GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
CHLORDIMEFORM OR CHLORDIMEFORM HYDROCHLORIDE
AS ACTIVE INGREDIENTS
059701
AND
059702
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
CASE NUMBER 0141
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TABLE OF CONTENTS
Introduction
I. Regulatory Position and Rationale
II. Requirement for Submission of Generic Data
III. Requirement for Submission of Product-Specific
Data
IV. Submission of Revised Labeling
A. Label Contents
B. Collateral Information . .
V. Instructions for Submission. .
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APPENDICES
Page
II-l Guide to Bibliography
II-2 Bibliography
II-3 FIFRA S3(c)(2)(B) Summary Sheet - EPA Form 8580-1 . .
II-4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580-2
III-l Product Specific Data Report (End-Use Products)
11
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA sec. 3(g)) directs EPA to reregister all pesticides as
expeditiously as possible.
To carry out this task, EPA has established the Regis-
tration Standards program, which will review all pesticide
products containing active ingredients first registered before
January 1, 1977. Pesticides generally will be reviewed in
use clusters which have been ranked to give earliest review
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. EPA's reassessment results in the development
of a regulatory position, contained in a Registration Standard,
on each pesticide and its uses. The Agency may require the
registrant to provide additional data to support existing
registration, 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
will not result in unreasonable adverse effects on the environ-
ment. The Registration Standard may lead to initiation of a
Special Review if it appears that use of the product may cause
unreasonable adverse effects on the environment. The Special
Review can result in a decision by the Agency to seek a change
in the conditions of registration, suspension, or cancellation
of the registration.
The scientific review, which is not contained in this
Guidance Package but is available from the National Technical
Information Service, focuses on the technical grade of the
active ingredient a'nd identifies missing generic data.
However, during the review of these data we are also looking
for potential hazards that may be associated with the end use
(formulated) products that contain the active ingredient. If we
have serious concerns, we will address end use products as
part of the Registration Standards program and will propose
regulatory actions to the extent necessary to protect the
public.
EPA has. the authority under FIFRA sec. 3(c)(2)(B) to
require registrants to submit data regarding the hazards
which may result from the intended use of a pesticide.
Although sec. 3(c)(2)(B) provides that all registrants are
responsible for these data, the Agency generally imposes
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generic data requirements only on the registrants of the
manufacturing use products (basic suppliers of the active
ingredient) and other producers who do not qualify for the
formulator's exemption.*
A producer who does not currently qualify but wishes to
qualify for the formulator's exemption may change his source
of supply, to a registered source, provided the source does
not share ownership in common with the registrant's firm. A
registrant may do so by submitting a new Confidential Statement
of Formula, EPA Form 8570-4, identifying the registered source
of "the active ingredient, to the appropriate Product Manager
within 90 days 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 cancel the regis-
tration of any of your products subject to the requirements
of this Guidance Document, please notify the Product Manager
named in the cover letter, within 90 days from the receipt
of this document, if you decide to maintain your product
registration(s), you must provide the information described in
the following pages within the timefra'mes outlined. EPA may
issue a notice of intent to cancel or suspend the registration
of any currently registered product which does not comply
with the requirements set forth in this Guidance Document.
You are reminded that FIFRA sec. 6(a)(2) requires you 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.
*The formulator1s exemption applies to a registrant of a
product if the source of his active ingredient(s): (1) is a
registered product and (2) is purchased from a source which
does not have ownership in common with the registrant's
firm.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
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. .
B. Multiple Active Ingredient
Products
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*
II. Products That Do Qualify For
The Formulator's Exemption
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 product"
will be subject to the labeling changes required for products i
above. If there are no manufacturing use products registered by any
company end use products will be required to be reregistered.
II'
NOTE: If all registrants in "I" above fail to meet the requirements i
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
*• A /*<\ \ •* *• ^*^ ^v* + c n*^ T_K a r% /^ Q
requirements in I-A and B.
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I. REGULATORY POSITION AND RATIONALE
A. j[ntroduction
This chapter contains the Agency's regulatory position and
rationale on manufacturing-use products containing the pesticides
chlordimeform or chlordimeform hydrochloride as sole active
ingredients. The Agency bases its position and rationale on a
consideration of all uses of chlordimeform and chlordimeform
hydrochloride appearing on pesticide products registered under
sections 3 and 24(c) of the FIFRA as well as on products authorized
for distribution in intrastate commerce under 40 CFR 162.17. Both
active ingredients are included in this one Guidance Document,
rather than in separate documents, because of their close chemical
association as well as the similarity of their data bases and use
pattern. The Agency has reviewed the known chemical, environmental,
and toxicological characteristics of these pesticides and
their 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 for registration of chlordimeform and chlordimeform
hydrochloride manufa' uring-use products (MPs) in order for their
products to be registered or reregistered under this Guidance
Document. Unique labeling requirements and certain data needs
for end-use products (EPs) containing either of these active
ingredients are also established by this Guidance Document.
Only those data and labeling requirements for current and future
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substantially similar MPs and EPs are addressed here. Applica-
tions to register products that differ appreciably from those
described in this Guidance Document may be subject to additional
data and/or labeling requirements.
B. Description of Chemical and Use Profile
"Chlordimeform" is the official common name given by the American
National Standards Institute (ANSI), the International Standards
Organization (ISO) and the British Standards Institute (BSD,
for the basic form. Chlordimeform hydrochloride (HC1) is the name
for the hydrochloride salt form. The nomenclature designations
in Acceptable Common Names and Chemical Names for the Ingredient
Statement on Pesticide Labels (U.S. EPA, 4tn edition, December
1979) are as follows:
Chlordimeform (ANSI) = N1-(4-Chloro-o-tolyl)-N,N-
dimethylformamidine
Chlordimeform hydrochloride (ANSI) = N'-(4-Chloro-o-
tolyl)-N,N-dimethylformamidine hydrochloride
Other identifying information and names are as follows:
Chlordimeform;
Molecular formula: C^oH13clN2
Molecular weight: 196.67
Elemental Composition: C-61.0~a, H-6.66%
Cl-18 , N-14.24%
Pesticide Chemical Code No.: 059701
Chemical Abstracts Service (CAS) Registry No.: 6164-98-3
Structural Formula:
Cl-
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Other names are: N1-(4-chloro-2-raethylphenyl)-N,N-dimethyl-
methanimidamide, N'-(4-chloro-o-tolyl)-N,N-dimethylformainidine,
N,N-dimethyl-Nl-(2-methyl-4-chlorophenyl)-formamidine, Acaron
(Schering AG, discontinued), Bermat®, chlorfenamidine,
chlorophenamidin, chlorophenamidine, chlorophenamidine (ISO,
withdrawn), C 8514, Ciba-8514, ENT-27335, EP-333, Fundal® 500,
Fundex® (Schering AG discontinued), Galecron®, RS 141,
Schering 36,268, SN 36268 (Schering AG), Spanon (Nichino;Japan),
Spanone® (Schering AG discontinued), and Spike (Australia).
Chlordimeform hydrochloride;
Molecular formula: C, 0H-, 3C1N2* HC1
Molecular weight: 233.13
Pesticide Chemical Code No.: 059702
Chemical Abstracts Service (CAS) Registry No.: 19750-95-9
Structural formula:
Cl-// \VN=cf HC1
Other names are: N1-(4-chloro-2-methylphenyl)-N,N-dimethyl-
methanimidamide monohydrochloride, N'-(4-chloro-o-tolyl)-N,
N-dimethylformamidine monohydrochloride chlorophenamidine
hydrochloride, ENT-27567, EP-333, Fundal* S Galecron* SP,
and Spanone®.
Chlordimeform is a medium strength base which forms crystalline
salts with strong acids, such as hydrochloric acid. Technical
Chlordimeform is a liquid to partly crystalline solid and is pale
yellow to brown in color. The melting point is 35°C and its boiling
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point is 163°C for the pure active ingredient. It readily
dissolves in organic solvents and hydrolyzes in neutral or
alkaline solutions to form N-formyl-4-chloro-o-toluidine and
then to 4-chloro-o-toluidine.
Technical chlordimeform HC1 is a crystalline powder of white to
tan color. The melting point is 225 to 227°C with decomposition
for the pure active ingredient. Chlordimeform HCl is highly
soluble in water.
Chlordimeform and chlordimeform HCl are manufactured in the
United States by Ciba-Geigy Corporation and Nor-Am Agricultural
Products, Inc. Both companies also produce end-use products,
as does FMC Corporation. There are a total of six products
currently registered which contain chlordimeform as the active
ingredient and five products which contain the hydrochloride.
Ciba-Geigy has two technical products, a 95 percent chlordimeform
and a 95 percent chlordimeform HCl, and two end-use products.
These are Galecron® 4E (48.5% ai) and Galecron SP (95% ai).
Nor-Am has two technicals, a 97 percent chlordimeform, a 97
percent chlordimeform HCl, a 90 percent chlordimeform manufacturing
intermediate product, and two end-use products. The EF re Fundal®
4EC (48.5% ai) and Fundal SP (soluble powder) (97% ai). FMC has
two EPs which are Fundal 4 EC (48.5% ai) and Fundal® SP (97% ai).
There are two Special Local Need (section 24(c)) products and 16
intrastate products.
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Chlordimeform and chlordimeform HC1 are currently registered for
use on cotton as insecticides and acaracides and as yield enhancers
Both pesticides are classified as Restricted-Use which permit
sale and use only by certified applicators or someone under their
direct supervision.
C. Regulatory Background
Chlordimeform and chlordimeform HCl were first registered in 1968
for use on apples. Between 1968 and 1976 the following additional
crops were registered: cotton, pears, cherries, nectarines,
peaches, plums (fresh prunes), broccoli, brussels sprouts, cabbage,
cauliflower, tomatoes, walnuts, seed alfalfa and clover. These
pesticides' major use was on cotton as ovicides and larvicides
against the bollworm and tobacco budworm. In 1976, all crops but
cotton were voluntarily withdrawn by the registrants for the
reasons discussed below. In 1982 the claim that chlordimeform
and chlordimeform HCl perform as cotton yield enhancers was added
to EP labels.
Before 1976, data from rat and dog studies had been generated to
support the chronic toxicology requirements of these pesticides
and their crop tolerances. None of these data demonstrated
carcinogenic effects. However, in 1976 Ciba-Geigy notified the
Agency that it was going to voluntarily initiate an immediate
halt to production, a stop sale and a recall of its products
because preliminary results of a chronic mouse toxicology study
suggested that chlordimeform was causing malignant tumors
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(hemangioendothelioma—tumor of the liver blood vessels). The
other registrants took similar action with their products.
Before the recall took effect in 1976, Ciba-Geigy monitored
workers in production and formulating plants. Chlordimeform and
its metabolites were found in plant workers' urine at levels of 2
to 40 parts per million.
Between the cessation of production in 1976 and 1978, the companies
developed a plan to reintroduce the pesticides for the use on
cotton only. The plan was to minimize exposure to all workers
involved with the mixing, loading and application of the pesticides
to cotton. New use restrictions included: 1) retain the cotton
use only and voluntarily cancel all others; 2) require the use of
protective clothing; 3) use closed systems for mixing and loading;
4) limit application by air only; 5) prohibit the use of flagmen;
6) reduce the maximum application rate on cotton from 1.0 to 0.25
Ib active ingredient per acre (a.i./A); 7) initiate a training and
exposure monitoring program for mixers, loaders and applicators;
and 8) label products with a 1-day reentry restriction. Closed
systems are equipment systems for pesticide storage, transfer,
/
mixing loading and application which have appropriate connections,
meters, pumps and plumbing designed to minimize (ideally, eliminate)
human exposure. Additionally, the Agency imposed the restricted
use classification for all EP products; this classification
requires applicators either to be "certified" or to work under
the direct supervision of a "certified applicator". In accepting
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the companies' plan as amended by EPA, the Agency believed that
implementation of these use restrictions would significantly reduce
the exposure to those involved in applying the products and still
provide pest control for cotton growers. With these modifications,
products were reintroduced in 1978. In 1982, Ciba-Geigy proposed a
cancer statement for its products. The Agency accepted the proposal
and imposed a cancer statement for all products.
D. Current Science Assessment
Toxicology
Oncogenicity
Since 1969 the Agency has received and reviewed 11 chronic feeding
and oncogenicity studies of chlordimeform and chlordimeform HCl and
the metabolites N-formyl-4-chloro-o-toluidine, 4-chlor-o-toluidine
HCl and 4-chloro-o-toluidine in the mouse and rat. Five of these
studies were conducted with the mouse and six with the rat. Most
of these 11 studies were conducted during the 1970's and submitted
to and originally reviewed by the Agency between 1978 and 1981.
The Agency's assessment of these studies reveals that certain
studies are more adequate than others for current testing standards.
Flaws or inadequacies in certain studies include such problems as a
lack in reported detail of methods and results, incomplete raw data
records, and incomplete histopathological examination. However,
because of the unusually high number of chronic studies and the
fact that there is a variety of test materials/test species and
strains combinations (i.e., technical pesticide compounds and
/O
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metabolites tested on different animal species and strains), it is
the Agency's opinion that the full composite of the data is
sufficient to adequately characterize the chronic toxicity and to
satisfy the data requirements.
Five chronic feeding studies were performed in mice. Chlordimeform
HCL, 4-chloro-o-toluidine, and N-formyl-4-chloro-o-toluidine were
each studied once, and 4-chloro-o-toluidine HCL was studied twice.
Four of these studies were considered adequate and they each demon-
strated significant dose-related increases in tumor rates in male
and female mice. The fifth study, an 80-week study of 4-chloro-o-
toluidine, was considered inadequate for a variety of reasons
including: non-treatment related disease in the test animals,
decomposition of tissues, and failure to collect or report data.
Of the four studies which were adequately conducted, three are
particularly useful; the fourth was givin less weight than the other
three for the purposes of this document because it was a bioassay
which was conducted with extremely high dose levels.
In the chlordimeform HC1 study, there was a significant increase
in the numbers of hemangioendotheliomas and hemangiomas in male and
female mice at the higher dosage levels of 100 and 500 ppm. The
lowest effect level (LED was 100 ppm and the no observable effect
level (NOEL) was 20 ppm. In one of the 4-chloro-o-toluidine HC1
studies, hemangioendotheliomas and hemangiomas were produced in
significant numbers in both sexes at the upper three dosage levels
of 20, 100 and 500 ppm; the LEL was 20 ppm and the NOEL was 2 ppm.
In the other 4-chloro-o-toluidine HCl study, an NCI bioassay with
H
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very high dosage levels, heraangiosarcoraas and hemangiomas were
produced at 1250 (lowest dose tested (LOT)) in females and at
15,000 ppm (HDT) in males; the NOEL for males was 3750 ppm. In the
fourth mouse study, N-formyl-4-chloro-o-toluidine was positive for
hemangioendothelioma and hemangiomas at the upper dosage levels of
100 and 500 ppm. The LEL was 100 ppm and the NOEL was 20 ppm.
There are six chronic feeding/oncogenicity rat studies that have
been submitted and reviewed by the Agency. Chlordimeform and
chlordimeform HCl and the metabolites 4-chloro-o-toluidine and
N-formyl-4-chloro-o-toluidine were each tested once and 4-chloro-o-
toluidine HCl was tested twice in the oncogenic studies. Chlordime-
form was tested at dose levels of 100, 250 and 500 ppm in the rat's
diet with no evidence of treatment related oncogenicity.
Chlordimeform HCl was tested at levels of 2, 20, 100 and 500 ppm in
the diet and was negative for oncogenicity. In the 4-chloro-o-
toluidine study, dose levels of 20, 100 and 500 ppm were tested. At
the highest dose level, there was a slight increase in tumor (hepatoma)
incidence compared to the control and the other treatment groups.
However, due to the lack of proper neoplasm characterization, it is
difficult to make a definitive conclusion about oncogenicity in this
study. NCI bioassayed 4-chloro-o-toluidine HCl at levels of 1250
and 5000 ppm for which there were no treatment related increase in
tumors. In the other 4-chloro-o-toluidine HCl study, in which the
dose levels were 2, 20, 100 and 500 ppm, the Agency concluded it was
not oncogenic at the levels tested. In the sixth oncogenic study,
with the N-formyl metabolite, dose levels of 2, 20, 100 and 500 ppm
were tested. At the highest dose level, there was an increase in
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benign cholangiomas. However, because the non-neoplastic histopath-
ology data are missing from the study, the Agency concludes that it
is inadequate to characterize the oncogenic effects. The Agency
believes that these rat studies do not clearly demonstrate that the
parent compounds or their metabolites are oncogenic in the rat.
The Agency's review of the oncogenicity data has resulted in the
classification of chlordimeform and chlordimeform HC1 as "probable
human carcinogens". This classification is based on the weight of
evidence from positive studies with multiple strains in one species
of test animal (mouse) and a dose related increase in the rate of
malignant tumors in that species. Additionally, the mutagenicity
findings, discussed below, support the carcinogenicity evidence.
This classification is based on the Agency's published Proposed
Guidelines for Carcinogen Risk Assessment (FR, 11/23/84). The
weight of evidence presented here falls into the group "B2," or
"probable human carcinogen."
The statistical evaluation of the data from the mouse studies
resulted in multiple potencies of carcinogenicity ranging from 0.5
to 19.2 (mg/kg/day)~l, depending upon the compound (parent or
metabolites) tested, sex of mouse, duration of the study and statis-
tical model. However, the calculated higher potency values (6.5,
12.0, 12.9 and 19.2 (mg/kg/day)"1) are not considered as meaningful
for risk assessment purposes as the other values because 1) the
control animals were not sacrificed until up to 7 1/2 months after
the higher dose animals were sacrificed, 2) because of this
additional life span, the older animals developed tumors and
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3) these circumstances skew the statistical analysis of these data
which result in artificially high potency values. A potency value
of 1.0 (mg/kg/day)~l, which approximates the most common of the
calculated values, was chosen to be used for the risk assessments,
which are presented below in section C., Risk Assessment.
Mutagenicity
The Agency has 20 mutagenicity studies on the technical and
metabolite compounds. From the ten studies with chlordimeform and
chlordimeform HC1, the data do not demonstrate mutagenicity.
However, the data from 10 other studies on metabolites, including
desmethyl chlordimeform (1 study), N-formyl-4-chloro-o-toluidine
(3 studies), 4-chloro-o-toluidine (3 studies), 4-chloro-o-toluidine
HC1 (1 study), 5-chloro-2-toluidine (1 study), and 4-4'-dichloro-2-
2'-dimethyl-azobenzene (1 study) do demonstrate mutagenic effects.
The desmethyl metabolite study suggests a slight increase in the
rate of base substitution mutations in Salmonella typhimurium. One
of the three N-formyl metabolite studies produced a back mutation
in the same test species. The other two studies were not
positive for mutagenic effects. In two of the three 4-chloro-o-
toluidine study, positive mut' enic effects (base substitution in
the above test species) were seen, in the other 4-chloro-o-
toluidine study, which was a mouse spot study, there was increased
incidence of color spots (genetic alteration). 4-chloro-o-toluidine
HCl produced back mutations in S. typhimurium. Both the 5-chloro-
2-toluidine and 4-4'-dichloro-2-2'-dimethyl azobenzene metabolites
were negative for mutagenic effects in S. typhimurium. These
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mutagenicity data suggest a correlation with the oncogenicity data.
The positive mutagenic effects occurred with the metabolites that
produced positive oncogenic effects in the mouse.
Other Chronic Effects
The effects seen in chronic rat studies with chlordimeform were
similar to those seen in a chronic dog study. There was reduced
food intake and growth in males and females at a dietary level as
low as 400 ppm (rat). Methemoglobin formation in female rats
occurred at 20 ppm. Erythrocyte and leukocyte counts, hematocrit,
hemoglobin and serum albumin were decreased as were spleen and
kidney weights (dog). There were also nodules and focal hyperplasia
of hepatocytes and bile duct hyperplasia. The NOELS were 2 ppm
(LOT) in the rat and 250 ppm (LDT) in the dog.
Teratology and Reproduction
Chlordimeform has been tested in two rabbit and one rat teratology
studies and it was not teratogenic at the highest dosages tested--
100 mg/kg (rabbit) and 50 mg/kg (rat). Parental mortality, abortion
rate, ratio of implantations to the corpus lutea, the average
number of pups per litter, incidence of resorptions, fetal weight
and length and the incidence of skeletal and soft tissue anomalies
were not affected. A 3-generation rat reproduction study with
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chlordimeform did not result in any adverse reproduction effects.
At the highest dose tested, 500 ppm, there was a reduced lactation
index and weight of the weanlings. However, the fertility, gestation
and live birth indices, sex ratio, the average number of pups per
litter and birth weight were normal. The fetal NOEL was 250 ppm.
This study was deficient however in detail reported and therefore
it must be upgraded by the submission of this missing detail.
Metabolism
Many of the animal and plant metabolites have not been identified.
However, from the available metabolism data it appears that the
metabolic pathways in animals and plants (cotton) are similar
and result in some of the same metabolites. Certain of these
metabolites (4-chloro-o-toluidine and N-formyl-chloro-o-toluidine)
are carcinogenic, as discussed above. 4-chloro-o-toluidine has
been found in human urine following the handling and application
of chlordimeform.
Metabolism studies in the rat, mouse, dog and goat show similar
qualitative characteristics. After oral dosing, chlordimeform is
quickly absorbed, metabolized and excreted. Within two to three
days, between 70 to 95% of the parent and metabolite t.^e excreted
in the urine and feces. The remaining amounts are incorporated
into tissues (primarily the liver and kidney).
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Acute Toxicity
Chlordimeform and chlordimeform HC1 are of moderate acute toxicity.
Oral LDso's in the rat and dog range from 140 to 406 mg/kg,
respectively. Acute dermal toxicity is moderate with a LD5Q (rabbit)
greater than 4000 mg/kg, mild skin irritation and no sensitization.
Chlordimeform does cause mild eye irritation. Human toxicity
effects include skin rash, abdominal pain, dysuria, urgency to
void, hematuria and hemorrhagic cystitis. These effects were
experienced in nine of 22 exposed workers in 1975 at a Chlordimeform
formulation plant, in which it is thought that these workers were
exposed to abnormally high levels of Chlordimeform.
Exposure
Pesticide Applicator Exposure
As part of this Registration Standard review, the Agency reviewed
exposure data collected by Ciba-Geigy in 1976 and 1977, by Ciba-
Geigy and Nor-Am from 1978 to 1981 under the terms of the
reintroduction program and by the California Department of Food and
Agriculture. Most of these monitoring studies only report the
metabolite residues in the urine of workers associated with the
pesticides' applications to cotton, urine metabolite monitorin^,
rather than dermal exposure sampling, was used as a means to monitor
individual worker exposure to these pesticides. Daily monitoring
was used to determine whether or not an individual's exposure had
reached a threshold level and he would have to refrain from work
until his residue level dropped to an acceptable level. This
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monitoring was not intended to measure dermal exposure.
These data are difficult to compare and evaluate because: 1)
they are in summary form, 2) they are reported in different formats
and presentations, and 3) total daily urine output for individual
workers, total potential worker exposure (dermal and inhalation)
and time and location relationships of exposures to urine samples
are unreported. More specifically, urine samples were collected
after the time period which is expected to have maximum residues;
there is difficulty in relating urine residue levels to total
dermal/body exposure; data are of pooled values rather than
individual, raw data; and, in the case of a dermal exposure study,
there are too few replicates. The Agency is requiring that these
deficiencies be corrected. Even though these deficiencies exist,
these data provide substantial insight to actual exposure levels
through their logical and consistent results. Because these studies
appear to be meaningful despite their deficiencies, they are
discussed below.
Between 1978 and 1981 extensive worker exposure monitoring studies
were performed by Ciba-Geigy and Nor-Am. Urine metabolite data
were collected from workers involved with chlordimeform spray
programs on cotton and in which the reintroduction use restrictions
(including protective clothing) were used. With these restrictions,
the distribution of average daily exposures was as follows: 51
percent of the workers were below the 0.05 ppm level of detection;
33 percent were between 0.05 and 0.29 ppm; 10 percent were between
0.30 and 0.99 ppm; and, 5 percent were 1.00 ppm or greater. This
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distribution was approximately the same for workers in the southeast
U.S., south high plains of Texas, and Mississippi delta cotton areas,
although the product is used primarily in the Mississippi delta.
Of the worker categories, pesticide loaders and maintenance workers
had the highest exposures and site management personnel had the
lowest. Based on these data, the Agency's calculated weighted
average for a daily level of metabolites in the workers' urine
samples is 0.1 ppm.
In 1976 and 1977, Ciba-Geigy conducted studies to compare worker
exposure to chlordimeform from the use of extensive protective
measures versus little or no protective measures. At the time of
the voluntary suspension, the only required worker protection
measure was the use of goggles when handling. The extensive
protective measures were those later proposed and adopted for the
reintroduction program. Exposure was measured by total chlordime-
form metabolites in urine. Without the protection measures, 40% of
the workers had between 0.05 and 0.29 ppm of metabolites in the
urine, 10% had between 0.30 and 0.99 ppm and 50% had 1.0 ppm or
greater. With the extensive protectionary measures, 60% of the
workers had between 0.05 and 0.29 ppm, 20% had between 0.30 and
0.99 ppm and 20% had 1.0 ppm or greater. Also, in the study with
protective measures 60% more active ingredient was applied per day.
Correcting for the greater amount of applied active ingredient that
workers may have been exposed to, there is a 3.6 fold decrease in
exposure from the use of protective clothing and equipment.
-------
In conducting a preliminary exposure assessment of these data,
the Agency also compared data it has received from other sources
because of the difficulties the Agency has with interpretation of
the Ciba-Geigy/Nor-Am data. In 1982 and 1983, the California
Department of Food and Agriculture (CDFA) conducted two exposure
studies of chlordimeform and chlordimeform HC1 for the cotton use.
Potential inhalation and dermal exposure to pilots, mixers/loaders
and flaggers was monitored. Aerial applications of soluble
powder and emulsifiable concentrate formulations were made.
Protective clothing was worn as required by the product labels.
Standard patch techniques were used to measure dermal exposure to
protected and unprotected areas of the body. Average dermal exposure
values for the two studies were: pilots—40 ug/hr, mixer/loaders —
34 ug/hr, and flaggers -- 35 ug/hr. No inhalation residues were
detected. The number of replicates in both studies was low, which
limits the utility of the data and results. The CDFA study notes
that dermal exposures of mixer/loaders might have been lower because
of extraordinary care taken in handling, mixing and loading due to
the workers' knowledge of the monitoring and the presence of
observers.
Also, the Agency compared results from a recent exposure study
conducted by the British Agrochemicals Association, Limited (BAAL).
BAAL monitored the exposure of protective clothing articles of
mixers/loaders to emulsifiable concentrate formulations of other
pesticides. The results were used to model exposure of the pesticide
to unprotected areas. The data were collected in terms of the
amount of exposure per work task rather than by time. However,
-------
after making adjustments for the time required for each task and
for the efficacy of specific articles of protective clothing, these
exposure measurements provide estimates for comparison of exposure
with and without certain protective clothing. This is presented in
more detail in footnote 3 of the table below.
The Agency compared the results of the CDFA studies with its
dermal exposure data base for surrogate pesticides and with studies
conducted by BAAL with surrogate pesticides. The comparative
yearly dermal exposure values for different worker categories is
presented below.
YEARLY EXPOSURE VALUES (mg/kg/year)
Worker
Category
Mixers/
Loaders
Pilots
Flaggers
EPA Data Base
10.3
0.2
0.6
1 CDFA Studies'2 BAAL Studies3
0.03 8.3
0.1
0.002
1 Studies were performed since 1979 with pesticides other than
chlordimeform but with similar formulations. Two studies
were used for the mixers/loaders exposure that used closed
systems and gloves for the workers. The flagger exposure was
reduced by 90% due to protective clothing requirements of the
label.
Studies conducted with very limited number of replicates using
both the SP and the EC formulations. The protective clothing
was worn as per label instructions.
3 This study measured mixer/loader exposure with EC formulations
and provided dermal exposure values assuming no protective
clothing. The exposure value assumes 90% of the dermal expo-
sure to the hands and the use of neoprene gloves which provides
a 90% reduction in hand exposure. Rain suits and aprons .were
assumed to reduce body exposure (other than hands) by 80%. The
use of a closed system was assumed to reduce total dermal
exposure by 90%.
zl
-------
At this time, the Agency believes that the exposure values from its
surrogate pesticide data base and the BAAL study are more accurate
and representative of actual chlordimeform exposure than the Ciba-
Geigy, Nor-Am or CDFA studies. As discussed above, the companies'
data have serious deficiencies and flaws that prevent the Agency
from making reliable and accurate estimates of whole body exposure.
Also, as stated above, the CDFA studies have only a limited number
of replicates which diminishes the reliability of the results.
If the two companies' data can be upgraded so that the Agency can
make reasonably accurate conversions from the urine metabolite data
to total body exposure values, then the Agency will consider these
data for exposure assessments.
Aside from the reported incident of chlordimeform formulation plant
workers which were effected, as mentioned above, the Agency is not
aware of any other incident or accident history with these pesticides.
There are no reported human poisoning cases in the Agency's Pesticide
Incident Monitoring System.
Dietary Exposure
Dietary exposure to chlordimeform and its metabolites results
from consuming cotton seed oil and meal, meat, poultry, eggs, and milk
and other dairy products containing residues of these compounds.
The established tolerances for these commodities range from 5.0 ppm
for the cotton seed oil to 0.25 ppm for the meat and poultry and
0.05 ppm for the eggs, milk and other dairy products. However,
available data suggest that realistically, the residue levels and
intake are more likely to be much lower than the tolerance levels
2.2.
-------
(level of detection is 0.05 ppm) . Historically, not more than 10%
of all cotton acreage is treated with either chlordimef orm or
chlordimeform HCl annually. Further, the available residue data
suggest that the real residues are one to two orders of magnitude
lower than many of the tolerances. For example, studies in food
producing animals have shown detectable residues in only liver and
kidney (about 0.1 ppm), not in muscle, poultry, fat, milk and eggs
which comprise most of the dietary intake for chlordimeform containing
commodities. With the use of these more realistic residue levels
the estimated dietary exposure is about 0.0006 mg/kg/day for the
average adult.
Risk Assessment
Workers
In a preliminary carcinogenicity risk assessment of workers,
the Agency used the dermal exposure values presented above in the
Yearly Exposure Values table. The resulting risk values are as
follows :
ESTIMATED RISKS FOR WORKERS1
Worker Agency Data Base CDFA Studies BAAL Studies
Category
Mixers/
Loaders
Pilots
Flaggers
4
8
2
x
x
x
10-3
10-5
10-4
1
4
8
x
X
X
10-5
10-5
10-7
3 x 10-3
-
-
These values are for the upper 95% level for a B2 oncogen
classification. They also reflect an estimated life expectancy
of 70 years and 35 years working lifetime. The potency factor
for chlordimeform is assumed to be 1.0. Dermal penetration is
assumed to be 30% according to preliminary human studies.
-------
Dietary
Dietary exposure from residues in cottonseed oil and in meat, milk
and eggs from animals consuming cottonseed hulls, results in the
upper bound 95% level of calculated carcinogenicity risk values
from 1 x 10"~4 to 10~7 depending upon residue levels assumed and
the percent of the cotton crop which is assumed to have been treated
with chlordimeform and chlordimeform hydrochloride. The 10~4 risk
level assumes that residues are at the level of detection and that
100 percent of the crop is treated, which is an assumption the
Agency traditionally makes in initial risk assessments.
Historically, between 5 and 10 percent of cotton has been treated
with these active ingredients. Using this estimate and more reason-
able expected residue levels, the dietary risk value is about 10~6
or less. However, both the worker and dietary risks may be under-
estimated because current analytical chemistry methods are not
adequate in detecting or quantifying all metabolites which may be
of toxicological concern in plant and animal tissues.
Environmental Fate
The available environmental fate data are inadequate to fully
characterize the fate of chlordimefor.u a,.d chlordimeform HCl in
the environment. However, the available data do suggest the
following characteristics.
-------
Chlordimeform hydrolyzes at a faster rate with increased pH and
temperature with N-formyl-4-chloro-o-toluidine being the major
hydrolysis product. Under aerobic conditions chlordimeform and
chlordimeform HC1 rapidly dissipate in loam, sandy loam, silt loam
and clay loam soils with half-lives of less than 60 days. These
pesticides may have low potential to leach through soil but are
mobile in runoff sediment. Leaching studies, which are not adequate
by Agency standards, indicate that chlordimeform and chlordimeform
HC1 are relatively immobile in muck, silt loam, silty clay, sandy
loam, silty clay loam and clay soils. The available data are
insufficient to fully characterize the leaching potential and other
environmental fate characteristics although, the potential for
contamination of ground water is thought to be low.
Ecological Effects
Chlordimeform is moderately toxic to both coldwater and warmwater
fish species, whereas available data on the formulated EP products
suggest that they are highly toxic to coldwater fish and moderately
toxic to warmwater fish. Chlordimeform is moderately toxic to
shrimp and oysters. There are insufficient toxicity data on
freshwater aquatic invertebrates and marine/estua- •*> fish.
Emulsifiable concentrate end-use formulations of chlordimeform
are slightly to moderately toxic to birds. Other pertinent
avian toxicity data are unavailable.
-------
E. Regulatory Position and Rationale
Based on the review and evaluation of available data and other
relevant information on chlordimeform and chlordimeforra HCl, the
Agency has made the following determinations:
Position 1
All products containing either chlordimeform or chlordimeform HCl
as sole active ingredients may continue to be registered for
sale, distribution, reformulation and use only on cotton and
subject to the terms and conditions specified in this Guidance
Document. Registrants must agree to develop and provide additional
data as specified in tables A and B in order to maintain existing
registrations or to obtain new registrations. Additionally, the
Agency is planning to proceed with a Special Review of chlordimeform
and chlordimeform HCl because of the carcinogenic potential
indicated above.
Rationale;
As discussed above in the Current Science Assessment section,
four mouse studies demonstrated a dose response for the formation
of hemangioendothelioma, hemangiosarcomas or hemangiomas fror..
lifetime feeding of chlordimeform HCl or one of two known
animal metabolites. The weight of the evidence from these
-------
four studies fully support the conclusion of carcinogenicity.
Further, mutagenicity studies with positive responses support this
carcinogenic response. Worker exposure studies have shown the
presence of one of these oncogenic metabolites in urine following
exposure to either chlordimeform or chlordimeform HCl. From these
findings, the Agency has classified these pesticides as B2 — a
probable human carcinogen. Applicator carcinogenic risk ranges from
about 10~3 to 10~6, when application is made under the required
stringent worker protection measures. The preliminary dietary risk
from the cotton use ranges from about 10"^ to 10"^, depending upon
assumptions used in the risk calculations. Therefore, as a result
of these findings and conclusions, the Agency is initiating its
Special Review of risks and benefits for these two pesticides.
Position 2
The Agency is requiring the submission of additional data in order
for the Agency to complete its scientific and regulatory assessment
of chlordimeform and chlordimeform HCl. The required additional
data are to be from studies on analytical chemistry, plant and
animal metabolism, animal reproduction, worker exposure, environ-
mental fate and avian, freshwater invertebrate and fish toxicity.
Rationale
The current data base is inadequate to enable the Agency to assess
fully the potential effects of chlordimeform and chlordimeform HCl
on man and the environment. Therefore, additional data are required
in order that this assessment can be made.
27
-------
The available chemistry data indicate that many of the plant and
animal metabolites may become conjugated with tissues. Animal
metabolism data suggest that up to 95% of all parent and metabolite
compounds are excreted within three days. Nevertheless, the
remaining metabolites have not been adequately identified or quan-
tified. Thus, the Agency is unable to determine whether or not
they may be of toxicological concern. New studies and improved
detection methods are required so that the Agency can better assess
the metabolism of chlordimeform and chlordimeform HC1 in plants and
animals and in so doing can refine its assessment of exposure and
the adequacy of established tolerances.
The reproduction data requirement has not been satisfied because
necessary detail and raw data were omitted from the submission.
These deficiencies impede the Agency's effort to make a complete
assessment of the adequacy of the study and chlordimeform1s and
chlordimeform HCl's potential effects on animal reproduction.
However, the available data do not suggest any adverse reproduction
effects. If these deficiencies cannot be corrected, a new
reproduction study will be required. Except for this data gap and
the animal metabolism deficiency discussed above, all other
toxicology requirements are satisfied.
Additional information is being required on dermal exposure to
workers involved in chlordimeform and chlordimeform HCl applications
to cotton. These data are needed in order for the Agency to refine
exposure and risk estimates. Extensive data have been submitted to
-------
the Agency; however, these data are difficult to interpret into
total body exposure. The majority of these data are of metabolite
residue values from workers' urine samples. There are also some
data on dermal exposure. However, there are serious flaws with all
of the studies and the manner in which the data were reported.
Therefore, the Agency is requiring that these studies be upgraded
by Ciba-Geigy and Nor-Am, if possible. Otherwise, additional
studies will be required.
The Agency is requiring additional environmental fate data because
the available data, as summarized in the Current Science Assessment
above, are not sufficient to fully assess the environmental fate of
these pesticides, including a complete characterization of their
leaching and ground water contamination potential.
The current ecological effects data base on chlordimeform and
chlordimeform HC1 is insufficient to adequately characterize the
potential toxicity to birds, freshwater invertebrates and estuarine/
marine fish. Acute oral and dietary toxicity studies on birds are
required so that the Agency can assess the hazard potential to avian
species from consuming food items contaminated with chlordimeform
and chlordimeform HC1 associated with cotton field applications. An
avian reproduction study is required because of the potential exp??:n
from multiple applications to cotton fields prior to and during the
breeding season of several upland game species which inhabit cotton
fields. Data on the toxicity to freshwater invertebrates and
marine/estuarine fish are required because of the pesticides'
-------
potential to runoff into and be used near aquatic systems.
Depending upon the Agency's conclusions from its assessment of
these required data, additional studies, including field testing
for birds and aquatic organisms, may be required. Also, these
conclusions may lead to the requirement for an endangered species
label warning.
Position 3
The Agency is imposing current and new label requirements that will,
in effect, help to reduce and minimize worker exposure and therefore,
decrease the carcinogenic risk and other hazards to workers. All
end-use chlordimeform or chlordimeform HCl products will continue
to be classified as Restricted-Use and the restricted-use label
statement will include a carcinogenicity statement as the reason
for the classification. A cancer warning statement will also be
retained for the manufacturing-use product labels.
All end-use products will continue to be labeled for the cotton use
only and with the use restrictions of: 1) closed systems for
mixing and loading, 2) protective clothing, 3) 0.25 Ib ai/A
application rate, 4) training and monitoring programs for workers
-iic. 5) Restricted use classification.
The Agency is changing the field reentry interval when protective
clothing is not required to be worn from 1 day to 5 days.
-------
Rationale
For the reintroduction of chlordimeform and chlordimeform HC1 in
1978, the Agency required that all products be labeled with the
restricted use statement. In 1982, Ciba-Geigy proposed to add a
cancer warning statement to its end-use product labels. In
response to this proposal the Agency imposed a cancer warning
statement for labels of all registered end-use and manufacturing-
use products. Since the Agency has determined that these active
ingredients are carcinogens, continuation of the restricted use
requirement and a cancer statement are warranted. The Agency
also believes that combining these two label statements on the EP
label will be more informative by providing the reason that the
products are classified for restrictive use.
The Agency believes that the use of closed systems, protective
clothing, a maximum application rate of 0.25 Ib ai/A, and worker
training and monitoring programs, as well as the restricted use
classification and the cancer statement discussed above, will
result in reduced exposure to chlordimeform and chlordimeform
HC1. These use restrictions provide the maximum protection from
exposure tha' -^n reasonably be obtained at this time.
The Agency is increasing the reentry interval because the data
base for dislodgeable residues of chlordimeform on cotton leaves
indicates that by five days the remaining dislodgeable residues
have dissipated to an acceptable exposure level.
3!
-------
After one day, the remaining dislodgeable residues are 0.17 ug/cm2,
or about 8-fold greater than the calculated allowable exposure level,
Whereas, after five days the residues are 0.02 ug/cm2, which are low
enough to give a field worker an exposure that is equal to or less
than the calculated allowable exposure level for these pesticides.
Therefore, the Agency believes it is prudent to lengthen ;_he
reentry period without the use of protective clothing to minimize
exposure to these chemicals.
The specific label statements that are imposed under these
regulatory positions are presented in section F below.
Position 4
Other use/label restrictions are imposed. All EP labels must have
use restrictions requiring a 21-day preharvest interval, prohibit-
ing the feeding of treated foliage or gin trash to livestock, and
prohibiting the grazing of livestock in treated areas. Also, all
EP labels must have a statement in the environmental hazards
section that warns of these pesticides' toxicity to fish.
Rationale
The residue chemistry d<- -a oase supports the established tolerances
associated with the use on cotton (refer section G, Tolerance
Reassessment Summary, below) provided that the above restrictions
are followed. The specific restrictions are presented in section
F below. The livestock feeding restriction does not include the
feeding of cottonseed hulls and oil to livestock. Both cottonseed
32-
-------
hulls and oil have established tolerances which are supported by
adequate residue data. Also, the tolerances for meat, milk,
poultry and eggs are supported by data which demonstrate that the
cottonseed hulls and oil with residues at their tolerance levels
can be fed to livestock. Similar data do not exist for foliage
or gin trash, herice the res Lrict-ion.
A fish toxicity label statement is required because the acute
toxicity data on an EP product formulation demonstrated high
acute toxicity to a representative coldwater fish species (rainbow
trout) and moderate toxicity to a warmwater species (bluegill
sunf ish) . Also, environmental fate data suggest that these
pesticides are mobile in runoff sediment which may contaminate
aquatic habitats. Therefore, a fish toxicity statement is required
to inform users of this potential hazard. The specific label
requirement is presented in Section F below.
Position 5
Registrants of end-use products must submit revised labeling
which incorporates the label changes specified in Section F below.
Rationale
The Agency believes that the label requirements prescribed in
this Guidance Document should promote reduced exposure and hazards
to workers and to the environment. As discussed above, the
extensive use restrictions, including the use of protective
clothing, closed systems and use by or under supervision of
-------
certified applicators, should reduce dermal exposure to workers
and, the environmental precautions should aid in reducing hazards
to fish and wildlife.
Position 6
The Agency will propose the revocation of established tolerances
of chlordimeform and chlordimeforra HCl associated with those
uses which were voluntarily withdrawn and removed from labels in
1978. The associated crops are listed above in Section B.
Rationale
The subject crop uses have been withdrawn since 1978; therefore, it
is not necessary to maintain tolerances for these uses. It is
reasonable to assume that all existing stocks of products which
were labeled for these uses have been used or recalled by the
registrants and therefore, it is unlikely these crops would have
residues in the future. Also, tolerance revocation would provide
a means of restricting the importation of commodities with residues,
D. Criteria for Registration Under This Standard
To be covered under this Guidance Document, prCv-uc_s must contain
chlordimeform or chlordimeform HCl as the sole active ingredient,
bear required labeling, and conform to the product composition,
acute toxicity limits, and use pattern requirements listed in
Section E of this document.
-------
The application for registration or reregistration of manufacturing-
use products subject to this Guidance Document must comply with
all terms and conditions described herein, including submission
of an up-to-date Confidential Statement of Formula, submission of
revised labeling, commitment to fill data gaps on the schedule
ipecifj.ec oy the Agency and, when applicable, offer to pay compen-
sation as required by 3(c)(l)(D) and 3(c)(2)(D) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended,
7 U.S.C. 136(c)(l)(D) and 136(c)(2)(D).
E. Acceptable Ranges and Limits
Product Composition Standard
To be covered under this Guidance Document, manufacturing-use
products must contain either chlordimeform or chlordimeform HCl
as the sole active ingredient. Each manufacturing-use product
formulation proposed for registration must be fully described
with an appropriate certification of limits, stating maximum and
minimum amounts of the active and intentionally added inert
ingredients which may be present in products.
Acute Toxicity Limits
The Agency will consider registration of technical grade and
manufacturing-use products containing chlordimeform or chlordime-
form HCl provided that the product labeling bears appropriate
precautionary statements for the acute toxicity category in which
each product is placed.
-------
Use Patterns
To be registered under this Standard, manufacturing-use products
containing chlordiraeform or chlordimeform HCl must be labeled
for formulation into other manufacturing-use products or into
end-use products only for the use on cotton. The attached index
entry provides the approved maximum application rate and
frequencies.
F. Required Labeling
All manufacturing-use and end-use chlordimeform and chlordimeform
HCl products must bear appropriate labeling as specified in 40
CFR 162.10. The Guidance Document for this Standard contains
information on label requirements.
Ingredient Statement
The ingredient statement for manufacturing-use products and
end-use products must list active ingredient as:
Chlordimeform: N1-(4-Chloro-o-tolyl)-N,N-dimethyl
f ormamidine %
Chlordimeform hydrochloride: N1-(4-chloro-o-tolyl)-
N,N-dimethyl formamidine
hydrochloride
-------
Statements For End-Use Products
1. All end-use products must bear the restricted-use statement
with the second paragraph in caps as it appears below:
RESTRICTED USE PESTICIDE
For retail sale to and use only be certified
applicators or tj--rcons under their direct
supervision and only for those uses covered
by the certified applicator's certification.
BECAUSE CHLORDIMEFORM HAS BEEN SHOWN TO CAUSE
CANCER IN LABORATORY MICE, THIS PRODUCT MAY
BE APPLIED ONLY BY CERTIFIED APPLICATORS OR
PERSONS UNDER THEIR DIRECT SUPERVISION. USE
OF PROTECTIVE CLOTHING AND EQUIPMENT AND
FOLLOWING THE USE PRECAUTIONS BELOW CAN REDUCE
RISK.
2. The reentry statement below must appear in the use directions
of labels of all products with directions for use on cotton:
Do not reenter treated areas for 5 days without wearing
protective clothing.
3. The preharvest interval, feeding and grazing restrictions below
must appear in the use directions of labels of all products
with directions for use on cotton:
To avoid illegal residues, 1) do not apply within 21 days
of picking, including when mixed with other pesticides
2) do not feed foliage from treated cotton plants or crop
residues, such as gin trash to livestock and 3) do not
allow livestock to graze treated areas.
4. The worker protection statements listed below must appear as
part of the precautionary statements for all end-use
products:
During mixing/loading or application wear a
protective suit which has long sleeves and long
pants. Wear chemical resistant gloves, a hat,
boots and goggles or a face shield. A helmet
37
-------
with visor may be substituted for the hat and
goggles during aerial application. Mixer/
loaders must also wear a chemical resistant
apron when handling the concentrated product.
Wash thoroughly with soap and water after
handling and before eating, urinating, or
smoking. Remove and wash clothing before
reuse. Clothing must be laundered separately
from household articles. Replace gloves
frequently. Clothing which has been drenched
and used gloves must be disposed of in
accordance with state and local regulations.
Instead of clothing and equipment specified
above, the applicator can use an enclosed
tractor cab or cockpit with properly filtered
air supply.
5. The following environmental hazards statement must appear on
each end-use product label in the Environmental Hazards
section:
This product is toxic to fish. Do not apply
directly to water or wetlands. Drift or runoff
from the treated areas may be hazardous to
aquatic organisms in neighboring areas. Do
not contaminate water by cleaning of equipment
or disposal of wastes.
Statements For Technical and Manufacturing-Use Products
1. The following environmental hazards statement must appear on
each technical and manufacturing-use product label in the
Environmental Hazards section:
This pesticide is toxic to fish. Do not discharge into
lakes, streams, ponds estuaries, oceans, or public water
unless this 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 in writing.
For guidance, contact your State Water Board or Regional
Office of the EPA.
-------
2. The following cancer warning must appear in caps on labels of
technical and manufacturing-use products:
THIS PRODUCT HAS BEEN SHOWN TO CAUSE CANCER IN LABORATORY
ANIMALS. THE USER MUST READ AND FOLLOW ALL PRECAUTIONARY
STATEMENTS AND INSTRUCTIONS.
G. Tolerance Reassessment Summary
40 CFR section 180.285 and 21 CFR sections 193.60 and 561.80
list the various established tolerances for chlordimeform and
chlordimeform HC1 and their metabolites that contain the 4-chloro-
o-toluidine moiety. These are as follows:
Crop Tolerances(ppm)
Pears 12.
*Cottonseed oil 5.
*Cottonseed hulls 10.
Cherries 5.
Nectarines 5.
Peaches 5.
Plums, incl. fresh prunes 4.
Prunes, dried 15.
Apples 3.
Apple pomace 25.
Broccoli 2.
Brussel sprouts 2.
Cabbage, sauerkraut 2.
Cauliflower 2.
Tomatoes 1.
*Cattle 0.25
*Goats 0.25
*Hogs 0.25
*Poultry 0.25
*Sheep 0.25
*Horses 0.25
*Eggs 0.05
*Milk & Dairy Products 0.05
Walnuts 0.10
*Tolerances which are associated with the application to cotton.
The above tolerances were established between 1968 and 1976 and
were based on a chronic toxicity data base that included subchronic
-------
feeding, teratology, reproduction and chronic feeding studies. A
dog chronic feeding study was used to establish a no-observable-
effect level (NOEL) for both active ingredients. This NOEL was
6.25 mg/kg/day, which factored into an Acceptable Daily Intake
(ADI) of 0.062 mg/kg/day.
A rereview of the chronic toxicology data base discloses a lower
NOEL (0.1 mg/kg/day) based on a more recent rat chronic feeding
study and upon the formation of methemoglobin.
The new ADI is calculated to be 0.001 mg/kg/day. The percent of
the new utilized ADI based upon all previously issued tolerances
is 671 percent for the general population. However, since the
current label carries use directions for cotton only, the percent
of the utilized ADI, based upon the application to cotton and the
associated animal product tolerances, is 134 percent for the
general population. This latter calculation is based on the
Agency's new Tolerance Assessment System (TAS). However, from
the TAS analysis it suggests that children, of the 1 through 6
years age group, have a dietary intake that exceeds the current
ADI by 307 percent. The Agency believes that this intake value
is artifici ly high because it is derived from the assumption that
all dietary items will be at tolerance residue levels. This
unrealistic intake, which was explained in the Dietary Exposure
section of the Current Science Assessment, below, suggests that
the realistic dietary intake is less than the ADI.
40
-------
The metabolism of chlordimeform has not been adequately described,
Should the required metabolism data indicate the presence of
additional metabolites of concern, the tolerance definition will
be revised accordingly. Also, the Agency will propose the
revocation of those tolerances for which there are no associated
registered uses.
Codex has established Maximum Residue Limits which are temporary
because Codex considered the ADI to be temporary. Codex is
not permitting residues above the level of detection (0.05 ppm)
on or in cotton seed and cotton seed oil, meat from cattle, pigs
and sheep, poultry, milk and milk products. Therefore, no
harmonization with U.S. tolerances is possible except for milk
and milk products.
There are no Canadian or Mexican tolerances for chlordimeform.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORDIMEFORM AND CHLORDIMEFORM HYDROCHLORIDE (HCl)
Guideline Citation and
Name of Test
§158.120 Product Chemistry
Product Identity:
ox L jri.*JvJUC-c icicnciuy arid uiodc/yuLfc?
of Ingredients
61-2 - Description of Beginning Materie
and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - rreliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods to Verify
Certified Limit
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
Test
Substance^
TGAI
Jls TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Guidelines
Status
R
R
R
CR
R
R
R
R
R
Are Data Footnote
Required ? Number
Yes No
[xj
[x]
[x]
fxj
[x]
lx]
[x]
[x]
I 1 3
n 4
n s
n e
n
n
n
n
n
Data Must Be
Submitted Within
Time Frames Listed
Below 2
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
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TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORDIMEFORM AND CHLORDIMEFORM HYDROCHLORIDE (HCl)
Guideline Citation and Test Guidelines
Name of Test Substance! Status
Are Data Footnote
Required ? Number
Yes No
Data must Be
Submitted Within
Time Frames Listed
Below 2
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-5 - Melting Point TCAI R
63-6 - Boiling Point TCAI R
63-7 - Density, Bulk Density, or TCAI R
Specific Gravity
63-8 - Solubility TCAI or PAI R
63-9 - Vapor Pressure PAI R
63-10 - Dissociation constant PAI R
63-11 - Octanol/water partition PAI R
coefficient
63-12 - pH TCAI R
63-13 - Stability TCAI R
Other Requirements:
(xJ
[x]
[x]
[x]
[x]
[x]
[x]
[xl
[x]
[ ]
n
n
I 1 7
n
n
n
n
n
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
64- 1 - Submittal of samples
TCAI, PAI
CR
Reserved 8
6 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDIMEFORM AND CHLORDIMEFORM HYDROCHLORIDE (HCl)
Data must Be
Guideline Citation and Test Guidelines Are Data Footnote Submitted Within
Name of Test Substance! Status Required ? Number Time Frames Listed
Yes No Below 2
§158.120 Product Chemistry (Continued)
1 Test substances are for both chlordimeform and chlordimeform hydrochloride. TGAI = Technical Grade of the Active
Ingredient; PAI = Pure Active Ingredient; R = Required; CR = Conditionally Required.
2 Data must be submitted within the indicated timeframes which begin on the date of this Guidance Document.
3 Current data on the manufacturing of technical chlordimeform lacks essential detail and is considered out-of-date.
4 All manufacturing procedures now in actual use must be submitted for each registered technical product.
5 The Agency has no data on the formation of unintentional ingredients. Data are required on each impurity believed
to be present at _>. 0.1%, based on the knowledge of starting materials, all possible chemical reactions and any
contamination. Also, the possibility of the presence or absence of nitrosamines must be addressed.
6 Current data are obsolete, therefore up-to-date data mast be submitted on the identity of every ingredient present
or intentially added, if _> 0.1% by weight. Five or mo/re representative samples must be analyzed by appropriate
method(s) and described in detail with a statement of the precision and accuracy, including methods for nitrosamines
if present. Certification of limits of all ingredients, including impurities, and the analytical method(s) and data
are required.
7 Quantitative data are required.
8 Reserved pending Agency decision as to whether the samples are required.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDIMEPORM AND CHLORDIMEPORM HYDROCHLORIDE (HC1)
Data Requirements
Compositionl
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
PIFRA § 3(c)(2)(B)7
Timeframes For Data
Submission 2
§138.125 Residue Chemistry
171-2 - Chemical Identity TGAI
171-3 - Directions for Use
171-4 - Nature of Residue (Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical Method
- Plant residues
- Animal residues
171-4 - Magnitude of the Residue-
Residue Studies for Each
Pood Use
Cotton
— Crop field trials TEP
Yes
PAIRA
PAIRA and Plant
Metabolites
TGAI and Metabolites
TGAI and Metabolites
Partial
Partial
No
No
Yes
00098977, 00100811
00099014, 00073479
00104272, 00103369
00098991, 00087052
00087053, 00087056
00087050, 00087051
00087054, 00087055
00097467,
00036949,
00069682,
00102410,
00098957,
00086695
00080099
00099031
00099011
00087046
No
No
Yes3 18 Months
Yes3,4 18 Months
Yes5 15 Months
Yes5 15 Months
Reserved
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORDIMEFORM AND CHLORDIMEFORM HYDROCHLORIDE (HCl)
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA S 3(C)(2)(B)?
Timeframes For Data
Submission 2
§158.125 Residue Chemistry - Continued
— Processed Food/Feed
— Meat/Milk/Poultry/Eggs
Other crops?
EP
TGAI or Plant
Metabolites
Yes
Yes
00098959
00087045, 00087049
00087059, 00098959
No6
1 Composition is for both chlordimeform and chlordimeform hydrochloride. TGAI = Technical grade of the active ingredi-
ent; PAIRA = Pure active ingredient, radiolabelled; TEP = Typical end-use product; EP = End-use product.
2 Data must be submitted within the indicated timeframe which begins on the date of the Guidance Document.
3 Existing data indicate that many of the plant and animal metabolites are conjugated with tissues. These conjugated
metabolites remain unidentified and may be of toxicological concern. These metabolites must be identified and
quantified.
4 Data must be submitted on poultry metabolism. The requirement on swine metabolism is reserved until the review of
poultry data.
5 Analytical methods for plant and animal metabolites must be improved to identify conjugated metabolites that may be
of toxicological concern.
6 Additional data may be required in the future if the required plant and animal metabolism studies show new meta-
bolites of toxicological concern.
7 Tolerances exist for the additional following crops: apples, broccoli, brussels sprouts, cabbage, cauliflower,
cherries, nectarines, peaches, pears, plums or fresh prunes, tomatoes and walnuts. However, the adequacy of the
supporting data for these tolerances is not presented here because there are no longer registered uses for these
crops and because the Agency intends to revoke these tolerances.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDIMEFORM AND CHLORDIMEFORM HYDROCHLORIDE (HCl)
Data Requirement
§158.130 Environmental Fate
DEGRADATION STUDIES- LAB:
161-1 - Hydrolysis
Pho todeg rada t ion
161-2 - In water
161-3 - On soil
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
MOBILITY STUDIES:
163-1 - Leaching and
Adsorp t ion/De-
Use
Composition* Pattern2
TGAI or PAIRA base
TGAI or PAIRA HCl
TGAI or PAIRA base
TGAI or PAIRA HCl
TGAI or PAIRA base
TGAI or PAIRA HCl
TGAI or PAIRA base
TGAI or PAIRA HCl
TGAI or PAIRA base
TGAI or PAIRA HCl
TGAI or PAIRA base
TGAI or PAIRA HCl
A
A
A
A
A
A
A
A
A
A
A
A
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Partial
No
No
No
No
No
NO
No
No
No
Partial
No
Must Additional Data
Be Submitted Under
Bibliographic FIFRA § 3(c)(2)(B)?
Citation Time Frame for Data
Submission 3
00098998 Yes*
Yes5
Yes5
Yes5
Yes5
Yes5
Yes5
Yes5
Yes5
Yes5
00044017 Yes5
Yes5
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
27 Months
27 Months
27 Months
27 Months
12 Months
12 Months
sorpt ion
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDIMEFORM AND CHLORDIMEFORM HYDROCHLORIDE (HCl)
Data Requirement
Campositionl
Use
Pattern2
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA S 3(c)(2)(B)?
Time Frame for Data
Submission 3
§158.130 Environmental Fate - Continued
DISSIPATION STUDIES-FIELD:
164-1 -
164-5 -
Soil
Soil, Long-term
TEP base
TEP HCl
TEP base
TEP HCl
A
A
A
A
NO
No
No
NO
Yes5
Yes5
Yes5
Yes5
27 Months
27 Months
50 Months
50 Months
ACCUMULATION STUDIES:
165-1 -
165-2 -
165-4 -
Rotational Crops
(Confined)
Rotational Crops
(Field)
In Fish
PAIRA base
PAIRA HCl
TEP base
TEP HCl
TGAI or PAIRA base
TGAI or PAIRA HCl
A
A
A
A
A
A
NO
NO
NO
No
NO
No
Yes5
Yes5
Yes5
Yes5
Yes5
Yes5
39 Months
39 Months
50 Months
50 Months
12 Months
12 Months
1 Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2 The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dcmestic Outdoor; I=lndoor.
3 Data must be submitted within the indicated time frames which begin on the date of the Guidance Document.
4 Data are required for chlordimeform HCl.
5 Studies may be conducted with either chlordimeform or chlordimeform HCl to satisfy the data requirement.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORDIMEFORM AND CHLORDIMEFORM HYDROCHLORIDE (HC1)
Data Requirement Compositionl
§158.135
Toxicology
Use
Pattern^
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
Tli is Require- Bibliographic FIFRA § 3(c)(2)(B)?
ment? (Yes, No Citation Time Frame for Data
or Partially) Submission 3
ACUTE TESTING:
81-1 -
81-2 -
81-3 -
81-4 -
81-5 -
81-6 -
Oral LDso
Dermal LDcQ
Inhalation LC^0
Primary Eye Irritation
Primary Dermal Irritation
Dermal Sensitization
TGAI base
TGAI HC1
TGAI base
TGAI HC1
TGAI base
TGAI HC1
TGAI base
TGAI HC1
TGAI base
TGAI HC1
TGAI base
TGAI HC1
A
A
A
A
A
A
A
A
A
A
A
A
Yes
Yes
No4
Yes
No4
Yes
Yes
No4
Yes
Yes
Yes
Yes
00066882 ,00082200 ,0098918 ,
00066883
00066886 ,00082202 ,0082203
00078159
00066822
00066872
00066884
00098901
00098919
00098919,00098901
00066872
No
No
No
No
No
No
No
No
No
NO
No
No
SUBCHRDNIC TESTING:
82-1 -
82-2 -
90-Day Feeding - Rodent
and Non-Rodent
21-Day Dermal
TGAI base
TGAI HC1
TGAI base
TGAI HC1
A
A
A
A
Yes
No4
Yes
Yes
00098914,00098913
00066872
00098920
NO
No
No
NO
''-I-;
-------
TABLE A
GENERIC DATA REQUIREMENTS POR CHDORDIMEFORM AND CHLORDIMEPORM HYDROCHLORIDE (HCl)
Data Requirement
§158.135
Toxicology - Continued
Composition!
Use
Pattern2
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
This Require- Bibliographic FIFRA § 3(c)(2)(B)?
ment? (Yes, No Citation Time Frame for Data
or Partially) Submission 3
CHRONIC TESTING:
83-1 -
83-2 -
83-3 -
83-4 -
Chronic Toxicity -
2 species:
- Rodent
- Non-rodent (Dog)
Oncogenicity -
2 species:
- Rat
- Mouse
Teratogenicity -
2 species:
- Rat
- Rabbit
Reproduction - Rat
2-generation
TGAI base
TGAI HCl
TGAI base
•IGAI HCl
TGAI base
TGAI HCl
TGAI base
TGAI HCl
TGAI base
TGAI HCl
TGAI base
TGAI HCl
TGAI base
TGAI HCl
A
A
A
A
A
A
A
A
A
A
A
A
A
A
Yes 00067569
Yes 00072168
Yes 00066887
Yes 00067569 ,00072168 ,00097888
00079920 ,00070981 ,00070982
00070983
Yes 00081013,00081041,00070979
00070980,00070983
Yes 00079934
Yes 00082198
Partial 00066881 ,00082199 ,00099009
No
NO
NO
No
No
NO
NO
No
No
NO
NO
NO
Yes5 6 Months
Yes5 6 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDIMEFORM AND CHLORDIMEFORM HYDRQCHLORIDE (HCl)
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Data Requirement
Use
Composition^ Pattern^
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3
§158.135 Toxicology - Continued
MUTAGENICITY TESTING
84-2 - Gene Mutation
SPECIAL TESTING
85-1 - Animal Metabolism
TGAI base
TGAI HCl
TGAI
Yes
Yes
Partial
00079923,
00079927,00087382
00079932,00079928
00042258,00079931,
00079924
00087050,00087051
00087054,00087055
No
No
Yes6
18 Months
Composition:PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabelled; Choice = Choice of several
test substances determined on a case-by-case basis.
The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aqautic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dcmestic Outdoor; I=Indoor.
Data must be submitted within the indicated time frames which begin on the the date of the Guidance Document.
Toxicology data on the technical base will support the technical HCl and vice versa.
The reproduction study did not contain enough data to make an adequate evaluation. The registrant is required
to submit the raw data and additional detail within 6 months. If these data are not available or if they
do not fulfill the requirements, a new reproduction study will be required.
Refer to GENERIC DATA REQUIREMENTS for residue chemistry, requirement 171-4, above, for an explanation of this entry.
Data applies to both the COM base and salt form.
Presently not a requirement. May have to be addressed depending upon the results of the environmental fate analysis.
This analysis was performed on COM base, salt and metabolite data.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR. CHLORDIMEFORM AND CHLORDIMEPORM HYDROCHLORIDE (HCl)
Must Additional Data
Be Submitted Under
FIFRA § 3(C)(2)(B)?
Time Frame for Data
Submission 3
Data Requirement
Use
Ccmpositionl Pattern2
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
§158.140 Reentry Protection
132-1 - Foliar Dissipation TEP
132-1 - Soil Dissipation TEP
133-3 - Dermal Exposure TEP
133-4 - Inhalation Exposure TEP
§158.142 Spray Drift
201-1 - Droplet Size Spectrum TEP
201-1 - Drift Field Evaluation TEP
A
A
A
A
A
A
Yes
NO
Partially
No
No
No
00099029
00085918
00099027
No
No
Yes 4
No
No
No
15 Months
1 Composition: TEP = Typical end-use product of either chlordimeforra or chlordimeform HCl.
2 The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAguatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dcmestic Outdoor; l=Indoor.
3 Data must be submitted within the indicated time frames which begin on the date of the Guidance Document.
4 Data on file with the Agency lacks sufficient detail and samples or it is inappropriate in which to determine
total body exposure. A new dermal exposure study is required. A protocol must be submitted and accepted by the
Agency.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDIMEPORM AND CHLORDIMEPORM HYDROCHLORIDE (HC1)
Data Requirement
Composition!
Use
Pattern2
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LDcn
71-2 - Avian Dietary
a. Waterfowl
b. Upland Game
71-4 - Avian Reporductlon
a. Waterfowl
b. Upland Game
71-5 - Simulated and
Actual Field Testing
for Mammals and Birds
TGAI base
TGAI HC1
TGAI base
TGAI HC1
TGAI base
TGAI HC1
TGAI base
TGAI HC1
TGAI base
TGAI HC1
TEP
A
A
A
A
A
A
A
A
A
A
No
No
Yes
No
Yes
No
No
No
No
No
No
Yes 9 Months
Yes2* 9 Months
00022923
00022923
No
Reserved5 9 Months
9 Months
No
Yes5
Yes6 24 Months
Yes6 24 Months
24 Months
Yes6 24 Months
Reserved7
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDIMEFORM AND CHLORDIMEPORM HYDROCHLORIDE (HC1)
Use
Data Requirement Compositionl Pattern2
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
72-1 - Freshwater Fish 1X50
a. Warmwater
b. Coldwater
72-2 - Acute LCso to Freshwater
Invertebrates
72-3 - Acute Toxicity to
Estuarine and Marine
Organisms
a. Fish
b. Shrimp
c. Oyster
TGAI base
TGAI HCl
TGAI base
TGAI HCl
TGAI base
TGAI HCl
TGAI base
TGAI HCl
TGAI base
TGAI HCl
TGAI base
TGAI HCl
A
A
A
A
A
A
A
A
A
A
A
A
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
This Require- Bibliographic PIFRA S 3(c)(2)(B)?
ment? (Yes, No Citation Tine Frame for Data
or Partially) Submission 3
Yes
Partial
Yes
Partial
NO
No
No
No
Yes
No
Yes
No
GS-0144-012 No
00085345 Np8
GS-0144-012 No
00102214 No
Yes
Yes
Yes9
No8
00078138 No
No8
00078138 No
No8
9 Months
9 Months
12 Months
•5-1
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDIMEFORM AND CHLORDIMEFORM HYDROCHLORIDE (HCl)
Data Requirement
§158.145 Wildlife and
Aquatic Organisms - Continued
AQUATIC ORGANISMS TESTING
72-4 - Fish Early Life Stage
and Aquatic Invertebrate
Life-cycle
72-5 - Fish - Life-Cycle
Ccmpositioni
TGAI base
TGAI HCl
TGAI base
TGAI HCl
Use
Pattern2
A ?
A
A
A
Does EPA Have
Data To Satisfy
This Require- Bibliographic
ment? (Yes, No Citation
or Partially)
No
No
No
No
Must Additional Data
Be Submitted Under
FIPRA S 3(c)(2)(B)?
Time Frame for Data
Submission 3
Reserved7
Reserved7
Reserved7
Reserved7
72-6 - Aquatic Organism
Accumulation
72-7 - Simulated or Actual
Field Testing
TGAI (base and
HCl), PAI or
degradation
product
No
Reserved7
a. Aquatic Organisms
TEP
No
Reserved7
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDIMEFORM AND CHLORDIMEFORM HYDROCHLORIDE (HCl)
Data Requirement
Compos itionl
Use
Pattern2
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted under
FIFRA § 3(c)(2)(B)?
Tims Frame for Data
Submission 3
§158.145 Wildlife and
Aquatic Organisms - Continued
1 Composition: TGAI = Technical grade of the active ingredient; PAI = pure active ingredient;
TEP = Typical end-use product;
2 The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop; OAquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dcmestic Outdoor; I=Indoor.
3 Data must be submitted within the indicated time frames which begin on the date of the Guidance Document,
4 Studies on the TGAI base can be used to support data requirements for chlordimeform TGAI HCl.
5 Most existing data suggest that the HCl form is not more toxic to birds than the base. However, an avian dietary
LCijp study on an upland game bird species is required to confirm this. Depending on the results, further testing
of the HCl form may be required.
6 Data are required because multiple applications are authorized in fields immediately proceeding, and during, breeding
season for several upland game species utilizing cotton fields for feeding/nesting. Data requirements for
chlordimeform HCl can be satisfied by the use of chlordimeform base data.
7 Requirement is reserved pending outcome of lower tier testing requirements for fish and aquatic invertebrates, or in
the case of avian studies, reproduction testing on birds.
8 Available data on fish toxicity of chlordimeform HCl, although no adequate by current test standards, is sufficient
to indicate that chlordimeform HCL is less toxic to fish than chlordimeform base. Therefore, additional data on
chlordimeform HCl is not required.
9 Data are required because use pattern encompasses greater than 300,000 acres in coastal counties of the U.S.,
therefore creating a potential to impact marine/estuarine org'anisms.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDIMEPORM AND CHLORDIMEPORM HYDROCHLORIDE (HC1)
Data Requirement
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
Use This Require- Bibliographic FIFRA § 3(c)(2)(B)?
Composition1 Pattern2 ment? (Yes, No Citation Tine Frame for Data
or Partially) Submission 3
§158.150 Plant Protection
121-1
- TARGET AREA
PHYTOTOXICITY
EP base
EP HC1
No
NO
NO4
NO4
NONTARGET AREA PHYTOTOXICITY
122-1
122-1
122-2
123-1
123-1
123-2
TIER I
- Seed Germination/
Seedling Emergence
- Vegetative vigor
- Aquatic Plant Growth
TIER II
- Seed Germination/
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
IGAI base
TGAI HC1
TGAI base
TGAI HC1
TGAI base
TGAI HC1
TGAI base
TGAI HC1
TGAI base
TGAI HC1
TGAI base
TGAI HC1
NO
No
No
No
NO
NO
No
No
No
NO
No
NO
No4
No4
No4
NO4
No4
NO4
NO4
No4
No4
No4
No4
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDIMEPORM AND CHDORDIMEFORM HYDROCHLORIDE (HCl)
Data Requirement
Use
Composition*- Pattern-*
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA S 3(c)(2)(B)7
Tine Frame for Data
Submission 3
§158.150 Plant Protection
(continued)
TIER III
124-1
124-2
- Terrestrial Field
- Aquatic Field
TEP base
TEP HCl
TEP base
TEP HCl
No
No
No
No
No4
NO4
No4
NO4
1
2
3
4
Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product. EP » End-use product.
The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop; OAquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhousef Non-Food; G=Forestry; H=Domestio Outdoor; I=lndoor.
Data must be submitted within the indicated time frame which begins on the date of the Guidance Document.
These requirements are generally waived unless it is believed there is a phototoxicity problem.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDIMEFORM AND CHLORDIMEFORM HYDRDCHLORIDE (HCl)
Data Requirement
§158.155 Nontarget Insects
NONTARGET INSECT TESTING -
POLLINATORS :
141-1 - Honey bee acute
contact toxicity
141-2 - Honey bee - toxicity
of residues on
foliage
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
NONTARGET INSECT TESTING -
AQUATIC INSECTS:
Use
Campos itionl Pattern2
TGAI base A
TCAI HCl A
TEP base A
TEP HCl A
( Reserved ) 5
TEP base A
TEP HCl A
Does EPA Have
Data To Satisfy
This Require- Bibliographic
ment? (Yes, No Citation
or Partially)
Yes 00028772
No
Yes 00077760
No
No
No
^fust Additional Data
Be Submitted Under
FIFRA § 3(C)(2)(B)?
Time Frame for Data
Submission 3
NO
NO
No6
142-1 - Acute toxicity to
aquatic insects
142-1 - Aquatic insect
life-cycle study
(Reserved)7
(Reserved)7
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDIMEPORM AND CHLORDIMEPORM HYDROCHLORIDE (HCl)
§ 158.155 - Non-target Insects - Continued
142-3 - Simulated or actual (Reserved)7
field testing for
aquatic insects
143-1 - NONTARGET INSECT (Reserved)7
thru TESTING - PREDATORS
143-3 AND PARASITES
1 Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2 The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop:
D=Aqautic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dcmestic Outdoor; I=Indoor.
3 Data must be submitted within the indicated time frame which begins on the date of the Guidance Document.
4 it is assumed that toxicity of chlordimeorm HCl will be similar to the base form, therefore no additional data
on chlordimeform HCl is required.
5 Requirement is reserved pending deveolopment of test methodology.
6 AS lower tier tests indicate low toxicity to bees, no further testing is required.
7 Reserved pending Agency decision as to whether the data requirement should be established.
I-C
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING
CHLORDIMEFORM AND CHLORDIMEFORM HYDROCHLORIDE
Guideline Citation and Test
Name of Test Substance
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and Disclosure MP
of Ingredients
61-2 - Description of Beginning Materials MP
and Manufacturing Process
61-3 - Discussion of Formation of MP
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to Verify MP
Certified Limit
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor MP
Guidelines
Status
R
R
R
CR
R
R
R
R
R
Are Data Footnote
Required Number
Yes No
[x] [~]
[x] M
[x] [~]
[xi n
[x] n
[xi n
[x] n
M n
[xi n
Data Must Be
Submitted Within
Time Frames Listed
Below V
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING
CHLORDIMEFORM AND CHLORDIMEFORM HYDROCHLORIDE
Guideline Citation and
Name of Test
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-15 - Flantnability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
Test
Substance
MP
MP
MP
MP
MP
MP
MP
MP
MP
Guidelines
Status
R
CR
CR
CR
R
R
CR
CR
R
Are Data Footnote
Required Number
Yes No
[x]
[x]
[x]
[x]
[x]
©
[x]
[x]
[x]
[ 1
[~]
n
n
n
n
n
n
n
Data Must Be
Submitted Within
Time Frames Listed
Below V
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
MP = Manufacturing-use Product; R = Required; CR = Conditionally Required
I/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document,
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING
CHLORDIMEFORM AND CHLDRDIMEFORM HYDROCHLORIDE
Data Requirement Composition!
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Must Additional Data
Be Submitted Under
Bibliographic FIFRA § 3(c)(2)(B)?
Citation Time Frame for Data
Submission 2
5158.135 Toxicology
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity
- Acute Dermal Toxicity
- Acute Inhalation Toxicity
- Primary Eye
Irritation
- Primary Dermal
Irritation
- Dermal Sensitization
MP base
MP HC1
MP base
MP HC1
MP base
MP HC1
MP base
MP HC1
MP base
MP HC1
MP base
MP HC1
A
A
A
A
A
A
A
A
A
A
A
A
Yes
Yes
No
Yes
No
Yes
Yes
No
Yes
Yes
Yes
Yes
00066882,00082200
00066883,00098918
00066886
00078159
00066872
00066872
00066884
00098901
00098919
00098919,00098901
00066872
No
NO
No3
No
No3
NO
NO
No3
No
No
No
No
1 Composition: MP = Manufacturing-use product.
2 Data must be submitted within the indicated time frames which begin on the date of the Guidance Document,
3 Acute toxicology data on the technical base will support the technical HCl and vice versa.
-------
EPA Index to Pesticide Chemicals
c059701 CHLORDIMEFORM*
TYPE PESTICIDE; Insecticide, Plant Regulator
FORMULATIONS;
Tech (90%, 95%, 97%)
EC (A Ib/gal)
GENERAL WARNINGS AND LIMITATIONS; RESTRICTED USE PESTICIDE. Do not mix
or use with alkaline materials. Do not reenter treated $reas for 5 days
without protective clothing. During mixing/loading or application wear a
protective suit which has long sleeves and long pants. Wear chemical re-
sistant gloves; a hat, boots and goggles or face shield. A helmet with
visor may be substituted for the hat and gog'gles during aerial applica-
tion. Mixer/loaders must also wear a chemical resistant apron when hand-
ling the concentrated product. Instead of clothing and equipment speci-
fied above, the applicator can use an enclosed tractor cab or cockpit with
properly filtered air supply.
Chlordimeform is toxic to fish. Do not apply directly to water or wet-
lands. Drift or runoff from the treated areas may be hazardous to aquatic
organisms in neighboring areas.
Chlordimeform must be transferred and mixed using closed system equipment.
A closed system is defined as appropriate connections, meters, pumps, and
plumbing designed to eliminate human contact. Do not use open mixing vats
or open pouring.
Agricultural Crop Tolerances (other than those listed in the text):
Apple 3 ppm
Apple (dried apple pomace) 25 ppm
Broccoli 2 ppm
Brussels Sprouts 2 ppm
Cabbage 2 ppm
Cauliflower 2 ppm
Cherries 5 ppm
Nectarine 5 ppm
Peach 5 ppm
Pear 12 ppm
Plums (fresh prunes) A ppm
Tomatoes 1 ppm
Walnut 0.1 ppm
Livestock and Poultry Tolerances;
Cattle (fat, meat, meat byproducts) 0.25 ppm
Eggs 0.05 ppm
Goats (fat, meat, meat byproducts) 0.25 ppm
Hogs (fat, meat, meat byproducts) 0.25 ppm
Horses (fat, meat, meat byproducts) 0.25 ppm
Milk 0.05 ppra
Poultry (fat, meat, meat byproducts) 0.25 ppm
Sheep (fat, meat, meat byproducts) 0.25 ppm
*Fundal EC
Galecron EC
N'-(4-chloro-o-tolyl)-N,N-dimethylformamidine
Issued: 8-19-82 III-059701-1
Provisional Update: 9-17-84
64
-------
EPA Index to Pesticide Chemicals
CHLORDIMEFORM
Site and Pest Dosages and Tolerance, Use, Limitations
FonnulationCs)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
/28007AA Cotton 5 ppm (cottonseed)
10 ppm (cottonseed hulls)
21 day .preharvest interval through
0.25 pound per acre for foliar
application.
24 hour reentry period.
Do not feed treated foliage or gin
trash to livestock. Do not allow
livestock to graze in treated areas.
Unless otherwise specified, apply
in a minimum of 1 gallon of water
per acre by aircraft or ground
equipment using low drift nozzles.
ITBCBOA Bollworm (includ- 0.125-0.25 Use limited to cotton growing
ing eggs) Ib/A states other than AZ and CA.
(4 Ib/gal EC) Foliar application. Repeat at 3 to
5 day intervals when moth flights
ITBCBNA Tobacco budworm 0.25 Ib/A begin and/or when eggs appear. Con-
(including eggs) (4 Ib/gal EC) tinue as long as eggs are present.
Apply the low rate when pest popula-
tions are low or egg deposition is
just starting.
ITBCBOA Bollworm (includ- 0.125-0.25 Use of the dosage range is limited
ing eggs) Ib/A to cotton growing states other than
ITBCBNA Tobacco budworm (4 Ib/gal EC) AZ and CA. Use of the high rate is
(including eggs) limited to AZ and CA.
Foliar application. Apply as a tank
mix with other insecticides when egg
hatch occurs because of delayed
application or other causes, or when
it is necessary to begin application
in a field where the target or other
pests have reached economic levels.
Tank mix with Bacillus thuringien-
sis, dimethoate, dicrotophos, methyl
parathion, azinphosmethyl, monocro-
tophos, chlorpyrifos, phosmet,
methomyl, methidathion, acephate,
polyhedral inclusion bodies of Heli-
othis nuclear polyhedrosis virus,
diflubenzuron, fenvalerate, permeth-
rin, profenofos, sulprofos, methyl
parathion plus EPN, and methyl para-
thion plus toxaphene.
Issued: 8-19-82 III-059701-2
-------
PZZ2ZZA
Site and Pest
Cotton (continued)
Increase yield
EPA Index to Pesticide Chemicals
CHLORDIMEFORM
Dosages and Tolerance, Use, Limitations
Fortaulation(s)
0.125-0.25 Increase yield. Foliar application.
Ib/A Apply as a broadcast spray. Apply
(A Ib/gal EC) 4 to 6 times at 5-7^day intervals
beginning at first'pinhead square
formation (5 to 7 true leaf stage).
Yield increase however, may not oc-
cur if 'plants are under stress dur-
ing treatment.
9001500
AAAAAAA
AERIAL. MOTHPROOFING AND TANK MIX APPLICATIONS
Aerial Application
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Cotton
9900300
AAAAAAA
Tank Mix
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Cotton
Issued: 8-19-82
III-059701-3
-------
6.095.0001
EPA Index to Pesticide Chemicals
CHLORDIMEFORM
Listing of Registered Pesticide Products by Formulation
95% technical chemical
chlordimeform (059701)
000100-00560
&097.0001 97% technical chemical
chlordimeform (059701)
002139-00105
&090.0001 90% formulation intermediate
chlordimeform (059701)
002139-00106
&104.0012 4 Ib/gal emulsifiable concentrate
chlordimeform (059701) plus aromatic petroleum distillate (006601)
000279-02852
chlordimeform (059701) plus xylene range aromatic solvent (086803)
000100-00551
9999999 State Label Registrations
AZ Reg. No.
002139-04356
CA Reg. No.
000100-OA301
002139-04337
FL Reg. No.
004841-06125
HI Reg. No.
007843-08573
ID Reg. No.
002139-04343
LA Reg. No.
004841-06123
004841-06129
004841-06137
NV Reg. No.
002139-04341
000279-09169
002139-04344
004841-06124
004841-06131
004841-06139
000279-09170 002139-04333
004841-06126
004841-06134
004841-06167
004841-06128
004841-06136
004841-06168
OR Reg. No.
002139-04328
002139-04331 002139-04345 002139-04355
Issued: 8-19-82
III-059701-4
c-7
-------
EPA Index to Pesticide Chemicals
CHLORDIMEFORM
Listing of Registered Pesticide Products by Formulation (continued)
VT Reg. No.
002139-04340 002139-04346
WA Reg. No.
002139-04329 002139-04330 002139-04342 002139-04352
Issued: 8-19-82 1II-059701-5
-------
Listing of
Chemical
Code
035201
041801
053501
058001
058901
059201
109301
111501
EPA Index to Pesticide Chemicals
CHLORDIMEFORM
Appendix A
Common Chemical Names Used on the Entry
Common Name
(source)
dicrotophos (ISO)
EPN
methyl parathion
EPA Acceptable
Common/Chemical Name
dimethyl phosphate ester with 3-
hydroxy-N,N-dimethyl-cis-crotonamide
0-ethyl 0-(p-nitrophenyl)phenyl-
phosphpnotaioate
0,0-dimethyl 0-p-nitrophenyl phosphoro-
thioate
azinphosraethyl (ISO) 0,0-dimethyl S-[(4-oxo-l,2,3-benzo-
triazin-3(4H)-yl)methyl] phosphoro- dithioate
monocrotophos (ISO) dimethyl phosphate of 3-hydroxy-N-
methyl-cis-crotonamide
phosmet (BSI)
fenvalerate (ISO)
sulprofos
N-(mercaptomethyl)phthaiimide S-(0,0-dimethyl
phosphorodithioate
cyano(3-phenoxyphenyl)methyl 4-chloro-
alpha-(l-methylethyl)benzeneacetate
0-ethyl 0-[4-(methylthio)phenyl] S-propyl
phosphorodithioate
Issued: 8-19-82
III-059701-6
- V
-------
/28007AA
ITBCBOA
PZZZZZA
ITBCBNA
EPA Index to Pesticide Chemicals
CHLORDIMEFORM
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Cotton
Bollworm (including eggs)
Increase yield
Tobacco budworm (including eggs)
(4 Ib/gal EC)
000100-00551
Issued: 8-19-82
III-059701-7
7c
-------
EPA Index to Pesticide Chemicals
C059702 CHLORDIMEFORM HYDROCHLORIDE*
TYPE PESTICIDE: Insecticide, Plant Regulator
FORMULATIONS:
Tech (95%, 97%)
SC/S (95%, 97%)
GENERAL WARNINGS AND LIMITATIONS; RESTRICTED USE PESTICIDE. Do not mix
or use with alkaline materials. Do not reenter treated ^rea for 5 days
without protective clothing. During mixing/loading or application wear a
protective suit which has long sleeves and long pants. Wear chemical re-
sistant gloves; a hat, boots and goggles or face shield. A helmet with
visor may be substituted for the hat and goggles during aerial applica-
tion. Mixer/loaders must also wear a chemical resistant apron when hand-
ling the concentrated product. Instead of clothing and equipment speci-
fied above, the applicator can use an enclosed tractor cab or cockpit with
properly filtered air supply.
Chlordimeform is toxic to fish. Do not apply directly to water or wet-
lands. Drift or runoff from the treated areas may be hazardous to aquatic
organisms in neighboring areas.
Chlordimeform must be transferred and mixed using closed system equipment.
A closed system is defined as appropriate connections, meters, pumps, and
plumbing designed to eliminate human contact. Do not use open mixing vats
or open pouring.
Agricultural Crop Tolerances (other than those listed in the text):
Apple 3 ppm
Apple (dried apple pomace) 25 ppm
Broccoli 2 ppm
Brussels Sprouts 2 ppm
Cabbage 2 ppm
Cauliflower 2 ppm
Cherries 5 ppm
Nectarine 5 ppm
Peach 5 ppm
Pear 12 ppm
Plums (fresh prunes) 4 ppm
Tomatoes 1 ppm
Walnut 0.1 ppm
Livestock and Poultry Tolerances:
Cattle (fat, meat, meat byproducts) 0.25 ppm
Eggs 0.05 ppm
Goats (fat, meat, meat byproducts) 0.25 ppm
Hogs (fat, meat, meat byproducts) 0.25 ppm
Horses (fat, meat, meat byproducts) 0.25 ppm
Milk 0.05 ppm
Poultry (fat, meat, meat byproducts) 0.25 ppm
*Fundal SP
Galecron SP
N'-(4-chloro-o-tolyl)-N,N-diraethylformamidine hydrochloride
Issued: 8-19-82 III-059702-1
Provisional Update: 9-11-85
-------
EPA Index to Pesticide Chemicals
CHLORDIMEFORM HYDROCHLORIDE
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
007AA Cotton 5 ppm (cottonseed)
10 ppm (cottonseed halls)
21 day preharvest interval through
0.24 pound per acre for foliar ap-
plication.
24 hour reentry period.
Do. not feed treated foliage or gin
trash to livestock. Do not allow
livestock to graze in treated areas.
Unless otherwise specified, apply
in a minimum of 1 gallon of water
per acre by aircraft or in a minimum
of 10 gallons of water per acre by
ground equipment.
BCBOA Bollworm (includ- 0.12-0.24 Use limited to cotton growing
ing eggs) Ib/A states other than AZ and CA.
(95-97% SC/S) Foliar application. Repeat at 3 to
5 day intervals when moth flights
BCBNA Tobacco budworm 0.24 Ib/A begin and/or when eggs appear. Con-
including eggs) (95-97% SC/S) tinue as long as eggs are present.
Apply the low rate when pest popula-
tions are low or egg deposition is
just starting.
BCBOA Bollworm (includ- 0.12-0.24 Use of the dosage range is limited
ing eggs) Ib/A to cotton growing states other than
BCBNA Tobacco budworm (95-97% SC/S) AZ and CA. Use of the high rate is
(including eggs) limited to AZ and CA.
Foliar application. Apply on a 3
to 5 day schedule when larvae reach
economic levels. Continue applica-
tions as long as eggs and larvae are
present. Apply as a tank mix with
other insecticides when egg hatch
occurs because of delayed applica-
tion or other causes, or when it is
necessary to begin application in a
field where the target or other
pests have reached economic levels.
Tank mix with Bacillus thuringien-
sis, dimethoate, dicrotophos, methyl
parathion, azinphosraethyl, monocro-
tophos, chlorpyrifos, phosmet,
methorny1, methidathion, acephate,
polyhedral inclusion bodies of Heli-
Issued: 8-19-82 III-059702-2
72-
-------
Site and Pest
Cotton (continued)
EPA Index to Pesticide Chemicals
CHLORDIMEFORM HYDROCHLORIDE
Dosages and Tolerance, Use, Limitations
Formulation(s)
othis nuclear polyhedrosis virus,
diflubenzuron, fenvalerate, permeth-
rin, profenofos, su^Lprofos, methyl
parathion plus EPN, and methyl para-
thion plus toxaphene.
PZZ2ZZA
Increase yield
Foliax. application (band). Apply
when cotton is small enough to be
fully covered by band.
0.12-0.24
Ib/A
{with 40 in.
row spacing
and 20 in.
band width]
or
[with 38 in.
row spacing
and 19 in.
band width]
(97% SC/S)
0.12-0.24 Increase yield. Foliar application.
Ib/A Apply as a broadcast spray. Apply
(95-97% SC/S) 4 to 6 times at 5-7 day intervals
beginning at first pinhead square
formation (5 to 7 true leaf stage).
Yield increase however, may not oc-
cur if plants are under stress dur-
ing treatment.
9001500
AAAAAAA
AERIAL. MOTHPROOFING AND TANK MIX APPLICATIONS
Aerial Application
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Cotton
9900300
AAAAAAA
Tank Mix
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Cotton
Issued: 8-19-82
III-059702-3
-------
5.0001
EPA Index to Pesticide Chemicals
CHLORDIMEFORM HYDROCHLOR1DE
Listing of Registered Pesticide Products uy Formulation
95% technical chemical
chlordimeform hydrochloride (059702)
000100-00562
7.0001 97% technical chemical
chlordimeform hydrochloride (059702)
002139-00113
5.0015 95% soluble concentrate/solid
chlordimeform hydrochloride (059702)
000100-00554
7.0015 97% soluble concentrate/solid
chlordimeform hydrochloride (059702)
000279-02848
'9999 State Label Registrations
AZ Reg. No.
002139-04323 002139-04357
CA Reg. No.
000100-04280 002139-04332
ID Reg. No.
002139-04349
NV Reg. No.
002139-04347
OR Reg. No.
002139-04335 002139-04350
WA Reg. No.
002139-04334 002139-04348
002139-04336 002139-04351
002139-04353
002139-04354
002139-04360
002139-04358
Issued: 8-19-82
III-059702-4
-------
Listing of
Chemical
Code
035201
041801
053501
058001
058901
059201
109301
111501
EPA Index to Pesticide Chemicals
CHLORDIMEFORM HYDROCHLORIDE
Appei.dix A
Common Chemical Names Used on the Entry
Common Name
(source)
dicrotophos (ISO)
EPN
methyl parathion
EPA Acceptable
Common/Chemical Name
dimethyl phosphate es££r with 3-
hydroxy-N,N-dimethyl-cis-crotonamide
0-ethyl 0-(p-nitrophenyl)phenyl-
phosphoncfthioate
0,0-dimethyl 0-p-nitrophenyl phosphoro-
thioate
azinphosmethyl (ISO) 0,0-dimethyl S-[(4-oxo-l,2,3-benzo-
triazin-3(4H)-yl)methyl] phosphoro- dithioate
monocrotophos (ISO) dimethyl phosphate of 3-hydroxy-N-
methyl-cis-crotonamide
phosmet (BSI)
fenvalerate (ISO)
sulprofos
N-(mercaptomethyDphthalimide S-(0,0-dimethyl
phosphorodithioate
cyano(3-phenoxyphenyl)methyl 4-chloro-
alpha-(l-methylethyl)benzeneacetate
0-ethyl 0-[4-(methylthio)phenyl] S-propyl
phosphorodithioate
Issued: 8-19-82
III-059702-5
"7S
-------
28007AA
TBCBOA
'ZZZZZA
:TBCBNA
EPA Index to Pesticide Chemicals
CHLORDIMEFORM HYDROCHLORIDE
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Cotton
Bollworm (including eggs)
Increase yield
Tobacco budworm (including eggs)
(95% SC/S)
000100-00554
(97% SC/S)
000279-02848
Issued: 8-19-82
III-059702-6
76
-------
REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA sec. 3(c)(2)(B). The
tables following this section list the data required for
maintaining the registrability of each product.
EPA has determined that additional generic data described
in Table A must be submitted to EPA for evaluation in order
to maintain in effect the registration(s) of your product(s)
identified as an attachment to the cover letter accompanying
this guidance document. As required by FIFRA sec. 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 deter-
mine which generic data you must submit by consulting Table A
at the end of this chapter. That table lists the generic
data needed to evaluate the continued registrability of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
EPA approved protocols (such as those contained in the Pesticide
Assessment Guidelines ^/ or data collected under the approved
protocols of the Organization for Economic Cooperation and
Development (OECD). If you do not wish to develop data
in support of certain uses appearing in your labeling, you
may delete those uses at the time you submit your revised
labeling.
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 type
£/ 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, regardless
of the product's unique composition or specific 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).
£/ The Pesticide Assessment Guidelines are available in hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
-------
for each major formulation category (e.g., emulsifiable concen-
trates, 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; "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 III of this document.
C. 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
II-3] 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
Pesticide Assessment 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.
OR
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.
OR
3. 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, Appendix II-4)*/
V FIFRA sec. 3(c)(2)(B) authorizes joint development of
data by 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 on next page)
-------
OR
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.)
OR
5. 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.)
D. Procedures for Requesting Changes in Testing Methodology
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 must 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.
(Footnote continued from previous page)
In EPA1s'opinion, joint data development by all regis-
trants subject to a data requirement 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 unnecessarily large number of
animals to testing.
As noted earlier, EPA has discretion to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it should encourage joint testing rather than duplicative
testing, and that suspension should be withheld in certain cases.
to further this goal. Accordingly, if (1) a registrant has
informed us of his intent to develop and submit data required
by this Notice; and (2) a second registrant 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.
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The extension request should state the reasons why you believe
that an extension is appropriate. While EPA considers your
request, you must strive to meet the deadline for submitting
the required data.
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III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: Unless stated otherwise in Section I, Regulatory
Position and Rationale, this Section applies only to manufac-
turing use products, not to 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 sec.
3(c)(2)(B), EPA has determined that you must submit these
data to EPA in order to reregister your product(s). All of
these data must be submitted not later than six months after
you receive this guidance document.
Table B--Product-Specific Data Requirements for Manufacturing
Use Products—lists the product specific data you must submit.
Data that are required to be submitted are identified in the
column of those tables entitled "Must Data By Submitted
Under §3(c)(2)(B)."
^J Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
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IV. SUBMISSION OF REVISED LABELING
Note: This section applies to all products.
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 CFR 162.10 (see
Appendix IV-1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix IV-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
If you fail to submit revised labeling information
complying with this section (supplemented by requirements
described in Section I, Regulatory Position and Rationale),
EPA may issue a notice of intent to cancel the registration
under FIFRA sec. 6(b)(l).
A. Label Contents
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items
listed below are keyed to 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.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. See Appendix IV-1. [40 CFR
162.10(d)]
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Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix IV-1.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
See Appendix IV-1. [40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. See Appendix IV-1. [40 CFR
162.10(g)]
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. See Appendix IV-1.
[40 CFR 162.10(h)(1)(ii)]
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Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. See Appendix IV-1.
[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. See Appendix iv-1. [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. See Appendix IV-1. [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.
See Appendix IV-1. [40 CFR I62.10(h)(1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix IV-1. [40 CFR 162.10
(h)(2)] .
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. See Appendix IV-1. [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. See Appendix IV-1. [40 CFR
162.10(h)(2)(ii)]
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Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability 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 require-
ment 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.
2. Criteria for declaration of non-flammability. The
following criteria will be used to determineif 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 flashpoint
greater than 350°F (177°C).
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches;
ii. There is no flashback; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C).
3. Declaration of non-flammability. Products which
meet the criteria for non-flammability specified above
may bear the notation "non-flammable" or "non-flammable
(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 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.
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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 I
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.
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. Front panel statement of restricted use classification.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 40 CFR 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:
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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 [There is no Item 9B].
Item 9C. 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.
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 [There is no Item 10B].
Item IOC. 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
IV-4, IV-5, and IV-6 to determine the storage and disposal
instructions appropriate for your products.
Item 10D. 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. See
Appendix IV-I. [40 CFR 162.10]
:n
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B. 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.
V. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing (name of
pesticide) as sole active ingredient.
1, Within 90 days from receipt of this document, you must
submit to the Product Manager in the Registration Division at
the address given at the end of this section the "FIFRA Section
3(c)(2)(B) Summary Sheet" EPA Form 8580-1. Refer to Appendix
II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also 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 information 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.)
2. Within 6 months from receipt of this document you must
submit to the Product Manager on the Registration Division:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific Data Report, EPA Form 8580-4
(Appendix III-l) .
c. Two copies of any required product-specific data
(See Tables B).
d. Two copies of draft labeling, including -the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. The labeling should be either typewritten
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text on 8-1/2 x 11 inch paper or a mockup of the labeling
suitable for storage in 8-1/2 x 11 inch files. The draft
label must indicate the intended colors of the final label,
clear indication of the front panel label, and the intended
type sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR 152.80-152.99
for latest requirements.
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 agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
B. For Manufacturing Use Products containing (name of pesticide)
in combination with other active ingredients
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-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a data
requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also 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 information 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.)
2. 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 agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
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C. For End Use Products containing (name of pesticide) alone
or in combination with other active ingredients;
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-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a '
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also 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 information 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.)
2. Within 6 months from receipt of this document you must
submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product-Specific Data Report, EPA Form 8580-4
(Appendix III-l), if applicable (if Table C lists required
product-specific data).
c. Two copies of any required product-specific data,
if applicable (if Table C lists required product-specific
data).
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of. this guidance document and the results of
the short-term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. 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 inch files. The draft label
must indicate the intended colors of the final label, clear
indication of the front panel label, and the intended type
sizes of the text.
3. Within the time frames set forth in Table A, submit all
generic data, unless you are eligible for the formulator's
exemption.
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Appendix II-l
Guide to Use of This Bibliography
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.
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.
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.
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.
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Appendix Il-l (continued)
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.
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlordimeform Standard
MRID CITATION
00028772 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1973) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. Rev. By Univ. of California—Riverside, Dept.
of Entomology. Riverside, Calif.: UC, Agricultural Extension
Service. (Also in unpublished submission received Apr 2, 1980
under 464-556; submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL:242149-Z)
00036949 E.I. du Pont de Nemours & Company (19??) Residues. (Unpublished
study received Jun 30, 1980 under 352-342; CDL:242819-A)
00042258 Schering, AG (1978) [Chlordimeforme HC1 in Mice]. (Unpublished
study received Feb 22, 1980 under 100-551; submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:241837-D)
00043058 Geissbuhler, H. (1965) C-8514: Determination of Total Residue in
Plant Material: Provisional Method. Method dated Mar 30, 1965.
(Unpublished study received May 31, 1967 under 8192-3; prepared
by Ciba, AG, Switzerland, submitted by Ciba Agrochemical Co.,
Summit, N.J.; CDL:102481-B)
00044017 Helling, C.S. (1971) Pesticide mobility in soils: II. Applications
of soil thin-layer chromatography. Soil Science Society of
America Proceedings 35:737-748. (Also in unpublished submission
received May 5, 1975 under 464-323; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:221997-S)
00066872 Hofmann, A. (1966) Toxicological Investigations with Preparation
39'012 (C-8514): Part II: Dermal Irritation to Rabbits following
Daily Application for 21 Days; Inhalation Toxicity in the Rat
following Single and Repeated Exposure. (Translation; unpub-
lished study received May 1, 1970 under OF0885; prepared by
Battelle Institute, West Germany, submitted by Ciba Agrochemical
Co., Summit, N.J.; CDL:091529-G)
00066880 Blackmore, R.H. (1969) Final Report: Segment I I—Teratology Study-
Rabbits: Project No. 728-157; Research Report CF-5231. (Unpub-
lished study received May 1, 1970 under OF0885; prepared by
TRW, Inc., submitted by Ciba Agrochemical Co., Summit, N.J.;
CDL:091529-R)
-1-
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MRID
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlordimeform Standard
CITATION
00066881 Blackmore, R.H. (1969) Final Report: Three-generation Reproduction
Study—Rats: Project No. 728-118; Research Report CF-5506.
(Unpublished study received May 1, 1970 under OF0885; prepared
by TRW, Inc., submitted by Ciba Agrochemical Co., Summit, N.J.;
CDL:091529-S)
00066882 Weir, R.J.; Ooyner, W. (1968) Final Report: Acute Oral Administra-
tion—Rats: Project No. 728-122; Research Report CF-5901.
(Unpublished study received May 1, 1970 under OF0885; prepared
by Hazleton Laboratories, Inc., submitted by Ciba Agrochemical
Co. .Summit, N.J.; CDL:091529-T)
00066883 Weir, R.J.; Marshall, P. (1967) Final Report: Acute Oral—Dogs:
Project .No. 728-123; Research Report CF-5902. (Unpublished
study received May 1, 1970 under OF0885; prepared by Hazleton
Laboratories, Inc., submitted by Ciba Agrochemical Co., Summit.
N.J.; CDL:091529-U)
00066884 Weir, R.J.; Clarke, 0. (1968) Final Report: Acute Eye Application-
Rabbits: Project No. 728-125; Research Report CF-5903. (Unpub-
lished study received May 1, 1970 under OF0885; prepared by
Hazleton Laboratories, Inc., submitted by Ciba Agrochemical Co.,
Summit, N.J.; CDL:091529-V)
00066886 Mastri, C. (1969) Report to Ciba Agrochemical Company, Ciba Corpo-
ration: Acute Oral Toxicity Study on Two Samples of Chlorphena-
midine [Technical—Free Base; HC1—Grimsby SP] in Male and
Female Albino Rats: IBT No. A7645; Research Report CF-5917.
(Unpublished study received May 1, 1970 under OF0885; prepared
by Industrial Bio-Test Laboratories, Inc., submitted by Ciba
Agrochemical Co., Summit, N.J.; CDL:091529-X)
00056887 Blackmore, R.H.; Shott, L.D. (1969) Final Report: Two-year Repeated
Feeding—Dogs: Project No. 728-127; Research Report CF-5904.
(Unpublished study received Apr 23, 1970 under OF0885; prepared
by TRW, Inc., submitted by Ciba Agrochemical Co., Summit, N.J.;
CDL:091525-A)
-2-
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlordimeform Standard
MRID CITATION
00067569 Blackmore, R.H.; Kundzin, T.; Crews, L.M. (1969) Final Report: 24-
month Repeated Feeding Study—Rats: Project No. 728-126. (Un-
published study received Apr 25, 1970 under OF0885; prepared by
TRW, Inc., submitted by Geigy Chemical Corp., New York, N.Y.;
CDL:091527-A)
00069682 Ussary, J.P.; Daniel, J.T.; Watkins, S.D.; et al. (1980) Residues
on Cottonseed from Permethrin-chlordimeform and Permethrin-
Methcmyl Tank Mix Application: Svuroary. (Unpublished study
received May 29, 1980 under 10182-18; submitted by ICI Americas,
Inc., Wilmington, Del.; CDL:242559-D)
00070979 Sachsse, K.; Suter, P.; Zak, F. (1978) N-Formyl-4-chloro-o-tolui-
dine: Lifespan Feeding Study in Mice: Project No. Siss M 4762/1.
Final rept. (Unpublished study received Mar 7, 1979 under 100-
551; prepared by Ciba-Geigy, Ltd., Switzerland, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:237724-A)
00070980 Sachsse, K.; Suter, P.; Zak, F. (1978) 4-Chloro-o-toluidine HC1:
Lifespan Feeding Study in Mice: Project No. Siss M 04760/1.
Final rept. (Unpublished study received Mar 7, 1979 under 100-
551; prepared by Ciba-Geigy, Ltd., Switzerland, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:237724-B)
00070981 Sachsse, K.; Suter, P. (1979) Lifespan (Chronic Toxicity and Car-
cinogenicity) Feeding Study in Rats with N-Formyl-4-chloro-o-
toluidine: Status Report after 24 Months of Treatment: Project
No. Siss R 05688/1. (Unpublished study received Mar 7, 1979 un-
der 100-551; prepared by Ciba-Geigy, Ltd., Switzerland, submit-
ted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237727-A)
00070983 U.S. National Institutes of Health (19??) Bioassay of 4-Chloro-o-
toluidine Hydrochloride for Possible Carcinogenicity. By Na-
tional Cancer Institute, Carcinogenesis Testing Program. Be-
thesda, Md.: USNIH. (DREW publication no. (NIH) 79-1721; pub-
lished study; CDL:237727-C)
00072168 Sachsse, K.; Suter, P.; Luetkemeier, H.; et al. (1979) Chlordime-
form HC1: Lifespan (Chronic Toxicity and Carcinogenicity) Feed-
ing Study in Rats: Report on the 24 Months Feeding Period:
Project No. Siss R 05658/1. (Unpublished study received Mar
7, 1979 under 100-551; prepared by Ciba-Geigy Ltd., Switzer-
land, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
237725-A; 237726)
-3-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlordimeform Standard
MRID CITATION
00073479 Nor-Am Agricultural Products, Incorporated (1967?) Chemical and
Physical Properties of Chlorphenamidine. (unpublished study
received on unknown date under 2139-106; CDL:025261-A)
00077760 Johansen, C. (19??) Small-scale Bee Poisoning Tests with Honey
Bees, Alkali Bees, and Alfalfa Leafcutting Bees. (Unpublished
study received Mar 16, 1970 under OF0961; submitted by Nor-Am
Agricultural Products, Inc., Naperville, 111.; CDL:093272-C)
00078138 Bionomics, EG & G, Incorporated (1975) Acute Toxicity of Chlordime-
form to Eastern Oysters (Grassestrea virginica) and Pink
Shrimp (Penaeus duorarum). (Unpublished study received Feb
23, 1978 under 100-551; submitted by Ciba-Geigy Corp., Greens-
boro, N.C.; CDL.-232926-B)
00078139 Sleight, B.H., III (1972) Acute Toxicity of Chlorphenamidine to
Bluegill (Lepomis macrochirus). (Unpublished study received
Feb 23, 1978 under 100-551; prepared by Bionomics, EG & G, Inc.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:232926-C)
00078159 Hurni, H.; Sachsse, K. (1969) Report on the Determination of the
Acute Dermal LD 50 to the Rat of C-8514 Technical. (Unpublished
study received Feb 23, 1978 under 100-551; prepared by Tierfarm
AG, Switzerland, submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:232926-W)
00079920 Ciba-Geigy Limited (1978) 4-Chloro-o-toluidine-HCL: Life Time Feed-
ing Study in Rats: PH 2.635. One year interim rept. (Unpub-
lished study received Feb 23, 1978 under 100-551; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:232924-C)
00079923 Rashid, K.A. (1974) Mutagenesis Induced in Two Mutant Strains of
Salmonella typhimurium by Pesticides and Pesticide Degradation
Products. Master's thesis, Pennsylvania State Univ., Dept. of
Entomology. (Unpublished study received Feb 23, 1978 under
100-551; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
232925-A)
00079924 Ami, P.; Muller, D. (1976) Salmonella/Mammalian-microsome Mutagen-
icity Test with C 8513 (Chlordimeform HC1): (Test for Mutagenic
Properites in Bacteria): PH 2.632. (Unpublished study received
Feb 23, 1981 under 100-551; prepared by Ciba-Geigy, Ltd.,
Switzerland, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:232925-B)
00079927 Konopka, E.A.; Heymann, H. (1977) Evaluation of Galecron (R)
(Chlordimeform) and of Two Derivatives for Mutagenic Activities
in the Salmonella/Microscme Test: Report 1. (Unpublished study
received Feb 23, 1978 under 100-551; submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:232925-E)
-4-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlordimeform Standard
MRID CITATION
00079928 Konopka, E.H.; Heymann, H. (1977) Microbial Mutagenicity Test on
Chlordimeform Hydrochloride (95% Purity) and Chlordimeform Tech-
nical (Base): Report 2. (Unpublished study received Feb 23,
1978 under 100-551; submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:232925-F)
00079931 Fritz, H. (1978) Dominant Lethal Study—C 8513—Mouse: (Test for
Cytotoxic or Mutagenic Effects on Male Germinal Cells): No. of
Experiment 327735. (Unpublished study received Feb 23, 1978
under 100-551; prepared by Ciba-Geigy, Ltd., Switzerland,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:232925-I)
00079932 Langauer, M.; Muller, D. (1977) Nucleus Anomaly Test in Somatic
Interphase Nuclei C 8513, Chinese Hamster: (Test for Mutagenic
Effects on Bone Marrow Cells): No. of Experiment 40050577. (Un-
published study received Feb 23, 1978 under 100-551; prepared by
Ciba-Geigy, Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:232925-J)
00079934 Fritz, H. (1975) Reproduction Study on C 8514 Techn., Rat: (Test
for Teratogenic or Embryotoxic Effects): Seg. II: No. of Ex-
periment 227533. (Unpublished study received Feb 23, 1978 under
100-551; prepared by Ciba-Geigy, Ltd., Switzerland, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:232925-L)
00079982 BASF Wyandotte Corporation (1971) BAS 3512 H: Experimental Herbi-
cide. Rev. Parsippany, N.J.: BASF. (Technical data sheet;
also""Inmunpublished submission received Jan 13, 1973 under
3G1309; CDL:099974-E)
00080099 Mobay Chemical Corporation (1981) Addition to Synopsis of Bolstar
(Bay NTN 9306): Residue Chemistry on Cotton. Summary of studies
070234-B through 070234-F. (Unpublished study received Aug 21,
1981 under 1F2561; CDL:070234-A)
00080101 Geissbuhler, H.; Kossmann, K.; Baunok, I.; et al. (1971) Determi-
nation of total residues of chlorphenamidine [N'-(4-chloro-
0-tolyl)-N,-dimethylformamine] in plant and soil mate-
rial by colorimetry and thin-layer and electron capture gas
chrcmatography. Journal of Agricultural and Food Chemistry 19
(2):365-371. (Submitter 66604; also in unpublished submission
received Aug 21, 1981 under 1F2561; submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:070234-C)
00081013 Suter, P.; Zak, F.; Sachsse, K. (1978) Chlordimeform-HCl: Lifespan
Feeding Study in Mice: Project No. Siss M 04761/1. Final rept.
(Unpublished study received Feb 23, 1978 under 100-551; prepared
by Ciba-Geigy Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:232922-A)
00081041 Suter, P.; Zak, F.; Sachsse, K. (1978) Chlordimeform—HCl: Lifespan
Feeding Study in Mice. Final rept. (Unpublished study received
Mar 7, 1979 under 100-551; prepared by Ciba-Geigy, Ltd., Swit-
zerland, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
237723-A)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlordimeform Standard
MRID CITATION
00082198 Blackmore, R.H. (1969) Final Report: Segment II—Teratology Study--
Rabbits: Project No. 728-157; Research Report CF-5231. (Un-
published study received on unknown date under OF0885; prepared
by TRW, inc., submitted by Ciba Agrochemical Co., Sunroit, N.J.;
CDL:098507-A)
00082199 Blackmore, R.H. (1969) Final Report: Three-generation Reproduction
Study—Rats: Project No. 728-118; Research Report CF-5506.
(Unpublished study received on unknown date under OF0885;
prepared by TRW, Inc., submitted by Ciba Agrochemical Co.,
Sunroit, N.J.; CDL:098507-B)
00082200 Weir, R.J.; Joyner, W. (1968) Final Report: Acute Oral Adminis-
tration—Rats: Project No. 728-122. (unpublished study re-
ceived on unknown date under OF0885; prepared by Hazleton Lab-
oratories, Inc., submitted by Ciba Agrochemical Co., Sutmit,
N.J.? CDL:098507-C)
00082202 Mastri, C. (1969) Report to Ciba Agrochemical Company, Ciba Cor-
poration: Acute Oral Toxicity Study on Two Samples of Chlor-
phenamidine in Male and Female Albino Rats: IBT No. A7645.
(Unpublished study received on unknown date under OF0885;
prepared by Industrial Bio-Test Laboratories, Inc., submitted
by Ciba Agrochemical Co., Sunnut, N.J.; CDL:098507-F)
00082203 Mastri, C. (1969) Report to Ciba Agrochemical Company, Ciba Cor-
poration: Acute Oral Toxicity Study on Two Samples of Chlor-
phenamidine in Male and Female Albino Rats: IBT No. A7645.
(Unpublished study received on unknown date under OF0885;
prepared by Industrial Bio-test Laboratories, Inc., submitted
by Ciba Agrochemical Co., Suwnit, N.J.; CDL:098507-G)
00083812 Nor-An Agricultural Products, Incorporated (1969) Colorimetric De-
termination of Chlorphenamidine HCl (Nor-£m EP-333) in Plant
Material: (Morton 333/7 Revised). Method 333/44 dated Jun 5,
1969. (Unpublished study received Oct 29, 1974 under 2139-98;
CDL-.101707-B)
00085345 Weir, R.J. (1967) Final Report: Acute Aqueous Exposure—Bluegill,
Trout, and Catfish; Dietary Administration—:Pekin Ducks and Bob-
white Quail: Project Nos. 728-139 and 728-140; Research Report
CF-2159. (Unpublished study received Dec 26, 1967 under 2139-
98; prepared by Hazleton Laboratories, Inc., submitted by Nor-Am
Agricultural Products, Inc., Naperville, 111.; CDL:008172-E)
00085918 Ciba-Geigy Corporation (1978) [Toxicity of Chlordimeform on Hu-
mans] . (Unpublished study received Mar 7, 1979 under 100-551;
CDL:237717-A)
00086695 Pennwalt Corporation (1968) Residue Chemistry: Introduction: [Penn-
cap-M (R)]. (unpublished study received Oct 28, 1981 under
4581-292; CDL:246182-A)
-6-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlordimeform Standard
MRID CITATION
00087045 Ciba-Geigy Corporation (1971) [Chlorphenamidine Residues in Eggs
and Poultry Tissue]. (Compilation; unpublished study received
Feb 23, 1978 under 100-551; CDL.-232928-A)
00087046 Ciba-Geigy Corporation (1976) [Residues of Chlorphenamidine in
Cotton]. (Compilation; unpublished study, including report
nos. 333/161, 333/197, 333/198..., received Feb 23, 1978 under
100-551; CDL:232928-B)
00087047 Ciba-Geigy Corporation (1971) N'-(4-Chloro-o-tolyl)-N,
N-dimethylformamidine: Spectrophotonetric Residue Assay
Method. Method CF-R4 dated Nov 4, 1971. (Unpublished-study
received Feb 23, 1978 under 100-551; CDL:232928-C)
00087049 Ciba-Geigy Corporation (1971) [Residues of C-8514 and Galecron in
Milk, Meat, Liver, Fat, and Kidney in Swiss Cows]. (Compila-
tion; unpublished study, including RVA 14/71 and RVA 24/71, re-
ceived Feb 23, 1978 under 100-551; CDL:232928-E)
00087050 Ifflaender, U. (1977) Distribution, Degradation and Excretion of
Chlorodimeform (CDF) in Mice and Rats: Project Report 38/77.
(Unpublished study received Feb 23, 1978 under 100-551; pre-
pared by Ciba-Geigy, Ltd., Switzerland, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:232928-F)
00087051 Ifflaender, U. (1977) Comparison of the Urinary Metabolite Pattern
of Mice and Rats after Oral Application of 14C-Chlorodime-
form: Project Report 39/77. (Unpublished study received Feb
23, 1978 under 100-551; prepared by Ciba-Geigy, Ltd., Switzer-
land, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
232928-G)
00087052 Ciba-Geigy Corporation (1976) [Residues of 14C-Chlorodimeform
in Cotton and Field Soil]. (Compilation; unpublished study, in-
cluding report nos. GAAC-76014 and ABR-76056, received Feb 23,
1978 under 100-551; CDL-.232928-H)
00087053 Fischer, W.C.; Cassidy, J.E. (1976) Identification of the Metabo-
lites of 14C-Chlordimeform in Mature Leaves of Spray Treated
Field Cotton: Report No. ABR-76073. (Unpublished study re-
ceived Feb 23, 1978 under 100-551; submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:232928-I)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlordimeform Standard
MRID CITATION
00087055 Secrest, W.L.; Fischer, W.C.; Cassidy, J.E. (1977) Comparisons of
Metabolism of [Phenyl]-14C-Chlordimeform in Rats Receiving
Oral, Dermal and Inhalation Treatments: Report No. ABR-77033.
(Unpublished study received Feb 23, 1978 under 100-551; submit-
ted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:232928-K)
00087056 Honeycutt, R.C.; Cassidy, J.E. (1977) Extraction and Characteri-
zation of Cottonseed Metabolites from Cotton Injected with
[Phenyl]-14C-Chlordimeform: Report No. ABR-77087. (Unpub-
lished study received Feb 23, 1978 under 100-551; submitted by
Ciba-Geigy Corp., Geeensboro, N.C.; CDL:232928-L)
00087059 Gupta, A.K.S.; Knowles, C.O. (1970) Galecron-14C (N'-(4-chlo-
ro-o-tolyl)-N,N-dimethylfonnamidine) metabolism in
the dog and goat. Journal of Economic Entomology 63(3):951-
956. (Also in unpublished submission received Feb 23, 1978
under 100-551; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:232928-Q)
00087382 Ami, P.; Muller, D. (1976) Salnonella/Mammalian-microscme Muta-
genicity Test with CGA 72647 (4-Chloro-o-toluidine HC1): (Test
for Mutagenic Properties in Bacteria): PH 2.632. (Unpublished
study received Feb 23, 1978 under 100-551; prepared by Ciba-
Geigy, Ltd., Switzerland, submitted by Ciba-Geigy Corp., Greens-
boro, N.C.; CDL:232925-D)
00097467 Nor-Am Agricultural Products, Incorporated (1981) Residues Report:
[Cotton]. (Compilation; unpublished study, including report
nos. 333/294, 333/297, 333/300..., received Mar 22, 1982 under
2139-EX-23; CDL:247061-A)
00097888 Sachsse, K.; Suter, P.; Luetkemeier, H.; et al. (1980) Chlordime-
form HCL: Lifespan (Chronic Toxicity and Carcinogenicity) Feed-
ing Study in Rats: Project No. Siss R 05658/1. Final rept.
(Unpublished study received Jul 13, 1981 under 100-55L; prepared
by Ciba-Geigy Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:245529-A; 245530)
00098901 Hofmann, A. (1966) Chlorphenamidine ... : Skin Irritation- in
Rabbits after Single Administration of the Base as Well as of
the Hydrochloride. (Translation; unpublished study received
Dec 26, 1967 under 2139-99; prepared by Battelle Institute,
West Germany, submitted by Nor-Am Agricultural Products, Inc.,
Naperville, 111.; CDL:050925-E)
00098913 Weir, R.J.; Kundzins, W. (1967) Three-month Repeated Feeding—Dogs:
Project No. 728-127; Research Report CF-2112. (Unpublished
study received Nov 17, 1967 under 8G0652; prepared by Hazleton
Laboratories, Inc., submitted by Ciba Agrochemical Co., Surmat,
N.J.; CDL:091137-D)
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-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlordimeform Standard
MRID CITATION
00098914 Weir, R.J. (1967) Three-month Repeated Feeding Study—Rats: Project
No. 728-126; Research Report CF-2113. (Unpublished study re-
ceived Nov 17, 1967 under 8G0652; prepared by Hazleton Labora-
tories, Inc., submitted by Ciba Agrochemical Co., Summit, N.J.;
CDL:091137-E)
00098918 Weir, R.J.; Joyner, W., Jr. (1967) Final Report: Acute Oral Admin-
istration—Rats: project No. 728-122. (Unpublished study re-
ceived Nov 17, 1967 under 8G0652; prepared by Hazleton Labora-
tories, Inc., submitted by Ciba Agrochemical Co., Summit, N.J.;
CDL:091137-I)
00098919 Hofmann, A. (1966) Battelle Institute Report on Cotoran: Toxico-
logical Studies with Preparation 39'012 (C 8514): Part I 1. Skin
Irritation in Rabbits after a Single Administration of the Base
As Well As of the Hydrochloride 2. Sensitizing Effect of the
Hydrochloride in Guinea Pigs: 66-3. (Translation fron German;
unpublished study received Nov 17, 1967 under 8G0652; prepared
by Battelle Institute, submitted by Ciba Agrochemical Co.,
Summit, N.J.; CDL:091137-J)
00098920 Hofmann, A.. (1966) Toxikologische Untersuchungen mit dem Praparat
39*012: Teil II Hautreizung am Kaninchen bei Taglicher Verabrei-
chung Wahrend 21 Tagen; Inhalationstoxizitat an der Ratte bei
Einmaliger und Wiederholter Exposition. (German text; unpub-
lished study received Nov 17, 1967 under 8G0652; prepared by
Battelle Institute, submitted by Ciba Agrochemical Co., Summit,
N.J.; CDL:09il37-K)
00098923 Ciba Agrochemical Company (1969) Results of Tests on the Amount
of Residue Remaining, Including a Description of the Analyti-
cal Method Used: [Chlorphenamidine]. (Compilation; unpublished
study received Apr 23, 1970 under OF0885; CDL:091524-A)
00098957 Newby, L. (1973) A Summary Report of Analytical Data Obtained fol-
lowing Multiple Applications of Galecron/Fundal in Tank Mix Com-
bination with Guthion Methyl Parathion and Methyl Parathion-tox-
-aphene to Cotton: Report No. GAAC-73003. (Unpublished study re-
ceived Jan 17, 1973 under 2139-98; prepared by Ciba-Geigy Corp.,
submitted by Nor-Am Agricultural Products, Inc., Naperville, IL;
CDL:008176-B)
00098959 Ciba Agrochemical Co. (1971) Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical
Method Used: [Galecron/Fundal]. (Compilation; unpublished
study received on unknown date under 1G1022; CDL:091073-A)
-9-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlordimeform standard
MRID CITATION
00098977 Ciba Agrochemical Co. (1971) Galecron (Ent. No. 27335) (Chlor-
phenamidine) an Acaricide, Ovicide, and Insecticide. Vero
Beach, FL: Ciba. (Research bulletin no. 65; also In unpublished
submission received Apr 16, 1971 under unknown admin, no.;
CDL:120464-B)
00098990 Ciba-Geigy Corp. (1971) Chlordimeform ...: Spectrophetcmetric Resi-
due Assay Method: CF-R4. (Unpublished study received Jun 11,
1974 under unknown admin, no.; CDL:120471-C)
00098991 Nor-Am Agricultural Products, Inc. (1972) Plant Uptake of Chlordi-
meform Soil Residues (Completion of Two Year Study): 333/141.
(Unpublished study received Jun 11, 1974 under unknown admin.
no.; submitted by Ciba Agrochemical Co., Summit, NJ; CDL:
120471-D)
00098998 Burkhard, N.; Ruegg, H. (1973) Galecron: Hydrolysis of Chlordirae-
form under Laboratory Conditions: Nr. SPR 43/73. (Unpublished
study received Jun 11, 1974 under unknown admin, no.; prepared
by Ciba-Geigy Ltd., submitted by Ciba Agrochemical Co., Summit,
NJ; CDL:120471-N)
00099001 Kossmann, K.; Geissbuhler, H.; Boyd, V. (1971) Specific determina-
tion of chlorphenamidine [Nl-(4-Chloro-o-tolyl)-N,N-diraethyl-
formamidine] in plants and soil material by colorimetry and
thin-layer and electron capture gas chromatography. J. Agr.
Food Chem. 19(2):360-364. (Also in unpublished submission re-
ceived Jun 11, 1974 under unknown admin, no.; submitted by Ciba
Agrochemical Co., Sumiit, NJ; CDL:120473-G)
00099009 Hazleton Laboratories (1968) Effects of Chlorphenamidine on Re-
production in the Rat—A Preliminary Report: Research Report
CF-2931. (Unpublished study received Dec 26, 1967 under unknown
admin, no.; submitted by Ciba Agrochemical Co., Sunmit, NJ;
CDL:127040-E)
00099011 Nor-Am Agricultural Products, Inc. (1975) Summary: Residue Data
for Tank Mix Applications of Chlordimeform Fundal/Galecron plus
Azodrin, Methyl Parathion/Toxaphene or Methyl Parathion When
Applied to Cotton. (Compilation; unpublished study received
Aug 15, 1975 under 2139-98; CDL:223839-A)
00099027 Ciba-Geigy Corp. (1978) [Galecron 4E Insecticide-ovicide & Fundal
4EC Insecticide-ovicide; Report on 1978 Re introduction Program/
Exposure Data]. (Unpublished study received Mar 7, 1979 under
100-551; CDL-.237718-A; 237719; 237720; 237721)
00099029 Nor-Am Agricultural Products, Inc. (1978) Human Exposure: [Chlor-
dimeform]. (Unpublished study received Feb 23, 1978 under 2139-
100; CDL:232918-C)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlordimeform Standard
MRID CITATION
00099031 Tweedy, B. (1978) [Residue studies of Chlordimeform in Cotton]:
ABR-78004. (Unpublished study received Feb 23, 1978 under
2139-100; prepared by Ciba-Geigy Corp., submitted by Nor-Am
Agricultural Products, Inc.; CDL:232918-E)
00100811 Morton Chemical Company (19??) Fundal(TM) Acaricide/Insecticide.
Chicago, 111.: Morton Chemical Co. (Technical information; also
in unpublished submission received Jan 14, 1969 under 100-554;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:023144-B)
00102214 Pitcher, F. (1972) [Galecron: Rainbow Trout (Salmo gairdneri)]:
Test No. 502. (U.S. Agricultural Research Service, Pesticides
Regulation Div., Animal Biology Laboratory; unpublished study;
CDL:130318-A)
00102215 Pitcher, F. (1972) [Galecron: Rainbow Trout (Salmo gairdneri)]:
Test No. 501. (U.S. Agricultural Research Service, Pesticides
Regulation Div., Animal Biology Laboratory; unpublished study;
CDL:130323-A)
00102410 Keckemet, 0. (1975) [Residue Data for Methyl Parathion on Cotton-
seed and Corn]. (Compilation; unpublished study received Sep
30, 1975 under 4581-292; submitted by Pennwalt Corp., Phila-
delphia, PA; CDL:195008-A)
00103369 Quimica Estrella (19??) Bermat. (Unpublished study received Jul
1, 1981; Jul 5, 1978 under MS 78/20; submitted by state of
Mississippi for Seedkem, Inc., Madison, WI; CDL:247654-A)
00104272 Nor-Am Agricultural Products, Inc. (19??) Fundal Miticide/Insec-
ticide. Chicago, IL: Nor-Am. (Technical information: DMO-10;
also in unpublished submission received Apr 16, 1971 under un-
known admin, no.; submitted by Ciba Agrochemical Co., Summit,
NJ; CDL:120464-C)
05000837 Johansen, C.A. (1972) Toxicity of field-weathered insecticide
residues to four kinds of bees. Environmental Entomology
l(3):393-394.
GS0141-001 Machin, M.; Dingle, J. (1977) Ultraviolet Determination of
Chlordimeform in Cattle Dipping Bath and Sprays. Journal of
the AOAC 60(3): 696-
GS0141-002 Rieger, J.; Allen, L.; Fisher, R. (1985) Extraction and Analysis
of Chlordimeform and Demethylchlordimeform from Human Tissue
Samples. Bulletin of Environmental Contamination and Toxicology
35:397-405.
-11-
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Appendix II-3
OMB Approval No. 20O04468 (Expires
FIFRA 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" dm imposed by the FIFRA action 3(C)(2)(B) notice contained in the referenced
Guidance Document, I tm responding in the following manner:
O 1. I will submit dan in a timely manner to satisfy the 1 olio wing 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:
Dl 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
requirement! The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
CD 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:
I—14. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
CD 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
EPA Form 8580-1 (10-821
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Appendix II—4
OMB Approval No. 200&O468 (Exoins: 12-31-83)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, certify ALL four h*ms) FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(j) 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:
NAME OF FIRM
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
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 requirec
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
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 ma
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) abc
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly info
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This staterm
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 8S80-6 (10-82)
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Appendix III-l
EPA Registration No.
PRODUCT SPECIFIC DATA REPORT
Guidance Document for_
Date
Registration
Guideline No.
§158.20
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
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
LJBoiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
pH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID#
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Nimbers
Assigned
-------
Appendix III-l (continued)
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
$158.135
TOXICODOGY
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_
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral LD-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 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#
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
DRAFT
6560-50
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
[OPP-36103;FRL ]
PESTICIDE REGISTRATION STANDARDS; AVAILABILITY FOR COMMENT
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of Availability of draft Standard for comment
SUMMARY: This notice announces the availability of certain
draft pesticide Registration Standard documents for comment.
The Agency has completed a review of each listed pesticide
and is making available a document describing its regulatory
conclusions and actions.
DATE: Written comments on each .Registration Standard should
be submitted on or before [insert date 60 days after date of
publication in the FEDERAL REGISTER].
ADDRESSES: Three copies of comments identified with the
docket number listed with each Registration Standard should
be submitted to: By mail:
Information Services Section,
Program Management and Support Division (TS-757C),
Office of Pesticide Programs,
Environmental Protection Agency,
401 M St., SW.,
Washington, D.C. 20460.
85P-2132
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-2-
In person, deliver comments to:
Rm. 236, CM#2,
1921 Jefferson Davis Highway,
Arlington, VA.
Information submitted as a comment in response to this
notice may be claimed confidential by marking any part or all of
that information as "Confidential Business Information" (CBI).
Information so marked will not be disclosed except in accor-
dance with procedures set forth in 40 CFR Part 2. A copy of
the comment that does not contain CBI must be submitted for
inclusion in the public docket. Information not marked confi-
dential will be included in the public docket without prior
notice. The public docket will be available for public
inspection in Rm. 236 at the address given above, from 8 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: To request a copy of a
Registration Standard, contact Frances Mann of the Information
Services Section, in Rm. 236 at the address given above
(703-557-3262). Requests should be submitted no later than
[insert date 30 days after date of publication in FEDERAL
REGISTER] to allow sufficient time for receipt before the
close of the comment period.
For technical questions related to each Registration
Standard, contact the Product Manager listed for that
Standard, at the phone number given.
-------
-3-
SUPPLEMENTARY INFORMATION: The Environmental Protection
Agency conducts a systematic review of pesticides to determine
whether they meet the criteria for continued registration
under section 3(c)(5) of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA). That review culminates in the
issuance of a Registration Standard, a document describing
the Agency's regulatory conclusions and positions on the
continued registrability of the pesticide. In accordance
with 40 CFR 155.34(c), published in the FEDERAL REGISTER on
November 27, 1985 (50 FR 48998), before issuing certain
Registration Standards, the Agency makes the draft document
available for public comment.
Draft Registration Standards for the following pesticides
are now available:
Name of pesticide Docket number Contact person
1. Acephate 30560-19-1 William H. Miller
Product Manager 16
(703-557-2600)
2. Amitraz 33089-61-1 Jay Ellenberger
Product Manager 12
(703-557-2386)
3. Chlordimeform 6164-98-3 Jay Ellenberger
4. Copper sulfate 1344-73-6 Richard Mountfort
Product Manager 23
(703-557-1830)
5. Oryzalin 19044-88-3 Robert Taylor
Product Manager 25
(703-557-1800)
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-4-
Copies of each Registration Standard may be obtained from
the Agency at the address listed under For Further Information
Contact. Because of the length of each Standard and the
limited number of copies available for distribution, only
one copy can be provided by mail to any one individual or
organization. Each Registration Standard is also available
for inspection and copying in EPA Regional Offices at the
addresses listed below after [insert date 30 days after date
of publication in the FEDERAL REGISTER].
LIST OF EPA REGIONAL OFFICES
Pesticides Branch
EPA - Region I
JFK Federal Building
Boston, MA 02203
Contact person: flaruld Kaziiiaitf-r— f\f\c\r£
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-5-
Toxic Materials Branch
EPA - Region v
230 South Dearborn St.
Chicago, IL 60604
Contact person: Lavarre Uhlken
Pesticide and Toxic Substances Branch
EPA - Region VI
1201 Elm St.
Dallas, TX 75270
Contact person: Norman Dyer
pesticide and Toxic Substances Branch
EPA - Region VII
324 East llth St.
Kansas City, MO 64106
Contact person: Leo Alderman
Toxic Substances Branch
EPA - Region VIII
1860 Lincoln St., Suite 900
Denver, CO 80295
Contact person: -fioh Harding. T)eti.n G/ /($sn
Hazardous Materials Branch
EPA - Region IX
215 Fremont St.
San Francisco, CA 94105
Contact person: Nanoy Frost l-&Uri-£
Air & Water Division
EPA - Region X
1200 6th Ave.
Seattle, WA 98101
Contact person: Lyn Frandoon' ChucK
Dated:
Director,
Office of Pesticide Programs
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