typed)
92
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