GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
(REGISTRATION STANDARD)
CONTAINING
AS THE ACTIVE INGREDIENT
PRONAMIDE
Case number: GS-0082
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
April 15, 1986
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TABLE OF CONTENTS
Page
INTRODUCTION 1
PART I. REGULATORY ASSESSMENT 3
A. Description of Chemical 4
B. Agency Assessment 5
C. Regulatory Position and Rationale 17
PART II, REQUIREMENTS FOR REGISTRATION 22
A. Acceptable Ranges and Limits 23
B. Labeling and Packaging Requirements ...... 24
C. Submission of Generic Data 28
D. Submission of Product Specific Data 34
E. Instructions for Submission 35
APPENDICES
A - Tables A and B - Data Requirements 38
B - EPA Index to Pesticide Chemicals 65
C - Labeling Requirements 8S
1. Submission of Revised Labeling
2. 40 CPR 162.10 Labeling Requirements
3- Table of Labeling Requirements
4. Physical/Chemical Hazards
Labeling Statement
5. Pesticide Storage Instructions
6. Container Disposal Instructions
7. Farmworker Safety Label Requirements
D - FIFRA §3(c)(2)(B) Summary Sheet 117
E - Certification of Attempt to Enter Into
an Agreement with Other Registrants for
Development of Data 119
F - Product Specific Data Report 121
G - Formulator's Exemption Statement 124
BIBLIOGRAPHY 126
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Section 3(g), directs EPA to reregister all pesticides as
expedltiously as possible.
To carry out this task EPA has established the Registration
Standards program, which reviews all pesticide products contain-
ing active ingredients first registered before January 1, 1977-
Pesticides are 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 studies required to maintain the registration
of the pesticide. These may be either 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 modify product labels to
provide additional precautionary statements, restrict the use of
the pesticide to certified applicators, establish 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 environment.
The scientific review, which is not contained in the Registration
Standard, but is available from the National Technical Information
Service, concentrates on the technical grade of the active
ingredient and identifies missing generic data. However, during
the review of these data, the Agency is also looking f*or potential
hazards that may be associated with the end-use (formulated)
products that contain the active ingredient. If the /Vgency has
serious concerns, the end-use products will be addressed as part
of the Registration Standards program and regulatory actions, to
the extent necessary to protect the public, will be proposed.
This Registration Standard contains the results of the Agency's
review of products containing pronamide as the sole active
ingredient. During this review, the Agency evaluated all Section 3,
Section 2i|(c) and intrastate uses registered for pronamide.
Part I of this Standard, Regulatory Assessment, contains a
description of pronamide and a summary of the Agency's assessment
of the chemical. This is followed by a more thorough discussion
of the data base and the resulting regulatory position.
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Part II of the Registration Standard, Requirements for Regis-
tration, addresses the necessary requirements for maintaining
registrations of products containing pronamide, along with the
instructions for submission of the data and information to the
Agency.
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PART I. REGULATORY ASSESSMENT
The Agency has conducted a thorough review of the existing
scientific data base on pronamide. This Part of the Standard
sets forth the results of that review beginning with a descrip-
tion of the chemical and its uses, followed by a discussion of
the risks and benefits associated with the use of pronamide.
A summary of the Agency's review and position precedes the
discussion.
This part concludes with the resulting regulatory position,
and the rationale for these positions.
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A. DESCRIPTION OP CHEMICAL
1. Description
Common Name
Chemical Name
Empirical Formula :
Trade Names :
Chemical Abstracts
Service (CAS) No. ;
OPP (Shaughnessy) No.:
Use Profile
Type or Pesticide :
Pest Controlled :
Registered Uses
Predominant Use
Method of Application
Mode of Activity
Rates of Application
Formulations
Pronamide
3 5-dichloro-N(l,l-dimethyl-2-
propynyl) benzamide
- or -
[N-(l.l-dimethylpropynyl)-3, 5-
dichlorobenzamide]
C12H11NOC12
Kerb
23950-58-5
101701
Preemergence herbicide
Annual and perennial grasses;
certain broadleaf weeds
Croplands; noncroplands
Lettuce and alfalfa
Ground spray equipment; incorporation
aerially: limited hand spray
Inhibition of root and shoot grow ;h
of germinating weed seedlings
0.5 to 4.0 Ibs. active ingredient
per acre, depending on crop and
weed problem
9*J% technical grade
50% formulation intermediate
End-use products: 50% wettable powder
<_!% granular formulations and
<1% granular formulations mixed
with fertilizer
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B. AGENCY ASSESSMENT
The Agency has conducted a thorough review of pronamide and its
scientific data base. The conclusions reached and requirements
to be imposed as a result of this review are discussed below.
Summary. The following summarizes the results of the Agency's
assessment of pronamide.
1. Pronamide poses a limited oncogenic risk for applicators.
In accordance with the Agency's proposed guidelines for
carcinogen risk assessment, pronamide has been classified in
Group C, Possible Human Carcinogen, pending consideration of
additional data required by this Standard. This classifica-
tion is based on a Medical College of Virginia (MCV) 18-month
mouse oncogenicity study which indicated that hepatocellular
carcinomas in male mice were present at feeding levels of
1000 and 2000 ppm. The results of this study have been
confirmed and clarified by a subsequent study (MIT).
2. Pronamide poses applicator exposure and risk which can be
reduced through the imposition of protective measures
(protective clothing, restricted use classification, water-
soluble packaging, etc.).
3. Pronamide has significant benefits that outweigh the
identified risks, if protective measures are instituted.
As a result of this review, the Agency has identified missing
data which are essential in completing assessment of the environ-
mental and human risks associated with the use of pronamide.
These data must be developed in order to maintain registrations
of products or register new products containing pronamide.
Specific data gaps are listed in Appendix A, Tables A and B.
The Agency has also determined that certain restrictions or
conditions are necessary to minimize environmental and human risks.
Significant requirements include continuation, from the RPAR
decision (see below), of classification as a restricted use
pesticide and water-soluble packaging for wettable powder end-use
products, and expansion of the protective clothing requirements
imposed by the RPAR decision. A complete discussion is contained
in Section C, Regulatory Position and Rationale, of this part;
the specific label language, when applicable, is set forth in
Part II.
Background. An RPAR (Rebuttable Presumption Against Registration,
or Special Review) of pronamide was initiated in 1977 on the basis
of a Medical College of Virginia (MCV) 18-month mouse oncogenicity
study which indicated that mice given diets containing 0, 1000,
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and 2000 ppm pronamide showed a treatment-related increase in
hepatocellular carcinomas. The incidence of tumors was observed
at 18 months in male mice only. At that time, this study provided
the only evidence that pronamide is likely to be a human carcinogen,
After reviewing all the available information, EPA determined that
the cancer risk presumption had not been rebutted, and that the
uses of pronamide posed risks of cancer to certain exposed groups.
The Agency also reviewed information relating to benefits of these
uses, and after considering risks in relation to benefits, deter-
mined that these risks may be reduced by modifying the terms and
conditions of registration for some uses. The RPAR review was
completed in 1979, and the final decision included the following:
a. Restricted use classification for 50% wettable powder end-use
products.
b. Use of protective clothing during mixing and application of
wettable powder formulations.
c. Implementation of water-soluble packaging for wettable powder
formulations.
d. Tolerance on lettuce lowered from 2 ppm to 1 ppm to reduce
dietary exposure.
Tolerance Reassessment. Tolerances have been established for
residues of pronamide in or on a wide range of raw agricultural
products listed in 40 CFR 180.317. These tolerances are:
Commodity Tolerance (ppm)
Alfalfa, fresh 10.0
Alfalfa, forage 10.0
Alfalfa, hay 10.0
Apples 0.1
Artichokes 0.1
Blackberries 0.05
Blueberries 0.05
Boysenberries 0.05
Cattle, fat 0.02
Cattle, kidney 0.2
Cattle, liver 0.2
Cattle, MBYP (exc.
kidney and liver) 0.02
Cattle, meat 0.02
Cherries 0.1
Clover 5.0
Crown vetch 5.0
Eggs 0.02
Endive (escarole) 2.0
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Goats, fat 0.02
Goats, kidney 0.2
Goats , liver 0.2
Goats, MBYP (exc.
kidney and liver) 0.02
Goats, meat 0.02
Grapes 0-1
Hogs, fat 0.02
Hogs, kidney 0.2
Hogs, liver 0.2
Hogs, MBYP (exc.
kidney and liver) 0.02
Hogs, meat 0.02
Horses, fat 0.02
Horses, kidney 0.2
Horses, liver 0.2
Horses, MBYP (exc.
kidney and liver) 0.02
Horses. meat 0.02
Lettuce 1.0
Milk 0.02
Nectarines 0.1
Peaches 0. 1
Pears 0.1
Plums 0.1
Poultry, fat 0.02
Poultry, kidney 0.2
Poultry, liver 0.2
Poultry, MBYP (exc.
kidney and liver) 0.02
Poultry, meat 0.02
Raspberries 0.05
Sainfoin 5.0
Sheep, fat 0.02
Sheep, kidney 0.2
Sheep, liver 0.2
Sheep, MBYP (exc.
kidney and liver) 0.02
Sheep, meat 0.02
Trefoil 5.0
Because insufficient data are available to fully assess the
established tolerances for residues of pronamide, any con-
clusions stated herein are subject to change.
The metabolism of pronamide in plants and animals is not ade-
quately understood. Plant metabolites were identified in alfalfa
only. The data were too variable to make definite conclusions
about relative abundances of the metabolites. The data do show
that if the carbonyl carbon of pronamide remains intact, all of
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the organoextractable terminal residues retain the 3,5-dichloro-
carboxyphenyl substituent. Additional data are required depicting
the distribution and metabolism of pronamide in alfalfa and lettuce,
If metabolism among these two crops differs significantly, metab-
olism studies will be required for a representative crop in each
crop group for which there is a registered use.
Residues were not characterized in tissues and milk of ruminants
and no poultry data were submitted; therefore, metabolism studies
utilizing ruminants and poultry are required. Residues in muscles,
fat, kidney, liver, milk, and eggs must be characterized and
quantified.
On receipt of the data, the tolerance definition will be examined
and changed to include only those metabolites found which are of
toxicological concern.
The methods of analysis of pronamide and its 3,5-dichloro-
benzene-containing metabolites (calculated as pronamide) in or
on plant and animal commodities are presently adequate for sample
analyses and tolerance enforcement.
Sufficient data are available to ascertain the adequacy of the
established tolerances for residues of pronamide in or on alfalfa
forage and hay, apples, artichokes, blackberries, blueberries,
cherries, clover, crown vetch, grapes, lettuce (head lettuce only),
nectarines, peaches, pears, plums, raspberries, sainfoin, and
trefoil.
The tolerance for residues in or on "fresh" alfalfa will be
revoked. Alfalfa is available in two forms: forage, which is
uncut, and hay, which is the cut alfalfa. Therefore, the term
"fresh" is a misnomer and the tolerance will be revoked. Several
commodity definitions and crop tolerance levels are recommended
for change as set out in Section C of this Standard.
Available data support the established tolerance in head lettuce
only. The preharvest interval of 55 days for residues in or on
leaf lettuce is inappropriate as many varieties mature in 45
days. The registrant must either withdraw the registered use on
leaf lettuce or revise the label directions so that use on leaf
lettuce is practical. If the registrant proposes a change in
the use directions, appropriate supportive data must be submitted.
Available data, in conjunction with data translated from lettuce,
indicate that the use of pronamide on endive should result in
residues no greater than 1 ppm. Therefore, the tolerance of 2
ppm should be reduced to 1 ppm for residues of pronamide in or
on endive (escarole).
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2re are no registered uses of pronamide on boysenberries.
2 established tolerance will be revoked unless appropriate
sidue data in support of this tolerance are submitted and i
;>istration for this use is secured.
The;
The
residue data in support of this tolerance are submitted and a
registration for this use is secured.
Available data are inadequate to evaluate the established
tolerances for residues in or on animal commodities.
Storage stability data for plant and animal residues must be
submitted. On receipt of the plant and animal metabolism and
storage stability data, the adequacy of established tolerances
will be determined.
Data are needed to determine whether food/feed additive tolerances
under Section 409 of the Federal Food, Drug and Cosmetic Act (FFDCA)
are needed for processed products of apples, alfalfa, plums, and
grapes. Under the FFDCA, food additive tolerances may be issued
only if it is established that the use of the food additive will
be safe. Should food/feed additive tolerances be required, the
Agency's review of data submitted in response to this Standard
will include consideration of Section 409's criterion known as
the Delaney Clause.
The provisional acceptable daily intake (PADI) for pronamide was
based on the NOEL of 7.50 mg/kg in the 2-year dog study (Larson,
P. and Borzelleca, J.). It should be noted that this PADI is
based on systemic toxicity (non-oncogenic). The current PADI is
0.0750 mg/kg/day and the current published tolerance for pronamide
has a calculated Total Maximum Residue Concentration (TMRC) of
0.0409 mg/day (1.5 kg diet). The percentage of PADI utilized is
0.91%.
Preliminary Risk Analysis. To assess the potential risks assoc-
iated with pronamide, the Agency reviewed the existing data base.
Based on this review, dietary risk and applicator exposure and
risk have been calculated. The following is a discussion of the
results of the risk assessment.
a. Review of Toxicological Studies. The toxicology data base
for pronamide is not complete. The following discussion
focuses on data relevant to the classification of pronamide
in accordance with the EPA draft Guidelines for Carcinogen
Risk Assessment.
1. Oncogenicity Studies. The Agency has available three
studies:"Eighteen month study of the carcinogenic
potential of Kerb (RH-315, Pronamide) in mice," Medical
College of Virginia (MCV), August 30, 1974; "Chronic
toxicity study in the mouse" by Newberne et al.,
Massachusetts Institute of Technology (MIT), August 10,
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1982; and "Toxicologic study on the effect of adding
RH-315 to the diet of rats for a period of two years,"
(MCV), June 11, 1970;
a. MCV Mouse Study. The MCV study indicated that
hybrid mice, B6C3F1, a strain with a high background
incidence of liver tumors, given diets containing
0, 1000, or 2000 ppm showed a treatment-related
increase in hepatocellular carcinomas. The incidence
of those tumors was observed at 18 months in male
mice only, and the results are summarized as follows:
Dose
0
1000
2000
b. MIT Mouse Study-
Tumor Incidence
7/100
18/100
24/99
The
and
MIT study was required by the
Agency to confirm and clarify the results of the
MCV study and employed males only of the same strain
(B6C3F1). Of particular concern were time-to-tumor
and dose-response relationships. Hence, the MIT study
included interim sacrifices and a wider range of dose
levels. The reported incidence of hepatocellular
carcinomas was as follows:
Dietary
Concentrations
Time on diet (months)
6
0/42
0/42
15
3/42
0/42
1/42
2/42
2/42
1/42
18
4/42
2/42
3/42
3/42
4/42
6/41
24
6/63
5/63
9/63
12/63
18/63
14/61
0*
0**
20**
100**
500**
2500
* Control group 1.
** Control group 2, not part of the
6-month phase of the study.
The following observations were also noted in the MIT
study:
(1) While dose-related carcinomas occurred late in
the lifespan of test mice (at 24 months), other
proliferative liver lesions were present at 15
and 18 months in the highest dose group.
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(2) Approximately 60 to 100 percent (for control and
test groups) of the animals examined at the end
of the study exhibited proliferative liver lesions
including hyperplasias, hyperplastic nodules,
adenomas, and carcinomas.
(3) The number of metastases observed was not
consistent with a dose-related increase.
(4) There was no dose-related effect on mortality of
treated mice.
c. Rat Study. Pronamide was administered in the diets
of rats at levels of 0, 30, 100. and 300 ppm. No
toxic effects were noted in the study and only minimal
effects on body weights were seen at 300 ppm. For
these reasons, it was concluded that the highest dose
level may have been too low and, therefore, compromised
the sensitivity of the study to assess the carcinogenic
potential of pronamide.
The study had several deficiencies, the test material
was not adequately described and no data for diet
analysis were reported. Clinical chemistry studies
were not conducted and hematology and urinalysis were
performed on only 5 rats/sex/group. No individual
data for body weights, food consumption, clinical
studies, or organ weights were reported, so the
summary data could not be validated; furthermore, the
methods for statistical analysis were not specified.
Because of these deficiencies, EPA cannot determine
whether a maximum tolerated dose was administered.
Mutagenicity Studies. The Agency has available to it four
mutagenicity tests: an in vitro spot assay for (gene) rever-
sion in Salmonella typhimurium strains TA 1530 and G46, con-
ducted only without metabolic activation; an in vitro assay
for mitotic recombination at only one dose in Saccharomyces
cerevis iae D3; a host-mediated assay in mice treated sub-
acutely (5 days) (by an unstated route of administration)
employing these microbial strains as indicator organisms;
and a cytogenetic assay for chromosomal aberations in
bone-marrow cells of rats. Although negative results were
reported for all of these assays, they are considered un-
acceptable by current Agency testing guidelines for adequate
studies because of major deficiencies in procedure and
reporting.
In the cytogenetic study, data confirming that the assay was
performed at the limits of clinical or cytological toxicity
were not presented. Therefore, it cannot be assessed if the
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dose range selected included sufficiently high levels. In
addition, all aberration parameters were reported to be "0"
for the negative control and for all dosages; although such
results are possible, the data appear to show unusually low
responses and are not consistent with historical control
incidence of aberrations.
Reporting for both iri vitro and the subacute in vivo host-
mediated assays for mutagenesis was inadequate. Only general
protocols were submitted, which do not clearly define what
was actually done to generate the data.
The Agency is requesting a full battery of studies to
evaluate the mutagenic endpoints (see Table A, Appendix A).
Risk Assessment. The Agency has classified pronamide
according to the EPA draft Guidelines for Carcinogen Risk
Assessment. EPA concludes that a tentative classification
of pronamide as a Group C oncogen (Possible Human Carcinogen)
can be made based on the effects observed in the mouse
studies.
The classification of pronamide as a tentative Group C
oncogen (providing limited evidence of oncogenicity) relies
on two studies in the mouse which showed a dose response in
heptacellular carcinoma. The MIT study was designed to
confirm and clarify the MCV study which reported an
increase in hepatocellular carcinoma in male mice only
at 18 months on diets of 1000 and 2000 ppm pronamide.
The MIT study utilized male mice only of the same strain
vB6C3F1) with dietary dosages ranging from 20 to 2500
ppm pronamide and sacrifices scheduled at 6. 15, 18, and
24 months. The two studies together do not provide
substantially different information than is provided by
either study alone. Both studies showed a dose response
in heptacellular carcinomas in a liver tumor prone
strain of mice and the results of the second study clearly
indicated that these dose related tumors occurred only
at the end of the study, i.e., there was no decrease in
the time to malignancy attributable to exposure to pronamide.
These studies in mice, together with the existing rat
study, constitute only limited evidence of oncogenicity,
leading to a Group C classification.
Because of the absence of adequate studies in other species
or well performed short term studies, EPA is not able to make
a final classification of pronamide at this time. The addi-
tional rat bioassay and short term studies required by this
Standard are expected to substantially assist in determining
an appropriate final classification for this pesticide.
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The final RPAR decision was based in part on the results of
the MCV oncogenicity study. It did not include the results
of the MIT oncogenicity study which was submitted after the
final RPAR decision. The results of the MIT mouse study do
not significantly alter EPA's assessment of the carcinogenic
risks to humans. Since pronamide has been regulated as a
carcinogen in the past, the Agency has recalculated risks
based on a more recently accepted statistical model.
c. Risk Estimation
Dietary Risks. Dietary risks were estimated from the
published tolerances. A partial listing of dietary risks
follows:
Meat
Products
Milk/
Dairy
Apples
mg/kg/day
.000327
.000069
.000143
.000063
Risk
(based on Q* = 1.63x10
10-6 to
10-6
10'6
10-6
[c]
[c]
[cj
TMRC
.0006833
10~5
[c]
The Theoretical Maximum Residue Contribution (TMRC)
assumes that residues occur at the tolerance level on
100 percent of the crops and thus overestimates the
actual dietary exposure. Using Q-j* = 1.63x10 as
the proper estimator of oncogenic potency, and the
multi-stage procedure programmed to fit the data and to
calculate the upper 95 percent bound on the risk associated
with expected doses of the compound under study, the
TMRC risk is lQ-5[c] .
Applicator Risk.
mg/kg/year are:
Exposure values for the major uses in
I/ [c] = Group C Classification (Possible Human Carcinogen), EPA's
Proposed Guidelines for Carcinogen Risk Assessment.
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Lettuce
Dermal
Inhalation
Loader
Applicator
210
210
0.3
Negligible
Alfalfa
Loader
Applicator
Dermal
3
3
Inhalation
0.004
Negligible
The lifetime average daily dose (LADD) was calculated from
the following equation:
LADD = (mg/kg/year) x (1/365) x (35 years
exposure/70 years/lifetime)
Dermal absorption of 100 percent is assumed, therefore,
perhaps exaggerating risks by an unknown amount.
Associated risks to lettuce and alfalfa applicators and
loaders are:
LETTUCE
Loader
Applicator
ALFALFA
Loader
Applicator
Lifetime Risk
5 x 10-3 [c]
5 x 10-3 [c]
6 x 10-5 rci
Risk with
Protective
Clothing
Risk with Protective
Clothing and Water
Soluble Packaging
1 x 10-3 [c]
1 x 10-3 [c]
1 x 10-5 [cl
6 x 10-5 [C] 1 x 10-5 [C]
1 x 10-4 [c]
1 x 10-3 [CJ
1 x 10-6 [c]
1 x 10-5 [c]
I/ [c] = Group C Classification (Possible Human Carcinogen), EPA's
Proposed Guidelines for Carcinogenic Risk Assessment
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Benefits and Use. Pronamide is an herbicide active on a variety
of annual and perennial grasses and certain annual broadleaf
weeds. It is taken in by plant roots and, therefore, must be
applied to the soil and taken by water into the root zone in
order to function. It is most effective against germinating
seedlings but will control some weeds (e.g., annual bluegrass)
after they have emerged. It is also specially effective against
perennial grasses because it interferes with underground stem
growth as well as root growth. Pronamide is inactivated by soil
organic matter and, therefore, is not to be used on muck, peat,
or other high-organic content soils.
Pronamide is sold as a wettable powder, as a granular material,
or as a granular with fertilizer. The wettable powder (50 per-
cent active ingredient (a.i.)) is used for all crop spray uses;
the granular products (0.125-1.0 percent a.i.) are applied to
bermudagrass turf, especially golf courses.
Pronamide is used on: lettuce (most use occurs in California
and Arizona); alfalfa and other forage legumes for hay (in
the Pacific northwest and upper midwest and east); alfalfa
and clover seed crops (Pacific northwest); berry crops
(Washington and Oregon only); ornamental bermudagrass turf,
such as golf courses, playgrounds, athletic fields, and
lawns (southeastern United States primarily, mostly for golf
courses); woody ornamentals, nursery stock and Christmas
trees (mostly north central and northwest states where quack-
grass and other perennial grasses are severe); sugarbeet
seed crops (Oregon only); globe artichokes in California;
tree fruits and grapes (chiefly in California, some in north-
eastern states); and fallow land to be planted to wheat,
barley or oats (Idaho, Oregon, and Washington).
Application to all sites except turf is predominantly by
conventional ground spray equipment or by incorporation (on
some lettuce). Often on lettuce, berries, and seed crops, it
is applied in bands on or near the row so that treated acreage
is about 1/2 to 1/3 of planted acreage. This reduces residues
of pronamide in the soil. Granular (sometimes plus fertilizer)
treatments are used on bermuda turf to carry the pronamide
through the thatch to the soil surface. Aerial application
is occasionally made to alfalfa (estimated at about 5 percent).
Rates of application range from 0.5 to 4 Ib. per acre, depending
on the crop and the weed problem. Except for spring applications
to summer lettuce, August applications to fall lettuce, and late
spring applications to alfalfa and clover seed crops, all applica-
tions are made in late fall or early winter, before the ground
freezes. This is largely due to the need to apply pronamide when
the protected crop is dormant. Because it acts as a cell division
inhibitor, pronamide will control growing winter weeds while not
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harming the dormant crop. This practice also results in minimal
residues in hay and berry crops the following summer.
There are 12 special local needs (Section 24c) registrations:
a. Aerial application to lettuce - Arizona and California;
b. Tank mix with "herbicide 273" (endothall) for use on sugar-
heets - Oregon;
c. Addition of Kerb 50-W to potassium or phosphate fertilizer to
provide granular application to alfalfa at the rate of 1.5 -
4 Ib. a.i. per acre depending on local need Pennsylvania;
d. Tank mix with dinoseb for established alfalfa - California.
e. Mixing pronamide with potash or phosphorus fertilizers -
New York and Oregon;
f. Fall application at 0.25-0.5 Ib. ai/A to land prior to summer
fallow before planting to winter wheat, oats, or barley -
Idaho, Oregon and Washington;
g. Directed spray at 4 Ib.ai/A to soil between rows of globe
artichokes after winter drainage ditching operations -
California; and
h. Aerial application at 3 Ib. ai/A to Christmas tree planta-
tions - Oregon.
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C. REGULATORY POSITION AND RATIONALE
Based on review and evaluation of all available data and other
relevant information on pronamide, the Agency has made the
following determinations. Where labeling requirements are
imposed, specific language in set forth in Part II.
1. If any of the risk criteria listed in Section 154.7 of
Title 40 of the U.S. Code of Federal Regulations has been
met or exceeded, a special review of the chemical is con-
ducted. Pronamide has not met any of the criteria, and
therefore is not being placed into the special review
process at this time.
Rationale: Although pronamide is an oncogen in male mice,
EPA does not believe that pronamide meets the criterion in
40 CFR 154.7(a)(2) for initiating a special review. EPA's
recently effective final special review rules provide that
the Administrator may conduct a special review if a pesticide
use "may pose a risk of inducing in humans an oncogenic
. . . effect, which is of concern in terms of either the
degree of risk to individual humans or the number of humans
at some risk . . ." (see 50 FR 49016, November 27, 1985).
EPA concludes that the risk of oncogenic effects is not of
sufficient concern to warrant a special review because the
most recently computed risk levels are comparable to those
achieved through the earlier RPAR on pronamide. Moreover, the
risk levels are, in their own right, relatively low and the
population of individuals the Agency knows are highly exposed,
i.e, applicators, is quite limited. Finally, EPA's assess-
ment of the risk must be tempered by the nature of the quali-
tative evidence indicating the carcinogenicity of pronamide.
Thus, the tentative Group C classification of pronamide
indicates that the Agency believes that the evidence of
carcinogenic activity is limited and, therefore, open to
some doubt.
2. No new significant tolerances will be considered until the
Agency has received data sufficient to thoroughly evaluate
pronamide. The Agency will require metabolism studies
utilizing ruminants and poultry, as well as storage stability
data for plant and animal residues. Residues in muscles,
fat, kidney, liver, milk and eggs must be characterized and
quantified. Additional data are required depicting the dis-
tribution and metabolism of pronamide in alfalfa and lettuce.
If metabolism among these two crops differs significantly,
metabolism studies will be required for a representative
crop in each crop group for which there is a registered use.
Rationale: The toxicological data base on pronamide is not
sufficient to consider establishment of new significant
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tolerances. The metabolism of pronamide in plants and animals
is not adequately defined. Plant metabolites were identified
in alfalfa only- The data were too variable to make definite
conclusions about relative abundances of metabolites. Residues
were not characterized in tissues and milk of ruminants and
uo poultry data were submitted. Moreover, EPA has insufficient
data to determine whether food additive regulations are required
for certain processed foods, as provided under Section 409 of
the Federal Food, Drug and Cosmetic Act.
3. Changes to the tolerance regulations under 40 CFR 180.317,
will be proposed as follows:
Present Wording New Wording
Alfalfa (fresh) (Will be Revoked)
Boysenberries (Will be Revoked)
Clover Clover (forage)
Crown vetch Crown vetch (forage)
Endive (escarole) - 2 ppm Endive (escarole) - 1 ppm
Sainfoin Sainfoin (forage)
Sheep meat - 0.2 ppm Sheep meat - 0.02 ppm
Trefoil Trefoil (forage)
Rationale: Alfalfa is used either as forage (uncut) or hay
(cut);therefore, the term "fresh" is a misnomer and the
tolerance should be revoked. There are no registered uses for
boysenberries; unless appropriate residue data in support
of this tolerance are submitted and a registration for this
use secured, the tolerance should be revoked. Available data,
in conjunction with data translated from lettuce, support a
tolerance for endive (escarole) of 1 ppm; therefore, the
tolerance should be reduced from 2 ppm to 1 ppm. The tolerance
for sheep meat has been incorrectly published as 0.2 ppm;
the correct tolerance is 0.02 ppm. The terminology for the
remaining commodities (clover, crown vetch, sainfoin, and
trefoil) should be changed to include the word "forage," vhich
is the uncut form of these commodities and the correct deli-
nition. This change would be consistent with the crop
definitions listed in the CFR.
4. The Agency will continue to classify 50% wettable powder
end-use products as restricted-use pesticides, as required
by the RPAR of pronamide.
Rationale: The processes of mixing and applying 50% wettable
powder products pronamide pose risks to the mixers and appli-
cators. These risks are discussed under Section B of this
Part. The risks can be reduced by requiring, among other
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things , that 50% wettable powder pronamide products only be
applied by personnel who have been made aware of these risks,
i.e., certified applicators who have received instructions
on the safe handling of pesticides, or those under the direct
supervision of certified applicators.
5. The following data are required to assess the chronic toxi-
city of pronamide: chronic feeding/oncogenic study (rat);
teratogenicity (rat); reproduction (2-generation); mutagenic
potential; metabolism (general), and dermal penetration.
Rationale: These data are normally required by rules in
40 CFR 158 for products with pronamide's use patterns. Most
of the existing studies on pronamide do not meet the guideline
standards for acceptable studies but provide only limited
information on the toxicity of pronamide or are unacceptable
or invalid. The Agency is, therefore, not able to thoroughly
assess the chronic toxicity of pronamide.
6. The following data are required to fully assess the
environmental fate of pronamide: photodegradation studies
on soil and in water; aerobic soil and anaerobic aquatic
metabolism studies; leaching and adsorption/desorption
studies; volatility studies; field dissipation studies;
and rotational crop and fish accumulation studies.
Rationale: Except for the hydrolysis data, all the
environmental data are preliminary and do not meet
guideline standards for acceptable testing. These data
are normally required under 40 CFR 158 and are necessary
to assess the environmental fate and transport and the
potential exposure to pronamide.
7. The Agency will require that labels of end-use products
contain protective clothing statements. Protective
clothing requirements for wettable powder formulations
were required by the RPAR.
Rationale: The potential for oncogenic risk from pronamide
use is discussed in the preceding Section. This risk
can be reduced significantly by requiring persons who
may have significant dermal contact with the chemical to
wear protective clothing, thereby reducing exposure to
pronamide at a small cost.
8. The RPAR for pronamide required that wettable powder
formulations be packaged in water soluble packaging.
The Agency will continue this requirement.
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Rationale: User exposure and risks are discussed in
Section B. This packaging technology reduces mixer/loader
contact with wettable powder formulations during mixing
operations, thereby reducing a major source of exposure.
9. Products containing pronamide must contain general pre-
cautionary language regarding dermal and ocular contact
with products containing pronamide, as required by the
RPAR. In addition, labels must also contain direction
about the handling of contaminated clothing.
Rationale: Because of the risks associated with pronamide
as previously discussed, the inclusion of precautionary
language will emphasize the need for users to exercise
caution while using pronamide and will limit risk if
contact with the product occurs.
10. Restrictions are being placed on planting of crops, for
which pronamide is not registered, in fields previously
treated with products containing pronamide. Labels of
end-use products must contain rotational crop statements.
Rationale: The crop restriction is necessary due to the
lack of adequate residue data on rotational crops. It
is the policy of the Agency to impose restrictions on
planting rotational crops when data are insufficient to
allow an assessment of the impact of planting subsequent
crops. This serves to protect the public from impermissable
residues in food and feed, as well as to warn growers about
how to avoid impermissible residues.
11. The Agency will continue to require that labels of granular
formulations must include instruction for watering turf
after application of pronamide, as originally required
by the RPAR.
Rationale: Data on particle size in the granular formula-
tions indicate that these products do not pose the same
level of risks to the applicator as wettable powders.
However, thorough watering of granular formulations of
pronamide after application will minimize exposure to
people entering the treated area and enhance efficacy-
12. Hand-spray application of products containing pronamide
will be limited to ornamentals and nursery stock. This
is a continuation of an RPAR requirement.
Rationale: Because of the method of application, hand-
spray application of products containing pronamide is
important in the minor uses on ornamentals and nursery
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stock. Because it is a minor use and because the product
registered for these uses will be a restricted use pesticide
requiring protective clothing which can provide hand-spray
users some protection from exposure to pronamide, such
uses on ornamentals and nursery stock will be permitted.
Data indicate that, for other uses, mechanical application
methods are used.
13. A reentry interval for currently registered uses of
pronamide is not required.
Rationale: The acute toxicity for pronamide is low
(Category III). Additionally, because pronamide is
primarily a preemergent herbicide, exposure and the
resultant risks to field workers are expected to be
minimal. Therefore, no reentry interval is required.
14. While the data gaps are being filled, currently registered
manufacturing-use products (MPs) and end-use products
(EPs) containing pronamide as the sole active ingredient
may be sold, distributed, formulated and used in the
United States, subject to the terms and conditions speci-
fied in this Standard. Registrants must provide or agree
to develop additional data, as specified in Tables A and
B of Appendix A in order to maintain existing registra-
tions. The Agency will issue registrations for sub-
stantially similar products. However, significant new
uses will not be registered until the Agency has received
data adequate to thoroughly evaluate the risks associated
with pronamide use.
Rationale: Under FIFRA, the Agency does not normally
cancel or withhold registration simply because data are
missing or inadequate (see FIFRA sections 3(c)(2)(B) and
Issuance of this Standard provides a mechanism for identify-
ing data needs. These data will be reviewed and evaluated
after which the Agency will determine if additional regula-
tory changes are necessary.
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PART II. REQUIREMENTS FOR REGISTRATION
This Part of the Registration Standard discusses data, labeling
revisions and packaging required to maintain existing registra-
tions or register new products containing pronamide. It also
contains the Instructions for submitting the necessary data
and information to the Agency.
To be covered under this Standard, products must contain
pronamide as the sole active ingredient, bear required label-
ing, and conform to the product composition, acute toxicity
limits, and use pattern requirements listed in this Part.
The applicant for registration or reregistration of products
subject to this Standard must comply with all terms and con-
ditions described in it, including submission of an up-to-
date Confidential Statement of Formula, submission of revised
labeling, commitment to fill data gaps on the schedule specified
by the Agency and, when applicable, offer to pay compensation
as required by Sections 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). Registration applicants
must contact the Agency for specific instructions, including
updated information on data requirements and companies whose
data have been used in support of registration.
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A. ACCEPTABLE RANGES AMD LIMITS
Product Composition Standard. To be covered under this Standard
products must contain pronamide as the sole active ingredient.
Each technical grade or manufacturing-use formulation proposed
for registration must be fully described with an appropriate
certification of limits.
Acute Toxicity Limits. The Agency will consider registration
of technical grade and manufacturing-use products containing
pronamide, provided that the product labeling bears appropriate
precautionary statements for the acute toxicity category In
which each product is placed, as required by ^0 CFR 162,10.
Use Patterns. To be registered under this Standard, technical
grade or manufacturing-use products containing pronamide may he
labeled for formulation into end-use products for use only on
the commodities listed below. Appendix R, EPA Index to Pesti-
cide Chemicals - Pronamide, lists all registered uses, as well
as the approved maximum application rates and frequencies.
-Terrestrial, non-domestic, food uses on- alfalfa, alfalfa
(seed crop), apples, globe artichokes, birdsfoot trefoil,
birdsfoot trefoil (seed crop), blackberries, blueberries,
cherries, clover, clover (seed crop), crown vetch, crown
vetch (seed crop), endive, grapes, lettuce, nectarines,
peaches, pears, plums, prunes, raspberries, sainfoin, and
sainfoin (seed crop).
-Terrestrial, non-domestic, non-food uses on: bermudagrass,
bermudagrass (seed crop), azalea, azalea (nursery stock),
Christmas tree plantations, Douglas fir, Douglas fir
(nursery stock), fir, fir (nursery stock), forsythia,
forsythia (nursery stock), holly, holly (nursery stock),
juniper, juniper (nursery stock), pine, pine (nursery
stock), rhododendron, rhododendron (nursery stock), yew,
and yew (nursery stock).
-Domestic outdoor uses on: bermudagrass, centipedegrass,
St. Augustinegrass, and zoysiagrass.
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B. LABELING AND PACKAGING REQUIREMENTS
All labeling changes required by this Standard must appear
on all products in channels of trade within two years of
Issuance of this Standard. As specified packaging for
wettable powder end-use products is a continuation of an
existing requirement, such packaging must immediately be in
use or, for new products, incorporated at the time of product
introduction.
In addition to the above, the following information must
appear on the labeling:
1. All Products. All products must bear appropriate
labeling as specified in 40 CPR 162.10. Specific
information on label requirements are contained in
Appendix C.
a. Ingredient Statement. The ingredient statement
must list the active ingredient as:
pronamide, 3,5-dichloro-N-(1,1-dimethy1-2-
propyny1)benzamide. . .%
or
pronamide [N-(1,l-dlmethylpropynyl)~3 ,5~
dichlorobenzamide] . . , .%
b. Disposal Statements. Because pronamide has not
been designated as an acute or toxic hazardous waste
under the Resource Conservation and Recovery Act
(RCRA), the following is the appropriate pesticide
disposal statement for pronamide products:
"Wastes resulting from the use of this product
may be disposed of on site or at an approved
waste disposal facility."
The labels of all products must bear the appropriate
container disposal statement (see Appendix C-6) .
2. Technical Grade/Manufacturing-Use Products
a. Use Pattern Statements. Labeling for all technical
grade and manufacturing-use pronamide products must
state that they are intended for formulation into
end-use herbicide products for the use patterns and
sites, as set forth In the preceding section under
Use Patterns. However, no use may be Included
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on the label if the registrant fails to agree to
comply with the data requirements for that use pattern,
as listed in Table A and/or Table R, Appendix A, as
appropriate.
Precautionary Statements. Labels Tor technical grade
and manufacturing-use pesticide products must hear
statements reflecting the compound's acute human toxi-
city, as specified in 40 CPR 162.10 (Appendix C-2),
and statements pertaining to environmental hazard.
Pronamide is in Toxicity Category III for dermal,
inhalation, and eye irritation routes of exposure; the
required precautionary statements associated with this
category, and the required environmental hazard state-
ments are set forth below.
"CAUTION - Harmful if absorbed through the skin or
inhaled. Causes moderate eye irritation. Avoid
contact with the skin, eyes, or clothing. Avoid
breathing dust. Wash thoroughly with soap and water
after handling. Remove contaminated clothing and
"Do not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or public
water unless this product is specifically identified
and addressed in an NPDES permit. Do not discharge
effluent containing this product into sewer systems
without previously notifying the sewage treatment
plant authority. For guidance contact your State Water
Board or Regional Office of the EPA."
Statements for End-Use Products. All end-use products with
outdoor agricultural uses which are applied to crops involv-
ing hand labor are required to bear precautionary label
language about farmworker safety. Appendix C-7 sets
forth the specific language to be used. All end-use products
must also bear an environmental hazard precaution (see
Appendix C-2), as set forth below along with additional
required statements:
"Do not apply directly to water. Do not
contaminate water by cleaning of equipment
n r> rllsnnsal nf washes "
contaminate water by cl
or disposal of wastes."
"GENERAL PRECAUTIONS: Avoid contact with eyes,
skin or clothing."
"PROTECTIVE CLOTHING: When mixing, loading or
applying this product, wear midforearm water-
proof gloves, long-sleeved shirts and long
-------
pants, preferably one piece (coveralls).
Hand-spray or hand-spreaders also require the
use of waterproof boots or shoe coverings.
Wash nondisposable gloves, boots and shoe
coverings thoroughly with soap and water
before removing."
"If water-soluble packaging is used, mixers
and loaders are exempted from protective
clothing requirements."
"Protective clothing/equipment is not needed
during application if an enclosed tractor cab
with filtered air supply or enclosed cockpit
is used."
"Any article of clothing worn while handling
product must be cleaned before reusing. Cloth-
ing should be laundered separately from house-
hold articles. Clothing which has been drenched
or heavily contaminated should be disposed of in
accordance with state or local regulations."
a. All 50% wettable powder end-use products must be packaged
in water-soluble packaging and bear the following
statements:
"RESTRICTED USE PESTICIDE: Because pronamide has
produced tumors in laboratory animals, this product
is for retail sale to and use only by Certified
Applicators or persons under their direct super-
vision, and only for those uses covered by the
Certified Applicator's certification."
"Crops other than those on which pronamide may
be applied may not be planted in pronamide-
treated soil."
"Hand-spray applications of pronamide may be
made only to ornamentals and nursery stock."
"Dilution Instructions
"The enclosed pouches of this product are water
soluble. Do not allow pouches to become wet
before adding them to the spray tank. Do not
handle the pouches with wet hands or gloves.
Always reseal overwrap bag to protect remaining
unused pouches. Do not remove water soluble
pouches from overwrap except to add directly
to the spray tank."
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"Add the required number of unopened pouches as
determined by the dosage recommendations into the
spray tank with agitation. Depending on the water
temperature and the degree of agitation, the pouches
should dissolve completely within approximately five
minutes from the time they are added to the water."
b. All pronamide granular formulations must bear the following
statement:
"Sites treated with this product must be thoroughly
watered after application."
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C. SUBMISSION OF GENERIC DATA
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. EPA has the
authority under PIFRA section 3(c)(2)(B) to require registrants
to submit data that will answer the Agency's questions regarding
the hazard that may result from the intended use of a pesticide.
This portion of the Registration Standard is issued under the
authority of PIFRA section 3(c)(2)(B). EPA has determined that
additional generic data described in Table A, Appendix A, must
be submitted to EPA for evaluation in order to maintain in
effect the product registration(s). As required by FIFRA
section 3(c)(2)(B), registrants are required to take appropriate
steps to comply with this Standard.
Although section 3(c)(2)(B) provides that all registrants are
responsible for these data, the Agency generally imposes generic
data requirements only on the registrants of the manufacturing-
use products (basic suppliers of the active ingredient) and
other registrants who do not qualify for the formulator's
exemption. The formulator's exemption applies to a registrant
of a product if the source of its 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.
A producer who currently does not qualify for the formulator's
exemption may qualify by changing its 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 Product Manager listed in Section E of this
Part within 90 days of receipt of the Registration Standard,
The chart on the following page shows what is generally requii-ed
of those who do and do not qualify for the formulator's exemption
in the Registration Standards program.
Registrants are reminded that FIFRA section 6(a)(2) requires
that factual information raising concerns of possible unreason-
able adverse effects of a pesticide must be promptly submitted.
If interim results of studies in progress show possible adverse
effects, the Agency is to be notified of those interim results.
EPA may suspend the registration of products unless, within the
specified time, the registrant informs EPA how it will satisfy
the requirements of this Standard. Any such suspension will
remain in effect until the registrant has complied with the
terms of this Standard.
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ACTION(S) REQUIRED TCf
MAINTAIN REGISTRATION
PRODUCTS SUBJECT TO THE
REGISTRATION STANDARD
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 Standard.
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 Standard, 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 humans or the environ-
ment 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 Registration
Standard for manufacturing-use product(s). Such end-use products
will be subject to the labeling changes required for products in "II"
above. If there are no manufacturing-use products registered by any
company, end-use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the data require-
ments in I-A and B above, the registrants in "II" lose their right
to qualify for the formulator's exemption and become subject to the
data requirements in I-A and B.
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1. What Generic Data Must be Submitted. Registrants may
determine which generic data must be submitted by consult-
ing Table A, Appendix A. That table lists the generic data
needed to evaluate the continued registrabillty 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 I/) or data collected under
the approved protocols of the Organization for Economic
Cooperation and Development (OECD). If registrants do not
wish to develop data in support of certain uses appearing in
their labeling, they may delete those uses at the time they
submit 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 for each major
formulation category (e.g., emulsifiable concentrates, wettable
powders, granulars, etc.) These are classified as generic
data and when needed are specified in Table A, Appendix A.
EPA may possess data on certain "typical formulations" but
not others.
2. Options Available for Complying With Requirements to Submit
Data. Within 90 days of receipt of this Standard, registrants
must submit to EPA a completed copy of the form entitled
"PIPRA Section 3(c)(2)(B) Summary Sheet," EPA Form 8580-1
(Appendix D), for each of their products. On that form,
registrants must state which of the following methods they
will use to comply with the requirements of this Standard:
a. Notify EPA that they will submit the data, and either
submit the existing data they believe will satisfy the
requirement, or state that they will generate the data
by conducting testing. If the test procedures they 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, Orgaii-
zation for Economic Cooperation and Development (OECD)
Chemicals Testing Programme, they must enclose the proto-
cols they will use.
OR
The Pesticide Assessment Guidelines are available in hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
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b. Notify EPA that they have entered into an agreement with
one or more other registrants to jointly develop (or
share in the cost of developing) the data. If they
elect this option, they must notify EPA which registrant(s)
are parties to the agreement.
OR
c. 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 E)l/
OR
d. Request that EPA amend their registrations by deleting
the uses for which the data are needed.
OR
e. Request voluntary cancellation of the reglstration(s) of
the products for which the data are needed.
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. In EPA's opinion, joint data develop-
ment by all registrants 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 EPA of its intent
to develop and submit data required by this Standard; 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)(ill); and (3) the first regis-
trant has declined to agree to enter into a cost-sharing agree-
ment, EPA will not suspend the second firm's registration.
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^. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time. EPA recognizes that registrants
may disagree with the Agency's conclusions regarding the
appropriate ways to develop the required data or how quickly
the data must be submitted. If the test procedures a regis-
trant plans 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, Organ-
ization for Economic Cooperation and Development (OECD)
Chemicals Testing Programme, the registrant must submit the
protocol for Agency review prior to the initiation of the
test.
If a registrant believes it will need more time to generate
the required data than is allowed by EPA's schedule, the
registrant may submit a request for an extension of time.
The extension request must be submitted in writing to the
Product Manager. The extension request should state the
reasons why the registrant believes that an extension is
appropriate. While EPA considers the request, the regis-
trant must strive to meet the deadline for submitting the
required data.
4 . Procedures for Requesting a Waiver of the Data Requirement.
If a registrant believes that a data requirement does not
(or should not) apply to its product or its uses, the
registrant must provide EPA with a statement of the reason
why it believes this is so. The statement must address the
specific composition or use factors that Lead the regis-
trant to believe that a requirement does not apply. Since
the Agency has carefully considered the composition and
uses of pesticide products in determining that a data
requirement applies, EPA does not anticipate that many
waivers will be granted. A request for waiver does not
automatically extend the timeframes for developing required
data, and if the waiver request is denied, the registration
may be suspended if the registrant fails to submit the data.
5 . Existing Stocks Provision Upon Suspension or Cancellation.
EPA may permit continued sale and distribution of existing
stocks of a pesticide product which has been suspended or
cancelled if doing so would be consistent with the purposes
of EIERA. However, the Agency has determined that if a
registration is suspended for failure to respond to a data
call in request under PIPRA section 3(c)(2)(B), an existing
stocks provision is not consistent with the Act. Accord-
ingly, the Agency does not anticipate granting permission
to sell or distribute existing stocks of suspended product
except in rare circumstances. If a registrant believes
that its product will be suspended or cancelled and that an
existing stocks provision should he granted, the registrant
-------
has the burden of clearly demonstrating to EPA that grant-
ing such permission would be consistent with the Act. The
following information must be included in any request for
an existing stocks provision:
a. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and an estimate of the time required
for their sale or distribution.
b. Demonstration that such a provision would be consistent
with the provisions of PIPRA.
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D. SUBMISSION OF PRODUCT SPECIFIC DATA
Note: This Section applies only to 50 percent formulation
intermediates (FI), not to end-use products.
A necessary first step in determining which statements must
appear on a 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 F) ,
to fill gaps Identified by EPA concerning the product. Under
the authority of FIFRA section 3(c)(2)(B), EPA has determined
that registrants must submit these data to EPA in order to
reregister their product(s).
Table B, Product-Specific Data Requirements for Manufacturing
Use Products, of Appendix A, lists the product specific data
registrants must submit. Data that are required to be sub-
mitted are identified in that table under the column entitled
"Must Data Be Submitted Under §3(c)(2)(B) . " These data must
be submitted not later than 6 to 12 months, as indicated on
the table, after receipt of this Registration Standard.
-------
E. INSTRUCTIONS FOR SUBMISSION
This section describes what raust be submitted and the timeframes
for the submissions. Addresses are provided at the end of this
section.
1. Requirements
a. For Technical Grade/Manufacturing-Use Products Containing
Pronamide as the Sole Active Ingredient
(1) Within 90 days from receipt of this Standard, regis-
trants must submit the "FIFRA Section 3(c)(2)(B)
Summary Sheet," EPA Form 8580-1 (Appendix D).
(2) Within 6 months from receipt of this Standard, regis-
trants must submit-
(a) Confidential Statement of Formula, FPA Form
8570-4.
(b) Two copies of draft labeling, including the
label and associated brochures. If current
labeling conforms to the requirements of this
Standard and the results of the short-term
data, such labeling must be submitted. The
labeling should be either typewritten text
on 8-1/2 x 11 Inch paper or a mockup of the
labeling suitable for storage in 8-1/2 x 11
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.
(c) Evidence of compliance with data support require-
ments of FIFRA section 3(c)(l)(D). Refer to
40 CFR 152.80-152.99 for requirements.
(3) Within the times set forth in Table A, Appendix A,
registrants must submit all generic data, unless
they request and are granted a waiver or extension,
or they are eligible for the formulator's exemption
b. For Technical Grade/Manufacturing-Use Products Contain-
ing Pronamide In Combination With Other Active Ingredient^
(1) Within 90 days from receipt of this Standard, regis-
trants must submit the "FIFRA Section 3(c)(2)(B)
Summary Sheet," EPA Form 8580-1 (Appendix D).
-------
(2) Within the times set forth in Table A, Appendix A,
registrants must submit all generic data, unless
they request and are granted a waiver or extension,
or they are eligible for the formulator's exemption.
c, For End-Use Products Containing Pronamide Alone or In
Combination With Other Active Ingredients
(1) Within 90 days from receipt of this Standard, regis-
trants must submit the "PIPRA Section 3(c)(2)(B)
Summary Sheet," EPA Form 8580-1 (Appendix D).
(2) Within 6 months from receipt of this Standard, regis-
trants must submit:
(a) Confidential Statement of Formula, EPA Form 8570-4.
(b) Two copies of draft labeling, including the label
and associated brochures. If current labeling
conforms to the requirements of this Standard and
the results of the short-term data, such labeling
should be submitted. End-use product labeling
must comply specifically with the instructions
in this Standard. Labeling should be either type-
written 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 times set forth in Table A, Appendix A,
registrants must submit all generic data, unless they
request and are granted a waiver or extension or they
are eligible for the formulator's exemption.
d. Products Qualifying for Formulator's Exemption. With tn
90 days from receipt of this Standard, registrants must
submit a Pormulator's Exemption Statement, Appendix f.
They must also submit a current Confidential Statement of
Formula or certify that the Confidential Statement of
Formula on file is complete, current and accurate.
e. For Intrastate Products Containing Pronamide Either as
the Sole Active Ingredient or in Combination with other
Active Ingredients.These products are being called in for
full Federal registration. Producers of these products are
being sent a letter instructing them how to submit an appli-
cation for registration.
- 36 -
-------
Submissions to Product Manager. Applications and other
required information should be submitted to the Product
Manager, Registration Division. If, for any reason, any
test is delayed or terminated so that the agreed schedule
cannot be met, the Product Manager must be notified as
soon as it becomes clear that the schedule cannot be met.
The address for submissions to the Product Manager is:
Mr. Robert J. Taylor
Product Manager (Team 25)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW.
Washington, D.G. 20460
Phone No. (703) 557-1800
Submissions to the Office of Compliance Monitoring. If,
on the VIFRA Section 3(c)(2) (B) Summary Sheet, a regls-
trant commits to develop the data, requests a minor chemical
exemption, presents arguments that a data requirement is not
applicable, or submits protocols or modified protocols for
Agency review, the registrant 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 Standard. Actual studies are
not to be submitted.
If for any reason any test is delayed or terminated so that
the agreed schedule cannot be met, the Office of Compliance
Monitoring must be notified as soon as it becomes clear that
the schedule cannot be met.
The address for submission to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20460
- 37 -
-------
APPENDIX A
TABLE A: GENERIC DATA REQUIREMENTS
FOR PRONAMIDE (9H% Technical)
TABLE B: PRODUCT SPECIFIC DATA REQUIREMENTS
FOR PRONAMIDE (50% PI)
Data must be submitted within the timeframes listed on Tables A
and B based on the issuance date of the Registration Standard.
The following symbols are used on Tables A and B. For more infor-
mation, refer to 40 CFR 158, Data Requirements for Pesticide
Registration.
Test Substance
TGAI = Technical Grade of the Active Ingredient
PAI = Pure Active Ingredient
PAIRA= Pure Active Ingredient, Radiolabelled
TEP = Typical End-Use Product
EP = End-Use Product
Guideline Status
R = Required
CR = Conditionally Required
Use Patterns
A = Terrestrial, Food Crop
B = Terrestrial, Non-Food
C = Aquatic, Food Crop
D = Aquatic, Non-Food
E = Greenhouse, Food Crop
F = Greenhouse5 Non-Food
G = Forestry
H = Domestic Outdoor
I = Indoor
38
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PRONAMIDE (94% Technical)
Guideline Citation and Test Guidelines
Name of Test Substance Status
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity and Disclosure TGAI R
of Ingredients
61-2 - Description of Beginning Materials TGAI R
and Manufacturing Process
61-3 - Discussion of Formation of TGAI R
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis TGAI CR
62-2 - Certification of Ingredient Limits MP P
62-3 - Analytical Methods to Verify HP R
Certified Limits
Physical and Chemical Characteristics
63-2 - Color TGAI R
63-^ - Physical State TGAI P
63-4 - Odor TGAI R
Are Data
Required
Yes No
FJ
Fx]
Fx]
Fx]
Fx]
Fx]
FJ
FJ
Fxl
Fx]
FJ
FJ
FJ
FJ
FJ
Fx]
Fx]
FJ
Footnote Data Must Be Sub-
Number mitted Within Time
Frames Listed Below
1 6 months
2 6 months
3 12 months
4,5 12 months
4,6 12 months
7 6 months
- A-l -
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PRONAMIDE (9*1% Technical)
Guideline Citation and
Name of Test
Test Guidelines
Substance Status
Are Data footnote
Required Number
Yes No
Data Must Be Sub-
mitted Within Time
Frames Listed Below
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-17
- Melting Point
- Boiling Point
- Density, Bulk Density, or
Specific Gravity
- .Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/water partition
coefficient
- PH
- Stability
- Storage Stability
TGAI
TGAI
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
MP
R
R
R
R
R
R
CR
CR
R
R
O
[11
O
O
O
Ex]
[x]
[x]
[x]
n
[x]
[x]
ra
[x]
ra
n
O 8
n
O 9
[x]
6 months
6 months
6 months
6 months
Cther Requirements
64-1 - Submittal of Samples
TGAI, PAI
CR
n
[x]
- A-2 -
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR PRONAMIDE (9^4% Technical)
§138.120 Product Chemistry (Continued)
_!/ The registrant must submit details of the manufacturing process, including the relative amounts of beginning
materials, a description of the equipment used to produce the product, reaction conditions the duration of
each step of the process, purification procedures and quality control measures, the name and address of the
manufacturer, producer or supplier of each beginning material used, and a copy of all available technical
specifications, data sheets, and other documents in which the manufacturer, producer, or supplier of the
beginning material describes its composition and properties,
2/ A discussion of each impurity believed to be present at X>.1% based on knowledge of the beginning materials,
all possible chemical reactions and any contamination must be provided.
37 Five or more representative samples must be analyzed for the amount of active ingredient and each impurity
present for which a certified limit is required (greater than 0.1%).
_V Since no MP's are registered, tests must be conducted on the TGAI.
*2/ Upper and lower limits for pronamide and upper limits for each impurity present at 0.1% must be provided and
certified.
6/ The registrant must submit quantitative methods to detect pronamide and all impurities and inerts for which a
certified limit is required. Each method must be accompanied by validation studies of the precision and
accuracy of the method.
77 The submitted description of the odor ("mild, inoffensive") is not sufficiently descriptive: a new description
must be submitted.
8/ Data on the octanol/water partition coefficient have been submitted, but were not reviewed in time for Inclusion
~ in the Registration Standard.
9/ Since no Information was provided as to the sensitivity to metal ions and metal, stability at evalated
~ temperatures, and sensitivity to sunlight, additional data are required.
- A-3 -
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRONAMIDE (94% Technical)
Does EPA Have Must Additional Data Be
Data To Satisfy Bibliographic Submitted Under FIFHA
Data Requirement Composition This Requirement? Citation §3(c) (2) (B)? Time Frames
For Data Submission
§158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
Plants PAIRA Partially
Livestock PAIRA and Plant Partially
Metabolites
171-4 - Residue Analytical Method
Plant Residues TGAI and Metabolites Yes
Animal Residues TGAI and Metabolites Yes
00107953 00107958
00107957 GS0082-01
00107954
00107958
00035563 00107958
00035565 00107959
00035566 00107960
00070933 00107961
00070934 00107965
00074523 00107967
00077215 00125382
00107957
Yes!/ - 18 months^/
Yes!/ - 18 months
No
171-4 Storage Stability TEP
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
Crop Group 1 - Leafy Vegetables^/
o Crop 1 - Endive
— Crop Field Trials TEP
No
YesV
Yes
00107957
No
- A-4 -
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR FRONAMIDE (94% Technical)
Data Requirement
Composition
Does EPA
Have Data To
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional Data Be
Submitted Under PIFRA
§3(c)(2)(B)? Time Frames
For Data Submission
§158.125 Residue Chemistry (Continued)
171-4 - Magnitude of the Residue - Residue Studies (Continued)
o Crop 2 - Lettuce
— Crop Field Trials
o Crop 3 - Rhubarb
— Crop Field Trials
TEP
TEP
Crop Group 2 - Pome Fruits Group°/
o Crop 1 - Apples
-- Crop Field Trials
o Crop 2 - Pears
— Crop Field Trials
Crop Group 3 ~ Stone Fruits Group
TEP
TEP
o Crop 1 - Cherries
-- Crop Field Trials
o Crop 2 - Nectarines
— Crop Field Trials
TFP
TFP
Yes
No
Partially
Yes
Yes
Yes
00070933
00107957
00107958
00035563
00074523
00035564
00074523
00074523
00074523
No!/
Yes9/ - 18 months2/
No
No
No
- A-5 -
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRONAMIDE (94t Technical)
Data Requirement
C/omposition
Does FPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frames for Data
Submission
§158.125 Residue Chemistry (Continued)
171-4 - Magnitude of the Residue - Residue Studies (Continued)
o Crop 3 - Peaches
— Crop Field Trials
o Crop 4 - Plums
— Crop Field Trials
TCP
TEP
Crop Group 4 - Small Fruits and Berries Group12/
o Crop 1 - Blackberries
— Crop Field Trials
o Crop 2 - Blueberries
— Crop Field Trials
o Crop 3 - Boysenberries
— Crop Field Trials
o Crop 4 - Grapes
— Crop Field Trials
o Crop 5 - Raspberries
— Crop Field Trials
Crop Group 5 - Grass Forage,
TEP
TEP
TEP
TEP
TEP
and Hay Group!5/
Yes
Partially
Yes
Yes
No
Partially
Yes
o Crop 1 - Grass forage, fodder and hay
— Crop Field Trials TEP
00035565
00074523
00074523
00107960
00035566
00074523
00107960
No
Yes!!/ - 18 months2
No
No
Yes!!/ - 18 months2
Yes!l/ - 18 months?
No
No
Nol/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRONAMIDE (94% Technical)
tta Requirement
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frames For Data
Submission
.58.125 Residue Chemistry (Continued)
-4 - Magnitude of the Residue - Residue Studies (Continued)
Crop Group 6 - Non-Grass Animal Feeds Group 16/
o Crop 1 - Alfalfa forage and hay
— Crop Field Trials
TEP
o Crop 2 - Clover forage and hay
— Crop Field Trials TEP
o Crop 3 - Crown Vetch Forage and Hay
— Crop Field Trials
TEP
o Crop 4 - Sainfoin Forage and Hay
— Crop Field Trials TEP
o Crop 5 - Trefoil Forage and Hay
— Crop Field Trials
Miscellaneous Commodities
o Crop 1 - Artichokes
-- Crop Field Trials
o Crop 2 - Safflower Seed
— Crop Field Trials
TEP
Partial
Yes
Yes
Yes
Yes
Yes
No
00077215
00125382
00033380 00107965 Yes!!/ - 18 months.2/
00107958 00107967
00107958
00107965
00107965
00107965
Nolly
No!/
c_n
- A-7 -
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRONAMIDE (9b% Technical)
Does EPA Have Data Must Additional Data
To Satisfy This Be Submitted Under
Requirement? (Yes, Bibliographic FTFRA § 3(c)(2)(B)?
Data Requirement Composition No, or Partially) Citation Time Frames For Data
_ _ _ __ _ Submission _
§158.125 Residue Chemistry (Continued)
-4 - Magnitude of the Residue - Residue Studies (Continued)
Meat/Milk/Poultry/Eggs TGAI or Plant No - Naif?/
Metabolites
V Registrants must submit data depicting the distribution and metabolism of ring-labeled [C] pronamide in: (i)
alfalfa harvested 25, 45, and 120 days after a post-emergent broadcast application using a rate sufficient to permit.
complete characterization of all l^C-residues , and (ii) lettuce harvested 55 days after a post-emergent broadcast
application preceded by a preplant or preemergent broadcast application at rates sufficiently high to permit complete
characterization of l^C-residues. If bound residues (i.e., residues not extracted by the solvent(s) used) represent
a significant proportion of the terminal residue, analyses must include hydrolysis and reextraction of plant
residues to determine the nature of conjugated residues of pronamide. If metabolism among these two representative
crops is found to differ significantly, metabolism will be required for a representative crop In each crop group for
which there is a registered use for pronamide. Representative samples from the above-described tests must also be
analyzed by the enforcement methods to ascertain that all metabolites of concern are detected.
2/ Registrants are provided 18 months to submit data commencing with the first planting season after issuance
of the Standard, consistent with PR Notice 85-5. Data are due no later than January 1988.
3/ Registrants must submit metabolism studies utilizing ruminants and poultry. Animals must be dosed for 3 days with
ring-labeled [^C] pronamide at a concentration in the total diet which will result in sufficient residues in the
tissues, milk, and eggs for characterization. Animals must be sacrificed within 24 hours of the final dose (milk
ar ! eggs must be collected twice daily). ^C-Residues must be characterized and quantified in muscle, fat, kidney,
1 ,ver, milk, and eggs. Samples from the studies should also be analyzed by the enforcement methods to ascertain
I nab all metabolites of concern are determined.
- A-8 -
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRONAMIDE (9H% Technical)
158.125 Residue Chemistry (Continued)
V The storage intervals and conditions of storage of samples used to support all established tolerances for residues in
or on plant commodities must be submitted. These data must be accompanied by data depicting the percent decline in
residues of pronamide at the times and under the conditions specified. After receipt of these data, the adequacy of
the tolerances will be evaluated. All residue data requested in this Standard must be accompanied by data regarding
the storage length and conditions of samples analyzed. These data must be accompanied by data depicting the stability
of residues under the conditions and for the time intervals specified. Since the nature of the residue in plants and
animals has not been adequately described, if the requested metabolism data reveal additional metabolites of
toxicological concern, additional data depicting the stability of such metabolites in storage will be required.
V A crop group tolerance Is not appropriate unless a use is proposed, and residue data submitted, for celery and
spinach, representative commodities. In addition, additional data are required for lettuce (leaf lettuce only).
fi/ The available data provide adequate support for the established tolerance covering residues of pronamide in or on
l-i^--id lettuce only. The registrant must either withdraw the registered use on leaf lettuce or revise the label
1 i f-^-A.ions to delete the post-emergent application method. If the registrant proposes a change in the use directions,
appropriate supportive residue data must be submitted.
7/ Mo conclusions regarding the adequacy of this proposed tolerance will be made at this time, because the data
submitted in support of the tolerance are under review.
ft/ A crop group tolerance is not appropriate unless data are submitted depicting residues of pronamide and its
metabolites in or on mature pears harvested from trees which received a single directed spray application of the
SO percent wettable powder at 4 Ib. ai/A the previous fall following harvest. Tests would have to be conducted in
California and Washington, which produce >70% of U.S. pears.
9/ The registrants must submit data indicating the level of residues in wet pomace, dry pomace, and juice processed
from apples bearing measurable weathered residues. Use of exaggerated application rates may be necessary to obtain
measurable residues in the raw commodity. If residues concentrate in any of these processed commodities, appropriate
food/feed additive tolerances must be proposed.
10/ Adequate data are available to support the established tolerances for the representative commodities, cherries,
peaches, and plums/fresh prunes, all at 0.1 ppm. Since registered usage on these crops is identical, it is
recommended that a crop group tolerance of 0.1 ppm be proposed.
ll/ The registrants must submit residue data from dried prunes processed from fresh prunes bearing measurable weathered
residues. Exaggerated rates may be necessary to achieve measurable initial residues in fresh prunes which are to be
processed into dried prunes. If concentration occurs, an appropriate food additive tolerance must be proposed.
- A-Q -
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TABLE A
GENERIC DATA REQUIREMENTS FOR PRONAMIDE (94* Technical)
§158.125 Residue Chemistry (Continued)
12/ A crop group tolerance is not appropriate unless residue data and proposed uses are submitted for cranberries
and strawberries, representative commodities.
137 There are no registered uses of pronamide on boysenberries, The tolerance for residues of pronamide in or on
boysenberries will be cancelled unless the registrant proposes a use and submits appropriate residue data in support
of the established tolerance, or if the proposed use directions and limitations are identical to those for black-
berries, the registrant may use translatable data from blackberries and raspberries in support of the established
tolerance.
1_V The registrants must submit data indicating residues of pronamide in raisins, wet pomace, dry pomace, raisin waste,
and juice processed fron grapes bearing measurable weathered residues. Use of exaggerated application rates may be
necessary to obtain measurable residues in the raw commodity. If residues concentrate in any of these processed
commodities, appropriate food/feed additive tolerances must be proposed.
157 Data submitted in support of a crop group tolerance are pending.
T5/ Based on the available data for the representative raw agricultural commodities alfalfa and clover, it i.s
recommended that a crop group tolerance of 10 ppm be proposed for the residues of pronamide and its metabolites
in or on non-grass animal feed forage and hay. Tolerances for alfalfa (10 ppm) and clover (5 ppm) do not vary ny
more than a factor of 5 from the tolerances for any crop in the group. These data satisfy the requirements for
crop group tolerance establishment.
177 The registrant must submit data depicting residues in or on alfalfa seed from alfalfa bearing measurable weathered
residues. An appropriate tolerance must be proposed If residues are higher in the seed than in the raw
agricultural commodity.
87 Sufficient data are available to support the tolerance for the combined residues of pronamide and its metabolites
~ in or on clover. The commodity definition "clover" in 40 CPR 180.317 will be changed to "clover (forage)," the
presently accepted term for this commodity. While data have been submitted for clover hay, a raw agricultural
commodity of clover, a corresponding tolerance has not been proposed or established. The registrant should propose
a tolerance for residues of pronamide and its metabolites in or on clover hay; a level of 5 ppm is recommended.
In lieu of such a proposal, the registrant may propose a crop group tolerance (see footnote 16).
97 Sufficient data are available to support the tolerance for the combined residues of pronamide and its metabolites
" i : or on crown vetch forage. The commodity definition "crown vetch" in 40 CFR 180.317 will be changed to "crown
vetch forage," the presently accepted term for this commodity. No data have been submitted for crown vetch hay,
a raw agricultural commodity of crown vetch, nor has a corresponding tolerance been proposed. The registrant
should submit a proposal for a tol^ance for residues In or on crown vetch hay; a level of 5 ppm is recommended,
based on translatable clover hay data. In lieu of such a proposal, the registrant may propose a crop group
tolerance (see footnote 16).
&»
DO
- A-1O -
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRONAMIDE (94% Technical)
§158.125 Residue Chemistry (Continued)
20/ Sufficient data are available to support the tolerance for the combined residues of pronamide and its metabolites
in or on sainfoin. The commodity definition "sainfoin" will be changed to "sainfoin forage," the presently
accepted term for this commodity. While data have been submitted for residues in or on sainfoin hay, a raw
agricultural commodity of sainfoin, a corresponding tolerance has not been proposed. The registrant should
propose a tolerance for residues of pronamide and its metabolites in or on sainfoin hay; a level of 5 ppn is
recommended, based on translation from clover hay. In lieu of such a proposal, a crop group tolerance can
be proposed (see footnote 16).
21/ Sufficient data are available to support the tolerance for the combined residues of pronamide and its metabolites
in or on trefoil. The commodity definition "trefoil" will be changed to "trefoil forage," the presently accepted
term for this commodity. No data have been submitted for trefoil hay, a raw agricultural commodity of trefoil
nor has a corresponding tolerance been proposed. The registrant should submit a proposal for a tolerance for
residues in or on trefoil hay; a level of 5 ppm is recommended, based on translatable clover hay data. In lieu
of such a proposal, the registrant may propose a crop group tolerance (see footnote 16).
227 The nature of the residue in animals has not been adequately described. On receipt of the requested animal
metabolism data, the appropriate nature of tolerances for residues in animal products will be determined and
the adequacy of the available data on the magnitude of residues In animal products will also be determined.
- A-ll -
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRONAMDE (9^% Technical)
Data Requirement
Composition
Use
Pattern
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 Frames For Data
Submission
§158.130 Environmental Pate
Degradation Studies-Lab
161-1 - Hydrolysis
Photodegradatlon
161-2 - In water
161-3 - On soil
161-4 - In Air
Metabolism Studies-Lab
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
L62-4 - Aerobic Aquatic
Mobility Studies
163-1 - Leaching and
Adso rpt ion/Desorpt ion
TGAI or PAIRA A,B,H
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
A,B,H
A
N/A3/
N/A3/
TGAI or PAIRA A,B,H
Yes
00107980
A,B
A
N/A3/
No
No
No
No
No
No
Yes - 9 months!,/
Yes^/
Yes - 27 monthsl/
Yes5/ - 12 months!
- A-12 -
-------
TABLF, A
GFNFRIC DATA REQUIREMENTS FOR PRONAMIDE (94% Technical)
Does EPA Have
Data To Satisfy
Use This Require-
Data Requirement Composition Pattern ment? (Yes, No
or Partially)
§158.130
Environmental Fate (Continued)
Must Additional Data
Be Submitted Under
Bibliographic FIFRA § 3(c)(2)(B)?
Citation Time Frames For Data
Submission
Mobility Studies (Continued)
163-2 -
163-3 -
D is si pa
164-1 -
164-2 -
164-3 -
164-4 -
Volatility (Lab) TEP A No
Volatility (Field) TEP A No
t.ion Studies-Field
Soil TEP A,B,H No
Aquatic (Sediment) TEP N/Al/
Forestry TEP N/Al/
Combination and N/A^/
Yes - 12 months
Reserved^/
Yes - 27 months!/
Tank Mixes
164-5 - Soil, Long-term
Accumulation Studies
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
TEP
PAIRA
TEP
No
No
No
Reserved!/
Yes - 39 months
Reserved?/
- A-13 ~
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRONAMIDE (9*1% Technical)
Does EPA Must Additional Data Be
Use Have Data To Bibliographic Submitted Under FIPRA
Data Requirement Composition Pattern Satisfy This Citation § 3(c)(2)(B)? Time Frames
__ _ _ _ _ Requirement? _ For Data Submission _
§158.130 Environmental Fate (Continued)
Accumulation Studies (Continued)
165-3 - Irrigated Crops TEP
-4 - In Pish TGAI or PAIRA A,B No - Yes - 12 months
165-5 - In Aquatic Non-Target TEP N/Al/
Organisms
_!/ Data for this requirement submitted In response to the May 1984 Special Data Call In Notice for Ground Water Data
have been determinal to be Invalid. Therefore, new or additional data must be submitted. Additional data to
supplement the previously submitted studies Include raw data to support conclusions; material balance; incubation
tanperature and pH; in addition, the solutions were not buffered; the test substance was not Identified sufficiently;
the light source was not specified; and the test was for less than 30 days.
21 Data to fill this requirement have been submitted but have not been reviewed.
3/ Not required for this chemical.
\l Data are due in June 1986, in accordance with the May 1984 Special Data Call In Notice for Ground Water Data.
5_/ Adsorption/desorptlon data are required for Domestic Outdoor use patterns. For the other use patterns, either
adsorptlon/desorption or any of the other methods (e.g. TLC, column) will be acceptable.
6/ Data will be required unless the results of the laboratory volatility study indicate these data are unnecessary .
7/ Tata will be required unless the results of the field dissipation study indicate these data are unnecessary.
B/ ata will be required unless the results of the confined crops study indicate these data are unnecessary.
- A-lU -
-------
TABLE A
GRNERIC DATA REQUIREMENTS FOR PRONAMIDE
Technical)
Data Requirement Composition
§158.135 Toxicology
Acute Testing
81-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dermal Toxicity
- Rabbit
•'-! 1 - -! - Acute Inhalation Toxicity
- Rat
8l -4 - Primary Eye Irritation
8l-5 - Primary Dermal Irritation
81-6 - Dermal Sensitization
81-7 - Delayed
TGAI
TGAI
TGAI
MP
MP
MP
TGAI
Use
Pattern
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
N/Ai/
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Yes
Yes
Yes
Yes
Yes
Yes
Bibliographic
Citation
00083663
00083663
00083663
00083663
00126574
00062605
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission
No
No
No
No
No
No
Neurotoxicity - Hen
Subchronic Testing
82-1 - 90-Day Feeding
- Rodent, and
- Non-rodent (Dog)
TGAI
M/AfL/
en
- A-15 -
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRONAMIDE
Technical)
Data Requirement
Composition
Use
Pattern
§138.135 Toxicology (Continued)
Subchronlc Testing (Continued)
82-2 - 21-Day Dermal - Rabbit TGAI
82-3 - 90-Day Dermal - Rabbit TGAI
82-4 - 90-Day Inhalation: TGAI
- Rat
82-5 - 90-Day Neurotoxicity: TGAI
- Hen
-Mammal
Chronic Testing
83-1 - Chronic Toxicity - TGAI
2 species:
- Rodent, and
- Non-rodent (Dog)
83-2 - Qncogenicity - TGAI
2 species:
- Rat (preferred), and
- Mouse (preferred)
N/A?/
N/AfV
N/A2/
N/Al/
A,B,H
A,B,H
A,B,H
A,B,H
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
No
Partially
No
Yes
"Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission
00107968
Yes - 50 months
No
Yes - 50 months
No
CJl
- A-16 -
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRONAMIDE (94% Technical)
Data
§158.
Use
Requirement Composition Pattern
135 Toxicology (Continued)
Does EPA Have
Data To Satisfy
This Require- Bibliographic
ment? (Yes, No Citation
or Partially)
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission
Chronic Testing (Continued)
83-3
- Teratogenicity - TGAI
2 species:
- Rat A,B,H
- Rabbit A,B,H
No
Yes 00148064
00148065
Yes - 15 months3/
No
83-4 - Reproduction - Rat
2-generation
TGAI
Mutagenicity Testing
84-2 - Gene Mutation (Ames Test) TGAI
84-2 - Structural Chromosomal TGAI
Aberration
84-4 - Other Genotoxic Effects TGAI
Special Testing
A,B,H
A,B,H
A,B,H
A,B,H
No
85-1
85-2
86-1
- General Metabolism
- Dermal Penetration
- Domestic Animal
.Safety
PAI or PAIRA A,B,H
Choice A,B,H
Choice N/AfL/
No
No
No
No
Mo
Yes - 39 months
Yes - 9 months
Yes - 12 months
Yes - 12 months
Yes - 24 months
Yes - 12 months
cn
- A-17 -
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PRONAMIDE (9H% Technical)
§158.135 Toxicology (Continued)
_!/ Pronamide is neither an organophosphate, nor an analog of a neurotoxic compound, hence, no delayed neurotoxicity
study is required.
_2/ Not applicable to exposure conditions.
3/ Data for this requirement submitted in response to the October 1982 Data Call In Notice have been determined to
be invalid. Therefore, new data must be submitted.
ON
- A-18 -
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRONAMIDE (94% Technical)
Does EPA Have
Data To Satisfy
Use This Require- Bibliographic
Data Requirement Composition Pattern ment? (Yes, No Citation
or Partially)
Must Additional Data
Be Submit ted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission
5158.115 Wildlife and Aquatic Organisms
Avian and Mammalian Testing
71-1 -
71-2 -
71-3 -
71-1 -
71-5 -
Aquatic
72-1 -
Acute Avian Oral Toxicity TGAI A,B,H Yes
Avian Subacute Dietary TGAI A,B,H Yes
Toxicity
-Upland Game Bird, and
-Waterfowl
Wild Mammal Toxicity TGAI N/Al/
Avian Reproduction TGAI N/AfL/
Simulated Field and Actual TEP N/A^/
Testing - Mammals and Birds
Organism Testing
Freshwater Fish Toxicity
- Coldwater Fish Species TGAI A,R,H Yes
- Varmwater Fish Species TGAI A,B,H Yes
00107997
00107993
00107991
00108002
00108003
00107996
00107196
00107996
No
No
No
No
72-2 - Acute Toxicity to 'TGAI
Freshwater Invertebrates
A,B,H
Yes
- 4-19 -
00098313
Mo
(J1
-------
TABLK A
GSNTRRIC DATA R^UIRd'IRMTS TOR PRONAMIDF.
Technical)
Use
Data Requirement Composition Pattern
§15B.145 Wildlife and
Aquatic Organisms (Continued)
Does F,PA Have
Data TO Satisfy
This Require-
ment? (Yes, Mo
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(?)(B)?
Time Frame for Data
Submission
Aquatic Organism ^Testing
72-3 - Acute Toxicity to
Kstuarine and ferine
Organisms
72-4 - Fish Early Life Stage
and Aquatic Invertebrate
Life-Cycle
72-5 - Fish - Life-Cycle
72-6 - Aquatic Organism
Accumulation
TGAI
TCAI
TCAI
N/A2/
N/A£?/
N/A2/
TCAI, PAI or
degradation
product
72-7 - Simulated or Actual
Field Testing - Aquatic
Organisms
TTCP
\J Data not normally required for these uses.
2/ Data not required due to low toxicity and low expected ecological effect.
01
CD
- A-20 -
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR PRONAMIDE (94% Technical)
)ata Requirement
. 155 Nontarget Insect
Nontarget Insect Testing -
Pollinators
-1 - Honey bee acute
contact toxicity
41-2 - Honey bee - toxicity
of residues on
foliage
-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
Nontarget Insect Testing -
Aquatic Insects
142-1 - Acute toxicity to
aquatic insects
142-1 - Aquatic insect
life-cycle study
I 42-3 - Simulated or actual
field testing for
aquatic insects
Composition
Use
Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
TGAI
TEP
A,B,H
N/Al/
Yes
00028772
TEP
N/Al/
Must Additional Data
Be Submitted Under
PIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission
No
Reserved?./
Reserved^/
Reserved^/
Reserved^/
- A-21 -
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRORAMDE (94% Technical)
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
TIse This Require- Bibliographic FIFRA 5 3(c)(2)(B)?
Data Requirement Composition Pattern ment? (Yes, No Citation Time Frame for Data
or Partially) Submission
§158-155 Nontarget Insect (Continued)
1^3-1 - Nontarget Insect Reserved^/
Testing - Predators
thru and Parasites
143-3
If Because data from the acute contact tests indicate low toxicity, data on residual toxicity are not required,
2/ This requirement is reserved pending development of test methodology.
3/ Data reviewed to date do not indicate any need for a field study.
5/ This requirement is reserved pending further evaluation to determine what and when data should be required, and
to develop appropriate test methods.
- A-22 -
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS TOR MANUFACTURING-USE PRODUCTS CONTAINING PRONAMIDE (50% PI)
Ideline Citation and
me of Test
Test
Substance
Guidelines
Status
Are Data
Required
Yes No
Footnote
Number
Data Must Be
Submitted Within
Time Frames
Listed Below
58.120 Product Chemistry
Product Identity
61-1 - Product Identity and Disclosure MP
of Ingredients
61-2 - Description of Beginning Materials MP
and Manufacturing Process
6l-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
MP
R
R
R
O ra
[xi n
[x] n
Ingredients
62-1
62-2
62-3
- Preliminary Analysis
- Certification of Limits
- Analytical Methods to Verify
Certified Limit
MP
MP
MP
CR
R
R
[x]
^
[x]
n
cj
n
Physical and Chemical Characteristics
63-2
63-2
- Color
- Physical State
MP
MP
R
R
n
n
[x]
[x]
6 months
12 months
6 months
6 months
6 months
- B-l -
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PRONAMIDE (50% PI)
Guideline Citation and
Name of Test
Test
Substance
Guidelines
Status
Data Must Be
Are Data Footnote Submitted Within
Required Number Time Frames
Yes No Listed Below
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics (Continued)
63-4
63-7
63-12
63-1^
63-15
63-16
63-17
63-18
63-19
63-20
- Odor
- Density, Bulk Density, or
Specific Gravity
- pH
- Oxidizing or Reducing
Action
- Flammability
- Explodability
- Storage Stability
- Viscosity
- Misclbillty
- Corrosion Characteristics
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
R
R
CR
CR
CR
R
R
CR
CR
R
[_]
[J
n
u
n
CD
rj
n
O
n
[x]
[x]
[x]
[x]
[x]
ro
[x]
[x]
[x]
[x]
Other Requirements
64-1 -
ON
ro
Submit tal of samples
MP
CR
- B-2 -
O
[x]
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PRONAMIDE (50% FI)
3roduct Chemistry §158.120 (Continued)
L/ The registrant must submit details of the manufacturing process, including the relative amounts of beginning
materials, a description of the equipment used to produce the product, reaction conditions, the duration of each step
of the process, purification procedures and quality control measures, the name and address of the manufacturer,
producer or supplier of each beginning material used, and a copy of all available technical specifications, data
sheets, and other documents in which the manufacturer, producer, or supplier of the beginning material describes its
composition and properties.
2/ A discussion of each impurity believed to be present at X).l% based on knowledge of the beginning materials, all
possible chemical reactions and any contamination must be submitted.
3/ Five or more representative samples should be analyzed for the amount of active ingredient and each impurity present
Tor which a certified limit is required (greater than 0.1%}.
V Upp>--r .ind lower limits for pronamide and for each intentionally added inert, and upper limits for each impurity
pi-i••:>.-1it at 0,1% (w/w) must be provided and certified.
5/ The registrant must submit quantitative methods to determine pronamide and all impurties and inerts for which a
certified limit is required (greater than 0.1%). Each method must be accompanied by validation studies of the
precision and accuracy of the method.
ON
CM
- B-3
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PRONAMIDE (50%
Data Requirements
Composition
Does EPA Have
Data ^o 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
§158.
135 Toxicology
Acute Testing
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat MP Yes
- Acute Dermal Toxicity MP Yes
- Rabbit
- Acute Inhalation Toxicity MP Yes
- Rat
- Primary Eye MP Yes
Irritation - Rabbit
- Primary Dermal MP Yes
Irritation - Rabbit
- Dermal Sensitization MP No
00085504 No
00085505
00133112
00085505 No
000855H
00133112 No
00085505 No
00133H2
00085505 No
00133112
Yes - 9 months
Guinea Pig
- B-4 -
-------
APPENDIX B
EPA INDEX TO PESTICIDE CHEMICALS - PRONAMIDE
65
-------
EPA Index to Pesticide Chemicals
3,5-DICHLORO-N-U,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
TYPE PESTICIDE: Herbicide
FORMULATIONS:
FTT50%1
G (0.32%, 0.33%, 0.4%, 0.9%, 1%)
WP (50%)
GENERAL WARNINGS AND LIMITATIONS; A selective, soil active herbicide used
for the preemergence or early postemergence control of many broadleaf
weeds and grasses. Moisture in the form of rain, melting snow, or irri-
gation is necessary to move the chemical into the root zone of germinat-
ing weeds. Apply in 20 to 50 gallons of water per acre by ground, or in
5 to 10 gallons by air. Aerial applications should be made only where
specified. Use a low pressure sprayer for ground applications. Pronamide
is most effective in coarse to medium textured soils with less than 4
percent organic matter content. Where a dosage range is given, use the
lower dosage on coarse and medium textured soils and the higher dosage on
fine soils. For best results, apply to a clean soil surface, free of de-
caying crop or weed aebris. Pronamide is more effective in cool weather;
degradation of the chemical occurs on the soil surface in warm weather.
If application is made when air temperature is above 85 F (29.4 C), chem-
ical should be incorporated to a shallow depth, or watered into the soil
as soon as possible after application. When a band application is made,
reduce dosage in proportion to band area actually treated. According to
Position Document/4 on pronamide, products with more than 1 percent a.i.
should be classified for restricted use.
Livestock Tolerances;
Cattle (fat, meat and mbyp
except kidney and liver) 0.02 ppm
Cattle (kidney and liver) 0.2 ppm
Eggs 0.02 ppm
Goats (fat, meat and mbyp .
except kidney and liver) 0.02 ppm
Goats (kidney and liver) 0.2 ppm
Hogs (fat, meat and mbyp
except kidney and liver) 0.02 ppm
Hogs (kidney and liver) 0.2 ppm
Horses (fat, meat and mbyp
except kidney and liver) 0.02 ppm
Horses (kidney and liver) 0.2 ppm
Milk 0.02 ppm
Poultry (fat, meat and mbyp
except kidney and liver) 0.02 ppm
Poultry (kidney and liver) 0.2 ppm
Sheep (fat, meat and mbyp
except kidney and liver) 0.02 ppm
Sheep (kidney and liver) 0.2 ppm
*Pronamide
Kerb
N-(1,1-dimethylpropyny1)-3,5-dichlorobenzamide
Issued: 1-17-84 1-101701-1
-------
EPA Index to Pesticide Chemicals
3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BMZAMIDE
DEFINITION OF TERMS:
a.i. *= active ingredient
lb = pounds
mbyp = meat byproducts
TIME REQUIRED FOR CONTROL; Three to 5 weeks are required to control an-
nual bluegrass.
MODE OF ACTION; Pronamide affects the meristematic tissues of roots re-
sulting in cell enlargement, necrosis, and an increase in nuclear volume
in the treated apices. Premature differentiation and maturation of root
tissues with eventual vacuolation of the apical meristematic cells com-
pletely inhibits root growth.
3ROADLEAF WEEDS CONTROLLED;
PEWAIBE Black nightshade
?FGAEBF Burning nettle
PADABBA Carpetweed
PAZAOBB Common chickweed
PBDAEBA Common lambsquarters
PEDADBA Common purslane
PBGADAA Dodder
PEWAIBG Hairy nightshade
PCOAFBA Henbit
PDAAHBD Little mallow
PBKBDBB London rocket
PAZADBC Mouseear chickweed
5DAEBI Nettleleaf goosefoot
r'LAAGBM Pale smartweed
PEAAGBD Prostrate knotweed
PCQBYBH Red clover
PBKAHBA Shepherdspurse
PBGAFBL Tall morningglory
PEWAKBA Tomato (volunteer)
PBKAFBE Wild mustard
PBKBABA Wild radish
(b)
(b)
(b)
(a)
(b)
(b)
(b)
(b)
(b)
(b)
(b)
(a)
(b)
(b)
(b)
(b)
(b)
(b)
(b)
(b)
(b)
(a) Preemergence and early postemergence control.
(b) Preemergence control only.
Issued: 1-17-84
1-101701-2
67
-------
EPA Index to Pesticide Chemicals
3 ,5-DICHLORO-N-d,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
GRASSES AND OTHER MONOCOTS CONTROLLED:
CABMBE Alta fescue
CACKBA Annual bluegrass
CABSAA Barley (volunteer)
CABHB3 Barnyardgrass
CAADAA Bentgrass
CACXAA Bluegrass
CACHBB Canarygrass
CAATBM Downy brome
CACEBD Fall panicum
CABSBC Foxtail barley
CABIBA Goosegrass
CABZBA Italian ryegrass
CACKBD Kentucky bluegrass
CABFBF Large crabgrass
CABKAA Lovegrass
CAAOAA Oat
CABB3A Orchardgrass
CABZBC Perennial ryegrass
CAACBA Quadcgrass
CACTAA Rye (volunteer)
CABRBA Velvetgrass
CADFBA Wheat (volunteer)
CAAOBB Wild oat
CACUBD Yellow foxtail
(a)
(a)
(b)
(a)
(b)
(a)
(b)
(a)
(b)
(a)
(a)
(b)
(b)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(b)
(a) Preemergence and early postemergence control.
(b) Preemergence control only.
Issued: 1-17-84
1-101701-3
68
-------
EPA Index to Pesticide Chemicals
3,5-DICHLORO-N-(1,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.i./A)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
General Warnings and Limitations: Crop rotation instructions:
1. When rotation crops other than artichoke, lettuce, endive or escarole
are to be. planted in treated areas, knock down the beds and cross-
disc the field before planting.
2. When pronamide treatment is to be followed by a rotation crop within
6 months of application, make bed-top or band applications.
3. When pronamide treatment of 0.5 Ib a.i./A or higher will be followed
by small grains or grasses within 1 year, treatment should be limited
to band or bed-top application.
4. a. When pronamide treatment is aade at 0.5 Ib a.i./A, artichoke,
lettuce, endive and escarole may be planted immediately; beans,
corn, cotton, sorghum, carrots, celery, broccoli, cabbage, cauli-
flower, cucurbits, spinach, sugarbeets, onions and tomatoes may
be planted after 3 months; wheat, barley, oats and grasses may be
planted after 6 months.
b. When pronamide treatment is made at 1 Ib a.i./A, artichoke, let-
tuce, endive and escarole may be planted immediately; beans,
corn, cotton, sorghum, carrots and celery may be planted after 3
months; broccoli, cabbage, cauliflower, cucurbits, spinach,
sugarbeets, onions and tomatoes may be planted after 4 months;
wheat, barley, oats and grasses may be planted after 9 months.
c. When pronamide treatment is made at 1.5 Ib a.i./A, artichoke,
lettuce, endive and escarole may be planted immediately; beans,
corn, cotton, sorghum, carrots and celery may be planted after 4
months; broccoli, cabbage, cauliflower, cucurbits, spinach,
sugarbeets, onions, and tomatoes may be planted after 6 months;
wheat, barley, oats and grasses may be planted after 9 months.
d. When pronamide treatment is made at 2 Ib a.i./A, artichoke, let-
tuce, endive and escarole may be planted immediately; beans,
corn, cotton, sorghum, carrots and celery may be planted after 5
months; broccoli, cabbage, cauliflower, cucurbits, spinach, sugar-
beets, onions and tomatoes may be planted after 7 months; wheat,
barley, oats and grasses may be planted after 12 months.
Issued: 1-17-84 1-101701-4
-------
23U01AA
23001BA
Site, Dosage
and Formulation
(Ib a.i./A)
Alfalfa
EPA Index to Pesticide Chemicals
3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
Tolerance, Use, Limitations
0.5-2
(50% WP)
0.75-1
(50% WP)
23001BA
Alfalfa (seed crop)
1.5-2
(50% WP)
1.5
(50% WP)
N.F. (seed)
10 ppm (fresh alfalfa, forage and hay)
Do not graze treated fields or harvest for forage
or hay for these intervals:
25 days in areas West of Mississippi River, when
the dosage is up to 1.5 Ib a.i./A;
45 days in areas West of Mississippi River, when
the dosage is 1.5 to 2 Ib a.i./A;
120 days in areas East of Mississippi River, when
the dosage is up to 2 Ib a.i./A.
Do not use more than 2 Ib a.i./A per crop season.
General Information: If fall treated alfalfa
should be killed in winter, do not plant small
grains or grass crops in the same field in the
spring.
Postemergence. Broadcast. Apply to established
alfalfa during fall or winter after the last cut-
ting when temperatures are cool. Apply to fall
seeded alfalfa after the trifoliate stage. Ap-
plication to spring seeded alfalfa should be made
the following fall or early winter.
Postemergence. Broadcast. Spring application
for control of downy brome. Apply just before or
just after germination of downy brome.
Also refer to Alfalfa (see^i crop) for more infor-
mation pertinent only to that site.
N.F. (seed)
10 ppm (fresh alfalfa, forage and hay)
Use limited to CA, ID, NV, OR, UT, and WA.
Broadcast. Spring application for preemergence
control of dodder in established alfalfa. Incor-
porate lightly at the time of application and
furrow irrigate within 7 days.
Use limited to CA, ID, NV, OR, UT, and WA.
Broadcast. Spring application for preemergence
control of dodder in established alfalfa. Flood
the field within 1 to 3 days after application.
Also refer to Alfalfa for additional use and dose
information.
Issued: 1-17-84
1-101701-5
-------
•OOIAA
,002AA
014AA
,003AA
:004AA
.003AA
i005AA
i006AA
bite, Dosage
and Formulation
Ub a.i./A)
Apple
Cherry
Grapes
Nectarine
Peach
Pear"
EPA Index to Pesticide Chemicals
3,5-DICHLORO-N-(1,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
Tolerance, Use, Limitations
1-4
(50% WP)
1013AA
Artichoke, Globe
(50% WP)
2-4
(50% WP)
0.1 ppm
Do not graze or feed treated foliage to livestock.
Do not use more than 4 lb a.i./A per season.
Directed spray. Broadcast or band. Make a single
application in the fall after fruit is harvested,
but prior to leaf-drop and before the soil freez-
es. Application may be made to bearing or non-
bearing trees and vines. Use only on established
plantings. Do not use on seedling trees or vines
less than 1 year old, or on fall transplanted
stock within 1 year of transplanting or on spring
transplanted stock within 6 months of transplant-
ing.
0.1 ppm
Sixty day preharvest interval.
General Information: Apply only once per crop
season. Rainfall or overhead sprinkler irrigation
is essential within 1 to 3 days after application
to activate the chemical. When dosage exceeds 2
lb a.i./A, do not plant anything except artichokes
for 18 months. For dosages up to 2 lb a.i./A,
follow crop rotation instructions given under
General Warnings and Limitations for Agricultural
Crops.
Posttransplant. Band application over the row.
Apply after transplanting the crowns but before
new shoots have 3 to 4 leaves. Apply preemergent
to the weeds. Do not use on peat or muck soils.
Postemergence. Band application over the row.
Apply to established crop preemergent to the weeds
and before artichoke leaves are more than 16
inches long. Use the higher dosage on fine soils.
Issued: 1-17-84
1-101701-6
-------
Index to Pesticide Chemicals
3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
Site, Dosage
and Formulation
(Ib a.i./A)
Tolerance, Use, Limitations
23011AA
23D1LBA
23003AA
23003BA
23T-24AA
23024BA
23021AA
23021BA
nino2AA
D1009AA
Birdsfoot Trefoil
Birdsfoot Trefoil
(seed crop)
Clover
Clover (seed crop)
Crown Vetch
Crown Vetch (seed
crop)
Sainfoin
Sainfoin (seed crop)
0.5-2
(50% WP)
Birdsfoot Trefoil
(seed crop)
Blackberry
Raspberry
1-3
(50% WP)
Blueberry
1-2
(50% WP)
5.0 ppm
N.F. (seed)
Do not graze treated fields or harvest for forage
for 120 days. Do not use more than 2 Ib a.i./A
per crop season.
General Information: If fall-treated legumes
should be killed in winter, do not plant small
grains or grass crops in the same field in the
spring.
Broadcast, Apply to established legumes during
fall or winter after the last cutting when tem-
peratures are cool but before the ground freezes.
Apply to fall-seeded legumes after the trifoliate
stage. Application to spring-seeded legumes
should be made the following fall or early winter.
See Birdsfoot Trefoil cluster.
0.05 ppm
Do not use more than 3 Ib a.i./A per year.
Use limited to OR and WA.. Broadcast or band.
Apply to established berries, and make only 1 ap-
plication per year. Apply in fall or winter,
preferably during November or December. Do not
apply when ground is frozen. Do not apply to
newly transplanted berries for at least 3 months.
Use 1 to 2 Ib a.i./A for control of annual blue-
grass, and 2 to 3 Ib a.i./A for control of peren-
nial ryegrass and quackgrass.
0.05 ppm
Do not use more than 2 Ib a.i./A per year.
Use limited to OR and WA. Broadcast or band.
Apply to established berries, and make only 1 ap-
plication per year. Apply in fall or winter,
preferably during November or December. Do not
apply when ground is frozen. Do not apply to
newly transplanted blueberries until the roots
are well established.
Issued: 1-17-84
1-101701-7
-------
'13015AA
13020AA
Site, Dosage
and Formulation
Clb a.i./A)
Cherry
Clover
Clover (seed crop)
Crown Vetch
Crown Vetch (seed
crop)
Endive (Sscarole)
Lettuce
EPA Index to Pesticide Chemicals
3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
Tolerance, Use, Limitations
1.5-2
(50% WP)
1-2
(50% WP)
1-2
(50% WP)
Grapes
Lettuce
Nectarine
Peach
Pear
Plum
Prune
Issued:
See Apple cluster.
See Birdsfoot Trefoil cluster.
See Birdsfoot Trefoil cluster.
See Birdsfoot Trefoil cluster.
See Birdsfoot Trefoil cluster.
2 ppm (endive (escarole))
1 ppm (lettuce)
Fifty-five day preharvest interval on lettuce.
General Information: Do not make more than 1 ap-
plication per crop season. Do not use on peat or
muck soils. Do not use more than 1.5 Ib a.i./A
on Val Temp, Grande Verde, and Prima Verde vari-
eties of crisp lettuce, or on endive and escarole.
Apply preemergence to the weeds, and water into
the soil immediately after application.
Preplant soil incorporation. Broadcast or band.
Where rainfall is not dependable or overhead
spinkler irrigation is not used, shallow preplant
incorporation followed by furrow irrigation is
recommended.
Preplant or preemergence,
face application.
Broadcast or band sur-
1-17-84
Postemergence. Broadcast or band surface ap-
plication. Apply before or after thinning of
lettuce.
See Apple cluster.
See Endive (Escarole) cluster.
See Apple cluster.
See Apple cluster.
See Apple cluster.
See Apple cluster.
See Apple cluster.
1-101701-8
-------
EPA Index to Pesticide Chemicals
3,5-DICHLORO-N-(l,l-DIMETKYL-2-PROPYNYL)BENZAMIDE
Site, Dosage
and Formulation
(Ib a.i./A)
Raspberry
Sainfoin
Tolerance, Use, Limitations
See Blackberry cluster.
See Birdsfoot Trefoil cluster.
Sainfoin (seed crop) See Birdsfoot Trefoil cluster.
TERRESTRIAL NON-FOOD CROP
(Agricultural Crops)
33017BA Bermudagrass (seed
crop)
0.5-1.5
(50% WP)
N.F. (seed)
Do not graze treated areas or feed clippings to
livestock.
Broadcast application for annual bluegrass con-
trol. Apply at any stage of annual bluegrass
growth from preemergence to seed formation. Use
the lower dosage for preemergence or early post-
emergence control. Use the higher dosage for
late postemergence control and when longer pre-
emergence residual control is desired. Irrigation.
or.rainfall within 24 hours of application is de-
sirable. May be applied by air.
Issued: 1-17-84
1-101701-9
-------
EPA Index to Pesticide Chemicals
3,5-DICHLORO-N-(1,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
Site, Dosage Tolerance, Use, Limitations
and Formulation
(lb a.i./A)
(Ornamental Plants and Forest Trees)
I22AA Azalea
I22DA Azalea (nursery
stockT
105AA Christmas Tree Plan-
tations
144AA Douglas-Fir
H4DA Douglas-Fir (nursery
stock)
151AA Fir"
151DA Fir (nursery stock)
)62AA Forsythia
)62DA Forsythia (nursery
170AA Holly
)70DA Holly (nursery
stock)
173AA Juniper
173DA Juniper (nursery
stock)
)98AA Pine
398DA Pine (nursery
stock)"
118AA Rhododendron
U8DA Rhododendron
(nursery stock)
130AA Yew
130DA Yew (nursery stock)
1-2 Broadcast or band. Make a single application in
(50% WP) fall prior to leaf-drop and before the soil
freezes. Apply over the top of ornamentals or as
a directed spray to the soil. Moisture is neces-
sary as rainfall or overhead sprinkler irrigation
to move the chemical into the soil. Use only on
established plantings. Do not use on seedling
trees or shrubs less than 1 year old, or on fall
transplanted stock within 1 year of transplanting,
or on spring transplanted stock within 6 months
of transplanting.
Azalea (nursery
~ stock) See Azalea cluster.
Issued: 1-17-84 1-101701-10
75
-------
EPA. Index to Pesticide Chemicals
33017AA
Site, Dosage
and Formulation
(Ib a.i./A)
Bermudagrass
3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
Tolerance, Use, Limitations
0.92-2.75 oz a,
5,000 sq.ft
(1% G)
(50% WP)
1.85-2.77 oz a.
5,000 sq.ft
(0.33% G)
i./
i./
0.92-2.75 oz a.i./
5,000 sq.ft
(50% WP)
0.87 oz a.i./
5,000 sq.ft
(0.322 G)
0.85 oz a.i./
5,000 sq.ft
(0.4% G)
0.81 oz a.i./
5,000 sq.ft
(0.9% G)
General Information: Use for control of annual
bluegrass in bermudagrass golf courses, lawns,
and playing fields. Do not spray on fairways or
other areas that may drain onto bentgrass greens,
or to areas overseeded with sensitive cool season
grasses. Do not apply to areas that are to be
overseeded with cool season grasses within 90
days before seeding. Do not use on golf greens.
Dichondra, bluegrass, annual and perennial rye-
grasses, fescues, zoysia, and bentgrass are sen-
sitive to pre- and postemergence applications of
pronamide. May be used for elimination of winter
overseeded cool season grasses.
Broadcast application for annual bluegrass con-
trol. Apply at any stage of annual bluegrass
growth from preemergence to seed formation. Use
the lower dosage for preemergence or early post-
emergence control. Use the higher dosage for
late postemergence control and when longer resid-
ual preemergence control is desired. Irrigation
or rainfall within 24 hours of application is
desirable.
Restricted Use Pattern. Applications should be
made only by certified applicators or persons
under their direct supervision. Broadcast appli-
cation for annual bluegrass control. Apply at
any stage of annual bluegrass growth from pre-
emergence to seed formation. Use the lower dosage
for preemergence or early postemergence control.
Use the higher dosage for late postemergence ^n-
trol and when longer residual preemergence control
is desired. Irrigation or rainfall within 24
hours of application is desirable.
season grasses. For "c^te^'of 7^rblue^ass
throL?n^lme a ltS §ermiQation in the fall
through the spring. For elimination of winter
overseeded cool season grasses and conversion to
bermudagrass on golf greens and tees, apply ln
spring when the weather is favorable for
bermudagrass growth.
Issued: 1-17-84
1-101701-11
76
-------
EPA Index to Pesticide Chemicals
3,5-DICHLORO-N-(1,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
Site, Dosag£ Tolerance, Use, Limitations
and^Formulation
(IbT.i./A)
Bermudagrass (continued)
1.73 oz a.i./5,000 Broadcast application for control of Kentucky
3q«ft bluegrass and bentgrass in areas other than golf
(0.32j£ G) greens and tees. Apply anytime when these grasses
are actively growing.
1.7 oz a.i.75,000
sq.f t
(0,4% G)
1.62 oz a.i.75,000
sq.f t
(0.9% G)
Douglas-Fir See Azalea cluster.
Douglas-Fir (nursery
stock) See Azalea cluster.
Fir See Azalea cluster.
Fir (nursery stock) See Azalea cluster.
Forsythia See Azalea cluster.
Forsythia (nursery
stock) See Azalea cluster.
Holly See Azalea cluster.
Holly (nursery stock) See Azalea cluster.
Juniper See Azalea cluster.
Juniper (nursery
stock)" See Azalea cluster.
Pine See Azalea cluster.
Pine (nursery stock) See Azalea cluster.
Rhododendron See Azalea cluster.
Rhododendron (nursery
_stoc_k)~ " See Azalea cluster.
Yew See Azalea cluster.
Yew (nursery stock) See Azalea cluster.
Issued: 1-17-84 1-101701-12 77
-------
EPA Index to Pesticide Chemicals
3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.i./A)
FORESTRY
Christmas Tree Plan-
tations See TERRESTRIAL NON-FOOD CROP, Azalea cluster,
AERIAL AND TANK MIX APPLICATIONS
001500 Aerial Application
AAAAAA — Refer to
TERRESTRIAL NON-FOOD CROP
(Agricultural Crops)
Bermudagrass (seed crop)
Issued: 1-17-84 1-101701-13 78
-------
EPA Index to Pesticide Chemicals
3,5-DICHLORO-N-C1,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
Listing of Registered Pesticide Products by Formulation
.0.0002 50% formulation intermediate
3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide (101701)
000707-00098
,0.3204 0.32% granular
3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide (101701)
000538-00084
fl.3304 0.33% granular
3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide (101701)
000557-01906
10.4004 0.4% granular
3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide (101701)
000538-00118
i!)J004 0.9% granular
3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide (101701)
000538-00115
11.0004 1% granular
3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide (101701)
005481-00170
J0.0006 50% wettable powder
3,5-dichloro-N-(l,l-dimethyl-2-propynyl)benzamide (101701)
000707-00159 002169-00248
59999 State Label Registrations
AZ Reg. No.
000707-07623
CA Reg. No.
000707-04595 005481-07509
FL Reg. No.
002342-06948
KS Reg. No.
000707-04594
NM Reg. No.
000707-06619
OR Reg. No.
000707-07620
WA Reg. No.
000707-04596
Issued: 1-17-84 1-101701-14 79
-------
I3001BA
'A001AA
13018AA
Z3011AA
I3011BA
H002AA
U009AA
15002AA
13003AA
'.300 3BA
EPA Index to Pesticide Chemicals
3 , 5-DICHLORO-N-C 1 , l-DIMETHYL-2-PROPYNYL) BENZAMIDE
Appendix B
Listing of Registration Numbers by Site and Formulation
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Alfalfa
(50% WP)
000707-00159
Alfalfa (seed crop)
(50% WP)
000707-00159
Apple
(50% WP)
000707-00159
Artichoke. Globe
(50% WP)
000707-00159
Birdsfoot Trefoil
(50% WP)
000707-00159
Birdsfoot Trefoil
(seed crop)
(50% WP)
000707-00159
Blackberry
(50% WP)
000707-00159
Blueberry
(50% WP)
000707-00159
Cherry
(50% WP)
000707-00159
Clover
(50% WP)
000707-00159
Clover (seed crop)
(50% WP)
000707-00159
Issued: 1-17-84
1-101701-15
80
-------
SPA Index to Pesticide Chemicals
3,5-DICHLORO-N-(1,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
Appendix B
Listing of Registration Numbers by Site and Formulation (continued)
S024AA Crown Vetch
(.507. WP)
000707-OOL59
)024BA Crown Vetch (seed
'crop!
(50% WP)
000707-00159
]015AA Endive (Escarole)
(50% WPl~
000707-00159
IU14AA Grapes
(50% WP)
000707-00159
3020AA Lettuce
(50% WP)
000707-00159
5003AA Nectarine
(50% WP)
000707-00159
'500 4AA Peach
(50% WP)
000707-00159
K003AA Pear
(50% WP)
000707-00159
'5005AA Plum
(50% WP)
000707-00159
]5006AA Prune
(50% WP)
000707-00159
31006AA Raspberry
T50% WP)
000707-00159
23021AA Sainfoin
(50% WP)
000707-00159
Issued: 1-17-84
1-101701-16
81
-------
23021BA
EPA Index to Pesticide Chemicals
3 ,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
Appendix B
Listing of Registration Numbers by Site and Formulation (continued)
Sainfoin (seed crop)
(50% WP)
000707-00159
J30173A
34022AA
34022DA
33017AA
35044AA
:ERRESTRIAL NON-FOOD CROP
(Agricultural Crops)
Bermudagrass (seed
crop)
(50% WP)
000707-00159
(Ornamental Plants and Forest Trees)
Azalea
(50% WP)
000707-00159
Azalea (nursery
stock)"
(50% WP)
000707-00159
Bermudagrass
(0.32% G)
000538-00084
(0.33% G)
000557-01906
(0.4% G)
000538-00118
(0.9% G)
000538-00115
(1% G)
005431-00170
(50% WP)
000707-00159
Douglas-Fir
(50% WP)
000707-00159
002169-00248
Issued: 1-17-84
1-101701-17
-------
15044DA
15051AA
15051DA
J4062AA
S4062DA
J4070AA
34070DA
35073AA
35073DA
35098AA
35098DA
EPA Index to Pesticide Chemicals
3 , 5-DICHLORO-N-C L , l-DIMETHYL-2-PROPYNYL) BENZAMIDE
Appendix B
Listing of Registration Numbers by Site and Formulation (continued)
(nursery
stock)_
(50% WP)
000707-00159
Fir
(50% UP)
000707-00159
Fir (nursery stock)
(50% WP)
000707-OOL59
Forsythia
(50% WP)
000707-00159
Forsythia (nursery
stock)
(50% WP)
000707-00159
Holly
(50% WP)
000707-00159
Holly (nursery
stock)
(50% WP)
000707-00159
Juniper
(50% WP)
000707-00159
Juniper (nursery
stock)
(50% WP)
000707-00159
Pine
I5~0% WP)
000707-00159
pi.ne (nursery
stock)
(50% WP)
000707-00159
Issued: 1-17-84
1-101701-18
83
-------
J41 Li3DA
35130AA
EPA Index to Pesticide Chemicals
3,5-DICHLORO-N-(l,l-DIMETHYL-2-PROPYNYL)BENZAMIDE
Appendix B
Listing of Registration Numbers by Site and Formulation (continued)
Rhododendron
(50% WP)
000707-00159
Rhododendron
(nursery sTock.)
(50% WP)
000707-00159
Yew
(50% WP)
000707-00159
Yew (nursery stock)
(.50% WP)
000707-00159
/30005AA
FORESTRY
Christmas Tree Plan-
tations
(50% WP)
000707-00159
Issued: 1-17-84
1-101701-19
-------
APPENDIX n
LABELING REQUIREMENTS
1. Submission of Revised Labeling
2. 40 CPR 162.10 Labeling Requirements
3- Table of Labeling Requirements
4. Physical/Chemical Hazards Labeling
Statement
5- Pesticide Storage Instructions
6. Container Disposal Instructions
7• Farmworker Safety Label Requirements
85
-------
APPENDIX C-l
SUBMISSION OF REVISED LABELING
PIFRA 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 (Appendix
0-2) and are summarized for products containing this active
ingredient in Appendix C-3- Applications submitted in response
to this Standard must Include draft labeling for Agency review.
If revised labeling information complying with this Appendix and
the requirements described in Part II of the Standard, is not
submitted, EPA may issue a notice of intent to cancel the regis-
tration under FIFRA sec. 6(b)(l).
A. LABEL CONTENTS. 40 CPR 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 C-3.
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 be located at the bottom of the
front panel or at the end of the label text.
Item 3- NET CONTENTS - A net contents statement Is required
on all labels or on the container of the pesticide. The
preferred location is the bottom of the front panel immediately
above the company name and address, or at the end of the
label text. The net contents must be expressed in the largest
suitable unit, e.g., "1 pound, 10 ounces" rather than "26
ounces." In addition to English units, net contents may be
expressed in metric units. [40 CFR l62.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number
assigned to the pesticide product must appear on the label
preceded by the phrase "EPA Registration No.," or "EPA Reg'
No." The registration number must be set in type of a size
and style similar to other print on that part of the label
on which it appears and must run parallel to it. The regis-
tration number and the required identifying phrase must not
appear in such a manner as to suggest or Imply recommendation
or endorsement of the product by the Agency. [40 CPR Ifi2.10(e)]
86
-------
_ 5. EPP^STABL^SHMENT NUMBER - The EPA establishment number,
preceded by the phrase "EPA Est." is the final establishment at
which the product was produced, and may appear in any suitable
location on the label or immediate container. It must also
appear on the wrapper or outside container of the package if the
EPA establishment number on the immediate container cannot be
clearly read through such wrapper or container. [40 CPR l62.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR l62.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricultural
formulations,the pounds per gallon of active ingredient must be
indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement "Keep
Out of Reach of Children" must be located on the front panel
above the signal word except where contact with children during
distribution or use is unlikely. [40 CFR 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - For products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "POISON" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word "POISON." [40 CFR 162.10(h)(1)(i)1
87
-------
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement of
practical treatment (first aid or other) shall appear on the
label of pesticide products In toxiclty Categories I, II,
and III. [40 CPR l62.10(h)(1)(111)1
Item 7E. REFERRAL STATEMENT - The statement "See Side (or
Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR I62.10(h)(l)(lil)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and It is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CPR 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. [40 CPR 162.10 (h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CPR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD -
1. Plammabllity statement. Precautionary statements relating
to flammability of a product are required to appear on the
label if it meets the criteria in Appendix C-4. 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 determine if a product is non-flammable
a. A "non-flammable gas" is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
88
-------
b. A "non-flammable liquid" is one having a flashpoint
greater than 350°P (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
ill. The flashpoint of the non-volatile liquid component
is greater than 350°P (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 flamrnablllty, appropriate statements of hazard
will be prescribed. Such statements may address hazards of
explosivity, oxidizing or reducing capability, or mixing
with other substances to produce toxic fumes.
Item 9A. RESTRICTED USE CLASSIFICATION - PIPRA section 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).
The Agency has determined that certain formulations of pronamide
are to be restricted. The Regulatory Position and Rationale
states which products containing this active ingredient are
classified for restricted use. The draft label(s) for these
products submitted to the Agency as part of the application
must reflect this determination (see below).
If a registrant does not believe that its product should be
classified for restricted use, the registrant must submit any
information and rationale with its application for reregistration.
During the Agency's review of the application, the proposed
classification determination will be evaluated in accordance
with the provisions of 40 CPR I62.11(c). The registrant will be
notified of the Agency's classification decision.
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1. For products classified for restricted use, the following
label requirements apply:
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. (40 CPR 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
the Standard). If use is restricted to certified appli-
cators, 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, For products with some but not all uses restricted, if stated
in the Regulatory Position and Rationale section, several
courses of action are available:
a. The product may be labeled for restricted use. The label
may include uses that are unrestricted, but they may not
be distinguished on the label as being unrestricted.
b. All restricted uses may be deleted from the label (submit
draft labeling bearing only unrestricted uses).
c. Two separate products with identical formulations, one
bearing only unrestricted uses and the other bearing
restricted uses, may be registered. To do so, submit
two applications for reregistration, each containing all
forms and necessary labels. Both applications should be
submitted simultaneously. 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 - A reentry interval has not been
established by the Agency for this chemical.
Item 10B - There is no Item 10B.
Item 10C- STORAGE AND DISPOSAL BLOCK - All labels are required
to bear storage and disposal statements. These statements are
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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. Part II
of the Standard contains the specific disposal statement
for pronamide and Appendix 0-6 sets forth the appropriate
container disposal statements.
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. [40 CFR 162,10]
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 Standard and submitted for review.
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Appendix C-2
Chapter 1—Environmental Protection Agency
SL62.10 Labeling requirements.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
Label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
sect ion;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
(e) of this section;
(v) The producing establishment number as prescribed in para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this sect ion;
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section;-
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this section.
(2} Prominence and legibility. (i) All words, statements,
graphic representations, designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be placed
with such conspicuousness (as compared with other words, state-
ments, designs, or graphic matter on the labeling) and expressed
in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(3) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear in the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling.
<4> Placement of Label—(i) General. The label" shall appear
on or be securely attached to the immediate container of the
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pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
tnat^a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
f^' Tank cars and other bulk containers — (A) Transportation.
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding o£ hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
de 1 i ve ry .
(3) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve .
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to § 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticida1 claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(11) A false or misleading statement concerning the. effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
dev ices ;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
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(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as. "safe," "nonpoisonous," "noninjurious,"
"harmless" or "nontoxic to humans and pets" with or without such
a crualifving phrase as "when used as directed"; and
(x) Non-numerical and/or comparative statements on the safety
of the product, including but not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals1 known"
(C) "Pollution approved"
(6) Final printed labeling. (i) Except as provided in
paragraph (a ) (6 ) (ii ) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant -to § 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unoualified n 5~'.e and =.o^re^o giv-en on the
laoei snail oe considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***," or "Sold by ***** to show that the name is not that of the
oroduce r .
(d) Net weight or measure of contents. ( 1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°F (20°C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms oE the
largest suitable units, i.e., "1 pound 10 ounces" rather than
11 26 ounces . "
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(5) In addition to the required units specified, net content
may be expressed in me trie•units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est. ", of 'the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or conta iner.
(g) Ingredient statement—(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement "Inert Ingredients,
none" is not required for pesticides which contain 100 percent
active ingredients. Unless the ingredient statement is a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the ingredient statement.
(2) Position of ingredient statement. (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
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(3) Names to be used in ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one, followed by the chemical name. the common name may be
used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case
will the use of a trademark or proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6). -
(4) Statements of percentages. The percentages o£ ingredients
shall be saated in terms of weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deteriorat ion. Pesticides which change in chemical
composition significantly must meet the following labeling re-
qu i remen ts:
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]."
(LI) The product must meet all label claims ap to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient statement
if he determines that such ingred ient ( s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
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Hazard Indicators
Oral ID
50
1 nhal at Ion LC
50
Dermal LD
50
Eye effects
Skin affects
1
1
»
Up to and
I Includ Ing
50 mg/kg
Up to and
Includ Ing
.2 mg/l Itar
Up to and
Includ Ing
200 mgAg
Corros Ive;
cornea 1- opac 1 1>
not ravers Ib I a
«*! thin 7 days
Corrosive
Toxicity (
II
From 50 thru'
500 mg/Xg
From .2 thru
2 mg/l Iter
From 200
thru 2000
Cornea 1 opacity
ravers Ible
within 7 days;
Irritation
pars 1 st Ing for
7 days
Severs Irritation
at 72 hours
rateqorles
1 1 1
From 500 thru
5000 mg/kg
From 2 thru
20 ing/ 1 1 tar
From 2,000 thru
20.000
No corneal opacity;
Irritation
revers Ible
within 7 days
Moderate Irritation
at 72 nours
IV
Greatar than
5000 mg/kg
Greater than
20 mg/t Iter
Greater than
20,000
Mo 1 rr 1 tat Ion
Mild or si Ight
Irritation at
72 nours
(i) Human hazard signal word.--(A} Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
to Toxicity Category I on
dermal toxicity (as distinct
word "Poison" shall appear
addition if the product was assigned
the basis of its oral, inhalation or
from skin and eye local effects) the
in red on a background of distinctly
skull and crossbones shall appear in
word "poison. "
(B) Toxicity Category II.
contrasting color and the
immediate proximity to the
criteria of Toxicity Category
the signal word "Warning."
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
All pesticide
II shall bear
products meeting the
on the front panel
All pesticide products meeting the
III shall bear on the front panel
All pesticide products meeting the
IV shall bear on the front panel
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(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is neces'sary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of -a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on theEfont panelthe"statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requ i rement.
(iii) Statement of
Ca teaorv
practical treatment—(A) Toxicitv
I
o r
A statement of practical treatment (first aid
oche r) shal1 appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(3) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, recuired elsewhere
on the label in accord with paragraph (h)(2) of this section if
t:iey do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the Label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of purchase and use. The
collowing table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
5 and under
Above 5 to 10
Above 10 to 15
Above 15 to 30
Over 30
Poir
Required
signal word,
all capitals
i n
18
its
"Keep out
of reach of
Children"
i n
I U
12
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(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall appear
together on the label under the general heading "Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental Hazard" and "Physical or
Chemical Hazard."
( *•) Hazard t?o humans and domestic animals. (A) Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate harard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
ha za rds .
Precautionary statements by toxlc'ty category
Tox I c I rr |__
category Oral, Inhalat'on, or dermal toxlclty
Skin and
local effects
IV
Fatal (poisonous) If swallowed [Inhaled or
absorbed through sklnl. Do not breathe
vapor Idust! or spray ulstl. Do not get
In eyes, on skin, or on clothing {Front
panel statement of- practical treatment
requ I red . 1 .
May be fatal If shallowed [Inhaled or
absorbed through the skin!. Co not breathe
vapors [dust or spray mlstl. Do not gat In
eyes, on skin, or on clothing. [Appropriate
first aid statements required.1.
Harmful If swallowed (Inhaled or absorbed
through the skint. Avoid breathing vapors
(dust or spray mlstl. Avoid contact *Ith
skin [eyes or clothing!. [Appropriate
first aid statement required.I.
[Ho precautionary statements required.].
I
Corrosive, causes eye and skin damage (or
3k'n 'i—Itatlonl. Do not gar In eyes, on
skin, or on cloth'ng. Wear goggles or face
sfifefd and rubber gloves when handling.
Harmful or fatal If swallowed.
[Aoproor'ate '•'-st aid sTat-^nent requ'-ed.l
Causes eye (and skin] Irrltat'on. Do not
get In eyes, on skin, or on clothing.
Harmful If swallowed. [Appropriate first
aid statement required.!.
Avoid contact with skin, eyes or clothing.
In case of contact Immed I 3taly flush
eyes or skin with plenty of water. Get
medical attention If Irritation persists.
I No precautionary statements required.!
(ii) Environmental hazards. Where a hazard exists to non-
target organisms excluding humans and domestic animals, precautionary
statements are required stating the nature of the hazard and the
appropriate precautions to avoid potential accident/- injury or
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damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral L&$Q of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) ff a pesticide intended for outdoor use contains an active
ingredient with a;fish acute LC50 of 1 ppm or less, the statement
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD$Q of 100 mg/kg or less, or
a subacute dietary LC5Q of 500 ppm or less/ the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes, "
(iii) Physical or chemical hazards. Warning statenents or the
f laminab i 1 i ty or explosive cnaracteristics of the pesticide are
required as follows:
Flash point | Required text
(A) PRESSURIZED CONTAINERS
. , _
-Ijsn point at or Oelo* 20*F; If tnere is a | Extremely flammable. Contents under
•ijsnbacK at jny valve ooening. | Keep a«ay from fire, sparks, and
| surfaces. Oo not puncture or Incinerate !
I container. Exposure to temperatures 3b3ve '
| I30"F may causa bursting. j
Flasn 3oint above 20*F and not over 3Q'f or i t \ Flammable. Contents under pressure. Keep away |
the flame extension is more than 18 in. long | from heat, sparKs, and open flame. Oo not |
at a distance of 6 In. from the flame. | puncture or Incinerate container. Exposure to|
| temperatures above 130*F may cause bursting. |
All otner pressurized containers | Contents under pressure. Oo not use or store |
| near heat or open flame. Oo not puncture or ]
| Incinerate container. Exposure to tempera- j
tures above 130*F may cause bursting. I
(BlNONPRESSURIZED CONTAINERS
| At or below 20'F » j Extremely flammable. Keep away from fire.
I ( sparks, and heated surfaces.
| Above 20'F and not over 80'F | Hammable. Keep away from heat and open flame.
| Above 30-F and not over 150'F | Oo not use or store near heat or open f|am*.
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( x } Directions for Use— ( 1) General requirements— ( i ) Adequacy
and clarity of directions. Directions for use must be stated in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of' the pesticide.
•vnen collowed, directions must be adequate to protect the public
from fraud ar^d from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of directions for use- Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
.accompanying leaflets or circulars, such as "See directions in
the enclosed circular." and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
( i- i i ) Exceptions to requirement for direction for use— ( A )
Detailed directions for use may be omitted from labeling-of
pesticides which are intended for use onlv by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
(_!_) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s ) of
products involved.
(2) Adequate information sucn as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(_3) The product will not come into the hands of the general
public except after incorporation into finished products; and
(4_) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
env i ronment.
(3) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(_!) The label clearly states that the product is for use only
by physicians or veterinarians;
(2) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(3) The product is also a drug and regulated under the provisions
of "the Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
(_U There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
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(2) The label clearly states that the product is intended for
use~only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
(3) The product as finally manufactured, formulated, mixed, or
repackaged'1^ registered; and
(4_) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
env ironment.
(2) Contents of Directions for Use- The directions for use
shall include the following, under the headings "Directions for
Use" :
(i) The statement of use classification as prescribed in
I62.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
( i. L i ) The s i te ( s ) of application, as for example the crops,
animals, areas, or objects to be treated.
(Lv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s^ of application, apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viiLl Spec"! fie limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in § 162. 10(h)( 1)( iv) .)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person-applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision of a certified
applicator who is physically present.
102
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(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
env ironment.
(^ Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a procuct labeled
for restricted use. Such products shall be subject to the
provisions of § 162 . 10( j)( 2).
(i) General Use Classification. Pesticide products bearing
directionsfor use(s)classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under che statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide.products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
be low:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in § 162. 10{h)(1)( iv) ) , and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(3) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators, the following statement is required: "For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation
(k) Advertising. [Reserved]
(40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, 19781
103
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APPENDIX C-3 - TABLE OF LABELING REQUIREMENTS
ITEM
1
2
3
H
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est, No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
Immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units In addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked .
Note type size requirements.
Note type size requirements.
O
-------
ITEM
7C
7D
7E
^B
~8A
~8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
.Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
CD
en
-------
ITEM
8C
9A
9C
10A
IOC
10D
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°P
All restricted
products
All products
All
cholinesterase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from other directions for
use.
May be in metric as well as U.S. units
o
-------
APPENDIX
Criteria
PJJISICAL-CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°P; or if there is a
flashback at any valve
opening.
B.
C.
Flashpoint above 20°F
and not over 30°F; or
if the flame extension
is more than 18 inches
long at a distance of
fi inches from the
valve opening.
All other pressurized
containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
B.
C.
D.
Flashpoint above 20°F
and not over 80°F.
Flashpoint over 80°F
and not over 150°F.
Flashpoint above
150°F.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
107
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APPENDIX C-5
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading: All products are required to bear specific label
instructions about storage and disposal. Storage and disposal
instructions must be grouped together in the directions for
use portion of the label under the heading STORAGE AND DISPOSAL.
Products intended solely for domestic use need not include
the heading "STORAGE AND DISPOSAL."
Storage Instructions: All product labels are required to have
appropriate storage instructions. Specific storage instructions
are not prescribed. Each registrant must develop its own storage
instructions, considering, when applicable- the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3- Specifications for handling the pesticide container, Includ-
ing movement of container within the storage area, proper
opening and closing procedures (particularly for opened
containers), and measures to minimize exposure while opening
or closing container.
4 . Instructions on what to do if the container Is damaged in
any way, or if the pesticide is leaking or has been spilled,
and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides during
storage to prevent cross-contamination of other pesticides,
fertilizer, food, and feed. General storage instructions
for household products should emphasize storage in original
container and placement in locked storage areas.
108
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APPEMDIX C-6
gQNTAINER_DIS_p_QSAL INSTRUCTIONS
e label of each product must bear container disposal Instructions
appropriate to the type of container.
l' °°S|sti^_j.is^_p_roducts_ must bear one of the following
container rHsnnsai 04--,-4-,-,„,„„..-,>.
^~S±ii^ — i^pe Statement
Non-aerosol products
(bottles, cans, 1ars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
All other products must bear container disposal instructions
based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol )
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of In a sanitary landfill, or by
other procedures approved by state and local
authorities .
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of In a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse Cor equivalent! . Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue Into application
equipment. Then dispose of liner In a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum Is contaminated and cannot be
reused!, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke .
Return empty cylinder for reuse (or
similar wording)
!/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
109
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APPENDIX C-7
A
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
V WASHINGTON, D.C. 20460
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
MAR 2 9
PR NOTICE 83-2
NOTICE TO MANUFACTURERS, FORMULATORS
AND REGISTRANTS OF PESTICIDES
Attention: Persons Responsible for Federal Registrations of
Pesticides
This notice is to inform you that the labels of all outdoor
agricultural use products which are applied to crops whose
culture requires hand labor are required to bear the following
information under the Farmworker Safety Label Improvement Program.
No application for amended registration is required, provided
you use the exact wording contained in this Notice. All affected
products released for shipment after December 31, 1984 must be
relabeled accordingly.
For the purposes of this Label Improvement Program, the terms
"reentry intervals", "farmworkers", and "protective clothing"
used in this notice are as defined in 40 CFR 170.2. Reentry
interval means the period of time immediately following the
application of a pesticide to a field when unprotected workers
should not enter. Farmworker refers to any person or persons
engaged in agricultural hand labor in the field. Protective
clothing means, at least, a hat or other suitable head covering,
a long sleeved shirt and long legged trousers or a coverall type
garment (all of closely woven fabric covering the body, including
the arms and legs), shoes and socks.
The term hand labor tasks, as used in this Notice, is defined as
commonly recognized crop production activities such as harvesting,
detasselling, thinning, weeding, topping, planting, sucker removal
summer pruning, moving irrigation equipment and other hand labor
tasks performed in the field by farmworkers who will come
in substantial contact with pesticide treated surfaces, such as
plants or plant parts. For the purposes of this notice, mixing,
loading, flagging, and equipment operation are considered to be
part of the application of the pesticide and are not normally
considered to be hand crop production tasks, and therefore, are
110
-------
Page 2
, to these provisions. At a minimum, the following
crops nave been determined to employ hand labor tasks:
Citrus Fruit
Cucurbits
Fruiting Vegetables
Leafy Vegetables
Root Crop Vegetables
Onions
Pome Fruits
Stone Fruits
Tobacco
Small Fruits
Corn (hybrid
Figs
Mango
Olives
Pineapples
(berries, grapes, nuts
seed, sweet and pop)
Registrants are responsible for determining whether use of their
products would involve any other crop activities that meet the
definition for hand labor tasks normally performed by farmworkers
and are, thus, subject to this Notice.
While "scouting" for determining efficacy may result in potential
exposure, it is not considered to be a commonly recognized hand
labor crop production task customarily performed by farmworkers
and therefore would normally be excluded from the hand labor
criteria of this Notice. However, if the definition of hand
labor would cover scouting for a particular use, then these
provisions would apply.
I. PRODUCTS AFFECTED:
All products with Outdoor agricultural uses which are applied to
crops utilizing hand labor tasks will be required to bear general
precautionary label language about farmworker safety (see Section
II.A.) In addition, the labels of the following pesticides,
either as sole active ingredients or in combination with other
pesticides, must bear specific precautionary label language
about reentry and farmworker safety (see Section II. A. and B.).
Ethyl Parathion
Methyl Parathion
Azinphos Methyl
Demeton
Monocrotophos
Phosalone
Carbophenothion
Endrin
Matasystox-R
Bidrin
Ethion
The requirements set forth in this Notice do not apply to: (1)
Mosquito abatement treatments and related public pest control
programs; (2) Greenhouse treatments; (3) Livestock and other
animal treatments; (4) Treatment of golf courses, forest uses
and similar nonagricultural areas; (5) Any uses, except pesticides
with systemic modes of action, for which soil incorporation
required.
is
1 1 1
-------
Page 3
The reentry intervals for the eleven pesticides listed above and EPN
were established through regulation at 40 CFR 170. EPN was, excluded
from this label improvement action because an RPAR is currently
under negotiation. Registrants will be notified separately of
requirements resulting from the RPAR action.
EPA, as part of the reregistration process, is evaluating the
reentry intervals and protective clothing requirements for all
pesticides including the ones addressed in this label improvement
program. Registrants will be advised through the Registration
Standards Program if future label changes are necessary.
II. REQUIRED LABEL CHANGES:
The following statements contain either the exact wording -that
must appear on the affected product labels, or are explicit in
Indicating the type of information that must be conveyed in
specific portions of the label text. See attached sample product
label for proper placement of each statement listed in this
Section (A and B) .
A. General Worker Protection Statements;
The labels of all products covered by this notice must bear the
following general precautionary statements about farmworker
safety- See the sample label provided in attachment B for .the
proper location for these statements.
1. "Do not apply this product in such a manner as to directly or
through drift expose workers or other persons. The area being
treated must be vacated by unprotected persons."
2. "It is a violation of Federal Law to use this product in a
manner inconsistent with its labeling."
3. The labels of all products in Toxicity Category I aod II,
in addition to the English signal word,, must include the
Spanish language equivalent on the front panel. The
appropriate Spanish signal word, "PELIGRO" (for DANGER) or
"AVISO" (for WARNING) must appear in capital letters of the
same type size as the equivalent English signal word.
112
-------
Page 4
4. Agricultural products in Toxicity Category I and II must
Dear minimum Spanish language precautionary statements.
ine following precautionary statement must be placed on
the label in proximity to the Spanish signal word:
"PRECAUTION AL USUARIO: Si usted no lee Lngles, no use
este producto hasta que le etigueta haya sido explicado
ampliamente" .
(TRANSLATION: TO THE USER: If you cannot read English, do
not use this product until the label has been fully explained
to you. The English translation of the Spanish precautionary
statement is not reguired to appear on ynur product label.)
5. All agricultural use products applied to crops utilizing
hand labor tasks, except as specified in Section B (1) of
this Notice, must bear the following label statement:
"Do not enter treated areas without protective clothing
until sprays have dried (or, if appropriate, dusts have
settled) . "
6. "Because certain states may require more restrictive
reentry intervals for various crops treated with this
product, consult your State Department of Agriculture for
further information."
7. "Written or oral warnings must be given to workers who are
expected to be in a treated area or in an area about to be
treated with this product. (Indicate specific oral warnings
which inform workers of areas or fields that may not be
entered without specific protective clothing, period of
time field must be vacated and appropriate actions to take
in case of accidental exposure.) When oral warnings are
given, warnings shall be given in a language customarily
understood by workers. Oral warnings must be given if
there is reason to believe that written warnings cannot be
understood by workers. Written warnings must include the
following information: '(Appropriate signal word DANGER or
WARNING). Area treated with (name of pesticide) on (date
of application). Do not enter without appropriate protective
clothing for "( insert here reentry interval for your_prod_uc_t_)_.
(insert here actions to take in case of accidental
exposure.)1" This statement may either appear on the label
(see Attachment B for specific location) or on the labeling
accompanying the product.
113
-------
Page 5
B. Specific Reentry and Farmworker Safety Statements;
Because of their inherent human toxicity and to reduce risks for
crop use patterns utilizing hand labor, the Agency has determined
that all products with reentry intervals established through
40 CFR 170 must bear the following label statement:
treated areas for (insert here appropriate
/-« H ^ »- 4- V*»^1 /~*t»r ^ VI/-MIV-C; 11 n 1 d o c?
'Do not enter
reentry time interval from chart below
appropriate protective clothing is
)_ hours
worn."
unless
Ethyl Parathion...48 hrs.
Metasystox-R 48 hrs.
Methyl Parathion..48 hrs.
Azinphos Methyl...24 hrs.
Reentry Intervals
Monocrotophos....48 hrs,
Phosalone 24 hrs,
Carbophenothion..48 hrs,
Endrin 48 hrs
Demeton,
Bidrin.,
Ethion.,
.48 hrs,
.48 hrs,
.24 hrs,
III. Compliance:
It is the responsibility of the registrants to ensure that the
labels of their products, including distributor products, contain
specific instructions pertaining to farmworker safety. Existing
stocks of products in channels of trade (that is, out of the
registrant's physical possession) prior to December 31, 1984.
need not be relabeled. All products released for shipment after
December 31, 1984, must meet the requirements of this Notice, or
they will be deemed misbranded under Section 2(q)(l)(G). Failure
to revise product labeling in accordance with this Notice may
also result in the initiation of cancellation proceedings.
If you wish to make changes not specified in this Notice, or to
modify any of the required statements, you must submit an
application for amended registration to the address listed below:
(Product Manager for your product listed in Attachment
Registration Division (TS-767-C)
U.S. Environmental Protection Agency
A)
114
-------
Page 6
IV. Further Information:
Questions on this Notice may be directed to the appropriate Product
Manager or Richard King, Policy & Liaison Staff, Registration
Division, at (703) 557-0592.
/ ~ -- "- I "' ' ' v_- -
Douglas p. Campt, Director
Registration Division (TS-767-C)
Attachments
A. Product Manager Assignments (Attachment A not included)
B. Sample Product Label
115
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ATTACHMENT B - Sample Label
Label
Statements
'choice of
one location
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
(4 DOMESTIC ANIMALS)
DANGER
STORAGE AND
DISPOSAL
STORAGE - •
DISPOSAL
CROP —-
RESTRICTED USE
PESTICIDE
For retail sale to anj use only by Certified
Applicators or persons under their direct
supervision and only for Uose us^\, covered by
the Certified Applicator's certi f ic.ition.
PRODUCT
NAME
ACTIVE INGREDIENT
INERT INGREDIENTS
TOTAL
THIS PRODUCT CONTAINS IBS OF PER
KEEP OUT OF REACHJ^CHILDREN
DANGiBFT—POISON
STATEMENT OF PRACTICAL TREATMENT
IF SWALLOWED;
IF INHALED
IF ON SKIN =^=^
IF IN EYES
SLE SIDE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
MFG BY- • "•
TOWN. STATE :— :
ESTABLISHMENT NO —
LPA REGISTRATION NO
NET CONTENTS:
A(3)
Equivalent
Spanish
Signal
Word
A( 4 )
Spanish
St a tement
Reqarding
Inability t
\ead Englis
-------
APPENDIX D
PIPRA §3(c)(2)(B) Summary Sheet
(EPA Form 8580-1)
1 17
-------
OMB Approval No. 2OOOO468 .
FIFHA SECTION 3
-------
APPENDIX E
Certification of Attempt to Enter Into
an Agreement with Other Registrants for
Development of Data
(EPA Form 8580-6)
-------
OMB Approval No. 20OOO468 .
(To qualify, certify ALL four tttmsl
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
My firm has offered in writing to enter into such an agreement. Copies of thp offers are attached. That offer was irrevocable and included an offer to be
bound bv an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following dzte(s):
NAME OF FIRM
DATE OF OFFFR
However, none of those firm(s| accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c|(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 8S8O-6 (10-82)
120
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APPENDIX P
Product Specific Data Report
(EPA Form 8540-1)
121
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PRODUCT SPECIFIC DATA REPORT
EPA Registration No._
_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
Boiling point
Density, bulk-
density, or
specific gravity-
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
pH
Test not
required
for
product
listed
above
( check
below)
Method of complying
with
data requirements
Citing MRID#
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
122
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Registration
Guideline No.
61FI3
63-14
63 15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Fiammability
Explodabillty
Storage stability
I 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
product
listed
above
( check
Delow)
Method of complying
with
data requirements
Citing MRID#
Submit-
ting
Data
(At-
tached )
(For EPA Use Only)
Accession Numbers
Assigned
"
12
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APPENDIX G
Pormulator's Exemption Statement
124
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FORMULATOR'S EXEMPTION STATEMENT
(40 CFR 152.85)
EPA File Symbol/Ren M
/Ke3- No- Product Name
Applicant's Name and Address"
AS^n futl]orized representative of the aool icant for registration of the
product identified above, i hereby certify that:
(1) This product contains the active ingredient(s):
(2) Each active ingredient listed in paragraph (1) is present solely
as the result o£ the incorporation into the product (during formulation re-
packaging) oE another product which contains that active ingredient, which
is registered under FIFRA sec. 3, and which is purchased by us from another
producer.
(3) Indicate by circling (A) or (B) below which paragraph applies:
(A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for
the above identified product is attached to this statement. That formula
statement indicates, by company name, registration number and product
name, the source of the active ingredient(s) listed in paragraph (1).
OR
(B) The Confidential Statement of Formula dated on file ^ith
the EPA is complete, current and accurate and contains the information
required on the current CSF Form No. 8570-4. The registered soureefs)
of the active ingredient(s) listed in paragraph (1) is/are listed l>-low:
Active ingredient Source: Product name and Reg. Mo.
Signature
Title
EPA Form (April 1985)
125
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BIBLIOGRAPHY
126
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Guide to Use of This Bibliography
X- CONTE^F_BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2, UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3- IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph Md)(4) below for a further explana-
tion, [n a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), ~~each~entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Autoor. Whenever the Agency could confidently identify
orveTThe Agency has chosen to show a personal author-
Whe-i no individual was Identified, the Agency has shown
127
-------
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 following
elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number- The next element-, immediately
following the word "under," is the registration
number, experimental use permit number, petition
number, or other administrative number associated
with the earliest known submission.
(3) Submitter- The third element is the submitter,
following the phrase "submitted by." When author-
ship is defaulted to the submitter, thin element is
omitted.
(^) Volume Identification (Accession Number). 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 123^56, the first study would be 123456-A;
128
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OFFICE OF PESTICIDE PROGRAMS
r-* *• . REGISTRATION STANDARD BIBLIOGRAPHY
Utations Considered to be Part of the Data Base Supporting
Kegistrations Under the Pronamide Standard
MR ID 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)
00033380 Lodge, M.D.; Santelmann, P.W.; Lawrence, S.C.; et al. (1972) Ana-
lytical Results of Kerb Residue: R.A.R. No. 2-71-128. (Unpub-
lished study including R.A.R. nos. 2-70-71, 2-70-86, 2-70-78...,
received Dec 20, 1972 under 3F1317; submitted by Rohm & Haas
Co., Philadelphia, Pa.; CDL:092251-A)
00035563 Choi let, C.C.; Chennault, B.; Ryan, J.B.; et al. (1973) Analytical
Results of Kerb Residue: R.A.R. No. 2-69-160. (Unpublished
study including R.A.R. nos. 2-71-240, 2-71-241, 2-71-242..., re-
ceived Aug 23, 1973 under 4G1426; submitted by Rohm & Haas Co.,
Philadelphia, Pa.; CDL:093801-D)
00035564 Choi let, C.C.; Lawrence, S.C. (1972) Analytical Results of Kerb
Residue: R.A.R. No. 2-71-239. (Unpublished study including
R.A.R. no. 2-72-333, received Aug 23, 1973 under 4G1426; submit-
ted by Rohm & Haas Co., Philadelphia, Pa.; CDL:093801-E)
00035565 Chollet, C.C.; Lawrence, S.C. (1972) Analytical Results of Kerb
Residue: R.A.R. No. 2-71-195. (Unpublished study including
R.A.R. no. 2-72-110, received Aug 23, 1973 under 4G1426; submit-
ted by Rohm & Haas Co., Philadelphia, Pa.; CDL:093801-F)
00035566 Lawrence, S.C.; Neidlinger, T.J.; Doughty, C.C.; et al. (1972) Ana-
lytical Results of Kerb Residue: R.A.R. No. 2-69-66. (Unpub-
lished study including R.A.R. nos. 2-71-155, 2-71-258, 2-72-
005..., received Aug 23, 1973 under 4G1426; submitted by Rohm &
Haas Co., Philadelphia, Pa.; CDL-.093801-G)
00062605 Sinkeldam, E.J. (1974) Sensitization Test with Kerb Technical in
Guinea Pigs: Report No. R 4448. (Unpublished study received
Feb 25, 1977 under 707-98; prepared by Central Instituut voor
Voedingsonderzoek TNO, Netherlands, submitted by Rohm & Haas
Co., Philadelphia, Pa.; CDL:233726-C)
00070933 Rohm and Haas Company (1981) Kerb(R) 50-W Herbicide (707-98):
Lettuce Residue Studies. Interim rept. (Unpublished study re-
ceived Mar 5, 1981 under 707-98; prepared in cooperation with
Craven Laboratories, Inc.; CDL:244519-A)
-1-
129
-------
OFFICE OF PESTICIDE PROGRAMS
KEG1SIRAI10N SIANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Pronamide Standard
MRID CITATION
00070934 Adler, I.L.; Gordon, C.F.; Haines, L.D.; et al. (1972) Determina-
tion or residues from herbicide N-(l,l-dimethylpropynyl)-3,b-
dichlorobenzamide by electron capture gas-liquid chromatography.
Journal or the Association of Official Analytical Chemists
55(4):802-805. (Also in unpublished submission received Mar 5,
1981 under /0/-98; submitted by Rohm & Haas Co., Philadelphia,
Pa.; CDL:244519-B)
00074523 Rohm & Haas Company (1979) Summary and Discussion: Kerb. (Com-
pilation; unpublished study received Jun 24, 1981 under /0/-159;
CDL:070157-A)
00077215 Rohm & Haas Company (1980) Summary and Discussion: Kerb(R).
(Compilation; unpublished study received Jun 24, 1981 under
707-159; CDL:070158-A)
00083663 Powers, M.B. (1970) Final Report: Acute Oral—Rats; Draize Eye--
Rabbits; Acute Dermal--Rabbits; Primary Skin—Rabbits; Acute
Inhalation Exposure—Rats: Project Nos. 417-337; 417-339;
417-341; 41/-340; 41/-338. (Unpublished study received Mar
13, 1971 under 1F1139; prepared by TRW, Inc., submitted by
Rohm & Haas Co., Philadelphia, Pa.; CDL:090919-C)
00085504 Larson, P.S.; Borzelleca, J.F. (1968) Acute Oral Toxicity of RH-
315, W.P. in Albino Rats. (Unpublished study received Jun 15,
1969 under 9G0821; prepared by Medical College of Virginia,
Dept. of Pharmacology, submitted by Rohm & Haas Co., Philadel-
phia, Pa.; CDL:091422-B)
0008bb05 Powers, M.B. (1966) Acute Oral Administration—Rats; Acute Eye
Irritation—Rabbits; Acute Dermal Application—Rabbits; Acute
Oral Administration—Dogs: Project No. 417-179 and No. 41/-180.
Final rept. (Unpublished study received Jun 15, 1969 under
9G0821; prepared by Hazleton Laboratories, Inc., submitted by
Rohm & Haas Co., Philadelphia, Pa.; CDL:091422-C)
0008bbll Larson, P.S.; Borzelleca, J.F. (19V?) Percutaneous Toxicity Study
of RH-315 WP in Rabbits. (Unpublished study received Jun 15,
1969 under 9G0821; prepared by Medical College of Virginia,
Dept. of Pharmacology, submitted by Rohm & Haas Co., Philadel-
phia, Pa.; CDL:091422-I)
00098313 Vilkas, A.G.; Browne, A.M. (1980) The Acute Toxicity of Kerb Tech-
nical (No Clay) to the Water Flea Daphnia magna Straus: UCCES
Project No. 11506-33-43. (Unpublished study received Apr 1,
1982 under 707-159; prepared by Union Carbide Corp., submitted
by Rohm & Haas Co., Philadelphia, Pa.; CDL:247155-A)
~2~ 130
-------
OFFICE Oh PESTICIDE PROGRAMS
, .. „ GISIRATION STANDARD BIBLIUGHAPHY
tatTons Considered to be Part ot the Data Base Supporting
Registrations Under the P~onamide Standard
MR ID CITATION
00107196 McCann, J. (1971) Kerb 50-U: Bluegill: Test No. 325. (U.S.
Agricultural Research Service, Pesticides Regulation Div.,
Animal Biology Laboratory; unpublished study; CDL:130346-A)
00107949 Larson, P.; Borzelleca, J. (1970) Toxicologic Study on the Effect
of Adding RH-315 to the Diet of Beagle Dogs for a Period of Two
Years. (Unpublished study received Mar 12, 1971 under 1F1139;
prepared by Medical College of Virginia, Dept. of Pharmacology,
submitted by Rohm & Haas Co., Philadelphia, PA; CUL:090918-A)
00107953 Yih, R.; Swithenbank, C. (1970) Identification of Metabolites of
N-(l,l-dimethylpropynyl)-3,5-dichlorobenzamide in Soil and Al-
falfa. (Unpublished study received Mar 12, 1971 under 1F1139;
submitted by Rohm & Haas Co., Philadelphia, PA; CDL:U9U918-G)
00107954 Yi'h, R.; Swithenbank, C. (1970) Identification of Metabolites of
N-(l,l-dimethylpropynyl)-3,5-dichlorobenzamide in Rat and Cow
Urine and Rat Feces. (Unpublished study received Mar 12, 1971
under 1F1139; submitted by Rohm & Haas Co., Philadelphia, PA;
CDL:090918-H)
00107957 Rohm & Haas Co. (1971) Results of Tests on the Amount of Residue
Remaining in or on Lettuce and Related Cnops and Soil Including
a Description of the Analytical Method: Kerb. (Compilation;
unpublished study received Mar 11, 1971 under 1F1139; COL:
090917-A; 090916)
00107958 Rohm & Haas Co. (1969) Results of Tests on the Amount of Residues
Remaining on or in Crops, Animal Tissues, Milk, and Soil Inves-
tigated and the Analytical Methods Used: RH-315. (Compila-
tion; unpublished study received Jun 16, 1969 under 9G0821; CDL:
091423-A)
00107959 Rohm & Haas Co. (1970) Ke-b: 3,5-Dichloro-N-(1,1-dimethyl-2-propy-
nyl) Benzamide: Report on a Study To Determine Residue Levels in
Eggs and Tissues from Poultry Feed Kerb. (Compilation; unpub-
lished study received on unknown date under 9G0821; CDL:
091424-A)
00107960 Rohm & Haas Co. (1972) Results of Tests on the Amount of Residues
Remaining in the Treated Canefruit Crops; A Description of the
Analytical Method: Kerb 75-W. (Compilation; unpublished
study received May 15, 1973 under 3F1317; CDL:09212«-A)
-3-
13
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRAIIUN STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Pronamide Standard
MRID CITATION
00107961 Rohm & Haas Co. (1969) Residues ot RH-315 in Lettuce, Alfalfa
and Milk. (Compilation; unpublished study received Feb 17,
1971 under 1F1139; CDL:093447-A)
0010/965 Rohm & Haas Co. (1972) Results of Tests on the Amount of Residue
Remaining in or on Alfalfa, Clover, Crown Vetch, Sainfoin and
Trefoil (Birdsfoot), Including a Description ot the Analytical
Method: Kerb. (Compilation; unpublished study received Dec
20, 1972 under 3F1317; CDL:092250-A; 092252)
00107967 Rohm & Haas Co. (1974) Analytical Methods and Residues: Kerb.
(Compilation; unpublished study received Sep 9, 1974 under
5F1552; CDL:094214-A)
00107968 Smith, J. (1974) Eighteen Month Study on the Carcinogenic Potential
of Kerb (RH-315; Pronamide) in Mice. (Unpublished study re-
ceived Sep 16, 1974 under 3F1317; prepared in cooperation with
Medical College of Virginia, submitted by Rohm & Haas Co.,
Philadelphia, PA; CDL:094304-A)
0010/980 Rohm and Haas Co. (1973) A Study or the Hydrolysis ot the Herbicide
Kerb in Water: Laboratory 23 Technical Report No. 23-73-8. (Un-
published study received Apr 27, 1973 tinder 70/-113; CDL:
120314-A)
00107993 Shellenberger, T. (1971) Subacute Toxicity Evaluation of Kerb 3,5-
dichloro-N-(l,l-dimethyl-2-propynyl)-benzamide with Young Adult
Bobwhite Quail (A Seven Day Range Finding Study): GSRI Project
No. NC-501. (Unpublished study received May 16, 1972 under /O/-
98; prepared by Gulf South Research Institute, submitted by
Rohm & Haas Co., Philadelphia, PA; CDL:120402-N)
00107994 Shellenberger, T. (1971) A Subacute Toxicity and Tissue Residue
Study of Kerb 3,5-dichloro-N-(1 ,l-dimethyl-2-propynyl)-ben-
zamide Herbicide in Young Adult Bobwhite Quail: GSRI Project
No. NC-501. Final rept. (Unpublished study received May 16,
1972 under 707-98; prepared by Gulf South Research Institute,
submitted by Rohm & Haas Co., Philadelphia, PA; CUL:120402-0)
00107996 Binns, R.; Clark, G. (1969) The Acute Toxicity to Fish of An Exper-
imental Herbicide RH-315-75WP: 2932/69/358. (Unpublished study
received Jun 22, 1970 under 707-EX-63; prepared by Huntingdon
Research Centre, Eng., submitted by Rohm & Haas Co., Phila-
delphia, PA; CDL:123888-A)
-4-
132
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part ot the Data Base Supporting
Registrations Unde^ the Pronamide Standard
MRID CITATION
00107997 Robinson, D.; Shi I lam, K. (1969) Toxicity ot RH-315 to the Japanese
Quail and the Mallard Duck: 2839/69/265. (Unpublished study re-
ceived Jun 22, 1970 under 707-EX-63; prepared by Huntingdon
Research Centre, Eng.s submitted by Rohm & Haas Co.$ Phila-
delphia, PA; CDL:123888-B)
00108002 Fink, R. (1975) Eight-day Dietary LC50--MaI Iard Duck: Technical
Kerb: Project No. 129-107. Final rept. (Unpublished study re-
ceived Feb 25, 1977 under 707-98; prepared by Truslow Farms
Inc., submitted by Rohm & Haas Co., Philadelphia, PA; CDL:
233/23-A)
00108003 Fink, R. (1975) Eight-day Dietary LC50--Bobwhite Quail: Technical
Kerb: Project No. 129-106. Final rept. (Unpublished study re-
ceived Feb 25, 1977 under 707-98; prepared by Truslow Farms
Inc., submitted by Rohm & Haas Co., Philadelphia, PA; CDL:
233723-B)
00125382 Rohm & Haas Co. (1982) Kerb 50-W Herbicide Use on Artichokes.
(Compilation; unpublished study received Feb 4, 1983 under
707-159; CDL:249475-A)
00126574 WARF Institute, Inc. (1972) Report: WARF No. 2060619, (Unpub-
lished study received Apr 23, 19/4 under b38-115; submitted by
O.M. Scott & Sons Co., Marysville, OH; CDL:028337-B)
00133112 Powers, M. (19/0) Acute Oral--Rats/Draize Eye--Rabbits/Acute De~»
mal--Rabbits/Primary Skin--Rabbits/Acute Inhalation Exposure--
Rats: Kerb 50-W. Final rept. (Unpublished study received Feb
25, 1971 under 707-98; prepared by Hazleton Laboratories, Inc.,
submitted by Rohm & Haas Co., Philadelphia, PA; CDL:OU43b8-A)
00148064 Costlow, R.; Kane, W. (1985) Range-finding Teratology Study with
Kerb in Rabbits: Report No. 83R-025. Unpublished study prepared
by Rohm and Haas Co. 145 p.
1)0148065 Costlow, R.; Kane, W. (1985) Teratology Study with Kerb Technical
00148065 tostm ,^ ingred1ent) in Rabbits: Report No. 83R-026. Unpub-
lished'study prepared by Rohm and Haas Co. 151 p.
nm YTh R • Swlthenbank, C.; McRae, D. (1970) Transformation or
-U01 Tin, "'• N_(1 j.dimethyIpropyny1)-3,5-dichIorobenzarmde
soil. Weed SCI.' 18:604-607.
i n
•5-
13
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