r
I
0 r
GUIDANCE FOR THE
REREGISTRATION OP PESTICIDE PRODUCTS
CONTAINING
FORMETANATE HYDROCHLORIDE (097301)
AS THE ACTIVE INGREDIENT
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, B.C. 20460
SEPTEMBER 1983
30460
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TABLE OF CONTENTS
»
r
Introduction . 1
I. Regulatory Position 4
II. Requirement for Submission of Generic Data 23
III. Requirement for Submission of Product-Specific
Data ; 48
IV. Submission of Revised Labeling and Packaging
Information 49
A. Label Contents 49
1. Product Name 49
2. Company Name and Address ............49
3. Net Contents 49
4. Product Registration Number 50
5. Producing Establishment
Registration Number 50
6A Ingredient Statement 50
6B Pounds Per Gallon Statement 50
7. Front Panel Precautionary Statements 50
7A Child Hazard Warning Statements 51
7B Signal Word 51
7C Skull and Crossbones and Word Poison 51
7D Statement of Practical Treatment 51
7E Referral Statement 51
8. Side/Back Panel Precautionary Labeling 51
8A Hazard to Humans and Domestic Animals 51
8B Environmental Hazard 52
8C Physical or Chemical Hazard 52
9 Misuse Statement 53
10A Storage and Disposal Block 53
10B Directions for Use 53
B. Collateral Information 53
V. Instructions for Submission 54
NOTE: Attached to this document are copies of the letters used
to transmit the document to registrants and notify them
of required studies.
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APPENDICES
II-l Bibliography
II-2 FIFRA $3(c)(2)(B) Summary Sheet - EPA Form 8580-1
II-3 Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580-6
III-l Product Specific Data Report (End-Use Products)
EPA Form 8580-4
IV-2 Table of Labeling Requirements and Sample Labels
IV-3 Physical/Chemical Hazards Labeling Statement
IV-5 Storage and Disposal Statements
Note: Appendices IV-1, IV-4 and IV-6 are not germane to this
document and are not included.
ii
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INTRODUCTION
!
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA Section 3(g), as amended in 1978, directs EPA to
reregister all pesticides as expeditiously as possible. Each
registrant of a manufacturing use product of the active
ingredient who wishes to continue to sell or distribute that
product must apply for reregistration.
To fulfill this Congressional mandate, we have established
the Registration Standards program which will review all pesti-
cide active ingredients first registered before January 1,
1977. These pesticides will be reviewed in use clusters
which are prioritized on the basis of a ranking scheme giving
preference to pesticides used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which, may not have been required when the product
was initially registered or studies that are now considered
insufficient. Our reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses. The regulatory position may
require the registrant to modify product labels to provide
additional precautionary statements, restrict the use of the
pesticide to certified applicators, provide reentry intervals,
modify uses or formulation types, specify certain packaging
limitations, or other requirements to assure that proper use
of the pesticide poses no potential adverse effects to human
health or the environment.
The scientific review, which is not contained herein
but is available upon request, concentrates on the technical
grade of the active ingredient and identifies missing generic
data. However, during the review of these data we are also
looking for potential hazards that may be associated with
the formulated (end-use) products that contain the active
ingredient. If we find serious concerns, we will bring
formulated products under the provisions of the Registration
Standards program to the extent necessary to protect the
public.
EPA has the authority under FIFRA §3(c)(2)(B) to require
that certain registrants submit generic data that will answer
our questions regarding the hazard that may result from the
intended use of the pesticide under review. Further, §3(c)
(2){B) provides that these data are to be submitted by
those registrants who do not qualify for the formulator's
exemption [FIFRA §3(c)(2)(D)]. Normally, this means that
the registrants who are responsible for filling the data
gaps are the manufacturing-use product producers (basic
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suppliers of the active ingredient). However, end-use producers
will not qualify for the formulator's exemption if the source
of their active ingredient: (1) is not registered with EPA,
and/or (2) is produced by the registrant's firm, or a firm
which has ownership in common with the registrant's firm.
These end-use producers can qualify for the formulator's
exemption if they change their source of supply to a registered
source, provided the source does not share ownership in
common with the registrant's firm. If the end-use product
registrant decides to switch sources* a new Confidential
Statement of Formula, EPA Form 8570-4, must_be submitted to
the appropriate Product Manager within 90 da'ys of receipt of
this Guidance Document. The chart on the following page
shows what is generally required of those who do and do not
qualify for the formulator's exemption in the Registration
Standards program.
If you decide to request the Agency to discontinue the
registration of any of your products subject to the reregistra-
tion requirements of this Guidance Document, please notify
the Product Manager named in the cover letter, within 90
days from the receipt of this document, that you wish to
voluntarily cancel the registration(s). If you decide to
maintain your product registration(s), you must provide the
information described in the following pages within the time-
frames outlined. EPA will issue a notice of intent to cancel
or suspend the registration of any currently registered
product if you fail to comply with the requirements set
forth in this Guidance Document.
This Guidance Document will be supplemented by EPA with
additional information about compliance with data support
requirements. In Monsanto v. Administrator, EPA was recently
enjoined from implementing in any way the "mandatory'data
licensing" aspects of §3(c)(l)(D) of FIFRA. EPA is assessing
the implications of the injunction for the reregistration
process. Because this situation is currently unresolved, EPA
has decided to proceed with the requirements in this Guidance
Document which do not relate to compliance with the §3(c)(l)(D)
provisions and to supplement the Document with additional
guidance when circumstances permit. Failure to comply with
the provisions of the subsequent guidance will also result
in issuance by EPA of an intent to cancel the affected product
reg istration(s).
Registrants are reminded that $6(a)(2) of FIFRA requires
you at any time to submit factual information raising concerns
of possible unreasonable adverse effects of a pesticide. You
should notify the Agency of interim results of studies in •
progress if those results show possible adverse effects.
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I
5 I
PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
B. Multiple Active Ingredient
Products
II. Products That Do Qualify For
The Formulator's Exemption
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis*
tration Standards Guidance
Document.
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt "with in a variety
of ways, including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
* End-use products of registrants who also produce a manufacturing-
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing-use product(s). Such end-use products
will be subject to the labeling changes required for products in "II"
above. If there are no manufacturing-use products registered by any
company end-use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and B above, then the registrants in "II* lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B.
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A. Introduction
This guidance document describes the Agency's regulatory posi-
tion on registered manufacturing-use products (MPs} containing
the miticide/insecticide formetanate hydrochloride (formetanate
RC1). The position is based on an evaluation of all accepted
uses of pesticide products., under section 3 and 24{c) of the
FIFRA, with formetanate HC1 as the pesticide active ingredient.
Other considerations include the known chemical and toxicologi-
cal characteristics of this pesticide chemical and the
established tolerances for residues in or on food and feed
commodities. From these considerations the Agency sets
forth the data and labeling requirements that must be met
by registrants and applicants of formetanate HC1 products in
order for the products to be reregistered or registered
under this document. Only those registration requirements
for current and future substantially similar MPs are addressed
here. Future MPs that differ appreciably from those described
in this document may require that amendments be made to this
document to reflect the differences.
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B' Description ofChemicalAnd Use Profile
Formetanate HC1 is the American National Standards Institute
(ANSI) acceptable common name for m-t[(Dimethylamino)methylene]
aminojphenyl methylcarbamate hydrochloride. The compound is
listed in the 8th Collective Index of the Chemical Abstracts
Service of the American Chemical Society as methylcarbamic
acid ester with N'-(m-hydroxy» phenyl)-N,N-dimethylformamidine
monohydrochloride. The 9th Collective Index chemical name
is: N,N-dimethyl-N'-I3-Il(methylamino) carbonyljoxyjphenyl}
methanimidamide monohydrochloride. Other names and code
designations are: Schering A.G. 36056, ENT-27566, SN-36056
and Dicarzol (the West German name for Carzol SP). The
current Chemical Abstract Service (CAS) registry number for
formetanate HC1 is 23422-53-9 and the EPA Shaughnessy number
is 097301.
Formetanate HC1 is a white crystalline solid with a faint
odor. The empirical formula is CilHi5N3O2.HCl. The
molecular weight is 257.8. Formetanate HC1 is more than 50%
soluble in water but only slightly soluble in most organic
solvents.
In addition to the federal registration, Carzol* SP is
registered for intra-state use in Arizona, California, Oregon,
Texas, Washington and Florida.
This pesticide is not produced domestically and is imported
into the U.S. only from West Germany, where it is manufactured
by the Schering A.G. Chemical Company. In the United States,
the sole importer and distributor of the chemical is NOR-AM
Agricultural Products, Inc. of Naperville, IL, a subsidiary of
Schering A.G. Chemical Company. Formetanate HC1 is formulated
and registered as a 92% watersoluble powder for both-the HP and
EP registrations. The MP is registered for the use of reformulat-
ing into an EP, and this is registered for use to control mites,
thrips and other insect pests on citrus, pome and stone fruit
crops, and alfalfa grown-for-seed.
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D. Regulatory Rationale
The Agency has determined that it should continue to allow the
registration of formetanate HC1 after considering the following:
1. Adequate studies are available to assess the acute toxi-
cological effects of formetanate HC1 to humans. Formet-
anate HC1 is assigned Toxicity Category I on the basis of
acute oral and eye effects. The eye irritation study
triggers one of the criteria [40 CFR 162.11(c)(1)(ii)]
used to classify pesticides. However, the classification
regulations also state [40 CFR 162:il(c)(3)] that if the
criteria are met, labeling precautions and directions must
be evaluated to determine if the potential hazard will
be mitigated. The use requirement to wear goggles, face
I shield or safety glasses as required by this guidance
1 document is adequate to protect a person from eye injury
f if exposed to this chemical. Therefore, formetanate HC1
. is not being classified as a Restricted Use Pesticide.
| The above precautionary statement along with other
human hazard precaution statements associated with
Toxicity Category I labeling [40 CFR 162.10(h)(2)(i)]
should minimize the acute hazards associated with these
routes of exposure.
2. Formetanate HC1 may potentially yield both aromatic and
alkyl amines. These amines may be converted to reactive
electrophilic species (such as nitroso species) with
possible oncogenic effects. The Agency will assess the
need for further characterization of the postulated
electrophilic species when the results of the required
chronic feeding and oncogenic studies are submitted and
reviewed. No other human toxicological hazards of
concern to the Agency have been identified.- It is
noted however, that a number of multiple dose toxicology
studies submitted in support of this pesticide were
conducted by Industrial Bio-Test Laboratories (IBT) and
have been determined to be invalid.
3. The tolerance reassessment and TMRC/ADI ratio must be
** completed. However, based on residue chemistry and
toxicological considerations, there is no evidence to
suggest that the current tolerances are likely to expose
the public to unreasonable adverse effects.
4. There is no record of any incident involving formetanate
HC1 having been reported to the Pesticide Incident
Monitoring System (PINS).
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Available data are insufficient to fully assess the
environmental fate of formetanate HC1. Formetanate HC1
appears to leach in soil and, therefore, has a potential
for contamination of groundwater. The additional studies
requested in this Guidance Document should allow us to im-
prove our assessment of the environmental fate of formetanate
HC1. Upon receipt and analysis of these data the Agency may
require additional studies such as groundwater monitoring.
Based on acceptable ecological effects studies, formeta-
nate HC1 is characterized as highly toxic to birds. It
is slightly toxic to warmwater fish and moderately
toxic to estuarine and marine organisms. It is moderately
toxic to honey bees with direct contact spray, but it has
very low toxicity to bees when they are exposed to residues
on plants. Label precautions required by this Guidance
Document should reduce the hazard to wildlife. Once data
gaps are filled, additional labeling precautions may be
required.
Under FIFRA, the Agency cannot cancel or withhold regis-
tration simply because data are missing or are inadequate
(see Sections 3(c)(2)(B) and 3(c){7) of the FIFRA).
Rather, issuance of this Guidance Document provides a
mechanism for identifying data needs. These data will be
reviewed and evaluated when they are received and the
Agency will determine at that time whether they will
affect the registration(s) of formetanate HC1.
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£. Criteria for Products Subject to the Guidance Document
This Guidance Document covers products that contain formetanate
RC1 as a pesticide active ingredient, and the chart in the Intro-
duction describes the extent to which such products are subject
to this Document. Applicants for registration or reregistration
of such products must comply with all terms and conditions
described herein. This includes making a commitment to fill
data gaps on a schedule specified by the Agency. Also, applicants
for reregistration must follow the instructions contained in
the Guidance Document and complete and submit the appropriate
forms within the specified times. End-use products must be in
compliance with the label changes specified in this Document.
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iff
Acceptable Ranges and Limits
!• Product Composition Standards
To be fully covered under this Guidance Document, manufac-
turing-use products must contain formetanate HC1 as the
sole active ingredient. Each MP formulation proposed for
registration must be fully described with an appropriate
certification of limits.
2. AcuteToxicity Limits
The Agency will consider for registration any MP whose acute
toxicity category (I, II, III or IV) is supported by adequate
acute toxicity data and labeling, including appropriate
precautionary statements.
3.
Use Patterns
To be registered under this Guidance Document, HP's may be
labeled for formulation only into end-use products for: 1)
terrestrial, nondomestic food crop uses on citrus (oranges,
lemons, tangerines, tangelos, limes and grapefruit), pome
fruits (apples and pears), stone fruits (peaches, nectarines,
plums, and prunes) and alfalfa grown-for-seed.
10
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G. Required Labeling
All manufacturing-use products and end-use products containing
formetanate HC1 roust bear appropriate labeling as specified in
40 CFR 162.10.
1. Label Requirements for Manufacturing-Use Products
a.
Ingredient Statements
The ingredient statement for HP's must list the active
ingredient as formetanate hydrochtoride (N,N-dimethyl-
N'-[3-1l(methylamino)carbonyl]oxy]phenyl]methanimida-
mide monohydrochloride) % or formetanate
hydrochloride (m-[[(Dimethylamino)methylene]amino]phenyl
methylcarbamate hydrochloride).... %.
b. Use Pattern Statement
1. All MPs must state that they are intended only
for formulation into end-use products for any
of the use patterns listed above (F-3). A
limiting factor will be the data that supports
these use patterns. No use may be included in
the labeling where the registrant fails to
agree to comply with the data requirements in
either Table A or Table B for that use pattern.
c. Precautionary Statements
Labels for all MP products containing formetanate HC1
must bear statements reflecting the acute human toxicity
of the compound. The following hazard statements must
appear on HP labels.
1. Statement for human hazards.
•HAZARDS TO HUMANS AND DOMESTIC ANIMALS"
"DANGER. Fatal if swallowed. Do not breathe spray
mist. Can cause irreversible eye damage. May cause
skin sensitization. Do not get in eyes, on skin or
on clothing. Wear goggles, face shield or safety
glasses. Wear a pesticide respirator approved jointly
by the Mining Enforcement and Safety Administration
(formerly U.S. Bureau of Mines) and by the National
Institute for Occupational Safety and Health under
the provisions of 30 CFR Part II. Wash thoroughly
with soap and water after handling and before eating
or smoking. Remove contaminated clothing and wash
before reuse."
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fe
Safety Administration (formerly U.S. Bureau of
Mines) and by the National Institute for Occupational
Safety and Health under the provisions of 30 CFR
Part II. Wash thoroughly with soap and water
after handling and before eating or smoking.
Remove contaminated clothing and wash before reuse.*
2. Statement for environmental hazard.
"ENVIRONMENTAL HAZARDS'
"This pesticide is toxic to wildlife. Do not apply
directly to water or wetlands. Do not contaminate
water by cleaning of equipment or disposal of
wastes. Cover or incorporate spills. This product
is toxic to bees exposed to direct treatment or
residues on blooming crops or weeds. Do not apply
this product if bees are visiting the treatment area.
*-.
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H. Tolerance Reassessment
Based on the established tolerances published in 40 CFR 180.276,
the theoretical maximum residue contribution (TMRC) from forme-
tanate HC1 residues to the human diet is calculated to be 0.41
ing/day from a 1.5 kg food diet for a 60 kg person.
The Agency considers the current values for the acceptable daily
intake (ADI) of 0.025 ingAg/day and the maximum permissible
intake (MFI) of 1.5 mg/day/60 kg (MPI = ADI x 60 kg) as provisional.
This is because a number of multiple dose toxicity studies submitted
to establish the ADI/MPI were conducted by IfeT and have been
determined to be invalid. Another reassessment and recalculation
of the ADI/MPI will be made when studies required to fill the
toxicology data gaps have been submitted and validated.
If different values are determined for the ADI and MPI then the
ratio between the MPI and TMRC will be reviewed. It is possible
at that time, that the established tolerances may be affected.
The Agency notes that formetanate HC1 is very unstable in rat
diets. The protocol of any feeding study should specify a daily
dietary preparation. In addition, we suggest that with the
protocol of any formetanate HC1 chronic or subchronic study,
adequate data or citations should be included to show that the
determination of cholinesterase inhibition, stipulated by the
protocol, is optimal for carbamates.
A petition for a tolerance for residues in or on alfalfa forage
and alfalfa hay must be submitted to support the alfalfa grown-
for-seed use or the use must be deleted from the label. No
residue data are available. A registration was granted when
this use was regarded as a non-food use. The Agency now considers
the use on alfalfa grown-for-seed to be a food use. -Alfalfa
sprouts are used as a human food item. Also, there is a likeli-
hood that the label restrictions will not be followed, with
the possibility of subsequent cuttings being fed to livestock
and poultry.
A new petition for a food additive tolerance for residues in or
on dried apple pomace must be submitted. A food additive petition
for dried apple pomace had been previously submitted but was
subsequently withdrawn.
If there is evidence to show a transfer of pesticide residues to
meat, poultry, milk or eggs, petitions for tolerances for the
residues in these commodities must also be submitted.
The U.S. and Canada have the same tolerances for residues in
citrus, apples and pears. Tolerances for peaches and plums
differ between the U.S. and Canada. In the U.S., the residue
limit for peaches is 5 ppm and for plums is 2 ppm, while the
Canadian residue limits are 3 ppm and 0.5 ppm, respectively. At
present, lowering the U.S. tolerances to meet the Canadian level
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is not desirable because the registered pesticide use rate and
the pre-harvest interval would be affected. All remaining
U.S. and Canadian tolerances are in agreement. There are no
listing for this pesticide by Mexico or in the Codex Alimentarius.
15
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I »
Site and Pest
EPA Index to Pesticide Chemicals
FORMETANATE HYDROCHLORZDE
Dosages and To1erance, Use, Limitations
Formulation(s)
Alfalfa (seed crop) (continued)
IQAMARA
Lygus bugs
ILAVBEA
t
Twospotted spider
mite
/04001AA
Apple
If
I
ITAPABA
*••
f. ITAPABA
ij
IRAFBAA
European red mite
Twospotted spider
mite
Tentiform leaf-
miners
Tentiform leaf-
miners
White apple leaf-
hopper
0.46-0.92
Ib/A
(92* .SC/S)
0.46-0.92
Ib/A
(922 SC/S)
Foliar application. Apply when
lygus bugs reach damaging numbers
and repeat as needed. Consult State
Agricultural Experiment Station or
Agricultural Extension Service for
proper timing information.
Foliar application. Apply by air-
craft in a minimum of 10 gallons of
water per acre or by ground equip-
ment in a minimum of 20 gallons of
water per acre.
3 ppm
7 day preharvest interval through
3.68 pounds per acre for foliar ap-
plication. Do not apply more than
3.68 pounds per acre in the growing
season.
0.23-0.46 lb/ Foliar application. Dosage used de-
100 gal pends on the size of the trees and
[400-900 the severity of the infestation.
gal/A]
(92% SC/S)
0.92-3.68
Ib/A
(92* SC/S)
0.115-0.23
lb/100 gal
[400 gal/A]
or
0.46-0.92
Ib/A
(92Z SC/S)
Foliar application. Apply as a con-
centrate spray in a minimum of 50
gallons of water per"acre.
Foliar application. Per acre rates
are to be applied as a concentrate
spray application in a minimum of 50
gallons of water per acre.
Issued: 8-31-81
III-097301-2
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702002AA
Site and Pest
Grapefruit
EPA Index to Pesticide Chemicals
FORKETANATE HYDROCHLORIDE
Dosages and To 1er ance, Use, Limi tat ions
Fonnulation(s)
4 ppm
7 day preharvest interval through
4.6 pounds per acre for foliar ap-
plication. Allow 30 days between
applications. Do not apply more
than 4.6 pounds per acre in a 12
month period.
: ILAJBCA
Citrus rust mite
' IMOAAAA
I
Thrips
fi /02004AA
If /02006AA
;•! /02008AA
Lemon
Orange
Tangerine
ILAVARA
Citrus red mite
ILASBCA
Citrus rust mite
0.0575-0.115
lb/100 gal
(500-1500
gal/A]
(92Z SC/S)
0.115-0.23
lb/100 gal
{500 gal/A]
(92Z SC/S)
0.46 lb/
100 gal
[100-300
gal/A]
or
0.46-1.38
Ib/A
(922 SC/S)
0.46 lb/
100 gal
[700-1,000
gal/A]
(92% SC/S)
0.0575-0.115
lb/100 gal
[500-1,500
gal/A]
(92% SC/S)
Use limited to FL.
Foliar application.
Use limited to TX.
Foliar application.
Use limited to AZ and. CA.
Foliar application. Apply per acre
rate by aircraft in a minimum of 10
gallons of water per acre.
4 ppm
7 day preharverst interval through
4.6 pounds per acre for foliar ap-
plication. Allow 30 days between
applications. Do not apply more
than 4.6 pounds per acre in a 12
month period.
Use limited to AZ and CA.
Foliar application.
Use limited to FL*
Foliar application.
Issued: 8-31-81
III-097301-3
18
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I
if
I
Site and Pest
EPA Index to Pesticide Chemicals
FORMETANATE HYDROCHLDR1DE
Dosages and Tolerance, Use. Limitations
Formulation(s)
Lemon cluster (continued)
• IMOAAAA
Thrips
/05003AA
Nectarine
0.115-0.23
lb/100 gal
[500 gal/A]
(922 SC/S)
0.46 lb/
100 gal
[100-300
gal/A]
or
0.46-1.38
Ib/A
(92Z SC/S)
Use limited to TX.
Foliar application.
Use limited to AZ and CA.
Foliar application. Apply per acre
rate by aircraft in a minimum of 10
gallons of water per acre.
4 ppm
14 day preharvest interval through
1.84 pounds per acre for foliar ap-
plication. Do not apply more than
3.68 pounds per acre in a growing
season.
I
ILAVASA
ILAVAYA
ILAVBEA
European red mite
HcDaniel spider
mite
Twospotted spider
mite
IMOAAAA
Thrips
Orange
Issued: 8-31-81
0.23 lb/
100 gal
[400-500
gal/A]
or
0.92-1.15
Ib/A
(922 SC/S)
0.23-0.345
lb/100 gal
[400-500
gal/Aj
or
0.92-1.84
Ib/A
(92Z SC/S)
Foliar application. Apply per acre
rate as a concentrate spray in a
minimum of 50 gallons of water per
acre.
Foliar application. Apply when
thrlps infest blossoms through petal
fall. Apply at night or when bees
are not working in blooms. Apply
per acre rate as a concentrate or
aerial application.
See Lemon cluster.
II1-097301-4
19
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05004AA
LAVASA
QAMARA
LAVAYA
QAQABA
LAVBEA
D4003AA
:LAVASA
1LAVBEA
fr
*
*.
JLAJAOA
'05005AA
'05006AA
[LAVASA
LLABAYA
ILAVBE/
Site and Pest
Peach
EPA Index to Pesticide Chemicals
FORMETANATE HYDROCHIORIDE
Dosages and Tolerance, Use. Limitations
Formulaeion(s)
5 ppm
21 day preharvest interval through
1.15 pounds per acre for foliar ap-
plication. Do not apply more than
2.3 pounds per acre in a growing
season.
European red mite
Lygus bugs
McDaniel spider
mite
Stink bugs
Twospotted spider
mite
Pear
European red mite
Twospotted spider
mite
Pear rust mite
European red mite
McDaniel spider
mite
Twospotted spider
mite
0.23 lb/
100 gal
(400-500
gal/A]
or
0.92-1.15
Ib/A
(92X SC/S)
0.23-0.46
lb/100 gal
[400-800
gal/A]
(92Z SC/S)
0.23 lb/
100 gal
[400-800
gal/A)
(922 SC/S)
0.23 lb/
100 gal
[400-600
gal/A]
or
0.92-1.38
Ib/A
(92% SC/S)
Foliar application. Apply per acre
rate as a concentrate spray in a
minimum of 50 gallons of vater per
acre.
3 ppm
7 day preharvest interval through
3.68 pounds per acre for foliar ap-
plication. Do not apply more than
3.68 pounds per acre in a growing
season.
Foliar application. Dosage used de-
pends on the sice of the trees and
the severity of the infestation.
Foliar application. Apply from
postbloom to harvest beginning
application at first sign of mite
infestation.
2 ppm (plums, fresh prunes)
7 day preharvest interval through
1.38 pounds per acre for foliar ap-
plication. Do not apply more than
2.76 pounds per acre in a growing
season.
Use limited to the West Coast.
Foliar application* Apply per acre
rate as a concentrate spray in a
minimum of 50 gallons of water per
acre.
Issued: 8-31-81
III-097301-5
20
-------
/02007AA
Site and Pest
Tangelo
1MOAAAA
Thrips
EPA Index to Pesticide Chemicals
FORMETANATE HYDROCHLORIDE
Dosages and Tolerance, Use, Limitations
Formulations)
4 ppm (tangerines)
7 day preharvest interval through
1.38 pounds per acre for foliar ap-
plication. Allow 30 days between
applications. Do not apply more
than 4.6 pounds per acre in a 12
month period.
Tangerine
0.46 lb/
100 gal
(100-300
gal/A]
or
0.46-1.38
Ib/A
(92% SC/S)
See Lemon cluster.
Use limi'ted to AZ and CA.
Foliar application. Apply per acre
rate as an aerial application in a
minimum of 10 gallons of water per
acre.
01500
AERIAL. MOTHPROOFING AND TANK MIX APPLICATIONS
Aerial Application
Refer to
AGRICULTURAL CROPS
Alfalfa, Grapefruit, Lemon, Orange,
Tangelo, Tangerine
Issued: 8-31-81
III-097301-6
21
-------
EPA Index to Pesticide Chemicals
FORtCTANATE HYDROCHLOR1DE
Listing of Registered Pesticide Products by Formulation
921 technical chemical
formetanate hydrochloride (097301)
002139-00114
92% soluble concentrate/solid
formetanate hydrochloride (097301)
002139-00099
State Label Registrations
AZ Reg. No.
002139-04325
CA Reg. No.
002139-04324
FL Reg. No.
002139-04326
OR Reg. No.
002139-04322
TX Reg. No.
002139-04327
WA Reg. No.
002139-04359
Issued: 8-31-81
III-097301-7
22
-------
II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA Section 3(c)(2)(B)
and describes, in table format, the data required
for maintaining the registrability of each product.
Additionally, a bibliography (Appendix II-l) is
included that identifies that data considered as
part of the data base supporting this standard. EPA
has determined that additional generic data described
in this Notice must be submitted to EPA for evaluation
in order to maintain in effect the registration^)
of your product(s) identified as an attachment to
the cover letter accompanying this guidance document.
As required by FIFRA Section 3(c)(2)(B), you are
required to take appropriate steps to comply with
this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA
how you will satisfy the requirements of this Notice.
Any such suspension will remain in effect until you have
complied with the terms of this Notice.
B. What Generic Data */ Must Be Submitted. You may ascertain
which generic data you must submit by consulting Table A
at the end of this chapter. That table shows all the
generic data needed to evaluate the continued registrability
of all products, and the dates by which the data must be
submitted. The required data must be submitted and any
necessary studies must be conducted in accordance with
EPA-approved protocols, the Pesticide Registration
Guidelines 2/, or data collected under the approved
protocols o? the Organization for Economic Cooperation
and Development (OECD). If you wish not to develop data
which are necessary to support the registration or
reregistration of certain uses appearing in your labeling,
you may delete those uses at the time you submit your
revised labeling.
Also for certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and in those cases EPA needs data of that
I/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient (or all such
products having a certain use pattern), regardless of any such
product's unique composition or use. Product-specific data relate
only to the properties or effects of a product with a particular
composition (or a group of products with closely similar composition)
2/ The Pesticide Registration Guidelines were reproposed on
November 24, 1982 in 47 Federal Register 53192.
23
-------
c.
type for each major formulation category (e.g.* emulsifiable
concentrates, wettable powders, granulars, etc.) These
are classified as generic data and when needed are
specified in Table A. EPA may possess data on certain
"typical formulations" but not others. Note: The "typical
formulation" data should not be confused with product-
specific data (Table B) which are required on each
formulation. Product-specific data are further explained
in Chapter IV of this document.
Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
I1-2] for each of your products. On that form you must
state which of the following methods you will use to comply
with the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe
will satisfy the requirement, or state that
you will generate the data by conducting
testing. If the test procedures you will
use deviate from (or are not specified in)
the Registration Guidelines or protocols
contained in the Reports of Expert Groups
to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must enclose
the protocols you will use.
4V
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly
develop (or share in the cost of developing) the
data. If you elect this option, you must notify EPA
which registrant(s) are parties to the agreement.
3. File with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for
Development of Data* (EPA Form 8580-6, Appendix II-3)V
4. Request that EPA amend your registration by deleting the
uses for which the data are needed. (This option is not
available to applicants for new products.)
*/ FIFRA Section 3(c)(2)(B) authorizes joint development of
data Ey two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued at bottom of next page)
24
-------
Request voluntary cancellation of the registration(s)
of your products for which the data are needed. (This
option is not available to applicants for new products.)
Procedures for Requesting Changesin TestingMethodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required
data or how quickly the data roust be submitted. If the
test procedures you plan to use deviate from (or are not
specified in) the registration guidelines or protocols
contained in the reports of the Expert Groups to the
Chemical Groups, Organization for Economic Cooperation
and Development (OECD) Chemicals Testing Programme, you
must submit the protocol for Agency review prior to the
initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product
Manager. The extension request should state the reasons
why you conclude that an extension is appropriate. While
EPA considers your request, you must strive to meet the
deadline for submitting the required data.
(Footnote continued from previous page)
In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest. Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, EPA has discretion not to suspend the
registration of a product when a registrant fails to submit data
required under FIPRA Section 3(c)(2)(B). EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing. Accordingly, if
(1) a registrant has informed us of his intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under FIFRA
Section 3(c)(2)(B)(iii)]; and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, EPA will not
suspend the second firm's registration. While the first firm is
not required to agree to jointly develop data, EPA is not required
to force the second firm to engage in economically inefficient
duplicative testing in order to maintain its registration.
25
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III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: This chapter applies only to manufacturing-use products,
not end-use products.
A necessary first step in determining which statements must
appear on your product's label is the completion and submission
to EPA of product-specific data* listed on the form entitled
"Product Specific Data Report" (EPA Form 8580-4, Appendix III-l)
to fill "gaps" identified by EPA concerning your product. Under
the authority of FIFRA Section 3(c)(2)(B), EPA has determined
that you must submit these data to EPA in order to register or
reregister your product(s). All of these data must be submitted
not later than six months after you receive this guidance document.
"Product-Specific Data Requirements for Manufacturing-Use
Products" appearing in Table B permit you to determine which
product-specific data you must submit. This can be done by
examining the entries in the column of those tables entitled
"Must Data Be Submitted Under S3(c)(2)(B)."
*/ Product specific data pertains to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicology data.
48
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t
ir:
IV. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This chapter applies only to manufacturing-use products,
not end-use products.
The Agency requires applicants for registration or reregistra-
tion to ensure that each label (1) contains accurate, complete,
and sufficient instructions and precautions, reflecting the
results of data concerning the product and its ingredients, and
(2) incorporates labeling format and terminology which are suffi-
ciently standardized to avoid user confusion.
As part of your application, you will be required to submit
draft labeling consistent with: applicable product-specific
data; the precautionary statements and use directions; and the
regulations concerning classification [40 CFR S162.11(c)], pack-
aging [40 CFR $162.16], and labeling [40 CFR $162.10], as indicated
by the following paragraphs of this chapter of the guidance
document.
You will Jae informed later when you must submit the revised
labeling set forth in this guidance package.
A. Label Contents
40 CFR $162.10 requires that certain specific labeling
statements must appear at certain locations on the label.
This is referred to as format labeling. Specific label
items listed below are keyed to Tables D, E, and F (Appendix
IV-2).
Item 1. PRODUCT NAME - The name, brand, or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading. [40 CFR
$162.10(b)]
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
[40 CFR §162.10(c)J
Item 3. NET CONTENTS - A net content statement is required
on all labels. The preferred location is the bottom of the
front panel immediately above the company name and address,
or at the end of the label text. The net contents must be
stated in terms of weight, expressed as avoirdupois pounds
49
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.
it
and ounces, and stated in terms of the largest suitable unit,
i.e., "1 pound 10 ounces" rather than "26 ounces." In
addition to the required units specified, net contents may be
expressed in metric units. [40 CFR $162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. Ho." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR Sl62.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment registration number on
the immediate container cannot be clearly read through such
wrapper or container. [40 CFR §162.10(f)]
Item 6. INGREDIENT STATEMENT - An ingredient statement
is required on the front panel and must contain the name and
percentage by weight of each active ingredient and the total
percentage by weight of all inert ingredients. The preferred
location is immediately below the product name. The ingredient
statement must run parallel with, and be clearly distinguished
from, other text on the panel. It must not be placed in the
body of other text. [40 CFR 162.10(g)J
Item 6A. POUNDS PER GALLON STATEMENT - For'liquid
agricultural formulations, the pounds per gallon of active
ingredient must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - All labels
are required to have precautionary statements grouped together
on the front panel, preferably within a block outline. The
table below shows the minimum type size requirements on
various size labels, as set forth in the Regulations.
50
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Size of Label
on Front Panel
in Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word as Re-
quired Minimum Type
Size Al1 Capi tals
6 point
10 point
12 point
14 point
18 point
"Keep Out of Reach
of Children"
asRequired
€ point
6 point
8 point
10 point
12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - All labels are
required to have the statement "Keep Out of Reach of Children"
located on the front panel above the signal word except where
contact with children during distribution or use is unlikely.
[40 CFR Sl62.10(h)(l)(ii)]
Item 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement. [40 CFR §162.10 (h)(l)(i)J
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, inhala-
tion, or dermal 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 S162.10(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 S162.10(h)(l)(iii>]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR $162.10 (h)(2)]
51
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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 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 S162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flamntability statement. Precautionary statements
relating to flammability of a product are required
to appear on the label if it meets the. criteria in
Appendix IV-3. 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 flam-
mability statements.
2. Criteria for declaration of non-flammability. The
following criteria will be used to determine if a
product is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of
gases) that will not ignite when a lighted match
is placed against the open cylinder valve.
b. A "non-flammable liquid" is one having a flash-
point greater than 350°F (177°C) as determined
by the method specified in 40 CFR Sl63.61-8(c)(13)
(ii) of Subpart D.
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches, using the
method specified in 40 CFR Sl63.61-8(c)(13)(ii);
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C),
determined by the method specified in 40 CFR
Sl63.61-8(c)(13)(i).
52
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3« Declaration of non-flammability. Products which meet
the criteria for non-flammability specified above may
bear the notation "non-flammable11 or "nonflammable
(gas, liquid, etc.)* on the label.
It may appear as a substatement to the ingredients
statement, or on a back or side panel, but shall not
be highlighted, or emphasized (as with an inordinately
large type size) in any way that may detract from
precaution.
4. Other physical/chemical hazard statements. When
chemistry data submitted in accordance with 40 CPR
S163.61-10(c) demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such
statements may address hazards of explosivity,
oxidizing or reducing capability, or mixing with
other substances to produce toxic fumes.
Item 9. MISUSE STATEMENT - The following statement is
required on your label: "It is a violation of Federal law to
use this product in a manner inconsistent with its labeling."
[40 CFR S162.10(l)(2)(ii)]
Item 10A. 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. Make certain that the statement you use
pertains specifically to your product. 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 IV-5 for the latest specific
storage and disposal product label statements.
Item 10B. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR $162.10]
B. Collateral Information
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, and other 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
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V.
INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
(Product Manager]
Phone No. (703)
Registration Division .(TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
•
For each product for which continued registration is desired:
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" EPA
Form 8580-1. Refer to Appendix II-2 with appropriate
attachments.
2. Within 6 months from receipt of this document registrants
must submit:
a. Confidential Statement of Formula, EPA Form 8S70-4.
%
b. Product Specific Data Report, EPA Form 8580-4 (Appendix
c. Two copies of any required product-specific data.
3. Within the time set forth in Table A, all generic data
must be submitted by the affected registrant (s).
Note: If for any reason any required test is delayed or aborted
so that meeting the agreed submission time will be delayed,
notify the Product Manager listed above.
You will be informed at a later date when you must submit your
Application for Amended Pesticide Registration (EPA Form 8570-1)
and the revised labeling set forth in this guidance package.
54
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Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00006652 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1973) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees:
Laboratory Studies. Rev. By Univ. of California, Dept. of
Entomology.; Riverside, Calif.: U.C. (Agricultural Extension
M-16; also In unpublished submission received Nov. 17, 1975 un-
der 359-620; submitted by Rhone-Poulenc, Inc., Monmouth Junc-
tion, MJ; CDL:223344-A)
00077656 Michigan State University (1968?) Residues of C 14 Formetanate-
hydrochloride in Green Sunfish following a Subacute Exposure.
(Unpublished study received Nay 18, 1973 under 2139-99; CDL:
124298-A)
00077658 McCann, J.A. (1970) Carzol SP: Bluegill (Lepomis macrochi-
rus): Test No. 284. (U.S. Agricultural Research Service,
Pesticides Regulation Div., Animal Biology Laboratory; unpub-
lished study; CDL:108518-A)
00077659 Nor-Am Agricultural Products, Incorporated (19??) Carzol SP: Chem-
ical and Physical Properties. (Unpublished study received July
22, 1968 under 2139-99; CDL:100133-A)
Schoenig, G. (1967) Report to Morton Chemical Company: Acute Tox-
icity Studies on EP-332 HC1, Technical: IBT No. A5341. (Unpub-
lished study received Sep 11, 1969 under 9G0746; prepared by
. Industrial Bio-Test Laboratories, Inc., submitted by Morton
Chemical Co., Woodstock, IL; CDL:091289-B)
00077668 Hathaway, D. (1967) Report to Morton Chemical Company: Acute Dust
Inhalation Toxicity of EP-332 HC1, Technical: IBT No. N5342.
(Unpublished study rceived Sep 11, 1969 under 9G0746; prepared
by Industrial Bio-Test Laboratories, Inc., submitted by Morton
Chemical Co., Woodstock, IL.; CDL:091289-D)
00077680 Sen Gupta, A.K.; Khowles, C.O. (1970) Fate of formetanate- 14C
acaricide in the rat. Journal of Economic Entomology 63(1):10-
14. (Also in unpublished submission received Jun 17, 1971 under
OF0961; submitted by Nor-Am Agricultural Products, Inc., Naper-
ville, IL.; CDL.-092155-H)
00077703 Knowles, C.O.; Sen Gupta, A.K. (1970) Metabolism of Formetanate
Acaricide by Orange Seedlings. (Unpublished study received Apr
12, 1970 under OF0961; prepared by Univ. of Missouri, Dept. of
Entomology, submitted by Nor-Am Agricultural Products, Inc.,
Naperville, IL.; CDL:091643-E)
VD77666
-------
Appendix II-l
(continued)
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
0007709 Jenny, N.A. (1969) Decomposition of Formetanate HC1 in United
States Soils: 332/47. (Unpublished study, including published
data, received Apr 12, 1970 under OF0961; submitted by Nor-Am
Agricultural Products, Inc., Naperville, IL.; CDL:091643-K)
00077728 Palazzolo, R.J. (1967) Report to Morton Chemical Company: Human
Repeated Insult Patch Test on EP-332 HC1: IBT No. 5343. (Unpub-
lished study received Apr 15, 1970 under OF0961; prepared by
Industrial Bio-Test Laboratories, Inc., submitted by Nor-Am
Agricultural Products Inc., Naperville, IL., CDL:091642-J)
00077730 Nor-Am Agricultural Products, Incorporated (1973) Disappearance of
Formetanate Rydrochloride Residues in Soil (Field Studies). (Un-
published study received may 18, 1973 under OF0961; CDL:091934-A)
00077731 Nor-Am Agricultural Products, Incorporated (1972) Pesticide Fate and
Movement in Soil: Summary of Soil Studies. (Compilation; unpub-
lished study received May 18, 1973 under OF0961; CDL: 091934-B)
' ^tf7732 Nor-Am Agricultural Products, Incorporated (1972) Pesticide Fate
and Movement in Soil: Summary of Soil Studies. (Compilation;
unpublished study received May 18, 1973 under OF0961; CDL:
091934-C)
00077733 Nor-Am Agricultural Products, Incorporated (1972) Pesticide Fate
and Movement in Soil: Summary of Soil Studies. (Compilation;
unpublished study, including published data, received May; 18,
1973 under OF0961; CDL:091934-D)
00077734 Nor-Am Agricultural Products, Incorporated (1973) Pesticide Fate
and Movement in Soil: Summary of Soil Studies. (Compilation;
unpublished data, received May 18, 1973 under OF0961; CDL:
091934-E)
00077735 Nor-Am Agricultural Products, Incorporated (1973) Pesticide Fate
and Movement in Soil. (Compilation; unpublished study, includ-
ing published data, received May 18, 1973 under OF0961; CDL:
091934-F)
00077760 Johansen, C. (19??) Small-scale Bee Poisoning Tests with Honey
Bees, Alkali Bees, and Alfalfa Leafcutting Bees. (Unpublished
Study received Mar 16, 1970 underOF0961; submitted by Nor-Am
Agricultural Products, Inc., Naperville, IL.; CDL:093272-C)
^7
t
-------
Appendix II-l
(continued)
GS0091005
GS0091006
GS0091009
GS0091010
GS0091011
1012
GS0091013
GS0091014
GS0091015
GS0091016
, GS0091017
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
Nor-Am Agricultural Products, Inc. (1968) Formetanate HC1: Chemical
and Physical Properties Analysis (Unpublished study received
Sep 7, 1968 under 900746; CDL:RCB-115705)
Nor-Am Agricultural Products, Inc. (1970) Formetanate HC1; Name,
Chemical, Identity and Composition (Unpublished study received
Mar 12, 1970 under OF0961; CDL:RCB-116585)
Nor-Am Agricultural Products, Inc. (1970) Metabolism of Formetanate
HC1 in Animals (Unpublished study received Apr 1, 1970 under
OF0961yCDLiRCB-116585)
Zwieg, Gunter, editor. (1974) Analytical Methods for Pesticides and
Plant Growth Regulators Vol. 7 Academic Press
Nor-Am Agricultural Products, Inc. (1968) Formetanate HC1: Residue
Data (Unpublished study received Aug 7, 1968 under 9G0746; COL:
PCB-115708)
Nor-Am Agricultural Products, Inc. (1970) Results of test on the
amount of residue remaining including a description of the
analytical method used (Unpublished study received Apr 1, 1970
under OF0961; CDL: RCB-116585)
Nor-Am Agricultural Products, Inc. (1971) Residues in Citrus Fruits
(Grapefruits and Tangerines) (Unpublished study received. Jan 11,
1971 under 1F1141; CDL:RCB-117306)
Nor-Am Agricultural Produts, Inc. (1972) Formetanate HC1: Results
of Tests on the Amount of Residue Remaining in Peaches, Plums,
Prunes, Nectarines and Grapes (Unpublished study received Mar
1, 1972 under 2F1238; CDL:RCB-117724)
Nor-Am Agricultural Products, Inc. (1970) Recovery of Formetanate
(Summary) (Unpublished study received Jun 5, 1970 under OF0989;
CDL:RCB-116295)
Nor-Am Agricultural Products, Inc. (1974) Residues in Grapes and
Grape By-Products (Unpublished study received Mar 5, 1973 under
3F1351; CDL:R€B-118095)
U.S. Department of Health, Education, and Welfare, Food and Drug
Administration. (1978) Pesticides Analytical Manual Vol. II. U.S.
Government Printing Office, Washington, D.C.
-------
Appendix II-l
(continued)
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
GS0091018 Lawrence, J.F. et al (1981) Determination of the Insecticide/
Acaracide Formetanate in Fresh Fruit by Reversal Phase Liquid
Chromotography. Journal Agriculture and Food Chemistry 29:722.
GS0091021 Nor-Am Agricultural Products, Inc. (1972) Formetanate HC1 in or on
Raisins and Dried Prunes (Unpublished study received Mar 1. 1972
under 2F1238; CDL:RCB-117725)
GS0091022 Nor-Am Agricultural Products, Inc. (1970) Residues in Apples and
Pears (Unpublished study received May 22, 1970 under OF0989;
CDL:RCB-116294)
GS0091030 Fletcher, D.; Jenkins, D.H.; Keplinger, M.L. (1971) Acute Oral
Ibxicity Study with Carzol in Mallard Ducks - Report No. J 260
(Unpublished study received on July 7, 1983 under 2139-99; Pre-
pared by Industrial Bio-Test Laboratories, Inc. Submitted by
Nor-Am Agricultural Products, Inc., Naperville, IL.; CDL:250683)
Fletcher, D; Jenkins, D.H.; Keplinger, M.L. (1971) Acute Oral
Ibxicity Study with Carzol in Bobwhite Quail - Report No. J259
(Unpublished study received on July 7, 1983 under 2139-99; Pre-
pared by Industrial Bio-Test Laboratories, Inc. Submitted by
Nor-Am Agricultural Products, Inc., Naperville, IL.; CDL:250684)
GS0091032 Jackson, G.L.; Fancher, O.E.; Calandra, J.C. (1967) Bird Wildlife
Studies EP-332 Ha - Report No. J5354 (Unpublished study received
on August 11, 1983 under 2139-99; Prepared by Industrial Bio-Test
Labs, Inc. Submitted by Nor-Am Agricultural Products, Inc.,
Naperville, IL.; CDL:250995)
GS0091033 Rausina, G. (1975) Four Day Static Aquatic Ibxicity Studies with
Carzol in Grass Shriirp and Shore Crabs - Report No. 621-06936
(Unpublished study received on August 11, 1983 under 2139-99;
Prepared by Industrial Bio-Test Labs, Inc. Submitted by NOR-AM
Agricultural Products, Inc. CDL:250994)
091031
-------
OMB Approval No. 20004468 (Expires 12-31-83)
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" date imposed by the FIFRA section 3{C)(2)(B) notice contained in the referenced
Guidance Document, I em responding in the following menner:
. I will submit date in • timely menner 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(C)(2)(B){ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT "
D 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
D 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
D 5. I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
iPA Form 8580-1 11042)
-------
Appendix III-l
EPA Registration No.
PRODUCT SPECIFIC DATA REPORT
Guidance Document for_
Date
Registration
Guideline No.
SI 58. 20
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
63-13
63-14
63-15
63-16
63-17
63-18
63-19
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
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRIDf
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
63-20
63-21
SI 58. 135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral LD-50,
rat
Acute dermal
ID-50
Acute inhalation,
LC-50 rat
Primary eye
irritation f rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
.
V
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-------
Appendix IV-3
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.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and 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, sparksr 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.
-------
Appendix IV-5
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
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." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under 6 point
Above 10 to 15 8 point
Above 15 to 30 10 point
Over 30 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. 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.
V
-------
Appendix IV-5
(continued)
f 4. Instructions on what to do if the container is damaged in
• any way, or if the pesticide is leaking or has been
j spilled, and precautions to minimize exposure if damage occurs.
i
* 5. General precautions concerning locked storage, storage in
• original container only, and separation of pesticides
i during storage to prevent cross-contamination of other
* pesticides, fertilizer, food, and feed.
I 6. General storage instructions for household products should v-
1 emphasize storage in original container and placement in
f locked storage areas.
i
, B. Pesticide Disposal Instructions;
The label of all products, except those intended solely for
I domestic use, must bear explicit instructions about pesticide
I disposal. The statements listed below contain the exact wording
J. that must appear on the label of these products:
j 1. The labels of all products, except domestic use, must
f 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
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide 'disposal
statement:
•Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance.*
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
-------
Appendix IV-5
(continued)
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
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."
3. 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."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
, 1. All products intended for domestic use must bear one
of the following container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
-------
Container Type
Appendix IV-5
(continued)
Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
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
reused1, 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).
^Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
2. The labels for all other products must bear container
disposal instructions, based on container type, listed
on the first page of this Appendix.
-------
Appendix IV-5
(continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (£)
when discarded.
List)
"Acutely Hazardous* Commercial Pesticides (RCRA *E'
Active Ingredients/ (no inerts);~~
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Nethomy1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
OctamethyIpyrophosphoramide (OMPA, schradan)
Parathion
-------
Appendix IV-5
(continued)
"Acutely Hazardous* Commercial Pesticides (RCRA "E" List)
Active Ingredients continued:
Phenylmercuric acetate (PNA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
(sulfotepp)
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List (RCRA "E" List).
-------
Appendix IV-5
(continued)
•Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients•
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,d)-pentalen-2-one
(kepone, chlordecone)
1t2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-DiChlorobenzene
Dichlorodifluoromethane (Freon 12*)
3,5-Dichloro-N-(1,1-d imethyl-2-propynyl) benzamide (pronamide,Kerb)
Oichloro diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
-------
Appendix IV-5
(continued)
'Toxic* Commercial Pesticide Products
Active Ingredients;
(RCRA *P" List)
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis {3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid,
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3f4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Preon 11*)
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Triehlorophenoxyacetic acid (2,4,5-T)
Xylene
0,0-diethyl, methyl ester
-------
Appendix IV-5
(continued)
'Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients;
I
•
I
Acetone
Acetonitrile
Ace toph e none
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluoromethane (Freon 12*)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichlorofluoromethane (Freon 11 )
Vinyl chloride
Xylene
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, O.C. 20460
OFFICE OF
PUTICIDCK AND TOXIC SUMTANCBS
CERTIFIED MAIL
SUBJECT: Initiation of Reregistration Process for Pesticide
Products Containing Formetanate Rydrochloride as
the Single Active Ingredient
Dear Registrant:
In accordance with the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended, EPA's Office of
Pesticide Programs has begun the reregistration process for
pesticide products containing the subject ingredient. Signifi-
cant changes to the statute were made in 1972, 1975, and
1978; thus, current requirements may be substantially different
from those in effect at the time your product(s) were registered,
The first phase of reregistration requires that you (1) make
a commitment to the Agency regarding data development and
(2) subsequently submit revised product labeling arid associated
information.
This mailing contains the Guidance Document for prepara-
tion of submissions, as well as a listing of your affected
product(s) (Attachment A), and a separate list of registrants
with products subject to this standard and which contain
this active ingredient (Attachment B). The latter list is
for the purpose of cooperative data development.
The Guidance Document sets out the Agency's evaluation
of all available data pertaining to the subject chemical and
its registered uses, and its rationale for the regulatory
actions being taken at this time. Additionally, the Guidance
Document contains instructions describing certain of the
-------
steps you must take to maintain registration for your product(s).
Products not brought into compliance with the Guidance Document
as supplemented by subsequent information from EPA about compliance
with certain data support requirements will be subject to suspension
and/or cancellation.
Specifically,
following:
the enclosed Guidance Document does the
I-
r-
1. Introduces the purpose of this document.
2. Explains the Agency's policy regarding data submis-
sion and identifies, in table format, the data
that must be submitted to complete the Agency's
evaluation of each product. In addition, a
bibliography identifying the data which is considered
part of the data base supporting the registration
standard is included.
3. Sets out time-frames for submission of required
data.
4. Explains how to revise labeling for maufacturing use
products. (As the Guidance Document explains,
labeling is not required at this time.)
5. Provides submission instructions.
Because of the variety and complexity of the requirements,
and the short statutory time-frames available for certain
actions, it is essential that you understand the specific require-
ments and procedures in order that you may respond in a correct
and timely manner. Since a part of these requirements is under
Section 3{c)(2)(B) of FIPRA, your first response may be required
within 90 days from receipt of this letter. Please note that
if you do not respond or do not comply fully with the requirements,
your application may be rejected or your product registration
cancelled or suspended^
If, after reviewing this material, you do not understand
what you must do or how or when you must respond, please contact
the Product Manager listed below who will assist you in every
reasonable way. If you wish to discuss the data requirements
or request that certain data be waived, you must write to the
Agency and indicate those data requirements with which you take
issue and your rationale for doing so. After the Agency has
had a chance to review your submission, the Product Manager will
contact you to set up a meeting for the purpose of resolving all
issues relative to data requirements.
-------
Please note that this guidance document will eventually
be supplemented by EPA with additional information about
compliance with data support requirements. In Monsanto v_,
Adm in is trator, EPA was recently enjoined by the District
Court for the Eastern District of Missouri from implementing
in any way the "mandatory data licensing" aspects of S3(c)(l)(D)
of FIFRA. EPA is assessing the implications of the injunction
for the reregistration process. Because of this unresolved
situation, EPA has decided to proceed with the requirements in
this guidance package which do not relate to the "data licensing1*
issue and to supplement the package with -additional guidance
when circumstances permit.
If you have any questions concerning this Guidance Document,
you may contact the Product Manager listed below:
Product Manager 12
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
Sincerely,
Douglas D. Campt, Director
Registration Division (TS-767)
Enclosure
-------
ATTACHMENT A
PRODUCTS AFFECTED BY THIS
REREGISTRATION PROCESS .
*
Following is a list of your products affected by this rereg-
istration process. If this list is incomplete or inaccurate
in any way, please notify the Product Manager (PM) identified
in the letter.
Product Name
Carzol SP
Formetanate Rydrochloride
EPA Reg. No,
2139-99
2139-114
-------
ATTACHMENT B
REGISTRANTS WITH PESTICIDE PRODUCTS CONTAINING
THE ACTIVE INGREDIENT
The information attached will allow registrants with pesticide
products containing the above ingredient to contact one
another regarding joint data development or sharing the cost
of data development under section 3(c)(2)(B) of FIFRA. This
information includes the following: EPA Reg. No., company
name, company address, active ingredient, percentage of active
ingredient and type of formulation, such as Manufacturing-Use
Product (MUP), Technical Product (TP), Wettable Powder (WP),
and Emulsifiable Concentrate (EC).
EPA Reg. No.
2139-99
2139-114
Co. Name and Address
Nor-Am Agricultural
Products, Inc.
350 West Shuman Blvd.
Naperville, IL 60566
-do-
Active
Ingredient
92%
Formulation
Type
WP
92%
MUP
------- |